Fortress Biotech (FBIO) investor relations material

Recent portfolio highlights

• NDA approval for Zycubo in January 2026, the first FDA-approved treatment for Menkes Disease; PRV sold for $205M in March 2026; Cyprium eligible for up to $128M in milestones and tiered royalties from Sentynl Therapeutics.

• Urica Therapeutics sold dotinurad to Crystalys for equity and a 3% royalty; Crystalys raised $205M (Series A) and $130M (Series B) to advance global Phase 3 trials for gout.

• Checkpoint Therapeutics acquired by Sun Pharma in May 2025; Fortress received $28M, is eligible for up to $4.8M CVR, and a 2.5% royalty on Unloxcyt sales.

• Emrosi received FDA approval in November 2024 for rosacea; commercial launch began Q1 2025; demonstrated superiority over standard of care in Phase 3 trials.

Strategic business model and portfolio

• Focus on commercial dermatology and clinical-stage assets in rare diseases, oncology, and dermatology, leveraging a diversified portfolio and unique acquisition model.

• Revenue generated from product sales ($61M in 2025), royalties (2.5–12.5%), equity dividends (2.5%), and strategic monetization events.

• Portfolio includes 9 subsidiaries/partner companies, 9 marketed dermatology products, and 14 clinical/preclinical candidates across 20+ indications.

• Business development targets assets with human proof-of-concept and ex-US approvals, aiming for scalability and multiple revenue streams.

Development pipeline and late-stage assets

• Three FDA approvals since Q4 2024: Emrosi (rosacea), Unloxcyt (cSCC), and Zycubo (Menkes Disease).

• Late-stage assets include Anselamimab (CAEL-101) for AL amyloidosis (regulatory submissions ongoing), dotinurad for gout (global Phase 3 trials), and Triplex immunotherapy for CMV, HIV, and NHL (multiple ongoing studies).

• Early- to mid-stage pipeline features candidates for Pompe disease, glioblastoma, Duchenne muscular dystrophy, and refractory epilepsy.