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We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services capabilities. The commercial re-launch and first commercial sales for this product commenced in August of 2019. by 2030. patients or other appropriate patient populations. Due to the COVID-19 pandemic, our plans to commence such evaluation have been delayed. In the future however, we may work with the FDA and the immunology and infectious disease community to design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population. hospitals. Contents revenues. We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our product candidates. In addition, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of our products. FDA may also conduct inspections, including remote regulatory assessments, of our facilities or the facilities of our contractors, both during product development and following approval. Any findings from those inspections could materially impact our business. Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee, which reviews data and makes recommendations to the sponsor regarding the trial. iPSP. Congress also passed legislation that will require that sponsors submit to the FDA a diversity action plan for Phase III or other pivotal studies, unless such requirement is waived by the FDA. studies, which are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. Applications maintain cGMP compliance. FDA, as well as reports of fatalities related to blood and blood component collection or transfusion. Establishments must also comply with the FDA’s regulatory standards which include a variety of requirements related to, among other areas, cGMPs, deviation investigation and reporting, donor screening and product testing, as well as product labeling. Facilities must further ensure that all tests and equipment that are used are appropriate for their intended use, which may include FDA clearance and/or approval of the applicable test or equipment. of Our Products future. are responsible for promptly reporting any known or suspected violations of environmental laws or any events that may result in a discharge or emissions of hazardous materials. We manufacture, market and develop specialty biologics for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection, and, as such, we consider our environmental impact to be low. These activities do not include either industrial production or distribution, and therefore do not use raw materials that would result in significant releases into the environment or greenhouse gas emissions from our manufacturing emissions. Further, our activities do not produce any particular noise nuisance for staff or neighboring tenants or residents as well as wildlife surrounding our facilities and offices. Annual electricity and water consumption are monitored and factored into our sustainable resource practices. staff. business. beyond. Boca Facility. emergencies. Depending on the seriousness of any findings, we or our suppliers may be subject to additional significant enforcement actions which could have a material impact on our business. accounts receivable. As of December 31, Virginia, Colorado, Connecticut and Utah have also enacted privacy laws that became effective in 2023 and are similar in many respects to the CCPA. Several other states have also enacted privacy laws similar to the CCPA that will become effective in the coming years, adding to potential privacy compliance obligations. Failure to comply with applicable governmental regulations may also impact the ultimate quality and compliance of our finished biologic products, which may have a material adverse effect on our business. If we are not able to maintain manufacturing compliance at our facilities or our vendors’ facilities for our products and product candidates, we may not be able to successfully develop and commercialize our products and product candidates and we may face potential contractual or regulatory actions, which would have an adverse impact on our business. Recent legislation and a final rule promulgated on December 29, 2023 delayed implementation of this portion of the rule until January 1, 2032. conduct and/or Corporate Integrity Agreements that impose ongoing compliance requirements on a manufacturer. agencies. increase, and recent regulations have established a civil monetary penalty for failure to refund these overcharges. resources, which could have an adverse impact on our business. Location Principal Business Activity Owned Owned We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services ADMA currently expects that this product’s rapid growth will continue throughout 2024 and beyond. older. and results of operations. and Valuation of Warrants operations. Examples of events or circumstances that may be indicative of impairment that would require the use of significant judgment by management include: deferred tax assets. 2022 Year Ended December 31, 2020 2019 Increase (Decrease) Revenues Cost of product revenue (exclusive of amortization expense shown below) Gross loss Research and development expenses Plasma center operating expenses Amortization of intangibles Selling, general and administrative expenses Loss from operations Interest expense Gain (loss) on extinguishment of debt Gain on transfer of plasma center assets Other income, net Net loss 2022: agreement. and Gross Profit the Consolidated Financial Statements). by approximately $21.4 million. 2021. 2021. plasma center operating expenses and SG&A. Consolidated Financial Statements). 2021: remains a top corporate priority. On the prepayment penalty. was 11.39%. capital expenditures, expansion and resources for commercialization activities, and other potential research and development and business opportunities. During the year ended December 31, 2021, we issued 5,540,831 shares of our common stock under the Distribution Agreement and received net proceeds of $6.9 million. We did not issue any shares under this agreement during the years ended December 31, 2023 and 2022, and we currently have approximately $42.8 million of shares available to sell under the Distribution Agreement. Year Ended December 31, 2020 2019 Net cash used in operating activities Net cash used in investing activities Net cash provided by financing activities Net change in cash and cash equivalents Cash and cash equivalents, including restricted cash - beginning of year Cash and cash equivalents - end of year operations of $59.5 million for the same period of a year ago. This improvement was mainly due to the improvement in our operating results, driven by higher revenues and gross margins, and a lower increase in inventories. Cash used in operations for the year ended December 31, Year Ended December 31, 2020 2019 Changes in accounts payable and accrued expenses Other Cash used in operations 2024. October 2021 underwritten public offering. cash flows.andthat are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project,” “continue,” or the negative thereof, or other variations or comparable terminology, although some forward-looking statements are expressed differently. The forward-looking statements included herein represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. These statements include statements about:·our ability to continue as a going concern;·our ability to manufacture BIVIGAM and ASCENIV on a commercial scale and commercialize these products as a result of their approval by the U.S. Food and Drug Administration (the “FDA”) in 2019;·our plans to develop, manufacture, market, launch and expand our commercial infrastructure and commercialize our current and future products and the success of such efforts;·the safety, efficacy and expected timing of and our ability to obtain and maintain regulatory approvals for our current products and product candidates, and the labeling or nature of any such approvals;·the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates;·our dependence upon our third-party customers and vendors and their compliance with applicable regulatory requirements;·our belief that we have addressed the delays experienced with final drug product Good Manufacturing Practices (“GMP”) release testing by our third-party vendors by adding additional release testing laboratories to our FDA-approved consortium listed in our drug approval documents;·our ability to obtain adequate quantities of FDA-approved plasma with proper specifications;·our plans to increase our supplies of source plasma, which include plasma collection center expansion, our ability to obtain and maintain regulatory compliance and receive FDA approvals of new plasma collection centers and reliance on third-party supply agreements as well as any extensions to such agreements;·the potential indications for our products and product candidates;·potential investigational new product applications;·the acceptability of any of our products, including BIVIGAM, ASCENIV and Nabi-HB, for any purpose, including FDA-approved indications, by physicians, patients or payers;·our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses;1Table of Contents·Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions;·concurrence by the FDA with our conclusions concerning our products and product candidates;·the comparability of results of our hyperimmune and immune globulin products to other comparably run hyperimmune and immune globulin clinical trials;·the potential for ASCENIV and BIVIGAM to provide meaningful clinical improvement for patients living with Primary Immune Deficiency Disease or Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) or other immune deficiencies or any other condition for which the products may be prescribed or evaluated;·our ability to market and promote Nabi-HB in a highly competitive environment with increasing competition from other antiviral therapies and to generate meaningful revenues from this product;·our intellectual property position and the defense thereof, including our expectations regarding the scope of patent protection with respect to ASCENIV or other future pipeline product candidates;·our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy;·our plans related to the expansion and efficiencies of our manufacturing capacity, yield improvements, supply-chain robustness, in-house fill-finish capabilities, distribution and other collaborative agreements and the success of such endeavors;·our estimates regarding revenues, expenses, capital requirements, timing to profitability and the need for and availability of additional financing;·possible or likely reimbursement levels for our currently marketed products;·estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM;·effects of the coronavirus COVID-19 pandemic on our business, financial condition, liquidity and results of operations, and our ability to continue operations in the same manner as previously conducted prior to the macroeconomic effects of the COVID-19 pandemic;·future domestic and global economic conditions or performance; and·expectations for future capital requirements.“BIVIGAM®,” “ASCENIVTM”, “BIVIGAM®” and “Nabi-HB®”,” which are protected under applicable intellectual property laws and are the property of ADMA Biologics, Inc., or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this Annual Report may appear without the ® or ™ symbols, but the absence of such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.2Table of ContentsItem 1. Business Item 1. Businessand indirectly-owned subsidiaries, ADMA Plasma Biologics, Inc.,BioManufacturing, LLC, a Delaware corporation,limited liability company (“ADMA BioManufacturing”), ADMA BioCenters Georgia Inc., a Delaware corporation (“ADMA BioCenters”) and ADMA BioManufacturing, LLC,Plasma Biologics, Inc., a Delaware limited liability companycorporation (“ADMA BioManufacturing”Plasma Biologics”). plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons., or Inborn Errors of Immunity, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing HBsAg and other listed exposures to Hepatitis B. We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent No. 10,259,865 related to methods of treatment and prevention of S. pneumoniainfection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae. Our products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases. 400,000-liter annual capacity plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”). Based on current production yields, our completed and our ongoing supply chain enhancementenhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products representing annual revenues of more than $250approximately $330 million in annual2024 and potentially $380 million in 2025. At these revenue beginninglevels, we forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%. These assumptions translate to potential fiscal year 2024 and 2025 net income of $65 million and $115 million or more and adjusted EBITDA of $90 million and $140 million or more, respectively.well as achieving profitability duringfurther described under “Non-GAAP Financial Measures”, excludes charges related to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations). We also generated positive cash flow from operations for the year ended December 31, 2023 for the first quartertime in the Company’s history, primarily as a result of 2024, asour significant revenue growth and continued physician, patient and payer acceptance of ASCENIV and BIVIGAM that we ramp-up productionhave experienced over the next three to fivepast several years.as an FDA-approvedten source plasma collection organizationfacilities in the U.S., all of which hold FDA licenses. This business unit, which we refer to as our Plasma Collection Centers business segment, provides us with a portion of ourthe blood plasma required for the manufacture of our products, and product candidates, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. As a part of our planned supply chain robustness initiative, we opened two new plasma collection centers during 2020, and we now have seven plasma collection centers in various stages of development and approval, including three that are fully operational and collecting plasma. With respect to our fully operational plasma collection centers, two hold FDA licenses and the third has a Biologics License Application (“BLA”) pending an FDA decision expected in the fourth quarter of 2021. In addition, onethree of our FDA-approved plasma collection centers also hashave approvals from the Korean Ministry of Food and Drug Safety (“MFDS”), as well as FDA approval to implementoperate a Hepatitis B immunization program. After giving effect to the progress we made in 2020 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 or more plasma collection centers in operation by 2024. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products or product candidates is sold to third-party customers in the U.S. and in other locations outside the U.S. where we are approved under supply agreements or in the open “spot” market.3Table of Contentsproducts. In January 2020, we announced our entry intoproducts, through a five-year manufacturing and supply agreement to produce and sell thesewe entered into in January 2020. These intermediate by-products which are used as the starting raw material to produce other plasma-derived biologics. In addition, from time to time we provide contract manufacturing and testing services for certain third-party clients.upon FDA approval and implementation ofutilizing our FDA-approved in-house fill-finish capabilities through our Vanrx SA25 Workcell aseptic filling machine.Recent DevelopmentsOn August 5, 2020, we entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we could offer and sell, from time to time, at our option, through or to Jefferies, up to an aggregate of $50 million of shares of the Company’s common stock (see “Liquidity and Capital Resources”). On November 5, 2020, we and Jefferies amended the Sale Agreement to provide for an increase in the aggregate offering amount under the Sale Agreement such that, as of November 5, 2020, the Company could sell shares having an additional aggregate offering price of up to $20 million. On February 3, 2021, we entered into an additional amendment to the Sale Agreement to provide for an additional increase in the aggregate offering amount under the Sale Agreement to allow us to sell shares having an additional aggregate offering price of up to $35.4 million.BIVIGAMBIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses, and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin G antibodies indicated for the treatment of PI, a group of genetic disorders. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs are a group of genetic disorders. Based on recent estimates, these disorders are no longer considered to be very rare, with as many as one in every 1,200 people in the United States having some form of PI.On May 9, 2019, the FDA approved the Prior Approval Supplement (the “PAS”) for the use of our IVIG manufacturing process, thereby enabling us to commence commercial sales of this product in the United States. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under FDA License No. 2019. Commercial sales for this product commenced in August of 2019.FDAHHS License No. 2019 using a process known as fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific J-codeproduct-specific-J-code for ASCENIV. Under the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) will becomebecame effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes.2021. As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to respiratory syncytial virus (“RSV”) using our proprietary microneutralization testing assay. We are able to identify the high titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV with our patented testing methods and assay. This type of high titer plasma is typically found in less than 10% of the total donor collection samples we test.4Table of ContentsPrimary Immune Deficiency Disorder (“PIDD”),PIDD or PI, a class of inherited genetic disorders that causes a deficient or absent immune system in adults and adolescents (12 to 17 years of age). Our pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work/school/daycare and unscheduled medical visits and hospitalizations. We believe this clinical data together with the FDA approval for the treatment of patients diagnosed with PIDD better positions ADMA to potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens. We planpathogens at an appropriate time. Due to the COVID-19 pandemic, our plans have been delayed. In the future, however, we may elect to work with the FDA and the immunology and infectious disease community to potentially design aan appropriate clinical trial to evaluate the use of ASCENIV in this patient population in the near future.population. Commercial sales of ASCENIV commenced in October of 2019 and in 2023, ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history. We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity as fewer batches will be needed to support our revenue goals. ASCENIV’s prescriber and patient base continued to expand during 2023, which drove record utilization and pull-through for this product. These elevated demand trends have sustained into 2024, and ADMA currently expects that this product’s rapid growth will continue throughout 2024 and beyond.HBsAg,HbsAg, prenatal exposure of infants born to HBsAg-positiveHbsAg-positive mothers, sexual exposure to HBsAg-positiveHbsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection in specific, listed settings. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. Itvirus, which is a major global health problem. ItThe Hepatitis B virus can cause chronic infection and putsplaces people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction. The FDA approved Nabi-HB on March 24, 1999. Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017. In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the U.S. and we continue to manufacture Nabi-HB under FDAHHS License No. 2019. We are currently working on bringing fill-finish capabilities for Nabi-HB in-house and anticipate a potential FDA decision during 2021.in industry journals,by The Plasma Proteins Market In The United States, the U.S. sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $8.1$10.5 billion in 20192022 and are expected to reach approximately $13.9exceed $20 billion in 2025 based upon an anticipated compounded annual growth rate of approximately 11%.5Table of Contentsserious infectionsSBI to less than one per year in each subject receiving IVIG. The secondary outcome was safety and included other pharmacokinetic (“PK”) data collection points including antibody titers for certain agents, including RSV antibody levels at various time points after infusion.BLA,Biologics License Application (“BLA”), exceed the requirement specified by FDA guidance of ≤ 1 SBIserious infection per patient-year.pathogen'spathogen’s specific measured baselines. The safety profile of ASCENIV is comparable to that of other immunoglobulins.ASCENIV™ASCENIV under an emergency United States Food and Drug Administration (“FDA”)FDA Investigational New Drug protocol.intendmay elect to evaluate ASCENIV for the treatment of RSV or other respiratory viral pathogens in immunocompromised patients.6Table of Contentshas seven sourceoperates a total of ten U.S.-based plasma collection facilities, in various stagesall of operations or development. Wewhich hold FDA licenses and are actively operatingcollecting source and collecting plasma athigh-titer RSV plasma. Currently, three source plasma collection facilities located in the U.S., two of which have an FDA license (of which one facility hasalso received approvals from MFDS andas well as FDA approval to implement a Hepatitis B immunization program), while a BLA for our third facility is pending FDA approval. In addition, we have four additional plasma collection facilities that are under various stages of construction and development.program. Source plasma that is collected from our FDA-licensed facilities provides us with a portion of ourthe blood plasma for the manufacture of our products and product candidates. After giving effect to the progress we made in 2020 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 or more plasma collection centers operating in the U.S. by 2024.products. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase, and market conditions at the time of sale. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products or product candidates are sold to third-party customers in the U.S. and other international locations where we are approved under supply agreements or in the open “spot” market.Acquisition Transaction with Biotest Pharmaceuticals CorporationOn June 6, 2017, we completed the acquisition of certain assets (the “Biotest Assets”) of the Therapy Business Unit (“BTBU”) of BPC Plasma, Inc. (formerly Biotest Pharmaceuticals Corporation (“BPC”), together with Biotest AG, “Biotest”), which included two FDA-licensed products, Nabi-HB and BIVIGAM, and the Boca Facility (the “Biotest Transaction”). Immediately following the acquisition, the Biotest Assets were contributed into ADMA BioManufacturing.Upon the completion of the Biotest Transaction, we gained control over the regulatory, quality, general operations and drug substance manufacturing process at the Boca Facility. In April 2018, we completed an FDA inspection and as a result of the inspection, our Boca Facility’s regulatory compliance status improved from Official Action Indicated (“OAI”) to Voluntary Action Indicated (“VAI”), allowing us to submit regulatory applications to the FDA for review. During the second quarter of 2019, we received FDA approval of the respective submissions for both ASCENIV and BIVIGAM, and the transfer of the BIVIGAM and Nabi-HB licenses from BPC to us was completed on July 2, 2019.specialized, targeted, plasma-derived therapeuticsspecialty biologics that are intended to extend and enhance the lives of individuals who are naturally or medically immune-compromised. The key elements of our strategy for achieving this goal are as follows:·BIVIGAMASCENIV and ASCENIVBIVIGAM for the treatment of patients with PI. Subject to the restrictions surrounding COVID-19, we planWe continue to enhance our recruiting initiatives and expand our existing specialty commercial sales force and commercial-facing organization to market ASCENIV and BIVIGAM and ASCENIV to appropriate sites of care including home healthcare infusion facilities, hospitals, physician offices/clinics and other specialty treatment and infusion center organizations. We also anticipate staffing our Company with additional personnel for patient support, medical affairs, quality assurance, quality control, inventory management, regulatory affairs, manufacturing, scientific affairs and third-party reimbursement. We currently use and may also usecontinue to partner with a network of national distributors to fulfill orders for BIVIGAMASCENIV and ASCENIV. We have implemented and continue to implement virtual customer engagement programs to adapt and change with the current restrictions in place due to COVID-19.BIVIGAM.7Table of Contents·Subject to the restrictions surrounding COVID-19, weWe plan to increase our marketing efforts and attend relevant virtual or in-person medical conferences during 2021,2024, raising awareness of the risks associated with Hepatitis B and the benefits and efficacy of Nabi-HB in its indicated populations. We have published and may continue to publish scientific data supporting the use of Nabi-HB in at-risk and appropriate patient populations.·planmay elect to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses. We believe that there may be other patient populations beyond PIDD that wouldcould potentially derive clinical benefit from ASCENIV, some of which may potentially be eligible for orphan status. We plan to leverage our previously conducted randomized, double-blind, placebo-controlled Phase II clinical trial evaluating RI-001, RI-002’s predecessor product candidate, in immune-compromised, RSV-infected patients to explore ASCENIV for the treatment of RSV or other potential respiratory viral pathogens.pathogens, as well as in other patient populations we may believe are appropriate.·Increasemanufacturing capacity,and ADMA BioCenters’ operating efficiencyefficiencies, yields and gross margins. During 2024, we plan to advance our biologic production yield enhancement initiative to capture additional IG production yields from our manufacturing process with the same quantities of starting raw material. These initiatives are subject to further evaluation, validation of commercial-scale production and requisite regulatory review. During 2021, we planreceived FDA approvals for our 4,400L expanded IVIG production scale, as well as our in-house fill-finish and related operations production line using our aseptic filling machine. In 2023, ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history. We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity as fewer batches will be needed to execute onsupport revenue goals. Our successful experience in ramping up BIVIGAM to this production scale over the capacity optimization efforts we putlast two years lends confidence to its ability to leverage these same processes for ASCENIV. We began to realize these benefits in place during 2020the fourth quarter of 2023.• increase the Boca Facility’s manufacturing capacity, operating efficiency and gross margins. We also plan to strengthenimprove efficiencies across our supply chain capabilitiesand production operations. In February 2024, we announced the successful initial use of our Artificial Intelligence (AI) program, named ADMAlytics. ADMAlytics combines AI and machine learning to potentially unlock efficiencies, improve and predict outcomes for production yields and provide more control and visibility for timing of commercial product releases. During 2020,operational processes. Recently, we successfully implemented several manufacturingproduced our first batch of ASCENIV utilizing this innovative ADMAlytics software to prospectively automate and realize efficiency improvements to plasma pooling during commercial manufacturing. We expect broad implementation of the new ADMAlytics capabilities will provide for rapid realization of efficiencies across our supply chain enhancements, includingand production operations.• purchase and installationongoing post-marketing clinical study of ASCENIV, which has successfully completed enrollment, may provide a new Vanrx SA25 Workcell aseptic filling machine. Both the capacitylabel expansion and fill finish projects are pending FDA approval, which is anticipatedopportunity to occur in the middle of 2021.include pediatric-aged PI patients as well as additional publications supporting product safety.··Develop and expand our plasma collection center network. We plan on As part of expanding our plasma collection network withproduct pipeline, we are looking to develop an S. pneumonia hyperimmune globulin. S. pneumonia is the goalpredominant cause of having 10 or more plasma collection facilities operatingcommunity-acquired pneumonia in the U.S. by 2024 to potentially bolster our long-term raw material supply, ranking as the ninth leading cause of overall mortality. We believe the strategic importance and prepare for production ramp-upunmet need are evident in both the prophylactic and growth to capitalizetherapeutic settings where documented anti-infective resistance is on the global growing IVIGrise. Annually, approximately one million U.S. adults contract pneumococcal pneumonia, resulting in 400,000 hospitalizations and source plasma markets, including obtaining FDA licenses for each new plasma collection centera 5-7% mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance. Despite vaccine availabilities, vaccine-naive and regulatory approvalimmune-compromised patient populations remain at risk and could potentially benefit from the immediately available neutralizing antibodies conferred with a hyperimmune globulin in additional jurisdictions.·newly secured, long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.Of these 250,000 people diagnosed with PIDD in the U.S.As reported by The Plasma Proteins Market In The United States 2022 and Marketing Research Bureau Inc., approximately 125,000 receive monthly infusions of IVIG and it is estimated that over 300,000 patients worldwide receive monthly IVIG infusions for PIDD. Industry reports indicateOctober 2022, the U.S. market for IG in 20192022 was $8.1$10.5 billion and is expected to grow to $13.9exceed $20 billion by 2025 based upon a compounded annual growth rate2030.·antibody deficiency and recurrent bacterial infections;·T-lymphocyte deficiency and opportunistic infections;·other lymphocyte defects causing opportunistic infections;·neutrophil defects causing immunodeficiency; and·complement deficiencies.ofin the severity and frequency of infections, prevention of chronic lung disease and prevention of enteroviral meningoencephalitis. Several immune globulin products have already been approved by the FDA.-– Background, Composition and Manufacturing·Red blood cells – Used to carry oxygen from the lungs to the body;·White blood cells – Used by the immune system to fight infection;·Platelets – Used for blood clotting; and·Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.9Table of ContentsFDA-approved,FDA-authorized, automated device with a sterile, self-contained collection kit. The plasma that is collected is known as “normal source plasma.” There are over 9001,000 plasma donation centers in the U.S. As noted in a variety of plasma industry trade reports and related conferences, approximately 4539 million liters of source plasma were collected in the U.S. in 2019.2021. In the U.S., a donor may donate plasma a maximum of two times during any seven-day period, with at least two days in between donations. Plasma donation centers in the U.S. typically pay donors $50 to $100 per donation and some donors with rare or high antibody levels can be paid more.10Table of Contentsin industry journals,by The Plasma Proteins Market In The United States 2022and Marketing Research Bureau Inc., October 2022, the U.S. sales of immune and hyperimmune globulin products for all its uses were reported to be approximately $8.1$10.5 billion in 2019,2022 and are expected to reach approximately $13.9exceed $20 billion in 2025 based upon an anticipated compounded annual growth rate of approximately 11%.2030. IVIG products are used to treat primary immune deficiencies, certain autoimmune diseases, and other illnesses for immune-compromised patients and certain neuropathy indications. New research and data, secondary immune deficiencies, additional labeled indications, an aging population and emerging countries with new markets are all adding to the worldwide demand and growth of IVIG utilization.10ten years. Source plasma is collected at any one of over 9001,000 FDA-licensed donation centers located throughout the U.S., using a process known as automated plasmapheresis. This sterile, self-contained, automated process separates red blood cells and other cellular components in the blood, which are then returned to the donor. Source plasma obtained by plasmapheresis is tested and must be negative for certain diseases, such as antibodies to human immunodeficiency virus types 1 and 2 (HIV-1/2), HBsAgHbsAg and Hepatitis C virus (“HCV”),HCV, using FDA-approved serological test procedures. This process is referred to as the Cohn method or cold ethanol method of fractionation. During cold ethanol fractionation, classes of proteins are precipitated and removed by centrifugation or filtration. The fractionation process includes the following steps; precipitation and absorption, depth filtration, centrifugation and chromatography. Because of the human origin of the raw material and the thousands of donations required in the fractionation process, a significant risk associated with plasma products is the transmission of blood-borne infectious pathogens. These purification processes have the potential to reduce the viral load. The manufacturing process also utilizes a multistep viral removal/inactivation system, which further increases the safety of the products. The following manufacturing processes have been validated for their capability to eliminate or inactivate viruses: precipitation during cold ethanol fractionation, solvent/detergent treatment and nanofiltration. We incorporate these processes into the manufacturing process, which ensures that our products comply with the requirements of the FDA and are safe and efficacious.as well asor through labeling,our own in-house fill-finish process, which was approved by the FDA in the second half of 2021. Labeling and packaging operations must further comply with regulatory requirements and DSCSAproducts must be labeled in accordance with their regulatory approval and Drug Supply Chain Security Act (“DSCSA”) serialization requirements. The end-to-end production cycle can take approximately nineseven to 12 months for a batch of FDA released drug product. DuringSince 2020, we have successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new Vanrx SA25 Workcell aseptic filling machine and the manufacturing of four conformance batches of BIVIGAM at an increased scale. These initiatives are designed to reduce operating costs, improve margins and provide for faster production cycle turnaround time, ultimately providing increased control and independence from third-party vendors and contractors. ADMA submitted the appropriate applications to the FDA during the fourth quarter of 2020 and upon FDA approval expects to begin benefitting from these initiatives as early as mid-2021.operates two FDA-licensedhas a total of ten source plasma collection facility locatedfacilities in its network, all of which are FDA-licensed, and should allow the U.S. which provides us with a portionCompany to be essentially self-sufficient for its raw material source plasma supply to produce its commercial IG product portfolio. Three of our bloodADMA BioCenters plasma collection facilities also have approvals from the South Korean MFDS and licensure from the FDA for the manufacturecollection and sale of our current products and product candidates. We also have a thirdHepatitis B hyperimmune plasma collection facility whereobtained from immunized donors. At the present time, we currently collect plasma for which a BLA is pending with the FDA. In addition, we have fourdo not plan to build additional plasma collection facilities that are under various stagesbeyond the existing ten, but we continue to have third-party supply contracts in place to augment our vertically integrated plasma collections.construction and development. After giving effect to the progress we made in 2020 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 or more plasma collection centers in operation by 2024. In addition, we intend to enter into additional third-party contracts to procure normal source and high-titer plasma.11Table of Contents with BPC, dated as of November 17, 2011 (the “2011 Plasma Purchase Agreement”), we have agreed to purchase from BPCour former contract manufacturer an annual minimum volume of source plasma containing antibodies to RSV to be used in the manufacture of ASCENIV. We must purchase a to-be-determined and agreed upon annual minimum volume from BPC, but maythe counterparty, and under the original 2011 Plasma Purchase Agreement we were permitted to also collect high-titer RSV plasma from up to five wholly-owned ADMA plasma collection facilities. During 2015, we amended the 2011 Plasma Purchase Agreement with BPC to (i) allow us the ability to collect our raw material RSV high-titer plasma from any number of wholly-owned ADMA plasma collection facilities and (ii) allow us to purchase our raw material RSV high-titer plasma from other third-party collection organizations, in each case, provided that the annual minimum volumes from our former contract manufacturer were met, thus allowing us to expand our reach for raw material supply as we execute our commercialization plans for ASCENIV. Unless terminated earlier, the 2011 Plasma Purchase Agreement expires in June 2027, after which it may be renewed for two additional five-year periods if agreed to by the parties. As part of the closing of the Biotest Transaction, we amended the 2011 Plasma Purchase Agreement to extend the initial term through the ten-year anniversary of the closing date of the Biotest Transaction. On December 10, 2018, BPCour former contract manufacturer assigned its rights and obligations under the 2011 Plasma Purchase Agreement to Grifols Worldwide Operations Limited (“Grifols”) as its successor-in-interest, effective January 1, 2019. On January 1, 2019, Grifols and ADMA entered into an additional amendment to the 2011 Plasma Purchase Agreement for the purchase of source plasma containing antibodies to RSV from Grifols. Pursuant to this amendment, until January 1, 2022, we may purchase RSV plasma from Grifols from the two previously-owned ADMA plasma collection facilities which we transferred to BPC on January 1, 2019 at a price equal to cost plus five percent (5%) (without any additional increase due to inflation).BPCour former contract manufacturer, pursuant to which BPCthe counterparty supplies, on an exclusive basis subject to certain exceptions, to ADMA BioManufacturing an annual minimum volume of hyperimmune plasma that contain antibodies to the hepatitisHepatitis B virus for the manufacture of Nabi-HB. The Plasma Supply Agreement has a 10-yearten-year term. On July 19, 2018, we entered into an amendment to the Plasma Supply Agreement with BPCwas amended to provide, among other things, that in the event BPCthe counterparty elects not to supply in excess of ADMA BioManufacturing’s specified amount of Hepatitis B plasma and ADMA BioManufacturing is unable to secure Hepatitis B plasma from a third party at a price which is within a low double digit percentage of the price which ADMA BioManufacturing pays to BPC,the counterparty, then BPCthe counterparty shall reimburse ADMA BioManufacturing for the difference in price ADMA BioManufacturing incurs. On December 10, 2018, BPCour former contract manufacturer assigned its rights and obligations under the Plasma Supply Agreement to Grifols, effective January 1, 2019.On June 6, 2017, we entered into a Plasma Purchase Agreement with BPC (the “2017 Plasma Purchase Agreement”), pursuant to which ADMA BioManufacturing purchases normal source plasma from BPC at agreed upon annual quantities and prices. The 2017 Plasma Purchase Agreement has an initial term of five years after which the 2017 Plasma Purchase Agreement may be renewed for two additional terms of two years each upon the mutual written consent of the parties. On July 19, 2018, we entered into an amendment to the 2017 Plasma Purchase Agreement with BPC to, among other things, provide agreed upon amounts of normal source plasma to be supplied by BPC to ADMA BioManufacturing in calendar year 2019 at a specified price per liter, provided that ADMA BioManufacturing delivers a valid purchase order to BPC. Additionally, pursuant to the amendment to the 2017 Plasma Purchase Agreement, BPC agrees that, for calendar years 2020 and 2021, it shall supply no less than a high double-digit percentage of ADMA BioManufacturing’s requested NSP amounts, provided that such requested normal source plasma amounts are within an agreed range, at a price per liter to be mutually determined. Furthermore, pursuant to the amendment to the 2017 Plasma Purchase Agreement, in the event BPC fails to supply ADMA BioManufacturing with at least a high double-digit percentage of ADMA BioManufacturing’s requested normal source plasma amounts, BPC shall promptly reimburse ADMA BioManufacturing the difference in price ADMA BioManufacturing incurs due to BPC’s election not to supply NSP to ADMA BioManufacturing in such amounts as requested. On December 10, 2018, BPC assigned its rights and obligations under the Plasma Purchase Agreement to Grifols, effective January 1, 2019. ASCENIV and Nabi-HB are sold primarily through independent distributors, drug wholesalers acting as sales agents, specialty pharmacies servicing both acute and ambulatory infusion centers and the home health infusion setting and other alternate site providers. In the U.S., independent distributors or third-party drug wholesalers ship our products through their distribution centers. These centers are generally stocked with adequate inventories to facilitate prompt customer service. Sales and distribution methods include frequent contact by sales and customer service representatives, automated communications via various electronic purchasing systems, circulation of catalogs and merchandising bulletins, direct-mail campaigns, trade publication presence and advertising.12Table of ContentsWe are in the process of expanding our current specialty sales force consisting of account managers, medical science liaisons and other normal and customary scientific, medical and detail representatives. Our management and Board of Directors (“Board”) have substantial prior direct marketing, sales and distribution experience with plasma-derived drugs, specialty immune globulins and other biological products. As is customary in the plasma products industry, we may also use a network of national distribution organizations that have specialty divisions that focus on plasma products to fulfill orders for ASCENIV.Subject to restrictions surrounding the COVID-19 pandemic, commercialization effortssmall, specialty sales force consisting of account managers, medical science liaisons and other customary scientific, medical and detail representatives to market BIVIGAM and ASCENIV to hospitals, physician offices/clinics, and other specialty treatment organizations as applicable. In addition, we have beenexpanded staffing our Companyefforts with additional personnel for patient support, medical affairs, quality assurance, regulatory affairs, scientific affairs, third-party reimbursement, inventory and logistics, human resources and financial and operational management. We may also use a network of national and regional distributors to assist with order fulfillment for BIVIGAM and ASCENIV for use by healthcare professionals and hospitalsJanuary 21, 2017,December 31, 2012, we granted to Biotest AG (“Biotest”) an exclusive license to market and sell RI-002ASCENIV in Europe and in selected countries in North Africa and the Middle East (the “Territory”), to have access to our testing services for testing of BPC’sBiotest’s plasma samples using our proprietary RSV assay, and to reference (but not access) our proprietary information for the purpose of Biotest seeking regulatory approval for the RI-002ASCENIV in the Territory. As consideration for the license, Biotest provided us with certain in-kind services at no charge and also compensated us with cash payments upon the completion of certain milestones. Biotest wasis also obligated to pay us an adjustable royalty based on a percentage of revenues from the sale of RI-002ASCENIV in the Territory for 20 years from the date of first commercial sale.Pharmaceutical Pricing and ReimbursementOur ProductsAll sales in the U.S. of BIVIGAM, ASCENIV and Nabi-HB depend in part upon the availability of reimbursement from third-party payers. Third-party payers include government health programs, managed care providers, private health insurers and other organizations. BIVIGAM and Nabi-HB are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D, the 340B/Public Health Service program, and pursuant to an existing contract with the Department of Veterans Affairs. Medicaid is a joint state and federal government health plan that provides covered outpatient prescription drugs for low-income individuals. Under Medicaid, drug manufacturers pay rebates to the states based on utilization data provided by the states. CMS has issued a permanent, product-specific-J-code for ASCENIV. Under the HCPCS, the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilized in the interim for reimbursement purposes.2020, three2023, two customers, BioCARE, Inc. (“BioCare”), Reliance Life Sciences Pvt Limited (“Reliance”) and Biolife Plasma Services, L.P. (“Biolife”), represented an aggregate of 82% of our consolidated revenues.As of December 31, 2020, three customers, BioCare, Reliance and Priority Healthcare Distribution, Inc. (“Curascript”), represented a totalan aggregate of 92%72% of our consolidated accounts receivable.U.S. basedU.S.-based and foreign producers of plasma products, some of which have lower cost structures, greater access to capital, greater resources for research and development, and more sophisticated marketing capabilities.Biologicals, Takeda, Octapharma Kedrion and BPL.Permira. There are four producers of plasma-derived products in the U.S. consisting of: CSL Behring, Grifols, Biologicals, Takeda and ADMA Biologics. In addition to competition from other large worldwide plasma productsproduct providers, we face competition in local areas from smaller entities. In Europe, where the industry is highly regulated and healthcare systems vary from country to country, local companies may have greater knowledge of local healthcare systems, more established infrastructures and existing regulatory approvals or a better understanding of the local regulatory process, allowing them to market their products more quickly. Moreover, plasma therapy generally faces competition from non-plasma products and other courses of treatments. For example, recombinant Factor VIII products compete with plasma-derived products in the treatment of Hemophilia A.13Table of Contents10,683,343,11,780,906, encompassing immunotherapeutic compositions and immunotherapeutic methods proprietary to us, also relate to ASCENIV. Corresponding foreign patents and patent applications also pertain to this technology.No. 10,259,856, issued in April 2019, pertainsNos. 10,259,865 and 11,084,870, each with a term through 2037, pertain to various aspects of this technology. Additional U.S. and numerous corresponding foreign patent applications also relate to this technology.patentpatents will be enforced or that our trade secret policies and practices or other agreements will adequately protect our intellectual property. We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. These processes, systems, and/or security measures may be breached, and we may not have adequate remedies as a result of any such breaches. Third parties may also own or could obtain patents that may require us to negotiate licenses to conduct our business, and there can be no assurance that the required licenses would be available on reasonable terms or at all. We have filed for other provisional patent applications with the U.S. which are pending related to expanded hyperimmune globulin products.Nabi-HB.Advantage Ig. We have spent considerable resources registering thethese trademarks and building brand awareness and equity of the ADMA Biologics trade name, which has been used in commerce since 2006. We expect to maintain and defend our various trademarks to the fullest extent possible.14Table of Contentscriminally prosecuted.debarred or excluded from participation in government healthcare programs. These requirements are continually evolving. We and our manufacturers may also be subject to regulations under other federal, state and local laws.In the U.S., the FDA regulates products under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and related regulations. The FDA's regulatory authority for the approval of biologics resides in the Public Health Service Act. However, biologics are also subject to regulation under the FDCA because most biological products also meet the FDCA’s definition of “drugs.” Most pharmaceuticals or “conventional drugs” consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps. In the U.S., the FDA regulates biologic products under the Federal Food, Drug and Cosmetic Act (the “FDCA”), the Public Health Service (“PHS”) Act and related federal regulations under Title 21 of the Code of Federal Regulations (“CFR”). The FDA also issues nonbinding guidance documents on a continuous basis, which provide the agency’s interpretation of its laws and regulations, as well as the FDA’s approach to scientific issues and questions. Biologics are also regulated under other federal, state, and local statutes and regulations by other regulatory authorities. The process required by the FDA before our product candidates may be marketed in the U.S. generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):·completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies performed in accordance with the FDA’s good laboratory practice regulations and other regulations;·submission to the FDA of an Investigational New Drug (“IND”) application which must become effective before clinical trials may begin;·performance of adequate and well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication;·manufacturing (through an FDA-approved facility) of product in accordance with good manufacturing practices (“cGMP”) to be used in the clinical trials and providing manufacturing information needed in regulatory filings;·submission of a BLA to the FDA;·satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with cGMP regulations and other applicable regulations; and·the FDA review and approval of a BLA prior to any commercial marketing, sale or shipment of the product.15Table of ContentsGood Laboratory Practices (“GLPs”),GLP and clinical trial plans, among other information, to the FDA as part of an IND application. Subject to certain exceptions, an IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, issues a clinical hold to delay a proposed clinical investigation due to concerns or questions about the product or the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during trials due to safety concerns or non-compliance.allowanceallowing us to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. The FDA must also approve certain changes to an existing IND, such as certain manufacturing changes. Further, an independent institutional review boardInstitutional Review Board (“IRB”) duly constituted to meet FDA requirements for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the safety of the study and study subjects until completed. Special clinical trial ethical considerations also must be taken into account if a study involves children. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical PracticeGCP requirements and regulations for informed consent and must be conducted with product meeting cGMPs.·Phase I clinical trials are initially conducted in a limited population to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients.·Phase II clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product candidate for specific targeted indications and to determine tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials.·Certain Phase III clinical trials are referred to as pivotal trials. When Phase II clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to provide substantial evidence of reproducibility of clinical efficacy results and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites. application or supplement for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the applicant has obtained a waiver or deferral. In 2012, the Food and Drug Administration Safety and Innovation Act amended the FDCA to require that a sponsor who is planning to submit such an application submit an initial Pediatric Study Plan (“PSP”iPSP”) within 60 days of an end-of-phase 2end-of-Phase II meeting or as may be agreed between the sponsor and the FDA. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers. The FDA and the sponsor must reach agreement on the PSP.studies.16Table of ContentsApplicationreviewshas agreed to specified performance goals in the review of BLAs under the PDUFA.submittedto determine if they are substantially complete before it accepts them for filingfiling. The FDA may refuse to file a BLA that it deems incomplete or not reviewable at the time of submission, in which case the BLA will have to be updated and resubmitted. The FDA may reject the filing as inadequate to merit review or mayalso request additional information to be submitted in a very short time frame before accepting a BLA for filing. Once a BLA is acceptedbegins an in-depthreviews the BLA to determine, among other things, whether the proposed product is safe, pure, and potent for its intended use, and whether the product is being manufactured in compliance with cGMP. During its review of a BLA, the application. FDA may refer the application for novel product candidates or products that present difficult questions to an advisory committee of experts for their review, evaluation and recommendation as to whether the application should be approved, which information is taken into consideration along with the FDA’s own review findings. The FDA’s PDUFA review goal is to review 90% of priority BLAs within six months of filing and 90% of standard applications within ten months of filing, but the FDA can and frequently does extend this review timeline to consider certain later-submitted information or information intended to clarify or supplement an initial submission. The FDA may not complete its review or approve a BLA within these established goal review times.During The FDA will not approve a product candidate unless cGMP compliance is satisfactory.a BLA,the application and after the inspection of the manufacturing facilities and clinical trial sites, the FDA may refer the application toissues either an advisory committee of experts for their review, evaluation and recommendation as to whether the application should be approved, which information is taken into consideration along with the FDA’s own review findings.The FDA may refuse to approve a BLA and issueapproval letter or a Complete Response Letter (“CRL”) if. A CRL generally outlines the applicable regulatory criteria are not satisfied ordeficiencies in the FDA has additional open questions for which it requires clarification. A CRLsubmission and may also require additional clinical or other data, including one or more additional pivotal Phase III clinical trials. Even if such requested data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval and issue a denial of the BLA. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue an approval letter; ifletter. If the evaluations are not favorable the FDA will issue a CRL, which may contain the conditions that must be met in order to secure final approval of the BLA. If a CRL is issued, a company has up to twelve12 months to resubmit or withdraw the BLA, unless the FDA allows for an extension as requested by a sponsor. If a CRL is issued, resubmissions for original applications and supplements of different types are subject to varying agency review procedures and review timing goals. For example, upon the resubmission of an original BLA application or efficacy supplement, CBER’s written Standard Operating Policy and Procedure (SOPP) 8405.1 states that itCBER will classify the resubmission as either Class 1 (triggering a two-month review goal for the FDA) or Class 2 (triggering a six-month review goal for the FDA) depending on the circumstances, and in this SOPPcircumstances. CBER stated goalalso includes specific goals for review of manufacturing and labeling supplement resubmissions for Prescription Drug User Fee Act (“PDUFA”) BLAs is (using the timeframes referencedsupplements, though in 21 C.F.R.§ 314.110(b)(1)(iii)) to review them within the same timeframe as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement) (for example, under the FDA’s published PDUFA goals for fiscal years 2018 – 2022, a goal of acting on 90% of manufacturing PASs within four months of receipt). In practice, FDA reviews may take longer than the stated goals.whichis needed, the sponsor of the BLA must submit a proposed REMS; the FDA will not approve the BLA without a REMS, if required. A REMS could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. Any of these limitations on approval or marketing can materially affect the potential market and profitability of the product. Theproduct.The FDA may also not approve label statements that are necessary for successful commercialization and marketing. Products may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label. The FDA does not allow drugs to be promoted for “off-label” uses – that is, uses that are not described in the product’s approved labeling and that differ from those that were approved by the FDA. Furthermore, the FDA generally limits approved uses to those studied in clinical trials. If there are any modifications to the product, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit for and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials, and/or require additional manufacturing data.17Table of Contentsseveralmany years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a product candidate is intended to treat a chronic disease, as was the case with ASCENIV, safety and efficacy data must be gathered over an extended period of time. Government regulation may delay or prevent marketing of product candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for any changes in dose form or new indications for a product candidate on a timely basis, or at all. Even if a product candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain, regulatory approvals for any of our product candidates would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.OtherBiological manufactured or distributed pursuant to FDA approvals are subject to extensive and continuing regulation by the FDA, including, among other things,which may impose a number of post-approval requirements relatedas a condition of approval of an application. For example, as a condition of approval of a BLA, the FDA may require post-marketing testing and surveillance to recordkeepingmonitor the product’s safety or efficacy. In addition, holders of an approved BLA are required to keep extensive records (including certain electronic recordrecords and signature requirements), periodic reporting, product samplingsubmit annual reports, report certain adverse reactions and distribution,production problems to the FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and promotion and reporting of certain adverse experiences, deviations, and other problems with the product.promotional labeling for their products. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are annual user fee requirements for any marketed products, as well as new application fees for supplemental applications with clinical data.Manufacturers must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.Manufacturers and certain other entities involved in the manufacturing and distribution of approved products are required to register their establishments with the FDA and certain state agencies, list the manufactured products, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. The cGMP requirements apply to all stages of the manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the product. Manufacturers must establish validated systems to ensure that products meet specifications and regulatory standards, and test each product batch or lot prior to its release. Recently, the information that must be submitted to FDA regarding manufactured products was expanded through the Coronavirus Aid, Relief, and Economic Security (“CARES)” Act to include the volume of drugs produced during the prior year. For biologics products in particular, for each product lot the applicant must submit materials related to that lot to the FDA before the lot can be released for distribution.Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.The FDA may impose a number of post-approval requirements as a condition of approval of an application. The FDA may withdraw a product approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, problems with manufacturing processes or failure to comply with regulatory requirements, may result in restrictions on the product or even complete withdrawal of the product from the market. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as refusal to approve pending applications, license suspension or revocation, withdrawal of approval of a BLA, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, suspension of manufacturing, sales or use, seizure of product seizures or recalls, import restrictions, injunctive action or possible fines and other penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If we or our present or future third-party manufacturers or suppliers are not ablethesecGMP requirements, which are extensive and require considerable time, resources and ongoing investment to ensure compliance. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval. Certain manufacturing deviations and unexpected manufacturing events must be investigated, corrected, and reported to the FDA.may halt our clinical trials, require usand certain state agencies, list the manufactured products to recall a product from distribution,the FDA, and are subject to periodic unannounced inspections or withdraw approvalremote regulatory assessments by the FDA and certain state agencies for compliance with cGMP and other laws. The cGMP requirements apply to all stages of our BLA forthe manufacturing process, including the production, processing, sterilization, packaging, labeling, storage and shipment of the product. Manufacturers must establish validated systems to ensure that product.18Table of ContentsThe FDA closely regulates the post-approval marketingproducts meet specifications and promotion of products, includingregulatory standards and test each product batch or lot prior to its release. The information that must be submitted to FDA regarding manufactured products was expanded through the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to include the volume of drugs produced during the prior year. For biologics products subject to lot release, for each product lot the applicant must submit materials related to that lot to the FDA prior to that lot being released for distribution.for direct-to-consumer advertising, off-label promotion, industry-sponsored scientificalso require investigation and educational activitiescorrection of any deviations from cGMP and promotional activities involvingimpose reporting and documentation requirements upon the Internet. A company can make only those claims relatingsponsor and any third-party manufacturers that the sponsor may decide to safetyuse. Accordingly, manufacturers must continue to expend time, money, and efficacy that are approved by the FDA. Failureeffort towards production and quality control to comply with these requirements can result in adverse publicity, warning and/or other regulatory letters, corrective advertising and potential major fines and other penalties. Drug Supply Chain Security Act (“DSCSA”),(“PDMA”“PDMA”). Trading partners within the drug supply chain must now ensure certain product tracing requirements are met and are required to exchange transactioncertain transaction-related information transaction history,in an electronic, and, transaction statements.as of November 2023, an interoperable form. Further, the DSCSA limits the distribution of prescription pharmaceutical products and imposes requirements to ensure overall accountability and security in the drug supply chain.chain, including requirements related to the detection and investigation of suspect and illegitimate products. The distribution of product samples continues to be regulated under the PDMA.business and our product candidates.business. It is impossible especially in light of the recent change to the U.S. administration, to predict whether further legislative or FDA regulation or other regulatory policy changes will be enacted or implemented and what the impact of such changes, if any, may be. It is possible that certain prior regulatory requirements may be postponed or frozen.undergo pre-licensureobtain BLA approval prior to distribution of any product. The approval of the BLA requires passage of an FDA inspection. ADMA BioCenters has completed these requirements and holds an FDA license for all ten of its existing plasma collection facility.facilities for source plasma. In order to maintain an FDA license, under FDA guidance each such facility operated by ADMA BioCenters will be inspected within the first year of operations and then at least every two years and must meet certain regulatory requirements. ADMA BioCenters is also required to submit annual reports to the FDA. of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.19Table of ContentsProduct Coverage,product candidatescurrent products may not be considered medically necessary or cost-effective. If third-party payers do not consider a product to be cost-effective compared to other available therapies, they may not cover the product after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit.By further example, on November 27, 2020, CMS issued an interim final rule implementing a Most Favored Nation payment model under which reimbursement for certain Medicare Part B drugs and biologicals willWe have addressed additional reforms related to government pricing programs that could be based on a price that reflects the lowest per capita Gross Domestic Product-adjusted (GDP-adjusted) price of any non-U.S. member country of the Organisation for Economic Co-operation and Development (OECD) with a GDP per capita that is at least sixty percent of the U.S. GDP per capita.relevant to our products below. These and any additional healthcare reform measures could further constrain our business or limit the amounts that federal and state governments will pay for healthcare products and services, which could result in additional pricing pressures. Adoption of government controls and measures and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals.an increasingthe emphasis on cost containment measures in the U.S. has increased and we expect will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.Federallaws also require manufacturers to calculate and report complex pricing metrics used to determine prescription rebates, ceiling prices charged, and provider reimbursementobligations under, the Medicaid Drug Rebate Program, state Medicaid supplemental rebate program(s), and other governmental pricing programs. For calendar quarters beginning January 1, 2022, manufacturers will be required to report the average sales price for certain drugs under the Medicare Partsprogram regardless of whether the manufacturer participates in the Medicaid Drug Rebate Program. Previously, this reporting obligation extended only to manufacturers participating in the Medicaid Drug Rebate Program. Under this Program, manufacturers are required to pay a rebate to each state Medicaid program for covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for their drugs under Medicaid and Part B of the Medicare program.D,quarterly basis to the Veterans Healthcare ActCMS, the federal agency that administers the Medicaid and Medicare programs. This data includes the average manufacturer price and, in the case of innovator products, the best price for each drug, which, in general, represents the lowest price available from the manufacturer to any entity in the U.S. in any pricing structure, calculated to include all sales and associated rebates, discounts, and other price concessions. The amount of the rebate is adjusted upward if the average manufacturer price increases more than inflation (measured by reference to the Consumer Price Index–- Urban). Currently, the rebate is capped at 100% of the average manufacturer price, but, effective January 1, 2024, this cap on the rebate will be removed, and our rebate liability could increase accordingly. Variousprograms similarly obligate usprograms. For these reasons, since 2004, False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth, leading to reportseveral substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and promoting off label uses.that is used as the basis for their reimbursement of pharmacieswhich requires tracking price increases and gifts and other remuneration and items of value provided to healthcare professionals and entities. In addition, some jurisdictions have laws requiring pharmaceutical sales representatives to be registered or licensed, and still others impose limits on co-pay assistance that pharmaceutical companies can offer to patients.negotiationcost of supplemental rebates. Paymentavailable tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to, but less prescriptive than, what is required by the HIPAA Security Rule. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.manufacturer’s drugsbreach of personal information. Some state laws impose significant data security requirements, such as encryption, to ensure ongoing protection of personal information. Additionally, in California, the California Consumer Privacy Act (“CCPA”) establishes certain requirements for data use and sharing transparency and creates new data privacy rights for California residents. The CCPA and its implementing regulations have already been amended multiple times since their enactment. In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot initiative, which introduced significant amendments to the CCPA and established and funded a dedicated California privacy regulator, the California Privacy Protection Agency (“CPPA”). The amendments introduced by these programs is conditionedthe CPRA became effective on submission of this pricing information. Recently, the Part D Medicare coverage gap rebate manufacturer percentage increased to 70%. Rebates under these programs can also increase when commercial prices increase.January 1, 2023. Failure to comply with the rules for calculating and submitting pricing information or otherwise overcharging the government or its beneficiariesCCPA may result in, criminal,among other things, significant civil penalties and injunctive relief, or administrative sanctionsstatutory or actual damages. In addition, California residents have the right to bring a private right of action in connection with certain types of security incidents. These claims may result in significant liability and damages. Virginia, Colorado, Connecticut and Utah have also enacted privacy laws that became effective in 2023 and are similar in many respects to the CCPA.actions,for non-compliance. For example, the European Union’s General Data Protection Regulation (“GDPR”), which imposes fines of up to EUR 20 million or 4% of the annual global revenue of a noncompliant company, whichever is greater, and expose usother data protection, privacy and similar national, state/provincial and local laws may also restrict the access, use and disclosure of patient health information abroad. We may be required to U.S. False Claims Act,expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers, or to alleviate problems caused by such breaches. Compliance with these laws is difficult, constantly evolving, time consuming, and requires a flexible privacy framework and substantial resources. Compliance efforts will likely be an increasing and substantial cost in the False Claims Act, liability.20Table of Contents2020,2023, we had a total of 407624 employees, comprisedall of 406 full-time employees and one part-time employee.whom are full-time. Over the course of the next year, we anticipate hiring additional full-time employees devoted to compliance, production, quality assurance, quality control, plasma collection and processing, sales and marketing, medical and scientific affairs general and administrative,administration, as well as hiring additional staff as part of the build-out offor our plasma collection centers as appropriate. We intend to use Clinical Research Organizations (“CROs”), third parties and consultants to perform our post-marketing commitment clinical studies and manufacturing, regulatory affairsother process and/or analytical development projects to augment our in-house capabilities and quality control services in addition to corporate marketing, branding and commercialization activities.Plasma Biologics,BioManufacturing, ADMA BioManufacturingBioCenters and ADMA BioCenters.Plasma Biologics. ADMA BioManufacturing was formed in January 2017 to facilitate the acquisition of BTBU.certain assets held by the Company’s then-third-party contract manufacturer. ADMA BioCenters is the Company’s source plasma collection business which operates in the U.S. Each of ADMA’s ten operational ADMA plasma collection center, once approved, willcenters have a license with the FDA and may obtain additional certifications from other regulatory agencies.SEC'sSEC’s website at www.sec.gov.Item 1A. Risk Factors·To date, we have generated limited product revenues, have a history of losses and will need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.·Our auditor’s report contains a going concern statement.·We are currently not profitable and may never become profitable.·The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, and could have a material adverse impact on our business, liquidity, financial condition and results of operations, as well as a change to the overall market size and potential for our products.· We contract with third parties for the filling, packaging, testing and labeling of the drug substance we manufacture. This reliance on third parties carries the risk that the services upon which we rely may not be performed in a timely manner or according to our specifications, which could delay the availability of our finished drug product and could adversely affect our commercialization efforts and our revenues.21Table of Contents·The estimates of market opportunity and forecasts of market and revenue growth included in our filings may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.·Both of our business segments and our facilities are subject to periodic inspections by the FDA, which, depending on the outcome of such inspection, could result in certain FDA actions, including the issuance of observations, notices, citations or warning letters.·Business interruptions could adversely affect our business.·If we are unsuccessful in obtaining regulatory approval for any of our product candidates or if any of our product candidates do not provide positive results, we may be required to delay or abandon development of such product, which would have a material adverse impact on our business.·If the results of our clinical trials do not support our product candidate claims, completing the development of such product candidate may be significantly delayed or we may be forced to abandon development of such product candidate altogether.·If we do not obtain and maintain the necessary U.S. or international regulatory approvals to commercialize a product candidate, we will not be able to sell that product candidate, which would make it difficult for us to recover the costs of researching and developing such product candidate.·Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, our ability to market or seek approval for ASCENIV for alternative indications could be limited and FDA could require clinical trials beyond what we may deem to be reasonable. Unless additional clinical trials are successfully conducted and the FDA approves a BLA or other required submission for review, we may not be authorized to market ASCENIV for any other indication.·With the approval to market ASCENIV, BIVIGAM and Nabi-HB, there can be no assurance that we will be successful in developing and expanding commercial operations or balancing our research and development activities with our commercialization activities.·We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials or test products and product candidates, and such parties are outside of our control.·We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA.·Our products, and any additional products for which we may obtain marketing approval in the future, could be subject to post-marketing restrictions or withdrawal from the market and we could be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products following approval.·Historically, a few customers have accounted for a significant amount of our total revenue and accounts receivable and the loss of any of these customers could have a material adverse effect on our business, results of operations and financial condition.·Issues with product quality and compliance could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.·If physicians, payers and patients do not accept and use our current products or our future product candidates, our ability to generate revenue from these products will be materially impaired.·Our long-term success may depend on our ability to supplement our existing product portfolio through new product development or the in-license or acquisition of other new products, product candidates and label expansion of existing products, and if our business development efforts are not successful, our ability to achieve profitability may be adversely impacted.·Our ADMA BioCenters operations collect information from donors in the U.S. that subjects us to consumer and health privacy laws, which could create enforcement and litigation exposure if we fail to meet their requirements.22Table of Contents·The Perceptive Credit Facility is subject to acceleration in specified circumstances, which may result in Perceptive taking possession and disposing of any collateral.·If we are unable to protect our patents, trade secrets or other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged.·Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation.·Our ability to continue to produce safe and effective products depends on the safety of our plasma supply, testing by third parties and the timing of receiving the testing results, and manufacturing processes against transmittable diseases.·We could become supply-constrained and our financial performance would suffer if we cannot obtain adequate quantities of FDA-approved source plasma with proper specifications or other necessary raw materials.·We require additional funding and may be unable to raise capital in the future, which would force us to delay, curtail or eliminate one or more of our research and development programs or potentially modify our ongoing operations, commercialization efforts and expansion plans, as well as impact the overall business plan for the organization.·The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance. have generated limited product revenues, have a history of losses and will needhave historically needed to raise, and in the future may be required to raise, additional capital to operate our business, which may not be available on favorable terms, if at all.Prior to the second half of 2019, we generated a substantial portion of our revenues from the sale of plasma by our plasma collection facilities. Following completion of the Biotest Transaction in June 2017, we began generating revenues from the sale of our plasma-derived immune globulins which include: BIVIGAM, ASCENIV, Nabi-HB, intermediate fractions and the contract manufacturing of plasma-derived products for a third-party. On May 9, 2019 we received approval from the FDA for BIVIGAM, and we commenced commercial sales of this product in August 2019. On April 1, 2019, the FDA approved ASCENIV, formerly referred to as RI-002, and the first commercial sales of this product took place in October 2019. In October 2019, we generated initial sales of our plasma-derived intermediate fractions.provide more control and visibility for timing of commercial product releases, raise additional capital, fund and successfully implement our research and development and commercial programs, establish andcontinue to build out a commercial sales force, medical affairs organization andour commercial infrastructure and meet our ongoing obligations. In addition, our end-to-end production cycle from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials.23Table of Contentsas well as the additional proceeds we expect to receive in connection with sales of our common stock pursuant to the Sale Agreement (as amended to date), that our current cash, cash equivalents and accounts receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, intoas currently conducted, through the fourthend of the first quarter of 2021. This time framefiscal 2025. However, our current outlook on cash flows and profitability may change based upon how quickly we are able to execute on our commercialization efforts and operational initiatives. However, ifinitiatives and whether or not the assumptions underlying our estimatedprojected revenues and expenses prove toare correct. Although we achieved net income on a non-GAAP basis (see “Non-GAAP Financial Measures” within Management’s Discussion and Analysis of Financial Condition and Results of Operations) and positive cash flow from operations for the first time in our history for the year ended December 31, 2023, at present we cannot be incorrect, we may have to raise additional capital sooner than we currently expect. We anticipatecertain that we will not be able to generate a sufficient amount of product revenue to achievemaintain profitability until the beginning ofthrough 2024 and as a result, we anticipate that we will need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing arrangements.beyond. If we are unable to generate sufficient positive cash flow throughout 2024 and cannot raise additional capital asif needed, we willmay have to delay, curtail or eliminate our commercialization efforts as well asand product development activities. Even if we are able to raise additional capital, such equity or debt financings may only be available on unattractive terms, resulting in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of our common stock may decline. In addition, if we raise additional funds through license arrangements or through the disposition of any of our assets, it may be necessary to relinquish potentially valuable rights to our product candidates or assets or grant licenses on terms that are not favorable to us.In addition, the auditor’s report on our financial statements for the year ended December 31, 2020 includes a going concern paragraph. To date, our products have not generated significant revenue. As a result, we have suffered recurring losses and require significant additional cash resources to execute our business plan. These losses are expected to continue for an extended period of time. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date of filing this Annual Report on Form 10-K. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern within one year after the date the financial statements are issued.We recognize that we will need to raise additional capital in order to continue to execute our business plan in the future. and private offerings of our common stock.stock and debt transactions. The actual amount of additional cash that we willmay need, if any, is subject to many factors. There can be no assurances that additional financing will be available whenif needed or that management will be able to obtain financing on terms acceptable to us or that we will becomecontinue to be profitable and generate positive operating cash flow. If we are unableraise sufficient additional funds, we will have to scale back our operations.We are currently not profitableachieve profitability in 2024 and may never become profitable.and expect to incur substantial losses and negative operating cash flows into fiscal 2022,through December 31, 2023, and we may nevernot be able to achieve or maintain profitability. For the years ended December 31, 20202023, 2022 and 2019,2021, we incurred net losses of $75.7$28.2 million, $65.9 million and $48.3$71.6 million, respectively. From our inception in 2004 through December 31, 2020,2023, we have incurred an accumulated deficit of $340.5$506.3 million. We expect that we willmay not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning ofthroughout 2024, and as a result,if we expect thatare unable to continue to generate positive cash flow we willmay need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements. We also expect to continue to incur significant operating and capital expenditures and anticipate that as our business continues to grow our operating expenses will increase substantially inaccordingly as we:foreseeable future as we:·expand commercialization and marketing efforts;·implement additional internal systems, controls and infrastructure;·hire additional personnel;·expand and build out our plasma center network; and·expand production capacity at the Boca Facility.24Table of Contentsachieve and maintain profitability. We may not be able to generate these revenues or achievemaintain profitability in the future. These factors raise substantial doubt about our ability to continue asgoing concern. Our failure to achieve or maintain profitability could negatively impact the valueresurgence of our securities.The COVID-19 pandemic and efforts to reduce its spread has significantly affected worldwide economic conditions, and could have a material adverse impact on our business, liquidity, financial condition and results of operationsThe COVID-19 pandemic has the potential to adversely impact several aspects of each of our business segments, our commercial manufacturing operations and plasma collection facilities, including but not limited to potential disruptions to our supply-chain operations, including procurement of raw materials and packaging materials, a portion of which are sourced internationally, and the testing of finished drug product that is required prior to its availability for commercial sale. Such testing has historically been performed by contract laboratories outside the United States. While we do not believe that the COVID-19 pandemic has significantly affected operations and immunoglobulin production at our Boca Facility or our ADMA BioCenters plasma collection operations at this time, we may experience adverse effects in the future, particularly in light of the recent increase in COVID-19 cases in the State of Florida. For example, our employees becoming ill, the imposition of additional mandatory remote working environments and federal, state and local responses to the pandemic could materially affect the efficiency and pace of our operations and manufacturing at our Boca Facility. Employee or donor illness, if not properly managed, could also impact the quality of our products and product candidates. In addition, travel and other restrictions that have been implemented in the United States could impact our commercial efforts with respect to any of our products, including BIVIGAM and ASCENIV, as trade shows, industry and medical conferences and other events we had been planning to utilize and exhibit and attend with our staff to increase awareness of our products by physicians and payers are subject to limitations, rescheduling or outright cancellation in response to the pandemic. Also, due to previous state and local “shelter-in-place” orders, as well as ongoing requirements around physical and social distancing, we have experienced, and may experience in the future, lower than expected donor collections at our FDA-licensed plasma collection centers. We were also subject to delays in shipments of source plasma from our contracted third-party suppliers, as well as delays in deliveries or price increases for personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture and distribution of our products. We have also experienced supply chain delays as a result of significant resources being diverted towards the rapid development and distribution of COVID-19 vaccines.In the future we may continue to experience pandemic related challenges with respect to obtaining and manufacturing a sufficient amount of supplies, raw materials, and finished product to meet our need for commercial and clinical product supply. If we or any of our suppliers or manufacturers are adversely impacted by the pandemic or the restrictions resulting from the outbreak, if they or we cannot obtain the necessary supplies, or if third parties need to prioritize other products or customers over us, including under the Defense Production Act, we may experience future delays or disruptions in our supply chain, which could have a material and adverse impact on our business. Moreover, we, our suppliers, and any third-party manufacturers may also need to implement measures and changes, or deviate from typical requirements, because of the pandemic that may otherwise adversely impact our supply chains or the quality of the resulting products or supplies. Depending on the change, we may need to obtain FDA pre-approval or otherwise provide FDA with a notification of the change.To the extent that we or our partners are conducting clinical trials, the pandemic could cause delays or disruptions in these or future development programs. By example, the pandemic, may result in slower enrollment, the need to suspend enrollment into studies, patient withdrawals, postponement of planned clinical or preclinical studies, redirection of site resources from studies, study modification, suspension, or termination, the introduction of remote study procedures and modified informed consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state licensing, study deviations or noncompliance, and changes or delays in site monitoring. The foregoing may require that we consult with relevant review and ethics committees, IRBs, and the FDA. The foregoing may also impact the integrity of our study data. The effects of the COVID-19 pandemic may also increase the need for clinical trial patient monitoring and regulatory reporting of adverse effects. The pandemic could further impact our ability to interact with the FDA or other regulatory authorities and may result in delays in the conduct of inspections or review of pending applications or submissions. Due to the potential impact of the COVID-19 outbreak on clinical trials, drug development, and manufacturing, FDA issued a number of guidances specifically concerning COVID-19, including guidances with respect to blood and blood components. FDA’s guidance is continually evolving.25Table of ContentsSince the onset of the COVID-19 pandemic, there has been a noticeable decline in certain medical prescriptions attributed to lower incident rates for illnesses, fewer RSV, influenza and other respiratory viral pathogen-infected patients, hospital admissions and a reduction in doctor visits. In addition, physical and social distancing guidelines issued by public health authorities and the resulting global changes in human behavior have resulted in an observed reduction in infection transmission rates and spread of bacterial and viral infections, resulting in lower rates of infection across all patient populations, which, if continued, could potentially negatively impact the use of our IVIG products by patients.The COVID-19 pandemic may also result in changes in laws and regulations. By example, in March 2020, the U.S. Congress passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which includes various provisions regarding FDA drug shortage reporting requirements, as well as provisions regarding supply chain security, such as risk management plan requirements, and the promotion of supply chain redundancy and domestic manufacturing. This and any future changes in law may require that we change our internal processes and procedures to ensure continued compliance.The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, operations, or financial condition, or on healthcare systems or the global economy as a whole. Although the COVID-19 pandemic has not adversely affected our capital and financial resources to date, the pandemic’s effects could have a material impact on our ability to access the capital markets as needed and on our operations and business, including those of the third parties on which we rely. Because we are unable to determine the ultimate severity or duration of the pandemic or its effects on, among other things, the global, national or local economies, the capital and credit markets, our workforce, our customers or our suppliers, at this time we are unable to predict whether COVID-19 will have a material adverse impact onaffect our business, financial condition, liquidity andor results of operations.manufacture.manufacture, and also obtain plasma from certain third parties. This reliance on third parties carries the risk that the services upon which we rely may not be performed in a timely manner, in sufficient quantities or according to our specifications, which could delay the availability of our finished drug product and could adversely affect our commercialization efforts and our revenues.Third-party fill/finish providersfill/finishthird-party providers experience could delay or interrupt our supply of finished drug product until the service provider cures the problem or until we locate, negotiate for, validate and receive FDA approval for an alternative provider (when necessary), if one is available. Failure to obtain the needed fill/finish services and products meeting the necessary quality standards or at all could have a material and adverse effect on our products, business, financial condition and results from operations.have builtare utilizing our ownFDA-approved fill/finish suite withinthat we built at the Boca Facility for a portion of our finished drug product and although we receive our raw material plasma from our ADMA BioCenters plasma collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug substance. In addition,product and to supply raw material source and high-titer RSV plasma. Any failure by us, our recently completedcontract fill/finish suite has yetfinishers, or other third parties involved in the process for producing our products or product candidates to be validatedcomply with the applicable manufacturing and approved by the FDA. regulatory requirements, including quality requirements, could place us and them at risk of regulatory enforcement actions, recalls and other adverse consequences, could adversely impact our products, and could adversely impact patients receiving our products, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs.·we may be unable to identify contract fill/finishers on acceptable terms or at all because the number of potential service providers is limited and the FDA must inspect and qualify any contract manufacturers for current cGMP compliance as part of our marketing application;·a new fill/finisher would have to be educated in, or develop substantially equivalent processes for, the production of our products and product candidates;·the COVID-19 pandemic could adversely affect our contracted fill/finishers’ operations, supply chain or workforce;26Table of Contents·our contracted fill/finishers’ resources and level of expertise with plasma-derived biologics may be limited, and therefore they may require a significant amount of support from us in order to implement and maintain the infrastructure and processes required to deliver our finished drug product;·our third-party fill/finishers might be unable to timely provide finished drug product in sufficient quantity to meet our commercial needs;·contract manufacturers may not be able to execute our inspection procedures and required tests appropriately;·contract manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations, and we do not have control over third-party providers’ compliance with these regulations;·our third-party fill-finishers could breach or terminate their agreements with us; and·our contract fill/finishers may have unacceptable or inconsistent drug product quality success rates and yields, and we have no direct control over our contract fill/finishers’ ability to maintain adequate quality control, quality assurance and qualified personnel.the commercialization of our products.revenues. These risks could also result in the delay in obtaining clinical supply,supplies, which would delay our development programs. In addition, our contract fill/finishers and our other third-party vendors may source their materials and supplies globally and are therefore subject to supply disruptions in the event of fire, weather related events such as hurricanes, wind and rain, international conflicts, trade and sanction requirements and limits, other acts of God or force majeure events or global health occurrences and emergencies, including the COVID-19 pandemic.accurate, including as a result of changing circumstances during the ongoing COVID-19 pandemic.accurate. In particular, the size and growth of the overall U.S. IVIG and source plasma markets and the potential market opportunity for an S. pneumonia hyperimmune globulin are subject to significant variables that can be difficult to measure, estimate or quantify. Our business depends on, among other things, successful commercialization of our existing products, market acceptance of such products and ensuring that our products are safe and effective. Further, there can be no assurance that we will be able to generate the revenue that we believe our products and plasma collection facilities are capable of generating. As a result, we may not be able to accurately forecast or predict revenue. For these reasons, the estimates and forecasts in our filings relating to revenue generation and growth may prove to be inaccurate. Even if the markets in which we compete meet our size estimates and forecasted growth, our business could fail to grow at similar rates, if at all.inspection,inspections, could result in certain FDAregulatory actions, including the issuance of observations, notices, citations or warning letters.isand other regulatory authorities are authorized to perform inspections and remote regulatory assessments of our and our suppliers’ facilities, including the Boca Facility. The FDA and other regulatory authorities also mustmay inspect and approve our and our third-parties’ facilities before they may be used for commercial production. AtIf we or our suppliers are not able to comply with the applicable regulatory requirements, we or they may be subject to regulatory enforcement actions, which can materially impact our business. For instance, at the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause the FDA to not approve the use of the facility and cause us to modify certain activities identified during the inspection and may not approve the use of the facility.inspection. Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations that do not meet the threshold of regulatory significance of a warning letter. FDA guidelines also provide for the issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. FDA also may issue warning letters and untitled letters in connection with events or circumstances unrelated to an FDA inspection.27Table of ContentsFDAapplicable regulator as a result of an inspection or without expending significant resources. We are unable to control the timing of FDA inspections, responses, meeting requests, teleconference requests, requests for clarificationscommunications and similar regulatory communications, as well asactions, and will be required to respond to the regulator and make certain submissions within certain timeframes. We also do not know whether or not the FDAregulator will change its requirements, guidance or expectations. If the FDAregulator determines that we have not remediated the issues identified in a warning letter or any other inspection issues and deficiencies, any failure of ours to address or provide requested documentation of corrections for these issues could disrupt our business operations and the timing of our commercialization efforts and could have a material adverse effect on our financial condition and operating results.materials and wastes.materials. We cannot eliminate the risk of contamination or injury from these materials, which could cause an interruption ofto our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized internally and by our third-party manufacturers and service providers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our commercial manufacturing, research and development, or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties, or other sanctions.28Table of Contentsuncertain.Humanuncertain.Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming. Furthermore, delays or setbacks can occur at any stage of the process, and we could encounter problems that cause us to abandon our product development programs and related INDs or BLAs, or to repeat clinical trials. The evolving COVID-19 pandemic may directly or indirectly affect the pace of enrollment in clinical trials as patients may be restricted in traveling to and accessing healthcare facilities and physicians’ offices. Additionally, such healthcare facilities and offices have their limited resources directed towards treating patients with COVID-19 symptoms. The commencement and completion of clinical trials or ultimate product approval for any current or future development product candidate may be delayed by several factors, including:·unforeseen safety issues;·determination of dosing issues;·lack of effectiveness during clinical trials;·slower than expected rates of patient recruitment;·inability to monitor patients adequately during or after treatment·inability or unwillingness of medical investigators to follow our clinical protocols; and·temporary suspension resulting from the COVID-19 pandemic.3)III) be demonstrated in two adequate and well-controlled clinical trials. However, if the FDA or an equivalent foreign regulatory authority determines that our Phase 3III clinical trial results do not demonstrate a statistically significant, clinically meaningful benefit with an acceptable safety profile, or if a relevant regulator requires us to conduct additional Phase 3III clinical trials in order to gain approval, we will incur significant additional development costs and commercialization of these products would be prevented or delayed and our business wouldcould be adversely affected.independent institutional review boardIRB may not permit us to commence a clinical trial, may require amendments to our clinical trial protocols, or may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA or IRB finds deficiencies in our IND submissions or the conduct of these trials. Regulatory authorities may also not accept data from clinical trials if the trials are not conducted in accordance with the applicable regulatory requirements. Failure to comply with the applicable regulatory requirements may also result in enforcement actions. Therefore, we cannot provide any assurance or predict with certainty the schedule for future clinical trials. In the event we do not ultimately receive regulatory approval for our product candidates, we may be required to terminate development of such product candidates. If we fail to obtain regulatory approval to market and sell our product candidates, or if approval is delayed, we will be unable to generate revenue from the sale of these products, our potential for generating positive cash flow will be diminished and the capital necessary to fund our operations will increase.29Table of Contents·We may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and our CROs;·Regulators may require us to perform additional or unanticipated clinical trials to obtain approval or we may be subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval;·Our third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;·The cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by FDA upon the filing of a marketing application;·The supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;·We may not be able to achieve sufficient study enrollment, subjects may drop out or be withdrawn from out studies, we may have delays in adding new investigators or clinical trial sites, or we may experience a withdrawal of clinical trial sites;·There may be flaws in our clinical trial design that are not discoverable until the clinical trial has progressed;·The FDA or comparable foreign regulatory authorities may disagree with our intended indications or study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials, may find that a product candidate’s benefits do not outweigh its safety risks, or may require that we conduct additional development or study work;·The FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or our contract manufacturer’s manufacturing facility for clinical and future commercial supplies;·We may need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected;·Global trade policies that may impact our or our manufacturers’ ability to obtain raw materials and/or finished product for commercialization;·FDA or comparable regulatory authorities may take longer than we anticipate to make decisions on our products or product candidates; and·We may not be able to demonstrate that a product or product candidate provides an advantage over current standards of care or current or future competitive therapies in development.30Table of Contents be able to generate revenue from our products and product candidates, our sources of revenue may continue to be from a product mix consisting only of plasma collection and sales revenues, revenues generated from sales of our FDA-approved commercial products, revenues generated from ongoingnew contract manufacturing forarrangements with third parties and revenues generated from the sales of manufacturing intermediates. We cannot assure you that we will receive the approvals necessary to commercialize any product candidate we may acquire or develop in the future.future or that we will be able to maintain our current approvals. In order to obtain FDA approval of any product candidate requiring FDA approval, our clinical development must demonstrate that the product candidate is safe for humans and effective for its intended use, and we must successfully complete an FDA BLA review. Obtaining FDA approval of a product candidate generally requires significant research and testing, referred to as preclinical studies, as well as human tests, referred to as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. We cannot predict whether our research and clinical approaches will result in products that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the product approval process and may require us to conduct additional preclinical and clinical testing or to perform post-marketing studies or may require additional CMC or other data and information, and the development and provision of this data and information may be time-consuming and expensive. The approval process may also be delayed by changes in government regulation, future legislation diversion of resources for FDA review during the ongoing COVID-19 pandemic or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may:·delay commercialization of, and our ability to derive revenues from, our product candidate;·impose costly procedures on us; and·diminish any competitive advantages that we may otherwise enjoy. generally does not allow drugs to be promoted for “off-label” uses — that is, uses that are not described in the product’s labeling and that differ from those that were approved by the FDA. The FDA limits approved uses to those studied by a company in its clinical trials. In addition to the FDA approval required for new formulations, any new indication for an approved product also requires FDA approval. Although we have received approval from the FDA to market ASCENIV as a treatment for PIDD, we cannot be sure whether we will be able to obtain FDA approval for any desired future indications for ASCENIV.31Table of Contentsor institute fines orrequire payment of civil fines or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, among other consequences, any of which could harm our reputation and our business.relatingrelated to clinical trials and receipt of approvals from the FDA and foreign regulatory bodies, with commercialization efforts, which can include problems related to managing manufacturing and supply, including supply chain constraints, directly or indirectly caused by the ongoing COVID-19 pandemic and government responses thereto, reimbursement, marketing challenges, development of a comprehensive compliance program, and other related and additional costs. For example, the raw material plasma we collect and procure to manufacture ASCENIV using our patented proprietary microneutralization assay is comprised of plasma collected from donors which contains high titerhigh-titer antibodies to RSV. This high titer plasmatiter-plasma which meets our internal specifications for the manufacture of ASCENIV that we are able to identify with our patented testing assay amounts to less than 10% of the total donor collection samples we test. As a result, we may experience an insufficient supply of this plasma.pre-and-postpre -and-post approval services, and such parties are,parties’ performance is, to some extent, outside of our control.clinical research organizations,CROs, contract manufacturers, contract fill/finishers, third-party plasma centers and consultants to conduct our preclinical activities, clinical trials, CMC testing and other activities under agreements with us. These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs or the impact that the ongoing COVID-19 pandemic will have on suchprograms. These third parties. These investigatorsparties may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If outside collaborators fail to devote sufficient time and resources to our product-developmentproducts and/or development programs, or if their performance is substandard or does not comply with the applicable regulatory standards, our trials may be repeated, extended, delayed, or terminated, the approval of our FDA application(s), if any, and our introduction of new products, if any, will be delayed.delayed, and we may not be able to maintain existing approvals or meet our regulatory requirements. We or they may also be subject to regulatory enforcement actions, may need to take corrective actions, including initiating recalls, and we may not be able to meet commercial demand. These collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist our competitors at our expense, our competitive position would be harmed. Additionally, any change in the regulatory compliance status of any of our vendors may impede our ability to receive and maintain approval for our product candidates.32Table of Contents our Boca Facility by approximately 50% or more. We also anticipate expanding our production capabilities through the addition of our fill-finish machine at our Boca Facility. Following the expansion of any of our manufacturing processes or the addition of new equipment, such as our fill-finish machine, we will need to validate the expanded facility and equipment, make the necessary submissions to FDA, obtain any FDA-required approvals and have it inspected by the FDA. Given the significant delays that may result during the validation process, including due to any diverted FDA attention during the COVID-19 pandemic, we may experience a significant supply shortage of our products or our production capabilities may be limited until completion of and validation of our facility expansion and new manufacturing equipment.relatingrelated to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding safeguarding the drug supply chain as well as the distribution of samples to physicians and recordkeeping. For example, the FDA’s approval of our PASapplication supplement to allow for the commercial relaunch of BIVIGAM, requiresas well as the FDA’s approval of our BLA for ASCENIV, require us to conduct specified post-marketing studies, related to our manufacturing controlsincluding pediatric and processes, and submit specified post-marketing reports to the FDA.safety studies. If, during the post marketingpost-marketing period (after marketing approval) previously unknown adverse events emerge, there is the discovery that the product is less effective than previously thought, or other potential concerns regarding our products or their manufacturing processes emerge, or we are observed in any way to fail to comply with the numerous regulatory requirements to which we are subject, those circumstances may yield various results, including:·restrictions on such products or manufacturing processes;·restrictions on the labeling or marketing of a product;·restrictions on product distribution or use;·clinical holds or termination of clinical trials;·requirements to conduct further post-marketing studies or clinical trials, implement risk mitigation strategies, or to issue corrective information;·warning letters or untitled letters;·withdrawal of the products from the market;·refusal to approve pending applications or supplements to approved applications that we submit;·recall of products;·restrictions on coverage by third-party payers;33Table of Contents·fines, restitution or disgorgement of profits or revenues;·suspension or withdrawal of marketing approvals;·refusal to permit the import or export of products;·FDA debarment, suspension and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from healthcare programs, consent decrees, or corporate integrity agreements;·product seizure or detention; or·injunctions or the imposition of civil or criminal penalties.2020, three2023, two customers, BioCare, RelianceBioCARE, Inc. (“BioCare”) and Biolife,Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution (“Curascript”), represented an aggregate of 82%72% of our consolidated revenues. For the year ended December 31, 2019, three2022, BioCare and Curascript represented an aggregate of 74% of our consolidated revenues.BiolifeHealix Infusion Therapy, LLC (“Healix”), Curascript, AmerisourceBergen Corporation and Sanofi Pasteur S.A. (“Sanofi”)Reliance Life Sciences Pvt. Ltd., represented an aggregate of 70%approximately 98% of our consolidated revenues.2020, three customers,2022, BioCare Reliance Curascript,and Healix represented a totalan aggregate of 92% of our consolidated accounts receivable. At December 31, 2019, two customers, BioCare and McKesson Corporation (“McKesson”), represented 89% of our consolidated accounts receivable.·our ability to sell our products at competitive prices;·our ability to maintain features and quality standards for our products sufficient to meet the expectations of our customers;·our ability to produce and deliver a sufficient quantity of our products in a timely manner to meet our customers’ requirements; and·the impact of the ongoing COVID-19 pandemic and government responses thereto on our customers and their businesses, operations and financial condition.34Table of Contents·perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;·cost-effectiveness of our products relative to competing products;·availability of reimbursement for our products from government or other healthcare payers; and·the effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.Nabi-HB, BIVIGAM and ASCENIV, as well as expanding our IP estate with patents issued for S. Pneumoniae hyperimmune IG. We have initiated smallsmall- scale preclinical activities to potentially expand our current portfolio through new product development efforts or to in-license or acquire additional products and product candidates.efforts. If we are not successful in developing or acquiring additional products and product candidates, we will have to depend on our ability to successfully commercialize ASCENIV, as well as our abilitycontinue to generate revenuerevenues from ASCENIV, BIVIGAM, Nabi-HB, BIVIGAM, contract manufacturing, intermediate fractions and plasma attributable to the operations of ADMA BioCenters to support our operations.among other things, obligations, including mandatory contractual terms,requirements with respect to safeguarding the privacy, security and transmission of individually identifiableprotected health information (“PHI”) held by covered entities and business associates. AHIPPAA “covered entity” is the primary type of HIPAA-regulated entity. Healthentities” include health plans/insurers, healthcare providers engaging in HIPPA standard electronic transactions (insurance/health plan claims and encounters, payment and remittance advice, claims status, eligibility, enrollment/disenrollment, referrals and authorizations, coordination of benefits and premium payments), and healthcare clearinghouses (switches that convert data between standard and non-standard data sets) are covered entities.clearinghouses. A “business associate” provides services to covered entities (directly or as subcontractors to other business associates) involving arranging, creating, receiving, maintaining, or transmitting protected health information (“PHI”)PHI on a covered entity’s behalf. In order to legally provide access to PHI to service providers, covered entities and business associates must enter into a “business associate agreement” (“BAA”) with the service provider PHI recipient. Among other things, HITECH made certain aspects of the HIPAA’s rules (notably the Security Rule) directly applicable to business associates – independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a servicereceives PHI on behalf of a coveredthe entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal court to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. The HHS Office of Civil Rights (“OCR”) has increased its focus on compliance and continues to train state attorneys general for enforcement purposes. OCR has recently increased both its efforts to audit HIPAA compliance and its level of enforcement, with one recent penalty exceeding $5.0 million.35Table of Contentseven when HIPAA does not apply, accordingpersonal information that we obtain pursuant to thea clinical trial may be subject to U.S. Federal Trade Commission (the “FTC”), failing privacy regulation. Failing to take appropriate steps to keep consumers’ personal information secure constitutesmay constitute an unfair actsact or practices in or affecting commerce in violation ofpractice violating Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Medical data is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to, but less prescriptive than, what is required by the HIPAA Security Rule. In addition, states impose a variety of laws protecting consumer information, with certain sensitive information such as HIV/Sexually Transmitted Disease status subject to heightened standards. In addition, federal and state privacy, data security, and breach notification laws, rules and regulations, and other laws apply to the collection, use and security of personal information, including social security number, driver’s license numbers, government identifiers, credit card and financial account numbers. Some state privacy and security laws apply more broadly than HIPAA and associated regulations. For example, California recently enacted legislation – the California Consumer Privacy Act, or CCPA – which went into effect January 1, 2020, and will bewas amended by the California Privacy Rights Act,CPRA, effective January 1, 2023. The CCPA, among other things, creates newimposes data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. It remains unclear what, if any, modifications will be made to this legislation or how it will be interpreted. We could be subject to enforcement action and litigation exposure if we fail to adhere to these data privacy and security laws.PerceptiveAres Credit Facility is subject to acceleration in specified circumstances, which may result in PerceptiveAres taking possession and disposing of any collateral.February 11, 2019December 18, 2023 (the “Perceptive“Ares Closing Date”), we entered into the Perceptivea new senior secured credit facility with Ares (the “Ares Credit Agreement with Perceptive Credit Holdings II, LP, as the lenderAgreement”) (see “Liquidity and administrative agent (“Perceptive”Capital Resources”). The PerceptiveAres Credit Agreement as amended, currently provides for a total of $135 million in senior secured term loan facility in the principal amount of $100.0 millioncredit facilities (the “Perceptive“Ares Credit Facility”), comprised consisting of (i) a term loan made onin the Perceptive Closing Date in theaggregate principal amount of $45.0$62.5 million as evidenced by our issuance of a promissory note in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”),and (ii) a term loanrevolving credit facility in the aggregate principal amount of $27.5$72.5 million evidenced by our issuance(collectively, the “Ares Loans”), both of a promissory note in favor of Perceptivewhich were fully drawn on May 3, 2019 (the “Perceptive Tranche II Loan”), (iii) a term loan in the principal amount of $12.5 million evidenced by our issuance of a promissory note in favor of Perceptive on March 20, 2020, (the “Perceptive Tranche III Loan”); and (iv) a term loan in the principal amount of $15 million evidenced by our issuance of a promissory note in favor of Perceptive on December 8, 2020 (the “Perceptive Tranche IV Loan,” and together with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”).Ares Closing Date. The Perceptive Loans each haveAres Credit Facility has a maturity date of March 1, 2024, subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement)December 20, 2027 (the “Ares Maturity Date”). The PerceptiveAres Loans are secured by substantially all of our assets, including our intellectual property. Events of Defaultdefault include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material judgments, cross-defaults to material contracts and events constituting a change of control. In addition toIf there is an event of default, we would incur an increase in the rate of interest on the PerceptiveAres Loans of 4%2% per annum, theannum. The occurrence of an Eventevent of Defaultdefault could result in, among other things, the termination of commitments under the PerceptiveAres Credit Facility, the declaration that all outstanding Loansloans are immediately due and payable in whole or in part, and PerceptiveAres taking immediate possession of, and selling, any collateral securing the PerceptiveAres Loans.36Table of Contentsare also uncoveringcontinue to discover novel aspects oftechnologies related to our products and are drafting patentswe may draft patent applications directed to cover our inventions.these technologies. We rely on a combination of patent rights, trade secrets and nondisclosure and non-competition agreements to protect our proprietary intellectual property, and we will continue to do so. There can be no assurance that our patents, trade secret policies and practices or other agreements will adequately protect our intellectual property. Our issued patents may be challenged, found to be over-broad or otherwise invalidated in subsequent proceedings before courts, or the U.S. Patent and Trademark Office.Office or foreign patent offices. Even if enforceable, we cannot provide any assurances that they will provide significant protection from competition. The processes, systems, and/or security measures we use to preserve the integrity and confidentiality of our data and trade secrets may be breached, and we may not have adequate remedies as a result of any such breaches. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. There can be no assurance that the confidentiality, nondisclosure and non-competition agreements with employees, consultants and other parties with access to our proprietary information to protect our trade secrets, proprietary technology, processes and other proprietary rights, or any other security measures relating to such trade secrets, proprietary technology, processes and proprietary rights, will be adequate, will not be breached, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information or that third parties will not otherwise gain access to our trade secrets or proprietary knowledge. To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. or limitations on the use or loss of such rights, could be material to us. In some countries, basic patent protections for our products may not exist because certain countries did not historically offer the right to obtain specific types of patents and/or we (or our licensors) did not file in those markets. In addition, the patent environment can be unpredictable and the validity and enforceability of patents cannot be predicted with certainty. Absent relevant patent protection for a product, once the data exclusivity period expires, generic versions can be approved and marketed.37Table of Contentsfacilities, augment our operational, financial and management systems and hire and train additional qualified personnel. Our ability to accomplish each of these factors may be negatively impacted as a consequence of the COVID-19 pandemic. If we are unable to manage our growth effectively, our business could be harmed.38Table of Contentsduring the COVID-19 pandemic, the risk of cybersecurity attacks and data breaches, particularly through phishing attempts, may be increased as we and third-partiesthird parties with whom we interact leverage our IT infrastructure in unanticipated ways during the ongoing COVID-19 pandemic.ways. In addition, an employee, contractor, or other third party with whom we do business may attempt to obtain such information and may purposefully or inadvertently cause a breach involving such information. While we have certain safeguards in place to reduce the risk of and detect cyberattacks, including a Company-wide cybersecurity policy, our information technology networks and infrastructure may be vulnerable to unpermitted access by hackers or other breaches, such as the IT disruption described elsewhere in this report, or employee error or malfeasance. Any such compromise of our data security and access to, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information and subject us to additional costs which could adversely affect our business.financeoperational management and accounting.plasma collections. In particular, over the next 12-24 months, we expect to hire several new employees devoted to our plasma collection centers, commercialization, sales, marketing, medical and scientific affairs, regulatory affairs, quality control, information technology, finance and general and operational management. Qualified individuals of the requisite caliber and number needed to fill these positions may be in short supply in some areas. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals is intense, and we cannot assure you that our search for such personnel will be successful, particularly if the COVID-19 pandemic causes significant changes in the competitive market for such personnel or travel restrictions related to COVID-19 prevent qualified personnel from applying for employment.successful. If we are unable to hire and retain personnel capable of consistently performing at a high level, our business and operations could be materially adversely affected. Additionally, any material increases in existing employee turnover rates or increases in labor costs could have a material adverse effect on our business, financial condition or operating results.approvallicensure for these facilities or obtain FDA approvallicensure for additional facilities that we createmay construct or acquire rights to, we may be adversely affected and may not be able to sell or use this human blood plasma for future commercial purposes.approvallicensure of our current and future ADMA BioCenters collection facilities for the collection of human blood plasma and we may seek other governmental and regulatory approvals for these facilities. We also plan to grow through the building and licensing of additional ADMA BioCenters facilities in various regions of the U.S. Collection facilities are subject to FDA and potentially other governmental and regulatory inspections and extensive regulation, including compliance with current cGMP and blood standards and FDA licensure and other governmentgovernmental approvals, as applicable. Failure to comply with applicable governmental regulations or to receive applicable approvals for our current or future facilities may result in enforcement actions, such as adverse inspection reports, warning or untitled letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of regulatory authority approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses, any of which may significantly delay or suspend our operations for these locations, potentially having a materiallymaterial adverse effect on our ability to manufacture our products or offer for sale plasma collected at the affected sites.39Table of ContentsOurThere is also no guarantee that we will be able to fulfill our contractual requirements to our customers. Moreover, to the extent that we use third-party vendors to fulfill our regulatory or contractual requirements, these third-party vendors may perform activities for themselves or other clients and we may not be privy to all regulatory findings or issues discovered by the FDA or other regulatory agencies. Such findings, which are out of our control, may adversely affect our ability to continue to work with these vendors, or our ability to release commercial drug product or perform necessary testing or other actions for us or our clients, which may be required in order to remain FDA compliant or to commercialize our products.statelocal levels by criminal, civil and administrative penalties.sanctions. Violations of laws such as the Federal Food, Drug, and Cosmetic Act, the Social Security Act (including the Anti-Kickback Statute), the Public Health Service Act, and the civil and criminal Federalfederal False Claims Act, the civil monetary penalty statute, requirements regarding the reporting and repayment of overpayments, other fraud and abuse laws and any regulations promulgated under the authority of the preceding, may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in or debarment from federal and state healthcare or government procurement programs, as may be determinedpursuant to enforcement actions by DOJ, Medicare, Medicaid, and HHSOIG and other regulatory authorities as well as by the courts.authorities. Similarly, the violation of applicable laws, rules and regulations of states, including the State of Florida, with respect to the manufacture and marketing of our products and product candidates may result in significant criminal and/or civil sanctions, including jail sentences, fines or exclusion from participation in applicable state healthcare programs. There can be no assurance that our activities will not come under the scrutiny of federal and/or state regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.forto induce or reward patient referrals, or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease, or ordering of any timeitem or service reimbursable in whole or in part by a federal healthcare program is prohibited. This places constraints on the marketing and promotion of products and on common business arrangements, such as discounted terms and volume incentives for customers in a position to recommend or choose products for patients, such as physicians and hospitals, and these practices can result in substantial legal penalties, including, among others, exclusion from participation in the Medicare and Medicaid programs. Arrangements with referral sources such as purchasers, group purchasing organizations, healthcare organizations, physicians and pharmacists must be structured with care to comply with applicable requirements. Legislators and regulators may seek to further restrict the scope of financial relationships that are considered appropriate. For example, HHS recently promulgated a regulation that is effective in two phases. First, the regulation excludes from the definition of “remuneration” limited categories of (a) PBM rebates or other reductions in price to a plan sponsor under Medicare Part D or a Medicaid Managed Care Organization plan reflected in point-of salepoint-of-sale reductions in price and (b) PBM service fees.fees paid by a manufacturer to a PBM. Second, effective January 1, 2023, the regulation expressly provides that rebates to plan sponsors under Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager, will not be protected under the anti-kickback discountAnti-Kickback Statute discounts safe harbor.40Table of Contentsproviders,professionals, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers thatprofessionals who prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare providersprofessionals to prescribe or purchase particular products or as a reward for past prescribing. Under the Patient Protection and Affordable Care Act (“ACA”) and the companion Health Care and Education Reconciliation Act, which together are referred to as the “HealthcareHealthcare Reform Law,” payments and transfers of value by pharmaceutical manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to or at the request of covered recipients, such as, but limited to, U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists and U.S. teaching hospitals, must be tracked and reported to CMS, and are publicly disclosed. Such “applicable manufacturers” are also required to report certain ownership interests held by physicians and their immediate family members. A number of states have similar laws in place. Additional and stricter prohibitions could be implemented by federal and state authorities. Where such practices have been found to be improper incentives to use such products, government investigations and assessments of penaltiessanctions against manufacturers have resulted in substantial damagesfines, penalties and fines.damages. Many manufacturers have been required to enter into consent decrees or orders that prescribe allowable corporate conduct.Federalfederal False Claims Act have recently been brought against companies accused of promoting off-label uses of drugs, because such promotion induces unapproved the use and subsequent claims for reimbursement under Medicare and other federal programs. Similar actions for off-label promotion have been initiated by several states for Medicaid fraud. The Healthcare Reform Law significantly strengthened provisions of the Federalfederal False Claims Act, the federal Anti-Kickback Statute that applies to Medicare and Medicaid,government healthcare programs, and other healthcare fraud provisions, leading to the possibility of greatly increased qui tam suitslawsuits by relatorswhistleblowers for perceived violations. Violations or allegations of violations of the foregoing restrictions could materially and adversely affect our business.will need to establishhave established systems for collecting and reporting this data accurately to CMS and institutehave instituted a compliance program to assure that the information collected is complete in all respects. If we report pricing information that is not accurate to the federal government, we could be subject to fines and other sanctions that could adversely affect our business. If we choose to pursue clinical development and commercialization in the European Union or otherwise market and sell our products outside of the U.S., we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval procedures vary among countries in complexity and timing. We may not obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all, which would preclude us from commercializing products in those markets.41Table of ContentsIncreasing numbers ofMost U.S.-based pharmaceutical companies have such programs. We will need to adopt healthcare compliance and ethics programs that would incorporate the OIG’s recommendations and voluntary industry guidelines and train our employees. Such a program may be expensive and may not provide assurance that we will avoid compliance issues.regulatoryapprovalregulatoryapprovals before our products and product candidates may be lawfully marketed, and our ability to obtain regulatory approval of our products and product candidates from the FDA in a timely manner, access the public markets and obtain necessary capital in order to properly capitalize and continue our operations may be hindered by inadequate funding for the FDA, the SEC and other state and local government agencies.contract research organizationsCROs are subject to extensive regulation by federal,Federal, state and local governmental authorities in the U.S. and other countries, with regulations differing from country to country. In the U.S., the FDA regulates, among other things, the pre-clinical and nonclinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products. Failure to comply with applicable requirements could result in, among other things, one or more of the following actions: notices of violation, untitled letters, warning letters, complete response letters,CRLs, fines and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product or product candidate, product recall or seizure, interruption of manufacturing or clinical trials, operating restrictions, injunctions and criminal prosecution. Our products and product candidates cannot be lawfully marketed in the U.S. without FDA and other federal,Federal, state and local business regulatory approval.approvals. Any failure to receive the marketing approvals necessary to commercialize our productproducts or product candidates could harm our business.andas well as statutory, regulatory, and policy changes. Average review times at the FDA and other federal, state and local business regulatory agencies have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for products and product candidate submissions to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last severalfew years, including in December 2018 and January 2019, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown reoccurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions and other reporting requirements which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.42Table of Contentssmallcertain amounts of work-in-progressraw materials and work-in-process inventory in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations and the reserves we have established for these purposes. Such write-offs or losses and other costs could cause material fluctuations in our results of operations. Product or component quality issues may also result in regulatory enforcement actions, liability, corrective actions and recalls, among other actions, as described elsewhere in this annual report.that a product’sour manufacturing process isprocesses are inadequate to inactivate or remove an infectious agent, our ability to manufacture and distribute that productour products would be impaired. If a new infectious disease were to emerge in the human population such as COVID-19, or if there were a reemergence of an infectious disease, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our ability to procure plasma, manufacture our products or both. Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for plasma-derived products. In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma. There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.43Table of ContentsWe do not and will not have adequateAdditionally, although we achieved plasma to manufacturesupply self-sufficiency with the approval of our products. Therefore,tenth plasma collection center in November 2023, we areremain reliant on the purchase of plasma from third parties and the collection of plasma from our FDA-licensed plasma collection centers to manufacture our products. We can give no assurances that appropriate plasma will be available to us through our own plasma collection facilities or on commercially reasonable terms, or at all, to manufacture our products. Further, the COVID-19 pandemic has resulted in, and may continue to result in significant constraints in raw material supply across various different industries, including the supply of plasma. It is possible that in the future, the COVID-19 pandemicpandemics and government responses thereto will have an adverse effect on our ability to source plasma from donors in quantity and quality sufficient for our manufacturing processes. In order to maintain a plasma center’s license, its operations must continue to conform to cGMP and other regulatory requirements. In the event that we determine that plasma was not collected in compliance with cGMP and other applicable regulatory requirements, we may be unable to use and may ultimately destroy plasma collected from that center, which would be recorded as a charge to cost of product revenue. Additionally, if non-compliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted. Consequently, we could experience significant inventory impairment provisions and write-offs which could adversely affect our business and financial results. We plan to increase our supplies of plasma for use in the manufacturing processes through increased purchases of plasma from third-party suppliers as well as collections from our existing ADMA BioCenters plasma collection facilities. This strategy is dependent upon our ability to maintain a cGMP compliant environment at our plasma collection facilities and to expand production and attract donors to our facilities. There is no assurance that the FDA will inspect and license any of our current or future unlicensed plasma collection facilities in a timely manner consistent with our production plans. If we misjudge the readiness of a center for an FDA inspection, we may lose credibility with the FDA and cause the FDA to more closely examine all of our operations. Such additional scrutiny could materially hamper our operations and our ability to increase plasma collections. Our ability to expand production and increase our plasma collection facilities to more efficient production levels may be affected by changes in the economic environment and population in selected regions where ADMA BioCenters operates its current or future plasma facilities, by the entry of competitive plasma centers into regions where ADMA BioCenters operates such centers, by misjudging the demographic potential of individual regions where ADMA BioCenters expects to expand production and attract new donors, by unexpected facility related challenges, or by unexpected management challenges at selected plasma facilities held by us from time to time.44Table of Contents new biosimilar pathway established as part of healthcare reform may make it easier for competitors to market biosimilar products.termsterms. The FDA approved the first biosimilar product in 2015 and has since approved a number of biosimilars. As a result of the biosimilar pathway in the U.S., we expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges.greater.greater, plus the inflation penalty if applicable. Effective January 1, 2010, the Healthcare Reform Law generally increased the size of the Medicaid rebates paid by manufacturers for single source and innovator multiple source (brand name) drug products from a minimum of 15.1% to a minimum of 23.1% of AMP, subject to certain exceptions.exceptions, plus the inflation penalty if applicable. For non-innovator multiple source (generic) products, the rebate percentage was increased from a minimum of 11.0% to a minimum of 13.0% of AMP.AMP, and the Bipartisan Budget Act of 2015 established a new inflation penalty for these drugs. In 2010, the Healthcare Reform Law also newly extended thisthe Medicaid drug rebate obligation to prescription drugs covered by Medicaid managed care organizations. These increases in required rebates may adversely affect our future financial prospects and performance. In order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program. The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer. As the 340B drug pricing is determined based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase.45Table of Contentsthere are ongoing legalthe possibility of future challenges including at the Supreme Court, which mayor legislative changes contribute to the uncertainty of the ongoing implementation and impact of the law and also underscores the potential for additional reform going forward. We cannot assure that the law, as currently enacted or as amended in the future, will not adversely affect our business and financial results and we cannot predict how future federalFederal or state legislative or administrative changes relating to healthcare reform will affect our business. Certain provisions of enacted or proposed legislative changes may negatively impact coverage and reimbursement of, or rebates paid by manufacturers for, healthcare items and services. We will continue to evaluate the effect that the Healthcare Reform Law and any potential changes may have on our business.Weprograms or commercialization efforts.Ourprograms.ForWhile we generated positive cash flow of $8.8 million for the year ended December 31, 2023, for the years ended December 31, 20202022 and 2019,2021, we had negative cash flows from operations of approximately $102.0$59.5 million and $76.2$112.4 million, respectively. We expect to continue to spend substantial amounts onfor collecting plasma at our plasma collection centers, maintaining our plasma collection centers, procurement of raw material plasma and other raw materials necessary to scale up our manufacturing operations, commercial product launches and capacity expansion at the Boca Facility, building additional plasma collection facilities, product development, quality assurance, regulatory affairs and conducting clinical trials for our product candidates and purchasing clinical trial materials, some of which may be required by the FDA.Facility. In addition, our end-to-end production cycle from procurement ofcollecting and procuring raw materialsmaterial source plasma to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial investments in raw material plasma and other manufacturing materials. We expecthad a net loss of $28.2 million for the year ended December 31, 2023 and although we achieved adjusted net income of $0.7 million which, as further described under “Non-GAAP Financial Measures”, excludes charges related to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations), at present we cannot be certain that we will not be able to generate a sufficient amount of product revenue to achieve profitability until the beginning ofon an ongoing basis. If we are unable to continue to generate positive cash flow throughout fiscal 2024, and, as a result, we expect that we willmay need to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing agreements. We currently anticipate, based upon our projected revenue and expenditures, as well as the additional funds we expect to receive from the sale of common stock pursuant to the Sale Agreement (as amended to date), that our current cash, cash equivalents and accounts receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, as currently conducted, intothrough the fourthfirst quarter of 2021. In orderfiscal 2025. Our current outlook with respect to have sufficient cash to fund our operations thereafter, we will need to raise additional equity or debt financing before the end of the fourth quarter of 2021. This time frameflows and profitability may change based upon how quicklyeffective we are ablein continuing to execute on our commercialization efforts and operational initiatives and the various financing options that may be available to us in 2021. However, ifwhether or not the assumptions underlying our estimatedprojected revenues and expenses prove to be incorrect,are correct. If we may haveare required to raise additional capital sooner than we currently expect. Untiland if such time, if ever, as we can generate a sufficient amount of product revenue to achieve profitability, we expect to continue to finance our operations through additional equity or debt financings or corporate collaboration and licensing arrangements. If we are unable to raise additional capital as needed, includingis not available due to widespread liquidity constraints or significant market instability that could result from the COVID-19 pandemic,widespread economic or geopolitical conditions, we willmay have to delay, curtail or eliminate our commercialization efforts or our product development activities.46Table of ContentsPerceptiveAres Credit Facility provides for termtotal senior secured loans of up toin an aggregate principal amount of $100.0up to $135.0 million, all of which has been drawn down and is currently outstanding. Borrowings under the PerceptiveAres Credit Facility currently bear interest at a weighted-average rate of approximately 10.4% per annum, equal to 7.5% pluswhich reflects the greater of (i) one-month LIBOR and (ii) 3.5%;three-month term SOFR rate; provided, however, that upon, and during the continuance of, an Eventevent of Default,default, the interest rate will automatically increase by an additional 400200 basis points. We are currently required to make monthlyquarterly payments of interest during the term of the PerceptiveAres Credit Facility of approximately $0.9$3.7 million, with all principal and unpaid interest due at maturity. In addition, our monthly interest rate obligation is subject to rising interest rates. The PerceptiveAres Credit Facility has a maturity date of March 1, 2024,December 20, 2027, subject to acceleration pursuant to the PerceptiveAres Credit Agreement, including upon an Eventevent of Default.default. All of our obligations under the PerceptiveAres Credit Facility are secured by a first-priority lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.willmay not be sufficient to repay all of our current outstanding debt obligations as they mature. If we are unable to achieve sufficient positive cash flow to repay our outstanding debt obligations as they mature, we will need to obtain additional financing and are otherwise unable to become profitable and generate cash from operations in the amounts necessary to repay our outstanding debt obligations when due, including as a result of the impact of the COVID-19 pandemic,due. If we are unable to repay our outstanding debt obligations when they mature, our creditors would be able to accelerate all of the amounts due and, in the case of the PerceptiveAres Credit Facility, seek to enforce their security interests, which could lead to our creditors taking immediate possession of and selling substantially all of our assets with no return provided to our stockholders.47Table of Contentsinvestors’ views of us and as a result,negatively affect the valuemarket price of our common stock. related rules, our management is required to report on the effectiveness of our internal control over financial reporting.reporting, including any material weaknesses in such internal controls. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we have been required to upgrade, and may need to implement further upgrades, to our financial, information and operating systems, implement additional financial and management controls, reporting systems and procedures and hire additional accounting and finance staff.and will continue to, incurincurred increased costs related to our compliance with Section 404 of the Sarbanes-Oxley Act.Act and will continue to do so. Our Audit Committee has retained the services of BDO, a Sarbanes-Oxley advisor, to assist with our internal controlscontrol over financial reporting and information technology relatingrelated to Section 404.the Sarbanes-Oxley Act. Moreover, if we have a material weakness in our internal control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated. If we identify material weaknesses in our internal control over financial reporting, if we are not ableunable to comply with the requirements of Section 404 applicable to usof the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal controls over financial reporting is effective or if our independent registered public accounting firm identifies deficiencies inis unable to express an opinion as to the effectiveness of our internal control over financial reporting, that are deemed to be material weaknesses,investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could decline andbe negatively affected. In addition, we could bebecome subject to sanctions or investigations by any stock exchange on which our securities are listed, the SEC or other regulatory authorities, which wouldcould require additional financial and management resources.2020,2023, we had federal and state NOLs of $239.8$315.6 million and $172.6$216.4 million, respectively. Federal and Statestate NOLs of approximately $115.8$35.6 million and $90.0$95.1 million, respectively, will begin to expire at various dates beginning in 2027,2028, if not limited by triggering events prior to such time. Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), changes in our ownership, in certain circumstances, will limit the amount of federal NOLs that can be utilized annually in the future to offset taxable income. In particular, Section 382 of the Code ("Section 382") imposes limitations on a company’s ability to use NOLs upon certain changes in such ownership. If we are limited in our ability to use our NOLs in future years in which we have taxable income, we will pay more taxes than if we were able to fully utilize our NOLs. The Biotest Transactionacquisition transaction that we completed on June 6, 2017 resulted in a change in ownership of ADMA under Section 382 and, as a result, we were required to write off $57.6 million of federalFederal NOLs. WeOn October 25, 2021, we completed a public offering of our common stock whereby we issued 57,500,000 shares of our common stock resulting in another change of ownership for ADMA under section 382 of the Code, resulting in an additional write-off of $3.0 million of Federal NOLs, $28.1 million of state NOLs and $1.0 million of research and development credits. Although we did not experience any ownership changes for the years ended December 31, 2023 and 2022, we may experience ownership changes in the future as a result of subsequent changes in our stock ownership that we cannot predict or control that could result in further limitations being placed on our ability to utilize our federalFederal NOLs.·sales or potential sales of substantial amounts of our common stock;·uncertainties in the equity markets related to the effects of the COVID-19 pandemic;·delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;·delay in a decision by federal, state or local business regulatory authority;·the timing of acceptance, third-party reimbursement and sales of BIVIGAM and ASCENIV;·announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;·developments concerning our licensors or third-party vendors;·litigation and other developments relating to our patents or other proprietary rights or those of our competitors;·conditions in the pharmaceutical or biotechnology industries;48Table of Contents·governmental regulation and legislation;·overall market volatility;·variations in our anticipated or actual operating results; and·change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.March 16, 2021,February 23, 2024, most of our 121,275,357228,220,236 outstanding shares of common stock, as well as a substantial number of shares of our common stock underlying outstanding warrants, were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.2020, Perceptive,2023, BlackRock Inc., Vanguard Group and our directors and executive officers and their affiliates beneficially owned approximately 22%16% of the outstanding shares of our common stock. Provisions of our Certificate of Incorporation, our Bylaws and Delaware law may have the effect of deterring unsolicited takeovers or delaying or preventing a change in control of our Company or changes in our management, including transactions in which our stockholders might otherwise receive a premium for their shares over then current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. These provisions include:·the inability of stockholders to call special meetings;·classification of our Board and limitation on filling of vacancies could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire control of our Company; and·authorization of the issuance of “blank check” preferred stock, with such designation rights and preferences as may be determined from time to time by the Board, without any need for action by stockholders.company,Company, thereby reducing the likelihood that you could receive a premium for your common stock in an acquisition. In addition, as a result of the concentration of ownership of our shares of common stock, our stockholders may, from time to time, observe instances where there may be less liquidity in the public markets for our securities.49Table of ContentsOur Board also recently adopted a short-term stockholder rights agreement with an expiration date of December 15, 2021 and an ownership trigger threshold of 10%. This stockholder rights agreement could render more difficult or discourage a merger, tender offer or assumption of control of the Company that is not approved by our Board. The rights agreement, however, should not interfere with any merger, tender or exchange offer or other business combination approved by our Board. In addition, the rights agreement does not prevent our Board from considering any offer that it considers to be in the best interest of the Company’s stockholders.PerceptiveAres Credit Agreement prohibits us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.Penny stock regulations may affect your ability to sell our common stock.Because the price of our common stock currently trades below $5.00 per share, our common stock is subject to Rule 15g-9 under the Exchange Act, which imposes additional sales practice requirements on broker dealers which sell these securities to persons other than established customers and accredited investors. Under these rules, broker-dealers who recommend penny stocks to persons other than established customers and “accredited investors” must make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to a transaction prior to sale, which includes an acknowledgement that the purchaser’s financial situation, investment experience and investment objectives forming the basis for the broker-dealer’s suitability determination are accurately stated in such written agreement. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the associated risks. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common stock and may make it more difficult for holders of our common stock to sell shares to third parties or to otherwise dispose of them.150,000,000300,000,000 shares of common stock. As of December 31, 2020,2023, there were 30,655,78431,033,333 shares remaining available for issuance, after giving effect to 11,777,09123,066,387 shares of our common stock that were subject to outstanding stock options, Restricted Stock UnitsRSUs and warrants as of December 31, 20202023 that may be issued by us without stockholder approval, as well as an additional 2,664,23719,837,248 shares reserved for the future issuance of awards under our equity compensation plans.Item 1B. Unresolved Staff Comments 50Table of ContentsItem 1B. Unresolved Staff CommentsItem 1C. Cybersecurity Item 2. Properties Item 2. Properties2020:2023:4,200September 30, 2021December 31, 2026 *84,46244,495Kennesaw, GAPlasma Collection Center12,167March 31, 2026Roswell, GAAdministration6,040November 30, 2023Knoxville, TNPlasma Collection Center11,657November 30, 2030Maryville, TNPlasma Collection Center10,800January 31, 2031Goose Creek, SCPlasma Collection Center14,968March 31, 2031Conyers, GAPlasma Collection Center11,996February 28, 2032 - Pursuant to a shared services agreement, as amended, with Areth, LLC (“Areth”("Areth") for office, warehouse space and related services. The agreement provides for automatic one-year renewals unless ADMA gives written noticeservices pursuant to which the Company pays Areth monthly lease payments of termination to Areth 60 days prior to the end of the term.$10,000. Areth is a company controlled by Dr. Jerrold B. Grossman, our Vice Chairman of the Board of Directors, and Adam S. Grossman, our President and Chief Executive Officer.Item 3. Legal Proceedings Item 3. Legal ProceedingsItem 4. Mine Safety DisclosuresItem 4. Mine Safety Disclosures 51Table of ContentsItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities As ofSince October 22, 2019, our Common Stock has been listed on the Nasdaq Global Market.2020,2023, there were ninefive record holders of our Common Stock, based upon information received from our transfer agent. However, this number does not include beneficial owners whose shares were held of record by nominees or broker dealers. As of February 1, 2021,2024, we estimate that there are more than 20,00030,000 beneficial owners of our Common Stock.Perceptive precludesAres preclude us from paying cash dividends without their consent. Therefore, we do not expect to pay any cash dividends for the foreseeable future.
Not applicable.2020,2023, we had no sales of unregistered securities that have not been previously disclosed in a Current Report on Form 8-K or Quarterly ReportsReport on Form 10-Q.2020.Item 6. Selected Financial DataNot applicable.52Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations Table of ContentsItem 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons.WeBIVIGAMASCENIV (Immune Globulin Intravenous, Human)Human – slra 10% Liquid), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of immunity in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the treatment of PI, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; (ii) ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an IVIG product indicated for the treatment of PI, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing HBsAg and other listed exposures to Hepatitis B. We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent No. 10,259,865 related to methods of treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae. Our products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases. 400,000-liter annual capacity plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”). Based on current production yields, our completed and our ongoing supply chain enhancementenhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products representing annual revenues of more than $250approximately $330 million in annual2024 and potentially $380 million in 2025. At these revenue beginninglevels, we forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%. These assumptions translate to potential fiscal year 2024 and 2025 net income of $65 million and $115 million or more and adjusted EBITDA of $90 million and $140 million or more, respectively.well as achieving profitability duringfurther described under “Non-GAAP Financial Measures”, excludes charges related to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations). We also achieved positive cash flow from operations for the year ended December 31, 2023 for the first quartertime in the Company’s history, primarily as a result of 2024, asour significant revenue growth and continued physician, patient and payer acceptance of ASCENIV and BIVIGAM that we ramp-up productionhave experienced over the next three to fivepast several years.as an FDA-approvedten source plasma collection organizationfacilities in the U.S., all of which hold FDA licenses. This business unit, which we refer to as our Plasma Collection Centers business segment, provides us with a portion of ourthe blood plasma required for the manufacture of our products, and product candidates, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. As a part of our planned supply chain robustness initiative, we opened two new plasma collection centers during 2020, and we now have seven plasma collection centers in various stages of approval and development, including three that are fully operational and collecting plasma. With respect to our fully operational plasma collection centers, two hold FDA licenses and the third has a Biologics License Application (“BLA”) pending an FDA decision expected in the fourth quarter of 2021. In addition, onethree of our FDA-approved plasma collection centers also hashave approvals from the Korean Ministry of Food and Drug Safety (“MFDS”), as well as FDA approval to implementoperate a Hepatitis B immunization program. After giving effect to the progress we made in 2020 with our plasma collection network expansion, we believe we remain on track to achieve our goal of having 10 or more plasma collection centers operating in the U.S. by 2024. A typical plasma collection center, such as those operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale. Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products or product candidates is sold to third-party customers in the U.S. and in other locations outside the U.S. where we are approved under supply agreements or in the open “spot” market.53Table of Contentsproducts. In January 2020, we announced our entry intoproducts, through a five-year manufacturing and supply agreement to produce and sell thesewe entered into in January 2020. These intermediate by-products which are used as the starting raw material to produce other plasma-derived biologics. In addition, from time to time we provide contract manufacturing and testing services for certain third-party clients.uponutilizing our FDA-approved in-house fill-finish capabilities.implementationthe immunology and infectious disease community to design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population. Following FDA approval in April 2019, commercial sales of ASCENIV commenced in October of 2019 and in 2023 ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history. We expect that this expansion should meaningfully improve the product’s margin profile and increase plant production capacity as fewer batches will be needed to support our in-house fill-finish capabilities through our Vanrx SA25 Workcell aseptic filling machine.On June 6, 2017, we completed the acquisition of certain assets (the “Biotest Assets”) of the Therapy Business Unit (“BTBU”) of Biotest Pharmaceuticals Corporation (“BPC”revenue goals. ASCENIV’s prescriber and together with Biotest AG, “Biotest”),patient base continued to expand during 2023, which included two FDA-licensed products, Nabi-HBdrove record utilization and BIVIGAM,pull-through for this product. These elevated demand trends have sustained into 2024, and an FDA-licensed plasma fractionation facility located in Boca Raton, FL (the “Boca Facility”) (the “Biotest Transaction”).Our Productscommence commercial sales ofre-launch and commercialize this product in the United States.U.S. We resumed production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S. Department of Health and Human Services (“HHS”) License No. 2019. We commencedThe commercial re-launch and first commercial sales for this product commenced in August of 2019.ASCENIVASCENIV isplasma-derived4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product. This increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has had a favorable impact on our gross margins, manufacturing efficiencies and operating results.contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent against infection and disease. We manufacture ASCENIV under HHS License No. 2019 using a process known as fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. UnderFDA approved the Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) will become effective April 1, 2021 and will replace the currently issued C-code for ASCENIV (C9072), which can continue to be utilizedexpansion of BIVIGAM’s label in the interimU.S. to now include the pediatric setting for reimbursement purposes. As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to respiratory syncytial virus (“RSV”) using our proprietary microneutralization testing assay. We are able to identify the high titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV with our patented testing methods and assay. This type of high titer plasma is typically found in less than 10% of the total donor collection samples we test.54Table of ContentsASCENIV is approved for the treatment of Primary Immune Deficiency Disorder (“PIDD”), a class of inherited genetic disorders that causes a deficient or absent immune system in adults and adolescents (12 to 17those two years of age). Our pivotal Phase 3 clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of infection, therapeutic antibiotic use, days missed from work/school/daycareage and unscheduled medical visits and hospitalizations. We believe this clinical data together with the FDA approval for the treatment of PIDD better positions ADMA to further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens. We plan to work with the FDA and the immunology and infectious disease community to design a clinical trial to evaluate the use of ASCENIV in this patient population in the near future. Commercial sales of ASCENIV commenced in October of 2019.virus. Itvirus, which is a major global health problem. ItThe Hepatitis B virus can cause chronic infection and putsplaces people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction. The FDA approved Nabi-HB on March 24, 1999. Production of Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017. In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the U.S. and we continue to manufacture Nabi-HB under HHS License No. 2019.IMPACT OF THE COVID-19 CRISISWe continue to closely monitor ongoing developments in connection with the COVID-19 pandemic and its impacts to our commercial manufacturing operations and plasma collections facilities, including but not limited to potential disruptions to our supply chain operations, including collections of source plasma, procurement of raw materials and packaging materials, a portion ofare sourced internationally, and testing of finished drug product that is required prior to its availability for commercial sale. Such testing has historically been performed by contract laboratories outside the United States. In addition, travel and other restrictions that have been implemented in the United States have impacted our commercial engagement efforts with respect to some of our products, including BIVIGAM and ASCENIV, as trade shows, industry and medical conferences and other events we had been planning to utilize and exhibit and attend with our staff to increase awareness of our products by physicians and payers remain subject to reduction in scope, rescheduling or outright cancellation due to the pandemic.We have experienced some delays with our third-party vendors and testing laboratories which perform final drug product GMP release testing. In response to these delays, we have added additional release testing laboratories to our FDA-approved consortium listed in our drug approval documents which we believe has adequately addressed this issue. In July 2020, we began receiving FDA lot releases with testing data from our new testing laboratory vendor. In addition, due to previous state and local “shelter-in-place” orders, as well as ongoing requirements around physical distancing, we have experienced, and may experience in the future, lower than normal donor collections at our FDA-approved plasma collection centers. We were also subject to delays in shipments of source plasma from our contracted third-party suppliers, as well as delays in deliveries for personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture and distribution of our products. We have also experienced supply chain delays as a result ofrendered certain of our suppliers diverting significant resources towardsIT systems inaccessible for less than one week. Our investigation of the rapid development and distributiondisruption has been completed with the assistance of COVID-19 vaccines. In addition,third-party consultants. While no definitive root cause was identified, as previously disclosed we believe that this IT systems disruption may have experienced challenges with respectbeen caused by a third-party who may have gained access to our customer engagement initiatives, as our sales and medical affairs field forces face difficulties communicating directly with physicians andthe system. There was no original financial systems or other healthcare professionals and the cancellationdata loss or postponementany evidence of a number of key scientific and medical conferences, further limiting our ability to communicate with potential customers. We have implemented a comprehensive suite of virtual engagement initiatives, though clinician engagement remains lowerfiles exfiltrated due to continuing COVID-19-related priorities at U.S. medical centers.55Table of ContentsAsthis disruption. Normal operations have resumed across our business units. At the time of the datedisruption, we were in production of this report, we do not believe that the operationstwo batches of BIVIGAM, and immunoglobulin and plasma productsafter a prolonged hold time, it was deemed to be a prudent GMP quality decision to discard these two in-process production at our Boca Facility, our contract fill/finishersbatches as these batches were no longer viable for further production or our plasma collection facilities have been significantly impacted by the COVID-19 pandemic. As a result, as of the date of this report, we have not experienced, and currently do not anticipate,had any material impairments with respect to any of our long-lived assets, including our property and equipment, goodwill or intangible assets.Although the COVID-19 pandemic has not, to date, materially adversely impacted our capital and financial resources, due to the economic uncertainty that has resulted from the pandemic, and the potential impact of such to our stakeholders, we are unable to predict with certainty any potential impacts to our business. Although we believe the effects of the COVID-19 pandemic on our business and our operations will be temporary, at the present time we are unable to determine the ultimate duration of the pandemic or its long-term effects on, among other things, the global, national or local economies, the capital and credit markets, our workforce, our customers or our suppliers.alternative use. As a result, we recorded a one-time, non-recurring charge of $2.1 million for this inventory in the second quarter of 2023, which is reflected in Cost of product revenue in the accompanying consolidated statements of operations for the year ended December 31, 2023. In addition, the Company’s Plasma center operating expenses were adversely impacted by approximately $0.7 million due to the temporary closing of our plasma collection centers while their IT systems were restored.unable to predict whether the COVID-19 crisis will have a material adverse impact onactively working with our business, financial condition, liquidityinsurance broker and resultscarriers.the realizable valuerebates and certain other deductions from gross revenues, impairment of accounts receivable,long-lived assets, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair value of awards granted under our equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for our deferred tax assets.and/or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from those estimates. Due to the estimation processes involved, the following summary of accounting policiesestimates and their application are considered to be critical to understanding our business operations, financial condition and results of operations. For a detailed discussion on the applicationdescription of these and our othersignificant accounting policies, see Note 2 to the Consolidated Financial Statements included elsewhere in this Annual Report on Form 10-K.Revenue RecognitionRevenues for Estimates and assumptions used in projecting future liquidity and capital requirements are described in Note 1 to the years ended December 31, 2020 and 2019 are comprised of (i) revenues from the sale of our FDA-approved immunoglobulin products, (ii)Consolidated Financial Statements.fromare subject to a variety of deductions, which are estimated and recorded in the salesame period that the revenues are recognized. These deductions primarily consist of human plasma collected from our Plasma Collection Centers business segment, (iii) product revenues from the salerebates, distribution fees, chargebacks and sales allowances. These deductions represent estimates of intermediate fractions, (iv) contract manufacturing and testing revenue from certain clients; and (v) license revenues attributable to the out-licensing of ASCENIV in December 2012 to Biotest to market and sell this product in Europe and selected countries in North Africa and the Middle East. Biotest has provided us with certain services and financial payments in accordance with the related Biotest license agreementobligations, some of which are contractual in nature and is obligateddo not require extensive judgment to pay us certain amounts inbe exercised by management, while other estimates require complex or subjective matters of knowledge and judgment when estimating the future if certain milestones are achieved. Deferredimpact of these revenue is recognized over the term of the Biotest license. Deferred revenue is amortized into incomedeductions on net revenues for a period of approximately 22 years, the term of the Biotest license agreement.Product revenue is recognized when the customer is deemedreporting period.have control over the product. Control is determined based on when the product is shippedthese estimates to reflect actual results or delivered and title passes to the customer. Revenue is recorded in an amount that reflects the consideration we expect to receive in exchange. Revenue from the sale of immunoglobulin products is generally recognized when the product reaches the customer’s destination, and is recorded net of distributor fees, estimated rebates, price protection arrangements and customer incentives, including prompt pay discounts, wholesaler chargebacks and other wholesaler fees. These estimates are based on historical experience and certain other assumptions, and we believe that such estimates are reasonable. For revenues associated with contract manufacturing and sales of our intermediates, control transfers to the customer and the performance obligation is satisfied when the customer takes possession of the product from the Boca Facility or a third-party warehouse that is utilized by the Company.56Table of ContentsProduct revenues from the sale of human plasma collected at our plasma collection centers are recognized at the time control of the product has been transferred to the customer, which generally occurs at the time of shipment. Product revenues are recognized at the time of delivery if we retain control of the product during shipment. Payments received from customers where the foregoing revenue recognition criteriaupdated expectations have not been satisfied are recorded as deferred revenue, which is reflected as a liability in our consolidated balance sheets.Accounts ReceivableAccounts receivable are reported at realizable value, net of allowances for contractual credits and doubtful accounts, which are recognized in the period the related revenue is recorded. We extend creditmaterial to our customers based upon an evaluation of each customer's financial condition and credit history. Evaluations of the financial condition and associated credit risk of customers are performed on an ongoing basis. Based on these evaluations,overall business. While we have concluded thatsome historical sales and rebate experience from our credit risk is minimal.Cost of Product RevenueCost of product revenue includes costs associated with the manufacture of the Company’s FDA approvedtwo primary immunoglobulin products, intermediates and the sale of human source plasma, as well as expenses related to conformance batch production, process development and scientific and technical operations when these operations are attributable to marketed products. When the activities of these operations are attributable to new products in development, the expenses are classified as research and development expenses. Costs of production for ASCENIV and BIVIGAM, since their FDA approvals in 2019, it is not extensive. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate estimates of our future experience, our results could be materially affected. Estimates that are most at risk for material adjustment are those associated with U.S. Medicaid rebates because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally take up to several years or more. These estimates may change from time to time based on changes in utilization, payor and channel mixes. While our results of operations to date have not required any material adjustment due to this risk, the delay between when this obligation is initially recorded and ultimately settled could potentially materially impact our revenues and our results of operations in the future.FDA approvalexpiration dates in determining whether it is appropriate to carry these materials on our balance sheet as a valid asset of April 1, 2019 and May 9, 2019, respectively, were not capitalized into inventory but were instead expensed as incurred.As a manufacturerthe Company. Changes in either of biological products, we are subject to the risks inherent in biological production, whichthese estimates could include normal course losses and failures inherent in the manufacturing process. Aspotentially materially impact our biologics production levels increase there may be normal course inventory losses as we ensure product quality and compliance with FDA, state and local regulations, or due to testing results not meeting specifications. Such losses are charged to cost of product revenue in the period they are incurred.restricted stock unitsRestricted Stock Units (“RSUs”), are recognized at their estimated fair value at the date of grant, and compensation expense is recognized on a straight-line basis over the grantee’s requisite vesting period. During the year ended December 31, 2020, we granted RSUs to members of our Board of Directors and certain members of our management and employees representing an aggregate of 361,000 shares of common stock. For the purpose of valuing stock options granted to our employees, directors and officers, we use the Black-Scholes option pricing model. We grantedThe Black-Scholes option pricing model was developed for use in estimating the fair value of publicly traded options, to purchase an aggregatewhich have no vesting restrictions and are fully transferable. The Company’s employee stock options have characteristics significantly different from those of 1,468,412traded options, and 1,508,000 shares of Common Stock duringchanges in the years ended December 31, 2020 and 2019, respectively.underlying Black-Scholes assumptions can materially affect the fair value estimate. To determine the risk-free interest rate, we utilize the U.S. Treasury yield curve in effect at the time of the grant with a term consistent with the expected term of our awards. The expected term of the options granted is in accordance with SEC Staff Accounting Bulletins 107 and 110 and is based on the average between vesting terms and contractual terms. The expected dividend yield reflects our current and expected future policy for dividends on our Common Stock. The expected stock price volatility for our stock options was calculated by examining the historical volatility of our Common Stock since our Common Stock became publicly traded in the fourth quarter of 2013. We will continue to analyze the expected stock price volatility and expected term assumptions and will adjust our Black-Scholes option pricing assumptions as appropriate. In accordance with Accounting Standards Update (“ASU”) No. 2016-09, ImprovementsAny changes in the foregoing Black-Scholes assumptions, or an election by us to Employee Share-Based Payment Accounting (Topic 718), we have elected notutilize an alternative method for valuing stock options granted to establish a forfeiture rate, asemployees, directors and officers, could potentially impact our stock-based compensation expense related to forfeituresand our results of unvested stock options is fully reversed atoperations.timeBlack-Scholes option pricing model for the purpose of forfeiture.57Table of ContentsResearch and Development ExpensesOur research and development (“R&D”) costs consist of clinical research organization costs, costs related to clinical trials, testing and evaluation of new or alternative products or processes, includingestimating the testing and development of a new filling line at one of our third-party fill/finishers for a process that has not been approved by the FDA, studies for potentially extending a product’s approved and labeled expiration dating and other potential label expansions, post-marketing commitment studies for BIVIGAM and ASCENIV, wages, benefits and stock-based compensation for employees directly related to research and development activities and, prior to April 1, 2019, assay development and testing, storage and transportation costs for high-titer plasma used in the manufacture of ASCENIV prior to its approval by the FDA. All research and development costs are expensed as incurred. InventoriesRaw materials inventory consists of various materials purchased from suppliers, including normal source plasma, that are used in the production of our products. Work-in-process and finished goods inventories reflect the cost of raw materials as well as costs for direct and indirect labor, primarily salaries, wages and benefits for applicable employees, as well as an allocation of overhead costs related to the Boca Facility including utilities, property taxes, general repairs and maintenance, consumable supplies and depreciation. The allocation of Boca Facility overhead to inventory is generally based upon the estimated square footage of the Boca Facility that is used in the production of our products relative to the total square footage of the facility.Inventories, including plasma intended for resale and plasma intended for internal use in the Company’s manufacturing, commercialization or research and development activities, are carried at the lower of cost or net realizable value determined by the first-in, first-out method. Net realizable value is generally determined based upon the consideration we expect to receive when the inventory is sold, less costs to deliver the inventory to the recipient. The estimates for net realizablefair value of inventory are based on contractual termswarrants we issue from time to time in connection with the issuance of notes payable. Changes in our Black-Scholes assumptions, or upon historical experiencean election by us to utilize an alternative method for valuing warrants issued to our lenders, could impact our interest expense and certain other assumptions which we believe are reasonable. Inventory is periodically reviewed to ensure that its carrying value does not exceed its net realizable value, and adjustments are recorded to write down such inventory, with a corresponding charge to costresults of product revenue, when the carrying value or historical cost exceeds its estimated net realizable value.definite-livedfinite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 20202023 and 2019,2022, we determined that there was no impairment of our long-lived assets.We have the option to perform a qualitative assessmentThe testing of goodwill for impairment requires us to determine whether it is more likely thanor not that the fair value of the reporting unit associated with the goodwill is less than its carrying amount, including goodwill and other intangible assets. If we conclude that this is the case, then we must perform a goodwill impairment test by comparing the fair value of the reporting unit to its carrying value. An impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value, with the impairment loss recognized not to exceed the total amount of goodwill allocated to that reporting unit. In order to determine the fair value of the reporting unit, we utilize the fair value of the Company as a whole, as determined by its market capitalization. Determination of the fair value and carrying value of each reporting unit, relative to the fair value of the Company, requires management to employ certain estimates, assumptions and judgment, which we believe are reasonable. However, any changes to these estimates and assumptions could impact our determination of whether or not our goodwill is impaired. We did not recognize any impairment charges related to goodwill for the years ended December 31, 20202023, 2022 and 2019.Recent Accounting PronouncementsIn June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326) (“ASU 2016-13”), which requires financial2021.to be presented at the net amount expected to be collected, with an allowance for credit losses to be deducted from the amortized cost basis of the financial asset such that the net carrying value of the asset is presented as the amount expected to be collected. Under ASU 2016-13, the entity’s statement of operations is required to reflect the measurement of credit losses for newly recognized financial assets, as well as expected increases or decreases in expected credit losses that have taken place during the period. For public business entities, ASU 2016-13 is effective for fiscal years beginning after December 15, 2019. We adopted ASU No. 2016-13 on January 1, 2020, and the adoption of this update did not have a significant impact on our consolidated financial statements.58Table of ContentsIn July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815)” (“ASU 2017-11”). ASU 2017-11 changed the classification analysis of certain equity-linked financial instruments (or embedded features within such instruments) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result have recorded no income tax benefit in the accompanying consolidated financial statements. This valuation allowance reflects our assessment of whether it is more likely than not that we will generate sufficient taxable income in the existencefuture to be able to utilize our deferred tax assets. In determining whether a valuation allowance is warranted, we evaluate factors such as prior earnings history, expected future earnings, carryback and carryforward periods and tax strategies. We consider all positive and negative evidence to estimate if sufficient future taxable income will be generated to realize our deferred tax assets. We consider cumulative losses in recent years to be a significant type of negative evidence, and based on our history of losses, at this time we have not included future projected taxable income as a down round feature. For freestanding equity classified financial instruments, the amendments require entities that present earnings per share (“EPS”) in accordance with ASC 260source of income to recognize the effect of the down round feature when it is triggered. That effect is treated as a dividend and as a reduction of income available to common shareholders in basic EPS. In addition, convertible instruments with embedded conversion options that have down round features are now subject to the specialized guidance for contingent beneficial conversion features in ASC 470-20, “Debt—Debt with Conversion and Other Options.” ASU 2017-11 became effective for us on January 1, 2019, and this update did not have a significant impact on our consolidated financial statements.In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance became effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. We adopted ASU 2016-02 on January 1, 2019 using the option to recognize the cumulative-effect adjustment, if any, as of the date of application, which was also January 1, 2019. As a result, there was no restatement of comparative periods. We recognized right-to-use assets of approximately $1.4 million and corresponding lease liabilities of approximately $1.6 million at the date of adoption. We also elected the “package of practical expedients,” which permits us to not reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. In addition, we elected the short-term lease recognition exemption for all or embedded leases that qualify.20202023 Compared to Year Ended December 31, 201920202023, compared to the year ended December 31, 2019:$ 42,219,783 $ 29,349,083 $ 12,870,700 61,291,426 39,504,238 21,787,188 (19,071,643 ) (10,155,155 ) (8,916,488 ) 5,907,013 2,343,848 3,563,165 4,170,051 2,169,629 2,000,422 715,353 844,938 (129,585 ) 35,050,817 25,910,757 9,140,060 (64,914,877 ) (41,424,327 ) (23,490,550 ) (11,985,066 ) (8,993,379 ) (2,991,687 ) 991,797 (9,962,495 ) 10,954,292 - 11,527,421 (11,527,421 ) 159,598 573,463 (413,865 ) $ (75,748,548 ) $ (48,279,317 ) $ (27,469,231 ) Year Ended December 31, (in thousands) 2023 2022 Increase (Decrease) Revenues Cost of product revenue Gross profit Research and development expenses Plasma center operating expenses Amortization of intangibles Selling, general and administrative expenses Income (loss) from operations Interest expense Loss on extinguishment of debt Other income (expense), net Net loss Adjusted EBITDA * Adjusted net income (loss) * * $42.2$258.2 million for the year ended December 31, 2023, as compared to $154.1 million for the year ended December 31, 2022, an increase of $104.1 million, or approximately 68%. The increase is primarily related to increased sales of our immunoglobulin products, mainly ASCENIV and BIVIGAM, generated by our Boca Facility manufacturing operations in 2023 of $105.8 million, as we continue to experience increased physician, payer and patient acceptance and utilization of ASCENIV and expand our customer base for BIVIGAM, partially offset by a decrease in sales of plasma in our Plasma Collection Centers business segment of $1.5 million. During 2023, we began utilizing a substantial majority of the plasma collected at our plasma collection facilities for our IVIG production, with significantly less emphasis on plasma sales to third-party customers.Year Ended December 31, (in thousands) 2022 2021 Increase (Decrease) Revenues Cost of product revenue Gross profit Research and development expenses Plasma center operating expenses Amortization of intangibles Selling, general and administrative expenses Loss from operations Interest expense Loss on extinguishment of debt Other expense, net Net loss Adjusted EBITDA * Adjusted net loss * * - See Non-GAAP Financial Measures appearing at the end of this discussion 2020,2022, as compared to $29.3$80.9 million during the year ended December 31, 2019,2021, an increase of $12.9$73.1 million, or approximately 44%90%. The increase is mainly due to increased sales of our immunoglobulin products and intermediate fractions generated by our Boca Facility manufacturing operations in 20202022 totaling $14.5$69.2 million partially offset byas we concluded our third full year of commercial sales of BIVIGAM and ASCENIV. We attribute this increase in revenue to the continued expansion of our customer base in 2022 and to increasing physician, payer and patient acceptance of both BIVIGAM and ASCENIV. We also experienced a $1.6$4.0 million decreaseincrease in plasma revenues generated by our Plasma Collection Centers business segment due to increased sales of plasma collection centers business segment.59Table of ContentsOur revenues for the year ended December 31, 2020 were greater than the prior year as a result ofthrough spot market opportunities beyond our continued commercial scale-up for BIVIGAM and ASCENIV following these products’ FDA approvals on May 9, 2019 and April 1, 2019, respectively, as well as from the manufacturing andlong-term supply agreement we entered into in January 2020 to produce and sell intermediate fractions to a certain customer.$61.3$118.8 million for the year ended December 31, 2020,2022, as compared to $39.5$79.8 million for the year ended December 31, 2019, an2021. This increase of $21.8 million. This increase reflects non-recurring production charges of $7.5$39.0 million for the manufacture of BIVIGAM conformance lots at an increased plasma pool production scale in connection with our planned capacity expansion and other production initiatives and investments at the Boca Facility. Cost of product revenue for the year ended December 31, 2020 also reflectsis primarily attributable to volume-related increases in product revenue costs of approximately $22.5 million related to the sale of our immunoglobulin products of $30.4 million and increased product revenue costs related to our ADMA BioCenters business segment in the amount of $4.3 million. In addition, we also experienced an increase in revenues, partially offset by a $7.4 million reduction in unabsorbedother manufacturing expenses resulting from increased production throughput at the Boca Facility.Researchof approximately $4.4 million in fiscal 2022 as compared to fiscal 2021, which is indicative of certain inflationary pressures being experienced by our industry for labor, materials, freight, fuel surcharges and Development ExpensesR&D expenses totaled $5.9third-party services.2020,2022 represents an improvement over the same period of a year ago of $34.1 million and is mainly due to the higher sales volume, the improved margins we are experiencing with BIVIGAM at the larger plasma pool production scale, and to the increased relative contribution of ASCENIV to our total revenues. As a result, we achieved a gross margin of 22.9% for the year ended December 31, 2022, as compared to $2.3a gross margin of 1.4% for the year ended December 31, 2021.2019. The increase is primarily due to $1.4 million of2022 was essentially unchanged from the year ended December 31, 2021, as the lower compensation costs incurred during 2020 for(including stock-based compensation) in 2022 resulting from the testing and development of a new filling line at one2021 resignation of our third-party fill/finishers for a process that has not been approvedformer Chief Medical and Chief Scientific Officer were offset by the FDA, a $1.0 million increase inincreased expenses associated with post-marketing commitment clinical studies mainlyfor ASCENIV and BIVIGAM post-marketing commitments, $0.4 million of costs incurred during 2020 for a study we commenced(see Note 10 to potentially extend ASCENIV’s approved and labeled expiration dating, $0.2 million of expenses in 2020 related to third-party assay development and a $0.2 million non-recurring expense for assistance with a third-party clinical research project.were $4.2increased by $5.6 million to $17.8 million for the year ended December 31, 2020,2022, as compared to $2.2$12.3 million for the year ended December 31, 2019.2021. Plasma center operating expenses consist of certain general and administrative plasma center costs, includinginitial opening, marketing and start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion expenses and computer software fees related to donor collections. The majority of our plasma collection centers have been in a development or start-up stage in fiscal 2022 and 2021.having additional plasmaincreases in donor fees, some of which are specialty programs and promotions by the newly opened centers, in operation in 2020, as well as higherof $10.7 million, employee compensation costs donor fees,of $5.8 million, softgoods and supplies of $3.8 million, depreciation andexpense of $1.1 million, rent expense all related toof $0.5 million, plasma center expansion activities that took placetesting expenses of $2.8 million, travel expense of $0.2 million, software maintenance expense of $0.4 million, janitorial and utilities expense of $0.5 million, professional services of $0.4 million, postage and freight of $0.3 million and advertising expenses of $0.3 million. These amounts were partially offset by a substantial increase in 2020. During the year ended December 31, 2019, we had one plasma collection facilitycollections which resulted in operation. During the year ended December 31, 2020, we opened two additional plasma collection centers and commenced construction and development activities on four additional plasma collection facilities. We expect additional increasesa reduction in our plasma center operating expenses in 2021 as we continue our expansion activities in this business segment.Selling, general and administrative$35.1$52.5 million for the year ended December 31, 2020,2022, an increase of $9.1$9.6 million from the year ended December 31, 2019. The2021. As we continued to support the increase was mainly due to higher employee compensation expenses of $5.1 million related to staffing increases in support of our commercialization efforts for BIVIGAM and ASCENIV as well as the overall growth in the size and scope of our operations. SG&ABoca Facility manufacturing and commercial operations in 2022, we experienced increases in employee compensation and related expenses, wereincluding travel, relocation and recruiting, of $4.6 million, $1.8 million of which is stock-based compensation. We also impactedexperienced increases in 2020 by increased insurance expense of $1.6$1.4 million and marketing consultingutilities of $0.5 million in 2022, as well as an increase in data services and market intelligence fees in the amount of $1.5 million in support of the commercialization efforts for BIVIGAM and ASCENIV. In addition, we incurred professional fees in connection with our ASCENIV commercialization effortsthe Morgan Stanley strategic alternatives process in the amount of $3.1$1.4 million, partially offset by lower travel expenses and information technology consulting fees. We expect our SG&A expenses to continue to increasewith no comparable amount in 2021 as we continue to execute on the various facets of our business plan (see Liquidity and Capital Resources).the Biotest Transactionan acquisition transaction was $0.7 million and $0.8 million for the years ended December 31, 20202022 and 2019, respectively.60Table of Contents$64.9$39.4 million for the year ended December 31, 2020,2022, as compared to $41.4$58.4 million for the year ended December 31, 2019.2021. The increasedecrease in operating loss was mainly due to the increase in costimproved gross profit for the year ended December 31, 2022 of product revenue and other operating expenses,$34.1 million, partially offset by the increaseincreases in revenues.$12.0$19.3 million for the year ended December 31, 2020,2022, as compared to $9.0$13.1 million for the year ended December 31, 2019.2021. The increase reflects a higher average debt principal balance carried in 2020 as compared to 2019 due to the additional draws onindebtedness and increase in amortization of debt discount resulting from the refinancing of our senior credit facility on March 23, 2022. The refinancing transaction resulted in Mayadditional indebtedness at closing in the approximate amount of 2019$51.8 million, and March of 2020our debt principal increased by an additional $3.0 million subsequent to closing as the Hayfin Credit Agreement (see “Liquidity and Capital Resources”), which resulted allowed us to pay “in kind” a portion of our monthly interest obligation in the form of additional indebtedness to the lender. We expect to continue to pay a portion of our monthly interest obligation “in kind” during 2023. As a result, and given the expected continued rise in SOFR, we expect our principal debt principalbalance and the associated interest expense to increase over the course of $42.5 million.Gain/fiscal 2023 as compared to previous years.In December of 2020, we refinanced our subordinated note payable to Biotest with an additional draw on our senior credit facility. As a result of this transaction and the payoff of the Biotest note, we recorded a gain on the extinguishment of debt in the amount of $1.0 million (see Note 8 to the Consolidated Financial Statements). in February of 2019,on March 23, 2022, we incurred a loss on the extinguishment of debt forin the retirementamount of $6.7 million as a result of the redemption premium we paid to retire our previously existing credit facility consistingin the amount of a $6.5$2.0 million, prepayment penalty, and the write-off of $3.5 million of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the previous credit facility.Gain on Transfer of Plasma Center AssetsAs part of the purchase price for the Biotest Assets, we agreed to transfer two of our plasma collection centers to BPC effective January 1, 2019. We had estimated the combined fair value of the two facilities to be $12.6 million, and we recorded a liability in our financial statements for this amount as of the date of the Biotest Transaction. On January 1, 2019, the two plasma collection facilities were transferred to BPC and we recorded a gain on this transfer in the amount of $11.5 million, which reflects the derecognition of the obligation to transfer ownership of the two facilities net of the carrying value of the assets associated with these facilities, primarily property and equipment and inventory, in the amount of $1.1 million.$75.7$65.9 million for the year ended December 31, 2020,2022, as compared to $48.3$71.6 million for the year ended December 31, 2019.2021. The increasedecrease in net loss of approximately $27.5$5.7 million was mainly due to the decrease in operating loss, largely offset by the higher interest expense and loss on extinguishment of debt in 2022.Years Ended December 31, (in thousands) 2023 2022 2021 Net loss Depreciation Amortization Interest expense EBITDA Stock-based compensation IT systems disruption Loss on extinguishment of debt Adjusted EBITDA the higher interest expense.Years Ended December 31, (in thousands) 2023 2022 2021 Net loss Loss on extinguishment of debt IT systems disruption Adjusted net income (loss) As of2020,2023, we had working capital of $133.8$207.2 million, includingprimarily consisting of $172.9 million of inventory, cash and cash equivalents of $55.9$51.4 million and stockholders’ equity$27.4 million of $88.2accounts receivable, partially offset by current liabilities of $49.8 million, as compared to working capital at December 31, 2022 of $71.8$231.1 million, includingprimarily consisting of $163.3 million of inventory, cash and cash equivalents of $26.8$86.5 million and stockholders’ equityaccounts receivable of $26.2$15.5 million, aspartially offset by current liabilities of December 31, 2019.$39.3 million. We have incurred an accumulated deficit of $340.5$506.3 million since inception and although we had positive cash flow from operations of $8.8 million for the year ended December 31, 2023, we had negative cash flows from operations of $102.0$59.5 million and $76.2$112.4 million for the years ended December 31, 20202022 and 2019,2021, respectively. We have funded our operations over the past few years primarily from the sale of our equity securities and debt securities.61Table of ContentsWe expect to continue to spend substantial amounts onfinancings. Our material cash requirements are primarily comprised of:operations, commercial product launches,operations;building additionaland to maintain our plasma collection facilities, product development, quality assurance, regulatory affairsfacilities;conductingcontinued commercialization efforts;product candidatesFDA-approved products; and purchasing clinical trial materials, some of which may be required by the FDA. investments ininventories of raw material plasma and other manufacturing materials. We expectand laboratory testing materials and single use disposables.not be able to continue to generate a sufficient amount of product revenue to achieve profitability until the beginning of 2024 and, as a result, we expect that we will need to continue to finance our operations through additional equity or debt financings or through corporate collaboration and licensing arrangements. Basedon an ongoing basis. We currently anticipate, based upon our current projected revenues, the remaining proceeds we expect to receive from the sale of common stock pursuant to the Sale Agreement (as amended to date) discussed belowrevenue and our projected expenditures, including capital expenditures and continued implementation of our commercialization and expansion activities, we currently believe that our current cash, cash equivalents projected revenue and accounts receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, as currently conducted, into the fourth quarter of 2021. In order to have sufficient cash to fund our operations thereafter, we will need to raise additional capital beforethrough the end of the fourthfirst quarter of 2021. These estimatesfiscal 2025. However, our current outlook with respect to cash flows and timeframesprofitability may change based upon several factors, including the success of our commercial manufacturing ramp-up activities,efforts with respect to the sale of our products and the continued acceptability and reimbursement of BIVIGAM and ASCENIVour immune globulin products by physicians, patients or payers, and the various financing options that may be available to us. We currently have no firm commitments for additional financing, and there can be no assurances that we will be able to secure additional financing on terms that are acceptable to us,whether or at all. Furthermore, if ournot the assumptions underlying our estimatedprojected revenues and expenses are correct. If we are unable to maintain positive cash flow throughout fiscal 2024, we may need to raise additional capital and revenues are incorrect,if such capital is not available due to widespread liquidity constraints or significant market instability that could result from international or global conflicts, economic uncertainty, COVID-19 or other pandemics, inflationary pressures or other factors beyond our control, we may have to raise additional capital sooner than currently anticipated.Our long-term liquidity depends upondelay, curtail or eliminate some of our abilitycommercialization efforts or product development activities. If we are unable to generate sufficient revenue to maintain positive cash flow throughout fiscal 2024 and need to raise additional capital, fund capacity expansion and commercial programs and generate sufficient revenues from our products, several of which have only recently achieved commercial status, to cover our operating expenses and meet our obligations on a timely basis. The COVID-19 pandemic has negatively affected the global economy and created significant volatility and disruption to the financial markets. Failure to secure any necessary financing in a timely manner and on commercially reasonable terms could have a material adverse effect on our business plan and financial performance and we could be forced to delay or discontinue our capacity expansion, commercialization, product development or clinical trial activities, delay or discontinue the approval efforts for any of our product candidates, or potentially cease operations. In addition, we could also be forced to reduce or forgo sales and marketing efforts and forgo attractive business opportunities.Due to numerous risks and uncertainties associated with the COVID-19 pandemic, FDA reviews, inspections and approvals related to our products, patient/payer acceptance of our products, ongoing compliance and maintenance requirements and capacity expansion efforts at the Boca Facility, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures required to fund our commercialization and other development activities. Our current estimates may be subject to change as circumstances regarding our business requirements evolve and are also subject to the effect of potential new government orders, policies and procedures that we must comply with which are outside of our control. As such, these factors raise substantial doubt about our ability to continue as a going concern.We may decide to raise capitaldo so through public or private equity offerings or debt financings, or obtain a bank credit facility orwe may enter into a corporate collaboration andor licensing arrangements.arrangement. The sale of additional equity securities or debt securities,financings, if convertible, could result in dilution to our stockholders and, in such event, the value and potential future market valueprice of our common stock may decline. The incurrenceadditional indebtedness would result in increased fixed obligationsstrategic alternatives, and could also result in covenants that would restrict our operations or other financing alternatives. In addition, we are exploring additional contract manufacturing arrangements and other business developmentthe exploration of value-creating opportunities which may provide additional liquidity to us.August 5, 2020, we entered into an Open Market Sale AgreementDecember 18, 2023 (the “Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”), pursuant to which we could offer and sell, from time to time, at our option, through or to Jefferies, up to an aggregate of $50 million of shares of our common stock. On November 5, 2020, we and Jefferies entered into an amendment to the Sale Agreement (as amended, the “Amended Sale Agreement”) to provide for an increase in the aggregate offering amount under the Sale Agreement, such that as of November 5, 2020, we may offer and sell shares having an additional aggregate offering price of up to $20 million. On February 3, 2021, we entered into an additional amendment to the Sale Agreement to provide for an additional increase in the aggregate offering amount under the Sale Agreement to allow us to sell shares having an aggregate offering price of up to $35.4 million.62Table of ContentsFor the year ended December 31, 2020, we sold 18,537,907 shares of our common stock under the Sale Agreement and received net proceeds in the amount of $42.5 million. Between January 1, 2021 and March 16, 2021, we sold an additional 16,311,084 shares of our common stock under the Sale Agreement and received net proceeds in the amount of $38.3 million, which leaves a remaining gross balance that can be raised under the Sale Agreement of $22.7 million. The net proceeds from this offering are being used for general corporate purposes, which may include (i) the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) supporting the ongoing commercial sales of our IVIG products; (iii) expanding the manufacturing capacity of our Boca Facility, including supply chain functions, and enhancing the robustness of our supply chain oversight; (iv) expanding our plasma collection facility network; and (v) research and development and business development opportunities.On February 11, 2019 (the “Perceptive“Ares Closing Date”), we and all of our subsidiaries entered into a Credit Agreement and Guarantynew senior secured credit facility (the “Perceptive“Ares Credit Agreement”) with Perceptive Credit Holdings II, LP, as the lenderAres Capital Corporation and administrative agent (“Perceptive”certain credit funds affiliated with Ares Capital Corporation (collectively, “Ares”). The PerceptiveAres Credit Agreement as amended, provides for a total of $135.0 million in senior secured term loan facility in a principal amount of $100.0 millioncredit facilities (the “Perceptive“Ares Credit Facility”), comprised consisting of (i) a term loan made onin the Perceptive Closing Date in theaggregate principal amount of $45.0$62.5 million as evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche I Note”) in favor of Perceptive on the Perceptive Closing Date (the “Perceptive Tranche I Loan”),and (ii) a term loanrevolving credit facility in the aggregate principal amount of $27.5$72.5 million (the “Perceptive Tranche II Loan”) evidenced by(collectively, the Company’s issuance“Ares Loans”), both of a promissory note (the “Perceptive Tranche II Note”) in favor of Perceptivewhich were fully drawn on May 3, 2019, (iii) a term loan in the principal amount of $12.5 million evidenced by the Company’s issuance of a promissory note (the “Perceptive Tranche III Note”) in favor of Perceptive on March 20, 2020 (the “Perceptive Tranche III Loan”); and (iv) a term loan in the principal amount of $15 million evidenced by our issuance of a promissory note in favor of Perceptive on December 8, 2020 (the “Perceptive Tranche IV Loan”, and together with the Perceptive Tranche I Loan, the Perceptive Tranche II Loan and the Perceptive Tranche III Loan, the “Perceptive Loans”).Ares Closing Date. The Perceptive Tranche III Loan is the result of an amendment to the Perceptive Credit Agreement that the Company and Perceptive entered into on May 3, 2019 (the “First Perceptive Amendment”), and the Perceptive Tranche III Loan became available to the Company upon the approval of BIVIGAM on May 9, 2019. The Perceptive Tranche IV Loan is the result of an amendment to the PerceptiveAres Credit Facility entered into on December 8, 2020 (the “Second Perceptive Amendment”), which also extended thehas a maturity date of the Perceptive Credit Facility to March 1, 2024December 20, 2027 (the “Maturity“Ares Maturity Date”), subject to acceleration pursuant to the Perceptive Credit Agreement, including upon an Event of Default (as defined in the Perceptive Credit Agreement).PerceptiveAres Closing Date, we used $30.0 millionthe proceeds from the Ares Loans, along with a portion of the Perceptive Tranche I Loanour existing cash on hand, to terminate and pay in full all of the outstanding obligations under its previously existingour previous senior credit agreement with Marathon Healthcare Finance Fund, L.P. (“Marathon”)facility (the “Marathon“Hayfin Credit Facility”). We also used proceeds from with Hayfin Services LLP (“Hayfin”) including the Perceptive Tranche I Loan to: (i) pay a deferred facility fee to Marathonoutstanding principal in the amount of $2.8$158.6 million, (ii) pay a prepayment penalty in the amount $11.1 million, an exit fee of $1.6 million, all accrued and unpaid interest outstanding on the Hayfin Credit Facility as of the Ares Closing date, as well as certain fees and expenses related thereto. In connection with the payoff and termination of the Hayfin Credit Facility, we also wrote off $15.0 million of unamortized debt discount related to Marathonthe Hayfin Credit Facility. As a result of this transaction, we recorded a loss on the extinguishment of the Hayfin Credit Facility in the amount of $6.5$26.2 million, (iii) pay outstanding accrued interest to Marathon in the amount of $0.7 million, and (iv) pay certain fees and expenses incurred in connection with the Perceptive Credit Facility of approximately $1.5 million. In addition, Marathon released $4.0 million of cash to us that was held in a debt service reserve account per the termswhich is mainly comprised of the Marathon Credit Facility. In connection withwrite-off of unamortized debt discount and the First Perceptive Amendment, we paid an additional facility fee to Perceptive in the amount of $0.1 million on May 3, 2019. In connection with the Second Perceptive Amendment, we paid a facility fee to Perceptive in the amount of $0.8 million. The proceeds from the Perceptive Tranche IV Loan were used to retire the $15.0 million subordinated note we had payable to Biotest, which had a maturity date of June 17, 2022.Perceptive Credit Agreementterm loan initially bear interest at the adjusted Term SOFR for a rate per annum equalthree‑month tenor in effect on the day that is two business days prior to 7.5%the first day of the applicable calendar quarter plus 6.50% (the “Initial SOFR Term Loan Applicable Margin”). Borrowings under the greaterrevolving facility initially bear interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of (i) one-month LIBOR and (ii) 3.5%; provided, however, that upon, and during the continuance of, an Event of Default,applicable calendar quarterplus3.75% (the “SOFR Revolving Facility Applicable Margin”). On the Ares Closing Date, the interest rate will automatically increase by an additional 400 basis points. Accruedon the term loan was approximately 11.9% and the interest rate on the revolving facility was approximately 9.1%, representing a weighted-average interest rate of approximately $0.9 million per month is payable10.4%. Prior to Perceptivethe Ares Closing Date, the interest rate on the last day of each month duringHayfin Credit Facility was approximately 13.9%.term of the Perceptive Credit Facility. The rate of interest in effect as of the Perceptive Closing Date and at December 31, 2020 was 11.0%.On theAres Maturity Date, we are required to pay PerceptiveAres the entire outstanding principal amount underlying the PerceptiveAres Loans and any accrued and unpaid interest thereon. TherePrior to the Ares Maturity Date, there are no scheduled principal payments on the Perceptive Loans priorAres Credit Facility, and we are required to make quarterly interest payments during the Maturity Date.term of Ares Credit Facility of approximately $3.7 million. We may prepay the outstanding principal under the revolving facility, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice with no prepayment premium. However, in the event that we prepay an amount under the revolving facility that is greater than 50% of the current $72.5 million outstanding balance, we will still be required to pay interest on 50% of this balance, or $36.3 million, through the term of Ares Credit Facility. We may prepay the outstanding principal on the Perceptive Loansterm loan, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice, subject to the payment to PerceptiveAres of (A) any accrued but unpaid interest on the prepaid principal amount plus (B) a redemptionprepayment premium amount equal to (i) 5.0%the present value as of such date of all remaining required interest payments on the principal amount being repaid plus 1.5% of the prepaid principal amount, if prepaid on or prior to December 31, 2021,the first anniversary of the Ares Closing Date, (ii) 2.0%1.5% of the prepaid principal amount, if prepaid after December 31, 2021the first anniversary of the Ares Closing Date and on or prior to December 31, 2022,the second anniversary of the Ares Closing Date, or (iii) 4.0%1.0% of the prepaid principal amount, if prepaid after December 31, 2022 and on or prior to the third anniversary of the Ares Closing Date.and (iv) 5.0% of the prepaid principal amount, if prepaid any time thereafter and prior to the Maturity Date.63Table of ContentsPerceptiveAres Credit Agreement are secured by a first-priority lien and security interest in substantially all of our tangible and intangible assets, including intellectual property and all of the equity interests in our subsidiaries. The PerceptiveAres Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative covenants include certain financial covenants, including maximum total leverage ratios and a $15.0 million liquidity covenant, and also restrict or limit our ability thatand the ability of our subsidiaries to, among other things and subject to certain exceptions contained in the PerceptiveAres Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to our or our subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Ares Credit Agreement); engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments under the Ares Credit Agreement. As of December 31, 2023, we were in compliance with all of the covenants contained in the Ares Credit Agreement.PerceptiveHayfin Credit Agreement. In addition, we mustwere required (i) at all times prior to the Hayfin Maturity Date to maintain a minimum cash balance of $3.0$6.0 million; and (ii) as of the last day of each fiscal quarter, commencing with the fiscal quarter ended June 30, 2019, report IVIG product and related revenues for the trailing 12-month period that exceed the amounts set forth in the PerceptiveHayfin Credit Agreement, which rangeranged from $31.2 million for the fiscal quarter ended March 31, 2021 to $55.0$75.0 million for the fiscal quarter ending June 30, 2022 to $110.0 million for the fiscal quarter ending September 30, 2023. As of the Ares Closing Date and December 31, 2021. At December 31, 2020,2022, we were in compliance with all of the financial covenants contained in the PerceptiveHayfin Credit Agreement.In February 2020,27,025,000our common stock. Net proceeds after underwriting discounts and expenses associated with the offering were approximately $64.6 million and were used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for working capital, capital expenditures and general corporate purposes.netgross proceeds of $57.5 million. Net proceeds, after underwriting discounts and other expenses associated with the offering, ofwere approximately $88.7 million. The proceeds from this offering$53.8 million, and were used (i) forto advance the commercial sales of our FDA approved products through the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV; (ii) to support the ongoing commercial sales of BIVIGAM and ASCENIV; (iii) to expand the manufacturing capacity of our Boca Facility and enhance our supply chain capabilities; (iv)ASCENIV, to expand our plasma collection facility network; (v) for researchnetwork, to scale up the manufacturing capacity of the Boca Facility and development andmake continuous improvements in order to adhere to cGMP compliance, to explore business development opportunities;opportunities and (vi) for general corporate purposes and other capital expenditures.May 21, 2019,September 3, 2021, we issued 12,937,500entered into a distribution agreement with Raymond James & Associates, Inc., as agent (“Agent”), pursuant to which we may offer and sell, from time to time, at our option, through or to the Agent, up to an aggregate of $50 million of shares of our Common Stock in an underwritten public offering for gross proceeds of $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by us. Thecommon stock (the “Distribution Agreement”). We currently intend to use any net proceeds of $48.4 million from the offering have been used (i) to supportsale of our common stock under the commercial launch of ASCENIV, which commenced in October 2019, (ii) for the commercial re-launch of BIVIGAM, (iii) to expand the manufacturing capacity of the Boca Facility, (iv) for the procurement of raw materials for the manufacturing of ASCENIV and BIVIGAM, (v) to expand our plasma collection facility network; and (vi)Distribution Agreement for general corporate purposes, including procurement of source plasma and other raw materials, supply chain initiatives and production expenditures, working capital, expenditures.$ (102,002,958 ) $ (76,193,504 ) (12,724,680 ) (3,811,838 ) 143,896,655 80,002,625 29,169,017 (2,717 ) 26,752,135 26,754,852 $ 55,921,152 $ 26,752,135 64Table of ContentsYears Ended December 31, (in thousands) 2023 2022 2021 Net cash provided by (used in) operating activities Net cash used in investing activities Net cash (used in) provided by financing activities Net change in cash and cash equivalents Cash and cash equivalents - beginning of year Cash and cash equivalents - end of year UsedProvided by (Used in) Operating ActivitiesOperating Activities2020 was $102.02022 of $59.5 million an increaserepresents a decrease of $25.8$52.9 million from the same period of a year ago, mainly due to the increaseimprovement in net loss.our operating results after giving effect to non-cash items, driven by higher revenues and gross margins, and reductions in accounts receivable related to the timing of shipments and collections from customers. The following table illustrates the primary components of our cash flows from operations:Net loss $ (75,748,548 ) $ (48,279,317 ) Non-cash expenses, gains and losses 7,526,908 5,588,584 Changes in accounts receivable (9,767,371 ) (2,077,478 ) Changes in inventories (28,470,864 ) (34,650,132 ) Changes in prepaid expenses and other current assets (512,873 ) (773,174 ) 5,300,930 4,080,553 (331,140 ) (82,540 ) $ (102,002,958 ) $ (76,193,504 ) Years Ended December 31, (in thousands) 2023 2022 2021 Net loss Non-cash expenses, gains and losses Changes in accounts receivable Changes in inventories Changes in prepaid expenses and other current assets Changes in accounts payable and accrued expenses Other Cash provided by (used) in operations 20202022 was $12.7$13.9 million, which primarily consisted of $7.6$8.7 million for capital expenditures at the Boca Facility, which includesconstruction and buildout of several new plasma collection facilities and $5.2 million for equipment purchases and implementationupgrades to the Boca Facility. Net cash used in investing activities for the year ended December 31, 2021 was $13.5 million, which consisted of our in-house fill/finish capabilities, and $5.1$8.6 million of capital expenditures for the construction and buildout of new plasma collection facilities. Cash used in investing activitiesfacilities and $4.9 million of $3.8 million for the year ended December 31, 2019 was mainly attributable to capital expenditures at the Boca Facility. AlthoughFacility, which included equipment purchases and continued implementation of our in-house fill/finish capabilities. While we do not have no specific materialany firm commitments for material capital expenditures as of December 31, 2020,in 2024, we expect our total capital expenditures will be between $12.0$8.0 million and $20.0$12.0 million for fiscal 2021.Cash provided by of $143.9 million for the year ended December 31, 2020 mainly consisted2023 was $39.0 million, as we reduced our outstanding debt principal by $23.6 million with the refinancing of $88.7our senior debt on December 18, 2023 and paid approximately $12.7 million ofto exit the Hayfin Credit Facility. Net cash provided by financing activities for the year ended December 31, 2022 was $108.9 million, as we received approximately $47.0 in net proceeds received from our underwritten public offering in February 2020, $42.5 million of proceeds received from the Sale Agreement during the second half of 2020 and $12.5 million of proceeds from the Perceptive Tranche III Loan receivedrefinancing of our senior credit facility in March 2020.of 2022 and $64.6 million in net proceeds from the December 9, 2022 public offering of our common stock. Cash provided by financing activities during the year ended December 31, 20192021 was $80.0$121.0 million, which is mainly comprised of the net proceeds received from our May 2019 equity offering in the amount of $48.4$67.3 million and the $31.6 million of net proceeds received from the refinancingsale of our senior credit facilitycommon stock through several sale agreements and $53.8 million from the subsequent Perceptive Tranche II Loan.or changing prices did notimpacted a number of facets of our business during the years ended December 31, 2023, 2022 and 2021 at each of our business segments. We experienced price increases for, among other items, certain raw materials, consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs, among other expenses. Based upon the macroeconomic environment, publicly available information and reports form the U.S. government, we expect this trend to continue in 2024 and potentially longer, which could potentially have a significant impact on our net sales, revenuesfuture results of operations. In addition, some of our third-party inventory purchase agreements provide for annual price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and has resulted in and could continue to result in higher source plasma and other raw material and supplies costs in 2024 and beyond. Also, in a higher inflationary environment, we may not be able to raise the prices of our products to keep up with the rate of inflation. We are unable to predict when these external drivers of inflation will subside.Item 7A. Quantitative and Qualitative Disclosures About Market Risk net loss for the years endedcaps, to mitigate this risk. As of December 31, 2020 or 2019.Item 7A. Quantitative2023, we had $135.0 million outstanding under our senior credit facility that is subject to a variable interest rate. As a result, the effect of a hypothetical, instantaneous and Qualitative Disclosures About Market RiskNot applicable.Item 8. Financial Statementsunfavorable change of 100 basis points in the interest rate would have an approximate $1.4 million annualized negative impact on our earnings and Supplementary DataItem 8. Financial Statements and Supplementary Data Item 9. Changes in and Disagreements With Accountants on Accounting and Financial DisclosureNone.Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 65Item 9A.Controls and Procedures Table of ContentsItem 9A. Controls and Procedures2020.2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’scompany’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any set of controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2020,2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.