United Therapeutics Corporation (UTHR) Earnings

Management highlights

Pipeline and Regulatory Progress • The company completed two major regulatory submissions to the FDA: a Supplementary New Drug Application (SNDA) for nebulized Tyveso in idiopathic pulmonary fibrosis (IPF), and a New Drug Application (NDA) for Relinapag for pulmonary arterial hypertension (PAH), both filed in late June 2026 • Additional regulatory filings planned for late 2026 include an Investigational New Drug (IND) application for Relinapag DPI and an NDA for Tuprastenil SMI • Enrollment in the Phase III TETON trial for progressive pulmonary fibrosis (PPF) is nearly complete, with a readout expected in H2 2027; if positive, this would open a market opportunity at least double that of IPF • Pending approvals for the three new indications/ products are expected in 2027, which management views as multi-billion dollar transformative opportunities Xenotransplantation and Organ Pipeline Progress • The U Kidney EXPAND study is on track to complete its initial 6-patient cohort by the end of 2026, and the eXYmoKidney extend registration enabling trial will initiate soon after • Following FDA clearance, the company is preparing to initiate the express uHeart study for xenotransplant cardiac organs • Construction of two additional commercial-scale development and production facilities in Minnesota and Texas will be completed by the end of 2026, giving United Therapeutics three active authorized clinical trials and leading the xenotransplantation space • The company recently acquired Thymune Therapeutics, adding a thymus-based regenerative medicine platform that expands its organ alternative strategy and immune function therapy pipeline Commercial Operations Updates • The company roughly doubled its sales force, with all new representatives deployed to the field by early July 2026, increasing physician engagement frequency across existing PAH and PHILD indications • The expanded sales force will also support future deep community outreach for the upcoming IPF launch, where most IPF patients are treated in community rather than academic settings • While Q2 2026 revenue was below expectations, management noted underlying commercial fundamentals are strong, with accelerating momentum exiting the quarter that is not fully reflected in the reported revenue line

Guidance

• Management expects H2 2026 total revenue and performance will be stronger than H1 2026, but is not reaffirming or updating prior full-year 2026 revenue growth expectations at this time • The prior projection of a $4 billion revenue run rate for the existing commercial portfolio by the end of 2027 remains achievable, though the path to this target has narrowed; adding revenue from the expected 2027 launches of IPF and Relinapag is expected to help the company meet and exceed this target • Potential 2027 approvals are on track for nebulized Tyveso in IPF, Relinapag in PAH, and the SMI device for PAH and PHILD • More detailed guidance on launch trajectories, peak sales potential and revenue ramp-up for new products will be shared in H2 2026 or early 2027, once regulatory timing (including potential priority review status) is confirmed

Segment performance

For Q2 2026, United Therapeutics reported total revenue of $783 million, which was flat quarter-over-quarter and below internal management expectations. The Tyveso franchise generated $453 million in total revenue for the quarter, accounting for approximately 57.9% of total company revenue. Nebulized Tyveso revenue continued to face pressure from increased competition in the inhaled prostacyclin category, while Tyveso DPI delivered consistent growth and exited the quarter with strong underlying demand momentum, with patient starts, referrals, total patients and commercial patients all reaching record levels. No other product segments disclosed separate financial performance in this call.

Risks & headwinds

• Existing commercial revenue for nebulized Tyveso is facing growing competitive pressure from new entrants in the inhaled prostacyclin category, which has pressured near-term results • The timing and success of FDA approvals for new indications and products is uncertain; review timelines depend on whether priority review is granted, which has not yet been confirmed • Requirements for additional clinical or bridging data to gain FDA approval for Tyveso DPI and SMI in the IPF indication are still under discussion with regulators and have not been finalized • Actual results may differ materially from forward-looking statements due to inherent clinical, regulatory and competitive risks, as detailed in the company's periodic SEC filings

Analyst Q&A

• Q: How much market momentum can the company recapture after losing share to increased competition, with new products like Relinapag and TRES-ME? /

  A: Management views both Relinapag and SMI as differentiated multi-billion dollar opportunities. Relinapag, the first once-daily oral prostacyclin with strong clinical trial data, has received positive early feedback from physicians. SMI offers potential tolerability benefits for inhaled therapy across all indications, further differentiating the company's portfolio from competitors.

• Q: What is the expected launch ramp-up for upcoming new products including nebulized Tyveso in IPF, Relinapag, and Tresmai? /

  A: Management will share detailed launch trajectory information in H2 2026 or early 2027, once additional details on regulatory review timing (including priority review status) are confirmed and commercial launch preparations are finalized. The company confirms both new product lines are expected to be multi-billion dollar opportunities, but the speed of reaching that scale is still being finalized.

• Q: What position does management expect nebulized Tyveso to take in the IPF treatment landscape, and what will drive future franchise growth? /

  A: The 2027 IPF launch will only include nebulized Tyveso, as FDA discussions for DPI and SMI indications are still ongoing. Early KOL feedback shows strong excitement for the new treatment option, and IPF is shifting toward a polytherapy treatment model similar to PAH. Most physicians expect to use Tyveso in combination with existing IPF treatments regardless of sequencing, creating broad demand for the product.

• Q: What is the status of the sales force expansion for upcoming launches, and how does it benefit existing business today? /

  A: The company completed its plan to roughly double the sales force by the July 1 2026 target, with only a small number of roles remaining to be filled. While new reps cannot detail unapproved products, they are already increasing physician reach and frequency for existing PAH and PHILD indications. The expansion is also designed to enable deeper community outreach for the upcoming IPF launch, where most patients receive care in community rather than academic settings.

• Q: When was the IPF SNDA filed, and what is the potential for priority review? /

  A: The SNDA was submitted in late June 2026. The company expects to learn shortly if priority review will be granted. Priority review would lead to a 6-month FDA review period, while a standard review would take 10 months.