United Therapeutics Corp earnings calls

recapturing momentum vs competition

Q (Joseph Thome · TD Cowen): Analyst asked how much momentum they can recapture in PAH given increased competition, and thoughts on ralinepag and Tresmi in PAH and PH-ILD.

A: Management said they view ralinepag as a multibillion-dollar opportunity and that early physician feedback is positive. They said ralinepag's clinical benefit and once-daily oral dosing should differentiate it. They also said SMI is a differentiated way to deliver inhaled therapies and may offer tolerability benefits.

"So I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multibillion-dollar opportunity." — Michael Benkowitz (COO)

launch ramp timing for new products

Q (Jiale Song · Jefferies): Analyst asked how to think about launch ramp-up for new products: nebulized IPF, Tyvaso IPF, ralinepag, and Tresmi.

A: Management said they will share more information on launch trajectory and ramps in the back half of the year or early 2027. They reiterated these are multibillion-dollar opportunities. They said timing will depend on regulatory status, including whether they receive priority review.

"I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027." — Michael Benkowitz (COO)

Tyvaso H2 revenue expectations

Q (Jessica Fye · JPMorgan): Analyst asked if the consensus for second-half Tyvaso revenue (~$1.047 billion) is achievable given a larger sales force and dynamics. They wanted clarity for near-term expectations.

A: Management declined to update or reaffirm specific numbers at this time. They said only that they expect the second half to be stronger than the first half. No further revenue guidance was given.

"As I said in my opening remarks, we expect it to be -- we expect the second half to be stronger than the first half." — Michael Benkowitz (COO)

Tyvaso position and delivery format in IPF

Q (Ryan Mcelroy · Leerink Partners): Analyst asked where Tyvaso will be positioned in the IPF treatment landscape and which delivery method (nebulizer, DPI, SMI) will drive future prescribing.

A: Management said the next-year launch in IPF will be solely with the nebulized Tyvaso. They said discussions with FDA on DPI and SMI for IPF are still ongoing. They added that physicians expect to use Tyvaso mostly in combination with other treatments, and use will be patient-dependent.

"So the launch next year will solely be nebulized in IPF." — Michael Benkowitz (COO)

data needed for DPI and SMI in IPF

Q (Benjamin Burnett · Wells Fargo): Analyst asked whether the DPI and SMI in IPF would need only bridging data or new efficacy data.

A: Management did not provide a substantive answer in this exchange. They said the SMI question could be addressed by Pat and that Leigh could comment on DPI bridging. The company deferred to other executives for details.

"Ben, thanks. I think for part of the question with the SMI, perhaps Pat can address that. And maybe, Leigh, if you want to add any commentary on bridging to the Tyvaso DPI." — Harrison Silvers

regulatory data expectations for DPI and SMI

Q (Patrick Poisson · Wells Fargo): Analyst asked if bridging data would be enough to get DPI and SMI into IPF or if new efficacy data is needed.

A: Management said they are engaged with the FDA to understand what will be required for Tyvaso DPI and that it is yet to be determined. They said they have ideas for bridging and will present a proposed strategy to the FDA, and that similar discussions apply to both SMI and DPI. They expect to review FDA feedback before deciding next steps.

sales force expansion for IPF and ralinepag

Q (Ashwani Verma · UBS): Analyst asked how much of the sales force expansion is deployed, and whether the different physician call points help current Tyvaso indications.

A: Management said their plan was to roughly double the size of the sales force to support IPF and ralinepag, and that they have done that. They accelerated hiring to get reps into the field by July 1, with only one or two openings left. They said reps are not detailing unapproved indications but are using the expansion to increase reach for approved PAH and PH-ILD indications and to go deeper into community physicians for IPF patients.

"So we -- what we've talked about in the past and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications." — Michael Benkowitz (COO)

IPF peak opportunity and PPF enrollment details

Q (Olivia Brayer · Cantor): Analyst asked for peak revenue expectations for IPF, how JASCAYD's uptake affects Tyvaso plans, and baseline characteristics of TETON PPF patients.

A: Management said they will provide more detail on peak potential, ramp and trajectory later in the second half of the year and into early 2027. They acknowledged JASCAYD's strong launch and that they are considering it alongside other treatments when planning Tyvaso's trajectory. They said TETON PPF enrollment is ahead of schedule and that baseline patient characteristics will be presented at upcoming conferences.

"we will present the baseline characteristics of those -- that patient population in upcoming conferences." — Leigh Peterson

IPF sNDA filing and review timing

Q (Lisa Walter · RBC): Analyst asked when the IPF sNDA was filed, when they will hear about acceptance, and whether priority review is possible.

A: Management said they submitted the sNDA in late June. They said they will learn shortly if they receive priority review but could not give a specific date. They added that priority review would mean a six-month review period and otherwise it would be 10 months.

"Yes. So we submitted late June, and we will be learning shortly if we're able to receive priority review, probably -- well, I can't really give a specific date on that." — Leigh Peterson