United Therapeutics NASDAQ: UTHR reported second-quarter 2026 revenue of approximately $783 million, essentially flat from the first quarter, as competitive pressure affected sales of its nebulized TYVASO therapy. Company executives said they expect stronger performance in the second half of the year but did not reaffirm or update previous 2026 revenue-growth expectations.
TYVASO revenue totaled $453 million during the quarter. President and Chief Operating Officer Michael Benkowitz said nebulized TYVASO faced increasing competition in the inhaled prostacyclin category, while TYVASO DPI continued to grow. He said the company exited the quarter with record levels of patient starts, referrals, total patients and commercial patients for the DPI formulation.
“We exited the second quarter with considerably more momentum than the reported revenue line alone would suggest,” Benkowitz said. United Therapeutics expects second-half 2026 performance to exceed first-half results, supported by expanded commercial coverage and patient-demand metrics.
Commercial Expansion Targets PAH and Pulmonary Fibrosis
United Therapeutics roughly doubled its sales force and deployed the expanded team in early July, according to Benkowitz. The representatives are currently promoting approved therapies in pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PH-ILD.
The larger field organization is intended to support potential future launches in idiopathic pulmonary fibrosis, or IPF, and PAH. Benkowitz said the IPF patient population is more concentrated in community settings than the company’s current customer base, requiring broader outreach beyond academic medical centers.
Management said the company still sees a path to its previously discussed $4 billion annualized revenue run rate by the end of 2027, although Benkowitz said that path has narrowed. He added that anticipated contributions from potential IPF and ralinepag launches could help the company reach or exceed that level.
- United Therapeutics expects second-half 2026 revenue performance to be stronger than the first half.
- The company did not provide updated 2026 revenue guidance or confirm analysts’ specific TYVASO revenue estimates.
- Management said TYVASO DPI demand indicators, including starts and referrals, reached record levels exiting the quarter.
Regulatory Filings Advance Respiratory Pipeline
Chairperson and Chief Executive Officer Martine Rothblatt said the company submitted two major regulatory applications following positive clinical results: a supplemental new drug application, or sNDA, for nebulized TYVASO in IPF and a new drug application, or NDA, for ralinepag in PAH.
Rothblatt characterized the TETON-1 IPF results as exceeding the TETON-2 findings reported last September. She also cited results from the ADVANCE OUTCOMES study of ralinepag, which management believes support the oral therapy’s potential in PAH.
Leigh Peterson, executive vice president of product development and xenotransplantation, said the IPF sNDA was submitted in late June. The company expects to learn shortly whether the FDA will grant priority review. A priority review would carry a six-month review period, compared with 10 months under a standard review, Peterson said.
The company expects potential approvals in 2027 for nebulized TYVASO in IPF, ralinepag in PAH, and its treprostinil small-molecule inhalation device, or SMI, in PAH and PH-ILD. United Therapeutics also plans to file an investigational new drug application for ralinepag DPI and an NDA for treprostinil SMI later this year.
Benkowitz said management views ralinepag as a potential once-daily oral prostacyclin option and a multibillion-dollar opportunity. He said physicians’ initial feedback on the ADVANCE OUTCOMES data has been positive. The company also expects SMI to offer a differentiated method of administering inhaled therapies, potentially including tolerability benefits.
IPF Launch Would Initially Use Nebulized TYVASO
If TYVASO receives approval in IPF next year, the initial launch would involve the nebulized formulation only. Benkowitz said United Therapeutics remains in discussions with the FDA regarding the data needed to support IPF indications for TYVASO DPI and SMI.
Peterson said the company has proposed bridging strategies for both DPI and SMI and is seeking FDA feedback. Management did not specify whether additional efficacy studies would be required.
In discussions with physicians following the TETON results, Benkowitz said clinicians have expressed interest in using TYVASO alongside other IPF medicines. He said providers expect IPF treatment to move toward a polytherapy approach, similar to treatment patterns in PAH, although sequencing would depend on individual patients.
United Therapeutics also said enrollment in its TETON PPF trial is nearly complete and ahead of schedule. The company expects to disclose baseline characteristics of enrolled progressive pulmonary fibrosis patients at future conferences and anticipates a Phase 3 readout in the second half of 2027.
Xenotransplantation and Organ Programs Progress
Beyond its pulmonary portfolio, United Therapeutics continues to advance organ-transplantation programs. Rothblatt said the UKidney EXPAND study’s initial six-patient cohort is expected to be completed later this year, while the company anticipates initiating the UThymoKidney EXTEND registration-enabling study. Following FDA clearance, the company is also preparing to begin the EXPRESS-UHeart study.
The company expects to complete construction by year-end on two additional commercial-scale designated pathogen-free facilities in Minnesota and Texas. Rothblatt also noted the recent acquisition of Thymmune Therapeutics, which added a thymus-based regenerative medicine platform to United Therapeutics’ organ-alternative strategy.
About United Therapeutics (NASDAQ:UTHR)
United Therapeutics Corporation NASDAQ: UTHR is a biotechnology company dedicated to the development and commercialization of unique products to address life-threatening illnesses. The company's primary focus has been on pulmonary arterial hypertension (PAH), where it has launched several therapies designed to improve functional capacity and quality of life for patients. Its marketed products include continuous infusion treprostinil (Remodulin), inhaled treprostinil (Tyvaso), oral treprostinil (Orenitram) and tadalafil (Adcirca), each tailored to different modes of administration and patient needs.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
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