United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation fourth quarter 2024 corporate update. My name is Cindy and I will be your conference 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, then 2 on your telephone keypad. Please note, this call is being recorded. I will now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.

Thank you, Cindy. And good morning. It's my pleasure to welcome you to the United Therapeutics Fourth Quarter 2024 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 these forward-looking statements. Also, today's remarks may discuss the progress and results of our 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 are available on our website. Accompany me on today's call. are Dr. Martine Rothblatt, our chairperson and chief executive officer, Michael Binkowitz, our president and chief operating officer, James Edgbund, our chief financial officer and treasurer, Dr. Lee Peterson, our executive vice president of product development and xenotransplantation, and Pat Pazan, our executive vice president of technical operations. Note that Michael Binkowitz and my colleague, Carrie Silvers, will participate in a fireside chat and one-on-one meetings at the TD Cowan 45th Annual Healthcare Conference in Boston on March 3rd. And along with Gil Golden, our chief medical officer, I will be at the UBS European Healthcare Conference on March 4th in London. And finally, James Edgman, Harry, and I will be at the Lyric Global Healthcare Conference in Miami on March 11th. Then our scientific, commercial, and medical affairs teams will present at the 20th Annual John Vane Memorial Symposia in London on March 7th and 8th, and at the International Society for Heart and Lung Transplantation Conference in Boston on April 27th to the 30th. And now I'll turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

Thank you, Dewey, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. Congratulations to the more than 1,300 Unitharians and to you, our shareholders. for supporting yet another record revenue year for United Therapeutics in 2024. In fact, 2024 was our third year in a row of record-setting revenue. This amazing performance was driven by our relentless drive to deliver patients with rare and underserved diseases a broad array of solutions to help them improve their lives. Beyond our stellar commercial performance, we have now begun our three-year cascade of clinical and regulatory events, starting with the recent IND clearance for our U-Kidney clinical trial. This trial is the first FDA-cleared, registration-supporting clinical trial of a xeno-organ and could provide an opportunity to put an end to dialysis for the hundreds of thousands of patients with end-stage renal disease who cannot qualify for a human kidney transplant or who have little chance of obtaining one before their health declines. We expect the first transplant in the middle of this year. Last month, we completed enrollment of the inhaled trococinil TETON1 study in idiopathic pulmonary fibrosis. We expect top-line data from the TETON2 study in the second half of this year and TETON1 top-line data in the first half of 2026. Triprostanil, which has been scientifically demonstrated to be anti-fibrotic, anti-proliferative, and anti-inflammatory, is far more than just a vasodilator. We believe its multifactorial mechanisms of action could be complementary to existing approved IPF agents and even to many of the potential IPF drugs in late stage development. IPF is extremely hard to treat, but we are encouraged with the success we saw in a post hoc analysis of IPF patients with pulmonary hypertension in the INCREASE study. Our goal is to bring this potential innovation to market as quickly as possible to patients in need of something additional to existing therapies on the market. And that's not all. We're tremendously excited for the potential of Rolinapag to be the first true once-a-day oral prostacyclin agonist for pulmonary arterial hypertension patients, if successful, Rolinapag could fundamentally change the positioning of prostacyclines in the PAH treatment paradigm, potentially leading to the upfront use of prostacyclines in PAH. As an example of the potential for Rolinapag, Flexipag, a twice-daily oral prostacyclin agonist, logs more than $1.5 billion in annual U.S. sales. And this is for a twice-daily oral product with a dose ceiling, unlike Rolinapag, We expect to conclude enrollment in the advanced outcome study later this year, allowing for top-line data in 2026. Literature has long suggested that earlier prostacyclin use leads to better results, and a once-a-day oral would complement traditional ERA and PDE5 orals that PAH patients generally use for first-line therapy. Any one of these potential products Eukidine inhaled tryprostenil for IPF or Rilinopag could fundamentally change how patients with ESRD, IPF, or PAH, respectively, are treated, and each represents a multibillion-dollar revenue opportunity for us. While we've posted record revenue performance, progressed several registration studies, and launched the first revolutionary trial of a xeno-organ, We remain focused on the needs of you, our shareholders, through a disciplined financial algorithm and capital allocation philosophy. In the past five quarters, we have touched on all three areas of our capital allocation philosophy across both our commercial and development portfolios. We've invested in CapEx to support our new Tyveso DPI manufacturing facility. and acquired additional real estate to support future commercial manufacturing needs. We also commissioned the world's first clinical-scale DPF in Virginia and plan to complete two others. On corporate development, we acquired IVIVA and Miramatrix to enhance our organ alternative development expertise, and we've licensed in new technologies to support our tryprostenol business. And with all this, we still returned $1 billion to you, our shareholders, through an accelerated share repurchase program that was universally well-received. We will continue to evaluate all three core areas of our capital allocation philosophy on an ongoing basis. Record performance, progress with our innovative and revolutionary development programs, discipline, financial management, and capital allocation, We've never been in a better position at United Therapeutics, and we're excited to forge ahead in 2025. And with that, I'll now turn the call over to our President, Mike Benkiewicz, who will give an overview of our commercial performance for the quarter.