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Fortress Biotech — Q3 2026 Earnings Summary

  • Financial Performance:

    • Consolidated net revenue increased approximately 9% year-over-year to $19.2 million for the third quarter of 2026, compared to $17.6 million in the third quarter of 2025.
    • Product revenue, net, totaled $18.9 million for the quarter, up from $17.0 million in the prior year period.
    • Consolidated research and development expenses were $1.7 million for the quarter, an increase from $0.2 million in the same period of 2025.
    • Consolidated selling, general and administrative costs were $17.8 million for the quarter, compared to $17.4 million in the third quarter of 2025.
    • Consolidated net loss attributable to common stockholders was $(7.9) million, or $(0.23) per share (basic and diluted), compared to net income of $3.7 million, or $0.13 per share basic and $0.11 per share diluted, in the third quarter of 2025.
    • Consolidated cash and cash equivalents totaled $152.2 million as of September 30, 2026, an increase of $72.8 million year-to-date from $79.4 million as of December 31, 2025.
    • Total assets increased to $280.2 million as of September 30, 2026, from $185.5 million as of December 31, 2025.
    • Total liabilities decreased to $103.2 million as of September 30, 2026, from $123.4 million as of December 31, 2025.
    • Equity investments at fair value increased to $29.5 million as of September 30, 2026, from $17.7 million as of December 31, 2025.
    • Accounts receivable, net, increased to $47.4 million as of September 30, 2026, from $29.8 million as of December 31, 2025.
  • Business Segments and Product Lines:

    • Journey Medical reported approximately 40,000 total prescriptions for Emrosi® in the third quarter of 2026, with net product revenues of $18.9 million, up from $17.0 million in the third quarter of 2025.
    • Cyprium Therapeutics recognized $0.2 million in royalty revenue on net sales of ZYCUBO® in the third quarter of 2026.
    • Fortress recognized $0.1 million in contingent consideration royalty income on net sales of UNLOXCYT™ in the third quarter of 2026.
    • A subsidiary entered into an exclusive licensing agreement for FB-607, a novel combination therapy for irritable bowel syndrome with diarrhea (IBS-D), currently in a Phase 2 study.
    • Crystalys Therapeutics closed a $130 million Series B financing in July 2026 to support the development of dotinurad; Fortress' subsidiary Urica holds equity and is eligible for a 3% royalty on future net sales.
    • Anselamimab (formerly CAEL-101) received approval in Japan in September 2026 for the treatment of systemic kappa light chain amyloidosis.
    • Triplex is conducting ongoing clinical trials for cytomegalovirus (CMV) treatment and prevention, including combination trials with CAR T cell therapies.
    • Fortress is exploring the initiation of a clinical trial for MB-109 in the first quarter of 2027 for patients with IL13Rα2-positive recurrent glioblastoma and high-grade astrocytoma.
  • Market and Competitive Landscape:

    • Emrosi® is available by prescription at specialty pharmacy chains and has seen continued improvement in the mix of prescriptions reimbursed by health plans.
    • Dotinurad is being evaluated in global Phase 3 trials (RUBY and TOPAZ) and a Phase 2 study (AMETHYST) for gout, with potential for best-in-class safety and efficacy.
    • Fortress maintains partnerships with leading academic institutions and biopharmaceutical companies, including AstraZeneca, City of Hope, Nationwide Children's Hospital, Columbia University, Dana-Farber Cancer Institute, and Sentynl Therapeutics.
  • Risks and Challenges:

    • The company faces risks related to financing, uncertainties regarding the timing and amounts of future milestone, royalty, or contingent value right revenue streams, and the need for substantial additional funds.
    • Risks include the early stage of product candidates, uncertainties in preclinical and clinical testing results, and the ability to obtain regulatory approvals for products under development.
    • Potential challenges involve the ability to successfully commercialize products, secure third-party manufacturing and distribution, and maintain patent and intellectual property rights.
    • Forward-looking statements are subject to risks that could cause actual results to differ materially from expectations, including competition and government regulation.
  • Management Commentary and Tone:

    • Lindsay A. Rosenwald, M.D., Chairman, President and CEO, stated the third quarter reflected continued execution across a diversified portfolio.
    • Management expressed confidence that Fortress is well positioned to continue driving long-term value for shareholders through growing royalty income and multiple potential catalysts across partnered programs.
    • Management highlighted the repayment of the Oaktree credit facility and the in-licensing of FB-607 as key strategic moves.
    • Management noted that Journey Medical continues to build momentum with Emrosi® and that anselamimab's approval in Japan represents a significant milestone.
  • Other Key Points:

    • Fortress repaid in full the remaining $15.0 million in outstanding principal under its senior secured credit agreement with Oaktree Fund Administration, LLC in September 2026, satisfying all indebtedness and releasing all liens; the company now has no outstanding debt at the parent level.
    • The company originally entered into the $50.0 million credit facility in July 2024.
    • Fortress is eligible to receive commercial milestone payments based on sales and a regulatory milestone payment upon FDA approval for anselamimab following the sale of Caelum Biosciences.
    • The gain on the sale of a priority review voucher, net of expenses, was $158.9 million for the nine months ended September 30, 2026.
    • The company reported a gain from the deconsolidation of a subsidiary of $186,000 for the nine months ended September 30, 2026.
    • Total stockholders' equity attributed to the Company increased to $160.0 million as of September 30, 2026, from $49.9 million as of December 31, 2025.
Company
FORTRESS BIOTECH INC
Sector
Healthcare
Industry
Biotechnology