United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation's second quarter 2021 earnings webcast. My name is Stephanie and I will be your conference operator today. All participants on the call portion of the webcast will be in a listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during that portion, simply press star then the number one on the telephone keypad. If you would like to answer your question, press the pound key. I will now turn the webcast over to Mr. Dewey Stedman, head of investor relations at United Therapeutics. Please go ahead.

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation second quarter 2021 earnings webcast. Accompanying me on today's webcast are Dr. Christine Rothblatt, our Chairperson and Chief Executive Officer, Mr. Michael Benkowitz, our President and Chief Operating Officer, Mr. James Edgman, our Chief Financial Officer and Treasurer, and 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 FCC 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. Today's remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles or GAAP. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found on our earnings release available on our website at ir.unifer.com. 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 our products are available on our website. Now I'll turn the webcast over to Dr. Rothblatt for a review of our second quarter 2021 financial results and business activities of United Air Athletics. Martin?

Thanks, Dewey. Good morning, everyone, and thank you for joining us on our quarterly earnings call. We have a lot of good news to share today, so it's going to be a very fun call. You've read in the press release the outstanding financial results, and in a moment I'm going to turn the mic over to Mike Bankowicz, who will speak a little bit more about the commercial success that we're experiencing. I'd like to talk a little bit about our pipeline, which is quite robust and doing very well. We have a number of studies in phase three. I'd like to highlight a few of them. Two of our studies are outside of Group 1 PAH, the PERFECT study in COPD, specifically a form of COPD that's associated with pulmonary hypertension, and another Phase 3 study in idiopathic pulmonary fibrosis, also known as IPF. That study is called the TETOM study within United Therapeutics. In addition to those Phase III studies, we have additional Phase III studies within Group 1 pulmonary hypertension. Two of those Phase III studies are using our once-a-day drug called Rolentopac, and both of those studies are growing quite nicely. In addition, we have a lot of next-generation tropostinal development activity Some of it's in phase one and then moving into bioequivalence testing over the next year or two. So that will provide an ongoing pipeline of next-generation tropostinal products for group one and possibly also group three pulmonary hypertension. Looking a little bit at the longer term, we're working on cures for pulmonary hypertension, either through gene therapy, and we do have a gene therapy trial also in phase three, or actually manufactured lungs, lungs that are manufactured in our laboratories and then transplanted into patients to completely cure either their pulmonary hypertension, pulmonary fibrosis, or many other end-stage lung diseases. In the meantime, on the clinical side, there is increasing evidence that current medicines dosed appropriately may, in fact, convert pulmonary hypertension into a lifelong manageable condition. And a lot of these data are coming from Europe and Japan. I think you're going to soon see more reports from the United States. But it's really startling to see reports with patients, more than 90% of the patients in a cohort living 20 years, over 10 years, with current medications, but dosed differently than kind of the traditional dosing, dosed according to a very specific protocol. So that's tremendously exciting for us in the pulmonary hypertension field. to be able to convert pulmonary hypertension into a lifelong manageable condition. And indeed, the goal of our next generation proprostinol products is to make these kind of lifelong manageable protocols as easy as possible for the patients, because they'll be on them for literally decades. Well, with that introduction to our pipeline and clinical development activities, I'd like to pass the microphone over to Mike Bankowitz to talk about the commercial operations. Mike?