United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation first quarter 2023 earnings webcast. My name is Danielle 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 the 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, please press star and then the number two. Please note this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Thank you, Danielle, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation First Quarter 2023 Earnings Webcast. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, and then Pat Poisson, our Executive Vice President of Technical Operations, and finally, Dr. Lee Peterson, our Senior Vice President of Product Development. 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 assumed no obligation to update these forward-looking statements. Today's remarks also 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 these products are available on the product's website. Now, I will turn the broadcast over to Dr. Rothblatt for an overview of our first quarter 2023 financial results and the business activities of United Therapeutics. Martin?

Thank you, Dewey. Very excited to welcome everyone to another great quarter at United Therapeutics. We are thrilled to continue on course toward our mid-decade goals of 25,000 patients being treated for pulmonary hypertension, and the doubling of our revenue run rate. This quarter, we move toward those goals with double digit revenue growth from first quarter 22 to first quarter 23. And that also includes, by the way, nearly 40% growth in our main growth driver, which is Tyveso. I think our double digit growth rate remains a solid forecast, even with the possibility of new FDA approvals of Sotatercept or Liquidia. The reason is that Sotatercept has not even been tested in our main growth market of group three pulmonary hypertension. Indeed, systemic drugs are generally contraindicated there due to them causing VQ or ventilation perfusion mismatch. In the disease Sotatercept was tested in, group one pulmonary arterial hypertension we expect it to be complementary to either our Renitram, Tyveso, or Remodulin products. So we don't forecast a realistic threat from Sirtatracept to our growth. Seasoned Liquidia, if approved, also does not challenge our projected double-digit growth is because it's not a generic product, but is instead a strongly differentiated drug device product, requiring 65% more drugs to even match Syveso's effect based on their own clinical trial data. Also exciting to report this quarter is the robust progress in our pipeline. We are spot on target to fully enroll our current big phase three trials by the end of next year, each of which have their own billion dollar potential. In other words, The pipeline embeds more than double our current total revenues, and then there is the aforementioned organic doubling of our revenues from our existing products already commercialized and now entering the market, such as Tybaso DPI, Remunity, and our new Arenatram dose titration kit. I'm also very excited to report big news on the use of capsule fronting. We have allocated a half billion dollars to a new Tyveso DPI manufacturing facility in Search Triangle Park, North Carolina, with 50,000 patient capacity. And by the way, this is in addition to our existing nearly $100 million allocation of capital to our new clinical xenotransplantation facility in Virginia. By the way, speaking about transplant, I'd like to thank the dozens of shareholders and other stakeholders who sent me Amy Silverstein's superb story of her heroism in the face of heart transplants and immunosuppressants. In that vein, I wanted to take a moment to update everyone on what we at United Therapeutics are doing to effectuate Amy's quest. In our own labs at our company, we reprogram differentiated cells from patients back to stem cells called IPSCs, or inducible pluripotent stem cells. By the end of this year, we'll be creating IPSCs from two patient donors every single month. In our own labs, we differentiate cells into different types of cells needed for cellularizing different organs. such as lung, including stromal cells and filial cells and different types of alveolar cells. In our own labs, we grow differentiated cells in 3D changes into the billions of cells needed to cover each organ. Indeed, in our own labs over the past three years, we have produced about 2 trillion cells every year. Also in our own labs, we cellularize our organ scaffolds with the cells that we have expanded. Indeed, last month, we achieved a kind of level of proof of concept where one of our own cellularized lungs provided a pig model with the level of oxygen considered acceptable for human lung transplants. Again, in our own labs, we produce, this time under GMP conditions, about 500 lung scaffolds every year and are now working on 3D printing kidney and liver scaffolds in partnership with 3D Systems. In short, Amy's vision of an immunosuppressant-free organ transplant is realistic for this decade, the 2020s. Here at United Therapeutics, we expect to have patient-derived stem cell differentiated autologous lungs, kidneys, and livers in the clinic within five years. Parts could also be done. No immunosuppressants would be needed because the transplanted organs will have the same DNA as the patient. So it is really the best of times here at United Therapeutics with record revenues, another half billion dollar quarter, record pipeline potential, $2 billion plus opportunities, and record deployment of capital for business expansion. At UT, our mantra is go big or go home. We are going big on pulmonary hypertension. We are going big on pulmonary fibrosis. And we are going big on creating an unlimited supply of transplantable, tolerable organs. Mike Bankowitz, our president and chief operating officer, We'll now give you a deeper dive into the business. Mike?