This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk02: Good morning and welcome to the United Therapeutics Corporation second quarter 2022 earnings webcast. My name is Dennis 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 Stenum, head of investor relations at United Therapeutics.
spk10: Good morning. Thank you, Dennis. It's my pleasure to welcome you to the United Therapeutics Corporation second 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 Edgmund, our Chief Financial Officer and Treasurer, 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 forward-looking statements. Today's remarks may discuss progress and details 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. And full prescribing information for these products are available on our website. Now I'll turn the webcast over to Dr. Rothblatt for an overview of the second quarter 2022 financial results and business activities of United Therapeutics. Martin?
spk09: Thanks, Dewey. Good morning, everyone, and welcome to our second quarter 2022 earnings call. We've hammered all of our numbers this past quarter, and the 31% growth reported in our Tyveso sales is truly impressive. actually for me even eye-popping, and very comforting because we continue at this 30-plus percent growth rate year over year. We will have achieved our stated goal of 25,000 patients. Well, we double our numbers every two and a half years at that percentage growth rate, so we will be able to achieve our 25,000 patient goal on target. Rather than have me read the entire release, Why don't we take a kind of 30,000 foot strategic overview of where we are and where we are going. We are now at nearly a $2 billion per year revenue run rate. And that really puts us on the cusp of three new generations of revenue at United Therapeutics. So I'm going to like stand at this where we are right now at a $2 billion revenue run rate and look out and see where are we going to go from here. And I think that there are three peaks coming in the years ahead. The first generation, or the first next peak of revenue, will be to double our $2 billion of revenue to around 2025 by expansion of our oral, inhaled, and cranial products in pulmonary hypertension. These products include our launched products, such as Arenatram, Tyveso, Tyveso DPI, and Revunity, as well as our late-stage pipeline products, such as Relenopeg and Tybaso for COPD. The launch products alone get us to a revenue doubling, as I just described in the beginning of my presentation, largely just by penetration of WHO Group 3 pulmonary hypertension by Tybaso, the type of results that you see so outstandingly presented in this quarter's numbers. All of the pipeline products are actually just additional gravy to getting us to that goal. Now at that point, this second generation of revenue kicks in above $4 billion. So going from the $2 billion revenue run rate where we are right now to the $4 billion is accomplished overwhelmingly with just our launching products. The second generation of revenue kicks in above and beyond that $4 billion threshold which we should achieve around 2025, with approval of our T-Ton studies as the basis of a disease-modifying treatment and the first disease-modifying treatment for ITF. Here we forecast an additional $4 billion in revenue coming from about 40,000 patients at roughly speaking $100,000 per year. With those kind of numbers, we should be able to close out the 2020s with about $8 billion in revenue annually, roughly half from pulmonary hypertension and half from pulmonary fibrosis. By that time, we'll be ready to monetize our organ manufacturing business with thousands of kidneys, hearts, and lungs, bringing us well over $10 billion in revenue in the 2030s. So that organ manufacturing business is the third peak that we would achieve in the years ahead. In summary, at the 30,000-foot level, we expect greater than five-fold growth in eight or so years. Now that I've shared where we are and where we are going and where after that, let me now turn the podium over to Michael Benkiewicz, our president, for more of a deep dive.
spk08: Mike? Thanks, Martine, and good morning, everyone.
spk06: We're very pleased to have achieved double-digit year-over-year revenue growth in our interpersonal business. And not only that, but we reach all-time high quarterly revenues for both Tyveso and the total treprosanil business. As usual, I'll provide some additional commercial color for each of our four main products, focusing primarily on our patient metrics. I remind everyone that our quarterly treprosanil revenue does not always track exactly with quarterly underlying patient demand due to specialty pharmacy ordering patterns, which can be seasonal. I'll start with Tyveso. which saw three similar events in the second quarter. First, we were thrilled to receive FDA approval for Tyveso DPI in May. This is the culmination of years of work by teams at United Therapeutics and our partners at Mankind. We were able to make our first shipments to specialty pharmacies in June, and the first patients started on therapy shortly thereafter. Physician engagement and enthusiasm around this new product is extremely high, which has translated into strong referrals or prescriptions and starts in the third quarter. Secondly, the CMS coverage update to include Tyveso for PHILD that went into effect in early June had a positive impact on new referrals late in the quarter, which, like Tyveso DPI, continues into the third quarter. As a reminder, CMS patients who started in our patient access programs before the coverage decision took effect will remain in those programs through the close of the calendar year, and then will convert to commercial patients next year. However, we have been aware that many physicians were waiting for a CMS coverage decision before referring their Medicare patients for Tyveso therapy, so it has been nice to see an uptick here. Finally, after two quarters of modest patient growth relative to Q2 and Q3 of last year, we added approximately 500 patients to our Tyveso total active patient census in the second quarter. And I should note, we accomplished this without the benefit of the CMS coverage decision or the Tyveso DPI approval because these events occurred so late in the quarter. Consequently, we think the momentum in patient ads we saw in the second quarter, coupled with Tyveso DPI approval and the CMS coverage decision and continued growth in new prescribers leave us well positioned for a strong second half of the year and to achieve our goal of 6,000 Tyveso patients by the end of the year. Moving to Orenatram, we saw yet another quarter of record patient counts as of the end of the second quarter. As we've discussed before, we believe this uptick is driven by the Freedom EV label expansion, now that we're able to have more robust interactions with prescribers about this data. Over the long term, arenatran will continue to be an important part of the PAH treatment armamentarium in patients that either prefer oral medications, have failed on Tyveso, or want to transition from remodulin after their RV function has normalized. Turning to Remodulin, in the second quarter, we saw the second highest level of Remodulin referrals ever, and relative resilience and stability in the business, despite the availability of generic competitors. The relaunch of the Remunity pump is proceeding well, and we expect Remunity starts and total patients on Remunity to grow over the balance of the year and into 2023. Finally, Unitux in demand remains strong as quarterly shipments from our distributors to hospitals remain consistent with the past few quarters. Our second quarter revenue was impacted by a decline in international ordering, as well as order timing and patterns in the U.S. market. Overall, we're very pleased with each of our products' performance in the second quarter, and we look forward to a strong second half of the year, particularly for Tyveso. So, Martin, I'll turn it back to you. Thanks, Mike.
spk09: Those are superb results, so nicely reviewed by you. Operator, can you please open the lines and any questions that come in, I'll be happy to refer them to the executive on the call whose area best fits with.
spk02: At this time, I would like to remind everyone, in order to ask a question, simply press star, then the number one on your telephone keypad. We'll pause for a moment to compile the Q&A roster. And your first question is from the line of Hartosh Singh with Oppenheimer & Company. Please go ahead.
spk08: Great. Thank you for the question. And really nice results, everyone. So congratulations. Just, you know, now that DPI is approved, just a question on generally the United Therapeutics sort of IP portfolio. I mean, could you, Martine, generate more IP over from DPI, you know, that we would hope to see over the next few months? And then maybe just talk a little bit about just your, you know, the IP that you're generating through innovation you know, with drug delivery like RemUnity and potentially future Relenapag, et cetera. Really appreciate the question.
spk09: Yeah, thanks so much, Hartaj, and so nice to hear your voice this morning. It's a really great question. You know, we have a robust IP program at UT. We are very, very fortunate to have in-house art IP counsel who's an expert in the field and He works directly for our general counsel, Paul Mann. His name is Sean Snader. And fortunately, he is extremely knowledgeable and proficient in the area of biotechnology, biochemistry, pharmacology, as well as drug device technology. So he constantly engages in kind of like a round-robin set of discussions with members of our product development team, drug device team, chemistry team, organ manufacturing team, and ends up with a continuous stream of new patent filings, especially here in the US, but also overseas. So I feel very confident that we will have a major new IP that we will be able to benefit from coming out throughout the balance of this decade in every area of our business, whether it is pulmonary hypertension, pulmonary fibrosis, COPD, organ manufacturing, wherever we are able to demonstrate something that is unique and innovative and meets all of the criteria for patenting, Shawn is going to be on that, and I think going forward, the core competency ultimately of UT is going to be its intellectual property portfolio. Thanks so much, Harthash, for the question. And operator, next question, please.
spk02: Your next question is from the line of Yun Yang with Jefferies. Please go ahead.
spk01: Thank you. Great quarter. I have a question on Phase III perfect trial in COPD patients. So you modified the trial with the increased number of patients and shorter single treatment period of 12 weeks. So can you give us kind of elaborate on the reason why you changed the study protocol and with this when we might expect the data? Thank you.
spk09: Yes. Thank you, Yun, for your question this morning, and thanks for joining the call. So we modified the trial. We actually just triggered a part of the trial as filed, which we had a pre-planned opportunity to switch from the crossover design to a parallel design. And we were able to make that decision according to the pre-approved protocol design with the FDA. and as pre-approved by all the IRBs at two or three different points during the trial. So at each of those points, we would ask ourselves, would switching from a crossover to a parallel design increase our probability even higher of having a successful outcome? And of course, always what we are obsessed with is having the highest possible probability of a successful outcome. When this opportunity arose, I guess it was like two months ago now, we decided collectively that if we switched from the crossover to the parallel design, we would be able to increase our odds of having a successful outcome, even though we probably would have been successful with the crossover, but why rest on probably when you can do an even higher level of assurance? We're all about success here at UT. So we went ahead and triggered the pre-approved switch from the crossover over to the parallel. In terms of when, we're continuing to enroll that study quite aggressively. All of the patients from the crossover, they flip over into the end for the parallel design. So, you know, I think that the study will read out in time to produce the additional patients. Like I said in my introductory remarks, these pipeline patients are, I mean, the product pipeline patients are not necessary for us doubling our revenues in the next few years, but they're gravy on top of that. So, you know, over the next... You know, it's in the middle of the phase three, so within the normal and customary timeframe for completing these phase three studies, we'll be able to complete that study as a parallel-decided study. Next question, operator.
spk02: Your next question is from the line of Joe Tome with Cowan. Please go ahead.
spk03: Hi there. Good morning. Thank you for taking my question, and congrats on the excellent progress this quarter. Maybe just in terms of Tyveso, can you comment on the penetration that you're seeing into more traditional ILD physicians in that PH ILD launch with Tyveso? And should this new CMS Medicare coverage decision and the DPI launch fuel uptake at these physician centers?
spk09: Yeah, thank you, Joe. Super insightful question, getting really right to the marrow of what's going on in the very exciting growth figures that we have for Tyveso. And I'm going to refer that question over to Mike Bankowitz to do a deep dive on the answer.
spk06: Sure. Thanks, Martin. Thanks, Joe, for the question. Yeah, in terms of penetration with the PHILD prescriber base, we have seen an uptick there. um in the second quarter and i think i think the inflection point or the tipping point you know for us with respect to those physicians was really uh towards the end of the first quarter this year when um it just seemed that that access to our sales reps opened up coupled with uh the return to in-person healthcare conferences so we had the uh the ishlt conference in boston we had the ats conference in san francisco both conferences well attended really gave us an opportunity our teams, a big opportunity to get back out in front of physicians and continue to talk about PHILD and Tyveso in that indication, both on a one-on-one basis, but also in terms of publications, presentations, poster presentations, what have you. And I think really since then, we're starting to see, like I said, a nice uptick. I think I'd have to go back and confirm this, but I believe we added somewhere, we increased our prescriber base by about 15 to 20% just in the second quarter alone. And a lot of that coming from the typical ILD treaters. So we definitely see some momentum there. And then the second part of your question, we absolutely believe the CMS coverage decision and a DPI will help us continue to penetrate in that prescriber base. As we've said for multiple quarters, we have heard anecdotally that physicians have been waiting for the coverage decision just to make it easier to get the patients through the reimbursement process. And then, you know, obviously with Tyvesa DPI, you have a more convenient delivery mechanism. So we think both of those things will continue to add and allow us to continue to grow our prescriber base as we move through the second half of the year.
spk09: Awesome, Mike. Thank you so much. Operator, next question, please.
spk02: Your next question is from the line of Jessica Fai with JP Morgan. Please go ahead.
spk04: Hey, good morning. Thanks for taking my questions. I was hoping you could elaborate on where you see near-term DPI starts coming from. How much use over the coming months do you think will come from new starts versus switches from nebulized Tyveso? And also, has there been any evolution to your thinking about the potential eventual mix between nebulized Tyveso and Tyveso DPI since you commented on that last quarter? And can you just remind us of your thinking there? Thank you.
spk09: Thank you, Jess. And really interesting questions. Back to like kind of the heart of the business here. So, so cool. I'm going to maybe comment on your second question. And then I'm going to bounce it over to Mike on your first question. Our view is that there's going to be a kind of a leveling out at about 50-50% between nebulized and tibeso DPI. And it's really very comparable to what we've seen over the years between sub-Q and IV in terms of parenteral. I mean, of course, most people would think, hello? Yeah, okay. Of course, most people would think that sub-Q was so much more convenient than IV that everybody would go on sub-Q, but it doesn't really work that way. And the fact of the matter is, depending on people's particular medical conditions, IV is a better solution for them than sub-Q. And while we are super excited about DPI and confident that it is the most convenient way imaginable to take Tyveso, I think because of people's particular medical conditions, long-term, you're going to see about a 50-50 mix between the nebulized and DPI form of Tyveso. But with those comments on your second question, I think really the much more exciting information will come from Mike on your first question. Mike?
spk06: Sure. Thanks, Martin. I think in terms of the mix between transitions and starts, we're not really preferring or going after one versus the other. When we launched in June, when you get an approval, there's some logistical things that have to happen. You have to print the final label. You have to get packaging. You have to get kidding, et cetera, et cetera. This is just, I guess, more for your information. We We started off by printing the maintenance kits for those patients that were already on the nebulizer. So those were sort of the kits that kind of came off the line first. And then a couple weeks behind that, we have the titration packs for new patients. So at this point, whether you're on the nebulizer with a TD300 and want to transition, you're able to do that. Whether you're a de novo patient and want to start need to start on a prostacyclin, we're able to do that as well. So I think as we move through the balance of the year, I think we're going to see, you know, I would expect a roughly equal mix of both transitions and new patients.
spk09: Thanks, Mike. Operator, next question, please.
spk02: Our next question is from the line of Andreas Argarides with Wedbush Securities. Please go ahead.
spk00: Yeah, good morning, and thanks for taking our question. I'm going to piggyback off Jess's last, and And we recently conducted a care wall call with a PH expert, and he noted that there's a big opportunity for DPI in PHILD. So if you could provide that mix that you mentioned about 50-50 for DPI specifically, that would be great. And then, you know, maybe to focus on the pipeline a bit, what can we expect next from the organ transplantation programs? Thanks.
spk09: Sure. So, yes, that 50-50 split, you know, approximately, obviously it's not exactly, is across the board for PAH, whether Group 1 or Group 3. And with regard to your organ question, we have two executives on the call. We have Pat Poisson, who's our Executive Vice President for Technical Operations, which includes the construction of our pathogen-free facility, and we have Dr. Lee Peterson, who is in charge of product development, which includes our xenokidney and xenohart programs. So maybe, Pat, first, if you could say a word or two about the manufacturing aspects of the organ business, and then Lee, if you could say a word or two about the product development aspects.
spk07: Yeah, sure. Thanks, Martin. So we've made really great progress over the last three months or so with the DPF facility. In Q2, we completed design of that facility. At the very end of the quarter, we started construction. We're anticipating substantial completion of the facility by the end of 23 and being prepared to support any Zeno trials that will start in 24. Thanks, Pat. Dr. Peterson?
spk05: Yeah, so thanks for the question. We're continuing to dialogue with the FDA about a clinical path forward. And in the meantime, we're working with our academic partners and continuing to conduct non-human primate studies. And when appropriate, the academic partners will also be conducting conducting the donor studies like those previously conducted and reported at NYU and UAB. And it's also up to the academic partners, but we expect that there might be additional living on a compassionate use basis recipients before we actually start the formal clinical trial.
spk09: Thanks, Dr. Peterson. So, you know, It was really a great set of questions that we had this morning, and it's amazing, really, because they kind of align very well with the 30,000-foot overview that I gave at the beginning. Partage's and Yoon's questions emphasize the ability of our current business to grow from our $2 billion revenue run rate to a $4 billion revenue run rate. based on continued expansion of Tybaso in particular, but also remodulin and arenatram in the existing approved indications, which are PAH, be it WHO Group 1 or Group 3. Then building on that, I think that Joe and Jess's question, you know, cast really a really nice spotlight on DPI. And ultimately, DPI is going to be so important as we move into pulmonary fibrosis, which is our ketone study. And that study is now enrolling very strongly. And I just could not be more excited about the fact that I really believe we are going to prove our hypothesis that we have a disease-modifying treatment for pulmonary fibrosis. U.S. alone, 100,000 patients already being treated or diagnosed with pulmonary fibrosis. So those patients are easy to touch and identify via their current prescriptions. We are testing our drug to come on top of their current medications. So no need for physicians to do a switch decision or anything like that, just layer it on top. And I believe that business will double us Again, from $4 billion up to $8 billion, even with just a 40% penetration of that market, notwithstanding it being a disease-modifying treatment based on the results of the study. And then finally, we had the really good question from Andreas about the organ manufacturing activity, and as Pat and Lee mentioned, pointed out, we are doing all of the strong platform work for that with our belief that we'll be able to monetize all of that IP. Again, a very good question raised by Hartaj about the IP. We'll be able to monetize all of that IP by the end of this decade and providing a super strong, you know, really edifice, a large building upon which we can build and build and build as we go from kidneys to hearts to lungs, livers, and other organs with our really portfolio of organ manufacturing activities, the xenotransplantation capability, the de-cell, re-cell activity, and then the 3D bioprinting. So could not be more happy about United Therapeutics, and we really appreciate everybody joining us on this second quarter printing call. Have a great day, everyone. Operator, you can wrap it up.
spk02: Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the events and presentation section of the United Therapeutics Investor Relations website at ir.unither.com.
Disclaimer