Record Annual Revenue and Growth
Full-year 2025 total revenue surpassed $3.0 billion for the first time in company history, representing 11% growth versus full-year 2024.
Fourth Quarter Revenue Increase
Q4 FY2025 total revenue was $790 million, a 7% increase year-over-year.
Tyvaso Strong Performance
Tyvaso generated $464 million in Q4 revenue, up 12% year-over-year, with Tyvaso DPI demonstrating robust 24% year-over-year growth.
Pipeline Milestones and Near-Term Unblindings
Upcoming unblindings: once-daily 'super prostacyclin' outcome study unblinding next week and the second pivotal Tyvaso IPF trial unblinding next month (TETON series). Management expects to file and commercially launch an IPF indication by no later than June 2027 if results confirm prior data.
Tresmi Soft Mist Inhaler (SMI) — Category Opportunity
Announced unsheathing of 'Tresmi', a proprietary treprostinil soft-mist inhaler claimed to reduce cough (the #1 dry-powder-related side effect) by up to ~90% in human studies to date; company intends to file for approval this year and commercially launch next year.
Transplantation and Regenerative Progress
Xeno program: 2 patients transplanted and doing well in FDA-approved trial; on track to enroll the 6-patient cohort by summer and pursue registration work in 2027 (commercial target ~2030). Miromatrix: completed first manufactured liver clinical trial enrollment and expects FDA guidance this year on regulatory path for liver and implanted kidney products.
Product and Clinical Data Enhancements
Commercial product improvements introduced (80-mcg cartridges and 96/112-mcg combination kits) to increase dosing flexibility and convenience; ARTISAN study preliminary data presented suggesting early high-dose treprostinil may reduce mean pulmonary arterial pressure and improve right ventricular function.
Reiterated Longer-Term Growth Target
Management reiterated a target to reach a $4.0 billion revenue run rate by the back half of 2027, stating this does not require the new product launches (which would be additive).