United Therapeutics (UTHR) Q1 FY26 earnings call: guidance and Q&A

What is the bridging strategy for Tyvaso DPI in IPF, and will it be available at launch? How does Tyvaso compare to other new IPF therapies like Esbriet?

The company is working with the FDA on a bridging strategy for Tyvaso DPI in IPF, likely involving healthy volunteer PK comparability and patient safety/efficacy studies. They agree there's significant pent-up demand for new IPF therapies, and Tyvaso is expected to be used either first-line or in combination with other treatments, similar to PAH.

“I mean, I guess the short answer is, we agree with you, and that's really kind of how we're starting to think about potential launch curve. We're starting to have conversations with physicians now.”

asked by Ashwani Verma · answered by Leigh Peterson

How will the commercial strategy and peak sales expectations change with the focus on triple combo ralinepag, ralinepag DPI, and SMI formulations?

The company will provide more granularity on forecasts later in the year. High-level, with ralinepag and the IPF indication, they expect to more than double current revenues over the next few years. The strategy is to offer multiple options (different indications, devices) to patients, similar to their approach in PAH.

“But I think high level, what Martin said in her opening remarks is right. I mean, if we're we're turning towards $4 billion by next -- $4 billion run rate by next year. We think, certainly, with just ralinepag and the IPF indication regardless of the delivery device. That puts us on a path to more than double revenues over the next few years.”

asked by Roanna Clarissa Ruiz · answered by Michael Benkowitz

Is ralinepag DPI the previously alluded-to NCE? When can we expect Phase I PK/PD data, and why DPI over SMI for ralinepag?

Ralinepag DPI is the product emerging from stealth mode. They are excited to work with MannKind again, leveraging their crystal carrier IP. They've had positive pre-IND engagement with the FDA and expect to complete a Phase I study before year-end. The half-life of ralinepag is promising for once-daily dosing without release-controlling materials. The choice of DPI over SMI was not explicitly stated but implied by the MannKind partnership.

“We've had a very positive pre-IND engagement with FDA, and we'll shortly be moving into some minimal nonclinical testing, which will be quickly followed by an IND in a Phase I study, which we believe will be completed before the end of the year.”

asked by Jessica Fye · answered by Patrick Poisson

How quickly can ralinepag DPI move through development? Can the oral ralinepag data accelerate its path to registration, especially for PAH?

The Advanced Outcomes data for oral ralinepag is very encouraging for ralinepag DPI's effectiveness in PAH, ILD, and IPF. They anticipate moving into PAH fairly quickly for approval with the solid dose. The solid dose data has been a big contributor to FDA engagement. They expect to complete the initial Phase I study by year-end and rapidly kick off efficacy studies for PAH, PH-ILD, IPF, and PPF, with PAH being the first approval.

“So I anticipate we'll complete the initial Phase I study by the end of the year, and we'll rapidly be able to kick off studies for PAH efficacy as well as PH ILD, IPF and TPF. So each of those will progress at different paces. And -- but initially, PAH will be the first approval.”

asked by Joseph Thome · answered by Patrick Poisson

Which IPF formulations (nebulized, DPI, SMI, Tyvaso vs. ralinepag) have the highest chance of success? What is the regulatory strategy for SMI, and when can ralinepag IPF studies start?

The company's strategy is 'multiple shots on goal' for IPF, similar to PAH, recognizing that patients are diverse and respond differently to various drug delivery approaches. They are agnostic to which product patients choose, as long as it's theirs. Regulatory strategy for nebulized Tyvaso in IPF will involve bridging studies for DPI and then direct filing. Ralinepag IPF studies will progress rapidly after the Phase I DPI study.

“And I think the point of all that is that I think what we've uncovered in PAH, and we think this is true in IPF is that patients are like now, right? They're not this homogenous group of people that rent all respond to the same drug delivery approach.”

asked by Olivia Brayer · answered by Michael Benkowitz

How should we think about the market opportunity for PH-COPD, and what is the product formulation and sequence for that indication?

For PH-COPD, they plan to use treprostinil SMI. A Phase I study is ongoing, followed by a Phase II study in PH-COPD patients, and then a Phase III study. They are considering learnings from previous years to enrich the patient population eligibility criteria. The market opportunity was not explicitly quantified but implied to be significant.

“Yes. So as far as the formulation, we're planning to use treprostinil SMA -- SMI, excuse me, for this -- and for PH COPD. And we're planning on doing it the study in a couple of phases.”

asked by Jiale Song · answered by Leigh Peterson