United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation first quarter 2025 corporate update. My name is Dhawan 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 one on your telephone keypad. If you would like to withdraw your question, simply press star then two on your telephone keypad. Please note, this call is being recorded. I would now like to turn the webcast over to Dewey Stedman, Head of Investor Relations at United Therapeutics. Please go ahead.

Thank you, Dorwin, and good morning. It is my pleasure to welcome you to the United Therapeutics Corporation first 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, and we assume no obligation to update these 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 those products are available on our website. Coming to me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgmund, 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. Our scientific commercial medical affairs team will present at the American Thoracic Society International Conference in San Francisco from May 16th to the 21st. And now I will turn the webcast over for 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. However, Mike and I will not speak directly to the slides. How often can a CEO report to their investors and stakeholders that we've had a record revenue quarter? For United Therapeutics, it has been nine quarters out of the past 12. That reflects on the strong execution of our long-term vision to be a biotech leader with a relentless drive to deliver to patients with rare and underserved diseases a broad array of solutions to help improve their lives. Our solid foundation built by Tyveso, Arenatram, Remodulin, and Unituxin continues to grow revenue by double digits. Now for 11 quarters in a row, we expect this momentum to continue, led by Tyveso and Tyveso DPI with continued solid performance by our other commercial products. Moving to our innovation and revolution waves, we believe our record revenue performance can continue for the foreseeable future as we have entered a sustained period of clinical and regulatory events poised to propel our business forward. We continue to grow our pipeline with five registration phase studies underway, a pending marketing application at the FDA, and several new preclinical candidates, including three xeno organs that should be ready for clinical trials within a year. We also have other exciting innovations we will share later that we expect will keep our product portfolio innovating for years to come. We're planning for the first transplant in our U kidney clinical study, which we're calling the expand study in the middle of this year. This will be followed by investigational new drug applications for the EXTEND study evaluating the euthymokidney and the EXPRESS study evaluating the UHEART. Both of those INDs are expected to be submitted within the next year. We recently received positive feedback from the FDA on our euthymokidney program that gives us confidence to file INDs for both the euthymal kidney and uHeart without conducting additional baboon clinical studies. What makes United Therapeutics unlike any other biotech is that we've been able to accomplish this massive business growth and unparalleled pipeline productivity while maintaining strict financial discipline. We never spend more than 50% of prior year revenue on cash operating expenses. And as a result, we have an industry leading productivity per employee and more than $1 billion in annual operating cash flow. We're deploying our capital thoughtfully and strategically to provide for a sustainable business in the years to come. In the past six 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 designated pathogen free facility in Virginia and plan to complete two others in short order. On corporate development, we acquired IVA and Miro matrix to enhance our organ alternative development expertise. And we've licensed in new technologies to support our small molecule business. And with all this, We still returned $1 billion to you, our shareholders, through an accelerated share repurchase program last year that was universally well received. We will continue to evaluate all three core areas of our capital allocation philosophy on an ongoing basis. And we plan to pursue multiple avenues of capital allocation in the future. Our commercial business is extremely strong and growing. That, along with five registration studies underway, several important data reads in the next 18 months, and revolutionary progress on revolutionary organ programs makes United Therapeutics a truly unique and compelling story. And I thank you, our stakeholders and shareholders, for joining us on this journey. We're only just beginning. And with that, I'll now turn the call over to our President, Mike Benkiewicz, who will give an overview of our spectacular commercial performance for the quarter. Mike?