Fortress Biotech (FBIO) Q1 2026 earnings summary

Executive summary

• Q1 2026 marked strong progress with consolidated net revenue rising to $16.0 million, up 21–22% year-over-year, driven by EMROSI (formerly AMZEEQ) growth and new royalty streams.

• A $205 million sale of a Rare Pediatric Disease Priority Review Voucher (PRV) generated a $158.9 million gain, resulting in net income attributable to common stockholders of $108.4 million, a sharp turnaround from a net loss in Q1 2025.

• Cash and cash equivalents increased to $255.8 million at quarter-end, with debt reduced to $15.0 million and strengthened financial position.

• Strategic focus remains on expanding EMROSI’s market share, payer reimbursement, launching up to two new niche dermatology products, and advancing pipeline assets including ATX-04 for Pompe disease.

• Operating expenses decreased year-over-year, reflecting lower R&D and SG&A costs and the deconsolidation of Checkpoint.

Financial highlights

• Total Q1 2026 revenue was $16 million, a 21–22% increase from $13.1 million in Q1 2025, primarily from Journey Medical's dermatology products.

• Product revenue increased to $15.9 million, with gross margin remaining strong despite higher cost of goods and a $1.3 million non-cash API inventory write-down.

• Net income for Q1 2026 was $108.4 million ($3.44 basic EPS, $2.82 diluted EPS), compared to a net loss of $12.7 million ($0.48 loss per share) in Q1 2025.

• Adjusted EBITDA was $600,000, up from negative $900,000 in Q1 2025.

• Cash and cash equivalents at March 31, 2026 were $255.8 million, up from $79.4 million at year-end 2025.

Outlook and guidance

• Expectation for continued positive adjusted EBITDA and positive EBITDA for the remainder of 2026 and beyond, with current cash expected to fund operations for at least the next 12 months.

• Management anticipates continued operating losses as R&D and commercialization efforts expand.

• Revenue for 2026 expected to exceed $61 million achieved in 2025, with detailed guidance to be provided later in the year.

• Anticipates increasing royalty revenue from ZYCUBO and UNLOXCYT™, with potential milestone payments from partnered assets and regulatory submissions for anselamimab (CAEL-101).