Fortress Biotech (FBIO) Q4 2024 earnings summary

Executive summary

• Achieved two FDA approvals in Q4 2024: Emrosi for rosacea and UNLOXCYT for metastatic or locally advanced cSCC; Emrosi commercial launch underway and first prescriptions filled.

• Checkpoint Therapeutics to be acquired by Sun Pharma; Fortress expects ~$28M at closing, 2.5% royalty on UNLOXCYT sales, and up to $4.8M in CVR.

• FDA accepted NDA for CUTX-101 (Menkes disease) for priority review; PDUFA goal date set for September 30, 2025.

• Strategic collaboration with Partex NV to leverage AI for asset acquisition and licensing.

Financial highlights

• Consolidated net revenue for 2024 was $57.7M, down from $84.5M in 2023; dermatology product revenue was $55.1M, down from $59.7M.

• Consolidated net loss attributable to common stockholders was $(55.9)M, or $(2.69) per share, compared to $(68.7)M, or $(8.47) per share, in 2023.

• Cash and cash equivalents at year-end 2024 totaled $57.3M, down from $80.9M at year-end 2023.

• R&D expenses including license acquisitions were $56.9M, down from $106.1M in 2023; SG&A costs were $87.7M, down from $91.0M.

Outlook and guidance

• Anticipates continued revenue growth from Emrosi and further monetization opportunities from late-stage pipeline and recent product approvals.

• Expects to receive a Priority Review Voucher upon CUTX-101 approval, with potential for additional value creation.