United Therapeutics Corporation

Good morning, everyone, and welcome to the United Therapeutics Corporation second quarter 2024 earnings webcast. My name is Cole, and I'll be your conference operator today. All participants on the call portion of this webcast will be in a 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 the star, then number one on your telephone keypad. If you would like to withdraw your question, please simply press the star, then the number two on your telephone keypad. And please note that this call is being recorded. I would now like to turn the webcast over to Dewey Sedman, Head of Investor Relations at United Therapeutics. Please go ahead.

Yes, thank you, Cole. Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation second quarter 2024 earnings webcast. Remarks we make 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, and we assume no obligation to update these forward-looking statements. Remarks today may discuss the progress and results of clinical trials or other developments with respect to our products, and these remarks are intended solely to educate investors and are not intended to serve as a basis for medical decision-making. or to suggest that any products are safe and effective for any unapproved or uninvestigational uses. And full prescribing information for our products are available on our website. Accompanying me on today's call are Dr. Martin Rothblatt, our chairperson and chief executive officer, Michael Binkowitz, our president and chief operating officer, James Edgman, our chief financial officer and treasurer, Dr. Lee Peterson, our executive vice president of product development and xenotransplantation, and Pat Poisson, our Executive Vice President of Technical Operations. Note that Michael Benkowitz and I will participate in a fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4th, and James Edgman and I will participate in a fireside chat and one-on-one meetings at the 2024 Wells Fargo Healthcare Conference in Boston the next day, September 5th. Our scientific, commercial, and medical affairs teams will be present at the Pulmonary Hypertension Association 2024 International PH Conference and Scientific Sessions, August 15th to 18th in Indianapolis, the European Respiratory Society Congress in Vienna, September 7th to 11th, and the American College of Chest Physicians Chest 2024 Annual Meeting in Boston, October 6th through the 9th. Now, I will turn the webcast over to Dr. Rothblatt, for an overview of our second quarter 2024 financial results and the business activities of United Therapeutics. Dr. Raspot.

Thank you very much, Dewey. We at UT are very pleased and proud to present the results of another record quarter. As described in the press release, PowerPoint, and the financials, we are doing very well across the board. Double digit revenue growth is the norm. In a moment, our president, Mike Benkowitz, will provide some deep insight into these numbers. So let me start with a strategic overview. We see our business as three waves of success. First, approved products that are market leaders for the mid-2020s. Second, next-generation products and new indications that can be market leaders in the late 2020s. Third, an organ manufacturing business that can transform the treatment of end-stage organ disease. Examples of the first wave are remodulin, tibeso, arenatram, and unituxin. Examples of the second wave are Relenopeg as a once-daily pill for pulmonary hypertension, and our TETON trial aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis. Now, I'm sometimes asked, with all of this success, Martine, what keeps you up at night? Well, let me start with what does not keep me up. What does not keep me up is our foundational business because I do not see any threats to the vitality of our Remodulin, Tyveso, or Orinatran products. For Remodulin and Tyveso, my confidence is born of the uniqueness and clinical efficacy of our drug device combination technology. For Remodulin, there is no other parenteral drug delivery device that is as small, accurate, and easy to use as our Remunity pump. Its patented acoustic volume sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts. For Tyveso, there is no other dry powder inhaler so well matched to deep lung delivery of our drug as the Mankind DPI. The proof is really in the pudding. In record time, thousands of patients have begun using our patented device in both old and new pulmonary indications, such as pulmonary arterial hypertension and interstitial lung disease. Competition in our current foundational business doesn't really keep me up either. because they are mostly used in combination with our drugs, or if not, use drug delivery devices that are not as elegant as our immunity and our DPI devices. Now, let me jump ahead to the organ business. That also doesn't keep me up, because in the last year, we have obtained multiple times scientific proof that our xenokidneys function well in human bodies with no more immunosuppression than an allograft. Folks, that cannot happen by accident. Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production. But I see no showstoppers, and we have achieved proof of concepts. It is only in our second wave of success, Tyveso for pulmonary fibrosis and Rolenopeg for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded. And even a study that is 90% powered for success, by definition, still has a 10% chance of missing. Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and RELENOPEG clinical trials. But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high. In conclusion, UT is a rock solid bet on its current foundational business. UT is a very, very good bet and a highly rewarding one at that in its next-stage generation products that are now in late-stage clinical trials. And UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs. With that strategic overview, I'd like to now turn the call over to our president, Michael Benkowitz. Mike?

Thanks, Martin. Good morning, everyone. As Martine noted, today we reported yet another quarter of record revenue at $715 million and 20% growth from the second quarter of 2023. We saw meaningful worldwide revenue growth for all of our key products, Tybaso, Arenatram, Remodulin, and Unituxin. First, I want to touch on Tybaso, which when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed prostacyclin treatment in the U.S. The total Tyveso revenue for the second quarter was $398 million, up 25% over last year, with growth led by continued uptake of Tyveso DPI, an increase in pricing, and increased commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act, or IRA. For the franchise, we saw record referrals and starts during the quarter. leading us to have confidence in the durability of our growth profile, as Martine mentioned. The percentage of TIDASO DPI patients using our patient access programs continues to tick down following the implementation of the first provisions of the IRA earlier this year, albeit not at the same rate we saw between the fourth quarter of 2023 and the first quarter of 2024. We could continue to see a modest decline in patient access program utilization through the remainder of the year as new patients on therapy are less likely to need patient assistance having met their copay obligations on another product before starting Tyveso DPI. The benefit from this could be offset by modest rebates from our initial contracting efforts to ensure parity of access in the future for Tyveso DPI. As an aside, We understand that CMS will soon publish the negotiated prices for the first 10 drugs selected under the IRA's drug price negotiation provision. I want to remind investors that our drugs are not on this list. In addition, based on our current understanding of the IRA statute and guidance issued by CMS thus far, we expect our troprosinol products will not be subject to price negotiation under the IRA because there is at least one marketed generic version of troprosinol. Moving to arenatram, we reported yet another quarter of record revenue at $107 million, representing 13% growth from the second quarter of 2023. Like the first quarter, this was driven by a combination of increased commercial utilization, pricing, and a modest increase in average dose from prior quarter levels. Recall that arenatram and remodulin are priced on a per milligram basis. Like with Tyveso DPI, we saw a modest decrease in patient access program use for arenatram in the second quarter. driven by the same dynamics. Likewise, we expect a modest decline in patient access program use through the remainder of the year. Our medical teams continue to have scientific discussions based on recent scientific publications with health care providers on the expedite induction protocol where PAH patients initiate on remodulin and then transition to a Renatran as an option for appropriate patients who may not want or need to go on long-term peripheral therapy. Moving to Remodulin, worldwide revenue of $147 million was up 16% from last year, with very strong performance across all of our underlying demand metrics. And this comes five years after the first launch of generics for Remodulin, reflecting our continued commitment to our patients and Remodulin. Remodulin, both intravenous and subcutaneous, remains the most prescribed coronal prostacyclin in the US. Our Remunity pump remains the only option for new subcutaneous patient starts. Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all sub-Q to proximal use to remodeling and our immunity pump, given the discontinuation of support for the CAD MS3 system by its manufacturer. We've seen this trend continue through the second quarter. Finally, Unituxim. Worldwide revenue at $52 million was up 17% from the prior year quarter. and U.S. Unitex in revenue of $47 million was up 18%. U.S. growth was driven by price and volume. To wrap up with our fifth quarter in a row of record revenue, our commercial products clearly have the innovation, interest, momentum, and muscle to continue to grow and serve our patients. With that, I'll turn the call back over to Martin to run the Q&A.

Michael, that was just such a perfect overview of everything. Thanks so much, and thanks for all of your leadership in all of those areas. Operator, You may now bring forward the first call.

Thank you. And we will now begin the question and answer session. If you would like to ask a question, please press star then one in your touchstone's phone. If you're using a speakerphone, please pick up your handset before pressing the key. And to withdraw your question, please press star then two. And at this time, we will pause momentarily for the first question. Today we'll come from Rowanna Reese with Lee Rink Partners. Please go ahead.

Hey, morning everyone. So I was curious, could you elaborate a bit on the different drivers you saw in the quarter for Tyveso DPI versus nebulized Tyveso? And were there any changes or reasons for greater confidence coming through? Like I think you mentioned increased number of referrals and possibly ramping the new field force that we should keep in mind going into 3Q this year.

Thank you for that question, Roana. That type of commercialization question would be best handled by Michael.

Sure. Thanks for the question. So I think the underlying demand metrics just kind of, you know, we continue to just, I think, plug along or chug along like we have the past few quarters with the referrals and with the starts, and it continues to come from both Group 1 PAH as well as Group 3 PHILD The second part of your question about the sales force, I think we are starting to see some of the impact of that sales force expansion in the second quarter. As you recall, we started that ramp up in the last fall, really fully deployed that team January 1. Of course, it takes a little bit of time for the reps to get out in the field. get in front of the physicians and have the opportunity to educate them on the benefits of our products. But what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers actually writing Tyveso. So when we first launched into PHILD a couple years ago, our efforts were really focused on educating around the need to screen for pulmonary hypertension. And then once they started to do that, suspect that the patients had pulmonary hypertension associated with ILD, then they could make the decision whether to refer that patient into the PH clinic or try and treat them themselves. I would say the vast majority of doctors at that time started referring to the PH clinic. But we knew really for us to, I think, realize the full opportunity that we have in PHILD, these physicians were going to have to start treating just because of the number of patients that are out there and the bandwidth constraints on the physicians in the PH clinic. So it's been really nice to see that over the last six months, we really started to increase both the breadth of ILD prescribers as well as the depth, and recall the depth metric we always look at is physicians with three-plus patients. And so we're seeing really positive momentum and growth on both of those key metrics.

Thank you so much, Mike, and thank you, Rowana, for your question. Operator, you can bring forward the next question.

And our next question will come from Jessica Fye with JPMorgan. Please go ahead.

Great. Good morning. Thanks for taking my question. I'm curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial winter of your launch. Do your observations line up with Merck's commentary yesterday? Have you noticed any changes in referrals or starts in PAH?

Thanks, Jeff. Nice to hear your voice this morning. Again, I think it's a market dynamics question that Michael is the best person to answer.

Yeah, sure. Thanks for the question, Jess. Yeah, I mean, I'm not going to really comment too much on Merck's product. I mean, they're plenty capable of speaking for themselves. With respect to our business and specifically in the PAH, I think the business remains very solid, very strong, really strong referral growth, really strong start growth, patient shipments, all of the underlying demand metrics continue to be in line with what we expect. and where we think we need to be, and that's obviously being reflected in the revenue line on our financial statement. So at this point, in the first quarter, no surprises there. As Martine said in her opening remarks, if you look at the Merck's clinical trial, most of those patients were using in combination with prostacyclines, and that certainly at least seems to be how that's playing out so far.

Perfect. Thanks so much, Mike. Thank you, Jeff. Operator, could you bring forward the next question, please?

And our next question will come from Ash Burma with UBS. Please go ahead.

Great. Thanks. Thanks for that. So my question just wanted to understand. So look, I mean, I think the stock has reacted pretty favorably to the ASR. And I know from a cash outflow, you mentioned last quarter that you have now a more specific understanding of what's required for Zeno. So given where we are right now, what's your appetite for another significant share buyback or another ASR?

Thank you for your question, Ash. That being basically a kind of a capital allocation question, I think the best person on the call to answer that would be our Chief Financial Officer, James Edgemond. James?

Great. Thanks, Martine. Ash, good to hear your voice. Thank you for the question. Two kind of responses to your question. One is our current ASR is still in process, right? The existing or the second tranche As we've described in our disclosure, the $700 million still is in process through the end of September of this year. So we're going to first focus on executing the existing ASR and share repurchase program. A second kind of consideration is we are still committed to allocating capital wisely and in the best interest of stakeholders by first deploying it As we've said historically, Ash, internally for our R&D initiatives, including manufacturing facilities, and included in those manufacturing facilities certainly is our consideration of future commercial DPF capital requirements. Second is we're going to still focus on corporate development to find those opportunities where we think can bring value to shareholders and values to patients. And third, kind of what we've said at the beginning, our current share repurchase program. So our capital allocation program will continue to be the same. We'll continue to evaluate and get more knowledgeable about the construction of the DPF facilities. But right now, we're just going to continue to focus on the ASR that's in place and then continue to use that capital allocation waterfall to evaluate any future opportunities, whether it's share repurchase or otherwise. But thank you for the question. Martin, back to you.

James, that was a 360-degree comprehensive answer to Ash, so greatly appreciated. Operator, next question, please.

And our next question will come from Joseph Stone with TD Cowan. Please go ahead.

Hi there. Good morning, and thank you for taking my question. Maybe just one on the filing strategy for IPF assuming success. I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing, or do you think there is a p-value level or level of, you know, benefit that you could see in one where, you know, you maybe would only need one of these studies to work? And any feedback from the FDA on that point will be helpful if you have it. Thank you.

Thank you, Joe, for that question. Fortunately, we have on our call the person who's in charge of that entire program, Dr. Lee Peterson. So, Dr. Peterson, could you kindly respond to Joe?

Yeah, sure. We haven't recently discussed this with FDA. I mean, this was really early, early discussions with the IND. they really just gave us the boilerplate, you know, language that they always do, which is typically we require two studies for, you know, two positive studies for registration. But of course, I mean, if we, you know, see, we'll likely see the TETON2 results coming out before TETON1, at least the top line results, because as you know, we completed the TETON2 enrollment period early. And so, we'll see those, and we will certainly continue discussions with FDA. I mean, assuming a really, you know, significant, highly positive, clinically significant result, then we will certainly have a discussion with them about that.

Thank you so much, Dr. Peterson. You know, because she's too modest to really toot her own horn, but I just want to remind everybody that Dr. Peterson and Dr. Smith, her right-hand clinical trial leader, they're the same team that executed so successfully our interstitial lung disease trial. that resulted in really much of what we are celebrating today, the explosive growth in group three PAH and the entry into that space of the DPI. So this team, I know for sure, because I see them often, they too, they swept this trial day and night And we are, this is our, if somebody said like, what is your number one priority? It is the, you know, success of the Teton trial and the indication to achieve an indication in pulmonary fibrosis, a market that is probably, you know, three times the size of the pulmonary hypertension market. And again, our trial design is in combination with already approved background therapies. So there's no real kind of having to like, you know, take a patient off a drug to start them on an inhaled tropostinol. And similarly, there's no need to put a patient on another drug to start them because we have both types of patients in the trial. So we would hope for all of that to be in the label. Anyway, sorry to ramble on there a bit, Dr. Peterson, but great answer to Joe. And operator, due to the time, we have time for just one more question.

And that question will come from Andreas Arge Reis with Oppenheimer. Please go ahead.

Good morning, and thanks for taking our questions and continuing on the topic of T-Ton. What kind of bridging study might the FDA require to approve subvasive DPI in addition to the nebulized if TECON is successful? And then how are you thinking about presenting the data? I mean, is there a chance for maybe like an interim readout of sorts or anything like that?

Okay, yeah. Thanks for those two questions. Again, I think Dr. Peterson would be the best person on the call to answer. Once again, just for your recollection, she and her team did the bridging study from the tibiasin nebulizer into the DPI for PAH. So she's very, very familiar with how to do that. She also was the lead author in a publication on those results in the New England Journal of Medicine. So very much on top of getting the word out in the most credible and respected way. So with that little toot-toot of your horn, Dr. Peterson, can you answer the questions?

Thank you. Yeah, sure. So for the bridging study, again, we will – well, let me answer the second question first for interim results. We will not do an interim analysis or an interim look. We have for TITAN-2, as I just said, we have completed enrollment, so we're in the final follow-up period, and we will have the actual final results within a year, just shortly after the year follow-up is up. So, we completed in July, so that would be July plus some time to clean those data just for the top-line results. So, that will be the first time we see the actual results from one of these studies. As far as bridging into DPI, now, as you know, so what we did for in our brief study, we looked at PAH patients. We transitioned from nebulized Tyveso to Tyveso DPI, and that was actually sufficient to get approval for both PAH patients and PHILD patients in PAH. for the Tyveso DPI. Now, for the IPF studies, we still have some ongoing discussions with FDA. We will be discussing as soon as, I mean, really when we get further into the follow-up period or when we get top line results, we're going to have a discussion because it's a different group. It's the pulmonary division for IPF versus the cardiorenal division for pH and pH ILDs. So, different group, different people, sometimes just slightly different requirements. So we need to just confirm what we need to do for the bridging. It might be a matter of a small sub-study in our Teton OLE program. So we need to sort that out. But again, it shouldn't delay. We'll get the results of the Teton studies We will pursue the approval based on the Teton I, Teton II, and then while that is occurring, we'll do what we need to do for bridging.

Excellent. Excellent answer. Thank you so much, Dr. Peterson. Thank you, everybody, for being on the call today. I'd like to just wrap up with drawing everybody's attention to the terrific PowerPoint that Dewey Steadman and his team released. I think it's... It's not only aesthetically beautiful, which it is, it's just rich in content, graphs, charts, numbers, kind of strategic overview kind of things. So please study that PowerPoint at depth if you really want to understand the beauty of the United Therapeutic story. And then finally, I'd like to just do a shout out to everybody who that is part of our United Therapeutics family, what we call Unitharians. We're now bumping up on 1,500 people, and it's in line with a metric that Michael, James, and I have long adopted at UT to grow our headcount in accordance with a with a revenue per head metric of approximately $2 million per head. And that's on par with the absolute best, not only of biotech, but of really American corporations in general. So now that we're knocking on the door of a $3 billion revenue run rate, that's $2 million per head for our knocking on the door of 1,500 people. And it's just another tremendous a testament to the success of United Therapeutics and to the fact that the leaders of this company, Michael, James, myself, Dr. Peterson, others, for all of us, our number one goal is to make sure that everybody working at our company is having the absolute best career development experience of their dreams. And so long as that is happening, then all of our goals pretty much happen automatically. I think another metric I can share with you that I got from our HR department is our percentage of employees who voluntarily terminate, what we call voluntary termination rate, is about 5%. That is far lower than I think any of our peers, but certainly far lower than the averages in the biotech sector and definitely outside biotech. So the numbers say we're doing things right. The people say we're doing things right. And I hope all of you agreed that we're doing the things you want to see us do. Have a great day. Operator, you can close the call.

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 presentations section of the United Therapeutics Investor Relations website at ir.unither.com. Thank you again for your participation. You may now disconnect.