United Therapeutics Corporation

Good morning, everyone, and welcome to the United Therapeutics Corporation second quarter 2024 earnings webcast. My name is Cole, 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, simply press the star, then number one on your telephone keypad. If you would like to withdraw your question, please simply press the star, then the number two on your telephone keypad. And please note that this call is being recorded. I would now like to turn the webcast over to Dewey Sedman, Head of Investor Relations at United Therapeutics. Please go ahead.

Yes, thank you, Cole. Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation second quarter 2024 earnings webcast. Remarks we make 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, and we assume no obligation to update these forward-looking statements. Remarks today may discuss the progress and results of clinical trials or other developments with respect to our products, and these remarks are intended solely to educate investors and are not intended to serve as a basis for medical decision-making. or to suggest that any products are safe and effective for any unapproved or uninvestigational uses. And full prescribing information for our products are available on our website. Accompanying me on today's call are Dr. Martin Rothblatt, our chairperson and chief executive officer, Michael Binkowitz, 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 Technical Operations. Note that Michael Benkowitz and I will participate in a fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4th, and James Edgman and I will participate in a fireside chat and one-on-one meetings at the 2024 Wells Fargo Healthcare Conference in Boston the next day, September 5th. Our scientific, commercial, and medical affairs teams will be present at the Pulmonary Hypertension Association 2024 International PH Conference and Scientific Sessions, August 15th to 18th in Indianapolis, the European Respiratory Society Congress in Vienna, September 7th to 11th, and the American College of Chest Physicians Chest 2024 Annual Meeting in Boston, October 6th through the 9th. Now, I will turn the webcast over to Dr. Rothblatt, for an overview of our second quarter 2024 financial results and the business activities of United Therapeutics. Dr. Raspot.

Thank you very much, Dewey. We at UT are very pleased and proud to present the results of another record quarter. As described in the press release, PowerPoint, and the financials, we are doing very well across the board. Double digit revenue growth is the norm. In a moment, our president, Mike Benkowitz, will provide some deep insight into these numbers. So let me start with a strategic overview. We see our business as three waves of success. First, approved products that are market leaders for the mid-2020s. Second, next-generation products and new indications that can be market leaders in the late 2020s. Third, an organ manufacturing business that can transform the treatment of end-stage organ disease. Examples of the first wave are remodulin, tibeso, arenatram, and unituxin. Examples of the second wave are Relenopeg as a once-daily pill for pulmonary hypertension, and our TETON trial aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis. Now, I'm sometimes asked, with all of this success, Martine, what keeps you up at night? Well, let me start with what does not keep me up. What does not keep me up is our foundational business because I do not see any threats to the vitality of our Remodulin, Tyveso, or Orinatran products. For Remodulin and Tyveso, my confidence is born of the uniqueness and clinical efficacy of our drug device combination technology. For Remodulin, there is no other parenteral drug delivery device that is as small, accurate, and easy to use as our Remunity pump. Its patented acoustic volume sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts. For Tyveso, there is no other dry powder inhaler so well matched to deep lung delivery of our drug as the Mankind DPI. The proof is really in the pudding. In record time, thousands of patients have begun using our patented device in both old and new pulmonary indications, such as pulmonary arterial hypertension and interstitial lung disease. Competition in our current foundational business doesn't really keep me up either. because they are mostly used in combination with our drugs, or if not, use drug delivery devices that are not as elegant as our immunity and our DPI devices. Now, let me jump ahead to the organ business. That also doesn't keep me up, because in the last year, we have obtained multiple times scientific proof that our xenokidneys function well in human bodies with no more immunosuppression than an allograft. Folks, that cannot happen by accident. Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production. But I see no showstoppers, and we have achieved proof of concepts. It is only in our second wave of success, Tyveso for pulmonary fibrosis and Rolenopeg for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded. And even a study that is 90% powered for success, by definition, still has a 10% chance of missing. Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and RELENOPEG clinical trials. But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high. In conclusion, UT is a rock solid bet on its current foundational business. UT is a very, very good bet and a highly rewarding one at that in its next-stage generation products that are now in late-stage clinical trials. And UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs. With that strategic overview, I'd like to now turn the call over to our president, Michael Benkowitz. Mike?