UNITED THERAPEUTICS Corp Q1 FY2021 Earnings Call

Good morning, and welcome to the United Therapeutics Corporation First Quarter 2021 Earnings Call. My name is Phyllis, and I will be your conference operator today. I will now turn the conference call over to Mr. Dewey Steadman, Head of Investor Relations at the United Therapeutics.

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation first quarter 2021 earnings call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Mr. Michael Benkowitz, our President and Chief Operating Officer; Mr. James Edgemond, our Chief Financial Officer and Treasurer; and Dr. Leigh Peterson, our Senior Vice President of Product Development.

Thank you, Dewey. Good morning, everybody. Thanks for joining us on our first quarter 2021 earnings call. I'm going to start off with a sort of 30,000-foot overview. And then after that, I'll open the line for any questions. If there are business questions, I'll refer them to our President, Michael Benkowitz. If there are financial questions, I'll refer them to our Chief Financial Officer, James Edgemond. And any scientific questions, I'll refer to our Senior Vice President, Dr. Leigh Peterson. I may even pass the odd legal question to Dewey. Well, I think from a 30,000-foot viewpoint, the main quantitative goal at United Therapeutics is what we call 25/25. This means increasing the number of patients that we are helping with our main medicine from over 8,000 patients today to over 25,000 patients by 2025. This quantitative metric is an especially important one to call out today because today is World Pulmonary Hypertension Day. It's the one day in the whole calendar that countries throughout the world have agreed to focus their thoughts, attention, and for many patients and families' prayers on the hopes for getting better therapies and treatments for people with pulmonary hypertension.

Thank you. I have a couple of questions. One is on Group three PH-ILD. So we heard from physicians that they see their patients every three to six months. And I know, Martine just mentioned that Group three is a more difficult disease to diagnose and quantify compared to PAH. But aside from targeting physicians, do you plan to target patients so that patients are actually seeking treatment with Tyvaso? And the second question is on subcutaneous Remodulin. I understand that you may be limited to what you can say, but in the 10-Q, the trial with Sandoz and Liquidia, you don't expect to begin before mid-2022 at the earliest. Does that mean that Liquidia cannot launch the product until the trial is over? Thank you.

Thank you for your question, Eun. Nice to hear your voice this morning. Due to the shortage of time on the call, we're only going to be able to allow one question per inquisitor, if I could say that. So I'm going to just take the first question and refer it to Michael because it's really in the domain of a business question. Mike, can you help Eun with understanding what our strategy is with regard to ILD-PH?

Sure. So let me - before I get to the specific question around the patient, maybe give a little bit of color around the PH-ILD launch. So Martine, I think, gave a great overview of sort of our 5-year vision of growing from roughly 8,000 total patients to 25,000 patients and roughly half of those being Tyvaso patients for various indications. With respect to the PH-ILD piece of that, I just want to reiterate what we've been saying since January. With this launch, we expect the number of patients on Tyvaso to approximately double by the end of next year. It's probably not going to be a straight line from here to that doubling. There'll be a little bit of a ramp and then something looks a little bit more hockey stick-like as we get later into the year and certainly into next year. This is due to various factors, including the fact that, and Eun touched on this, we have a new group of ILD treaters. They need to go through the process of getting their patients in, screening those patients, diagnosing those patients, and then clearing that with payers. So that process is ongoing. I will say, in the first three to four weeks of the launch, it's very early days. We're incredibly pleased with what we've seen in terms of referral activity, in terms of the number of referrals that have come in. We actually have patients that have started since the launch on Tyvaso.

Awesome, Mike. Thanks so much. Operator, next question.

Your next question comes from the line of Liana Moussatos with Wedbush Securities.

Thank you for taking my question and congratulations on all the progress. How are you going to commercialize Tyvaso solution versus Tyvaso DPI at the end of the year, presuming approval?

Thanks so much, Liana. So great to hear your voice again as well. That’s squarely a business question. So Mike, can you help describe the differential launch plans?

Sure. We're really excited about the prospect of bringing the DPI to market. We think it provides a more convenient, easier way to deliver Tyvaso. But if you step back and look at the history of United Therapeutics and what our objective and mission has been, and that is the right patient options. Patients with options - different ways to take our medicines in a way that meets where they are in their disease and is most convenient to them. We started with Remodulin, developed two versions of Remodulin, and then eventually got to Orenitram, which is the simplest version of all of them. The DPI fits into that strategy of providing patient options. With the DPI, I expect that a significant number or majority of patients will want to transition to the dry powder inhaler, and that's fantastic. However, there will be patients who choose to stay on the nebulizer for various reasons, and that's great. We’re going to continue to support that product. I think when the dust settles, you're probably looking at something around a 70-30 split between dry powder and nebulizer. So we're going to continue to provide both options and support them.

Perfect. Thanks so much, Mike. Operator, next question, please.

Your next question comes from the line of Hartaj Singh with Oppenheimer & Company.

Great, thank you for the question and great work. I have a question on Orenitram. Since the approval of the FREEDOM-EV study, the growth trajectory of the product has definitely increased substantially in the last two years. Johnson & Johnson with Uptravi, the old Actelion drug, indicates about 20% on average growth every quarter. Can you give us color there and also help walk us through how you see Orenitram adding those additional 3,000 patients, as you mentioned earlier in your prepared commentary? Thank you for the question.

Great. Hartaj, so awesome to hear your voice this morning as well. Very interesting question. Very much in the range of what we call business and market strategy. So Mike, if I can ask you to provide Hartaj with some insight into the business ramp plans for Orenitram?

Yes. Happy to do that. With Orenitram, you have to kind of step back and look at the timing of the launch and where it fit with COVID. At a high level, as a company, we continue to be very pleased with the physician reaction to the EV data. Our underlying patient trends continue to be very solid. In particular, in late Q1 and heading into Q2, referrals and starts have seen a nice uptick over previous months. In hindsight, as I look back over the last 18 months and think about the label expansion we received in October 2019 and the publication that came out shortly before the world shut down, we saw a nice uptick during that initial 4 to 6-month period, which then plateaued due to COVID's impact on our ability to access physicians. However, we are starting to come out of this. We’re getting access again, and having fruitful discussions with physicians about the Orenitram value proposition. I think the doctors are seeing that. Moving forward, we have a lot of runway with Orenitram as we continue to educate physicians on the value proposition. This includes the data that supports treating patients to pressure—starting them on Remodulin, driving down their pulmonary arterial pressure, and then switching them over to Orenitram. Lastly, we have OreniPro, the once-daily formulation that provides a more convenient dosing option and potentially better tolerability. It’s a combination of building on the momentum we've seen and leveraging the data around this treat-to-pressure idea.

Excellent, Mike. Thank you so much. Operator, I believe we have time for one last question.

Your next question comes from the line of Joe Thome with Cowen & Company.

Good morning and thank you for taking my question. Just a quick one on the TETON program. As you start thinking about adding more trials here and expanding Tyvaso's opportunity, is it possible to study the DPI alone in some of these trials? Maybe the increased adherence or ease of use would drive better treatment outcomes? Or do you have to start with the nebulized version and maybe do a PK study to show equivalents there?

Yes. I would say that was close to a scientific question as we've gotten this morning. I'd like to bounce that one over to Dr. Peterson to discuss.

Yes. Thank you for the question. We have been told, and we have in writing, that once we receive approval for Tyvaso for new indications and the Tyvaso DPI for PAH, the approval will automatically be granted for the additional indications for DPI as they come along. Given that, it depends on how we decide at the time regarding supply, ease of use, and patients' preferences for the DPI versus the inhaler. We have studied the DPI for human factors in different indications, whether PAH, PH-ILD, or other ILDs without diagnosed PH. They are quite similar. However, some patients might prefer a nebulized form for various reasons. We'll continue to do additional studies to investigate that. TETON one is already in the works, and the sites are open with a protocol, and we should have enrollment any day now.

Thanks so much, Dr. Peterson. We appreciate your input today. We have been happy to share our business, scientific, and financial progress with everyone during this first quarter earnings call. On this World Pulmonary Hypertension Day, we expect to double the number of patients on Tyvaso by the end of next year, and by 2025, we aim to help approximately three times as many patients with our treprostinil suite of products compared to today. Given the data showing that around 15% to 20% of patients progress in their disease each year, the goal of going from 8,000 to 25,000 patients is realistic and necessary. Thank you so much, everyone, for joining us on this call. We look forward to seeing you at an upcoming healthcare conference. Operator, you can wrap it up.

Thank you for participating in today’s United Therapeutics Corporation Conference Call. A rebroadcast will be available for replay for one week by dialing 1800-585-8367 with international callers dialing 1416-621-4642 and using access code 3044748.