United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation third quarter 2021 earnings webcast. My name is Audra 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 the number one again on your telephone keypad. I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead, sir.

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation third quarter 2021 earnings webcast. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Binkowitz, our President and Chief Operating Officer, James Edgeman, our Chief Financial Officer and Treasurer, and Dr. Lee Peterson, 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. 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. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website at ir.unithr.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 the products are available on our website. Now I'll turn the call over to Dr. Rothblatt for an overview of the third quarter 2021 financial results and business activities of United Therapeutics. Dr. Rothblatt?

Thank you very much, Dewey. Good morning, everyone, and welcome to our third quarter 2021 financial results call. We've had an absolutely fantastic quarter, and I really have only great news to share with you this morning. For example, we have experienced double-digit growth in revenues, double-digit growth in non-GAAP earnings, Within our revenues, we've experienced double-digit growth in Tyveso, double-digit growth in Arenatram, double-digit growth in Unituxen. It's just amazing. All the way across the board, we've had a fantastic quarter. In fact, in no product category have sales decreased from last year. So like I said, all good news today. In addition to these operating results, We also are making really great progress with all of our phase three clinical trials. We have a number of phase three clinical trials going on. We've got in the area of pulmonary hypertension our gene therapy trial called SAFIRE. We also have our RUNAPEG II trials, all those in pulmonary hypertension. In pulmonary fibrosis, we have two phase three trials. We call them TETON1 and TETON2. And in COPD, at least a type of COPD associated with pulmonary hypertension, we have another phase three clinical trial going on called PERFECT. We also are just now wrapping up a phase three trial in our organ transplantation area dealing with ex vivo lung perfusion. So really just a huge amount of pipeline activity going on. In addition to all of that, we have some very exciting earlier stage activity where we are developing next generation forms of our parenteral, inhaled, and oral products. So all the way across the board. The one which we expect to launch soonest will be the next generation product for our inhaled product. That's our dry powder inhaler. We just recently launched our next generation product for Remodulin, which is Remunity. And in our pipeline, we have even next generation improvements on that product. And we are working on our next generation better dosing product for our Renatran pill. And then following that, as noted earlier, we expect Relenapag to make a huge difference in the oral treatment of pulmonary hypertension. So, you know, it's kind of like, you know, a best-case situation here at United Therapeutics. We love what we're doing. We love that we're doing it all so well. And on that note, let me turn the podium over to our President and Chief Operating Officer, Mike Benkowitz, who is responsible for so much of this great news.