
400 Professional Drive, ~~Gaithersburg , Maryland~~			~~20879~~Suite 400
(Address of Principal Executive Offices)
Gaithersburg	MD	20879
(City)	(State)	(Zip Code)

Registrant's Telephone Number, Including Area Code: (240) 631-3200

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common stock, $0.001 par value per share	EBS	New York Stock Exchange

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of Securities Act. Yes ý☒ No ☐

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ý

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.

See the definitions of "large accelerated filer," "accelerated filer," "non-accelerated filer", "smaller reporting company" and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check on):

Large accelerated filer ý☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to ~~section~~Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☒ No ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No 

☒

The aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant as of June 30, ~~2018~~2021 was approximately ~~$2.1~~$3.4 billion based on the price at which the registrant's common stock was last sold on that date as reported on the New York Stock Exchange.

As of February ~~15, 2019,~~18, 2022, the registrant had ~~51.2 million~~50,501,421 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant's definitive proxy statement for its ~~2019~~2022 annual meeting of stockholders scheduled to be held in May ~~2019,~~2022, which is expected to be filed with the Securities and Exchange Commission not later than 120 days after the end of the registrant's fiscal year ended December 31, ~~2018,~~2021, are incorporated by reference into Part II, Item 5. and Part III of this annual report on Form 10-K. With the exception of the portions of the registrant's definitive proxy statement for its ~~2019~~2022 annual meeting of stockholders that are expressly incorporated by reference into this annual report on Form 10-K, such proxy statement shall not be deemed filed as part of this annual report on Form 10-K.

EMERGENT BIOSOLUTIONS INC.

ANNUAL REPORT ON FORM 10-K

FOR THE FISCAL YEAR ENDED DECEMBER 31, ~~2018~~2021

TABLE OF CONTENTS

~~INDEX~~
			Page
PART I
	Item 1.	Business		3
	Item 1A.	Risk Factors		23
	Item 1B.	Unresolved Staff Comments		54
	Item 2.	Properties		55
	Item 3.	Legal Proceedings		55
	Item 4.	Mine Safety Disclosures		55
PART II
	Item 5.	Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities		56
	Item 6.	~~Selected Financial Data~~[Reserved]		56
	Item 7.	Management's Discussion and Analysis of Financial Condition and Results of Operations		57
	Item 7A.	Quantitative and Qualitative Disclosures About Market Risk		68
	Item 8.	Financial Statements and Supplementary Data		69
	Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		109
	Item 9A.	Controls and Procedures		109
	Item 9B.	Other Information		111
~~PART III~~ Item 9C.	D i sclosure Regarding Foreign Jurisdictions That Prevent Inspections		111
PART III
Item 10.	Directors, Executive Officers and Corporate Governance		112
	Item 11.	Executive Compensation		112
	Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		112
	Item 13.	Certain Relationships and Related Transactions, and Director Independence		112
	Item 14.	Principal Accountant Fees and Services		112
PART IV
	Item 15.	Exhibits and Financial Statement Schedules		112
Item 16.	~~Signatures~~Form 10-K Summary		113

Exhibit Index			114
Signatures			121

~~NOTE REGARDING COMPANY REFERENCES~~

~~References in this report to “Emergent,” the “Company,” “we,” “us,” and “our” refer to Emergent BioSolutions Inc. and its consolidated subsidiaries.~~

~~NOTE REGARDING TRADENAMES~~

BioThrax® (Anthrax Vaccine Adsorbed), RSDL® (Reactive Skin Decontamination Lotion Kit), BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)], Anthrasil® (Anthrax Immune Globulin Intravenous [human]), NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), VIGIV [Vaccinia Immune Globulin Intravenous (Human)], Trobigard™ (atropine sulfate, obidoxime chloride), ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live), Vivotif® (Typhoid Vaccine Live Oral Ty21a), Vaxchora® (Cholera Vaccine, Live, Oral), NARCAN® (naloxone HCI) Nasal Spray and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are the property of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This annual report on Form 10-K and the documents we incorporate by reference include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the future earnings and performance of Emergent BioSolutions Inc. or any of our businesses, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and the continued impact of the COVID-19 pandemic, are forward-looking statements. We generally identify forward-looking statements by using words like ~~“will,” “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates”~~"will," "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates" and similar expressions in conjunction with, among other things, discussions of financial performance or financial condition, growth strategy, product sales, manufacturing capabilities, product development, regulatory approvals or expenditures. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. You should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. You are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date on which such statement is made, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including, among others:

•the availability of U.S. Government (USG) funding for procurement of AV7909 (Anthrax vaccine adsorbed (AVA), adjuvanted) and/or BioThrax® (Anthrax Vaccine Adsorbed) or ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) and our other USG procurement and development contracts;

•our ability to meet our commitments to quality and manufacturing compliance at our manufacturing facilities, and the potential impact on our ability to continue production of bulk drug substance for Johnson & Johnson’s COVID-19 vaccine;

•the impact of a generic marketplace on NARCAN® (naloxone HCI) Nasal Spray and future NARCAN sales;

•our ability to perform under our contracts with the USG, including the timing of and specifications relating to deliveries;

•our ability to provide contract development and manufacturing (CDMO) services for the development and/or manufacture of product and/or product candidates of our customers at required levels and on required timelines;

•our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals and our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations;

•our ability to negotiate additional USG procurement or follow-on contracts for our Public Health Threat (PHT) products that have expired or will be expiring;

•the negotiation of further commitments or contracts related to the collaboration and deployment of capacity toward future commercial manufacturing under our CDMO contracts;

•the results of pending shareholder litigation and government investigations and their potential impact on our business;

•our ability to comply with the operating and financial covenants required by our senior secured credit facilities (Senior Secured Credit Facilities) and our 3.875% Senior Unsecured Notes due 2028;

•the procurement of products by USG entities under regulatory exemptions prior to approval by the U.S. Food and Drug Administration (FDA) and corresponding procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country;

•the full impact of COVID-19 disease (COVID-19) on our markets, operations and employees as well as those of our customers and suppliers;

•the impact on our revenues from and duration of declines in sales of our vaccine products that target travelers due to the reduction of international travel caused by the COVID-19 pandemic;

•our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria;

•the success of our commercialization, marketing and manufacturing capabilities and strategy; and

•the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.

~~appropriations for the procurement of BioThrax~~^® ~~(Anthrax Vaccine Adsorbed) and our other products addressing public health threats;~~

our ability to perform under our contracts with the U.S. government related to BioThrax, our NuThrax™ product candidate, and our other public health threat products, including the timing of and specifications relating to deliveries;

~~our ability to obtain Emergency Use Authorization pre-approval for NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) from the U.S. Food and Drug Administration, or FDA;~~

~~the availability of funding for our U.S. government grants and contracts;~~

~~our ability to secure follow-on procurement contracts for our public health threat products that are under procurement contracts that have expired or will be expiring;~~

~~our ability and the ability of our collaborators to protect our intellectual property rights;~~

~~our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria;~~

~~our ability to successfully integrate and realize the benefits of our acquisitions of PaxVax Holding Company Ltd. and Adapt Pharma Limited, both of which were acquired in October 2018;~~

our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement of development milestones, current development contracts with the U.S. government;

~~our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations;~~

~~the results of regulatory inspections;~~

~~the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facilities;~~

~~our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;~~

the procurement of products by U.S. government entities under regulatory exemptions prior to approval by the FDA and corresponding procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country;

~~the success of our commercialization, marketing and manufacturing capabilities and strategy; and~~

~~the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.~~

The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. New factors emerge from time to time and it is not possible for management to predict all such factors, nor can it assess the impact of any such factor on the business or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. You should consider this cautionary statement, the risk factors identified in the ~~section~~sections entitled “Risk Factor Summary” and “Risk Factors” in this annual report on Form 10-K and the risk factors identified in our other periodic reports filed with the Securities and Exchange Commission (SEC) when evaluating our forward-looking statements.

NOTE REGARDING COMPANY REFERENCES

References in this report to “Emergent,” the “Company,” “we,” “us,” and “our” refer to Emergent BioSolutions Inc. and its consolidated subsidiaries.

NOTE REGARDING TRADENAMES

Emergent®, BioThrax®, BaciThrax®,RSDL®, BAT®, Trobigard®, Anthrasil® , CNJ-016®, ACAM2000®, Vivotif®, Vaxchora®, NARCAN® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are the property of their respective owners.

PART I

ITEM 1.BUSINESS

~~OVERVIEW~~

~~Emergent BioSolutions Inc. is~~OVERVIEW

We are a global life sciences company focused on providing ~~to civilian and military populations a portfolio of~~ innovative preparedness and response ~~products and~~ solutions ~~that address~~addressing accidental, deliberate and naturally occurring public health threats ~~(“PHTs,” each~~(PHTs). Our solutions include a ~~“PHT”). We were incorporated in the State~~product portfolio, a product development portfolio, and a CDMO services portfolio. The types of ~~Michigan in May 1998 and subsequently reorganized as a Delaware corporation in June 2004.~~

WePHTs we are currently addressing are focused on the following ~~four distinct PHT~~five categories: ~~Chemical, Biological, Radiological, Nuclear~~

•chemical, biological, radiological, nuclear and ~~Explosives (“CBRNE”)~~explosives (CBRNE);

•emerging infectious diseases ~~(“EID”)~~(EID);

•travel health;

•public health crises (such as the opioid crisis and the COVID-19 pandemic); ~~travelers’ diseases;~~and

•acute, emergency, and ~~opioids. We have~~community care.

Our revenues are derived from a combination of the sale and procurement of our product/product candidate portfolio (described below), the provision of our CDMO services to external customers, and the securing of non-dilutive contract and grant funding for research and development (R&D) projects by us from various third-party sources.

OUR BUSINESS LINES

In the fourth quarter of 2021, we reorganized our operating structure such that we now operate under three separate business lines, each focused on distinct customer or market types. These three business lines are:

•the Government - Medical Countermeasures (MCM) business line;

•the Commercial business line; and

•the Services - CDMO business line.

In connection with the reorganization, we also centralized our R&D organization and established an enterprise-wide governance approach to managing our portfolio of ~~eleven~~R&D projects.

Government - MCM Business Line

Our Government - MCM business line focuses primarily on procurement of MCM products ~~(vaccines, antibody therapeutics,~~ and ~~drug-device combination products) that generate a majority of~~procured product candidates by domestic and international government customers, with an emphasis on the USG, who is our ~~revenue.~~largest customer. We also ~~have a development pipeline consisting of a diversified mix of both pre-clinical~~sell MCM products and ~~clinical stage~~procured product candidates ~~(vaccines, antibody therapeutics,~~to domestic and ~~drug-device combination products). Finally, we also have a fully-integrated~~international non-government organizations and governments outside of the United States.

Commercial Business Line

Our Commercial business line primarily focuses on sales of NARCAN®(naloxone HCI) Nasal Spray and our travelers' vaccines. NARCAN® is sold commercially through physician-directed or standing order prescriptions at retail pharmacies and to state and local governments and first responders including police, firefighters and emergency medical teams. Our travelers' vaccines include Vaxchora® and Vivotif®, which are approved for use in the United States and other territories, and are sold primarily to private travel clinics, retail pharmacies and integrated hospital networks.

Services - CDMO Business Line

Our portfolio of ~~contract~~CDMO services consists of three distinct but interrelated service pillars: development services (process and analytical development); drug substance manufacturing; and drug product manufacturing (fill/finish). These services, which we collectively refer to as a “molecule-to-market” offering, employ diverse technology platforms (mammalian, microbial, viral and plasma across a network of development and manufacturing sites operated by us. These CDMO services support all phases of the drug development life cycle, from pre-clinical development programs through commercial manufacturing of approved pharmaceutical products. The customer base for CDMO services is primarily innovators in the biotechnology and pharmaceutical segments, but also includes government sponsored entities as well as non-governmental organizations (NGOs).

OUR STRATEGY

Our ongoing five-year strategic plan, 2020-2024, is focused on leveraging core competencies, relationships and operating systems we have developed over the last 23 years and driving growth across various segments of the PHT market. The strategic plan specifies employing five core strategies. They are:

Execute Core Business — We are focused on continuing to build our leadership positions across several markets in the PHT space. These include, but are not limited to, MCMs, opioid rescue and travel health. Additionally, our Core Business includes our growing CDMO services. ~~The U.S.~~We believe our diversified portfolio of products and services, combined with our quality development and manufacturing services across a spectrum of differentiated and complex manufacturing processes position us for continued growth across the PHT landscape. Additionally, we will continue to leverage our specialized government ~~(the “USG”) is~~relations and contracting operations to negotiate long-term, profitable procurement and development agreements that enable us to protect and enhance lives around the ~~largest purchaser~~world and that help ensure sustainability of our ~~products~~business.

Grow Through Mergers and ~~provides~~Acquisitions (M&A) — We have successfully executed and integrated several product and facility acquisitions that have increased our diversification, allowed expansion into new markets, and provided a differentiated R&D pipeline. We plan to continue to leverage our M&A and partnering strengths not only to solidify our leadership positions in the MCM market, but also to expand our businesses in PHT markets where the government is not the primary customer. We aim to accomplish this goal through a disciplined approach to acquiring accretive or clinical-stage assets and to forming partnerships that help us ~~with substantial funding for the development of a number of~~to achieve our ~~product candidates.~~strategic objectives.

Strengthen R&D Portfolio — We continue to ~~pursue acquiring~~focus on expanding and advancing our pipeline of vaccines and therapeutic product candidates, with the aim of developing ~~products and solutions that provide an opportunity to serve both government customers and commercial (non-government) customers (“Dual Market”).~~

~~STRATEGY~~

~~Our strategy is centered on our core business of addressing PHTs. This strategy contemplates that we:~~

·	~~Continue to leverage and expand our leadership position in the PHT market, now further expanded to encompass the opioid and travelers’ markets as well as the CBRNE and EID markets;~~

·	~~Grow through the acquisition of products and businesses, particularly those that are revenue-generating and accretive;~~

·	~~Develop and manufacture innovative products and solutions, particularly with funding from governments and non-governmental organizations to defray research and development costs;~~

·	~~Focus on globalization and related international commercial capabilities; and~~

·	~~Diversify our product mix to include products that have Dual Market potential.~~

~~In executing on our strategy, we are leveraging our core competencies. These competencies~~ ~~include~~:

·	~~Unique and valuable commercial and government solutions for PHTs through formation of public-private partnerships;~~

·	~~Quality manufacturing across a spectrum of specialized and complex manufacturing processes, using multiple platform technologies;~~

·	~~Specialized government relations and contracting operations to support our government contracting business;~~

·	~~Successful completion of business and product acquisitions; and~~

·	~~Financial discipline driven by a prudent capital allocation strategy focused on generating positive returns on invested capital.~~

~~GROWTH THROUGH ACQUISITIONS AND COLLABORATIONS~~

We have a track record of growth through the acquisition of revenue-generating and accretive products and businesses. Our goal is to continue our expansion through targeted acquisitions of (1) government-procured products; (2) Dual-Market product opportunities, which aredifferentiated products that ~~have~~address unmet needs in the PHT space. We fund our pipeline by investing our own funds and through securing government contracts, grants, or other non-dilutive funding. We plan to grow our R&D pipeline to expand our portfolio of marketed and procured PHT products.

Build Scalable Capabilities — Achieving our 2024 strategic objectives requires an investment in infrastructure, internal governance and capabilities that help us realize the benefits of scale. This includes investing new capital into our development and manufacturing facilities, strengthening our global sales and procurement models, upgrading our technology and growing our commercial infrastructure. These, and other capabilities, are intended to help us operate in a more efficient, customer-focused manner, while better serving both government and non-government ~~/ commercial market potential; and (3) products that~~customers.

Evolve the Culture --- We are ~~purely commercial in nature, but would leverage our core competencies in a unique way. Below is a summary~~proud of our ~~significant acquisitions, transactions~~heritage and ~~collaborations.~~

~~Adapt Pharma Limited~~

~~On October 15, 2018,~~the organization we ~~completed~~have built, and further believe that the ~~acquisition~~growth we are striving for requires continued improvement and refinement of ~~Adapt Pharma Limited (“Adapt”), and its NARCAN® (naloxone HCl) Nasal Spray marketed product,~~ the ~~first and only needle-free formulation~~culture of ~~naloxone approved by~~ the Food and Drug Administration (“FDA”), and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. This acquisition includes the NARCAN® Nasal Spray marketed product and a development pipeline of new treatment and delivery optionsorganization. We anticipate continuing to ~~address opioid overdose, and approximately 50 employees, located~~invest in the ~~U.S., Canada,~~development of our people and ~~Ireland, including those responsible for supply chain management, research~~our culture consistent with our values. We are committed to attracting, developing, and retaining the best talent reflecting a diversity of ideas, backgrounds, and perspectives and seek to demonstrate that commitment through our talent development ~~government affairs,~~strategy, processes and ~~commercial operations.~~company-wide programs.

~~We paid approximately $581.5 million~~Assuming successful execution of this strategic plan, we anticipate total revenue in ~~cash~~2024 of at ~~the closing (inclusive~~least $2 billion and an adjusted EBITDA margin1 in 2024 of ~~closing adjustments) and issued 733,309 shares of Common Stock, based on the volume-weighted average price per share of the Common Stock~~27-30%.

1 Adjusted EBITDA Margin is equal to Adjusted EBITDA divided by total revenue. Adjusted EBITDA is defined as ~~reported on the New York Stock Exchange for the ten-trading day period ending two days~~net income before closing, or $65.28 per share (an aggregate total of $47.9 million, inclusive of adjustments). The remaining consideration payable for the acquisition consists of up to $100 million in cash based on the achievement of certain sales milestones through 2022. The Company funded the cash portion of the payments made at closing using a combination of cash-on-hand and borrowings under its Amended Credit Agreement, as described in the ~~Long-term debt~~ ~~section below.~~

~~PaxVax Holding Company Ltd.~~

On October 4, 2018, we completed the acquisition of PaxVax Holding Company Ltd. (“PaxVax”), a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. This acquisition includes Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever, Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, an adenovirus 4/7 vaccine candidate being developed for military personnel under contract with the U.S. Department of Defense (“DoD”) and additional clinical-stage vaccine candidates targeting chikungunyainterest, taxes, depreciation, amortization and other ~~emerging infectious diseases, European-based~~specified items that can be highly variable or difficult to predict or to reflect the non-cash impact of charges or accounting changes.

PRIMARY PRODUCTS AND PRODUCT CANDIDATES

Government - MCM Business Line Products

The current good manufacturing practices (“cGMP”) biologics manufacturing facilities, and approximately 250 employees including those in research and development, manufacturing, and commercial operations with a specialty vaccines salesforce in the U.S. and in select European countries.

~~At the closing, we paid a cash purchase price of $273.1 million~~ ~~(inclusive of closing adjustments), using a combination of cash-on-hand and borrowings under our senior secured credit agreement.~~

~~ACAM2000~~

~~In October 2017, we completed the acquisition of the ACAM2000~~^® (Smallpox (Vaccinia) Vaccine, Live) business of Sanofi Pasteur Biologics, LLC. This acquisition included ACAM2000, the only smallpox vaccine licensed by the FDA, a licensed, live-viral manufacturing facility and office and warehouse space, both in Canton, Massachusetts (for which we received FDA manufacturing approval for the transfer of the upstream portion of the manufacturing process of ACAM2000 in November 2017), and a live-viral fill/finish facility in Rockville, Maryland. With this acquisition, we also acquired a 10-year contract with the Centers for Disease Control and Prevention (“CDC”), which expired in March 2018. This contract was originally valued at up to $425 million, and upon acquisition had a remaining value at acquisition of up to approximately $160 million, reflecting the value of doses of ACAM2000 remaining to be delivered to the U.S. Strategic National Stockpile (“SNS”). As of December 31, 2018, there remains a portion of doses still to be delivered to the SNS under the current BARDA procurement contract. We expect to complete deliveries of such doses in 2019. We are negotiating a new multi-year contract with the Assistant Secretary for Preparedness and Response (“ASPR”) to deliver additional doses into the SNS.

Total consideration for this acquisition was $125 million. At closing, we paid $117.5 million in cash. The agreement also included an additional cash milestone payment of $7.5 million based upon FDA approval of the Canton facility for the manufacturing of ACAM2000. This regulatory milestone was achieved based on such approval in November 2017 and paid in cash in the fourth quarter of 2017.

~~raxibacumab~~

In October 2017, we completed the acquisition from Human Genome Sciences, Inc. and GlaxoSmithKline LLC, collectively GSK, of raxibacumab, the first fully-human monoclonal antibody product licensed by the FDA for the treatment and prophylaxis of inhalational anthrax. Total consideration for this acquisition was up to $96 million. At closing, we paid $76 million in cash. The agreement also included up to $20 million in future cash payments tied to product sales and manufacturing-related milestones. As of December 31, 2018, the milestones had not yet been achieved. With the acquisition, we assumed responsibility for a multi-year contract with the Biomedical Advanced Research and Development Authority (“BARDA”) with a remaining value at acquisition of up to approximately $130 million, to supply raxibacumab to the SNS through November 2019. We are currently in the process of pursuing FDA licensure for the transfer of bulk manufacturing of raxibacumab to our Bayview facility and the fill/finish process to our Camden facility, and under the terms of the acquisition agreements we will purchase product from GSK to enable completion of deliveries to the SNS under the current BARDA procurement contract.

~~Spin-Off of Biosciences Business~~

~~In August 2016, we completed a tax-free spin-off~~portfolio of our ~~former biosciences~~Government - MCM business into a separate, stand-alone publicly-traded company, Aptevo Therapeutics Inc. (“Aptevo”). As part of the spin-off transaction, the assets that were a part of our former biosciences business segment were transferred to Aptevo. These assets included our former biosciences commercial products IXINITY [coagulation factor IX (recombinant)], WinRho^® ~~SDF [(Rh~~_o~~(D) Immune Globulin Intravenous (Human)], HepaGam B~~^® ~~[Hepatitis B Immune Globulin Intravenous (Human)] and VARIZIG~~^® ~~[Varicella Zoster Immune Globulin (Human)], as well as our former oncology and hematology therapeutics development assets and platforms.~~

~~Cangene Corporation~~

In February 2014, we acquired Cangene Corporation, which included the following products: BAT® for the treatment of botulism; Anthrasil for the treatment of anthrax infection; and VIGIV for the treatment of adverse reactions to vaccinia virus vaccinations. The acquisition also included a hyperimmune technology platform as part of a manufacturing site in Winnipeg, Manitoba, Canada (our Winnipeg site), and which is used to manufacture the BAT, Anthrasil and VIGIV products. We also acquired Cangene's fill/finish contract manufacturing services business in Baltimore, Maryland (our Camden facility), including agreements with customers to fill/finish a number of commercial and clinical-stage products worldwide.

~~Other Acquisitions and Collaborations~~

~~In recent years, we have also entered into the following other transactions.~~

·	In August 2018, our collaboration with the Coalition for Epidemic Preparedness Innovations (“CEPI”) and Profectus BioSciences, Inc. (“Profectus”), under which we intend to advance the development and manufacture of a vaccine against the Lassa virus;

·	In November 2017, our agreement with Profectus to have the option to license multiple vector vaccine product candidates, including those for Nipah, and viral hemorrhagic fevers caused by Ebola, Marburg and Lassa viruses;

In July 2017, our collaboration with Southwest Research Institute, an independent, nonprofit applied research and development organization headquartered in San Antonio, Texas, under which we are developing an intra-nasal spray device for the treatment of known or suspected acute cyanide poisoning; and

·	~~In December 2015, our acquisition of Unither Virology LLC, which held a broad family of iminosugar small molecules that have activity against a variety of enveloped viruses.~~

~~OUR BUSINESS UNITS~~

~~We are organized into four business units: Vaccines and Anti-Infectives; Devices; Antibody Therapeutics; and Contract Development and Manufacturing.~~

~~Vaccines and Anti-Infectives~~

~~Products~~

~~Our Vaccines and Anti-Infectives business unit contains a portfolio of specialty vaccines and unique anti-infectives that address existing and emerging PHTs. The current portfolio~~line consists of the following ~~products.~~products:

~~VACCINES AND~~ ~~ANTI-INFECTIVES UNIT~~
GOVERNMENT - MCM PRODUCTS
Product			Indication(s)		Regulatory Approvals
~~Product~~			~~Indication(s)~~	~~Regulatory Approvals~~
~~BioThrax~~^ACAM2000® ~~(Anthrax Vaccine Adsorbed)~~	~~GUP - General use prophylaxis of anthrax disease; and~~ ~~PEP - Post-exposure prophylaxis of anthrax disease in combination with appropriate antibacterial drugs.~~	~~United States, Germany, Singapore, UK, Germany, Netherlands, France, Poland, Italy and Canada.~~
~~ACAM2000~~^® ~~(Smallpox~~, (Smallpox (Vaccinia) Vaccine, Live)	~~Vaccination~~Vaccine for active immunization against smallpox disease for persons determined to be at high risk for ~~smallpox.~~smallpox infection.			United States, Australia, Singapore
~~Vaxchora®~~Anthrasil® [Anthrax Immune Globulin Intravenous (Human)]			Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.		United States, Canada
BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)]			Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.		United States, Canada, Ukraine, Singapore
BioThrax® (~~Cholera~~Anthrax Vaccine ~~Live Oral)~~Adsorbed)			~~Oral vaccine~~ Vaccine for active immunization for the prevention of ~~cholera.~~		~~United States~~
~~Vivotif®~~disease caused by Bacillus anthracis in persons 18 through 65 years of age. BioThrax is approved for: ~~(Typhoid Vaccine Live Oral Ty21a)~~	~~Oral vaccine for the prevention~~1.Pre-exposure prophylaxis of ~~typhoid fever.~~ disease in persons at high risk of exposure. 2.Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.	United States, Canada, France (where it is known as BaciThrax®), Germany, Italy, the Netherlands, Poland, Singapore and UK
Raxibacumab injection, a fully human monoclonal antibody			Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.		United States
RSDL® (Reactive Skin Decontamination Lotion Kit)			Intended to remove or neutralize chemical warfare agents and T-2 Toxin from the skin.		United States (510k), Australia, New Zealand, Singapore, South Korea, Hong Kong, Malaysia, UK, France, Italy, Portugal, Spain, Switzerland, Belgium, Luxembourg, The Netherlands, Germany, Austria, Norway, Denmark, Finland, Sweden, The Czech Republic, SlovakiaCanada, European Union and Israel
Trobigard® atropine sulfate, obidoxime chloride auto-injector			Indicated for the emergency treatment of known or suspected exposure to nerve agents or toxic organophosphates in adults > 18 years of age.		Belgium*
VIGIV CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)]			Treatment of complications due to vaccinia vaccination, including: •Eczema vaccinatum •Progressive vaccinia; •Severe generalized vaccinia; •Vaccinia infections in individuals who have skin conditions; and •Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis). VIGIV is not indicated for postvaccinial encephalitis.		United States, Canada
*TROBIGARD is not approved by the FDA. It is only approved by the Belgian Health Authority but has been procured by various government buyers under special circumstances.

~~BioThrax~~^®~~(Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the FDA for the general use prophylaxis (“GUP”),~~

Description of anthrax disease. In April 2014, the FDA granted orphan drug designation to BioThrax for the post-exposure prophylaxis (“PEP”), indication, (please see “Regulation – Marketing Approval – Biologics, Drugs and Vaccines– Orphan Drugs”), giving it market exclusivity in the United States until November 2022. In November 2015, the FDA approved our supplemental Biologics License Application (“BLA”), to expand the BioThrax label to include the PEP indication for BioThrax administered in combination with antimicrobial therapy. Anthrax is a potentially fatal disease caused by the spore forming bacterium, ~~Bacillus anthracis.~~ Inhalational anthrax is the most lethal form of anthrax. Death due to inhalational anthrax infection often occurs within 24-36 hours of the onset of advanced respiratory complications. In the U.S., BioThrax is administered in a GUP setting by intramuscular injection in a three-dose primary series over an initial six-month period. The vaccine is protective after completion of this three-dose primary series. After the primary series, two additional doses are given one each at 12 and 18 months, with booster doses annually thereafter. BioThrax is administered in a PEP setting in conjunction with recommended antibacterial drugs following suspected or confirmed ~~Bacillus anthracis~~ exposure. The vaccination schedule for PEP consists of three doses of BioThrax administered subcutaneously at 0, 2- and 4-weeks post-exposure combined with antimicrobial therapy. In December 2016, we signed a follow-on contract with the CDC, an agency within the U.S. Department of Health and Human Services (“HHS”) for the supply of up to approximately 29.4 million doses of BioThrax for delivery into the SNS, over a five-year period ending in September 2021. The potential value of this contract is approximately $911 million, if all procurement options are exercised. In March 2017, we entered into an additional contract with BARDA, originally valued at up to $100 million, for the delivery of BioThrax to the SNS, over a two-year period of performance. We completed deliveries under this contract in 2017.MCM Products

In August 2016, the FDA licensed Building 55, our large-scale manufacturing facility in Lansing, Michigan, for the manufacture of BioThrax. This facility has the potential to manufacture up to 20 to 25 million doses of BioThrax annually.

ACAM2000^® ~~(Smallpox (Vaccinia) Vaccine, Live)~~.ACAM2000 is ~~the only~~a smallpox vaccine licensed by the FDA and is the primary smallpox vaccine designated for use in a bioterrorism ~~emergency, with more than 230 million doses having been supplied to the SNS.~~emergency. ACAM2000 is also licensed in Australia and Singapore and is currently stockpiled both in the United States and internationally.Smallpox is a highly contagious disease caused by the ~~variola virus, a member of the orthopox virus family.~~Variola virus. According to the ~~CDC,~~Centers for Disease Control and Prevention (CDC), it is one of the most devastating diseases with a mortality rate as high as 30%. ~~ACAM2000 is administered by percutaneous route in one dose with a bifurcated needle using the multiple puncture method.~~ The vaccine stimulates a person's immune system to develop antibodies and cells in the blood and elsewhere that can then help the body fight off a smallpox infection if exposure to smallpox occurs. ~~Upon~~

On September 3, 2019, we announced the ~~closing~~award by the USG of ~~the ACAM2000 acquisition, we acquired~~ a ~~10-year CDC contract, which expired in March 2018. The original~~ contract valued at up to ~~$425 million, called~~approximately $2 billion over 10 years for the ~~delivery~~continued supply of ACAM2000 into the Strategic National Stockpile (SNS), assuming all contract options are exercised. This multiple-year contract is intended to support the ~~SNS~~replacement of the smallpox vaccine stockpile and ~~establishing U.S.-based manufacturing~~included a one-year base period of performance in 2019 valued at approximately $170 million, and nine option years. The number of doses under the base period were delivered by year end 2019. On May 28, 2020, we announced the exercise by the U.S. Department of Health and Human Services (HHS) of the first contract option, valued at $176 million, to procure doses of ACAM2000. The number of doses under the first contract option were delivered by year end 2020. On July 13, 2021, we announced the exercise by HHS of the second contract option, valued at $182.2 million, to procure doses of ACAM2000. The actual number of ACAM2000 ~~specifically~~doses to be procured in the ~~transfer of the upstream portion of the ACAM2000 production process from Austria to a U.S.-based manufacturing facility. This technology transfer was completed~~future is dependent on certain timing and ~~approved by the FDA in November 2017 and we~~tiered-pricing terms that are ~~continuing to make deliveries under the prior contract. At acquisition, there was $160 million of remaining value on the prior contract~~ subject to the ~~availability~~discretion of ~~government funding, and we expect to fulfill~~HHS.

Anthrasil®. Anthrasil is the ~~remaining product deliveries to the SNS in the first half of 2019. We are negotiating a new multi-year contract with ASPR to deliver additional doses into the SNS.~~

~~Vaxchora®. (Cholera Vaccine Live Oral) Vaxchora is a live attenuated cholera vaccine for oral administration and the first vaccine approved~~only polyclonal antibody therapeutic licensed by the FDA for the ~~prevention~~treatment of ~~cholera infection. Cholera, a potentially life-threatening bacterial infection~~inhalational anthrax. Anthrasil is licensed by the FDA for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. Anthrasil also received orphan drug designation for that ~~occurs~~indication, resulting in market exclusivity in the ~~intestines and causes severe diarrhea and dehydration, has~~United States until March 2022. We currently have two contracts with HHS: a low incidence in the U.S., but a high incidence in Africa, Southeast Asia, and other locations around the world. These areas draw travelers from the U.S., so cholera can occur in patients who return to the U.S. from visits to these regions. Vaxchora is indicated for active immunization against cholera caused by the bacterium ~~V. cholerae~~ ~~serogroup O1. Vaxchora is approved for use in patients 18–64 years of age who are traveling to known cholera-infected areas.~~

~~Vivotif~~®. (Typhoid Vaccine Live Oral Ty21a) Vivotif is a live attenuated vaccine for oral administration to prevent typhoid fever. The vaccine contains the attenuated strain Salmonella typhi Ty21a (1,2). Typhoid fever is a potentially severe and occasionally life-threatening febrile illness caused by Salmonella enterica serotype Typhi (S Typhi), a bacterium that only lives in humans. It is usually acquired by consumption of water or food that has been contaminated by feces of an infected person. Typhoid fever is uncommon in North America and Europe. However, travelers from North America and Europe going to Asia, Africa, and Latin America have been particularly at risk. Even short-term travel to high-incidence areas is associated with risk for typhoid fever. In the U.S., Vivotif is indicated for immunization of adults and children greater than 6 years of age against disease caused by S Typhi.

~~Product Candidates~~

~~The chart below highlights our primary Vaccines and Anti-infectives product candidates.~~

~~Product Candidate~~	~~Partner~~	~~Platform~~	~~Threat Type~~
~~NuThrax™~~ ~~Next generation anthrax vaccine~~	~~HHS - BARDA~~	~~Vaccine~~	~~Biological~~
~~CHIKUNGUNYA~~ ~~Chikungunya VLP vaccine~~	--	~~Vaccine~~	~~EID~~
~~ADENOVIRUS 4/7~~ ~~Live, attenuated vaccine~~	~~DoD - USAMRAA~~	~~Vaccine~~	~~EID~~
~~rVSV-Lassa~~ ~~Vaccine for prevention of Lassa fever~~	~~CEPI~~	~~Vaccine~~	~~EID~~
~~rVSV-Marburg~~ ~~Vaccine for prevention of Marburg hemorrhagic fever~~	--	~~Vaccine~~	~~Biological~~
~~rVSV-Sudan~~ ~~Vaccine for prevention of Sudan hemorrhagic fever~~	--	~~Vaccine~~	~~Biological~~
~~rVSV-QUAD~~ ~~Vaccine for prevention of hemorrhagic fever caused by infection with Lassa, Ebola, Sudan or Marburg virus~~	~~NIAID (to Profectus)~~	~~Vaccine~~	~~Biological~~
~~rVSV-Ebola~~ ~~Vaccine for prevention of Ebola hemorrhagic fever~~	--	~~Vaccine~~	~~Biological~~

~~NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant)~~. We are developing NuThrax, an anthrax vaccine product candidate based on BioThrax combined with CPG 7909, an adjuvant that we license from Pfizer Inc. We are developing NuThrax, in part with funding from the National Institute of Allergy and Infectious Diseases (“NIAID”) and BARDA, to potentially elicit a more rapid onset of immune response using fewer doses than BioThrax while still providing protective immunity in patients. Using funds from our 2010 development contract with NIAID, in October 2014, we completed a Phase 2 safety, immunogenicity and dose ranging clinical trial of NuThrax in which all endpoints were successfully met, including requiring a two-dose regimen, versus the BioThrax three-dose regimen, which may shorten the recommended antibiotic (60-day) regimen for anthrax post-exposure prophylaxis. In September 2014, we also obtained additional funding through a five-year development contract with NIAID of up to $29 million to support the development of a dry formulation of NuThrax, including: assay development and non-clinical activities through the preparation of an Investigational New Drug (“IND”) application to the FDA. The dry formulation of NuThrax is intended to increase stability of the vaccine candidate at ambient and higher temperatures, with the objective of eliminating the need for cold chain during shipping and storage. In March 2015, we signed a development contract with BARDA valued at $31 million to develop NuThrax for post-exposure prophylaxis of anthrax disease. In September 2016, we signed a combination development and procurement contract ~~with BARDA~~that expires in September 2023, and a multiple award, indefinite delivery/indefinite quantity contract for ~~up to approximately $1.5 billion, including a five-year base period~~the collection of ~~performance valued initially at approximately $200 million to develop NuThrax for post-exposure prophylaxis~~anti-anthrax plasma, as well as the manufacture of ~~anthrax disease~~such plasma into bulk drug substance and to deliver to the SNS an initial two million doses, subsequently modified to three million doses in March 2017, following Emergency Use Authorization (“EUA”) pre-approval by the FDA. We applied for EUA in the fourth quarter of 2018finished drug product and ~~although there can be no assurances, we anticipate that the FDA could grant EUA designation to NuThrax as early as this year, triggering the initial three million dose~~ delivery of ~~NuThrax~~finished product into the ~~SNS in 2019. The~~SNS. This contract ~~also includes procurement~~covers extended plasma storage, and the options for ~~the~~manufacturing and product delivery, of an additional 7.5 million to 50 million doses of NuThrax into the SNS, valued from approximately $255 million to up to $1.3 billion, respectively, and options for an additional clinical study and post-marketing commitments valued at $48 million, which ~~if all were~~are available to be exercised ~~in full, could increase the total contract value~~by HHS through September 2023. In addition to ~~approximately $1.5 billion. See “Management’s Discussion and Analysis of Financial Conditions and Results of Operations~~ – ~~Overview – Highlights and Business Accomplishments for 2018”~~ ~~for additional details.~~domestic,

~~Chikungunya.~~ We licensed the chikungunya virus (“CHKV”), a virus-like particle (“VLP”), vaccine product candidate from the Vaccine Research Center ("VRC") at the National Institutes of Health ("NIH"). VLPs for alphaviruses are comparable to the physical structure of the native virus, and contain repetitive, high density displays of viral surface proteins that present conformational viral epitopes that elicit strong B- and T-cell immune responses. Since VLPs cannot replicate, they provide a safer alternative to attenuated and inactivated vaccines throughout production and use and can be administered in unrestricted target populations. VRC has previously demonstrated in this product candidate both nonclinical and clinical (Phase 1) safety, immunogenicity and efficacy data. A key passive transfer study demonstrated that mice dosed with purified antibody from VLP-immunized NHPs were protected from an otherwise lethal CHKV infection. We established and scaled a CHKV cGMP production process at our facilities in San Diego, California. A Phase 1 trial demonstrated that the vaccine elicits anti-CHKV neutralizing antibody responses in humans significantly above the level believed to be protective in the passive transfer study. Two Phase 2 safety and immunogenicity trials are currently ongoing. The NIH has sponsored a Phase 2 trial at multiple endemic sites in the Caribbean. The study is a double-blind, placebo-controlled study with 200 subjects, which was initiated in 2016. The subjects are currently being followed for safety, immunogenicity and efficacy. As of August 2018, we have completed enrollment of the Phase 2 study. The primary objectives are to assess safety and anti-CHKV neutralizing antibody responses with different doses, different formulations and different dosing schedules. The study will also assess duration of neutralizing antibody responses induced by different formulations and schedules. Upcoming development activities include Phase 3 development, including process validation and manufacture, Phase 3 clinical studies in the U.S. and CHKV endemic areas, supportive nonclinical toxicity and efficacy studies, and a BLA submission. Collectively, these studies are intended to provide clinical and regulatory data for U.S. licensure and possible World Health Organization prequalification.

~~Adenovirus 4/7.~~ In 2014, we formed a partnership with the DoD to modernize the production of the Adenovirus vaccine (“ADVV-MP”). An IND application for a new ADVV-MP was submitted to the FDA on January 30, 2017 and a Phase 1 studyUSG sales, Anthrasil has been ~~completed that demonstrates high seroconversion rates for Ad 7, indicating vaccine efficacy. Further development activities of~~sold to several foreign governments, including the ~~ADVV-MP will be dependent upon a continued partnership with the DoD and subject to government funding.~~Canadian government.

~~rVSV-VHF (vector vaccines for hemorrhagic fever)~~BAT®. In November 2017, we entered into an agreement with Profectus to have the option to license multiple vector vaccine product candidates, including those for Nipah, and viral hemorrhagic fevers caused by Ebola, Marburg and Lassa viruses. In April 2018, we exercised our development license for rVSV-Marburg and rVSV-Quad vaccines. In October 2018, we exercised our development rights to rVSV-Lassa, rVSV-Ebola and rVSV-Sudan. The rVSV-Quad vaccine development is currently being funded by a contract award to Profectus from the NIAID under which we are performing manufacturing activities.

In August 2018, CEPI announced a collaboration with us and Profectus, under which the parties may receive up to $36 million to advance the development and manufacture of a vaccine against the Lassa virus. Lassa virus infection—a single-stranded RNA virus belonging to the family Arenaviridae—can cause the acute viral hemorrhagic illness known as Lassa fever. The virus is spread to humans via contact with food or household items that have been contaminated with urine or feces from ~~Mastomys~~ rats. Under the terms of the Framework Partnering Agreement for the collaboration among the three parties, Profectus will receive development funding from CEPI for advancing its Lassa virus vaccine. CEPI will provide $4.3 million to support the first phase of the project, with options to invest up to a total of $36 million over five years, including procurement of the vaccine for stockpiling purposes. We will provide technical and manufacturing support for the CEPI-funded program. Through our agreement executed with Profectus in October 2018, we have exercised the option to license and to assume control of development activities for the rVSV-Lassa vaccine from Profectus.

~~Below is a brief description of the primary rVSV-VHF candidates.~~

·	~~rVSV-Lassa, a recombinant vesicular stomatitis virus vectored vaccine for prevention of Lassa fever;~~

·	~~rVSV-Marburg, a recombinant vesicular stomatitis virus vectored vaccine for prevention of viral hemorrhagic fever caused by infection with Marburgvirus;~~

·	~~rVSV-Ebola, a recombinant vesicular stomatitis virus vectored vaccine for prevention of viral hemorrhagic fever caused by infection with~~ ~~Zaire ebolaviruses~~;

·	~~rVSV-Sudan, a recombinant vesicular stomatitis virus vectored vaccine for prevention of viral hemorrhagic fever caused by infection with Sudan Ebolavirus; and~~

·	~~rVSV-QUAD, a recombinant vesicular stomatitis virus vectored vaccine for prevention of hemorrhagic fever caused by infection with Lassa, Ebola, Marburg or Sudan virus infections.~~

~~Our Vaccines and Anti-Infectives business unit~~ ~~has other product candidates addressing PHTs, including influenza, anti-bacterials, and antivirals, among others.~~

~~Devices~~

~~Products~~

Our Devices business unit contains a broad portfolio of drug-device combination products that incorporate convergent technologies that enable both governments and patients (Dual Market) opportunities to address PHTs and challenging life-threatening conditions. The current portfolio consists of the following drug-device combination products.

~~DEVICES UNIT~~
~~Product~~	~~Indication(s)~~	~~Regulatory Approvals~~
~~NARCAN® (naloxone HCl)Nasal Spray~~	~~Emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression~~	·~~United States~~ ·~~Canada~~
~~RSDL~~^® ~~(Reactive Skin Decontamination Lotion Kit)~~	~~Removal or neutralization of chemical warfare agents and T-2 toxin from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin.~~	·~~United States (510k)~~ ·~~Canada~~ ·~~Australia~~ ·~~European Union~~ ·~~Israel~~
~~Trobigard™~~ ~~(atropine sulfate, obidoxime chloride~~	~~Auto-injector device designed for intramuscular self-injection of atropine sulfate and obidoxime chloride as a nerve agent countermeasure.~~	Trobigard is not currently approved or cleared by the FDA or any similar regulatory body, and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.

~~NARCAN® (naloxone HCl) Nasal Spray. NARCAN® (naloxone HCl) Nasal Spray~~ BAT is the ~~first and~~ only ~~needle-free formulation of naloxone approved~~equine plasma antitoxin licensed by the FDA and Health Canada for the ~~emergency~~ treatment of ~~known~~all seven botulinum neurotoxin serotypes. BAT is licensed by the FDA for the treatment of symptomatic botulism following suspected or documented exposure to botulinum neurotoxin serotypes A, B, C, D, E, F or G in adults and pediatric patients. It is also licensed in Canada pursuant to Health Canada’s Extraordinary Use New Drugs regulations. BAT is also approved in Singapore and Ukraine. BAT is the only heptavalent botulism antitoxin available in the United States and Canada for treating naturally occurring botulism in adults or pediatric patients. Botulinum toxin is a nerve toxin produced by the bacterium Clostridium botulinum that causes botulism, a serious paralytic illness. On May 8, 2020, we announced the finalization of a previously announced contract with HHS, valued at up to $550 million, if all options under the contract are exercised. The contract has two deliverables. The first deliverable, negotiated in September 2019 and valued at up to approximately $90 million, is to supply annual doses of BAT into the SNS for 10 years by converting existing bulk drug substance into final drug product. This deliverable also includes options for additional doses valued at up to approximately $94 million over 10 years. The second deliverable, valued at up to approximately $366 million, is for the production of additional doses of bulk drug substance over 10 years to maintain the plasma collection and production capability for botulism response planning. In addition to domestic government sales, BAT continues to be sold internationally, with deliveries to over 16 foreign governments in 2021.

BioThrax®.BioThrax is the only vaccine licensed by the FDA for pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure. BioThrax is also approved by the FDA for post-exposure prophylaxis administration in combination with antimicrobial therapy in the event of suspected ~~opioid overdose~~or confirmed exposure to Bacillus anthracis. BioThrax was granted orphan drug designation (market exclusivity) for the post-exposure prophylaxis indication through November 2022; see “Regulation - Marketing Approval - Biologics, Drugs and Vaccines - Orphan Drugs” for a description of orphan drug status. Anthrax is a potentially fatal disease caused by the spore-forming bacterium, Bacillus anthracis. Inhalational anthrax is the most lethal form of anthrax. In the United States, BioThrax is administered in a pre-exposure prophylaxis setting by intramuscular injection as ~~manifested~~a three-dose primary series over a six-month period. Per the U.S. label, booster doses are administered 6 and 12 months after completion of the primary series and at 12- month intervals thereafter.

BioThrax is administered in a post-exposure prophylaxis setting as three subcutaneous injections two weeks apart in conjunction with recommended antibacterial drugs following suspected or confirmed Bacillus anthracis exposure. When we report the revenue associated with “anthrax vaccines,” it reflects the combined revenue from the procurement and sale of BioThrax as well as the product candidate AV7909 (described below).

In December 2016, we signed a follow-on contract with the CDC for the supply of up to approximately 29.4 million doses of BioThrax for delivery into the SNS, over a five-year period ending in September 2021. On September 29, 2021, we were granted a no-cost contract extension, which extended the date through which the USG may procure BioThrax to March 31, 2022.

Raxibacumab injection, a fully human monoclonal antibody.Our raxibacumab product is the first fully human monoclonal antibody therapeutic licensed by ~~respiratory and/~~the FDA for the treatment and prophylaxis of inhalational anthrax due to Bacillus anthracis. Our raxibacumab product is indicated for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or ~~central nervous system depression. The primary customers~~appropriate. We assumed responsibility for ~~NARCAN® Nasal Spray~~a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) from Human Genome Sciences, Inc. and GlaxoSmithKline LLC (collectively referred to as GSK) to supply the product to the SNS through November 2019. All deliveries under this contract are state health departments, local law enforcement agencies, community-based organizations, substance abuse centers, federal agencies and consumers through physician directed or standing order prescriptions.complete.

RSDL^® ~~(Reactive Skin Decontamination Lotion Kit)~~. RSDL is the only medical device cleared by the FDA that is intended to remove or neutralize chemical warfare agents from the skin, including tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin. RSDL has also been cleared as a medical device by Health Canada, has a current European Conformity ~~(“CE”)~~(CE) mark under European Directives, and is licensed by the Israel Ministry of Health and by Australia's ~~Therapeutics~~Therapeutic Goods Administration. To date, the principal customers for RSDL have been agencies of the USG, including the ~~DoD~~Department of Defense (DoD) and the National Guard. Our current contract with the DoD, awarded in September 2017, ~~after the expiration of our initial DoD contract,~~ is a five-year ~~follow-on~~ contract valued at up to approximately $171 million to supply RSDL for use by all branches of the U.S. military. In addition to the DoD and other USG agencies, beginning in 2017, we made RSDL available for the first time for purchase by civilians in the United ~~States on Amazon.com.~~States. We have also sold RSDL to 3533 foreign countries outside the United States, since the device was cleared in 2003. ~~We intend to continue our sales to USG agencies and the DoD and to identify new markets where RSDL can be promoted and sold under its current FDA clearance.~~

Trobigard^TM ~~(Atropine Sulfate/Obidoxime Chloride auto-injector)~~. ~~Trobigard auto-injector is designed to deliver~~® atropine sulfate, ~~and~~ obidoxime chloride auto-injector. TROBIGARD was approved by the Federal Agency for Medicines and Health Products of the Belgium Health Authority on February 18, 2021. TROBIGARD is not currently approved or cleared by the FDA. TROBIGARD is only distributed to authorized government buyers for use outside the United States. In Belgium, the TROBIGARD Auto-injector is indicated for the emergency treatment of ~~organophosphate~~known or suspected exposure to nerve ~~agent~~agents or ~~insecticide poisoning.~~ toxic organophosphates in adults (age 18 and up). In ~~October 2017, we were~~February 2019, Emergent was awarded a 10-year contract, ~~valu~~edvalued at up to approximately ~~$25~~$100 million, by the U.S. Department of State, ~~(“DoS”),~~ to deliver our ~~Trobigard~~TROBIGARD product, ~~and~~ training auto-injectors and RSDL for emergency use outside of the United States. The contract consists of a ~~one-year~~five-year base period of performance with ~~a six-month~~five one-year option period. Trobigard is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.periods.

~~Product Candidates~~

~~Within our Devices business unit, we are leveraging our proprietary auto-injector platform to develop several investigational stage product candidates, including:~~

~~SIAN (stabilized isoamyl nitrite).~~ In September 2017, we were awarded a contract by BARDA valued at approximately $63 million to develop an antidote intra-nasal spray device for the treatment of known or suspected acute cyanide poisoning. The single-use intranasal spray device is being developed to deliver a stabilized form of isoamyl nitrite (“SIAN”) and is intended to be developed for use by first responders and medical personnel following a cyanide incident.

~~D4.~~ In July 2017, we were awarded a contract by DoD valued at up to approximately $23 million to develop a multi-drug auto-injector for nerve agent antidote delivery (atropine and pralidoxime chloride), which we refer to as D4.

~~Development Candidates from Adapt Acquisition. We acquired from Adapt multiple constructs in various stages of development focused on new treatments and delivery options for opioid overdose response.~~

~~In addition, we are continuing to look at opportunities to expand our portfolio of auto-injector product candidates and, eventually, product line.~~

~~Antibody Therapeutics~~

~~Products~~

Our Antibody Therapeutics business unit contains a broad portfolio of specialty antibody-based therapeutics and prophylactics that address a broad range of existing and emerging PHTs. The current portfolio consists of the following products.

~~ANTIBODY THERAPEUTICS UNIT~~
~~Product~~	~~Indication(s)~~	~~Regulatory Approvals~~
~~raxibacumab~~	Treatment and prophylaxis of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.	~~United States~~
~~Anthrasil~~^® ~~[Anthrax Immune Globulin Intravenous (Human)]~~	~~Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs.~~	~~United States, Canada~~
~~BAT~~^® ~~[Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)]~~	~~Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients.~~	~~United States, Canada~~
~~VIGIV~~ ~~[Vaccinia Immune Globulin Intravenous (Human)]~~	~~Treatment of complications due to vaccinia vaccination, including:~~ ~~• Eczema vaccinatum;~~ ~~• Progressive vaccinia;~~ ~~• Severe generalized vaccinia; and~~ ~~• Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).~~	~~United States, Canada~~

~~raxibacumab~~. ~~raxibacumab is the first fully-human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax due to~~ ~~bacillus anthracis~~. It was licensed by the FDA in December 2012 and has orphan drug designation in the United States, giving it market exclusivity in the United States until December 2019. raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate. raxibacumab has been supplied to the SNS since 2009 under contracts with BARDA. Upon the closing of our acquisition of raxibacumab from GSK, we assumed responsibility for a multi-year contract with BARDA, valued at up to approximately $130 million at acquisition, to supply the product to the SNS through November 2019. We intend to pursue negotiation of a follow-on contract with the USG to ensure the uninterrupted supply of this medical countermeasure (“MCM”) to the SNS. Under the terms of our acquisition agreements, we intend to purchase product from GSK to enable completion of deliveries to the SNS under the existing BARDA procurement contract. We have initiated the process of the transfer of raxibacumab bulk manufacturing from GSK to our Bayview facility and fill/finish activities to our Camden facility.

~~Anthrasil~~^® ~~[Anthrax Immune Globulin Intravenous (Human)]~~. Anthrasil is the only polyclonal antibody therapeutic licensed by the FDA for the treatment of inhalational anthrax. Anthrasil is comprised of purified human polyclonal immune globulin G (“IgG”) containing polyclonal antibodies directed to the anthrax toxins of ~~Bacillus anthracis~~, the bacteria that causes anthrax disease, and is prepared using plasma collected from healthy, screened donors who have been immunized with our BioThrax vaccine. Anthrasil was licensed by the FDA in March 2015 for the treatment of suspected or documented inhalational anthrax in combination with appropriate antibacterial drugs. Simultaneous with FDA approval in 2015, Anthrasil also received orphan drug designation, resulting in market exclusivity in the United States until March 2022. To date, the principal customer for Anthrasil has been the USG, specifically HHS. Anthrasil is procured by BARDA for delivery into the SNS. We have two current contracts with BARDA: a development and procurement contract that expires in April 2021 and a multiple award, indefinite delivery/indefinite quantity contract for the collection of anti-anthrax plasma, as well as the manufacture of such plasma into bulk drug substance and finished drug product and delivery of finished product into the SNS. BARDA issued a task order under this second contract for the collection of anti-anthrax plasma, which was completed in 2015. BARDA issued a second task order in 2018 under this contract to extend the plasma collection storage, and to include options for manufacturing and product delivery; these options are available to be exercised by BARDA through September 2023. In addition to domestic government sales, Anthrasil has been sold to several foreign governments. In December 2017, we were awarded a contract by the Canadian Department of National Defence, valued at approximately $8 million, to deliver Anthrasil to the Canadian government. This contract award follows the December 2017 approval of Anthrasil by Health Canada under the Extraordinary Use New Drug (“EUND”) Regulations, which provide a regulatory pathway in Canada for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.

~~BAT~~^® ~~[Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)]~~. BAT is the only heptavalent antibody therapeutic licensed by the FDA and Health Canada for the treatment of botulism. BAT is comprised of purified polyclonal equine immune globulins (antibodies) directed to the seven toxins (A through G) produced by ~~Clostridium botulinum~~. BAT was licensed by the FDA in the United States in March 2013 for the treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or G. It was also licensed in Canada in December of 2016 pursuant to Health Canada’s EUND regulations. Simultaneous with FDA licensure in 2013, BAT also received orphan drug designation, resulting in market exclusivity in the United States until March 2020. BAT is the only heptavalent botulism antitoxin available in the United States or Canada for treating naturally occurring botulism in adults or pediatric patients. Botulinum toxin is a nerve toxin produced by the bacterium ~~Clostridium botulinum~~ that causes botulism, a serious paralytic illness. Naturally occurring cases are mainly seen in infants or in adults who have consumed improperly processed foods. Botulinum toxin can also be used as a bioterrorism agent and has been identified in the United States as one of the highest priority bioterrorism threats. To date, the principal customer for BAT has been the USG, specifically HHS. We are currently operating under a procurement contract with BARDA in support of the program; this contract also includes stability testing, post marketing commitments, and manufacturing. We signed a modification to our contract with BARDA to manufacture and store bulk drug substance for BAT in March 2017, valued at approximately $53 million with a five-year period of performance. This modification to the contract is intended to enable future filling and deliveries of final drug product to the SNS. In addition to domestic government sales, BAT continues to be sold internationally, with deliveries to over 15 foreign governments in 2018. For example, we have a 10-year contract, executed in 2012, to supply BAT to the Canadian Department of National Defense as well as the Public Health Agency of Canada and individual provincial health authorities.

VIGIV ~~[Vaccinia Immune Globulin Intravenous (Human)]~~CNJ-016®. VIGIV is the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from replicating virus smallpox vaccination. VIGIV is comprised of purified polyclonal human immune globulins (antibodies) directed to the vaccinia virus, the virus that is used in replicating virus vaccinations, such as ACAM2000, a product that is currently being procured and delivered into the SNS. VIGIV is prepared using plasma collected from healthy, screened donors who have been immunized with our ACAM2000 vaccine or previously immunized with the DryVax vaccine. Vaccinia is not the virus that causes smallpox, but it is similar enough to elicit a protective immune response when used as a smallpox vaccine. Individuals who are susceptible to vaccinia may develop an infection from ACAM2000 or other similar replicating virus vaccines, and these patients may benefit from treatment with VIGIV. VIGIV was licensed by the FDA in May 2005 and by Health Canada in May 2007 for counteracting certain complications that can be associated with smallpox vaccination. Although VIGIV has been sold to foreign governments, to date, theThe principal customer for VIGIV ~~has been~~is the USG, specifically HHS. ~~We are operating under~~In June 2019, we announced a contract ~~for the supply of VIGIV through early 2019 and anticipate negotiating a follow-on contract~~award by HHS valued at approximately $535 million over 10 years for the continued supply of VIGIV into the ~~SNS.~~SNS for smallpox preparedness. VIGIV has also been procured by a limited number of foreign governments.

Commercial Business Line Products

The current portfolio of our Commercial business line consists of the following products:


COMMERCIAL PRODUCTS
Product	Indication(s)	Regulatory Approvals
NARCAN®(naloxone HCI) Nasal Spray	Emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.	United States, Canada
Vaxchora® (Cholera Vaccine Live Oral)	Vaccine indicated in the United States for active immunization against disease caused by Vibrio cholerae serogroup 01 in persons 2 through 64 years of age traveling to cholera-affected areas.	United States, EU
Vivotif® (Typhoid Vaccine Live Oral Ty21a)	For immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi.	United States, Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Finland, Germany, Italy, Luxembourg, Malaysia, the Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland and UK

Description of Commercial Business Line Products

NARCAN®. NARCAN, a product we obtained in connection with our acquisition of Adapt Pharma Inc. in 2018, is an intranasal formulation of naloxone approved by the FDA and Health Canada for the emergency treatment of known or suspected opioid overdose as demonstrated by respiratory and/or central nervous system depression. The primary customers for NARCAN are state health departments, local law enforcement agencies, community-based organizations, substance abuse centers, federal agencies and consumers through pharmacies fulfilling physician-directed or standing order prescriptions. We completed two important product life cycle improvements in 2020. First, we launched the Generation II NARCAN device, which has a claim for enhanced temperature excursions and storage below 25°C. Second, we gained FDA approval for an extension of the shelf life of NARCAN from 24 months to 36 months.

In addition, we have also secured an agreement with Sandoz Inc. (Sandoz) to distribute an authorized generic naloxone nasal spray, which was launched in December 2021 and will be available in the United States via retail pharmacies and institutions, including hospitals.

Vaxchora®.Vaxchora is a live attenuated cholera vaccine for oral administration and the first vaccine approved by the FDA for the prevention of cholera infection. Cholera is a potentially life-threatening bacterial infection that occurs in the intestines and causes severe diarrhea and dehydration. It has a low incidence in the United States and Europe, but a high

incidence in Africa, Southeast Asia, and other locations around the world. These areas have historically drawn travelers from the United States and Europe, so cholera can occur in patients who return to the United States or Europe from visits to these regions. Vaxchora is approved in the United States for active immunization against disease caused by V. cholerae serogroup 01 in persons 2 to 64 years of age traveling to cholera-affected areas. Vaxchora is indicated in the EU for active immunization against disease caused by V. cholerae serogroup 01 in adults and children aged 2 years and older.

We have marketed Vaxchora to a subset of travelers primarily from the United States. Our sales of Vaxchora were diminished in 2020 and 2021 due to the broad disruption to travel caused by the COVID-19 pandemic. We expect limited sales to resume in 2022 in line with limited anticipated return to international travel.

Vivotif®.Vivotif is a live attenuated vaccine for oral administration to prevent typhoid fever. Typhoid fever is a potentially severe and occasionally life-threatening febrile illness caused by Salmonella enterica serotype Typhi, a bacterium that only lives in humans. It is usually acquired by consumption of water or food that has been contaminated by feces of an infected person. Travelers from North America and Europe going to Asia, Africa, and Latin America have historically been particularly at risk.

We have marketed Vivotif to a subset of travelers primarily from the United States and the European Union. Our sales of Vivotif were diminished in 2020 and 2021 due to the broad disruption to travel caused

by the COVID-19 pandemic. We expect limited sales to resume in 2022 in line with limited anticipated return to international travel.

Product Candidates

The chart below highlights our ~~primary Antibody Therapeutics~~ product candidates:


PRODUCT CANDIDATES
Product Candidate			Target Indication
~~FLU-IGIV~~ ~~Seasonal influenza therapeutic~~AP003 (Naloxone multidose nasal spray)			~~Treatment~~Emergency treatment of ~~serious Influenza A infection in hospitalized patients.~~known or suspected opioid overdose as demonstrated by respiratory and/or central nervous system depression.
~~ZIKV-IG~~ ~~Zika therapeutic~~AP007 (Sustained release nalmefene injectable)			~~Prophylaxis~~Treatment of Opioid Use Disorder in combination with a comprehensive management program that includes psychosocial support.
AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted)			Post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administrated in conjunction with recommended antibacterial drugs (currently procured by the USG prior to approval by the FDA and included in revenue for ~~Zika infections~~Anthrax Vaccines).
CGRD-001 (Pralidoxime chloride/atropine auto-injector)			Treatment of poisoning by organophosphorus nerve agents or organophosphorus compounds.
CHIKV VLP Chikungunya virus VLP vaccine			Active immunization to prevent disease caused by Chikungunya virus.
COVID-HIG (Human polyclonal hyperimmune with antibodies to SARS-CoV2)			Early treatment of COVID-19 disease in ~~at risk populations.~~outpatients.
EGRD-001 (Diazepam auto-injector)			Adjunct treatment in status epilepticus and severe recurrent convulsive seizures caused by nerve agent poisoning.
SIAN (stabilized isoamyl nitrite)			Antidote for initial treatment of certain or suspected acute cyanide poisoning. Standard of care supportive measures should be applied as appropriate. SIAN is not a substitute for ongoing emergency medical care.
UniFlu (Universal influenza vaccine)			Intended to induce broad and supra-seasonal immunity against influenza A and B viruses.

~~FLU-IGIV (NP025)~~

Description of Product Candidates

AP003. AP003 (Naloxone multidose nasal spray) is being developed for the emergency treatment of a known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.Naloxone hydrochloride is an opioid antagonist that is intended to antagonize opioid effects by competing for the same receptor sites. Naloxone hydrochloride is intended to reverse the effects of opioids, including respiratory depression, sedation, and hypotension. It is also intended to reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.

AP007.AP007 (Sustained release Nalmefene Injectable) is being developed for the treatment of opioid use disorder. AP007 is an extended-release formulation of Nalmefene, an opioid receptor antagonist, intended to continually release an effective dose of Nalmefene for up to three months and to be administered through intramuscular injection.

AV7909.We are ~~utilizing our hyperimmune platform~~developing AV7909, an anthrax vaccine product candidate based on anthrax vaccine adsorbed combined with an adjuvant for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. In 2021, AV7909 was granted orphan drug designation by the FDA. Studies have shown that AV7909 elicits a stronger immune response using fewer doses than BioThrax, allowing patients to reach a protective level of immunity more rapidly. AV7909 is expected to provide protection with a two-dose regimen (versus the BioThrax three-dose regimen) for post-exposure prophylaxis of anthrax disease, when administered in combination with the recommended antibacterial drugs. In September 2016, we signed a combination development and procurement contract with BARDA, which included a five-year base period of performance to develop ~~NP025,~~AV7909 for post-exposure prophylaxis of anthrax disease and to deliver to the SNS an initial two million doses, subsequently modified to three million doses in March 2017. The contract also includes procurement options for the delivery of an additional 7.5 million to 50 million doses of AV7909 into the SNS and options for an additional clinical study and post marketing commitments. In 2019, we initiated and completed enrollment of a Phase 3 study; the 3,850 subject trial evaluating safety, immunogenicity and lot consistency was completed in 2020. In collaboration with us, the CDC filed with the FDA a pre-Emergency Use Authorization (EUA) submission package related to AV7909. Following this submission, BARDA began procuring AV7909, exercising its first contract option in July 2019 (valued at approximately $261 million) to procure doses to be

delivered to the SNS through June of 2020, its second contract option in June 2020 (valued at $258 million) to procure additional doses of AV7909 for delivery into the SNS over 12 months and, most recently, in September 2021 funding another contract option (valued at approximately $399 million) to deliver doses of AV7909 to the SNS over 18 months. In December 2021, we commenced our submission of a BLA for AV7909 to the FDA, although there can be no assurance it will be approved by the FDA. When we report the revenue associated with “anthrax vaccines,” it reflects the combined revenue from the procurement and sale of AV7909 as well as BioThrax (described above).

CGRD-001.The CGRD-001 auto-injector is being developed for treatment of poisoning by organophosphorus nerve agents, as well as organophosphorus compounds, in an auto-injector for protection of soldiers and first responders.CGRD-001 is being developed as an auto-injector capable of delivering intramuscular 2-PAM (600 mg) and atropine (2 mg) through self- or buddy-aid to service members following nerve agent exposure.

CHIKV VLP.We are developing a chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, to be administered as a single dose for active immunization against chikungunya disease. There is currently no licensed vaccine, VLP or otherwise, to prevent chikungunya virus disease. The structure of the CHIKV VLP is nearly identical to the wild-type virus but does not pose a risk of replication. Studies conducted by the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center and Emergent have shown that the CHIKV VLP vaccine is safe and elicits high titer neutralizing antibodies, which are needed to protect against chikungunya virus. In 2021, we initiated a Phase 3 clinical trial for CHIKV VLP. Our CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and May 2018, respectively, and PRIME designation from the European Medicines Agency (EMA) in September 2019.

COVID-HIG.COVID-HIG is a fully human polyclonal antibody therapeutic ~~enriched~~product candidate made from plasma with ~~influenza antibodies for the~~high titers to SARS-CoV-2.COVID-HIG is being developed as a potential treatment of ~~serious illness~~COVID-19 disease in SARS-CoV-2 positive outpatients who are at high risk of progression to severe disease.In collaboration with NIAID and BARDA, Emergent is currently participating in an international Phase 3 clinical trial in outpatients known as INSIGHT-012.With DoD funding, in 2021, we initiated a Phase 1 clinical study evaluating alternate routes of administration (low-dose IV, subcutaneous, and intramuscular) to enable broader access to treatment.COVID-HIG has been provided under emergency

Investigational New Drug (IND) to treat hospitalized patients in need.

EGRD-001.The EGRD-001 auto-injector is being developed for treatment of status epilepticus and severe recurrent convulsive seizures caused by ~~influenza A infection~~nerve agent poisoning, in ~~hospitalized patients. Development~~an auto-injector for protection of soldiers and first responders. EGRD-001 is being developed as an ~~influenza immune globulin product could address the significant public health burden~~auto-injector capable of delivering intramuscular Diazepam (10 mg) through buddy-aid to service members who are actively seizing.

SIAN.We are developing SIAN (stabilized Isoamyl nitrate) as an antidote for ~~severe hospitalized influenza. In 2017, a Phase 2 study was initiated~~initial treatment of acute poisoning of cyanide that is judged to be serious or life threatening. The USG's 2015 Public Health Emergency Medical Countermeasure Enterprise Strategy and Implementation Plan identifies cyanide (CN) as a ~~randomized, double-blind, placebo-controlled dose ranging study evaluating~~high-priority threat. Historically, CN has been used as a chemical warfare agent and could be an agent for a terrorist attack. CN also represents a threat from accidental poisoning, such as industrial accidents or exposure during building fires. This BARDA-funded medical countermeasure will see the ~~safety, pharmacokinetics~~development of a single-use intranasal spray device that can be rapidly deployed and ~~clinical benefit of FLU-IGIV~~easily dispensed so that it will deliver SIAN following a cyanide incident or in a ~~targeted hospitalized~~mass exposure setting.

UniFlu.We are developing a universal influenza ~~patient population. This~~vaccine candidate based on a nanoparticle vaccine that self-assembles during production and that displays a cross-reactive hemagglutinin (HA) antigen for active immunization against influenza virus A and B. The self-assembling HA stabilized stem nanoparticle technology was developed by and licensed from the NIAID Vaccine Research Center. Using this technology, a universal influenza vaccine could be designed to confer protection against divergent, constantly evolving strains and subtypes of influenza virus. In 2021, we initiated a phase 1 study ~~is currently ongoing at multiple sites in North America~~designed to demonstrate safety, tolerability, and immunogenicity of the influenza virus A components of the vaccine candidate with ~~a target completion in 2019.~~future studies planned to investigate additional components for full coverage against all influenza virus A and B strains.

~~ZIKV-IG(NP024). ZIKV-IG is a sterile purified liquid immunoglobulin preparation containing a standardized amount~~Description of neutralizing antibody to Zika Virus. It is produced from plasma collected from healthy donors who have recovered from Zika infection (convalescent) and have high levels of neutralizing antibody for ZIKV; such collection is being done out of FDA licensed plasma collection establishments. The Phase 1 trial to evaluate the safety of ZIKV-IG completed enrollment in 2018. Several non-clinical studies are ongoing to evaluate efficacy and safety of ZIKV-IG in collaboration with several academic partners who have received funding from NIAID and other agencies.Services

Services - CDMO Business Line.Our ~~Antibody Therapeutics~~CDMO Services business ~~unit also has other product candidates addressing PHTs, including viral hemorrhagic fevers caused by Filoviruses (Ebola, Marburg and Sudan), among others.~~

~~Contract Development and Manufacturing~~

~~Our Contract Development and Manufacturing business unit, which~~line is based on our established ~~manufacturing infrastructure and expertise, consists of a broad range of contract~~ development and manufacturing ~~services, directed to both internal products owned by us~~infrastructure, technology platforms and expertise, as well as continuing capital expenditure projects to ~~third-party customers with specific~~expand our capabilities and ~~unique needs.~~increase capacity.

Our CDMO Services business line consists of development services, bulk drug substance manufacturing, fill, finish, and packaging of final drug product. Collectively, this portfolio of services provides “molecule-to-market” solutions to clients engaged in

all stages of drug development and commercialization. These services ~~include: pharmaceutical~~are provided to innovator biopharmaceutical companies and NGOs. The biologics technology platforms consist of mammalian, microbial, viral and plasma.

We have ten development and manufacturing sites spread across multiple locations in the United States and internationally. Six of these sites currently provide CDMO services to customers and the others are either ready now or in various stages of investment to advance them for servicing CDMO customers.

•Our Winnipeg and Gaithersburg sites house our development services expertise;

•Our Bayview, Lansing, Winnipeg, San Diego, Bern and Canton sites house our drug substance expertise; and

•Our Camden, Winnipeg, Rockville and Hattiesburg sites house our drug product ~~process~~and packaging expertise.

We currently have over 60 active CDMO customers. Below is a description of the most significant CDMO arrangements that were active during the fiscal year ended December 31, 2021.

Johnson & Johnson COVID-19 Vaccine Arrangement.On July 2, 2020, we executed a large-scale drug substance manufacturing agreement related to Johnson & Johnson's lead COVID-19 vaccine candidate, with an initial term based on volume, valued at approximately $480 million, with an option for an additional three year term to provide capacity to support volume commitments. This agreement was preceded by an agreement valued at approximately $135 million to provide CDMO services and capacity reservation to Johnson & Johnson.

AstraZeneca COVID-19 Vaccine Arrangement.On July 26, 2020, following BARDA's direction to release capacity at our Bayview facility to AstraZeneca, we executed a large-scale manufacturing agreement with AstraZeneca for their COVID-19 vaccine candidate. The Company, at the direction of AstraZeneca, ceased manufacturing of the AstraZeneca product in April 2021. The Company is working with AstraZeneca to wind down the agreement.

Providence Therapeutics Vaccine Arrangement.On September 14, 2021, we entered into a five-year CDMO services agreement with Providence Therapeutics to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development and manufacturing ~~and filling~~at our Winnipeg site. The agreement is valued at approximately $90 million, covering manufacturing services, ~~for injectable and other sterile products, inclusive of process design, technical transfer, manufacturing validations, laboratory analytical development~~studies to support ~~aseptic filling, lyophilization, final packaging and accelerated and ongoing stability studies,~~global

supply chain activities, as well as facility and equipment investments.

BARDA Center for Innovation in Advanced Development and Manufacturing Relationship. In 2012, we entered into the Center for Innovation in Advanced Development and Manufacturing (CIADM) Contract with the US Government, a 25-year agreement with BARDA under which we would prepare a facility to be able to manufacture 50 million doses of influenza vaccine in four months in the case of a pandemic. Since that time, we have invested over $200 million of our own funds towards readiness of the facility. In mid 2020, following declaration of a public health emergency due to the COVID-19 pandemic, BARDA issued task orders under this agreement to reserve capacity at the facility to control which vaccine candidates would be manufactured in the facility’s reserved space. On November 1, 2021, we entered into contract modifications (the Modifications) with BARDA under which we mutually agreed to terminate the CIADM, along with all associated task orders, including the task order issued on May 30, 2020 to reserve capacity and expand manufacturing of ~~vial and pre-filled syringe formats, bulk~~ drug ~~product and finished units of clinical and commercial drugs. We provide~~substance for third-party COVID-19 vaccine candidates. The Modifications reduced the total contract value to be realized under the task orders to $470.9 million from $650.8 million. The total base CIADM Contract value to be realized was reduced to $140.5 million from $163.2 million. Other than customary post-termination activities, there are no ongoing obligations related to these services for a wide variety of drug products – small molecule, biologics, and blood products – in all stages of development and commercialization, including over 30 licensed products which are currently sold in approximately 50 countries. Our third-party customers range from small biopharmaceutical companies to major multinational pharmaceutical companies. We perform work for this business unit at the following sites:contracts.

~~Camden (Baltimore, Maryland).~~ Primarily supporting our Contract Development and Manufacturing business unit, our Camden facility has provided manufacturing services to more than 50 domestic and international customers and has manufactured over 20 commercial products distributed in approximately 50 countries. This fill/finish manufacturing site offers customers a broad portfolio of capabilities essential to their product development and commercialization efforts.

~~Bayview (Baltimore, Maryland).~~ Our Bayview facility was designated by the HHS as a Center for Innovation in Advanced Development and Manufacturing (“CIADM”) through a contract with BARDA in June 2012, one of three such sites in the U.S. Through this contract, we have responded to four Task Order Requests issued by BARDA for the development and manufacture of product candidates primarily addressing EID threats of high priority to the USG, including Zika and viral hemorrhagic fevers such as Ebola. In support of our Contract Development and Manufacturing business unit, our Bayview facility also provides manufacturing services to non-U.S. Government partners and customers.

~~Canton, Massachusetts~~. Our Canton, Massachusetts facility is equipped with large-scale bioreactors for cell culture propagation and viral infection as well as downstream processing equipment for the production of live viral vaccine products, including ACAM2000. This site also operates as a contract manufacturing operation (“CMO”) facility and we intend to expand on this capability.

~~Lansing, Michigan.~~ Our Lansing campus is our primary manufacturing location servicing our Vaccines and Anti-Infectives business unit for the production of BioThrax and NuThrax. Our Lansing facilities also provide our Contract Development and Manufacturing business unit with capability for both small- and large- scale biologics bulk product manufacturing. We conduct CMO activities in our small-scale facility, Building 12, and we seek to market our available capacity in Lansing to enhance overall facility utilization.

~~Winnipeg, Manitoba, Canada.~~ Our facilities in Winnipeg contain the primary location for product development and manufacturing in support of our Antibody Therapeutics business unit. These facilities also support our Contract Development and Manufacturing business unit through product development and manufacturing support to a number of other customers.

Marketing and Sales

We have dedicated sales channels for each of our business lines.

~~Our product sales can be divided into two primary categories: i) sales to the U.S. Government; and ii) commercial sales.~~Government - MCM Business Line.

~~Government Procurement~~

~~For our Vaccines and Anti-Infectives, Antibody Therapeutics and Devices business units, our largest customers are~~We partner with stakeholders in the USG and domestic ~~non-government organizations. All three business units share a team~~NGOs to support procurement of ~~dedicated marketing~~our MCM products and ~~sales personnel.~~ procured product candidates.

We ~~intend to use a similar approach to the marketing and sales of other product candidates that we either successfully develop or acquire. In addition to domestic sales, we sell our products to allied~~also partner with foreign governments as well as ~~non-governmental organizations~~NGOs to support procurement of MCM products and procured product candidates internationally.

Our specialized team has expertise and experience in ~~foreign jurisdictions. For our non-U.S. sales, we use a combination~~the public and private sector, dealing with counterterrorism, CBRNE preparedness and public health.

Commercial Business Line.

NARCAN is sold directly to state and local governments and used by first responders, including: police, firefighters and emergency medical teams. In addition, NARCAN is dispensed to patients at risk of ~~our employees~~an opioid overdose through retail pharmacies as well as third-party marketing distributors and representatives to sell our products in key international markets, including Europe, the Middle East, Asia and the Pacific Rim. We anticipate engaging additional representatives as interest in countermeasures addressing PHTs increases outside the United States.

~~Our Contract Development and Manufacturing business unit is supported~~prescribed by a ~~dedicated group of business development professionals qualified to represent the full spectrum of contract product development~~physician.

Vivotif® and ~~manufacturing services that we offer.~~

~~Commercial Sales~~

~~NARCAN® Nasal Spray is sold commercially through physician directed or standing order prescriptions at retail pharmacies.~~

~~Vivotif and~~ Vaxchora® are vaccines intended for use by travelers heading to regions where there is a risk of exposure to certain infectious diseases and, therefore, are sold to channels that address travel health. We sell to both wholesalers and distributors as well as directly to healthcare practitioners. The primary commercial customers of Vivotif and Vaxchora are private travel clinics, retail pharmacies and integrated hospital networks. Sales of these products were significantly reduced in 2020 and 2021 due to the broader disruption to travel caused by the COVID-19 pandemic. We expect limited sales to resume in 2022 in line with limited anticipated return to international travel.

~~Competition~~Services - CDMO Business Line.

We market our CDMO services to the global pharmaceutical and biotechnology industry and government/NGOs. We also provided CDMO services to the USG, which ended in 2021. Our CDMO services are supported by a dedicated group of sales and business development, marketing, customer experience, and commercial operations professionals qualified to represent our full breadth of service offerings to the global pharmaceutical and biotechnology industry and governments/NGOs.

~~Our products and product candidates intended for the treatment or prevention of CBRNE, EID threats, travelers’ diseases and opioids face significant competition.~~ Competition

Our products and any product or product candidate that we acquire or successfully develop and commercialize are likely to compete with current products and product candidates that are in development for the same indications. Specifically, the competition for our products and product candidates includes the following:

•AV7909 and BioThrax.AV7909 and BioThrax are currently procured, primarily by the USG, for prevention of anthrax disease. While there are no vaccines, other than BioThrax, approved by the FDA for prevention of anthrax disease, and none other than AV7909 and BioThrax that have been procured by the SNS, we face potential future competition for the supply of anthrax vaccines if the USG chooses to procure products or product candidates for any programs currently in development. Altimmune, Inc., GC Pharma, Blue Willow Biologics, and Greffex are each currently developing anthrax vaccine product candidates, which are in various stages of clinical development. Of the product candidates, Altimmune and Blue Willow Biologics have completed Phase 1 trials.

•NARCAN®.NARCAN is the first FDA-approved intranasal naloxone spray for the emergency reversal of opioid overdoses. Teva Pharmaceuticals Industries Ltd. and its Canadian affiliate (collectively, Teva) have

filed applications for generic versions of an intranasal naloxone spray based on NARCAN with the FDA and Health Canada. Teva recently launched its generic naxolone nasal spray in the United States. NARCAN also faces branded competition from other injectable naloxone, auto-injectors and improvised nasal kits, including Kloxxado™ (naloxone HCI) nasal spray 8 mg, a branded product developed by Hikma Pharmaceuticals, Inc. which delivers a higher dose naloxone nasal spray. Amphastar Pharmaceuticals, Inc.'s naloxone injection product, Teleflex Medical Inc's Intranasal Mucosal Atomization Device and Zimhi™ (naloxone), a branded injectable product developed by Adamis. In addition, Orexo AB and Harm Reduction Therapeutics both have development programs for naloxone nasal spray formulations intended for use in opioid overdose reversal. NARCAN may face additional generic and branded competition in the future.

•ACAM2000®. ACAM2000 faces competition from JYNNEOSTM, which is licensed by the FDA for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. JYNNEOS is also approved in Canada and in the European Union under the trade names IMVAMUNE® and IMVANEX®, respectively. ACAM2000 remains the primary smallpox vaccine stockpiled by the USG and offers key features for public health mass vaccination programs that are critical, including a single dose vaccination schedule and multi-dose vial presentation. While therapeutics generally do not compete directly with vaccines, our sales to the USG are dependent upon U.S. policy of stockpiling vaccines for emergency use. There are two approved smallpox therapeutics medicines in the United States made by SIGA Technologies, Inc. (SIGA) and Chimerix (TEMBEXA®)and in the event USG policy regarding smallpox vaccine and therapeutic stockpiling was to change, our sales could be adversely affected.

•Raxibacumab injection, a fully human monoclonal antibody and Anthrasil®. Our raxibacumab product is the first FDA licensed fully human anthrax monoclonal antibody therapeutic and Anthrasil is the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate

~~BioThrax and NuThrax~~. BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease. However, we face potential future competition for the supply of anthrax vaccines to the USG if such products are approved. Altimmune, Inc., Pfenex Inc., Soligenix, Inc., Immunovaccine Inc. and NanoBio Corporation are each currently developing anthrax vaccine product candidates. The majority of these product candidates are in Phase 2 and we will continue to monitor the competitive landscape as we move NuThrax into Phase 3 and through to licensure.

antibacterial drugs. Elusys Therapeutics, Inc. has obtained FDA licensure for Anthim® (obiltoxaximab) injection, a chimeric (or partially human) antibody indicated for the treatment and prophylaxis of inhalational anthrax. Obiltoxaximab is also approved in Canada and the EU.

•BAT®.Our botulinum antitoxin immune globulin product is the only heptavalent antitoxin licensed by the FDA and Health Canada for the treatment of symptomatic botulism for all seven botulinum neurotoxin serotypes. Direct competition is currently limited.

•CNJ-016®. Our VIGIV product is the only therapeutic licensed by the FDA and Health Canada to address adverse events from smallpox vaccination with replicating virus smallpox vaccines. While direct competition in terms of the treatment of smallpox vaccination side effects is limited, SIGA has obtained FDA approval for TPOXX® (tecovirimat), an oral therapy for the treatment of smallpox disease TPOXX is currently procured by the SNS. Chimerix has also recently been granted FDA approval for TEMBEXA®(brincidofovir) tablets and oral suspension approval for the treatment of smallpox.

•RSDL®. In the United States, the RSDL Kit is the only medical device cleared by the FDA to remove or neutralize chemical warfare agents and T-2 toxin from the skin. Internationally, various Ministries of Defense have procured Fullers Earth, Dutch Powder and French Powder as a preparedness countermeasure for the decontamination of liquid chemical weapons from the skin.

•Trobigard® atropine sulfate, obidoxime chloride auto-injector.In the United States, Meridian Medical Technologies has been the primary supplier of nerve-agent antidote auto-injectors. In the United States and internationally, there have been supply disruptions of Meridian Medical Technologies auto-injectors leading to shortages of these emergency use devices. The USG has funded the development of a number of nerve agent antidote auto-injectors including development programs at Emergent, Aktiv Pharma Group, Kaleo and others. Outside of the United States there are a number of suppliers of these devices though few with approvals from national or regional regulatory authorities.

•Vivotif®. Vivotif is the only FDA-approved oral typhoid vaccine. In the markets where Vivotif

~~NARCAN® (naloxone HCl) Nasal Spray.~~ With respect to NARCAN® Nasal Spray, we face competition from injectable naloxone, auto-injectors and improvised nasal kits. Amphastar Pharmaceuticals, Inc. competes with NARCAN® Nasal Spray with their naloxone injection product. Kaléo competes with NARCAN® Nasal Spray with their auto-injector known as EVZIO™ (naloxone HCl injection) Auto-Injector. In 2016, Teva Pharmaceuticals Industries Ltd. (“Teva”) filed, and in 2018 Perrigo UK FINCO Limited Partnership (“Perrigo”), filed Abbreiviated New Drug Applications (“ANDAs,” each an “ANDA”) with the FDA seeking regulatory approval to market a generic version of NARCAN® Nasal Spray. Although NARCAN® Nasal Spray was the first FDA-approved naloxone nasal spray for the emergency reversal of opioid overdoses and has advantages over certain other treatments, we expect the treatment to face additional competition.

is licensed, it competes primarily with Sanofi Pasteur’s Typhim VI® vaccine, an injectable polysaccharide typhoid vaccine.

~~ACAM2000~~. ACAM2000 is the only FDA-licensed approved smallpox vaccine in the United States. Investigational stage competitor vaccine Imvamune® of Bavarian Nordic may be used in a smallpox emergency under the appropriate regulatory mechanism (~~i.e.,~~ IND or EUA). Imvamune is approved in Canada and in the European Union where it is marketed under the trade name Imvanex®. It was designed for use in people for whom replicating smallpox vaccines are contraindicated and is indicated for use in immunocompromised patients, including HIV-infected individuals and those undergoing immunosuppressive therapy. A BLA was submitted by Bavarian Nordic to the FDA in October 2018.

•Vaxchora®. In the United States, Vaxchora is the only FDA-licensed vaccine available indicated to prevent cholera. Vaxchora is the only single dose cholera vaccine in the EU and is subject to competition by Valneva’s Dukoral® two-dose cholera vaccine in the EU.

Services - CDMO Business Line

~~raxibacumab and Anthrasil~~. Raxibacumab is the first FDA licensed fully human anthrax monoclonal antibody therapeutic and Anthrasil is the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of toxemia resulting from inhalational anthrax. However, Elusys Therapeutics, Inc. has obtained FDA licensure for Anthim® (obiltoxaximab) injection, indicated for the treatment and prophylaxis of inhalational anthrax.

We also compete for CDMO services with a number of biopharmaceutical product R&D organizations, contract manufacturers of biopharmaceutical products, other embedded CDMO organizations, and university research laboratories.

~~BAT~~. Our botulinum antitoxin immune globulin product is the only heptavalent therapeutic licensed approved by the FDA and Health Canada for the treatment of botulism and has orphan drug designation. Other companies may be developing therapies aimed at treating or preventing botulism infections, however, direct competition is currently limited.

~~VIGIV~~. Our VIGIV product is the only therapeutic licensed approved by the FDA and Health Canada to address adverse events from smallpox vaccination with ACAM2000. Other companies may be developing therapies aimed at treating or preventing vaccinia infections; however, direct competition is currently limited. SIGA Technologies, Inc. is developing Tecovirimat (Arestvyr™, ST-26), an oral therapy that targets orthopox viruses such as vaccinia and potentially smallpox. Chimerix is also developing brincidofovir, a nucleotide analog lipid conjugate for treatment of smallpox.

~~RSDL~~. In the United States, the RSDL Kit is the only medical device cleared by the FDA to remove or neutralize chemical warfare agents and T-2 toxin from the skin. Internationally, various Ministries of Defense have procured Fullers Earth, Dutch Powder and French Powder as a preparedness countermeasure for the decontamination of liquid chemical weapons from the skin.

~~Vivotif~~®. Vivotif is the only licensed FDA-approved oral typhoid vaccine globally. In the markets where Vivotif is licensed, it competes with Sanofi Pasteur’s Typhim VI® vaccine, an injectable polysaccharide typhoid vaccine.

~~Vaxchora~~®. In the United States, Vaxchora is the only FDA-licensed approved vaccine available indicated to prevent cholera. Dukoral®, an injectable cholera vaccine manufactured by Valneva, is available outside of the U.S.

~~Trobigard~~. Trobigard auto-injector delivers obidoxime chloride and atropine sulfate for emergency treatment of organophosphate nerve agent or insecticide poisoning. Meridian Medical Technologies, a subsidiary of Pfizer, is currently the sole owner of FDA-approved nerve agent antidote auto-injector devices to the USG and many international allied governments. Internationally, the remaining market is fragmented and served by regional or national-based defense product manufacturers.

~~Contract Development and Manufacturing Services Business~~. We compete for contract manufacturing service business with a number of biopharmaceutical product development organizations, contract manufacturers of biopharmaceutical products and university research laboratories, including, among others: Lonza Group Ltd., OSO BioPharmaceuticals Manufacturing, LLC, Par Pharmaceutical Companies, Inc., Jubilant Hollister-Stier Laboratories LLC (a subsidiary of Jubilant Life Sciences Limited), Patheon Inc., Hospira Inc., Ajinomoto Althea, Inc. (a subsidiary of Ajinomoto Co., Inc.), Cook Pharmica LLC (a subsidiary of Cook Group Inc.), and Albany Molecular Research, Inc. We also compete with in-house research, development and support service departments of other biopharmaceutical companies.

•Companies with which we compete for CDMO services include, among others: Lonza Group Ltd., Catalent, Inc., Thermo Fisher Scientific, Curia Global, Inc., Charles River Laboratories, Avid Bioservices, KBI Biopharma, Vetter Pharma, and FUJIFILM Dionsynth Biotechnologies. We also compete with in-house research, development and support service departments of other biopharmaceutical companies.

Geographical Reliance

For the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016, our product sales~~2019, the Company's revenue from U.S. customers as a percentage of total revenues were ~~73%~~92%, ~~67%~~93% and ~~58%~~90%, respectively.

MANUFACTURING

OPERATIONS

Our Lansing, Michigan site is a vertically integrated manufacturing campus and the location of our BioThrax manufacturing and NuThrax development operations. Located within the Lansing site is Building 55, our large-scale manufacturing facility, which was licensed by the FDA in August 2016 for the manufacture of BioThrax. This facility has the potential to manufacture up to 20 to 25 million doses of BioThrax annually on a single manufacturing train and has the physical footprint to add an additional manufacturing train, if needed. The manufacturing capabilities of Building 55 are central to our Vaccines and Anti-Infectives business unit. Our Lansing site also comprises biologics bulk product manufacturing capability (large- and small-scale), which we market to Contract Development and Manufacturing customers.

Our manufacturing facilities located at our Winnipeg, Manitoba, Canada, site are actively engaged in plasma-derived hyperimmune therapeutics manufacturing, chromatography-based plasma fractionation, downstream processing, aseptic filling, packaging and warehousing, quality assurance and control, and include development laboratories and office space. At these facilities, we manufacture and fill our hyperimmune specialty plasma products, including Anthrasil, BAT and VIGIV, and we conduct bulk manufacture our RSDL lotion. At these facilities, we also manufacture other hyperimmune products for contract manufacturing customers. The facilities at this site will play a key role in executing both product development and manufacturing ~~activities in support of our Antibody Therapeutics~~network allows us to deploy capabilities and ~~Contract Development~~capacity for clinical and ~~Manufacturing business units.~~commercial supply needs.

Our primary contract fill/finish services manufacturing site is located in Baltimore, Maryland, and is referred to as our “Camden Site.” The Camden Site provides pharmaceutical product development and filling services for injectable and other sterile products, as well as process design, technical transfer, manufacturing validations, laboratory support, aseptic filling, lyophilization, final packaging and accelerated and ongoing stability studies support. This facility is an approved manufacturing facility under the regulatory regimes in the United States, Canada, Japan, Brazil, the Middle East as well as various other countries. The facility includes warehousing space used for cold-storage and freezer capacity to support contract manufacturing customers. Additionally, we intend for this facility to provide fill/finish services to many of our business units for our development and commercial-stage products and product candidates.

Our manufacturing facility focused on disposable manufacturing for viral and non-viral products is located in Baltimore, Maryland, and is referred to as our “Bayview Site.” This facility is designed to take advantage of single-use bioreactor technology and to be capable of manufacturing several different products, including products derived from cell culture or microbial systems. In June 2012, we entered into a contract with BARDA, which established our Bayview Site as a CIADM. In May 2017 we completed work to expand this facility to double its original size to meet the needs of our customers. The facility is one of three centers designated by HHS to provide advanced development and manufacturing of MCMs to support the USG’s national security and public health emergency needs. This facility has also been and will continue to be marketed to non-USG clients in need of bulk manufacturing services. We are currently in the process of pursuing FDA licensure for the transfer of bulk manufacturing of raxibacumab to our Bayview facility.

We also currently lease a packaging facility in Hattiesburg, Mississippi, at the University of Southern Mississippi’s Accelerator, a technology innovation and commercialization center. This facility is equipped to package RSDL. RSDL bulk lotion that is manufactured in Winnipeg is shipped to Hattiesburg, Mississippi, for combination with RSDL sponges, which are further manufactured, packaged and then released for sale. All RSDL packets are packaged at this facility.

In October 2017, in connection with our acquisition of the ACAM2000 business from Sanofi, we acquired a live viral manufacturing facility and a leased office and warehouse space, both in Canton, Massachusetts, and a leased cGMP live viral fill/finish facility in Rockville, Maryland. Our Rockville facility is an FDA-licensed manufacturing facility under the regulatory regimes of the United States, Australia and Singapore. In November 2017, we received FDA approval of our supplemental BLA for the transfer of the upstream portion of the manufacturing process of ACAM2000 to our live viral manufacturing facility in Canton, Massachusetts.

~~In October 2018, in connection with our acquisition of PaxVax, we acquired a live viral manufacturing facility located in Bern, Switzerland and a fill/finish facility located in San Diego, California.~~

Supplies and Raw Materials

We currently rely on contract manufacturers and other third parties to manufacture some of the supplies we require for pre-clinical studies and clinical trials, as well as supplies and raw materials used in the production of our products. Typically, we acquire these supplies and raw materials on a purchase order basis and, when possible, in quantities we believe adequate to meet our needs. We obtain ~~Alhydrogel®~~Alhydrogel® adjuvant 2%, used to manufacture ~~BioThrax~~AV7909 and ~~NuThrax,~~BioThrax, from a single-source supplier for which we currently have no alternative source of supply. However, we maintain stored supplies of this adjuvant in quantities believed to be sufficient to meet our expected manufacturing ~~needs for these products.~~needs. We also utilize single-source suppliers for other raw materials in our manufacturing processes.

We utilize single source suppliers for all components of ~~NARCAN® Nasal Spray.~~NARCAN. It is manufactured by a third party, which operates a full service offering from formulation to final packaging. Materials for production of ~~NARCAN® Nasal Spray,~~NARCAN, such as ~~Naloxone API~~the naloxone active pharmaceutical ingredient and other excipients, along with the vial, stopper and device are produced around the world by other third parties and delivered to the primary manufacturer and released to manufacturing following appropriate testing.

We rely on single source suppliers for our plasma collection to support the Anthrasil, VIGIV and BAT programs. We work closely with our suppliers for these specialty programs and operate under long term agreements. We order quantities of material in advance in quantities believed to be sufficient to meet upcoming demand requirements.

The rapid demand for COVID-19 vaccines and therapeutics in light of the current pandemic has caused significant demand for raw materials for the vaccine and therapeutics we are manufacturing. Furthermore, competition for limited supplies of such raw materials from other manufacturers of COVID-19 vaccines and therapeutics may limit our ability to manufacture on a timely basis.

INTELLECTUAL PROPERTY

We actively seek to protect ~~the~~ intellectual property ~~that arises from~~related to our ~~activities. It is our policy to respect the intellectual property~~Company's assets, including patent rights, trademark rights, trade secrets and proprietary confidential information, through defense and enforcement of ~~others. In general,~~existing rights and ~~where practicable, we pursue patent~~pursuit of protection ~~for~~on new and ~~innovative processes and products that we develop.~~arising innovations. The duration of and the type of protection ~~afforded by a~~for patent ~~varies on a product-by-product basis and country-to-country basis and~~rights depends upon many factors including the type of patent, the scope of its coverage, the availability of regulatory-related extensions or administrative term adjustments, the availability of legal remedies in a particular country, and the validity and enforceability of the patents. In some cases, we may decide that the best way to protect certain intellectual property is to retain proprietary information as trade secrets rather than apply for patent protection, which requires disclosure of the proprietary information to the public. We take a number of measures to protect our trade secrets and other confidential information, including entering into confidentiality agreements with employees and third parties. In general, and where practicable, we also pursue registered trademarks for our products and product candidates. We are a party to ~~a number of~~various license agreements, including those under which we license patents, patent applications, trademarks, and other intellectual ~~property. We enter into these agreements~~property rights. It is our policy to ~~augment~~ethically consider the enforcement and defense of our ~~own~~ intellectual property rights, and to ~~secure freedom to operate where necessary. These agreements sometimes impose various commercial diligence and financial payment obligations on us. We expect to continue to enter into these types~~respect the intellectual property rights of ~~agreements in the future.~~others.

REGULATION

Regulations in the United States and other countries have a significant impact on our product development, manufacturing and marketing activities.

Government Contracting

Our status as a USG contractor means that we are subject to various statutes and regulations, including:

the Federal Acquisition Regulation (“FAR”) and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;

•the Federal Acquisition Regulation (FAR) and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;

•the Defense Federal Acquisition Regulations (DFARs) and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of DoD government contracts;

the Defense Federal Acquisition Regulations (“DFARs”) and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of DoD government contracts;

•the Department of State Acquisition Regulation (DOSAR) which regulates the relationship between a Department of State organization and a contractor or potential contractor;

•business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;

~~the Department of State Acquisition Regulation (“DOSAR”)~~ ~~which regulates the relationship between a Department of State organization and a contractor or potential contractor;~~

•export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms Regulations); and

business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;

~~export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms Regulations); and~~

~~laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.~~

•laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.

USG agencies routinely audit and investigate government contractors for compliance with applicable laws and standards. ~~These~~Our role and status as a large government supplier to HHS, particularly BARDA and the SNS, increases the likelihood of Congressional review and oversight. The oversight and regulations we are subject to can impose stricter penalties than those normally applicable to commercial contracts, such as criminal and civil liability and suspension and debarment from future government contracting. In addition, pursuant to various regulations, our government contracts can be subject to unilateral termination or modification by the government for convenience, detailed auditing and accounting systems requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes.

The Project BioShield. Act of 2004.The Project BioShield Act of 2004 (“(Project BioShield) was enacted to augment market incentives for companies pursuing the development of MCMs of which the government is the only significant market. Project ~~BioShield”) provides expedited procedures~~BioShield provided $5.6 billion over 10 years to develop, purchase, and stockpile MCMs for ~~bioterrorism-related~~use in a public health emergency against chemical, biological, radiological, and nuclear (CBRNE) agents.

The Pandemic and All Hazards Preparedness Act of 2006 and Reauthorization Acts.The Pandemic and All Hazards Preparedness Act of 2006 (PAHPA) established a new Assistant Secretary for Preparedness and Response (ASPR) within HHS and provided new authorities for a number of programs, including the creation of BARDA for the advanced research and development and procurement of MCMs for CBRNE. The Pandemic All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) continued BARDA’s role and reauthorized Project BioShield funding through fiscal year 2018 and provided BARDA with additional appropriations to support advanced R&D. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) reauthorized Project BioShield’s special reserve fund and authorized 10-year funding for product development. BARDA has used the incentives under Project BioShield and subsequent reauthorizations of it to build a robust pipeline of MCMs for multiple CBRNE threat agents. It has also procured and stockpiled many of our related products for potential use in the event of a PHT emergency, including BioThrax, ACAM2000, Anthrasil, BAT, VIGIV and raxibacumab.

Funding for BARDA is provided by annual appropriations by Congress. Congress appropriates annual funding for procurements of MCMs for the SNS (currently managed by ASPR) and for the NIAID to conduct biodefense research. This appropriation funding supplements amounts available under Project BioShield.

Emergency Use Authorization

As amended by Project BioShield and subsequent legislation, including PAHPRA and the ~~awarding of research grants, making it easier for HHS to rapidly commit funds to countermeasure projects. Project BioShield relaxes procedures under~~21st Century Cures Act, the ~~FAR for procuring property or services used in performing, administering or supporting biomedical countermeasure research and development. In addition, if~~FDCA permits the Secretary of HHS ~~deems~~to authorize the introduction into interstate commerce of unapproved MCMs, or approved MCMs for unapproved uses, in the context of an actual or potential emergency that ~~there is a pressing need, Project BioShield authorizes~~has been declared by designated government officials (known as emergency use). The types of emergencies that trigger these authorities include public health emergencies announced by the Secretary of HHS, military emergencies announced by the Secretary of Defense, domestic emergencies announced by the Secretary of Homeland Security, and the identification of a material threat pursuant to Section 319-F-2 of the Public Health Service Act (PHSA) that is sufficient to affect national security or the health and security of United States citizens living abroad. After one of the emergencies has been announced, the Secretary of HHS may authorize the issuance of, and the FDA Commissioner may issue, EUAs for the use ~~an expedited award process, rather than~~of specific products based on criteria established by statute, including that the ~~normal peer review process, for grants, contracts~~product at issue may be effective in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by CBRNE threat agents when there are no adequate, approved, and ~~cooperative agreements related~~available alternatives. EUAs are subject to ~~biomedical countermeasure research~~additional conditions and ~~development activity.~~ restrictions, are product-specific, and terminate when the emergency determination underlying the EUA terminates.

Under ~~Project BioShield, in limited specified circumstances, HHS can contract to~~PAHPRA, the USG may also, at its discretion, purchase ~~unapproved countermeasures~~critical biodefense products for the SNS ~~and authorize~~prior to FDA approval after the ~~emergency use~~filing of ~~medical products that have~~a pre-EUA application with the FDA. BARDA is currently procuring AV7909 from us pursuant to this authority, a product candidate which has not yet been approved by the FDA.

~~First Responders Act~~. The First Responder Anthrax Preparedness Act of 2016 directs the Secretary of Homeland Security, in consultation with the Secretary of HHS, to establish a pilot program to provide short-dated vaccines from the SNS to emergency response providers on a voluntary basis.

Public Readiness and Emergency Preparedness Act.The Public Readiness and Emergency Preparedness Act ~~(“PREP Act”) was signed into law in December 2005. The PREP Act~~(PREP Act) creates liability ~~protection~~immunity for manufacturers of ~~biodefense countermeasures~~MCMs when the Secretary of HHS issues a declaration for their manufacture, administration or use. A PREP Act declaration is intended to provide liability ~~protection~~immunity from claims under federal or state law for loss arising out of the administration or use of a covered ~~countermeasure~~MCM under a government contract. The only statutory exception to this immunity is for actions or failures to act that constitute willful misconduct. The Secretary of HHS has ~~issued~~issued PREP Act declarations identifying BioThrax, ACAM2000, raxibacumab, Anthrasil, BAT and VIGIV, as covered ~~countermeasures.~~MCMs. These declarations expire in 2022. ~~Manufacturers are not entitled~~

Support Anti-Terrorism by Fostering Effective Technology Act of 2002 (SAFETY Act). The SAFETY Act was enacted to ~~protection~~create liability limitations for qualifying anti-terrorism technologies for claims arising from or

related to an act of terrorism. Renewal of coverage of BioThrax under the ~~PREP~~SAFETY Act ~~in cases~~is pending. Even if we renew coverage of ~~willful misconduct~~the SAFETY Act for BioThrax and ~~accordingly, the PREP Act~~RSDL, such benefits may not provide adequate protection from all claims made against us.

~~Support Anti-Terrorism by Fostering Effective Technology Act of 2002~~. The Support Anti-Terrorism by Fostering Effective Technology Act of 2002 (“SAFETY Act”) is intended to create product liability limitations for qualifying anti-terrorism technologies for claims arising from or related to an act of terrorism. Certain of our products, namely BioThrax and RSDL, are certified anti-terrorism products covered under the protections of the SAFETY Act. Although we are covered by the benefits of the SAFETY Act for BioThrax and RSDL, the SAFETY Act may not provide adequate protection from all claims made against us.

Product Development for Therapeutics and Vaccines

Pre-Clinical ~~Testing. Before beginning testing of compounds in human subjects in the United States, stringent government requirements for pre-clinical data must be satisfied. Pre-clinical testing generally includes both~~ ~~in vitro, or in an artificial environment outside of a living organism, and~~ ~~in vivo, or within a living organism, laboratory evaluation and characterization of the safety and efficacy of a drug and its formulation.~~Testing. We generally perform pre-clinical safety and efficacy testing on our product candidates before we initiate clinical trials.

Animal Rule.~~For product candidates that are intended to treat or prevent infection from rare life-threatening diseases, conducting~~ Conducting controlled clinical trials with human patients to determine efficacy may sometimes be unethical or unfeasible. ~~Under regulations issued by~~In such circumstances, products may be approved under the FDA’s “Animal Rule.” According to the FDA, ~~in 2002, often referred to as~~this regulatory pathway can only be pursued if conducting human efficacy studies is unethical and field trials, after an accidental or deliberate exposure, are not feasible. Under the “Animal Rule,” under some circumstances, approval of ~~such~~ product candidates can be based on clinical data from trials in healthy subjects that demonstrate adequate safety and immunogenicity as well as efficacy data from ~~adequate and well-controlled~~ animal studies. Among other requirements, the animal studies must establish that the drug or biological product is reasonably likely to produce clinical benefit in humans. Because the FDA must agree that data derived from animal studies may be extrapolated to establish safety and efficacy in humans, these studies add complexity and uncertainty to the testing and approval process. In addition, products approved under the Animal Rule are subject to additional requirements, including post-marketing study requirements, restrictions imposed on marketing or distribution or requirements to provide information to patients.

Investigational New Drug ~~Application~~.Application. Before clinical testing may begin, the results of pre-clinical testing ~~together with manufacturing information, analytical data~~ and ~~any~~ other available clinical data ~~or literature,~~and manufacturing information must be submitted to the FDA as part of an ~~IND~~Investigational New Drug (IND) application. The ~~sponsor must also include an initial protocol detailing the first phase of the proposed clinical investigation. The pre-clinical~~ data must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical ~~studies in human volunteers.~~studies. The ~~IND automatically becomes effective 30 days after receipt by the~~ FDA ~~unless the FDA imposes~~may impose a full or partial clinical hold ~~within that 30-day period.~~on clearance of an IND pending receipt of additional information.

Clinical ~~Trials~~. Trials.Clinical trials ~~generally~~ involve ~~the~~ administration of ~~the~~a product candidate to healthy human volunteers or to patients under the supervision of a qualified physician ~~(also called an investigator) pursuant~~under a regulatory agency approved protocol for the country in which the human trial is to ~~an FDA-reviewed protocol. In certain cases, described below, animal studies may~~ be ~~used in place of human studies.~~conducted. Human clinical trials typically are conducted in the following three sequential ~~phases, although the phases may overlap with one another and trial designs vary depending on the Therapeutic or Prophylactic nature~~phases.

•Phase 1 involves introduction of the ~~product. Clinical~~drug into healthy human subjects to assess safety, metabolism, pharmacokinetics, pharmacological actions, side effects and early evidence of effectiveness.

•Phase 2 involves studies to assess the efficacy of the drug in specific, targeted indications, explore tolerance, optimal dosage, and safety.

•Phase 3 trials must demonstrate clinical efficacy and safety in a larger number of healthy subjects or patients, and permit the FDA to evaluate the overall benefit-risk

relationship of the product and provide adequate information for drug labeling.

Phase 4 studies may also be conducted ~~under protocols~~following marketing approval to provide additional data related to drug use. The FDA may impose a temporary or permanent clinical hold, or other sanctions, if it believes that ~~detail~~a clinical trial is not being conducted in accordance with the ~~objectives of the study, the parameters to be used to monitor safety and the efficacy criteria, if any, to be evaluated. Each protocol must be submitted~~FDA requirements or presents an unacceptable risk to the ~~FDA as part of the IND.~~clinical trial subjects.

~~Phase 1 clinical trials test for safety, dose tolerance, absorption, bio-distribution, metabolism, excretion and clinical pharmacology and, if possible, for early evidence regarding efficacy.~~

Phase 2 clinical trials involve a small number of patients with the target disease or disorder and seek to assess the efficacy of the drug for specific indications to determine dose response and the optimal dose range and to gather additional information relating to safety and potential adverse effects.

Phase 3 clinical trials consist of expanded, larger-scale studies of patients with the target disease or disorder to obtain definitive statistical evidence of the efficacy and safety of the proposed product candidate using a specific dosing regimen. The safety and efficacy data generated from Phase 3 clinical trials typically form the basis for FDA approval of the product candidate.

Phase 4 clinical trials are sometimes conducted after a product has been approved. These trials can be conducted for a number of purposes, including to collect long-term safety information or to collect additional data about a specific patient population. As part of a product approval, the FDA may require that certain Phase 4 studies, which are sometimes called post-marketing commitment studies, be conducted post-approval.

Good Clinical ~~Practice~~.Practice. All phases of clinical studies must be conducted in conformance with the FDA’s bioresearch monitoring regulations and Good Clinical Practices ~~(“GCP”)~~(GCP) which are ethical and scientific quality standards for conducting ~~recording and reporting~~ clinical ~~trials to assure that the data and reported results are credible and accurate and that the rights, safety and well-being of trial participants are protected.~~

trials.

Marketing Approval – Biologics, Drugs and Vaccines

Biologics License Application/New Drug ~~Application~~.Application. For large molecule ~~products, including~~ products, such as vaccines, products derived from blood and blood components, and antibodies, ~~and other recombinant proteins,~~ all data obtained from a development program, including research and product development, manufacturing, pre-clinical and clinical trials, labeling and related information are submitted in a BLA to the FDA and in similar regulatory filings with the corresponding agencies in other countries for review and approval. For small molecule drugs, this information is submitted in a new drug application ~~(“NDA”)~~(NDA) filing. The submission of an application is not a guarantee that the FDA will find the application complete and accept it for filing. The FDA may issue a refuse to file, or RTF, letter to the ~~application~~applicant and request additional information, ~~rather than accept the application for filing,~~ in which case the application must be ~~resubmitted with~~resubmitted. Most applications are subject to a substantial application fee and, if approved, will be assessed an annual fee. Under the ~~supplemental information. Once an application is accepted for filing, the Prescription Drug User Fee Act (“PDUFA”) requires~~FDCA, the FDA has the authority to ~~review the application within 10 months~~grant waivers of ~~its 60-day filing date, although in practice, longer review times may occur.~~

~~In addition, under the Pediatric Research Equity Act of 2003 (“PREA”), BLAs, NDAs and~~ certain supplements must contain data to assess the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug or biologic for an indication for which orphan drug designation has been granted.

user fees.

In reviewing a BLA or NDA, the FDA may grant approval, request more information or data, or deny the application if it determines the application does not provide ~~an adequate basis~~substantial evidence of effectiveness and/or that the drug is not safe for ~~approval. Even if such additional information and data are submitted,~~use under the conditions of use in the proposed labeling. If the FDA ~~may ultimately decide that~~decides not to approve an application, it will issue a complete response letter, or CRL. The FDA will also typically inspect one or more clinical sites to ensure compliance with GCPs as well as the facility or facilities at which the candidate is manufactured to ensure compliance with current good manufacturing practices (cGMPs).

We are working on a BLA ~~or NDA does not satisfy~~for filing with the ~~criteria for approval.~~ FDA related to AV7909, a portion of which we submitted to the FDA in December of 2021.The receipt of regulatory approval ~~often takes~~may take many years, ~~involving~~and typically

involves the expenditure of substantial financial resources. ~~The speed with which~~Accordingly, there can be no assurances we will receive approval ~~is granted often depends on a number of factors, including~~for AV7909 from the ~~severity of the disease in question, the availability of alternative treatments and the risks and benefits of the product candidate as demonstrated in clinical trials.~~FDA. The FDA may also impose conditions upon approval. For example, it may require a Risk Evaluation and Mitigation Strategy (“REMS”) for a product. This can include various required elements, such as publication of a medication guide, patient package insert, a communication plan to educate health care providers of the drug’s risks and/approval or ~~restrictions on distribution and use such as limitations on who may prescribe or dispense the drug. The FDA may also~~ significantly limit the indications approved for a given product and/or require, as a condition of approval, enhanced labeling, ~~special~~ packaging, ~~or labeling,~~ post-approval clinical trials, expedited reporting of certain adverse events, pre-approval of promotional materials or restrictions on ~~direct-to-consumer~~consumer advertising, ~~any of~~ which could negatively impact the commercial success of a product.

~~Fast Track Designation~~. The FDA may designate a product as a fast track drug if it is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for this disease or condition. Sponsors granted a fast track designation for a drug are granted more opportunities to interact with the FDA during the approval process and are eligible for FDA review of the application on a rolling basis, before the application has been completed. The FDA granted fast track status to NuThrax in June 2011 and to ZIKV-IG in December 2017.

~~Orphan Drugs~~. Under the Orphan Drug Act, an applicant can request the FDA to designate a product as an “orphan drug’’ in the United States if the drug is intended to treat an orphan, or rare, disease or condition. A disease or condition is considered orphan if it affects fewer than 200,000 people in the United States. A manufacturer must request orphan drug designation prior to submitting a BLA or NDA. Products designated as orphan drugs are eligible for special grant funding for research and development, FDA assistance with the review of clinical trial protocols, potential tax credits for research, reduced filing fees for marketing applications and a special seven-year period of market exclusivity after marketing approval. Orphan drug exclusivity (afforded to the first applicant to receive approval for an orphan designated drug) prevents FDA approval of applications by others for the same drug for the designated orphan disease or condition. The FDA may approve a subsequent application from another applicant if the FDA determines that the application is for a different drug or different use, or if the FDA determines that the subsequent product is clinically superior, or that the holder of the initial orphan drug approval cannot assure the availability of sufficient quantities of the drug to meet the public’s need. A grant of an orphan designation is not a guarantee that a product will be approved.

~~Our products with current orphan drug exclusivity in the United States include the following:~~

~~BioThrax for post-exposure prophylaxis of disease following suspected or confirmed~~ ~~B. anthracis~~ ~~exposure, when administered in conjunction with recommended antibacterial drugs, with exclusivity though November 2022;~~

raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate, with exclusivity through December 2019;

Anthrasil for the treatment of toxemia associated with inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs, with exclusivity through March 2022; and

~~BAT for the treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or G, with exclusivity through March 2020.~~

~~Post-Approval Requirements~~. Any drug, biologic or medical device product for which we receive FDA approval will be subject to continuing regulation by the FDA, including, among other things, record keeping requirements, reporting of adverse experiences, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, cGMPs and restrictions on advertising and promotion. Adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s distribution or use and, potentially, withdrawal or suspension of the product from the market. In addition, the FDA has post-approval authority to require post-approval clinical trials and/or safety labeling changes if warranted by the appearance of new safety information. In certain circumstances, the FDA may impose a REMS after a product has been approved. Facilities involved in the manufacture and distribution of approved products are required to register their facility with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA for compliance with cGMP and other laws. The FDA also closely monitors advertising and promotional materials we may disseminate for our products for compliance with restrictions on off-label promotion and other laws. We may not promote our products for conditions of use that are not included in the approved package inserts for our products. Certain additional restrictions on advertising and promotion exist for products that have so-called “black box warnings” in their approved package inserts, such as Anthrasil and VIGIV in the United States.

~~Vaccine and~~ ~~Therapeutic Product Lot Release and FDA Review~~. Because the manufacturing process for biological products is complex, the FDA requires for many biologics, including most vaccines and immune globulin products, that each product lot undergo thorough testing for purity, potency, identity and sterility. All of our vaccines and immune globulin products are subject to lot release protocols by the FDA and other regulatory agencies. The length of the review process depends on a number of factors, including reviewer questions, license supplement approval, reviewer availability and whether our internal testing of product samples is completed before or concurrently with regulatory agency testing, if applicable.

~~Priority Review Vouchers~~. In 2007, the Food and Drug Administration Amendments Act added Section 524 to the Food, Drug, and Cosmetic Act and established the Neglected Tropical Disease Priority Review Voucher (“PRV”) program. This PRV program was expanded in 2012 by the Food and Drug Administration Safety and Innovation Act to include rare pediatric diseases. In December 2016, the 21^st Century Cures Act established a PRV program within the FDA for MCMs for chemical, biological, radiological or nuclear threats, and those vaccines, therapeutics and MCMs, that prevent or treat material threat agents as identified in the Public Health Service Act. Under the PRV program, upon approval of a qualified product, companies receive a special voucher which allows them to have a drug reviewed under FDA’s priority review system, with the anticipation that it will accelerate the regulatory review to get the product to market more rapidly. Recipients of a PRV may transfer that voucher to another party for consideration.

~~Several of our investigational stage product candidates may~~ be eligible for PRV under multiple PRV programs upon the product approval. We believe that ZIKV-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis and treatment for Zika infections in at risk populations may have the potential for a PRV under the Neglected Tropical Disease PRV program. We believe that the Chikungunya VLP vaccine, being developed for prevention of disease caused by chikungunya infections, may have the potential for a PRV under the Neglected Tropical Disease PRV program and under the MCM PRV program. We also believe that rVSV-Quad, rVSV-Lassa, rVSV-Ebola, rVSV-Marburg and rVSV-Sudan, the candidate viral hemorrhagic fever virus vaccines, may have potential for a PRV under either the Neglected Tropical Disease PRV program or the MCM PRV program. However, there can be no assurances that any of these candidates will obtain PRV status.

~~Marketing Approval – Devices~~

Devices may fall within the definition of a Medical Device or may be a Combination Product including both a device for delivery of a drug product and the drug product itself. Medical Devices are also subject to FDA clearance or approval and extensive regulation under the U.S. Food, Drug and Cosmetic Act (“FDCA”). Under the FDCA, medical devices are classified into one of three classes: Class I, Class II or Class III. The classification of a device generally depends on the degree of risk associated with the medical device and the extent of control needed to ensure safety and effectiveness. The RSDL Kit is regulated as a non-restricted Class II medical device. Our Trobigard auto-injector product is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.

Class I devices are those for which safety and effectiveness can be assured by adherence to a set of general controls. These general controls include compliance with the applicable portions of the FDA’s Quality System Regulation (“QSR”) which sets forth requirements for manufacturing practices, record keeping, reporting of adverse medical events, labeling and promotion only for cleared or approved intended uses.

Class II devices are also subject to these general controls and to any other special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Review and clearance by the FDA for these devices is typically accomplished through the 510(k)-pre-market notification procedure. When 510(k) clearance is sought, a sponsor must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a device approved by the FDA after May 28, 1976. This previously-cleared device is called the predicate device. If the FDA agrees that the proposed device is substantially equivalent to the predicate device, then 510(k) clearance to market will be granted. After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could require pre-market approval. If a proposed device is substantially equivalent to a predicate device that was cleared prior to May 28, 1976, the proposed device is cleared based on a pre-amendment and is cleared as an unclassified device.

A Class III device requires approval of a pre-market application (“PMA”) which is an expensive, lengthy and uncertain process requiring many years to complete. Clinical trials are almost always required to support a PMA. These trials generally require submission of an application for an investigational device exemption (“IDE”). An IDE must be supported by pre-clinical data, such as animal and laboratory testing results, which show that the device is safe to test in humans and that the study protocols are scientifically sound. The IDE must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and is eligible for more abbreviated investigational device exemption requirements.

Both before and after a medical device is commercially distributed, manufacturers and marketers of the device have ongoing responsibilities under FDA regulations. The FDA reviews design and manufacturing practices, record keeping, reports of adverse events, labeling and other information to identify potential problems with marketed medical devices. Device manufacturers are subject to periodic and unannounced inspection by the FDA for compliance with cGMP requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, servicing, labeling, storage, installation and distribution of all finished medical devices intended for human use. If the FDA finds that a manufacturer has failed to comply or that a medical device is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and remedies, ranging from a public warning letter to more severe actions, including:

§ ~~fines, injunctions, and civil penalties;~~

§ ~~recall or seizure of products;~~

§ ~~operating restrictions, partial suspension or total shutdown of production;~~

§ ~~refusal of requests for 510(k) clearance or PMA approval of new products;~~

§ ~~withdrawal of 510(k) clearance or PMA approvals already granted; and~~

§ ~~criminal prosecution.~~

The FDA also has the authority to require repair, replacement or refund of the cost of any medical device. The FDA also administers certain controls over the export of medical devices from the United States, as international sales of medical devices that have not received FDA approval are subject to FDA export requirements.

Combination Products, of the type described above, are subject to the BLA/NDA regulatory regime. Our Trobigard auto-injector is a combination product and is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.

Abbreviated New Drug Applications and Section 505(b)(2) New Drug Applications. Most drug products obtain FDA marketing approval ~~pursuant to an~~under a full NDA for innovator products, or an ~~ANDA~~abbreviated new drug application for generic products. Relevant to ~~ANDAs,~~Abbreviated New Drug Applications (ANDAs, each an ANDA) the Hatch-Waxman amendments to the FDCA established a statutory procedure for submission and FDA review and approval of ANDAs for generic versions of branded drugs previously approved by the FDA ~~(such previously approved drugs are also referred to as listed drugs)~~(RLDs)). Because the safety and efficacy of ~~listed drugs~~RLDs have already been established by the brand company (sometimes referred to as the innovator), the FDA does not require ~~a demonstration of~~ANDA applicants to independently demonstrate safety and efficacy of generic products. However, a generic manufacturer is ~~typically~~ required to ~~conduct bioequivalence studies of~~demonstrate that its ~~test~~ product ~~against~~contains the ~~listed drug. The bioequivalence studies for orally administered, systemically available drug products assess~~same active ingredient as, and is bioequivalent to, the ~~rate and extent to which the API is absorbed into the bloodstream from the drug product and becomes available at the site of action.~~innovator product. Bioequivalence is established when there is an absence of a significant difference in the rate and extent for absorption of the generic product and the listed drug. ~~In addition to the bioequivalence data, an ANDA must contain patent certifications and chemistry, manufacturing, labeling and stability data.~~

~~The~~A third alternative isfor approval of a ~~special type of NDA,~~drug product is commonly referred to as a Section 505(b)(2) NDA, which enables the applicant to rely, in part, on the FDA’s findings of safety and efficacy of an existing product ~~or published literature,~~ in support of its application. Section 505(b)(2) NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The applicant may rely upon the FDA’s findings with respect to certain ~~preclinical~~pre-clinical or clinical studies conducted for an approved product. The FDA may also require companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product candidate for certain label indications for which the referenced product has been approved, as well as for any new indication sought by the ~~Section 505(b)(2)~~ applicant.

In seeking approval for a drug through an NDA, including a 505(b)(2) NDA, applicants are required to list with the FDA certain patents of the applicant or that are held by third parties whose claims cover the

applicant’s product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the Orange Book. Any subsequent applicant who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a 505(b)(2) NDA referencing a drug listed in the Orange Book must make one of the following certifications to the FDA concerning patents: (1) the patent information concerning the ~~reference listed drug product~~RLD has not been submitted to the FDA; (2) any such patent that was filed has expired; (3) the date on which such patent will expire; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. This last certification is known as a paragraph IV certification. A notice of the paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or 505(b)(2) application refers. The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent.

If the ~~reference~~RLD’s NDA holder or patent owners assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the paragraph IV certification notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the paragraph IV certification, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that is favorable to the applicant. The ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the branded reference drug has expired. ~~Thus~~

Biosimilar Products.When a biological product is licensed for marketing by FDA with approval of a ~~Section 505(b)(2) NDA~~BLA, the product may be entitled to certain types of market and data exclusivity barring FDA from approving competing products for certain periods of time under the Biologics Price Competition and Innovation Act of 2009 (the BPCIA). The BPCIA amended the PHSA to create an abbreviated approval pathway for biological products that are biosimilar to or ~~ANDA~~interchangeable with an FDA-licensed reference biological product.The FDA may approve a biosimilar product if it finds that there are no clinically meaningful differences between the innovator product and the proposed biosimilar product.For the FDA to approve an interchangeable biosimilar product, it must conclude that the product can be ~~stalled~~expected to produce the same clinical results as the reference product and would increase safety risks or risks of diminished efficacy.

An innovator biological product is granted 12 years of exclusivity from the time of first licensure of the product, and the FDA will not accept an application for a biosimilar or interchangeable product based on that biological product until ~~all~~four years after the ~~listed patents claiming~~date of first licensure of the ~~referenced~~reference product. However, another company could market a competing version of that product if the FDA approves a full BLA for such product containing the sponsor’s own pre-clinical data and data from adequate and

well‑controlled clinical trials to demonstrate the safety, purity, and potency of their product.There have ~~expired, until any non-patent~~been recent government proposals to reduce the 12-year reference product exclusivity period, but none has been enacted to date.At the same time, since passage of the BPCIA, many states have passed laws or amendments to laws, which address pharmacy practices involving biosimilar products.

Post-Approval Requirements. Any drug, biologic or medical device product for which we receive FDA approval will be subject to continuing regulation by the FDA, including, among other things, record keeping requirements, reporting of adverse experiences, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, cGMPs and restrictions on advertising and promotion. Adverse events that are reported after marketing approval can result in additional limitations being placed on the product’s distribution or use and, potentially, withdrawal or suspension of the product from the market. The FDA may also require post-approval clinical trials and/or safety labeling changes.

Facilities involved in the manufacture and distribution of approved products are required to be registered with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA for compliance with cGMP and other laws.

A company that is found to have improperly promoted unapproved or off-label uses or otherwise not to have met applicable promotion rules may be subject to significant liability under both the FDCA and other statutes, including the False Claims Act.

Orphan Drugs.Under the Orphan Drug Act, an applicant can request the FDA to designate a product as an “orphan drug" in the United States if the drug is intended to treat an orphan, or rare, disease or condition. A disease or condition is considered orphan if it affects fewer than 200,000 people in the United States. A manufacturer must request orphan drug designation prior to submitting a BLA or NDA. Products designated as orphan drugs are eligible for special grant funding for R&D, FDA assistance with the review of clinical trial protocols, potential tax credits for research, reduced filing fees for marketing applications and a special seven-year period of market exclusivity after marketing approval. A grant of an orphan designation is not a guarantee that a product will be approved.

Orphan drug exclusivity (afforded to the first applicant to receive approval for an orphan designated drug) prevents FDA approval of applications by others for the same drug for the designated orphan disease or condition. Orphan drug exclusivity will not bar approval of the same product marketed by a different

manufacturer under certain circumstances, including if the company with orphan drug exclusivity is not able to meet market demand or the subsequent product is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care.

Vaccine and Therapeutic Product Lot Protocol.Because the manufacturing process for biological products is complex, the FDA requires for many biologics, including most vaccines and immune globulin products, that each product lot undergo thorough testing for purity, potency, identity and sterility. Several of our vaccines are subject to lot release protocols by the FDA and other regulatory agencies.

Marketing Approval – Devices

Medical devices are classified into one of three classes -- Class I, Class II or Class III - depending on the degree of risk and the level of control necessary to assure the safety and effectiveness of each medical device. Medical devices deemed to pose lower risks are generally placed in either Class I or II. Pre-market review and clearance by the FDA for Class I and II medical devices is accomplished through a pre-market notification procedure, unless the device is exempt. Devices deemed by the FDA to pose the greatest risk, such as ~~exclusivity~~life-supporting or implantable devices, are generally placed in Class III.

A combination product is a product comprised of two or more regulated components (e.g., a drug and device) that are combined into a single product, co-packaged, or sold separately but intended for co-administration, as evidenced by the labeling for the products. Like their constituent products—e.g., drugs and devices—combination products are highly regulated and subject to a broad range of post marketing requirements including cGMPs, adverse event reporting, periodic reports, labeling and

advertising and promotion requirements and restrictions, market withdrawal and recall.

The FDA also administers certain controls over the export of medical devices from the United States, as international sales of medical devices that have not received FDA approval are subject to FDA export requirements.

Manufacturing Requirements

The FDA's regulations require that medicinal products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of ~~a new chemical entity, listed~~personnel, buildings and facilities, equipment, control of components and product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. Manufacturers and other entities involved in the ~~Orange Book~~manufacture and distribution of approved products are required to register their establishments with the FDA and some state agencies, and they are subject to periodic unannounced inspections by the FDA for compliance with cGMPs and other requirements.

Inspections must follow a "risk-based schedule" that may result in certain establishments being inspected more frequently. Manufacturers may also have to provide, on request, electronic or physical records regarding their establishments. Delaying, denying, limiting, or refusing inspection by the ~~referenced~~FDA may lead to a product ~~has expired,~~being deemed to be adulterated. Changes to the manufacturing process, specifications or container closure system for an approved product are strictly regulated and often require prior FDA approval before being implemented. The FDA's regulations also require, among other things, the investigation and correction of any deviations from cGMP and the imposition of reporting and documentation requirements upon the sponsor and any third-party manufacturers involved in producing the ~~case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement~~approved product.

Regulation Outside of the ~~lawsuit or a decision in the infringement case that is favorable to the ANDA or Section 505(b)(2) applicant.~~U.S.

~~Foreign Regulation~~

Currently, we maintain a commercial presence in the United States and Canada as well as ~~select foreign~~certain other countries. ~~We intend to further expand our commercial presence to additional foreign countries and territories.~~ In the European Union, medicinal products are authorized following a process that is similarly demanding as the process required in the United States. ~~Medicinal~~Drug products ~~must~~may be authorized in one of two ways, either through the decentralized procedure, which provides for the mutual recognition procedure of national approval decisions by the competent authorities of the European Union ~~(“EU”)~~(EU) Member States or through the centralized procedure by the European Commission, which provides for the grant of a single

marketing authorization that is valid for all EU member states. ~~The authorization process is essentially the same irrespective of which route is used.~~ Each foreign country subjects medical devices to its own regulatory requirements.We are also subject to many of the same continuing post-approval requirements in the EU as we are in the United States (~~e.g.~~(e.g., good manufacturing practices). ~~Additionally, each foreign country subjects medical devices~~

Potential Sanctions.

For all FDA-regulated products, if the FDA finds that a manufacturer has failed to ~~its own regulatory requirements. In the European Union, a harmonized medical device directive legislates approval requirements. Within this framework, the CE Mark, an attestation of conformity~~comply with ~~the essential health, safety~~applicable laws and environmental requirements and compliance with relevant European Union legislation, allows for the legal marketing of the product in all European Economic Area member states. Additionally, to the extentregulations, or that a product is ~~marketed outside~~ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and remedies, including but not limited to:

•restrictions on such products, manufacturers or manufacturing processes;

•restrictions on the labeling or marketing of a product;

•restrictions on distribution or use of a product;

•requirements to conduct post-marketing studies or clinical trials;

•warning letters or untitled letters;

•withdrawal of the ~~United States, a facility may also be registered with applicable ex-U.S.~~products from the market;

•refusal to approve pending applications or supplements to approved applications that are submitted;

•recall of products;

•fines, restitution or disgorgement of profits or revenues;

•suspension or withdrawal of marketing approvals;

•refusal to permit the import or export of our products;

•product seizure; and

•injunctions or the imposition of civil or criminal penalties.

Health regulatory authorities ~~who may also require inspections for compliance with local marketing regulations.~~in other countries have similar rules and regulations although the specifics vary jurisdiction to jurisdiction.

Fraud, Abuse and Anti-Corruption Laws

The United States and most other jurisdictions have detailed requirements that apply to government and private health care programs, and a broad range of fraud and abuse laws, transparency laws, and other laws. Relevant U.S. federal and state healthcare laws and regulations include:

~~As part~~•The federal Anti-Kickback Statute;

•The False Claims Act;

•The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), as

amended by the ~~Affordable~~Health Information Technology for Economic and Clinical Health (HITECH) Act;

•The price reporting requirements under the Medicaid Drug Rebate Program and the Veterans Health Care Act ~~the~~of 1992;

•The federal ~~government enacted the~~ Physician Payment Sunshine ~~Act. Manufacturers of drugs are required to publicly report payments~~Act, being implemented as the Open Payments Program; and ~~transfers of value made to physicians~~

•Analogous and ~~teaching hospitals. This information is posted on a public website.~~ similar state laws and regulations.

Failure to ~~timely~~comply with these laws and ~~accurately submit required information~~regulations could subject us to criminal or civil penalties.

Our operations are also subject to compliance with the Foreign Corrupt Practices Act ~~(“FCPA”)~~(FCPA) which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. We also may be implicated under the FCPA by the activities of our partners, collaborators, contract research organizations, vendors or other agents. As a public company, the FCPA also requires us to make and keep books and records that accurately and fairly reflect all of our transactions and to devise and maintain an adequate system of internal accounting controls. Our operations are also subject to compliance with the U.K. Bribery Act, which applies to bribery activities both in the public and private sector, Canada’s Corruption of Foreign Public Officials Act and similar laws in other countries.

Regulations Governing Reimbursement

The marketing practices of U.S. pharmaceutical manufacturers are also subject to federal and state healthcare laws related to government funded healthcare programs.

In the United States, certain of our products are reimbursed under federal and state health care programs such as Medicaid, Medicare, TriCare, and or state pharmaceutical assistance programs. Many foreign countries have similar laws.

Various U.S. federal health care laws apply when we or customers submit claims for items or services that are reimbursed under federally funded health care programs, including federal and state anti-kickback laws, false claims laws, and anti-self-referral laws, which may apply to federal and state-funded Medicaid and other health care programs and private third-party payers.

Failure to comply with these laws and regulations could subject us to criminal or civil penalties.

Additionally, drug pricing is an active area for regulatory reform at the federal and state levels, and significant changes to current drug pricing and reimbursement structures in the United States continue to be considered and enacted.

Data Privacy Laws

A number of states in the United States have passed or introduced bills, which, if passed, impose operational requirements on U.S. companies similar to the requirements reflected in the General Data Protection Regulation (GDPR) in the EU. For example, the California Consumer Privacy Act of 2018 (CCPA), which came into effect on January 1, 2020, requires covered companies that process personal information on California residents to make new disclosures to consumers about their data collection, use and sharing practices, allows consumers to opt out of certain data sharing with third parties and provides a new private right of action for data breaches. Additionally, the Federal Trade Commission and many state attorney generals are interpreting federal and state consumer protection laws to impose standards for the online collection, use, dissemination and security of data. The compliance and other burdens imposed by the EU's GDPR, CCPA and similar privacy laws and regulations may be substantial as they are subject to differing interpretations and implementation among jurisdictions. The restrictions imposed by such laws may require us to modify our data handling practices and impose additional compliance costs and burdens.

Other Industry Regulation

Our present and future business has been and will continue to be subject to various other laws and regulations. Various laws, regulations and recommendations relating to ~~the use of data,~~ safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import, export, use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents used in connection with our product development, are or may be applicable to our activities.

~~EMPLOYEES~~

As of February 15, 2019, we had 1,705 full-time employees. None of our employees is represented by a labor union or covered by collective bargaining agreements. We believe that our relations with our employees are good.

AVAILABLE INFORMATION

Our common stock is traded on the New York Stock Exchange under the ticker symbol “EBS.” Our principal executive offices are located at 400 Professional Drive, Suite 400, Gaithersburg, Maryland 20879. Our telephone number is (240) 631-3200, and our website address is www.emergentbiosolutions.com. We ~~maintain a website at www.emergentbiosolutions.com. We~~ make available, free of charge on our website, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports filed or furnished pursuant to Section 13(a) or

15(d) of the Securities Exchange Act of 1934 (the ~~“Exchange Act”)~~Exchange Act) as soon as reasonably practicable after we electronically file those reports with, or furnish them to, the ~~Securities and Exchange Commission (the “SEC”).~~

SEC.

We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. In addition, we intend to make available on our website all disclosures that are required to be posted by applicable law, the rules of the SEC or the New York Stock Exchange listing standards regarding any amendment to, or waiver of, our code of business conduct and ethics. We have included our website address as an inactive textual reference only. The information contained on, or that can be accessed through, our website is not a part of, or incorporated by reference into, this Annual Report on Form 10-K.

HUMAN CAPITAL

We value our employees and the contributions each of them makes to achieving our mission to protect and enhance life. We are committed to working together toward our long-term aspiration to protect and enhance one billion lives by 2030. One of the five core objectives of our 2020-2024 strategic plan is to evolve the culture of our organization consistent with our strategic objectives and our values. We strive to create an environment that is professionally and personally rewarding by offering challenging work and projects for individual and team contribution, and opportunities for professional and personal development. Another core objective of our current strategic plan is to build scalable capabilities; this objective includes continuing to invest in growing and developing leadership, innovation and engagement at all levels of our workforce. As of December 31, 2021, we had approximately 2,416 employees.

Health, Wellness and Safety

Employee safety and well-being is of paramount importance to us and was of continued focus in 2021 in light of COVID-19. In response to the global pandemic, we immediately adjusted our operations to ensure that only operation-critical development and manufacturing employees worked on-site, and we transitioned all other employees to remote work and equipped them with productivity and collaboration tools and resources.

As the extent of the pandemic unfolded, increased attention was focused on the health and safety of our on-site employees. We provided them with personal protective equipment and implemented new safety protocols, including re-engineered

workplace designs that facilitate physical distancing, temperature screening and access to COVID-19 testing. The frequency and methods of communication between management and employees were increased with regular all-hands virtual meetings to discuss what we were doing as a company to combat COVID-19 in conjunction with our USG and private sector partners, and what we were doing to protect our workers.

In addition, we enhanced and promoted programs to support our employees’ physical and mental well-being. For example, we offered supplemental paid time off to employees who were unable to work due to COVID-19 symptoms or diagnosis, or who needed to address family COVID-19 issues. We arranged and paid for COVID-19 tests for employees who worked on-site. We also partnered with a leading provider of online mental health support and counseling to maintain and expand our employees’ access to available mental health resources.

Hiring and Talent Management

We focus on building leaders at every level with the requisite scientific, technical and professional skills to develop and deliver products and services that protect life. In 2021, we expanded our global workforce and hired and onboarded over 600 full-time employees. We have consistent talent processes and systems across the company including performance management, training and development and succession planning. We recognize the need for ongoing skill enhancement and support continued learning through on-the-job assignments, training programs, tuition assistance professional memberships and professional conference attendance. We use the Gallup Q12 instrument to measure employee engagement and inclusion on an annual basis and administer “pulse surveys” throughout the year to gather feedback on matters of interest and importance to our employees and our business.

Compensation and Benefits

Our total rewards plan consists of competitive salaries, bonuses, and for employees in eligible roles, equity awards based on company, group and individual performance. We focus on results and behavior because we value how we do things as much as getting them done. It is this approach that underpins our pay-for-performance philosophy and emphasis on salary transparency. By providing salary ranges, information on individual performance, and the linkage of those two to merit increases, employees have a fuller understanding of their compensation and confidence that their pay is fair and competitive. We recognize the need for ongoing skill enhancement and support continued learning through on-the-job assignments, training programs, tuition assistance, professional memberships and professional conference attendance.

Diversity, Equity, and Inclusion Commitment

Diversity, equity and inclusion (DEI) is integral to how we operate and our success. We are committed to attracting, developing, and retaining the best talent reflecting a diversity of ideas, backgrounds, and perspectives. DEI fuels our business growth, drives innovation in the products and services we develop, in the way we solve problems, and how we serve the needs of a global and diverse patient, customer and partner base. We recognize the value that diversity contributes to our global organization and the competitive advantage we can maintain by cultivating a culture of inclusion to benefit from our broad range of talents, perspectives, and ideas. We demonstrate respect for the individual by providing fair and equal treatment to all our employees and continuously identifying ways to recognize their various needs and interests. In this regard, we recently launched three inaugural Emergent Resource Groups (ERGs) for black, women and veteran employees.While aligned by constituency, our ERGs are open to all employees and are another way we will continue building a sense of belonging and connection to the organization, which will strengthen our community. These groups will open pathways of communication, help to expand learning opportunities, and offer avenues to advance our business strategy.

We thrive on our differences while sharing the same core values to achieve our mission — to protect and enhance life.

ENVIRONMENTAL SOCIAL AND GOVERNANCE

Our mission to protect and enhance life has motivated us to explore our impact at a broader scale — environmental, social and governance (ESG) stewardship, corporate responsibility, and ethics. Our approach to these issues is the foundation of good governance and strengthens accountability in all aspects of our business activities and relationships. ESG has always been an area of focus for us, but in 2021 we established a formal ESG review process focused on identifying, measuring, and reporting on our ESG activities and progress and issued our inaugural ESG report in the fourth quarter of last year (the ESG Report). The ESG Report can be found at: https://www.emergentbiosolutions.com/wp-content/uploads/2022/01/EBSI-2020-ESG-Report.pdf.

Starting in 2012, we also established a platform, that we call eGIVE (Give, Invest, Volunteer), that we have continued to expand since its inception. Through this platform, we have encouraged employees to make contributions to select charitable organizations and volunteer their time, which we have supported with paid time off to support socially responsible activities.

ITEM 1A. RISK FACTORS

~~You should carefully consider the~~The following risk factors ~~in addition to the~~and other information included in this Annual Report on Form 10-K ~~when evaluating~~should be carefully considered. The occurrence of any of the following risks or of unknown risks and uncertainties may adversely affect our business, ~~because these risk factors may have~~operating results and financial condition.

RISK FACTOR SUMMARY

There are a ~~significant~~number of government contracting risks that could impact on our business, financial condition, operating results and cash flows, including:

•Reduced demand for and/or funding for procurement of AV7909 and/or BioThrax or ACAM2000 and discontinuation of funding of our other USG procurement and development contracts.

•Inability to receive FDA licensure of AV7909 and realize the full value of our contract for development and procurement of AV7909.

There are a number of manufacturing risks that could impact our business, financial condition, operating results and cash ~~flows.~~ flows, including:

•Our inability to maintain quality and manufacturing compliance at our manufacturing facilities has hindered and could continue to hinder our ability to produce bulk drug substance for Johnson & Johnson's

COVID-19 vaccine and other products and product candidates for our CDMO customers.

•Disruption at, damage to or destruction of our development and/or manufacturing facilities may impede our ability to manufacture our products, as well as deliver our CDMO services.

•Our operations, including our use of hazardous materials, chemicals, bacteria and viruses expose us to significant potential liabilities.

There are a number of product development and commercialization risks that could impact our business, financial condition, operating results and cash flows, including:

•The COVID-19 product candidates we are working on for our CDMO customers may not be safe or effective and we may be unable to manufacture sufficient quantities to meet demand.

•Clinical trials of product candidates are expensive and time-consuming, and their outcome is uncertain.

•We may fail to capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.

Due to numerous factors, the COVID-19 coronavirus pandemic could have a material adverse impact on our business, results of operations and financial performance, including:

•Changes in government priorities resulting from the pandemic and supply chain shortages could impact our overall business.

•COVID-19 may impede our workers ability to work and may result in reduced production of products or services.

•The evolving nature of COVID-19 and related vaccines and treatments and resulting changes in demand for such product candidates may impact sales of related services offered by our CDMO business.

There are a number of regulatory and compliance risks that could impact our business, financial condition, operating results and cash flows, including:

•Failure to comply with complex laws and regulations pertaining to government contracts and resources required for responding to related government inquiries.

•Conditions associated with approvals and ongoing regulation of products may limit how and the extent to which we manufacture and market them.

•Failure to comply with various health care laws could result in substantial penalties.

•Failure to comply with obligations under USG pricing programs may require reimbursement for underpayments and the payment of substantial penalties, sanctions and fines.

•The extent to which we may be able to lawfully offer to sell and sell unapproved products in many jurisdictions may be unclear or ambiguous and such activities may subject us to regulatory enforcement actions.

There are a number of competitive and political risks that could impact our business, financial condition, operating results and cash flows, including:

•Development and commercialization of pharmaceutical products are subject to evolving private and public sector competition.

•NARCAN is currently subject to generic competition and may be subject to additional branded and generic competition.

•Biologic Products may be affected by the approval and entry of follow-on biologics, or biosimilars in the United States and other jurisdictions.

There are a number of risks related to our intellectual property that could impact our business, financial condition, operating results and cash flows, including:

•Challenges in defense or enforcement of our intellectual property rights including against current or potential infringers.

•Potential discrepancies or challenges with respect to third party licenses, including our failure to comply with obligations under such licenses.

•Potential loss of proprietary information and know-how, which carries the risk of reducing the value of our technology and products.

•Entry of competing generic drugs upon patent expiry or with patents no longer in force.

There are a number of risks related to reliance on third parties that could impact our business, financial condition, operating results and cash flows, including:

•The loss of sole-source suppliers or an increase in the price of inventory.

•If ~~any~~third parties do not perform as contractually required or as expected, we may not be able to obtain regulatory approval for or commercialize our product candidates.

There are a number of legal and reputational risks that could impact our business, financial condition, operating results and cash flows, including:

•Unfavorable results of legal proceedings and government investigations could adversely impact our business, financial condition and results of operations.

•Our work on PHTs has exposed us to criticism and may expose us to further criticism, from the media, government personnel and others, which could further harm our reputation, negatively effect on our share price, operations and our ability to attract and retain talent.

•The potential for cyber security incidents to harm our ability to operate our business effectively in light of our heightened risk profile.

•Inherent product liability exposure due to our unique business.

There are a number of financial risks that could impact our business, financial condition, operating results and cash flows, including:

•Our ability to maintain sufficient cash flow from our operations to pay our substantial debt, both now and in the future.

•Our ability to obtain additional funding and be able to raise capital when needed.

•Our ability to comply with the covenants under our Senior Secured Credit Facilities and other debt agreements.

There are a number of risks related to our strategic acquisitions and collaborations that could impact our business, financial condition, operating results and cash flows, including:

•Our strategy of generating growth through acquisitions may be unsuccessful.

•Our failure to successfully integrate acquired businesses and/or assets into our operations and our ability to realize the benefits of such acquisitions.

There are a number of risks associated with our common stock, including, but not limited to:

•Our business or our share price could be negatively affected as a result of the actions of shareholders.

•Although he is retiring, our Executive Chairman currently has the ability to exert significant influence over us with respect to the election of the members of our Board of Directors and to delay or prevent a change of

control of us, due to his substantial ownership percentage.

•The price of our common stock has been and remains subject to extreme volatility.

The risk factors below contain more detailed descriptions of the risks ~~described below or in subsequent reports we file with the SEC actually occur, they~~identified above, which may materially harm our business, financial condition ~~operating~~or results orof cash flows. Additional risks and uncertainties that we have not yet identified or that we presently consider to be immaterial may also materially harm our business, financial condition, operating results or cash flows. The discussion of these factors is incorporated by reference into and considered an integral part of Part II, Item 7, “Management’s Discussion and Analysis of Financial Conditions and Results of Operations.”

GOVERNMENT CONTRACTING RISKS

We currently derive a substantial portion of our revenue from ~~sales~~USG procurement of ~~BioThrax to~~AV7909 and ACAM2000 and have historically derived a substantial portion of our ~~largest customer, the USG.~~revenue from USG procurement of BioThrax. If the USG’s demand for and/or funding for procurement of AV7909 and/or BioThrax or ACAM2000 is substantially reduced, our business, financial condition, operating results and cash flows would be materially harmed.

We derive a substantial portion of our current and expected future revenues from sales of BioThrax, our anthrax vaccine licensed by the FDA to the USG. In December 2016, we signed a follow-on procurement contract with the CDC for the delivery of approximately 29.4 million doses of BioThrax for placement into the SNS over a five-year period ending in September 2021. The potential value of this contract is approximately $911 million if all procurement options are exercised.

~~The~~USG procurement of ~~doses~~AV7909. As AV7909 is a product development candidate, there is a higher level of risk that we may encounter challenges causing delays or an inability to deliver AV7909 than with BioThrax, ~~by the CDC is subject~~which may have a material effect on our ability to the availability of funding. We have no certainty that funding will be made available for the procurement of doses under the CDC contract. If the SNS priorities change, funding to procure doses of BioThrax may be limited or not available,generate and ~~our business, financial condition and operating results and cash flows would be materially harmed.~~ recognize revenue.

The success of our business and our future operating results are significantly dependent on anticipated funding for the procurement of ~~BioThrax~~our anthrax vaccines and the terms of ~~our BioThrax sales to~~such procurement by the USG, including the price per dose, the number of doses and the timing of deliveries. We have no certainty that funding will be made available for the procurement of our anthrax vaccines. If priorities for the SNS change generally, or as a result of the conclusion of the USG’s audit of the SNS, or with respect to the level of procurement of our anthrax vaccines, funding to procure future doses of AV7909 or BioThrax may be delayed, limited or not available, BARDA may never complete the anticipated full transition to stockpiling AV7909 in support of anthrax preparedness, and our future business, financial condition, operating results and cash flows could be materially harmed.

In addition, we currently derive a substantial portion of our revenues from sales of ACAM2000 to the USG. If priorities for the SNS change with respect to ACAM2000 or the USG decides not to exercise additional options under our ACAM2000 contract, our future business, financial condition, operating results and cash flows could be materially harmed.

~~Our submission of NuThrax for EUA pre-approval and~~We may not receive eventual FDA licensure ~~may not be approved by the FDA~~of AV7909 in a timely manner or at all. Delays in our ability to achieve ~~such pre-approval and licensure~~ a favorable outcome from the FDA

could prevent us from realizing the full potential value of our BARDA contract for the advanced development and procurement of ~~NuThrax.~~

AV7909.

In ~~September 2016, we entered into a contract~~collaboration with ~~HHS through BARDA for~~us, the ~~advanced development and procurement of NuThrax, our next generation anthrax vaccine candidate. The contract, as modified in March 2017, is valued at up to approximately $1.5 billion.~~

~~We recently submitted an application~~CDC filed with the FDA a pre-Emergency Use Authorization (EUA) submission package related to AV7909, which enables FDA review of data in anticipation of a request for ~~EUA pre-approval~~an EUA. Following this submission, BARDA began procuring AV7909, exercising its first contract option in July 2019 to procure 10 million doses of ~~NuThrax,~~AV7909, its second contract option in July 2020 and, ~~although there~~most recently, funding another procurement commitment in October 2021 for inclusion of additional doses into the SNS in support of anthrax preparedness.

We are also working on a BLA for filing with the FDA related to AV7909 and we submitted part of the BLA to the FDA in December 2021. There can be no ~~assurances,~~guarantee that we ~~currently anticipate that~~will meet our target date for the FDA could authorize NuThrax for emergency use as early this year, triggering deliveries of NuThrax to the SNS for use in an emergency situation as early as this year. However, the FDA does not have review deadlines with respect to such submissions and, therefore, the timing of any approvalcompletion of our ~~EUA pre-approval submission is uncertain. We cannot guarantee that~~submission. Moreover, even if we do, the ~~FDA will review our data in a timely manner, or that the FDA will accept the data when reviewed. The~~ FDA may decide that our data are insufficient ~~for EUA pre-approval~~ and require additional pre-clinical, clinical or other ~~studies and refuse to approve our application.~~studies. If we are unsuccessful in obtaining ~~EUA pre-approval for NuThrax and eventual~~ FDA licensure, in a timely manner or at all, we may not be able to realize the full potential value of the contract, which could have a material adverse effect on our future business, financial condition, operating results and cash flows.

~~In addition,~~ Furthermore, prior to FDA licensure, if ~~priorities for~~we obtain an EUA, the ~~SNS change, funding to procure any future doses of NuThrax may be limited or not available, and our future business, financial condition, operating results and cash flows~~EUA could be ~~materially harmed.~~

terminated if the emergency determination underlying the EUA terminates.

Our USG procurement and development contracts require ongoing funding decisions by the USG. ~~Reduced~~Simultaneous reduction or ~~discontinued~~discontinuation of funding of these contracts could cause our business, financial condition, operating results and cash flows to suffer materially.

The USG is the principal customer for our ~~PHT-focused~~ MCMs and is the primary source of funds for the development of most of our product candidates in our development pipeline, most notably our ~~NuThrax~~AV7909 procured product candidate. We anticipate that the USG will also be a principal customer for those MCMs that we successfully develop within our existing product development pipeline, as well as those we acquire in the future. Additionally, a significant portion of our revenue comes from USG development contracts and grants. Over its lifetime, a USG procurement or development program may be implemented through the award of many different individual contracts and subcontracts. The funding for such government programs is subject to Congressional appropriations, generally made on a fiscal year basis, even for programs designed to continue for several years. For example, ~~sales~~procurement of ~~BioThrax~~AV7909 to be supplied under our development and procurement contract with ~~the CDC are~~BARDA is subject to the availability of funding, mostly from annual appropriations. These appropriations can

be subject to political considerations, changes in priorities due to global pandemics, the results of elections and stringent budgetary constraints.

Additionally, our government-funded development contracts typically give the USG the right, exercisable in its sole discretion, to extend these contracts for successive option periods following a base period of performance. The value of the services to be performed during these option periods may constitute the majority of the total value of the underlying contract. For example, the September 2016 contract award from BARDA for the development and delivery to the SNS of ~~NuThrax~~AV7909 for post-exposure prophylaxis of anthrax disease consists of a five-year base period of ~~performance valued at approximately $200 million.~~performance. The contract award also includes options for the delivery of additional doses of ~~NuThrax~~AV7909 to the SNS and options for an additional clinical study and post-marketing ~~commitments which if both were to be exercised~~commitments. This contract was extended in ~~full, would increase~~September 2021 through 2025, and provides for additional procurement of AV7909 for the ~~total contract value to up to $1.5 billion.~~SNS over 18 months. If levels of government expenditures and authorizations for public health countermeasure preparedness decrease or shift to programs in areas where we do not offer products or are not developing product candidates, or if the USG otherwise declines to exercise its options under our existing contracts, our revenues would suffer, as well as our business, financial condition, operating results and cash flows.

There can be no assurance that we will be able to secure follow-on procurement contracts with the USG upon the expiration of any of our ~~current~~ product procurement contracts.

~~The majority~~A significant portion of our revenue is substantially dependent upon product procurement contracts with the USG and foreign governments for our ~~PHT products.~~MCMs. Upon the expiration of a procurement contract, we may not be able to negotiate a follow-on procurement contract for the particular product for a similar product volume, period of performance, pricing or other terms, or at all. The inability to secure a similar or increased procurement contract could materially affect our revenues and our business, financial condition, operating results and cash flows could be harmed. For example, ~~although there are remaining deliverables under~~in November 2019, the ~~contract, the CDC procurement contract for ACAM2000 that we acquired in our acquisition of the ACAM2000 business from Sanofi expired on March 31, 2018. The~~ BARDA procurement contract for raxibacumab that we acquired in our 2017 acquisition of ~~raxibacumab~~the product from ~~Human Genome Sciences, Inc. and~~ GlaxoSmithKline LLC ~~collectively referred to as GSK, will expire in November 2019. Our CDC procurement contract for BioThrax expires in 2021.~~was completed. We intend to negotiate a follow-on procurement contract for raxibacumab and other follow-on procurement contracts for ~~each~~most of our ~~PHT products~~MCMs upon the expiration of a related procurement contract, ~~including our procurement contract for ACAM2000,~~ but there can be no assurance that we will be successful obtaining any follow-on contracts. Even if we are successful in negotiating a follow-on procurement contract, it may be for a lower product volume, over a shorter period of performance or be on less favorable pricing or other

terms. An inability to secure follow-on procurement contracts for our products or procured product candidates could materially and adversely affect our revenues, and our business, financial condition, operating results and cash flows could be harmed.

The government contracting process is typically a competitive bidding process and involves unique risks and requirements.

Our business involves government contracts and grants, which may be awarded through competitive bidding. Competitive bidding for government contracts presents many risks and requirements, including:

•the possibility that we may be ineligible to respond to a request for proposal;

~~the possibility that we may be ineligible to respond to a request for proposal issued by the government;~~

•the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals;

•the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;

~~the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us;~~

•the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and

•in the event our competitors protest or challenge contract or grant awards made to us through competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.

~~the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;~~

~~the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and~~

in the event our competitors protest or challenge contract or grant awards made to us pursuant to competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.

The USG may choose not to award us future contracts for either the development of our new product candidates or for the procurement of our existing MCM products ~~addressing PHTs~~ and may instead award such contracts to our competitors. If we are unable to secure particular contracts, we may not be able to operate in the market for products that are provided under those contracts. Additionally, if we are unable to consistently win new contract awards over an extended period, or if we fail to anticipate all of the costs or resources that we will be required to secure and, if applicable, perform under such contract awards, our growth strategy and our business, financial condition and operating results and cash flows could be materially and adversely affected.

Laws and regulations affecting government contracts make it costlier and more difficult for us to successfully conduct our business. Failure to comply with these laws could result in significant civil and criminal penalties and materially damage our reputation and relationship with the USG, which could have a material adverse effect on our business, financial condition, operating results and cash flows.

As a manufacturer and supplier of MCMs to the USG addressing PHTs, we must comply with numerous laws and regulations relating to the procurement, formation, administration and performance of government contracts. These laws and regulations govern how we transact business with our government clients and, in some instances, impose additional costs and related obligations on our business operations. Among the most significant government contracting regulations that affect our business are:

~~the FAR and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;~~

~~the DFARs and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of DoD government contracts;~~

~~the DOSAR, which regulates the relationship between a Department of State organization and a contractor or potential contractor;~~

~~export and import control laws and regulations, including but not limited to International Traffic in Arms Regulations; and~~

~~laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.~~

USG agencies routinely audit and investigate government contractors for compliance with applicable laws and standards. Even though we take significant precautions to identify, prevent and deter fraud, misconduct and non-compliance, we face the risk that our personnel or outside partners may engage in misconduct, fraud or improper activities. If we are audited and such audit were to uncover improper or illegal activities, we could be subject to civil and criminal penalties, administrative sanctions, including suspension or debarment from government contracting, and suffer significant reputational harm. Loss of our status as an eligible government contractor would have a material adverse effect on our business.

The amount we are paid under our fixed price government procurement contracts is based on estimates we have made of the time, resources and expenses required for us to perform under those contracts. If our actual costs exceed our estimates, we

may not be able to earn an adequate return or may incur a loss under these contracts, which could harm our operating results and materially reduce our net income.

Our current procurement contracts with HHS and ~~the~~ DoD are generally fixed price contracts. We expect that additional future procurement contracts we successfully secure with the USG would likely also be fixed price contracts. Under a fixed price contract, we are required to deliver our products at a fixed price regardless of the actual costs we incur. Estimating costs that are related to performance in accordance with contract specifications is difficult, particularly where the period of performance is over several years. Our failure to anticipate technical problems, estimate costs accurately or control costs during performance of a fixed price contract could reduce the profitability of such a contract or cause a loss, which could harm our operating results and materially reduce our net income.

Unfavorable provisions in government contracts, some of which may be customary, may subject our business to material limitations, restrictions and uncertainties and may have a material adverse impact on our business, financial condition, operating results and cash flows.

Government contracts customarily contain provisions that give the USG substantial rights and remedies, many of which are not typically found in commercial contracts, including provisions that allow the USG to:

•terminate existing contracts, in whole or in part, for any reason;

•unilaterally reduce or modify contracts or subcontracts;

•decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;

•decline to renew a procurement contract;

•claim certain rights to facilities or to products, including intellectual property, developed under the contract;

•require repayment of contract funds spent on construction of facilities in the event of contract default;

•take actions that result in a longer development timeline than expected;

•direct the course of a development program in a manner not chosen by the government contractor;

•suspend or debar the contractor from doing business with the government or a specific government agency;

•pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and

~~terminate existing contracts, in whole or in part, for any reason or no reason;~~

•control or prohibit the export of products.

~~unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;~~

~~cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;~~

~~decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;~~

~~decline to renew a procurement contract;~~

~~claim rights to facilities or to products, including intellectual property, developed under the contract;~~

~~require repayment of contract funds spent on construction of facilities in the event of contract default;~~

~~take actions that result in a longer development timeline than expected;~~

~~direct the course of a development program in a manner not chosen by the government contractor;~~

~~suspend or debar the contractor from doing business with the government or a specific government agency;~~

~~pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and~~

~~control or prohibit the export of products.~~

Generally, government contracts contain provisions permitting unilateral termination or modification, in whole or in part, at the USG’s convenience. Under general principles of government contracting law, if the USG terminates a contract for convenience, the government contractor may recover only its incurred or committed costs, settlement expenses and profit on work completed prior to the termination. If the USG terminates a contract for default, the government contractor is entitled to recover costs incurred and associated profits on accepted items only and may be liable for excess costs incurred by the government in procuring undelivered items from another source. All of our ~~contracts, both~~ development and procurement contracts with the USG are terminable at the ~~USG’s~~USG's convenience with these potential consequences.

In addition, our USG contracts grant the USG the right to use technologies developed by us under the government contract or the right to share data related to our technologies, for or on behalf of the USG. Under our USG contracts, we ~~might~~may not be able to ~~prohibit~~limit third parties, including our competitors, from accessing ~~such~~certain of these technology or data rights, including intellectual property, in providing products and services to the USG.

MANUFACTURING RISKS

~~The loss of any of our non-exclusive, sole-source or single source suppliers or an increase in the price of inventory supplied~~An inability to ~~us could have an adverse effect on our business, financial condition and results of operations.~~

~~We purchase certain supplies used in~~maintain manufacturing compliance at our manufacturing ~~processes from non-exclusive, or single sources due to quality considerations, costs or constraints resulting from regulatory requirements, including key components for~~ ~~NARCAN® Nasal Spray (~~Naloxone API, along with the vial, stopper and device). Where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly. This is largely due to the FDA approval system, which mandates validation of materials prior to use in our products, and the complex nature of manufacturing processes. In addition, we may lose a sole-source supplier due to, among other things, the acquisition of such a supplier by a competitor (which may cause the supplier to stop selling its products to us) or the bankruptcy of such a supplier, which may cause the supplier to cease operations. Any reduction or interruption by a sole-source supplier of the supply of materials or key components used in the manufacturing of our products or an increase in the price of those materials or components could adversely affect our business, financial condition and results of operations.

~~Additionally, any failure by us to forecast demand for, or our suppliers to maintain an adequate supply of, the raw material and finished product for producing~~ ~~NARCAN® Nasal Spray~~ ~~could result in an interruption in the supply of~~ ~~NARCAN® Nasal Spray~~ ~~and a decline in sales of the product.~~

~~REGULATORY AND COMPLIANCE RISKS~~

Our long-term success depends, in part, upon our ability to develop, receive regulatory approval for and commercialize product candidates we develop or acquire and, if we are not successful, our business, financial condition, operating results and cash flows may suffer.

Our product candidates and the activities associated with their development, including testing, manufacture, recordkeeping, storage and approval, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. Except under limited circumstances related to certain government sales, failure to obtain regulatory approval for a product candidate will prevent us from commercializing the product candidate.

In the United States, to obtain approval from the FDA to market any of our future biologic products, we will be required to submit a BLA to the FDA. Ordinarily, the FDA requires a company to support a BLA with substantial evidence of the product candidate’s safety and efficacy in treating the targeted indication based on data derived from adequate and well-controlled clinical trials, including Phase 3 safety and efficacy trials conducted in patients with the disease or condition being targeted.

However, NuThrax and many of our MCM product candidates, for example, are subject to a different regulatory approval pathway under the FDA’s “Animal Rule.” The Animal Rule provides a regulatory pathway for drug and biologic products targeting indications for which human efficacy studies are not feasible or would be unethical. Instead, efficacy must be demonstrated, in part, by utilizing animal models rather than testing in humans. We cannot guarantee that the FDA will permit us to proceed with licensure of NuThrax or any of our PHT MCM candidates under the Animal Rule. Even if we are able to proceed pursuant to the Animal Rule, the FDA may decide that our data are insufficient to support approval and require additional preclinical, clinical or other studies, refuse to approve our products, or place restrictions on our ability to commercialize those products. Furthermore, products approved under the Animal Rule are subject to certain additional post-marketing requirements. For example, to the extent feasible and ethical, manufacturers of products approved pursuant to the Animal Rule must conduct post-marketing studies, such as field studies, to verify and describe the product candidate's clinical benefit and to assess its safety when used as indicated. We cannot guarantee that we will be able to meet this regulatory requirement even if one or more of our product candidates are approved under the Animal Rule.

The FDA has substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient to support approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate.

~~We intend to transfer the manufacturing of raxibacumab, which we acquired from GSK, to our bulk and fill finish~~ facilities, ~~in Baltimore, Maryland, and this transfer of manufacturing operations requires FDA approval.~~

~~Under our arrangements with GSK for our acquisition of the raxibacumab product, we will continue to purchase product from GSK to satisfy deliveries to the SNS under the current BARDA contract, which~~ ~~expires in November 2019~~. We intend to seek FDA approval to transfer the manufacturing of raxibacumab to our Baltimore, Maryland bulk and fill finish manufacturing facilities and currently anticipate FDA approval of this technology transfer in 2020. Approval of this technology transfer may involve complications or may not be secured on a timely basis or at all. Any delay in the approval of this anticipated technology transfer would delay our expected benefits and synergies from this product acquisition and could materially harm ~~our revenues and our business, financial condition, operating results and cash flows could be harmed. Until approval of this technology transfer, we must rely on GSK to supply product to us to satisfy deliveries to the SNS under the BARDA contract, and GSK may fail to meet delivery obligations,~~ which could ~~result in our inability to satisfy requirements under the BARDA contract.~~

Even after regulatory approval is received, if we fail to comply with regulatory requirements, or if we experience unanticipated problems with our approved products, they could be subject to restrictions, penalties or withdrawal from the market.

Any vaccine, therapeutic product or medical device for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory bodies. Our approved products are subject to these requirements and ongoing review. These requirements include submissions of safety and other post-marketing information and reports, registration requirements, cGMP requirements relating to potency and stability, quality control, quality assurance, restrictions on advertising and promotion, import and export restrictions and recordkeeping requirements. In addition, various state laws require that companies that manufacture and/or distribute drug products within the state obtain and maintain a manufacturer or distributor license, as appropriate. Because of the breadth of these laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

Our regulators enforce cGMP and other requirements through periodic unannounced inspections of manufacturing facilities. The FDA is authorized to inspect domestic manufacturing facilities without prior notice at reasonable times and in a reasonable manner. Health Canada may conduct similar inspections of our facilities where Canadian marketed products are produced, or related formulation and filling operations are conducted. The FDA, Health Canada, and other foreign regulatory agencies conduct periodic inspections of our facilities. Following several of these inspections, regulatory authorities have issued inspectional observations, some of which were significant, but all of which are being, or have been, addressed through corrective actions. If, in connection with any future inspection, regulatory authorities find that we are not in substantial compliance with all applicable requirements, or if they are not satisfied with the corrective actions we take, our regulators may undertake enforcement action against us, which may include:

~~warning letters and other communications;~~

~~product seizure or withdrawal of the product from the market;~~

~~restrictions on the marketing or manufacturing of a product;~~

~~suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;~~

~~fines or disgorgement of profits or revenue; and~~

~~injunctions or the imposition of civil or criminal penalties.~~

Similar action may be taken against us should we fail to comply with regulatory requirements, or later discover previously unknown problems with our products or manufacturing processes. For instance, our products are tested regularly to determine if they satisfy potency and stability requirements for their required shelf lives. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval. Regulatory approval may also contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. If we experience any of these post-approval events, our business, financial condition, operating results and cash flows could be materially and adversely ~~affected.~~

~~Additionally, companies may not promote drugs for “off-label” uses (i.e.,~~ uses that are not described in the product’s labeling and that differ from those approved by the applicable regulatory agencies). A company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil and administrative remedies (such as entering into corporate integrity agreements with the USG), as well as criminal sanctions. If our employees or agents engage in “off-label” marketing of any of our products, we could be subject to civil or criminal investigations, monetary and injunctive penalties, which could adversely impact our ability to conduct business in certain markets, negatively affect our business, financial condition, operating results and cash ~~flows, and damage our reputation.~~flows.

~~One or more~~The FDA conducts periodic inspections of our ~~products~~manufacturing facilities for compliance with cGMP requirements relating to quality control. The failure to maintain compliance with such standards at our manufacturing facilities has hindered and could ~~be subject~~continue to ~~early generic competition.~~

~~One or more of~~hinder our products is approved under the provisions of the FDCA, which renders it susceptible to potential competition from generic manufacturers via the Hatch-Waxman Act and ANDA process. Generic manufacturers pursuing ANDA approval are not required to conduct costly and time-consuming clinical trials to establish the safety and efficacy of their products; rather, they are permitted to rely on the innovator’s data regarding safety and efficacy. Additionally, generic drug companies generally do not expend significant sums on sales and marketing activities, instead relying on physicians or payers to substitute the generic form of a drug for the branded form. Thus, generic manufacturers can sell their products at prices much lower than those charged by the innovative pharmaceutical or biotechnology companies who have incurred substantial expenses associated with the research and development of the drug product and who must spend significant sums marketing a new drug.

The ANDA procedure includes provisions allowing generic manufacturers to challenge the innovator’s patent protection by submitting “Paragraph IV” certifications to the FDA in which the generic manufacturer claims that the innovator’s patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the generic product. A patent owner who receives a Paragraph IV certification may choose to sue the generic applicant for patent infringement. If the patent owner files suit within 45 days of receiving notice from an ANDA filer, the patent owner is entitled to receive a 30 month stay on the FDA’s ability to ~~give final approval~~continue manufacturing for CDMO customers, including the ~~generic product that is the subject of the ANDA.~~

In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge the applicability of patents listed in the FDA’s Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, on a wide array of innovative therapeutic products. We expect this trend to continue and to affectbulk drug ~~products with even relatively modest revenues.~~

Although we intend to vigorously enforce our intellectual property rights, there can be no assurance that we will prevail in our enforcement or defense of our patent rights. Our existing patents could be invalidated, found unenforceable, or found not to cover a generic form of our product.

~~Failure to obtain or maintain regulatory approval in international jurisdictions could prevent us from marketing our products abroad and could limit the growth of our business.~~

We intend to sell certain of our products, outside the United States and recently received market authorization under the mutual recognition procedure to sell BioThrax, in France, Italy, the Netherlands, Poland, and the U.K. To market our products in foreign jurisdictions under normal circumstances, we may need to obtain separate regulatory approvals and comply with numerous and varying requirements or use alternative “emergency use” or other exemptions from general approval and import requirements. Approval by the FDA in the United States or the mutual recognition procedure in the European member states does not ensure approval by all foreign regulatory authorities. The approval procedures in foreign jurisdictions can vary widely and can involve additional clinical trials and data review beyond that required by the FDA or under the mutual recognition procedure. We and our collaborators may not be able to obtain foreign regulatory approvals on a timely basis, if at all, and we may be unable to successfully commercialize our products internationally if no alternate procurement pathway is identifiedsubstance for authorized government customers in a particular jurisdiction. We have limited experience in preparing, filing and prosecuting the applications necessary to gain foreign regulatory approvals and expect to rely on third-party contract research organizations and consultants to assist us in this process.

~~Our international operations increase our risk of exposure to potential claims of bribery and corruption.~~

As we continue to expand our commercialization activities outside of the United States, we are subject to an increased risk of inadvertently conducting activities in a manner that violates the U.S. Foreign Corrupt Practices Act (the “FCPA”), the U.K. Bribery Act, Canada's Corruption of Foreign Public Officials Act, or other similar foreign laws, which prohibit corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. In the course of establishing and expanding our commercial operations and seeking regulatory approvals outside of the United States, we will need to establish and expand business relationships with various third parties and will interact more frequently with foreign officials, including regulatory authorities and physicians employed by state-run healthcare institutions who may be deemed to be foreign officials under the FCPA or similar foreign laws. If our business practices are found to be in violation of the FCPA or similar foreign laws despite our training and compliance efforts, we and our senior management may be subject to significant civil and criminal penalties, potential debarment from public procurement and reputational damage,Johnson & Johnson’s COVID-19 vaccine, which could ~~have a material adverse effect on~~adversely affect our business, financial condition, operating results and cash ~~flows and growth prospects.~~flows.

~~The expansion of our international operations increases our risk of exposure to credit losses.~~

As we continue to expand our business activities with foreign governments in certain countries that have experienced deterioration in credit and economic conditions or otherwise, our exposure to uncollectible accounts will rise. Global economic conditions and liquidity issues in certain countries have resulted and may continue to result in delays in the collection of accounts receivables and may result in credit losses. Future governmental actions and customer specific actions may require us to re-evaluate the collectability of our accounts receivable and we may potentially incur credit losses that may materially impact our operating results.

~~MANUFACTURING RISKS~~

Disruption at, damage to or destruction of our manufacturing facilities could impede our ability to manufacture ~~BioThrax~~anthrax vaccines, ACAM2000 or our other products, as well as ~~deliver our contract development and manufacturing~~impact the delivery of CDMO services, which would harm our business, financial condition, operating results and cash flows.

~~An interruption~~

Any further interruptions in our manufacturing operations could result in our inability to produce ~~our PHT countermeasures~~products and product candidates for delivery to satisfy the ~~product~~ demands of our customers in a timely manner, which would reduce our revenues and materially harm our business, financial condition, operating results and cash flows. A number of factors could cause interruptions, including:

•equipment malfunctions or failures;

•technology malfunctions;

~~equipment malfunctions or failures;~~

•cyber-attacks;

•work stoppages or slowdowns, particularly due to the impact of COVID-19;

~~technology malfunctions;~~

•civil unrest and protests, including by animal rights activists;

•injunctions;

~~cyber-attacks;~~

•damage to or destruction of one or more facilities;

•FDA facility inspection findings/recommendations; and

~~work stoppages or slow-downs;~~

•product contamination or tampering.

~~protests, including by animal rights activists;~~

~~injunctions;~~

~~damage to or destruction of the facility; and~~

~~product contamination or tampering.~~

Providers of ~~PHT countermeasures~~MCMs could be subject to an increased risk of terrorist activities. The USG has designated both our Lansing, Michigan and our Bayview bulk manufacturing facility in Baltimore, Maryland as facilities requiring additional security. Although we continually evaluate and update security measures, there can be no assurance that any additional security measures would protect these facilities from terrorist efforts determined to disrupt our manufacturing activities.

The factors listed above could also cause disruptions at our other facilities, including our manufacturing facilities in Winnipeg, Manitoba, Canada; other Baltimore, Maryland facilities in Camden; facilities in Canton, Massachusetts; Rockville, Maryland; and Hattiesburg, Mississippi.facilities. We do not have any redundant manufacturing facilities for any of our ~~marketed~~ products. Accordingly, any damage to, or disruption ~~damage,~~ or destruction of ~~these~~one or more of our facilities could impede our ability to manufacture our ~~marketed~~ products, our product candidates and our ability to ~~produce products~~provide manufacturing and development services for external customers, result in losses and delays, including ~~delay~~delays in the performance of our contractual obligations or ~~delay~~delays in our clinical trials, any of which could be costly to us and materially harm our business, financial condition, operating results and cash flows.

We may not be able to utilize the full manufacturing capacity of our manufacturing facilities, which could impact our future revenues and materially harm our business, financial condition, operating results and cash flows.

Despite our ongoing efforts to optimize the utilization of our manufacturing infrastructure (including bulk, fill/finish, support, aseptic filling, lyophilization, final packaging), we may not be able to realize full utilization, which could adversely affect our future revenues, financial condition, operating results and cash flows.

Problems may arise during the production of our ~~marketed~~ products and product candidates, as well as those we produce for our CDMO customers, due to the complexity of the processes involved in their development, manufacturing and shipment. Significant delays in product manufacturing or development and our ability to ramp up production to meet the needs of our customers could cause delays in recognizing revenues, which would harm our business, financial condition, operating results and cash flows.

~~BioThrax, raxibacumab, ACAM2000, Anthrasil, BAT, VIGIV, Vivotif, Vaxchora, and many~~The majority of our ~~current~~products and product candidates ~~including NuThrax,~~ are biologics. Manufacturing ~~biologic products,~~biologics, especially in large quantities, is complex. The products must be made consistently and in compliance with a ~~clearly defined~~clearly-defined manufacturing process. Problems during manufacturing may arise for a variety of reasons, including problems with raw materials, equipment malfunction and failure to follow specific protocols and procedures. ~~In addition, slight~~Slight deviations anywhere in the manufacturing process, including obtaining materials, maintaining master seed or cell banks and preventing genetic drift, seed or cell growth, fermentation, contamination including from particulates among other things, filtration, filling, labeling, packaging, storage and shipping, potency and stability issues and other quality control testing, may result in lot failures or manufacturing shut-downs, delays in the release of lots, product recalls, spoilage or regulatory action. Such deviations may require us to revise manufacturing processes or change manufacturers. Additionally, as our equipment ages, it will need to be ~~replaced. Replacement of equipment~~replaced, which has the potential to ~~introduce variations in the manufacturing process that may~~ result in ~~lot failures or manufacturing shut-downs, delay in the release of lots, product recalls, spoilage or regulatory action.~~similar consequences. Success rates can also vary dramatically at different stages of the manufacturing process, which can reduce yields and increase costs. From time to time, we may experience deviations in the manufacturing process that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and could cause us to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to delays in our clinical trials, result in litigation or regulatory action against us, including the issuance of Forms FDA 483, warning letters and other restrictions on the marketing or manufacturing of a product, or cause the FDA to cease releasing product until the deviations are explained and corrected, any of which could be costly to us, damage our reputation and negatively impact our business. For example in April 2021, we temporarily stopped manufacturing bulk drug substance material for Johnson & Johnson’s COVID-19 vaccine at our Baltimore Bayview facility after issues were identified in a viral vaccine drug substance batch

Additionally, if changes are made to the manufacturing process, we may be required to provide the FDA with pre-clinical and clinical data showing the

comparable identity, strength, quality, purity or potency of any impacted products before and after the changes.

We are contractually required to ship our biologic products at a prescribed temperature range and variations from that temperature range could result in loss of product and could significantly and adversely impact our revenues, which would harm our business, financial condition, operating results and cash flows.

In addition, we may not be able to ramp up our manufacturing processes to meet the rapidly changing demand or specifications of our customers on the desired timeframe, if at all. For example, we have not previously had to ramp our organization for a commercial launch of any product or manufacture any product for our CDMO customers at the current pace required to address treatments related to COVID-19 and doing so in a pandemic environment with an urgent, critical global need creates unique manufacturing challenges, challenges related to distribution channels, and the need to establish teams of people with the relevant skills. Our inability to ramp up manufacturing to meet the demand or specifications of our customers or the inability to timely obtain regulatory authorization to produce the products or product candidates of our customers could also harm our business, financial condition, operating results and cash flows.

~~Manufacturing delays, lot failures, shipping deviations, spoilage or~~Our products and product candidates procured by the USG and other ~~loss during shipping could cause~~customers require us to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to delays in potential clinical trials or result in litigation or regulatory action against us, any of which could be costly to usperform tests for and ~~otherwise harm our business.~~

~~We are required to obtain~~meet certain potency and lot release standards prescribed by the FDA ~~approval prior to the release of each lot of BioThrax~~ and ~~ACAM2000,~~other agencies, which may not be ~~obtained~~met on a timely basis or at all.

Our products and product candidates procured by the USG and other customers require us to perform tests for and meet certain potency and lot release standards prescribed by the FDA ~~approval is required for the release of each lot of BioThrax~~ and ~~ACAM2000.~~other agencies, which may not be met on a timely basis or at all. We are ~~not able~~unable to sell any ~~lots~~products and product candidates that fail to satisfy ~~the release~~such testing specifications. For example, we must provide the FDA with the results of certain tests, including potency tests, before certain lots are released for sale. Potency testing of each applicable lot ~~of BioThrax and each lot of ACAM2000~~ is performed against qualified control lots that we maintain. We continually monitor the status of ~~our~~such reference lots for FDA compliance and periodically produce and qualify a new reference lot to replace the existing reference lot. If we are ~~not able~~unable to ~~produce and qualify a new reference lot or otherwise~~ satisfy ~~the FDA's~~USG requirements for the release of ~~BioThrax~~our products or ~~ACAM2000,~~product candidates, our ability to ~~sell BioThrax or ACAM2000~~supply such products and product candidates to authorized buyers would be impaired until such time as we become able to meet ~~the FDA's~~such requirements, which ~~would~~could materially harm our future business, financial condition, operating results and cash flows.

If we are unable to obtain supplies for the manufacture of our products and product candidates in sufficient quantities, at an acceptable cost and in acceptable quality, our ability to manufacture or to develop and commercialize our products and product candidates could be impaired, which could materially harm our revenues, lead to a termination of one or more of our contracts, lead to delays in clinical trials or otherwise materially harm our business.

We depend on certain single-source suppliers for key materials and services necessary for the manufacture of BioThrax and our other products and product candidates. For example, we rely on a single-source supplier to provide us with Alhydrogel in sufficient quantities to meet our needs to manufacture BioThrax and NuThrax, and currently rely on a single-source supplier to manufacture raxibacumab. We also rely on single-source suppliers for the sponge applicator device and the active ingredient used to make RSDL as well as the specialty plasma in our hyperimmune specialty plasma products and certain ingredients for ACAM2000. A disruption in the availability of such materials or services from these suppliers or in the quality of the material provided by such suppliers could require us to qualify and validate alternative suppliers. If we are unable to locate or establish alternative suppliers, our ability to manufacture our products and product candidates could be adversely affected and could harm our revenues, cause us to fail to satisfy contractual commitments, lead to a termination of one or more of our contracts or lead to delays in our clinical trials, any of which could be costly to us and otherwise materially harm our business, financial condition, operating results and cash flows.

Our operations, including our use of hazardous materials, chemicals, bacteria and viruses, require us to comply with regulatory requirements and expose us to significant potential liabilities.

Our operations involve the use of hazardous materials, including chemicals, bacteria and viruses, and may produce dangerous waste products. Accordingly, we, along with the third parties that conduct clinical trials and manufacture our products and product candidates on our behalf, are subject to federal, state, local and foreign laws and regulations that govern the use, manufacture, distribution, storage, handling, exposure, disposal and recordkeeping with respect to these materials. Under the Federal Select Agent Program, pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act, we are required to register with and be inspected by the CDC and the Animal and Plant Health Inspection Service if we have in our possession, or if we use or transfer, select biological agents or toxins that could pose a threat to public health and safety, to animal or plant health or to animal or plant products. This legislation requires stringent safeguards and security measures for these select agents and toxins, including controlled access and the screening of entities and personnel and establishes a comprehensive national database of registered entities. We are also subject to a variety of environmental and occupational health and safety laws. Compliance with current or future laws and regulations in this area can require significant costs and we could be subject to substantial fines and penalties in the event of noncompliance. In addition, the risk of contamination or injury from these materials cannot be completely eliminated. In such event, we could be held liable for substantial civil damages or costs associated with the cleanup of hazardous materials. From time to time, we have been involved in remediation activities and may be so involved in the future. Any related cost or liability might not be fully covered by insurance, could exceed our resources and could have a material adverse effect on our business, financial condition, operating results and cash flows. In addition to complying with environmental and occupational health and safety laws, we must comply with special regulations relating to biosafety administered by the CDC, HHS, U.S. Department of Agriculture and the DoD, as well as regulatory authorities in Canada.

PRODUCT DEVELOPMENT AND COMMERCIALIZATION RISKS

~~RISKS RELATED TO STRATEGIC ACQUISITIONS AND COLLABORATIONS~~

~~Our strategy of generating growth through acquisitions~~The COVID-19 product candidates we are working on for our CDMO customers may not be ~~successful.~~safe or effective and even if they are, we may be unable to manufacture sufficient quantities to meet demand.

~~Our business strategy includes growing~~

We are providing CDMO services for the development and/or manufacture of multiple vaccine and therapeutic product candidates. There can be no assurance that any of these product candidates will be safe or effective. There can also be no assurance that any of these product candidates will be authorized for emergency use or approved by the FDA or any other health regulatory authority or that our ~~business through acquisition~~facilities will receive authorization from the FDA to release additional batches of COVID-19 drug substance. Even if these product candidates are safe and/or effective and ~~in-licensing transactions. We may not be successful in identifying, effectively evaluating, structuring, acquiring~~receive authorization or ~~in-licensing, and developing and commercializing additional products on favorable terms,~~approval by a health regulatory authority or we receive authorization to produce drug substance at ~~all. Competition~~our facilities, the manufacturing processes for ~~attractive product opportunities is intense and may require us to devote substantial resources, both managerial and financial, to an acquisition opportunity. A number of more established companies~~our CDMO COVID-19 programs are also pursuing strategies to acquire or in-license products in the biopharmaceutical field. These companies may have a competitive advantage over us due to their size, cash resources, cost of capital, effective tax rate and greater clinicalunder development and ~~commercialization capabilities.~~

~~Acquisition efforts~~are complex. There can ~~consume significant management attention and require substantial expenditures, which could detract from our other programs. In addition,~~be no assurance that we may devote significant resources to potential acquisitions that are never completed. Even if we are successful in acquiring a company or product, it may not result in a successfully developed or commercialized product or, even if an acquired product is commercialized, competing products or technologies could render a product noncompetitive, uneconomical or obsolete. Moreover, the cost of acquiring other companies or in-licensing products could be substantial, and in order to acquire companies or new products, we may need to incur substantial debt or issue dilutive securities.

If we are unsuccessful in our efforts to acquire other companies or in-license and develop additional products, or if we acquire or in-license unproductive assets, it could have a material adverse effect on the growth of our business, and we could be compelled to record significant impairment charges to write-down the carrying value of our acquired intangible assets, which could materially harm our, business, financial condition, operating results and cash flows.

Our failure to successfully integrate acquired businesses and/or assets into our operations could adversely affect our ability to realize the benefits of such acquisitions and, therefore, to grow our business.

~~We may not~~will be able to ~~integrate~~produce any ~~acquired business successfully or operate any acquired business profitably, including our recent acquisitions~~significant quantity of ~~Adapt and PaxVax. In addition, cost synergies, if achieved at all, may be less than we expect, or may take greater time to achieve than we anticipate.~~

~~Issues that could delay or prevent successful integration or cost synergies of an acquired business or products include, among others:~~

~~retaining existing customers and attracting new customers;~~

~~retaining key employees;~~

~~diversion of management attention and resources;~~

~~conforming internal controls, policies and procedures, business cultures and compensation programs;~~

~~consolidating corporate and administrative infrastructures;~~

~~successfully executing technology transfers and obtaining required regulatory approvals;~~

~~consolidating sales and marketing operations;~~

~~identifying and eliminating redundant and underperforming operations and assets;~~

~~assumption of known and unknown liabilities;~~

~~coordinating geographically dispersed organizations; and~~

~~managing tax costs or inefficiencies associated with integrating operations.~~

If we are unable to successfully integrate pending and future acquisitions with our existing businesses, or operate any acquired business profitably, we may not obtain the advantages that the acquisitions were intended to create, which may materially adversely affect the growth of our business, financial condition, operating results and cash flows.

~~COMPETITIVE AND POLITICAL RISKS~~

~~We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.~~

The development and commercialization of new biopharmaceutical and medical technology products is highly competitive and subject to rapid technological advances. We may face future competition from other companies and governments, universities and other non-profit research organizations in respect to our products, any products that we acquire, our current product candidates and any products we may seek to develop or commercialize in the future. Our competitors may develop products that are safer, more effective, more convenient or less costly than any products that we may develop or market. Our competitors may have greater resources to devote to marketing or selling their products, adapt more quickly to new technologies, scientific advances or patient preferences and needs, initiate or withstand substantial price competition more successfully than we can, or more effectively negotiate third-party licensing and collaborative arrangements.

There are a number of companies with products or product candidates addressing PHT preparedness that are competing with us for both USG procurement and development resources. Many of our competitors have greater financial, technical and marketing resources than we do. Our competitors may receive patent protection that dominates, blocks or adversely affects our products or product candidates.

~~Any reduction in demand for our products or reduction or loss of development funding for our products or~~these product candidates in ~~favor of~~ a ~~competing product could lead~~timely basis or at all, or negotiate further commitments under our existing CDMO contracts to ~~a loss of market share for our products and cause reduced revenues, margins and levels of profitability for us,~~manufacture vaccines against COVID-19, which could adversely affect our business, financial condition, operating results and cash ~~flows.~~flows.

~~Our Biologic Products may face risks of competition from biosimilar manufacturers.~~

Competition for BioThrax, raxibacumab, ACAM2000, Anthrasil, BAT, VIGIV, Vivotif and Vaxchora otherwise referred to as our “Biologic Products,” may be affected by follow-on biologics, or “biosimilars,” in the United States and other jurisdictions. Regulatory and legislative activity in the United States and other countries may make it easier for generic drug manufacturers to manufacture and sell biological drugs similar or identical to our Biologic Products, which might affect the profitability or commercial viability of our Biologic Products. Under the Biologics Price Competition and Innovation Act of 2010, the FDA cannot approve a biosimilar application until the 12-year exclusivity period for the innovator biologic has expired. Regulators in the European Union and in other foreign jurisdictions have already approved biosimilars. The specific regulatory framework for this biosimilar approval path and the extent to which an approved biosimilar would be substituted for the innovator biologic are not yet clear and will depend on many factors. If a biosimilar version of one of our Biologic Products were approved, it could have a material adverse effect on the sales and gross profits of the affected Biologic Product and could adversely affect our business, financial condition, operating results and cash flows.

~~We expect our recently acquired NARCAN® Nasal Spray marketed product to face future competition from other treatments.~~

~~Our marketed product~~ ~~NARCAN® Nasal Spray~~ faces substantial competition from other treatments, including injectable naloxone, auto-injectors and improvised nasal kits. In addition, other entrants may seek approval to market generic versions of ~~NARCAN® Nasal Spray~~ ~~before the underlying patents expire. For example, in 2016 Teva filed, and in 2018 Perrigo filed, ANDAs which seek regulatory approval to market generic versions of~~ ~~NARCAN® Nasal Spray~~ ~~before the expiration of certain underlying patents.~~ Additionally, in January 2019, the FDA released new proposed template Drug Facts Labels to assist sponsors of investigation naloxone nasal sprays and auto-injectors seeking approval from the FDA for over-the-counter naloxone products. ~~Any reduction in demand for~~ ~~NARCAN® Nasal Spray~~ in favor of a competing product, or unsuccessful efforts to defend underlying patents from infringement by generic entrants, could lead to a loss of market share and cause reduced revenues, margins and levels of profitability for us, which could adversely affect our business, financial condition, operating results and cash flows.

~~Political or social factors may delay or impair our ability to market our products and may require us to spend significant management time and financial resources to address these issues.~~

Products developed to counter the potential impact of PHTs, whether CBRNE or EID, are subject to changing political and social environments. The political responses and social awareness of the risks of these threats on military personnel or civilians may vary over time. If the threat of terrorism were to decline, then the public perception of the risk on public health and safety may be reduced. This perception, as well as political or social pressures, could delay or cause resistance to bringing our products in development to market or limit pricing or purchases of our products, any of which could negatively affect our revenues and our business, financial condition, operating results and cash flows.

In addition, substantial delays or cancellations of purchases could result from protests or challenges from third parties. Lawsuits brought against us by third parties or activists, even if not successful, could require us to spend significant management time and financial resources defending the related litigation and could potentially damage the public's perception of us and our products. Any publicity campaigns or other negative publicity may adversely affect the degree of market acceptance of our PHT countermeasures and thereby limit the demand for our products, which would adversely affect our business, financial condition, operating results and cash flows.

~~PRODUCT DEVELOPMENT AND COMMERCIALIZATION RISKS~~

~~Our~~Our growth depends on our success in developing and commercializing our product candidates. If we are unable to commercialize these product candidates, or experience significant delays or unanticipated costs in doing so, our business would be materially and adversely affected.

We have invested significant ~~effort~~efforts and financial resources in the development of our vaccines, therapeutics and medical device product candidates and the acquisition of additional product candidates. In addition to our product sales, our ability to generate revenue is dependent on a number of factors, including the success of our development programs, the USG's interest in providing development funding for or procuring certain of our product candidates, and the commercial viability of our acquired or developed product candidates. The commercial success of our product candidates ~~will~~can depend on many factors, including accomplishing the following in an economical manner:

•successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory requirements;

•successful program partnering;

•successful completion of clinical or non-clinical development;

•receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;

•establishment of commercial manufacturing processes and product supply arrangements;

•training of a commercial sales force for the product;

•successful registration and maintenance of relevant patent and/or other proprietary protection;

•competitive pricing and market access; and

•acceptance of the product by potential government and other customers.

Clinical trials of product candidates are expensive and time-consuming, and their outcome is uncertain. We must invest substantial amounts of time and financial resources in these trials, which may not yield viable products. Failure to obtain regulatory approval for product candidates, particularly in the United States, could materially and adversely affect our financial resources, which would adversely affect our business, financial condition, operating results and cash flows.

Before obtaining regulatory approval of our product candidates, we and our collaborative partners, where applicable, must conduct pre-clinical studies and clinical trials to establish proof of concept and demonstrate the safety and efficacy of our product candidates. Pre-clinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of such trials do not necessarily predict final results. An unexpected result in one or more of our clinical trials can occur at any stage of testing.

Pre-clinical and clinical testing for certain of our MCM product candidates may face additional difficulties and uncertainties because they cannot ethically or feasibly be tested in human subjects. We therefore expect to rely on the Animal Rule to obtain regulatory approval for some of our MCM product candidates. The Animal Rule permits, for certain limited diseases and circumstances, the use of animal efficacy studies, together with human clinical safety and immunogenicity trials, to support an application for marketing approval. For a product approved under the Animal Rule, certain additional post-marketing requirements apply. For example, to the extent feasible and ethical, applicants must conduct post-marketing studies, such as field studies, to verify and describe the drug's clinical benefit and to assess its safety when used as indicated. It is possible that results from the animal efficacy studies used to support approval under the Animal Rule may not be predictive of the actual efficacy of our product candidates in humans.

Prior to FDA approval of certain MCM product candidates, the Secretary of HHS can contract to purchase MCMs for the SNS under Project BioShield

~~successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory requirements;~~

under specific circumstances. Under PAHPRA, the USG may also, at its discretion, purchase critical biodefense products for the SNS prior to FDA approval after the filing of a pre-EUA application with the FDA. If our MCM product candidates are not procured or funded under Project BioShield, or do not qualify for EUA, they generally will have to be fully approved by the FDA through traditional regulatory mechanisms prior to sale and distribution in the United States.

We may experience unforeseen events or issues during, or as a result of, pre-clinical testing, clinical trials or animal efficacy studies. These issues and events, which could delay or prevent our ability to receive regulatory approval for a product candidate, include, among others:

•our inability to manufacture sufficient quantities for use in trials;

•the unavailability or variability in the number and types of subjects for each study;

•safety issues or inconclusive or incomplete testing, trial or study results;

•drug immunogenicity;

•lack of efficacy of product candidates during the trials;

•government or regulatory restrictions or delays; and

•greater than anticipated costs of trials.

We may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.

We continue to evaluate our product development strategy and, as a result, may modify our strategy in the future. In this regard, we may, from time to time, focus our product development efforts on different product candidates or may delay or halt the development of various product candidates. We may change or refocus our existing product development, commercialization and manufacturing activities based on government funding decisions. This could require changes in our facilities and our personnel. Any product development changes that we implement may not be successful. In particular, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates or choose candidates for which government development funds are not available. Our decisions to allocate our R&D, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources from better business opportunities. Similarly, our decisions to delay or terminate product

~~successful program partnering;~~

development programs may also prove to be incorrect and could cause us to miss valuable opportunities.

GLOBAL PANDEMIC RISK

The COVID-19 coronavirus pandemic could have a material adverse impact on our business, results of operations and financial performance.

Our business, operations and financial condition and results have been and may continue to be impacted by the COVID-19 pandemic to varying degrees. The pandemic has presented a number of risks and challenges for our business, including, among others, government-mandated work-from-home or shelter-in-place orders; manufacturing disruptions and delays, including at our Baltimore Bayview facility, supply chain interruptions or delays, including challenges related to reliance on third-party suppliers; disruptions to pipeline development and clinical trials and decreased product demand for our travel health vaccines due to the significant reduction in international travel. Additional travel restrictions and other governmental measures may result in further disruptions or continued delays in delivery of supplies by our third-party contractors and suppliers.

We also face uncertainties related to our efforts and those of our collaborative partners to develop a potential treatment or vaccine for COVID-19, including uncertainties related to pre-clinical or clinical trials, the risk that such development programs may not be successful, commercially viable, or that EUA or regulatory approval will not be received from regulatory authorities.

In addition, the trading price of our common stock, and that of other biopharmaceutical companies, has been highly volatile due to the COVID-19 pandemic, especially as a result of investor concerns and uncertainty related to the impact of the pandemic on the economies of countries worldwide. These broad market and industry fluctuations, as well as general economic, political and market conditions, may negatively impact the market price of shares of our common stock.

The COVID-19 pandemic continues to rapidly evolve. The extent to which the pandemic and variants of COVID-19 further negatively impact our business, affect the supply chain, disrupt key clinical trials, divert government funding away from our primary procured products and product candidates due to changes in government priorities and potential delays in the delivery of products to our customers will depend on future developments, which are highly uncertain. The ultimate geographic spread of COVID-19 and new variants of the disease, the duration of the pandemic, further travel restrictions

~~successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;~~

and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease cannot be predicted with certainty.

The continually evolving nature of the COVID-19 pandemic and the resulting public health response, including the changing demand for various COVID-19 vaccines and treatments from both patients and governments around the world, may affect the demand for COVID-19 product candidates manufactured by our CDMO business.

Through our CDMO business, we provide services for a variety of product candidates intended for the prevention or treatment of COVID-19 and its symptoms and effects. These services include product development, the manufacture of bulk drug substance and drug product fill and finish services.

None of the COVID-19-related product candidates we develop and manufacture have yet to receive full regulatory approval from any regulatory authority, although some are being offered and sold pursuant to an EUA from the FDA or the equivalent authorization from non-U.S. regulatory authorities. Should the facilities producing these product candidates be denied an EUA or one or more of these COVID-19-related product candidates be denied an EUA (or equivalent) or be denied full regulatory approval by the FDA or other major non-U.S. regulatory authority, the demand for such product candidates could decrease significantly and therefore decrease customer orders for additional CDMO services for such product candidates. Additionally, the need for continued manufacture and supply of vaccines (including potential “booster” doses) and therapies to address the COVID-19 pandemic, including new and developing variants of COVID-19, is highly uncertain and subject to various political, economic and regulatory factors that are outside of our control. Should the United States or other major regions worldwide determine that additional manufacturing of COVID-19 vaccines, boosters, or therapies is no longer necessary, or necessary to a lesser degree, it could adversely affect our revenue and financial condition and our ability to grow our CDMO business in the near term. In addition, highly-public political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines could contribute to changes in public perception of COVID-19 vaccines manufactured by us, which could decrease demand for a COVID-19 related product candidate we develop or manufacture (in whole or in part).

~~receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;~~

The impact of COVID-19 may further impede our employees’ ability to work and may result in reduced production or services.

One of the significant areas of impact of COVID-19 on our business has been the disruption of our employees’ ability to work effectively. A significant number of our administrative employees continue to work from home due to policies necessitated by COVID-19. Working remotely could increase our cybersecurity risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations. In addition, our on-site staff conducting R&D may not be able to access our laboratories if conditions worsen, due to COVID-19 variants, state and local restrictions, and these core activities may be significantly limited or curtailed, possibly for extended periods of time.

Inadequate funding for the FDA, the SEC and other government agencies, including from the COVID-19 pandemic and government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

In response to the COVID-19 pandemic, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume routine surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis. The FDA has developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections. As of May 2021, certain inspections, such as foreign

~~establishment of commercial manufacturing processes and product supply arrangements;~~

preapproval, surveillance, and for-cause inspections that are not deemed mission-critical, remain temporarily postponed. In April 2021, the FDA issued guidance for industry formally announcing plans to employ remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates and in May 2021 announced plans to continue progress toward resuming standard operational levels. Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intends to issue a complete response letter or defer action on the application until an inspection can be completed.

As of May 26, 2021, the FDA noted it was continuing to ensure timely reviews of applications for medical products during the ongoing COVID-19 pandemic in line with its user fee performance goals and conducting mission critical domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA quality standards. However, the FDA may not be able to continue its current pace and review timelines could be extended, including where a pre-approval inspection or an inspection of clinical sites is required and due to the ongoing COVID-19 pandemic and travel restrictions, the FDA is unable to complete such required inspections during the review period. If such disruption continues, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

REGULATORY AND COMPLIANCE RISKS

There are a number of complex laws and regulations that pertain to government contracts and compliance with those laws and regulations require significant time and cost, which could have a material adverse effect on our business, financial condition, operating results and cash flows.

As a manufacturer and supplier of MCMs to the USG addressing PHTs, we must comply with numerous laws and regulations relating to the procurement, formation, administration and performance of government contracts. These laws and regulations govern how we transact business with our government clients and, in some instances, impose additional costs and related obligations on our business operations. For a detailed description of the most significant regulations that affect our government contracting business, see the prior discussion under “Regulation - Government Contracting.”

~~training of a commercial sales force for the product, whether alone or in collaboration with others;~~

We may be subject to government investigations of compliance with government acquisition regulations. USG agencies routinely audit and investigate government contractors for compliance with applicable laws and standards. Even though we take significant precautions to identify, prevent and deter fraud, misconduct and non-compliance, we face the risk that our personnel or outside partners may engage in misconduct, fraud or improper activities. If we are audited or investigated and such audit or investigation were to uncover improper or illegal activities, we could be subject to civil and criminal fines and penalties, administrative sanctions, including suspension or debarment from government contracting, and suffer significant reputational harm. The loss of our status as an eligible government contractor or significant fines or penalties associated with contract non-compliance or resulting from investigations could have a material adverse effect on our business.

Our product candidates and the activities associated with them are subject to extensive FDA regulation and oversight, as well as oversight by other regulatory agencies in the United States and by comparable authorities in other countries. This includes, but is not limited to, laws and regulations governing product development, including testing, manufacturing, record keeping, storage and approval, as well as advertising and promotion. In limited circumstances, governments may procure products that have not obtained regulatory approval. In all other circumstances, failure to obtain regulatory approval for a product candidate will prevent us from selling and commercializing the product candidate.

In the United States, to obtain approval from the FDA to market and sell any of our future drug, biologic, or vaccine products, we will be required to submit an NDA or BLA to the FDA. Ordinarily, the FDA requires a company to support an NDA or BLA with substantial evidence of the product candidate’s effectiveness, safety, purity and potency in treating the targeted indication based on data derived from adequate and well-controlled clinical trials, including Phase 3 trials conducted in patients with the disease or condition being targeted.

However, many of our MCM product candidates, for example, may take advantage of a different regulatory approval pathway under the FDA’s “Animal Rule.” Under the Animal Rule, efficacy must be demonstrated, in part, by utilizing animal models rather than testing in humans. We cannot guarantee

~~successful registration and maintenance of relevant patent and/or other proprietary protection; and~~

that the FDA will permit us to proceed with licensure of any of our MCM product candidates under the Animal Rule. Even if we are able to proceed under the Animal Rule, product development can take a considerable amount of time, and the FDA may decide that our data are insufficient to support approval and require additional pre-clinical, clinical or other studies, refuse to approve our products, or place restrictions on our ability to commercialize those products. Furthermore, products approved under the Animal Rule are subject to certain additional post-marketing requirements. We cannot guarantee that we will be able to meet this regulatory requirement even if one or more of our product candidates are approved under the Animal Rule.

The process of obtaining these regulatory approvals is expensive, often takes many years if approval is obtained at all, and can vary substantially based upon the type, complexity and novelty of the product candidate involved. Changes in the regulatory approval process may cause delays in the approval or rejection of an application. There is a high rate of failure inherent in this process, and potential products that appear promising at early stages of development may fail for a number of reasons, and positive results from pre-clinical studies may not be predictive of similar results in human clinical trials. Similarly, promising results from earlier clinical trials of a product candidate may not be replicated in later clinical trials.

There are many other difficulties and uncertainties inherent in pharmaceutical R&D that could significantly delay or otherwise materially delay our ability to develop future product candidates, mostly related to clinical trials.

Failure to successfully develop future product candidates may materially adversely affect our business, financial condition, operating results and cash flows.

Once an NDA or BLA is submitted, the FDA has substantial discretion and may refuse to accept any application or may decide that our data are insufficient to support approval and require additional pre-clinical, clinical or other studies.

Unapproved and investigational stage products are also subject to the FDA's laws and regulations governing advertising and promotion, which prohibit the promotion of both unapproved products and unapproved uses of approved products. There is some risk that the FDA could conclude that our communications relating to unapproved products or unapproved uses of approved products constitute the promotion of an unapproved product or product use in violation of FDA laws and regulations. There is also a risk that a regulatory authority in another country could take a similar position under that country's laws

~~acceptance of the product by potential government and other customers.~~

and regulations and conclude that we have violated the laws and regulations related to product development, approval, or promotion in that country. Therefore, there is a risk that we could be subject to enforcement actions if found to be in violation of such laws or regulations.

~~Under~~Even if we or our collaborators obtain marketing approvals for our product candidates, the conditions of approvals and ongoing regulation of our products may limit how we manufacture, market and sell our products, which could materially impair our ability to generate revenue.

Once approval has been granted, an approved product and its manufacturer and marketer remain subject to ongoing review and extensive regulation.

We and our collaborators must therefore comply with requirements concerning advertising and promotion for any of our product candidates for which we obtain marketing approval. Promotional communications with respect to FDA-regulated products are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to sell any products we develop for indications or uses for which they are not approved.

If we and our collaborators are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market and sell any products could be limited, which could adversely affect our ability to achieve or sustain profitability. Further, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

Any product candidate for which we or our collaborators obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.

Any product candidate for which we or our collaborators obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control and manufacturing, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and

recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine.

Certain of our products are subject to post marketing requirements (PMRs), which we are required to conduct, and post marketing commitments (PMCs), which we have agreed to conduct. The FDA has the authority to take action against sponsors who fail to meet the obligations of a PMR, including civil monetary penalties and/or misbranding charges.

The FDA and other agencies, including the U.S. Department of Justice (DOJ) and the HHS Office of Inspector General (OIG), closely regulate and monitor the pre-approval and post-approval marketing and promotion of products to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA, DOJ, and OIG impose stringent restrictions on manufacturers’ communications regarding unapproved products and unapproved uses of approved products and if we market unapproved products or market our approved products for unapproved indications, we may be subject to enforcement action. Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription products may lead to investigations and enforcement actions alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturing partners or manufacturing processes, or failure to comply with regulatory requirements, may result in various penalties and sanctions. For all FDA-regulated products, if the FDA finds that a manufacturer has failed to comply with applicable laws and regulations, or that a product is ineffective or poses an unreasonable health risk, it can institute or seek a wide variety of enforcement actions and remedies, including but not limited to:

•restrictions on such products, manufacturers or manufacturing processes;

•restrictions on the labeling or marketing of a product;

•restrictions on distribution or use of a product;

•requirements to conduct post-marketing studies or clinical trials;

•warning letters or untitled letters;

•refusal to approve pending applications or supplements to approved applications that are submitted;

•fines, restitution or disgorgement of profits or revenues;

•suspension or withdrawal of marketing approvals;

•refusal to permit the import or export of our products;

•product seizure; and

•injunctions or the imposition of civil or criminal penalties.

Non-compliance with EU requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the EU and other legal and regulatory requirements regarding the protection of personal information can also lead to significant penalties and sanctions. Non-compliance with similar requirements in other foreign jurisdictions can also result in enforcement actions and significant penalties.

Current and future legislation may increase the difficulty and cost for us and any collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.

In the United States and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the health care system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other health care reform measures that may be adopted in the future, may result in more rigorous coverage criteria and additional downward pressure on the price that we, or any collaborators, may receive for any approved products.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the ACA), passed in 2010 substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted the U.S. biopharmaceutical industry. However, some provisions of the ACA have yet to be fully implemented and certain provisions have been subject to legal and political challenges, as well as efforts by the last Presidential administration to repeal or replace certain aspects of the ACA. On January 28, 2021, however, the President issued an executive order to strengthen implementation of the ACA. Concurrently, Congress

considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA, such as removing penalties as of January 1, 2019 for not complying with the ACA’s individual mandate to carry health insurance, delaying the implementation of certain ACA-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court’s decision, the current Presidential administration issued an executive order initiating a special enrollment period during 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare. It is unclear how healthcare reform measures enacted by Congress or implemented by the current Presidential administration or other challenges to the ACA, if any, will impact the ACA or our business.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted that may negatively impact us. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of up to 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2031 under the Coronavirus Aid, Relief and Economic Security Act, or CARES Act. These Medicare sequester reductions have been suspended through the end of March 2022. From April 2022 through June 2022 a 1% sequester cut will be in effect, with the full 2% cut resuming thereafter.

Additionally, there has been recent heightened federal governmental scrutiny over the manner in which manufacturers set prices for their marketed products. For example, there have been several recent Congressional inquiries and has been proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies

for drug products. For example, the last Presidential administration released a “Blueprint”, or plan, to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out-of-pocket costs of drug products paid by consumers.

For example, in October 2020, HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program, or SIP, to import certain prescription drugs from Canada into the United States. The final rule is currently the subject of ongoing litigation, but at least six states (Vermont, Colorado, Florida, Maine, New Mexico, and New Hampshire) have passed laws allowing for the importation of drugs from Canada with the intent of developing SIPs for review and approval by the FDA.

Further, on July 9, 2021, the President signed Executive Order 14063, which focuses on, among other things, the price of pharmaceuticals. The Order directs HHS to create a plan within 45 days to combat "excessive pricing of prescription pharmaceuticals and enhance domestic pharmaceutical supply chains, to reduce the prices paid by the federal government for such pharmaceuticals, and to address the recurrent problem of price gouging." On September 9, 2021, HHS released its plan to reduce pharmaceutical prices. The key features of that plan are to: (a) make pharmaceutical prices more affordable and equitable for all consumers; (b) improve and promote competition throughout the prescription pharmaceutical industry; and (c) foster scientific innovation to promote better healthcare and improve health by supporting public and private research and making sure that market incentives promote discovery of valuable and accessible new treatments.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. A number of states, for example, require drug manufacturers and other entities in the drug supply chain, including health carriers, pharmacy benefit managers, wholesale distributors, to disclose information about pricing of pharmaceuticals. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical

products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing. We expect that additional state and federal health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

If we fail to comply with foreign, federal, state and local health care laws, including fraud and abuse and health information privacy and security laws, and antitrust laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.

In the United States, certain of our products are reimbursed under federal and state health care programs such as Medicaid, Medicare, TriCare, and/or state pharmaceutical assistance programs. Many foreign countries have similar laws. Federal and state laws designed to prevent fraud and abuse under these programs prohibit pharmaceutical companies from offering valuable items or services to customers or potential customers to induce them to buy, prescribe, or recommend our product (the so-called “anti-kickback” laws). Exceptions are provided for discounts and certain other arrangements if specified requirements are met. Other federal and state laws, and similar foreign laws, not only prohibit us from submitting any false information to government reimbursement programs but also prohibit us, our employees, or any third party acting on our behalf from doing anything to cause, assist, or encourage our customers to submit false claims for payment to these programs. We are also subject to various federal, state and foreign antitrust and competition laws that prohibit certain activities that may have an impact against potential competitors. Violations of the various fraud and abuse and antitrust laws may result in severe penalties against the responsible employees and us, including jail sentences, large fines, and the exclusion of our products from reimbursement under federal and state programs. Some of the laws that may affect our ability to operate include:

•the federal Anti-Kickback Statute makes it illegal for any person or entity, including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, receive, offer or pay remuneration, directly or indirectly, overtly or covertly, to induce, or in return for, either the referral of an individual, or the purchase, lease, prescribing or recommendation of an item, good, facility or service reimbursable by a

federally funded health care program, such as the Medicare or Medicaid program. The term “remuneration” has been interpreted broadly and may constrain our marketing practices, educational programs, pricing policies and relationships with health care providers or other entities, among other activities;

•the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal health care program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government, with potential liability, including mandatory treble damages and significant per-claim penalties.

•the U.S. federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement, in connection with the delivery of, or payment for, health care benefits, items or services. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

•HIPAA, as amended by HITECH, and their respective implementing regulations mandates, among other things, the adoption of uniform standards for the electronic exchange of information in common health care transactions, as well as standards relating to the privacy, security and transmission of individually identifiable health information, which require the adoption of administrative, physical and technical safeguards to protect such information. Among other things, HITECH makes HIPAA's security standards directly applicable to “business associates,” or independent

contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity;

•the Physician Payments Sunshine Act and its implementing regulations require certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Centers for Medicare & Medicaid Services (CMS) to report certain payments and transfers of value made to U.S. physicians, other healthcare providers and teaching hospitals, and ownership or investment interests held by physicians, other healthcare providers and their immediate family members; and

•state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; state, local and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, obtain pharmaceutical agent licensure, and/or otherwise restrict payments that may be made to health care providers and entities; and state, local and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to health care providers or entities, or marketing expenditures.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under the federal Anti-Kickback Statute, it is possible that some of our business activities could be subject to challenges under one or more of such laws. Moreover, recent health care reform legislation has strengthened these laws. For example, the ACA, among other things, amends the intent requirement of the federal Anti-Kickback Statute and criminal health care fraud statutes, so that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the ACA provides that the government may assert that a claim including items or services

resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

If our operations are found to be in violation of any of the laws described above or otherwise, we ~~might~~may be subject to penalties, including civil and criminal penalties, damages, fines, individual imprisonment, integrity obligations, exclusion from funded health care programs and the curtailment or restructuring of our operations. Any such penalties could adversely affect our financial results. We continue to improve our corporate compliance program designed to ensure that our development, marketing, and sales of existing and future products and product candidates are in compliance with all applicable laws and regulations, but we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Efforts to ensure that our business arrangements with third parties will comply with health care laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving fraud and abuse or other health care laws and regulations. If our operations are found to be in violation of any of these laws, we may be subject to significant civil, criminal and administrative penalties, damages, fines, individual imprisonment, integrity obligations, exclusion from government funded health care programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If a third party fails to comply with applicable laws and regulations while acting on our behalf, we may also be subject to criminal, civil, and administrative penalties, including those listed above.

We are committed to conducting the development, marketing and sale of our applicable products and product candidates and all of our activities in compliance with all applicable laws and regulations, but certain applicable laws and regulations may impose liability even in the absence of specific intent to defraud. Furthermore, should an employee or third party acting on our behalf violate these laws without our knowledge, a governmental authority may impose civil and/or criminal sanctions on us.

The United States government, state governments and private payors regularly investigate the pricing and competitive practices of pharmaceutical companies and biotechnology companies, and many file actions alleging that inaccurate reporting of prices has

improperly inflated reimbursement rates. We may also be subject to investigations related to our pricing practices. Regardless of merit or eventual outcome, these types of investigations and related litigation can result in:

•Diversion of management time and attention;

•Significant legal fees and payment of damages or penalties;

•Limitations on our ability to continue certain operations;

•Decreased product demand; and

•Injury to our reputation.

Moreover, an adverse outcome, or the imposition of penalties or sanctions for failing to comply with the fraud and abuse and antitrust laws, could adversely affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows.

If we fail to comply with our obligations under U.S. governmental pricing programs, we could be required to reimburse government programs for underpayments and could pay penalties, sanctions and fines.

The issuance of regulations and coverage expansion by various governmental agencies relating to the Medicaid rebate program will continue to increase our costs and the complexity of compliance and will be time-consuming. Changes to the definition of average manufacturer price (AMP), and the Medicaid rebate amount under the ACA and CMS and the issuance of final regulations implementing those changes has affected and could further affect our 340B “ceiling price” calculations. Because we participate in the Medicaid rebate program, we are required to report average sales price (ASP), information to CMS for certain categories of drugs that are paid for under Part B of the Medicare program. Future statutory or regulatory changes or CMS binding guidance could affect the ASP calculations for our products and the resulting Medicare payment rate and could negatively impact our results of operations.

Pricing and rebate calculations vary among products and programs, involve complex calculations and are often subject to interpretation by us, governmental or regulatory agencies and the courts. The Medicaid rebate amount is computed each quarter based on our submission to CMS of our current AMP and “best price” for the quarter. If we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter in which the data originally were due. Any such revisions could have the

impact of increasing or decreasing our rebate liability for prior quarters, depending on the direction of the revision. Such restatements and recalculations would increase our costs for complying with the laws and regulations governing the Medicaid rebate program. Price recalculations also may affect the “ceiling price” at which we are required to offer our products to certain covered entities, such as safety-net providers, under the 340B/Public Health Service (PHS) drug pricing program.

In addition, if we are found to have made a misrepresentation in the reporting of ASP, we are subject to civil monetary penalties for each such price misrepresentation and for each day in which such price misrepresentation was applied. If we are found to have knowingly submitted false AMP or “best price” information to the government, we may be liable for civil monetary penalties per item of false information. Any refusal of a request for information or knowing provision of false information in connection with an AMP survey verification would also subject us to civil monetary penalties. In addition, our failure to submit monthly/quarterly AMP or “best price” information on a timely basis could result in a civil monetary penalty per day for each day the information is late beyond the due date. Such failure could also be grounds for CMS to terminate our Medicaid drug rebate agreement, under which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, no federal payments would be available under Medicaid or Medicare Part B for our covered outpatient drugs. Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. We cannot assure that our submissions will not be found by CMS to be incomplete or incorrect.

In order for our products to be reimbursed by the primary federal governmental programs, we must report certain pricing data to the USG. Compliance with reporting and other requirements of these federal programs is a pre-condition to: (i) the availability of federal funds to pay for our products under Medicaid and Medicare Part B; and (ii) procurement of our products by the Department of Veterans Affairs (DVA), and by covered entities under the 340B/PHS program. The pricing data reported are used as the basis for establishing Federal Supply Schedule (FSS), and 340B/PHS program contract pricing and payment and rebate rates under the Medicare Part B and Medicaid programs, respectively. Pharmaceutical companies have been prosecuted under federal and state false claims laws for submitting inaccurate and/or incomplete pricing information to the government that resulted in increased payments made by these programs. Although we maintain and follow strict procedures to ensure the maximum possible integrity

for our federal pricing calculations, the process for making the required calculations is complex, involves some subjective judgments and the risk of errors always exists, which creates the potential for exposure under the false claims laws. If we become subject to investigations or other inquiries concerning our compliance with price reporting laws and regulations, and our methodologies for calculating federal prices are found to include flaws or to have been incorrectly applied, we could be required to pay or be subject to additional reimbursements, penalties, sanctions or fines, which could have a material adverse effect on our business, financial condition and results of operations.

To be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we also must participate in the DVA FSS pricing program. To participate, we are required to enter into an FSS contract with the DVA, under which we must make our innovator “covered drugs” available to the “Big Four” federal agencies-the DVA, the DoD, the PHS (including the Indian Health Service), and the Coast Guard-at pricing that is capped under a statutory federal ceiling price (FCP) formula set forth in Section 603 of the Veterans Health Care Act of 1992 (VHCA). The FCP is based on a weighted average wholesale price known as the Non-Federal Average Manufacturer Price (Non-FAMP), which manufacturers are required to report on a quarterly and annual basis to the DVA. Under the VHCA, knowingly providing false information in connection with a Non-FAMP filing can subject us to significant penalties for each item of false information. If we overcharge the government in connection with our FSS contract or Section 703 Agreement, whether due to a misstated FCP or otherwise, we are required to disclose the error and refund the difference to the government. The failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement action, can be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

From time to time, we sell unapproved MCMs to government ~~entities.~~entities under certain circumstances. While this is permissible in some cases, the extent to which we may be able to lawfully ~~market~~offer to sell and sell unapproved products in many jurisdictions may be unclear or ambiguous. Such sales could subject us to regulatory enforcement action, product liability and reputational risk.

Under certain circumstances, MCMs may be procured by government entities prior to approval by the FDA or other regulatory ~~authorities.~~authorities, a practice which we follow in connection with certain MCMs, including AV7909 and TROBIGARD in the United States. In the United States, Project BioShield permits the Secretary of HHS to contract to purchase MCMs for the SNS prior to FDA approval of the ~~countermeasure~~MCM in specified circumstances. Project BioShield and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 also allow the FDA Commissioner to authorize the emergency use of medical products that have not yet been approved by the FDA under an EUA. An EUA ~~pre-approval.~~terminates when the emergency determination underlying the EUA terminates. An EUA is not a long-term alternative to obtaining FDA approval, licensure, or clearance for a product. Absent an applicable exception, our MCM product candidates generally will have to be approved by the FDA or other regulatory authorities in the relevant country through traditional pathways before we can sell those products to governments. Additionally, the laws in certain jurisdictions regarding the ability of government entities to purchase unapproved product candidates are ambiguous, and the permissibility of exporting unapproved products from the United States and importing them to foreign countries may be unclear. Nevertheless, government bodies, such as U.S. federal entities other than HHS, state and local governments within the United States, and foreign governments have sought and may further seek to procure our MCM product candidates that are not yet approved. If so, we would expect to assess the permissibility and liability implications of ~~marketing~~supplying our product candidates to such entities on a case-by-case basis, which presents certain challenges, both in the case of U.S. and foreign governments, and particularly under emergency conditions. In addition, agencies or branches of one country’s government may take different positions regarding the permissibility of such sales than another country’s government or even other agencies or branches of the same government. If ~~we determine~~local enforcement authorities disagree with our conclusion that ~~we believe~~ such activities are permissible, ~~local enforcement authorities could disagree with our conclusion and~~they may take enforcement action against us.

In addition, the sale of unapproved products also could give rise to product liability claims for which we may not be able to obtain indemnification or insurance coverage. For example, liability protections applicable to claims arising under U.S. law and resulting from the use of certain unlicensed or unauthorized products, such as a declaration issued under the PREP Act, may lead plaintiffs to assert that their claims are not ~~cover claims arising~~barred under ~~non-U.S. law.~~

the PREP Act.

Regardless of the permissibility and liability risks, in the event a user of one or more of our products suffers an adverse event, we may be subject to

additional reputational risk if the product has not been approved by the FDA or the corresponding regulatory authority of another country, particularly because we will not have approved labeling regarding the safety or efficacy of those products. In addition, legislatures and other governmental bodies that have oversight responsibility for procuring agencies may raise concerns after the fact, even if procurement was permissible at the time, which could result in negative publicity, reputational risk and harm to our business prospects.

There is also a risk that our communications with governments about our unapproved products, such as in the procurement context, could be considered promotion of an unapproved product or unapproved use of an approved product. Therefore, there is a risk that we could be subject to enforcement actions if found to be in violation of such laws or regulations.

~~Clinical~~Even after regulatory approval is received, if we fail to comply with regulatory requirements, or if we experience unanticipated problems with our approved products, they could be subject to restrictions, penalties or withdrawal from the market.

In addition to the requirements and uncertainties related to the pre-approval activities discussed previously, any vaccine, therapeutic product or medical device for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to the continual requirements of and review by the FDA and other regulatory bodies. Our approved products are subject to these requirements and ongoing review. These requirements include submissions of safety and other post-marketing information and reports, plasma donor testing, registration requirements, cGMP, requirements relating to potency and stability, quality control, quality assurance, restrictions on advertising and promotion, import and export restrictions and recordkeeping requirements. In addition, various state laws require that companies that manufacture and/or distribute drug products within the state obtain and maintain a manufacturer or distributor license, as appropriate. Because of the breadth of these laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws.

Government regulators enforce cGMP and other requirements through periodic unannounced inspections of manufacturing facilities. The FDA is authorized to inspect domestic and foreign manufacturing facilities without prior notice at reasonable times and in a reasonable manner. Health Canada may conduct similar inspections of our domestic and foreign facilities where products offered and sold in Canada are produced, or related formulation and filling operations are conducted. The

FDA, Health Canada, and other foreign regulatory agencies conduct periodic inspections of our facilities. Following several of these inspections, regulatory authorities have issued inspectional observations, some of which were significant, but all of which are being, or have been, addressed through corrective actions. If, in connection with any future inspection, regulatory authorities find that we are not in substantial compliance with all applicable requirements, or if they are not satisfied with the corrective actions we take, our regulators may undertake enforcement action against us, which may include:

•warning letters and other communications;

•product seizure or withdrawal of the product from the market;

•restrictions on the marketing or manufacturing of a product;

•suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;

•fines or disgorgement of profits or revenue; and

•injunctions or the imposition of civil or criminal penalties.

Similar action may be taken against us should we fail to comply with regulatory requirements, or later discover previously unknown problems with our products or manufacturing processes. For instance, our products are tested regularly to determine if they satisfy potency and stability requirements for their required shelf lives. Failure to meet potency, stability or other specification requirements could result in delays in distributions, recalls or other consequences. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or sold or to the conditions of approval. Regulatory approval may also contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. If we experience any of these post-approval events, our business, financial condition, operating results and cash flows could be materially and adversely affected.

Additionally, companies may not promote unapproved products or unapproved uses of approved products (i.e. “off-label” uses or uses that are not described in the product’s approved labeling and that differ from the uses approved by the applicable regulatory agencies). A company that is found to have improperly promoted an unapproved product or unapproved use of an approved product may be subject to significant liability, including civil and administrative remedies (such as entering into

corporate integrity agreements with the USG), as well as criminal sanctions. If our employees or agents engage in marketing of an unapproved product or the unapproved use of an approved product, we could be subject to civil or criminal investigations and monetary and injunctive penalties, which could adversely impact our ability to conduct business in certain markets, negatively affect our business, financial condition, operating results and cash flows, and damage our reputation.

Failure to obtain or maintain regulatory approval in international jurisdictions could prevent us from marketing our products abroad and could limit the growth of our business.

We currently sell certain of our products outside the United States and intend to expand the countries in which we sell our products and have received market authorization under the mutual recognition procedure to sell BioThrax in France, Italy, the Netherlands, Poland, and the United Kingdom. To market or sell our products in foreign jurisdictions under normal circumstances, we generally need to obtain separate regulatory approvals and comply with numerous and varying requirements or use alternative “emergency use” or other exemptions from general approval and import requirements. Approval by the FDA in the United States or the mutual recognition procedure in the European member states does not ensure approval by all foreign regulatory authorities. The approval procedures in foreign jurisdictions can vary widely and can involve additional clinical trials and data review beyond that required by the FDA or under the mutual recognition procedure. There is also a risk that a regulatory authority in another country could conclude that we have violated the rules and regulations related to product development, approval or promotion in that country. Therefore, there is a risk that we could be subject to a foreign enforcement action if found to be in violation of such laws and regulations. We and our collaborators may not be able to obtain foreign regulatory approvals on a timely basis, if at all, and we may be unable to successfully commercialize our products in desired jurisdictions internationally if no alternate procurement pathway is identified for authorized government customers in a particular jurisdiction. We have limited experience in preparing, filing and prosecuting the applications necessary to gain foreign regulatory approvals and expect to rely on third-party contract research organizations and consultants to assist us in this process. Our reliance on third parties can introduce additional uncertainty into the process.

As of January 1, 2021, the Medicines and Healthcare products Regulatory Agency (the MHRA), became responsible for supervising medicines and medical devices in Great Britain, comprising England, Scotland and Wales under domestic law, whereas

Northern Ireland will continue to be subject to European Union rules under the Northern Ireland Protocol. The MHRA will rely on the Human Medicines Regulations 2012 (SI 2012/1916) (as amended). or the HMR, as the basis for regulating medicines. The HMR has incorporated into the domestic law of the body of European Union law instruments governing medicinal products that pre-existed prior to the United Kingdom's withdrawal from the European Union. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, may force us to restrict or delay efforts to seek regulatory approval in the United Kingdom for our product candidates, which could significantly and materially harm our business.

Laws and regulations governing international operations may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.

As we continue to expand our commercialization activities outside of the United States, we are subject to an increased risk of, and must dedicate additional resources towards avoiding inadvertently conducting activities in a manner that violates the Foreign Corrupt Practices Act (FCPA), the U.K. Bribery Act, Canada's Corruption of Foreign Public Officials Act, and other similar foreign laws, which prohibit corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the Company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Compliance with the FCPA is expensive and ~~time-consuming,~~difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Many countries, including the United States, also have various lobbying laws and regulations governing the conduct of individuals and companies who interact with government officials. These laws and regulations typically include certain restrictions and disclosure obligations. We believe we are currently in compliance

with such laws and regulations. If we, our employees, or third parties acting on our behalf do not comply with these laws and regulations, we may be subject to civil and criminal penalties.

Many countries, including the United States, restrict the export or import of products to or from certain countries through, for example, bans, sanction programs, and boycotts. Such restrictions may preclude us from supplying products in certain countries, which could limit our growth potential. Furthermore, if we, or third parties acting on our behalf, do not comply with these restrictions, we may be subject to civil and criminal penalties.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we continue to expand our presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs.

The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

COMPETITIVE AND POLITICAL RISKS

Development and commercialization of pharmaceutical products, including for PHT preparedness, are routinely subject to evolving private and public sector competition.

The development and commercialization of new biopharmaceutical and medical technology products is highly competitive and subject to rapid technological advances. We may face future competition from other companies and governments, universities and other non-profit research organizations in respect to our products, any products that we acquire, our current product candidates and any products we may seek to develop or commercialize in the future. The market for current products can be subject to development of safer, more effective, more convenient or less costly products. The market for current products can also depend on what resources can be devoted to marketing or selling products, or how companies are positioned to adapt more quickly to new technologies, respond to scientific advances or patient preferences and needs, initiate or withstand substantial price

competition and/or procure third-party licensing and collaborative arrangements.

There are a number of companies with products or product candidates addressing PHT preparedness that are competing with us for both USG procurement and development resources. Factors to consider include competitors' financial, technical, marketing and selling resources as well as potential leverage that their ~~outcome~~intellectual property estates may offer.

Any reduction in demand for our products or reduction or loss of development funding for our products or product candidates in favor of a competing product could lead to a loss of market share for our products and cause reduced revenues, margins and levels of profitability for us, which could adversely affect our business, financial condition, operating results and cash flows.

Our Biologic Products may face risks of competition from biosimilar manufacturers.

Biological products and product candidates, otherwise referred to as our “Biologic Products,” can be affected by the approval and entry of “biosimilars” in the United States and other jurisdictions. Biosimilar drugs are “highly similar,” but close enough in duplication to accomplish the same therapeutic and clinical result. Biologic Products in our current pipeline include AV7909, BioThrax, and ACAM2000. If a biosimilar version of one of our Biologic Products were approved, it could have a material adverse effect on the sales and gross profits of the affected Biologic Product and could adversely affect our business, financial condition, operating results and cash flows.

NARCAN® (naloxone HCI) Nasal Spray is ~~uncertain. We must invest substantial amounts~~currently subject to generic competition and may be subject to additional branded and generic competition in the future.

NARCAN currently faces generic competition. In 2016, Teva Pharmaceuticals Industries Limited and Teva Pharmaceuticals USA (collectively, Teva) filed an Abbreviated New Drug Application (ANDA) seeking regulatory approval to market a generic version of NARCAN. In patent litigation related to Teva’s ANDA filing, a trial Court decided in favor of Teva, and this decision was subsequently affirmed by the Court of Appeals for the Federal Circuit.

On December 22, 2021, Teva commenced the launch of their generic naloxone nasal spray. On the same date, Sandoz initiated distribution of an authorized generic naloxone nasal spray having entered into agreement with Emergent for this purpose.

NARCAN may face additional generic competition from other parties, including from Perrigo UK FINCO Limited Partnership (Perrigo), who filed their own ANDA in 2018. Emergent settled with Perrigo on

February 12, 2020 providing for a license effective upon the Teva litigation decision.

Sales of generic versions of NARCAN at prices lower than our branded product or provided at no cost by Teva have the potential to erode our sales and could impact our product revenue related to NARCAN. For example, certain U.S. state laws allow for, and in some instances in the absence of specific instructions from the prescribing physician, mandate the dispensing of generic products rather than branded products where a generic version is available. In addition, in January 2019, the FDA released new proposed template Drug Facts Labels to assist sponsors of investigational naloxone nasal sprays and auto-injectors seeking approval from the FDA for over-the-counter naloxone products.

NARCAN may also face branded competition.For example, on April 30, 2021, the FDA approved Kloxxado™, a branded product developed by Hikma Pharmaceuticals, Inc. which delivers a higher dose naloxone nasal spray.In addition, Orexo AB and Harm Reduction Therapeutics both have development programs for novel naloxone nasal spray formulations intended for use in opioid overdose reversal.

Additional branded competition may correspond to other injectable naloxone, auto-injectors and improvised nasal kits including Amphastar Pharmaceuticals, Inc.'s naloxone injection product and Kaléo's EVZIO™ (naloxone HCI injection) Auto-Injector.

Political or social factors may delay or impair our ability to market and sell our products and may require us to spend significant management time and financial resources to address these issues.

Products developed to counter the potential impact of PHTs are subject to changing political and social environments. The political responses and social awareness of the risks of these threats on military personnel or civilians and the level of emphasis placed on such risks by the USG may vary over time. If the threat of terrorism were to decline, then the public perception of the risk on public health and safety may be reduced. This perception, as well as political or social pressures, could delay or cause resistance to bringing our products in ~~these trials,~~development to market or limit pricing or purchases of our products, any of which ~~may~~could negatively affect our revenues and our business, financial condition, operating results and cash flows.

could potentially damage the public's perception of us and our products. ~~Failure to obtain regulatory approval for product candidates, particularly in the United States, could materially and~~Any publicity campaigns or other negative publicity may adversely affect the degree of market acceptance of our ~~financial resources,~~MCMs and thereby limit the demand for our products, which would adversely affect our business, financial condition, operating results and cash flows.

We may not be able to obtain orphan drug exclusivity for product candidates we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.

~~Before obtaining regulatory~~

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug or biologic intended to treat a rare disease or condition. Generally, if a product candidate with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same product for the same therapeutic indication for that time period. The applicable period is seven years in the United States.

In order for the FDA to grant orphan drug exclusivity to one of our products, the agency must find that the product is indicated for the treatment of a condition or disease with a patient population of fewer than 200,000 individuals annually in the United States. The FDA may conclude that the condition or disease for which we seek orphan drug exclusivity does not meet this standard. Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different products can be approved for the same condition. In addition, even after an orphan drug is approved, the FDA can subsequently approve the same product for the same condition if the FDA or such authorities conclude that the later product is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusivity may also be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of the patients with the rare disease or condition.

INTELLECTUAL PROPERTY RISKS

Protection of our intellectual property rights is an important tool for sustaining our business and the failure to do so could impact our financial condition, operating results, and cash flows.

We actively seek to protect intellectual property rights related to our Company's assets, including patent rights, trademark rights, trade secrets and proprietary confidential information, through defense

and enforcement of existing rights and pursuit of protection on new and arising innovations.

Obtaining, maintaining and defending our intellectual property rights in the United States and other countries remains a critical component of the development and commercialization of our Company's assets.

Some of the risks associated with procurement, maintenance and enforcement of intellectual property rights include changes in patent laws or administrative patent office rules, evolving criteria and eligibility of obtaining patent protection on particular subject matter, the validity and enforceability of our intellectual property rights, the potential scope of coverage of our intellectual property rights, and/or the availability or strength of legal remedies in a particular country to defend and enforce intellectual property rights.

Other risks include associated costs, such as costs of patent prosecution and maintenance and costs associated with post-grant challenges. For example, such costs include inter partes review (IPR) proceedings in the United States and oppositions in Europe, as well as costs associated with litigating and enforcing patent and trademark rights.

Additional risks include limitations on our extent or ability to procure, maintain or defend intellectual property rights associated with in-licensed or acquired intellectual property, where, for example, third parties may have the first right to maintain or defend intellectual property rights in which we have an interest, or may pursue strategies that are divergent to the interest of our Company.

Third party challenges for patent infringement could impact our business, financial condition, operating results, and cash flows.

Challenges by third parties for alleged patent infringement could delay or affect the development and commercialization of our products. Such challenges, while ongoing, could be costly, requiring and utilizing company resources. Such challenges, if successful, may impact marketing or launch of products, or require ongoing license and/or royalty fees associated with potential settlement agreements. These may have the potential to materially harm our business, financial condition, operating results, and cash flows.

Intellectual property licenses with third parties carry risks of challenges, which may be costly and time consuming and could impact the commercialization of our products.

We are a party to a number of license agreements and expect to enter into additional license agreements in the future. Such license agreements or collaboration arrangements can be subject to

challenges if interests or expectations under such license agreements diverge. Such challenges may be costly, risk time and resources, and could delay or impact development, commercialization or launch of our products.

Potential loss of proprietary information and know-how generally carries the risk of reducing the value of our technology and products.

We also rely upon unpatented proprietary technology, processes, and know-how, particularly as to our proprietary manufacturing processes. These types of confidential information and trade secrets can be difficult to protect. We seek to protect this confidential information, in part, through agreements with our employees, consultants, and third parties, as well as confidentiality policies and audits, although these may not always be successful in protecting our trade secrets and confidential information.

One or more of our products could be subject to early competition from generic drugs and biosimilars.

One or more of our products is approved as a drug product under the provisions of the FDCA, which may render it susceptible to potential competition from generic manufacturers via the Hatch-Waxman Act and ANDA process. Other of our products may be susceptible to challenges by entry of biosimilars through the route established under the Biologics Price Competition and Innovation Action of 2009.

RISKS RELATED TO RELIANCE ON THIRD PARTIES

The loss of any of our non-exclusive, sole-source or single source suppliers, a shortage of related supplies or an increase in the price of inventory supplied to us could have an adverse effect on our business, financial condition and results of operations.

We purchase certain supplies used in our manufacturing processes from non-exclusive, or single sources due to quality considerations, costs or constraints resulting from regulatory requirements. We depend on certain single-source suppliers for key materials and services necessary to manufacture the majority of our products and certain product candidates. For example, we rely on a single-source supplier to provide us with Alhydrogel in sufficient quantities to meet our needs to manufacture AV7909 and BioThrax and the specialty plasma in our hyperimmune specialty plasma products and certain ingredients for ACAM2000. We also rely on single-source suppliers for the materials necessary to

produce NARCAN, such as the naloxone active pharmaceutical ingredient and other excipients, along with the vial, stopper and device.

Where a particular single-source supply relationship is terminated, we may not be able to establish additional or replacement suppliers for certain components or materials quickly. This is largely due to the FDA approval system, which mandates validation of materials prior to use in our products, and the complex nature of manufacturing processes. In addition, we may lose a sole-source supplier due to, among other things, the impact of COVID-19 on such supplier, the acquisition of a supplier by a competitor (which may cause the supplier to stop selling its products to us) or the bankruptcy of such a supplier, which may cause the supplier to cease operations. Any reduction or interruption by a sole-source supplier of the supply of materials or key components used in the manufacturing of our products or product candidates, a reduction in quality or an increase in the price of those materials or components could adversely affect us. If we are unable to locate or establish alternative suppliers, our ability to manufacture our products and product candidates could be adversely affected and could harm our ~~collaborative partners, where applicable, must conduct preclinical studies and clinical trials~~revenues, cause us to ~~establish proof~~fail to satisfy contractual commitments, lead to a termination of concept and demonstrate the safety and efficacy of our product candidates. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in preclinical testing and early clinical trials does not ensure that later clinical trials or animal efficacy studies will be successful, and interim results of a clinical trial or animal efficacy study do not necessarily predict final results. An unexpected result in one or more of our contracts or lead to delays in our clinical trials, ~~can occur at~~ any ~~stage~~ of ~~testing.~~

For certain of our product candidates addressing CBRNE threats, we expect to rely on the Animal Rule to obtain regulatory approval. The Animal Rule permits, in certain limited circumstances, the use of animal efficacy studies, together with human clinical safety and immunogenicity trials, to support an application for marketing approval. For a product approved under the Animal Rule, certain additional post-marketing requirements apply. For example, to the extent feasible and ethical, applicants must conduct post-marketing studies, such as field studies, to verify and describe the drug's clinical benefit and to assess its safety when used as indicated. We have limited experience in the application of these rules to the product candidates that we are developing. It is possible that results from these animal efficacy studies may not be predictive of the actual efficacy of our product candidates in humans.

Under Project BioShield, the Secretary of HHS can contract to purchase MCMs for the SNS prior to FDA approval of the countermeasure in specified circumstances. Project BioShield also allows the FDA commissioner to authorize the emergency use of medical products that have not yet been approved by the FDA under an Emergency Use Authorization. If our product candidates are not selected under this Project BioShield authority, they generally will have to be approved by the FDA through traditional regulatory mechanisms for distribution in the United States.

~~We may experience unforeseen events or issues during, or as a result of, preclinical testing, clinical trials or animal efficacy studies. These issues and events,~~ which could ~~delay or prevent~~be costly to us and otherwise materially harm our ~~ability to receive regulatory approval for a product candidate, include, among others:~~

~~our inability to manufacture sufficient quantities of materials for use in trials;~~

~~the unavailability or variability in the number and types of subjects for each study;~~

~~safety issues or inconclusive or incomplete testing, trial or study results;~~

~~drug immunogenicity;~~

~~lack of efficacy of product candidates during the trials;~~

~~government or regulatory restrictions or delays; and~~

~~greater than anticipated costs of trials.~~

business, financial condition, operating results and cash flows.

We depend on third parties to conduct many of our clinical and non-clinical trials. If these third parties do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates and, as a result, our business, financial condition, operating results and cash flows may suffer.

~~We do not have the ability to independently conduct the clinical and non-clinical trials required to obtain regulatory approval for our product candidates.~~ We depend on third parties, such as independent clinical investigators, contract research organizations and other third-party service providers to conduct the clinical and non-clinical trials of our product candidates and expect to continue to do so. We rely heavily on these third parties for successful execution of our clinical and non-clinical trials, but do not exercise day-to-day control over their activities. Our reliance on these service providers does not relieve us of our regulatory responsibilities, including ensuring that our trials are conducted in accordance with good clinical practice regulations and the plan and protocols contained in the relevant regulatory application. In addition, these organizations may not complete these activities on our anticipated or desired timeframe. We also may experience unexpected cost increases that are beyond our control. Problems with the timeliness or quality of the work of a contract research organization may lead us

to seek to terminate the relationship and use an alternative service provider, which may prove difficult, costly and result in a delay of our trials. Any delay in or inability to complete our trials could delay or prevent the development, approval and commercialization of our product candidates.

In certain cases, government entities and ~~non-government organizations~~NGOs conduct studies of our product candidates, and we may seek to rely on these studies in applying for marketing approval for certain of our product candidates. These government entities and ~~non-government organizations~~NGOs have no obligation or commitment to us to conduct or complete any of these studies or clinical trials and may choose to discontinue these development efforts at any time. Furthermore, government entities depend on annual Congressional appropriations to fund their development efforts, which may not be approved.

If we are unable to obtain any necessary third-party services on acceptable terms or if these service providers do not successfully carry out their contractual duties or meet expected deadlines, our efforts to obtain regulatory approvals for our product candidates may be delayed or prevented.

LEGAL AND REPUTATIONAL RISKS

Our financial condition and operating results could be adversely impacted by unfavorable results of legal proceedings or government investigations.

We are subject to various claims, legal proceedings and government investigations that have not yet been fully resolved, including stockholder derivative and putative class action lawsuits, and new matters may ~~fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.~~

~~We continue to evaluate our product development strategy and, as a result, may modify our strategy~~arise in the future. In ~~this regard, we~~addition, agreements entered into by us sometimes include indemnification provisions which can subject us to costs and damages in the event of a claim against an indemnified third party. The number of claims, legal proceedings and government investigations involving us, and the alleged magnitude of such claims, proceedings and government investigations, has generally increased over time and may ~~from time~~continue to ~~time, focus our product development efforts on different product candidates~~increase. Certain of these actions include, and future actual or threatened legal actions may include, claims for substantial and indeterminate amounts of damages, or may ~~delay or halt the development~~result in other actions adverse to us.

For example, multiple purported class action lawsuits have been filed against us and certain of ~~various product candidates. We may change or refocus~~ our ~~existing product development, commercialization~~current and manufacturing activities based on government funding decisions. This could require changes in our facilities and our personnel. Any product development changes that we implement may not be successful. In particular, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates or choose candidates for which government development funds are not available. Our decisions to allocate our research and development, management and financial resources toward particular product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources from better business opportunities. Similarly, our decisions to delay or terminate product development programs may also prove to be incorrect and could cause us to miss valuable opportunities.

~~INTELLECTUAL PROPERTY RISKS~~

~~If we are unable to protect our proprietary rights, our business, financial condition, operating results, and cash flows could be materially harmed.~~

~~Our success will depend, in large part, on our ability to obtain and maintain protection~~former senior officers in the United States ~~and other countries~~District Court for the ~~intellectual property incorporated into~~District of Maryland seeking unspecified damages on behalf of a putative class of persons who purchased or ~~covering our technology, products, and product candidates. Obtaining and maintaining protection~~otherwise acquired shares of our ~~intellectual property is very costly.~~common stock during various date ranges. The ~~patentability of technology in the biopharmaceutical field generally is highly uncertain~~complaints, allege, among other things, that we made materially false and ~~involves complex legal~~misleading statements regarding our procedures and ~~scientific questions.~~

~~We may not be able to obtain additional issued patents~~quality controls relating to vaccine

production, in violation of federal securities laws. As another example, multiple stockholder derivative lawsuits were filed in The Court of Chancery of the State of Delaware and the United States District Court for the District of Maryland on behalf of the Company against certain current and former officers and directors for breach of fiduciary duties, waste of corporate assets, unjust enrichment and insider trading, each allegation related to the Company’s capabilities to manufacture COVID-19 vaccine bulk drug substance. In addition to monetary damages, the complaints seek the implementation of multiple corporate governance and internal policy changes.

In addition, we have received inquiries and subpoenas to produce documents from Representative Carolyn Maloney and Representative Jim Clyburn, members of the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis, Senator Murray of the Committee on Health, Education, Labor and Pensions, the Financial Industry Regulatory Authority, the Department of Justice), the SEC, the Maryland Attorney General’s Office, and the New York Attorney General’s Office. We are producing and have produced documents as required in response and will continue to cooperate with these government inquiries.

Regardless of merit, litigation can be both time-consuming and disruptive to our ~~technology~~operations and cause significant expense and diversion of management’s attention. The outcome of litigation or ~~products. Even if issued, patents may inadvertently lapse~~government investigations is also inherently uncertain. If one or more legal matters were resolved against us or an indemnified third party in a reporting period for amounts above management’s expectations, our financial condition and operating results for that reporting period could be ~~challenged, narrowed, invalidated,~~materially adversely affected. Further, such an outcome could result in significant compensatory, punitive or ~~circumvented,~~trebled monetary damages, disgorgement of revenue or profits, remedial corporate measures or injunctive relief against us and ~~such happenings~~ could require us to change our business practices or limit our ability to ~~stop competitors from marketing similar~~offer certain products and services, all of which could materially adversely affect our financial condition and operating results. While we maintain insurance coverage for certain types of claims, such insurance coverage may be insufficient to cover all losses or ~~limit the duration~~all types of ~~patent protection we~~claims that may ~~have for~~arise.

We rely significantly on information technology systems and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ~~products. In the past, we have abandoned the prosecution and/or maintenance of patent applications related~~ability to patent families in the ordinary course of business. In the future we may choose to abandon such prosecution and/or maintenance in a similar fashion. If these patent rights are later determined to be valuable or necessary tooperate our business our competitive position may be adversely affected. Changes in patent laws or administrative patent office rules or changes in interpretations of patent laws in the United States and in other countries may diminish the value of our intellectual property, narrow the scope of our patent protection,effectively or result in ~~costly defensive measures. In addition, some countries do not grant patent claims directed~~data leakage of proprietary and confidential business and employee information.

Our business is increasingly dependent on critical, complex and interdependent information technology

systems, including Internet-based systems, to ~~methods~~support business processes as well as internal and external communications. We also have contracted with the USG and pharmaceutical companies, such as Johnson & Johnson, for the development and manufacture of ~~treating humans~~a significant quantity of COVID-19 vaccines, and separately we are working on a proprietary COVID-19 therapeutic with support from the USG and other private sector entities, which has raised our security profile, and heightened potential risks that malicious actors may seek to disrupt our systems or misappropriate our information. The size and complexity of our computer systems make them potentially vulnerable to interruption, invasion, computer viruses, destruction, malicious intrusion and additional related disruptions, which may result in ~~these countries, patent~~the impairment of production and key business processes. Our systems are also potentially vulnerable to data security breaches through employee error, phishing scams and malfeasance, which may expose sensitive data to unauthorized persons. No system of protection ~~may not be available at all~~is adequate to protect ~~our products~~against all such threats, even if they are deemed to be industry standard, and there can be no assurance that we will be able to repel any such attacks. Data security breaches could lead to the loss of trade secrets or ~~product candidates.~~

~~The cost~~other intellectual property or the public exposure of litigation to uphold the validity of patents to prevent or stop infringement or to otherwise protect or enforce our proprietary rights could be substantial and, from time to time, our patents may be subjected to opposition proceedings or validity challenges. Somepersonal information, including sensitive personal information, of our ~~competitors~~employees, clinical trial patients, customers and others. Responding to any such threats may ~~choose to or~~also be ~~better able to sustain the costs of complex patent litigation. Intellectual property lawsuits are~~ expensive and ~~unpredictable~~time-consuming.

A significant business disruption or a breach in security resulting in misappropriation, theft or sabotage with respect to proprietary and ~~consume management's time~~confidential business and ~~attention~~employee information could result in significant financial losses, legal, business or reputational harm to us, compromise our business prospects and our commitments to the USG or other resources, even if the outcome is successful. In addition, there is a risk that a court could decide that our patents are not valid, are unenforceable, or are not infringed by a competitor product. There is also a risk that, even if the validity of a patent is upheld, a court could refuse to stop the other party from using the invention(s), including on the grounds that its activities do not infringe the patent. Ifcustomers, any of ~~these events occur, our business, financial condition, operating results and cash flows could be materially and adversely affected.~~

Our collaborators and licensors may not adequately protect our intellectual property rights. These third parties may have the first right to maintain or defend intellectual property rights that we have an interest and, although we may have the right to assume the maintenance and defense of such intellectual property rights if these third parties do not do so, our ability to maintain and defend such intellectual property rights may be compromised by the acts or omissions of these third parties. For example, we license from:

·	~~Pfizer, Inc. an oligonucleotide adjuvant, CPG 7909, for use in our~~ ~~NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant) anthrax~~ ~~vaccine product candidate.~~

·	~~Opiant Pharmaceuticals, Inc. formulations of naloxone, for use in our NARCAN® Nasal Spray.~~

·	Pharma Consult GmbH autoinjectors, including the autoinjector used for our Trobigard® (atropine sulfate, obidoxime chloride) autoinjector.*

*Trobigard® is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the US. This product is not distributed in the US.

We also will rely on current and future trademarks to establish and maintain recognized brands. If we fail to acquire and protect such trademarks, our ability to market and sell our products, and therefore our business, financial condition, operating results, and cash flows could be materially and adversely affected.

~~Third parties may choose to file patent infringement claims against us; defending ourselves from such allegations could be costly, time-consuming, distracting to management, and~~which could materially and adversely affect our business, financial condition and operating ~~results, and cash flows.~~

results.

Our ~~development~~work on PHTs has exposed us to criticism and ~~commercialization activities, as well as any product candidates or products resulting~~may expose us to further criticism, from ~~these activities,~~the media, government personnel, and others, that can negatively affect our share price, reputation, operations, and our ability to attract and retain talent and secure new customer contracts.

Our work on PHTs, including manufacturing issues at our Baltimore Bayview facility, has exposed us to criticism and may ~~infringe or be claimed~~expose us to ~~infringe patents~~additional potential criticism, from the media, government personnel, and others. In addition, our work on PHTs has exposed us to governmental inquiries and investigations, including by Congress and other ~~intellectual property rights~~government agencies. For example, a joint panel of ~~third parties for which we do not hold sufficient licenses or~~the U.S. House of Representatives launched an

investigation into, among other ~~rights. Additionally, third parties may~~things, the cause of the previously mentioned cross-contamination issues identified in a viral vaccine drug substance batch at the Baltimore Bayview facility. Such criticism can be ~~successful~~particularly acute during a public health emergency like the COVID-19 pandemic. The unfavorable media coverage and increased government scrutiny, including the Congressional inquiry, could further harm our reputation, distract management’s attention from our operations, and impact our ability to attract and retain talent and result in ~~obtaining patent protection for technologies that cover development~~further declines to our share price. We have already incurred significant legal costs to respond to government inquiries and ~~commercialization activities in which we~~ are ~~already engaged. Third parties may own or control these patents and intellectual property rights in the United States and abroad. These third parties could bring claims against us that could cause us~~likely to incur ~~substantial expenses to defend against these claims and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement~~additional costs. Any adverse actions by government authorities may result in significant civil or ~~other similar suit is brought against us, we could be forced to stop~~criminal fines or ~~delay development, manufacturing, or sales~~penalties, all of ~~the product or product candidate that is the subject of the suit. Intellectual property litigation in the biopharmaceutical industry is common, and we expect this trend to continue.~~

As a result of patent infringement or other similar claims, or to avoid potential claims, we may choose or be required to seek a license from a third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we are able to obtain a license, the rights may be non-exclusive, which could ~~result in~~adversely impact our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations. If, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms, if at all, or if an injunction is granted against us, these could materially harm our business, financial condition, operating results and cash flows.

~~If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.~~

We are a party to a number of license agreements and expect to enter into additional license agreements in the future. Our existing licenses impose, and we expect future licenses will impose, various diligence, milestone payment, royalty, insurance, and other obligations on us. If we fail to comply with these obligations, the licensor may have the right to terminate the license and/or sue us for breach, which could cause us to not be able to market any product that is covered by the license and subject us to damages, which may be material.

~~If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.~~

We also rely upon unpatented proprietary technology, processes, and know-how, particularly as to our proprietary manufacturing processes. Because we do not have patent protection for all of our current products, our only other intellectual property protection for products, other than trademarks, is confidentiality regarding our manufacturing capability and specialty know-how, such as techniques, processes, and unique starting materials. However, these types of confidential information and trade secrets can be difficult to protect. We seek to protect this confidential information, in part, through agreements with our employees, consultants, and third parties, as well as confidentiality policies and audits, although these may not be successful in protecting our trade secrets and confidential information.

These agreements may be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become known, including through a potential cyber security breach, or may be independently developed by competitors. If we are unable to protect the confidentiality of our proprietary information and know-how, or if others independently develop our proprietary information or processes, competitors may be able to use this information to develop products that compete with our products, which could materially and adversely impact our business.

~~FINANCIAL RISKS~~

~~Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our operations to pay our substantial debt.~~

Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility. Debt financing could have significant adverse consequences for our business, including:

~~requiring us to dedicate a substantial portion of any cash flow from operations to payment on our debt, which would reduce the amounts available to fund other corporate initiatives;~~

~~increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;~~

subjecting us, as under our senior secured credit facilities, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;

~~requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;~~

~~limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and~~

~~placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.~~

We may not have sufficient funds or be able to obtain additional financing to pay the amounts due under our indebtedness. In addition, failure to comply with the covenants under our debt instruments could result in an event of default under those instruments. An event of default could result in the acceleration of amounts due under a particular debt instrument and a cross default and acceleration under other debt instruments, and we may not have sufficient funds or be able to obtain additional financing to make any accelerated payments. Under these circumstances, our lenders could seek to enforce security interests in our assets securing our indebtedness.

~~Our current indebtedness and any additional debt financing may restrict the operation of our business and limit the cash available for investment in our business operations.~~

In connection with the acquisition of Adapt, we entered into an amendment and restatement of our 2017 credit agreement to provide for new five-year syndicated senior secured credit facilities that replaced our existing facility. The senior secured credit facilities include a $450 million Term Loan and the ability to borrow up to a $600 million revolver, of which we have drawn down $450 million and $318 million, respectively. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility. Debt financing could have significant adverse consequences for our business, including:

~~the level, timing and cost of product sales and contract manufacturing services;~~

~~the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;~~

~~the acquisition of new facilities and capital improvements to new or existing facilities;~~

~~the payment obligations under our indebtedness;~~

~~the scope, progress, results and costs of our development activities;~~

~~our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;~~

~~the extent to which we repurchase additional common stock under our authorized share repurchase program; and~~

~~the costs of commercialization activities, including product marketing, sales and distribution.~~

We may require significant additional funding and may be unable to raise capital when needed or on acceptable terms, which would harm our ability to grow our business, and our results of operations and financial condition.

If our capital resources are insufficient to meet our future capital requirements, we will need to finance our cash needs through public or private equity or debt offerings, bank loans or collaboration and licensing arrangements. In August 2018, we filed an automatic shelf registration statement, which immediately became effective under SEC rules. For so long as we continue to satisfy the requirements to be deemed a “well-known seasoned issuer” under SEC rules (which include, among other things, the timely filing of our reports under the Exchange Act and maintenance of at least $700 million of public float or issuing an aggregate amount of $1 billion of non-convertible securities, other than common stock, in registered offerings for cash during the past three years), this shelf registration statement, effective until August 8, 2021, allows us to issue an unrestricted amount of equity, debt and certain other types of securities through one or more future primary or secondary offerings. If we do not file a new shelf registration statement prior to August 8, 2021, the existing shelf registration statement will expire, and we will not be able to publicly raise capital or issue debt until a new registration statement is filed and becomes effective. There can be no assurance that we will be eligible to file an automatically effective shelf registration statement at a future date when we may need to raise funds publicly.

If we raise funds by issuing equity securities, our stockholders may experience dilution. Public or bank debt financing, if available, may involve agreements that include covenants, like those contained in our senior secured credit facilities, limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities or declaring dividends. If we raise funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that may not be favorable to us. We are not restricted under the terms of the indenture governing our 2.875% Convertible Senior Notes due 2021 (“Senior Convertible Notes”) from incurring additional debt, securing existing or future debt, recapitalizing our debt or taking a number of other actions that could have the effect of diminishing our ability to make payments on our indebtedness. However, our senior secured credit facilities restrict our ability to incur additional indebtedness, including secured indebtedness.

Economic conditions may make it difficult to obtain financing on attractive terms, or at all. If financing is unavailable or lost, our business, operating results, financial condition and cash flows would be adversely affected, and we could be forced to delay, reduce the scope of or eliminate many of our planned activities.

~~We may not maintain profitability in future periods or on a consistent basis.~~

Although we have been profitable for each of the last five fiscal years, we have not been profitable for every quarter during that time. For example, we incurred a net loss in the second quarter of 2016 and in each of the first quarters of 2018, 2015, 2014 and 2013. Our profitability has been substantially dependent on BioThrax product sales, which historically have fluctuated significantly from quarter to quarter, and we expect that they will continue to fluctuate significantly based primarily on the timing of our fulfillment of orders from the USG. We may not be able to achieve consistent profitability on a quarterly basis or sustain or increase profitability on an annual basis.

~~THE SPIN-OFF OF OUR BIOSCIENCES BUSINESS~~

If the spin-off distribution on August 1, 2016 of all of the outstanding shares of Aptevo Therapeutics Inc. common stock to our stockholders does not qualify as a tax-free transaction for U.S. federal income tax purposes, we and our stockholders could be subject to significant tax liabilities.

It was our intention that our distribution on August 1, 2016 of all of the outstanding shares of Aptevo common stock to our stockholders (the “Distribution”), together with certain related transactions, qualify as a tax-free transaction described under Sections 355 and 368(a)(1)(D) of the Internal Revenue Code of 1986, as amended (the “Code”). In anticipation of the Distribution, we received a favorable private letter ruling from the Internal Revenue Service (the “IRS”), regarding certain U.S. federal income tax matters relating to the Distribution and certain related transactions and an opinion of counsel substantially to the effect that, for U.S. federal income tax purposes, the Distribution, together with certain related transactions, will qualify as a transaction described under Sections 355 and 368(a)(1)(D) of the Code. A “private letter ruling,” is a written statement issued to a taxpayer by an Associate Chief Counsel Office of the Office of Chief Counsel that interprets and applies the tax laws to a specific set of facts. Our private letter ruling is based on certain facts and representations submitted by us to the IRS and the opinion of counsel was based upon and relied on, among other things, the IRS private letter ruling and certain facts and assumptions, as well as certain representations and covenants of us and Aptevo contained in a tax matters agreement and certain representations contained in representation letters provided by us, Aptevo and certain stockholders to such counsel, including representations and covenants relating to the past and future conduct of us, Aptevo and such stockholders. If any of these facts, assumptions, representations, or covenants are, or become, inaccurate or incomplete, the IRS private letter ruling and/or the opinion of counsel may be invalid and the conclusions reached therein could be jeopardized and, as a result, the Distribution, together with certain related transactions, could fail to qualify as a tax-free transaction described under Sections 355 and 368(a)(1)(D) of the Code for U.S. federal income tax purposes.

In addition, the IRS private letter ruling only addresses certain limited matters relevant to determining whether the Distribution, together with certain related transactions, qualifies as a transaction described under Sections 355 and 368(a)(1)(D) of the Code, and the opinion of counsel only represents the judgment of such counsel, which is not binding on the IRS or any court. Accordingly, notwithstanding the IRS private letter ruling and the opinion of counsel, there can be no assurance that the IRS will not assert that the Distribution, together with certain related transactions, should be treated as a taxable transaction for U.S. federal income tax purposes or that a court would not sustain such a challenge.

If the Distribution, together with certain related transactions, fails to qualify as a tax-free transaction described under Sections 355 and 368(a)(1)(D) of the Code, for U.S. federal income tax purposes, in general, (i) we would recognize taxable gain on the Distribution equal to the amount by which the fair market value of the Aptevo shares distributed to our stockholders exceeded our tax basis in the Aptevo shares and (ii) each of our stockholders who received Aptevo shares in the Distribution would be treated as receiving a taxable distribution equal to the fair market value of the Aptevo shares received by such stockholder.

Under the tax matters agreement that we entered into with Aptevo in connection with the spin-off, Aptevo may be required to indemnify us against any tax liabilities and related expenses resulting from the failure of the Distribution, together with certain related transactions, to qualify as a transaction described under Sections 355 and 368(a)(1)(D) of the Code to the extent that the failure to so qualify is attributable to actions, events or transactions relating to Aptevo’s stock, assets or business, or a breach of the relevant representations or covenants made by Aptevo in the tax matters agreement or the IRS private letter ruling or in the representation letters provided to our counsel for purposes of their opinion. Any such indemnity obligations could be material, and there can be no assurance that Aptevo will be able to pay any such indemnification.

To preserve the tax-free treatment of the Distribution, together with certain related transactions, and in addition to Aptevo's indemnity obligation, the tax matters agreement, which expired on August 2, 2018, restricted Aptevo from taking any action that prevents such transactions from being tax-free for U.S. federal income tax purposes. In particular, for the two-year period following the Distribution, Aptevo was restricted from taking certain actions (including restrictions on share issuances, business combinations, sales of assets, amendments to organizational documents and similar transactions) that could cause the Distribution, together with certain related transactions, to fail to qualify as a tax-free transaction for U.S. federal income tax purposes. There can be no assurance that Aptevo adequately complied with these restrictions. If a finding is made by the IRS through a tax audit that Aptevo failed to satisfy its obligations, this could have a substantial impact on our tax obligations, consolidated financial condition and cash flows.

In connection with Aptevo’s separation from us, Aptevo agreed to indemnify us for certain matters. This indemnity may not be sufficient to hold us harmless from the full amount of losses that we may incur in connection with these matters, and Aptevo may not be able to satisfy its indemnification obligations to us.

Pursuant to the agreements that we entered into with Aptevo at the time of Aptevo’s separation from us, Aptevo agreed to indemnify us for certain matters, including liabilities related to Aptevo’s business or for which Aptevo otherwise agreed to be responsible in the separation. This indemnity from Aptevo may not be sufficient to protect us against the full amount of losses that we may incur in connection with these matters, including if third parties assert claims against us for liabilities that were allocated to Aptevo in the separation. Moreover, Aptevo may dispute its indemnification obligation to us or have insufficient resources to satisfy its indemnification obligations to us. Even if we ultimately succeed in recovering from Aptevo the amount of any losses that we incur in connection with these matters, the recovery could take a substantial amount of time and we may be required to bear these losses ourselves while we seek recovery. Each of these risks could negatively affect our business, operating results, financial condition and cash flows.

~~OTHER BUSINESS RISKS~~

WeWe face product liability exposure, which could cause us to incur substantial liabilities and negatively affect our business, financial condition and results of operations.

We face an inherent risk of product liability exposure related to the sale of our products, any other products that we successfully acquire or develop and the testing of our product candidates in clinical trials.

One measure of protection against such lawsuits is coverage under the PREP Act, which was signed into law in December 2005. The PREP Act creates liability protection for manufacturers of biodefense countermeasures when the Secretary of HHS issues a declaration for their manufacture, administration or use. A PREP Act declaration is meant to provide liability protection from all claims under federal or state law for loss arising out of the administration or use of a covered countermeasure under a government contract. The Secretary of HHS has issued PREP Act declarations identifying certain of our products, namely BioThrax, ACAM2000, raxibacumab, Anthrasil, BAT and VIGIV, as covered ~~countermeasures. These declarations~~countermeasures, which expire ~~in 2022.~~ this year.Manufacturers are not entitled to protection under the PREP Act in cases of willful ~~misconduct.~~misconduct or for cases brought in non-U.S. tribunals or under non-U.S. law. We cannot predict whether the Secretary of HHS will renew the declarations when they expire, whether Congress will fund the relevant PREP Act compensation programs, or whether the necessary prerequisites for immunity would be triggered with respect to our products or product candidates.

Additionally, certain of our products, namely BioThrax and RSDL, are certified anti-terrorism products covered under the protections of the SAFETY Act. The SAFETY Act creates product liability limitations for qualifying anti-terrorism technologies for

claims arising from or related to an act of terrorism. Although we are entitled to the benefits of the SAFETY Act for BioThrax and RSDL, the SAFETY Act may not provide adequate protection from claims made against us.

If we cannot successfully defend ourselves against future claims that our products or product candidates caused injuries and if we are not entitled to indemnity by the USG, or the USG does not honor its obligations to us under the PREP Act or SAFETY Act, or if the ~~indemnification~~liability protections under the PREP Act and SAFETY Act isare not adequate to cover all claims, we may incur substantial liabilities. Regardless of merit or eventual outcome, product liability claims may result in:

•decreased demand or withdrawal of a product;

~~decreased demand or withdrawal of a product;~~

•injury to our reputation;

•withdrawal of clinical trial participants;

~~injury to our reputation;~~

•costs to defend the related litigation;

•substantial monetary awards to trial participants or patients;

~~withdrawal of clinical trial participants;~~

•loss of revenue; and

•an inability to commercialize products that we may develop.

~~costs to defend the related litigation;~~

~~substantial monetary awards to trial participants or patients;~~

~~loss of revenue; and~~

~~an inability to commercialize products that we may develop.~~

The amount of insurance that we currently hold may not be adequate to cover all liabilities that we may ~~occur.~~incur. Further product liability insurance may be difficult and expensive to obtain. We may not be able to maintain insurance coverage at a reasonable cost and we may not be able to obtain insurance coverage that will be adequate to satisfy all potential liabilities. For example, we may not have sufficient insurance against potential liabilities associated with a possible large-scale deployment of BioThrax as a countermeasure to a bioterrorism threat. We rely on PREP Act protection for BioThrax, raxibacumab, ACAM2000, Anthrasil, BAT and VIGIV, and SAFETY Act protection for BioThrax and RSDL in addition to our insurance coverage to help mitigate our product liability exposure for these products. Additionally, potential product liability claims related to our commercial products, including ~~NARCAN® Nasal Spray~~,NARCAN, Vivotif and Vaxchora, may be made by patients, health care providers or others who sell or consume these products. Such claims may be made even with respect to those products that possess regulatory approval for commercial sale. Claims or losses in excess of our product liability insurance coverage could have a material adverse effect on our business, financial condition, operating results and cash flows.

FINANCIAL RISKS

We have incurred significant indebtedness in connection with our acquisitions and servicing our debt requires a significant amount of cash. We may not have sufficient cash flow from our operations to pay our substantial debt.

Our ability to make scheduled payments of the principal of, to pay interest on or to further refinance our indebtedness depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility. Debt financing can have significant adverse consequences for our business, including:

•requiring us to dedicate a substantial portion of cash flows from operations to payment on our debt, which would reduce available funds for other corporate initiatives;

•increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase, to the extent we are unable to offset such risk through our hedging instruments;

•subjecting us, as under our Senior Secured Credit Facilities and the indenture governing the 3.875% Senior Unsecured Notes due 2028 (Senior Unsecured Notes), to restrictive covenants that reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;

•requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;

•limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and

•placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.

We may not have sufficient funds or be able to obtain additional financing to pay the amounts due under our indebtedness. In addition, failure to comply with the covenants under our Senior Secured Credit Facilities and other debt agreements, including the maintenance of a specified consolidated net leverage ratio and debt service coverage ratio under our Senior Secured Credit Facilities, could result in an event of default under those agreements. An event of default could result in the acceleration of amounts due under a particular debt agreement and a cross default and acceleration under other debt agreements, and we may not have sufficient funds to pay or be able to

obtain additional financing to make any accelerated payments. Under these circumstances, our lenders could seek to enforce security interests in our assets securing our indebtedness.

Our current indebtedness restricts and any additional debt financing may restrict the operation of our business and limit the cash available for investment in our business operations.

The Senior Secured Credit Facilities include a $450 million Term Loan Facility which had an outstanding principal balance was $396.6 million as of December 31, 2021 and the ability to borrow up to $600 million under our Revolving Credit Facility, of which we had no outstanding borrowings as of December 31, 2021. On August 7, 2020, we completed an offering of $450 million aggregate principal amount of Senior Unsecured Notes, of which $353 million of the net proceeds were used to pay down our Revolving Credit Facility. We may also seek additional debt financing to support our ongoing activities or to provide additional financial flexibility. Debt financing can have significant adverse consequences for our business, including:

•the level, timing and cost of product sales and CDMO services;

•the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;

•the acquisition of new facilities and capital improvements to new or existing facilities;

•the payment obligations under our indebtedness;

•the scope, progress, results and costs of our development activities;

•our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;

•the extent to which we repurchase common stock under any future share repurchase program; and

•the costs of commercialization activities, including product marketing, sales and distribution.

Our hedging program is subject to counterparty default risk.

We manage our interest rate risk in part by entering into interest rate swaps with a number of counterparties to swap a portion of our indebtedness that is based on variable interest rates to a fixed rate. As a result, we are subject to the risk that the counterparty to one or more of these contracts defaults on its performance under the contract. During

an economic downturn, the counterparty's financial condition may deteriorate rapidly and with little notice and we may be unable to take action to protect our exposure. In the event of a counterparty default, we could incur losses, which may harm our business and financial condition. In the event that one or more of our counterparties becomes insolvent or files for bankruptcy, our ability to eventually recover any losses suffered as a result of that counterparty's default may be limited by the liquidity of the counterparty.

We may require significant additional funding and be unable to raise capital when needed or on acceptable terms, which would harm our ability to grow our business, and our results of operations and financial condition.

If our capital resources are insufficient to meet our future capital requirements, we will need to finance our cash needs through public or private equity or debt offerings, bank loans or collaboration and licensing arrangements. In August 2021, we filed an automatic shelf registration statement, which immediately became effective under SEC rules. For so long as we continue to satisfy the requirements to be deemed a “well-known seasoned issuer” under SEC rules (which include, among other things, the timely filing of our reports under the Exchange Act and maintenance of at least $700 million of public float or issuing an aggregate amount of $1 billion of non-convertible securities, other than common stock, in registered offerings for cash during the past three years), this shelf registration statement, effective until August 9, 2024, allows us to issue an unrestricted amount of equity, debt and certain other types of securities through one or more future primary or secondary offerings. If we do not file a new shelf registration statement prior to August 9, 2024, the existing shelf registration statement will expire, and we will not be able to publicly raise capital or issue debt until a new registration statement is filed and becomes effective. There can be no assurance that we will be eligible to file an automatically effective shelf registration statement at a future date when we may need to raise funds publicly.

If we raise funds by issuing equity securities, our stockholders may experience dilution. Debt financing, if available, may involve agreements that include covenants, like those contained in our Senior Secured Credit Facilities and the indenture governing the Senior Unsecured Notes, limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities or declaring dividends. If we raise funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that may not be favorable to us. Our Senior Secured Credit

Facilities as well as the indenture governing the Senior Unsecured Notes restrict our ability to incur additional indebtedness.

We may not maintain profitability in future periods or on a consistent basis.

Although we have been profitable on an annual basis since becoming a public company, we have not been profitable for every quarter during that time. Our profitability has been substantially dependent on product sales, which historically have fluctuated significantly from quarter to quarter, and we expect that they will continue to fluctuate significantly based primarily on the timing of our fulfillment of orders from the USG. We may not be able to achieve consistent profitability on a quarterly basis or sustain or increase profitability on an annual basis.

The expansion of our international operations increases our risk of exposure to credit losses.

As we continue to expand our business activities with foreign governments in certain countries that have experienced deterioration in credit and economic conditions or otherwise, our exposure to uncollectible accounts will rise. Global economic conditions and liquidity issues in certain countries have resulted and may continue to result in delays in the collection of accounts receivable and may result in credit losses. Future governmental actions and customer specific actions may require us to re-evaluate the collectability of our accounts receivable and we may potentially incur credit losses that materially impact our operating results.

A substantial portion of our indebtedness bears interest at variable interest rates based on LIBOR and certain of our financial contracts are also indexed to LIBOR. Changes in the method of determining LIBOR, or the replacement of LIBOR with an alternative reference rate, may adversely affect interest rates on our current or future indebtedness and may otherwise adversely affect our financial condition and results of operations.

In July 2017, the Financial Conduct Authority, the authority that regulates the London Inter-bank Offered Rate (LIBOR) announced that it intended to stop compelling banks to submit rates for the calculation of LIBOR.

On December 31, 2021, the International Exchange (ICE) Benchmark Association, which administrates LIBOR, ceased (i) entering into new

contracts that use LIBOR as a reference rate and (ii) publication of two LIBOR rates (one-week and two-month) and has announced that the remaining LIBOR rates (overnight, one-month, three-month, six-month and 12-month) will be retired on June 30, 2023. It is unclear if LIBOR will cease to exist at that time or if new methods of calculating LIBOR will be established such that it continues to exist after 2023. We have certain financial contracts, including the amended credit agreement related to our Senior Secured Credit Facilities and our interest rate swaps, that are indexed to LIBOR. Changes in the method of determining LIBOR, or the replacement of LIBOR with an alternative reference rate, may adversely affect interest rates on our current or future indebtedness. Any transition process may involve, among other things, increased volatility or illiquidity in markets for instruments that rely on LIBOR, reductions in the value of certain instruments or the effectiveness of related transactions such as hedges, increased borrowing costs, uncertainty under applicable documentation, or difficult and costly consent processes. The transition away from LIBOR may result in increased expenses, may impair our ability to refinance our indebtedness or hedge our exposure to floating rate instruments, or may result in difficulties, complications or delays in connection with future financing efforts, any of which could adversely affect our financial condition and results of operations.

RISKS RELATED TO STRATEGIC ACQUISITIONS AND COLLABORATIONS

Our strategy of generating growth through acquisitions may not be successful.

Our business strategy includes growing our business through acquisition and in-licensing transactions. We may not be successful in identifying, effectively evaluating, structuring, acquiring or in-licensing, and developing and commercializing additional products on favorable terms, or at all. Competition for attractive product opportunities is intense and may require us to devote substantial resources, both managerial and financial, to an acquisition opportunity. A number of more established companies are also pursuing strategies to acquire or in-license products in the biopharmaceutical field. These companies may have a competitive advantage over us due to their size, cash resources, cost of capital, effective tax rate and greater clinical development and commercialization capabilities.

Acquisition efforts can consume significant management attention and require substantial expenditures, which could detract from our other programs. In addition, we may devote significant resources to potential acquisitions that are never completed. Even if we are successful in acquiring a

company or product, it may not result in a successfully developed or commercialized product or, even if an acquired product is commercialized, competing products or technologies could render a product noncompetitive, uneconomical or obsolete. Moreover, the cost of acquiring other companies or in-licensing products could be substantial, and in order to acquire companies or new products, we may need to incur substantial debt or issue dilutive securities.

If we are unsuccessful in our efforts to acquire other companies or in-license and develop additional products, or if we acquire or in-license unproductive assets, it could have a material adverse effect on the growth of our business, and we could be compelled to record significant impairment charges to write-down the carrying value of our acquired intangible assets, which could materially harm our business, financial condition, operating results and cash flows.

We may not be able to integrate any acquired business successfully or operate any acquired business profitably. In addition, cost synergies, if achieved at all, may be less than we expect, or may take greater time to achieve than we anticipate.

Issues that could delay or prevent successful integration or cost synergies of an acquired business or products include, among others:

•retaining existing customers and attracting new customers;

•retaining key employees;

•diversion of management attention and resources;

•conforming internal controls, policies and procedures, business cultures and compensation programs;

•consolidating corporate and administrative infrastructures;

•successfully executing technology transfers and obtaining required regulatory approvals;

•consolidating sales and marketing operations;

•identifying and eliminating redundant and underperforming operations and assets;

•assumption of known and unknown liabilities;

•coordinating geographically dispersed organizations;

•managing tax costs or inefficiencies associated with integrating operations; and

•risks associated with intellectual property rights related to an acquisition or collaboration.

RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK

Our business or our share price could be negatively affected as a result of the actions of shareholders.

In recent years, some shareholders have placed increasing pressure on publicly traded companies in our industry and others to effect changes to corporate governance practices, executive compensation practices, social and environmental practices and to undertake certain corporate actions. This may be true even if they only hold a minority of shares. In addition, many institutional investors are increasingly focused on ESG factors. These investors may be seeking enhanced ESG disclosures or to implement policies adverse to our business. There can be no assurances that shareholders will not publicly advocate for us to make corporate governance changes or engage in certain corporate actions. Responding to challenges from shareholders, such as proxy contests, media campaigns or other public or private means, could be costly and time consuming and could have an adverse effect on our reputation and divert the attention and resources of management and our board, which could have an adverse effect on our business and operational results. Any such shareholder actions or requests, or the mere public presence of shareholders with a reputation for taking such actions among our shareholder base, could also cause the market price of our common stock to experience periods of significant volatility.

Although he is retiring, Fuad El-Hibri, executive chairman of our Board of Directors, currently has significant influence over us through his substantial beneficial ownership of our common stock, including an ability to influence the election of the members of our Board of Directors, or delay or prevent a change of control of us.

Although Mr. El-Hibri is retiring after the end of the first quarter of 2022, he currently has the ability to significantly influence the election of the members of our Board of Directors due to his substantial beneficial ownership of our common stock. As of December 31, 2021, Mr. El-Hibri was the beneficial owner of approximately 9% of our outstanding

common stock. As a result, Mr. El-Hibri could exercise substantial influence over corporate actions requiring board or stockholder approval, including a change of control, or any amendment of our certificate of incorporation or by-laws. The control by Mr. El-Hibri may prevent other stockholders from influencing significant corporate decisions. In addition, Mr. El-Hibri's significant beneficial ownership of our shares could present the potential for a conflict of interest.

Provisions in our certificate of incorporation and by-laws and under Delaware law may discourage acquisition proposals, delay a change in control or prevent transactions that stockholders may consider favorable.

Provisions in our certificate of incorporation and by-laws may discourage, delay or prevent a merger, acquisition or other changes in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management.

These provisions include:

•the classification of our directors;

•limitations on changing the number of directors then in office;

•limitations on the removal of directors;

•limitations on filling vacancies on the board;

•advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;

•the inability of stockholders to act by written consent;

•the inability of stockholders to call special meetings; and

•the ability of our Board of Directors to designate the terms of and issue a new series of preferred stock without stockholder approval.

The affirmative vote of holders of our capital stock representing at least 75% of the voting power of all outstanding stock entitled to vote is required to amend or repeal the above provisions of our certificate of incorporation. The affirmative vote of either a majority of the directors present at a meeting of our Board of Directors or holders of our capital stock representing at least 75% of the voting power of all outstanding stock entitled to vote is required to amend or repeal our by-laws.

In addition, we are subject to Section 203 of the Delaware General Corporation Law (Section 203). In general and subject to certain exceptions, Section 203 prohibits a publicly-held corporation from

engaging in a business combination with an interested stockholder, generally a person which, together with its affiliates, owns or within the last three years has owned 15% or more of the corporation's voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of us.

Our Board of Directors may implement a new stockholder rights plan without stockholder approval, which could prevent a change in control of us in instances in which some stockholders may believe a change in control is in their best interests.

Our Board of Directors may implement a stockholder rights plan without stockholder approval. We previously implemented a stockholder rights plan, which expired on November 14, 2016. Under our prior stockholder rights plan, we issued to each of our stockholders one preferred stock purchase right for each outstanding share of our common stock. Each right, when exercisable, would have entitled its holder to purchase from us a unit consisting of one one-thousandth of a share of series A junior participating preferred stock at a purchase price of $150 in cash, subject to adjustments. Our stockholder rights plan was intended to protect stockholders in the event of an unfair or coercive offer to acquire us and to provide our Board of Directors with adequate time to evaluate unsolicited offers.

Our Board of Directors may implement a new stockholder rights plan, which may have anti-takeover effects, potentially preventing a change in control of us in instances in which some stockholders may believe a change in control is in their best interests. This could cause substantial dilution to a person or group that attempts to acquire us on terms that our Board of Directors does not believe are in our best interests or those of our stockholders and may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.

Our stock price is volatile, and purchasers of our common stock could incur substantial losses.

instability. From November 15, 2006, when our common stock first began trading on the New York Stock Exchange, through February 18, 2022, our common stock has traded as high as $137.61 per share and as low as $4.17 per share. Due to fears associated with COVID-19, the stock market has been experiencing extreme volatility and the market for biopharmaceutical companies has generally experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price of our common stock may be influenced by many factors, including, among others:

•contracts, decisions and procurement policies by the USG affecting our anthrax vaccines and our other products and product candidates;

•CDMO contracts related to COVID-19 with collaboration partners;

•the success of competitive products or technologies;

•results of clinical and non-clinical trials of our product candidates;

•announcements of acquisitions, financings or other transactions by us;

•litigation or legal proceedings;

•public concern as to the safety of our products;

•termination or delay of a development program;

•the recruitment or departure of key personnel;

•variations in our product revenue and profitability; and

•the other factors described in this “Risk Factors” section.

Because we currently do not pay dividends, investors will benefit from an investment in our common stock only if it appreciates in value.

We currently do not pay dividends on our common stock. Our Senior Secured Credit Facilities and the indenture governing our Senior Unsecured Notes limit and any future debt agreements that we enter into may limit our ability to pay dividends. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for our stockholders based on current expectations.

Future issuances of our common stock or securities convertible into common stock could result in dilution of our stockholders and could cause our share price to decline.

We expect to continue to opportunistically seek access to additional capital to license or acquire additional products, product candidates or companies

to expand our operations or for general corporate purposes. To the extent we raise additional capital by issuing equity securities or securities convertible or exchangeable into common stock, our stockholders may experience substantial dilution. We may sell common stock, and we may sell convertible or exchangeable securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell such common stock, convertible or exchangeable securities or other equity securities in subsequent transactions, existing stockholders may be materially diluted.

GENERAL RISKS

The accuracy of our financial reporting depends on the effectiveness of our internal control over financial reporting. AAny additional material weakness in our internal control over financial reporting could have an adverse effect on our business and financial results and our ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our common stock.

Internal control over financial reporting can provide only reasonable assurance with respect to the preparation and fair presentation of financial statements and may not prevent or detect misstatements. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Failure to maintain effective internal control over financial reporting, or lapses in disclosure controls and procedures, could impact our financial information and disclosures, require significant resources to remediate, and expose us to legal or regulatory proceedings.

We regularly review and update our internal controls and disclosure controls and procedures. In addition, we are required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. ~~Our~~In the quarter ended September 30, 2021, we identified a material weakness in our internal control over financial reporting related to our technical accounting assessment of the BARDA COVID-19 Development Public Private Partnership and CDMO revenue contracts and related accounting judgments primarily focused on (a) the scoping of lease and non-lease components and (b) the recognition of revenue.

Although the material weakness has been remediated as of December 31, 2021, our system of

internal controls, however well-designed, can provide only reasonable, not absolute, assurances that the objectives of the system are met. If we, or our independent registered public accounting firm, determine that our internal controls over financial reporting, or the internal controls of other companies we may acquire, are not effective, or we discover additional areas that need improvement in the future, these shortcomings could have an adverse effect on our business and financial reporting, and the trading price of our common stock could be negatively affected.

We rely significantly on information technology systems and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ability to operate our business effectively or result in data leakage of proprietary and confidential business and employee information.

Our business is increasingly dependent on critical, complex and interdependent information technology systems, including Internet-based systems, to support business processes as well as internal and external communications. The size and complexity of our computer systems make them potentially vulnerable to interruption, invasion, computer viruses, destruction, malicious intrusion and additional related disruptions, which may result in the impairment of production and key business processes.

In addition, our systems are potentially vulnerable to data security breaches—whether by employee error, malfeasance or other disruption—which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual property or could lead to the public exposure of personal information, including sensitive personal information, of our employees, clinical trial patients, customers and others.

A significant business disruption or a breach in security resulting in misappropriation, theft or sabotage with respect to our proprietary and confidential business and employee information could result in financial, legal, business or reputational harm to us, any of which could materially and adversely affect our business, financial condition and operating results.

Our success is dependent on our continued ability to attract, motivate and retain key personnel, and any failure to attract or retain key personnel may negatively affect our business.

Because of the specialized scientific nature of our business, our ability to develop products and to compete with our current and future competitors largely depends upon our ability to attract, retain and motivate highly qualified managerial and key scientific and technical ~~personnel.~~personnel (including quality and manufacturing personnel). If we are unable to retain the services of one or more of the principal members of senior management or other key employees, our ability to implement our business strategy could be materially harmed. We face intense competition for qualified employees from biopharmaceutical companies, research organizations and academic institutions. Attracting, retaining or replacing these personnel on acceptable terms may be difficult and time-consuming given the high demand in our industry for similar personnel. We believe part of being able to attract, motivate and retain personnel is our ability to offer a competitive compensation package, including equity incentive awards. If we cannot offer a competitive compensation package to attract and retain the qualified personnel necessary for the continued development of our business, we may not be able to maintain our operations or grow our business.

~~RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK~~

Fuad El-Hibri, executive chairman of our Board of Directors, has significant influence over us through his substantial beneficial ownership of our common stock, including an ability to influence the election of the members of our Board of Directors, or delay or prevent a change of control of us.

Mr. El-Hibri has the ability to significantly influence the election of the members of our Board of Directors due to his substantial beneficial ownership of our common stock. As of February 15, 2019, Mr. El-Hibri was the beneficial owner of approximately 11% of our outstanding common stock. As a result, Mr. El-Hibri could exercise substantial influence over all corporate actions requiring board or stockholder approval, including a change of control, or any amendment of our certificate of incorporation or by-laws. The control by Mr. El-Hibri may prevent other stockholders from influencing significant corporate decisions. In addition, Mr. El-Hibri's significant beneficial ownership of our shares could present the potential for a conflict of interest.

~~These provisions include:~~

~~the classification of our directors;~~

~~limitations on changing the number of directors then in office;~~

~~limitations on the removal of directors;~~

~~limitations on filling vacancies on the board;~~

~~advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;~~

~~the inability of stockholders to act by written consent;~~

~~the inability of stockholders to call special meetings; and~~

~~the ability of our Board of Directors to designate the terms of and issue a new series of preferred stock without stockholder approval.~~

In addition, we are subject to Section 203 of the Delaware General Corporation Law (“Section 203”). In general and subject to certain exceptions, Section 203 prohibits a publicly-held corporation from engaging in a business combination with an interested stockholder, generally a person which, together with its affiliates, owns or within the last three years has owned 15% or more of the corporation's voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of us.

~~Our stock price is volatile and purchasers of our common stock could incur substantial losses.~~

Our stock price has been, and is likely to continue to be, volatile. The market price of our common stock could fluctuate significantly for many reasons, including in response to the risks described in this “Risk Factors” section, or for reasons unrelated to our operations, such as reports by industry analysts, investor perceptions or negative announcements by our customers, competitors or suppliers regarding their own performance, as well as industry conditions and general financial, economic and political instability. From November 15, 2006, when our common stock first began trading on the New York Stock Exchange, through February 15, 2019, our common stock has traded as high as $73.89 per share and as low as $4.40 per share. The stock market in general as well as the market for biopharmaceutical companies in particular has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price of our common stock may be influenced by many factors, including, among others:

~~contracts, decisions and procurement policies by the USG affecting BioThrax and our other products and product candidates;~~

~~the success of competitive products or technologies;~~

~~results of clinical and non-clinical trials of our product candidates;~~

~~announcements of acquisitions, financings or other transactions by us;~~

~~litigation or legal proceedings;~~

~~public concern as to the safety of our products;~~

~~termination or delay of a development program;~~

~~the recruitment or departure of key personnel;~~

~~variations in our product revenue and profitability; and~~

~~the other factors described in this “Risk Factors” section.~~

~~Because we currently do not pay dividends, investors will benefit from an investment in our common stock only if it appreciates in value.~~

We currently do not pay dividends on our common stock. Our senior secured credit facilities limit and any future debt agreements that we enter into may limit our ability to pay dividends. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for our stockholders for the foreseeable future.

~~A significant portion of our shares may be sold into the market at any time. This could cause the market price of our common stock to drop significantly.~~

Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales or the perception in the market that the holders of a large number of shares intend to sell shares could reduce the market price of our common stock. Moreover, holders of an aggregate of approximately 6 million shares of our common stock outstanding as of February 15, 2019, have the right to require us to register these shares of common stock under specified circumstances.

ITEM 1B. UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 2. PROPERTIES

We own and lease approximately ~~1.8~~1.6 million square feet of building space for development and manufacturing, laboratories, fill/finish facility services, offices and warehouse space for the conduct of our businesses at 1925 locations in North America and Europe. ~~In North America, we own and lease approximately 1.1 million square feet and 0.2 million square feet of building space, respectively, at 17 locations. Leased properties~~Properties that have been leased expire on various dates ~~from 2019~~between 2023 to ~~2027.~~2034. Principal locations include:


Location			Use		Approximate square feet		Owned/leased
~~Bern, Switzerland~~Lansing, Michigan			Manufacturing operations, office and laboratory space.		336,000		Owned
Winnipeg, Manitoba, Canada			Manufacturing operations, office and laboratory space.		315,000 (Owned); 15,800 (Leased)		Owned/Leased
Gaithersburg, Maryland			Laboratory space, office space and rental real estate.		173,000		Owned
Canton, Massachusetts			Manufacturing operations and warehouse space.		122,508 (Owned); 27,000 (Leased)		Owned/Leased
Baltimore, Maryland (Bayview)			Manufacturing facilities, office and laboratory space.		112,000		Owned
Elkridge, Maryland			Warehouse space.		103,182		Leased
Baltimore, Maryland (Camden)			Manufacturing facilities, office and laboratory space.		86,900 (Owned); 41,000 (Leased)		Owned/Leased
San Diego, California			Manufacturing facilities and office ~~and laboratory space~~space.		~~511,000~~66,012		~~Owned~~Leased
~~Lansing, Michigan~~Bern, Switzerland			Manufacturing operations, ~~facilities, office space and laboratory space~~		~~336,000~~	~~Owned~~
~~Winnipeg, Manitoba, Canada~~	~~Manufacturing operations facilities, office space and laboratory space~~	~~315,000~~	~~Owned~~
~~Gaithersburg, Maryland~~	~~Office space and rental real estate~~	~~130,000~~	~~Owned~~
~~Baltimore, Maryland (Bayview)~~	~~Manufacturing facilities and~~ office and laboratory ~~space~~space.	~~112,000~~81,000		Owned
Rockville, Maryland			Manufacturing facilities, office and warehouse space.		59,000		Leased

Each property is considered to be in good condition, adequate for its purpose, and suitably utilized according to the individual nature and requirements of the relevant operations. Our policy is to improve and replace property as considered appropriate to meet the needs of the individual ~~operation.~~operations.

ITEM 3.LEGAL PROCEEDINGS

See "Item 8 of Part II, “Financial Statements and Supplemental Data — Notes to consolidated financial statements — Note 17”

~~ANDA Litigation~~

On September 14, 2018, Adapt Pharma Inc., Adapt Pharma Operations Limited and Adapt Pharma Ltd., or collectively, Adapt Pharma, and Opiant Pharmaceuticals, Inc., or Opiant, received notice from Perrigo UK FINCO Limited Partnership, or Perrigo, that Perrigo had filed an Abbreviated New Drug Application, or ANDA, with the United States Food and Drug Administration, or FDA, seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray before the expiration of U.S. Patent Nos. 9,211,253, or the ‘253 Patent, 9,468,747, or the ‘747 Patent, 9,561,177, or the ‘177 Patent, 9,629,965, or the ‘965 Patent, and 9,775,838, or the ‘838 Patent. On or about October 25, 2018, Perrigo sent a subsequent notice letter relating to U.S. Patent No. 10,085,937, or the ‘937 Patent. Perrigo’s notice letters assert that its generic product will not infringe any valid and enforceable claim of these patents.

On or about February 27, 2018, Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant received notice from Teva Pharmaceuticals Industries Ltd. and Teva Pharmaceuticals USA, Inc., or collectively Teva, that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 2 mg/spray before the expiration of U.S. Patent No. 9,480,644, or the ‘644 Patent, and U.S. Patent No. 9,707,226, or the '226 Patent. Teva's notice letter asserts that the commercial manufacture, use or sale of its generic drug product described in its ANDA will not infringe the '644 Patent or the '226 Patent, or that the '644 Patent and '226 Patent are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey.

On or about September 13, 2016, Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant received notice from Teva that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4 mg/spray before the expiration of U.S. Patent No. 9,211,253, or the '253 Patent. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant received additional notices from Teva relating to the '747, the '177, the '965, the '838, and the ‘937 Patents. Teva's notice letters assert that the commercial manufacture, use or sale of its generic drug product described in its ANDA will not infringe the '253, the '747, the '177, the '965, the '838, or the ‘937 Patent, or that the '253, the '747, the '177, the '965, the '838, and the ‘937 Patents are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey with respect to the '253 Patent. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant also filed complaints for patent infringement against Teva in the United States District Court for the District of New Jersey with respect to the '747, the '177, the '965, and the '838 Patents. All five proceedings have been consolidated. As of February 21, 2019, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant, are evaluating Teva's notice letter related to the ‘937 Patent.

In the complaints described in the paragraphs above, the Plaintiffs seek, among other relief, orders that the effective date of FDA approvals of the Teva ANDA products and the Perrigo ANDA product be a date not earlier than the expiration of the patents listed for each product, equitable relief enjoining Teva and Perrigo from making, using, offering to sell, selling, or importing the products that are the subject of Teva and Perrigo’s respective ANDAs, until after the expiration of the patents listed for each product, and monetary relief or other relief as deemed just and proper by the court.

~~Shareholder Class Action Lawsuit filed July 19, 2016~~

On July 19, 2016, Plaintiff William Sponn (“Sponn”), filed a putative class action complaint in the United States District Court for the District of Maryland on behalf of purchasers of the Company’s common stock between January 11, 2016 and June 21, 2016, inclusive (the “Class Period”), seeking to pursue remedies under the Exchange Act against the Company and certain of its senior officers and directors (collectively, the “Defendants”). The complaint alleged, among other things, that the Defendants made materially false and misleading statements about the government’s demand for BioThrax and expectations that the Company’s five-year exclusive procurement contract with HHS would be renewed, and omitted certain material facts. Sponn sought unspecified damages, including legal costs. On October 25, 2016, the court added City of Cape Coral Municipal Firefighters’ Retirement Plan and City of Sunrise Police Officers’ Retirement Plan as plaintiffs and appointed them Lead Plaintiffs and Robbins Geller Rudman & Dowd LLP as Lead Counsel. On December 27, 2016, the Plaintiffs filed an amended complaint that cited the same class period, named the same defendants and made similar allegations to the original complaint. The Defendants filed a Motion to Dismiss on February 27, 2017. The Plaintiffs filed an opposition brief on April 28, 2017. The Defendants’ Motion to Dismiss was heard and denied on July 6, 2017. The Defendants filed an answer on July 28, 2017. The parties then engaged in the process of exchanging discovery. The Plaintiffs filed an amended motion for class certification and appointment of Lead Plaintiffs, Sponn, and Geoffrey L. Flagstad (“Flagstad”) as Class Representatives on December 20, 2017. A hearing on that motion was heard on May 2, 2018. On June 8, 2018 the Court granted class certification with a shortened class period, May 5, 2016 to June 21, 2016. In that same order, the court appointed Flagstad as Class Representative and Robbins Geller Rudman & Dowd LLP as Class Counsel. The Defendants have denied, and continue to deny, any and all allegations of fault, liability, wrongdoing, or damages. However, recognizing the risk, time, and expense of litigating any case to trial, on August 27, 2018, the Defendants reached an agreement in principle with Plaintiffs to settle all of the related claims of any individual plaintiff that purchased or acquired Company stock from January 11, 2016 to June 21, 2016, for $6.5 million, an amount that was paid by the Company’s insurance carrier. The settlement required no payment by any of the Defendants. The Defendants continue to deny any and all liability. The parties executed the settlement agreement on October 16, 2018 and filed the agreement with the court on October 17, 2018. The court granted preliminary approval of the settlement on October 18, 2018, issued an amended preliminary approval of the settlement on October 25, 2018, and scheduled a hearing regarding final approval for January 22, 2019. At the time of the final approval hearing on January 22, 2019, there were no objections to the settlement, but there were two shareholders who had submitted opt-outs so that they could be excluded from the settlement. On January 25, 2019, the court issued an order and final judgment approving the settlement. Although the court has approved the settlement, the court’s decision can be appealed for a period of time. In addition, the shareholders who opted out could try to bring their own claims. The Company, therefore, at this time, cannot predict the results of this lawsuit and possible other legal proceedings with certainty. Defendants continue to believe that the allegations in the complaint are without merit.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable

~~Not applicable.~~

PART II

ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information and Holders

Our common stock trades on the New York Stock Exchange under the symbol "EBS".

As of February ~~15, 2019,~~18, 2022, the closing price per share of our common stock on the New York Stock Exchange was ~~$66.16~~$41.82 and we had ~~30 holders~~19 holders of record of our common stock. ~~This~~This number does not include beneficial owners whose shares are held by nominees in street name.

Purchases of Equity Securities

The table below presents information regarding shares of our common stock that we repurchased during the year ended December 31, 2021.


Issuer Purchases of Equity Securities
Periods	Total Number of Shares Purchased	Average Price Paid Per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs	Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plans or Programs
November 2021	889,872	$	41.96	889,872
December 2021	1,744,926	$	43.03	1,744,926
Total	2,634,798			2,634,798	$	137,578,873

(1) On November 11, 2021, the Company announced that the Board of Directors had authorized management to repurchase, from time to time, up to an aggregate $250.0 million of our common stock under a board-approved share repurchase program (the Share Repurchase Program). As of December 31, 2021, the Company has 51.3 million shares of common stock outstanding. The Share Repurchase Program does not obligate the Company to acquire any specific number of shares. Repurchased shares will be available for use in connection with our stock plans and for other corporate purposes. The Share Repurchase Program expires on November 11, 2022.

Dividend Policy

We have not declared or paid any cash dividends on our common stock since becoming a publicly traded company in November 2006. We currently have no plans to pay dividends.

Recent Sales of Unregistered Securities

On October 15, 2018, we issued 733,309 shares of common stock in a private placement under Section 4(2) of the Securities Act of 1933, as amended, and Rule 506 promulgated thereunder, as partial consideration for our acquisition of Adapt ~~based on the volume-weighted average price per share of the Common Stock as reported on the New York Stock Exchange for the~~ ~~ten-trading day period ending two days before closing, or $65.28 per share (an aggregate total of $47.9 million, inclusive of adjustments).~~

~~Use of Proceeds~~

Not applicable.

Use of Proceeds

~~Purchases of Equity Securities~~Not applicable.

~~There were no repurchases of common stock that were made through open market transactions during the~~ ~~three months ended December 31, 2018~~.

Issuer Purchases of Equity Securities
(in millions, except for per share data)
Period Total number of shares (or units) purchased Average price paid per share (or unit)(a) Total number of shares (or units) purchased as part of publicly announced plans or programs(b) Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased under the plans or programs (a)(b)
October 1, 2018 - October 31, 2018
- $ - - $ -
November 1, 2018 - November 30, 2018 - - - -
December 1, 2018 - December 31, 2018 - - - -
Total - $ - - $ 50.0

~~(a)~~ The ~~amounts do not give effect~~remaining information required by Item 5 is hereby incorporated by reference from our Definitive Proxy Statement relating to ~~any fees, commissions or other costs associated with repurchases of shares.~~

~~(b) Under the stock repurchase program, management was authorized to purchase shares~~our 2022 Annual Meeting of the ~~Company's common stock, from time~~Stockholders, to time, through open market purchases or privately negotiated transactions at prevailing prices or pursuant to one or more accelerated stock repurchase agreements or other derivative arrangements as permitted by securities laws and other legal requirements, and subject to stock price, business and market conditions and other factors. In March 2018, our board of directors authorized our management to repurchase from time to time up to an aggregate of up to $50 millionbe filed with the SEC within 120 days following the end of our common stock under a board-approved share repurchase program. The term of the authorization expires on December 31, 2019. Any repurchased shares will be available for use in connection with our stock plans and for other corporate purposes. As of December 31, 2018, we have not made any repurchases under this program. We historically have funded and in the future may fund stock repurchases through a combination of cash on hand and cash generated by operations and our senior secured credit facilities or future financing transactions.fiscal year.

ITEM 6. [Reserved]

~~ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA~~

Year Ended December 31,
(in millions, except per share data) 2018 2017 2016 2015 2014

Statements of operations data:
Revenues:
Product sales $ 606.5 $ 421.5 $ 296.3 $ 329.0 $ 281.8
Contract manufacturing 98.9 68.9 49.1 43.0 30.9
Contracts and grants 77.0 70.5 143.4 117.3 91.8
Total revenues 782.4 560.9 488.8 489.3 404.5
Operating expenses:
Cost of product sales and contract manufacturing 322.3 187.7 126.3 102.1 96.6
Research and development 142.8 97.4 106.9 117.8 103.5
Selling, general & administrative 202.5 142.9 143.1 120.6 108.1
Amortization of intangible assets 25.0 8.6 7.0 7.3 7.1
Total operating expenses 692.6 436.6 383.3 347.8 315.3
Income from operations 89.8 124.3 105.5 141.5 89.2
Other income (expense):
Interest expense (9.9 ) (6.6 ) (7.6 ) (6.5 ) (8.2 )
Other income (expense), net 1.6 0.9 1.3 0.7 3.2
Total other income (expense), net (8.3 ) (5.7 ) (6.3 ) (5.8 ) (5.0 )

Income from continuing operations before provision for income taxes 81.5 118.6 99.2 135.7 84.2
Provision for income taxes 18.8 36.0 36.7 44.3 29.9
Net income from continuing operations 62.7 82.6 62.5 91.4 54.3
Net loss from discontinued operations - - (10.7 ) (28.5 ) (17.6 )
Net income $ 62.7 $ 82.6 $ 51.8 $ 62.9 $ 36.7

Net income per share from continuing operations-basic $ 1.25 $ 1.98 $ 1.56 $ 2.37 $ 1.45
Net loss per share from discontinued operations-basic - - (0.27 ) (0.74 ) (0.47 )
Net income per share-basic $ 1.25 $ 1.98 $ 1.29 $ 1.63 $ 0.98

Net income per share from continuing operations-diluted $ 1.22 $ 1.71 $ 1.35 $ 2.02 $ 1.26
Net loss per share from discontinued operations-diluted - - (0.22 ) (0.61 ) (0.38 )
Net income per share-diluted (1) $ 1.22 $ 1.71 $ 1.13 $ 1.41 $ 0.88

Weighted average number of shares — basic 50.1 41.8 40.2 38.6 37.3
Weighted average number of shares — diluted 51.4 50.3 49.3 47.3 45.8

As of December 31,
(in millions) 2018 2017 2016 2015 2014

Balance Sheet Data:
Cash and cash equivalents $ 112.2 $ 178.3 $ 271.5 $ 308.3 $ 276.8
Working capital 420.4 385.3 404.4 425.9 312.8
Total assets 2,229.4 1,070.2 970.1 931.8 815.6
Total long-term liabilities 1,018.1 57.8 268.1 274.6 281.5
Total stockholders’ equity 1,010.9 912.2 596.2 575.0 454.5

~~(1) See "Earnings per share" footnote for details on calculation.~~

ITEM 7.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis is meant to provide material information relevant to an assessment of the financial condition and results of operations of our company, including an evaluation of the amounts and uncertainties of cash flows from operations and from outside resources, so as to allow investors to better view our company from management’s perspective. You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this annual report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this annual report on Form 10-K, including information with respect to our plans and strategy for our business and financing, includes forward-looking statements that involve risks and uncertainties. You should carefully review the "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" sections of this annual report on Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Business Overview

PHTs. Our solutions include a product portfolio, a product development portfolio and a CDMO services portfolio.

We are currently focused on the following ~~four distinct public~~five PHT categories: CBRNE, EID, travel health, ~~threat categories: CBRNE; EID; travelers’ diseases;~~emerging health crises, and ~~opioids.~~acute/emergency care. We have a product portfolio of eleven products ~~(vaccines, antibody therapeutics, and drug-device combination products)~~ that ~~generate~~contribute a ~~majority~~substantial portion of our ~~revenue.~~revenue and are sold to government and commercial customers. We also have a product candidate that is procured under special circumstances by the USG, although it is not approved by the FDA. Additionally, we have a development pipeline consisting of a diversified mix of both pre-clinical and clinical stage product ~~candidates (vaccines, antibody therapeutics, and drug-device combination products).~~candidates. Finally, we ~~also~~ have a fully-integrated portfolio of ~~contract~~CDMO services. Our CDMO service offerings cover development services, drug substance manufacturing and drug product manufacturing and packaging.

In October 2021, the Company implemented a new organizational structure organized around markets and customers whereas our historical structure was organized around product/platform and service types. The key components of the new business structure include a Government - MCM business line, Commercial business line, and Services - CDMO business line as well as the centralization of R&D functions and capabilities at the enterprise level.

The majority of our product revenue comes from the following products and procured product candidates:

Government - MCM Products

•Anthrax vaccines, including our AV7909 (Anthrax vaccine adsorbed (AVA), adjuvanted) procured product candidate being developed as a next-generation anthrax vaccine for post-exposure prophylaxis and BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the FDA for the general use prophylaxis and post-exposure prophylaxis of anthrax disease. AV7909 has not been approved by the FDA, but is procured by certain authorized government buyers for their use;

•ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live), the only single-dose smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;

•BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)), the only heptavalent antitoxin licensed by the FDA and Health Canada for the treatment of botulism;

•CNJ-016® (Vaccinia Immune Globulin Intravenous (Human) (VIGIV)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination;

•Raxibacumab injection, a fully human monoclonal antibody, the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax;

•Anthrasil® (Anthrax Immune Globulin Intravenous (human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax;

•RSDL® (Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to remove or neutralize the following chemical warfare agents from the skin: tabun,

updates in the assumed timing of or achievement of net sales and/or the achievement of development and regulatory milestones. For additional information on the Company's contingent consideration, refer to Note 4, of Item 8. Financial Statements and Supplementary Data.

Income Taxes

The Company recognizes deferred tax assets and liabilities for future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss and R&D tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. Valuation allowances are recorded as appropriate to reduce deferred tax assets to the amount considered likely to be realized.

The Company’s income tax expense, deferred tax assets and liabilities and liabilities for unrecognized tax benefits reflect management’s best assessment of estimated current and future taxes to be paid. As tax laws are complex and subject to different interpretations, significant management judgement is required in (1) calculating the Company's income tax expense, deferred tax assets and deferred tax liabilities, (2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as the interest and penalties related to such uncertain tax positions. The Company's estimates and assumptions may differ from tax benefits ultimately realized. For additional information on the Company's income taxes, refer to Note 11, of Item 8. Financial Statements and Supplementary Data.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of additional risks arising from our operations, see “Item 1A—Business—Risk Factors” in this ~~2018~~2021 Annual Report.

Market Risks

~~Our exposure to market risk is currently confined to our cash and cash equivalents.~~ We ~~currently do not hedge~~have interest rate ~~exposure or~~and foreign currency exchange exposure, and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of operations. We have not used derivative financial instruments for speculation or trading purposes.market risk. Because of the short-term maturities of our cash and cash equivalents, we believe that an increase in market rates would likely not have a significant impact on the realized value of our ~~investments, but any increase in market rates would likely increase the interest expense associated with our debt.~~investments.

Interest Rate Risk

We have debt with a mix of fixed and variable rates of interest. Floating rate debt carries interest based generally on the eurocurrency rate, as defined in our Amended Credit Agreement, plus an applicable

margin. ~~Increases~~We manage the impact of interest rate changes on our variable debt through derivative instruments such as interest rate swap arrangements. For debt that we have not hedged through our interest rate swap arrangements increases in interest rates could therefore increase the associated interest payments that we are required to make on this debt. See Note ~~11,~~8, "Long-term debt," to the Notes of our consolidated financial statements included in this ~~2018~~2021 Annual Report under the caption Item 8, "Financial Statements and Supplementary Data.”

We have assessed our exposure to changes in interest rates by analyzing the sensitivity to our operating results assuming various changes in market interest rates. A hypothetical increase of one percentage point in the eurocurrency rate as of December 31, ~~2018~~2021 would increase our interest expense by approximately ~~$8.0~~$0.7 million annually.

Foreign Currency Exchange Rate Risk

We have exposure to foreign currency exchange rate fluctuations worldwide and primarily with respect to the Euro, Canadian dollar, Swiss franc and British pound. We manage our foreign currency exchange rate risk primarily by either entering into foreign currency hedging transactions or incurring ~~to the extent practicable,~~ operating ~~and financing~~ expenses in the local currency in the countries in which we ~~operate.~~operate, to the extent practicable. We currently do not hedge all of our foreign currency exchange exposure and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of operations.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Emergent BioSolutions Inc. ~~and subsidiaries~~

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Emergent BioSolutions Inc. and subsidiaries (the Company) as of December 31, ~~2018~~2021 and ~~2017,~~2020, the related consolidated statements of operations, comprehensive income,, changes in ~~stockholders'~~stockholders’ equity and cash flows for each of the three years in the period ended December 31, ~~2018,~~2021, and the related notes and financial statement schedule listed in the Index at Item 15 (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, ~~2018~~2021 and ~~2017,~~2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, ~~2018,~~2021, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, ~~2018,~~2021, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February ~~21, 2019~~25, 2022 expressed an unqualified opinion thereon.

~~Adoption of ASU No. 2014-09~~

~~As discussed in Note 2 to the consolidated financial statements, the Company changed its method for accounting for revenue in 2018 due to the adoption of Accounting Standards Update (ASU) No. 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606), and the amendments in ASUs 2015-14, 2016-08, 2016-10, 2016-12, 2016-20 and 2017-14.~~

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.


						Revenue recognition
Description of the Matter						As described in Notes 2 and 3 to the consolidated financial statements, the Company recognized revenues of $1,792.7 million for the year ended December 31, 2021. The Company enters into or periodically modifies revenue contracts whose terms are complex and require a significant level of judgment. At contract inception, management assesses the products or services promised in its contracts with customers and identifies a performance obligation for each promise to transfer to the customer a product or service that is distinct, including evaluating whether the contract includes a customer option for additional goods or services which could represent a material right. The Company estimates the transaction price of the contract, including variable consideration that is subject to a constraint. For commercial contracts, revenue is recognized at a point in time, and the Company’s estimation of variable consideration includes allowances for returns, certain fees, discounts, rebates and chargebacks. For CDMO arrangements, revenue is recognized over time, and the Company uses an input method to measure progress toward the satisfaction of the related performance obligation based on costs incurred as a percentage of total costs to complete. Auditing revenue recognition involved significant auditor judgment because it involves subjective assumptions and estimates made by management. For example, auditing management’s identification of performance obligations was challenging as contracts include implicit and explicit goods and services. Further, significant judgment is required in the evaluation of whether the identified promised goods and services are both capable of being distinct and distinct within the context of the contract. In addition, the estimated rebates and returns for commercial arrangements are subject to significant judgment because their expected value is based on assumptions including sales or invoice data, expected utilization rates, historical payment experience, and changes in product pricing. These estimates are forward-looking and could be affected by future economic conditions and the competitive environment. Further, management’s estimate of the total costs as a measure of progress to completion of the performance obligation requires the use of assumptions and estimates. Finally, the identified material weakness relating to the technical accounting assessment of specific attributes within complex revenue arrangements with customers affected our audit procedures in this area.
How We Addressed the Matter in Our Audit						We obtained an understanding, evaluated the design, and tested the operating effectiveness of controls over the Company’s revenue recognition. For example, we tested controls over management’s review over the assumptions used in the estimation of the rebates and returns, and management’s review over the identification of actual costs incurred and the Company’s estimation of total expected costs used in its measure of progress calculations. We also tested management’s controls over the completeness and accuracy of the data used in the underlying calculations. To test revenue recognized, our audit procedures included, among others, reading certain executed contracts, understanding the methodologies utilized and testing the completeness and accuracy of the information used in management’s assessment. For example, we inspected a sample of the Company’s contracts and evaluated whether the performance obligations and pattern of revenue recognition were appropriately identified based on the terms of the contract and in response to the material weakness, we performed incremental audit procedures in this area specifically for CDMO revenue contracts. To test management’s determination of variable consideration, we reviewed the historical data and trends available and compared to management’s estimated rebates and returns. To test management’s assumptions used in the Company’s determination of costs applied to the input measure of progress, we tested, among other things, the Company’s approved budgets and/or forecasts, inquired of operational personnel and reviewed project development timelines to corroborate the measure of progress and tested the completeness and accuracy of the underlying data.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2004.

Baltimore, Maryland

February ~~21, 2019~~25, 2022

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Balance Sheets

(in millions, except per share data)

December 31,
2018 2017
ASSETS
Current assets:
Cash and cash equivalents $ 112.2 $ 178.3
Restricted cash 0.2 1.0
Accounts receivable, net 262.5 143.7
Inventories 205.8 142.8
Income tax receivable, net 8.6 2.4
Prepaid expenses and other current assets 31.5 17.2
Total current assets 620.8 485.4

Property, plant and equipment, net 510.2 407.2
Intangible assets, net 761.6 119.6
In-process research and development 50.0 -
Goodwill 259.7 49.1
Deferred tax assets, net 13.4 2.8
Other assets 13.7 6.1
Total assets $ 2,229.4 $ 1,070.2

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 80.7 $ 41.8
Accrued expenses and other current liabilities 30.7 4.8
Accrued compensation 58.2 37.9
Long-term indebtedness, current portion 10.1 -
Contingent consideration, current portion 5.6 2.4
Income taxes payable, net 4.5 -
Deferred revenue, current portion 10.6 13.2
Total current liabilities 200.4 100.1

Contingent consideration, net of current portion 54.4 9.9
Long-term indebtedness, net of current portion 784.5 13.5
Deferred tax liability 67.5 -
Income taxes payable 11.2 12.5
Deferred revenue, net of current portion 62.5 17.3
Other liabilities 38.0 4.6
Total liabilities 1,218.5 157.9

Stockholders’ equity:
Preferred stock, $0.001 par value; 15.0 shares authorized, 0 shares issued and outstanding at both December 31, 2018 and 2017 - -
Common stock, $0.001 par value; 200.0 shares authorized, 52.4 shares issued and 51.2 shares outstanding at December 31, 2018; 50.6 shares issued and 49.4 shares outstanding at December 31, 2017 0.1 0.1
Treasury stock, at cost, 1.2 common shares at both December 31, 2018 and 2017 (39.6 ) (39.5 )
Additional paid-in capital 688.6 618.3
Accumulated other comprehensive loss (5.5 ) (3.7 )
Retained earnings 367.3 337.1
Total stockholders’ equity 1,010.9 912.3
Total liabilities and stockholders’ equity $ 2,229.4 $ 1,070.2


	December 31,
	2021		2020
ASSETS
Current assets:
Cash and cash equivalents	$	576.1	$	621.3
Restricted cash	0.2		0.2
Accounts receivable, net	274.7		230.9
Inventories, net	350.8		307.0
Prepaid expenses and other current assets	70.3		36.5
Total current assets	1,272.1		1,195.9

Property, plant and equipment, net	800.1		644.1
Intangible assets, net	604.6		663.1
Goodwill	224.9		266.7
Other assets	57.3		113.4
Total assets	$	2,959.0	$	2,883.2

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	128.9	$	136.1
Accrued expenses	51.7		46.9
Accrued compensation	88.7		84.6
Debt, current portion	31.6		33.8
Other current liabilities	72.9		83.1
Total current liabilities	373.8		384.5

Contingent consideration, net of current portion	4.5		34.2
Debt, net of current portion	809.4		841.0
Deferred tax liability	94.9		53.2
Contract liabilities, net of current portion	4.7		55.5
Other liabilities	52.7		67.8
Total liabilities	1,340.0		1,436.2

Stockholders’ equity:
Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued and outstanding	—		—
Common stock, $0.001 par value; 200.0 shares authorized, 55.1 and 54.3 shares issued; 51.3 and 53.1 shares outstanding, respectively.	0.1		0.1
Treasury stock, at cost, 3.8 and 1.2 common shares, respectively	(152.2)		(39.6)
Additional paid-in capital	829.4		784.9
Accumulated other comprehensive loss, net	(16.1)		(25.3)
Retained earnings	957.8		726.9
Total stockholders’ equity	1,619.0		1,447.0
Total liabilities and stockholders’ equity	$	2,959.0	$	2,883.2

The accompanying notes are an integral part of the consolidated financial statements.

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statements of Operations

(in millions, except per share data)

Year Ended December 31,
2018 2017 2016
Revenues:
Product sales $ 606.5 $ 421.5 $ 296.3
Contract manufacturing 98.9 68.9 49.1
   Contracts and grants 77.0 70.5 143.4
Total revenues 782.4 560.9 488.8

Operating expenses:
Cost of product sales and contract manufacturing 322.3 187.7 126.3
Research and development 142.8 97.4 106.9
Selling, general and administrative 202.5 142.9 143.1
   Amortization of intangible assets 25.0 8.6 7.0
        Total operating expenses 692.6 436.6 383.3

Income from operations 89.8 124.3 105.5

Other income (expense):
Interest expense (9.9 ) (6.6 ) (7.6 )
Other income (expense), net 1.6 0.9 1.3
Total other income (expense), net (8.3 ) (5.7 ) (6.3 )

Income from continuing operations before provision for income taxes 81.5 118.6 99.2
Provision for income taxes 18.8 36.0 36.7
Net income from continuing operations 62.7 82.6 62.5
Net loss from discontinued operations - - (10.7 )
Net income $ 62.7 $ 82.6 $ 51.8

Net income per share from continuing operations-basic $ 1.25 $ 1.98 $ 1.56
Net loss per share from discontinued operations-basic - - (0.27 )
Net income per share-basic $ 1.25 $ 1.98 $ 1.29

Net income per share from continuing operations-diluted $ 1.22 $ 1.71 $ 1.35
Net loss per share from discontinued operations-diluted - - (0.22 )
Net income per share-diluted (1) $ 1.22 $ 1.71 $ 1.13

Weighted-average number of shares - basic 50.1 41.8 40.2
Weighted-average number of shares - diluted 51.4 50.3 49.3

~~(1)~~ ~~See "Earnings per share" footnote for details on calculation.~~


	Year Ended December 31,
	2021		2020		2019
Revenues:
Product sales, net	$	1,023.9	$	989.8	903.5
CDMO:
Services	334.9		166.7		80.0
Leases	299.7		283.8		—
Total CDMO	634.6		450.5		80.0
Contracts and grants	134.2		115.1		122.5
Total revenues	1,792.7		1,555.4		1,106.0

Operating expenses:
Cost of product sales	382.0		392.0		372.3
Cost of CDMO	375.5		132.0		61.2
Research and development	234.0		234.5		226.2
Selling, general and administrative	348.4		303.3		273.5
Goodwill impairment	41.7		—		—
Amortization of intangible assets	58.5		59.8		58.7
Total operating expenses	1,440.1		1,121.6		991.9

Income from operations	352.6		433.8		114.1

Other income (expense):
Interest expense	(34.5)		(31.3)		(38.4)
Other, net	(3.7)		4.7		1.7
Total other income (expense), net	(38.2)		(26.6)		(36.7)

Income before income taxes	314.4		407.2		77.4
Income taxes	83.5		102.1		22.9
Net income	$	230.9	$	305.1	$	54.5

Net income per common share
Basic	$	4.32	$	5.79	$	1.06
Diluted	$	4.27	$	5.67	$	1.04

Shares used in computing net income per share
Basic	53.5		52.7		51.5
Diluted	54.1		53.8		52.4

The accompanying notes are an integral part of the consolidated financial statements.

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statements of Comprehensive Income

(in millions)

December 31,

2018 2017 2016

Net income $ 62.7 $ 82.6 $ 51.8
Other comprehensive income (loss), net of tax:
Currency translation adjustments (1.6 ) 0.6 (1.6 )
Unrealized losses on pension benefit obligation (0.2 ) - -
Other comprehensive income (loss), net of tax (1.8 ) 0.6 (1.6 )
Comprehensive income $ 60.9 $ 83.2 $ 50.2


	Year Ended December 31,
	2021		2020		2019
Net income	$	230.9	$	305.1	$	54.5
Other comprehensive income (loss), net of tax:
Foreign currency translation	(1.0)		(1.7)		0.4
Unrealized gains (losses) on hedging activities	6.5		(9.4)		(1.6)
Unrealized gain (losses) on pension benefit obligation	3.7		(4.3)		(3.2)
Total other comprehensive income (loss), net of tax	9.2		(15.4)		(4.4)
Comprehensive income (loss), net of tax	$	240.1	$	289.7	$	50.1

The accompanying notes are an integral part of the consolidated financial statements.

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(in millions)

Year Ended December 31,
2018 2017 2016
Cash flows from operating activities:
Net income $ 62.7 $ 82.6 $ 51.8
Adjustments to reconcile to net cash provided by (used in) operating activities:
Stock-based compensation 23.2 15.2 18.5
Depreciation and amortization 62.2 42.6 38.2
Deferred income taxes 8.6 3.3 5.2
Change in fair value of contingent obligations 3.1 7.8 (10.8 )
Impairment and abandonment of long-lived assets - 1.9 5.6
Excess tax benefits from stock-based compensation - - (10.6 )
Other 1.1 1.0 1.0
Changes in operating assets and liabilities, net of business acquisitions:
Accounts receivable (94.2 ) (4.8 ) (22.4 )
Inventories (1.9 ) 6.1 (9.0 )
Income taxes (5.1 ) 20.1 (3.4 )
Prepaid expenses and other assets (7.9 ) (3.7 ) (2.1 )
Accounts payable (7.0 ) 16.1 (14.8 )
Accrued expenses and other liabilities (11.6 ) 1.6 0.6
Accrued compensation 8.4 3.3 2.2
Deferred revenue 0.2 15.0 4.6
Net cash provided by operating activities 41.8 208.1 54.6
Cash flows from investing activities:
Purchases of property, plant and equipment (72.1 ) (54.8 ) (76.2 )
Proceeds from sale of assets 2.6 - -
Asset acquisitions - (77.6 ) -
Business acquisitions, net of cash acquired (827.7 ) (117.5 ) -
Net cash used in investing activities (897.2 ) (249.9 ) (76.2 )
Cash flows from financing activities:
Proceeds from long-term debt obligations 798.0 - -
Proceeds from issuance of common stock upon exercise of stock options 15.9 19.3 17.1
Excess tax benefits from stock-based compensation - - 10.6
Debt issuance costs (13.4 ) (1.4 ) -
Taxes paid on behalf of employees for equity activity (6.6 ) (4.3 ) (1.1 )
Principal payments on long-term indebtedness (2.8 ) - -
Payment of notes payable to Aptevo - (20.0 ) -
Distribution to Aptevo - - (45.0 )
Contingent consideration payments (3.4 ) (10.9 ) (1.4 )
Receipts and payments of restricted cash 1.1 (1.0 ) -
Purchase of treasury stock (0.1 ) (33.1 ) -
Net cash (used in) provided by financing activities 788.7 (51.4 ) (19.8 )

Effect of exchange rate changes on cash and cash equivalents (0.2 ) - 0.1

Net decrease in cash and cash equivalents (66.9 ) (93.2 ) (41.3 )
Cash and cash equivalents at beginning of year (1) 179.3 272.5 312.8
Cash and cash equivalents at end of year (1) $ 112.4 $ 179.3 $ 271.5

Supplemental disclosure of cash flow information:
Cash paid during the year for interest $ 10.2 $ 8.4 $ 8.2
Cash paid during the year for income taxes $ 14.0 $ 12.0 $ 10.1
Supplemental information on non-cash investing and financing activities:
Issuance of common stock to acquire Adapt Pharma $ 37.7 $ - $ -
Purchases of property, plant and equipment unpaid at year end $ 14.7 $ 4.6 $ 13.5

~~(1) As of December 31, 2018 and December 31, 2017, the balance includes restricted cash of $0.2 million and $1.0 million, respectively.~~


	Year Ended December 31,
	2021		2020		2019
Cash flows from operating activities:
Net income	$	230.9	$	305.1	$	54.5
Adjustments to reconcile net income to net cash provided by operating activities:
Stock-based compensation expense	42.4		51.0		26.7
Depreciation and amortization	123.8		114.5		110.7
Change in fair value of contingent obligations, net	2.9		31.7		24.8
Amortization of deferred financing costs	4.1		3.5		3.0
Impairments	41.7		29.0		12.0
Deferred income taxes	46.9		(2.4)		(1.1)
Write off of contract asset and liability	(17.2)		—		—
Other	2.0		(5.2)		(0.2)
Changes in operating assets and liabilities:
Accounts receivable	(48.2)		49.0		(8.2)
Inventories	(44.0)		(83.2)		(16.7)
Prepaid expenses and other assets	(24.7)		(29.2)		(39.1)
Accounts payable	(2.5)		19.8		16.5
Accrued expenses and other liabilities	(9.2)		19.4		(15.1)
Accrued compensation	4.0		21.8		4.2
Contract liabilities	(31.8)		11.2		16.0
Net cash provided by operating activities	321.1		536.0		188.0
Cash flows from investing activities:
Purchases of property, plant and equipment	(225.0)		(141.0)		(86.9)
Milestone payment from prior asset acquisition	—		(10.0)		(10.0)
Net cash used in investing activities	(225.0)		(151.0)		(96.9)
Cash flows (used in) provided by financing activities:
Purchases of treasury stock	(106.0)		—		—
Proceeds from revolving credit facility	—		—		130.0
Proceeds from senior unsecured notes	—		450.0		—
Principal payments on convertible senior notes	(10.6)		—		—
Principal payments on revolving credit facility	—		(373.0)		(105.0)
Principal payments on term loan facility	(25.3)		(14.1)		(11.3)
Proceeds from stock-based compensation activity	15.9		31.6		8.2
Taxes paid for stock-based compensation activity	(13.8)		(13.8)		(7.4)
Debt issuance costs	—		(8.4)		—
Contingent consideration payments	(1.2)		(2.8)		(50.4)
Net cash (used in) provided by financing activities:	(141.0)		69.5		(35.9)
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(0.3)		(1.0)		0.4
Net change in cash, cash equivalents and restricted cash	(45.2)		453.5		55.6
Cash, cash equivalents and restricted cash at beginning of period	621.5		168.0		112.4
Cash, cash equivalents and restricted cash at end of period	$	576.3	$	621.5	$	168.0
Supplemental disclosure of cash flow information:
Cash paid during the year for interest	30.4		21.0		34.5
Cash paid during the year for income taxes	71.6		109.3		30.8
Supplemental information on non-cash investing and financing activities:
Purchases of property, plant and equipment unpaid at period end	20.0		22.0		12.3
Purchases of treasury stock	6.6		—		—
Reconciliation of cash and cash equivalents and restricted cash:
Cash and cash equivalents	576.1		621.3		167.8
Restricted cash	0.2		0.2		0.2
Total	$	576.3	$	621.5	$	168.0

The accompanying notes are an integral part of the consolidated financial statements.

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statement of Changes in Stockholders' Equity

(in millions, except per share data)

$0.001 Par Value Common Stock Additional Paid-In Treasury Stock Accumulated Other Comprehensive Retained Total Stockholders'
Shares Amount Capital Shares Amount Loss Earnings Equity
Balance at December 31, 2015 39.8 $ - $ 318.0 (0.4 ) $ (6.4 ) $ (2.7 ) $ 351.1 $ 660.0

Employee equity plans activity 1.2 - 34.4 - - - - 34.4
Separation of Aptevo - - - - - - (148.4 ) (148.4 )
Net income - - - - - - 51.8 51.8
Other comprehensive loss - - - - - (1.6 ) - (1.6 )
Balance at December 31, 2016 41.0 $ - $ 352.4 (0.4 ) $ (6.4 ) $ (4.3 ) $ 254.5 $ 596.2

Employee equity plans activity 1.1 - 28.0 - - - - 28.0
Shares issued to extinguish convertible notes 8.5 0.1 237.9 - - - - 238.0
Treasury stock - - - (0.8 ) (33.1 ) - - (33.1 )
Net income - - - - - - 82.6 82.6
Other comprehensive income - - - - - 0.6 - 0.6
Balance at December 31, 2017 50.6 $ 0.1 $ 618.3 (1.2 ) $ (39.5 ) $ (3.7 ) $ 337.1 $ 912.3
Adoption of new accounting standard (ASC 606), net of tax - - - - - - (32.5 ) (32.5 )
Balance at January 1, 2018 50.6 0.1 618.3 (1.2 ) (39.5 ) (3.7 ) 304.6 879.8
Employee equity plans activity 1.1 - 32.6 - - - - 32.6
Issuance of common stock in acquisition 0.7 - 37.7 - - - - 37.7
Treasury stock - - - - (0.1 ) - - (0.1 )
Net income - - - - - - 62.7 62.7
Other comprehensive loss - - - - - (1.8 ) - (1.8 )
Balance at December 31, 2018 52.4 $ 0.1 $ 688.6 (1.2 ) $ (39.6 ) $ (5.5 ) $ 367.3 $ 1,010.9


	$0.001 Par Value Common Stock			Additional Paid-In Capital		Treasury Stock			Accumulated Other Comprehensive Loss		Retained Earnings		Total Stockholders' Equity
	Shares	Amount				Shares	Amount
Balance at January 1, 2019	52.4	$	0.1	$	688.6	(1.2)	$	(39.6)	$	(5.5)	$	367.3	$	1,010.9
Share-based compensation activity	0.6	—		27.5		—	—		—		—		27.5
Net income	—	—		—		—	—		—		54.5		54.5
Other comprehensive income (loss), net of tax	—	—		—		—	—		(4.4)		—		(4.4)
Balance at December 31, 2019	53.0	$	0.1	$	716.1	(1.2)	$	(39.6)	$	(9.9)	$	421.8	$	1,088.5
Share-based compensation activity	1.3	—		68.8		—	—		—		—		68.8
Net income	—	—		—		—	—		—		305.1		305.1
Other comprehensive income (loss), net of tax	—	—		—		—	—		(15.4)		—		(15.4)
Balance at December 31, 2020	54.3	$	0.1	$	784.9	(1.2)	$	(39.6)	$	(25.3)	$	726.9	$	1,447.0
Share-based compensation activity	0.8	—		44.5		—	—		—		—		44.5
Net income	—	—		—		—	—		—		230.9		230.9
Repurchases of stock	—	—		—		(2.6)	(112.6)		—		—		(112.6)
Other comprehensive income (loss), net of tax	—	—		—		—	—		9.2		—		9.2
Balance at December 31, 2021	55.1	$	0.1	$	829.4	(3.8)	$	(152.2)	$	(16.1)	$	957.8	$	1,619.0

The accompanying notes are an integral part of the consolidated financial statements.

Emergent BioSolutions Inc. and Subsidiaries

Notes to consolidated financial statements

1.1. Nature of the business and organization

Organization and business

Emergent BioSolutions Inc. (the "Company" or "Emergent") is a global life sciences company focused on providing ~~specialty products for civilian~~innovative preparedness and ~~military populations that address~~response solutions addressing accidental, ~~intentional~~deliberate, and naturally occurring ~~public health threats ("PHTs," each~~Public Health Threats (PHTs). The Company's solutions include a ~~“PHT”).~~

product portfolio, a product development portfolio, and a contract development and manufacturing (CDMO) services portfolio.

The Company is focused on ~~innovative preparedness and response products and solutions addressing~~ the following ~~four distinct~~5 PHT categories: ~~Chemical, Biological, Radiological, Nuclear~~chemical, biological, radiological, nuclear and ~~Explosives ("CBRNE")~~explosives (CBRNE); emerging infectious diseases ~~("EID")~~(EID); ~~travelers’ diseases;~~travel health; emerging health crises; and ~~opioids.~~acute/emergency care. The Company has a product portfolio of ~~eleven~~11 products (vaccines, ~~antibody~~ therapeutics, and drug-device combination products) that ~~generate~~contribute a ~~majority~~substantial portion of ~~our~~its revenue. The Company has 1 product candidate that is procured under special circumstances by the U.S. government ~~(the "USG')~~(USG), although it is not approved by the ~~Company's largest customer~~U.S. Food and ~~provides us with substantial funding for~~Drug Administration (FDA). The Company recently reorganized the ~~development of a number~~structure of its ~~product candidates.~~

business with a focus on markets and customers. As such, the key components of the business structure include a Government - Medical Countermeasures (MCM) business line, a Commercial business line and a Services line focused on CDMO.

The Company's products and services include:

Government - MCM Products

▪AV7909®, is a procured product ~~portfolio includes:~~candidate being developed as a next generation anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure. The USG has largely switched from procuring BioThrax to AV7909 for the Strategic National Stockpile (SNS) prior to its approval by the FDA; and

▪BioThrax®, the only vaccine licensed by the FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;

~~Vaccines~~▪ACAM2000®, the only single-dose smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;

▪BAT®, the only heptavalent antitoxin licensed by the FDA and ~~Anti-Infectives~~Health Canada for the treatment of botulism; and;

▪CNJ-016®, the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination.

▪Raxibacumab injection, a fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax;

▪Anthrasil®, the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax;

▪RSDL®, the only medical device cleared by the FDA to remove or neutralize the following chemical warfare agents from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas, and T-2 toxin.

▪Trobigard® atropine sulfate, obidoxime chloride AUTO-INJECTOR, is a combination drug-device auto-injector procured product candidate that contains atropine sulfate and obidoxime chloride. It has not been approved by the FDA, but it is procured by certain authorized government buyers under special circumstances for potential use as a nerve agent countermeasure.

Commercial Products

▪NARCAN® (naloxone HCl) Nasal Spray, the first needle-free formulation of naloxone approved by the FDA and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression; Recently, the Company licensed an authorized generic of naloxone nasal spray to Sandoz; and

▪Vaxchora® (Cholera Vaccine, Live, Oral), the only single-dose oral vaccine licensed by the FDA and the European Medicines Agency (EMA) for the prevention of cholera; and

~~BioThrax~~^® ~~(Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration ("FDA"), for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;~~

▪Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever.

Services - Contract Development and Manufacturing

The Company's services line focused on CDMO offerings cover development services, drug substance manufacturing, drug product manufacturing, and when necessary, suite reservations, which depending on facts and circumstances could be considered a lease. These services are provided across the pharmaceutical and biotechnology industries as well as the USG and non-governmental organizations. The Company's technology platforms include mammalian, microbial, viral, plasma and advanced therapies utilizing the Company's core capabilities for manufacturing to third parties on a clinical and commercial (small and large) scale. Additional services include fill/finish formulation and analytical development services for injectable and other sterile products, inclusive of process design, technical transfer, manufacturing validations, aseptic filling, lyophilization, final packaging and stability studies, as well as manufacturing of vial and pre-filled syringe formats on multiple platforms.

The Company operates as 1 operating segment.

~~ACAM2000~~^® ~~(Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;~~

~~Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera; and~~

~~Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever.~~

~~Devices~~

NARCAN® (naloxone HCl) Nasal Spray, the first and only needle-free formulation of naloxone approved by the FDA and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression;

~~RSDL~~^® (Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to remove or neutralize the following chemical warfare agents from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin; and

~~Trobigard™ (atropine sulfate, obidoxime chloride),~~ ~~an auto-injector device designed for intramuscular self-injection~~ of atropine sulfate and obidoxime chloride, as a nerve agent countermeasure. This product is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.

~~Antibody Therapeutics~~

~~raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax;~~

~~Anthrasil~~^® ~~[Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax;~~

~~BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)], the only heptavalent antibody therapeutic licensed by the FDA and Health Canada for the treatment of botulism; and~~

~~VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination.~~

2. Summary of significant accounting policies

Basis of presentation and consolidation

The accompanying consolidated financial statements include the accounts of Emergent and its wholly owned subsidiaries. All significant ~~intercompany~~inter-company accounts and transactions have been eliminated in consolidation.

~~Reclassification~~

The Company has reclassified amortization of intangible assets for the years ended December 31, 2017 and 2016 from cost of product sales and contract manufacturing to amortization of intangible assets to conform to the current period presentation on the Company’s consolidated statements of operations.

Use of estimates

The preparation of financial statements ~~in accordance with U.S. generally accepted accounting principles (“GAAP”)~~ requires management to make estimates, judgments and assumptions that affect ~~the~~reported amounts and disclosures ~~reported in the consolidated financial statements~~for asset impairments, revenue recognition, allowances for doubtful accounts, inventory, depreciation and ~~accompanying notes.~~amortization, business combinations, contingent consideration, stock-based compensation, income taxes, and other contingencies. Management continually re-evaluates its estimates, judgments and ~~assumptions, and management’s evaluations could change.~~assumptions. These estimates are sometimes complex, sensitive to changes in assumptions and require fair value determinations using Level 3 fair value measurements. Actual results may differ materially from those estimates.

Estimates and judgments inherent in the preparation of the consolidated financial statements include accounting for asset impairments, revenue recognition, allowances for doubtful accounts, inventory, depreciation and amortization, business combinations, stock-based compensation, income taxes, and other contingencies.

Cash, cash equivalents and restricted cash

Cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions. Also, the Company maintains cash balances with financial institutions in excess of insured limits. ~~The Company does not anticipate any losses with such cash balances.~~ Restricted cash includes cash that is not readily available for use in the Company's operating activities. Restricted cash is primarily comprised of cash pledged under letters of credit.

Fair value measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value include:


Level 1 —			Observable inputs for identical assets or liabilities such as quoted prices in active markets;

Level 2 —

Inputs other than quoted prices in active markets that are either directly or indirectly observable; and

Level 3 —

Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.

~~The~~On a recurring basis, the Company measures and records money market funds (level 1), contingent purchase consideration (level 3) and interest-rate swap arrangements (level 2) using ~~level 3~~ fair value measurements in the accompanying financial statements. The carrying amounts of the Company's short-term financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable and convertible senior notes approximate their fair values due to their short maturities. The carrying amounts of the Company’s long-term variable interest rate debt arrangements ~~approximates~~(level 2) approximate their fair ~~values due to variable interest rates which fluctuate with changes in market rates.~~values.

Significant customers and accounts receivable

Billed accounts receivable are stated at invoice amounts and consist ~~primarily~~ of amounts due from the USG, commercial CDMO customers, as well as amounts due under reimbursement contracts with other government entities and non-government organizations. The Company's branded and generic opioid overdose reversal product is sold commercially through physician-directed or standing order prescriptions at retail pharmacies, as well as state health departments, law enforcement agencies, state and local community based organizations, substance abuse centers and federal agencies. If necessary, the Company records a ~~provision~~reserve for doubtful receivables to allow for amounts which may be unrecoverable. This provision is based upon an analysis of the Company's prior collection experience, customer creditworthiness and current economic trends. Amounts determined to be uncollectible are charged or written-off against the reserve. Unbilled accounts receivable relates to various service contracts for which work has been performed ~~though~~and the Company has a right to bill but invoicing has not yet occurred. Contract assets include revenues recognized in advance of billings and the Company does not have a right to invoice the customer under the terms of the contract. The Company has receivables from contracts containing lease components. At each reporting period, the Company assesses whether it is probable that the Company will collect all future lease payments. The Company considers payment history and current credit status when assessing collectability. The Company does not adjust our receivables for the effects of a significant financing component at contract inception if we expect to collect the receivables in one year or less from the time of sale.

~~Concentrations~~Concentration Risk

Customers

The Company has long-term contracts with the USG that expire at various times from ~~2019~~2022 through ~~2027.~~2029. The Company has derived a significant portion of its revenue from sales of ~~BioThrax~~ACAM2000 and Anthrax Vaccines under contracts with the USG. The Company's current ~~Centers for Disease Control ("CDC") contract does~~USG contracts do not necessarily increase the likelihood that it will secure future comparable contracts with the USG. The Company expects that a significant portion of the business will continue to be under government contracts that present a number of risks that are not typically present in the commercial contracting process. USG contracts for ~~BioThrax~~ACAM2000 and Anthrax Vaccines are subject to unilateral termination or modification by the government. The Company may fail to achieve significant sales of ~~BioThrax~~ACAM2000 and Anthrax Vaccines to customers in addition to the USG, which would harm ~~its~~their growth opportunities. The ~~Company may not be able~~Company's other product sales, largely Nasal Naloxone Products, are largely sold commercially through physician-directed or standing order prescriptions at retail pharmacies, as well as to ~~manufacture BioThrax consistently in accordance with FDA specifications.~~

state health departments, local law enforcement agencies, community-based organizations, substance abuse centers and other federal agencies. Our CDMO customers are generally third-party pharmaceutical companies.

Although the Company seeks to expand its customer base and to renew its agreements with its customers prior to expiration of a contract, a delay in securing a renewal or a failure to secure a renewal or securing a renewal on less favorable terms may have a material adverse effect on the Company’s financial condition and results of operations.

The Company’s ~~trade receivables~~accounts receivable do not represent a significant concentration of credit risk. The USG accounted for ~~more than 76%~~approximately 50%, ~~78%~~64% and ~~86%~~61% of total ~~consolidated~~ revenues for ~~2018, 2017~~2021, 2020 and ~~2016, respectively, and more than 76% and 89% of total~~2019, respectively. The Company’s accounts receivable as of December 31, ~~2018~~2021 and ~~2017, respectively. Because accounts receivable consists~~2020, consist primarily of amounts due from the USG or other large multi-national highly reputable customers for product sales, ~~and~~CDMO services or from government agencies under government ~~grants and development contracts, management~~grants. Management does not deem ~~the~~ credit risk to be significant.

Financial Institutions

Cash and cash equivalents are maintained with several financial institutions. The Company has deposits held with banks that exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and are maintained with financial institutions of reputable credit and, therefore, bear minimal credit risk.

Lender Counterparties

There is alender counterparty risk ~~that~~associated with the ~~counterparties associated with~~Company's revolving credit facility and derivatives instruments. There is risk that the Company’s revolving credit facility investors and derivative counterparties will not be available to fund as ~~obligated under the terms of the facility and that the Company may, at the time of such unavailability to fund.~~obligated. If funding under the revolving credit facility is unavailable, the Company may have to acquire a replacement credit facility from different counterparties at a higher cost or may be unable to find a suitable replacement. ~~Typically, the~~The Company seeks to manage ~~such~~ risks from its revolving credit facility and derivative

instruments by contracting with experienced large financial institutions and monitoring the credit quality of its lenders. As of December 31, ~~2018,~~2021, the Company ~~did~~does not anticipate nonperformance by any of its counterparties.

Inventories

Inventories are stated at the lower of cost or net realizable value with cost being determined using a standard cost method, which approximates average cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs) and includes the services and products of third-party suppliers. The Company analyzes its inventory levels quarterly and writes down, in the applicable period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected customer demand. The Company also writes off, in the applicable period, the costs related to expired inventory. Costs of purchased inventories are recorded using weighted-average costing. The Company determines normal capacity for each production facility and allocates fixed production-overhead costs on that basis.

The Company records inventory acquired in business acquisitions utilizing the comparative sales method, which estimates the expected sales price reduced for all costs expected to be incurred to complete/dispose of the inventory with a profit on those costs.

Property, plant and equipment

Property, plant and equipment are stated at cost less accumulated depreciation and impairments. ~~Depreciation is computed using~~subject to reviews for impairment whenever events or changes in circumstances indicate that the ~~straight-line method over~~carrying amount of the ~~following estimated useful lives:~~

~~Buildings~~	~~31-39 years~~
~~Building improvements~~	~~10-39 years~~
~~Furniture and equipment~~	~~3-15 years~~
~~Software~~	~~3-7 years or product life~~
~~Leasehold improvements~~	~~Lesser of the asset life or lease term~~

~~Upon retirement or sale, the~~asset may not be recoverable. The cost of ~~assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain~~normal, recurring or ~~loss is credited or charged to operations. Repairs~~periodic repairs and maintenance ~~costs~~activities related to property, plant and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related acquisition or construction of assets, is capitalized if the repair will result in future economic benefits.

Interest costs incurred during the construction of major capital projects are capitalized until the underlying asset is ready for its intended use, at which point the interest costs are amortized as depreciation expense over the life of the underlying asset.

The Company capitalizes internal-use software when both (a) the software is internally developed, acquired, or modified solely to meet the entity’s internal needs and (b) during the software’s development or modification, no substantive plan either exists or is being developed to market the software externally. Capitalization of qualifying internal-use software costs begins when the preliminary project stage is completed, management with the relevant authority, implicitly or explicitly, authorizes and commits to the funding of the software project, and it is probable that the project will be completed and the software will be used to perform the function intended.

The Company generally depreciates or amortizes the cost of its property, plant and equipment using the straight-line method over the estimated useful lives of the respective assets, which are summarized as follows:


Land			Not depreciated
Buildings			31-39 years
Building improvements			10-39 years
Furniture and equipment			3-15 years
Software			3-7 years
Leasehold improvements			Lesser of the asset life or lease term

Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.

The Company determines the fair value of the property, plant and equipment acquired in a business combination utilizing either the cost approach or the sales comparison approach. The cost approach is determined by establishing replacement cost of the asset and then subtracting any value that has been lost due to economic obsolescence, functional obsolescence, or physical deterioration. The sales comparison approach determines an asset is equal to the market price of an asset of comparable features such as design, location, size, construction, materials, use, capacity, specification, operational characteristics and other features or descriptions.

Income taxes

Income taxes includes federal, state, local and foreign taxes. Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax ~~bases~~basis and net operating loss and ~~research and development~~R&D tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled.

Valuation allowances are recorded as appropriate to reduce deferred tax assets to the amount considered likely to be realized.

Deferred income tax effects of transactions reported in different periods for financial reporting and income tax return purposes are recognized under the asset and liability method of accounting for income taxes. This method gives consideration to the future tax consequences of the deferred income tax items and immediately recognizes changes in income tax laws in the year of enactment. On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act (the “Tax Reform Act”). Further information on the tax impacts of the Tax Reform Act is included in Note 12 of the Company’s consolidated financial statements.

The Company's ability to realize deferred tax assets depends upon future taxable income as well as the limitations discussed below. For financial reporting purposes, a deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized prior to expiration. The Company considers future taxable income and ongoing tax planning strategies in assessing the need for valuation allowances. In general, if the Company determines that it is more likely than not to realize more than the recorded amounts of net deferred tax assets in the future, the Company will reverse all or a portion of the valuation allowance established against its deferred tax assets, resulting in a decrease to ~~the provision for~~ income taxes in the period in which the determination is made. Likewise, if the Company determines that it is not more likely than not to realize all or part of the net deferred tax asset in the future, the Company will establish a valuation allowance against deferred tax assets, with an offsetting increase to ~~the provision for~~ income taxes, in the period in which the determination is made.

Under sections 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a "loss corporation", as defined therein, there are annual limitations on the amount of net operating losses and deductions that are available. The Company has recognized the portion of net operating losses and ~~research and development~~R&D tax credits acquired that will not be limited and are more likely than not to be realized.

Because tax laws are complex and subject to different interpretations, significant judgment is required. As a result, the Company makes certain estimates and assumptions, in (1) calculating the Company's income tax expense, deferred tax assets and deferred tax liabilities, (2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as the interest and penalties related to such uncertain tax positions. The Company's estimates and assumptions may differ ~~significantly~~ from tax benefits ultimately realized.

~~Acquisitions~~

In determining whether an acquisition is a business combination versus an asset acquisition, the accounting guidance requires an entity to first evaluate whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If that threshold is met, the set of assets and activities is not a business and therefore treated as an asset acquisition. If that threshold is not met, the entity evaluates whether the set meets the definition of a business. If an acquired asset or asset group does not meet the definition of a business, the transaction is accounted for as an asset acquisition. Otherwise, the acquisition is treated as a business combination.

In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the merger or acquisition at their respective fair values with limited exceptions and generally use Level 3 fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair values that do not reflect the Company's intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company's consolidated financial statements after the date of the merger or acquisition. If the Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an asset acquisition and recorded at cost rather than a business combination and, therefore, no goodwill will be recorded.

The fair values of intangible assets, including acquired in-process research and development ("IPR&D"), are determined utilizing information available at or near the merger or acquisition date based on expectations and assumptions that are deemed reasonable by management. Given the considerable judgment involved in determining fair values, the Company typically obtains assistance from third-party valuation specialists for significant items. Amounts allocated to acquired IPR&D are capitalized and accounted for as indefinite-lived intangible assets. Upon successful completion of each project, the Company will make a separate determination as to the remaining useful life of the asset and begin amortization. The judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a business combination, as well as asset lives, can materially affect the Company’s results of operations.

The fair values of identifiable intangible assets related to current products and product rights are primarily determined by using an income approach through which fair value is estimated based on each asset’s discounted projected net cash flows. The Company's estimates of market participant net cash flows consider historical and projected pricing, margins and expense levels, the performance of competing products where applicable, relevant industry and therapeutic area growth drivers and factors, current and expected trends in technology and product life cycles, the time and investment that will be required to develop products and technologies, the ability to obtain marketing and regulatory approvals, the ability to manufacture and commercialize the products, the extent and timing of potential new product introductions by the Company’s competitors, and the life of each asset’s underlying patent, if any. The net cash flows are then probability-adjusted where appropriate to consider the uncertainties associated with the underlying assumptions, as well as the risk profile of the net cash flows utilized in the valuation. The probability-adjusted future net cash flows of each product are then discounted to present value utilizing an appropriate discount rate.

The fair values of identifiable intangible assets related to IPR&D are determined using an income approach, through which fair value is estimated based on each asset’s probability-adjusted future net cash flows, which reflect the different stages of development of each product and the associated probability of successful completion. The net cash flows are then discounted to present value using an appropriate discount rate. Indefinite-lived intangible assets are tested for impairment annually or whenever events or changes in circumstances indicate that its carrying amount may not be recoverable.

Assets acquired and liabilities assumed in a business combination that arise from contingencies are recognized at fair value if fair value can reasonably be estimated. If the acquisition date fair value of an asset acquired or liability assumed that arises from a contingency cannot be determined, the asset or liability is recognized if probable and reasonably estimable; if these criteria are not met, no asset or liability is recognized.

Asset Impairment Analysis

Goodwill and Indefinite-lived Intangible Assets

Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets when accounted for using the purchase method of accounting. Goodwill is not amortized, but is reviewed for impairment. Goodwill is allocated to the Company's reporting units, which are components of our business for which discrete cash flow information is available one level below its operating segment. The Company evaluates goodwill and other indefinite-lived intangible assets for impairment annually as of October 1 and earlier if an event or other circumstance indicates that we may not recover the carrying value of the asset. If the Company believes that as a result of its qualitative assessment it is more likely than not that the fair value of a reporting unit or other indefinite-lived intangible asset is greater than its carrying amount, the quantitative impairment test is not required. If however it is determined that it is not more likely than not that the fair value of a reporting unit or other indefinite-lived intangible asset is greater than its carrying amount, a quantitative test is required.

The quantitative goodwill impairment test is performed using a ~~two-step~~one-step process. The ~~first step of the~~ process is to compare the fair value of a reporting unit with its carrying ~~amount, including goodwill.~~amount. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not ~~impaired and the second step of the quantitative impairment test is not necessary.~~impaired. If the carrying amount of a reporting unit exceeds its fair value, ~~the second step of the quantitative~~ goodwill impairment test is required to be performed to measure the amount of impairment loss, if any. The second step of the quantitative goodwill impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. In other words, the estimated fair value of the reporting unit’s identifiable net assets excluding goodwill is compared to the fair value of the reporting unit ~~as if the reporting unit had been acquired in a business combination~~is impaired and ~~the fair value of the reporting unit was the purchase price paid. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill,~~ an impairment loss is recognized in an amount equal to that ~~excess.~~excess up to the total amount of goodwill included in the reporting unit.

~~Following~~When the Company has material indefinite lived intangible assets associated with in-process research and development (IPR&D) a qualitative assessment ~~indicating~~is performed. If the qualitative assessment indicates that it is not

more likely than not that the fair value of the indefinite lived intangible asset exceeds its carrying amount, ~~impairment of other intangible assets not subject to amortization involves a comparison of~~the Company compares the estimated fair value of the intangible ~~asset~~ with its carrying value. If the carrying value of the intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. Determining fair value requires the exercise of judgment about appropriate discount rates, perpetual growth rates and the amount and timing of expected future cash ~~flows.~~

The Company used a qualitative assessment for our goodwill impairment testing for 2018 and 2017. The qualitative evaluation completed during the years ended December 31, 2018 and 2017 indicated no impairment losses. The Company did not have material indefinite lived intangible assets until its acquisitions which were completed in the fourth quarter of 2018.

flows (see Note 7).

Long-lived Assets

Long-lived assets such as intangible assets and property, plant and equipment are not required to be tested for impairment annually. Instead, ~~long-lived assets~~they are tested for impairment whenever circumstances indicate that the carrying amount of the asset may not be recoverable, such as when the disposal of such assets is likely or there is an adverse change in the market involving the business employing the related assets. If an impairment analysis is required, the impairment test employed is based on whether the Company’s intent is to hold the asset for continued use or to hold the asset for sale. If the intent is to hold the asset for continued use, the impairment test first requires a comparison of undiscounted future cash flows to the carrying value of the asset. If the carrying value of the asset exceeds the undiscounted cash flows, the asset would not be deemed to be recoverable. Impairment would then be measured as the excess of the asset’s carrying value over its fair value. Fair value is typically determined by discounting the future cash flows associated with that asset. If the intent is to hold the asset for sale and certain other criteria are met, the impairment test involves comparing the asset’s carrying value to its fair value less costs to sell. To the extent the carrying value is greater than the asset’s fair value less costs to sell, an impairment loss is recognized in an amount equal to the difference. Significant judgments used for long-lived asset impairment assessments include identifying the appropriate asset groupings and primary assets within those groupings, determining whether events or circumstances indicate that the carrying amount of the asset may not be recoverable, determining the future cash flows for the assets involved and assumptions applied in determining fair value, which include, reasonable discount rates, growth rates, market risk premiums and other assumptions about the economic environment.

Contingent Consideration

~~The~~In connection with the Company's acquisitions accounted for as business combinations, the Company records contingent consideration associated with sales-based royalties, sales-based milestones and development and regulatory milestones at fair value. The fair value model used to calculate ~~this obligation~~these obligations is based on the income approach (a discounted cash flow model) that has been risk adjusted based on the probability of achievement of net sales and achievement of the milestones. The inputs the Company uses for determining the fair value of the contingent consideration associated with sales-based royalties, sales-based milestones and development and regulatory milestones are Level 3 fair value measurements. The Company re-evaluates the fair value on a quarterly basis. Changes in the fair value can result from adjustments to the discount rates and updates in the assumed timing of or achievement of net sales and/or the achievement of development and regulatory milestones. Any future increase or decrease in the fair value of the contingent consideration associated with sales-based royalties and sales-based milestones along with development and regulatory milestones are based on an ~~increased~~assessment of the likelihood that the underlying net sales or milestones will be achieved.

The associated ~~payment or~~ payments which will become due and payable for sales-based royalties and ~~sales-based~~ milestones ~~associated with products will~~ result in a charge to cost of product sales ~~and contract manufacturing~~ in the period in which the increase is determined. Similarly, any future decrease in the fair value of contingent consideration associated with sales-based royalties and sales-based milestones will result in a reduction in cost of product ~~sales and contract manufacturing.~~sales. The changes in fair value for potential future sales-based royalties associated with product candidates in development will result in a charge to ~~selling, general and administrative expense~~cost of product sales in the period in which the increase is determined. ~~Similarly, any~~

Leases

The Company has operating leases for corporate offices, R&D facilities and manufacturing facilities. The Company determines if an arrangement is a lease at inception. Operating leases with future ~~decrease~~minimum lease payments in excess of 12 months and total lease payments greater than $0.1 million are included in right-of-use (ROU) assets and liabilities. The Company has elected to record expense on a cash basis for leases with minimum lease payments of 12 months or less and/or total lease payments less $0.1 million.

ROU assets represent the ~~fair~~Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of ~~contingent consideration associated with potential future sales-based royalties for products candidates will result~~lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in ~~a reduction in selling, general and administrative expense.~~determining the present value of lease payments.

The ~~associated payment~~Company uses an implicit rate when readily determinable. At the beginning of a lease, the operating lease ROU asset also includes any concentrated lease payments expected to be paid and excludes lease incentives. The Company's lease ROU asset may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise those options.

Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which ~~will become due and payable~~are accounted for development and regulatory milestones will result in a charge to research and development expense in the period in which the increase is determined. Similarly, any future decrease in the fair value for development and regulatory milestones will result in a reduction in research and development expense.separately.

Revenue recognition

On January 1, 2018 the Company adopted ASC topic 606 using the modified retrospective approach applied to those contracts in effect as of January 1, 2018. Under this transition method, results for reporting periods beginning after January 1, 2018 are presented under the new standard, while prior period amounts are not adjusted and continue to be reported in accordance with historical accounting under Topic 605. See further discussion of the adoption of Topic 606, including the impact to our 2018 financial statements within the recently issued accounting standards section below.

The Company recognizes revenue when the Company's customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services by analyzing the following five steps: (1) identify the contract with a customer(s); (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. To indicate the transfer of control for the Company’s product sales and contract manufacturing services, it must have a present right to payment, legal title must have passed to the customer, and the customer must have the significant risks and rewards of ownership. Revenue for long-term development contracts is generally recognized based upon the cost-to-cost measure of progress, provided that the Company meets the criteria associated with transferring control of the good or service over time.

Multiple performance obligations

At contract inception, the Company assesses the products or services promised in a contract and identifies a performance obligation for each promise to transfer to the customer a product or service that is distinct, including evaluating whether the contract includes a customer option for additional goods or services which could represent a material right. A performance obligation is a promise in a contract to transfer a distinct product or service to a customer and is the unit of account under ASC 606. Contracts sometimes include more than one product, a lease, or options for customers to purchase additional products or services in the future for free or at a discount, which gives rise to separate performance obligations. For contracts with multiple performance obligations, the Company allocates the ~~contract’s transaction~~contract price to each performance obligation on a relative standalone selling price basis using the Company’s best estimate of the standalone selling price of each distinct product or service in the contract. The primary method used to estimate standalone selling price is the price observed in standalone sales to customers, however when prices in standalone sales are not available the Company may use third-party pricing for similar products or services or estimate the standalone selling price. Allocation of the transaction price is determined at the contracts’ inception.

Transaction price and variable consideration

Once the performance obligations in the contract have been identified, the Company estimates the transaction price of the contract. The estimate includes amounts that are fixed as well as those that can vary based on expected outcomes of the activities or contractual terms. The Company's variable consideration includes ~~for example~~net profit received from sales of the Company's generic Nasal naloxone product, certain products sold on a net basis, cost-plus-fee contract terms and consideration transferred under its development contracts ~~with the USG~~ as consideration received can vary based on developmental progression of the product ~~candidate(s).~~candidate. When a contract's transaction price includes variable consideration, the Company evaluates ~~the estimate of~~ the variable consideration to determine whether the estimate needs to be constrained; therefore, the Company includes the variable consideration in the transaction price only to the extent that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration estimates are updated at each reporting date. There were no significant constraints or material changes to the Company's variable consideration estimates as of or during the twelve months ended December 31, ~~2018.~~2021.

~~Contract financing~~

In determining the transaction price, the Company adjusts the promised amount of consideration for the effects of the time value of money if the timing of payments agreed to by the parties to the contract (either explicitly or implicitly) provides the customer with a significant benefit of financing the transfer of goods or services to the customer, which is called a significant financing component. The Company does not adjust transaction price for the effects of a significant financing component when the period between the transfer of the promised good or service to the customer and payment for that good or service by the customer is expected to be one year or less.

Product sales

~~CBRNE~~

~~The Company's~~ ~~CBRNE~~ products are as follows: BioThrax, ACAM2000, raxibacumab, Anthrasil, BAT, VIGIV, RSDL and Trobigard. The primary customer for the Company's CBRNE products and the primary source of funding for the development of its CBNRE product candidate portfolio is the USG. The Company's contracts for the sale of CBRNE products generally have a single performance obligation. Certain product sales contracts with the USG include multiple performance obligations, which generally include the marketed product, stability testing associated with that product, expiry extensions and plasma collection. The USG contracts for the sale of the Company's CBRNE products are normally multi-year contracts.

~~The transaction price for product sales are based on a cost build-up model with a mark-up.~~ For our product sales, we recognize revenue at a ~~"point~~point in ~~time"~~time when the Company’s performance obligations have been satisfied and control of the products transfer to the customer. To indicate the transfer of control the Company will have a present right to payment, legal title must have passed to the customer, and the customer must have the significant risks and rewards of ownership. This ~~“point~~point in ~~time”~~time depends on several factors, including delivery, transfer of legal title, transition of risk and rewards of the product to the customer and the Company's right to payment.

The ~~USG~~Company's contracts for the sale of the Company's ~~CBRNE~~Government - MCM products ~~also~~ include certain acceptance criteria before title passes to the customer. The primary customer for the Company's Government - MCM products and the primary source of funding for the development of its MCM product candidate portfolio is the USG. The USG

~~Travelers' diseases and Opioids~~

~~The~~contracts for the sale of the Company's ~~travelers' disease and opioid~~Government - MCM products are ~~as follows: Vivotif, Vaxchora and NARCAN® Nasal Spray. Revenues are recognized when~~normally multi-year contracts with annual options.

For the Company’s commercial products, upon transfer of control of the goods ~~are transferred to our customers, in an amount that~~the Company reflects estimates of the consideration that the Company ~~expects to be entitled to in exchange for those goods or services.~~expects. Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. ~~Allowances~~Estimates of variable consideration include allowances for returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, chargebacks and rebates under managed care ~~plans are considered in determining the variable consideration. Revenues from sales of products~~plans.

Revenue is recognized to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with such variable consideration is subsequently resolved. ~~Product sales revenue is recognized when control has transferred to the customer, which occurs at a point in time, which is typically upon delivery to the customer.~~ Provisions for variable consideration revenues from sales of products are recorded at the net sales price, which includes estimates of variable consideration for which provisions are established and which relate to returns, specialty distributor fees, wholesaler fees, prompt payment discounts, government rebates, chargebacks and rebates under managed care plans.price. Calculating certain of these provisions involves estimates and judgments and the Company determines their expected value based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates, the Company's expectations regarding future utilization rates for these programs and channel inventory data. These provisions reflect the Company's best estimate of the amount of consideration to which the Company is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The Company reassesses the Company's provisions for variable consideration at each reporting date. ~~Historically, adjustments to estimates for these provisions have not been material.~~

Provisions for returns, specialty distributor fees, wholesaler fees, government rebates and rebates under managed care plans are included within current liabilities in the Company's consolidated balance sheets. Provisions for chargebacks and prompt payment discounts are shown as a reduction in accounts receivable.

~~Contract manufacturing~~

CDMO services

The Company performs ~~contract manufacturing~~CDMO services for third parties. Under these contracts, activities can include ~~pharmaceutical~~drug substance and drug product ~~process development,~~ manufacturing ~~and filling~~ services for injectable and other sterile products, ~~inclusive of~~and development services such as pharmaceutical product process development, process design, ~~technical~~technology transfer, manufacturing validations, laboratory analytical development support, aseptic filling, lyophilization, final packaging, stability studies, and ~~accelerated and ongoing stability studies.~~suite-reservations. These contracts vary in duration, activities, and number of performance obligations. Performance obligations identified under these arrangements may include drug substance and/or drug product manufacturing, technology transfer activities, and suite-reservations.

Drug substance, drug product manufacturing, development services and technology transfer performance obligations are recognized as revenue over-time because the Company’s performance does not create an asset with a duration that is less than one year, generally include a single performance obligation as the customer benefits from our performance upon full completion of our services. The performance obligation is satisfied whenan alternative use and the Company ~~must have a present~~has an enforceable right to payment ~~because legal title has passed~~for performance completed as work is performed. In drug product arrangements, the customer typically owns and supplies the active pharmaceutical ingredient (API), that is used in the manufacturing process; in drug substance arrangements, the customer provides certain seed material that is used in the manufacturing process. The transaction price generally contains both a fixed and variable component. The fixed component is stated in the agreement as a fixed price per unit with no contractual provision for a refund or price concession and the variable component generally results from pass-through costs that are billed at cost-plus over the life of the contract. The Company uses an input method to measure progress toward the satisfaction of the related performance obligations based on costs incurred as a percentage of total costs to complete which the Company believes best depicts the transfer of control of goods or services promised to its customers.

Suite reservations are classified as leases when the customer directs the use of the identified suite and obtains substantially all the economic benefits from the manufacturing capacity. If a customer reserves more than one suite, the allocation of contract value is based on relative selling price which varies due to size, location, capacity, production capability for drug product or drug substance, and the time of planned use. The associated revenue is recognized on a straight-line basis over the period of performance. For arrangements that contain both lease and non-lease components, consideration in the contract is allocated on a relative standalone selling price basis.

The Company’s CDMO customer contracts generally include provisions entitling the Company to a termination penalty when the contract is terminated prior to the ~~customer, the goods are~~contract’s nominal end date. The termination penalties in the ~~customer’s possession with all~~customer contracts vary but are generally considered substantive for accounting purposes and create enforceable rights and obligations throughout the ~~risks~~stated duration of the contract. The Company accounts for a contract cancellation as a contract modification. The determination of the contract termination penalty is based on the terms stated in the related customer agreement. As of the modification date, the Company updates its estimate of the transaction price, subject to constraints, and ~~rewards~~recognizes the amount over the remaining performance period or measure of ~~ownership,~~progress under the arrangement.

For contracts that contain lease components, the Company assesses the collectability of the lease payments. If the collectability of the lease payments is probable, the Company recognizes lease income over the term of the

lease on a straight-line basis. If collectability is not deemed probable at any time during the term of the lease, the Company’s lease income is limited to the lesser of (i) the lease payments that have been collected from the lessee, or the straight-line recognition of the contract value. If the collectability assessment changes to probable after the Company has determined collectability is not deemed probable, any difference between the lease income that would have been recognized if collectability had always been assessed as probable and the ~~efficacy of the goods has been confirmed. The Company recognizes revenue at~~lease income recognized to date is recognized as a ~~"point in time" based on when the performance obligation~~current-period adjustment to lease income. Changes to the ~~customer is satisfied.~~collectability of operating leases are recorded as adjustments to lease income in the consolidated statements of operations in the period that they occur.

Contracts and grants

The Company generates contract and grant revenue primarily from cost-plus-fee contracts associated with development of certain product candidates. Revenues from reimbursable contracts are recognized as costs are incurred, generally based on allowable costs incurred during the period, plus any recognizable earned fee. The Company uses this input method to ~~measue~~measure progress as the customer has ~~the benefit of~~ access to the development research under these projects and ~~therefore~~ benefits ~~from the Compny’s performance~~ incrementally as ~~research and development activites occur under each project. We consider~~R&D activities occur. When applicable, the Company considers fixed fees under cost-plus-fee contracts to be earned in proportion to the allowable costs incurred in performance of the ~~contract. We analyze~~contract, the cost-to-cost measure of progress. The Company analyzes costs for contracts and reimbursable grants to ensure reporting of revenues gross versus net is appropriate. Revenue for long-term development contracts is considered variable consideration, because the deliverable is dependent on the successful completion of development and is generally recognized based upon the cost-to-cost measure of progress, provided that the Company meets the criteria associated with satifiying the performance obligation over time. The USG contracts for the development of the Company's ~~CBRNE~~MCM product candidates are normally multi-year contracts. For the three years in the period ended December 31, 2018, 2017, and 2016, the costs incurred under the contracts and grants was 32%, 43% and 67%, respectively, of total research and development expenses incurred.

Research and development

~~We expense research and development~~The Company expenses R&D costs as incurred. The Company's ~~research and development~~R&D expenses consist primarily of:

▪personnel-related expenses;

▪fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of the Company's clinical trials and obtaining and evaluating data from the Company's clinical trials and non-clinical studies;

~~personnel-related expenses;~~

▪costs of CDMO services for clinical trial material; and

▪costs of materials used in clinical trials and R&D.

fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of the Company's clinical trials and obtaining and evaluating data from the Company's clinical trials and non-clinical studies;

~~costs of contract manufacturing services for clinical trial material; and~~

~~costs of materials used in clinical trials and research and development.~~

Comprehensive income

Comprehensive income is comprised of net income and other changes in equity that are excluded from net income. The Company includes translation gains and losses incurred when converting its subsidiaries' financial statements from their functional currency to the U.S. dollar in accumulated other comprehensive income as well as gains and losses on its pension benefit ~~obligation.~~obligation and derivative instruments.

Translation of Foreign Currencies

For our non-U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency exchange rates for the period. Adjustments resulting from the translation of the financial statements of our foreign operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity. For subsidiaries where the functional currency of the assets and liabilities differ from the local currency, non-monetary assets and liabilities are translated at the rate of exchange in effect on the date assets were acquired while monetary assets and liabilities are translated at current rates of exchange as of the balance sheet date. Income and expense items are translated at the average foreign currency rates for the period. Translation adjustments of these subsidiaries are included in other income (expense), net in our consolidated statements of income.

Earnings per share

~~The Company calculates basic earnings~~Basic net income per common share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period.

~~For the year ended December 31, 2018, the Company calculated diluted earnings~~ Diluted income per common share is computed using the treasury method by dividing net income by the weighted average number of shares of common stock outstanding during the period. For the years ended December 31, 2017 and 2016, the Company calculated diluted earnings per share using the if-converted method by dividing the adjusted net income by the adjusted weighted average number of shares of common stock outstanding during the period. The adjusted net income is adjusted for interest expense and amortization of debt issuance cost, both net of tax, associated with the Company's 2.875% Convertible Senior Notes due 2021 (the "Notes"). The weighted average number of diluted shares isperiod, adjusted for the potential dilutive effect of other securities if such securities were converted or exercised and are not anti-dilutive.

Treasury stock

When stock is acquired for purposes other than formal or constructive retirement, the ~~exercise of stock options and the vesting of restricted stock units along with the assumption~~purchase price of the ~~conversion~~acquired stock is recorded in a separate treasury stock account, which is separately reported as a reduction of equity.

When stock is retired or purchased for formal or constructive retirement, the purchase price is initially recorded as a reduction to the par value of the ~~Notes, each at the beginning of the period. During the fourth quarter of 2017, the Company issued~~shares repurchased, with any excess purchase price over par value recorded as a ~~notice of termination of conversion rights~~reduction to additional paid-in capital related to the ~~Notes~~series of shares repurchased and ~~issued 8.5 million~~any remainder excess purchase price recorded as a reduction to retained earnings. If the purchase price exceeds the amounts allocated to par value and additional paid-in capital related to the series of shares repurchased and retained earnings, the remainder is allocated to additional paid-in capital related to other series of ~~common~~shares.

To determine the cost of treasury stock ~~due to conversions~~ that ~~occurred~~is either sold or reissued, the Company uses the last in, ~~2017.~~first out method. If the proceeds from the re-issuance of treasury stock are greater than the cost, the excess is recorded as additional paid-in capital. If the proceeds from re-issuance of treasury stock are less than the cost, the excess cost first reduces any additional paid-in capital arising from previous treasury stock transactions for that class of stock, and any additional excess is recorded as a reduction of retained earnings.

Accounting for stock-based compensation

The Company has ~~one~~1 stock-based employee compensation plan, the Emergent BioSolutions Inc. Stock Incentive Plan (the ~~"Emergent Plan")~~Emergent Plan), under which ~~includes both~~the Company may grant various types of equity awards including stock options, ~~and~~ restricted stock units and performance stock units.

The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Emergent Plan is determined by the compensation committee of the Company's board of directors, which administers the Emergent Plan. Each equity award granted under the Emergent Plan vests as specified in the relevant agreement with the award recipient and no option can be exercised after ~~ten~~seven years from the date of grant. The Company ~~charges~~records the estimated fair value of awards ~~against income~~in expense on a straight-line basis over the requisite service period, which is generally the vesting period. Where awards are made with non-substantive vesting periods (for instance, where a portion of the award vests upon retirement eligibility), the Company ~~estimate~~estimates and ~~recognize~~recognizes expense based on the period from the grant date to the date the employee becomes retirement eligible.

The Company determines the fair value of restricted stock units using the closing market price of the Company's common stock on the day prior to the date of grant. The Company's performance stock units settle in the Company's stock. The fair value is determined on the date of the grant using the number of shares expected to be earned and the ending market value of the stock on the day prior to the grant date. The number of shares expected to vest is determined by assessing the probability that the performance criteria will be met and the associated targeted payout level that is forecasted will be achieved.

The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth below is a discussion of the Company's methodology for developing each of the assumptions used:

▪Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.

▪Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.



~~Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.~~

▪Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.

▪Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company's expectation of option exercise behavior subsequent to vesting of options.



Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.



~~Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.~~



Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company's expectation of optionee exercise behavior subsequent to vesting of options.

Pension plans

The Company maintains defined benefit plans for employees in certain countries outside the U.S., including retirement benefit plans required by applicable local law. The plans are valued by independent actuaries using the projected unit credit method. The liabilities correspond to the projected benefit obligations of which the discounted

net present value is calculated based on years of employment, expected salary increase, and pension adjustments. The Company reviews its actuarial assumptions on an annual basis and makes modifications to the assumptions based on current rates and trends. Actuarial gains and losses are deferred in accumulated other comprehensive ~~loss,~~income, net of tax and are amortized over the remaining service attribution periods of the employees under the corridor method. Differences between the expected long-term return on plan assets and the actual annual return are amortized to net periodic benefit cost over the estimated remaining life as a component of selling, general and ~~adminstrative~~administrative expenses in the consolidated statements of operations.

Derivative Instruments and Hedging Activities

The Company is exposed to certain risks arising from both its business operations and economic conditions. The Company principally manages its exposures to a wide variety of business and operational risks through management of its core business activities. The Company manages economic risks, including interest rate, liquidity, and credit risk primarily by managing the amount, sources, and duration of its assets and liabilities and the use of derivative financial instruments. Specifically, the Company has entered into interest rate swaps to manage exposures that arise from the Company's senior secured credit agreement's payments of variable interest rate debt.

The Company's interest rate swaps qualify for hedge accounting as cash flow hedges. All derivatives are recorded on the balance sheet at fair value. Hedge accounting provides for the matching of the timing of gain or loss recognition on these interest rate swaps with the recognition of the changes in interest expense on the Company's variable rate debt. For derivatives designated as cash flow hedges of interest rate risk, the gain or loss on the derivative is recorded in accumulated other comprehensive income and subsequently reclassified into interest expense in the same period during which the hedged transaction affects earnings. Amounts reported in accumulated other comprehensive income related to derivatives will be reclassified to interest expense as interest payments are made on the Company’s variable-rate debt. The cash flows from the designated interest rate swaps are classified as a component of operating cash flows, similar to interest expense.

The valuation of the interest rate swaps is determined using widely accepted valuation techniques, including discounted cash flow analysis on the expected cash flows of each interest rate swap. This analysis reflects the contractual terms of the interest rate swaps, including the period to maturity, and uses observable market-based inputs, including interest rate curves and implied volatilities. The fair values of interest rate swaps are determined using the market standard methodology of netting the discounted future fixed cash payments (or receipts) and the discounted expected variable cash receipts (or payments). The variable cash payments (or receipts) are based on an expectation of future interest rates (forward curves) derived from observable market interest rate curves. To comply with the provisions of ASC 820, Fair Value Measurement, the Company incorporates credit valuation adjustments in the fair value measurements to appropriately reflect both its own nonperformance risk and the respective counterparty’s nonperformance risk. These credit valuation adjustments were concluded to not be significant inputs for the fair value calculations for the periods presented. In adjusting the fair value of the Company's derivative contracts for the effect of nonperformance risk, it has considered the impact of netting and any applicable credit enhancements, such as the posting of collateral, thresholds, mutual puts and guarantees. The valuation of interest rate swaps fall into Level 2 in the fair value hierarchy. See Note 9 for further details on the interest rate swaps.

Out-of-period adjustments

During the year ended December 31, 2021, the Company identified and recorded immaterial out-of-period adjustments. In prior years, the Company had recognized revenue for drug substance and drug product manufacturing performance obligations when the goods were released, legal title had passed and the customer had possession. Beginning in 2021, the Company began recognizing revenue over time using an input measure based on costs incurred as a percentage of total estimated contract costs for drug substance and drug product revenue. As batch production and fill-finish manufacturing generally take place over short intervals, the adjustments to the financial statements were not material. Additionally, the Company determined that the classification of its suite reservations, when the customer directs the use of the identified suite and obtains substantially all the economic benefits reflected in CDMO service revenue, are more appropriately classified as leases. Although either classification generally results in recognition of revenue on a straight line basis over-time, the Company identified one lease component commencement date change which impacted the revenue recognized during our 2020 and 2021 periods. The Company has included incremental lease accounting disclosures in these financial statements (see Note 3).

The Company evaluated the materiality of the out-of-period adjustments from quantitative and qualitative perspectives and concluded that the amounts were immaterial to the Company’s prior period interim and annual consolidated financial statements. As a result, no amendments to previously filed interim or annual periodic reports are required. These out-of-period adjustments in the current consolidated statements of operations are as follows:


(in millions)	Year Ended December 31, 2021
Contract development and manufacturing revenue:
Services	$	28.8
Leases	(5.5)
Total contract development and manufacturing revenue	23.3
Cost of CDMO	16.2
Income before income taxes	7.1
Net income	$	5.3

Reclassifications

In addition, during the year ended December 31, 2021, the Company revised its presentation on the consolidated statement of operations to separately present (i) lease revenue as opposed to combining with CDMO services revenues and (ii) cost of CDMO services as opposed to combining with cost of product sales. As the Company's lease revenue is solely associated with CDMO services and is substantially related to one arrangement which ended in 2021, the Company has combined the costs of CDMO services and leases on the consolidated statement of operations. All associated prior period amounts have been reclassified to conform to the current period presentation.

Recently issued accounting standards

Recently Adopted

ASU ~~No. 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606)~~ ~~("ASU 2014-09")~~

~~In May 2014, the~~ ~~Financial~~2019-12, Simplifications to Accounting ~~Standards Board ("FASB")~~ issued ASU No. 2014-09. ASU No. 2014-09 (known as ASC 606) supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue recognition issues. The Company adopted ASC 606 as of January 1, 2018 using the modified retrospective method resulting in an adjustment to opening retained earnings of $32.5 million for the cumulative effect of initially applying the new standard.

Under ASC 606, the Company finalized the review of its portfolio of revenue contracts that were not complete as of the adoption date and made its determination of its revenue streams as well as completed extensive contract specific reviews to determine the impact of the new standard on its historical and prospective revenue recognition. Because many of the Company's significant contracts with customers have unique contract terms, the Company reviewed all its non-standard agreements in order to determine the effect of adoption. ~~The Company tested a sample of remaining agreements to verify that there were no changes in accounting based on the assumption that these contracts~~ had similar characteristics and that the effects on the financial statements would not differ materially from applying this guidance to the individual contracts. To estimate the financial impacts of the adoption, the Company did not apply the contract modification practical expedient and retrospectively restated long-term contracts for any contract modifications.

The opening balance sheet adjustment was the result of the Centers for Innovation in Advanced Development and Manufacturing ("CIADM") contract with the Biomedical Advanced Research and Development Authority ("BARDA"). Under ASC 606 at January 1, 2018, the Company determined that the performance obligation under the arrangement is to provide ongoing manufacturing capability to the USG and would recognize the consideration received in the initial 7 year base period on a straight-line basis over a 24-year period as the capability being created during the base period of the contract is being provided to the customer over both the base period contract term as well as 17 additional option periods. As the Company’s performance obligation is providing the USG with continuous access to its production capabilities throughout the contract duration, a time-based measure resulting in straight-line revenue recognition is proportionate to the Company’s progress in satisfying the performance obligation when compared to the total progress. This measure of progress is most reflective of the Company satisfying the performance obligation over time. Beginning in June 2013, the Company was expected to be able to stand ready and be available to respond to the USG and importantly to respond to any task orders that may be issued during the base period and additional option periods. Being able to stand ready to perform in the event of an outbreak is of importance to the USG and by entering into this arrangement with the Company, the USG expected to receive the benefit of having access to Company’s readiness and its capability to immediately respond to public health threats. Prior to June 2013, the Company was performing fulfillment and set-up activities to be able to perform under the contract. The Company concluded the identified stand-ready performance obligations represent a series of distinct services that are substantially the same and have the same pattern of transfer to the customer.

Income Taxes (ASU 2019-12)

In addition, the Company determined the CIADM contract includes a significant financing component which is included in the transaction price. The Company calculated the financing component using an interest rate the Company had on its other debt obligations at inception of the contract. The difference in revenue recognized under ASC 605 vs. ASC 606, as of the adoption date, was primarily attributable to the difference in the overall consideration or transaction price resulting from different accounting treatment related to options within the contract and the inclusion of a significant financing component under ASC 606.

Prior to the adoption of ASC 606, the Company recognized revenue under the CIADM contract on a straight-line basis, based upon its estimate of the total payments to be received under the contract. The Company analyzes the estimated payments to be received on a quarterly basis to determine if an adjustment to revenue was required. As a result of the adoption of ASC 606, as of January 1, 2018, there was an increase in the deferred revenue liability of $42.4 million and an increase in deferred tax assets of $9.9 million with an offsetting reduction to retained earnings of $32.5 million.

~~ASU 2016-16,~~ ~~Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory~~ ~~("ASU 2016-16")~~

~~In October 2016,~~December 2019, the FASB issued ASU ~~2016-16.~~2019-12. ASU ~~2016-16 improves the accounting~~2019-12 removes certain exceptions for ~~the~~recognizing deferred taxes for investments, performing intra-period allocation and calculating income ~~tax consequences of intra-entity transfers of assets other than inventory.~~taxes in interim periods. The ~~new standard will require entities~~ASU also adds guidance to ~~recognize the income tax consequences of an intra-entity transfer~~reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a ~~non-inventory asset when~~consolidated group. ASU 2019-12 is effective for all entities for fiscal years beginning after December 15, 2020, and earlier adoption is permitted. As of January 1, 2021, the ~~transfer occurs. The~~ Company adopted the ~~guidance on January 1, 2018~~standard, which ~~did not have a significant impact on the presentation of the Company’s financial statements.~~

~~ASU 2016-15,~~ ~~Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments~~ ~~("ASU 2016-15")~~

In August 2016, the FASB issued Accounting Standard Update ("ASU") 2016-15. ASU 2016-15 eliminates the diversity in practice related to the classification of certain cash receipts and payments for debt prepayments or extinguishment costs, the maturing of a zero-coupon bond, the settlement of contingent liabilities arising from a business combination, proceeds from insurance settlements, distributions from certain equity method investees and beneficial interests obtained in a financial asset securitization. ASU 2016-15 designates the appropriate cash flow classification, including requirements to allocate certain components of these cash receipts and payments among operating, investing and financing activities. The Company adopted the new standard effective January 1, 2018 and has determined the impact of ASU No. 2016-15 on its consolidated financial statements will be related to the settlement of contingent liabilities arising from a business combination.

~~ASU 2016-18,~~ ~~Restricted Cash (Topic 230): Statement of Cash Flows~~ ~~("ASU 2016-18")~~

In November 2016, the FASB issued ASU 2016-18. ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning of period and end of period balances on the statement of cash flows upon adoption of this standard. The Company adopted the new standard effective January 1, 2018 on a prospective basis.

~~ASU No. 2017-09,~~ ~~Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting~~ ~~("ASU 2017-09")~~

In May 2017, the FASB issued ASU 2017-09. ASU 2017-09 clarifies which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The Company adopted the new standard effective January 1, 2018, which did not have a material impact on its consolidated financial statements.

~~ASU No. 2018-07,~~ ~~Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting~~ ~~("ASU 2018-07")~~

In June 2018, the FASB issued ASU 2018-07. ASU 2018-07 expands the scope of Topic 718 to include share-based payments issued to nonemployees for goods and services. ASU No. 2018-07 is intended to reduce cost and complexity and to improve financial reporting for share-based payments issued to nonemployees (for example, service providers, external legal counsel, suppliers, etc.). The standard will be effective after December 15, 2018 for the Company, with early adoption permitted, but no earlier than the Company's adoption date of Topic 606. The Company early adopted the new standard effective April 1, 2018. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

Not Yet Adopted

ASU ~~No. 2017-07,~~ ~~Compensation - Retirement Benefits~~2020-04, Reference Rate Reform (Topic ~~715)~~848): ~~Improving~~Facilitation of the ~~Presentation~~Effects of ~~Net Periodic Pension Costs and Net Periodic Postretirement Benefit Cost~~ ~~("ASU 2017-07")~~

Reference Rate Reform on Financial Reporting

In March ~~2017,~~2020, the FASB issued ~~ASU 2017-07.~~Topic 848, which was further amended in January 2021. Topic 848 provides relief for impacted areas as it relates to impending reference rate reform. ASC 848 contains optional expedients and exceptions to debt arrangements, contracts, hedging relationships, and other areas or transactions that are impacted by reference rate reform. This standard requires that an employer disaggregate the service cost component from the other components of net benefit cost. This standard also provides explicit guidance on how to present the service cost component and the other components of net benefit cost in the statements of income and allows only the service cost component of net benefit cost to be eligible for capitalization. The other components of the net periodic benefit cost must be presented separately from the line items that include service cost and outside of any subtotal of operating income on our consolidated statements of income. The Company adopted this standard on January 1, 2018. The adoption of this standard did not have a material impact on the consolidated financial statements.

~~ASU No. 2017-01,~~ ~~Business Combinations (Topic 805): Clarifying the Definition of a Business~~ ~~("ASU 2017-07")~~

In January 2017, the FASB issued ASU 2017-01. This guidance that amends the definition of a business and provides a threshold which must be considered to determine whether a transaction is an acquisition (or disposal) of an asset or a business. Under the current accounting guidance, the minimum inputs and processes required for a “set” of assets and activities to meet the definition of a business is not specified. That lack of clarity has led to broad interpretations of the definition of a business. Under this guidance, when substantially all of the fair value of gross assets acquired is concentrated in a single asset (or group of similar assets), the assets acquired would not represent a business. In addition, in order to be considered a business, an acquisition would have to include at a minimum an input and a substantive process that together significantly contribute to the ability to create an output. The amended guidance also narrows the definition of outputs by more closely aligning it with how outputs are described in FASB guidance for revenue recognition. The guidance is effective ~~on a prospective basis beginning January 1, 2018.~~

~~Not Yet Adopted~~

~~ASU 2016-02,~~ ~~Leases (Topic 842)~~ ~~("ASU 2016-02")~~

~~In February 2016, the FASB issued ASU 2016-02. ASU 2016-02 increases transparency~~upon issuance for all entities and ~~comparability among organizations by requiring the recognition~~elections of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The standard is effective January 1, 2019, with early adoption permitted. The Company will adopt the new standard effective January 1, 2019 using the modified retrospective approach. An entity that applies the transition provisions at the beginning of the period of adoption records its cumulative adjustment to the opening balance of retained earnings in the period of adoption rather than in the earliest period presented (i.e., January 1, 2019 for a calendar year-end entity that adopts the standard on that date). In this case, an entity continuescertain optional expedients are required to apply the ~~legacy guidance in ASC 840, including its disclosure requirements, in~~provisions of the ~~comparative periods presented in the year it adopts the standard.~~

guidance. The Company will take advantage of the transition package of certain practical expedients permitted: ASC 842-10-65-1(f) and ASC 842-10-65-1(g). The Company will make an accounting policy election that will keep leases with an initial term of 12 months or less off of the balance sheet and will result in recognizing those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. In addition, the Company has made an accounting policy election, by class of underlying asset, to not separate non-lease components from lease components and instead to account for each separate lease component, and the non-lease components associated with that lease component, as a single lease component.

~~While the Company is continuing~~continues to assess all potential impacts of the standard and will disclose the nature and reason for any elections that the Company currently expects total liabilities to increase with an offsetting increase to leased assets by an amount not in excess of 5% of total liabilities as of the date of adoption. The difference between these amounts will be recorded as an adjustment to retained earnings. The Company does not believe the standard will materially affect the Company's consolidated net earnings. These estimates, based on the Company's current lease portfolio, may change as it continues to evaluate the new standard. The estimates could also change due to changes in the lease portfolio, which could include (a) lease volume, (b) lease commencement dates, and (c) renewal option and lease termination expectations. The Company will update its estimates each quarter as changes occur.makes.

~~ASU 2016-13,~~ ~~Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments~~ ~~("ASU 2016-13")~~

~~In June 2016, the FASB issued~~ ~~ASU 2016-13. ASU 2016-13 provides~~ guidance on measurement of credit losses on financial instruments that changes the impairment model for most financial assets and certain other instruments, including trade and other receivables, held-to-maturity debt securities and loans, and that requires entities to use a new, forward-looking “expected loss” model that is expected to generally result in the earlier recognition of allowances for losses. The guidance is effective for annual periods beginning after December 15, 2019, including interim periods within those years, but early adoption is permitted. The Company is evaluating the effect that the pronouncement will have on the Company's consolidated financial statements.

~~ASU 2017-04,~~ ~~Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment~~ ~~("ASU 2017-04")~~

In January 2017, the FASB issued ASU 2017-04. ASU 2017-04 simplifies the subsequent measurement of goodwill and eliminates Step 2 from the goodwill impairment test. ASU 2017-04 is effective for annual and interim goodwill tests beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates on or after January 1, 2017. The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements.

~~ASU 2018-02,~~ ~~Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income~~ ~~("ASU 2018-02")~~

In February 2018, the FASB issued ASU 2018-02. ASU 2018-02 provides the option to reclassify certain income tax effects related to the Tax Cuts and Jobs Act passed in December of 2017 between accumulated other comprehensive income and retained earnings and also requires additional disclosures. ASU 2018-02 is effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with early adoption permitted. Adoption of ASU 2018-02 is to be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the tax laws or rates were recognized. The Company is currently evaluating the impact of adopting ASU 2018-02 on its consolidated financial statements.

~~ASU 2018-13,~~ ~~Fair Value Measurement - Disclosure Framework (Topic 820)~~ ~~("ASU 2018-13")~~

In August 2018, the FASB issued ASU 2018-13. ASU 2018-13 improves the disclosure requirements on fair value measurements. The updated guidance if effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted for any removed or modified disclosures. The Company is currently assessing the timing and impact of adopting the updated provisions.

~~ASU 2018-14,~~ ~~Compensation - Retirement Benefits - Defined Benefit Plans - General (Topic 715-20): Disclosure Framework - Changes to the Disclosure Requirements for Defined Benefit Plans~~ ~~("ASU 2018-14")~~

~~In August 2018, the FASB issued ASU 2018-14. ASU 2018-14 modifies the disclosure requirements for defined benefit pension plans and other postretirement plans. ASU 2018-14 is effective for~~ ~~all entities for fiscal years ending after December 15, 2020, and earlier adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2018-14 on its consolidated financial statements.~~

~~ASU 2018-15,~~ ~~Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract~~ ~~("ASU 2018-15")~~

~~In August 2018, the FASB issued ASU 2018-15. ASU 2018-15 clarifies the accounting for implementation costs in cloud computing arrangements. ASU 2018-15 is effective for~~ ~~all entities for fiscal years beginning after December 15, 2019, and earlier adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2018-15 on its consolidated financial statements.~~

~~SEC's Disclosure Update and Simplification~~

In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification. Among the amendments is the requirement to present the changes in stockholders’ equity in the interim financial statements (either in a separate statement or footnote) in quarterly reports on Form 10-Q. The amendments are effective for all filings made on or after November 5, 2018. However, registrants may begin providing the new interim reconciliations of stockholders' equity in the Form 10-Q for the interim period beginning after the effective date. The Company plans to implement the changes required by these amendments to its Statements of Equity in its Form 10-Q filing for the period ended March 31, 2019.

3. Revenue recognition

The Company operates in ~~one~~1 business segment. Therefore, results of the Company's operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting.

For the ~~year~~years ended December 31, ~~2018, there was a nominal difference between revenues recognized under ASC 606~~2021, 2020, and ~~revenues recognized based on the prior revenue recognition guidance for the same period.~~

~~For the year ended December 31, 2018,~~2019, the Company's revenues disaggregated by the major sources ~~was~~were as follows:


(in millions)	Year Ended December 31,
	2021						2020						2019
	U.S Government		Non-U.S. Government		Total		U.S Government		Non-U.S. Government		Total		U.S Government		Non-U.S. Government		Total
Product sales	$	530.0	$	493.9	$	1,023.9	$	626.0	$	363.8	$	989.8	$	568.8	$	334.7	$	903.5
CDMO:
Services	—		334.9		334.9		—		166.7		166.7		—		80.0		80.0
Leases	237.6		62.1		299.7		253.3		30.5		283.8		—		—		—
Total CDMO	237.6		397.0		634.6		253.3		197.2		450.5		—		80.0		80.0
Contracts and grants	130.2		4.0		134.2		109.2		5.9		115.1		105.9		16.6		122.5
Total revenues	$	897.8	$	894.9	$	1,792.7	$	988.5	$	566.9	$	1,555.4	$	674.7	$	431.3	$	1,106.0

(in millions) Year Ended December 31, 2018
U.S Non-U.S.
Government Government Total

Product sales $ 526.1 $ 80.4 $ 606.5
Contract manufacturing — 98.9 98.9
Contracts and grants 71.5 5.5 77.0
Total revenues $ 597.6 $ 184.8 $ 782.4

For the years ended December 31, 2021, 2020 and 2019, the Company's product sales from Anthrax Vaccines, ACAM2000, Nasal Naloxone products and Other products as a percentage of total product sales were as follows:


	2021		2020		2019
% of product sales:
Anthrax vaccines	25	%	38	%	19	%
Nasal naloxone products	43	%	31	%	31	%
ACAM2000	20	%	20	%	27	%
Other products	12	%	11	%	23	%

As of December 31, 2021, 2020 and 2019, aside from sales to the USG, there were no sales to an individual customer in excess of 10% of total revenues. For the years ended December 31, 2021, 2020, and 2019, the Company’s revenues from customers within the United States comprised 92%, 93% and 90%, respectively, of total revenues.

BARDA Centers of Innovation and Advanced Development and Manufacturing (CIADM) agreement

The Company and BARDA had a CIADM agreement which began in June 2012 and terminated on November 1, 2021. The value of this base arrangement was $163.2 million and was recorded as a stand-ready performance obligation and reflected as a component of contracts and grants revenue in the consolidated statements of operations. In 2020, we announced that we had been issued a task order under CIADM for COVID-19 vaccine development and manufacturing (the BARDA COVID-19 Development Public Private Partnership). The task order and associated amendments which allowed BARDA to reserve drug substance and drug product manufacturing capacity at various manufacturing sites had a contract value of $650.8 million that was accounted for as a lease. On November 1, 2021, the Company and BARDA mutually agreed to terminate the CIADM agreement and associated task orders which resulted in an adjusted contract value of $140.5 million for the base arrangement and $470.9 million for the BARDA COVID-19 Development Public Private Partnership. For the base arrangement, the Company released $55.2 million of contract liabilities which is reflected as a component of contract and grants revenue on the consolidated statements of operations. Total revenues associated with the base arrangement were $71.3 million, $15.8 million and $15.8 million during the years ended December 31, 2021, 2020 and 2019 and are reflected as a component of contracts and grants revenue on the consolidated statements of operations. Revenues associated with the BARDA COVID-19 Development Public-Private Partnership were $237.6 million and $233.3 million during the years ended December 31, 2021 and 2020 and are recorded as CDMO leases on the consolidated statements of operations. There were no revenues from the BARDA COVID-19 Development Public-Private Partnership during the year ended December 31, 2019. The termination resulted in the write off of $38.0 million in contract assets to R&D expense on the consolidated statements of operations.

CDMO Operating Leases

Certain multi-year CDMO service arrangements with non-USG customers include operating leases whereby the customer has the right to direct the use of and obtain substantially all of the economic benefits of specific manufacturing suites operated by the Company. The associated revenue is recognized on a straight-line basis over the term of the lease. The remaining term on the Company's operating lease components approximates 3.0 years. The Company utilizes a cost-plus model to determine the stand-alone selling price of the lease component to allocate contract consideration between the lease and non-lease components. During the year ended December 31, 2021, the Company's non-USG lease revenues were $62.1 million, which is included within CDMO leases in the consolidated statement of operations. The Company has allocated contracted operating lease revenues due under our long-term CDMO service arrangements as follows:


(in millions)	Year Ended December 31,
2022	45.8
2023	50.7
2024	11.5
	$	108.0

Transaction price allocated to remaining performance obligations

As of December 31, 2021, the Company expects future revenues of approximately $1.3 billion associated with all arrangements entered into by the Company. The Company expects to recognize a majority of the $1.3 billion of unsatisfied performance obligations within the next 24 months. The amount and timing of revenue recognition for unsatisfied performance obligations can change. The future revenues associated with unsatisfied performance obligations exclude the value of unexercised option periods in the Company’s revenue arrangements. Often the timing of manufacturing activities changes based on customer needs and resource availability. Regulatory compliance may also impact the status of the Company’s COVID-19 related CDMO arrangements. Government funding appropriations can impact the timing of product deliveries. The success of the Company's development activities that receive development funding support from the USG under development contracts can also impact the timing of revenue recognition.

Contract assets

The Company considers unbilled accounts receivable and deferred costs associated with revenue generating contracts, which are not included in inventory or property, plant and equipment, as contract assets. As of December 31, 2021, the Company had $21.5 million from revenue generating contracts recorded within accounts receivable, net on the consolidated balance sheets. As of December 31, 2020, deferred costs from revenue generating contracts recorded as contract assets were $41.1 million, which is reflected as a component of other assets on the consolidated balance sheets.

Contract liabilities

When performance obligations are not transferred to a customer at the end of a reporting period, cash received associated with the amount allocated to those performance obligations ~~are~~is reflected as ~~deferred revenue~~contract liabilities on the consolidated balance sheets and ~~are~~is deferred until control of these performance obligations is transferred to the customer. The following table presents the ~~rollforward~~roll forward of ~~deferred revenue~~the contract liabilities:

(in millions)
Balance at December 31, 2017 $ 30.5
Adoption of new accounting standard (ASC 606) 42.4
Balance at January 1, 2018 72.9
Deferral of revenue 29.3
Recognition of revenue included in beginning of year contract liability (29.1 )
Balance at December 31, 2018 $ 73.1


(in millions)
December 31, 2019	$	88.9
Deferral of revenue	146.2
Revenue recognized	(135.0)
Balance at December 31, 2020	100.1
Deferral of revenue	279.7
Revenue recognized	(363.4)
Balance at December 31, 2021	$	16.4

~~Transaction price allocated to remaining performance obligations~~

As of December 31, ~~2018,~~2021 and 2020, the ~~Company had expected future revenues associated with performance obligations that have not been satisfied~~current portion of ~~approximately $550 million. The Company expects to recognize a majority of these revenues within the next 24 months, with the remainder recognized thereafter. However, the amount~~contract liabilities was $11.7 million and ~~timing of revenue recognition for unsatisfied performance obligations can materially change due to timing of funding appropriations from the USG~~$44.6 million, respectively, and the overall success of the Company's development activities associated with its CBRNE product candidates that are then receiving development funding support from the government under development contracts. In addition, the amount of future revenues associated with unsatisfied performance obligations excludes the value associated with unexercised option periods in the Company's contracts (which are not performance obligations as of December 31, 2018).

~~Contract assets~~

~~The Company considers unbilled accounts receivables and deferred costs associated with revenue generating contracts, that are not~~was included in inventory or property, plant and equipments, as contract assets. As of December 31, 2018 and 2017, the Company had contract assets associated with deferred costs of $1.2 million and $2.9 million, respectively, which is included in prepaid expenses and other current ~~assets~~liabilities on the ~~Company's consolidated~~ balance ~~sheets.~~sheet.

Accounts receivable

Accounts receivable including unbilled accounts receivable contract assets consist of the following:


	December 31,
(in millions)	2021		2020
Billed, net	$	224.9	$	172.7
Unbilled	49.8		58.2
Total, net	$	274.7	$	230.9

December 31,
(in millions) 2018 2017
Billed, net $ 234.0 $ 118.9
Unbilled 28.5 24.8
Total, net $ 262.5 $ 143.7

As of December 31, ~~2018~~2021 and ~~2017,~~2020, the Company's accounts receivable balances were comprised of 76% and 89%, respectively, from the USG. The overall decrease in the percentage of accounts receivable attributed to the USG was due primarily to the increase of non-USG related accounts receivable from PaxVax and Adapt, both acquired in October 2018. As of December 31, 2018, allowance for doubtful accounts ~~were de minimis. The Company did not have any allowance for doubtful accounts as of December 31, 2017.~~was $3.2 million and $3.1 million, respectively.

4. ~~Discontinued operations~~

~~On August 1, 2016, the Company completed the spin-off of Aptevo~~ ~~through~~ the distribution of 100% of the outstanding shares of common stock of Aptevo to the Company's shareholders (the "Distribution"). After the Distribution, the Company no longer holds shares of Aptevo's common stock. In addition, on August 1, 2016, the Company entered into a non-negotiable, unsecured promissory note with Aptevo to provide an additional $20 million in funding, which the Company paid in January 2017.

Fair value measurements

The historical statements of operations of Aptevo have been presented as discontinued operations in the consolidated financial statements. Discontinued operations include results of Aptevo's business except for certain allocated corporate overhead coststable below presents information about our assets and ~~certain costs associated with transition services provided by the Company to Aptevo. These allocated costs remain part of continuing operations.~~

~~The following table summarizes results from discontinued operations of Aptevo included in the consolidated statements of operations for the year ended December 31, 2016:~~

Year ended December 31,

(in millions) 2016

Revenues:
Product sales $ 21.2
Collaborations 0.2
Total revenues 21.4

Operating expense:
Cost of product sales 11.6
Research and development 18.0
Selling, general and administrative 23.8
Total operating expense 53.4

Loss from discontinued operations before benefit from income taxes (32.0 )
Benefit from income taxes (21.3 )
Net loss from discontinued operations $ (10.7 )

~~The following table summarizes the cash flows of Aptevo included in the year ended December 31, 2016~~ ~~consolidated statements of cash flows:~~

Year ended December 31,
(in millions) 2016
Net cash used in operating activities $ (10.3 )
Net cash used in investing activities (1.9 )
Net cash provided by financing activities 7.7

Net decrease in cash and cash equivalents $ (4.5 )

~~5. Acquisitions~~

~~Acquisition of Adapt~~

~~On October 15, 2018, the Company completed the acquisition of Adapt Pharma Limited ("Adapt")~~liabilities that are regularly measured and its NARCAN® (naloxone HCl) Nasal Spray marketed product, the first and only needle-free formulation of naloxone approved by the FDA and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. This acquisition includes the NARCAN® Nasal Spray marketed product and a development pipeline of new treatment and delivery options to address opioid overdose, and approximately 50 employees, located in the U.S., Canada, and Ireland, including those responsible for supply chain management, research and development, government affairs, and commercial operations. The acquisition will expand the Company’s scope of capabilities to deliver critical medical counter measures to its customers.

~~The preliminary purchase consideration is as follows:~~

(in millions) October 15, 2018
Cash $ 581.5
Equity 37.7
Fair value of contingent purchase consideration 48.0
Total preliminary purchase consideration $ 667.2

~~The Company issued 733,309 shares of Common Stock~~carried at $60.44 per share, the closing price of Emergent's share price on October 15, 2018, for a total of $44.3 million (inclusive of adjustments). The $44.3 million value of the common stock shares issued has been adjusted to a fair value ~~of $37.7 million considering a discount for lack of marketability due to a two-year lock-up period beginning on October 15, 2018. The remaining consideration payable for~~and indicate the ~~acquisition consists of up to $100 million in cash based on the achievement of certain sales milestones through 2022 which the Company has determined~~level within the fair value ~~of to be $48.0 million as~~hierarchy of the ~~acquisition date. The~~valuation techniques we utilized to determine fair value of the contingent purchase consideration is based on management’s assessment of the potential future realization of the contingent purchase consideration payments. This assessment is based on inputs that have no observable market (Level 3). The obligation is measured using a discounted cash flow model.value:


	December 31, 2021								December 31, 2020
(In millions)	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Assets:
Money market accounts	$	152.4	$	152.4	$	—	$	—	$	352.2	$	352.2	$	—	$	—
Time deposits	200.0		—		200.0		—		—		—		—		—
Total	$	352.4	$	152.4	$	200.0	$	—	$	352.2	$	352.2	$	—	$	—
Liabilities:
Contingent consideration	$	37.2	$	—	$	—	$	37.2	$	58.1	$	—	$	—	$	58.1
Derivative instruments	6.1		—		6.1		—		15.0		—		15.0		—
Total	$	43.3	$	—	$	6.1	$	37.2	$	73.1	$	—	$	15.0	$	58.1

This transaction will be accounted for by the Company under the acquisition method of accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of Adapt will be recorded as of October 15, 2018, the acquisition date, at their respective fair values, and combined with those of the Company. The purchase price allocation is preliminary as the Company needs to continue to gather data necessary to complete the fair value valuation of various closing balance sheet items such as, but not limited to intangible assets (including acquired in-process research and development ("IPR&D")) acquired and income taxes.

~~The table below summarizes the preliminary allocation of the purchase price based upon estimated fair values of assets acquired and liabilities assumed at October 15, 2018.~~Contingent consideration

(in millions) October 15, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:
Cash $ 17.7
Accounts receivable 21.3
Inventory 41.4
Prepaid expenses and other assets 7.8
Accounts payable (32.2 )
Accrued expenses and other liabilities (50.4 )
Deferred tax liability, net (62.4 )
Total estimated fair value of tangible assets acquired and liabilities assumed (56.8 )

Acquired in-process research and development 41.0
Acquired intangible asset 534.0
Goodwill 149.0
Total purchase price $ 667.2

The Company determined the estimated fair value of the intangible asset using the income approach, which is based on the present value of future cash flows. The fair value measurements are based on significant unobservable inputs that are developed by the Company using estimates and assumptions of the respective market and market penetration of the Company's products.

The preliminary estimated fair value of the intangible asset acquired for Adapt's marketed product NARCAN® Nasal Spray is valued at $534.0 million. The Company has determined the useful life of the NARCAN® Nasal Spray intangible asset to be 15 years. The Company estimated the fair value of the NARCAN® Nasal Spray intangible asset using the income approach with a present value discount rate of 10.5%, which is based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of Adapt. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value these intangible assets. The projected cash flows from the NARCAN® Nasal Spray intangible asset were based on key assumptions including: estimates of revenues and operating profits; and risks related to the viability of and potential alternative treatments in any future target markets.

~~The intangible asset~~Contingent consideration liabilities associated with ~~IPR&D acquired from Adapt is related to a product candidate. Management determined that the estimated acquisition-date~~business combinations are measured at fair ~~value of intangible assets related to IPR&D was $41.0 million. The estimated fair value was determined using the income approach, which discounts expected future cash flows to present~~ value. The Company estimated the fair value using a present value discount rate of 11%, which is based on the estimated weighted-average cost of capital for companies with that profiles substantially similar to that of Adapt and IPR&D assets at a similar stage of development as the product candidate. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value the IPR&D. The projected cash flows for the product candidate were based on key assumptions including: estimates of revenues and operating profits, considering its stage of development on the acquisition date; the time and resources needed to complete the development and approval of the product candidate; the life of the potential commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and other regulatory agencies; and risks related to the viability of and potential for alternative treatments in any future target markets. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts (see Note 10).

The Company determined the fair value of the inventory using the comparative sales method, which estimates the expected sales price reduced for all costs expected to be incurred to complete/dispose of the inventory with a profit on those costs.

The Company recorded approximately $149.0 million in goodwill related to the Adapt acquisition, which is calculated as the purchase price paid in excess of the fair value of the tangible and intangible assets acquired representing the future economic benefits the Company expects to receive as a result of the acquisition. The goodwill created from the Adapt acquisition is associated with early stage pipeline products. Substantially all of the goodwill generated from the Adapt acquisition is not expected to be deductible for tax purposes.

The Company has incurred transaction costs related to the Adapt acquisition of approximately $16.3 million for the year ended December 31, 2018, which have been recorded in selling, general and administrative expenses.

~~Acquisition of PaxVax~~

On October 4, 2018, the Company completed the acquisition of PaxVax Holding Company Ltd. ("PaxVax"), a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. This acquisition includes Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever, Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, an adenovirus 4/7 vaccine candidate being developed for military personnel under contract with the DoD, and additional clinical-stage vaccine candidates targeting chikungunya and other emerging infectious diseases, European-based current good manufacturing practices ("cGMP") biologics manufacturing facilities, and approximately 250 employees including those in research and development, manufacturing, and commercial operations with a specialty vaccines salesforce in the U.S. and in select European countries. The products and product candidates within PaxVax's portfolio are consistent with the Company’s mission and will expand the Company’s core business of addressing PHTs. In addition, the acquisition expands the Company's manufacturing capabilities.

At the closing, the Company paid a cash consideration of $273.1 million (inclusive of closing adjustments). This transaction will be accounted for by the Company under the acquisition method of accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of PaxVax will be recorded as of October 4, 2018, the acquisition date, at their respective fair values, and combined with those of the Company. As of the date of this filing, the initial accounting for the PaxVax acquisition is preliminary due to the Company's need to continue to gather data to assess the fair value valuation of property, plant and equipment along with the acquired intangible assets (including IPR&D) and accounting for taxes.

~~The table below summarizes the preliminary allocation of the purchase consideration based upon estimated fair values of assets acquired and liabilities assumed at October 4, 2018.~~

(in millions) October 4, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:

Cash $ 9.0
Accounts receivable 4.1
Inventory 19.7
Prepaid expenses and other assets 12.2
Property, plant and equipment 57.8
Deferred tax assets, net 3.8
Accounts payable (3.5 )
Accrued expenses and other liabilities (33.6 )
Total estimated fair value of tangible assets acquired and liabilities assumed 69.5

Acquired in-process research and development 9.0
Acquired intangible assets 133.0
Goodwill 61.6
Total purchase consideration $ 273.1

The preliminary estimated fair value of the intangible assets acquired for PaxVax's marketed products are valued at a total of $133.0 million. The Company has determined that the weighted average useful lives of the intangible assets to be 19 years.

The Company determined the estimated fair value of the intangible assets using the income approach, which is based on the present value of future cash flows. The fair value measurements are based on significant unobservable inputs that are developed by the Company using estimates and assumptions of the respective market and market penetration of the Company's products.

The Company estimated the fair value of the Vivotif and Vaxchora intangible assets using the income approach with a present value discount rate of 14.5% and 15%, respectively, which is based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of PaxVax. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value these intangible assets. The projected cash flows from these intangible assets were based on key assumptions including: estimates of revenues and operating profits; and risks related to the viability of and potential alternative treatments in any future target markets.

The intangible asset associated with IPR&D acquired from PaxVax is related to a product candidate. Management determined that the estimated acquisition-date fair value of intangible assets related to IPR&D was $9.0 million. The estimated fair value was determined using the income approach, which discounts expected future cash flows to present value. The Company estimated the fair value using a present value discount rate of 15.5%, which is based on the estimated weighted-average cost of capital for companies with that profiles substantially similar to that of PaxVax and IPR&D assets at a similar stage of development as the product candidate. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value the IPR&D. The projected cash flows for the product candidate was based on key assumptions including: estimates of revenues and operating profits, considering its stage of development on the acquisition date; the time and resources needed to complete the development and approval of the product candidate; the life of the potential commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and other regulatory agencies; and risks related to the viability of and potential for alternative treatments in any future target markets. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts (see Note 10).

The Company determined the fair value of the property, plant and equipment utilizing either the cost approach or the sales comparison approach. The cost approach is determined by establishing replacement cost of the asset and then subtracting any value that has been lost due to economic obsolescence, functional obsolescence, or physical deterioration. The sales comparison approach determines an asset is equal to the market price of an asset of comparable features such as design, location, size, construction, materials, use, capacity, specification, operational characteristics and other features or descriptions.

The Company recorded approximately $61.6 million in goodwill related to the PaxVax acquisition, calculated as the purchase price paid in the acquisition that was in excess of the fair value of the tangible and intangible assets acquired representing the future economic benefits the Company expects to receive as a result of the acquisition. The goodwill created from the PaxVax acquisition is associated with early stage pipeline products along with potential contract manufacturing services. The majority of the goodwill generated from the PaxVax acquisition is expected to be deductible for tax purposes.

The Company has incurred transaction costs related to the PaxVax acquisition of approximately $4.5 million for the year ended December 31, 2018, which have been recorded in selling, general and administrative expenses.

~~Proforma Financial Information~~

The following unaudited pro forma information has been presented as if the acquisition of Adapt and Pax Vax occurred on January 1, 2017. The information is based on the historical results of operations of the acquired businesses, adjusted for:

~~the allocation of purchase price and related adjustments, including adjustments to amortization expense related to the fair value of intangible assets acquired;~~

~~impacts of debt financing, including interest for debt issued and amortization of debt issuance costs;~~

~~the exclusion of acquisition-related costs incurred during the year-ended December 31, 2018; and~~

~~associated tax-related impacts of adjustments.~~

The pro forma results do not necessarily represent what would have occurred if the transactions had taken place on January 1, 2017 nor do they represent the results that may occur in the future. The pro forma adjustments were based on available information and upon assumptions that the Company believes are reasonable to reflect the impact of these acquisitions on the Company's historical financial information on a supplemental pro forma basis. The following table presents the Company's pro forma combined revenues and net income.

December 31,
(in millions, except per share value) 2018 2017
(Unaudited)
Revenues $ 949.3 $ 683.8
Net income $ 27.7 $ 12.3
Net income per share - basic $ 0.55 $ 0.29
Net income per share - diluted $ 0.54 $ 0.28

~~Acquisition of ACAM2000 business~~

On October 6, 2017, the Company completed the acquisition of the ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) business of Sanofi Pasteur Biologics, LLC ("Sanofi"). This acquisition includes ACAM2000, the only smallpox vaccine licensed by the FDA, a current good manufacturing practices ("cGMP") live viral manufacturing facility and office and warehouse space, both in Canton, Massachusetts, and a cGMP viral fill/finish facility in Rockville, Maryland. With this acquisition, the Company also acquired an existing 10-year contract with the CDC, which expired in March 2018. This contract had a stated value up to $425 million, with a remaining contract value of up to approximately $160 million as of the acquisition date, for the delivery of ACAM2000 to the SNS and establishing U.S.-based manufacturing of ACAM2000. ~~This acquisition added to the Company's product portfolio and expanded the Company's manufacturing capabilities.~~

At the closing, the Company paid $97.5 million in an upfront payment and $20 million in milestone payments earned as of the closing date tied to the achievement of certain regulatory and manufacturing-related milestones, for a total payment in cash of $117.5 million. The agreement includes an additional milestone payment of up to $7.5 million upon achievement of a regulatory milestone, which was achieved in November 2017. The $7.5 million milestone payment was made during the fourth quarter of 2017. This transaction will be accounted for by the Company under the acquisition method of accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of the ACAM2000 business will be recorded as of October 6, 2017, the acquisition date, at their respective fair values, and combined with those of the Company.

The contingent purchase consideration obligation is based on a regulatory milestone. At October 6, 2017, the contingent purchase consideration obligation related to the regulatory milestone was recorded at a fair value of $2.2 million. The Level 3 fair value of this obligation was based on a present value model of management's assessment of the probability of achievement of the regulatory milestone as of the acquisition date. This assessment is based on inputs that have no observable market.

~~The total purchase price is summarized below:~~

(in millions)
Amount of cash paid to Sanofi $ 117.5
Fair value of contingent purchase consideration 2.2
Total purchase price $ 119.7

The table below summarizes the allocation of the purchase price based upon the fair values of assets acquired at October 6, 2017. The Company did not assume any liabilities in the acquisition. The Company has finalized the purchase price allocation related to this acquisition.

(in millions)
Fair value of tangible assets acquired:
Inventory $ 74.9
Property, plant and equipment 20.0
Total fair value of tangible assets acquired 94.9

Acquired intangible asset 16.7
Goodwill 8.1
Total purchase price $ 119.7

The Company determined the fair value of the intangible asset using the income approach, which is based on the present value of future cash flows. The fair value measurements are based on significant unobservable inputs that are developed by the Company using estimates and assumptions of the respective market and market penetration of the Company's products. The Company determined the fair value of the ACAM2000 intangible asset using the income approach with a present value discount rate of 15.50%, based on the estimated weighted-average cost of capital for substantially similar companies. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value these intangible assets. The projected cash flows from ACAM2000 intangible asset were based on key assumptions, including: estimates of revenues and operating profits, the life of the potential commercialized product and associated risks, and risks related to the viability of and potential alternative treatments in any future target markets. The Company has determined the ACAM2000 intangible asset will be amortized over 10 years.

The Company determined the fair value of the inventory using the probability adjusted comparative sales method, which estimates the expected sales price reduced for all costs expected to be incurred to complete/dispose of the inventory with a profit on those costs.

The Company determined the fair value of the property, plant and equipment utilizing either the cost approach or the sales comparison approach. The cost approach is determined based on the replacement cost of the asset and then subtracting any value that has been lost due to economic obsolescence, functional obsolescence, or physical deterioration. The sales comparison approach determines an asset is equal to the market price of an asset of comparable features such as design, location, size, construction, materials, use, capacity, specification, operational characteristics and other features or descriptions.

The Company recorded approximately $8.1 million in goodwill related to the ACAM2000 acquisition, calculated as the purchase price paid in the acquisition that was in excess of the fair value of the tangible and intangible assets acquired and ~~represents the future economic benefits the Company expects to receive as a result of the acquisition. Goodwill generated from the ACAM2000 acquisition is not expected to be deductible for tax purposes.~~

~~Proforma financial information for the ACAM2000 acquisition has not been included as the financial impact is not material.~~

~~Impact of Business Acquisitions~~

The operations of each of the three business acquisitions discussed above were included in the consolidated financial statements as of each of their respective acquisition dates. The following table presents their revenue and earnings as reported within the consolidated financial statements.

(in millions) December 31, 2018 December 31, 2017

Revenue $ 167.8 $ 11.5
Operating income (loss) $ 13.4 $ (0.9 )

~~Acquisition of raxibacumab asset~~

On October 2, 2017, the Company completed the acquisition of raxibacumab, a fully human monoclonal antibody therapeutic product approved by the U.S. Food and Drug Administration ("FDA") for the treatment and prophylaxis of inhalational anthrax, from Human Genome Sciences, Inc. and GlaxoSmithKline LLC (collectively referred to as "GSK"). The all-cash transaction consists of a $76 million upfront payment and up to $20 million in product sale and manufacturing-related milestone payments. The Company recorded an asset (including transaction costs) of $77.6 million, at date of acquisition, which is recorded within intangible assets, net line item of the consolidated balance sheets. None of the milestones have been achieved as of December 31, 2018. The Company has determined that substantially all of the value of raxibacumab is attributed to the raxibacumab asset and therefore the raxibacumab acquisition is considered an asset acquisition.

6.~~Fair value measurements~~

~~The Company’s fair value measurement items primarily consist of contingent consideration liabilities that have been generated from our acquisitions.~~ These liabilities represent an obligation of the Company to transfer additional assets to the selling shareholders and owners if future events occur or conditions are met. ~~The Company’s contingent consideration is~~These liabilities associated with business combinations are measured ~~initially~~at fair value at inception and ~~subsequently~~ at each subsequent reporting ~~date at fair value.~~date. The changes in the fair value ~~of contingent consideration obligations~~ are primarily due to the expected amount and timing of future net sales, ~~and achieving regulatory milestones,~~ which are inputs that have no observable ~~market (Level 3).~~market. Any changes in ~~expectations~~fair value for the contingent consideration liabilities related to the Company’s products are classified in the Company's statement of operations as cost of product ~~sales and contract manufacturing.~~sales. Any changes in ~~expectations~~fair value for the contingent consideration liabilities related to the Company’s product candidates are recorded in ~~research and development~~R&D expense for regulatory and development milestones.

The following table is a reconciliation of the beginning and ending balance of the contingent consideration liabilities measured at fair value ~~using significant unobservable inputs (Level 3)~~ during the years ended December 31, ~~2018~~2021 and ~~2017.~~2020.

(in millions)
Balance at December 31, 2016 $ 13.2
(Income) expense included in earnings 7.8
Settlements (10.9 )
Additions due to acquisition 2.2
Balance at December 31, 2017 $ 12.3
(Income) expense included in earnings 3.1
Settlements (3.4 )
Additions due to acquisition 48.0
Balance at December 31, 2018 $ 60.0


(in millions)
Balance at December 31, 2019	$	29.2
Expense included in earnings	31.7
Settlements	(2.8)
Balance at December 31, 2020	$	58.1
Expense included in earnings	2.9
Settlements	(23.8)
Balance at December 31, 2021	$	37.2

As of December 31, 2021 and 2020, the current portion of the contingent consideration liability was $32.7 million and $23.9 million, respectively, and was included in other current liabilities on the consolidated balance sheets.

The recurring Level 3 fair value measurements for the Company's contingent consideration liability include the following significant unobservable inputs:

Contingent Consideration Liability

Fair Value as of December 31, 2021

Valuation Technique

Unobservable Input

Range

Weighted Average

Revenue milestone and royalty based

$37.2 million

Discounted cash flow

Discount rate

—% - 7.4%

1.5%

Probability of payment

25.0% - 100.0%

87.0%

Projected year of payment

2022 - 2028

2022

Non-Variable Rate Debt

As of December 31, 2021 and December 31, 2020, the fair value of the Company's 3.875% Senior Unsecured Notes was $433.3 million and $466.0 million, respectively. The fair value was determined through market sources, which are level 2 inputs and directly observable. The carrying amounts of the Company’s other long-term variable interest rate debt arrangements approximate their fair values (see Note 8).

Non-recurring fair value measurements

Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. As of December 31, ~~2018~~2021 and ~~2017,~~2020, other than those outlined in Note 7, there were no material assets or liabilities measured at fair value on a non-recurring ~~basis, except for the assets acquired from PaxVax and Adapt, along with the ACAM2000 business. See Note 5. "Acquisitions" for further details on the acquisitions.~~basis.

7.~~Inventories~~

5. Inventories

Inventories consist of the following:

December 31,
(in millions) 2018 2017
Raw materials and supplies $ 51.8 $ 36.1
Work-in-process 103.2 76.6
Finished goods 50.8 30.1
Total inventories $ 205.8 $ 142.8


	December 31,
(in millions)	2021		2020
Raw materials and supplies	$	217.5	$	160.6
Work-in-process	95.8		102.5
Finished goods	37.5		43.9
Total inventories	$	350.8	$	307.0

~~The increase in inventories as~~Inventories, net is stated at the lower of ~~December 31, 2018 was primarily due to the acquisition of PaxVax and Adapt in October 2018.~~

8.~~Property, plant and equipment~~

~~Property, plant and equipment consist of the following:~~

December 31,
(in millions) 2018 2017
Land and improvements $ 44.6 $ 21.8
Buildings, building improvements and leasehold improvements 216.2 160.0
Furniture and equipment 293.9 206.8
Software 55.2 50.8
Construction-in-progress 71.8 100.2
681.7 539.6
Less: Accumulated depreciation and amortization (171.5 ) (132.4 )
Total property, plant and equipment, net $ 510.2 $ 407.2

~~For~~cost or net realizable value. During the year ended December 31, ~~2018,~~2021, the Company recorded inventory write-offs at its Bayview facility of $41.5 million,which were the result of the cross-contamination event at the Bayview facility. The inventory write-off resulted from the Company's plan to discard raw materials and in-process batches that were deemed unusable. The charge was reflected as a component of cost of CDMO services on the Company's consolidated statements of operations.

6. Property, plant and equipment, net

Property, plant and equipment, net consists of the following:


	December 31,
(in millions)	2021		2020
Land and improvements	$	52.1	$	52.7
Buildings, building improvements and leasehold improvements	269.7		246.3
Furniture and equipment	513.5		362.1
Software	60.7		58.7
Construction-in-progress	223.2		183.4��
	1,119.2		903.2
Less: Accumulated depreciation and amortization	(319.1)		(259.1)
Total property, plant and equipment, net	$	800.1	$	644.1

For the years ended December 31, 2021 and 2020, construction-in-progress primarily includes costs incurred related to ~~manufacturing equipment. For the year ended December 31, 2017, construction-in-progress primarily includes costs related~~construction to ~~the build out of~~advance the Company's ~~CIADM manufacturing facility.~~

CDMO capabilities.

Depreciation and amortization expense associated with property, plant and equipment was ~~$36.3~~$62.2 million, ~~$32.2~~$50.1 million and ~~$28.0~~$49.5 million for the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016,~~2019, respectively.

9.7. Intangible assets and goodwill

The Company's intangible assets consist of ~~CBRNE, travelers' and opioid~~ products acquired via business combinations or asset ~~acquisition. Changes in~~acquisitions. Components of the Company’s intangible assets, excluding ~~goodwill~~IPR&D and ~~IPR&D,~~goodwill, consisted of the following:


		December 31, 2021
(in millions)	Estimated Life	Cost		Accumulated Amortization		Net
Products	9-22 years	$	798.0	$	193.5	$	604.5
Customer relationships	8 years	28.6		28.6		—
CDMO	8 years	5.5		5.4		0.1
Total intangible assets		$	832.1	$	227.5	$	604.6

(in millions) Total
Cost basis
Balance at December 31, 2017 $ 151.4
Additions 667.0
Balance at December 31, 2018 $ 818.4

Accumulated amortization
Balance at December 31, 2017 $ (31.8 )
Amortization (25.0 )
Balance at December 31, 2018 $ (56.8 )

Net book value at December 31, 2018 $ 761.6


		December 31, 2020
(in millions)	Estimated Life	Cost		Accumulated Amortization		Net
Products	9-22 years	$	798.0	$	137.8	$	660.2
Customer relationships	8 years	28.6		26.5		2.1
CDMO	8 years	5.5		4.7		0.8
Total intangible assets		$	832.1	$	169.0	$	663.1

For the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016,~~2019, the Company recorded amortization expense for intangible assets of ~~$25.0~~$58.5 million, ~~$8.6~~$59.8 million and ~~$7.0~~$58.7 million, respectively, which is included in the amortization of intangible assets ~~line item of~~in the consolidated statements of operations. As of December 31, ~~2018,~~2021, the weighted average amortization period remaining for intangible assets is ~~14.6~~11.9 years.

Future amortization expense as of December 31, ~~2018~~2021 is as follows:

(in millions)
2019 $ 57.7
2020 57.6
2021 56.1
2022 53.4
2023 and beyond 536.8
Total remaining amortization $ 761.6


(in millions)
2022	$	55.9
2023	55.8
2024	55.8
2025	55.8
2026 and beyond	381.3
Total remaining amortization	$	604.6

As a result of the Company's expectation that it would not generate future cash flows to recover the asset balance of the Company's IPR&D intangible asset, the Company recorded an intangible asset impairment charge of $29.0 million during the year ended December 31, 2020. As such, there is no remaining balance recorded on the Company's consolidated balance sheets at December 31, 2021 and 2020. The impairment charge is reflected as a component of R&D expense in the consolidated statement of operations for the year ended December 31, 2020.

The following table is a summary of changes in goodwill:


	Year ended December 31,
(in millions)	2021		2020
Balance at beginning of the year	$	266.7	$	266.6
Goodwill impairment (1)	(41.7)		—
Foreign currency translation	(0.1)		0.1
Balance at end of the year	$	224.9	$	266.7

Year Ended December 31,
(in millions) 2018 2017

Balance at beginning of the year $ 49.1 $ 41.0
Additions 210.6 8.1
Balance at end of the year $ 259.7 $ 49.1

(1) The carrying amount of goodwill included accumulated impairments of $41.7 million as of December 31, 2021. There were no impairment charges or accumulated impairments as of December 31, 2020.

On October 1, 2021, the date of the Company's annual goodwill impairment testing, the Company reorganized its lines of business resulting in a change in the composition of two of its reporting units. The Company performed quantitative tests to determine fair values of the reporting units using both a market based (comparable company multiple) and income based (discounted cash flows) approach, each a level three non recurring fair value measurement, of the reporting units both before and after the reorganization of the lines of business and its reporting units and determined that there was a goodwill impairment of $41.7 million associated with the new commercial reporting unit. The Company utilized a quantitative assessment for our goodwill impairment testing of one reporting unit in 2020. The Company used a qualitative assessment for our goodwill impairment testing for all other reporting units in 2020. The assessments completed during the year ended 2020 indicated no impairment.

~~10.~~

8. Long-term debt

The components of ~~long-term indebtedness~~debt are as follows:

December 31,
(in millions) 2018 2017
Senior secured credit agreement - Term loan due 2023 $ 447.2 $ -
Senior secured credit agreement - Revolver loan due 2023 348.0 -
2.875% Convertible Senior Notes due 2021 10.6 10.6
Other 3.0 3.0
Total long-term indebtedness $ 808.8 $ 13.6
Current portion of long-term indebtedness, net of debt issuance costs (10.1 ) -
Unamortized debt issuance costs (14.2 ) (0.1 )
Noncurrent portion of long-term indebtedness $ 784.5 $ 13.5


	December 31,
(in millions)	2021		2020
Senior secured credit agreement - Term loan due 2023	$	396.6	$	421.9
Senior secured credit agreement - Revolver loan due 2023	—		—
3.875% Senior Unsecured Notes due 2028	450.0		450.0
2.875% Convertible Senior Notes due 2021	—		10.6
Other	3.0		3.0
Total debt	$	849.6	$	885.5
Current portion of debt, net of debt issuance costs	(31.6)		(33.8)
Unamortized debt issuance costs	(8.5)		(10.7)
Debt, net of current portion	$	809.4	$	841.0

As of December 31, 2021, the Company had approximately $2.0 million and $1.6 million of debt issuance costs associated with the revolver loan that were classified as other current assets and other assets, respectively, on the Company's consolidated balance sheets because there was no outstanding revolver balance at December 31, 2021. As of December 31, 2020, the Company had approximately $2.0 million and $3.5 million of debt issuance costs associated with the revolver loan that were classified as other current assets and other assets, respectively, on the Company's consolidated balance sheets because there was an outstanding revolver balance at December 31, 2020.

3.875% Senior ~~secured credit agreement~~

Unsecured Notes due 2028

On ~~September 29, 2017,~~August 7, 2020, the Company completed its offering of $450 million aggregate principal amount of 3.875% Senior Unsecured Notes due 2028 (the 2028 Notes) of which the majority of the net proceeds were used to pay down the Revolving Credit Facility (as defined below). Interest on the 2028 Notes is payable on February 15th and August 15th of each year until maturity, beginning on February 15, 2021. The 2028 Notes will mature on August 15, 2028.

On or after August 15, 2023, the Company may redeem the 2028 Notes, in whole or in part, at the redemption prices set forth in the related Indenture, plus accrued and unpaid interest. Prior to August 15, 2023 the Company may redeem all or a portion of the 2028 Notes at a redemption price equal to 100% of the principal amount of the 2028 Notes plus a “make-whole” premium and accrued and unpaid interest. Prior to August 15, 2023, the Company may redeem up to 40% of the aggregate principal amount of the 2028 Notes using the net cash proceeds of certain equity offerings at the redemption price set forth in the related Indenture. Upon the occurrence of a change of control, the Company must offer to repurchase the 2028 Notes at a purchase price of 101% of the principal amount of such 2028 Notes plus accrued and unpaid interest.

Negative covenants in the Indenture governing the 2028 Notes, among other things, limit the ability of the Company to incur indebtedness and liens, dispose of assets, make investments, enter into certain merger or consolidation transactions and make restricted payments.

Senior Secured Credit Agreement

Also on August 7, 2020, the Company entered into a Second Amendment (the Credit Agreement Amendment) to its senior secured credit agreement, ~~(the “2017 Credit Agreement”)~~dated October 15, 2018, with ~~four~~multiple lending ~~financial~~ institutions ~~which replaced~~relating to the ~~Company's prior~~Company’s senior secured credit ~~agreement~~facilities (the ~~"2013 Credit Agreement").~~

~~On October 15, 2018, the Company entered into an Amended and Restated~~ Credit Agreement, ~~(the "Amended Credit Agreement"), which modified~~and as amended, the ~~2017 Credit Agreement. The~~ Amended Credit ~~Agreement (i) increased the~~Agreement), consisting of a senior revolving credit facility (the ~~"Revolving Credit Facility") from $200 million to $600 million, (ii) extended the maturity of the~~ Revolving Credit ~~Facility from September 29, 2022 to October 13, 2023, (iii) provided for a~~Facility) and senior term loan ~~in the original principal amount of $450 million~~facility (the ~~"Term~~Term Loan Facility," and together with the Revolving Credit Facility, the ~~"Senior~~Senior Secured Credit ~~Facilities"), (iv) added several additional lenders, (v)~~Facilities). The Credit Agreement Amendment amended, among other things, the definition of incremental facilities limit, the consolidated net leverage ratio financial covenant by increasing the maximum level, increased the permissible applicable ~~margin such that borrowings with respect to~~margins based on the ~~Revolving Credit Facility will bear interest at~~Company’s consolidated net leverage ratio and increased the ~~annual rate described below, (vi) amended the provision relating to incremental credit facilities such~~commitment fee that the Company ~~may request one or more incremental term loan facilities, or one or more increases~~is required to pay in respect of the average daily unused commitments under the Revolving Credit Facility, depending on the Company’s consolidated net leverage ratio.

The Amended Credit Agreement includes (i) a Revolving Credit Facility of $600 million with a maturity date of October 13, 2023, and (ii) a Term Loan Facility with a principal amount of $450 million. The Company may request

incremental term loan facilities or increases in the Revolving Credit Facility (each an ~~"Incremental Loan"), in any amount if,~~Incremental Loan) as long as certain requirements involving our net leverage ratio will be maintained on a pro forma basis, the Company's consolidated secured net leverage ratio does not exceed 2.50 to 1.00 after such incurrence, plus $200 million and (vii) amended the maximum consolidated net leverage ratio financial covenant from 3.50 to 1.0 (subject to 0.50% step up in connection with material acquisitions) to the maximum consolidated net leverage ratio described below.

In October 2018, the Company borrowed $318 million under the Revolving Credit Facility and $450 million under the Term Loan Facility to finance a portion of the consideration for the PaxVax and Adapt acquisitions and related expenses.

~~For the years ended December 31, 2018 and 2017, we capitalized debt issuance costs of $13.4 million and $1.4 million, as a direct reduction to the Term Loan and the revolver, respectively.~~

basis. Borrowings under the Revolving Credit Facility and the Term Loan Facility ~~will~~ bear interest at a rate per annum equal to (a) a eurocurrency rate plus a margin ranging from ~~1.25%~~1.3% to ~~2.00%~~2.3% per annum, depending on the Company's consolidated net leverage ratio or (b) a base rate (which is the highest of the prime rate, the federal funds rate plus ~~0.50%~~0.5%, and a eurocurrency rate for an interest period of one month plus ~~1%)~~1.0% plus a margin ranging from ~~0.25%~~0.3% to ~~1.00%~~1.3%, depending on the Company's consolidated net leverage ratio. The Company is required to make quarterly payments on the last business day of each calendar quarter under the Amended Credit Agreement for accrued and unpaid interest on the outstanding principal balance, based on the above interest rates. In addition, the Company is required to pay commitment fees ranging from ~~0.15%~~0.2% to ~~0.30%~~0.4% per annum, depending on the Company's consolidated net leverage ratio, ~~in respect of~~for the average daily unused commitments under the Revolving Credit Facility. The Company is to repay the outstanding principal amount of the Term Loan Facility in quarterly installments on the last business day of each calendar quarter based on an annual percentage equal to 2.5% of the original principal amount of the Term Loan Facility during each of the first two years of the Term Loan Facility, 5%5.0% of the original principal amount of the Term Loan Facility during the third year of the Term Loan Facility and 7.5% of the original principal amount of the Term Loan Facility during each year of the remainder of the term of the Term Loan Facility until the maturity date of the Term Loan Facility, at which time the entire unpaid principal balance of the Term Loan Facility will be due and payable. The Company has the right to prepay the Term Loan Facility without premium or penalty. The Revolving Credit Facility and the Term Loan Facility mature ~~(unless earlier terminated)~~ on October 13, 2023.

The Amended Credit Agreement also requires mandatory prepayments of the Term Loan Facility in the event the Company or its ~~Subsidiaries~~subsidiaries (a) incur indebtedness not otherwise permitted under the Amended Credit Agreement or (b) receive cash proceeds in excess of $100 million during the term of the ~~Amended~~ Credit Agreement from certain dispositions of property or from casualty events involving their property, subject to certain reinvestment rights.

The financial covenants under the Amended Credit Agreement ~~contains affirmative~~currently require the quarterly presentation of a minimum consolidated 12-month rolling debt service coverage ratio of 2.5 to 1.0, and ~~negative covenants customary~~a maximum consolidated net leverage ratio of 4.5 to 1.0 (subject to an increase to 5.0 to 1.0 for ~~financings~~an applicable four quarter period, at the election of ~~this type.~~the Company, in connection with a permitted acquisition having an aggregate consideration in excess of $75.0 million). Negative covenants in the Amended Credit Agreement, among other things, limit the ability of the Company ~~to:~~to incur indebtedness and ~~liens;~~liens, dispose of ~~assets;~~assets, make investments, ~~including loans, advances, guarantees, or acquisitions (other than permitted acquisitions, subject to compliance with the financial covenants and certain other conditions); and~~ enter into certain merger or consolidation ~~transactions. The Amended Credit Agreement also contains financial covenants, including (1) a minimum consolidated debt service coverage ratio of 2.50 to 1.00,~~transactions and (2) a maximum consolidated net leverage ratio of 4.00 to 1.00 through September 29, 2019, 3.75 to 1.00 from September 30, 2019 through September 29, 2020 and 3.50 to 1.00 thereafter, which may be adjusted to 4.00 to 1.00 for a four quarter period in connection with a material permitted acquisition, subject to the terms and conditionsmake restricted payments. As of the ~~Amended Credit Agreement. Each~~date of ~~the ratios referred to in the foregoing clauses (1) and (2) is calculated on a consolidated basis for each consecutive four fiscal quarter period. As of December 31, 2018,~~these financial statements, the Company is in compliance with all affirmative and negative covenants.

2.875% Convertible Senior Notes Due 2021

On January 29, 2014, the Company issued 2.875% convertible senior notes due 2021

~~On January 29, 2014, the Company issued $250.0 million aggregate principal amount of 2.875% Convertible Senior Notes due 2021~~ (the ~~"Notes")~~Notes). The Notes ~~bear~~bore interest at a rate of 2.875% per ~~year,~~year, payable semi-annually in arrears on January 15 and July 15 of each year. The Notes ~~mature~~matured and were paid on January 15, 2021 unless earlier purchased by the Company or converted. The original conversion rate is equal to 30.8821 shares of common stock per $1,000 principal amount of notes (which is equivalent to a conversion price of approximately $32.38 per share of common stock). The conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. The Company incurred approximately $8.3 million in debt issuance costs associated with the Notes, which has been capitalized on the consolidated balance sheets and is being amortized over seven years. As of August 1, 2016, certain conversion features were triggered due to the completion of the Aptevo spin-off. The conversion rate under the Notes was adjusted in accordance with the terms of the indenture. Effective August 12, 2016, the conversion rate was adjusted to 32.3860 shares of common stock per $1,000 principal amount of notes (which is equivalent to a conversion price of approximately $30.88 per share of common stock).

Debt Maturity

On November 14, 2017, the Company issued a notice of termination of conversion rights for its outstanding Notes, of which $250.0 million was outstanding as of the notice date. In connection with the notice of termination, bondholders were given the option to convert their notes into the Company’s stock at a rate of 32.386 per $1,000 of principal outstanding, plus a make-whole of an additional 3.1556 shares per $1,000 principal outstanding, in accordance with the terms of the indenture. The Company was not obligated to pay accrued or unpaid interest on converted notes, and bondholders who did not convert by the deadline of December 28, 2017 would retain their bonds but lose the conversion rights associated with the Notes and be paid interest of 2.875% until the earlier of maturity of the Notes in 2021 or the bonds being called and repaid in full by the Company. Between July 15, 2017 and the notification of termination of conversion rights, the Company accrued interest on the converted Notes of $2.4 million which was recorded as an increase in additional paid-in-capital on the balance sheet. Between November 14, 2017 and December 28, 2017 (the “conversion period”), approximately $239.4 million of bonds were converted into 8.5 million shares of the Company’s common stock, inclusive of shares issued as part of the make-whole provision. In addition, the Company recorded a reduction in additional paid-in-capital on the Company’s balance sheet of $3.6 million associated with debt issuance costs attributable to the converted notes. After giving effect to the converted bonds, the outstanding principal balance of the Notes as of December 31, 2018 was $10.6 million.

Future debt payments of long-term indebtedness are as follows:


(in millions)	December 31, 2021
2022	$	33.8
2023	363.6
2024	0.2
2025	—
2026 and thereafter	452.0
Total debt	$	849.6

(in millions) December 31, 2018
2019 $ 11.3
2020 14.1
2021 35.9
2022 33.8
2023 and thereafter 713.7
Total long-term indebtedness $ 808.8

9. Derivative Instrumentsand hedging activities

Risk management objective of using derivatives

As of December 31, 2021, the Company had the following outstanding interest rate swap derivatives that were designated as cash flow hedges of interest rate risk:


(in millions, except number of instruments)	Number of Instruments	Notional amount
Interest Rate Swaps	7	$350.0

~~11.~~The table below presents the fair value of the Company’s derivative financial instruments designated as hedges as well as their classification on the balance sheet.

Liability Derivatives

December 31, 2021

December 31, 2020

(in millions)

Balance Sheet Location

Fair Value

Balance Sheet Location

Fair Value

Interest Rate Swaps

Other Current Liabilities

4.5

Other Current Liabilities

5.7

Other Liabilities

1.6

Other Liabilities

9.3

The table below presents the effect of cash flow hedge accounting on accumulated other comprehensive income.


(in millions)	Cumulative Amount of Gain/(Loss) Recognized in OCI on Derivative				Location of Gain or (Loss) Reclassified from Accumulated OCI into Income	Amount of Gain or (Loss) Reclassified from Accumulated OCI into Income
(in millions)	December 31, 2021		December 31, 2020			December 31, 2021		December 31, 2020
Interest Rate Swaps	$	(6.1)	$	(15.0)	Interest expense	$	(5.8)	$	(3.9)

If current fair values of designated interest rate swaps remained static over the next twelve months, the Company would reclassify $1.6 million of net deferred losses from accumulated other comprehensive loss to the statement of operations over the next twelve month period. All outstanding cash flow hedges mature in October 2023.

10. Stockholders' equity

Preferred stock

The Company is authorized to issue up to 15.0 million shares of preferred stock, $0.001 par value per share ~~("Preferred Stock")~~(Preferred Stock). Any Preferred Stock issued may have dividend rights, voting rights, conversion privileges, redemption characteristics, and sinking fund requirements as approved by the Company's board of directors.

Common stock

The Company currently has one class of common stock, $0.001 par value per share common stock ~~("Common Stock")~~(Common Stock), authorized and outstanding. The Company is authorized to issue up to 200.0 million shares of Common Stock. Holders of Common Stock are entitled to ~~one~~1 vote for each share of Common Stock held on all matters, except as may be provided by law.

Repurchase programs

On November 11, 2021, the Company announced that its Board of Directors authorized management to repurchase, up to an aggregate of $250.0 million of Common Stock under a board-approved Share Repurchase Program, of which $112.6 million has been utilized to purchase 2.6 million shares as of December 31, 2021. The number of shares repurchased includes trades executed in December and settled in January due to timing. The Share Repurchase Program does not obligate the Company to acquire any specific number of shares. Repurchased shares will be available for use in connection with our stock plans and for other corporate purposes.

Accounting for stock-based compensation

The Company has ~~one~~1 stock-based employee compensation plan, the Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (the ~~"Emergent Plan")~~Emergent Plan), which includes ~~both~~ stock options and performance and restricted stock units.

As of December 31, ~~2018,~~2021, an aggregate of ~~21.9~~25.4 million shares of common stock were authorized for issuance under the Emergent Plan, of which a total of approximately ~~3.8~~6.7 million shares of common stock remain available for future awards to be made to plan participants. The exercise price of each option must be not less than 100% of the fair market value of the shares underlying such option on the date of grant. ~~Awards~~Options granted under the Emergent Plan have a contractual life of ~~no more than 10~~7 years.

The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth below are the assumptions used in valuing the stock options granted:


	Year Ended December 31,
	2021		2020		2019
Expected dividend yield	0	%	0	%	0	%
Expected volatility	47-48%		39-48%		37-39%
Risk-free interest rate	0.43-0.94%		0.27-1.42%		1.57-2.48%
Expected average life of options	4.5 years		4.5 years		4.5 years

Year Ended December 31,
2018 2017 2016
Expected dividend yield 0% 0% 0%
Expected volatility 38-39% 37-40% 31-33%
Risk-free interest rate 2.54-3.03% 1.66-1.88% 0.93-1.22%
Expected average life of options 4.5 years 4.3 years 4.3 years

Stock options, restricted and ~~restricted~~performance stock units

The following is a summary of stock option award activity under the Emergent Plan:


(in millions, except per share data)	Number of Shares	Weighted-Average Exercise Price		Aggregate Intrinsic Value
Outstanding at December 31, 2020	1.3	$	49.07	$	53.4
Granted	0.3	89.47
Exercised	(0.3)	35.91
Forfeited	(0.1)	71.77
Outstanding at December 31, 2021	1.2	$	60.83	$	3.0
Exercisable at December 31, 2021	0.6	$	47.28	$	3.0

Emergent Plan
(in millions, except share and per share data) Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value
Outstanding at December 31, 2017 2,121,405 $ 25.48 $ 44.5
Granted 460,902 51.39
Exercised (665,183 ) 21.36
Forfeited (45,656 ) 33.14
Outstanding at December 31, 2018 1,871,468 $ 32.59 $ 50.1
Exercisable at December 31, 2018 1,081,513 $ 26.13 $ 35.9
Options expected to vest at December 31, 2018 696,083 $ 41.10 $ 12.8

~~The following is a summary of restricted stock unit award activity under the Emergent Plan:~~

(in millions, except share and per share data) Number of Shares Weighted-Average Grant Price Aggregate Intrinsic Value
Outstanding at December 31, 2017 851,720 $ 30.84 $ 39.6
Granted 557,767 52.70
Vested (427,610 ) 30.12
Forfeited (60,784 ) 38.77
Outstanding at December 31, 2018 921,093 $ 42.82 $ 54.6

The weighted average remaining contractual term of options outstanding as of both December 31, ~~2018~~2021 and ~~2017~~2020 was ~~4.0 years and 4.0 years, respectively.~~4.3 years. The weighted average remaining contractual term of options exercisable as of December 31, ~~2018~~2021 and ~~2017~~2020 was ~~3.0~~3.2 years and ~~3.2~~2.9 years, respectively.

The weighted average grant date fair value of options granted during the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016~~2019 was ~~$18.48, $10.53~~$35.16, $21.69 and ~~$9.24~~$21.13 per share, respectively. The total intrinsic value of options exercised during the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016~~2019 was ~~$24.4~~$15.7 million, ~~$13.9~~$38.2 million and ~~$15.6~~$5.3 million, respectively.

The following is a summary of performance stock and restricted stock unit award activity under the Emergent Plan.


(in millions, except per share data)	Number of Shares	Weighted-Average Grant Price		Aggregate Intrinsic Value
Outstanding at December 31, 2020	1.1	$	63.30	$	96.3
Granted	0.7	76.72
Vested	(0.5)	61.76
Forfeited	(0.2)	74.42
Outstanding at December 31, 2021	1.1	$	70.82	$	47.6

The total fair value of restricted stock unit awards vested during ~~2018, 2017~~2021, 2020 and ~~2016~~2019 was ~~$16.9~~$30.8 million, ~~$17.9~~$35.3 million and $16.9 million, respectively. As of the year ended December 31, ~~2018,~~2021, the total compensation cost and weighted average period over which total compensation is expected to be recognized related to unvested equity awards was ~~$32.8~~$60.7 million and ~~2.2~~1.6 years, respectively.

Stock-based compensation expense was recorded in the following financial statement line items:

Year Ended December 31,
(in millions) 2018 2017 2016
Cost of product sales $ 1.7 $ 1.1 $ 1.0
Research and development 3.1 2.5 2.3
Selling, general and administrative 18.4 11.6 14.1
Continuing operations 23.2 15.2 17.4
Discontinued operations - - 1.1
Total stock-based compensation expense $ 23.2 $ 15.2 $ 18.5


	Year Ended December 31,
(in millions)	2021		2020		2019
Cost of product sales	$	6.4	$	8.9	$	2.3
Cost of CDMO services	1.1		3.5		0.8
Research and development	5.0		8.4		4.0
Selling, general and administrative	29.9		30.2		19.6
Total stock-based compensation expense	$	42.4	$	51.0	$	26.7

~~Share Repurchase Program~~Accumulated Other Comprehensive (Loss) Income

The following table includes changes in accumulated other comprehensive (loss) income by component, net of tax:

~~In March 2018,~~


	Defined Benefit Pension Plan		Derivative Instruments		Foreign Currency Translation Losses		Total
(in millions)
Balance, December 31, 2019	$	(3.4)	$	(1.6)	$	(4.9)	$	(9.9)
Other comprehensive (loss) income before reclassifications	(4.3)		(13.3)		(1.7)		(19.3)
Amounts reclassified from accumulated other comprehensive income	—		3.9		—		3.9
Net current period other comprehensive income (loss)	(4.3)		(9.4)		(1.7)		(15.4)
Balance, December 31, 2020	$	(7.7)	$	(11.0)	$	(6.6)	(25.3)
Other comprehensive (loss) income before reclassifications	4.3		0.7		(1.0)		4.0
Amounts reclassified from accumulated other comprehensive income	(0.6)		5.8		—		5.2
Net current period other comprehensive income (loss)	3.7		6.5		(1.0)		9.2
Balance, December 31, 2021	$	(4.0)	$	(4.5)	$	(7.6)	$	(16.1)

The following table presents the ~~Company's board~~tax effects related to each component of ~~directors authorized management to repurchase, from time to time, up to an aggregate of $ million of the Company's common stock under a board-approved share repurchase program.~~ ~~The term of the board authorization of the repurchase program is until December 31, 2019. Any repurchased shares will be available for use in connection with the Company's stock plans and for~~accumulated other ~~corporate purposes. As of December 31, 2018, the Company has not repurchased any shares under this program.~~comprehensive (loss) income:


	December 31, 2021						December 31, 2020						December 31, 2019
(in millions)	Pretax		Tax Benefit (Expense)		Net-of-tax		Pretax		Tax Benefit (Expense)		Net-of-tax		Pretax		Tax Benefit (Expense)		Net-of-tax
Defined Benefit Pension Plan	4.3		(0.6)		3.7		(5.0)		0.7		(4.3)		(3.7)		0.5		(3.2)
Derivative Instruments	8.9		(2.4)		6.5		(13.0)		3.6		(9.4)		(2.0)		0.4		(1.6)
Foreign Currency Translation Losses	(1.2)		0.2		(1.0)		(1.8)		0.1		(1.7)		0.4		—		0.4
Total Adjustments	$	12.0	$	(2.8)	$	9.2	$	(19.8)	$	4.4	$	(15.4)	$	(5.3)	$	0.9	$	(4.4)

~~12.~~11. Income taxes

On December 22, 2017, the President of the United States signed into law the Tax Reform Act. The legislation significantly changes U.S. tax law by, among other things, lowering corporate income tax rates, implementing a territorial tax system and imposing a repatriation tax on deemed repatriated earnings of foreign subsidiaries. The Tax Reform Act permanently reduces the U.S. corporate income tax rate from a maximum of 35% to a flat 21% rate, effective January 1, 2018.

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse. Valuation allowances are recorded as appropriate to reduce deferred tax assets to the amount considered likely to be realized. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under the Tax Reform Act, the Company revalued its ending net deferred tax liabilities in the United States at December 31, 2017 and recognized a provisional $13.4 million tax benefit in the Company’s consolidated statement of income for the year ended December 31, 2017. During 2018 we adjusted the provisional estimate by approximately $4.5 million, bringing the total tax benefit recorded to date to $17.9 million related to the revaluation of our deferred tax assets and liabilities.

The Tax Reform Act provided for a one-time deemed mandatory repatriation of post-1986 undistributed foreign subsidiary earnings and profits (“E&P”) through the year ended December 31, 2017. The Company had an estimated $95.4 million of undistributed foreign E&P subject to the deemed mandatory repatriation and recognized a provisional transition tax of $13.6 million of income tax expense in the Company’s consolidated statement of income for the year ended December 31, 2017. During 2018 we reduced the provisional transition tax by $0.2 million, bringing the total transition tax to $13.4 million. The Company has elected to pay U.S. federal cash taxes on the deemed mandatory repatriation over eight years.

While the Tax Reform Act provides for a territorial tax system, beginning in 2018, it includes two new U.S. tax base erosion provisions, the global intangible low-taxed income (“GILTI”) provisions and the base-erosion and anti-abuse tax (“BEAT”) provisions.

The GILTI provisions require the Company to include in its U.S. income tax return foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets. The Company is subject to incremental U.S. tax on GILTI ~~income beginning in 2018.~~income. The Company has elected to account for GILTI tax in the period in which it is incurred, and therefore has not provided any deferred tax impacts of GILTI in its consolidated financial statements for the year ended December 31, ~~2018.~~

~~On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does~~2021 and 2020. BEAT provisions do not have material impact on the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Reform Act. The Company recognized the provisional tax impacts related to deemed repatriated earnings and the revaluation of deferred tax assets and liabilities and included these amounts in its consolidated financial ~~statements for~~statements.

For the ~~year~~years ended December 31, ~~2017. During 2018,~~2021 and 2020, the Company ~~completed~~has not recognized deferred tax liabilities for temporary differences related to investments in foreign subsidiaries that were deemed indefinitely reinvested. Determination of the ~~analysis~~amount of ~~The Tax Reform Act’s~~unrecognized deferred income tax ~~effects based~~liabilities on ~~legislative updates relating to the Act currently available. This resulted in an additional SAB 118 tax benefit of $ million in the third quarter of 2018 related to an adjustment to the transition tax~~these outside basis differences is not practicable because such liability, if any, depends on certain circumstances existing if and ~~the remeasurement of certain~~when remittance occurs. A deferred tax ~~assets~~liability will be recognized if and ~~liabilities upon~~when the ~~filing of the 2017 U.S. corporate income tax return.~~Company no longer plans to indefinitely reinvest these undistributed earnings.

Significant components of ~~the provisions for~~ income taxes attributable to operations consist of the following:


	December 31,
(in millions)	2021		2020		2019
Current
Federal	$	(3.7)	$	62.8	$	1.4
State	14.9		27.7		11.6
International	28.4		14.0		11.0
Total current	39.6		104.5		24.0
Deferred
Federal	38.0		1.1		1.9
State	4.3		—		1.1
International	1.6		(3.5)		(4.1)
Total deferred	43.9		(2.4)		(1.1)
Total income taxes	$	83.5	$	102.1	$	22.9

Year Ended December 31,
(in millions) 2018 2017 2016
Current
Federal $ 1.8 $ 29.4 $ 29.2
State 2.4 3.0 2.3
International 6.0 0.3 1.0
Total current 10.2 32.7 32.5
Deferred
Federal 7.5 (6.0 ) 10.0
State 3.0 (0.6 ) (0.2 )
International (1.9 ) 9.9 (5.6 )
Total deferred 8.6 3.3 4.2
Total provision for income taxes $ 18.8 $ 36.0 $ 36.7

The Company's net deferred tax asset (liability) consists of the following:

December 31,
(in millions) 2018 2017
Federal losses carryforward $ 10.7 $ 1.6
State losses carryforward 18.1 17.2
Research and development carryforward 10.1 3.5
State research and development carryforward 5.0 -
Scientific research and experimental development credit carryforward 13.1 �� 16.5
Stock compensation 7.5 5.3
Foreign NOLs 35.4 34.1
Deferred revenue 11.6 -
Inventory reserves 3.4 1.6
Other 4.9 3.9
Deferred tax asset 119.8 83.7
Fixed assets (46.4 ) (23.1 )
Intangible assets (60.4 ) (2.2 )
Other (0.7 ) (10.5 )
Deferred tax liability (107.5 ) (35.8 )
Valuation allowance (66.4 ) (45.1 )
Net deferred tax asset (liability) $ (54.1 ) $ 2.8

As of December 31, 2018, the Company has a net U.S. deferred tax liability in the amount of $4.8 million and a foreign net deferred tax liability in the amount of $49.3 million. The Company had a net U.S. deferred tax liability in the amount of $13.1 million and a foreign net deferred tax asset in the amount of $15.9 million as of December 31, 2017.


	December 31,
(in millions)	2021		2020
Federal losses carryforward	$	7.6	$	8.1
State losses carryforward	3.3		3.1
Research and development carryforward	9.5		7.5
State research and development carryforward	5.0		5.0
Scientific research and experimental development credit carryforward	2.1		8.4
Stock compensation	8.9		8.6
Foreign losses carryforward	10.2		36.9
Deferred revenue	0.4		26.2
Inventory reserves	2.9		1.7
Lease liability	6.5		8.2
IRC 263A capitalized costs	3.9		2.3
Other	5.6		8.5
Deferred tax asset	65.9		124.5
Valuation allowance	(25.0)		(51.1)
Net deferred tax asset	40.9		73.4
Fixed assets	(75.1)		(54.6)
Intangible assets	(47.6)		(50.4)
Right-of-use asset	(6.1)		(7.7)
Other	(2.8)		(4.5)
Deferred tax liability	(131.6)		(117.2)
Net deferred tax liability	$	(90.7)	$	(43.8)

As of December 31, ~~2018,~~2021, the Company ~~currently~~ has approximately ~~$50.7~~$36.0 million ($~~10.6~~7.6 million tax effected) in ~~U.S~~U.S. federal net operating loss ~~carryforwards along with $14.1 million in research and development tax credit carryforwards for U.S. federal and state tax purposes that will begin to expire in 2027 and 2024, respectively.~~carryforwards. The U.S. federal net operating loss carryforwards are recorded with a ~~$24.3~~$4.7 million valuation allowance. States have their own statutes concerning whether a NOL should be carried forward pre or post apportionment. The ~~research~~US federal and ~~development~~state R&D tax credit carryforwards of $14.5 million have a valuation allowance in the amount of ~~$9.6~~$9.1 million. The ~~Company has $280.4 million ($18.1 million tax effected) in state~~ net operating loss carryforwards and the R&D tax credits will begin to expire in 2031 and 2024, respectively. Certain of the net operating loss carryforwards and the R&D tax credit carryforwards are subject to an annual limitation pursuant to Internal Revenue Code Section 382 and 383.

As of December 31, 2021, the Company had pre-apportionment state NOLs totaling approximately $1,083.9 million (de minimis when tax effected) primarily in Maryland which will begin to expire in 2025 and post-apportionment NOLs totaling approximately $76.4 million ($3.2 million tax effected) primarily in California that will begin to expire in ~~2019.~~2025. The U.S. state tax loss carryforwards are recorded with a valuation allowance of ~~$245.9~~$79.4 million ($~~16.4~~3.2 million tax effected).

The Company has approximately ~~$192.6~~$46.7 million ($~~35.4~~8.2 million tax effected) in net operating losses from foreign jurisdictions ~~that will~~as of December 31, 2021, some of which have an indefinite life ~~unless~~(unless the foreign entities have a change in the nature or conduct of the business in the three years following a change in ~~ownership.~~ownership), and some of which begin to expire in 2022. A valuation allowance in respect to these foreign losses has been recorded in the tax effected amount of ~~$35.5~~$6.0 million. The change in foreign losses and the corresponding valuation allowance is primarily attributable to liquidation of an inactive foreign entity during the year.

As of December 31, 2021, the Company ~~currently~~ has approximately ~~$13.2~~$2.1 million in Manitoba scientific research and experimental development credit carryforwards that will begin to expire in ~~2026.~~2040. The use of any of these net

100

operating losses and ~~research and development~~R&D tax credit carryforwards may be restricted due to future changes in the Company's ownership.

~~The provision for income~~Income taxes ~~differs~~differ from the amount of taxes determined by applying the U.S. federal statutory rate to income before ~~the provision for income~~ taxes as a result of the following:


	December 31,
(in millions)	2021		2020		2019
US	$	112.0	$	362.0	$	63.9
International	202.4		45.2		13.5
Earnings before taxes on income	314.4		407.2		77.4
Federal tax at statutory rates	$	65.8	$	85.5	$	16.3
State taxes, net of federal benefit	16.1		23.2		10.3
Impact of foreign operations	(16.8)		(7.8)		(6.9)
Change in valuation allowance	4.3		1.5		(1.0)
Tax credits	(4.7)		(7.6)		(3.6)
Stock compensation	(4.9)		(7.9)		(2.4)
Impairments	8.3		—		—
Return to provision true-ups	0.8		(0.7)		(2.3)
Transaction costs	0.3		6.0		4.7
Compensation limitation	2.9		2.2		1.3
FIN 48	0.3		(0.3)		1.1
GILTI, net	11.4		5.4		3.6
Permanent differences	(0.3)		2.6		1.8
Income taxes	$	83.5	$	102.1	$	22.9

Year ended December 31,
(in millions) 2018 2017 2016
US $ 71.0 $ 80.7 $ 63.3
International 10.5 37.9 35.9
Earnings before taxes on income 81.5 118.6 99.2

Federal tax at statutory rates $ 17.1 $ 41.5 $ 34.7
State taxes, net of federal benefit 4.3 1.3 0.5
Impact of foreign operations 2.8 (2.2 ) (9.9 )
Change in valuation allowance (0.1 ) 0.3 10.5
Tax credits (1.8 ) (1.9 ) (1.6 )
Transition tax (0.2 ) 13.6 -
Change in U.S. tax rate (4.5 ) (13.4 ) -
Stock compensation (5.8 ) (4.0 ) -
Other differences (0.9 ) 0.4 (0.6 )
Return to provision true-ups 1.1 (0.5 ) 1.7
Transaction costs 5.4 - -
GILTI, net 0.4 - -
Permanent differences 1.0 0.9 1.4
Provision for income taxes $ 18.8 $ 36.0 $ 36.7

The effective annual tax rate for the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016~~2019 was ~~23%~~27%, ~~30%~~25% and ~~37%~~30%, respectively.

The effective annual tax rate of ~~23%~~27% in ~~2018~~2021 is higher than the statutory rate primarily due to the impact of goodwill impairment, state taxes, GILTI and other non-deductible items. This is partially offset by stock option deduction benefits, tax credits, and favorable rates in foreign jurisdictions. The jurisdictional mix of profit has changed from the prior year largely due to lower US CDMO margins, the termination of the CIADM arrangement in the US and an increase in sales of NARCAN in which a portion of the profit is attributable to a foreign subsidiary.

The effective annual tax rate of 25% in 2020 is higher than the statutory rate primarily due to the impact of state taxes, GILTI, ~~acquisition transaction costs and~~contingent consideration, other non-deductible items and the jurisdictional mix of earnings. This is partially offset by ~~the impact of the SAB 118 benefit and the~~ stock option deduction ~~benefit.~~

benefits, tax credits, and favorable rates in foreign jurisdictions.

The effective annual tax rate of 30% in ~~2017 differs from~~2019 is higher than the statutory rate primarily due to the ~~jurisdictional mix of earnings. Due to the~~ impact of the Tax Reform Act enacted on December 22, 2017, the Company recognized a $13.4 million tax benefit as a result of revaluing the U.S. ending net deferred tax liabilities from 35% to the newly enacted U.S. corporate income tax rate of 21%. The tax benefit was fullystate taxes, GILTI, contingent consideration, and other non-deductible items. This is partially offset by stock option deduction benefits, tax ~~expense of $13.6 million for the transition tax on the deemed mandatory repatriation of undistributed earnings.~~

~~The increase~~credits, and favorable rates in the effective annual tax rate in 2016 was primarily related to tax on the sale, within the Company’s consolidated group, of assets from Canadian subsidiaries to U.S. subsidiaries in preparation of the spin-off of Aptevo, and a valuation allowance charge recorded in its continuing operations related to Aptevo deferred tax assets prior to the distribution. The Company determined that upon spin-off, the deferred tax assets of Aptevo would be unrealizable.

foreign jurisdictions.

The Company recognizes interest in interest expense and recognizes potential penalties related to unrecognized tax benefits in selling, general and administrative expense. ~~Of the~~The total unrecognized tax benefits recorded at December 31, ~~2018~~2021 and ~~2017, $0.4~~2020 of $9.8 million and ~~$0.8 million, respectively, is classified as a current liability and $8.4 million and $1.2~~$9.2 million, respectively, is classified as a non-current liability on the balance sheet.

101

The table below presents the gross unrecognized tax benefits activity for ~~2018, 2017~~2021, 2020 and ~~2016:~~2019:

(in millions)
Gross unrecognized tax benefits at December 31, 2015 $ 1.5
Increases for tax positions for prior years -
Decreases for tax positions for prior years -
Increases for tax positions for current year 0.3
Settlements -
Lapse of statute of limitations -
Gross unrecognized tax benefits at December 31, 2016 1.8
Increases for tax positions for prior years -
Decreases for tax positions for prior years -
Increases for tax positions for current year 0.5
Settlements (0.3 )
Lapse of statute of limitations -
Gross unrecognized tax benefits at December 31, 2017 2.0
Increases for tax positions for prior years -
Unrecognized tax benefits acquired in business combinations 6.5
Decreases for tax positions for prior years -
Increases for tax positions for current year 0.3
Settlements -
Lapse of statute of limitations -
Gross unrecognized tax benefits at December 31, 2018 $ 8.8


(in millions)
Gross unrecognized tax benefits at December 31, 2018	$	8.8
Increases for tax positions for prior years	0.5
Increases for tax positions for current year	1.5
Settlements	(0.4)
Gross unrecognized tax benefits at December 31, 2019	$	10.4
Increases for tax positions for prior years	—
Increases for tax positions for current year	0.6
Settlements	(1.8)
Gross unrecognized tax benefits at December 31, 2020	$	9.2
Increases for tax positions for prior years	0.4
Increases for tax positions for current year	0.2
Gross unrecognized tax benefits at December 31, 2021	$	9.8

The ~~increase in the~~total gross unrecognized tax benefit ~~in the amount~~ of ~~$6.5~~$9.8 million, ~~relating~~includes $7.4 million that relates to the 2018 acquisition of PaxVax Holdings Company, Ltd., which is entirely offset by a $7.4 million receivable pursuant to a Tax Indemnity Agreement that became effective as at the close of the acquisition.

When resolved, substantially all of these ~~reserves~~liabilities would impact the effective tax rate.

The Company's federal and state income tax returns for the tax years ~~2013 to~~ 2017 and onwards remain open to examination. ~~The Company's tax returns in the United Kingdom remain open to examination for the tax years 2010 to 2017, and tax returns in Germany remain open indefinitely.~~ The Company's tax returns for Canada remain open to examination for the tax years ~~2011~~2013 to ~~2017.~~

2020. The Company's Irish tax returns remain open to examination for the tax years 2015 to 2019.

As of December 31, ~~2018,~~2021, the Company’s Canadian ~~2017~~2019 and 2020 Scientific Research and Experimental Development Claim is under audit. ~~As of December 31, 2018, the~~The Company's ~~2013~~2016 and ~~2014 federal~~2017 Canadian income tax returns for the Adapt entities are under audit.

~~13.~~12. Defined benefit and 401(k) savings plan

~~Defined benefit plan~~

The Company sponsors a defined benefit pension plan ~~as assumed through the acquisition of PaxVax~~ covering eligible employees in Switzerland (the ~~"Swiss Plan")~~Swiss Plan). Under the Swiss Plan, the Company and certain of its employees with annual earnings in excess of government determined amounts are required to make contributions into a fund managed by an independent investment fiduciary. Employer contributions must be in an amount at least equal to the employee’s contribution. The Swiss ~~Plan~~Plan's assets are comprised of an insurance contract that has a fair value consistent with its contract value based on the practicability exception using level 3 inputs. The entire liability is listed as non-current because plan assets are greater than the expected benefit payments over the next year. The Company recognized pension expense related to the Swiss Plan of ~~$0.3~~$2.0 million, $2.4 million and $1.5 million reflected as a component of selling, general and administrative for the ~~year~~years ended December 31, ~~2018.~~2021, 2020 and 2019, respectively.

102

The funded status of the Swiss Plan is as follows:


(in millions)	December 31, 2021		December 31, 2020
Fair value of plan assets, beginning of year	$	27.6	$	20.6
Employer contributions	1.4		1.4
Employee contributions	0.9		0.8
Net benefits received (paid)	0.5		6.8
Actual return on plan assets	(0.1)		0.3
Settlements	—		(4.5)
Currency impact	(1.0)		2.2
Fair value of plan assets, end of year	$	29.3	$	27.6
Projected benefit obligation, beginning of year	$	49.2	$	35.2
Service cost	2.4		1.9
Interest Cost	—		0.1
Employee contributions	0.9		0.8
Actuarial (gain) loss	(4.6)		5.0
Net benefits received (paid)	0.5		6.8
Settlements	—		(4.5)
Currency impact	(1.6)		3.9
Projected benefit obligation, end of year	$	46.8	$	49.2
Funded status, end of year	$	(17.5)	$	(21.6)
Accumulated benefit obligation, end of year	$	41.8	$	43.0

December 31,
(in millions) 2018
Fair value of plan assets, beginning of year $ —
Acquisitions 18.2
Employer contributions 0.2
Employee contributions 0.1
Benefits paid 0.3
Actual administration expenses —
Actual return on plan assets —
Settlements (0.6 )
Currency impact —
Fair value of plan assets, end of year 18.2
Projected Benefit Obligation, beginning of year $ —
Acquisitions 28.3
Service cost 0.3
Interest Cost 0.1
Employee contributions 0.1
Actuarial loss 0.3
Benefits paid (refunded) (0.1 )
Actual administration expenses, taxes —
Plan amendment 0.1
Settlements (0.6 )
Currency impact 0.1
Projected benefit obligation, end of year $ 28.6
Funded status, end of year $ (10.4 )
Accumulated benefit obligation, end of year $ 25.6

~~Since assets exceed the present value of expected benefit payments for the next twelve months, all of the liability is noncurrent.~~

Components of net periodic pension cost incurred during the year are as follows:


(in millions)	December 31, 2021		December 31, 2020		December 31, 2019
Service cost	$	2.4	$	1.9	$	1.3
Interest cost	—		0.1		0.2
Expected return on plan assets	(0.8)		(0.6)		(0.5)
Amortization of loss	0.6		0.2		—
Amortization of prior service cost	(0.2)		(0.2)		—
Settlements	—		1.0		0.5
Net periodic benefit cost	$	2.0	$	2.4	$	1.5

December 31,
(in millions) 2018
Service cost $ 0.3
Interest cost 0.1
Expected return on plan assets (0.1 )
Amortization of loss —
Amortization of prior service cost —
Net periodic benefit cost $ 0.3

The weighted average assumptions used to calculate the projected benefit obligations are as follows:


	December 31, 2021		December 31, 2020
Discount rate	0.30	%	0.02	%
Expected rate of return	3.0	%	3.0	%
Rate of future compensation increases	1.4	%	1.4	%

	~~December 31,~~
	~~2018~~
~~Discount rate~~	~~0.9%~~
~~Expected rate of return~~	~~3.0%~~
~~Rate of future compensation increases~~	~~1.5%~~

The overall expected long-term rate of return on assets assumption considers historical returns, as well as expected future returns based on the fact that investment returns are insured, and the legal minimum interest crediting rate as applicable. Total contributions expected to be made into the plan for the year-ended December 31, ~~2019~~2022 is ~~$1.0~~$1.4 million.

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The following table presents losses recognized in accumulated other comprehensive (income) loss before income tax related to the Company’s defined benefit pension plans:


(in millions)	Year Ended December 31, 2021		Year Ended December 31, 2020
Net actuarial (gain) loss	$	5.9	$	9.9
Prior service cost	(1.3)		(1.0)
Total recognized in accumulated other comprehensive (income) loss	$	4.6	$	8.9

Year Ended December 31,
(in millions) 2018
Net actuarial loss $ 0.1
Prior service cost 0.1
Total recognized in accumulated other comprehensive loss $ 0.2

Actuarial losses in accumulated other comprehensive loss related to the Company’s defined benefit pension plans expected to be recognized as components of net periodic benefit cost over the year ending December 31, 2019 are de minimis.

Future benefits expected to be paid as of December 31, ~~2018~~2021 are as follows:

(In millions) December 31, 2018
2019 $ 1.0
2020 2.0
2021 0.8
2022 1.4
2023 0.9
Thereafter 5.8
Total $ 11.9


(In millions)	December 31,
2022	$	2.2
2023	1.7
2024	1.7
2025	1.8
2026	1.8
Thereafter	37.6
Total	$	46.8

401(k) savings plan

The Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. The 401(k) Plan covers substantially all U.S. employees. Under the 401(k) Plan, employees may make elective salary deferrals. During the ~~year~~years ended December 31, ~~2018,~~2021, 2020 and 2019, the Company made matching contributions of approximately ~~$3.1~~$8.9 million, ~~which includes our acquisitions of Adapt and PaxVax. During the years ended December 31, 2017 and 2016, the Company made matching contributions of approximately $2.7~~$6.6 million and ~~$2.5~~$5.1 million, respectively.

~~14.~~13. Leases

The Company leases fill/finish, manufacturing, laboratory, warehouse and office facilities, office equipment and vehicles under various operating lease agreements to operate its business. For the years ended December 31, 2018, 2017, and 2016, totalcomponents of lease expense ~~was $3.3 million, $1.6 million and $1.4 million, respectively.~~were as follows:


	Year Ended December 31,
(In millions)	2021		2020		2019
Operating lease cost:
Amortization of right-of-use assets	$	5.6	$	4.5	$	2.7
Interest on lease liabilities	1.3		1.1		0.6
Total operating lease cost	$	6.9	$	5.6	$	3.3

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Supplemental balance sheet information related to leases was as follows:

~~Future minimum~~


		Year Ended December 31,
(In millions, except lease term and discount rate)	Balance Sheet Location	2021			2020
Operating lease right-of-use assets	Other assets	$	28.3		$	31.0

Operating lease liabilities, current portion	Other current liabilities	5.8			5.4
Operating lease liabilities	Other liabilities	24.2			27.8
Total operating lease liabilities		$	30.0		$	33.2

Operating leases:
Weighted average remaining lease term (years)		7.0			7.7
Weighted average discount rate		4.1		%	4.1		%

The Company's leases have remaining lease ~~payments under operating lease obligations~~terms of 1 year to 12 years, some of which include options to extend the leases for up to 5 years, and some of which include options to terminate the leases within 1 year.

Lease maturities as of December 31, ~~2018 were~~2021, are as follows:

(in millions)
2019 $ 3.4
2020 2.5
2021 2.5
2022 2.0
2023 2.6
2024 and beyond 2.5
Total minimum lease payments $ 15.5


(in millions)	Operating leases
2022	$	6.9
2023	6.9
2024	4.7
2025	3.1
2026	2.7
Thereafter	10.4
Total undiscounted lease liabilities	34.7
Less: Imputed interest	(4.7)
Total Lease liabilities	$	30.0

~~15.~~14. Earnings per share

The following table presents the calculation of basic and diluted net income per share:

Year ended December 31,
(in millions, except per share data) 2018 2017 2016
Numerator:
Net income from continuing operations $ 62.7 $ 82.6 $ 62.5
Interest expense, net of tax - 2.6 3.3
Amortization of debt issuance costs, net of tax - 0.7 0.8
Net income, adjusted from continuing operations 62.7 85.9 66.6
Net loss from discontinued operations - - (10.7 )
Net income, adjusted $ 62.7 $ 85.9 $ 55.9

Denominator:
Weighted-average number of shares-basic 50.1 41.8 40.2
Dilutive securities-equity awards 1.3 1.1 1.0
Dilutive securities-convertible debt - 7.4 8.1
Weighted-average number of shares-diluted 51.4 50.3 49.3

Net income per share-basic from continuing operations $ 1.25 $ 1.98 $ 1.56
Net loss per share-basic from discontinued operations - - (0.27 )
Net income per share-basic $ 1.25 $ 1.98 $ 1.29

Net income per share-diluted from continuing operations $ 1.22 $ 1.71 $ 1.35
Net loss per share-diluted from discontinued operations - - (0.22 )
Net income per share-diluted $ 1.22 $ 1.71 $ 1.13


	Year Ended December 31,
(in millions, except per share data)	2021		2020		2019
Numerator:
Net income	$	230.9	$	305.1	$	54.5

Denominator:
Weighted-average number of shares-basic	53.5		52.7		51.5
Dilutive effect of employee incentive plans	0.6		1.1		0.9
Weighted-average number of shares-diluted	54.1		53.8		52.4

Net income per share-basic	$	4.32	$	5.79	$	1.06
Net income per share-diluted	$	4.27	5.67		$	1.04

~~For~~Basic net income per share is computed by dividing net income by the ~~year ending December 31, 2018 and 2017, substantially all~~weighted average number of ~~the outstanding stock options to purchase~~ shares of common stock ~~were included in~~outstanding during the ~~calculation~~period. Diluted income per share is computed using the treasury method by dividing net income by the weighted average number of ~~diluted earnings per share. For the years ending December 31, 2016, outstanding stock options to purchase approximately 1.4 million~~ shares of common stock ~~respectively,~~outstanding during the period,

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adjusted for the potential dilutive effect of other securities if such securities were converted or exercised and are not anti-dilutive.

The following table presents the share-based awards that are not considered in the diluted ~~earnings~~net income per share calculation generally because the exercise price of ~~these options is~~the awards was greater than the average per share closing price during the year ending December 31, 2021, 2020 and ~~their effect would~~2019. In certain instances awards may be ~~anti-dilutive.~~anti-dilutive even if the average market price exceeds the exercise price when the sum of the assumed proceeds exceeds the difference between the market price and the exercise price.


	Year Ended December 31,
	2021	2020	2019
Anti-dilutive stock awards	1.0	—	$	0.9

~~16.~~15. Purchase ~~commitment~~

commitments

As of December 31, ~~2018~~2021 the Company has approximately ~~$66.7~~$132.0 million of purchase commitments associated with raw materials and ~~contract manufacturing~~CDMO services that will be purchased in the next ~~three~~3 years. For the years ended December 31, ~~2018, 2017,~~2021, 2020, and ~~2016,~~2019, the Company purchased ~~$12.1~~$110.7 million, ~~$3.0~~$108.0 million and ~~$4.5~~$51.3 million, respectively, of materials under ~~this commitment.~~these commitments.

~~17.~~16. Segment information

~~For financial reporting purposes, the~~The Company reports financial information for ~~one~~1 reportable segment. This reportable segment engages in business activities based on financial information that is provided to and resources which are allocated by the Chief Operating Decision Maker. The accounting policies of the reportable segment isare the same as those described in the summary of significant accounting policies.

~~For the year ended December 31, 2018, 2017 and 2016, the Company's revenues disaggregated by the major sources was as follows:~~

(in millions)
Year Ended December 31,
2018 2017 2016

U.S Non-U.S. U.S Non-U.S. U.S Non-U.S.
Government Government Total Government Government Total Government Government Total

Product sales $ 526.1 $ 80.4 $ 606.5 $ 374.8 $ 46.7 $ 421.5 $ 283.2 $ 13.1 $ 296.3
Contract manufacturing - 98.9 98.9 - 68.9 68.9 - 49.1 49.1
Contracts and grants 71.5 5.5 77.0 65.1 5.4 70.5 138.1 5.3 143.4
Total revenues $ 597.6 $ 184.8 $ 782.4 $ 439.9 $ 121.0 $ 560.9 $ 421.3 $ 67.5 $ 488.8

For the years ended December 31, 2018, 2017, and 2016, the Company’s revenues within the United States comprised 91%, 89% and 94%, respectively, of total revenues. For the years ended December 31, 2018, 2017, and 2016, product sales from BioThrax to the USG comprised approximately 45%, 67% and 80%, respectively, of total product sales.

~~The Company's product sales from BioThrax, ACAM2000 and Other comprised approximately:~~

2018 2017 2016
% of product sales:
BioThrax 46% 68% 80%
ACAM2000 19% 0% 0%
Other 35% 32% 20%

~~As of December 31, 2018, 2017 and 2016, aside from BioThrax and ACAM2000, there were no other product sales to an individual customer or for an individual product in excess of 10% of total revenues.~~

For years ended December 31, ~~2018~~2021 and ~~2017,~~2020, the Company had long-lived assets outside of the United States of approximately ~~$82.9~~$111.9 million and ~~$28.6~~$98.6 million, respectively, which are primarily located within Canada and Switzerland.

~~18.Quarterly financial data (unaudited)~~17. Litigation

Securities and Shareholder Litigation

~~Quarterly financial information for~~On April 20, 2021, May 14, 2021, and June 2, 2021, purported class action lawsuits were filed against the ~~years ended December 31, 2018~~Company and ~~2017 is presented in the following tables:~~

Quarter Ended
(in millions, except per share data) March 31, June 30, September 30, December 31,
2018:
Revenue $ 117.8 $ 220.2 $ 173.7 $ 270.7
Income (loss) from operations (9.5 ) 66.8 21.3 11.2
Net income (loss) (4.9 ) 50.1 20.9 (3.4 )

Net income (loss) per share-basic $ (0.10 ) $ 1.00 $ 0.42 $ (0.07 )
Net income (loss) per share-diluted $ (0.10 ) $ 0.98 $ 0.41 $ (0.07 )

2017:
Revenue $ 116.9 $ 100.8 $ 149.4 $ 193.8
Income from operations 14.9 8.5 47.8 53.1
Net income 10.5 4.6 33.6 33.9

Net income per share-basic $ 0.26 $ 0.11 $ 0.81 $ 0.77
Net income per share-diluted $ 0.23 $ 0.11 $ 0.68 $ 0.67

~~19. Litigation~~

~~ANDA Litigation~~

~~On September 14, 2018, Adapt Pharma Inc., Adapt Pharma Operations Limited~~certain of its current and Adapt Pharma Ltd., or collectively, Adapt Pharma, and Opiant Pharmaceuticals, Inc., or Opiant, received notice from Perrigo UK FINCO Limited Partnership, or Perrigo, that Perrigo had filed an Abbreviated New Drug Application, or ANDA, with the United States Food and Drug Administration, or FDA, seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray before the expiration of U.S. Patent Nos. 9,211,253, or the ‘253 Patent, 9,468,747, or the ‘747 Patent, 9,561,177, or the ‘177 Patent, 9,629,965, or the ‘965 Patent, and 9,775,838, or the ‘838 Patent. On or about October 25, 2018, Perrigo sent a subsequent notice letter relating to U.S. Patent No. 10,085,937, or the ‘937 Patent. Perrigo’s notice letters assert that its generic product will not infringe any valid and enforceable claim of these patents.

On October 25, 2018, Emergent BioSolutions’ Adapt Pharma subsidiaries and Opiant, or collectively, Plaintiffs, filed a complaint for patent infringement of the ‘253, ‘747, ‘177, ‘965, and the ‘838 Patents against Perrigoformer senior officers in the United States District Court for the District of ~~New Jersey arising~~Maryland on behalf of purchasers of the Company’s common stock, seeking to pursue remedies under the Securities Exchange Act of 1934 (the Exchange Act). These complaints were filed by Plaintiff Palm Tran, Inc. – Amalgamated Transit Union Local 1577 Pension Plan; Plaintiff Alan I. Roth; and Plaintiff Stephen M. Weiss, respectively. The complaints allege, among other things, that the defendants disseminated materially false and misleading information about its capabilities to manufacture COVID-19 vaccine bulk drug substance in violation of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder. These cases were consolidated on December 23, 2021, under the caption In re Emergent BioSolutions Inc. Securities Litigation, No. 8:21-cv-00955-PWG. The Lead Plaintiffs in the consolidated matter are Nova Scotia Health Employees’ Pension Plan and The City of Fort Lauderdale Police & Firefighters’ Retirement System. The Lead Plaintiff is to prepare an amended consolidated complaint by March 10, 2022. The defendants believe that the allegations in the complaints are without merit and intend to defend the matters vigorously. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot reasonably estimate the possible loss or range of loss, if any, that may result from ~~Perrigo’s ANDA filing~~the consolidated action.

With respect to the specific legal proceedings and claims described below, unless otherwise noted, the amount or range of possible losses is not reasonably estimable. There can be no assurance that the settlement, resolution, or other outcome of one or more matters, including the matters set forth below, during any subsequent reporting period will not have a material adverse effect on the Company's results of operations or cash flows for that period or on the Company's financial condition.

On June 29, 2021, Lincolnshire Police Pension Fund and on August 16, 2021, Pooja Sayal, filed putative stockholder derivative lawsuits in the United States District Court for the District of Maryland on behalf of the

106

Company against certain of its current and former officers and directors for breach of fiduciary duties, waste of corporate assets, and unjust enrichment, each allegation related to the Company’s capabilities to manufacture COVID-19 vaccine bulk drug substance. In addition to monetary damages, the complaints seek the implementation of multiple corporate governance and internal policy changes. On November 16, 2021, both cases were consolidated under the caption In re Emergent BioSolutions Inc. Stockholder Derivative Litigation, Master File No. 8:21-cv-01595-PWG. The defendants believe that the allegations in the complaints are without merit and intend to defend the matter vigorously.

On September 15, 2021, September 16, 2021, and November 12, 2021, putative stockholder derivative lawsuits were filed by Chang Kyum Kim, Mark Nevins and Employees Retirement System of the State of Rhode Island, North Collier Fire Control and Rescue District Firefighters Pension Plan, and Pembroke Pines Firefighters & Police Officers Pension Fund in The Court of Chancery of the State of Delaware on behalf of the Company against certain of its current and former officers and directors for breach of fiduciary duties, unjust enrichment and insider trading, each allegation related to the Company’s capabilities to manufacture COVID-19 vaccine bulk drug substance. In addition to monetary damages, the complaints seek the implementation of multiple corporate governance and internal policy changes. On February 2, 2022, the cases were consolidated under the caption In re Emergent BioSolutions, Inc. Derivative Litigation, C.A. No. 2021-0974-MTZ with the ~~FDA. Plaintiffs~~institutional investors as co-lead plaintiffs. The defendants believe that the allegations in the complaints are without merit and intend to defend the matters vigorously.

On December 3, 2021, December 22, 2021 and January 18, 2022, putative stockholder derivative lawsuits were filed ~~a second complaint against Perrigo~~by Zachary Elton, Eric White and Jeffrey Reynolds in the Circuit Court for Montgomery County, Maryland on ~~December 7, 2018, for the infringement~~behalf of the ~~‘937 Patent. As a result~~Company against certain of ~~timely filing~~its current and former officers and directors for breach of fiduciary duty, unjust enrichment, waste of corporate assets, failing to maintain internal controls, making or causing to be made false and/or misleading statements and material omissions, insider trading and otherwise violating the first lawsuit in accordance with the Hatch-Waxman Act, a 30-month stay of approval will be imposed by the FDA on Perrigo’s ANDA, which is expected to remain in effect until March 2021 absent an earlier judgment, unfavorablelaws, each allegation related to the ~~Plaintiffs, by~~Company’s capabilities to manufacture COVID-19 vaccine bulk drug substance. The complaints seek monetary and punitive damages. The defendants believe that the ~~Court.~~ allegations in the complaints are without merit and intend to defend the matters vigorously.

~~On or about February 27, 2018,~~In addition to the above actions, the Company has received preliminary inquiries and subpoenas to produce documents related to these matters from Representative Carolyn Maloney and Representative Jim Clyburn, members of the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis, Senator Murray of the Committee on Health, Education, Labor and Pensions, the Financial Industry Regulatory Authority, the Department of Justice, the SEC, the Maryland Attorney General’s Office, and the New York Attorney General’s Office. The Company is producing and has produced documents as required in response and will continue to cooperate with these government inquiries.

Intellectual Property

Emergent BioSolutions’ Adapt Pharma subsidiaries (Emergent) are as follows: Emergent Devices Inc. ~~and~~(EBPA), formerly known as Adapt Pharma Inc.; Emergent Operations Ireland Limited (EIRE), formerly known as Adapt Pharma Operations Limited; and Emergent BioSolutions Ireland Limited (EIR2), formerly known as Adapt Pharma Limited.

ANDA Litigation - Teva 4mg

Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant Pharmaceuticals Inc. (Opiant) received notice letters from Teva Pharmaceuticals Industries ~~Ltd.~~Limited and Teva Pharmaceuticals USA ~~Inc., or collectively Teva,~~(collectively, Teva) that Teva had filed an ~~ANDA~~Abbreviated New Drug Application (ANDA) with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone ~~hydrochloride)~~HCI) Nasal Spray 24 mg/spray before the expiration of ~~U.S. Patent No. 9,480,644,~~ certain patents listed on the FDA’s website for Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book Listed Patents) for NARCAN. Teva’s notice letters alleged that claims of certain Orange Book Listed Patents for NARCAN were invalid and/or would not be infringed by the ~~‘644 Patent, and U.S. Patent No. 9,707,226, or the '226 Patent. Teva's notice letter asserts that the commercial manufacture, use or sale of its generic drug product~~activities described in ~~its ANDA will not infringe the '644 Patent or the '226 Patent, or that the '644 Patent and '226 Patent are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations Limited~~Teva’s ANDA. Emergent and Opiant filed ~~a complaint for patent infringement~~complaints against Teva in the ~~United States~~U.S. District Court for the District of New ~~Jersey.~~Jersey alleging infringement of certain Orange Book Listed Patents for NARCAN. On June 5, 2020, the U.S. District Court for the District of New Jersey ruled in favor of Teva. Emergent appealed the District of New Jersey’s decision to the Court of Appeals for the Federal Circuit (CAFC). On February 10, 2022, the CAFC issued a decision affirming the District Court’s decision and the Company intends to petition for a rehearing.

Emergent filed suit in the Federal Court in Canada against Teva Pharmaceuticals in July 2020. The litigation in Canada related to Teva Pharmaceuticals’ filing of an abbreviated new drug submission (ANDS) in Canada seeking to

~~On or about September 13, 2016,~~

107

manufacture and sell a generic form of NARCAN® (naloxone HCI) Nasal Spray ahead of the expiry of the Canadian patent covering NARCAN. In January 2022, Emergent and Teva settled the matter and mutually agreed to discontinue the litigation.

ANDA Litigation - Teva 2mg

Emergent BioSolutions’ Adapt Pharma ~~Inc.~~subsidiaries EBPA and ~~Adapt Pharma Operations Limited~~EIRE, and Opiant received a notice letter from Teva that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone ~~hydrochloride)~~HCI) Nasal Spray 42 mg/spray before the expiration of ~~U.S. Patent No. 9,211,253,~~ certain Orange Book Listed Patents for the 2 mg/spray dose of NARCAN®. Teva’s notice letter alleged that claims of certain Orange Book Listed Patents for the 2 mg/spray dose of NARCAN® were invalid and/or would not be infringed by the '253 Patent. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant received additional notices from Teva relating to the '747, the '177, the '965, the '838, and the ‘937 Patents. Teva's notice letters assert that the commercial manufacture, use or sale of its generic drug productactivities described in its ANDA will not infringe the '253, the '747, the '177, the '965, the '838, or the ‘937 Patent, or that the '253, the '747, the '177, the '965, the '838, and the ‘937 Patents are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations LimitedTeva’s ANDA. Emergent and Opiant filed ~~a complaint for patent infringement~~complaints against Teva in the ~~United States~~U.S. District Court for the District of New Jersey ~~with respect to the '253 Patent. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant also filed complaints for patent~~alleging infringement ~~against Teva in the United States District Court~~of certain Orange Book Listed Patents for the ~~District~~2 mg/spray dose of New Jersey with respect to the '747, the '177, the '965, and the '838 Patents. All five proceedings have been consolidated. As of February 21, 2019, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant, are evaluating Teva's notice letter related to the ‘937 Patent.

~~In the complaints described in the paragraphs above, the Plaintiffs seek, among other relief, orders that the effective date of FDA approvals~~NARCAN. This case is currently stayed pending final outcome of the ~~Teva ANDA products and the Perrigo ANDA product be a date not earlier than the expiration~~appeal of the patents listed for each product, equitable relief enjoining Teva and Perrigo from making, using, offering to sell, selling, or importing the products that are the subject of Teva and Perrigo’s respective ANDAs, until after the expiration of the patents listed for each product, and monetary relief or other relief as deemed just and proper by the court.NARCAN 4 mg/spray case.

~~As of the date of this filing, the range of potential gain cannot be determined or estimated for the above mentioned complaints.~~

~~Shareholder Class Action Lawsuit filed July 19, 2016~~

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Not applicable.

ITEM 9A.CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, ~~2018.~~2021. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, ~~2018,~~2021, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management's Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Our management assessed the effectiveness of our internal control over financial reporting as of December 31, ~~2018.~~2021. In making this assessment, our

management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework~~(2013~~ (2013 Framework).Based on this assessment, our management concluded that, as of December 31, ~~2018,~~2021, our internal control over financial reporting was effective based on those criteria.

Management’s assessment of and conclusion on the effectiveness of disclosure controls and procedures and internal controls over financial reporting did not include the internal controls related to the operations acquired in the acquisition of PaxVax Holding Company Ltd. ("PaxVax") and Adapt Pharma Limited ("Adapt") which are included in the 2018 consolidated financial statements of Emergent BioSolutions, Inc. and subsidiaries and constituted $1.1 billion and $942.0 million of total and net assets, respectively, as of December 31, 2018 and $51.1 million and $28.7 million of revenues and operating loss, respectively, for the year then ended. Our audit of internal control over financial reporting of Emergent BioSolutions Inc. and subsidiaries also did not include an evaluation of the internal control over financial reporting of PaxVax and Adapt.

Ernst & Young LLP, the independent registered public accounting firm that has audited our consolidated financial statements included herein, has issued an attestation report on the effectiveness of our internal control over financial reporting as of December 31, ~~2018,~~2021, a copy of which is included in this annual report on Form 10-K.

Changes in Internal Control Over Financial Reporting

During the quarter ended September 30, 2021, we identified and disclosed a material weakness in our controls over the accounting assessment of specific attributes within complex revenue arrangements with our customers (Revenue Accounting Issue). To remediate the material weakness, we designed and implemented controls and enhanced and revised the design of existing controls and procedures to properly assess Revenue Accounting Issues.

~~There have~~During the quarter ended December 31, 2021, we successfully completed the testing necessary to conclude that the material weakness has been remediated.

Except as noted above, there has been no ~~changes~~change in ~~our~~the Company's internal control over financial reporting ~~(as~~as defined in ~~Rule~~Rules 13a-15(f)~~) identified in connection with the evaluation required by Rule 13a-15(d) of the Exchange Act~~ and 15d-15(f) that occurred during the ~~period covered by this report~~quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

109

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Emergent BioSolutions Inc. ~~and subsidiaries~~

Opinion on Internal Control over Financial Reporting

We have audited Emergent BioSolutions Inc. and subsidiaries’ internal control over financial reporting as of December 31, ~~2018,~~2021, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Emergent BioSolutions Inc. and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, ~~2018~~2021, based on the COSO criteria.

As indicated in the accompanying Management’s Report on Internal Control Over Financial Reporting, management’s assessment of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of PaxVax Holding Company Ltd. (PaxVax) or Adapt Pharma Limited (Adapt), which are included in the 2018 consolidated financial statements of the Company, and constituted $1.1 billion and $942.0 million of total and net assets, respectively, as of December 31, 2018 and $51.1 million and $28.7 million of revenues and operating loss, respectively, for the year then ended. Our audit of internal control over financial reporting of the Company also did not include an evaluation of the internal control over financial reporting of PaxVax or Adapt.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, ~~2018~~2021 and ~~2017,~~2020, the related consolidated statements of operations, comprehensive income,, changes in ~~stockholders'~~stockholders’ equity and cash flows for each of the three years in the period ended December 31, ~~2018,~~2021, and the related notes and financial statement schedule listed in the Index at Item 15 and our report dated February ~~21, 2019~~25, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Ernst & Young LLP

Baltimore, Maryland

February ~~21, 2019~~25, 2022

110

ITEM 9B. OTHER INFORMATION

Not applicable.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

Not applicable.

111

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Code of Ethics

We have adopted a code of business conduct and ethics that applies to our directors, officers (including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions), as well as our other employees. A copy ofour code of business conduct and ethics is available on our website at www.emergentbiosolutions.com. We intend to post on our website all disclosures that are required by applicable law, the rules of the ~~Securities and Exchange Commission~~SEC or the New York Stock Exchange concerning any amendment to, or waiver of, our code of business conduct and ethics.

The remaining information required by Item 10 is hereby incorporated by reference from our Definitive Proxy Statement relating to our ~~2019~~2022 Annual Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.

ITEM 11. EXECUTIVE COMPENSATION

The information required by Item 11 is hereby incorporated by reference from our Definitive Proxy Statement relating to our ~~2019~~2022 annual meeting of stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by Item 12 is hereby incorporated by reference from our Definitive Proxy Statement relating to our ~~2019~~2022 Annual Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by Item 13 is hereby incorporated by reference from our Definitive Proxy Statement relating to our ~~2019~~2022 Annual Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by Item 14 is hereby incorporated by reference from our Definitive Proxy Statement relating to our ~~2019~~2022 Annual Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

Financial Statements

The following financial statements and supplementary data are filed as a part of this annual report on Form 10-K in Part I,II, Item 8.

•Report of Independent Registered Public Accounting Firm (PCAOB ID: 42)

•Consolidated Balance Sheets at December 31, ~~2018~~2021 and ~~2017~~2020

•Consolidated Statements of Operations for the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019

•Consolidated Statements of Comprehensive Income for the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019

•Consolidated Statements of Cash Flows for the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019

•Consolidated Statement of Changes in Stockholders' Equity for the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019

•Notes to Consolidated Financial Statements

Financial Statement Schedules

Schedule II - Valuation and Qualifying Accounts for the years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019 has been filed as part of this annual report on Form 10-K. All other financial statement schedules are omitted because they are not applicable or the required information is included in the financial statements or notes thereto.

Exhibits

Those exhibits required to be filed by Item 601 of Regulation S-K are listed in the Exhibit Index immediately preceding the exhibits hereto and such listing is incorporated herein by reference.

112

SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS


(in millions)	Beginning Balance		Charged to Costs and Expenses		Deductions		Ending Balance
Year Ended December 31, 2021
Inventory allowance	$	37.6	$	37.9	$	(32.8)	$	42.7
Prepaid expenses and other current assets allowance	3.9		0.2		(0.4)		3.7

Year Ended December 31, 2020
Inventory allowance	$	17.9	$	48.0	$	(28.3)	$	37.6
Prepaid expenses and other current assets allowance	4.0		0.5		(0.6)		3.9

Year Ended December 31, 2019
Inventory allowance	$	14.0	$	23.0	$	(19.1)	$	17.9
Prepaid expenses and other current assets allowance	4.3		—		(0.3)		4.0

(in millions) Beginning Balance Charged to costs and expenses Deductions Ending Balance
Year Ended December 31, 2018
Inventory allowance $ 3.8 $ 14.6 $ (8.8 ) $ 9.6
Prepaid expenses and other current assets allowance 5.3 - (1.0 ) 4.3

Year Ended December 31, 2017
Inventory allowance $ 3.5 $ 8.8 $ (8.5 ) $ 3.8
Prepaid expenses and other current assets allowance 4.9 0.4 - 5.3
��
Year Ended December 31, 2016
Inventory allowance $ 1.6 $ 10.0 $ (8.1 ) $ 3.5
Prepaid expenses and other current assets allowance 2.0 2.9 - 4.9

ITEM 16. FORM 10-K SUMMARY

Not applicable.

113

Exhibit Index

All documents referenced below were filed pursuant to the Securities Exchange Act of 1934 by the Company, (File No. 001-33137), unless otherwise indicated.

~~Exhibit~~
Exhibit Number				Exhibit Description
~~2.1~~3.1				~~Contribution Agreement, dated July 29, 2016, by and among Emergent BioSolutions Inc., Aptevo Therapeutics Inc., Aptevo Research and Development LLC and Aptevo BioTherapeutics LLC~~ ~~(incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K, filed on August 4, 2016).~~
~~2.2~~		~~Separation and Distribution Agreement, dated July 29, 2016, by and between Emergent BioSolutions Inc. and Aptevo Therapeutics Inc.~~ ~~(incorporated by reference to Exhibit 2.2 to the Company's Current Report on Form 8-K, filed on August 4, 2016).~~
~~2.3~~		~~Asset Purchase Agreement, dated July 14, 2017, among Sanofi Pasteur Biologics, LLC, Acambis Research Ltd. and Emergent BioSolutions Inc.~~ ~~(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on July 14, 2017).~~
~~2.4~~		~~Asset Purchase Agreement, dated July 19, 2017, among GlaxoSmithKline LLC, Human Genome Sciences, Inc., and Emergent BioSolutions Inc.~~ ~~(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 3, 2017).~~
~~2.5~~	†	~~Merger Agreement, dated August 8, 2018, by and among Emergent BioSolutions Inc., PaxVax Holding Company Ltd., Panama Merger Sub Ltd., and PaxVax SH Representative LLC~~ ~~(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 5, 2018).~~
~~2.6~~	†	~~Share Purchase Agreement, dated August 28, 2018, by and among Emergent BioSolutions Inc., the Sellers identified therein, Seamus Mulligan and Adapt Pharma Limited~~ ~~(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 15, 2018).~~
~~3.1~~		Third Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3 to the Company's Quarterly Report on Form 10-Q filed on August 5, 2016).
3.2				Amended and Restated By-laws of the Company (incorporated by reference to Exhibit 3 to the Company's Current Report on Form 8-K filed on August 16, 2012).
4.1				Specimen Common Stock Certificate ~~(incorporated~~(incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Company's Registration Statement on Form S-1 filed on October 20, 2006) (Registration No. 333-136622).
4.2				Registration Rights Agreement, dated as of September 22, 2006, among the Company and the stockholders listed on Schedule 1 thereto (incorporated by reference to Exhibit 4.3 to Amendment No. 1 to the Company's Registration Statement on Form S-1 filed on September 25, 2006) (Registration No. 333-136622).
4.3			#	Agreement to Terminate Class A Stockholders Registration Rights Agreement, dated December 9, 2021 by and among Emergent BioSolutions Inc., Intervac, L.L.C. and BioVac, L.L.C.
4.4				Indenture, dated as of January 29, 2014, between the Company and Wells Fargo Bank, National Association, including the form of 2.875% Convertible Senior Notes due 2021 (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on January 29, 2014).
~~9.1~~4.5				~~Voting and Right of First Refusal Agreement,~~Indenture, dated as of ~~October 21, 2005, between~~August 7, 2020, by and among the ~~William J. Crowe, Jr. Revocable Living Trust~~Company, certain subsidiaries of the Company and ~~Fuad El-Hibri~~U.S. Bank National Association, as trustee. (incorporated by reference to Exhibit ~~9.1 to the Company's Registration Statement on Form S-1 filed on August 14, 2006) (Registration No. 333-136622).~~
~~10.1~~		~~Credit Agreement, dated September 29, 2017, among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the Administrative Agent~~ ~~(incorporated by reference to Exhibit 10~~4.1 to the Company's Current Report on Form 8-K, filed on ~~October 2, 2017)~~August 7, 2020.) (incorporated by reference to Exhibit 4.1 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
~~10.2~~4.6				Form of 3.875% Senior Unsecured Note due 2028 (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K, filed on August 7, 2020.) (incorporated by reference to Exhibit 4.2 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
4.7				Description of the Company's Securities(incorporated by reference to Exhibit 4.6 to the Company's Annual Report on Form 10-K filed on February 19, 2021).
10.1				Amended and Restated Credit Agreement, dated October 15, 2018, by and among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the Administrative Agent (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K, filed on October 15, 2018).
~~10.3~~10.2			*	~~Emergent BioSolutions Inc. Employee Stock Option Plan,~~First Amendment to Amended and Restated Credit Agreement, dated June 27, 2019 (incorporated by reference to Exhibit 10.2 to the Company's Annual Report on Form 10-K filed on February 19, 2021).
10.3			*	Second Amendment to Amended and Restated Credit Agreement, dated August 7, 2020 (incorporated by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K, filed on August 7, 2020).
10.4			† †	Purchase Agreement, dated as ~~amended~~of August 4, 2020, by and ~~restated on January 26, 2005~~among the Company, the subsidiaries of the Company named therein as guarantors, and Wells Fargo Securities, LLC, as representative of the several initial purchasers identified therein. (incorporated by reference to Exhibit 10.1 to the Company's ~~Registration Statement~~Current Report on Form ~~S-1~~8-K, filed on August ~~14, 2006) (Registration No. 333-136622).~~7, 2020.
~~10.4~~10.5			*	Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 5 to the Company's Registration Statement on Form S-1 filed on October 30, 2006) (Registration No. 001-33137).
~~10.5~~10.6			*	Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on August 7, 2009).
~~10.6~~10.7			*	Second Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 6, 2012).
~~10.7~~10.8			*	Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan ~~(incorporated~~ (incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 7, 2014).

114


~~10.8~~Exhibit Number				Exhibit Description
10.9			*	Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on August 5, 2016).
~~10.9~~10.10			*	Emergent BioSolutions Inc. Stock Incentive Plan (incorporated by reference to Exhibit 99 to Registration Statement on Form S-8, filed on May 30, ~~2018.)~~2018).
~~10.10~~10.11			#**	Form of Director Nonstatutory Stock Option ~~Agreement.~~Agreement (incorporated by reference to Exhibit 10.10 to the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.11~~10.12			#**	Form of Director Restricted Stock Unit ~~Agreement.~~Agreement (incorporated by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.12~~10.13			#**	Global Form of Restricted Stock Unit Award Agreemen t (incorporated by reference to Exhibit 10.13 to the Company's Annual Report on Form 10-K filed on February 19, 2021).
10.14			*	Global Form of Non-Qualified Stock Option ~~Agreement.~~
~~10.13~~	#*	~~Form of Restricted Stock Unit Agreement.~~
~~10.14~~	#*	~~Form of Non-Qualified Stock Option Agreement. – Canadian Participant.~~
~~10.15~~	#*	~~Form of Restricted Stock Unit Agreement. – Canadian Participant.~~
~~10.16~~	#*	~~Form of Non-Qualified Stock Option Agreement. – UK Participant.~~
~~10.17~~	#*	~~Form of Restricted Stock Unit Agreement. – UK Participant.~~
~~10.18~~	#*	~~Form of Non-Qualified Stock Option Agreement. – Swiss Participant.~~
~~10.19~~	#*	~~Form of Restricted Stock Unit Agreement. – Swiss Participant.~~
~~10.20~~	#*	~~Form of Non-Qualified Stock Option Agreement. – Irish Participant.~~
~~10.21~~	#*	~~Form of Restricted Stock Unit Agreement. – Irish Participant.~~
~~10.22~~	*	~~Form of Performance-Based Stock Unit Award~~ Agreement (incorporated by reference to Exhibit 1010.11 to the Company’s ~~Current~~Annual Report on Form ~~8-K~~10-K filed on February ~~21, 2017)~~25, 2020).
~~10.23~~10.15			*	Form of ~~2018-2020~~2019-2021 Performance-Based Stock Unit Award Agreement~~(incorporated by reference to Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 14, 2018).~~
~~10.24~~	*	~~Form of 2019-2021 Performace-Based Stock Unit Award Agreement~~ (incorporated by reference to Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 12, 2019).
~~10.25~~10.16			*	Form of 2020-2022 Performance-Based Stock Unit Award Agreement (incorporated by reference to Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 18, 2020).
10.17			*	Form of 2021-2023 Performance-Based Stock Unit Award Agreement (incorporated by reference to Exhibit 99 to the Company’s Current Report on Form 8-K filed on February 16, 2021).
10.18			*	Form of Indemnity Agreement for ~~directors~~Directors and ~~senior officers~~Senior Officers (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on January 18, 2013).
~~10.26~~10.19			*	~~Director Compensation Program~~ ~~(incorporated by reference to Exhibit 10.10 to the Company's Annual Report on Form 10-K filed on March 8, 2013).~~
~~10.27~~	*	Annual Bonus Plan for Executive Officers ~~(incorporated~~(incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K filed on March 5, 2010).
~~10.28~~10.20			*	Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on December 22, 2011).
~~10.29~~10.21			*	Second Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on July 16, 2015).
~~10.30~~10.22			†	~~Amended and Restated Marketing Agreement, dated as of November 5, 2008, between Emergent Biodefense Operations Lansing LLC~~ ~~(formerly known as Emergent Biodefense Operations Lansing Inc.) and Intergen N.V. (incorporated by reference to Exhibit 10.27 to the Company's Annual Report on Form 10-K filed on March 6, 2009).~~
~~10.31~~	†	Solicitation/Contract/Order for Commercial Items (the ~~"CDC~~CDC BioThrax Procurement ~~Contract")~~Contract), effective December 8, 2016, from the Centers for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K, filed on February 28, 2017).
~~10.32~~10.23			†	Modification No. 1, effective January 27, 2017, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.22 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
~~10.33~~10.24			†	Modification No. 2, effective February ~~23,2017,~~23,2017, to the CDC BioThrax Procurement Contract~~(incorporated~~ (incorporated by reference to Exhibit 10.23 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
~~10.34~~10.25				Modification No. 3, effective March 22, 2017, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.24 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
~~10.35~~10.26			†	Modification No. 4, effective April 5, 2017, to the CDC BioThrax Procurement Contract~~(incorporated~~ (incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
~~10.36~~10.27			†	Modification No. 5, effective September 8, 2017, to the CDC BioThrax Procurement Contract~~(incorporated~~ (incorporated by reference to Exhibit ~~10.26~~10.2 to the Company's Quarterly Report on Form 10-Q filed on November 3, 2017).
~~10.37~~10.28			†	Modification No. 6, effective September 21, 2017, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.27 the Company’s Annual Report on Form 10-K filed on February 23, 2018).
~~10.38~~10.29			†	Modification No. 7, effective February 26, 2018, to the CDC BioThrax Procurement Contract~~(incorporated~~ (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2018).
~~10.39~~10.30				Modification No. 8, effective March 6, 2018, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2018).
~~10.40~~10.31			†	Modification No. 9, effective June 6, 2018, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).

115


~~10.41~~Exhibit Number		Exhibit Description
10.32	†	Modification No. 10, effective June 18, 2018, to the CDC BioThrax Procurement ~~Contract.~~ Contract~~(incorporated~~ (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
~~10.42~~10.33	†	Modification No. 11, effective June 20, 2018, to the CDC BioThrax Procurement ~~Contract.~~Contract (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
~~10.43~~10.34	†	Modification No. 12, effective June 21, 2018, to the CDC BioThrax Procurement ~~Contract.~~Contract (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
~~10.44~~10.35	†	Modification No. 13, effective ~~December 6,~~September 21, 2018 to the CDC BioThrax Procurement~~(incorporated~~ (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 2, 2018).
~~10.45~~10.36	#††	Modification No. 14, effective October 1, 2018, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.45 the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.46~~10.37	#††	Modification No. 15, effective December 7, 2018, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.46 the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.47~~10.38	#	Modification No. 16, effective ~~December 8, 2018,~~January 14, 2019, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.47 the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.48~~10.39	††	Modification No. 17, effective June 13, 2019, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on August 2, 2019).
10.40	††	Modification No. 18, effective September 11, 2019, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.39 the Company’s Annual Report on Form 10-K filed on February 25, 2020).
10.41	††	Modification No. 19, effective January 6, 2020, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.40 the Company’s Annual Report on Form 10-K filed on February 25, 2020).
10.42	††	Modification No. 20, effective January 7, 2020, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.41 the Company’s Annual Report on Form 10-K filed on February 25, 2020).
10.43	††	Modification No. 21, effective January 7, 2020, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.45 the Company’s Annual Report on Form 10-K filed on February 19, 2021)
10.44	††	Modification No. 22 to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.46 the Company’s Annual Report on Form 10-K filed on February 19, 2021)
10.45	††	Modification No. 23, effective September 30, 2020, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.47 the Company’s Annual Report on Form 10-K filed on February 19, 2021)
10.46	††	Modification No. 24, effective February 2, 2021, to the CDC BioThrax Procurement Contract. (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on November 5, 2021).
10.47	††	Modification No. 25, effective September 29, 2021, to the CDC BioThrax Procurement Contract (incorporated by reference to Exhibit 10.6 to the Company's Quarterly Report on Form 10-Q filed on November 5, 2021).
10.48	#††	Modification No. 26, effective November 1, 2021, to the CDC BioThrax Procurement Contract.
10.49	†	Award/Contract (the ~~“BARDA NuThrax Contract”)~~BARDA AV7909 Contract), effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product Development Gaithersburg Inc.~~(incorporated~~ (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 9, 2016).
~~10.49~~10.50	†	Modification No. 1, effective March 16, 2017, to the BARDA ~~NuThrax~~AV7909 Contract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November ~~9, 2016) (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on May~~ 5, ~~2017).~~2021)
~~10.50~~10.51	†	Modification No. 2, effective August 29, 2018, to the BARDA ~~NuThrax~~AV7909 Contract (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on November ~~2, 2018)~~5, 2021).

116


Exhibit Number		Exhibit Description
10.52	††	Modification No. 3, effective July 30, 2019, to the BARDA AV7909 C ontract (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on November 9, 2019).
~~10.51~~10.53	††	Modification No. 4, effective March 3, 2020, to the BARDA AV7909 C ontract (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on May 1, 2020).
10.54	††	Modification No. 5, effective April 10, 2020, to the BARDA AV7909 C ontract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on May 1, 2020).
10.55	††	Modification No. 6, effective July 13, 2020, to the BARDA AV7909 C ontract (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.56	††	Modification No. 7, effective December 2, 2020, to the BARDA AV7909 Contract (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.57	††	Modification No. 8, effective March 22, 2021, to the BARDA AV7909 Contract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.58	††	Modification No. 9, effective April 21, 2021, to the BARDA AV7909 Contract (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.59	††	Modification No. 10, effective June 10, 2021 to the BARDA AV7909 Contract (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.60	††	Modification No. 11, effective September 30, 2021, to the BARDA AV7909 Contract (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on November 5, 2021).
10.61	#††	Modification No. 1 2 , effective December 2 , 2021, to the BARDA AV7909 Contract .
10.62	†	License Agreement, dated as of December 15, 2014, by and between Opiant Pharmaceuticals, Inc. (formerly known as Lightlake Therapeutics Inc.) and Adapt Pharma Operations Limited. (incorporated by reference to Exhibit 10.51 the Company’s Annual Report on Form 10-K filed on February 22, 2019).
~~10.52~~10.63	#††	Amendment No. 1 to License Agreement, dated as of December 13, 2016, by and between Opiant Pharmaceuticals, Inc. and Adapt Pharma Operations Limited. (incorporated by reference to Exhibit 10.52 the Company’s Annual Report on Form 10-K filed on February 22, 2019).
2110.64	#	Amendment No. 2 to License Agreement, dated December 15, 2014, by and between Opiant Pharmaceuticals, Inc. and Adapt Pharma Operations Limited, effective March 18, 2019 (incorporated by reference to Exhibit 10.1 the Company’s Quarterly Report on Form 10-Q filed on May 8, 2019).
10.65	††	Award/Contract, effective August 30, 2019 (ACAM 2000 Contract), from the Assistant Secretary, U.S. Department of Health and Human Services (ASPR/OPM) to Emergent Product Development Gaithersburg Inc. (incorporated by reference to Exhibit 10.48 the Company’s Annual Report on Form 10-K filed on February 25, 2020).
10.66	††	Modification No. 1, effective, May 28, 2020 to the ACAM 2000 Contract (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on July 31, 2020).
10.67	††	Modification No. 2, effective, October 28, 2020 to the ACAM 2000 Contract (incorporated by reference to Exhibit 10.60 the Company’s Annual Report on Form 10-K filed on February 19, 2021).
10.68	††	Modification No. 3 , effective, A pril 1, 202 1 to the ACAM 2000 Contract (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.69	#††	Modification No. 4, effective, July 13, 2021 to the ACAM2000 Contract.
10.70	#††	Modification No. 5, effective, September 29, 2021 to the ACAM2000 Contract.
10.71	#††	Modification No. 6, effective, November 1, 2021 to the ACAM2000 Contract.
10.72	†	Award/Contract, effective June 15, 2012 (BARDA ADM Contract), from the BioMedical Advance Research and Development Authority to Emergent Manufacturing Operations Baltimore LLC. (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on July 31, 2020).

117


Exhibit Number		Exhibit Description
10.73	††	Order for Supplies and Services Between Emergent Manufacturing Operations Baltimore LLC and the BioMedical Advance Research and Development Authority, dated April 2, 2020, under the BARDA ADM Contract (Task Order 75A50120F33006) (incorporated by reference to Exhibit 10.8 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.74	††	Modification No. 1, effective April 12, 2021, to Task Order 75A50120F33006 (incorporated by reference to Exhibit 10.9 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.75	#††	Modification No. 3, effective October 1 , 2021 , to Task Order 75A50120F33006.
10.76	#††	Modification No. 4, effective November 1, 2021 , to Task Order 75A50120F33006.
10.77	††	Order for Supplies and Services Between Emergent Manufacturing Operations Baltimore LLC and the BioMedical Advance Research and Development Authority, dated May 24, 2020, under the BARDA ADM Contract (Task Order 75A50120F33007) (incorporated by reference to Exhibit 10.4 totheCompany'sQuarterlyReportonForm10-QfiledonJuly 31, 2020).
10.78	††	Modification No. 1, effective August 24, 2020, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.9 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.79	††	Modification No. 2, effective September 18, 2020, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.64 to the Company's Annual Report on Form 10-K filed on February 19, 2021).
10.80	††	Modification No. 3, effective October 7, 2020, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.65 to the Company's Annual Report on Form 10-K filed on February 19, 2021).
10.81	††	Modification No. 4, effective January 29, 2021, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.82	††	Modification No. 5, effective February 22, 2021, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.83	††	Modification No. 6, effective March 24, 2021, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.84	††	Modification No. 7, effective Ma y 24, 2021, to Task Order 75A50120F33007 (incorporated by reference to Exhibit 10.10 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.85	#††	Modification No. 8, effective November 1 , 2021, to Task Order 75A50120F33007.
10.86	††	Order for Supplies and Services Between Emergent Manufacturing Operations Baltimore LLC and the BioMedical Advance Research and Development Authority, dated August 6, 2020, under the BARDA ADM Contract (Task Order 75A50120F33008). (incorporated by reference to Exhibit 10.10 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.87	††	Modification No. 1, effective August 24, 2020, to Task Order 75A50120F33008 (incorporated by reference to Exhibit 10.11 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.88	††	Modification No. 2, effective November 17, 2020, to Task Order 75A50120F33008. (incorporated by reference to Exhibit 10.68 the Company’s Annual Report on Form 10-K filed on February 19, 2021).
10.89	††	Modification No. 19, effective, May 25, 2020, to the BARDA ADM Contract (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on July 31, 2020).
10.90	††	Modification No. 20, effective, May 26, 2020, to the BARDA ADM Contract (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on July 31, 2020).
10.91	††	Modification No. 21, effective June 12, 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.92	††	Modification No. 22, effective June 12, 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.93	††	Modification No. 23, effective July 22, 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.6 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).

118


Exhibit Number		Exhibit Description
10.94	††	Modification No. 24, effective August 28, 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.95	††	Modification No. 25, effective September 2 3 , 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.8 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.96	††	Modification No. 26, effective November 2, 2020 to the BARDA ADM Contract (incorporated by reference to Exhibit 10.77 the Company’s Annual Report on Form 10-K filed on February 19, 2021).
10.97	††	Modification No. 27, effective May 6, 2021, to the BARDA ADM Contract (incorporated by reference to Exhibit 10.6 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.98	††	Modification No. 28, effective May 27, 2021, to the BARDA ADM Contract (incorporated by reference to Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.99	††	Modification No. 30, effective September 30, 2021, to the BARDA ADM Contract (incorporated by reference to Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q filed on November 5, 2021).
10.100	#††	Modification No. 31, effective October 20, 2021, to the BARDA ADM Contract.
10.101	#††	Modification No. 32, effective November 1, 2021, to the BARDA ADM Contract.
10.102	††	Master Services Agreement, dated July 24, 2020, by and between Emergent Manufacturing Operations Baltimore, LLC and AstraZeneca Pharmaceuticals LP. (AZ MSA) (incorporated by reference to Exhibit 10.12 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.103	††	Manufacturing Product Schedule, dated July 26, 2020 to AZ MSA (incorporated by reference to Exhibit 10.13 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.104	††	Work Order to Manufacturing Services Agreement, dated June 10, 2020, between Emergent Manufacturing Operations Baltimore, LLC and AstraZeneca Pharmaceuticals LP (included as part of AZ MSA) (incorporated by reference to Exhibit 10.14 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.105	††	Amendment No. 1, effective September 30, 2020, to AZ MSA (incorporated by reference to Exhibit 10.15 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.106	††	Amendment No. 2, effective October 30, 2020, to AZ MSA (incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.107	††	Amendment No. 3, effective November 25, 2020, to AZ MSA (incorporated by reference to Exhibit 10.6 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.108	††	Amendment No. 4, effective January 21, 2021, to AZ MSA (incorporated by reference to Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
10.109	††	Change Order No. 1 to Work Order #5997-01, effective July 31, 2020, to AZ MSA (incorporated by reference to Exhibit 10.11 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.110	††	Change Order No. 2 to Work Order #5997-01, effective August 04, 2020, to AZ MSA (incorporated by reference to Exhibit 10.12 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.111	††	Change Order No. 4 to Work Order #5997-01, effective November 17, 2020, to AZ MSA (incorporated by reference to Exhibit 10.13 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.112	††	Change Order No. 5 to Work Order #5997-01, effective September 16, 2020, to AZ MSA (incorporated by reference to Exhibit 10.14 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.113	††	Change Order No. 6 to Work Order #5997-01, effective October 13, 2020, to AZ MSA (incorporated by reference to Exhibit 10.15 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.114	††	Change Order No. 10 to Work Order #5997-01, effective March 10, 2021, to AZ MSA (incorporated by reference to Exhibit 10.16 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).
10.115	††	Change Order No. 13 to Work Order #5997-01, effective April 23, 2021, to AZ MSA (incorporated by reference to Exhibit 10.17 to the Company's Quarterly Report on Form 10-Q filed on July 30, 2021).

119


Exhibit Number				Exhibit Description
10.116			††	Manufacturing Services Agreement, dated July 2, 2020, by and between Emergent Manufacturing Operations Baltimore, LLC and Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ MSA) (incorporated by reference to Exhibit 10.16 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2020).
10.117			††	Amendment No. 1, effective February 25, 2021, to JNJ MSA (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on April 30, 2021).
21			#	Subsidiaries of the Company.
23			#	Consent of Independent Registered Public Accounting Firm.
31.1			#	Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
31.2			#	Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
32.1			#	Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2			#	Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
~~101.INS~~101			#	~~XBRL Instance Document~~ The following financial information related to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Income, (iv) the Consolidated Statements of Cash Flows, (v) the Consolidated Statement of Changes in Stockholders' Equity; and (vi) the related Notes to Consolidated Financial Statements.
~~101.SCH~~104			#	~~XBRL Taxonomy Extension Schema Document~~Cover Page Interactive Data File, formatted in iXBRL and contained in Exhibit 101.
~~101.CAL~~			#	~~XBRL Taxonomy Calculation Linksbase Document~~Filed herewith
~~101.DEF~~			†	~~XBRL Taxonomy Definition Linksbase Document~~
~~101.LAB~~		~~XBRL Taxonomy Label Linksbase Document~~
~~101.PRE~~		~~XBRL Taxonomy Presentation Linksbase Document~~
	#	~~Filed herewith~~
	†	Confidential treatment granted by the ~~Securities and Exchange Commission~~SEC as to certain portions. Confidential materials omitted and filed separately with the ~~Securities and Exchange Commission.~~SEC.
			††	~~Confidential treatment requested~~Certain confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the ~~Securities~~identified confidential portions (i) are not material and ~~Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.~~(ii) would be competitively harmful if publicly disclosed.
			*	Management contract or compensatory plan or arrangement filed herewith in response to Item 15(a) of Form 10-K.

Attached as Exhibit 101 to this Annual Report on Form 10-K are the following formatted in XBRL (Extensible Business Reporting Language): (i) Consolidated Balance Sheets as of December 31, ~~2018~~2021 and ~~2017,~~2020, (ii) Consolidated Statements of Operations for the Years Ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016,~~2019, (iii) Consolidated Statements of Comprehensive Income for the Years Ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016~~2019 (iv) Consolidated Statements of Cash Flows for the Years Ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016,~~2019, (v) Consolidated Statements of Changes in Stockholders' Equity for the Years ended December 31, ~~2018, 2017~~2021, 2020 and ~~2016,~~2019, and (vi) Notes to Consolidated Financial Statements.

120

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


			EMERGENT BIOSOLUTIONS INC.

			By: /s/RICHARD S. LINDAHL
			Richard S. Lindahl
			Executive Vice President, Chief Financial Officer and Treasurer
			Date: February ~~21, 2019~~25, 2022

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature

Title

Date

/s/~~Daniel J. Abdun-Nabi~~Robert G. Kramer Sr.

~~Daniel J. Abdun-Nabi~~Robert G. Kramer Sr.

President, Chief Executive Officer and Director

(Principal Executive Officer)

February ~~21, 2019~~25, 2022

/s/Richard S. Lindahl

Richard S. Lindahl

Executive Vice President, Chief Financial Officer and Treasurer

(Principal Financial and Accounting Officer)

February ~~21, 2019~~25, 2022

/s/Fuad El-Hibri

Fuad El-Hibri

Executive Chairman of the Board of Directors

February ~~21, 2019~~25, 2022

/s/Zsolt Harsanyi, Ph.D.

Zsolt Harsanyi, Ph.D.

Director

February ~~21, 2019~~25, 2022

/s/Kathryn Zoon, Ph.D.

Kathryn Zoon, Ph.D.

Director

February ~~21, 2019~~25, 2022

/s/Ronald B. Richard

Ronald B. Richard

Director

February ~~21, 2019~~25, 2022

/s/Louis W. Sullivan, M.D.

Louis W. Sullivan, M.D.

Director

February ~~21, 2019~~25, 2022

~~/s/Dr. Sue Bailey~~

~~Dr. Sue Bailey~~

~~Director~~

~~February 21, 2019~~

/s/George Joulwan

George Joulwan

Director

February ~~21, 2019~~25, 2022

/s/Jerome Hauer, Ph.D.

Jerome Hauer, Ph.D.

Director

February ~~21, 2019~~25, 2022

/s/Marvin White

Marvin White

Director

February 25, 2022

121


Delaware						14-1902018
(State or Other Jurisdiction of Incorporation or Organization)						(IRS Employer Identification No.)

	§	~~raxibacumab, acquired in October 2017;~~
			Cost of Product Sales
l			Gross profit margin for product sales

	§	~~manufacturing development activities related to our NuThrax product candidate;~~
			Research and Development expense
l			Research and Development expense, net of contracts and grants revenue and IPR&D impairment expense


(in millions)
		December 31, 2021
Total Capacity		Outstanding Letters of Credit	Outstanding Indebtedness	Unused Capacity
$	600.0	2.3	—	$	597.7
		December 31, 2020
$	600.0	2.8	—	$	597.2


☒			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Issuer Purchases of Equity Securities
(in millions, except for per share data)
Period	Total number of shares (or units) purchased		Average price paid per share (or unit)(a)			Total number of shares (or units) purchased as part of publicly announced plans or programs(b)		Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased under the plans or programs (a)(b)
October 1, 2018 - October 31, 2018		-		$	-		-		$	-
November 1, 2018 - November 30, 2018		-			-		-			-
December 1, 2018 - December 31, 2018		-			-		-			-
Total		-		$	-		-		$	50.0

	Year Ended December 31,
(in millions, except per share data)	2018			2017			2016			2015			2014

Statements of operations data:
Revenues:
Product sales	$	606.5		$	421.5		$	296.3		$	329.0		$	281.8
Contract manufacturing		98.9			68.9			49.1			43.0			30.9
Contracts and grants		77.0			70.5			143.4			117.3			91.8
Total revenues		782.4			560.9			488.8			489.3			404.5
Operating expenses:
Cost of product sales and contract manufacturing		322.3			187.7			126.3			102.1			96.6
Research and development		142.8			97.4			106.9			117.8			103.5
Selling, general & administrative		202.5			142.9			143.1			120.6			108.1
Amortization of intangible assets		25.0			8.6			7.0			7.3			7.1
Total operating expenses		692.6			436.6			383.3			347.8			315.3
Income from operations		89.8			124.3			105.5			141.5			89.2
Other income (expense):
Interest expense		(9.9	)		(6.6	)		(7.6	)		(6.5	)		(8.2	)
Other income (expense), net		1.6			0.9			1.3			0.7			3.2
Total other income (expense), net		(8.3	)		(5.7	)		(6.3	)		(5.8	)		(5.0	)

Income from continuing operations before provision for income taxes		81.5			118.6			99.2			135.7			84.2
Provision for income taxes		18.8			36.0			36.7			44.3			29.9
Net income from continuing operations		62.7			82.6			62.5			91.4			54.3
Net loss from discontinued operations		-			-			(10.7	)		(28.5	)		(17.6	)
Net income	$	62.7		$	82.6		$	51.8		$	62.9		$	36.7


Net income per share from continuing operations-basic	$	1.25		$	1.98		$	1.56		$	2.37		$	1.45
Net loss per share from discontinued operations-basic		-			-			(0.27	)		(0.74	)		(0.47	)
Net income per share-basic	$	1.25		$	1.98		$	1.29		$	1.63		$	0.98

Net income per share from continuing operations-diluted	$	1.22		$	1.71		$	1.35		$	2.02		$	1.26
Net loss per share from discontinued operations-diluted		-			-			(0.22	)		(0.61	)		(0.38	)
Net income per share-diluted (1)	$	1.22		$	1.71		$	1.13		$	1.41		$	0.88

Weighted average number of shares — basic		50.1			41.8			40.2			38.6			37.3
Weighted average number of shares — diluted		51.4			50.3			49.3			47.3			45.8

	As of December 31,
(in millions)	2018			2017			2016			2015			2014

Balance Sheet Data:
Cash and cash equivalents		$	112.2		$	178.3		$	271.5		$	308.3		$	276.8
Working capital			420.4			385.3			404.4			425.9			312.8
Total assets			2,229.4			1,070.2			970.1			931.8			815.6
Total long-term liabilities			1,018.1			57.8			268.1			274.6			281.5
Total stockholders’ equity			1,010.9			912.2			596.2			575.0			454.5


Legend
	Nasal Naloxone Products	CDMO Leases
	ACAM2000	CDMO Services
	Anthrax vaccines	Contracts and Grants
	Other Product Sales

	§	~~fill/finish services provided to third parties;~~
			Cost of CDMO
l			Gross profit margin for CDMO


			Selling, General and Administrative
l			SG&A as a percentage of total revenue

§	~~the timing of BAT deliveries of $28.4 million to the SNS;~~
		Interest expense
		Other income (expense)


(in millions, except percentages)	December 31, 2021		December 31, 2020		Change %
Financial assets:
Cash and cash equivalents	$	576.1	$	621.3	(7)	%

Borrowings:
Debt, current portion	31.6		33.8		(7)	%
Debt, net of current portion	809.4		841.0		(4)	%
Total borrowings	841.0		874.8		(4)	%

Working capital:
Current assets	1,272.1		1,195.9		6	%
Current liabilities	373.8		384.5		(3)	%
Total working capital	898.3		811.4		11	%

	Payments due by period
			Less than		1 to 3		3 to 5		More than
(in millions)	Total		1 year		Years		Years		5 years
Contractual obligations:
Long-term indebtedness	$	836.6	$	14.3	$	103.3	$	719.0	$	-
Operating lease obligations		15.5		3.4		5.0		4.6		2.5
Deemed mandatory repatriation tax (1)		11.3		1.1		4.2		6.0		-
Purchase commitments		66.7		60.1		6.6		-		-
Total contractual obligations	$	930.1	$	78.9	$	119.1	$	729.6	$	2.5

	$0.001 Par Value Common Stock				Additional Paid-In		Treasury Stock						Accumulated Other Comprehensive			Retained			Total Stockholders'
	Shares		Amount		Capital		Shares			Amount			Loss			Earnings			Equity
Balance at December 31, 2015		39.8	$	-	$	318.0		(0.4	)	$	(6.4	)	$	(2.7	)	$	351.1		$	660.0

Employee equity plans activity		1.2		-		34.4		-			-			-			-			34.4
Separation of Aptevo		-		-		-		-			-			-			(148.4	)		(148.4	)
Net income		-		-		-		-			-			-			51.8			51.8
Other comprehensive loss		-		-		-		-			-			(1.6	)		-			(1.6	)
Balance at December 31, 2016		41.0	$	-	$	352.4		(0.4	)	$	(6.4	)	$	(4.3	)	$	254.5		$	596.2

Employee equity plans activity		1.1		-		28.0		-			-			-			-			28.0
Shares issued to extinguish convertible notes		8.5		0.1		237.9		-			-			-			-			238.0
Treasury stock		-		-		-		(0.8	)		(33.1	)		-			-			(33.1	)
Net income		-		-		-		-			-			-			82.6			82.6
Other comprehensive income		-		-		-		-			-			0.6			-			0.6
Balance at December 31, 2017		50.6	$	0.1	$	618.3		(1.2	)	$	(39.5	)	$	(3.7	)	$	337.1		$	912.3
Adoption of new accounting standard (ASC 606), net of tax		-		-		-		-			-			-			(32.5	)		(32.5	)
Balance at January 1, 2018		50.6		0.1		618.3		(1.2	)		(39.5	)		(3.7	)		304.6			879.8
Employee equity plans activity		1.1		-		32.6		-			-			-			-			32.6
Issuance of common stock in acquisition		0.7		-		37.7		-			-			-			-			37.7
Treasury stock		-		-		-		-			(0.1	)		-			-			(0.1	)
Net income		-		-		-		-			-			-			62.7			62.7
Other comprehensive loss		-		-		-		-			-			(1.8	)		-			(1.8	)
Balance at December 31, 2018		52.4	$	0.1	$	688.6		(1.2	)	$	(39.6	)	$	(5.5	)	$	367.3		$	1,010.9

(in millions)	Year Ended December 31, 2018
	U.S			Non-U.S.
	Government			Government			Total

Product sales		$	526.1		$	80.4		$	606.5
Contract manufacturing			—			98.9			98.9
Contracts and grants			71.5			5.5			77.0
Total revenues		$	597.6		$	184.8		$	782.4

(in millions)	October 15, 2018
Cash	$	581.5
Equity		37.7
Fair value of contingent purchase consideration		48.0
Total preliminary purchase consideration	$	667.2

(in millions)	October 15, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:
Cash	$	17.7
Accounts receivable		21.3
Inventory		41.4
Prepaid expenses and other assets		7.8
Accounts payable		(32.2	)
Accrued expenses and other liabilities		(50.4	)
Deferred tax liability, net		(62.4	)
Total estimated fair value of tangible assets acquired and liabilities assumed		(56.8	)

Acquired in-process research and development		41.0
Acquired intangible asset		534.0
Goodwill		149.0
Total purchase price	$	667.2

(in millions)	October 4, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:

Cash	$	9.0
Accounts receivable		4.1
Inventory		19.7
Prepaid expenses and other assets		12.2
Property, plant and equipment		57.8
Deferred tax assets, net		3.8
Accounts payable		(3.5	)
Accrued expenses and other liabilities		(33.6	)
Total estimated fair value of tangible assets acquired and liabilities assumed		69.5

Acquired in-process research and development		9.0
Acquired intangible assets		133.0
Goodwill		61.6
Total purchase consideration	$	273.1

	December 31,
(in millions, except per share value)	2018			2017
	(Unaudited)
Revenues		$	949.3	$	683.8
Net income		$	27.7	$	12.3
Net income per share - basic		$	0.55	$	0.29
Net income per share - diluted		$	0.54	$	0.28

(in millions)
Amount of cash paid to Sanofi	$	117.5
Fair value of contingent purchase consideration		2.2
Total purchase price	$	119.7

(in millions)
Fair value of tangible assets acquired:
Inventory	$	74.9
Property, plant and equipment		20.0
Total fair value of tangible assets acquired		94.9

Acquired intangible asset		16.7
Goodwill		8.1
Total purchase price	$	119.7

(in millions)	December 31, 2018		December 31, 2017

Revenue	$	167.8	$	11.5
Operating income (loss)	$	13.4	$	(0.9	)

(in millions)
Balance at December 31, 2016	$	13.2
(Income) expense included in earnings		7.8
Settlements		(10.9	)
Additions due to acquisition		2.2
Balance at December 31, 2017	$	12.3
(Income) expense included in earnings		3.1
Settlements		(3.4	)
Additions due to acquisition		48.0
Balance at December 31, 2018	$	60.0


(in millions)	Total
Cost basis
Balance at December 31, 2017	$	151.4
Additions		667.0
Balance at December 31, 2018	$	818.4

Accumulated amortization
Balance at December 31, 2017	$	(31.8	)
Amortization		(25.0	)
Balance at December 31, 2018	$	(56.8	)

Net book value at December 31, 2018	$	761.6

(in millions)
2019	$	57.7
2020		57.6
2021		56.1
2022		53.4
2023 and beyond		536.8
Total remaining amortization	$	761.6

	Emergent Plan
(in millions, except share and per share data)	Number of Shares			Weighted-Average Exercise Price		Aggregate Intrinsic Value
Outstanding at December 31, 2017		2,121,405		$	25.48	$	44.5
Granted		460,902			51.39
Exercised		(665,183	)		21.36
Forfeited		(45,656	)		33.14
Outstanding at December 31, 2018		1,871,468		$	32.59	$	50.1
Exercisable at December 31, 2018		1,081,513		$	26.13	$	35.9
Options expected to vest at December 31, 2018		696,083		$	41.10	$	12.8

	Quarter Ended
(in millions, except per share data)	March 31,			June 30,		September 30,		December 31,
2018:
Revenue	$	117.8		$	220.2	$	173.7	$	270.7
Income (loss) from operations		(9.5	)		66.8		21.3		11.2
Net income (loss)		(4.9	)		50.1		20.9		(3.4	)

Net income (loss) per share-basic	$	(0.10	)	$	1.00	$	0.42	$	(0.07	)
Net income (loss) per share-diluted	$	(0.10	)	$	0.98	$	0.41	$	(0.07	)

2017:
Revenue	$	116.9		$	100.8	$	149.4	$	193.8
Income from operations		14.9			8.5		47.8		53.1
Net income		10.5			4.6		33.6		33.9

Net income per share-basic	$	0.26		$	0.11	$	0.81	$	0.77
Net income per share-diluted	$	0.23		$	0.11	$	0.68	$	0.67