ADMA Biologics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $141.1 million, a 5% increase year-over-year (YoY) and 13% increase sequentially.
• ASCENIV revenue was $124.7 million, up 31% YoY and 21% sequentially.
• BIVIGAM revenue was $15.4 million, down 35.2% YoY and 20.6% sequentially.
• GAAP net income was $49.9 million, up 37% YoY and 32% sequentially.
• Adjusted net income was $51.1 million, up 31% YoY and 31% sequentially.
• GAAP basic EPS was $0.22, up 47% YoY and 29% sequentially.
• Adjusted basic EPS was $0.23, up 44% YoY.
• Adjusted EBITDA was $77.3 million, up 32% YoY and 25% sequentially.
• Gross margin was 71%, expanding approximately 1,450 basis points YoY and 200 basis points sequentially.
• Gross profit was $99.9 million, up from $75.6 million in the prior-year quarter.
• Research and development expenses were $4.5 million, up from $1.5 million YoY.
• Selling, general and administrative expenses were $26.6 million, up from $21.7 million YoY.
• For the nine months ended September 30, 2026, total revenue was $380.0 million (up 2% YoY), and GAAP net income was $133.0 million.
• Cash and cash equivalents were $124.6 million as of September 30, 2026, compared to $87.6 million as of December 31, 2025.
• Total debt (current and long-term) was $195.9 million as of September 30, 2026, compared to $72.1 million as of December 31, 2025.

Guidance and Future Outlook:

• Reiterated FY2026 total revenue guidance of at least $530 million.
• Increased FY2026 Adjusted Net Income guidance to at least $180 million.
• Increased FY2026 Adjusted EBITDA guidance to at least $275 million.
• Outlook reflects continued ASCENIV commercial momentum and conservative assumptions for competitive conditions in the U.S. standard immune globulin market.
• Favorable ASCENIV utilization trends are expected to continue into the fourth quarter.
• SG-001 development is advancing toward clinical trials following constructive FDA feedback on the pre-IND meeting package.

Business Segments and Product Lines:

• ASCENIV growth was driven by expanding physician adoption, new patient starts, and growing end-user utilization.
• BIVIGAM utilization showed encouraging signs of stabilization despite competitive pricing and channel inventory pressures.
• ADMA plans to present real-world health outcomes data for 127 medically complex primary immunodeficiency patients at the ACAAI annual conference in mid-November.
• SG-001, an investigational pneumococcal hyperimmune globulin, advanced preclinical, assay development, and manufacturing-readiness activities.
• SG-001 development utilized the ADMAlytics screening platform incorporating computational modeling and AI to improve analytical efficiency.
• If approved, SG-001 represents a potential $300-500 million annual revenue opportunity.
• ADMA repurchased 2.7 million shares in Q3 2026; year-to-date repurchases totaled 16.5 million shares (6.3% of outstanding stock as of Dec 31, 2025).
• The company is on track to complete its $200 million or more 2026 share repurchase target.

Market and Competitive Landscape:

• ASCENIV demonstrates a strong clinical value proposition among medically complex primary immunodeficiency patients, supported by real-world evidence showing reductions in infection-related hospitalizations and healthcare utilization.
• The standard immune globulin market faces competitive pricing and aggressive competitor rebating and discounting.
• ADMA maintains a disciplined commercial participation strategy rather than matching aggressive competitor discounting.
• ASCENIV is protected by numerous issued patents in the U.S. and internationally.

Risks and Challenges:

• Competitive pressures in the standard immune globulin market continue to impact BIVIGAM revenue.
• Ongoing litigation matters have contributed to increased legal fees and professional expenses.
• Forward-looking statements regarding SG-001 development, regulatory approvals, and financial guidance are subject to risks and uncertainties.
• ASCENIV carries warnings regarding thrombosis, renal dysfunction, acute renal failure, and other adverse reactions including aseptic meningitis and hemolytic anemia.

Management Commentary and Tone:

• CEO Adam Grossman stated that results demonstrate the ability to translate accelerating ASCENIV demand into substantial earnings growth.
• Management expressed confidence in the durability of ASCENIV's growth trajectory and significant remaining market opportunity.
• Management noted encouraging signs of stabilization in underlying BIVIGAM utilization despite competitive pressures.
• Management highlighted the scalability and increasing profitability of the business, supported by expanding margins and operating leverage.
• Management emphasized disciplined capital allocation and robust cash generation as drivers for long-term stockholder value.
• Management expressed encouragement regarding constructive FDA feedback on the SG-001 pre-IND package, viewing it as an important milestone.

Other Key Points:

• The company received constructive FDA feedback regarding the proposed clinical development strategy and assay for SG-001.
• The company intends to incorporate FDA recommendations into the final clinical protocol for SG-001 and advance preparations for an IND submission.
• A gain on the sale of plasma centers of $7.98 million was recognized in the nine months ended September 30, 2026.
• The company operates an FDA-licensed plasma fractionation and purification facility in Boca Raton, Florida, and source plasma collection centers via its ADMA BioCenters subsidiary.
• The company has a $200 million or more share repurchase target for 2026.