Core Insights - ADMA Biologics, Inc. announced preliminary unaudited full-year 2025 revenue estimates of approximately $510-$511 million and ended the year with about $88 million in cash, including roughly $40 million in operating cash flow generated in Q4 2025 [1][7] - The company increased its 2026 revenue guidance to approximately $635 million from $630 million and raised its adjusted EBITDA outlook to approximately $360 million from $355 million, indicating growing confidence in margin expansion [3][7] - Management forecasts revenues of approximately $775 million in 2027, net income of approximately $315 million, and adjusted EBITDA of roughly $455 million, with expectations of over $1.1 billion in fiscal 2029 [8] Revenue and Financial Performance - ADMA's revenue for 2025 is estimated at $510-$511 million, with a cash balance of approximately $88 million at year-end [1][7] - The company raised its 2026 revenue outlook to approximately $635 million and adjusted EBITDA guidance to about $360 million, reflecting confidence in production scaling [3][7] - Forecasts for 2027 include revenues of approximately $775 million and adjusted EBITDA of roughly $455 million, with a long-term goal of exceeding $1.1 billion in revenues by 2029 [8] Product and Market Dynamics - ADMA's lead product, Asceniv, is a plasma-derived intravenous immune globulin for treating primary immunodeficiency disease, with record demand and expanding payer coverage expected to drive revenue growth [4][5][9] - The company divested three plasma collection centers for $12 million while retaining seven, and entered long-term plasma supply agreements, enhancing supply visibility and production capacity [10][11] - ADMA is also developing other candidates, including SG-001, which could represent a $300-$500 million peak annual revenue opportunity if successful [13] Strategic Initiatives - The company implemented a more flexible, capital-efficient sourcing model to improve long-term supply visibility and support increased production capacity of Asceniv [11] - A new authorized distribution agreement with McKesson Specialty was signed in Q4 2025, expanding access to additional care sites for Asceniv and Bivigam [12] - The shift towards yield-enhanced production is expected to deliver cost savings starting in 2026, with the first full year of monetizing these batches anticipated in 2026 [11]

Company Overview - ADMA Biologics is a specialty producer of unique plasma-derived biologic products, primarily focusing on IVIG products that extract antibodies from human plasma [3] - The company has three FDA-approved commercial products and has preannounced total revenue of over $510 million for its commercial organization [3] Financial Performance - For the fourth quarter, ADMA expects revenue to exceed $139 million, with EBITDA projected at $77 million to $78 million or more, and net income anticipated to be around $50 million or more [3] - This financial performance represents a substantial increase compared to the third quarter of 2025 [3] Intellectual Property - The company holds intellectual property that protects its lead product ASCENIV until June 2035, focusing on the testing and identification processes [4]

Core Insights - ADMA Biologics has provided strong revenue guidance for 2025, 2026, and 2027, with expectations of over $510 million in revenue for 2025, $635 million for 2026, and $775 million for 2027, alongside significant EBITDA projections [2][6][19] Financial Performance - For 2025, ADMA anticipates revenue exceeding $510 million, with EBITDA around $235 million and net income greater than $158 million [2] - The company expects fourth-quarter 2025 revenue to surpass $139 million, with EBITDA between $77 million and $78 million, and net income around $50 million [2][6] - Long-term projections include a target of $1.1 billion in revenue and approximately $700 million in EBITDA by 2029 [1][6] Product and Market Focus - ADMA's primary product, Asceniv, is a respiratory-focused immune globulin, with the company holding three FDA-approved commercial products [3][7] - The IVIG market is projected to grow from over $13 billion in 2024 to more than $30 billion by 2033, with ADMA capturing about 3% of the U.S. immunoglobulin market [8] - The total addressable market for Asceniv is estimated at 25,000 patients, with ADMA currently serving over 1,000 patients [8] Manufacturing and Supply Chain Developments - ADMA is divesting three plasma centers for approximately $12 million, which will help reduce operating costs by $13 million to $15 million [4][14] - The company has secured long-term supply contracts and expanded third-party plasma collection to over 280 centers, ensuring a steady supply of raw materials for Asceniv [4][15] - An FDA-approved yield enhancement strategy allows ADMA to produce 20% more finished goods per plasma unit, which is expected to improve margins starting in 2026 [5][11] Pipeline and Future Opportunities - ADMA plans to pursue a pediatric label expansion for Asceniv and is developing the SG01 program, which could represent a revenue opportunity of $300 million to $500 million if successful [19] - The SG01 program is not included in the 2029 revenue guidance but has an intellectual property runway through 2037 [4][19]

Summary of ADMA Biologics FY Conference Call Company Overview - **Company Name**: ADMA Biologics - **Ticker Symbol**: ADMA (NASDAQ) - **Industry**: Biologics, specifically plasma-derived products - **Headquarters**: Ramsey, New Jersey; manufacturing in Boca Raton, Florida; plasma center operations in North Carolina - **Key Products**: IVIG products, including Asceniv and Bivigam Financial Performance - **Total Revenue**: Pre-announced $510 million for the fiscal year 2025, with Q4 revenue exceeding $139 million [2][3] - **EBITDA**: Expected to be between $77-$78 million for Q4 2025, with net income projected at over $50 million [3] - **2026 Guidance**: Forecasting $635 million in revenue and $360 million in EBITDA [24] - **2027 Guidance**: First-time guidance of $775 million in revenue and $455 million in EBITDA [24] Product and Market Insights - **Asceniv**: Unique polyclonal immunoglobulin targeting patients with primary immunodeficiency (PI) and respiratory syncytial virus (RSV) [12][13] - **Market Size**: The immunoglobulin market is projected to grow from over $13 billion in 2024 to over $30 billion by 2033 [10] - **Target Patient Population**: Approximately 250,000 patients with PI, with ADMA targeting about 25,000 patients who do not respond well to standard IG therapy [11][12] Strategic Developments - **Plasma Collection Network**: Currently operates 10 plasma centers, divesting three centers while expanding third-party plasma collection from 250 to 280 centers [4][5] - **Yield Enhancement Strategy**: Achieved a 20% increase in manufacturing yield, allowing for more finished goods from the same raw material [19][44] - **FDA Approval**: First company to receive FDA approval for yield enhancement manufacturing strategy [6][19] Growth Opportunities - **Pipeline Expansion**: Plans to submit a pre-IND package for SG01, a new product expected to generate $300-$500 million in revenue [22][23] - **Pediatric Market**: Anticipating label expansion for Asceniv to include pediatric patients aged 2 to 12 [21] - **Distribution Partnerships**: New agreement with McKesson Specialty to enhance distribution capabilities [18] Operational Efficiency - **Cost Management**: Divestiture of plasma centers expected to reduce operating costs by $13-$15 million [25][40] - **Production Mix**: Shift towards higher production of Asceniv, projected to account for 90% of revenue by 2029 [17] Competitive Landscape - **Market Position**: ADMA is the last U.S.-based producer of intravenous immune globulins, insulated from low-cost competition from emerging markets [6] - **Innovation**: Focus on capital-efficient R&D and leveraging proprietary technology for product differentiation [23][38] Conclusion - ADMA Biologics is positioned for significant growth with a strong financial outlook, innovative product offerings, and strategic operational efficiencies. The company is focused on expanding its market share in the U.S. while exploring future opportunities in pediatric care and new product development.

Revenue Projections and Growth Opportunities - The company projects total annual revenue opportunity between $300 million and $500 million by 2026[6] - ADMA anticipates a potential annual revenue opportunity of over $1.1 billion in FY 2029 from high-titer plasma supply contracts[9] - Revenue for FY 2025 is projected to be between $510 million and $511 million, with a cash flow from operations of $40 million in Q4 2025[33] - The company is targeting annual revenue exceeding $1.1 billion and adjusted EBITDA of $700 million by FY 2029[35] - Estimated revenue CAGR from 2025 to 2029 is approximately 20%, with adjusted EBITDA CAGR expected to be around 30%[31] Product Development and R&D - The company is committed to enhancing its R&D pipeline with additional opportunities for specialty biologics[5] - The company is investing in innovative R&D pipelines, particularly in hyperimmune globulin targeting S. pneumoniae, to advance its product offerings[35] - The company is focused on expanding its market presence through innovative product development and strategic partnerships[8] - The company is focused on addressing the needs of clinicians and patients requiring additional therapeutic interventions[17] Manufacturing and Supply Chain - The company operates state-of-the-art FDA-licensed facilities dedicated to human plasma collection[6] - The company maintains a vertically integrated U.S.-based manufacturing supply chain, ensuring compliance with cGMP standards[7] - The company has established in-house control of critical manufacturing functions, supporting long-term revenue growth and product supply continuity[7] - The FDA has approved the company's unique manufacturing process, which allows for greater visibility and efficiency in the supply chain[8] - The company is focused on enhancing its manufacturing lead time, which currently stands at 6-9 months[8] Financial Performance and Metrics - The company reported a year-over-year revenue growth rate of 53% and earnings growth of 46%[32] - Adjusted EBITDA reached $58.7 million, compared to $45.4 million in the prior year, reflecting a strong operational performance[34] - Adjusted EBITDA margins are forecasted to be approximately 46% in 2025, 57% in 2026, and 59% in 2027[31] - The company expects adjusted net income to show significant growth, aligning with its revenue growth strategy[31] - The company has authorized a share repurchase program of up to $500 million, demonstrating commitment to shareholder returns[35] Clinical Efficacy and Market Demand - ASCENIV reported zero serious bacterial infections (SBIs) in a one-year study of patients with primary immunodeficiency (PI)[14] - The study defined SBIs as a rate of less than 1.0 cases per patient per year, demonstrating the efficacy of ASCENIV in reducing infection rates[14] - There is a high demand for tailored therapeutic interventions for underserved high-risk immunodeficient patients[17] - The total addressable market (TAM) for the company is estimated at 250,000 diagnosed patients, with a penetration rate of approximately 4% to date[17] Strategic Partnerships and Market Presence - The company has established distribution partnerships to efficiently handle cold-chain products, enhancing its product portfolio offerings[19] - The commercial model is designed to support growth, with engagement among approximately 300-400 specialists serving the target patient population[19] - The company aims to expand its prescriber coverage through both increased depth and broader breadth[19] - The company has established a diversified third-party high-titer plasma supply network comprising four counterparties[9] Operational Efficiency and Cost Management - The anticipated cost savings from realizing meaningful efficiencies will commence post-transaction closing[9] - The company is focused on optimizing its capital structure and reducing costs through bank-syndicated debt refinancing[35] - The company is targeting high unmet needs patient populations with its SG-001 program for pneumonia infections, with patent protection extending into 2037[5] - The company is engaged in contract manufacturing to enhance its capabilities in the market[5]

Core Insights - ADMA Biologics, Inc. reported preliminary unaudited total revenue for FY 2025 of approximately $510–511 million, meeting or exceeding prior guidance [1] - The company reiterated its FY 2025 adjusted EBITDA and adjusted net income guidance, with cash holdings at year-end 2025 growing to approximately $88 million [1][5] - For FY 2026 and FY 2027, ADMA expects revenues of approximately $635 million and $775 million, respectively, with adjusted net income projected at approximately $255 million and $315 million [1][5] Financial Performance - FY 2025 total revenue is estimated at approximately $510–511 million, with adjusted net income and adjusted EBITDA guidance reiterated [1][5] - FY 2026 total revenue is expected to increase to approximately $635 million, up from a previous estimate of $630 million, with adjusted EBITDA also revised upward to approximately $360 million from $355 million [5] - FY 2027 total revenue is projected at approximately $775 million, with adjusted net income and adjusted EBITDA expected to be approximately $315 million and $455 million, respectively [5] Growth Projections - ADMA targets greater than $1.1 billion in annual revenue by FY 2029, representing a compound annual growth rate (CAGR) of approximately 20% [1] - The company aims for greater than $700 million in adjusted EBITDA by FY 2029, indicating a CAGR of approximately 30% [1] Operational Developments - 2026 is expected to be ADMA's first full year of yield-enhanced production, which is anticipated to support sustained margin expansion [1][2] - The strategic repositioning of the plasma collection network is expected to enhance margins and strengthen long-term supply visibility [1][2] Market Dynamics - Record demand for ASCENIV is anticipated to continue, driven by payer coverage expansion and increasing confidence in long-term plasma supply availability [2][5] - Positive real-world outcomes for ASCENIV are expected to be presented at the CIS in May 2026, with additional data anticipated throughout 2026 [1][5] Pipeline and Future Initiatives - The SG-001 pipeline program is advancing, with an anticipated FDA pre-IND submission in 2026 [1][5] - Ongoing share repurchases and capital structure strengthening are aimed at enhancing stockholder value [1][5]

ADMA Biologics Realizing the Potential of Specialty Biologics with Groundbreaking Immunotechnology January 2026 NASDAQ: ADMA Forward-Looking Statements This presentation contains "forward-looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. and its subsidiaries (collectively, "we," "our" or the "Company"), including, without limitation, statements that may predict, forecast, indicate, or imply future results, performan ...

Core Viewpoint - ADMA Biologics, Inc. will participate in the J.P. Morgan Healthcare Conference on January 12, 2026, highlighting its focus on specialty biologics for immunodeficient patients [1]. Company Overview - ADMA Biologics is a U.S.-based biopharmaceutical company that manufactures, markets, and develops specialty biologics aimed at treating immunodeficient patients and those at risk for infectious diseases [3]. - The company currently offers three FDA-approved plasma-derived biologics: ASCENIV™ for primary humoral immunodeficiency, BIVIGAM for primary immunodeficiency, and NABI-HB for enhanced immunity against hepatitis B [3]. - ADMA is also developing SG-001, a pre-clinical hyperimmune globulin targeting S. pneumonia [3]. - The company operates an FDA-licensed plasma fractionation and purification facility in Boca Raton, Florida, and has a subsidiary, ADMA BioCenters, which collects source plasma for its products [3]. - ADMA holds numerous U.S. and foreign patents related to its products and candidates [3].

Company Overview - ADMA Biologics, Inc. is a biopharmaceutical company that develops, manufactures, and markets specialty plasma-derived biologics for the treatment of immune deficiencies and infectious diseases in the United States and internationally [4]. Product Portfolio - The company markets BIVIGAM, an intravenous immune globulin product for treating primary humoral immunodeficiency, and Nabi-HB, a human polyclonal antibody product for acute exposure to blood containing Hepatitis B surface antigen [2][4]. Financial Performance - In the third quarter of 2025, ADMA Biologics updated its revenue guidance for 2025, now expecting total revenue of $510 million, an increase from the previous guidance of over $500 million [3]. - The adjusted net income for 2025 was also revised to $158 million, reflecting a higher effective tax rate [3].

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