1Q 2026 Total Revenue of $114.5 Million, Flat Year-Over-Year

 

1Q 2026 ASCENIV Revenue +28% Year-Over-Year; BIVIGAM Revenue -54% Year-Over-Year

 

1Q 2026 Adjusted Net Income⁽¹⁾ of $40.7 Million, 22% Year-Over-Year Growth

 

1Q 2026 Adjusted EBITDA⁽²⁾ of $59.7 Million, Representing 24% Year-Over-Year Growth

 

1Q 2026 Cash from Operations of $58 Million Highlights Strong Cash Generation

 

Strong Balance Sheet and Financial Flexibility Support Continued Execution

 

Reiterates Confidence in ASCENIV Growth Outlook Driven by Durable Demand Fundamentals

 

Updates FY 2026 Outlook and Withdraws Long-Term Guidance to Reflect Evolving U.S. Plasma Products and IG Market Competitive Dynamics

 

 

“During the first quarter, the market for U.S. plasma derived therapies (PDT) and immunoglobulin (IG) experienced increased competitive dynamics which, along with variability in distributor ordering patterns, created near-term topline pressures, particularly impacting BIVIGAM,” said Adam Grossman, President and Chief Executive Officer of ADMA. “Importantly, these dynamics were limited to distribution and inventory behavior and we believe do not reflect any deterioration in underlying ASCENIV demand, where fundamentals remained strong and continue to improve – with record utilization growth throughout the quarter, as illustrated by ASCENIV’s 28% year-over-year revenue growth. We continue to see strength across key ASCENIV demand metrics, including record new patient starts, growing prescriber breadth, product pull-through and patient adherence, and we are encouraged that the second quarter run rate based on April demand is in-line with the level of first quarter direct sales.”

 

Mr. Grossman continued, “We believe the first quarter results likely represent a trough revenue baseline driven by what we anticipate is a temporary market dislocation, and we expect to drive growth over the coming quarters. Despite this backdrop, in the quarter ADMA delivered 22% year-over-year Adjusted Net Income growth, 24% Adjusted EBITDA growth, expanded gross margins to 71% and generated $58 million of operating cash flow on revenue that was essentially flat – underscoring the resilience of our business model in a challenging PDT and IG landscape. We believe the current pricing environment and inventory dislocation in the U.S. IG and PDT market will prove temporary, and ADMA has remained disciplined in its pricing strategy. With ASCENIV demand at record levels, supported by durable and enduring fundamentals, and still forecasted to be early in its penetration curve, we remain confident in our ability to drive growth from this baseline through expanding margins and increasing cash generation. We also see meaningful long-term opportunity in SG-001, where our capital-efficient development approach and existing platform position us to leverage our commercial infrastructure, if approved, for a potentially rapid commercial ramp toward what we believe is a $300 to $500 million annual market opportunity.”

 

Updated Financial Guidance and Outlook

 

 

 

 

 

FY 2026 outlook reflects the rapidly changing competitive dynamics and sustained pressure with standard IG pricing throughout the balance of the year.  ASCENIV growth outlook remains strong, supported by durable underlying demand fundamentals.

 

Commercial and Operational Execution Supporting Long-Term ASCENIV Growth

 

First Quarter 2026 Financial Results:

 

 

Gross profit for the quarter ended March 31, 2026 was $80.8 million, compared to $61.1 million in the prior-year period, resulting in gross margin of 71% in 2026 compared to 53% in the prior-year period. The improved gross margins year-over-year reflect the product mix shift towards the higher margin ASCENIV 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 March 31, 2026 were $2.6 million, compared to $0.8 million in the prior-year period, primarily due to the investments in the SG-001 development project.

 

Selling, general and administrative expenses for the quarter ended March 31, 2026 were $26.7 million, compared to $24.1 million in the prior-year period, primarily driven by higher employee-related costs of $2.4 million, which included the impact of share-based compensation modification related to the departure of the Company’s former Chief Financial Officer and Treasurer in the amount of $0.8 million, and increased headcount to support the business.

 

GAAP net income for the quarter ended March 31, 2026 was $45.3 million, compared to $26.9 million for the quarter ended March 31, 2025. The 68% growth in GAAP net income year-over-year was driven primarily by a shift in product mix from BIVIGAM to ASCENIV and also benefited from the divestiture of three plasma collection centers during the quarter.

 

Adjusted Net Income for the quarter ended March 31, 2026 was $40.7 million, representing 22% year-over-year growth.

 

Adjusted EBITDA for the quarter ended March 31, 2026 was $59.7 million, representing 24% year-over-year growth.

 

About ASCENIV™

 

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.

 

Additional Important Safety Information About ASCENIV™

 

For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

ASCENIV™ Contraindications:

 

History of anaphylactic or severe systemic reactions to human immunoglobulin.

 

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

 

ASCENIV™ Warnings and Precautions:

 

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.

 

ASCENIV™ Adverse Reactions:

 

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 www.fda.gov/medwatch.http://www.fda.gov/medwatch

 

About ADMA Biologics, Inc. (ADMA)

 

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.

 

Use of Non-GAAP Financial Measures

 

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.

 

Cautionary Note Regarding Forward-Looking Statements

 

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,” “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 (including baseline levels), Adjusted Net Income, Adjusted EBITDA, cash and cash flow, earnings and earnings potential, financial guidance in future periods; our balance sheet and financial position; the current U.S. IG and PDT market, including competitive pressures; customer ordering patterns and inventory levels; expected benefits of the McKesson Specialty distribution agreement; our commercial execution initiatives and intended financial benefits; ASCENIV revenue growth, margins, earnings power, cash generation, addressable market, demand and utilization; share repurchases and capital structuring; internal controls, financial reporting and commercial practices; and SG-001, its data, regulatory filings and clinical trial timeline and revenue potential. 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.

INVESTOR RELATIONS CONTACT:

Argot Partners | 212-600-1902 | ADMA@argotpartners.com

MEDIA CONTACT:

Longacre Square Partners | ADMABiologics@longacresquare.com

ADMA BIOLOGICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS

 

 

(a) Add-backs reflected during the three months ended March 31, 2025 exclude estimated tax effect of $1.3 million. Add-backs reflected during the three months ended March 31, 2026 were tax affected using the first quarter 2026 effective tax rate.

⁽¹⁾ Due to Nabi-HB historically representing less than 10% of the Company’s revenue within the ADMA BioManufacturing segment, it has been included under intermediates and other products.

---