ADMA BIOLOGICS, INC. - Annual Report: 2022 (Form 10-K)

 

UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One)

Commission File Number: 001-36728

 

Delaware		56-2590442
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

 

465 State Route 17, Ramsey, New Jersey		07446
(Address of Principal Executive Offices)		(Zip Code)

 

 Registrant’s telephone number, including area code: (201) 478-5552 

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

 

Title of each class	Trading Symbol	Name of each exchange on which registered
Common stock, par value $0.0001 per share	ADMA	Nasdaq Global Market

 

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

 

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

 

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

 

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

 

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

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated Filer	☐	Accelerated Filer	☐
Non-accelerated Filer	☒	Smaller Reporting Company	☒
		Emerging Growth Company	☐

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

 

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

 

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.  ☐

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

The aggregate market value of the registrant’s common stock held by non-affiliates was $372,622,681 as of June 30, 2022 (the last business day of the registrant’s most recently completed second fiscal quarter), based on a total of 188,193,273 shares of common stock held by non-affiliates and a closing price of $1.98 as reported on the Nasdaq Global Market on June 30, 2022. 

 

As of March 17, 2023, there were 222,155,625 shares of the issuer’s common stock outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Portions of the ADMA Biologics, Inc. definitive proxy statement to be filed pursuant to Regulation 14A within 120 days after the end of the fiscal year are incorporated by reference into Part III of this Annual Report on Form 10-K and certain documents are incorporated by reference into Part IV.

 

PART I
Item 1.	Business	3
Item 1A.	Risk Factors	30
Item 1B.	Unresolved Staff Comments	60
Item 2.	Properties	60
Item 3.	Legal Proceedings	60
Item 4.	Mine Safety Disclosures	60
PART II
Item 5.	Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	61
Item 6.	Reserved	61
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	62
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	73
Item 8.	Financial Statements and Supplementary Data	73
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	73
Item 9A.	Controls and Procedures	73
Item 9B.	Other Information	74
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	74
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	75
Item 11.	Executive Compensation	75
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	75
Item 13.	Certain Relationships and Related Transactions, and Director Independence	75
Item 14.	Principal Accounting Fees and Services	76
PART IV
Item 15.	Exhibits, Financial Statement Schedules	76
Item 16.	Form 10-K Summary	81

•

our ability to manufacture BIVIGAM and ASCENIV 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;

•

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;

•

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 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;

•

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;

•

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;

•

the comparability of results of our hyperimmune and immune globulin (“IG”) 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, Primary Humoral Immunodeficiency Disease or Inborn Errors of Immunity (“PIDD”, “PI” or “IEI”) 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;

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

•

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;

•

effects of the coronavirus COVID-19 pandemic and other potential pandemics 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 and other potential pandemics; and

•

future domestic and global economic conditions, including, but not limited to, supply chain constraints, inflationary pressures or performance.

Item 1.

Business

•

Continue to expand the commercial production of our IG products, as well as the commercial presence, penetration and sales of BIVIGAM and ASCENIV for the treatment of patients with PI. Subject to the continuing restrictions surrounding COVID-19, we continue to enhance our recruiting initiatives and expand our existing specialty commercial sales force and commercial-facing organization to market 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, scientific affairs and third-party reimbursement. We currently use and may continue to partner with a network of national distributors to fulfill orders for BIVIGAM and ASCENIV. We have implemented and continue to implement virtual customer engagement programs to adapt to restrictions in place due to COVID-19, as well as continue with our in-person presence with customers and healthcare professionals and attend appropriate trade-related and scientific medical conferences as COVID-19 restrictions ease in various geographic regions of the country.

•

Increase marketing efforts around Nabi-HB. Subject to the restrictions surrounding COVID-19, we plan to increase our marketing efforts and attend relevant virtual or in-person medical conferences during 2022, 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.

•

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 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.

•

Improve the Boca Facility’s and ADMA BioCenters’ operating efficiencies, yields and gross margins. During 2023, we plan to continue to execute on the capacity optimization efforts we put in place during 2021 to increase the Boca Facility’s manufacturing capacity throughput, while seeking additional operating efficiencies and gross margin improvements. We also plan to strengthen our supply chain capabilities to potentially unlock efficiencies, improve production yields and provide more control and visibility for timing of commercial product releases for all of our FDA-approved commercial products. 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 corporate 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. The Company’s 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 believe these benefits could be realized as early as the second half of 2023.

•

Label expansion. The ongoing post-marketing clinical studies may provide label expansion opportunities for both BIVIGAM and ASCENIV to include pediatric-aged PI patients as well as additional publications supporting product safety.

•

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.

•

Develop and expand our plasma collection center network. We plan on expanding our plasma collection network with the goal of having 10 FDA-licensed plasma collection facilities operating in the U.S. by the end of 2023 as we seek to achieve plasma supply self-sufficiency over the next few years and prepare for production ramp-up and growth to capitalize on the global growing IVIG and source plasma markets, including obtaining FDA licenses for each new plasma collection center and regulatory approval in additional jurisdictions.

•

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 newly secured, long-term CMO supply agreement to produce and sell plasma-derived intermediate fractions.

•

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.

•

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;

•

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

•

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;

•

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.

•

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 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.

•

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.

Item 1A.

Risk Factors

•

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.

•

We are currently not profitable and may never become profitable.

•

The COVID-19 pandemic or other pandemics and efforts to reduce their 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.

•

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 inspections, could result in certain FDA actions, including the issuance of observations, notices, citations or warning letters.

•

Business interruptions could adversely affect our business.

•

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 further 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 for or test our 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.

•

Our senior credit facility with Hayfin Services LLP (“Hayfin”) is subject to acceleration in specified circumstances, which may result in Hayfin 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.

•

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;

•

hire additional personnel;

•

expand and build out our plasma center network; and

•

expand production capacity at the Boca Facility.

•	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;

•	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;

•

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

•	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.

•

unforeseen safety issues;

•

determination of dosing issues;

•

lack of safety or effectiveness during clinical trials;

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slower than expected rates of patient recruitment;

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inability to monitor patients adequately during or after treatment; and

•

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

•

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;

•

impose costly procedures on us; and

•

diminish any competitive advantages that we may otherwise enjoy.

•

restrictions on such products or manufacturing processes;

•

restrictions on the labeling or marketing of a product;

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restrictions on product distribution or use;

•

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;

•

warning letters or untitled letters;

•

withdrawal of the products from the market;

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

•

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;

•

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;

•

product seizure or detention; or

•

injunctions or the imposition of civil penalties or criminal fines.

•

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;

•

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.

•

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.

•

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;

•

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.

•

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.

Item 1B.

Unresolved Staff Comments

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 6.

Reserved

Item 7.

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

		Year Ended December 31,
		2022				2021				Increase (Decrease)
Revenues		$	154,079,692			$	80,942,625			$	73,137,067
Cost of product revenue			118,814,535				79,769,341				39,045,194
Gross profit			35,265,157				1,173,284				34,091,873
Research and development expenses			3,613,764				3,646,060				(32,296	)
Plasma center operating expenses			17,843,096				12,288,723				5,554,373
Amortization of intangibles			715,353				715,353				-
Selling, general and administrative expenses			52,458,024				42,896,889				9,561,135
Loss from operations			(39,365,080	)			(58,373,741	)			19,008,661
Interest expense			(19,279,373	)			(13,056,834	)			(6,222,539	)
Loss on extinguishment of debt			(6,669,941	)			-				(6,669,941	)
Other expense, net			(589,556	)			(217,043	)			(372,513	)
Net loss		$	(65,903,950	)		$	(71,647,618	)		$	5,743,668

•

The procurement of raw material plasma and other raw materials necessary to maintain and scale up our manufacturing operations;

•

Employee compensation and benefits;

•

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

•

Plasma donor fees and plasma center supplies;

•

Interest on our debt;

•

Marketing programs and continued commercialization efforts;

•

Boca Facility maintenance, repairs and supplies; and

•

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

		Year Ended December 31,
		2022				2021
Net cash used in operating activities		$	(59,508,257	)		$	(112,368,982	)
Net cash used in investing activities			(13,911,171	)			(13,511,258	)
Net cash provided by financing activities			108,851,852				121,048,206
Net change in cash and cash equivalents			35,432,424				(4,832,034	)
Cash and cash equivalents - beginning of period			51,089,118				55,921,152
Cash and cash equivalents - end of period		$	86,521,542			$	51,089,118

		Year Ended December 31,
		2022				2021
Net loss		$	(65,903,950	)		$	(71,647,618	)
Non-cash expenses, gains and losses			24,680,958				10,959,055
Changes in accounts receivable			13,071,809				(15,339,567	)
Changes in inventories			(38,555,957	)			(43,188,489	)
Changes in prepaid expenses and other current assets			(755,900	)			(1,292,779	)
Changes in accounts payable and accrued expenses			8,334,553				9,697,041
Other			(379,770	)			(1,556,625	)
Cash used in operations		$	(59,508,257	)		$	(112,368,982	)

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

Item 9B.

Other Information

Item 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 10.

Directors, Executive Officers and Corporate Governance

Item 11.

Executive Compensation

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13.

Certain Relationships and Related Transactions, and Director Independence

Item 14.

Principal Accounting Fees and Services

Item 15.

Exhibits, Financial Statement Schedules

	Page
Report of Independent Registered Public Accounting Firm	F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021	F-4
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021	F-5
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021	F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021	F-7
Notes to Consolidated Financial Statements	F-8

Exhibit No.		Description
2.1		Master Purchase and Sale Agreement, dated as of January 21, 2017, by and among Biotest Pharmaceuticals Corporation, ADMA BioManufacturing, LLC, ADMA Biologics, Inc., Biotest AG and Biotest US Corporation (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2017).
3.1		Second Amended and Restated Certificate of Incorporation of the Company (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on August 23, 2019).
3.1.1		Certificate of Amendment of the Second Amended and Restated Certificate of Incorporation of ADMA Biologics, Inc., dated as of May 27, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on May 28, 2021).
3.2		Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on October 7, 2016).
3.3		Certificate of Designation of Series A Junior Participating Preferred Stock of ADMA Biologics, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2021).
4.1		Specimen Common Stock Certificate (incorporated herein by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Current Report on Form 8-K/A, filed with the SEC on March 29, 2012).
4.2		Warrant Agreement, dated December 21, 2012, issued by the Company to Hercules Technology Growth Capital, Inc. (incorporated herein by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on February 11, 2013).
4.3		Form of Warrant Agreement, dated May 13, 2016, issued by the Company to Oxford Finance LLC (incorporated herein by reference to Exhibit 4.6 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2016).
4.4		Warrant to Purchase Stock, dated October 10, 2017, issued by the Company to Marathon Healthcare Finance Fund, L.P. (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on October 11, 2017).
4.5		Warrant to Purchase Stock, dated February 11, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
4.6		Warrant to Purchase Stock, dated May 3, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2019).
4.7		Warrant to Purchase Stock, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, LP (incorporated by reference to Exhibit 4.7 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 24, 2021).
4.8		Note, dated February 11, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
4.9		Note, dated May 3, 2019, issued by the Company to Perceptive Credit Holdings II, LP (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed with the SEC on May 3, 2019).

4.10		Note, dated December 8, 2020, issued by the Company to Perceptive Credit Holdings II, L.P. (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 9, 2020).
4.11		Description of Securities Registered under Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.11 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2022).
4.12		Form of Warrant to Purchase Stock, in the form issued by the Company to various entities affiliated with Hayfin Services LLP, dated as of March 23, 2022 (incorporated by reference to Exhibit 4.13 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2022).
10.1†		2007 Employee Stock Option Plan, as amended by Amendment No. 3 (incorporated herein by reference to Exhibit A to the Information Statement on Schedule 14C, filed with the SEC on October 29, 2012).
10.2†		Amended and Restated ADMA Biologics, Inc. 2014 Omnibus Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-8, filed with the SEC on August 18, 2017).
10.3†		Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc. and Adam Grossman (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 29, 2019).
10.3.1†		Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc. and Adam Grossman (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021).
10.4†		Amended and Restated Employment Agreement, dated January 29, 2019, by and between ADMA Biologics, Inc. and Brian Lenz (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on January 29, 2019).
10.4.1†		Amendment to Employment Agreement, dated as of September 29, 2021, by and between ADMA Biologics, Inc. and Brian Lenz (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on October 1, 2021).
10.5+		Plasma Purchase Agreement, dated as of November 17, 2011, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc., as amended by First Amendment to Plasma Purchase Agreement, dated as of December 1, 2011, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.9 to Amendment No. 3 to the Company’s Current Report on Form 8-K/A, filed with the SEC on June 22, 2012).
10.5.1+		Second Amendment to Plasma Purchase Agreement, dated as of December 18, 2015, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.3.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 23, 2016).
10.5.2		Third Amendment to Plasma Purchase Agreement, dated as of April 8, 2016, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.3.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 13, 2016).
10.5.3		Fourth Amendment to Plasma Purchase Agreement, dated as of June 6, 2017, by and between Biotest Pharmaceuticals Corporation and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.9 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
10.5.4+		Fifth Amendment to Plasma Purchase Agreement, dated as of January 1, 2019, by and between Grifols Worldwide Operations Limited (as successor-in-interest to Biotest Pharmaceuticals Corporation) and ADMA Biologics, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 2, 2019).

10.6+		Plasma Supply Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
10.6.1+		Amendment #1 to the Plasma Supply Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 10, 2018).
10.7+		Plasma Purchase Agreement, dated as of June 6, 2017, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
10.7.1+		Amendment to Plasma Purchase Agreement, dated as of July 19, 2018, by and between Biotest Pharmaceuticals Corporation and ADMA BioManufacturing, LLC (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 10, 2018).
10.8		Amended and Restated Agreement for Services, effective as of January 1, 2016, as amended, by and between ADMA Biologics, LLC and Areth LLC (incorporated herein by reference to Exhibit 10.18 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 12, 2016).
10.9		Lease, effective as of February 17, 2017, by and between Home Center Properties, LLC and ADMA BioCenters Georgia Inc. (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on February 24, 2017).
10.10		Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K, filed with the SEC on February 13, 2012).
10.11		Credit Agreement and Guaranty, dated as of February 11, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).
10.12		Amendment No. 1 to Credit Agreement and Guaranty, dated as of May 3, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2019).
10.13		Amendment No. 2 to the Credit Agreement and Guaranty, dated December 8, 2020, by and among the Company, ADMA Plasma Biologics, Inc., ADMA BioCenters Georgia Inc., ADMA BioManufacturing, LLC and Perceptive Credit Holdings II, LP. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 9, 2020).
10.14		Security Agreement, dated as of February 11, 2019, by and among the Company, ADMA Plasma Biologics, Inc., ADMA Bio Centers Georgia Inc., ADMA BioManufacturing, LLC, and Perceptive Credit Holdings II, LP. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on February 12, 2019).

10.15+		License Agreement, effective as of December 31, 2012, by and between ADMA Biologics, Inc. and Biotest AG (incorporated herein by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1, filed with the SEC on February 11, 2013).
10.15.1		First Amendment to License Agreement, dated as of June 6, 2017, by and between the Company and Biotest AG (incorporated herein by reference to Exhibit 10.8 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 11, 2017).
10.16+		Manufacturing Agreement, dated as of September 30, 2011, by and between ADMA BioManufacturing, LLC (as successor-in-interest to Biotest Pharmaceuticals Corporation) and Sanofi Pasteur S.A. (incorporated herein by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
10.16.1+		Amendment #2 to the Manufacturing Agreement, effective as of August 1, 2016, by and between ADMA BioManufacturing, LLC (as successor-in-interest to Biotest Pharmaceuticals Corporation) and Sanofi Pasteur S.A. (incorporated herein by reference to Exhibit 10.24.1 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
10.16.2+		Amendment #3 to the Manufacturing Agreement, effective as of December 21, 2017, by and between ADMA BioManufacturing, LLC and Sanofi Pasteur S.A. (incorporated herein by reference to Exhibit 10.24.2 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 29, 2018).
10.17		Stockholders Agreement, dated as of June 6, 2017, by and between the Company and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on June 12, 2017).
10.18+		Transition Services Agreement, dated as of January 1, 2019, by and between the Company and Biotest Pharmaceuticals Corporation (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 13, 2019).
10.19++		Amendment #1 to Transition Services Agreement, dated as of August 29, 2019, by and between ADMA BioManufacturing, LLC and Biotest Pharmaceuticals Corporation (incorporated by reference from Exhibit 10.1 to Current Report on Form 8-K, filed on September 5, 2019).
10.20		Amendment 3 to the Amended and Restated Agreement for Services, effective as of November 7, 2019, by and between ADMA Biologics, LLC and Areth LLC (incorporated herein by reference to the Exhibit 10.27 to the Company’s Annual Report on Form 10-K filed March 12, 2020).
10.21		Amendment 4 to the Amended and Restated Agreement For Services Between ADMA BioManufacturing, LLC and Areth LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on November 9, 2022).
10.22		Distribution Agreement, dated September 3, 2021, by and between ADMA Biologics, Inc. and Raymond James & Associates, Inc. (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on September 3, 2021).
10.23		Form of Retention Bonus Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 1, 2021).
10.24		Separation Agreement and Release, dated August 6, 2021, by and between ADMA Biologics, Inc. and James Mond (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on August 11, 2021).
10.25		Credit Agreement and Guaranty, dated as of March 23, 2022, by and among the Company, Hayfin Services LLP and the lenders party thereto (incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2022).

10.25.1*		Amendment No. 1 to Credit Agreement and Guaranty, dated March 23, 2023 by and among the Company, Hayfin Services LLP and the lenders party thereto.
10.26		Security Agreement, dated as of March 23, 2022, by and among the Company, certain subsidiaries of the Company and Hayfin Services LLP (incorporated by reference to Exhibit 10.25 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 24, 2022).
10.27†		ADMA Biologics, Inc. 2022 Equity Compensation Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the Commission on June 21, 2022)
21.1*		Subsidiaries of the Company.
23.1*		Consent of CohnReznick LLP.
31.1*		Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*		Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*		The following materials from ADMA Biologics, Inc. Form 10-K for the year ended December 31, 2022, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets at December 31, 2022 and December 31, 2021, (ii) Consolidated Statements of Operations for the years ended December 31, 2022 and 2021, (iii) Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021; and (v) Notes to Consolidated Financial Statements.

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Item 16.

Form 10-K Summary

	ADMA Biologics, Inc.
Date: March 23, 2023	By:	/s/ Adam S. Grossman
	Name: Title:	Adam S. Grossman President and Chief Executive Officer

Signature		Title		Date
/s/ Adam S. Grossman
Adam S. Grossman		President and Chief Executive Officer (Principal Executive Officer) and Director		March 23, 2023
/s/ Brian Lenz
Brian Lenz		Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)		March 23, 2023
/s/ Steven A. Elms
Steven A. Elms		Chairman of the Board of Directors		March 23, 2023
/s/ Dr. Jerrold B. Grossman
Dr. Jerrold B. Grossman		Vice Chairman of the Board of Directors		March 23, 2023
/s/ Martha J. Demski
Martha J. Demski		Director		March 23, 2023
/s/ Bryant E. Fong
Bryant E. Fong		Director		March 23, 2023
/s/ Lawrence P. Guiheen
Lawrence P. Guiheen		Director		March 23, 2023
/s/ Young T. Kwon
Young T. Kwon		Director		March 23, 2023

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

 

CONSOLIDATED FINANCIAL STATEMENTS

 

TABLE OF CONTENTS

		Page
Report of Independent Registered Public Accounting Firm (PCAOB ID )596		F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021		F-4
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021		F-5
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2022 and 2021		F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021		F-7
Notes to Consolidated Financial Statements		F-8

/s/ CohnReznick LLP
We have served as the Company’s auditor since 2008.
Parsippany, New Jersey
March 23, 2023

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

December 31, 2022 and 2021

 

		December 31,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	86,521,542			$	51,089,118
Accounts receivable, net			15,505,048				28,576,857
Inventories			163,280,047				124,724,091
Prepaid expenses and other current assets			5,095,146				4,339,245
Total current assets			270,401,783				208,729,311
Property and equipment, net			58,261,481				50,935,074
Intangible assets, net			1,013,415				1,728,768
Goodwill			3,529,509				3,529,509
Right to use assets			10,485,447				7,262,658
Deposits and other assets			4,770,246				4,067,404
TOTAL ASSETS		$	348,461,881			$	276,252,724
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	13,229,390			$	12,429,409
Accrued expenses and other current liabilities			24,989,349				17,214,988
Current portion of deferred revenue			142,834				142,834
Current portion of lease obligations			905,369				591,084
Total current liabilities			39,266,942				30,378,315
Senior notes payable, net of discount			142,833,063				94,866,239
Deferred revenue, net of current portion			1,833,031				1,975,865
End of term fee			1,500,000				-
Lease obligations, net of current portion			10,704,176				7,462,388
Other non-current liabilities			350,454				397,351
TOTAL LIABILITIES			196,487,666				135,080,158
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding			-				-
Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 221,816,930 and 195,813,817 shares issued and outstanding			22,182				19,581
Additional paid-in capital			629,968,704				553,265,706
Accumulated deficit			(478,016,671	)			(412,112,721	)
TOTAL STOCKHOLDERS’ EQUITY			151,974,215				141,172,566
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	348,461,881			$	276,252,724

    

The accompanying notes are an integral part of these consolidated financial statements.

 

 ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

Years Ended December 31, 2022 and 2021

 

		Years Ended December 31,
		2022				2021
REVENUES:
Product revenue		$	153,936,858			$	80,799,791
License revenue			142,834				142,834
Total revenues			154,079,692				80,942,625
Cost of product revenue			118,814,535				79,769,341
Gross profit			35,265,157				1,173,284
OPERATING EXPENSES:
Research and development			3,613,764				3,646,060
Plasma center operating expenses			17,843,096				12,288,723
Amortization of intangible assets			715,353				715,353
Selling, general and administrative			52,458,024				42,896,889
Total operating expenses			74,630,237				59,547,025
LOSS FROM OPERATIONS			(39,365,080	)			(58,373,741	)
OTHER INCOME (EXPENSE):
Interest income			44,833				34,532
Interest expense			(19,279,373	)			(13,056,834	)
Loss on extinguishment of debt			(6,669,941	)			-
Other expense			(634,389	)			(251,575	)
Other expense, net			(26,538,870	)			(13,273,877	)
NET LOSS		$	(65,903,950	)		$	(71,647,618	)
BASIC AND DILUTED LOSS PER COMMON SHARE		$	(0.33	)		$	(0.51	)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted			197,874,895				139,578,538

    

The accompanying notes are an integral part of these consolidated financial statements. 

  

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

Years Ended December 31, 2022 and 2021

  

										Additional								Total
		Common Stock								Paid-in				Accumulated				Stockholders’
		Shares				Amount				Capital				Deficit				Equity
Balance at December 31, 2020			104,902,888			$	10,490			$	428,704,039			$	(340,465,103	)		$	88,249,426
Stock-based compensation			-				-				3,488,253				-				3,488,253
Issuance of common stock, net of offering expenses			90,846,029				9,085				121,135,018				-				121,144,103
Vesting of Restricted Stock Units, net of shares withheld for taxes and retired			64,900				6				(61,604	)			-				(61,598	)
Net loss			-				-				-				(71,647,618	)			(71,647,618	)
Balance at December 31, 2021			195,813,817				19,581				553,265,706				(412,112,721	)			141,172,566
Stock-based compensation			-				-				5,214,531				-				5,214,531
Warrants issued in connection with note payable			-				-				9,569,604				-				9,569,604
Vesting of Restricted Stock Units, net of shares withheld for taxes			1,808,561				181				(2,899,021	)			-				(2,898,840	)
Stock options exercised			68,679				7				175,008				-				175,015
Issuance of common stock, net of offering expenses			24,125,873				2,413				64,642,876				-				64,645,289
Net loss			-				-				-				(65,903,950	)			(65,903,950	)
Balance at December 31, 2022			221,816,930			$	22,182			$	629,968,704			$	(478,016,671	)		$	151,974,215

   

The accompanying notes are an integral part of these consolidated financial statements. 

    

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

Years Ended December 31, 2022 and 2021

 

		Years Ended December 31,
		2022				2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss		$	(65,903,950	)		$	(71,647,618	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			7,113,369				5,495,502
Loss on disposal of fixed assets			426,536				220,761
Interest paid in kind			2,997,746				-
Stock-based compensation			5,214,531				3,488,253
Amortization of debt discount			2,401,669				1,897,373
Loss on extinguishment of debt			6,669,941				-
Amortization of license revenue			(142,834	)			(142,834	)
Changes in operating assets and liabilities:
Accounts receivable			13,071,809				(15,339,567	)
Inventories			(38,555,957	)			(43,188,489	)
Prepaid expenses and other current assets			(755,900	)			(1,292,779	)
Deposits and other assets			122,468				(1,775,205	)
Accounts payable			799,981				1,355,700
Accrued expenses			7,534,572				8,341,341
Other current and non-current liabilities			(502,238	)			218,580
Net cash used in operating activities			(59,508,257	)			(112,368,982	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment			(13,911,171	)			(13,511,258	)
Net cash used in investing activities			(13,911,171	)			(13,511,258	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Principal payments on notes payable			(100,000,000	)			-
Proceeds from issuance of common stock, net of offering expenses			64,645,289				121,144,103
Payment of debt refinancing fees			(2,000,000	)			-
Proceeds from issuance of note payable			151,750,000				-
Taxes paid on vested Restricted Stock Units			(2,898,840	)			(61,598	)
Payments on finance lease obligations			(36,684	)			(34,299	)
Proceeds from the exercise of stock options			175,015				-
Payment of deferred financing fees			(2,782,928	)			-
Net cash provided by financing activities			108,851,852				121,048,206
Net increase (decrease) in cash and cash equivalents			35,432,424				(4,832,034	)
Cash and cash equivalents - beginning of year			51,089,118				55,921,152
Cash and cash equivalents - end of year		$	86,521,542			$	51,089,118

   

The accompanying notes are an integral part of these consolidated financial statements.