United Therapeutics (NASDAQ:UTHR) reported first-quarter financial results on Wednesday. The transcript from the company’s first-quarter earnings call has been provided below.
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The full earnings call is available at https://app.webinar.net/4yJGk8ngNEA
Summary
United Therapeutics Corp reported a first-quarter 2026 revenue of $782 million, with Tyvaso contributing $458 million despite some operational issues.
The company announced significant progress and promising results from clinical trials for Ralinepag in PAH and Tyvaso in IPF, projecting these to significantly boost revenue.
Strategic initiatives include multiple product formulations and regulatory filings, aiming to expand their market presence in PAH and IPF with a forecast of doubling revenues.
Management highlighted the success of their ‘multiple shots on goal’ strategy and the potential of their new chemical entity, Ralpi, for inhalation across various indications.
Future outlook remains positive with expectations for FDA approvals and market expansions, emphasizing relentless innovation and patient-focused strategies.
Full Transcript
JL (Operator)
4 3. Good morning and welcome to the United Therapeutics Corporation First Quarter 2026 Corporate Update. My name is JL and I will be your operator today. All participants on the call portion of this webcast will be in listen only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, simply press Star then the number one on your telephone keypad. If you would like to withdraw your questions, simply press STAR and the number one again on your telephone keypad. Please note that this call is being recorded. I’ll now turn the webcast over to Harry Silvers, Investor Relations at United.
Harry Silvers (Investor Relations)
Thank you. JL Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation First Quarter 2026 Corporate Update Webcast remarks today will include forward looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10K and 10Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward looking statements. Today’s remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Accompanying me on Today’s call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer James Edgeman, our Chief Financial officer and treasurer Dr. Lee Peterson, our Executive Vice President of Product Development and Xenotransplantation and and Pat Poisson, our Executive Vice President of Strategic Development. Note that James Edgeman and I will participate in a fireside chat and one on one meetings at the RBC Global Healthcare Conference in New York on May 19th as well as the Jefferies Global Healthcare Conference in New York on June 3rd. Our scientific, commercial and medical affairs teams will be present at the American Thoracic Society International conference in Orlando May 15th to the 21st. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities.
Martine Rothblatt
Martine thank you Harry. Okay folks, it’s going to be a great and exciting call today. UT is doing so frickin amazing that it is hard to imagine any other mid cap biotech right now with prospects as good as ours. Here’s what I mean. We just proved Beyond a shadow of a doubt, with a P value of less than 0.0001, that we have two different therapeutics in two different diseases of substantial size, each of which has been shown to produce better clinical outcomes than any other drug ever approved for either indication. Wow, that’s got to sink in. I personally have not seen anything like that from a single pharma company. All accomplished within six months. The two diseases we will be the best therapeutic for, based on the completed phase three trials, are IPF with Tyvaso and PAH with Ralinepag. Each of the two products will exceed our total revenues of today. A revenue run rate of 3 billion, going to 4 billion by the end of 2027. Let’s take Ralinepag first. Every patient with PAH should be prescribed that once daily pill because it actually gives them their best shot at clinical improvement. Specifically, we showed a threefold reduction in disease progression compared to background therapy. Ralinepag hit this and all other primary endpoints with better hazard ratios than Selexipag. And durably, through four years, frankly, this is the drug I dreamed of in starting United Therapeutics. This is why we’ve been calling Ralinepag a super prostacyclin. There is simply no reason that virtually every PAH patient shouldn’t be on it. Hence, I fully expect within two years of launch, it will double our number of PH patients to over 30,000 total. Next, let’s look at Tyvaso for IPF. I said this will become the most prescribed drug for IPF because it improves force vital capacity far more than the three existing drugs it and only. It boosted Forced Vital Capacity to over 100 milliliters of oxygen. And. And it did so quickly, and it did so durably. With tens of thousands of PH patients and tens of thousands of IPF patients, it is nearly certain that these two drugs, once approved, will lap our 2027 $4 billion revenue run rate twice over. And coming right behind Tyvaso for IPF will be Tyvaso DPI for IPF and right behind that, Tyvaso SMI for IPF. Our goal is to leave no IPF patient behind, regardless of how their particular body best absorbs Tyvaso. Now let’s take a breath and reflect back on United Therapeutics. UT has been ahead of schedule as a habit. We were ahead of schedule on outcomes on blinding. We were ahead of schedule on Teton on blinding. And today I am excited to announce another ahead of schedule, the next blockbuster product to emerge from stealth mode. In our Skunk Works division and inhaled formulation of our new chemical entity Ralenopag called Ralpi R A L D P I in stealth mode. A few months ago we activated our exclusive option with Mankind for a second dpi. We now feel confident based on subsequent PK computational biology via our proven climb digital lung model and the results of the outcomes and Teton studies that this will be our biggest product ever. As you can see in the distributed market capture graph, we foresee our raw pie product rising to tens of thousands of treated patients through PAH, ILD, IPF and PPF. Indeed, we will need all the capacity of the Danbury, Connecticut Mankind production plant and all the capacity of the new United Therapeutics NC DPI facility to keep up with the Tyvaso DPI and Ralpi demand.
Martine Rothblatt
Now let’s delve into the science to better appreciate what a generational product Ralpi will be for IPF. Ralenopag is the most potent member of the class of drugs that includes Treprostanol. This is super clear from the extraordinary results of the outcome study. Second, it is now indisputable that this class of drugs via inhalation has significant anti fibrotic effects as we proved in the two Teton trials. Ergo, we very reasonably and scientifically expect Ralpi to show after further clinical trials that it is the best in class treatment for IPF and pps. The scientific reason lies in the chemical differences between the new ralinepag molecule and the old treprostanol molecule, both of which are digitally mirrored in our climb predictive computational biology model. Ralenopeg has 8 fewer hydrogen atoms than triprostanol but instead has a key nitrogen and a key chlorine atom that treprostenol lacks. These changes in molecular chemistry make all the difference in the world for pharmacodynamics and pharmacokinetics.
Martine Rothblatt
Now troprostanol is a very very good molecule delivering very very good results. But not R Tryprostanol, not not insmeds, not liquidious treprostanol. None of these can ever be the super prostacycline that is Ralenopeg. It is just not in their chemistry, but it is in ralenapeg’s chemistry. It is this change in chemistry that makes Ralenapeg a generational product for IPF. In summary, UT’s long standing multiple shots on goal strategy has now yielded its greatest reward.
Martine Rothblatt
A proven once daily NCE in PAH formulated to use a proven DPI drug device for the best in disease treatment of the largest indications to which we aim. And as we march to this summit, we are rising through a series of great product stages that give us ever greater reach into the PAH and IPF communities. Namely, we are rising through Tyvaso for ILD and IPF, Tyvaso DPI for ILD and IPF, Open Label Extension, tyvaso, SMI or Tres MI for PAH, ILD and IPF and many more such combinations of products and diseases to treat which are still in stealth mode in our Skunk Works division.
Martine Rothblatt
Each incremental product indication platform that I just mentioned. Each of these we are now aggressively developing for new and existing markets and each of these brings UT ever closer to the ultimate goal depicted in the forecast chart released today. Thanks for listening and digesting all of this great science and great clinical development work. And now I’ll turn to Michael to describe how the demand for our existing products from doctors and patients is strong as ever.
Michael Benkowitz
thank you Martine. That’s a tough act to follow, but I’m going to do my best. Good morning everyone. For the first quarter of 2026 we recorded $782 million in total revenue. Typical historical seasonality trends persisted in the first quarter in addition to severe winter weather and pharmacy operations issues that slowed starts during the quarter. These have since been rectified, but it did impact our sales in …
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