# ADMA BIOLOGICS, INC. (ADMA) FY 2023 MD&A

Verbatim Item 7 Management's Discussion and Analysis from ADMA BIOLOGICS, INC.'s 10-K for fiscal year 2023.

SEC filing source: https://www.sec.gov/Archives/edgar/data/1368514/000114036124010147/ef20015264_10k.htm
Accession: 0001140361-24-010147
Filing date: 2024-02-28
Report date: 2023-12-31
Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary.
Confidence: high

Company profile: /company/ADMA/
All MD&A years: /company/ADMA/mda/
Previous year: /company/ADMA/mda/fy2022/ (FY 2022)
Next year: /company/ADMA/mda/fy2024/ (FY 2024)

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form
10-K. The various sections of this discussion contain a number of forward-looking statements, all of which are based on our current expectations and could be materially affected by the uncertainties and risk factors described throughout this Annual
Report. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially.

OVERVIEW

Our Business

ADMA Biologics, Inc. (the “Company,” “ADMA,” “we,” “us” or “our”) is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of
immunodeficient patients at risk for infection and others at risk for certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be
immune-suppressed for medical reasons.

Through our ADMA BioManufacturing business segment, we currently have three products with U.S. Food and Drug Administration (the “FDA”) approval, all of which are currently marketed and commercially available: (i)
ASCENIV (Immune Globulin Intravenous, Human – slra 10% Liquid), an Intravenous Immune Globulin (“IVIG”) product indicated for the treatment of Primary Humoral Immunodeficiency (“PI”), also known as Primary Immunodeficiency Disease (“PIDD”) or
Inborn Errors of immunity in adults and adolescents, for which we received FDA approval on April 1, 2019 and commenced first commercial sales in October 2019; (ii) BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the
treatment of PI, and for which we received FDA approval on May 9, 2019 and commenced commercial sales in August 2019; and (iii) Nabi-HB (Hepatitis B Immune Globulin, Human), which is indicated for the treatment of acute exposure to blood containing
HBsAg and other listed exposures to Hepatitis B. We seek to develop a pipeline of plasma-derived therapeutics, including a product based on our most recently approved patent application under U.S. Patent No. 10,259,865 related to methods of
treatment and prevention of S. pneumonia infection for an immunoglobulin manufactured to contain standardized antibodies to numerous serotypes of S. pneumoniae. Our
products and product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with or at risk for certain infectious diseases.

We manufacture these products at our FDA-licensed, plasma fractionation and purification facility located in Boca Raton, Florida with a peak annual processing capability of up to 600,000 liters (the “Boca Facility”).
Based on current production yields, our completed and ongoing supply chain enhancements and capacity expansion initiatives, we believe this facility has the potential to produce sufficient quantities of our immune globulin (“IG”) products
representing annual revenues of approximately $330 million in 2024 and potentially $380 million in 2025. At these revenue levels, we forecast achieving consolidated gross margins in the range of 40-50% and net income margins in the range of 20-30%.
These assumptions translate to potential fiscal year 2024 and 2025 net income of $65 million and $115 million or more and adjusted EBITDA of $90 million and $140 million or more, respectively.

For the year ended December 31, 2023 we had a net loss of loss of $28.2 million and achieved adjusted net income of $0.7 million which, as further described under “Non-GAAP Financial Measures”, excludes charges related
to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million (see Management’s Discussion and Analysis of Financial Condition and Results of Operations). We also achieved positive cash flow from operations for
the year ended December 31, 2023 for the first time in the Company’s history, primarily as a result of our significant revenue growth and continued physician, patient and payer acceptance of ASCENIV and BIVIGAM that we have experienced over the
past several years.

Through our ADMA BioCenters subsidiary, we currently operate ten source plasma collection facilities in the U.S., all of which hold FDA licenses. This business unit, which we refer to as our Plasma Collection Centers
business segment, provides us with the blood plasma required for the manufacture of our products, and also allows us to sell certain quantities of source and hyperimmune plasma to third-party customers for further manufacturing. In addition, three
of our FDA-approved plasma collection centers also have approvals from the Korean Ministry of Food and Drug Safety (“MFDS”), as well as FDA approval to operate a Hepatitis B immunization program. A typical plasma collection center, such as those
operated by ADMA BioCenters, can collect approximately 30,000 to 50,000 liters of source plasma annually, which may be sold for different prices depending upon the type of plasma, quantity of purchase and market conditions at the time of sale.
Plasma collected from ADMA BioCenters’ facilities that is not used to manufacture our products is sold to third-party customers in the U.S. and in other locations outside the U.S. where we are approved under supply agreements or in the open “spot”
market.

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We sell plasma-derived intermediate fractions to certain customers, which are generated as part of our FDA-approved manufacturing process for IG and IVIG products, through a five-year manufacturing and supply agreement
we entered into in January 2020. These intermediate by-products are used as the starting raw material to produce other plasma-derived biologics. In addition, from time to time we provide contract manufacturing services for certain third-party
clients. We also provide laboratory contracting services to certain customers and anticipate providing contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.

Our Products

ASCENIV

ASCENIV is a plasma-derived IVIG that contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses, and prevent
against infection and disease. We manufacture ASCENIV under HHS License No. 2019 using a process known as fractionation. The Centers for Medicare and Medicaid Services (“CMS”) has issued a permanent, product-specific-J-code for ASCENIV. Under the
Healthcare Common Procedure Coding System (“HCPCS”), the J-code (J1554) became effective April 1, 2021. As part of our proprietary manufacturing process for ASCENIV, we leverage our unique, patented plasma donor screening methodology and tailored
plasma pooling design, which blends normal source plasma and plasma from donors tested to have high levels of neutralizing antibody titers to Respiratory Syncytial Virus (“RSV”) using our proprietary microneutralization testing assay. With our
patented testing methods and assay, we are able to identify the high-titer or “hyperimmune” plasma that meets our internal and required specifications for ASCENIV. This type of high-titer plasma is typically found in less than 10% of the total
donor collection samples we test.

ASCENIV is approved for the treatment of PIDD or PI, a class of inherited genetic disorders that causes a deficient or absent immune system in adults and adolescents (12 to 17 years of age). Our pivotal Phase 3
clinical trial in 59 PIDD patients met the primary endpoint of no Serious Bacterial Infections (“SBI”) reported during 12 months of treatment. Secondary efficacy endpoints further demonstrated the benefits of ASCENIV in the low incidence of
infection, therapeutic antibiotic use, days missed from work, school and daycare and unscheduled medical visits and hospitalizations. We believe this clinical data together with the FDA approval for the treatment of PIDD better positions ADMA to
potentially further evaluate ASCENIV in immune-compromised patients infected with or at-risk for RSV infection or potentially other respiratory viral pathogens at an appropriate time. Due to the COVID-19 pandemic, our plans have been delayed. In
the future however, we may elect to work with the FDA and the immunology and infectious disease community to design an appropriate clinical trial to evaluate the use of ASCENIV in this patient population. Following FDA approval in April 2019,
commercial sales of ASCENIV commenced in October of 2019 and in 2023 ADMA commenced manufacturing ASCENIV at the 4,400 Liter production scale for the first time in the Company’s history. We expect that this expansion should meaningfully improve the
product’s margin profile and increase plant production capacity as fewer batches will be needed to support our revenue goals. ASCENIV’s prescriber and patient base continued to expand during 2023, which drove record utilization and pull-through for
this product. These elevated demand trends have sustained into 2024, and ADMA currently expects that this product’s rapid growth will continue throughout 2024 and beyond.

BIVIGAM

BIVIGAM is a plasma-derived IVIG that contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients
against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin G antibodies indicated for the treatment of PI, a group of genetic disorders. This includes, but is not limited to, the
humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs are a group of genetic disorders. Based on recent
estimates, these disorders are no longer considered to be very rare, with as many as one in every 1,200 people in the United States having some form of PI.

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On May 9, 2019, the FDA approved the Prior Approval Supplement (the “PAS”) for the use of our IVIG manufacturing process, thereby enabling us to re-launch and commercialize this product in the U.S. We resumed
production of BIVIGAM during the fourth quarter of 2017 and commercial production is ongoing, using our FDA-approved IVIG manufacturing process under U.S. Department of Health and Human Services (“HHS”) License No. 2019. The commercial re-launch
and first commercial sales for this product commenced in August of 2019.

On April 28, 2021, we announced that the FDA granted approval for our expanded plasma pool production scale process, allowing for a 4,400-liter plasma pool for the manufacture of our BIVIGAM IVIG product. This
increased IVIG plasma pool scale, which allows us to produce BIVIGAM at an expanded capacity utilizing the same equipment, release testing assays and labor force, has had a favorable impact on our gross margins, manufacturing efficiencies and
operating results.

On December 12, 2023, we announced that the FDA approved the expansion of BIVIGAM’s label in the U.S. to now include the pediatric setting for those two years of age and older.

Nabi-HB

Nabi-HB is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a
Hepatitis B vaccine. Nabi-HB is indicated for the treatment of acute exposure to blood containing HBsAg, prenatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with
acute Hepatitis B virus infection in specific, listed settings. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus, which is a major global health problem. The Hepatitis B virus can cause chronic infection
and places people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented record of long-term safety and effectiveness since its initial market introduction. The FDA approved Nabi-HB on March 24, 1999. Production of
Nabi-HB at the Boca Facility has continued under our leadership since the third quarter of 2017. In early 2018, we received authorization from the FDA for the release of our first commercial batch of Nabi-HB for commercial distribution in the U.S.
and we continue to manufacture Nabi-HB under HHS License No. 2019.

IT SYSTEMS DISRUPTION

On June 19, 2023, we experienced an IT systems disruption, which rendered certain of our IT systems inaccessible for less than one week. Our investigation of the disruption has been completed with the assistance of
third-party consultants. While no definitive root cause was identified, as previously disclosed we believe that this IT systems disruption may have been caused by a third-party who may have gained access to the system. There was no original
financial systems or other data loss or any evidence of files exfiltrated due to this disruption. Normal operations have resumed across our business units. At the time of the disruption, we were in production of two batches of BIVIGAM, and after a
prolonged hold time, it was deemed to be a prudent GMP quality decision to discard these two in-process production batches as these batches were no longer viable for further production or had any alternative use. As a result, we recorded a
one-time, non-recurring charge of $2.1 million for this inventory in the second quarter of 2023, which is reflected in Cost of product revenue in the accompanying consolidated statements of operations for the year ended December 31, 2023. In
addition, the Company’s Plasma center operating expenses were adversely impacted by approximately $0.7 million due to the temporary closing of our plasma collection centers while their IT systems were restored.

We carry appropriate insurance for these types of instances, and while there can be no assurances ADMA will be reimbursed for the insurance claims made pertaining to these charges, we are actively working with our
insurance broker and carriers.

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RESULTS OF OPERATIONS

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our consolidated financial statements, which have been prepared in accordance with Accounting Principles Generally
Accepted in the United States of America (“U.S. GAAP”). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. On an
ongoing basis, we evaluate these estimates and assumptions, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These
estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.
Significant estimates include rebates and certain other deductions from gross revenues, impairment of long-lived assets, valuation of inventory, assumptions used in projecting future liquidity and capital requirements, assumptions used in the fair
value of awards granted under our equity incentive plans and warrants issued in connection with the issuance of notes payable and the valuation allowance for our deferred tax assets.

Some of the estimates and assumptions we have to make under U.S. GAAP require difficult, subjective or complex judgments about matters that are inherently uncertain and, as a result, actual results could differ from
those estimates. Due to the estimation processes involved, the following summary of accounting estimates and their application are considered to be critical to understanding our business operations, financial condition and results of operations.
For a description of our significant accounting policies, see Note 2 to the Consolidated Financial Statements included elsewhere in this Annual Report on Form 10-K. Estimates and assumptions used in projecting future liquidity and capital
requirements are described in Note 1 to the Consolidated Financial Statements.

Revenues

Our gross product revenues are subject to a variety of deductions, which are estimated and recorded in the same period that the revenues are recognized. These deductions primarily consist of rebates, distribution fees,
chargebacks and sales allowances. These deductions represent estimates of the related obligations, some of which are contractual in nature and do not require extensive judgment to be exercised by management, while other estimates require complex or
subjective matters of knowledge and judgment when estimating the impact of these revenue deductions on net revenues for a reporting period.

Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material to our overall business. While we have some historical sales and rebate experience from our two
primary immunoglobulin products, ASCENIV and BIVIGAM, since their FDA approvals in 2019, it is not extensive. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate estimates of our future experience,
our results could be materially affected. Estimates that are most at risk for material adjustment are those associated with U.S. Medicaid rebates because of the extensive time delay between the recording of the accrual and its ultimate settlement,
an interval that can generally take up to several years or more. These estimates may change from time to time based on changes in utilization, payor and channel mixes. While our results of operations to date have not required any material
adjustment due to this risk, the delay between when this obligation is initially recorded and ultimately settled could potentially materially impact our revenues and our results of operations in the future.

Valuation of Inventory

Estimates related to the valuation of inventory include net realizable value of inventory in determining whether the cost of inventory exceeds its net realizable value which, if this were the case, would require a
charge against earnings to write down the value of the inventory to its net realizable value. Net realizable value of inventory is based on our management’s estimate of the future net selling price of the inventory, which is subject to market
conditions and the estimation processes we use for revenues as discussed above. With respect to raw materials inventory, we are required to estimate the level and timing of usage of these materials prior to their expiration dates in determining
whether it is appropriate to carry these materials on our balance sheet as a valid asset of the Company. Changes in either of these estimates could potentially materially impact our cost of product revenue and results of operations.

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Stock-Based Compensation and Valuation of Warrants

All equity-based payments, including grants of stock options and Restricted Stock Units (“RSUs”), are recognized at their estimated fair value at the date of grant, and compensation expense is recognized on a
straight-line basis over the grantee’s requisite vesting period. For the purpose of valuing stock options granted to our employees, directors and officers, we use the Black-Scholes option pricing model. The Black-Scholes option pricing model was
developed for use in estimating the fair value of publicly traded options, which have no vesting restrictions and are fully transferable. The Company’s employee stock options have characteristics significantly different from those of traded
options, and changes in the underlying Black-Scholes assumptions can materially affect the fair value estimate. To determine the risk-free interest rate, we utilize the U.S. Treasury yield curve in effect at the time of the grant with a term
consistent with the expected term of our awards. The expected term of the options granted is in accordance with SEC Staff Accounting Bulletins 107 and 110 and is based on the average between vesting terms and contractual terms. The expected
dividend yield reflects our current and expected future policy for dividends on our Common Stock. The expected stock price volatility for our stock options was calculated by examining the historical volatility of our Common Stock since our Common
Stock became publicly traded in the fourth quarter of 2013. We will continue to analyze the expected stock price volatility and expected term assumptions and will adjust our Black-Scholes option pricing assumptions as appropriate. Any changes in
the foregoing Black-Scholes assumptions, or an election by us to utilize an alternative method for valuing stock options granted to employees, directors and officers, could potentially impact our stock-based compensation expense and our results of
operations.

We also use the Black-Scholes option pricing model for the purpose of estimating the fair value of warrants we issue from time to time in connection with the issuance of notes payable. Changes in our Black-Scholes
assumptions, or an election by us to utilize an alternative method for valuing warrants issued to our lenders, could impact our interest expense and results of operations.

Impairment of Long-Lived Assets

We assess the recoverability of our long-lived assets, which include property and equipment and finite-lived intangible assets, whenever significant events or changes in circumstances indicate impairment may have
occurred. If indicators of impairment exist, projected future undiscounted cash flows associated with the asset are compared to its carrying amount to determine whether the asset’s carrying value is recoverable. Any resulting impairment is recorded
as a reduction in the carrying value of the related asset in excess of fair value and a charge to operating results. For the years ended December 31, 2023 and 2022, we determined that there was no impairment of our long-lived assets. Examples of
events or circumstances that may be indicative of impairment that would require the use of significant judgment by management include:

[[GREPCENT_TABLE]]
[["","\u2022","A significant adverse change in legal factors or in the business climate that could affect the value of the asset."]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Significant and continued cash flow losses."]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","A significant adverse change in the extent or manner in which an asset is used, such as a restriction imposed by the FDA or other regulatory authorities that could affect our ability to manufacture our products using a particular asset."]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","An expectation of losses or reduced profits associated with an asset. This could result, for example, from the introduction of a competitor\u2019s product that impacts projected revenue growth, or a change in the acceptance of a product by patients, physicians and payers that results in an inability to sustain projected product revenues."]]
[[/GREPCENT_TABLE]]

Goodwill is not amortized but is assessed for impairment on an annual basis or more frequently if impairment indicators exist. The testing of goodwill for impairment requires us to determine whether or not the fair
value of the reporting unit associated with the goodwill is less than its carrying amount, including goodwill and other intangible assets. An impairment charge is recorded to the extent the reporting unit’s carrying value exceeds its fair value,
with the impairment loss recognized not to exceed the total amount of goodwill allocated to that reporting unit. In order to determine the fair value of the reporting unit, we utilize the fair value of the Company as a whole, as determined by its
market capitalization. Determination of the fair value and carrying value of each reporting unit, relative to the fair value of the Company, requires management to employ certain estimates, assumptions and judgment, which we believe are reasonable.
However, any changes to these estimates and assumptions could impact our determination of whether or not our goodwill is impaired. We did not recognize any impairment charges related to goodwill for the years ended December 31, 2023, 2022 and 2021.

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Deferred Tax Assets

We have historically maintained a full valuation allowance against all of our net deferred tax assets, and as a result have recorded no income tax benefit in the accompanying consolidated financial statements. This
valuation allowance reflects our assessment of whether it is more likely than not that we will generate sufficient taxable income in the future to be able to utilize our deferred tax assets. In determining whether a valuation allowance is
warranted, we evaluate factors such as prior earnings history, expected future earnings, carryback and carryforward periods and tax strategies. We consider all positive and negative evidence to estimate if sufficient future taxable income will be
generated to realize our deferred tax assets. We consider cumulative losses in recent years to be a significant type of negative evidence, and based on our history of losses, at this time we have not included future projected taxable income as a
source of income to recognize our deferred tax assets.

Year Ended December 31, 2023 Compared to Year Ended December 31, 2022

The following table presents a summary of the changes in our results of operations for the year ended December 31, 2023, compared to the year ended December 31, 2022:

[[GREPCENT_TABLE]]
[["","","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"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["*","- See Non-GAAP Financial Measures appearing at the end of this discussion"]]
[[/GREPCENT_TABLE]]

Revenues

We recorded total revenues of $258.2 million for the year ended December 31, 2023, as compared to $154.1 million for the year ended December 31, 2022, an increase of $104.1 million, or approximately 68%. The increase
is primarily related to increased sales of our immunoglobulin products, mainly ASCENIV and BIVIGAM, generated by our Boca Facility manufacturing operations in 2023 of $105.8 million, as we continue to experience increased physician, payer and
patient acceptance and utilization of ASCENIV and expand our customer base for BIVIGAM, partially offset by a decrease in sales of plasma in our Plasma Collection Centers business segment of $1.5 million. During 2023, we began utilizing a
substantial majority of the plasma collected at our plasma collection facilities for our IVIG production, with significantly less emphasis on plasma sales to third-party customers.

Cost of Product Revenue and Gross Profit

Cost of product revenue was $169.3 million for the year ended December 31, 2023, as compared to $118.8 million for the year ended December 31, 2022. This increase is primarily attributable to volume-driven increases
in product revenue costs related to the increased sales of our immunoglobulin products of $54.9 million. Cost of product revenue was also impacted by the inventory losses of $2.1 million related to the June 2023 IT disruption, partially offset by
a decrease in other manufacturing expenses of approximately $6.2 million in 2023, mainly due to a shorter planned shutdown of the Boca Facility in 2023 as compared to 2022.

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For the year ended December 31, 2023, we had gross profit of $88.9 million, as compared to $35.3 million for the same period of a year ago. This gross profit increase of $53.7 million was primarily due to the revenue
increases and the supply chain and manufacturing enhancements at the Boca Facility which include producing at the increased 4,400 liter scale, along with the reduction in other manufacturing costs discussed above as we elected to extend our
otherwise-routine plant shutdown in the first quarter of 2022 in order to complete certain projects. We also experienced a more favorable sales mix in 2023 toward our higher margin products and benefitted from price increases for ASCENIV and
BIVIGAM that were implemented late in 2022. As a result, we achieved a gross margin of 34.4% for the year ended December 31, 2023 as compared to 22.9% for the year ended December 31, 2022.

Research and Development Expenses

Research and development (“R&D”) expenses totaled $3.3 million for the year ended December 31, 2023, as compared to $3.6 million for the year ended December 31, 2022. The decrease is primarily due to lower
expenditures attributable to a third-party service provider in connection with an R&D project that was completed in early 2023.

Plasma Center Operating Expenses

Plasma Center Operating Expenses decreased from $17.8 million in the year ended December 31, 2022 to $4.3 million in the year ended December 31, 2023. As a result of our now having ten plasma centers in operation, we
were able to more than double the number of liters of plasma collected, with a corresponding reduction in the cost per liter, in 2023 as compared to 2022, coupled with the changes in the market price of normal source plasma and its impact on the
net realizable value of our plasma inventory, the amount of plasma center costs we capitalized into inventory increased by approximately $43.2 million in 2023. This amount was largely offset by increases in donor fees of $12.8 million,
compensation, benefits and temporary labor of $3.9 million, softgoods and supplies of $5.0 million, donor testing expenses of $4.8 million, depreciation of $0.8 million, software maintenance expense of $0.9 million, janitorial, security and
utilities expense of $0.5 million, travel expenses of $0.1 million, advertising expense of $0.2 million, repairs and maintenance expense of $0.2 million and rent of $0.2 million. In addition, our plasma center collections and operating costs were
unfavorably impacted by approximately $0.7 million due to the temporary closing of our plasma collection centers attributable to an IT disruption occurring in June 2023, of which all systems have since been fully restored.

Amortization of Intangibles

Amortization expense mainly pertains to the amortization of intangible assets acquired in a 2017 acquisition transaction and was $0.7 million for the years ended December 31, 2023 and 2022.

Selling, General and Administrative Expenses

Selling, general and administrative (“SG&A”) expenses were $59.0 million for the year ended December 31, 2023, an increase of $6.6 million from the year ended December 31, 2022. The increase reflects higher
expenses for employee-related costs including salaries, benefits, stock-based compensation, travel, relocation and recruiting of $2.4 million, data services and market intelligence fees in support of the continued ASCENIV and BIVIGAM
commercialization efforts in the amount of $1.8 million, marketing and advertising expenses of $1.0 million, insurance expense of $0.6 million, software maintenance expense of $0.6 million and state and local taxes of $0.2 million.

Income/Loss from Operations

For the year ended December 31, 2023, we had operating income of $21.6 million, as compared to an operating loss of $39.4 million for the year ended December 31, 2022. The $61.0 million improvement in operating results
was mainly due to the improved gross profit of $53.7 million and the lower total operating expenses of $7.3 million.

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Interest Expense

Interest expense for the year ended December 31, 2023 was $25.0 million, as compared to $19.3 million for the year ended December 31, 2022. The increase is mainly due to approximately $51.8 million of additional debt
principal resulting from the refinancing of our senior credit facility on March 23, 2022, additional debt principal resulting from interest payments made “in kind” in the form of additional indebtedness of approximately $6.8 million, as well as an
increase in the stated interest rate on our senior debt from 10.75% in 2022 to as high as 14.4% at certain points in fiscal 2023 as a result increases in the Secured Overnight Financing Rate (“SOFR”). We expect our interest expense to decrease in
2024 as a result of the refinancing transaction we completed in December of 2023 (see “Liquidity and Capital Resources”), which resulted in a lower debt principal balance and a reduction in the interest rate.

Loss on Extinguishment of Debt

In connection with the foregoing refinancing of our senior debt in December of 2023, we incurred a loss on extinguishment of debt in the amount of $26.2 million, which is comprised of a prepayment penalty paid to our
previous lender in the amount of $11.1 million, and the write-off of unamortized discount related to the retired indebtedness in the approximate amount of $15.1 million (see “Liquidity and Capital Resources”).

In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to retire
our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements).

Other Income (Expense), Net

Other income, net, for the year ended December 31, 2023 was $1.3 million, as compared to other expense, net, of $0.6 million for the year ended December 31, 2022. The increase is mainly due to an increase in interest
income of approximately $1.6 million in 2023 due to higher interest earned on our cash balances in 2023.

Net Loss

Our net loss was $28.2 million for the year ended December 31, 2023, as compared to $65.9 million for the year ended December 31, 2022. The $37.7 million decrease in net loss was mainly due to the improvement in
operating income/loss of $61.0 million and the $1.9 million increase in other income/expense, partially offset by a higher loss on extinguishment of debt of $19.5 million and higher interest expense of $5.7 million.

Year Ended December 31, 2022 Compared to December 31, 2021

The following table presents a summary of the changes in our results of operations for the year ended December 31, 2022 compared to the year ended December 31, 2021:

[[GREPCENT_TABLE]]
[["","","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"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["*","- See Non-GAAP Financial Measures appearing at the end of this discussion"]]
[[/GREPCENT_TABLE]]

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Revenues

We recorded total revenues of $154.1 million during the year ended December 31, 2022, as compared to $80.9 million during the year ended December 31, 2021, an increase of $73.1 million, or approximately 90%. The
increase is mainly due to increased sales of our immunoglobulin products and intermediate fractions generated by our Boca Facility manufacturing operations in 2022 totaling $69.2 million as we concluded our third full year of commercial sales of
BIVIGAM and ASCENIV. We attribute this increase in revenue to the continued expansion of our customer base in 2022 and to increasing physician, payer and patient acceptance of both BIVIGAM and ASCENIV. We also experienced a $4.0 million increase in
plasma revenues generated by our Plasma Collection Centers business segment due to increased sales of plasma through spot market opportunities beyond our long-term supply agreement.

Cost of Product Revenue and Gross Profit

Cost of product revenue was $118.8 million for the year ended December 31, 2022, as compared to $79.8 million for the year ended December 31, 2021. This increase of $39.0 million is primarily attributable to
volume-related increases in product revenue costs related to the sale of our immunoglobulin products of $30.4 million and increased product revenue costs related to our ADMA BioCenters business segment in the amount of $4.3 million. In addition, we
also experienced an increase in other manufacturing expenses of approximately $4.4 million in fiscal 2022 as compared to fiscal 2021, which is indicative of certain inflationary pressures being experienced by our industry for labor, materials,
freight, fuel surcharges and third-party services.

Our gross profit of $35.3 million for the year ended December 31, 2022 represents an improvement over the same period of a year ago of $34.1 million and is mainly due to the higher sales volume, the improved margins we
are experiencing with BIVIGAM at the larger plasma pool production scale, and to the increased relative contribution of ASCENIV to our total revenues. As a result, we achieved a gross margin of 22.9% for the year ended December 31, 2022, as
compared to a gross margin of 1.4% for the year ended December 31, 2021.

Subsequent to the FDA approvals for BIVIGAM and ASCENIV received in 2019 through December 31, 2022, substantially all of the normal source plasma (“NSP”) used in our Boca Facility IG production was sourced under a
supply agreement we had in place with Grifols Worldwide Operations Limited (“Grifols”). This agreement expired on December 31, 2022 and was not renewed. Although we have executed additional agreements with other third-party suppliers of NSP, we
anticipate that the NSP used in IG production in 2023 and beyond will be sourced from our ADMA BioCenters plasma collection facilities. As a number of these facilities are still in their initial stages of operation, we expect that the cost of
collecting NSP at many of these facilities will exceed the price per liter of NSP we were paying to Grifols and other third-party suppliers. As a result, we expect the production costs for our immune globulin products to increase in the near term,
which could adversely impact our cost of product revenue and gross margins, without giving effect to other supply chain initiatives completed and anticipated manufacturing efficiencies expected in the future.

Research and Development Expenses

R&D expenses of $3.6 million for the year ended December 31, 2022 was essentially unchanged from the year ended December 31, 2021, as the lower compensation costs (including stock-based compensation) in 2022
resulting from the 2021 resignation of our former Chief Medical and Chief Scientific Officer were offset by increased expenses associated with post-marketing commitment clinical studies for ASCENIV and BIVIGAM (see Note 10 to the Consolidated
Financial Statements).

Plasma Center Operating Expenses

Plasma center operating expenses increased by $5.6 million to $17.8 million for the year ended December 31, 2022, as compared to $12.3 million for the year ended December 31, 2021. Plasma center operating expenses
consist of certain general and administrative plasma center costs, initial opening, marketing and start-up costs, rent expense, maintenance, utilities, compensation and benefits for center and administrative staff, advertising and promotion
expenses and computer software fees related to donor collections. The majority of our plasma collection centers have been in a development or start-up stage in fiscal 2022 and 2021.

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During fiscal 2022, we opened three new plasma collection facilities, and an additional facility opened in March of 2023. In addition, for those plasma collection centers that were in construction or development but
not yet operational, we still needed to incur staffing, training, travel and other costs during the build-out period so that these facilities can be operational on the day they open. The increase in plasma center operating expenses in 2022 is
mainly attributable to increases in donor fees, some of which are specialty programs and promotions by the newly opened centers, of $10.7 million, employee compensation costs of $5.8 million, softgoods and supplies of $3.8 million, depreciation
expense of $1.1 million, rent expense of $0.5 million, plasma testing expenses of $2.8 million, travel expense of $0.2 million, software maintenance expense of $0.4 million, janitorial and utilities expense of $0.5 million, professional services of
$0.4 million, postage and freight of $0.3 million and advertising expenses of $0.3 million. These amounts were partially offset by a substantial increase in plasma collections which resulted in a reduction in our plasma center operating expenses by
approximately $21.4 million.

Selling, General and Administrative Expenses

SG&A expenses were $52.5 million for the year ended December 31, 2022, an increase of $9.6 million from the year ended December 31, 2021. As we continued to support the increase in the size and scope of our Boca
Facility manufacturing and commercial operations in 2022, we experienced increases in employee compensation and related expenses, including travel, relocation and recruiting, of $4.6 million, $1.8 million of which is stock-based compensation. We
also experienced increases in insurance expense of $1.4 million and utilities of $0.5 million in 2022, as well as an increase in data services and market intelligence fees in the amount of $1.5 million in support of the commercialization efforts
for BIVIGAM and ASCENIV. In addition, we incurred professional fees in connection with the Morgan Stanley strategic alternatives process in the amount of $1.4 million, with no comparable amount in 2021.

Amortization of Intangibles

Amortization expense for intangible assets acquired in an acquisition transaction was $0.7 million for the years ended December 31, 2022 and 2021.

Loss from Operations

Our operating loss was $39.4 million for the year ended December 31, 2022, as compared to $58.4 million for the year ended December 31, 2021. The decrease in operating loss was mainly due to the improved gross profit
for the year ended December 31, 2022 of $34.1 million, partially offset by the increases in plasma center operating expenses and SG&A.

Interest Expense

Interest expense was $19.3 million for the year ended December 31, 2022, as compared to $13.1 million for the year ended December 31, 2021. The increase reflects the additional indebtedness and increase in amortization
of debt discount resulting from the refinancing of our senior credit facility on March 23, 2022. The refinancing transaction resulted in additional indebtedness at closing in the approximate amount of $51.8 million, and our debt principal increased
by an additional $3.0 million subsequent to closing as the Hayfin Credit Agreement (see “Liquidity and Capital Resources”) allowed us to pay “in kind” a portion of our monthly interest obligation in the form of additional indebtedness to the
lender. We expect to continue to pay a portion of our monthly interest obligation “in kind” during 2023. As a result, and given the expected continued rise in SOFR, we expect our principal debt balance and the associated interest expense to
increase over the course of fiscal 2023 as compared to previous years.

Loss on Extinguishment of Debt

In connection with the refinancing of our senior credit facility on March 23, 2022, we incurred a loss on the extinguishment of debt in the amount of $6.7 million as a result of the redemption premium we paid to retire
our previously existing credit facility in the amount of $2.0 million, and the write-off of unamortized debt discount of $4.7 million related to that facility (see Note 7 to the Consolidated Financial Statements).

Net Loss

Our net loss was $65.9 million for the year ended December 31, 2022, as compared to $71.6 million for the year ended December 31, 2021. The decrease in net loss of $5.7 million was mainly due to the decrease in
operating loss, largely offset by the higher interest expense and loss on extinguishment of debt in 2022.

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Non-GAAP Financial Measures

Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”), Adjusted EBITDA and Adjusted Net Income (Loss)

EBITDA, Adjusted EBITDA and Adjusted net income (loss) are important non-GAAP financial measures used by our management and Board of Directors to assess our operating performance. We use EBITDA, Adjusted EBITDA and
Adjusted net income (loss) as key performance measures because we believe that they facilitate operating performance comparisons from period to period that exclude, in the case of Adjusted net income (loss), items that are expected to be
non-recurring, and in the case of EBITDA and Adjusted EBITDA, potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as, in the case of Adjusted EBITDA, stock-based compensation or
certain one-time and non-recurring items. In addition, we believe that EBITDA, Adjusted EBITDA and Adjusted net loss and similar measures are widely used by investors, securities analysts, ratings agencies and other parties in evaluating companies
in our industry as a measure of financial performance and debt-service capabilities. See below for a reconciliation of our EBITDA, Adjusted EBITDA and Adjusted net income (loss) to net loss, the most directly comparable financial measure calculated
and presented in accordance with U.S. GAAP.

Because EBITDA, Adjusted EBITDA and Adjusted net income (loss) are measures not deemed to be in accordance with U.S. GAAP and are susceptible to varying calculations, our EBITDA, Adjusted EBITDA and Adjusted net income
(loss) may not be comparable to similarly titled measures of other companies, including companies in our industry, because other companies may calculate EBITDA, Adjusted EBITDA and Adjusted net income (loss) in a different manner than we calculate
these measurements. Although the Company uses Adjusted EBITDA as one of several financial measures to assess its operating performance, its use is limited as it excludes certain significant operating expenses. EBITDA, Adjusted EBITDA and Adjusted
net income (loss) are not intended to represent cash flows for the periods presented, nor have they been presented as an alternative to operating income/loss, net income/loss or as an indicator of operating performance and should not be considered
in isolation or as a substitute for measures of performance prepared in accordance with U.S. GAAP. The following table presents the reconciliation of net loss to EBITDA and Adjusted EBITDA for the years ended December 31, 2023, 2022 and 2021:

[[GREPCENT_TABLE]]
[["","","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",")"]]
[[/GREPCENT_TABLE]]

Adjusted EBITDA increased by $67.9 million for the year ended December 31, 2023 as compared to the same period of a year ago. The improvement is driven primarily by an increase in operating income in 2023 of $61.0
million. Adjusted EBITDA improved by $22.0 million for the year ended December 31, 2022 as compared to the year ended December 31, 2021, mainly due to the decreasing in operating loss in 2022 of $19.0 million.

The following table presents the reconciliation of Net loss to Adjusted net income (loss) for the years ended December 31, 2023, 2022 and 2021:

[[GREPCENT_TABLE]]
[["","","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",")"]]
[[/GREPCENT_TABLE]]

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LIQUIDITY AND CAPITAL RESOURCES

At December 31, 2023, we had working capital of $207.2 million, primarily consisting of $172.9 million of inventory, cash and cash equivalents of $51.4 million and $27.4 million of accounts receivable, partially offset
by current liabilities of $49.8 million, as compared to working capital at December 31, 2022 of $231.1 million, primarily consisting of $163.3 million of inventory, cash and cash equivalents of $86.5 million and accounts receivable of $15.5
million, partially offset by current liabilities of $39.3 million. We have incurred an accumulated deficit of $506.3 million since inception and although we had positive cash flow from operations of $8.8 million for the year ended December 31,
2023, we had negative cash flows from operations of $59.5 million and $112.4 million for the years ended December 31, 2022 and 2021, respectively. We have funded our operations over the past few years primarily from the sale of our equity
securities and debt financings. Our material cash requirements are primarily comprised of:

[[GREPCENT_TABLE]]
[["","\u2022","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;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Employee compensation and benefits;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Capital expenditures for equipment upgrades and capacity expansion at the Boca Facility and to maintain our plasma collection facilities;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Interest on our debt;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Marketing programs, medical education and continued commercialization efforts;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Boca Facility maintenance, repairs and supplies;"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Conducting required post-marketing clinical trials for our FDA-approved products; and"]]
[[/GREPCENT_TABLE]]

[[GREPCENT_TABLE]]
[["","\u2022","Continuous improvements and updates to our IT infrastructure, laboratory equipment and assays, and facilities and engineering equipment."]]
[[/GREPCENT_TABLE]]

In addition, our end-to-end production cycle time from procurement of raw materials to commercial release of finished product can take between seven and 12 months or potentially longer, requiring substantial inventories of raw material plasma
and other manufacturing and laboratory testing materials and single use disposables.

For the year ended December 31, 2023 we had a net loss of loss of $28.2 million and achieved adjusted net income of $0.7 million which, as further described under “Non-GAAP Financial Measures”, excludes charges related
to the refinancing of our senior debt of $26.2 million and an IT systems disruption of $2.7 million, as well as positive cash flow from operations, both for the first time in our history. However, at present we cannot be certain that we will be
able to continue to generate a sufficient amount of product revenue to achieve profitability on an ongoing basis. We currently anticipate, based upon our projected revenue and expenditures, that our current cash, cash equivalents and accounts
receivable, along with our projected future operating cash flow, will be sufficient to fund our operations, as currently conducted, through the end of the first quarter of fiscal 2025. However, our current outlook with respect to cash flows and
profitability may change based upon several factors, including the success of our commercial efforts with respect to the sale of our products and the continued acceptability of our immune globulin products by physicians, patients or payers, and
whether or not the assumptions underlying our projected revenues and expenses are correct. If we are unable to maintain positive cash flow throughout fiscal 2024, we may need to raise additional capital and if such capital is not available due to
widespread liquidity constraints or significant market instability that could result from international or global conflicts, economic uncertainty, COVID-19 or other pandemics, inflationary pressures or other factors beyond our control, we may have
to delay, curtail or eliminate some of our commercialization efforts or product development activities. If we are unable to generate sufficient revenue to maintain positive cash flow throughout fiscal 2024 and need to raise additional capital, we
may decide to do so through public or private equity offerings or debt financings, or we may enter into a corporate collaboration or licensing arrangement. The sale of additional equity securities or debt financings, if convertible, could result in
dilution to our stockholders and, in such event, the value and potential future market price of our common stock may decline.

ADMA continues to evaluate a variety of strategic alternatives, and the exploration of value-creating opportunities remains a top corporate priority.

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On December 18, 2023 (the “Ares Closing Date”), we and all of our subsidiaries entered into a new senior secured credit facility (the “Ares Credit Agreement”) with Ares Capital Corporation and certain credit funds
affiliated with Ares Capital Corporation (collectively, “Ares”). The Ares Credit Agreement provides for a total of $135.0 million in senior secured credit facilities (the “Ares Credit Facility”) consisting of (i) a term loan in the aggregate
principal amount of $62.5 million and (ii) a revolving credit facility in the aggregate principal amount of $72.5 million (collectively, the “Ares Loans”), both of which were fully drawn on the Ares Closing Date. The Ares Credit Facility has a
maturity date of December 20, 2027 (the “Ares Maturity Date”). On the Ares Closing Date, we used the proceeds from the Ares Loans, along with a portion of our existing cash on hand, to terminate and pay in full all of the outstanding obligations
under our previous senior credit facility (the “Hayfin Credit Facility”) with Hayfin Services LLP (“Hayfin”) including the outstanding principal in the amount of $158.6 million, a prepayment penalty in the amount $11.1 million, an exit fee of
$1.6 million, all accrued and unpaid interest outstanding on the Hayfin Credit Facility as of the Ares Closing date, as well as certain fees and expenses related thereto. In connection with the payoff and termination of the Hayfin Credit
Facility, we also wrote off $15.0 million of unamortized debt discount related to the Hayfin Credit Facility. As a result of this transaction, we recorded a loss on the extinguishment of the Hayfin Credit Facility in the amount of $26.2 million,
which is mainly comprised of the write-off of unamortized debt discount and the prepayment penalty.

Borrowings under the term loan initially bear interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the applicable calendar quarter plus
6.50% (the “Initial SOFR Term Loan Applicable Margin”). Borrowings under the revolving facility initially bear interest at the adjusted Term SOFR for a three‑month tenor in effect on the day that is two business days prior to the first day of the
applicable calendar quarterplus3.75% (the “SOFR Revolving Facility Applicable Margin”). On the Ares Closing Date, the interest rate on the term loan was approximately 11.9% and the interest rate on the revolving facility was approximately 9.1%,
representing a weighted-average interest rate of approximately 10.4%. Prior to the Ares Closing Date, the interest rate on the Hayfin Credit Facility was approximately 13.9%.

On the Ares Maturity Date, we are required to pay Ares the entire outstanding principal amount underlying the Ares Loans and any accrued and unpaid interest thereon. Prior to the Ares Maturity Date, there are no
scheduled principal payments on the Ares Credit Facility, and we are required to make quarterly interest payments during the term of Ares Credit Facility of approximately $3.7 million. We may prepay the outstanding principal under the revolving
facility, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice with no prepayment premium. However, in the event that we prepay an amount
under the revolving facility that is greater than 50% of the current $72.5 million outstanding balance, we will still be required to pay interest on 50% of this balance, or $36.3 million, through the term of Ares Credit Facility. We may prepay
the outstanding principal on the term loan, together with any accrued but unpaid interest on the prepaid principal amount, at any time and from time to time upon three business days’ prior written notice, subject to the payment to Ares of a
prepayment premium equal to (i) the present value as of such date of all remaining required interest payments on the principal amount being repaid plus 1.5% of the prepaid principal amount, if prepaid on or prior to the first anniversary of the
Ares Closing Date, (ii) 1.5% of the prepaid principal amount, if prepaid after the first anniversary of the Ares Closing Date and on or prior to the second anniversary of the Ares Closing Date, or (iii) 1.0% of the prepaid principal amount, if
prepaid on or prior to the third anniversary of the Ares Closing Date.

In connection with the closing of the Ares Credit Facility, we incurred fees and expenses related to the transaction of approximately $2.7 million, including a $1.7 million original issue discount payable to Ares,
all of which was deducted from the Ares loan proceeds. In addition, we are also required to pay Ares an exit fee of $1.7 million upon the earlier of any prepayment date or the Ares Maturity Date, and this amount has been accrued as a separate
liability in our consolidated balance sheet as of December 31, 2023. As a result, we recognized an aggregate debt discount of $4.4 million as of the Ares Closing Date, and the weighted-average effective interest rate on the Ares Loans as of
December 31, 2023 was 11.39%.

All of our obligations under the Ares Credit Agreement are secured by a first-priority lien and security interest in substantially all of our tangible and intangible assets, including intellectual property and all of
the equity interests in our subsidiaries. The Ares Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative
covenants include certain financial covenants, including maximum total leverage ratios and a $15.0 million liquidity covenant, and also restrict or limit our ability and the ability of our subsidiaries to, among other things and subject to
certain exceptions contained in the Ares Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to our or our subsidiaries’ business
activities; make certain Investments or Restricted Payments (each as defined in the Ares Credit Agreement); engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting our
ability to make loan repayments under the Ares Credit Agreement. As of December 31, 2023, we were in compliance with all of the covenants contained in the Ares Credit Agreement.

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Events of default on the Ares Loans include, among others, non-payment of principal, interest or fees, violation of covenants, inaccuracy of representations and warranties, bankruptcy and insolvency events, material
judgments, cross-defaults to material contracts and events constituting a change of control. If there is an event of default, we will incur an increase in the rate of interest on the Ares Loans of 2% per annum.

On March 23, 2022 (the “Hayfin Closing Date”), we and all of our subsidiaries entered into the Hayfin Credit Agreement with Hayfin. The Hayfin Credit Agreement, as amended, provided for a senior secured term loan
facility in a principal amount of up to $175.0 million (the “Hayfin Credit Facility”), composed of (i) a term loan made on the Hayfin Closing Date in the principal amount of $150.0 million (the “Hayfin Closing Date Loan”), and (ii) a delayed draw
term loan in the principal amount of $25.0 million (the “Hayfin Delayed Draw Loan” and, together with the Hayfin Closing Date Loan, the “Hayfin Loans”). The Hayfin Delayed Draw Loan was not drawn prior to the Hayfin Closing Date. The Hayfin Credit
Facility had a maturity date of March 23, 2027 (the “Hayfin Maturity Date”), subject to acceleration pursuant to the Hayfin Credit Agreement, including upon an Event of Default (as defined in the Hayfin Credit Agreement).

On the Hayfin Closing Date, we used $100.0 million of the Hayfin Closing Date Loan to terminate and pay in full all of the outstanding obligations under our previous senior credit facility with Perceptive (see Note 7
to the Consolidated Financial Statements). We also used $2.0 million of the Hayfin Closing Date Loan proceeds to pay a redemption premium to Perceptive and used approximately $1.0 million of the Hayfin Closing Date Loan proceeds to pay certain fees
and expenses incurred in connection with this transaction. In addition, a $1.8 million upfront fee payable to Hayfin was paid “in kind” and was added to the outstanding principal balance in accordance with the terms of the Hayfin Credit Agreement.

Borrowings under the Hayfin Credit Agreement bore interest at the adjusted Term SOFR for either a one-month or three-month tenor, as elected by us, and subject to a floor of 1.25%, plus an applicable margin of 9.5%
(the “Applicable Margin”); provided, however, that upon, and during the continuance of, an Event of Default, the Applicable Margin would increase by an additional 3% per annum. On May 1, 2023 the Hayfin Credit Agreement was amended to reduce the
Applicable Margin from 9.5% to 8.5%. On the last day of each calendar month prior to the Ares Closing Date we paid accrued interest to Hayfin. On the Hayfin Closing Date, December 31, 2022 and the Ares Closing Date, the stated interest rate on the
Hayfin Loans was 10.75%, approximately 13.7% and approximately 13.9%, respectively. We were also permitted to pay “in kind” a portion of the interest on the Hayfin Loans for each monthly interest period in an amount equal to 2.5% per annum, which
was added to the principal amount of the outstanding debt under the Hayfin Credit Facility. From the Hayfin Closing Date through December 31, 2022, $3.0 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.
For the year ended December 31, 2023, $3.8 million of interest was paid in kind and added to the balance of the outstanding Hayfin Loans.

On the Ares Closing Date, we paid Hayfin the entire outstanding principal amount underlying the Hayfin Loans and any accrued and unpaid interest thereon, as well as an exit fee of 1.0% of the outstanding principal
amount being paid. In accordance with the terms of the Hayfin Credit Agreement, we also paid Hayfin the early prepayment fee in the amount equal 7.0% of the prepaid principal amount, or $11.1 million.

All of our obligations under the Hayfin Credit Agreement were secured by a first-priority lien and security interest in substantially all of our tangible and intangible assets, including intellectual property and all
of the equity interests in our subsidiaries. The Hayfin Credit Agreement contained certain representations and warranties, affirmative covenants, negative covenants and conditions that are customarily required for similar financings. The negative
covenants restricted or limited our ability and the ability of our subsidiaries to, among other things and subject to certain exceptions contained in the Hayfin Credit Agreement, incur new indebtedness; create liens on assets; engage in certain
fundamental corporate changes, such as mergers or acquisitions, or changes to our or our subsidiaries’ business activities; make certain Investments or Restricted Payments (each as defined in the Hayfin Credit Agreement); change our fiscal year;
pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments under the Hayfin Credit
Agreement. In addition, we were required (i) at all times prior to the Hayfin Maturity Date to maintain a minimum cash balance of $6.0 million; and (ii) as of the last day of each fiscal quarter, report IVIG product and related revenues for the
trailing 12-month period that exceed the amounts set forth in the Hayfin Credit Agreement, which ranged from $75.0 million for the fiscal quarter ending June 30, 2022 to $110.0 million for the fiscal quarter ending September 30, 2023. As of the
Ares Closing Date and December 31, 2022, we were in compliance with all of the financial covenants contained in the Hayfin Credit Agreement.

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On December 9, 2022, we completed an underwritten public offering whereby we issued 24,125,873 shares of our common stock. Net proceeds after underwriting discounts and expenses associated with the offering were
approximately $64.6 million and were used to accelerate commercialization and production activities, complete plasma center buildouts and obtain FDA approvals, to conclude post‑FDA marketing approval research and development projects, and for
working capital, capital expenditures and general corporate purposes.

On October 25, 2021, we completed an underwritten public offering whereby we issued 57.5 million shares of our common stock and received gross proceeds of $57.5 million. Net proceeds, after underwriting discounts and
expenses associated with the offering, were approximately $53.8 million, and were used to advance the commercial sales of our FDA approved products through the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV, to expand our
plasma collection facility network, to scale up the manufacturing capacity of the Boca Facility and make continuous improvements in order to adhere to cGMP compliance, to explore business development opportunities and for general corporate purposes
and other capital expenditures.

On September 3, 2021, we entered into a distribution agreement with Raymond James & Associates, Inc., as agent (“Agent”), pursuant to which we may offer and sell, from time to time, at our option, through or to
the Agent, up to an aggregate of $50 million of shares of our common stock (the “Distribution Agreement”). We currently intend to use any net proceeds from the sale of our common stock under the Distribution Agreement for general corporate
purposes, including procurement of source plasma and other raw materials, supply chain initiatives and production expenditures, working capital, capital expenditures, expansion and resources for commercialization activities, and other potential
research and development and business opportunities. During the year ended December 31, 2021, we issued 5,540,831 shares of our common stock under the Distribution Agreement and received net proceeds of $6.9 million. We did not issue any shares
under this agreement during the years ended December 31, 2023 and 2022, and we currently have approximately $42.8 million of shares available to sell under the Distribution Agreement.

Cash Flows

The following table sets forth a summary of our cash flows for the periods indicated:

[[GREPCENT_TABLE]]
[["","","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"]]
[[/GREPCENT_TABLE]]

Net Cash Provided by (Used in) Operating Activities

Cash provided by operations for the year ended December 31, 2023 was $8.8 million, as compared to cash used in operations of $59.5 million for the same period of a year ago. This improvement was mainly due to the
improvement in our operating results, driven by higher revenues and gross margins, and a lower increase in inventories. Cash used in operations for the year ended December 31, 2022 of $59.5 million represents a decrease of $52.9 million from the
same period of a year ago, mainly due to the improvement in our operating results after giving effect to non-cash items, driven by higher revenues and gross margins, and reductions in accounts receivable related to the timing of shipments and
collections from customers. The following table illustrates the primary components of our cash flows from operations:

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[[GREPCENT_TABLE]]
[["","","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",")"]]
[[/GREPCENT_TABLE]]

Net Cash Used in Investing Activities

Cash used in investing activities for the year ended December 31, 2023 was $5.0 million, which was primarily comprised of capital expenditures of $3.0 million for equipment purchases and facilities upgrades at the Boca
Facility, and $1.8 million to complete the buildout of our plasma collection facilities. Net cash used in investing activities for the year ended December 31, 2022 was $13.9 million, which consisted of $8.7 million for the construction and buildout
of several new plasma collection facilities and $5.2 million for equipment purchases and upgrades to the Boca Facility. Net cash used in investing activities for the year ended December 31, 2021 was $13.5 million, which consisted of $8.6 million
for the construction and buildout of new plasma collection facilities and $4.9 million of capital expenditures at the Boca Facility, which included equipment purchases and continued implementation of our in-house fill/finish capabilities. While we
do not have any firm commitments for material capital expenditures in 2024, we expect our total capital expenditures will be between $8.0 million and $12.0 million for fiscal 2024.

Net Cash (Used in) Provided by Financing Activities

Net cash used in financing activities for the year ended December 31, 2023 was $39.0 million, as we reduced our outstanding debt principal by $23.6 million with the refinancing of our senior debt on December 18, 2023
and paid approximately $12.7 million to exit the Hayfin Credit Facility. Net cash provided by financing activities for the year ended December 31, 2022 was $108.9 million, as we received approximately $47.0 in net proceeds from the refinancing of
our senior credit facility in March of 2022 and $64.6 million in net proceeds from the December 9, 2022 public offering of our common stock. Cash provided by financing activities during the year ended December 31, 2021 was $121.0 million, which is
mainly comprised of the net proceeds of $67.3 million from the sale of our common stock through several sale agreements and $53.8 million from the October 2021 underwritten public offering.

Effect of Inflation

Inflation impacted a number of facets of our business during the years ended December 31, 2023, 2022 and 2021 at each of our business segments. We experienced price increases for, among other items, certain raw
materials, consumable supplies, services for repairs and maintenance of our facilities, utilities, shipping and freight charges, fuel surcharges and labor costs, among other expenses. Based upon the macroeconomic environment, publicly available
information and reports form the U.S. government, we expect this trend to continue in 2024 and potentially longer, which could potentially have a significant impact on our future results of operations. In addition, some of our third-party inventory
purchase agreements provide for annual price increases that are tied to various consumer price indices, which have resulted in higher than historical percentage price increases and has resulted in and could continue to result in higher source
plasma and other raw material and supplies costs in 2024 and beyond. Also, in a higher inflationary environment, we may not be able to raise the prices of our products to keep up with the rate of inflation. We are unable to predict when these
external drivers of inflation will subside.

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