United Therapeutics Corporation

Good morning and welcome to the United Therapeutics Corporation third quarter 2022 earnings webcast. My name is Chantal and I will be your conference operator today. All participants on the call portion of the 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'd like to withdraw your question, simply press star, the number one, again, on your telephone keypad. I will now turn the webcast over to Julie Steadman, Head of Investor Relations at United Therapeutics.

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation third quarter 2022 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 Edgman, our Chief Financial Officer and Treasurer, and Pat Poisson, our Executive Vice President of Technical Operations, 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 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. Also, 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 send the webcast over to Dr. Rothblatt for an overview of our third quarter 2022 financial results and business activities of United Therapeutics.

Martin? Thanks, Dewey. Good morning, everyone. Currently, we are helping about 12,000 patients, including over 10,000 troposomal patients, a high mark for our company. And we are making great progress on our goal of 25 by 25, meaning helping 25,000 patients by the year 2025. Now achieving that goal will require annual growth in patient ads per quarter. Over the past year, we have increased our patient ads per quarter by about 66% from our historic rate of around 300 per quarter in 2021 to around 500 per quarter in 2022. Of course, there are monthly ups and downs in quarterly variability, but maintaining even half our current growth rate for the next three years seems eminently doable and will allow us to nail 25,000 patients by 2025. Further supporting the achievability of continued growth in quarterly patient ad rate is that we have really just begun with multiple new products and new product information. For example, we have just started our Remunity relaunch. We have just released our Expedite top-line results for Renitram. And we have just commenced our WHO Group 3 penetration of ILD with Tyveso. Then, on top of all of this, we are at the very beginning stages of a truly warm embrace by physicians, patients, and payers of Tyveso DPI. Hence, with three years to go to 2025 and a 30,000 patient group three market waiting to be penetrated with Tyveso, we feel confident that year after year we can increase our quarterly patient ads at the rate needed to meet our announced goals. Now, upon getting even close to 25 by 25, we expect our revenues will be about double what they are now, since right now we have about half that number of patients. I believe that level of double PAH revenues will be sustainable well into the 2030s, due to our expected launch of once daily Relenopeg and continued patient-focused improvements in delivery systems and in protocols for Remunity, Tyveso, and Arenatramp. Now on top of all of that, we expect soon after 2025, a successful outcome of our two ketone phase three trials in pulmonary fibrosis, also known as IPF. That new indication for us, with about 100,000 US patients, will enable our revenues to grow so rapidly that by the end of this decade, I expect our IPF revenues will actually be even greater than our PAH revenues. In other words, by around 2030, I'd expect to see something like a 60-40 split of $10 billion in revenues between IPF and PAH. Meanwhile, I believe this past year, we have proven that genetically modified xenografts and lab cellularized organ scaffolds are practically doable. These achievements are the technology from which we plan to produce an unlimited supply of hearts, lungs, and kidneys. We will use the next few years of rapid growth in PAH and IPF revenues to flesh out the numerous aspects of turning our technological accomplishments into the preclinical, clinical, and commercial manufacturing precursors of an exciting new transplant business. As our PAH revenues start to plateau in the 2030s, we should be ready to ship thousands of lifesaving manufactured organs each year. In summary, UT has a pragmatic, step-by-step business plan of ever more unique and important products that produce ever more value for patients, physicians, and payers. Furthermore, this business is resilient against generic products due to our unique drug delivery technologies, and it is resilient against NCEs such as Sotatercept or existing drugs such as Nintetamib, or perfenadone due to our additive or therapy stacking approach to treatment. We all feel extraordinarily fortunate to work at UT for multi-year goals, as is evidenced by our industry-leading retention rates and multiple Best Places to Work awards. With that high-level overview, let me now turn things over to our president, Mike Bankowitz, for a whole raft of really great news.