United Therapeutics (UTHR) Q2 FY26 earnings call: guidance and Q&A

How much momentum can ralinepag and SMI recapture given increased competition in the space?

Ralinepag is seen as a multibillion-dollar opportunity due to its super prostacyclin data and once-daily oral differentiation. SMI is viewed as a differentiated delivery method for inhaled therapies with potential tolerability benefits, positioning the company well against competition.

“I think with -- similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications.”

asked by Joseph Thome · answered by Michael Benkowitz

How should investors think about the launch ramp-up for nebulized Tyvaso in IPF, ralinepag, and SMI, especially given the 2027 guidance reaffirmation?

More information on launch trajectories will be shared in late 2026 or early 2027, as it depends on regulatory timelines (e.g., priority review) and ongoing commercial preparations. Both are considered multibillion-dollar opportunities.

“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.”

asked by Jiale Song · answered by Michael Benkowitz

Is the consensus of $1.47 billion for H2 Tyvaso revenue achievable, or should expectations be adjusted?

The company is not reaffirming or updating prior expectations at this point, only stating that H2 FY26 is expected to be stronger than H1 FY26.

“As I said, we're not really kind of reaffirming or updating anything at this point. As I said in my opening remarks, we expect it to be -- we expect the second half to be stronger than the first half. And I think we're just going to leave it at that for right now.”

asked by Jessica Fye · answered by Michael Benkowitz

What type of data (e.g., bridging data, new efficacy data) would be needed to get Tyvaso DPI and SMI approved for IPF?

The company is engaged with the FDA to determine the requirements for DPI and SMI in IPF. They have proposed a bridging strategy based on existing populations and look forward to FDA feedback, similar to past bridging efforts.

“Yes. So as Pat said, we're engaging with FDA. We have some good ideas and for bridging and with regard to our current population that's enrolled as far as potentially new starts. We have a proposed strategy that we'll be presenting to them, and we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging -- so -- and that goes for both SMI and DPI.”

asked by Ben Burnett · answered by Leigh Peterson

How much of the expanded sales force is deployed, and how does the different call point for IPF patients impact current Tyvaso indications?

The sales force has been roughly doubled and deployed by early July. While not detailing unapproved IPF/ralinepag, they are increasing reach for approved PAH/PH ILD indications. IPF patients are more community-based, requiring deeper penetration into that setting, but not necessarily different physicians.

“our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. -- and we've done that. So we accelerated that process. I made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1, which we've essentially done.”

asked by Ashwani Verma · answered by Michael Benkowitz

Can the company provide details on the baseline characteristics of PPF patients enrolled, given enrollment is near completion, and will these details be published?

PPF study enrollment is ahead of schedule and finishing very shortly. The company confirms that baseline characteristics of the patient population will be presented at upcoming conferences.

“Yes. So as we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up in very, very shortly. And yes, we will present the baseline characteristics of those -- that patient population in upcoming conferences.”

asked by Olivia Saunders · answered by Leigh Peterson

When was the IPF sNDA filed, when can acceptance be expected, and is there potential for priority review?

The sNDA was submitted in late June. The company will learn "shortly" if it receives priority review. If granted, it would be a 6-month review period; 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. But again, that would be a 6-month review period if that is received and 10 months otherwise.”

asked by Lisa Walter · answered by Leigh Peterson