ADMA BIOLOGICS, INC. (ADMA)

Item 2.

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

The following discussion of our financial condition and results of operations, which refers to our historical results, should be read in conjunction with the other sections of this Quarterly Report on Form 10-Q, including “Risk Factors” and our unaudited consolidated financial statements and the notes thereto appearing elsewhere herein, and in conjunction with the Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in our Annual Report on Form 10-K for the year ended December 31, 2025, filed on February 25, 2026 (the “2025 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 affected by the uncertainties and risk factors described throughout or referenced within this Quarterly Report on Form 10-Q. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from our current expectations.

OVERVIEW

Our Business

ADMA Biologics, Inc. (the “Company,” “ADMA,” “we,” “us” or “our”) is a U.S. based, 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 children ages two and above, for which we received FDA approval
in April 2019 and commenced first commercial sales in October 2019; (ii)
BIVIGAM (Immune Globulin Intravenous, Human), an IVIG product indicated for the
treatment of PI in adults and children ages two and above, and for
which we received FDA approval in May 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 Hepatitis
B surface antigen (“HBsAg”) and other
listed exposures to Hepatitis B. In addition to our
commercially available immunoglobulin products, we generate revenues from the
sale of intermediate by-products that result from the immunoglobulin production
process and from time to time provide contract manufacturing and laboratory
services for certain clients.

We are also developing a
pipeline of plasma-derived therapeutics, including a product related to its
issued U.S. Patent Nos. 10,259,865, 11,084,870, 11,897,943 and 12,612,450
pertaining to methods of treatment and prevention of S. pneumoniae infection
using an immunoglobulin manufactured to contain standardized antibodies to S.
pneumoniae serotypes. We have successfully completed production of a
pilot-scale batch and are conducting animal studies for our S.
pneumoniae hyperimmune globulin program, SG-001. We anticipate
submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal
year 2026, which could enable us to progress development of SG-001 directly
into a registrational clinical trial.

We manufacture our commercial 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 products.

Through our ADMA BioCenters
subsidiary, we currently operate seven 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 a
significant portion of 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, each of our FDA-approved plasma collection centers also has approval
from the Korean Ministry of Food and Drug Safety, and ADMA BioCenters has 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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Index

From time to time, we may provide contract manufacturing services for certain third-party clients. We also provide laboratory contracting services to certain customers and may provide contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.

Trends and Developments

For the year ended December
31, 2024, we achieved net income of $197.7 million, the first time in our
history that we achieved net income in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”), and generated
positive cash flows from operations of $118.7 million. Positive cash flows from
operations continued throughout fiscal year 2025. Our improved operating
results were primarily the result of the substantial revenue growth and
continued physician, patient and payer acceptance of ASCENIV.

In April 2025, the FDA
approved our Prior Approval Supplement (a “PAS”) for our innovative yield
enhancement production process benefiting both ASCENIV and BIVIGAM. This PAS
approval amends the Biologics License Application (“BLA”) approvals for ASCENIV
and BIVIGAM and will continue to be the process by which we will manufacture
these products on a go-forward basis. The production methods approved in this
PAS have resulted in additional bulk drug yield from the same starting raw
material source plasma volumes and we believe we should experience meaningful
revenue and earnings accretion accelerating further into 2026 and beyond. This
innovative process has demonstrated an ability to increase ASCENIV and BIVIGAM
production yields by 20% or more from the same starting source plasma volume.
Fiscal year 2026 is our first full year of yield-enhanced production,
supporting anticipated sustained margin expansion.

In July 2025, the One Big
Beautiful Bill Act ("OBBBA") was enacted, which includes numerous
changes to existing tax law including extending or making permanent certain
business provisions initially established under the 2017 Tax Cuts and Jobs Act,
which were set to expire. The OBBBA permanently eliminates the requirement to
capitalize and amortize U.S.-based research and experimental expenditures,
making these expenditures fully deductible in the period incurred. The OBBBA
also permanently extends recognition of the accelerated bonus depreciation on
qualifying assets in the period acquired. In 2025, these provisions resulted in
a reduction of current income tax liabilities and a corresponding reduction to
income tax expense.

In July 2025, we completed the
acquisition of real estate in Boca Raton, Florida for a total purchase price of
$12.6 million. This real estate purchase is intended to allow us to expand our
production operations and related activities as well as provide for certain
redundancies for ambient and cold-chain storage of raw materials, work in
process and finished goods inventory.

In December 2025, we entered
into an agreement for the divestiture of three of our plasma collection centers
for an aggregate purchase price of $12.0 million. The sale of these plasma
centers was completed during the first quarter of 2026. We continue to own and
operate seven plasma collection centers. In conjunction with the divestiture
agreement, we entered into a long-term respiratory syncytial virus (“RSV”) plasma supply agreement with the purchaser of
the three plasma collection centers, further diversifying our third-party
high-titer plasma supply base. Collectively, these actions reflect a deliberate
focus on a more flexible, capital-efficient supply model and are expected to
deliver accretive cost savings in fiscal year 2026, improve capital efficiency,
support increased ASCENIV production capacity, and provide durable plasma
supply confidence through the late 2030s.

Beginning in the second half of 2025 and continuing
into 2026, new FDA-approved IVIG products, and other pharmaceutical products
which compete with certain IVIG product uses, entered the market with
aggressive pricing tactics, including extended payment terms, rebates and
discounts. This has led to increases in raw material plasma supply and finished
goods inventory across the distribution network. This created competitive
intensity and distribution recalibration across the industry which has impacted
our results for the first half of 2026, mainly as it relates to BIVIGAM, but
broadly across the IVIG complex. If this trend of competitive pricing tactics
continues, future results and market adoption for our products may be adversely
impacted.

Our Products

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Index

ASCENIV

ASCENIV
is a plasma-derived IVIG product 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 U.S. Department of Health
and Human Services (“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, the J-code (J1554) became effective in April 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 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 children ages two and above. Our pivotal
Phase III 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, reduced days missed
from work, school and daycare and reduced unscheduled medical visits and
hospitalizations. We believe this clinical data together with the FDA approval of
ASCENIV for the treatment of PIDD better positions ADMA to potentially further evaluate ASCENIV in i

[Excerpt truncated for page length; source filing is linked above.]

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 a U.S. based, 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 in April 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 in May 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 Nos. 10,259,865 and 11,084,870 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. We have successfully completed production of a pilot-scale batch and are conducting animal studies for our S. pneumoniae hyperimmune globulin program, SG-001. We anticipate submitting a pre-Investigational New Drug (“IND”) package to the FDA in fiscal year 2026, which could enable us to progress development of SG-001 directly into a registrational clinical trial. In September 2025, a Commissioner’s National Priority Voucher (CNPV) application was submitted and, if accepted, could accelerate FDA review by two fiscal quarters or more. 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, FL 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.

Through our ADMA BioCenters subsidiary, we currently operate eight 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, one of our FDA-approved plasma collection centers also has approval from the Korean Ministry of Food and Drug Safety (“MFDS”), and ADMA BioCenters has 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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Table of Contents

From time to time, we may provide contract manufacturing services for certain third-party clients. We also provide laboratory contracting services to certain customers and may provide contract filling, labeling and packing services utilizing our FDA-approved in-house fill-finish capabilities.

Trends and Developments

For the year ended December 31, 2024, we achieved net income of $197.7 million, the first time in our history that we achieved net income on a GAAP basis and generated positive cash flow from operations of $118.7 million. Positive cash flow from operations continued throughout fiscal year 2025. Our improved operating results were primarily the result of the substantial revenue growth and continued physician, patient and payer acceptance of ASCENIV.

In April 2025, the FDA approved our Prior Approval Supplement (the “PAS”) for our innovative yield enhancement production process (the “Yield Enhancement”) benefiting both ASCENIV and BIVIGAM. This PAS approval amends the Biologics License Application (“BLA”) approvals for ASCENIV and BIVIGAM and will continue to be the process by which we will manufacture these products on a go-forward basis. The production methods approved in this PAS have started to result in additional bulk drug yield from the same starting raw material source plasma volumes and the Company believes it should experience meaningful revenue and earnings accretion accelerating further into 2026 and beyond. This innovative process has demonstrated an ability to increase ASCENIV and BIVIGAM production yields by 20% or more from the same starting source plasma volume. Fiscal year 2026 will be our first full year of yield-enhanced production, supporting anticipated sustained margin expansion.

In July 2025, the One Big Beautiful Bill Act ("OBBBA") was enacted, which includes numerous changes to existing tax law including extending or making permanent certain business provisions initially established under the 2017 Tax Cuts and Jobs Act, which were set to expire. The OBBBA permanently eliminates the requirement to capitalize and amortize U.S.-based research and experimental expenditures, making these expenditures fully deductible in the period incurred. The OBBBA also permanently extends recognition of the accelerated bonus depreciation on qualifying assets in the period acquired. In 2025, these provisions resulted in a reduction of current income tax liabilities and a corresponding reduction to income tax expense.

In July 2025, we completed the acquisition of real estate in Boca Raton, FL for a total purchase price of $12.6 million. This real estate purchase is intended to allow us to expand our production operations and related activities as well as provide for certain redundancies for ambient and cold-chain storage of raw materials, work in process and finished goods inventory.

In December 2025, we entered into an agreement for the divestiture of three of our plasma collection centers for an aggregate purchase price of $12.0 million. As of the date of this Annual Report on Form 10-K, two of the plasma collection centers have been sold to the purchaser. The closing of the third center is anticipated to occur in the first quarter of 2026. After the divestiture of all three centers, we will continue to own and operate seven plasma collection centers. In conjunction with the divestiture agreement, we entered into long-term plasma supply agreements with the purchaser of the three plasma collection centers, further diversifying our third-party high-titer plasma supply base. Collectively, these actions reflect a deliberate shift toward a more flexible, capital-efficient supply model and are expected to deliver accretive cost savings beginning in fiscal year 2026, improve capital efficiency, support increased ASCENIV production capacity, and provide durable plasma supply confidence through the late 2030s.

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 in April 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.

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Table of Contents

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 III 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. In the future, 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 2019 and in 2023 we commenced manufacturing ASCENIV at the 4,400 Liter production scale. This expansion has improved the product’s margin profile and increased plant production capacity as fewer batches are needed to support our revenue goals. ASCENIV’s prescriber and patient base continued to expand during 2024, which drove record utilization and pull-through for this product. These elevated demand trends continued throughout fiscal year 2025, and we expect the product’s rapid growth to continue through 2026 and beyond.

In June 2025, we filed our sBLA for the expansion of ASCENIV’s label to include the pediatric setting for patients who are two years and

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]