Strong Top-Line Growth
Total revenue for FY2025 was $291.8M, an increase of 44% year-over-year; Q4 revenue was $85.8M, up 43% year-over-year.
Recorlev Outperformance
Recorlev revenue was $45.3M in Q4 and $139.3M for FY2025, growing more than 100% for both the quarter and full year; patient base ended 2025 at ~700 patients, nearly double year-end 2024.
Durable Contributions from Gvoke and Keveyis
Gvoke generated $24.6M in Q4 and $94.1M for FY2025 (full-year growth of 14%), providing steady, predictable revenue. Keveyis produced $12.8M in Q4 and $47.6M for FY2025 and increased the average number of patients on therapy.
First Full-Year Net Income and Positive Adjusted EBITDA
Company delivered net income for the full year 2025 and adjusted EBITDA of $59.4M for FY2025 (Q4 adjusted EBITDA $25.1M, an improvement of $16.8M year-over-year).
High and Improving Gross Margins
Gross margin was 87% in Q4 and 85% for FY2025, reflecting improvement versus prior year driven by favorable product mix.
Financial Self-Sustainability and Strong Balance Sheet
Management stated the company reached financial self-sustainability in 2025, with an improved balance sheet that provides flexibility to fund growth, advance XP-8121, and support commercial investments.
Ambitious 2026 Guidance
2026 revenue guidance of $375M to $390M (midpoint implying >30% growth versus 2025) with expectation to remain adjusted EBITDA positive and to grow adjusted EBITDA in absolute dollars versus 2025.
Progressing High-Value Pipeline Asset: XP-8121
XP-8121 is on track to initiate Phase III in H2 2026; company projects potential peak sales of $1B–$3B. Management estimates 20M hypothyroid patients on oral therapy with 3M–5M potentially unable to maintain normal ranges due to GI absorption, representing the target opportunity.
Commercial Investment to Drive Future Growth
Recorlev commercial team nearly doubled in January 2026 (sales, patient support, medical affairs, pharmacy services) to accelerate awareness and adoption, with management expecting impact to be notable in H2 2026 and beyond.
Intellectual Property Protection for Recorlev
Company filed a patent infringement lawsuit against two ANDA filers and cites four Orange Book-listed patents for Recorlev that extend to March 2040 plus orphan drug exclusivity through end of 2028.