What United Therapeutics (UTHR) Said on Its Q3 Earnings Call

Key Points

• United Therapeutics reported record Q3 2026 revenue of $833 million, including record Tyvaso sales of $504 million. Management cited stronger patient demand, increased dosing and more than 1,000 product referrals in October.
• The company delayed its soft mist inhaler regulatory submission to 2027 to generate additional supporting data. The expanded sales force is expected to contribute more to revenue in Q4 and into 2027.
• Oral ralinepag remains under FDA review with a June 24, 2027 action date, while the company works to address a supplier compliance issue. Potential launches of ralinepag and nebulized Tyvaso in IPF remain subject to regulatory approval.

United Therapeutics NASDAQ: UTHR reported record third-quarter 2026 revenue of $833 million, driven in part by record Tyvaso sales of $504 million, while pushing back a planned regulatory submission for its soft mist inhaler to 2027.

President and Chief Operating Officer Michael Benkowitz said the Tyvaso performance reflected stronger underlying demand, including patient starts, referrals and increased dosing. He said the company received more than 1,000 referrals for its products in October, its highest total for a single month.

The company’s commercial momentum comes as it prepares for potential launches of nebulized Tyvaso in idiopathic pulmonary fibrosis, or IPF, and oral ralinepag in pulmonary arterial hypertension, or PAH. Both remain subject to regulatory approval.

Tyvaso demand and competitive landscape

Benkowitz attributed the third-quarter performance to consistent execution by the sales team and greater use of higher doses of Tyvaso DPI, the dry powder version of the drug. He said inventory and seasonal factors did not materially drive the quarter’s results.

United Therapeutics introduced an 80-microgram cartridge and higher-dose kits earlier in the year. Among patients who started Tyvaso DPI after their introduction, approximately one in three reached higher doses, about twice the prior rate, Benkowitz said.

He said an expansion of the sales force contributed to more consistent physician outreach during the quarter, but likely had a limited direct effect on third-quarter revenue. The company began seeing an increase in referrals around mid-September and expects the expanded sales force to have a greater revenue impact in the fourth quarter and into 2027, he said.

Benkowitz also discussed a court decision upholding United Therapeutics’ intellectual property and a settlement involving Liquidia’s YUTREPIA. He said the settlement removes pulmonary hypertension associated with interstitial lung disease, or PH-ILD, from YUTREPIA’s label and restricts its promotion for that indication.

Existing YUTREPIA patients are not required to switch to Tyvaso DPI under the settlement, Benkowitz said. He characterized near-term expectations for such transitions as moderate and said the larger opportunity is to find eligible patients and generate new prescriptions in the PH-ILD market.

Soft mist filing delayed

Pat Poisson, executive vice president of strategic development, said United Therapeutics now expects to submit its new drug application for the soft mist inhaler in 2027 rather than by the end of 2026. The change followed a planned meeting with the Food and Drug Administration about the filing strategy.

Poisson said additional data must be generated to support the application, although he described the work as consistent with what had already been planned. The company is working with its development partner to establish an updated filing timeline, he said.

For pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH-COPD, Executive Vice President of Product Development and Xenotransplantation Leigh Peterson said the company has investigational new drug clearance for a phase 2 study. Peterson said the study’s patient selection criteria were informed by an examination of the earlier PERFECT study population.

Ralinepag and other development plans

United Therapeutics is working with an active pharmaceutical ingredient supplier to address an FDA compliance status identified after an inspection earlier this year, Poisson said. The company is also pursuing alternative plans, with the goal of preventing an impact on the ralinepag regulatory review. The FDA action date for oral ralinepag is June 24, 2027, Chief Financial Officer James Edgemond said.

Edgemond said the company’s transaction to buy down royalty obligations tied to ralinepag reflected its confidence in both the oral product’s potential and dry powder inhalation formulations under development. He did not provide details about the price negotiations.

For ralinepag DPI, Peterson said the company is conducting studies to support an investigational new drug application and planning a phase 1 study in healthy volunteers. It initially plans a study in PH-ILD, followed closely by or alongside efforts in IPF and progressive pulmonary fibrosis. Those indications will require pivotal safety and efficacy studies, Peterson said.

Separately, Poisson said the company is evaluating options for a triple oral pill after the FDA indicated that a bioequivalence study was insufficient for a filing. United Therapeutics is considering alternative approaches to present to the agency, he said.

About United Therapeutics (NASDAQ:UTHR)

United Therapeutics Corporation is a biotechnology company focused on developing and commercializing therapies for patients with life-threatening conditions, particularly pulmonary arterial hypertension (PAH). The company's portfolio includes Tyvaso and Tyvaso DPI, inhaled formulations of treprostinil; Remodulin, an injectable treprostinil product; and Orenitram, an oral treprostinil therapy. These treatments are designed to improve exercise ability and delay disease progression in people with PAH.

The company also markets Unituxin, an antibody therapy used as part of treatment for high-risk neuroblastoma, a type of childhood cancer.

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