Q1 2026 Revenue and Near-Term Growth Outlook
Total revenue of $782 million in Q1 2026 with Tyvaso revenue of $458 million. Company expects to return to sequential growth in the near term and targets a revenue run rate moving from $3 billion to $4 billion by the end of 2027.
Tyvaso DPI Adoption and Demand Momentum
Tyvaso DPI drove 9% year-over-year growth for the DPI format. Patient shipments have grown for five consecutive months, prescriber referral/prescription rates are approximately at pre-YUTREPIA levels, and there's increasing uptake of higher-dose DPI options (80 mcg single capsule, 96 mcg and 112 mcg combination kits).
Breakthrough ADVANCE OUTCOMES for Ralinepag
Top-line ADVANCE OUTCOMES showed a threefold reduction in disease progression versus background therapy; ralinepag met all primary endpoints with superior hazard ratios versus selexipag and durable benefit through four years. Company projects a multibillion-dollar opportunity for oral ralinepag, expects a potential mid-next-year launch on a smooth FDA timeline, and anticipates ralinepag could double the treated PAH population to over 30,000 within two years of launch.
TETON 1 & 2 Success — Tyvaso for IPF
Both TETON trials of nebulized Tyvaso in IPF were described as resounding successes, showing meaningful forced vital capacity (FVC) improvements versus existing drugs. Company plans to file a supplemental NDA by the end of the summer with the possibility of priority review; under a standard review, a launch is expected by Q2 next year.
RALDPI (Inhaled Ralinepag) Out of Stealth with Rapid Development Plan
RALDPI program activated ~6 months ago with MannKind; formulation development completed, manufacturing of tox supplies underway, positive pre-IND engagement with FDA. Company expects to enter Phase I and complete the study before year-end and believes inhaled ralinepag could be a once-daily product without release-controlling excipients.
Commercial Preparations and Long-Term Outlook
Sales force investments are being deployed mid-year to support upcoming launches (ralinepag, IPF indications). Management reiterates confidence in a durable commercial engine and expects to deliver sustained double-digit long-term growth while expanding reach in PH-ILD, PAH and IPF markets.