Fortress Biotech | 10-Q: FY2025 Q3 Revenue Misses Estimate at USD 17.63 M

Revenue: As of FY2025 Q3, the actual value is USD 17.63 M, missing the estimate of USD 21.02 M.

EPS: As of FY2025 Q3, the actual value is USD 0.11.

EBIT: As of FY2025 Q3, the actual value is USD -4.805 M.

Segment Revenue

• Journey: Revenue of $17,025,000 for the three months ended September 30, 2025, compared to $14,629,000 for the same period in 2024. Revenue of $45,173,000 for the nine months ended September 30, 2025, compared to $42,514,000 for the same period in 2024.
• Avenue, Mustang, Fortress: No product revenue reported for the three and nine months ended September 30, 2025 and 2024.

Operational Metrics

• Journey: Loss from operations of -$1,529,000 for the three months ended September 30, 2025, compared to -$2,894,000 for the same period in 2024. Loss from operations of -$7,729,000 for the nine months ended September 30, 2025, compared to -$15,911,000 for the same period in 2024.
• Avenue: Loss from operations of -$724,000 for the three months ended September 30, 2025, compared to -$3,156,000 for the same period in 2024. Loss from operations of -$2,331,000 for the nine months ended September 30, 2025, compared to -$9,687,000 for the same period in 2024.
• Mustang: Loss from operations of -$624,000 for the three months ended September 30, 2025, compared to -$1,457,000 for the same period in 2024. Loss from operations of -$1,762,000 for the nine months ended September 30, 2025, compared to -$15,228,000 for the same period in 2024.
• Fortress: Loss from operations of -$3,934,000 for the three months ended September 30, 2025, compared to -$4,864,000 for the same period in 2024. Loss from operations of -$15,572,000 for the nine months ended September 30, 2025, compared to -$18,373,000 for the same period in 2024.

Cash Flow

• Operating Cash Flow: Net cash used in operating activities was -$53,233,000 for the nine months ended September 30, 2025, compared to -$67,284,000 for the same period in 2024.
• Free Cash Flow: Not explicitly stated, but implied negative due to operating cash flow and ongoing losses.

Unique Metrics

• Equity Method Investment: Urica’s equity interest in Crystalys increased by $15,075,000 during the three months ended September 30, 2025.
• Gain from Deconsolidation: Fortress recognized a gain of $27,127,000 from the deconsolidation of Checkpoint in May 2025.

Future Outlook and Strategy

Core Business Focus

• Journey: Focus on expanding payer coverage for Emrosi and continuing the commercialization of its dermatology products.
• Checkpoint: Acquired by Sun Pharma, with Fortress eligible for a 2.5% royalty on net sales of UNLOXCYT and up to $4.8 million upon achievement of the contingent value right.
• Triplex: Ongoing Phase 2 clinical trials for CMV control in various patient populations, with topline data expected in early 2026.
• CAEL-101: AstraZeneca plans to submit pre-specified subgroup analysis from the CARES trials with regulatory authorities.
• CUTX-101: Sentynl expects to resubmit the NDA shortly following a Complete Response Letter from the FDA.

Non-Core Business

• Urica: Transitioned the development of dotinurad to Crystalys, which announced a $205 million Series A financing to support global Phase 3 clinical studies.
• Baergic: Acquired by Axsome, with Avenue eligible for milestone payments and royalties on future sales of AXS-17 (formerly BAER-101).

Priority

• Checkpoint: Significant focus on the successful integration and commercialization of UNLOXCYT under Sun Pharma’s ownership, with potential milestone and royalty payments to Fortress.
• Journey: Continued emphasis on the commercialization and payer coverage expansion for Emrosi, which has shown strong initial sales performance.
• Urica: Leveraging the partnership with Crystalys to advance the development of dotinurad, with significant financial backing from the recent Series A financing.