Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights

Core Insights - Fortress Biotech received FDA approval for Emrosi, a treatment for inflammatory lesions of rosacea, marking a significant milestone for the company and its partner, Journey Medical [2][3] - The company anticipates potential FDA approvals for cosibelimab by December 28, 2024, targeting metastatic or locally advanced cutaneous squamous cell carcinoma [2][3] - Fortress reported a consolidated net revenue of $14.6 million for Q3 2024, a decrease from $34.8 million in Q3 2023, primarily from marketed dermatology products [8][9] Regulatory Updates - Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) was approved by the FDA in November 2024, expected to launch in early 2025 [3] - The FDA accepted the BLA resubmission for cosibelimab in July 2024, with a PDUFA goal date set for December 28, 2024 [3] - Fortress completed the asset transfer of CUTX-101 to Sentynl Therapeutics in December 2023, with a rolling submission of the NDA expected in Q4 2024 [3] Clinical Updates - Clinical data presented in October 2024 showed Emrosi provides higher dermal concentration than doxycycline, indicating a potential clinical advantage for treating rosacea [4] - Longer-term data for cosibelimab presented in September 2024 demonstrated improved response rates over time in patients with locally advanced and metastatic cSCC [4] Financial Results - As of September 30, 2024, Fortress had consolidated cash and cash equivalents of $58.9 million, down from $80.9 million at the end of 2023 [8] - Consolidated net loss attributable to common stockholders was $(15.0) million, or $(0.76) per share, for Q3 2024, compared to a net loss of $(7.1) million, or $(0.94) per share, in Q3 2023 [9][16] - Research and development expenses totaled $9.4 million for Q3 2024, significantly lower than $20.3 million in Q3 2023 [8] Commercial Product Updates - Journey Medical reported net product revenues of $14.6 million for Q3 2024, a slight decrease from $14.9 million in Q2 2024 [6] General Corporate Updates - Fortress paused dividend payments on its Series A Preferred Stock in July 2024 to maintain financial flexibility, deferring approximately $0.7 million in monthly cash payments [7] - Fortress reduced its total debt by entering a new loan agreement with Oaktree Capital Management, receiving an initial tranche of $35 million [7]