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Fortress Biotech Reports 2024 Financial Results and Recent Corporate Highlights
FBIOFortress Biotech(FBIO) GlobeNewswire·2025-03-31 20:05

Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately 28millionatclosing,alongwitha2.528 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of 4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional 0.70[3]−Fortressraisedapproximately0.70 [3] - Fortress raised approximately 21.1 million through equity offerings in 2024, while Checkpoint raised about 32.8millionduringthesameperiod[11]RegulatoryUpdates−TheFDAapprovedEmrosi(MinocyclineHydrochlorideExtended−ReleaseCapsules,40mg)fortreatinginflammatorylesionsofrosaceainNovember2024,withcommerciallaunchinitiatedinMarch2025[7][2]−UNLOXCYTwasapprovedbytheFDAinDecember2024fortreatingmetastaticorlocallyadvancedcutaneoussquamouscellcarcinoma[7]−TheFDAacceptedtheNewDrugApplicationforCUTX−101forpriorityreview,withaPDUFAgoaldatesetforSeptember30,2025[7][2]ClinicalUpdates−Phase3clinicaltrialsforEmrosidemonstrateditsefficacy,safety,andtolerabilityintreatingmoderate−to−severepapulopustularrosacea,withresultspublishedintheJournaloftheAmericanMedicalAssociation−Dermatology[7]−ClinicaldataforUNLOXCYTpresentedattheEuropeanSocietyforMedicalOncologyCongress2024showedimprovedresponseratesovertime[7]−APhase2clinicaltrialforTriplex,acytomegalovirusvaccine,commencedinJanuary2025,targetingpatientsundergoinghematopoieticstemcelltransplantation[7]FinancialResults−Fortressreportedconsolidatednetrevenueof32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of 57.7 million for the year ended December 31, 2024, down from 84.5millionin2023,withproductrevenuefromdermatologyproductstotaling84.5 million in 2023, with product revenue from dermatology products totaling 55.1 million [10][17] - Consolidated research and development expenses decreased to 56.9millionin2024from56.9 million in 2024 from 106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was (55.9)million,or(55.9) million, or (2.69) per share, for the year ended December 31, 2024, compared to a net loss of (68.7)million,or(68.7) million, or (8.47) per share, in 2023 [10][17]