United Therapeutics Q1 Earnings Call Highlights

Key Points

• Management reported phase 3 wins for TYVASO (IPF) and Ralinepag (PAH), calling the results “beyond a shadow of a doubt” with a p<0.0001; Ralinepag showed a threefold reduction in disease progression with durable effects through four years and management expects it could double PAH patients to >30,000 within two years.
• United announced an inhaled dry‑powder Ralinepag program (“raldpi”) out of stealth with a planned phase 1 by year‑end, an sNDA for TYVASO in IPF by end of summer (potential priority review), and a targeted launch of oral Ralinepag mid‑next year if regulatory timelines are standard.
• First‑quarter revenue was $782 million with TYVASO $458 million; executives said severe winter weather and pharmacy issues slowed patient starts but have been resolved and they expect a return to sequential growth, noting Tyvaso DPI delivered 9% YoY growth and patient shipments have risen for five months.

United Therapeutics NASDAQ: UTHR executives highlighted what they characterized as significant recent clinical and pipeline progress while also detailing first-quarter revenue of $782 million and reiterating expectations for a return to sequential growth after operational disruptions earlier in the quarter.

Management points to major clinical readouts in PAH and IPF

Chairperson and CEO Martine Rothblatt said the company has recently generated phase 3 results supporting two therapies in two different diseases: idiopathic pulmonary fibrosis (IPF) with TYVASO and pulmonary arterial hypertension (PAH) with Ralinepag. Rothblatt described the outcomes as “beyond a shadow of a doubt” and cited “a P value of less than 0.0001,” adding that the completed phase 3 trials showed “better clinical outcomes than any other drug ever approved for either indication.”

Rothblatt said the company believes Ralinepag could become widely prescribed in PAH due to what she described as a “threefold reduction in disease progression compared to background therapy,” with durable effects “through four years.” She also said she expects that “within two years of launch,” Ralinepag will double the company’s number of PAH patients “to over 30,000 total.”

On IPF, Rothblatt said TYVASO “will become the most prescribed drug for IPF” and emphasized improvements in forced vital capacity (FVC) versus “the three existing drugs,” stating that TYVASO “boosted FVC to over 100 mL … quickly … and durably.” She also pointed to additional planned formats behind nebulized TYVASO, including “Tyvaso DPI for IPF” and “Treprostinil SMI for IPF,” describing the company’s goal as leaving “no IPF patient behind” regardless of which delivery method works best for individual patients.

New Ralinepag DPI program “out of stealth,” with phase 1 targeted by year-end

Rothblatt also introduced a new program emerging from what she called the company’s “Skunk Works division”: an inhaled dry powder inhaler (DPI) formulation of its new chemical entity Ralinepag referred to as “raldpi.” She said the company activated an exclusive option with MannKind for a second DPI and, based on pharmacokinetic work, its “Klein digital lung model,” and recent study results, the company believes raldpi “will be our biggest product ever.”

Executive Vice President of Strategic Development Patrick Poisson said United began work on raldpi about six months ago, has completed formulation development, and has transitioned into manufacturing toxicology study supplies. Poisson said the company has had “a very positive pre-IND engagement with FDA” and expects to move into “minimal non-clinical testing,” followed by an IND and a phase 1 study, which he said the company believes “will be completed before the end of the year.”

Poisson said the company believes the half-life of Ralinepag and other characteristics under investigation are promising for a once-daily inhaled product “without the addition of any release controlling materials.” In response to a question about the formulation, Poisson said United will leverage MannKind’s Crystal Carrier IP for Ralinepag, “very similar to what we have for Treprostinil,” and emphasized that raldpi “is not going to be a pro drug.”

Poisson also suggested that existing data from oral Ralinepag is informing the regulatory approach for raldpi, saying the “solid dose has been a big contributor” to FDA engagement and to the “minimal amount of pre-IND work” needed. He said the company anticipates completing the initial phase 1 study by year-end and then “rapidly” initiating efficacy studies across PAH as well as PH-ILD, IPF, and PPF, with PAH expected to be “the first approval.”

First-quarter revenue and TYVASO trends

President and COO Michael Benkowitz reported total revenue of $782 million for the first quarter of 2026 and said “typical historical seasonality trends persisted,” with “severe winter weather and pharmacy operations issues” that slowed patient starts, particularly in February. He said those issues have been rectified and the company expects to return to sequential growth “in the near term.”

TYVASO revenue totaled $458 million in the quarter. Benkowitz said nebulized TYVASO sales “lagged a little bit,” while Tyvaso DPI delivered 9% year-over-year growth driven by increased patient demand. He also addressed competition in inhaled prostacyclins, calling the market “attractive and growing,” and said United expects its “proven expertise to continue to win in the long term.”

On demand indicators, Benkowitz said TYVASO referral or prescription rates exiting the quarter were “at approximately the same level they were before Yutrepia launched,” and that patient shipments “have grown for the last five months.” He said prescriber breadth and depth continue to grow and cited increased use of higher-dose Tyvaso DPI options following the launch of an 80 mcg single capsule and 96 mcg and 112 mcg combination kits.

Regulatory and launch planning: IPF sNDA by end of summer; Ralinepag launch targeted mid-next year

Benkowitz said both TETON-1 and TETON-2 trials of nebulized TYVASO in IPF were successful and that the company expects to file a supplemental new drug application (sNDA) “by the end of the summer.” He said the company believes the evidence could support an expedited approval via priority review, but if the FDA uses a standard timeline, the company would “expect to launch by Q2 of next year.” Benkowitz added that launch preparations are underway and that, if approved, the company will work with payers to secure coverage for the new IPF indication “as soon as possible.”

On Ralinepag, Benkowitz described the “advent OUTCOMES” top-line results as “unprecedented” and said the drug could be “the first true once-a-day oral prostacyclin agonist.” He said the company expects to launch oral Ralinepag “mid-next year,” assuming a smooth FDA review under a standard timeline.

Additional pipeline note: PH-COPD program to use Treprostinil SMI

In the Q&A, Executive Vice President of Product Development and Xenotransplantation Leigh Peterson said the company plans to use Treprostinil SMI for pulmonary hypertension associated with COPD (PH-COPD). Peterson said a phase 1 study in healthy volunteers is ongoing, with a phase 2 study in PH-COPD patients planned, followed by a phase 3 program. She said the company is considering “several learnings over the years” and is looking to start studies with “enriched patient population eligibility criteria.”

During the call, executives also discussed efforts to bridge Tyvaso DPI into IPF. Peterson said United is working with the FDA on a bridging strategy that will “likely” include healthy volunteer pharmacokinetic comparability studies as well as patient studies to demonstrate safety and efficacy, though she said sample size and duration are still being determined as part of a clinical development plan.

Separately, Benkowitz said the company has been tracking early launch metrics for JASCAYD (nerandomilast) and believes they “suggest that there is a lot of pent-up demand for new therapies in IPF.” He said physicians have told the company they are impressed by TYVASO’s data, and he relayed feedback from an advisory board of IPF treaters that use could be patient-dependent, with some patients receiving TYVASO first and others starting on JASCAYD before adding TYVASO. Benkowitz said clinicians “fully expect” IPF treatment to resemble PAH, where combination therapy is common.

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.

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