Fortress Biotech (FBIO) reported its fiscal 2025 Q1 earnings on May 15th, 2025. The company's results showcased narrowing losses, with a 36.7% improvement in net income. Despite ongoing financial headwinds, Fortress Biotech's strategic initiatives have positioned it at a potential inflection point. The company maintained revenue growth in line with expectations and projected continued progress. Guidance remained consistent, with anticipated milestones, including the PDUFA date for CUTX-101, potentially leading to significant monetization events. The company's robust pipeline and recent product launches indicate promising future prospects.
Revenue Fortress Biotech's total revenue increased by 0.8% to $13.14 million in Q1 2025, compared to $13.03 million in Q1 2024. This revenue growth was attributed solely to product sales, reflecting ongoing commercial activities within its dermatology and pharmaceutical segments.
Earnings/Net Income Fortress Biotech reported a reduction in losses, with EPS improving to a loss of $0.48 per share in Q1 2025 from a loss of $1.04 per share in Q1 2024. The net loss narrowed to $24.69 million, a 36.7% improvement from the previous year's $39.02 million. The company’s EPS improvement reflects positive financial management.
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CEO Commentary Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, stated, “Fortress entered 2025 with strong momentum following a transformational fourth quarter marked by the U.S. Food and Drug Administration approvals of Emrosi™ and UNLOXCYT™, and the acceptance of the New Drug Application for CUTX-101. Looking ahead, we are focused on key value drivers, including the September 30, 2025 Prescription Drug User Fee Act action date for CUTX-101, which may also result in a Priority Review Voucher upon approval. Our robust pipeline positions us for continued revenue growth, value-driving milestones, and additional monetization opportunities, while we remain committed to delivering innovative therapies to patients and building long-term shareholder value.”
Guidance Fortress Biotech expects to maintain revenue growth with projected product revenues of approximately $13.1 million for Q1 2025, consistent with the previous year. The company anticipates a narrowing of net losses, projecting a net loss of approximately $(12.7) million or $(0.48) per share. Key milestones include the PDUFA date for CUTX-101 on September 30, 2025, which may lead to potential monetization events and royalties from successful product launches, including Emrosi, with initial prescriptions filled and revenue contributions expected to grow in upcoming quarters.
Additional News Fortress Biotech has recently entered a merger agreement for its subsidiary, Checkpoint Therapeutics, to be acquired by Sun Pharma. This transaction is expected to bring approximately $28 million upon closing, along with potential future royalties and contingent value rights. The acquisition is subject to approval at a special meeting of Checkpoint stockholders scheduled for May 28, 2025. Additionally, Fortress Biotech has announced a strategic collaboration with Partex NV, leveraging artificial intelligence to identify potential biopharmaceutical compounds for acquisition or licensing. Furthermore, the FDA's acceptance of the New Drug Application for CUTX-101, with a PDUFA goal date set for September 30, 2025, marks a significant regulatory milestone for the company.
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