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United Therapeutics
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Latest analysis
Updated Nov 4, 2026
United Therapeutics posts record Q3 revenue of $833M on Tyvaso momentum; ralinepag PDUFA June 2027, SMI filing delayed to 2027
United Therapeutics delivered record quarterly revenue of $833 million in Q3 2026, driven by Tyvaso revenue of $504 million, reflecting sustained commercial execution and physician engagement gains across PAH and PH-ILD. A favorable settlement with Liquidia removing PH-ILD from YUTREPIA labeling clears the path for uncontested Tyvaso growth in that indication. However, the company pushed the soft mist inhaler (SMI) NDA submission to 2027 following FDA feedback requiring additional data, and flagged an Official Action Indicated status at ralinepag's API supplier that poses near-term regulatory risk, though contingency manufacturing plans are in progress. Management projects two multi-billion-dollar launch opportunities ahead with nebulized Tyvaso in IPF and oral ralinepag in PAH, positioned to accelerate growth from an already re-accelerating base business.
Tone: bullishRevenue
$3.2B
UTHR 10-K · FY 2025
Employees
1,400
Revenue FY2024
$2.9B
Founded
1996
Profile
UTHR 10-K Item 1 · Feb 25, 2026United Therapeutics is a public benefit corporation focused on rare disease therapies and organ manufacturing technologies. It markets five commercial products for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the United States, plus an oncology product for high-risk neuroblastoma. The company is simultaneously developing xenotransplantation, regenerative medicine, and ex vivo lung perfusion technologies to expand the supply of transplantable organs.
Read filing description ↓ Collapse description ↑
Founded by our Chairperson and Chief Executive Officer, Martine Rothblatt, to find a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension (PAH), United Therapeutics advances therapies for people living with serious diseases with unmet medical needs. Our mission is to transform the treatment of rare diseases and expand the availability of transplantable organs through innovative organ manufacturing technologies. As a public benefit corporation (PBC), we aim to deliver meaningful impacts for our patients, our people, our shareholders, and other stakeholders. Our public benefit purpose, as outlined in our charter and approved by our shareholders, is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. We market and sell commercial therapies in the United States to treat PAH: Tyvaso DPI, Nebulized Tyvaso, Remodulin, Orenitram, and Adcirca. Tyvaso DPI and Nebulized Tyvaso are also approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). In the United States, we also market and sell Unituxin for the treatment of high-risk neuroblastoma. Outside the United States, we derive revenues from sales of Nebulized Tyvaso, Remodulin, and Unituxin. We also have products in development for PAH, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF), and other diseases with unmet medical needs. Our long-term goals include creating an unlimited supply of tolerable manufactured organs and organ alternatives through xenotransplantation, regenerative medicine, and ex vivo lung perfusion.
Primary products
- Tyvaso DPI (treprostinil) Inhalation Powder
- Tyvaso (treprostinil) Inhalation Solution (Nebulized Tyvaso)
- Remodulin (treprostinil) Injection
- Remunity Pump and RemunityPRO Pump for Remodulin
- Orenitram (treprostinil) Extended-Release Tablets
- Adcirca (tadalafil) Tablets
Business segments
End markets
Geographies
Named customers
We recorded revenue from two distributors in the United States that exceeded ten percent of total revenues. Revenue from these two distributors as a percentage of total revenues is as follows: Distributor 1: 51%, 51%, 51% and Distributor 2: 36%, 35%, 34% for years ended December 31, 2025, 2024, and 2023, respectively.
Named competitors
“Nebulized Tyvaso, Tyvaso DPI, and Yutrepia are currently the only FDA-approved inhaled prostacyclin analogues available in the United States for newly diagnosed patients.” Competitive position, as stated in the filing
Revenue commentary · FY 2025
Total revenues increased from $2,877.4 million in 2024 to $3,182.7 million in 2025, driven primarily by continued growth in Tyvaso DPI net product sales and growth in Orenitram revenues.
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