United Therapeutics (NASDAQ:UTHR) used its fourth-quarter 2025 corporate update webcast to highlight what executives described as a set of near-term product and clinical milestones aimed at reshaping its pulmonary hypertension and interstitial lung disease franchises, while also reiterating confidence in sustained revenue growth and outlining progress in its organ manufacturing and transplantation programs.
New inhaler and clinical catalysts highlighted
Chairperson and CEO Dr. Martine Rothblatt centered her remarks on the company’s “unsheathing” of Tresmi, which she described as a proprietary drug-device formulation of treprostinil delivered via a soft mist inhaler. Rothblatt said the company’s human studies to date suggest Tresmi could reduce coughing—what she called the “number one side effect of dry powder inhalers”—by up to 90%.
Rothblatt also pointed to upcoming data events. She said an outcomes study for the company’s “super prostacyclin” pill is scheduled to be unblinded next week, which she suggested could support a “new era of once-a-day treatments” for pulmonary hypertension. In addition, she said the company expects to unblind next month its second pivotal trial of Tyvaso in idiopathic pulmonary fibrosis (IPF), and, if confirmed, plans to file quickly with a goal to launch in IPF “not later than June 2027.”
Revenue growth and Tyvaso DPI updates
President and COO Michael Benkowitz said 2025 marked another year of record revenue, driven by double-digit percentage growth from Tyvaso and Orenitram. He reported 11% total revenue growth over full year 2024 and said the company surpassed $3 billion in total revenue for the first time. For the fourth quarter, Benkowitz said United Therapeutics recorded $790 million in total revenue, representing 7% growth from the fourth quarter of 2024.
Benkowitz reiterated the company’s historical seasonal ordering patterns, noting that the first and fourth quarters tend to be lighter, while the second and third quarters tend to be heavier, due to the timing and magnitude of distributor orders.
On Tyvaso, Benkowitz said fourth-quarter revenue was $464 million, up 12% year over year, and noted 24% year-over-year growth in Tyvaso DPI. He said referrals for total Tyvaso through mid-February were at their highest level in two years and that, in three of the last four months, referral rates were at or above levels seen heading into a competitive launch last summer.
He also highlighted product enhancements for Tyvaso DPI, including newly introduced 80 microgram cartridges intended to allow delivery of the equivalent of 15 nebulized treprostinil breaths in a single DPI breath, plus 96 and 112 microgram combination kits. Benkowitz said the additions improve convenience and dosing flexibility and may support broader adoption, particularly for patients with more advanced dosing needs.
Competitive dynamics discussed in Q&A
During Q&A, analysts asked about the impact of a competitor and market dynamics. Benkowitz said Tyvaso remains “the well-entrenched market leader” for inhaled therapy in pulmonary hypertension and said providers continue to affirm United Therapeutics’ leadership position. He acknowledged there was “initial curiosity to evaluate a new market entrant,” but said physicians are recognizing Tyvaso DPI’s “easy and importantly, consistent delivery” in one breath.
He added that the company’s market research and demand trends suggest that belief in what he characterized as a competitor’s “unsubstantiated claims” is “waning.” Benkowitz said referrals have been at pre-launch levels in three of the last four months, and that prescriber breadth and depth and patient retention are at or better than before the competitor’s launch. He said patient starts have lagged those trends, attributing the gap to typical fourth-quarter seasonality and severe weather in January, but said the “logjam” appeared to break in February. If trends continue, he said the company would expect a return to sequential revenue growth “no later than Q2.”
IPF trial confidence and once-daily prostacyclin endpoints
Questions also focused on the upcoming readout from the TETON-1 IPF study. Executive Vice President of Product Development and Xenotransplantation Dr. Leigh Peterson said she was “extremely enthusiastic” about prior TETON-2 results and expressed confidence those results would translate to TETON-1, citing similar baseline characteristics across the two studies and the robustness of the TETON-2 effect.
Peterson referenced TETON-2 outcomes, including a statistically significant primary endpoint related to forced vital capacity (FVC), stating the company observed an improvement in absolute FVC of 95.6 milliliters, as well as significant improvements in secondary endpoints.
On the company’s once-daily “super prostacyclin,” Peterson said the drug binds the IP receptor tightly and has a long half-life, which she said supports once-daily dosing and could potentially improve tolerability. She said the company will be looking for statistically significant and clinically meaningful benefit on clinical worsening versus placebo and noted that favorable results on hospitalizations and mortality would be meaningful. Rothblatt and Peterson said the study is scheduled to unblind next week.
Organ manufacturing and AI-enabled modeling efforts
Beyond its commercial pulmonary business, Rothblatt highlighted business development discussions with three pharmaceutical companies centered on what she described as United Therapeutics’ “AI-enabled digital lung model,” which she said can run “hundreds” of in silico phase III trials faster than a single in vivo trial.
She also provided updates on transplantation initiatives, saying the company’s “Zeno” program has transplanted two patients who are “doing well” in an FDA-approved clinical trial, with plans to enroll the six-patient cohort by the summer. Rothblatt said the company expects to enroll the balance of the trial needed for registration in 2027, and said the company’s pace could support a commercial Zeno product by 2030. She also noted that Miromatrix has fully enrolled and completed what she described as the first manufactured liver clinical trial, and said the company expects FDA guidance this year on regulatory pathways for its liver failure recovery product and a “mirokidney implanted product.”
The webcast ended early after management noted technical issues affecting call participants.
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.
