

(Mark One)
☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the quarterly period ended	September 30, ~~2017~~2019

OR

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


	For the transition period from to

Commission file number: 001-33137

EMERGENT BIOSOLUTIONS INC.

(Exact Name of Registrant as Specified in Its Charter)



Delaware		14-1902018
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

400 Professional Drive Suite 400
Gaithersburg,	Maryland	20879
(Address and zip code of Principal Executive Offices)			~~(Zip Code)~~

~~(240)~~ (240) 631-3200

(Registrant's Telephone Number, Including Area Code)



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, Par Value $0.001 per share	EBS	New York Stock Exchange

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 ~~and posted on its corporate website, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files). ☒Yes☐No

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," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):

 ~~Large accelerated filer~~  ~~Accelerated filer~~  ~~Non-accelerated filer~~  ~~Smaller reporting company~~ ☐



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

~~(Do not check if a smaller reporting 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 13(a) of the Exchange Act. ☐

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

☒

As of October ~~27, 2017,~~30, 2019, the registrant had ~~41,395,398~~51,623,596 shares of common stock outstanding.

Emergent BioSolutions Inc.

Index to Form 10-Q



Part I. Financial Information
	Page No.
Item 1.	~~Unaudited~~ Financial Statements	5
	Condensed Consolidated Balance Sheets	5
	Condensed Consolidated Statements of Operations	6
	Condensed Consolidated Statements of Comprehensive Income	7
	Condensed Consolidated Statements of Cash Flows	8
	Condensed Consolidated Statements of Changes in Stockholders' Equity	9
	Notes to Condensed Consolidated Financial Statements	10
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35
~~Part II. Other Information~~

Part II. Other Information
Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	66
Item 3.	Defaults Upon Senior Securities	66
Item 4.	Mine Safety Disclosures	66
Item 5.	Other Information	66
Item 6.	Exhibits	66
	~~Signatures~~
	~~Exhibit Index~~Signatures	68

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), raxibacumab, a fully human monoclonal antibody 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.

EMERGENT BIOSOLUTIONS INC.

PART I. FINANCIAL INFORMATION

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q 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, are forward-looking statements. We generally identify forward-looking statements by using words like ~~"will",~~"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:

appropriations for the procurement of our products addresssing public health threats (PHTs);

the continued exercise of discretion by the Biomedical Advanced Research and Development Authority (BARDA) to procure additional doses of AV7909 (anthrax vaccine adsorbed with adjuvant) in reliance on the company’s pre-Emergency Use Authorization (pre-EUA) submission to the U.S. Food and Drug Administration (FDA);

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

our ability to perform under our contracts with the U.S. government (USG) related to BioThrax, our AV7909 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 from the U.S. Food and Drug Administration;~~

~~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 current contracts that will be expiring;~~EUA and eventual licensure of AV7909 from the FDA within the anticipated timeframe, if at all;

the availability of funding for our USG grants and contracts;

our ability to secure follow-on procurement contracts for our PHTs that are under procurement contracts that have expired or will be expiring;

	§
•	~~our ability to successfully execute our growth strategy and achieve our financial and operational goals;~~

our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities, businesses or products that we acquire, including our recently completed acquisitions of the ACAM2000 business from Sanofi Pasteur Biologics, LLC and raxibacumab from GlaxoSmithKline LLC and the timing and receipt of required FDA approvals for actions contemplated in connection with our integration of these products;

~~our ability to identify and acquire companies or in-license products or late-stage product candidates that satisfy our selection criteria;~~

~~our ability to realize synergies and benefits from acquisitions or in-licenses within expected time periods or at all;~~

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 to obtain and maintain intellectual property protection for our products and product candidates;~~

~~our ability and plans to expand our manufacturing capabilities and utilize the capacity of our manufacturing facilities;~~

our ability and the ability of our ~~contractors and suppliers~~collaborators to ~~maintain compliance with current good manufacturing practices and other regulatory obligations;~~defend underlying patents related to NARCAN Nasal Spray from infringement by generic entrants;

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

~~the results of regulatory inspections;~~

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

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

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

~~the outcome of the class action lawsuit filed against us and possible other future material legal proceedings;~~

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

~~the rate and degree of market acceptance and clinical utility of our products;~~

the results of regulatory inspections;

~~the success of our ongoing and planned development programs, non-clinical activities and clinical trials of our product candidates;~~

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

EMERGENT BIOSOLUTIONS INC.

the procurement of products by USG 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 entitled "Risk Factors" in this quarterly report on Form 10-Q 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

~~PART I.FINANCIAL INFORMATION~~

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)), 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 brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent 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.

ITEM 1.FINANCIAL STATEMENTS

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Balance Sheets

(in thousands, except share and per share data)

September 30, 2017 December 31, 2016
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 340,991 $ 271,513
Restricted cash 1,043 -
Accounts receivable, net 129,357 138,478
Inventories 68,889 74,002
Income tax receivable, net - 9,996
Prepaid expenses and other current assets 15,754 16,229
Total current assets 556,034 510,218

Property, plant and equipment, net 386,457 376,448
Intangible assets, net 29,202 33,865
Goodwill 41,001 41,001
Deferred tax assets, net 4,864 6,096
Other assets 6,644 2,483
Total assets $ 1,024,202 $ 970,111

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 30,111 $ 34,649
Accrued expenses and other current liabilities 3,918 6,368
Accrued compensation 32,626 34,537
Notes payable - 20,000
Contingent consideration, current portion 2,393 3,266
Income taxes payable 1,875 -
Deferred revenue, current portion 4,509 7,036
Total current liabilities 75,432 105,856

Contingent consideration, net of current portion 9,398 9,919
Long-term indebtedness 248,994 248,094
Deferred revenue, net of current portion 24,966 8,433
Other liabilities 1,702 1,604
Total liabilities 360,492 373,906

Stockholders' equity:
  Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both September 30, 2017 and December 31, 2016 - -
  Common stock, $0.001 par value; 200,000,000 shares authorized, 41,807,978 shares issued and 41,382,429 shares outstanding at September 30, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016 41 41
  Treasury stock, at cost, 425,549 and 422,830 common shares at September 30, 2017 and December 31, 2016, respectively (6,503 ) (6,420 )
  Additional paid-in capital 370,855 352,435
  Accumulated other comprehensive loss (3,815 ) (4,331 )
  Retained earnings 303,132 254,480
  Total stockholders' equity 663,710 596,205
     Total liabilities and stockholders' equity $ 1,024,202 $ 970,111

Emergent BioSolutions Inc.

~~The accompanying notes are an integral part of these consolidated financial statements.~~Condensed Consolidated Balance Sheets

(unaudited, in millions, except per share amounts)

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statements of Operations

(in thousands, except share and per share data)

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
(Unaudited) (Unaudited)
Revenues:
Product sales $ 114,296 $ 96,698 $ 259,875 $ 208,785
Contract manufacturing 18,912 14,712 52,700 32,455
Contracts and grants 16,226 31,504 54,489 95,879
Total revenues 149,434 142,914 367,064 337,119

Operating expenses:
Cost of product sales and contract manufacturing 44,503 39,560 125,449 93,025
Research and development 22,659 27,188 68,886 81,173
Selling, general and administrative 34,503 40,688 101,521 108,328
Income from operations 47,769 35,478 71,208 54,593

Other income (expense):
Interest income 637 358 1,593 764
Interest expense (1,991 ) (2,049 ) (5,734 ) (5,082 )
Other expense, net (101 ) (234 ) (387 ) (176 )
Total other expense, net (1,455 ) (1,925 ) (4,528 ) (4,494 )

Income from continuing operations before provision for income taxes 46,314 33,553 66,680 50,099
Provision for income taxes 12,763 13,165 18,028 19,861
Net income from continuing operations 33,551 20,388 48,652 30,238
Net income (loss) from discontinued operations - 952 - (15,854 )
Net income $ 33,551 $ 21,340 $ 48,652 $ 14,384

Net income per share from continuing operations - basic $ 0.81 $ 0.50 $ 1.19 $ 0.75
Net income (loss) per share from discontinued operations - basic - 0.02 - (0.40 )
Net income per share - basic $ 0.81 $ 0.52 $ 1.19 $ 0.35

Net income per share from continuing operations - diluted $ 0.68 $ 0.43 $ 1.03 $ 0.68
Net income (loss) per share from discontinued operations - diluted - 0.02 - (0.32 )
Net income per share - diluted (1) $ 0.68 $ 0.45 $ 1.03 $ 0.36

Weighted-average number of shares - basic 41,222,504 40,465,423 40,989,813 40,071,730
Weighted-average number of shares - diluted 50,467,829 49,440,313 50,090,088 48,826,597



	September 30, 2019			December 31, 2018
ASSETS
Current assets:
Cash and cash equivalents	$	139.2		$	112.2
Restricted cash	0.2			0.2
Accounts receivable, net	281.2			262.5
Inventories	230.2			205.8
Prepaid expenses and other current assets	49.2			40.1
Total current assets	700.0			620.8

Property, plant and equipment, net	529.1			510.2
Intangible assets, net	727.7			761.6
In-process research and development	41.0			50.0
Goodwill	268.6			259.7
Other assets	67.4			27.1
Total assets	$	2,333.8		$	2,229.4

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	91.3		$	80.7
Accrued expenses	51.8			30.7
Contingent consideration, current portion	55.7			5.6
Accrued compensation	55.8			58.2
Debt, current portion	10.1			10.1
Other current liabilities	10.6			15.1
Total current liabilities	275.3			200.4
Contingent consideration	14.5			54.4
Debt	813.3			784.5
Deferred tax liability	61.1			67.5
Contract liabilities	81.6			62.5
Other liabilities	53.0			49.2
Total liabilities	$	1,298.8		$	1,218.5
Commitments and contingencies (Notes 8 & 16)
Stockholders' equity:
Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued or outstanding at both 2019 and 2018	—			—
Common stock, $0.001 par value; 200.0 shares authorized, 52.8 shares issued and 51.6 shares outstanding at 2019; 52.4 shares issued and 51.2 shares outstanding at 2018	0.1			0.1
Treasury stock, at cost, 1.2 common shares at both 2019 and 2018	(39.7		)	(39.6		)
Additional paid-in capital	708.8			688.6
Accumulated other comprehensive loss	(9.1		)	(5.5		)
Retained earnings	374.9			367.3
Total stockholders' equity	1,035.0			1,010.9
Total liabilities and stockholders' equity	$	2,333.8		$	2,229.4

~~(1)~~ See ~~"Earnings~~accompanying notes.

Emergent BioSolutions Inc.

Condensed Consolidated Statements of Operations

(unaudited, in millions, except per ~~share" footnote for details on calculation.~~

~~The accompanying notes are an integral part of these consolidated financial statements.~~share amounts)

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Comprehensive Income

(in thousands)

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
(Unaudited) (Unaudited)

Net income $ 33,551 $ 21,340 $ 48,652 $ 14,384
Foreign currency translations, net of tax (296 ) (492 ) 516 (859 )
Comprehensive income $ 33,255 $ 20,848 $ 49,168 $ 13,525



	Three Months Ended September 30,						Nine Months Ended September 30,
	2019			2018			2019			2018
Revenues:
Product sales, net	$	256.2		$	133.3		$	592.7		$	389.1
Contract manufacturing	20.0			22.1			54.6			72.0
Contracts and grants	35.6			18.2			98.4			50.6
Total revenues	311.8			173.6			745.7			511.7

Operating expenses:
Cost of product sales and contract manufacturing	108.0			69.3			300.7			208.8
Research and development	53.4			37.0			163.4			90.8
Selling, general and administrative	65.0			42.1			201.3			121.8
Amortization of intangible assets	14.7			3.9			43.9			11.7
Total operating expenses	241.1			152.3			709.3			433.1

Income from operations	70.7			21.3			36.4			78.6

Other income (expense):
Interest expense	(10.3		)	(0.6		)	(29.3		)	(1.8		)
Other (expense) income, net	(1.5		)	0.8			(1.2		)	1.2
Total other income (expense), net	(11.8		)	0.2			(30.5		)	(0.6		)

Income before income taxes	58.9			21.5			5.9			78.0
Income tax expense (benefit)	15.7			0.6			(1.7		)	11.8
Net income	$	43.2		$	20.9		$	7.6		$	66.2

Net income per common share
Basic	$	0.84		$	0.42		$	0.15		$	1.33
Diluted	$	0.83		$	0.41		$	0.15		$	1.29
Shares used in computing income per share
Basic	51.6			50.1			51.4			49.9
Diluted	52.3			51.5			52.3			51.2

~~The~~See accompanying ~~notes are an integral part~~notes.

Emergent BioSolutions Inc.

Condensed Consolidated Statements of ~~these consolidated financial statements.~~Comprehensive Income

(unaudited, in millions)

Emergent BioSolutions Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(in thousands)

Nine Months Ended September 30,
2017 2016
Cash flows from operating activities: (Unaudited)
Net income $ 48,652 $ 14,384
Adjustments to reconcile to net cash provided by (used in) operating activities:
Stock-based compensation expense 11,805 14,527
Depreciation and amortization 29,899 28,155
Income taxes 18,618 4,814
Change in fair value of contingent consideration 1,350 (1,253 )
Debt issuance costs (1,426 ) -
Abandonment of long-lived assets - 3,749
Excess tax benefits from stock-based compensation - (10,825 )
Other 703 2,467
Changes in operating assets and liabilities:
Accounts receivable 9,411 45,035
Inventories 5,113 (16,183 )
Income taxes (5,515 ) (10,072 )
Prepaid expenses and other assets (2,157 ) (3,146 )
Accounts payable 2,965 (1,305 )
Accrued expenses and other liabilities (2,334 ) (1,699 )
Accrued compensation (1,902 ) (152 )
Provision for chargebacks - 103
Deferred revenue 14,006 (1,348 )
Net cash provided by operating activities 129,188 67,251
Cash flows from investing activities:
Purchases of property, plant and equipment and other (42,381 ) (56,243 )
Net cash used in investing activities
(42,381 ) (56,243 )
Cash flows from financing activities:
Issuance of common stock upon exercise of stock options 10,799 14,981
Excess tax benefits from stock-based compensation - 10,825
Taxes paid on behalf of employees for equity activity (4,184 ) (4,590 )
Payments of notes payable (20,000 ) -
Distribution of Aptevo - (45,000 )
Contingent consideration payments (2,744 ) (1,226 )
Restricted cash (1,043 ) -
Purchase of treasury stock (83 ) -
Net cash used in financing activities (17,255 ) (25,010 )

Effect of exchange rate changes on cash and cash equivalents (74 ) 139

Net increase (decrease) in cash and cash equivalents 69,478 (13,863 )
Cash and cash equivalents at beginning of period 271,513 312,795
Cash and cash equivalents at end of period $ 340,991 $ 298,932



	Three Months Ended September 30,						Nine Months Ended September 30,
	2019			2018			2019			2018
Net income	$	43.2		$	20.9		$	7.6		$	66.2
Other comprehensive (loss) income, net of tax:
Foreign currency translation	(1.1		)	(0.2		)	0.6			(1.0		)
Unrealized losses on hedging activities	(3.0		)	—			(4.2		)	—
Total other comprehensive loss	(4.1		)	(0.2		)	(3.6		)	(1.0		)
Comprehensive income	$	39.1		$	20.7		$	4.0		$	65.2

~~The~~See accompanying ~~notes are an integral part~~notes.

Emergent BioSolutions Inc.

Condensed Consolidated Statements of ~~these consolidated financial statements.~~Cash Flows

(unaudited, in millions)



	Nine Months Ended September 30,
	2019			2018
Cash flows provided by operating activities:
Net income	$	7.6		$	66.2
Adjustments to reconcile net income to net cash provided by operating activities:
Share-based compensation expense	21.0			16.7
Depreciation and amortization	82.8			37.1
Amortization of deferred financing costs	2.2			—
Deferred income taxes	(5.7		)	12.8
Change in fair value of contingent consideration, net	12.4			1.9
Other	0.7			1.5
Changes in operating assets and liabilities:
Accounts receivable	(18.6		)	66.5
Inventories	(24.4		)	17.1
Prepaid expenses and other assets	(36.5		)	(16.1		)
Accounts payable	2.5			(5.7		)
Accrued expenses	5.2			2.5
Accrued compensation	(2.4		)	3.9
Contract liabilities	19.1			3.2
Net cash provided by operating activities:	65.9			207.6
Cash flows used in investing activities:
Purchases of property, plant and equipment and other	(50.8		)	(51.3		)
Milestone payment from asset acquisition	(10.0		)	—
Proceeds from sale of assets	—			2.6
Net cash used in investing activities:	(60.8		)	(48.7		)
Cash flows provided by provided by financing activities:
Proceeds from revolving credit facility	130.0			—
Principal payments on revolving credit facility	(95.0		)	—
Principal payments on term loan facility	(8.4		)	—
Issuances of stock under share-based benefit plans	5.7			11.4
Taxes paid on behalf of employees for equity activity	(6.6		)	(6.3		)
Contingent consideration payments	(3.7		)	(2.2		)
Purchase of treasury stock	—			(0.1		)
Net cash provided by financing activities:	22.0			2.8
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(0.1		)	(0.6		)
Net increase in cash, cash equivalents and restricted cash	27.0			161.1
Cash, cash equivalents and restricted cash at beginning of period	112.4			179.3
Cash, cash equivalents and restricted cash at end of period	$	139.4		$	340.4

See accompanying notes.

Emergent BioSolutions Inc.

Condensed Consolidated Statements of Changes in Stockholders' Equity

(unaudited, in millions)



	$0.001 Par Value Common Stock			Additional Paid-In Capital		Treasury Stock					Accumulated Other Comprehensive Loss			Retained Earnings			Total Stockholders' Equity
	Shares	Amount		Additional Paid-In Capital		Shares		Amount			Accumulated Other Comprehensive Loss			Retained Earnings			Total Stockholders' Equity

Balance at December 31, 2018	52.4	$	0.1	$	688.6	(1.2	)	$	(39.6	)	$	(5.5	)	$	367.3		$	1,010.9
Employee equity plans activity	0.4	—		20.2		—		(0.1		)	—			—			20.1
Net income	—	—		—		—		—			—			7.6			7.6
Other comprehensive income	—	—		—		—		—			(3.6		)	—			(3.6		)
Balance at September 30, 2019	52.8	$	0.1	$	708.8	(1.2	)	$	(39.7	)	$	(9.1	)	$	374.9		$	1,035.0

Balance at June 30, 2019	52.7	$	0.1	$	701.8	(1.2	)	$	(39.7	)	$	(5.0	)	$	331.7		$	988.9
Employee equity plans activity	0.1	—		7.0		—		—			—						7.0
Net income	—	—		—		—		—			—			43.2			43.2
Other comprehensive loss	—	—		—		—		—			(4.1		)	—			(4.1		)
Balance at September 30, 2019	52.8	$	0.1	$	708.8	(1.2	)	$	(39.7	)	$	(9.1	)	$	374.9		$	1,035.0

Balance at December 31, 2017	50.6	$	0.1	$	618.3	(1.2	)	$	(39.5	)	$	(3.8	)	$	337.1		$	912.2
Adoption of new revenue 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		)	(3.8		)	304.6			879.7
Employee equity plans activity	0.8	—		21.8		—		(0.1		)	—			—			21.7
Net income	—	—		—		—		—			—			66.2			66.2
Other comprehensive loss	—	—		—		—		—			(1.0		)	—			(1.0		)
Balance at September 30, 2018	51.4	$	0.1	$	640.1	(1.2	)	$	(39.6	)	$	(4.8	)	$	370.8		$	966.6

Balance at June 30, 2018	51.2	$	0.1	$	632.6	(1.2	)	$	(39.6	)	$	(4.6	)	$	349.9		$	938.4
Employee equity plans activity	0.2	—		7.5		—		—			—			—			7.5
Net income	—	—		—		—		—			—			20.9			20.9
Other comprehensive loss	—	—		—		—		—			(0.2		)	—			(0.2		)
Balance at September 30, 2018	51.4	$	0.1	$	640.1	(1.2	)	$	(39.6	)	$	(4.8	)	$	370.8		$	966.6

See accompanying notes.

EMERGENT BIOSOLUTIONS INC. ~~AND SUBSIDIARIES~~

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

~~(UNAUDITED)~~(unaudited, in millions, except share and per share amounts)

1.~~Summary~~ Business

Emergent is a global life sciences company focused on providing specialty products for civilian and military populations that address accidental, deliberate and naturally occurring PHTs.

The Company is focused on innovative preparedness and response products and solutions addressing the following four distinct PHT categories: Chemical, Biological, Radiological, Nuclear and Explosives (CBRNE); emerging infectious diseases (EID); traveler health; and opioids. The USG is the Company's largest customer and provides the Company with substantial funding for the development of ~~significant accounting policies~~a number of the Company's product candidates.

The majority of the Company's revenue comes from the following products and product candidates:


•	Vaccines - AV7909® (Anthrax Vaccine Absorbed with Adjuvant), BioThrax® (Anthrax Vaccine Adsorbed), ACAM2000® (Smallpox (Vaccinia) Vaccine, Live), Vaxchora® (Cholera Vaccine, Live, Oral), and Vivotif® (Typhoid Vaccine, Live, Oral Ty21a).


•	Devices - NARCAN® (naloxone HCl) Nasal Spray for opioid overdose, and RSDL® (Reactive Skin Decontamination Lotion Kit).


•	Therapeutics - raxibacumab (Anthrax Monoclonal antibody therapeutic for anthrax),Anthrasil®( Anthrax Immune Globulin Intravenous (Human)), BAT®(Botulism Antitoxin Heptavalent), and VIGIV (Vaccinia Immune Globulin Intravenous (Human) therapeutic) for complications from smallpox vaccinations.

The Company also generates revenue from contract development and manufacturing services on a clinical and commercial (small and large) scale by providing such services to the pharmaceutical and biotechnology industry. These services include process development and bulk drug substance and drug product manufacturing of biologics, 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 across bacterial, viral and mammalian therapy technology platforms.

We operate as 1 operating segment.

2. Basis of Presentation and Principles of Consolidation

Basis of ~~presentation and consolidation~~

Presentation

The accompanying unaudited condensed consolidated financial statements include the accounts of Emergent ~~BioSolutions Inc. ("Emergent" or the "Company")~~ and its ~~wholly owned and majority owned~~wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the ~~Securities and Exchange Commission ("SEC").~~SEC. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with ~~U.S. generally accepted accounting principles~~GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2018, as filed with the SEC.

On August 1, 2016, the Company completed the spin-off of Aptevo Therapeutics Inc. ("Aptevo") and has classified the results of operations of Aptevo as discontinued operations for the three and nine months ended September 30, 2016. The historical financial statements and footnotes have been revised accordingly. See Note 2 "Discontinued operations" for further details regarding the spin-off. For financial reporting purposes, in the periods following the spin-off, the Company operates as one operating segment and therefore has a single reportable segment.

~~In the opinion of the Company's management, any~~All adjustments contained in the accompanying unaudited condensed consolidated financial statements are of a normal recurring nature and are necessary to present fairly the financial position of the Company as of September 30, ~~2017.~~2019. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

~~Revenue recognition~~

Significant Accounting Policies

During the ~~three and~~ nine months ended September 30, ~~2017,~~2019, there have been no significant changes to the Company's summary of significant accounting policies contained in the Company's Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2018, as filed with the SEC, except for ~~revenue recognition associated with the Biomedical Advanced Research~~recently adopted accounting standards.

Fair Value Measurements

Separate disclosure is required for assets and Development Authority ("BARDA") procurement contract for BioThrax (the "BARDA BioThrax Contract") and the modification of the BARDA development and procurement contract for the NuThrax product candidate (the "BARDA NuThrax Contract").

~~The BARDA NuThrax Contract was entered into~~liabilities measured at fair value on ~~September 30, 2016. This contract is~~ a service arrangement that includes multiple elements. The deliverables under the BARDA NuThrax Contract are the completion of development for NuThrax and the procurement of NuThrax for the Strategic National Stockpile ("SNS").recurring basis from those measured at fair value on a non-recurring basis. The Company has ~~determined~~cash held in money market acocunts, contingent consideration and interest rate swaps that ~~the procurement~~are measured at fair value on a recurring basis (Note 8 and Note 9). As of ~~NuThrax under the BARDA NuThrax Contract is a contingent deliverable, as it is dependent upon successful completion of development; therefore~~September 30, 2019, the Company ~~has excluded this from the allocation~~held cash in money market accounts of ~~the contract consideration.~~$34.6 million. The Company allocated the value of the contract to the development for the NuThrax product candidate based on an approach using the best estimate of selling price ("BESP methodology"). The BESP methodology for the development deliverable takes into account a cost build-up for internal and external costs, plus a specified mark-up.did 0t have cash held in money markets at December 31, 2018. The Company ~~has allocated $147.5 million to~~also records the ~~development services deliverable~~assets and ~~will recognize revenue as the services are provided.~~liabilities of acquisitions

EMERGENT BIOSOLUTIONS INC.

~~On March 16, 2017,~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

at fair value (Note 3). As of September 30, 2019 and December 31, 2018, the Company ~~entered into a contract with BARDA, valued~~had no other significant assets or liabilities that were measured at ~~$100 million,~~fair value.

Reclassifications

Certain prior year amounts have been reclassified for ~~the delivery of BioThrax to the SNS over a two-year period of performance. In conjunction~~consistency with the signing of this contract, the Company entered into a modification to its BARDA NuThrax Contract that increases the number of doses of NuThrax to be delivered under the base period from two million to three million doses with a commensurate reduction in dose price for the initial deliveries. The modification also provides for a discountcurrent year presentation. These reclassifications had no effect on the ~~sales price for doses to be procured during~~reported results of operations. Interest income, which was previously reported as a separate line item on the ~~option period up to $100 million. As a result~~condensed consolidated statement of ~~the modification of the BARDA NuThrax Contract in conjunction~~operations has been combined with ~~execution of the BARDA BioThrax Contract, the Company has determined that the two agreements are linked under the revenue recognition requirements of~~other income (expense), net.

Recently Adopted Accounting Pronouncements

Leases

In February 2016, the Financial Accounting Standards Board ~~("FASB")~~ ~~Topic 605, Revenue Recognition. The Company analyzed these agreements and determined that the units of accounting under the linked agreements are:~~

·	~~development services for the NuThrax product candidate under the BARDA NuThrax Contract; and~~

·	~~procurement of BioThrax under the BARDA BioThrax Contract.~~

The Company's allocation of contract consideration for the development services was updated based on the services provided prior to March 17, 2017. The allocation of contract consideration for the BioThrax doses to be sold under the BARDA BioThrax Contract was determined based on similar pricing provided to other customers. The Company's determination of the amount of contract consideration to be allocated to the discounts was based on an undiscounted probability adjusted model, which factored in the expected timing of regulatory approval for the NuThrax product candidate, expected levels of procurement of the NuThrax product candidate upon regulatory approval and the market conditions for these types of medical countermeasures. The Company allocated the contract consideration to the two units of accounting as follows:

·	~~$137.1 million was allocated to the development services for the NuThrax product candidate under the BARDA NuThrax Contract; and~~

·	~~$93.6 million was allocated to the procurement of BioThrax under the BARDA BioThrax Contract.~~

The Company will defer a portion of the consideration received for doses delivered under the BARDA BioThrax Contract and the development services for the NuThrax product candidate. The Company will recognize the deferred revenue upon the delivery of NuThrax doses under the BARDA NuThrax Contract, or upon the future extinguishment of the Company's obligation to deliver NuThrax doses to which the discount applies.

~~Recently issued accounting standards~~

~~In May 2014, the FASB~~(FASB) issued Accounting ~~Standards~~Standard Update ~~("ASU") No. 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606)~~ ("~~ASU No. 2014-09"). ASU No. 2014-09 supersedes the revenue recognition requirements in~~ ~~Topic 605, Revenue Recognition~~(ASU) 2016-02, Leases, 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. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in exchange for the promised goods or services, the provider should apply 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. ASU No. 2014-09 also specifies the accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. The Company will adopt the requirements of the new standard in the first quarter of 2018 using the modified retrospective method. The modified retrospective method requires companies to recognize the cumulative effect of initially applying the new standard as an adjustment to opening retained earnings. The Company is finalizing its review of its revenue contract portfolio and has made an initial determination of its revenue streams. The Company is completing the detailed analysis of its multiple deliverable and procurement contracts with the U.S. government and believes there will be changes to the revenue recognition for its multiple deliverable contracts. The Company is in the process of finalizing its accounting policy and designing and implementing the necessary changes to processes and controls in order to account for revenue under the new standard beginning on the adoption date. Based on the Company's timeline and planned resources, the Company anticipates completing its implementation by the adoption date.

~~In February 2016, the FASB issued ASU 2016-02,~~ ~~Leases (Topic 842)~~ ("~~ASU No. 2016-02"). ASU No. 2016-02~~which increases transparency and comparability among organizations by requiring the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The Company adopted the new standard ~~will be~~ effective January 1, 2019 ~~for~~using the ~~Company, with early adoption permitted. The standard will be applied using a~~ modified retrospective approach to the beginning of the earliest period presented in the financial statements. The Company is currently evaluating when it will adopt the standard and the expected impact to its consolidated financial statements and related disclosures.

~~In March 2016, the FASB issued ASU No. 2016-09,~~ ~~Compensation - Stock Compensation (Topic 718)~~ ("ASU No. 2016-09"). ASU No. 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including: (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification on the statement of cash flows.approach. As of January 1, ~~2017,~~2019 total right of use assets increased $13.4 million, while total operating lease liabilities increased $14.0 million. There was no adjustment to the opening balance of retained earnings as of January 1, 2019. The standard will not materially affect the Company's consolidated net earnings. The Company continues to apply the legacy guidance from the old lease accounting standard, including its disclosure requirements, in the comparative periods presented. The Company did not reassess existing contracts for lease classification or the classification of existing leases or associated costs. The Company will not reflect leases with an initial term of 12 months or less as a right of use asset or liability, but will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. In addition, the Company will account for non-lease components of the arrangement separate from lease components (see Note 6).

SEC Simplification

In August 2018, the SEC issued Final Rule Release No. 33-10532, Disclosure Update and Simplification, which makes a number of changes meant to simplify interim disclosures. The new rule requires a presentation of changes in stockholders’ equity and noncontrolling interest in the form of a reconciliation, for the current and comparative year-to-date interim periods. The Company adopted the new disclosure requirements beginning in its March 31, 2019 Form 10-Q and ~~performed~~included these disclosures in the ~~evaluation required by the standard and~~condensed consolidated statements of changes in stockholders' equity. The additional elements of this release did not ~~identify any conditions or events that would~~ have a material impact on the ~~current disclosures in~~Company's overall condensed consolidated financial statements.

Tax Effects from Accumulated Other Comprehensive Income

In February 2018, the ~~financial statements. The Company has retrospectively adjusted~~FASB issued ASU 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018-02 provides the operating and financing sections within the statement of cash flows for the classification of employee taxes paid associated with equity award activities for the nine months ended September 30, 2016. In addition, the Company prospectively adopted the provisionsoption to reclassify certain income tax effects related to the ~~excess tax benefits,~~Tax Cuts and ~~as a result prior periods were not adjusted. If~~Jobs Act passed in December of 2017 between accumulated other comprehensive income and retained earnings and also requires additional disclosures. The Company adopted the ~~Company had adopted this provision retrospectively, there would have been~~new standard effective January 1, 2019. There was no ~~change to the estimated effective annual tax rate~~impact for the ~~three and nine months ended September 30, 2016, but for the nine months ended September 30, 2016, there would have been a tax benefit associated with stock option activity~~adoption of ~~$3.5 million recorded in the provision for income taxes~~ASU 2018-02 on the Company's ~~statement~~condensed consolidated financial statements.

New Accounting Pronouncements

Financial Instruments - Credit Losses

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses. ASU 2016-13 provides guidance on measurement of ~~operations.~~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, that requires entities to use a new, forward-looking “expected loss” model that is likely to result in the earlier recognition of allowances for losses. The guidance was further amended in January 2019 to clarify or address stakeholders’ specific issues about certain aspects of the amendments in the update and in May 2019 to provide an option to irrevocably elect the fair value option for certain financial assets previously measured on an amortized cost basis. 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 currently evaluating the effect that the pronouncement will have on its consolidated financial statements.

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

Goodwill

In January 2017, the FASB issued ASU ~~No. 2017-01,~~ ~~Business Combinations (Topic 805): Clarifying the Definition of a Business~~ ("ASU No. 2017-01"). ASU No. 2017-01 provides clarification for the definition of a business with the objective of adding guidance and providing a more robust framework to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The new standard will be effective for all annual periods beginning after December 15, 2017. The Company has early adopted ASU 2017-01 and determined the acquisition of raxibacumab, acquired on October 2, 2017, is an asset acquisition. See Note 12 "Subsequent events" for further details regarding this acquisition.

~~In January 2017, the FASB issued ASU No.~~ 2017-04, Intangibles - Goodwill and Other (Topic ~~250)~~350):Simplifying the Test for Goodwill Impairment (". ASU ~~No. 2017-04"). The standard~~2017-04 simplifies the subsequent measurement of goodwill and eliminates ~~the second step in~~Step 2 from the goodwill impairment test, which requires an entity to determine the implied fair value of the reporting unit's goodwill. Instead, an entity should recognize an impairment loss if the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, with the impairment loss not to exceed the amount of goodwill allocated to the reporting unit. The standardtest. ASU 2017-04 is effective for annual and interim goodwill ~~impairment~~ tests ~~conducted in fiscal years~~ 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 condensed consolidated financial statements.

Fair Value Measurements

In August 2018 the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. This new standard modifies certain disclosure requirements on fair value measurements. This new standard will be effective for the Company on January 1, 2020. The Company is currently evaluating the impact of adopting ASU 2018-13 on its disclosures.

Compensation - Retirement Benefits - Defined Benefit Plans

In August 2018, the FASB issued ASU 2018-14, Compensation - Retirement Benefits - Defined Benefit Plans - General. 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 ~~does not believe that~~is currently evaluating the ~~new standard will have a material~~ impact of adopting ASU 2018-14 on its consolidated financial statements.

There are no other recently issued accounting pronouncements that are expected to have a material impact on the Company's financial position, results of operations or cash flows.

~~2. Discontinued operations~~3. Acquisitions

Adapt

On October 15, 2018, the Company acquired Adapt, a company focused on developing new treatment options and commercializing products addressing opioid overdose and addiction. Adapt's NARCAN® (naloxone HCl) Nasal Spray marketed product is 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. This acquisition includes 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 products and product candidates within Adapt's portfolio are consistent with the Company's mission and expands the Company's core business of addressing public health threats.

Under the acquisition method of accounting, the assets and liabilities of Adapt have been recorded as of October 15, 2018, the acquisition date, at their respective fair values, and combined with those of the Company. As the Company continues to finalize the fair value of assets acquired and liabilities assumed, purchase price adjustments have been recorded and additional purchase price adjustments may be recorded during the measurement period. The Company reflects measurement period adjustments in the period in which the adjustments occur. The adjustments for the nine months ended September 30, 2019 resulted from the receipt of additional financial information associated with certain acquired contract assets and the value of associated contingent purchase consideration. These adjustments did not impact the Company's statements of operations. As of September 30, 2019, certain fair value estimates relating to income taxes could be subject to further adjustment.

The total purchase price, revised for measurement period adjustments is summarized below:



	October 15, 2018
Cash	$	581.5
Equity	37.7
Fair value of contingent purchase consideration	48.0
Preliminary purchase consideration	667.2
Adjustments	1.5
Updated purchase consideration	$	668.7

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

The Company issued 733,309 shares of common stock at $60.44 per share, the closing price of Emergent's common stock on October 15, 2018, with a total value of $44.3 million. The $44.3 million value of the common 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 contingent consideration payable for 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 had a fair value of $58.6 million as of September 30, 2019 and for the payment of additional consideration based on the collectability of identified acquired contract assets. The 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 inputs (Level 3). The obligation is measured using a discounted cash flow model.

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 updated for measurement period adjustments recorded through September 30, 2019.



	October 15, 2018			Measurement Period Adjustments			Updated October 15, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:
Cash	$	17.7		$	—		$	17.7
Accounts receivable	21.3			—			21.3
Inventory	41.4			—			41.4
Prepaid expenses and other assets	7.8			3.0			10.8
Accounts payable	(32.2		)	—			(32.2		)
Accrued expenses and other liabilities	(50.4		)	—			(50.4		)
Deferred tax liability, net	(62.4		)	(0.5		)	(62.9		)
Total estimated fair value of tangible assets acquired and liabilities assumed	(56.8		)	2.5			(54.3		)

Acquired in-process research and development	41.0			—			41.0
Acquired intangible assets	534.0			—			534.0
Goodwill	149.0			(1.0		)	148.0
Total purchase price	$	667.2		$	1.5		$	668.7

The Company determined that the estimated acquisition-date fair value of intangible assets was $534.0 million. The estimated fair value was determined using the income approach, which discounts expected future cash flows to present value. The Company has determined the useful life of the NARCAN® Nasal Spray intangible asset to be 15 years. The Company estimated the fair value using a 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 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 acquired company's products.

The intangible asset associated with the in-process research and development (IPR&D) acquired from Adapt is related to a product candidate. Management determined that the estimated acquisition-date 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 discount rate of 11.0%, which is based on the estimated weighted-average cost of capital for companies with 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, the stage of development of pipeline programs on the acquisition date; the time and resources needed

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

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 7).

The Company determined the fair value of 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 has recorded $148.0 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 due to the legal structure of the transaction.

PaxVax

On ~~August 1, 2016,~~October 4, 2018, the Company completed the ~~spin-off~~acquisition of ~~Aptevo~~ ~~through~~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 ~~distribution~~only oral vaccine licensed by the FDA for the prevention of ~~100%~~typhoid fever, Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, and 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 infrastructure and related capabilities.

The Company paid cash consideration of $273.1 million for PaxVax. As of the ~~outstanding shares~~date of ~~common stock of Aptevo~~this filing, the accounting for the PaxVax acquisition is preliminary due to the Company's ~~shareholders (the "Distribution").~~need to gather data to assess the fair value accounting for taxes. The ~~Distribution was made~~table below summarizes the preliminary allocation of the purchase price based upon estimated fair values of assets acquired and liabilities assumed at October 4, 2018 updated for measurement period adjustments recorded through September 30, 2019.



	October 4, 2018			Measurement Period Adjustments			Updated October 4, 2018
Estimated fair value of tangible assets acquired and liabilities assumed:
Cash	$	9.0		$	—		$	9.0
Accounts receivable	4.1			—			4.1
Inventory	19.7			—			19.7
Prepaid expenses and other assets	12.2			(0.3		)	11.9
Property, plant and equipment	57.8			—			57.8
Deferred tax assets	3.8			(0.2		)	3.6
Accounts payable	(3.5		)	—			(3.5		)
Accrued expenses and other liabilities	(33.6		)	(0.4		)	(34.0		)
Total estimated fair value of tangible assets acquired and liabilities assumed	69.5			(0.9		)	68.6

Acquired in-process research and development	9.0			(9.0		)	—
Acquired intangible assets	133.0			—			133.0
Goodwill	61.6			9.9			71.5
Total purchase price	$	273.1		$	—		$	273.1

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

The estimated fair value of the intangible assets acquired for PaxVax's marketed products is a total of $133.0 million. 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 acquired products. The Company has determined that the weighted average useful lives of the intangible assets to be 19 years. The Company estimated the fair value of the Vivotif and Vaxchora intangible assets using a present value discount rate of 14.5% and 15.0%, 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 ~~Company's shareholders~~estimated internal rate of ~~record~~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 the IPR&D acquired from PaxVax is related to a product candidate. The Company has adjusted the provisional amounts recognized at the acquisition date to reflect new information obtained about facts and circumstances that existed as of the ~~close~~acquisition date that, if known, would have affected the measurement of ~~business~~the amounts recognized as of that date. The Company estimates the fair value based on ~~July 22, 2016 (the "Record Date"),~~the income approach.

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 determined the fair value of the property, plant and ~~provided for~~equipment utilizing both the cost approach and 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 values an asset based on the market price of assets with comparable features such ~~shareholders~~as design, location, size, construction, materials, use, capacity, specification, operational characteristics and other features or descriptions.

The Company recorded approximately $71.5 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 ~~one share of Aptevo common stock for every two shares of Emergent common stock held~~ as a result of the ~~Record Date.~~acquisition. The ~~Distribution was intended~~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 ~~qualify as a tax-free distribution~~be deductible for ~~federal income~~ tax purposes based upon the structure used in the ~~United States. In the aggregate, approximately 20.2 million shares~~acquisition.

Impact of ~~Aptevo common stock were distributed to the Company's shareholders~~Business Acquisitions

The operations of ~~record as~~each of the Record Date in 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.

~~The historical statements of operations of Aptevo have been presented as discontinued operations~~2 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 ~~prior period~~consolidated financial statements.



	Three months ended September 30,		Nine months ended September 30,
	2019		2019
Revenue	$	83.7	$	246.8
Operating income	4.9		9.3

4. Inventories

The components of inventory are as follows:



	September 30, 2019		December 31, 2018
Raw materials and supplies	$	69.0	$	51.8
Work-in-process	106.6		103.2
Finished goods	54.6		50.8
Total inventories	$	230.2	$	205.8

5. Property, Plant and Equipment

Property, plant and equipment consisted of the following:



	September 30, 2019			December 31, 2018
Land and improvements	$	46.3		$	44.6
Buildings, building improvements and leasehold improvements	234.6			216.2
Furniture and equipment	310.8			293.9
Software	54.0			55.2
Construction-in-progress	83.4			71.8
Property, plant and equipment, gross	729.1			681.7
Accumulated depreciation	(200.0		)	(171.5		)
Total property, plant and equipment, net	$	529.1		$	510.2

6. Leases

The Company has ~~been restated. Discontinued operations include results~~operating leases for corporate offices, research and development facilities and manufacturing facilities. We determine if an arrangement is a lease at inception. Operating leases are included in right-of-use (ROU) assets and liabilities.

ROU assets represent the 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 ~~Aptevo's business except for certain allocated corporate overhead costs and certain costs associated with transition services provided by~~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 determining the present value of lease payments. The 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 ~~Aptevo. These allocated costs remain part of continuing operations. Due~~be paid and excludes lease incentives. The Company's lease ROU asset may include options to ~~differences between~~extend or terminate the ~~basis of presentation for discontinued operations and the basis of presentation as a stand-alone company, the financial results of Aptevo included within discontinued operations for~~lease when it is reasonably certain that the Company ~~may not be indicative~~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 are accounted for separately. The Company's leases have remaining lease terms of ~~actual financial results~~1 year to 15 years, some of ~~Aptevo.~~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.

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

The components of lease expense were as follows:



	Three months ended September 30,		Nine months ended September 30,
	2019		2019
Operating lease cost:
Amortization of right-of-use assets	$	0.8	$	2.1
Interest on lease liabilities	0.1		0.4
Total operating lease cost	$	0.9	$	2.5

Supplemental balance sheet information related to leases was as follows:



(In millions, except lease term and discount rate)	Balance Sheet Location	September 30, 2019
Operating lease right-of-use assets	Other assets	$	19.4

Operating lease liabilities, current portion	Other current liabilities	2.5
Operating lease liabilities	Other liabilities	17.4
Total operating lease liabilities		$	19.9

Operating leases:
Weighted Average Remaining Lease Term (years)		9.3
Weighted Average Discount Rate		4.2		%

7. Intangible Assets

The Company's intangible assets consist of products acquired via business combinations or asset acquisitions. The following table summarizes ~~results from discontinued operations~~the carrying amount of ~~Aptevo included~~the Company's intangible assets and goodwill, net of accumulated amortization:



	September 30, 2019
	Estimated Life (years)	Cost		Measurement Period Adjustment			Additions		Gross Total		Accumulated Amortization			Net
Intangible assets, net	5-22	$	818.4	$	—		$	10.0	$	828.4	$	(100.7	)	$	727.7
IPR&D	indefinite	50.0		(9.0		)	—		41.0		—			41.0
Goodwill	indefinite	259.7		8.9			—		268.6		—			268.6



	December 31, 2018
	Estimated Life (years)	Cost		Measurement Period Adjustment		Additions		Gross Total		Accumulated Amortization			Net
Intangible assets, net	5-22	$	151.4	$	—	$	667.0	$	818.4	$	(56.8	)	$	761.6
IPR&D	indefinite	50.0		—		—		50.0		—			50.0
Goodwill	indefinite	49.1		—		210.6		259.7		—			259.7

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

During the ~~consolidated statements of operations for the three and~~ nine months ended September 30, ~~2016:~~

Three Months Ended September 30, Nine Months Ended September 30,
(in thousands) 2016 2016

Revenues:
Product sales $ 3,019 $ 21,183
Collaborations 68 187
Total revenues 3,087 21,370

Operating expense:
Cost of product sales 907 11,556
Research and development 2,509 18,024
Selling, general and administrative 7,499 23,792
Loss from operations (7,828 ) (32,002 )

Other expense, net: (116 ) (41 )

Loss from discontinued operations before benefit from income taxes (7,944 ) (32,043 )
Benefit from income taxes (8,896 ) (16,189 )
Net income (loss) from discontinued operations $ 952 $ (15,854 )

~~The following table summarizes~~2019 and 2018, the ~~cash flows~~Company recorded amortization expense for intangible assets of ~~Aptevo included in the September 30, 2016 consolidated statements of cash flows:~~

Nine Months Ended September 30,
(in thousands) 2016
Net cash used in operating activities $ (10,299 )
Net cash used in investing activities (1,926 )
Net cash provided by financing activities 7,733

Net decrease in cash and cash equivalents $ (4,492 )

3.~~Fair value measurements~~

~~Contingent consideration are liabilities measured at fair value on a recurring basis. For~~$43.9 million and $11.7 million, respectively. During the three months ended September 30, ~~2017,~~2019 and 2018, the ~~contingent consideration obligation associated with the EV-035 series~~Company recorded amortization expense for intangible assets of ~~molecules~~$14.7 million and ~~the broad spectrum antiviral platform program increased by a nominal amount. For the three months ended~~3.9 million, respectively. As of September 30, ~~2016,~~2019, the ~~contingent consideration obligation associated with~~weighted average amortization period remaining for intangible assets was 13.8 years. IPR&D assets are considered to be indefinite-lived until the EV-035 series of molecules and the broad spectrum antiviral platform program increased by $0.1 million. For the nine months ended September 30, 2017 and 2016, the contingent consideration obligation associated with the EV-035 series and platform program decreased by $0.1 million and $0.3 million, respectively. The changes are primarily due to the estimated timing and probability of success for certain development and regulatory milestonescompletion or abandonment of the ~~program, which are inputs that have no observable market (Level 3). These changes are classified in the Company's statement of operations as both selling, general and administrative expense and~~associated research and development ~~expense.~~efforts.

~~For the three~~

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and ~~nine months ended September 30, 2017, the contingent purchase~~per share amounts)

8. Contingent Consideration

Contingent consideration ~~obligations~~liabilities associated with ~~RSDL increased by $0.9 million~~business combinations are fair value measurement items. These liabilities represent an obligation of the Company to transfer additional assets to the selling shareholders and ~~$1.4 million, respectively. For the three and nine months ended September 30, 2016, the contingent purchase consideration obligations~~owners if future events occur or conditions are met. These liabilities associated with ~~RSDL decreased by $2.3 million~~business combinations are measured at fair value at inception and ~~$1.0 million, respectively.~~at each subsequent reporting date. The changes in the fair value ~~of the RSDL contingent consideration obligations~~ are primarily due to the expected amount and timing of future net sales, which are inputs that have no observable market (Level 3).

The Company also has contingent consideration associated with its asset acquisitions. These ~~changes~~liabilities are ~~classified in~~not recorded as level 3 fair value measurements, but rather are accrued when the ~~Company's statement of operations as cost of product sales~~milestone has been achieved and ~~contract manufacturing.~~is payable.

The following table is a reconciliation of the beginning and ending balance of ~~the liabilities, consisting only of~~ contingent ~~consideration, measured at fair value, using~~considerations and is based on level 3 significant unobservable inputs, ~~(Level 3) during~~other than the milestone accrual, which is based on achievement of contractual milestones.




Balance at December 31, 2018	$	60.0
Milestone achievement - asset acquisition	10.0
Measurement period adjustment	1.5
Change in fair value	12.4
Settlements	(13.7		)
Balance at September 30, 2019	$	70.2

During the nine months ended September 30, 2019, a contingent milestone was achieved related to the Company's acquisition of raxibacumab in October 2017. The acquisition of raxibacumab was accounted for as an asset acquisition and therefore the achievement of the $10.0 million milestone resulted in an increase to the contingent consideration liability with a corresponding increase in intangible assets.

(in thousands)
Balance at December 31, 2016 $ 13,185
Expense included in earnings 1,350
Settlements (2,744 )
Balance at September 30, 2017 $ 11,791

~~Separate disclosure~~9. Derivative Instruments and Hedging Activities

Risk Management Objective of Using Derivatives

The Company is ~~required for~~exposed to certain risk 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 ~~measured~~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.

Accounting Policy for Derivative Instruments and Hedging Activities

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~~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 ~~recurring basis from those measured at~~component of operating cash flows, similar to interest expense. If current fair ~~value on a non-recurring basis. As~~values of ~~September 30, 2017 and 2016,~~designated interest rate swaps remained static over the next twelve months, the Company ~~had no significant assets or liabilities that were measured at fair value on a non-recurring basis.~~

~~On January 29, 2014, the Company issued $250.0~~would reclassify $0.4 million ~~aggregate principal amount~~ of ~~2.875% Convertible Senior Notes due 2021 (the "Notes"). The Notes mature on January 15, 2021, unless earlier purchased by the Company or converted. The Notes are subject~~net deferred losses from accumulated other comprehensive loss to the ~~fair value disclosure requirements. The estimated fair value~~statement of operations over the ~~Notes at September 30, 2017 was $359.5 million. The fair value of the Notes was determined via broker quote.~~next twelve months. All outstanding cash flow hedges mature in October 2023.

EMERGENT BIOSOLUTIONS INC.

4.~~Inventories~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

~~Inventories consisted of the following:~~

September 30, December 31,
(in thousands) 2017 2016
Raw materials and supplies $ 34,075 $ 30,687
Work-in-process 14,776 19,821
Finished goods 20,038 23,494
Total inventories $ 68,889 $ 74,002

~~5. Property, plant and equipment~~

~~Property, plant and equipment consisted of the following:~~

September 30, December 31,
(in thousands) 2017 2016
Land and improvements $ 20,333 $ 20,340
Buildings, building improvements and leasehold improvements 152,064 147,130
Furniture and equipment 194,385 190,157
Software 52,613 52,564
Construction-in-progress 100,328 77,813
Property, plant and equipment, gross 519,723 488,004
Less: Accumulated depreciation and amortization (133,266 ) (111,556 )
Total property, plant and equipment, net $ 386,457 $ 376,448

As of September 30, ~~2017 and December 31, 2016, construction-in-progress primarily includes costs related to~~2019, the ~~build out~~Company had the following outstanding interest rate derivatives that were designated as cash flow hedges of interest rate risk:



	Number of Instruments	Notional
Interest Rate Swaps	7	$	350.0

The table below presents the fair value of the ~~Company's Center~~Company’s derivative financial instruments designated as hedges as well as their classification on the balance sheet.

Asset Derivatives

Liability Derivatives

September 30, 2019

December 31, 2018

September 30, 2019

December 31, 2018

Balance Sheet Location

Fair Value

Balance Sheet Location

Fair Value

Balance Sheet Location

Fair Value

Balance Sheet Location

Fair Value

Interest Rate Swaps

Other Assets

—

Other Assets

—

Other Liabilities

4.2

Other Liabilities

—

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, we incorporate credit valuation adjustments in the fair value measurements to appropriately reflect both our own nonperformance risk and the respective counterparty’s nonperformance risk. These credit valuation adjustments were concluded to not be significant inputs for ~~Innovation~~the fair value calculations for the periods presented. In adjusting the fair value of our derivative contracts for the effect of nonperformance risk, we have 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 ~~Advanced Development~~the fair value hierarchy.

The table below presents the effect of cash flow hedge accounting on accumulated other comprehensive income.



Hedging derivatives	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
	September 30, 2019			September 30, 2018		September 30, 2019		September 30, 2018
Interest Rate Swaps	$	(4.2	)	—	Interest expense	$	0.5	$	—

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and ~~Manufacturing ("CIADM") facility.~~per share amounts)

6.~~Intangible assets~~

10. Debt

The ~~Company recorded amortization expense~~components of debt are as follows:

Three Months Ended September 30, Nine Months Ended September 30,
(in thousands) 2017 2016 2017 2016

Operating expenses:
     Cost of product sales and contract manufacturing $ 1,067 $ 1,163 $ 3,199 $ 3,873
     Research and development 348 348 1,044 1,044
     Selling, general and administrative 140 140 420 420
Total amortization expense $ 1,555 $ 1,651 $ 4,663 $ 5,337

~~As of September 30, 2017, the weighted average amortization period remaining for intangible assets was 68 months.~~

7.~~Long-term debt~~



	September 30, 2019			December 31, 2018
Senior secured credit agreement - Term loan due 2023	$	438.8		$	447.2
Senior secured credit agreement - Revolver loan due 2023	383.0			348.0
2.875% Convertible Senior Notes due 2021	10.6			10.6
Other	3.0			3.0
Total debt	835.4			808.8
Current portion of long-term debt, net of debt issuance costs	(10.1		)	(10.1		)
Unamortized debt issuance costs	(12.0		)	(14.2		)
Non-current portion of debt	$	813.3		$	784.5

Senior Secured Credit Agreement

On September 29,, 2017, the Company entered into a ~~senior secured credit agreement~~ ~~(the "2017 Credit Agreement") with four~~ ~~lending financial institutions, which replaced the Company's prior~~ senior secured credit agreement (the ~~"2013~~“2017 Credit Agreement”) with 4 lending financial institutions. On October 15, 2018, the Company entered into an Amended and Restated Credit Agreement (the "Amended Credit Agreement")~~. The 2017 Credit Agreement provides for a senior secured credit facility of up to $200 million through September 29, 2022. The 2017 Credit Agreement also includes a $100 million accordion feature,~~ with multiple lending institutions, which could provide an additional $100 million in revolver or incremental term loans, at the option of the Company, resulting in a potential aggregate commitment of up to $300 million, subject to certain conditions and requirements set forth inmodified the 2017 Credit Agreement. ~~As of September 30, 2017, no amounts were drawn under the~~ ~~2017 Credit Agreement~~.

The ~~Company's payment obligations under the 2017~~Amended Credit Agreement ~~are secured by a lien on substantially all~~(i) increased the revolving credit facility (the "Revolving Credit Facility") from $200 million to $600 million, (ii) extended the maturity of the ~~Company's assets, including~~Revolving Credit Facility from September 29, 2022 to October 13, 2023, and (iii) provided for a term loan in the ~~stock~~original principal amount of ~~all of~~$450 million (the "Term Loan Facility," and together with the ~~Company's domestic subsidiaries, and~~Revolving Credit Facility, the ~~assets of~~"Senior Secured Credit Facilities"). The Company may request incremental term loan facilities or increases in the ~~subsidiary guarantors.~~ Revolving Credit Facility (each an "Incremental Loan") as long as requirements relating to net leverage ratio will be maintained on a pro forma basis.

Borrowings under the ~~2017~~Revolving Credit ~~Agreement~~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 ~~1.50%~~1.25% to ~~2.50%~~2.00% 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%, and a eurocurrency rate for an interest period of one month plus 1%) plus a margin ranging from ~~0.50%~~0.25% to ~~1.50%~~1.00%, depending on the Company's consolidated net leverage ratio. The Company is required to make quarterly payments under the ~~2017~~Amended Credit Agreement offor 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 ~~0.25%~~0.15% to ~~0.40%~~0.30% per annum, depending on the Company's consolidated net leverage ratio, in respect of the average daily unused commitments under the ~~2017~~Revolving Credit ~~Agreement~~.

Facility. The Company is to repay the outstanding principal amount of the Term Loan Facility in quarterly installments 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% 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 ~~2017~~Amended Credit Agreement also requires mandatory prepayments of the Term Loan Facility in the event the Company or its 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 Amended Credit Agreement contains affirmative and negative covenants customary for financings of this type. Negative covenants in the 2017 Credit Agreement, among other things, limit the Company's ability to incur indebtedness and liens; dispose of assets; make investments including loans, advances, guarantees, or acquisitions (subject to compliance with the financial covenants, ~~and certain other conditions); and enter into certain mergers or consolidation transactions.~~which were amended in June 2019. The ~~2017 Credit Agreement also contains~~ financial covenants ~~tested~~require the quarterly ~~and in connection with any triggering events under the 2017 Credit Agreement: (1)~~presentation of a minimum consolidated 12-month rolling debt service coverage ratio of 2.50 to 1.00, and ~~(2) a~~an amended maximum consolidated net leverage ratio of 4.95 to 1.00 for the quarter ended June 30, 2019, 4.75 to 1.00 for the quarter ending September 30, 2019, 3.75 to 1.00 for the quarterly filing periods from October 1, 2019 through September 29, 2020 and 3.50 to ~~1.00,~~1.0, thereafter, which may be adjusted to 4.00 to 1.00 for a four quarter period in connection with a material permitted ~~acquisition, subject~~acquisition. The Amended Credit Agreement also contains affirmative and negative covenants, which were also amended in June 2019 to limit the ~~terms and conditions~~amount of restricted payments as defined in the Amended Credit Agreement to $25 million until the filing of the ~~2017~~Company's December 31, 2019 Form

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

10-K. Negative covenants in the Amended Credit ~~Agreement. Each~~Agreement, among other things, limit the ability of the ~~ratios referred~~Company to incur indebtedness and liens, dispose of assets, make investments and enter into certain merger or consolidation transactions. As of the date of 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 ~~foregoing clauses (1)~~Company issued 2.875% convertible senior notes due 2021 (the "Notes"). The Notes bear interest at a rate of 2.875% per year, payable semi-annually in arrears on January 15 and ~~(2) is calculated~~July 15 of each year. The Notes mature on January 15, 2021.

11. Revenue recognition

The Company operates as 1 operating segment. Therefore, results of its operations are reported on a consolidated basis for ~~each consecutive four fiscal quarter periods.~~purposes of segment reporting, consistent with internal management reporting. The Company's revenues disaggregated by the major sources were as follows:



	Three Months Ended September 30, 2019						Three Months Ended September 30, 2018
	U.S. Government		Non-U.S. Government		Total		U.S. Government		Non-U.S. Government		Total
Product sales	$	170.2	$	86.0	$	256.2	$	127.3	$	6.0	$	133.3
Contract manufacturing	—		20.0		20.0		—		22.1		22.1
Contracts and grants	35.6		—		35.6		16.7		1.5		18.2
Total revenues	$	205.8	$	106.0	$	311.8	$	144.0	$	29.6	$	173.6



	Nine Months Ended September 30, 2019						Nine Months Ended September 30, 2018
	U.S. Government		Non-U.S. Government		Total		U.S. Government		Non-U.S. Government		Total
Product sales	$	338.1	$	254.6	$	592.7	$	363.2	$	25.9	$	389.1
Contract manufacturing	—		54.6		54.6		—		72.0		72.0
Contracts and grants	94.3		4.1		98.4		46.7		3.9		50.6
Total revenues	$	432.4	$	313.3	$	745.7	$	409.9	$	101.8	$	511.7

Contract liabilities

When performance obligations are not transferred to a customer at the end of a reporting period, cash received associated with amounts allocated to those performance obligations is reflected as contract liabilities on the consolidated balance sheets and is deferred until control of these performance obligations is transferred to the customer. The following table presents the rollforward of the contract liability balances:




December 31, 2018	$	73.1
Prepayments	34.6
Revenue recognized	(18.1		)
September 30, 2019	$	89.6

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

Transaction price allocated to remaining performance obligations

As of September 30, 2019, the Company had expected future revenues of approximately $659.6 million associated with performance obligations that have not been satisfied. The Company expects to recognize a majority of these revenues within the next 24 months, with the remainder recognized thereafter. However, the amount and timing of revenue recognition for unsatisfied performance obligations can materially change due to timing of funding appropriations from the USG and the overall success of the Company's development activities associated with its PHT product candidates that are then receiving development funding support from the USG 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.

Contract assets

The Company ~~recorded~~considers unbilled accounts receivables and deferred costs associated with revenue generating contracts, which are not included in inventory or property, plant and equipment, as contract assets. As of September 30, 2019 and December 31, 2018, the Company had contract assets associated with deferred costs of $27.3 million and $1.2 million, respectively, which is reflected as a ~~loss~~component of prepaid expenses and other current assets on ~~extinguishment~~the Company's consolidated balance sheets.

Accounts receivable

Accounts receivable, including unbilled accounts receivable contract assets, consist of ~~debt~~the following:



	September 30, 2019		December 31, 2018
Billed, net	$	251.4	$	234.0
Unbilled	29.8		28.5
Total, net	$	281.2	$	262.5

As of ~~$0.4 million~~September 30, 2019 and December 31, 2018, allowances for doubtful accounts were de minimis.

12. Income taxes

The estimated effective annual tax rate for the ~~three and~~Company, which excludes discrete adjustments, was 26% for the nine months ended September 30, ~~2017~~2019 and 2018. For each of the nine month periods ended September 30, 2019 and 2018, the Company recorded a discrete tax benefit of $3.0 million and $8.7 million, respectively, primarily due to activity associated with ~~termination of the 2013 Credit Agreement. Loss~~equity awards and finalizing positions taken on ~~extinguishment of debt consisted of expensing unamortized debt issuance costs.~~

~~The Company entered into a standby letter of credit and guarantee arrangement with a bank in the amount of $1.0 million that is fully collateralized by cash, which is classified as restricted cash in~~ the Company's ~~consolidated balance sheet.~~

8. ~~Equity~~

~~As of~~income tax filings. For the three months ended September 30, ~~2017,~~2019and 2018, the Company ~~had one~~recorded a discrete tax (expense) benefit of $(0.2) million and $5.5 million, respectively, primarily due to finalizing positions taken on the Company's income tax filings and equity ~~award plan, the Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (the "2006 Plan"), which includes both stock options and restricted stock units.~~awards.

~~The following is a summary of stock option award activity under the 2006 Plan:~~

Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value
Outstanding at December 31, 2016 2,559,331 $ 22.94 $ 25,348,245
Granted 418,141 30.85
Exercised (512,542 ) 19.90
Forfeited (24,625 ) 27.81
Outstanding at September 30, 2017 2,440,305 $ 24.88 $ 37,991,459

~~The following is a summary of restricted stock unit award activity under the 2006 Plan:~~

Number of Shares Weighted-Average Grant Price Aggregate Intrinsic Value
Outstanding at December 31, 2016 875,584 $ 28.94 $ 28,754,179
Granted 454,513 30.86
Vested (413,752 ) 20.66
Forfeited (34,355 ) 28.87
Outstanding at September 30, 2017 881,990 $ 30.39 $ 35,676,496

9.13. Earnings per share

The following table presents the calculation of basic and diluted net income per share:



	Three Months Ended September 30,				Nine Months Ended September 30,
	2019		2018		2019		2018
Numerator:
Net earnings	$	43.2	$	20.9	$	7.6	$	66.2

Denominator:
Weighted-average number of shares—basic	51.6		50.1		51.4		49.9
Dilutive securities—equity awards	0.7		1.4		0.9		1.3
Weighted-average number of shares—diluted	52.3		51.5		52.3		51.2

Net earnings per share - basic	$	0.84	$	0.42	$	0.15	$	1.33
Net earnings per share - diluted	$	0.83	$	0.41	$	0.15	$	1.29

Three Months Ended September 30, Nine Months Ended September 30,
(in thousands, except share and per share data) 2017 2016 2017 2016
Numerator:
Net income from continuing operations $ 33,551 $ 20,388 $ 48,652 $ 30,238
Interest expense, net of tax 704 934 2,445 2,234
Amortization of debt issuance costs, net of tax 195 183 586 569
Net income, adjusted from continuing operations 34,450 21,505 51,683 33,041
Net income (loss) from discontinued operations - 952 - (15,854 )
Net income, adjusted $ 34,450 $ 22,457 $ 51,683 $ 17,187

Denominator:
Weighted-average number of shares—basic 41,222,504 40,465,423 40,989,813 40,071,730
Dilutive securities—equity awards 1,148,857 878,390 1,003,794 658,367
Dilutive securities—convertible debt 8,096,468 8,096,500 8,096,481 8,096,500
Weighted-average number of shares—diluted 50,467,829 49,440,313 50,090,088 48,826,597

Net income per share from continuing operations - basic $ 0.81 $ 0.50 $ 1.19 $ 0.75
Net income (loss) per share from discontinued operations - basic - 0.02 - (0.40 )
Net income per share - basic $ 0.81 $ 0.52 $ 1.19 $ 0.35

Net income per share from continuing operations - diluted $ 0.68 $ 0.43 $ 1.03 $ 0.68
Net income (loss) per share from discontinued operations - diluted - 0.02 - (0.32 )
Net income per share - diluted $ 0.68 $ 0.45 $ 1.03 $ 0.36

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and per share amounts)

For the three and nine months ended September 30, ~~2017~~2019 and ~~2016,~~2018, basic earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period.

For the three and nine months ended September 30, ~~2017~~2019 and ~~2016,~~2018, diluted earnings per share is computed using the ~~"if-converted"~~treasury method by dividing ~~the~~ net income ~~adjusted for interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes~~ by the weighted average number of shares of common stock outstanding during the ~~period. The weighted average number of shares is~~period, adjusted for the potential dilutive effect of other securities if such securities were converted or exercised and are not anti-dilutive. The share-based awards that were excluded from the ~~exercise~~calculation of ~~stock options and the vesting of restricted stock units along with the assumption of the conversion of the Notes, at the beginning of the period.~~

~~For~~diluted income per share, because they were anti-dilutive, was approximately 1.0 million for the three and nine months ended September 30, ~~2017, along with~~2019.

14. Share-based compensation

During the nine months ended September 30, ~~2016, substantially all of~~2019, the ~~outstanding~~Company granted stock options to purchase 0.3 million shares of common stock ~~were included in~~and 0.5 million restricted stock units under the ~~calculation of diluted earnings per share. For~~Emergent BioSolutions Inc. Stock Incentive Plan. The grants vest over three equal annual installments beginning on the ~~three months ended September 30, 2016, approximately 0.4 million stock options were excluded from the calculation of diluted earnings per share due~~day prior to the ~~fact that~~anniversary of the ~~exercise prices were~~grant date.

15. Defined benefit plan

The Company sponsors a defined benefit pension plan covering eligible employees in Switzerland (the 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 ~~average per share closing price during~~employee’s contribution. The Swiss Plan assets are comprised of an insurance contract that has a fair value consistent with its contract value based on the ~~period.~~

~~10. Restructuring~~

~~In August 2016,~~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 adopted a plan to restructure and reprioritize the operations at the Emergent BioDefense Operations Lansing LLC ("EBOL") site. This plan was initiated as a result of the Company's large-scale manufacturing facility at the EBOL site commencing manufacturing operations. Severance and other related costs and asset-related charges are reflected within the Company's consolidated statement of operationsrecognizes pension expense as a component of selling, general and administrative expense.

The ~~Company has completed~~measurement date used for the ~~EBOL restructuring.~~Swiss Plan is December 31, annually. The ~~costs~~expense components of the ~~restructuring as of September 30, 2017 are detailed below:~~

Incurred in Inception
(in thousands) 2017 to Date
Termination benefits $ 40 $ 5,286
Abandonment of equipment - 3,749
Other costs - 691
Total $ 40 $ 9,726

During the year ended December 31, 2016, the Company abandoned certain equipment and associated assets at its EBOL facility related to the manufacturing process at Building 12 ("manufacturing process") asset group. During the third quarter of 2016, the Company recorded a charge for the manufacturing process asset group of $3.7 million. The additional expense is classified in the Company's statements of operations as selling, general and administrative expense.

~~The following is a summary~~Swiss Plan consisted of the ~~activity for the liabilities related to the restructuring:~~

Termination
(in thousands) Benefits
Balance at December 31, 2016 $ 4,357
Expenses incurred 40
Amount paid (4,298 )
Balance at September 30, 2017 $ 99

following:

~~11.~~



	Three Months Ended September 30, 2019			Nine Months Ended September 30, 2019
Net service cost	$	0.3		$	1.0
Expected return on plan assets, net of expenses	(0.1		)	(0.4		)
Total pension expense	$	0.2		$	0.6

16. Commitments and Contingencies

ANDA Litigation

- Perrigo 4mg

On ~~July 19, 2016, Plaintiff William Sponn,~~September 14, 2018, Adapt Pharma Inc., Adapt Pharma Operations Limited and Adapt Pharma Ltd. (collectively, Adapt Pharma), and Opiant Pharmaceuticals, Inc. (Opiant), received notice from Perrigo UK FINCO Limited Partnership (Perrigo) that Perrigo had filed an Abbreviated New Drug Application (ANDA) with the 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 (the ‘253 Patent), 9,468,747 (the ‘747 Patent), 9,561,177 (the ‘177 Patent), 9,629,965 (the ‘965 Patent), and 9,775,838 (the ‘838 Patent). On or ~~Sponn,~~about October 25, 2018, Perrigo sent a subsequent notice letter relating to U.S. Patent No. 10,085,937 (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 (collectively, Plaintiffs), filed a ~~putative class action~~ complaint for patent infringement of the ‘253, ‘747, ‘177, ‘965, and the ‘838 Patents against Perrigo in the United States District Court for the District of ~~Maryland~~New Jersey arising from Perrigo’s ANDA filing with the FDA. Plaintiffs filed a second complaint against Perrigo on ~~behalf of purchasers~~December 7, 2018, for the infringement of the ~~Company's common stock between January 11, 2016~~‘937 Patent. As a result of timely filing 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, unfavorable to the Plaintiffs, by the Court.

EMERGENT BIOSOLUTIONS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in millions, except share and ~~June 21, 2016, inclusive,~~per share amounts)

ANDA Litigation - Teva 2mg

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. (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 (the ‘644 Patent), and U.S. Patent No. 9,707,226 (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 ~~Class Period,~~'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.

ANDA Litigation - Teva 4mg

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 ~~pursue remedies under~~market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4 mg/spray before the ~~Securities Exchange Act~~expiration of ~~1934 against~~ the ~~Company~~'253 Patent. Adapt Pharma Inc. and ~~certain~~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 ~~senior officers and directors, collectively,~~generic drug product described in its ANDA will not infringe the ~~Defendants. The complaint alleges, among other things,~~'253, the '747, the '177, the '965, the '838, or the ‘937 Patent, or that the ~~Company made materially false~~'253, the '747, the '177, the '965, the '838, and ~~misleading statements about~~ the ~~government's demand~~‘937 Patents are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant filed a complaint for ~~BioThrax and expectations that~~patent infringement against Teva in the ~~Company's five-year exclusive procurement contract~~United States District Court for the District of New Jersey with the U.S. Department of Health and Human Services would be renewed and omitted certain material facts. Sponn is seeking 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 Robins Geller Rudman & Dowd LLP as Lead Counsel. On December 27, 2016, the Plaintiffs filed an amended complaint that cites the same class period, names the same defendants and makes similar allegationsrespect to the ~~original complaint. The Company~~'253 Patent. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant also filed a Motion to Dismiss on February 27, 2017. The Plaintiffs filed an opposition brief on April 28, 2017. The Company's Motion to Dismiss was heard and denied on July 6, 2017. The Company filed its answer on July 28, 2017. The parties are currentlycomplaints for patent infringement against Teva in the ~~process~~United States District Court for the District of ~~exchanging discovery,~~New Jersey with respect to the '747, the '177, the '965, and ~~Plaintiffs' class certification motion is due by November 29, 2017. The Defendants believe that~~ the ~~allegations in the complaint are without merit and intend to defend themselves vigorously against those claims.~~'838 Patents. All five proceedings have been consolidated. As of the date of this filing, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant, have not filed a complaint related to the ~~range~~‘937 Patent.

In the complaints described in the paragraphs above, the Plaintiffs seek, among other relief, orders that the effective date of ~~potential loss cannot~~FDA approvals of the Teva ANDA products and the Perrigo ANDA product be ~~determined~~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 ~~estimated.~~

~~12. Subsequent events~~

~~Acquisition~~importing the products that are the subject of ~~raxibacumab~~

~~On October 2, 2017,~~Teva and Perrigo’s respective ANDAs, until after the ~~Company completed~~expiration of the ~~acquisition of raxibacumab, a fully human monoclonal antibody~~patents listed for each product, ~~approved~~and monetary relief or other relief as deemed just and proper by the ~~U.S. Food~~court.

Nalox-1 Pharmaceuticals, a non-practicing entity, filed petitions with the United States Patent and ~~Drug Administration~~Trademark Office Patent Trial and Appeal Board ("~~FDA"~~PTAB") ~~for the treatment and prophylaxis~~requesting inter parties review (IPR) 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. With the acquisition, the Company assumed responsibility for a multi-year contract with BARDA, with a remaining value of up to approximately $130 million, to supply the product to the SNS through November 2019. The Company has determined that substantially allfive of the ~~value~~six patents listed in the Orange Book related to NARCAN® Nasal Spray 4mg/spray. In a series of ~~raxibacumab is attributed~~decisions, the PTAB agreed to ~~the raxibacumab asset and therefore the raxibacumab acquisition is considered an asset acquisition.~~

~~Acquisition of ACAM2000~~

~~On October 6, 2017, the Company completed the acquisition~~institute a review of the ~~ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) business of Sanofi Pasteur Biologics, LLC ("Sanofi"). This acquisition includes ACAM2000,~~'253 Patent, the ~~only smallpox vaccine approved by~~'747 Patent and 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 assumed responsibility for an existing 10-year contract with the Centers for Disease Control and Prevention ("CDC"), which will expire and be up for renewal or extension in March 2018. This contract was originally valued at up to $425 million, with a remaining value of up to approximately $160 million, for the delivery of ACAM2000 to the SNS and establishing U.S.-based manufacturing of ACAM2000.

~~At the closing, the Company paid $97.5 million in an upfront payment and $20 million in milestone payments earned as~~'965 Patent but denied review of the ~~closing date tied to~~'177 Patent and the achievement of certain regulatory and manufacturing-related milestones, for a total payment in cash of $117.5 million. The agreement includes a potential additional milestone payment of up to $7.5 million. 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'838 Patent. Nalox-1 did not request review of the ~~ACAM2000 business will be recorded as~~'937 Patent.

17. Supplemental Information

The following table provides a reconciliation of ~~October 6, 2017, the acquisition date, at their respective fair values,~~cash, cash equivalents and ~~combined with those of the Company.~~restricted cash:



	September 30, 2019		December 31, 2018
Cash and cash equivalents	$	139.2	$	112.2
Restricted cash	0.2		0.2
Total cash, cash equivalents and restricted cash	$	139.4	$	112.4

As of the date of this filing, the valuation of acquired intangible assets, inventory, deferred taxes, property plant and equipment, contingent purchase consideration and other fair value adjustments are not complete, and as such the purchase price allocation is subject to change.

EMERGENT BIOSOLUTIONS INC.

~~ITEM 2.~~MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

~~You should read the~~

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations ~~together~~should be read in conjunction with our unaudited condensed consolidated financial statements and ~~the related~~accompanying notes and other financial information included elsewhere in this quarterly report on Form ~~10-Q.~~10-Q and our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2018. Some of the information contained in this discussion and analysis or set forth elsewhere in this quarterly report on Form 10-Q, ~~including~~includes information with respect to our plans and strategy for our business and financing, ~~includes~~as well as forward-looking statements that involve risks and uncertainties. You should carefully review the "Special Note Regarding Forward-Looking Statements" and "Risk Factors" sections of this quarterly report on Form 10-Q 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.

Overview

We are a global life sciences company ~~seeking to protect and enhance life by focusing~~focused on providing to civilian and military populations ~~specialty~~a portfolio of innovative preparedness and response products and ~~services~~solutions that address accidental, ~~intentional~~deliberate and naturally ~~emerging public health threats, or PHTs.~~occurring PHTs.

~~In terms~~We are focused on the following four distinct PHT categories: CBRNE; EID; traveler health; and opioids. We have a product portfolio of ten products (vaccines, therapeutics, and drug-device combination products) that contribute a substantial portion of our specialty products, we develop, manufacture and commercialize medical countermeasures, or MCMs, that address two categories of PHTs: (1) Chemical, Biological, Radiological and Nuclear, and explosives, or CBRNe; and (2) Emerging Infectious Diseases, or EID. With the recent acquisitions of raxibacumab and ACAM2000, we have a portfolio of eight revenue-generating products, as well as a pipeline of various investigational stage product candidates addressing select aspects of CBRNe and EID threats. The U.S. government is the primary purchaser of our products and provides us with substantial funding for the development of many of our product candidates.

~~Our marketed MCMs are:~~

~~BioThrax~~^® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or the FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease. BioThrax is also licensed by the Paul-Ehrlich-Institut of the German Federal Ministry of Health for general use prophylaxis of anthrax disease;

~~Anthrasil~~^® ~~[Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed by the FDA for the treatment of inhalational anthrax;~~

~~BAT~~^® ~~[Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)- (Equine)], the only heptavalent therapeutic licensed by the FDA and Health Canada for the treatment of botulinum disease;~~

~~VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA to address certain complications from smallpox vaccination;~~

~~RSDL~~^® ~~(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin;~~

~~Trobigard™ (atropine sulfate, obidoxime chloride),~~ ~~an auto-injector drug-device combination product designed for intramuscular self-injection~~ of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product is not currently approved or cleared by the FDA or any other similar regulatory body, and is only distributed to authorized government buyers for use outside the U.S. The product is not distributed in the U.S.;

~~ACAM2000~~^® (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed in the U.S. by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox (acquired from Sanofi Pasteur Biologics, LLC in October 2017); and

~~raxibacumab, a fully human monoclonal antibody approved by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017).~~

~~Our lead investigational stage MCM candidates, many of which are under an active development contract with significant funding from the U.S. government are:~~

~~NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;~~

~~UV-4B, a novel antiviral being developed for dengue and influenza infections;~~

~~GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed for~~ ~~Burkholderia pseudomallei~~;

~~FLU-IG (NP025), a human polyclonal antibody therapeutic being developed to treat seasonal influenza;~~

~~ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections;~~

~~FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat Ebola infections;~~

~~ZIKV-VLA1601, a highly purified inactivated vaccine candidate against the Zika virus; and~~

~~SIAN, a stabilized form of isoamyl nitrite in a spray device for the treatment of known or suspected acute cyanide poisoning.~~

revenue. We also have ~~programs~~two product candidates that ~~leverage our proven manufacturing infrastructure and expertise. We have responded to specific Task Order Requests issued by the Biomedical Advanced Research and Development Authority, or BARDA~~, for the development and manufacture of specific MCMs as part of our Center for Innovation in Advanced Development and Manufacturing, or CIADM, program focused on imminent public health threats. The manufacturing done under our CIADM arrangement is performed out of our Bayview facility located in Baltimore, Maryland.

~~In addition, we provide contract manufacturing services to third-party customers. The majority of these services~~ are performed at our Camden facilities located in Baltimore, Maryland. At our Camden facility, we manufacture both vial and pre-filled syringe formats for a wide variety of third-party owned drug products - small molecule and biological - in all stages of development and commercialization. This facility produces finished units of clinical and commercial drugs for a variety of customers ranging from small biopharmaceutical companies to major multinationals. The facility is an approved or inspected manufacturing facility under the regulatory regimes in the United States, Canada, Japan, Brazil, the Middle East and several countries in the European Union.

~~Highlightsand Business Accomplishments for 2017~~

~~On October 6, 2017, we completed the acquisition of the ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) business of Sanofi Pasteur Biologics, LLC, or Sanofi, for~~ $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, with~~ ~~a potential additional milestone payment of up to $7.5 million tied to the achievement of a regulatory milestone event. This acquisition includes ACAM2000, the only smallpox vaccine~~not approved by the FDA or any other health agency that are procured by certain government agencies under special circumstances. Additionally, we have a ~~current good~~development pipeline consisting of a diversified mix of both pre-clinical and clinical stage product candidates (vaccines, therapeutics, devices and combination products). Finally, we have a fully-integrated portfolio of contract development and manufacturing ~~practices,~~services. We continue to pursue acquiring and developing products and solutions that provide an opportunity to serve both government and commercial (non-government) customers globally.

The majority of revenue comes from the following products and product candidates:

Vaccines

AV7909 (Anthrax Vaccine Adsorbed with Adjuvant), is a product candidate being developed as a next generation anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or 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, we also assumed responsibility for an existing 10-year contract withconfirmed Bacillus antracis exposure;

BioThrax® (Anthrax Vaccine Adsorbed), the ~~Centers for Disease Control and Prevention, or CDC, originally valued at up to $425 million and with a remaining value of up to approximately $160 million,~~only vaccine licensed by the FDA for the ~~delivery~~general use prophylaxis and post-exposure prophylaxis of ~~ACAM2000 to~~anthrax disease;

ACAM2000® (Smallpox (Vaccinia) Vaccine, Live), the ~~U.S. Strategic National Stockpile, or SNS, and establishing U.S.-based manufacturing of ACAM2000.~~

~~On October 4, 2017, we were awarded a contract valued at up to approximately $25 million~~only single-dose smallpox vaccine licensed by the ~~U.S. Department~~FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;

Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of ~~State~~typhoid fever; and

Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera; it is orally delivered.

Devices

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;

RSDL® (Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to ~~supply Trobigard~~ ~~auto-injector,~~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® is a combination drug-device ~~combination~~audto-injector product ~~for emergency use in the event of nerve agent or organophosphate poisoning. Trobigard is designed for intramuscular self- or buddy-administration of~~candidate that contains atropine sulfate and obidoxime ~~chloride~~chloride. It has not been approved by the FDA or any similar health regulatory body, but is procured by certain authorized government buyers under special circumstances for ~~pre-hospital intervention.~~potential use as a nerve agent countermeasure.

Therapeutics

~~On October 2, 2017, we completed~~raxibacumab (Anthrax Monoclonal), the ~~acquisition of raxibacumab, a~~first fully human monoclonal antibody ~~approved~~therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational ~~anthrax, from Human Genome Sciences, Inc.~~anthrax;

Anthrasil® (Anthrax Immune Globulin Intravenous (Human)), the only polyclonal antibody

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and GlaxoSmithKline LLC, which we collectively refer to as GSK. With the acquisition, we assumed responsibility for a multi-year contract with BARDA, with a remaining value of up to approximately $130 million, to supply the product to the SNS through November 2019. ~~The all-cash transaction consisted of a $76 million upfront payment and up to $20 million in product sale and manufacturing-related milestone payments.~~per share amounts)

On September 29, 2017, we completed a new five-year, $200 million syndicated senior secured credit facility, with a $100 million accordion feature, which could expand total commitments to up to $300 million, subject to certain conditions and requirements set forth in the senior secured credit agreement. The new facility enhances our financial flexibility, providing increased capacity to drive growth through strategic acquisitions along with working capital as needed.

~~On September 25, 2017, we were awarded a five-year follow-on contract valued at up to approximately $171 million~~therapeutic licensed by the ~~U.S. Department of Defense, or DoD, to supply RSDL for use by all branches of the U.S. military.~~

~~On September 18, 2017, we were awarded a contract valued at approximately $63 million by BARDA to develop an antidote spray device~~FDA and Health Canada for the treatment of ~~known or suspected acute cyanide poisoning. The single-use intranasal spray device will deliver a stabilized form of isoamyl nitrite, or SIAN,~~inhalational anthrax;

BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)), the only heptavalent antibody therapeutic licensed by the FDA and ~~is intended for use by first responders and medical personnel following a cyanide incident.~~

On July 31, 2017, we were awarded a contract valued at up to approximately $23 million to develop a novel multi-drug auto-injector for nerve agent antidote delivery from the DoD. Our device is being designed for intramuscular self- or buddy-administration of antidotes for use in military environments and for civilian emergencies.

On July 26, 2017, we announced a licensing agreement with Valneva SE, or Valneva, for global exclusive rights to Valneva's Zika vaccine technology, ZIKV. We will co-develop ZIKV-VLA1601, a highly purified inactivated vaccine candidate against the Zika virus, from preclinical development through completion of a Phase 1 safety and immunogenicity clinical trial. ZIKV-VLA1601, which has shown to elicit functional antibody responses, is based on Valneva's established inactivated, whole virus manufacturing platform on which its licensed Japanese Encephalitis vaccine was developed and produced. A Phase 1 clinical trial is expected to commence in late 2017 or early 2018.

On March 31, 2017, we signed a modification to our contract with BARDA to manufacture and store bulk drug substance for our botulism antitoxin, BAT, 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. BAT is indicatedHealth Canada for the treatment of ~~symptomatic botulism following documented or suspected exposure~~botulism; and

VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to ~~botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults~~address certain complications from smallpox vaccination.

Highlights and ~~pediatric patients.~~

Business Accomplishments for 2019

On ~~March 16, 2017,~~September 3, 2019, we ~~entered into a~~announced the contract ~~with BARDA, valued at $100 million, for~~award by the ~~delivery of BioThrax to the Strategic National Stockpile, or SNS, over a two-year period of performance. In conjunction with the signing~~Office of the ~~$100 million contract~~Assistant Secretary for ~~delivery of BioThrax, the BARDA BioThrax Contract, with BARDA, we entered into a modification to our previously disclosed multi-year contract with BARDA for the advanced development~~Preparedness and delivery of the leading next generation anthrax vaccine candidate NuThrax, or the BARDA NuThrax Contract. The modification increases the number of doses of NuThrax to be delivered under the base period from two million to three million doses with a commensurate reductionResponse (ASPR) in dose price for the initial deliveries. The modification also reduces the purchase price for doses to be procured during the option period by $100 million thereby reducing the total contract value to be up to $1.5 billion.

On February 13, 2017, we received a task order from BARDA valued at up to $30.5 million to develop monoclonal antibody therapeutics for viral hemorrhagic fever. This task order will utilize our CIADM facility located in Baltimore, Maryland. Using monoclonal antibodies from Mapp Biopharmaceutical Inc., we will conduct technology transfer of process materials and information, perform process and analytical method development, execute small-scale production runs, and perform cGMP and cell banking leading to cGMP manufacture of bulk drug substance. The task order consists of a 36-month period of performance with a base task order valued at $7.4 million and options that, if executed, will bring the total task order value over three years to up to $30.5 million.

On January 27, 2017, we received from the Paul-Ehrlich-Institut the regulatory agency under the German Federal Ministry of Health, approval for our large-scale manufacturing facility, Building 55, located in Lansing, Michigan. This approval allows us to market in Germany BioThrax manufactured in Building 55.

~~Aptevo Spin-off~~

On August 1, 2016, we completed the spin-off of Aptevo Therapeutics Inc., or Aptevo. As a result of the spin-off, the operating results of Aptevo have been reflected as discontinued operations for the three and nine months ended September 30, 2016. Unless otherwise stated, financial results herein for the three and nine months ended September 30, 2016 reflect such results on a continuing operations basis.

~~Litigation~~

~~On July 19, 2016, Plaintiff William Sponn, or Sponn, filed a putative class action complaint in the United States District Court for the District of Maryland, or the Court,~~ on behalf of purchasers of our common stock between January 11, 2016 and June 21, 2016, inclusive, or the Class Period, seeking to pursue remedies under the Securities Exchange Act of 1934 against us and certain of our senior officers and directors, collectively, the Defendants. The complaint alleges, among other things, that we made materially false and misleading statements about the government's demand for BioThrax and expectations that our five-year exclusive procurement contract with the U.S. Department of Health and Human Services ~~or HHS, would be renewed and omitted certain material facts. Sponn is seeking unspecified damages, including legal costs. On October 25, 2016,~~(HHS) valued at approximately $2 billion over 10 years for the ~~Court added City~~continued supply of Cape Coral Municipal Firefighters' Retirement Plan and City of Sunrise Police Officers' Retirement Plan as plaintiffs and appointed them Lead Plaintiffs and Robins Geller Rudman & Dowd LLP as Lead Counsel. On December 27, 2016, the Plaintiffs filed an amended complaint that cites the same class period, names the same defendants and makes similar allegations to the original complaint. We filed a Motion to Dismiss on February 27, 2017. The Plaintiffs filed an opposition brief on April 28, 2017. Our Motion to Dismiss was heard and denied on July 6, 2017. The Company filed its answer on July 28, 2017. The parties are currently in the process of exchanging discovery, and Plaintiffs' class certification motion is due by November 29, 2017. The Defendants believe that the allegations in the complaint are without merit and intend to defend themselves vigorously against those claims.

~~Financial Operations Overview~~

~~Revenues~~

~~We have derived a majority of our historical product sales revenues from BioThrax sales to~~ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) into the U.S. ~~government. We are a party to~~Strategic National Stockpile (SNS) in support of smallpox preparedness.

On June 3, 2019, we announced a contract ~~with the CDC, an operating division of HHS,~~award by ASPR valued at ~~up to $911~~approximately $535 million over 10 years for the continued supply of VIGIV into the SNS in support of smallpox preparedness.

On May 15, 2019, we announced that BARDA informed the company that it will begin procuring AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) for delivery into the SNS. On July 30, 2019, BARDA exercised its first contract option valued at $261 million to ~~supply approximately 29.4 million~~procure doses ~~of BioThrax~~to be delivered to the SNS through ~~September 2021. Through September 30, 2017,~~June of 2020.

Awarded a letter contract for the continued supply of BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)] into the SNS in support of botulism preparedness and response activity. The maximum value of this 10-year contract is $490 million, with approximately $90 million of deliverables agreed to and the potential value for the remaining deliverable to be negotiated and agreed upon within 180 days from the time of the award.

On April 16, 2019, we ~~have delivered~~announced results from an interim analysis of our Phase 2 clinical study evaluating the safety and ~~recognized revenue on~~immunogenicity of our chikungunya virus virus-like particle vaccine candidate, CHIKV VLP, across a series of dosing regimens. The interim analysis has shown that with a single dose administered, up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus by day 7. Further, the immune response was

shown to be persistent through the six-month visit, following the one-dose regimen.

On March 19, 2019, we announced the initiation of a Phase 3 trial to evaluate the lot consistency, immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with adjuvant) following a two-dose schedule administered intramuscularly in healthy adults. AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure.

On February 28, 2019, we announced that we had signed an indefinite-delivery, indefinite-quantity contract with the U.S. Department of State to establish a long-term, reliable, and stable supply chain for medical countermeasures intended to remove or neutralize chemical warfare agents and certain related toxins from the skin. The contract is comprised of a five-year base period of performance along with five one-year option periods with a total contract value of a minimum of approximately ~~3.4~~$7 million ~~doses, representing approximately~~to a maximum of $100 million ~~in revenue under this contract.~~over the contract’s period of performance. We ~~are focused on increasing~~will be supplying two of our current medical countermeasures addressing chemical threats.

Financial Operations Overview

Revenues

We generate revenues from the ~~sales~~sale of our marketed ~~MCMs to U.S. government customers,~~products, the performance of contract development and manufacturing services, and our performance of research and development services under contracts and grants that we receive from the USG and others. The USG is the largest purchaser of our CBRNE products and primarily purchases our products for the SNS, a national repository of medical countermeasures including critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. The USG primarily purchases our products under long-term, firm fixed-price procurement contracts.

Our opioid overdose reversal product, NARCAN® Nasal Spray, is sold commercially through physician-directed or standing order prescriptions at retail pharmacies, as well as ~~expanding~~to state health departments, local law enforcement agencies, community-based organizations, substance abuse centers, and federal agencies.

Our travelers’ disease products, comprising Vivotif and Vaxchora, are sold to wholesalers and distributors, as well as directly to healthcare practitioners, private

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

travel clinics, retail pharmacies and integrated hospital networks.

We also generate revenue from the ~~market~~performance of contract development and manufacturing services for third-parties. Our services include fill/finish activities as well as the production of bulk drug substances on behalf of our ~~marketed MCMs portfolio to other customers domestically and internationally.~~

customers.

We have received ~~contract~~contracts and ~~grant~~grants funding from ~~BARDA, DoD, CDC,~~ the ~~Defense Threat Reduction Agency, or DTRA,~~USG and ~~the National Institute of Allergy~~other non-governmental organizations to perform research and ~~Infectious Diseases, or NIAID, for the following~~ development ~~programs:~~activities related to programs addressing certain CBRNE threats and EIDs.

~~Development Programs~~	~~Funding Source~~	~~Award Date~~	~~Performance Period~~
~~Anthrasil~~	~~BARDA~~	~~09/2005~~	~~9/2005 — 4/2021~~
	~~BARDA~~	~~09/2013~~	~~9/2013 — 9/2018~~
~~Auto-injector platform~~	~~DoD~~	~~07/2017~~	~~7/2017 — 6/2022~~
~~BAT~~	~~BARDA~~	~~05/2006~~	~~5/2006 — 12/2027~~
~~CIADM~~	~~BARDA~~	~~06/2012~~	~~6/2012 — 6/2037~~
~~GC-072~~	~~DTRA~~	~~08/2014~~	~~8/2014 — 3/2018~~
~~Large-scale manufacturing for BioThrax~~	~~BARDA~~	~~07/2010~~	~~7/2010 — 7/2017~~
~~NuThrax~~	~~NIAID~~	~~08/2014~~	~~8/2014 — 1/2019~~
	~~BARDA~~	~~03/2015~~	~~3/2015 — 12/2017~~
	~~BARDA~~	~~09/2016~~	~~9/2016 — 9/2021~~
~~SIAN~~	~~BARDA~~	~~09/2017~~	~~9/2017 — 9/2022~~
~~UV-4B~~	~~NIAID~~	~~09/2011~~	~~9/2011 — 9/2018~~
~~VIGIV~~	~~CDC~~	~~08/2012~~	~~8/2012 — 8/2017~~

Our revenue, operating results and profitability have varied, and we expect that they will continue to vary on a quarterly basis.

Critical Accounting Policies and Estimates

During the nine months ended September 30, ~~2017,~~2019, there have been no significant changes to our ~~Critical Accounting Policies~~critical accounting policies and ~~Estimates~~estimates contained in our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2018, as filed with the ~~Securities~~SEC, except for the adoption of the new lease standard (see Note 2 and ~~Exchange Commission.~~Note 6 to the accompanying condensed consolidated financial statements).

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

Results of Operations

~~Three Months Ended September 30, 2017 Compared to Three Months Ended September 30, 2016~~



	Three Months Ended September 30,											Nine Months Ended September 30,
	2019			2018			$ Change			% Change		2019			2018			$ Change			% Change
Product sales net:
NARCAN Nasal Spray	$	75.0		$	—		$	75.0		NM		$	213.5		$	—		$	213.5		NM
ACAM2000	112.1			38.4			73.7			NM		164.1			116.7			47.4			41	%
Anthrax vaccines	40.3			45.9			(5.6		)	(12	%)	79.9			143.7			(63.8		)	(44	%)
Other	28.8			49.0			(20.2		)	(41	)%	135.2			128.7			6.5			5	%
Total product sales, net	256.2			133.3			122.9			92	%	592.7			389.1			203.6			52	%
Contract manufacturing	20.0			22.1			(2.1		)	(10	)%	54.6			72.0			(17.4		)	(24	%)
Contracts and grants	35.6			18.2			17.4			96	%	98.4			50.6			47.8			94	%
Total revenues	311.8			173.6			138.2			80	%	745.7			511.7			234.0			46	%

Operating expenses:
Cost of product sales and contract manufacturing	108.0			69.3			38.7			56	%	300.7			208.8			91.9			44	%
Research and development	53.4			37.0			16.4			44	%	163.4			90.8			72.6			80	%
Selling, general and administrative	65.0			42.1			22.9			54	%	201.3			121.8			79.5			65	%
Amortization of intangible assets	14.7			3.9			10.8			NM		43.9			11.7			32.2			NM
Total operating expenses	241.1			152.3			88.8			58	%	709.3			433.1			276.2			64	%

Income from operations	70.7			21.3			49.4			NM		36.4			78.6			(42.2		)	(54	%)

Other income (expense):
Interest expense	(10.3		)	(0.6		)	(9.7		)	NM		(29.3		)	(1.8		)	(27.5		)	NM
Other income (expense), net	(1.5		)	0.8			(2.3		)	NM		(1.2		)	1.2			(2.4		)	NM
Total other expense, net	(11.8		)	0.2			(12.0		)	NM		(30.5		)	(0.6		)	(29.9		)	NM

Income before income taxes	58.9			21.5			37.4			NM		5.9			78.0			(72.1		)	NM
Income tax expense (benefit)	15.7			0.6			15.1			NM		(1.7		)	11.8			(13.5		)	NM
Net income	$	43.2		$	20.9		$	22.3		NM		$	7.6		$	66.2		$	(58.6	)	(89	%)

NM - Not meaningful

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

Total Revenues

Three Months Ended September 30,
(in thousands) 2017 2016 Change % Change

Product sales:
     BioThrax $ 83,485 $ 94,116 $ (10,631 ) (11 %)
     Other 30,811 2,582 28,229 1,093 %
             Total Product sales 114,296 96,698 17,598 18 %
Contract manufacturing 18,912 14,712 4,200 29 %
Contracts and grants 16,226 31,504 (15,278 ) (48 %)
Total revenues $ 149,434 $ 142,914 $ 6,520 5 %



	NARCAN Nasal Spray		Other Product Sales
	ACAM2000		Contract Manufacturing
	Anthrax vaccines		Contracts and Grants

Product ~~sales:~~Sales, net

NARCAN Nasal Spray

NARCAN Nasal Spray was acquired in October 2018 in connection with the Company's acquisition of Adapt resulting in an increase in product sales in the current quarter and year-to-date periods.

ACAM2000

The increase in ~~Product~~ACAM2000 sales for the three and nine months ended September 30, 2019 was primarily due to the ~~increase in other product sales related~~volume and contractual per unit pricing increases of ACAM2000 delivered to the ~~timing~~SNS as a result of ~~BAT~~the contract awarded by ASPR in September 2019. Deliveries under this contract began in September.

Anthrax Vaccines

The decrease in anthrax vaccine sales for the three and nine months ended September 30, 2019 was primarily due to the lower number of BioThrax deliveries to the SNS ~~and RSDL shipments~~during the period as compared to the ~~DoD, along with international~~prior comparable period. The USG purchased fewer units of BioThrax during the three and nine months ended September 30, 2019, in anticipation of the transition to the Company's next generation anthrax vaccine, AV7909.

Deliveries of AV7909 to the USG began in September of 2019 under the base period and option period executed by the USG in July 2019. Substantially all of the anthrax vaccine product sales ~~for~~revenues are made to the USG under long-term procurement contracts. The fluctuations in anthrax vaccine revenues is largely related to changes in volume depending on when the USG requests delivery and how much product we have ready in inventory to ship and funding available from the USG. The USG delivery schedule varies based on funding and management of the SNS inventory.

Volume is also contingent on the availability of product based on timing of manufacturing.

Other Product Sales

The decrease in the Company's other product sales during the three months ended September 30, 2019 was primarily due to a decrease in sales of VIGIV and ~~Trobigard~~.raxibacumab partially offset by the contribution of products associated with the PaxVax acquisition. The increase in the Company's other product sales during the nine-months ended September 30, 2019 was primarily due to the contribution of products associated with the PaxVax acquisition as well as increased sales of raxibacumab and BAT®, which were partially offset by a decrease in other sales, largely VIGIV and Trobigard, compared to the nine months ended September 30, 2018.

Contract Manufacturing

The decrease in contract manufacturing revenue for the three and nine months ended September 30, 2019 is due to contracts to design, construct and validate manufacturing capability at our Lansing, Michigan site

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

and contract manufacturing activities at our Canton, Massachusetts site that were performed during the three and nine months ended September 30, 2018 for which no similar services were provided during in the current period.

Contracts and Grants

The increase in contracts and grants revenue for the three and nine months ended September 30, 2019 primarily reflects research and development activities related to clinical trial activities for AV7909. These increases were partially offset by a decrease in BioThrax sales due to the timing of BioThrax deliveries to the SNS coupled with a $5.6 million deferral of revenue associated with the allocation of contract consideration due to the modification of the BARDA NuThrax Contract in conjunction with execution of the BARDA BioThrax Contract.

~~Contract manufacturing:~~

The increase in Contract manufacturing is primarily due to increased fill/finish services provided to third parties, manufacturing services performed for third party development stage product candidates and manufacturing services for Aptevo.

~~Contracts and grants:~~

~~The decrease in Contracts and grants primarily reflects a~~ reduction in ~~revenue associated with~~development funding for ACAM2000 stability testing which were performed during the ~~successful completion of multiple U.S. Government contracts as well as reduced R&D activities related to certain ongoing funded development programs, including:~~three and nine months ended September 30, 2018 for which no similar services were provided in the current period.

~~decreased development funding of $10.1 million related to our CIADM program, which includes a decrease of $5.2 million for CIADM task orders primarily related to Ebola and Zika;~~

~~decreased development funding of $3.2 million for VIGIV related to the timing of plasma collection; and~~

decreased development funding of $1.8 million for large scale manufacturing of BioThrax primarily due to the successful completion of the Building 55 development program in 2016 that did not recur in 2017.

Cost of Product Sales and Contract Manufacturing



	Cost of Product Sales and Contract Manufacturing
l	Gross profit margin for product sales and contract manufacturing

Cost of product sales and contract manufacturing increased ~~by $4.9~~for the three and nine months ended September 30, 2019 primarily due to the acquisitions of Adapt and PaxVax, both acquired in October 2018. The increases are proportional to the increase in product

sales and contract manufacturing revenues during the three and nine months ended September 30, 2019.

Research and Development Expenses (Gross and Net)



	Research and Development expense
l	Research and Development expense, net of contracts and grants revenue

The increase in research and development expenses during the three and nine months ended September 30, 2019 is primarily due to the acquisitions of Adapt and PaxVax, both acquired in October 2018 as well as the timing of manufacturing development activities for our AV7909 product candidate.

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

Selling, General and Administrative Expenses



	Selling, General and Administrative
l	SG&A as a percentage of total revenue

Selling, general and administrative expenses increased for the three and nine months ended September 30, 2019 primarily due to $19.9 million ~~or 12%,~~and $61.9 million in expenses related to ~~$44.5~~the operations and integration of newly acquired entities during the three and nine months ended September 30, 2019, respectively. The newly acquired entities were both acquired in October 2018. The remaining increase is due to an increase in professional services and staffing to support the Company's growth.

Amortization of intangible Assets

The increase in amortization of intangible assets from $3.9 million to $14.7 million for the three months ended September 30, ~~2017~~2019 compared to 2018 and from ~~$39.6~~$11.7 million to $43.9 million for the nine months ended

September 30, 2019 compared to 2018, was primarily due to the acquisitions of Adapt and PaxVax.

Total Other Income (Expense), Net



	Interest expense
	Other income (expense)

Total other expense, net increased by $12.0 million and $29.9 million for the three and nine months ended September 30, ~~2016. The increase was~~2019 due primarily ~~attributable~~ to ~~the increase in RSDL deliveries to the DoD, BAT sales to the SNS, along with~~ an increase in ~~international sales for VIG~~ borrowings on our senior secured credit facilities established in October 2018 to fund our acquisitions of Adapt and ~~Trobigard.~~PaxVax.

EMERGENT BIOSOLUTIONS INC.

~~Research~~MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and ~~Development Expenses~~per share amounts)

~~Research and development expenses decreased by $4.5 million, or 17%, to $22.7 million for~~

Income Tax Expense (Benefit)



	Income tax expense (benefit)
l	Effective tax rate

The decrease in income tax expense during the ~~three~~nine months ended September 30, ~~2017 from $27.2 million for~~2019 is primarily due to a decrease in pre-tax income as compared to the ~~three months ended September 30, 2016. This decrease primarily reflects lower contract service costs. Net of contracts and grants revenues,~~corresponding period in 2018. The increase in tax expense during the three months ended September 30, 2017, we incurred net research and development expenses of $6.5 million and during the three months ended September 30, 2016, our research and development expenses were fully funded, resulting in a net contribution from funded development programs of $4.3 million.

~~Our principal research and development expenses for the three months ended September 30, 2017 and 2016 are shown in the following table:~~

Three Months Ended
September 30,
(in thousands) 2017 2016 Change % Change

NuThrax $ 7,384 $ 6,182 $ 1,202 19 %
FLU-IG (NP025) 1,832 - 1,832 N/A
UV-4B 1,407 2,147 (740 ) (34 %)
BAT 838 814 24 3 %
Auto-injector platform 1,107 2,475 (1,368 ) (55 %)
CIADM task orders 330 2,600 (2,270 ) (87 %)
EV-035 series of molecules 772 1,331 (559 ) 42 %
VIGIV 374 1,474 (1,100 ) (75 %)
Large-scale manufacturing for BioThrax 64 1,491 (1,427 ) (96 %)
Anthrasil 247 178 69 (39 %)
BioThrax related programs 238 1,012 (774 ) (76 %)
Other 8,066 7,484 582 8 %
Total $ 22,659 $ 27,188 $ (4,529 ) (17 %)

The increase in expense for NuThrax was primarily due to the timing of non-clinical animal studies and manufacturing activities. The expense for FLU-IG (NP025) was primarily due to clinical trial preparation. The decrease in expense for UV-4B was primarily due to the timing of clinical trial activity to evaluate safety and tolerability. The increase in expense for our BAT program was primarily related to the timing of stability testing. The decrease in expense for our Auto-injector platform was due to the timing of formulation development. The decrease in expense for CIADM task orders was due to the timing of manufacturing development for Ebola monoclonal antibodies and Zika. The decrease in expense for our EV-035 series of molecules was primarily due to the timing of formulation development activities, along with screening of molecules within the series. The decrease in expense for VIGIV was primarily due to the timing of plasma collection. The decrease in expense for large-scale manufacturing of BioThrax was primarily due to the completion of development work and the licensure of the large-scale manufacturing facility in August 2016. The increase in expense for our Anthrasil program was primarily for non-clinical activities. The decrease in expense for BioThrax related programs was primarily related to the timing of clinical studies to support applications for label expansion for BioThrax. The increase in spending for our Other activities was primarily due to increased expense related to our funded pre-clinical product candidates and manufacturing development activities.

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses decreased by $6.2 million, or 15%, to $34.5 million for the three months ended September 30, 2017 from $40.7 million for the three months ended September 30, 2016. The decrease2019 is primarily due to ~~costs associated with restructuring activities at our Lansing, Michigan site during the third quarter of 2016.~~greater pre-tax income.

~~Nine Months Ended September 30, 2017 Compared to Nine Months Ended September 30, 2016~~

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

~~Revenues~~(unaudited, amounts in millions, except share and per share amounts)

Nine Months Ended September 30,
(in thousands) 2017 2016 Change % Change

Product sales:
     BioThrax $ 179,620 $ 193,255 $ (13,635 ) (7 %)
     Other 80,255 15,530 64,725 417 %
             Total Product sales 259,875 208,785 51,090 24 %
Contract manufacturing 52,700 32,455 20,245 62 %
Contracts and grants 54,489 95,879 (41,390 ) (43 %)
Total revenues $ 367,064 $ 337,119 $ 29,945 9 %

~~Product sales:~~

The increase in Product sales was primarily due to the increase in other product sales related to the timing of BAT deliveries to the SNS and RSDL shipments to the DoD, along with international sales for VIGIV and Tro~~bigard~~. These increases were partially offset by a decrease in BioThrax sales due to the timing of BioThrax deliveries to the SNS, along with a $6.3 million deferral of revenue associated with allocation of contract consideration due to the modification of the BARDA NuThrax Contract in conjunction with execution of the BARDA BioThrax Contract.

~~Contract manufacturing:~~

~~Contracts and grants:~~

The decrease in Contracts and grants primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. Government contracts as well as reduced R&D activities related to certain ongoing funded development programs, including:

~~decreased development funding of $20.3 million related to our CIADM program, which includes a decrease of $10.5 million for CIADM task orders primarily related to Ebola and Zika;~~

~~decreased development funding of $18.8 million for VIGIV due to the timing of plasma collection; and~~

decreased development funding of $3.7 million for large scale manufacturing of BioThrax primarily due to the successful completion of the Building 55 development program in 2016 that did not recur in 2017.

~~Cost of Product Sales and Contract Manufacturing~~

Cost of product sales and contract manufacturing increased by $32.4 million, or 35%, to $125.4 million for the nine months ended September 30, 2017 from $93.0 million for the nine months ended September 30, 2016. The increase was primarily attributable to the increase in RSDL deliveries to the DoD, BAT sales to the SNS, international sales for VIG and Trobigard, along with increased costs associated with the expansion of our contract manufacturing business.

~~Research and Development Expenses~~

Research and development expenses decreased by $12.3 million, or 15%, to $68.9 million for the nine months ended September 30, 2017 from $81.2 million for the nine months ended September 30, 2016. This decrease primarily reflects lower contract service costs. Net of contracts and grants revenues, we incurred net research and development expenses of $14.4 million during the nine months ended September 30, 2017. Net of contracts and grants revenues, our research and development expenses were fully funded during the nine months ended September 30, 2016, resulting in a net contribution from funded development programs of $14.7 million.

~~Our principal research and development expenses for the nine months ended September 30, 2017 and 2016 are shown in the following table:~~

Nine Months Ended
September 30,
(in thousands) 2017 2016 Change % Change

NuThrax $ 23,964 $ 15,847 $ 8,117 51 %
FLU-IG (NP025) 5,189 - 5,189 N/A
UV-4B 4,663 4,179 484 12 %
BAT 2,509 2,964 (455 ) (15 %)
Auto-injector platform 2,551 7,646 (5,095 ) (67 %)
CIADM task orders 2,511 7,899 (5,388 ) (68 %)
EV-035 series of molecules 1,856 2,972 (1,116 ) (38 %)
VIGIV 1,211 7,428 (6,217 ) 84 %
Large-scale manufacturing for BioThrax 885 4,870 (3,985 ) (82 %)
Anthrasil 737 626 111 18 %
BioThrax related programs 594 2,701 (2,107 ) (78 %)
Other 22,216 24,041 (1,825 ) (8 %)
Total $ 68,886 $ 81,173 $ (12,287 ) (15 %)

The increase in expense for NuThrax was primarily due to the timing of non-clinical animal studies and manufacturing activities. The expense for FLU-IG (NP025) was primarily due to clinical trial preparation. The increase in expense for UV-4B was primarily due to the timing of clinical trial activity to evaluate safety and tolerability. The decrease in expense for our BAT program was primarily related to the timing of stability testing. The decrease in expense for our Auto-injector platform was due to the timing of formulation development. The decrease in expense for CIADM task orders was due to the timing of manufacturing development for Ebola monoclonal antibodies and Zika. The decrease in expense for our EV-035 series of molecules was primarily due to the timing of formulation development activities, along with screening of molecules within the series. The decrease in expense for VIGIV was primarily due to the timing of plasma collection. The decrease in expense for large-scale manufacturing of BioThrax was primarily due to the completion of development work and the licensure of the large-scale manufacturing facility in August 2016. The increase in expense for our Anthrasil program was primarily for non-clinical activities. The decrease in expense for BioThrax related programs was primarily related to the timing of clinical studies to support applications for label expansion for BioThrax. The decrease in spending for our Other activities was primarily due to decreased expense related to our funded pre-clinical product candidates and manufacturing development activities.

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses decreased by $6.8 million, or 6%, to $101.5 million for the nine months ended September 30, 2017 from $108.3 million for the nine months ended September 30, 2016. The decrease is primarily due to costs associated with the restructuring activities at our Lansing, Michigan site during 2016.

~~Provision for Income Taxes~~

Provision for income taxes decreased by $1.9 million, or 10%, to $18.0 million for the nine months ended September 30, 2017 from $19.9 million for the nine months ended September 30, 2016. The decrease was primarily due to a valuation allowance charge recorded in our continuing operations related to Aptevo deferred tax assets prior to the distribution in 2016, partially offset by an increase in our income before provision for income taxes of $16.6 million.

Liquidity and Capital Resources

Sources of Liquidity

~~From inception~~We have historically financed our operating and capital expenditures through ~~September 30, 2017, we have funded our~~ cash ~~requirements principally with a combination of product sales revenues,~~on hand, cash from operations, debt financing and development ~~funding, the net proceeds~~funding. We also obtain financing from ~~our initial public offering and~~ the sale of our common stock upon exercise of stock options. We have operated profitably for each of the last five years for the period ended December 31, ~~2016.~~2018. As of September 30, ~~2017,~~2019, we had unrestricted cash and cash equivalents of ~~$341.0~~$139.2 million. ~~The closing~~As of September 30, 2019, we believe that we have sufficient liquidity to fund our operations over the ~~acquisitions of ACAM2000 and raxibacumab in early October resulted in combined cash outflows of $193.5 million.~~

next 12 months.

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, ~~2017~~2019 and ~~2016:~~2018:

Nine Months Ended
September 30,
(in thousands) 2017 2016
Net cash provided by (used in):
Operating activities(i) $ 129,114 $ 67,390
Investing activities (42,381 ) (56,243 )
Financing activities (17,255 ) (25,010 )
Net increase (decrease) in cash and cash equivalents $ 69,478 $ (13,863 )



	Nine Months Ended September 30,
	2019			2018
Net cash provided by (used in):
Operating activities	$	65.9		$	207.6
Investing activities	(60.8		)	(48.7		)
Financing activities	22.0			2.8
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(0.1		)	(0.6		)
Net increase in cash, cash equivalents and restricted cash	$	27.0		$	161.1

~~(i) Includes the effect of exchange rates on cash~~

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and ~~cash equivalents.~~per share amounts)

Operating ~~Activities:~~

Activities

Net cash provided by operating activities of ~~$129.1~~$65.9 million for the nine months ended September 30, ~~2017~~2019 was primarily due to ~~our~~ net income excluding non-cash items of ~~$48.7~~$121.0 million ~~non-cash charges~~offset by working capital changes of $29.9 million for depreciation and amortization, a $14.0 million increase in deferred revenue, a $13.1 million increase in net income taxes, a $11.8 million increase in stock-based compensation expense, a $9.4 million decrease in accounts receivable related to the timing of collection of amounts billed primarily to the CDC, and a $5.1 million decrease in inventories due primarily to the timing of deliveries of BAT and VIGIV.

$55.1 million.

Net cash provided by operating activities of ~~$67.4~~$207.6 million for the nine months ended September 30, ~~2016~~2018 was primarily due to ~~our~~ net income excluding non-cash items of ~~$14.4~~$136.2 million ~~a $45.0 million decrease in accounts receivable related to the timing~~and working capital changes of collection of amounts billed primarily to the CDC along with non-cash charges of $28.2 million for depreciation and amortization and a $14.5 million increase in stock-based compensation expense, partially offset by an increase in inventories of $16.2 million, primarily due to the timing of deliveries of BioThrax to the CDC.$71.4 million.

Investing ~~Activities:~~

Activities

Net cash used in investing activities of ~~$42.4~~$60.8 million for the nine months ended September 30, ~~2017 was due to~~2019 reflects infrastructure and equipment ~~investments, including the construction of a third manufacturing suite at our Baltimore CIADM manufacturing facility.~~

investments.

Net cash used in investing activities of ~~$56.2~~$48.7 million for the nine months ended September 30, ~~2016 was due to~~2018 reflects infrastructure and equipment ~~investments, including construction at our Baltimore CIADM manufacturing facility.~~investments.

Financing ~~Activities:~~

Activities

Net cash ~~used in~~provided by financing activities of ~~$17.3~~$22.0 million for the nine months ended September 30, ~~2017~~2019 was primarily due to ~~the payment~~$26.6 million of a $20.0 million note payable to Aptevo in conjunction with the spin-off, $4.2 million associated with the taxes paid on behalf of employees for equity activity and $2.7 million in contingent obligation payments, partially offset by $10.8 million innet proceeds from the ~~issuance~~credit facility, primarily offset by contingent consideration payments of ~~common stock pursuant to our~~$3.7 million and employee ~~equity awards plan.~~

share-based compensation activity.

Net cash ~~used~~provided by financing activities of ~~$25.0~~$2.8 million for the nine months ended September 30, ~~2016~~2018 was primarily due to $45.0 million in cash provided to Aptevo on date of distribution, August 1, 2016 and $4.6 million associated with the taxes paid on behalf of employees for equity activity, partially offset by $15.0 million in proceeds from the issuance of common stock pursuant to employee ~~equity plans and $10.8 million in excess tax benefits from exercise of stock options.~~

share-based compensation activity.

Funding Requirements

We expect to continue to fund our anticipated operating expenses, capital expenditures, debt service requirements and any future repurchase of our common stock from the following sources:

existing cash and cash equivalents; ~~revenues~~

net proceeds from ~~product sales;~~ the sale of products and contract manufacturing services;

development contracts and grants funding; ~~contract manufacturing services~~ and

our senior secured credit ~~facility~~facilities and any other lines of credit we may establish from time to time.

There are numerous risks and uncertainties associated with product sales and with the development and commercialization of our product candidates. We may

seek additional external financing to provide additional financial flexibility. Our future capital requirements will depend on many factors, including (but not limited to):

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



~~our ability to secure a new BioThrax procurement contract on favorable terms;~~

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

~~the level, timing and cost of product sales;~~

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



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

the payment obligations under our indebtedness;



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

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



~~the payment obligations under our indebtedness;~~

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



~~the scope, progress, results~~the extent to which we repurchase additional common stock under our authorized share repurchase program; 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 our common stock under our share repurchase program; and~~



the costs of commercialization activities, including product marketing, sales and distribution.

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 May 2015, we filed an automatic shelf registration statement, which immediately became effective under the Securities and Exchange Commission, or SEC, rules. For so long as we continue to satisfy the requirements to be deemed a "well-known seasoned issuer" under SEC rules, this shelf registration statement, effective until May 2018, 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 May 2018, 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 ~~revolving~~ credit ~~facility,~~facilities, which could limit or restrict our ability to take specific actions, such as incurring additional debt, making capital expenditures, pursuing acquisition opportunities, buying back shares or declaring dividends. If we raise funds through collaboration and licensing arrangements with third parties, itmay 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 ~~senior convertible notes~~2.875% Convertible Senior Notes due 2021 from incurring additional debt, securing existing or future debt, recapitalizing our debt or taking a number of

EMERGENT BIOSOLUTIONS INC.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

(unaudited, amounts in millions, except share and per share amounts)

other actions ~~that are not limited by the terms of the indenture governing our notes~~ that could have the effect of diminishing our ability to make payments on our indebtedness. However, our senior secured credit ~~facility restricts~~facilities restrict our ability to incur additional indebtedness, including secured ~~indebtedness, as discussed in Note 7 to the Consolidated Financial Statements (Unaudited) included in Item 1, Part I.~~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, ~~of operations and~~ 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.

Share Repurchase Program

In March 2018, our board of directors authorized our management to repurchase from time to time up to an aggregate of $50 million of our common stock under a board-approved share repurchase program through December 31, 2019. Any repurchased shares will be available for use in connection with our stock plans and for other corporate purposes. As of September 30, 2019, we have not made any repurchases under this program.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKETRISK

For a discussion of additional risks arising from our operations, see “Item 1A-Risk Factors” in this quarterly report.

~~Our exposure~~Market Risk

We have interest rate and foreign currency market risk. We manage our interest rate risk in part by entering into interest rate swaps to ~~market risk~~swap a portion of our indebtedness that is ~~currently confined~~based on variable interest rates to ~~our cash and cash equivalents.~~a fixed rate. We currently do not hedge ~~interest rate exposure or~~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. We have not used derivative financial instruments for ~~speculation or trading~~speculative purposes. 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 realizedvalue of our investments, but any increase in market rates would likely increase the interest expense associated with our debt.

Interest Rate Risk

We have debt with a mix of variable and fixed rates of interest. Floating rate debt carries interest based on the eurocurrency, as defined in our Amended Credit Agreement, plus an applicable margin. Increases in interest rates could therefore increase the associated

interest payments that we are required to make on this debt.

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 with consideration to outstanding debt and interest rate swap commitments as of September 30, 2019, would increase our interest expense by $4.7 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 incurring, to the extent practicable, operating and financing expenses in the local currency in the countries in which we operate.

ITEM 4.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 September 30, ~~2017.~~2019. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act, 1934 or(the Exchange ~~Act,~~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 September 30, ~~2017,~~2019, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls

EMERGENT BIOSOLUTIONS INC.

and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act that occurred during the quarter ended September 30, ~~2017~~2019 that ~~has~~have materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

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. and Adapt Pharma Limited, which are included in our unaudited condensed consolidated financial statements for the nine months ended September 30, 2019, and which constituted $1.1 billion and $842.6 million of total assets and net assets, respectively as of September 30, 2019 and $246.0 million and $9.6 million of revenues and operating income, respectively, for the nine months ended September 30, 2019.

PART II.OTHER INFORMATION

ITEM 1.LEGAL PROCEEDINGS

ANDA Litigation - Perrigo 4mg

~~From time~~On September 14, 2018, Adapt Pharma Inc., Adapt Pharma Operations Limited and Adapt Pharma Ltd. and Opiant Pharmaceuticals, Inc., received notice from Perrigo UK FINCO Limited Partnership that Perrigo had filed an ANDA with the FDA, seeking regulatory approval to ~~time, we may be involved in various legal proceedings~~market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray before the expiration of the ‘253 Patent, the ‘747 Patent, the ‘177 Patent, the ‘965 Patent, and ~~claims~~the ‘838 Patent. On or about October 25, 2018, Perrigo sent a subsequent notice letter relating to the ‘937 Patent. Perrigo’s notice letters assert that ~~arise in or outside the ordinary course of our business. We believe that the outcome~~its generic product will not infringe any valid and enforceable claim of these ~~pending legal proceedings in the aggregate is unlikely to have a material adverse effect on our business, financial condition or results of operations.~~

~~Purported Shareholder Class Action Lawsuit filed July 19, 2016~~

patents.

On ~~July 19, 2016, Plaintiff William Sponn, or Sponn,~~October 25, 2018, Emergent BioSolutions’ Adapt Pharma subsidiaries and Opiant (collectively, Plaintiffs), filed a ~~putative class action~~ complaint for patent infringement of the ‘253, ‘747, ‘177, ‘965, and the ‘838 Patents against Perrigo in the United States District Court for the District of ~~Maryland~~New Jersey arising from Perrigo’s ANDA filing with the FDA. Plaintiffs filed a second complaint against Perrigo on ~~behalf of purchasers~~December 7, 2018, for the infringement of the ~~Company's common stock between January 11, 2016~~‘937 Patent. As a result of timely filing 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, unfavorable to the Plaintiffs, by the Court.

ANDA Litigation - Teva 2mg

On or about February 27, 2018, Adapt Pharma Inc. and ~~June 21, 2016, inclusive,~~Adapt Pharma Operations Limited and Opiant received notice from Teva Pharmaceuticals Industries Ltd. and Teva Pharmaceuticals USA, Inc., 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 the ‘644 Patent, and 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 ~~Class Period,~~'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.

ANDA Litigation - Teva 4mg

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 ~~pursue remedies under~~market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4 mg/spray before the ~~Securities Exchange Act~~expiration of ~~1934 against~~ the ~~Company~~'253 Patent. Adapt Pharma Inc. and ~~certain~~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 ~~senior officers~~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 ~~directors, collectively,~~ the ~~Defendants. The~~‘937 Patents are invalid or unenforceable. Adapt Pharma Inc. and Adapt Pharma Operations Limited and Opiant filed a complaint ~~alleges,~~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 the date of this filing, Adapt Pharma Inc., Adapt Pharma Operations Limited, and Opiant, have not filed a complaint related to the ‘937 Patent.

In the complaints described in the paragraphs above, the Plaintiffs seek, among other ~~things,~~relief, orders that the ~~Company made materially false~~effective date of FDA approvals of the Teva ANDA products and ~~misleading statements about~~ the ~~government's demand~~Perrigo ANDA product be a date not earlier than the expiration of the patents listed for ~~BioThrax~~each product, equitable relief enjoining Teva and ~~expectations~~Perrigo from making, using, offering to sell, selling, or importing the products that are the ~~Company's five-year exclusive procurement contract~~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.

Nalox-1 Pharmaceuticals, a non-practicing entity, filed petitions with ~~HHS would be renewed~~the United States Patent and ~~omitted certain material facts. Sponn is seeking unspecified damages, including legal costs. On October 25, 2016,~~Trademark Office Patent Trial and Appeal Board ("PTAB") requesting inter parties review (IPR) of five of 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 Robins Geller Rudman & Dowd LLP as Lead Counsel. On December 27, 2016, the Plaintiffs filed an amended complaint that cites the same class period, names the same defendants and makes similar allegations to the original complaint. The Company filed a Motion to Dismiss on February 27, 2017. The Plaintiffs filed an opposition brief on April 28, 2017. The Company's Motion to Dismiss was heard and denied on July 6, 2017. The Company filed its answer on July 28, 2017. The parties are currentlysix patents listed in the ~~process~~Orange Book related to NARCAN® Nasal Spray 4mg/spray. In a series of ~~exchanging discovery,~~decisions, the PTAB agreed to institute a review of the '253 Patent, the '747 Patent and ~~Plaintiffs' class certification motion is due by November 29, 2017. The Defendants believe that~~ the ~~allegations in~~'965 Patent but denied review of the ~~complaint are without merit~~'177 Patent and ~~intend to defend themselves vigorously against those claims.~~the '838 Patent. Nalox-1 did not request review of the '937 Patent.

ITEM 1A. RISK FACTORS

You should carefully consider the following risk factors in addition to the other information in this Quarterly Report on Form 10-Q when evaluating our business because these risk factors may have a significant impact on our business, financial condition, operating results or cash flows. If any of the risks described below or in subsequent reports we file with the SEC actually occur, they may materially harm our business, financial condition, operating results or cash ~~flow.~~flows. Additional risks and uncertainties that we have not yet identified or that we presently consider

EMERGENT BIOSOLUTIONS INC.

to be immaterial may also materially harm our business, financial condition, operating results or cash flows. Discussion of these factors is incorporated by reference into and considered an integral part of Part I, Item 2, ~~"Management's~~“Management’s Discussion and Analysis of Financial Conditions and Results of Operations."

”

GOVERNMENT CONTRACTING RISKS

We currently derive ~~the majority~~a substantial portion of our revenue from sales of BioThrax and, subject to certain regulatory actions, anticipate receiving substantial future revenues from sales of AV7909 to our ~~principal~~ largestcustomer, the ~~U.S. government.~~USG. If the ~~U.S. government's~~USG’s demand for and/or funding for procurement of BioThrax or AV7909 is substantially reduced, our business, financial condition, operating results and cash ~~flow~~flows would be materially harmed.

We ~~have derived, and expect for the foreseeable future to~~ derive ~~the majority~~a substantial portion of our ~~revenue~~current and expected future revenues from sales of BioThrax, our anthrax vaccine licensed by the ~~U.S. Food and Drug Administration, or the~~ FDA to the ~~U.S. government.~~ USG, and, subject to certain regulatory actions, anticipate receiving substantial future revenues from sales of AV7909 to the USG, our next generation anthrax vaccine product candidate. 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 than with BioThrax, which may have a material effect on our ability to generate and recognize revenue.

In December 2016, we signed a follow-on procurement contract with the Centers for Disease Control and Prevention ~~or the CDC,~~(CDC) for the delivery of approximately 29.4 million doses of BioThrax for placement into ~~the Strategic National Stockpile, or~~ 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 September 2016, we entered into a contract with HHS, through BARDA for the advanced development and procurement of AV7909. The contract, as modified in March 2017, is valued at up to approximately $1.5 billion if all procurement options are exercised.

The success of our business and our future operating results are significantly dependent on anticipated funding for the procurement of ~~doses~~our anthrax vaccines and the terms of our BioThrax ~~by the CDC is subject~~and AV7909 sales to the ~~availability~~USG, including the price per dose, the number of ~~funding.~~doses and the timing of deliveries. We have no certainty that funding will be made available for the procurement of ~~doses under~~these vaccines. If priorities for the ~~CDC contract. If the~~ SNS ~~priorities~~ change, funding to procure future doses of BioThrax or AV7909 may be 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.

Although a pre-EUA submission package related to AV7909 has been submitted to the FDA, we may not receive EUA and eventual FDA licensure may not be approved by the FDA in a timely manner or at all. Delays in our ability to achieve 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 AV7909.

In collaboration with us, the CDC filed with the FDA a pre-EUA submission package related to AV7909, which enables FDA review of data in anticipation of a request for an EUA. This submission triggered BARDA to exercise its first contract option (valued at $261M) in July 2019 to procure 10M doses of AV7909 for inclusion into the SNS in support of anthrax preparedness.

Notwithstanding, the FDA may decide that our data are insufficient and require additional pre-clinical, clinical or other studies. If we are unsuccessful in obtaining EUA and, ultimately, 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, ~~and~~ operating results ~~would be materially harmed. The success of our business~~ and our operating results for the foreseeable future are significantly dependent on funding for the procurement of BioThrax and the terms of our BioThrax sales to the U.S. government, including the price per dose, the number of doses and the timing of deliveries.

cash flows.

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

The ~~U.S. government~~USG is the principal customer for our ~~public health threat-focused medical countermeasures~~PHT-focused MCMs and is the primary source of funds for the development of our product candidates in our development pipeline, most notably our ~~NuThrax~~AV7909 product candidate. We anticipate that the ~~U.S. government~~USG will also be a principal customer for those ~~medical countermeasures~~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 ~~U.S. government~~USG development contracts and grants. Over its lifetime, a ~~U.S. government~~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 of BioThrax to be supplied under our procurement contract with the CDC are subject to the availability of funding, mostly from annual appropriations. These appropriations can be subject to political considerations and stringent budgetary constraints.

EMERGENT BIOSOLUTIONS INC.

Additionally, our government-funded development contracts typically give the ~~U.S. government~~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. 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 in full, would increase the total contract value to up to $1.5 billion. 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 ~~U.S. government~~USG otherwise declines to exercise its options under our existing contracts, our revenues would suffer, as well as our business, ~~revenues,~~financial condition, operating results and cash ~~flows would suffer.~~

flows.

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

~~Our~~The majority of our revenue is substantially dependent upon product procurement contracts with the ~~U.S. government~~USG and foreign governments for our ~~public health threat~~PHT products. 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, ~~revenues,~~financial condition, operating results and cash ~~flows.~~flows could be harmed. For example, the ~~CDC procurement contract for ACAM2000 that we recently assumed responsibility for in our acquisition of the ACAM2000 business from Sanofi will be up for renewal or extension in March 2018. The~~ BARDA procurement contract for raxibacumab that we ~~recently assumed responsibility for~~acquired in our acquisition of raxibacumab from ~~GSK expires~~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. We intend to negotiate follow-on procurement contracts for each of our ~~public health threat~~PHT products upon the expiration of a related procurement contract, including our procurement contract for raxibacumab, but there can be no assurance that we will be successful ~~in doing so.~~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 could

materially and adversely affect our revenues, and our business, financial condition, operating results and cash flows ~~and business prospects.~~

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 ~~a number of~~many risks and requirements, including:

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 for contracts that may not be awarded to us;

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 ~~U.S. government~~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 products addressing ~~public health threats,~~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~~There are a number of laws and regulations ~~affecting~~that pertain to government contracts ~~make it more costly~~ and ~~difficult for us to successfully conduct our business. Failure to comply~~compliance with ~~these~~those laws ~~could result in~~and regulations require significant ~~civil~~time and ~~criminal penalties and materially damage our relationship with the U.S. government,~~

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cost, which could have a material adverse effect on our business, financial condition, operating results and ~~operating results.~~cash flows.

As a manufacturer and supplier of ~~medical countermeasures~~MCMs to the ~~U.S. government~~USG addressing ~~public health threats,~~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 Federal Acquisition Regulation, or FAR,~~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, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense, or DoD,the Defense Federal Acquisition Regulations (DFARs), and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense (DoD) government contracts;

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 International Traffic in Arms Regulations; and~~

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

~~U.S.~~We may be subject to government investigations of business practices and 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.

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 fixed price contracts. We expect that future procurement contracts we successfully secure with the ~~U.S. government~~USG would 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 ~~operating results.~~

cash flows.

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

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

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

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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 ~~to:~~contractor;

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

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

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

~~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 ~~U.S. government's~~USG’s convenience. Under general principles of government contracting law, if the ~~U.S. government~~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 ~~U.S. government~~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, with the ~~U.S. government,~~USG, are terminable at the ~~U.S. government's~~USG’s convenience with these potential consequences.

In addition, our ~~U.S. government~~USG contracts grant the ~~U.S. government~~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 ~~U.S. government.~~USG. Under our ~~U.S. government~~USG contracts, we might not be able to prohibit third parties, including our competitors, from accessing such technology or data, including

intellectual property, in providing products and services to the ~~U.S. government.~~

USG.

REGULATORY AND COMPLIANCE RISKS

Our submission of NuThrax for Emergency Use Authorization, or EUA, pre-approval and eventual FDA licensure may not be approved by the FDA in a timely manner or at all. Delays in our ability to achieve such pre-approval and licensure could prevent us from realizing the full potential value of our BARDA contract for the advanced development and delivery of NuThrax.

In September 2016, we entered into a contract with HHS through BARDA for the advanced development and delivery 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 intend to submit an application in 2018 with the FDA for EUA pre-approval of NuThrax, and although there can be no assurances, we currently anticipate that the FDA could authorize NuThrax for emergency use as early as 2018, triggering deliveries of NuThrax to the SNS for use in an emergency situation as early as 2019. However, the FDA does not have review deadlines with respect to such submissions and, therefore, the timing of any approval of an EUA pre-approval submission is uncertain. We cannot guarantee that 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. 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, if priorities for the SNS change, funding to procure any future doses of NuThrax may be limited or not available, and our future business, financial condition and operating results could be materially harmed.

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, ~~and~~ 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. We have limited experience in preparing, filing and prosecuting the applications necessary to gain regulatory approvals and expect to rely on third-party contract research organizations and consultants to assist us in this process.

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 biologics license application ~~or BLA,~~(BLA) to the FDA. Ordinarily, the FDA requires a company to support a BLA with substantial evidence of the product ~~candidate's~~candidate’s safety, purity and ~~efficacy~~potency in treating the targeted indication based on data derived from adequate and well-controlled clinical trials, including Phase ~~III safety and efficacy~~3 trials conducted in patients with the disease or condition being targeted.

However, ~~NuThrax or any~~many of our ~~medical countermeasure~~MCM product candidates, for example, ~~are subject to~~may take advantage of a different regulatory approval pathway under the ~~FDA's "Animal Rule".~~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 ~~public health threat countermeasure~~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

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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 during the development period, changes in or the enactment of additional statutes or regulations, or changes in the regulatory review process generally may cause delays in the approval or rejection of an application.

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.

~~Under~~Unapproved and investigational products are also subject to FDA's laws and regulations governing advertising and promotion, which prohibit the ~~CDC procurement contract for ACAM2000~~promotion of both unapproved products and unapproved uses of approved products. There is some risk that the FDA could conclude that our discussions with third parties related 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 and regulations and conclude that we ~~assumed responsibility for~~have violated the laws and regulations related to product development, approval, or promotion in ~~our acquisition of the ACAM2000 business from Sanofi, we must secure FDA approval of the sBLA~~ that ~~was filed for the transfer of the upstream manufacturing process for ACAM2000 from~~country. Therefore, there is a ~~European-based facility to our U.S.-based manufacturing facility prior to being able to complete deliveries under the current procurement contract with CDC.~~

~~The existing CDC procurement contract for ACAM2000~~risk that we ~~assumed responsibility~~could be subject to enforcement actions if found to be in violation of such laws or regulations.

Even if we or our collaborators obtain marketing approvals for in our ~~recent acquisition expires in March 2018~~product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products, which could materially impair our ability to generate revenue.

Once marketing approval has ~~approximately $160 million remaining in~~been granted, an approved product ~~deliveries. Under the contract,~~and its manufacturer and marketer are 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 ~~must secure FDA approval of the sBLA that was filed~~obtain marketing approval. Promotional communications with respect to ~~the transfer~~FDA-regulated products are subject to a variety of the upstream manufacturing process for ACAM2000 from a European-based facility to our U.S.-based manufacturing facility prior to being able to complete deliveries under the current procurement contractlegal and regulatory restrictions and must be consistent with the ~~CDC. We~~information in the product’s approved labeling. Thus,

we will not be able to ~~make deliveries~~promote any products we develop for indications or uses for which they are not approved.

In addition, manufacturers of ~~ACAM2000~~approved products and those manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to cGMPs, which include requirements relating to quality control and quality assurance as well as the ~~SNS under~~corresponding maintenance of records and documentation and reporting requirements. We and our collaborators and our contract manufacturers could be subject to periodic unannounced inspections by the ~~contract until~~FDA to monitor and ensure compliance with cGMPs.

Accordingly, were we to receive marketing approval for one or more of our product candidates, we would continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control.

If we and our collaborators are not able to comply with post-approval regulatory requirements, we could have the ~~sBLA is approved,~~marketing approvals for our products withdrawn by regulatory authorities and our ability to market 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 ~~anticipate~~or our collaborators obtain marketing approval could ~~occur in 2018. However this approval, if ever secured,~~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 ~~delays~~problems with our product candidates, when and ~~complications,~~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

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the medicine, including the ~~receipt~~requirement to implement a risk evaluation and mitigation strategy.

The FDA and other agencies, including the Department of Justice (DOJ), closely regulate and monitor the 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 and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our products for their approved indications, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act 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, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

restrictions on such products, manufacturers or manufacturing processes;

restrictions on the labeling or marketing of a ~~complete response letter~~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 products from the ~~FDA,~~market;

refusal to approve pending applications or supplements to approved applications that we submit;

recall of products;

damage to relationships with collaborators;

unfavorable press coverage and damage to our reputation;

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;

injunctions or the imposition of civil or criminal penalties; and

litigation involving patients using our products.

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’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

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 ~~prevent remaining~~regulate post-approval activities and affect our ability to profitably sell any product ~~deliveries~~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 in additional downward pressure on the price that we, or any collaborators, may receive for any approved products.

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the ACA). Among the provisions of the ACA of potential importance to our business and our product candidates are the following:

an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription products and biologic agents;

an increase in the statutory minimum rebates a manufacturer must pay under the ~~current procurement contract.~~ Medicaid Drug Rebate Program;


•	a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for products that are inhaled, infused, instilled, implanted or injected;


•	expansion of health care fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new

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government investigative powers and enhanced penalties for noncompliance;

a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand products to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient products to be covered under Medicare Part D;

extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;

expansion of eligibility criteria for Medicaid programs;

expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

new requirements to report certain financial arrangements with physicians and teaching hospitals;

a new requirement to annually report product samples that manufacturers and distributors provide to physicians;

a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

a new Independent Payment Advisory Board (IPAB), which has authority to recommend certain changes to the Medicare program to reduce expenditures by the program that could result in reduced payments for prescription products; and

established the Center for Medicare and Medicaid Innovation within the Centers for Medicare & Medicaid Services (CMS) to test innovative payment and service delivery models.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. In August 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.

These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in April 2013 and will remain in effect through 2024 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other health care funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

Since enactment of the ACA, there have been numerous legal challenges and Congressional actions to repeal and replace provisions of the law. For example, with enactment of the Tax Cuts and Jobs Act of 2017, which was signed by the President on December 22, 2017, Congress repealed the “individual mandate.” The repeal of this provision, which requires most Americans to carry a minimal level of health insurance, became effective on January 1, 2019. In addition, Congress will likely consider other legislation to replace elements of the ACA, during the next Congressional session. It is possible that such initiatives, if enacted into law, could ultimately result in fewer individuals having health insurance coverage or in individuals having insurance coverage with less generous benefits. We will continue to evaluate the effect that the ACA and its possible repeal and replacement could have on our business.

The Trump Administration has also taken executive actions to challenge or delay implementation of the ACA. Since January 2017, President Trump has signed two Executive Orders designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. One Executive Order directs federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, health care providers, health insurers, or manufacturers of pharmaceuticals or medical devices. The second Executive Order terminates the cost-sharing subsidies that reimburse insurers under the ACA. In addition, the CMS has proposed regulations that would give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. On November 30, 2018, CMS announced a proposed rule that would amend the Medicare Advantage and Medicare Part D prescription

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drug benefit regulations to reduce out of pocket costs for plan enrollees and allow Medicare plans to negotiate lower rates for certain drugs. Among other things, the proposed rule changes would allow Medicare Advantage plans to use pre authorization (PA) and step therapy (ST) for six protected classes of drugs, with certain exceptions, permit plans to implement PA and ST in Medicare Part B drugs; and change the definition of “negotiated prices,” while providing a definition of “price concession” in the regulations. It is unclear whether these proposed changes will be accepted, and if so, what effect such changes will have on our business. Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results.

The costs of prescription pharmaceuticals have also been the subject of considerable discussion in the United States, and members of Congress and the Trump Administration have stated that they will address such costs through new legislative and administrative measures. While any proposed measures will require authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures are increasingly 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.

Specifically, there have been several recent U.S. congressional inquiries and proposed federal and proposed and enacted state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. At the federal level, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. For example, on May 11, 2018, the Administration issued a plan to lower drug prices. Under this blueprint for action, the Administration indicated that HHS will: take steps to end the gaming of regulatory and patent processes by drug makers to unfairly protect monopolies; advance biosimilars and generics to boost price competition; evaluate the inclusion of prices in drug makers’ ads to enhance price competition; speed access to and lower the cost of new drugs by clarifying policies for sharing information between insurers and drug makers; avoid excessive pricing by relying more on

value-based pricing by expanding outcome-based payments in Medicare and Medicaid; work to give Part D plan sponsors more negotiation power with drug makers; examine which Medicare Part B drugs could be negotiated for a lower price by Part D plans, and improving the design of the Part B Competitive Acquisition Program; update Medicare’s drug-pricing dashboard to increase transparency; prohibit Part D contracts that include “gag rules” that prevent pharmacists from informing patients when they could pay less out-of-pocket by not using insurance; and require that Part D plan members be provided with an annual statement of plan payments, out-of-pocket spending, and drug price increases. More recently, on January 31, 2019, the HHS Office of Inspector General proposed modifications to the federal Anti-Kickback Statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.

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. 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 ~~receive a complete response letter~~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

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programs prohibit pharmaceutical companies from ~~the FDA, there is no assurance~~offering valuable items or services to customers or potential customers to induce them to buy, prescribe, or recommend our product (the so-called “antikickback” 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 and our employees 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 ~~we would be able to satisfactorily address FDA comments. In connection with the approval process~~prohibit certain activities that may have an impact against potential competitors. Violations of the ~~sBLA,~~various fraud and abuse and antitrust laws may result in severe penalties against the ~~FDA will also inspect~~responsible employees and us, including jail sentences, large fines, and the exclusion of our ~~facility~~products from reimbursement under federal and ~~there can be no assurance that we can timely address any FDA observations or that our facility will be deemed acceptable by the FDA. An inability to secure approval~~state programs. Some of the ~~sBLA~~laws that may affect our ability to operate include:

the federal Anti-Kickback Statute makes it illegal for any person or ~~unanticipated delays~~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 ~~FDA~~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, currently set at $10,781 to $21,563 per false claim;

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 ~~sBLA,~~delivery of, or payment for, health care benefits, items or services. Similar to the U.S. federal Anti-Kickback Statute, 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 the Health Information Technology for Economic and Clinical Health (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, which requires 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), certain payments and transfers of value made to physicians and teaching hospitals, and ownership or investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers will also be required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives; and

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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 ~~corresponding prevention~~ relevant compliance guidance promulgated by the federal government, obtain pharmaceutical agent licensure, and/or ~~delay~~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 U.S. federal Anti-Kickback Statute, it is possible that some of our business activities could be subject to challenge 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 any governmental regulations that apply to us, we 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 are developing and implementing a corporate compliance program designed to ensure that we will market and sell any future products that we successfully develop from our product ~~delivery~~candidates in compliance with all applicable laws and ~~revenue, could significantly delay or prevent~~regulations, but we cannot guarantee that this program will protect us from ~~recognizing the anticipated benefits of this acquisition~~governmental

investigations or other actions or lawsuits stemming from a failure to be in compliance 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 ~~expected timeframe and materially and adversely harm~~ business, including the imposition of significant fines or other sanctions.

Efforts to ensure that our business ~~revenues, operating~~arrangements with third parties will comply with applicable 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 applicable fraud and abuse or other health care laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, 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 any of the physicians or other health care providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusion from government funded health care programs.

We are committed to conducting the sales and marketing of our applicable products and all our activities in compliance with the health care fraud and abuse and antitrust laws, but certain applicable laws may impose liability even in the absence of specific intent to defraud. Furthermore, should there be ambiguity, a governmental authority may take a position contrary to a position we have taken, or should an employee violate these laws without our knowledge, a governmental authority may impose civil and/or criminal sanctions.

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;

Expenditure of large amounts of cash on legal fees, costs and payment of damages or penalties;

Limitations on our ability to continue some of our operations;

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Decreased demand for our products; 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.

~~We intend~~The issuance of regulations and coverage expansion by various governmental agencies relating to ~~transfer~~ the ~~manufacturing of raxibacumab, which we recently acquired from GSK, to our 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~~Medicaid rebate program will continue to ~~purchase product from GSK to satisfy deliveries~~increase our costs and the complexity of compliance and will be time-consuming. Changes to the ~~SNS~~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 ~~BARDA contract,~~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 ~~expires in 2019~~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 ~~has approximately $130 million in product deliveries remaining~~recalculations 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 ~~current contract. We intend~~340B/PHS drug pricing program.

In addition to ~~seek FDA approval~~ retroactive rebate liability and the potential for 340B program refunds, if we are found

to ~~transfer~~have made a misrepresentation in the ~~manufacturing~~reporting of ~~raxibacumab~~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 also would subject us to civil monetary penalties. In addition, our ~~Baltimore, Maryland manufacturing facilities and currently anticipate FDA approval of this technology transfer in 2020. Approval of this technology transfer may involve complications~~failure to submit monthly/quarterly AMP or ~~may not be secured~~“best price” information 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 business, revenues, operating results and cash flows~~. 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 a civil monetary penalty per day for each day the information is late beyond the due date. Such failure also could be grounds for CMS to terminate our ~~inability~~Medicaid drug rebate agreement, pursuant to ~~satisfy~~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 you 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 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 ~~BARDA contract.~~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. The rules governing the calculation of certain reported prices are highly complex. 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 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,

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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 as well as to be purchased by certain federal agencies and certain federal 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 Public Health Service (including the Indian Health Service), and the Coast Guard-at pricing that is capped pursuant to 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. Pursuant to the VHCA, knowing provision of 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.

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, 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.

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. For example, our Lansing Building 55 facility was inspected most recently by the FDA in June 2016, our Lansing Building 12 facility was inspected most recently by the FDA in April 2016, our Winnipeg manufacturing facility was inspected most recently by the FDA in May 2017 and Health Canada in November 2016, our Canton, Massachusetts manufacturing facility was inspected most recently by the FDA in November 2015, our Rockville facility was inspected most recently by the FDA in March 2017, and our Baltimore (Camden) facility was most recently inspected by the Health Products Regulatory Authority of Ireland in February 2017, FDA in January 2017 and Health Canada in October 2016. 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;

~~warning letters and other communications;~~

product seizure or withdrawal of the product from the market;

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

restrictions on the marketing or manufacturing of a product;

~~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;

~~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

~~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 ormay also contain requirements for costly post-marketing testing and surveillance to

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monitor the safety or efficacy of the product. If we experience any of these post-approval events, our business, financial condition, ~~and~~ operating results and cash flows could be materially and adversely affected.

Additionally, companies may not promote drugs for ~~"off-label"~~“off-label” uses (~~i.e.~~(i.e., uses that are not described in the ~~product's~~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 ~~U.S. government)~~USG), as well as criminal sanctions. If our employees or agents engage in ~~"off-label"~~“off-label” marketing of any of our products, 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 ~~results of operations,~~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 intend to sell certain of our products, outside the United ~~States.~~States and 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 ~~the European Union and many other~~ foreign jurisdictions under normal circumstances, we may need to obtain separate regulatory approvals and comply with numerous and varying ~~regulatory~~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.~~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 ~~therefore~~ we may be unable to successfully commercialize our products ~~internationally.~~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.~~process..

Additionally, on June 23, 2016, the electorate in the United Kingdom voted in favor of leaving the European Union, commonly referred to as Brexit. On March 29, 2017, the United Kingdom formally notified the European Union of its intention to withdraw

~~Our~~

pursuant to Article 50 of the Lisbon Treaty. Since a significant proportion of the regulatory framework in the United Kingdom is derived from European Union directives and regulations, Brexit could materially impact the regulatory regime with respect to the approval of our products or product candidates in the United Kingdom or the European Union. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, would prevent us from commercializing product candidates in the United Kingdom and/or the European Union and could restrict our ability to generate revenue and achieve and sustain profitability. 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 an enforcement action if found to be in violation of such laws or regulations.

Laws and regulations governing international operations ~~increase our risk~~may preclude us from developing, manufacturing and selling certain products outside of ~~exposure~~the United States and require us to ~~potential claims of bribery~~develop and ~~corruption.~~

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 U.S. Foreign Corrupt Practices Act ~~or FCPA,~~(FCPA), the U.K. Bribery Act, Canada's Corruption of Foreign Public Officials Act, orand 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 difficult, particularly in countries in which corruption is a recognized problem. In addition, the ~~course of establishing~~FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and ~~expanding our commercial operations~~doctors and ~~seeking regulatory approvals~~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.

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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 expand our presence outside of the United States, it will ~~need~~require us to ~~establish~~dedicate additional resources to comply with these laws, and ~~expand business relationships~~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 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 ourlaws governing international business practices ~~are found to be~~may result 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~~substantial civil and criminal penalties ~~potential~~and suspension or debarment from ~~public procurement and reputational damage, which could have a material adverse effect~~government contracting. The SEC also may suspend or bar issuers from trading securities on ~~our business, financial condition, results~~U.S. exchanges for violations of ~~operations and growth prospects.~~

the FCPA’s accounting provisions.

MANUFACTURING RISKS

Disruption at, damage to or destruction of our manufacturing facilities could impede our ability to manufacture BioThrax, AV7909, ACAM2000, NARCAN Nasal Spray or our other products, as well as deliver our contract development and manufacturing services, which would harm our business, financial condition, operating results and ~~operating results.~~

cash flows.

An interruption in our manufacturing operations ~~at Building 55, our FDA-approved large-scale manufacturing facility on our Lansing, Michigan campus,~~ could result in our inability to produce ~~BioThrax~~our PHT countermeasures 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;

~~equipment malfunctions or failures;~~

technology malfunctions;

~~technology malfunctions;~~

cyber-attacks;

~~cyber-attacks;~~

work stoppages or slow-downs;

~~work stoppages or slow-downs;~~

protests, including by animal rights activists;

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

injunctions;

~~injunctions;~~

damage to or destruction of the facility; and

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

product contamination or tampering.

Providers of ~~public health threat~~PHT countermeasures could be subject to an increased risk of terrorist activities. The ~~U.S. government~~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 ~~our~~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;~~Maryland facilities in Camden; facilities in Canton, Massachusetts; Rockville, ~~Maryland;~~Maryland, Bern, Switzerland; and Hattiesburg, Mississippi. ~~Any such~~We do not have any redundant manufacturing facilities for any of our marketed products. Accordingly, any disruption, damage, or destruction of these facilities could impede our ability to manufacture our ~~Biologic Products,~~marketed products, our product candidates and our ability to produce products for external customers, result in losses and delays, including delay in the performance of our contractual obligations or delay in our clinical trials, any of which could be costly to us and materially harm our business, financial condition, operating results and ~~operating results.~~

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 could be adversely affected.~~flows.

~~Our~~Problems may arise during the production of our marketed products and ~~our~~ product candidates ~~are complex~~due to ~~manufacture~~the complexity of the processes involved in their manufacturing and ~~ship, which could cause us to experience~~shipment. Significant delays in product manufacturing or development ~~and~~could cause delays in ~~revenues.~~

revenues, which would harm our business, financial condition, operating results and cash flows.

BioThrax, raxibacumab, ACAM2000, Anthrasil, BAT, ~~Anthrasil,~~ VIGIV, Vivotif, Vaxchora, and many of our current product candidates, including ~~NuThrax,~~AV7909, are biologics. Manufacturing biologic products, especially in large quantities, is complex. The products must be made consistently and in compliance with a 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 deviations anywhere in the manufacturing process, including obtaining materials, maintaining master seed or cell banks and preventing genetic drift, seed or cell growth,

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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-down,~~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 has the potential to introduce variations in the manufacturing process that may result in lot failures or manufacturing ~~shut-down,~~shut-downs, delay in the release of lots, product recalls, spoilage or regulatory action. 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 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.

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.~~

revenues, which would harm our business, financial condition, operating results and cash flows.

Manufacturing delays, lot failures, shipping deviations, spoilage or other loss during shipping 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 potential clinical trials or result in litigation or regulatory action against us, any of which could be costly to us and otherwise harm our business.

We are required to obtain FDA approval prior to the release of each lot of ~~BioThrax,~~raxibacumab and certain other products, which may not be obtained on a timely basis or at all.

FDA approval is required for the release of each lot of ~~BioThrax. A "lot" is approximately 181,000 doses.~~raxibacumab. We are not able to sell any lots that fail to satisfy the FDA release testing specifications. For example, we must provide the FDA with the results of certain tests, including potency tests, before lots are released for sale. Potency testing of each lot of ~~BioThrax~~raxibacumab is performed against a qualified control ~~lot~~lots that we maintain. We ~~have one mechanism for conducting this potency testing that is reliant on a unique animal strain for which we currently have no alternative. We~~ continually

monitor the status of our reference ~~lot~~lots for FDA compliance and periodically produce and qualify a new reference lot to replace the existing reference lot. If we are not able to produce and qualify a new reference lot or otherwise satisfy the ~~FDA's~~FDA’s requirements for release of ~~BioThrax,~~raxibacumab, our ability to sell ~~BioThrax~~raxibacumab would be impaired until such time as we become able to meet the ~~FDA's~~FDA’s 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 marketed 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 marketed 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. 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. 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 and operating results.

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 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 ~~results of operations.~~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

EMERGENT BIOSOLUTIONS INC.

Agriculture and the DoD, as well as regulatory authorities in Canada.

RELIANCE ON THIRD PARTIES

~~RISKS RELATED TO STRATEGIC ACQUISITIONS AND COLLABORATIONS~~

~~Our strategy~~The loss of ~~generating growth through acquisitions may not be successful.~~

~~Our business strategy includes growing~~any of our ~~business through acquisition and in-licensing transactions. We may not be successful in identifying, effectively evaluating, structuring, acquiring~~non-exclusive, sole-source or ~~in-licensing, and developing and commercializing additional products on favorable terms,~~single source suppliers 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~~increase in the ~~biopharmaceutical field. These companies may have a competitive advantage over~~price of inventory supplied to 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. For example, in part to fund our acquisition of Cangene Corporation, we issued $250 million of senior convertible notes in January 2014. Our recently completed acquisition of the ACAM2000 business required initial payments of $117.5 million and may require an additional milestone payment of up to $7.5 million tied to the achievement of a regulatory event. In addition, our recently completed acquisition of raxibacumab required a $76 million upfront payment and may require up to $20 million in additional milestone payments, all of which would likely become due in 2019.

~~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~~an 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~~ financial condition and ~~operating results.~~

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

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, 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 ~~integrate any acquired business successfully~~establish additional or ~~operate any acquired business profitably.~~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, ~~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~~lose a sole-source supplier due to, among other things, the ~~advantages that~~acquisition of such a supplier by a competitor (which may cause the ~~acquisitions were intended~~supplier to ~~create,~~stop selling its products to us) or the bankruptcy of such a supplier, which may ~~materially adversely affect~~cause the ~~growth~~supplier to cease operations. Any reduction or interruption by a sole-source supplier of ~~our business and our financial condition and operating results.~~

~~COMPETITIVE AND POLITICAL RISKS~~

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

The development and commercialization of new biopharmaceutical 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 commercializekey components used 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~~manufacturing of companies with products or product candidates addressing public health threat preparedness that are competing with us for both U.S. government 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~~an increase in ~~demand for our products~~the price of those materials 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, whichcomponents could adversely affect our business, financial condition and ~~operating results.~~results of operations.

~~Our Biologic Products may face risks~~Additionally, any failure by us to forecast demand for, or our suppliers to maintain an adequate supply of, ~~competition from biosimilar manufacturers.~~

~~Competition~~the raw material and finished product for ~~BioThrax, raxibacumab, ACAM2000, BAT, Anthrasil and VIGIV, otherwise referred to as our "Biologic Products," may be affected by follow-on biologics, or "biosimilars,"~~producing NARCAN® Nasal Spray could result in an interruption in the ~~United States~~supply of NARCAN® Nasal Spray and ~~other jurisdictions. Regulatory and legislative activity~~a decline 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 and operating results.~~product.

~~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 public health threats, whether Chemical, Biological, Radiological, Nuclear and explosives, or CBRNe, and Emerging Infectious Diseases, 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 marketed products, any of which could negatively affect our revenues and our financial condition and operating results.

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 public health threat countermeasures and thereby limit the demand for our products, which would adversely affect our business, financial condition and operating results.

~~PRODUCT DEVELOPMENT AND COMMERCIALIZATION RISKS~~

~~Our growth depends on our success in developing and commercializing our product candidates.~~ If we are unable to ~~commercialize these~~obtain supplies for the manufacture of our products and product candidates ~~or experience significant delays or unanticipated costs~~ in ~~doing so, our business would be materially~~sufficient quantities, at an acceptable cost and ~~adversely affected.~~

~~We have invested significant effort 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,~~acceptable quality, our ability to ~~generate revenue is dependent on a number of factors, including the success of~~manufacture or to develop and commercialize our ~~development programs, the U.S. government's interest in providing development funding for or procuring certain of our product candidates,~~products and the commercial viability of our acquired or developed product candidates. The commercial success of our product candidates will 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, including toxicology studies and studies in approved animal models;~~

~~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, whether alone or in collaboration with others;~~

~~successful registration and maintenance of relevant patent and/or other proprietary protection; 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 could be impaired, which could materially ~~and adversely affect~~harm our ~~financial resources, results~~revenues, lead to a termination of ~~operations and cash flows.~~

Before obtaining regulatory approval for the sale of our product candidates, we and our collaborative partners, where applicable, must conduct extensive preclinical studies and clinical trials to establish proof 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 ~~clinical trials can occur at any stage of testing.~~

~~For certain of our product candidates addressing CBRN threats, we expect~~contracts, lead to ~~rely on the Animal Rule to obtain regulatory approval. The Animal Rule permits,~~delays 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 the Project BioShield Act of 2004, or Project BioShield, the Secretary of HHS can contract to purchase countermeasures 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.

~~We may experience unforeseen events or issues during, or as a result of, preclinical testing,~~ clinical trials or ~~animal efficacy studies. These issues~~otherwise materially harm our business.

We depend on certain single-source suppliers for key materials and ~~events, which~~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 AV7909, 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, toxins to manufacture BAT 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 ~~delay~~require us to qualify and validate alternative suppliers. If we are unable to locate or ~~prevent~~establish alternative suppliers, our ability to ~~receive regulatory approval for~~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 ~~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.~~

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.

We depend on third parties to conduct 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 ~~of operations~~ 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 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

EMERGENT BIOSOLUTIONS INC.

and non-government organizations 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.

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.

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 be able to integrate any acquired business successfully or operate any acquired business profitably, including our acquisitions 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

EMERGENT BIOSOLUTIONS INC.

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 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.

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 NARCAN® Nasal Spray marketed product to face future competition from other treatments.

Our marketed product NARCAN® Nasal Spray faces potentially substantial competition from other treatments, including injectable naloxone, auto-injectors, nasal sprays or improvised nasal spray 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 and in April 2019, Teva received FDA approval to market its generic version of NARCAN® Nasal Spray. Teva may decide to launch its approved generic product although the launch would be at risk since the litigation we instituted against Teva is still ongoing.

Additionally, 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. 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

EMERGENT BIOSOLUTIONS INC.

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 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 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 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, including toxicology studies and studies in approved animal models;

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, whether alone or in collaboration with others;

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

acceptance of the product by potential government and other customers.

Under certain circumstances, we might sell unapproved MCMs to government entities. While this is permissible in some cases, the extent to which we may be able to lawfully market 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. In the United States, the Project BioShield Act of 2004 (Project BioShield) permits the Secretary of HHS to contract to purchase MCMs for the SNS prior to FDA approval of the countermeasure 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. Absent an applicable exception, our MCM product candidates generally will have to be approved by the FDA or other regulatory authorities 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, may 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 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 that we believe such activities are permissible, local enforcement authorities could disagree with our conclusion and take enforcement action against us.

EMERGENT BIOSOLUTIONS INC.

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 products, such as a declaration issued under the Public Readiness and Emergency Preparedness Act (the PREP Act) may not cover claims arising under non-U.S. law.

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.

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 for the marketing of our product candidates, we and our collaborative partners, where applicable, must conduct preclinical studies and clinical trials to establish proof 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 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 EUA. 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 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.

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

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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, ~~of operations~~ and cash flows could be materially harmed.

Our success ~~especially with respect to our small molecule product candidates,~~ will depend, in large part, on our ability to obtain and maintain protection in the United States and other countries for the intellectual property ~~covering~~incorporated into or ~~incorporated into~~covering our technology, products, and product candidates. Obtaining and maintaining ~~this~~ protection of our intellectual property is very costly. The patentability of technology in the biopharmaceutical field generally is highly uncertain and involves complex legal and scientific questions.

We may not be able to obtain additional issued patents relating to our technology or products. Even if issued, patents may inadvertently lapse or be challenged, narrowed, invalidated, or circumvented, ~~which~~and such happenings could limit our ability to stop competitors from marketing similar products or limit the duration of patent protection we may have for our products. In the past, we have abandoned the prosecution and/or maintenance of patent applications related 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 to 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, or narrow the scope of our patent protection, or result in costly defensive measures. In addition, some countries do not grant patent claims directed to methods of treating humans and, in these countries,

patent protection may not be available at all to protect our products or product candidates.

Changes to the U.S. patent system under the Leahy-Smith America Invents Act (the America Invents Act), affected the way patent applications are filed, prosecuted and litigated. For example, the America Invents Act enacted proceedings involving post-issuance patent review procedures, such as inter partes review (IPR) post-grant review (PGR) and covered business methods review (CBM). These proceedings are conducted before the Patent Trial and Appeal Board (the PTAB) of the U.S. Patent and Trademark Office. Each proceeding has different eligibility criteria and different patentability challenges that can be raised. In this regard, the IPR process permits any person (except a party who has been litigating the patent for more than a year) to challenge the validity of some patents on the grounds that it was anticipated or made obvious by prior art. As a result, non-practicing entities associated with hedge funds, pharmaceutical companies who may be our competitors and others have challenged certain valuable pharmaceutical U.S. patents based on prior art through the IPR process. A decision in such a proceeding adverse to our interests could result in the loss of valuable patent rights which would have a material adverse effect on our business, financial condition, results of operations and growth prospects. The America Invents Act and any other potential future changes to the U.S. patent system could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

The cost 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 ~~are subject~~may be subjected to opposition ~~proceedings.~~proceedings or validity challenges. Some of our competitors may choose to or be better able to sustain the costs of complex patent ~~litigation because they may have substantially greater financial resources.~~litigation. Intellectual property lawsuits are expensive and unpredictable and ~~would~~ consume management's time and attention and other resources, even if the outcome ~~were~~is successful. In addition, there is a risk that a court ~~would~~could decide that our patents are not valid, are unenforceable, or ~~must be interpreted narrowly and that we do~~are not ~~have the right to stop another party from using the inventions covered~~infringed by ~~or incorporating them.~~a competitor product. There is also a risk that, even if the validity of a patent ~~were~~is upheld, a court ~~would~~could refuse to stop the other party from using the invention(s), including on the grounds that its activities do not infringe the patent. If any of these events ~~were to~~ 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 in which 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

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intellectual property rights may be compromised by the acts or omissions of these third parties. For example, we license from ~~Pfizer,~~Opiant Pharmaceuticals, Inc. ~~an oligonucleotide adjuvant, CPG 7909,~~formulations of naloxone, for use in our ~~NuThrax anthrax vaccine product candidate.~~NARCAN® Nasal Spray.

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 ~~would~~could be costly, time-consuming, distracting to management, and could materially and adversely affect our business, financial condition, operating results, and cash flows.

Our development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe or be claimed to infringe patents and other intellectual property rights of third parties for which we do not hold sufficient licenses or other rights. Additionally, third parties may be successful in obtaining patent protection for technologies that cover development 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 ~~may have substantially greater financial resources than us and~~ could bring claims against us that could cause us 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 or other similar suit ~~were~~is brought against us, we could be forced to stop or delay development, manufacturing, or sales 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 ~~the~~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 ~~were~~are able to obtain a license, the rights may be non-exclusive, which could result in 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 ~~licensed patents~~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.

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 U.S. Food, Drug and Cosmetic Act (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

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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 pharmacists 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 for the generic product that is the subject of the ANDA.

In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge the validity 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 affect 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.

Further, the 2010 Patient Protection and Affordable Care Act, which was signed into law on March 23, 2010, included a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCIA). That Act established a regulatory scheme authorizing the FDA to approve biosimilars

and interchangeable biosimilars. As of January 1, 2018, the FDA has approved nine biosimilar products for use in the United States. No interchangeable biosimilars, have been approved. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars. Additional guidance is expected to be finalized by FDA in the near term.

Under the Act, a manufacturer may submit an application for licensure of a biologic product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” In order for the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product and proposed biosimilar product in terms of safety, purity and potency. For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and (for products administered multiple times) that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date of approval of the reference product. The FDA may not approve a biosimilar product until 12 years from the date on which the reference product was approved. Even if a product is considered to be a reference product eligible for exclusivity, 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 preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

FINANCIAL RISKS

~~Servicing~~We have incurred significant indebtedness in connection with our acquisitions and servicing our debt requires a significant amount of ~~cash, and we~~cash. We may not have sufficient cash flow from our operations to pay our substantial debt.

~~As of September 30, 2017, our total consolidated indebtedness was approximately $253 million, including approximately $250 million of obligations under our senior convertible notes due in 2021.~~ Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness ~~including the senior convertible notes,~~ depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not continue to generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.

~~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 addition to our current debt, we recently entered into a five-year $200 million syndicated senior secured revolving credit facility that replaced our prior $100 million facility, which was scheduled to expire in December 2018. The senior secured credit facility also includes a $100 million accordion feature, which could expand total commitments to up to $300 million with an additional $100 million in revolver or incremental term loans, at our option, subject to certain conditions and requirements under the credit agreement. 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;

~~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;~~

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~~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 revolving credit facility, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;

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

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

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

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

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

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 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 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 had outstanding borrowings of $439 million and

$383 million, respectively, as of September 30, 2019. 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 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~~agreements 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~~agreement and a cross default and acceleration under other debt ~~instruments,~~agreements, 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 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

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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 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.

We may require significant additional funding to grow our business, including efforts to acquire other companies or products, in-license and develop additional products, enhance our manufacturing capacity, support commercial marketing activities or otherwise provide additional financial flexibility. We may also require additional funding to support our ongoing operations in the event that our ability to sell BioThrax to the U.S. government is interrupted for an extended period of time, reducing our BioThrax revenues and decreasing our cash balances.

~~As of September 30, 2017, we had approximately $341.0 million of cash and cash equivalents. Our future capital requirements will depend on many factors, including, among others:~~

~~the level, timing and cost of product sales;~~

~~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 our common stock under our share repurchase program; and~~

~~the costs of commercialization activities, including product marketing, sales and distribution.~~

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 ~~May 2015,~~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~~“well-known seasoned ~~issuer"~~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 ~~May 2018,~~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 ~~May 2018,~~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 ~~revolving~~ credit ~~facility,~~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 ~~senior convertible notes~~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 ~~facility restricts~~facilities restrict our ability to incur additional indebtedness, including secured indebtedness.

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 2015, 2014, 2013 and 2012.~~ 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 ~~U.S. government.~~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.

~~THE SPIN-OFF OF OUR BIOSCIENCES BUSINESS~~

IfAs 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 ~~spin-off distribution on August 1, 2016~~collection 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~~accounts receivables 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, or the Distribution, together with certain related transactions, qualify as a tax-free transaction described under Sections 355may result in credit losses. Future governmental actions and 368(a)(1)(D) of the Internal Revenue Code of 1986, as amended, or the Code. In anticipation of the Distribution, we received a favorable private letter ruling from the Internal Revenue Service, or 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 acustomer specific ~~set of facts. Our private letter ruling is based on certain facts and representations submitted by~~actions may require us to re-evaluate 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 Emergent and Aptevo contained in a tax matters agreement and certain representations contained in representation letters provided by Emergent, Aptevo and certain stockholders to such counsel, including representations and covenants relating to the past and future conduct of Emergent, 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 shareholders exceeded our tax basis in the Aptevo shares and (ii) eachcollectability of our ~~shareholders 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 shareholder.~~

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 restricts 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 is 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 will comply with these restrictions. Failure of Aptevo to satisfy its obligations 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 timeaccounts receivable and we may ~~be required to bear these~~potentially incur credit losses ~~ourselves while we seek recovery. Each of these risks could negatively affect~~that may materially impact our ~~business, results of operations and financial condition.~~

operating results.

OTHER BUSINESS RISKS

~~Pending litigation and legal proceedings and the impact of any finding of liability or damages could adversely impact our business, financial condition and results of operations.~~

From time to time, we may be named as a defendant in various legal actions or other proceedings. Certain of these actions include and future actual or threatened legal actions may include, claims for substantial and indeterminate amounts of damages, or may result in other action adverse to us.

For example, a purported class action lawsuit was filed against us and several of our senior officers and directors in the United States District Court for the District of Maryland seeking unspecified damages on behalf of a putative class of persons who purchased or otherwise acquired our common stock between January 11, 2016 and June 21, 2016. The complaint, as amended on December 27, 2016, alleges, among other things, that we made materially false and misleading statements about the government's demand for BioThrax and expectations that our five-year exclusive procurement contract with HHS would be renewed and omitted certain material facts.

The results of this lawsuit and possible other future legal proceedings cannot be predicted with certainty. Accordingly, we cannot determine whether our insurance coverage would be sufficient to cover the costs or potential losses, if any. Regardless of merit, litigation may be both time-consuming and disruptive to our operations and cause significant expense and diversion of management attention. If we do not prevail in the purported class action lawsuit or in other future legal proceedings, we may be faced with significant monetary damages or injunctive relief against us that may adversely affect our business, financial condition and results of operations.

We 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 ~~Public Readiness and Emergency Preparedness Act, or~~ 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

EMERGENT BIOSOLUTIONS INC.

declarations identifying certain of our products, namely BioThrax, ACAM2000, raxibacumab, Anthrasil, BAT ~~Anthrasil~~ and VIGIV, as covered countermeasures. These declarations expire in 2022. Manufacturers are not entitled to protection under the PREP Act in cases of willful misconduct. 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 Support Anti-Terrorism by Fostering Effective Technology Act of 2002 or(the SAFETY ~~Act.~~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 ~~U.S. government,~~USG, or the ~~U.S. government~~USG does not honor its obligations to us under the PREP Act or SAFETY Act, or if the indemnification under the PREP Act and SAFETY Act is 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;

injury to our reputation;

withdrawal of clinical trial participants;

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~~large-scale deployment of BioThrax as a countermeasure to a bioterrorism threat. We rely on PREP Act protection for BioThrax, raxibacumab, ACAM2000, Anthrasil, BAT ~~Anthrasil~~ 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, 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 ~~results of operations.~~

cash flows.

The accuracy of our financial reporting depends on the effectiveness of our internal control over financial reporting. ~~If we identify a~~A material weakness in our internal control over financial reporting it 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 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 areas that need improvement in the future, these shortcomings could have an adverse effect on our

EMERGENT BIOSOLUTIONS INC.

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~~breaches-whether by employee error, malfeasance or other ~~disruption—which~~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. 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 October ~~27, 2017,~~25, 2019, Mr. El-Hibri was the beneficial owner of approximately ~~13%~~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.

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;

~~the classification of our directors;~~

limitations on changing the number of directors then in office;

~~limitations on changing the number of directors then in office;~~

limitations on the removal of directors;

~~limitations on the removal of directors;~~

limitations on filling vacancies on the board;

~~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;

~~advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;~~

EMERGENT BIOSOLUTIONS INC.

~~the inability of stockholders to act by written consent;~~

~~the inability of stockholders to call special meetings; and~~

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 ~~or Section 203.~~(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~~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.

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"~~“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 October ~~27, 2017,~~25, 2019, our common stock has traded as high as ~~$44.38~~$73.89 per share and as low as ~~$4.40~~$4.20 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 U.S. government~~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;~~

termination or delay of a development program;

~~the recruitment or departure of key personnel;~~

EMERGENT BIOSOLUTIONS INC.

~~variations in our product revenue and profitability; and~~

~~the other factors described in this "Risk Factors"~~

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 ~~facility limits~~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 ~~October 27, 2017,~~September 30, 2019, have the right to require us to register these shares of common stock under specified circumstances. In May 2015, 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, this shelf registration statement, effective until May 2018, would provide for a secondary offering of these shares from time to time.

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share and per share data)


	September 30, 2017			December 31, 2016
ASSETS	(unaudited)
Current assets:
Cash and cash equivalents	$	340,991		$	271,513
Restricted cash		1,043			-
Accounts receivable, net		129,357			138,478
Inventories		68,889			74,002
Income tax receivable, net		-			9,996
Prepaid expenses and other current assets		15,754			16,229
Total current assets		556,034			510,218

Property, plant and equipment, net		386,457			376,448
Intangible assets, net		29,202			33,865
Goodwill		41,001			41,001
Deferred tax assets, net		4,864			6,096
Other assets		6,644			2,483
Total assets	$	1,024,202		$	970,111

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	30,111		$	34,649
Accrued expenses and other current liabilities		3,918			6,368
Accrued compensation		32,626			34,537
Notes payable		-			20,000
Contingent consideration, current portion		2,393			3,266
Income taxes payable		1,875			-
Deferred revenue, current portion		4,509			7,036
Total current liabilities		75,432			105,856

Contingent consideration, net of current portion		9,398			9,919
Long-term indebtedness		248,994			248,094
Deferred revenue, net of current portion		24,966			8,433
Other liabilities		1,702			1,604
Total liabilities		360,492			373,906

Stockholders' equity:
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both September 30, 2017 and December 31, 2016		-			-
Common stock, $0.001 par value; 200,000,000 shares authorized, 41,807,978 shares issued and 41,382,429 shares outstanding at September 30, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016		41			41
Treasury stock, at cost, 425,549 and 422,830 common shares at September 30, 2017 and December 31, 2016, respectively		(6,503	)		(6,420	)
Additional paid-in capital		370,855			352,435
Accumulated other comprehensive loss		(3,815	)		(4,331	)
Retained earnings		303,132			254,480
Total stockholders' equity		663,710			596,205
Total liabilities and stockholders' equity	$	1,024,202		$	970,111

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2017			2016			2017			2016
	(Unaudited)						(Unaudited)
Revenues:
Product sales	$	114,296		$	96,698		$	259,875		$	208,785
Contract manufacturing		18,912			14,712			52,700			32,455
Contracts and grants		16,226			31,504			54,489			95,879
Total revenues		149,434			142,914			367,064			337,119

Operating expenses:
Cost of product sales and contract manufacturing		44,503			39,560			125,449			93,025
Research and development		22,659			27,188			68,886			81,173
Selling, general and administrative		34,503			40,688			101,521			108,328
Income from operations		47,769			35,478			71,208			54,593

Other income (expense):
Interest income		637			358			1,593			764
Interest expense		(1,991	)		(2,049	)		(5,734	)		(5,082	)
Other expense, net		(101	)		(234	)		(387	)		(176	)
Total other expense, net		(1,455	)		(1,925	)		(4,528	)		(4,494	)

Income from continuing operations before provision for income taxes		46,314			33,553			66,680			50,099
Provision for income taxes		12,763			13,165			18,028			19,861
Net income from continuing operations		33,551			20,388			48,652			30,238
Net income (loss) from discontinued operations		-			952			-			(15,854	)
Net income	$	33,551		$	21,340		$	48,652		$	14,384


Net income per share from continuing operations - basic	$	0.81		$	0.50		$	1.19		$	0.75
Net income (loss) per share from discontinued operations - basic		-			0.02			-			(0.40	)
Net income per share - basic	$	0.81		$	0.52		$	1.19		$	0.35


Net income per share from continuing operations - diluted	$	0.68		$	0.43		$	1.03		$	0.68
Net income (loss) per share from discontinued operations - diluted		-			0.02			-			(0.32	)
Net income per share - diluted (1)	$	0.68		$	0.45		$	1.03		$	0.36

Weighted-average number of shares - basic		41,222,504			40,465,423			40,989,813			40,071,730
Weighted-average number of shares - diluted		50,467,829			49,440,313			50,090,088			48,826,597

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Comprehensive Income
(in thousands)

	Three Months Ended September 30,								Nine Months Ended September 30,
	2017				2016				2017		2016
	(Unaudited)							(Unaudited)

Net income		$	33,551		$	21,340			$	48,652	$	14,384
Foreign currency translations, net of tax			(296	)		(492	)			516		(859	)
Comprehensive income		$	33,255		$	20,848			$	49,168	$	13,525

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)

	Nine Months Ended September 30,
	2017			2016
Cash flows from operating activities:	(Unaudited)
Net income	$	48,652		$	14,384
Adjustments to reconcile to net cash provided by (used in) operating activities:
Stock-based compensation expense		11,805			14,527
Depreciation and amortization		29,899			28,155
Income taxes		18,618			4,814
Change in fair value of contingent consideration		1,350			(1,253	)
Debt issuance costs		(1,426	)		-
Abandonment of long-lived assets		-			3,749
Excess tax benefits from stock-based compensation		-			(10,825	)
Other		703			2,467
Changes in operating assets and liabilities:
Accounts receivable		9,411			45,035
Inventories		5,113			(16,183	)
Income taxes		(5,515	)		(10,072	)
Prepaid expenses and other assets		(2,157	)		(3,146	)
Accounts payable		2,965			(1,305	)
Accrued expenses and other liabilities		(2,334	)		(1,699	)
Accrued compensation		(1,902	)		(152	)
Provision for chargebacks		-			103
Deferred revenue		14,006			(1,348	)
Net cash provided by operating activities		129,188			67,251
Cash flows from investing activities:
Purchases of property, plant and equipment and other		(42,381	)		(56,243	)
Net cash used in investing activities		(42,381	)		(56,243	)
Cash flows from financing activities:
Issuance of common stock upon exercise of stock options		10,799			14,981
Excess tax benefits from stock-based compensation		-			10,825
Taxes paid on behalf of employees for equity activity		(4,184	)		(4,590	)
Payments of notes payable		(20,000	)		-
Distribution of Aptevo		-			(45,000	)
Contingent consideration payments		(2,744	)		(1,226	)
Restricted cash		(1,043	)		-
Purchase of treasury stock		(83	)		-
Net cash used in financing activities		(17,255	)		(25,010	)

Effect of exchange rate changes on cash and cash equivalents		(74	)		139

Net increase (decrease) in cash and cash equivalents		69,478			(13,863	)
Cash and cash equivalents at beginning of period		271,513			312,795
Cash and cash equivalents at end of period	$	340,991		$	298,932

(in thousands)
Balance at December 31, 2016	$	13,185
Expense included in earnings		1,350
Settlements		(2,744	)
Balance at September 30, 2017	$	11,791

	September 30,		December 31,
(in thousands)	2017		2016
Raw materials and supplies	$	34,075	$	30,687
Work-in-process		14,776		19,821
Finished goods		20,038		23,494
Total inventories	$	68,889	$	74,002

	Number of Shares			Weighted-Average Exercise Price		Aggregate Intrinsic Value
Outstanding at December 31, 2016		2,559,331		$	22.94	$	25,348,245
Granted		418,141			30.85
Exercised		(512,542	)		19.90
Forfeited		(24,625	)		27.81
Outstanding at September 30, 2017		2,440,305		$	24.88	$	37,991,459

	Number of Shares			Weighted-Average Grant Price		Aggregate Intrinsic Value
Outstanding at December 31, 2016		875,584		$	28.94	$	28,754,179
Granted		454,513			30.86
Vested		(413,752	)		20.66
Forfeited		(34,355	)		28.87
Outstanding at September 30, 2017		881,990		$	30.39	$	35,676,496

	Incurred in		Inception
(in thousands)	2017		to Date
Termination benefits	$	40	$	5,286
Abandonment of equipment		-		3,749
Other costs		-		691
Total	$	40	$	9,726


	Termination
(in thousands)	Benefits
Balance at December 31, 2016	$	4,357
Expenses incurred		40
Amount paid		(4,298	)
Balance at September 30, 2017	$	99

	Three Months Ended
	September 30,
(in thousands)	2017		2016		Change			% Change

NuThrax	$	7,384	$	6,182	$	1,202			19	%
FLU-IG (NP025)		1,832		-		1,832			N/A
UV-4B		1,407		2,147		(740	)		(34	%)
BAT		838		814		24			3	%
Auto-injector platform		1,107		2,475		(1,368	)		(55	%)
CIADM task orders		330		2,600		(2,270	)		(87	%)
EV-035 series of molecules		772		1,331		(559	)		42	%
VIGIV		374		1,474		(1,100	)		(75	%)
Large-scale manufacturing for BioThrax		64		1,491		(1,427	)		(96	%)
Anthrasil		247		178		69			(39	%)
BioThrax related programs		238		1,012		(774	)		(76	%)
Other		8,066		7,484		582			8	%
Total	$	22,659	$	27,188	$	(4,529	)		(17	%)

	Nine Months Ended
	September 30,
(in thousands)	2017		2016		Change			% Change

NuThrax	$	23,964	$	15,847	$	8,117			51	%
FLU-IG (NP025)		5,189		-		5,189			N/A
UV-4B		4,663		4,179		484			12	%
BAT		2,509		2,964		(455	)		(15	%)
Auto-injector platform		2,551		7,646		(5,095	)		(67	%)
CIADM task orders		2,511		7,899		(5,388	)		(68	%)
EV-035 series of molecules		1,856		2,972		(1,116	)		(38	%)
VIGIV		1,211		7,428		(6,217	)		84	%
Large-scale manufacturing for BioThrax		885		4,870		(3,985	)		(82	%)
Anthrasil		737		626		111			18	%
BioThrax related programs		594		2,701		(2,107	)		(78	%)
Other		22,216		24,041		(1,825	)		(8	%)
Total	$	68,886	$	81,173	$	(12,287	)		(15	%)



Exhibit Number	Description
10.1^#†	Modification #3, effective July 30, 2019, to the Award/Contract, effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product Development Gaithersburg Inc.
10.2^#†	Notice of Award Letter, dated August 30, 2019, from the Department of Health and Human Services to Emergent Product Development Gaithersburg, Inc. awarding Contract 75A50119C00052 (Requisition: OS245611) for Acquiring Doses of ACAM2000.
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	XBRL Instance Document the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH	Inline XBRL Taxonomy Extension Schema Document.
101.CAL	Inline XBRL Taxonomy Calculation Linksbase Document.
101.DEF	Inline XBRL Taxonomy Definition Linksbase Document.
101.LAB	Inline XBRL Taxonomy Label Linksbase Document.
101.PRE	Inline XBRL Taxonomy Presentation Linksbase Document.


(ii)	Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2019 and 2018;


(iii)	Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018;


(iv)	Condensed Consolidated Statements of Cash Flows for the six months ended September 30, 2019 and 2018; and


(v)	Condensed Consolidated Statement of Changes in Stockholders' Equity for the nine months ended September 30, 2019 and 2018; and