United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation fourth quarter and full year 2021 earnings webcast. My name is Emma 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'd like to ask a question during that time, simply press star then the number one on your telephone keypad. If you'd like to withdraw your question, simply press the star and the number one again. I will now turn the webcast over to Dewey Studman, Head of Investor Relations at United Therapeutics.

Good morning, and thank you, Emma. It's my pleasure to welcome you to United Therapeutics Corporation fourth quarter and full year 2021 earnings webcast. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Bickowitz, our President and Chief Operating Officer, James Edgeman, our Chief Financial Officer and Treasurer, Pat Poisson, our Executive Vice President of Technical Operations, 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 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. Reconciliations of these 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.unithair.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 these products are available on our website. Now I'll turn the call over to Dr. Rothblatt for an overview of the fourth quarter and full year 2021 financial results and business activities of United Therapeutics. Dr. Rothblatt?

Good morning, and thank you, Dewey, for that great introduction. We are very excited about this 2021 annual results call. It's 2021, I think beyond a doubt, has been the most exciting year in our company's history. There are a couple of big picture observations here that I'd like to start with, and then I'll go into some more details. From the big picture standpoint, first of all, we grew both patient count and revenues by double digit percentages in 2021. as we had forecast we would do at the start of the year. Generics have not impacted our terprocinal growth trajectory because patients, physicians, payers, they all recognize our outstanding commitment and track record for customer service and supply chain reliability. Our continued double-digit percentage patient growth is how we get to our announced goal of 25,000 patients by 2025, And we remain right on target to make that goal. In fact, we expect double-digit patient growth again this year in 2022. The second real big-picture item is that our organ manufacturing products made a dramatic and highly successful debut with one 10-gene U-heart, two 10-gene U-kidneys, and two U-thymokidneys transplanted. Of course, the focus of everybody is on our living UHeart recipient, Mr. David Bennett, Sr. So I'm very pleased to report that he is doing well at almost two months post-transplant. Specifically, his cardiovascular function at seven weeks is excellent, and there's no sign of rejection even after a 30-day post-operative biopsy. Although he has a lot of non-heart serious health challenges, he said last night, thank you for this chance to live. And my response to Mr. Bennett was, thank you, Mr. Bennett, for giving us this chance to let countless thousands of others also live. I believe our clear-cut successes in 2021 with Xenoproducts Coupled with our core competencies in this area, our gal safe meat, for example, was approved by the FDA in December 2020, and our core competencies in GMP manufacturing and product development all show that our organ manufacturing pipeline is now more credible than ever and of truly momentous potential. Now, beyond these big picture headlines, there has been a great deal of progress in advancing our pharmaceutical pipeline as well. Some highlights are, first, our once-daily treatment for PAH, Relenopeg, is progressing nicely toward wrapping up its Phase III enrollment. Second, our Phase III PERFECT trial, which is testing a first-ever treatment for COPD-related pulmonary hypertension, is steadily racking up more patient randomizations month by month toward completion of its Phase III trial. Our revolutionary disease-modifying effort of idiopathic pulmonary fibrosis, or IPF, which we call the TETON trial, is doing so well in its U.S. Phase III enrollment that we opened up a TETON II Phase III trial outside the U.S. so that we could hopefully offer this product worldwide. Our super convenient Tyveso DPI product remains well positioned for its summer 2022 launch. The FDA did just delay its approval decision from this month to May, but that three-month detour is not important compared to the product's blockbuster revenue potential and patent life well into the 2030s. Three months delay to start on a billion-dollar revenue trajectory is no big deal. Mike will now brief you on our commercial progress, but in summary, for 2021, I can say we hit our patient growth and revenue growth targets. We validated three new xeno organ product candidates, and in so doing, we've launched a whole new category of biotechnology. We have seven phase three trials underway with multiple new product candidates. And most important of all, in this past year, I'd like to say we saved the life of Mr. Bennett with a 10-gene XenoHeart. We saved the lives of at least 100 children stricken with neuroblastoma thanks to our Unituxin medicine. We have now saved over 200 lives of lung transplant patients by increasing the usable donor lung supply with our lung bioengineering technology. And we have saved or improved the lives of thousands of pulmonary hypertension patients in the past year with our Remodulin, Remunity, Tyveso, and Arenatran products. From the headline saving of one life, to the kind of like prayers granted saving of 100 children's lives, to the now almost routine saving and improving of thousands of lives, I can most confidently report that UT's first year as a public benefit company has been super true to our public benefit purpose. Mike, can you lead us off now with commercial operations?