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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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(Former name or former address, if changed since last report.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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| Item 2.02 |
Results of Operations and Financial Condition.
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| Item 7.01 |
Regulation FD.
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| Item 9.01 |
Exhibits.
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Exhibit No.
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Description
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Press Release of the Company, dated as of January 12, 2026.
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ADMA Biologics, Inc. January 2026 Corporate Presentation.
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104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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January 12, 2026
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ADMA Biologics, Inc.
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By:
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/s/ Adam S. Grossman
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Name:
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Adam S. Grossman
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Title:
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President and Chief Executive Officer
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FY 2025 preliminary unaudited total revenue expected to be approximately $510-511 million
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FY 2025 expected Adjusted Net Income and Adjusted EBITDA reiterated
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FY 2026 expected total revenue increased to approximately $635 million, up from $630 million previously
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FY 2026 expected Adjusted Net Income reiterated at approximately $255 million
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FY 2026 expected Adjusted EBITDA increased to approximately $360 million, up from $355 million previously
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FY 2027 total revenue expected to be approximately $775 million
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FY 2027 Adjusted Net Income expected to be approximately $315 million
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FY 2027 Adjusted EBITDA expected to be approximately $455 million
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Targeting greater than $1.1 billion of total annual revenue in fiscal year 2029, translating to at least $700 million in Adjusted EBITDA
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Accelerating Demand Momentum. Exiting 2025, ASCENIV
utilization accelerated, driven by record demand and expanding prescriber adoption. ASCENIV demand momentum is expected to continue with anticipated payer coverage expansion and increasing confidence in long-term supply continuity.
Year-end utilization trends provide clear visibility into sustained demand growth throughout 2026.
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Compelling Clinical Differentiation. Multiple,
independent sets of real-world outcomes data generated during 2025 reinforce ASCENIV’s clinical differentiation. Statistically significant reductions in infection
rates observed in an investigator-initiated analysis support physician confidence, payer engagement, and expanded medical education initiatives expected to further drive utilization in 2026.
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An independent, peer-reviewed publication by Tan et al., presented at ACAAI 2025 and published in Clinical Immunology evaluated real-world outcomes in patients with primary or secondary
immunodeficiencies who failed prior standard immunoglobulin replacement therapy (IgRT) and were subsequently treated with ASCENIV. The analysis demonstrated significant reductions in infections and hospitalizations, with 71% of patients
showing clinical improvement and the greatest impact observed within the first six months of treatment. These findings reinforce ASCENIV’s effectiveness in patients with recurrent respiratory infections who have not responded adequately to
conventional intravenous immunoglobulin (IVIG) therapy.
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Strong Payer Access. ASCENIV and BIVIGAM benefit from
strong payer coverage supported by long-standing strategic agreements that have maintained broad access across key commercial, Medicare, and Medicaid segments. These partnerships have reinforced coverage stability while preserving
favorable positioning, resulting in sustainable—and in some cases expanded—coverage that supports consistent patient access and provider confidence.
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Strategic Plasma Network Repositioning and Enhanced Supply Visibility. In December 2025, ADMA entered into a purchase agreement for the divestiture of three plasma centers for total proceeds of $12 million. After the divestiture, ADMA will continue to own and operate seven internal
plasma collection centers. In conjunction with the transaction, the Company entered into long-term plasma supply agreements with the purchaser, further diversifying its third-party high-titer plasma supply base. During 2025, third-party
suppliers outperformed initial expectations, expanding access to approximately 280+ plasma collection centers and materially improving long-term high-titer plasma supply visibility. 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 2026, improve capital efficiency, support increased ASCENIV production capacity, and provide durable supply confidence
through the late 2030s.
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Disciplined Commercial Execution. Disciplined commercial
execution and operating leverage continued to strengthen during 2025. Targeted field execution, expanded medical education, and patient engagement initiatives supported accelerating utilization while maintaining cost discipline, which
should position ADMA for expanding operating leverage and margin growth in 2026.
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Strengthened Financial Position. Balance sheet strength and
liquidity improved meaningfully during the fourth quarter of 2025. ADMA exited the year with approximately $88 million in total cash, representing approximately $40 million of operating cash flow generated during the fourth quarter. This
cash balance substantially excludes anticipated proceeds expected to be received from plasma center divestitures. Entering 2026, the Company anticipates accelerated cash generation, accretive cost savings from plasma center divestitures,
and increased financial flexibility to support growth initiatives, balance sheet optimization, and stockholder capital returns.
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Expanding Distribution Footprint. ADMA is engaged in
constructive discussions with potential distributors to further diversify its commercial network. During the fourth quarter of 2025, the Company entered into a new authorized distribution agreement for both ASCENIV and BIVIGAM with
McKesson Specialty, which is anticipated to open additional sites of care and patient populations. In 2026, ADMA anticipates further diversification of its distribution and customer network, supporting expanded reach and continued growth
for both products.
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Yield-Enhanced Production Execution. Yield-enhanced
production moved into routine commercial execution during 2025, with continued FDA lot releases of yield-enhanced batches. These developments position 2026 as ADMA’s first full year of yield-enhanced production, supporting sustained gross
margin expansion and increasing earnings power.
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Pipeline Optionality. Pipeline progress provides long-term
optionality beyond current guidance. The SG-001 pre-clinical development program advanced during 2025, with anticipated submission of a pre-IND package to the FDA in 2026, which would potentially enable the Company to progress development
of SG-001 directly into a registrational clinical trial and further strengthen ADMA’s long-term pipeline outlook. The Company continues to believe SG-001 represents a potential $300–500 million annual revenue opportunity at peak.
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WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
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Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization,
hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
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.
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