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5/6/2026
Good morning and welcome to the United Therapeutics Corporation First Quarter 2026 Corporate Update. My name is Yale 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 1 on your telephone keypad. If you would like to withdraw your question, simply press star and the number 1 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.
Thank you, J.L. 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 10-K and 10-Q, 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 Bankowitz, our president and chief operating officer, James Edgman, our chief financial officer and treasurer, Dr. Lee Peterson, our executive vice president of product development and xenotransplantation, and Pat Poisson, our executive vice president of strategic development. Note that James Edgman 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 Jeffries 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. I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?
Thank you, Harry. Okay, folks, it's going to be a great and exciting call today. EG 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 .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 Tyveso and PAH with Rilenepeg. 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 Relenopec 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 three-fold reduction in disease progression compared to background therapies. Rolenapeg hit this and all other primary endpoints with better hazard ratios than Celexapeg and durably through four years. Frankly, this is the drug I dreamed of in starting United Therapeutics. This is why we've been calling Rolenapeg a super prostacyclin. There is simply no reason that virtually every pH 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 Tyveso 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. And only it boosted FVC to over 100 milliliters of oxygen, 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 Tyveso for IPF will be Tyveso DPI for IPF. And right behind that, Tyveso SMI for IPF. Our goal is to leave no IPF patient behind, regardless of how their particular body best absorbs Tyveso. 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'm excited to announce another ahead of schedule. The next Blockbuster product to emerge from stealth mode in our stumpworks division, an inhaled formulation of our new chemical entity, RALDPI, 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 TITAN studies, that this will be our biggest product ever. As you can see in the distributed market capture graph, we foresee our raw type product rising to tens of thousands of treated patients through PAH, ILB, 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 North Carolina DPI facility to keep up with the Tyveso DPI and Raltide demand. Now, let's delve into the science to better appreciate what a generational product Raltide will be for IPF. Bolenopeg is the most potent member of the class of drugs that includes triprostenol. 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 antifibrotic effects, as we proved in the two TETON trials. Ergo, We very reasonably and scientifically expect RAL-Pi to show, after further clinical trials, that it is the best-in-class treatment for IPF and PPF. The scientific reason lies in the chemical differences between the new Relenopeg molecule and the old proprostenol molecule, both of which are digitally mirrored in our cline predictive computational biology model. Relenopag has eight fewer hydrogen atoms than tryprosinol, but instead has a key nitrogen and a key chlorine atom that tryprosinol lacks. These changes in molecular chemistry make all the difference in the world for pharmacodynamics and pharmacokinetics. Now, tropostanol is a very, very good molecule, delivering very, very good results. But not R-tropostanol, not INSMEDs, not liquidius tropostanol, none of these can ever be the superprostacyclin that is RolenoPeg. It is just not in their chemistry. But it is in RolenoPeg's chemistry. It is this change in chemistry that makes RolenoPeg a generational product. In summary, UT's longstanding multiple shots on goal strategy has now yielded its greatest reward, 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 aimed. 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 Tybaso for ILD and IPF, Tybaso DPI for ILD and IPF open label extension, Tybaso SMI or TRESMI for PAH, ILV, and IPF, and many more such combinations of products and diseases to treat, which are still in stealth mode in our Skunk Works division. 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 detected 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. Mike?
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