Fortress Biotech Reports Strong 2024 Results with Two FDA Approvals and Strategic Acquisition Deal
核心洞察
Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi (搜索) for inflammatory lesions of rosacea (搜索) and UNLOXCYT (搜索) for advanced cutaneous squamous cell carcinoma (搜索), with commercial launch of Emrosi already underway.
Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT (搜索) sales.
FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.
Fortress Biotech announced significant achievements in its 2024 financial results and corporate highlights, marking a transformative period for the innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term shareholder value.
FDA Approvals Strengthen Commercial Portfolio
In the fourth quarter of 2024, Fortress Biotech secured two critical FDA approvals that substantially enhanced its commercial portfolio. In November, the FDA approved Emrosi (搜索) (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for the treatment of inflammatory lesions of rosacea (搜索) in adults. The commercial launch of Emrosi is already underway through Fortress's partner company, Journey Medical Corporation (Nasdaq: DERM), with initial distribution ongoing and first prescriptions filled.
In December, the FDA approved UNLOXCYT (搜索) (cosibelimab), an anti-PD-L1 (搜索) antibody developed by Fortress's partner company Checkpoint Therapeutics. UNLOXCYT is indicated for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (搜索) (cSCC (搜索)) who are not candidates for curative surgery or radiation.
"The fourth quarter of 2024 was transformational for Fortress, marked by two FDA approvals — Emrosi (搜索) and UNLOXCYT (搜索) — as well as the FDA's recent acceptance of the New Drug Application for CUTX-101," said Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer.
Strategic Acquisition Deal with Sun Pharma
In a significant monetization development, Fortress's subsidiary Checkpoint Therapeutics entered into an agreement in March 2025 to be acquired by Sun Pharmaceutical Industries Limited. Under the terms of the agreement, Checkpoint stockholders will receive an upfront cash payment of $4.10 per share and a non-transferable contingent value right (CVR) entitling stockholders to receive up to an additional $0.70 per share if cosibelimab is approved in the European Union or major European markets.
Fortress owns approximately 6.9 million shares of Checkpoint's common stock and will be eligible for a 2.5% royalty on future sales of UNLOXCYT (搜索). The company expects to receive approximately $28 million at closing, plus up to an additional $4.8 million if the CVR is achieved.
"This transaction is also a successful milestone for Fortress as we expect to receive approximately $28 million at closing in addition to a 2.5% royalty on net sales of UNLOXCYT (搜索), and up to an additional $4.8 million if the contingent value right is achieved," Dr. Rosenwald noted. "These milestones continue to validate the Fortress business model."
CUTX-101 Priority Review and Potential Priority Review Voucher
The FDA recently accepted the New Drug Application submission for CUTX-101 (copper histidinate) for priority review with a PDUFA goal date of September 30, 2025. CUTX-101 is being developed for the treatment of Menkes disease (搜索), a rare and fatal pediatric disease.
In December 2023, Fortress completed the asset transfer of CUTX-101 to Sentynl Therapeutics (搜索), a wholly owned subsidiary of Zydus Lifesciences Ltd. Importantly, Cyprium Therapeutics (搜索), Fortress's subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA Priority Review Voucher that may be issued at NDA approval, representing a potentially significant monetization opportunity.
Clinical Progress and Pipeline Advancement
Fortress reported several clinical advances across its portfolio:
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Full results from two Phase 3 trials of Emrosi (搜索) for moderate-to-severe papulopustular rosacea (搜索) in adults were published in the Journal of the American Medical Association - Dermatology, demonstrating efficacy, safety, and tolerability.
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The first patient was dosed in a Phase 2 clinical trial evaluating Triplex (搜索), a cytomegalovirus (CMV) vaccine, in patients undergoing hematopoietic stem cell transplantation.
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A separate Phase 2 study of Triplex (搜索) in patients undergoing liver transplantation was initiated, with the first patient dosed in May 2024. This trial is funded by a grant from the National Institute of Allergy and Infectious Diseases that could provide over $20 million in non-dilutive funding.
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Longer-term data from Checkpoint's pivotal trial of UNLOXCYT (搜索) in locally advanced and metastatic cSCC (搜索) demonstrated deepening of response over time, with higher objective response and complete response rates than initially observed.
Financial Performance
Fortress reported consolidated net revenue of $57.7 million for the full year ended December 31, 2024, which included $55.1 million in net revenue generated from marketed dermatology products. This compares to consolidated net revenue of $84.5 million for 2023, which included $59.7 million from dermatology products.
The company's consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, compared to $80.9 million as of December 31, 2023. This includes $20.9 million attributable to Fortress and private subsidiaries, $2.6 million to Avenue, $6.6 million to Checkpoint, $6.8 million to Mustang, and $20.3 million to Journey Medical.
Consolidated research and development expenses including license acquisitions decreased to $56.9 million for 2024, compared to $106.1 million for 2023. Consolidated selling, general and administrative costs were $87.7 million for 2024, compared to $91.0 million for 2023.
Consolidated net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for 2024, compared to net loss of $(68.7) million, or $(8.47) per share for 2023.
Strategic Initiatives and Capital Raising
In March 2025, Fortress entered into a strategic collaboration with Partex NV to identify and evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing.
Throughout 2024, Fortress and its partner companies raised significant capital:
- Fortress raised approximately $21.1 million through equity offerings
- Checkpoint raised approximately $32.8 million
- Mustang Bio raised approximately $11.2 million, plus an additional $6.9 million in February 2025
- Avenue Therapeutics raised approximately $9.8 million
- Journey Medical raised approximately $7.9 million
Additionally, Fortress reduced its total debt by entering into a new loan agreement with Oaktree Capital Management in July 2024, resulting in an outstanding debt reduction of approximately $15 million.
Looking Ahead
"Looking ahead, we are focused on our next key milestone: the September 30, 2025, Prescription Drug User Fee Act goal date for CUTX-101," said Dr. Rosenwald. "Upon approval of the New Drug Application, our majority-owned subsidiary, Cyprium Therapeutics (搜索), may be eligible for a Priority Review Voucher. The commercial launch of Emrosi (搜索) for inflammatory lesions of rosacea (搜索) is underway with first prescriptions filled, and we expect continued revenue growth, portfolio milestone achievements and additional future monetization opportunities given our significant pipeline of late clinical-stage candidates and recently approved products."
Fortress Biotech continues to advance its business model of acquiring, developing, and commercializing pharmaceutical assets while creating value through product revenue, equity holdings, and royalty streams. With eight marketed prescription pharmaceutical products and over 20 programs in development, the company remains positioned to deliver innovative treatment options to patients with unmet medical needs while building long-term shareholder value.