ADMA Biologics Reports Second Quarter 2026 Financial Results and Provides Business Update

2Q 2026 Total Revenue of $124.4 Million, Increasing 2% Year-over-Year

2Q 2026 ASCENIV Revenue of $102.9 Million, Increasing 24% Year-over-Year

BIVIGAM Utilization Stabilized with Sequential Improvement in Demand and Revenue

2Q 2026 GAAP Net Income of $37.8 Million, Increasing 11% Year-over-Year

2Q 2026 Adjusted Net Income (1) of $39.0 Million, Increasing 8% Year-over-Year

2Q 2026 GAAP Basic EPS of $0.17, Increasing 17% Year-over-Year

2Q 2026 Adjusted EBITDA (2) of $61.8 Million, Increasing 22% Year-over-Year

Strong Balance Sheet and Financial Flexibility Support Continued Execution

ACAAI Abstract Submitted Highlighting Significant Real-World Health Outcomes and Healthcare Resource Utilization Improvements in PI Patients Treated with ASCENIV

Accelerating ASCENIV Demand and Expanding Real-World Evidence Reinforce ADMA’s Robust Growth Opportunity

Reiterates FY2026 Financial Guidance

RAMSEY, N.J. and BOCA RATON, Fla., Aug. 05, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S.-based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced its second quarter 2026 financial results and provided a business update.

“Our second quarter results reflect strong execution across the business and demonstrate the power of ASCENIV’s growth trajectory,” said Adam Grossman, President and Chief Executive Officer of ADMA. “ASCENIV continued to outperform, supported by increasing physician adoption, broader prescriber engagement, new patient starts and higher patient utilization. Growth in ASCENIV utilization accelerated in the quarter, with June delivering the strongest sequential month-over-month utilization growth since the first half of 2024. BIVIGAM demand continued to stabilize during the quarter, resulting in sequential improvement in utilization and revenue. Together, these trends reinforce our confidence in sustained growth throughout the balance of 2026."

Mr. Grossman continued, “During the first half of 2026, ADMA further enhanced its robust real-world health outcomes and healthcare resource utilization data, which we believe further differentiates ASCENIV in later-line, refractory and medically complex primary immunodeficiency patients. We generated data comprising 127 real-world ASCENIV-treated patients, the majority of whom had previously received other immune globulin therapies and switched to ASCENIV. The study’s findings demonstrated that patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use following ASCENIV administration, and the findings have been submitted as an abstract to the November 2026 American College of Allergy, Asthma & Immunology (“ACAAI”) Annual Scientific Meeting. Supported by this expanding real-world evidence base, we believe these datasets will further strengthen ASCENIV’s already robust patient access and commercial payer coverage. We believe ASCENIV remains early in its penetration of this underserved market, supporting our confidence in meeting or exceeding guidance ranges for 2026 and unwavering optimism in the product’s peak revenue potential.”

• FY2026 total revenue expected to be $530 million to $560 million

• FY2026 Adjusted Net Income expected to be $170 million to $200 million

• FY2026 Adjusted EBITDA expected to be $265 million to $300 million

The FY2026 outlook continues to reflect sustained competitive dynamics and pricing pressure within the U.S. immune globulin market through the balance of the year. ASCENIV is expected to remain ADMA’s principal growth driver, supported by accelerating demand, expanding physician adoption and an increasing body of differentiated clinical and real-world evidence.

• ASCENIV Demand Continued to Accelerate. ASCENIV demand accelerated throughout the second quarter, culminating in June with the strongest sequential month-over-month utilization growth since the first half of 2024. The acceleration in distributor reported end-user utilization in the second quarter of 2026 reinforces management’s view that ASCENIV remains early in its penetration of the later-line, refractory primary immunodeficiency (“PI”) market.

• ASCENIV Continued to Outperform in its Insulated Total Addressable Market (TAM) and BIVIGAM Utilization is Stabilizing Despite an Evolving, Competitive U.S. IG Market Backdrop. ASCENIV continued to outperform, supported by increasing physician adoption, broader provider engagement, new patient starts and higher patient utilization. BIVIGAM demand stabilized during the second quarter, resulting in sequential improvement in utilization and revenue.

• New Real-World Health Outcomes Data Further Differentiated ASCENIV. ADMA submitted an abstract for publication at the 2026 ACAAI Annual Scientific Meeting highlighting results from a large real-world health outcomes and healthcare resource utilization analysis of 127 medically complex PI patients, the majority of whom had previously received other immune globulin therapies. Following initiation of ASCENIV treatment, patients experienced statistically significant reductions in infection-related hospitalizations, outpatient healthcare utilization, oral antibiotic use and corticosteroid use. The proportion of patients experiencing infection-related emergency-room visits also declined. The Company believes these findings further validate ASCENIV's differentiated value proposition, reinforce its positioning in later-line, refractory PI patients and support continued physician adoption, payer access and utilization. These findings complement ASCENIV's broad commercial payer coverage and support its continued commercial expansion. The study population consisted of complex patients who, in addition to PI, had one of: (1) respiratory comorbidities (i.e., Asthma, COPD, bronchiectasis, etc.), (2) significant corticosteroid, antibiotic or respiratory antiviral use, or (3) recurrent infection-related healthcare resource utilization (i.e., hospitalizations, ER visits) in a calendar year. The analysis compared patient outcomes and healthcare resource utilization during the 12 months before ASCENIV initiation with the 12 months following administration.

• Commercial Momentum Supports Reiterated FY2026 Financial Guidance. Accelerating ASCENIV demand, stabilization in BIVIGAM, and continued strong cash generation reinforce management’s confidence in meeting or exceeding the Company’s FY2026 financial guidance.

• Disciplined Capital Allocation Continues to Enhance Stockholder Value. During the second quarter, ADMA repurchased approximately 7.1 million shares of common stock under its previously authorized share repurchase program. Year-to-date total stock repurchases through June 30, 2026 were approximately 13.8 million shares, amounting to 5.3% of the Company’s common stock outstanding. In addition to the Company’s accelerated share repurchase (ASR) program completed in the second quarter, ADMA’s stock repurchases were funded through organically generated operating cash flow, while the Company maintained substantial financial flexibility to support commercial expansion, manufacturing initiatives and pipeline development. The Company remains active with share repurchases and is on track to complete its previously stated $200 million or more 2026 share repurchase target.

• SG-001 Development Remains on Track. ADMA continues to advance plasma collection optimization, potency assay development and preclinical activities supporting planned conformance lot production during the second half of 2026, ahead of the anticipated submission of its pre-Investigational New Drug (IND) meeting package to the U.S. Food and Drug Administration by year-end. Leveraging ADMA’s existing platform and commercial infrastructure, the Company believes it is positioned for a potentially rapid commercial ramp-up toward an approximately $300 to $500 million market opportunity. Immunocompromised patients remain at a disproportionately high risk for severe pneumococcal disease. Underlying impairments in functional immunity limit vaccine-mediated protection, leaving a persistent need for alternative targeted preventive strategies in the patients at greatest risk. ADMA believes SG-001 has the potential to mitigate the burden of the disease and is encouraged by the pre-clinical studies conducted to date.

• The study population consisted of complex patients who, in addition to PI, had one of: (1) respiratory comorbidities (i.e., Asthma, COPD, bronchiectasis, etc.), (2) significant corticosteroid, antibiotic or respiratory antiviral use, or (3) recurrent infection-related healthcare resource utilization (i.e., hospitalizations, ER visits) in a calendar year.

• The analysis compared patient outcomes and healthcare resource utilization during the 12 months before ASCENIV initiation with the 12 months following administration.

• Immunocompromised patients remain at a disproportionately high risk for severe pneumococcal disease. Underlying impairments in functional immunity limit vaccine-mediated protection, leaving a persistent need for alternative targeted preventive strategies in the patients at greatest risk. ADMA believes SG-001 has the potential to mitigate the burden of the disease and is encouraged by the pre-clinical studies conducted to date.

Total revenue for the quarter ended June 30, 2026 was $124.4 million, compared to $122.0 million for the quarter ended June 30, 2025. ASCENIV revenue of $102.9 million in the quarter demonstrated 24% growth year-over-year, while BIVIGAM revenue was $19.4 million, a 49% decline year-over-year, however, growing sequentially from the first quarter 2026 trough levels.

Gross profit for the quarter ended June 30, 2026 was $86.3 million, compared to $67.2 million in the prior-year period, resulting in gross margin of 69% in 2026 compared to 55% in the prior-year period. The gross margin expansion year-over-year reflects the product mix shift towards the higher margin ASCENIV product as well as the continued impact of the Company’s yield enhanced manufacturing process approved in 2025.

Research and development expenses for the quarter ended June 30, 2026 were $6.0 million, compared to $1.0 million in the prior-year period, primarily driven by investment in the SG-001 development project.

Selling, general and administrative expenses for the quarter ended June 30, 2026 were $26.7 million, compared to $22.2 million in the prior-year period, primarily driven by higher employee-related costs, increased software maintenance costs, higher professional and consulting fees associated with ongoing legal and related matters, and strategic initiatives supporting corporate growth.

GAAP net income for the quarter ended June 30, 2026 was $37.8 million, compared to $34.2 million for the quarter ended June 30, 2025. The 11% growth in GAAP net income year-over-year was driven primarily by a favorable product mix, reflecting continued ASCENIV growth and higher gross margins, partially offset by an increase in the effective tax rate to 24.7% in the current period as compared to 14.7% in the second quarter of 2025.

GAAP Basic EPS was $0.17 for the quarter ended June 30, 2026, compared to $0.14 in the prior-year period, representing 17% year-over-year growth.

Adjusted Net Income for the quarter ended June 30, 2026 was $39.0 million, representing 8% year-over-year growth.

Adjusted EBITDA for the quarter ended June 30, 2026 was $61.8 million, representing 22% year-over-year growth.

Total revenue for the six months ended June 30, 2026 was $238.9 million, compared to $236.8 million for the six months ended June 30, 2025. ASCENIV revenue of $200.4 million in the first half of 2026 demonstrated 26% growth year-over-year, while BIVIGAM revenue was $34.8 million, representing a year-over-year decline of 51%.

Gross profit for the six months ended June 30, 2026 was $167.0 million, compared to $128.3 million in the prior-year period, resulting in gross margin of 70%, compared to 54% in the prior-year period. The year-over-year gross margin expansion reflects a favorable product mix driven by continued ASCENIV growth, as well as the ongoing benefits of the Company's yield-enhanced manufacturing process approved in 2025.

Research and development expenses for the six months ended June 30, 2026 were $8.6 million, compared to $1.9 million in the prior-year period, primarily reflecting continued investment in the advancement of the Company's SG-001 pipeline program.

Selling, general and administrative expenses for the six months ended June 30, 2026 were $53.5 million, compared to $46.3 million in the prior-year period, primarily driven by an increase in personnel costs, including stock-based compensation, and an increase in professional and consulting fees associated with ongoing legal and related matters and strategic initiatives supporting corporate growth.

GAAP net income for the six months ended June 30, 2026 was $83.1 million, compared to $61.1 million in the prior-year period. The 36% year-over-year increase in GAAP net income was primarily driven by favorable product mix resulting from continued ASCENIV growth and higher gross margins, and also benefited from the divestiture of three plasma collection centers during the first quarter of 2026.

GAAP Basic EPS for the six months ended June 30, 2026 was $0.36, compared to $0.26 in the prior-year period, representing 38% year-over-year growth.

Adjusted Net Income for the six months ended June 30, 2026 was $79.6 million, representing 15% year-over-year growth.

Adjusted EBITDA for the six months ended June 30, 2026 was $121.5 million, representing 23% year-over-year growth.

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ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and children (2 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV 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 that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company’s website at www.admabiologics.com.

History of anaphylactic or severe systemic reactions to human immunoglobulin.

IgA deficient patients with antibodies to IgA and a history of hypersensitivity.

IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1]

Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4]

In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9]

Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment.

Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5]

Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6]

Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7]

Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

ADMA Biologics 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. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM ® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB ® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia. ADMA manufactures its immune globulin products and product candidates at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products and product candidates. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The Company believes Adjusted EBITDA and Adjusted Net Income are useful to investors in evaluating the Company’s financial performance. The Company uses Adjusted EBITDA and Adjusted Net Income as key performance measures because it believes that they facilitate operating performance comparisons from period to period that exclude 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 non-recurring items, and in the case of Adjusted Net Income, certain non-recurring items. The Company believes that investors should have access to the same set of tools used by its management and Board of Directors to assess its operating performance. Adjusted EBITDA and Adjusted Net Income should not be considered as measures of financial performance under GAAP, and the items excluded from Adjusted EBITDA and Adjusted Net Income are significant components in understanding and assessing the Company’s financial performance. Accordingly, these key business metrics have limitations as an analytical tool. They should not be considered as an alternative to net income, cash flows from operations, or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. Please refer to the tables below for the reconciliation of GAAP measures to these non-GAAP measures for applicable periods.

The Company has not provided a reconciliation of its forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measure because certain items that are excluded from such non-GAAP financial measures cannot be reasonably predicted or estimated without unreasonable effort. These items may include, but are not limited to, costs associated with potential business development, licensing, collaboration, acquisition, divestiture or other strategic transactions; unusual legal, litigation, regulatory, settlement and related professional fees, expenses and other organizational optimization costs; and other unusual, non-recurring, infrequent or non-cash items that may arise during the applicable period.

The timing, occurrence, and magnitude of these items are inherently uncertain and depend on a variety of factors that are outside of the Company's control or cannot be reasonably predicted at this time. Accordingly, management is unable to estimate these amounts with reasonable certainty or determine the probable significance of such items to the corresponding GAAP financial measure without unreasonable effort. These items could have a material impact on the Company's GAAP results for the applicable reporting period.

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “position us,” “positioned,” “support,” “should,” “could,” “would,” “may,” “potential,” “view,” “opportunity” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s total revenue, Adjusted Net Income, Adjusted EBITDA, earnings and earnings potential, financial guidance in future periods and related assumptions; the current U.S. immune globulin market, including competitive pressures; sustained competitive dynamics, pricing pressure, customer ordering patterns and inventory levels; our commercial execution initiatives and intended financial benefits; ASCENIV revenue growth and potential, value proposition, growth trajectory, penetration curve, appropriate market, patient access, commercial payer coverage, adoption, demand and utilization; our share repurchase target; and SG-001, its data, development, regulatory filings, revenue potential and clinical trial timeline. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

(1) Adjusted Net Income is a non-GAAP financial measure. For a reconciliation of Adjusted Net Income to the most comparable GAAP measure, see the reconciliation included in the financial tables. All non-GAAP adjustments are presented pre-tax.

(2) Adjusted EBITDA is a non-GAAP financial measure. For a reconciliation of Adjusted EBITDA to the most comparable GAAP measure, see the reconciliation included in the financial tables.