Fortress Biotech Reports Q2 2025 Results, Notable Acquisitions, and FDA Approval

Fortress Biotech reported Q2 2025 net income of $13.4 million and consolidated revenue of $16.4 million. The company's subsidiary, Checkpoint Therapeutics, was acquired by Sun Pharma for $28 million upfront, with potential for additional CVR and royalties. The FDA accepted CUTX-101 for priority review, with a PDUFA date set for September 30, 2025. Journey Medical reported $15 million in product revenues, with Emrosi launching commercially and expanding payer coverage. Fortress Biotech's cash position strengthened, with cash and cash equivalents totaling $74.4 million as of June 30, 2025.

Fortress Biotech (NASDAQ: FBIO) reported its second-quarter 2025 financial results, highlighting significant milestones and a robust financial position. The company's subsidiary, Checkpoint Therapeutics, was acquired by Sun Pharma for $28 million upfront, with potential for additional contingent value rights (CVR) and royalties. The FDA accepted CUTX-101 for priority review, with a PDUFA date set for September 30, 2025. Journey Medical reported $15 million in product revenues, with Emrosi launching commercially and expanding payer coverage. Fortress Biotech's cash position strengthened, with cash and cash equivalents totaling $74.4 million as of June 30, 2025.

The acquisition of Checkpoint Therapeutics by Sun Pharma delivered immediate value with $28 million upfront, plus potential for an additional $4.8 million under a CVR and ongoing 2.5% royalties on UNLOXCYT™ sales. This acquisition validates Fortress's business strategy of building and monetizing subsidiaries.

The FDA acceptance of CUTX-101's NDA with priority review (PDUFA: September 30, 2025) represents another potential near-term catalyst. Fortress retained 100% ownership of any Priority Review Voucher that could be issued upon approval, which typically sells for $100-120 million.

Commercial operations show stability with Journey Medical generating $15 million in Q2 product revenue, essentially flat year-over-year. The recent launch of Emrosi for rosacea has expanded payer coverage to 65% of U.S. commercial lives, up from 54% in May 2025.

Financially, Fortress has strengthened its position with consolidated cash increasing to $74.4 million (from $57.3 million at year-end 2024), while reporting quarterly net income of $13.4 million ($0.50 per share basic) compared to a net loss of $13.3 million in Q2 2024. R&D expenses decreased by 36% to $8.1 million, likely reflecting the Checkpoint divestiture.

The subsidiary portfolio continues advancing with Mustang Bio receiving Orphan Drug Designation for MB-101 in recurrent diffuse and anaplastic astrocytoma and glioblastoma, supporting their innovative combination strategy with MB-108 oncolytic virus to improve CAR-T efficacy in solid tumors.

References:
[1] https://www.stocktitan.net/news/FBIO/fortress-biotech-reports-second-quarter-2025-financial-results-and-yrpk778hw4p2.html