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2/25/2026
Good morning, everyone, and welcome to the United Therapeutics Corporation fourth quarter 2025 corporate update conference call. My name is Jamie, and I'll be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, please simply press star and then the number one on your telephone keypads. If you would like to withdraw your questions, you may simply press star and the number two on your telephone keypads. We do ask that you please limit yourselves to one question. Please also note today's event is being recorded. At this time, I'd like to turn the webcast over to Harry Silvers, Investor Relations Manager at United Therapeutics.
Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation fourth quarter 2025 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 Bankiewicz, 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 Michael Benkowitz, James Edgman, and I will participate in a fireside chat and one-on-one meetings at the TD Cowan 46th Annual Healthcare Conference in Boston on March 2nd. Additionally, Martine Rothblatt, James, and I will be at the Lee Rink Global Healthcare Conference in Miami on March 9th. for a fireside chat and one-on-one meetings. Finally, James and I will also participate in one-on-one meetings at the UBS Biotech Summit in Miami on March 10th. Our scientific, commercial, and medical affairs teams will be present at the 21st Annual John Vane Memorial Symposia in London, March 13th and 14th, and at the International Society for Heart and Lung Transplantation in Toronto, April 22nd to 25th. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?
Thank you, Harry. Good morning, everyone. Today I'm going to share with you news that transforms the fields of pulmonary hypertension and IPF. This news is our unsheathing of a category killer product called Tresmi, T-R-E-S-M-I. This product is a revolutionary product proprietary drug device formulation of troprostanol into a soft mist inhaler. It will reduce the number one side effect of dry powder inhalers, which is coughing, by up to 90% based on the human studies we've done so far. And we intend to file for its approval in PAH and ILD this year and commercially launch it next year. The days of people discontinuing their PAH or ILD therapy due to cough will be over. Anyone would rather have soft mist than dry powder. Also transformative for our markets will be the unblinding of our outcome study next week. We are optimistic that this unblinding will usher in a new era of once-a-day treatments for pulmonary hypertension. The reason we can promise once-a-day treatment is because the new medicine is a superprostacyclin. It is a superprostacyclin because it lasts much longer and binds molecules much more efficiently than all other approved forms of prostacyclin. Hence, between our superprostacyclin once-daily pill and our coughless soft mist inhaler, or SMI, We have solved the two biggest problems in our diseases, cough and dose frequency. Also very exciting is our unblinding next month of our second pivotal trial of Tyveso for IPF. You'll recall from last quarter that our first pivotal trial showed Tyveso to be much better than any other IPF drug the FDA has ever approved. with confirmation of those results next month, will quickly file for approval and commercially launch into IPF not later than June of 2027. In summary, for 2027, we should have three disease-transformative paradigm-shattering commercial launches. One, a once-daily superprostacycline for PAH, Two, a category-crushing Tresmite coughless inhaler for ILD. And three, a better-than-everything new treatment for IPF. Hell, yeah, we are pumped. Now, let me review some of the other major management areas that I track as CEO. We are religious about revenue growth at UT.
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