PART I
Item 1.	Business	4
Item 1A.	Risk Factors	31
Item 1B.	Unresolved Staff Comments	60
Item 1C.	Cybersecurity	60
Item 2.	Properties	61
Item 3.	Legal Proceedings	61
Item 4.	Mine Safety Disclosures	61
PART II
Item 5.	Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	62
Item 6.	Reserved	63
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	64
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	80
Item 8.	Financial Statements and Supplementary Data	80
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	80
Item 9A.	Controls and Procedures	80
Item 9B.	Other Information	81
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	81
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	81
Item 11.	Executive Compensation	81
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	82
Item 13.	Certain Relationships and Related Transactions, and Director Independence	82
Item 14.	Principal Accounting Fees and Services	82
PART IV
Item 15.	Exhibits, Financial Statement Schedules	82
Item 16.	Form 10-K Summary	86

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our ability to manufacture ASCENIV and BIVIGAM on a commercial scale and further commercialize these products as a result of their approval by the U.S. Food and Drug Administration (the “FDA”) in 2019;

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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;

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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;

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the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates;

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our dependence upon our third-party customers and vendors and their compliance with applicable regulatory requirements;

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our belief that we have addressed the delays experienced with final drug product current Good Manufacturing Practices (“cGMP”) release testing by our third-party vendors by adding additional release testing laboratories to our FDA-approved consortium listed in our drug approval documents;

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our ability to obtain adequate quantities of FDA-approved plasma with proper specifications;

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our plans to increase our supplies of source plasma, our ability to obtain and maintain regulatory compliance and reliance on third-party supply agreements as well as any extensions to such agreements;

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the potential indications for our products and product candidates;

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potential investigational new product applications;

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the acceptability of any of our products, including ASCENIV, BIVIGAM and Nabi-HB, for any purpose, including FDA-approved indications, by physicians, patients or payers;

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our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses;

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Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions;

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concurrence by the FDA with our conclusions concerning our products and product candidates;

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the comparability of results of our hyperimmune and immune globulin (“IG”) products to other comparably run hyperimmune and immune globulin clinical trials;

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the potential for ASCENIV and BIVIGAM to provide meaningful clinical improvement for patients living with Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or Inborn Errors of Immunity, or other immune deficiencies or any other condition for which the products may be prescribed or evaluated;

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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;

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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;

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our ability to develop, manufacture, receive regulatory approval and commercialize our potential pipeline of any new hyperimmune globulins;

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our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy;

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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;

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our estimates regarding revenues, expenses, capital requirements, timing to profitability and positive cash flows and the potential need for and availability of additional financing;

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possible or likely reimbursement levels for our currently marketed products;

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estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM;

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pandemics, or a resurgence of a pandemic, may adversely affect our business, financial condition, liquidity or results of operations; and

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future domestic and global economic conditions including, but not limited to, supply chain constraints, inflationary pressures or performance or geopolitical conditions, including the continuing conflict in Europe or the evolving conflict in the Middle East and surrounding areas.

Item 1.

Business

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Continue to expand the commercial production of our IG products, as well as the commercial presence, penetration and sales of ASCENIV and BIVIGAM for the treatment of patients with PI. We continue to enhance our recruiting initiatives and expand our existing specialty commercial sales force and commercial-facing organization to market ASCENIV and BIVIGAM 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 continue to partner with a network of national distributors to fulfill orders for ASCENIV and BIVIGAM.

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Increase marketing efforts around Nabi-HB.We plan to increase our marketing efforts and attend relevant virtual or in-person medical conferences during 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.

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Expand ASCENIV’s FDA-approved uses. Having received approval by the FDA for ASCENIV as a treatment for PIDD, we may 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 could 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, as well as in other patient populations we may believe are appropriate.

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Improve the Boca Facility’s and ADMA BioCenters’ operating efficiencies, 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 received 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 support revenue goals. Our successful experience in ramping up BIVIGAM to this production scale over the last two years lends confidence to its ability to leverage these same processes for ASCENIV. We began to realize these benefits in the fourth quarter of 2023.

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Broadly Implement Innovative AI Program, ADMAlytics, to improve efficiencies across our supply chain and 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 improve and predict outcomes for production and operational processes. Recently, we successfully produced 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 and production operations.

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Label expansion. Upon regulatory approval, the ongoing post-marketing clinical study of ASCENIV, which has successfully completed enrollment, may provide a label expansion opportunity to include pediatric-aged PI patients as well as additional publications supporting product safety.

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Expand and develop our pipeline with additional specialty plasma and/or hyperimmune immunoglobulin products. Our core competency is in the development, manufacturing, testing and commercialization of plasma-derived therapeutics. We believe there are a number of under-addressed medical conditions for which plasma-derived therapeutics may be beneficial. Utilizing our intellectual property patents, which include our proprietary testing assay and other standardization methods and technologies, we have identified potential new product candidates that we may advance into preclinical activities. As part of expanding our product pipeline, we are looking to develop an S. pneumonia hyperimmune globulin. S. pneumonia is the predominant cause of community-acquired pneumonia in the U.S., ranking as the ninth leading cause of overall mortality. We believe the strategic importance and unmet need are evident in both the prophylactic and therapeutic settings where documented anti-infective resistance is on the rise. Annually, approximately one million U.S. adults contract pneumococcal pneumonia, resulting in 400,000 hospitalizations and a 5-7% mortality rate, of which approximately 7,000 deaths annually are attributable to anti-infective resistance. Despite vaccine availabilities, vaccine-naive and immune-compromised patient populations remain at risk and could potentially benefit from the immediately available neutralizing antibodies conferred with a hyperimmune globulin in both the in-patient and out-patient treatment settings. We estimate that an S. pneumonia hyperimmune globulin, if approved, has the potential to generate peak revenue of $300-500 million.

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Secure new supply contracts for potential contract manufacturing organization (“CMO”) opportunities. We are exploring new potential CMO, contract testing and business development opportunities, which include fill-finish capabilities, with our multi-faceted revenue generation platform, while continuing to fulfill our long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.

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antibody deficiency and recurrent bacterial infections;

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T-lymphocyte deficiency and opportunistic infections;

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other lymphocyte defects causing opportunistic infections;

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neutrophil defects causing immunodeficiency; and

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complement deficiencies.

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Red blood cells – Used to carry oxygen from the lungs to the body;

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White blood cells – Used by the immune system to fight infection;

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Platelets – Used for blood clotting; and

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Plasma – Used to carry the aforementioned components throughout the body and provide support in clotting and immunity.

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completion of extensive preclinical laboratory tests, preclinical, nonclinical and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations and other applicable laws and regulations;

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submission to the FDA of an Investigational New Drug (“IND”) application which must become effective before clinical trials may begin;

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obtaining approval by an Institutional Review Board (“IRB”) at each clinical site before a clinical trial may be initiated at that site;

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performance of adequate and well-controlled clinical trials meeting FDA requirements, commonly referred to as Good Clinical Practices (“GCP”), and other additional requirements for the protection of human research subjects and to establish the safety and efficacy of the product candidate for each proposed indication;

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manufacturing (through an FDA-approved facility) of product in accordance with the FDA’s current Good Manufacturing Practices (“cGMP”) to be used in the clinical trials and providing manufacturing information needed in regulatory filings;

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submission of a BLA to the FDA for marketing approval that includes substantial evidence of safety, purity and potency from results of clinical trials; the results of preclinical testing; detailed information about the Chemistry, Manufacturing, and Controls (“CMC”) and proposed labeling and packaging for the product candidate;

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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;

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satisfactory completion of potential FDA inspections of the preclinical study and clinical trial sites that generate the data in support of the BLA; and

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FDA review and approval of a BLA prior to any commercial marketing, sale or shipment of the product, including agreement on post-marketing commitments, and compliance with any post approval commitments, such as Risk Evaluation and Mitigation Strategies (“REMS”) and post approval studies required by the FDA.

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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.

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Phase II clinical trials are generally conducted in a larger but 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.

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Phase III trials are conducted to establish the overall risk/benefit profile of the product. Certain Phase III clinical trials are referred to as pivotal trials. Phase III clinical trials aim to provide substantial evidence of reproducibility of clinical efficacy and safety results for approval and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

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We have a history of losses and we may, in the future, need to raise additional capital to operate our business, which may not be available on favorable terms, if at all.

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Although we achieved net income on a non-GAAP basis and generated positive cash flows for the year ended December 31, 2023 for the first time, we may not be able to achieve profitability and generate positive cashflows in the future.

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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.

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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.

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Both of our business segments and our facilities are subject to periodic inspections by the FDA, which, depending on the outcome of such inspections, could result in certain FDA actions, including the issuance of observations, notices, citations, warning letters or other enforcement actions.

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Business interruptions could adversely affect our business.

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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.

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With the approval to market ASCENIV, BIVIGAM and Nabi-HB, there can be no assurance that we will be successful in further developing and expanding commercial operations or balancing our research and development activities with our commercialization activities.

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We depend on third-party researchers, developers and vendors to develop, manufacture, supply materials for or test our products and product candidates, and such parties are outside of our control.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Our senior secured credit facility with Ares Capital Corporation and certain of its affiliates (“Ares”) is subject to acceleration in specified circumstances, which may result in Ares taking possession and disposing of any collateral.

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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.

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Cyberattacks and other security breaches could compromise our proprietary and confidential information, which could harm our business and reputation.

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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 the manufacturing processes we have in place to counter transmittable diseases.

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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.

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The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

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expand commercialization and marketing efforts;

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implement additional internal systems, controls and infrastructure;

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hire additional personnel; and

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expand production capacity at the Boca Facility.

•	we may be unable to identify contractors 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;

•	a pandemic, or the resurgence of a pandemic such as the COVID-19 pandemic, could adversely affect our contracted fill/finishers’ operations, supply chain or workforce;

•	our contracted fill/finishers’ resources and level of expertise with plasma-derived biologics may be limited, 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 contractors might be unable to timely provide finished drug product or raw material plasma in sufficient quantity to meet our commercial needs;

•	contractors may not be able to execute our inspection procedures and required tests appropriately;

•	contractors 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;

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contractors may fail to comply with applicable regulatory requirements, placing them and us at risk of regulatory enforcement actions, recalls and other adverse consequences, and which place our patients at risk, which may negatively impact our business and their ability to supply products to meet our development, clinical and commercial needs;

•	our third parties 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.

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unforeseen safety issues;

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determination of dosing issues;

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lack of safety or effectiveness, or other adverse study results during clinical trials;

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slower than expected rates of patient recruitment or noncompliance with clinical trial requirements;

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inability to monitor patients adequately during or after treatment; and

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inability or unwillingness of medical investigators to follow our clinical protocols.

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Delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites and our CROs;

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Regulators requiring us to perform additional or unanticipated clinical trials to obtain approval or becoming subject to additional post-marketing testing, surveillance, or REMS requirements to maintain regulatory approval;

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Failure by our third-party contractors 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 our being required to engage in additional clinical trial site monitoring;

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The cost of clinical trials of our product candidates being greater than we anticipate or our having insufficient funds for a clinical trial or to pay the substantial user fees required by FDA upon the filing of a marketing application;

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Insufficient supply or inadequate quality of our product candidates or other materials necessary to conduct clinical trials;

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Inability to achieve sufficient study enrollment, subjects dropping out or withdrawing from our studies, delays in adding new investigators or clinical trial sites or a withdrawal of clinical trial sites;

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Flaws in our clinical trial design that are not discoverable until the clinical trial has progressed;

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Disagreement by the FDA or comparable foreign regulatory authorities with our intended indications or study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials, finding that a product candidate’s benefits do not outweigh its safety risks or requiring that we conduct additional development or study work;

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The need to make changes to our product candidates that require additional testing or that cause our product candidates to perform differently than expected;

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Global trade policies that may impact our ability to obtain raw materials and/or finished product for commercialization;

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FDA or comparable regulatory authorities taking longer than we anticipate to make decisions on our products or product candidates; and

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Potential inability to demonstrate that a product or product candidate provides an advantage over current standards of care or current or future competitive therapies in development.

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delay commercialization of, and our ability to derive revenues from, our product candidates;

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impose costly procedures on us; and

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diminish any competitive advantages that we may otherwise enjoy.

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restrictions on such products or manufacturing processes;

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restrictions on the labeling or marketing of a product;

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restrictions on product distribution or use;

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clinical holds or termination of clinical trials;

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requirements to conduct further post-marketing studies or clinical trials, implement risk mitigation strategies, or to issue corrective information;

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warning letters or untitled letters;

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withdrawal of the products from the market;

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

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recall of products;

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restrictions on coverage by third-party payers;

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fines, restitution or disgorgement of profits or revenues;

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suspension or withdrawal of marketing approvals;

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refusal to permit the import or export of products;

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FDA debarment, suspension and debarment from government programs, refusal of orders under existing government contracts, exclusion from participation in federal healthcare programs, consent decrees, deferred or non-prosecution agreements or corporate integrity agreements;

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product seizure or detention; or

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injunctions or the imposition of civil penalties or criminal fines.

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our ability to sell our products at competitive prices;

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our ability to maintain features and quality standards for our products sufficient to meet the expectations of our customers;

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our ability to produce and deliver a sufficient quantity of our products in a timely manner to meet our customers’ requirements;

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the impact of a pandemic, or the resurgence of a pandemic, and government responses thereto on our customers and their businesses, operations and financial condition; and

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widespread economic conditions or geopolitical conditions, including the exacerbated conflicts in Europe, the Middle East and the surrounding areas.

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perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;

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cost-effectiveness of our products relative to competing products;

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availability of reimbursement for our products from government or other healthcare payers; and

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the effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

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sales or potential sales of substantial amounts of our common stock;

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delay or failure in initiating or completing preclinical or clinical trials or unsatisfactory results of these trials;

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delay in a decision by Federal, state or local business regulatory authority;

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the timing of acceptance, third-party reimbursement and sales of BIVIGAM and ASCENIV;

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announcements about us or about our competitors, including clinical trial results, regulatory approvals or new product introductions;

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developments concerning our licensors or third-party vendors;

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litigation and other developments relating to our patents or other proprietary rights or those of our competitors;

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conditions in the pharmaceutical or biotechnology industries;

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governmental regulation and legislation;

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overall market volatility;

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global and economic uncertainty;

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variations in our anticipated or actual operating results; and

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change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations.

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the inability of stockholders to call special meetings;

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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

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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.

Item 1B.

Unresolved Staff Comments

Item 1C.

Cybersecurity

Item 2.

Properties

Location	Principal Business Activity	Approximate Square Feet	Owned or expiration date of lease
Ramsey, NJ	Corporate Headquarters	4,200	December 31, 2026 *
Boca Raton, FL	Manufacturing and Administration	84,462	Owned
Boca Raton, FL	Laboratory and Administration	44,495	Owned

Item 3.

Legal Proceedings

Item 4.

Mine Safety Disclosures

Item 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

		Year Ended December 31,
(in thousands)		2023				2022				Increase (Decrease)
Revenues		$	258,215			$	154,080			$	104,135
Cost of product revenue			169,273				118,815				50,458
Gross profit			88,942				35,265				53,677
Research and development expenses			3,300				3,614				(314	)
Plasma center operating expenses			4,266				17,843				(13,577	)
Amortization of intangibles			724				715				9
Selling, general and administrative expenses			59,020				52,458				6,562
Income (loss) from operations			21,632				(39,365	)			60,997
Interest expense			(25,027	)			(19,279	)			(5,748	)
Loss on extinguishment of debt			(26,174	)			(6,670	)			(19,504	)
Other income (expense), net			1,330				(590	)			1,920
Net loss		$	(28,239	)		$	(65,904	)		$	37,665
Adjusted EBITDA *		$	40,251			$	(27,627	)		$	67,878
Adjusted net income (loss) *		$	705			$	(59,234	)		$	59,939

		Year Ended December 31,
(in thousands)		2022				2021				Increase (Decrease)
Revenues		$	154,080			$	80,943			$	73,137
Cost of product revenue			118,815				79,770				39,045
Gross profit			35,265				1,173				34,092
Research and development expenses			3,614				3,646				(32	)
Plasma center operating expenses			17,843				12,289				5,554
Amortization of intangibles			715				715				-
Selling, general and administrative expenses			52,458				42,897				9,561
Loss from operations			(39,365	)			(58,374	)			19,009
Interest expense			(19,279	)			(13,057	)			(6,222	)
Loss on extinguishment of debt			(6,670	)			-				(6,670	)
Other expense, net			(590	)			(217	)			(373	)
Net loss		$	(65,904	)		$	(71,648	)		$	5,744
Adjusted EBITDA *		$	(27,627	)		$	(49,608	)		$	21,981
Adjusted net loss *		$	(59,234	)		$	(71,648	)		$	12,414

		Years Ended December 31,
(in thousands)		2023				2022				2021
Net loss		$	(28,239	)		$	(65,904	)		$	(71,648	)
Depreciation			7,608				6,398				4,780
Amortization			724				715				715
Interest expense			25,027				19,279				13,057
EBITDA			5,120				(39,512	)			(53,096	)
Stock-based compensation			6,187				5,215				3,488
IT systems disruption			2,770				-				-
Loss on extinguishment of debt			26,174				6,670				-
Adjusted EBITDA		$	40,251			$	(27,627	)		$	(49,608	)

		Years Ended December 31,
(in thousands)		2023				2022				2021
Net loss		$	(28,239	)		$	(65,904	)		$	(71,648	)
Loss on extinguishment of debt			26,174				6,670				-
IT systems disruption			2,770				-				-
Adjusted net income (loss)		$	705			$	(59,234	)		$	(71,648	)

•

The collection and procurement of raw material source plasma, which includes plasma donor fees and plasma center supplies, and other raw materials necessary to maintain and scale up our manufacturing operations;

•

Employee compensation and benefits;

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Capital expenditures for equipment upgrades and capacity expansion at the Boca Facility and to maintain our plasma collection facilities;

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Interest on our debt;

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Marketing programs, medical education and continued commercialization efforts;

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Boca Facility maintenance, repairs and supplies;

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Conducting required post-marketing clinical trials for our FDA-approved products; and

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Continuous improvements and updates to our IT infrastructure, laboratory equipment and assays, and facilities and engineering equipment.

		Years Ended December 31,
(in thousands)		2023				2022				2021
Net cash provided by (used in) operating activities		$	8,800			$	(59,508	)		$	(112,369	)
Net cash used in investing activities			(4,981	)			(13,911	)			(13,511	)
Net cash (used in) provided by financing activities			(38,989	)			108,852				121,048
Net change in cash and cash equivalents			(35,170	)			35,433				(4,832	)
Cash and cash equivalents - beginning of year			86,522				51,089				55,921
Cash and cash equivalents - end of year		$	51,352			$	86,522			$	51,089

		Years Ended December 31,
(in thousands)		2023				2022				2021
Net loss		$	(28,239	)		$	(65,904	)		$	(71,648	)
Non-cash expenses, gains and losses			47,162				24,682				10,959
Changes in accounts receivable			(11,917	)			13,072				(15,340	)
Changes in inventories			(9,625	)			(38,556	)			(43,188	)
Changes in prepaid expenses and other current assets			(239	)			(756	)			(1,293	)
Changes in accounts payable and accrued expenses			11,369				8,334				9,697
Other			289				(380	)			(1,556	)
Cash provided by (used) in operations		$	8,800			$	(59,508	)		$	(112,369	)

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Item 8.

Financial Statements and Supplementary Data

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9A.

Controls and Procedures