United Therapeutics Corporation (UTHR) Q4 2024 Earnings Report, Transcript and Summary

Good morning, and welcome to the United Therapeutics Corporation Fourth Quarter 2024 Corporate Update. My name is Cindy, 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, press the number one on your telephone keypad. Please note this call is being recorded. I will now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.

Thank you, Cindy, and good morning. It's my pleasure to welcome you to the United Therapeutics Fourth Quarter 2024 corporate update webcast. We marked today will include forward-looking statements representing our expectations or beliefs regarding future events. Statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-Ks 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 our trials and or other developments with respect to our products. 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 investigational uses. Full prescribing information for the products is available on our website. At company meet on today's call are Doctor Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Doctor Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Hazan, our Executive Vice President of Technical Operations. Note that Michael Benkowitz and my colleague Carrie Silvers will participate in a fireside chat and one-on-one meetings at the TD Cowen Fifth Annual Healthcare Conference in Boston on March third. And along with Gil Golden, our Chief Medical Officer, I will be at the UBS Europe European Healthcare Conference on March fourth in London. And finally, James Edgemond, Carrie, and I will be at the LEARNIC Global Healthcare Conference in Miami on March eleventh. Then our scientific, commercial, and medical affairs teams will present at the Twentieth Annual John Vane Memorial Symposia in London on March seventh and eighth. And at the International Society for Heart and Lung Transplantation Conference in Boston on April twenty-seventh to the thirtieth. And now I'll turn the webcast over to Martine for an overview of our development pipeline activities. Martine?

Thank you, Dewey, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides, but congratulations to the more than thirteen hundred United Therapeutics employees and to you, our shareholders, for supporting yet another record revenue year for United Therapeutics in 2024. In fact, 2024 was our third year in a row of record-setting revenue. This amazing performance was driven by our relentless drive to deliver patients with rare and underserved diseases a broad array of solutions to help them improve their lives. Beyond our stellar commercial performance, we have now begun our three-year cascade of clinical and regulatory events starting with the recent IND clearance for the uKidney clinical trial. This trial is the first FDA-cleared registration supporting clinical trial of a xenorgan and could provide an opportunity to put an end to dialysis for the hundreds of thousands of patients with end-stage renal disease who cannot qualify for a human kidney transplant or who have little chance of obtaining one before their health declines. We expect the first transplant in the middle of this year. Last month, we completed enrollment of the inhaled treprostinil Teton 1 study in idiopathic pulmonary fibrosis. We expect top-line data from the Teton 2 study in the second half of this year, and Teton 1 top-line data in the first half of 2026. Treprostinil, which has been scientifically demonstrated to be anti-fibrotic, anti-proliferative, and anti-inflammatory, is far more than just a vasodilator. We believe its multifactorial mechanisms of action could be complementary to existing approved IPF agents and even to many of the potential IPF drugs in late-stage development. IPF is extremely hard to treat, but we are encouraged with the success we saw in a post hoc analysis of IPF patients with pulmonary hypertension in the INCREASE study. Our goal is to bring this potential innovation to market as quickly as possible to patients in need of something additional to existing therapies on the market. And that's not all. We're tremendously excited for the potential of Ralinepag to be the first true once-a-day oral prostacyclin agonist for pulmonary arterial hypertension patients. If successful, Ralinepag could fundamentally change the positioning of prostacyclins in the PAH treatment paradigm, potentially leading to the upfront use of prostacyclins in PAH. As an example of the potential for Ralinepag, FlexiPag, a twice-daily oral prostacyclin antagonist, logs more than $1.5 billion in annual US sales. And this is for a twice-daily oral product with a dose ceiling, unlike Ralinepag. We expect to conclude enrollment in the advanced outcome study later this year, allowing for top-line data in 2026. Literature has long suggested that earlier prostacyclin use leads to better results, and the once-a-day barrel would complement traditional ERA and PDE5 orals that PAH patients generally use for first-line therapy. Any one of these potential products, uKidney, inhaled treprostinil for IPF, or Ralinepag, could fundamentally change how patients with ESRD, IPF, or PAH respectively are treated, and each represents a multibillion-dollar revenue opportunity for us. We've posted record revenue performance, progressed several registration studies, and launched the first revolutionary trial of a xeno organ. We remain focused on the needs of you, our shareholders, through a disciplined financial algorithm and capital allocation philosophy. In the past five quarters, we have touched on all three areas of our capital allocation philosophy across both our commercial and development portfolios. We've invested in capex to support our new Tyvaso DPI manufacturing facility and acquired additional real estate to support future commercial manufacturing needs. We also commissioned the world's first clinical scale DPF in Virginia and plan to complete two others. On corporate development, we acquired IVVA and MirrorMatrix to enhance our organ alternative development expertise. And we've licensed in new technologies to support our treprostinil business. And with all this, we still returned $1 billion to you, our shareholders, through an accelerated share repurchase program that was universally well received. We will continue to evaluate all three core areas of our capital allocation philosophy on an ongoing basis. Record performance, progress with our innovative and revolutionary development programs, disciplined financial management, and capital allocation. We've never been in a better position at United Therapeutics, and we're excited to forge ahead in 2025. And with that, I'll now turn the call over to our President, Mike Benkowitz, who will give an overview of our commercial performance for the quarter. Mike?

Thank you, Martine, and good morning, everyone. Today, as Martine mentioned, we are pleased to report another year of record-breaking revenue driven by double-digit percent revenue growth for all our major revenue contributors: Tyvaso, U.S. Remodulin, Orenitram, and Unituxin, leading to almost 24% growth over the full year 2023. For the quarter, we saw 20% revenue growth from the fourth quarter of 2023 and saw record total treprostinil referrals and patient shipments along with near-record total starts. Our fourth-quarter total net revenue was down slightly sequentially while our gross revenues for the fourth quarter were record-setting. The modest decline in net revenue is due in part to our recent contracting efforts for Tyvaso, which I will discuss in a moment. Total Tyvaso revenue for the fourth quarter was $4 million, a 19% increase over the previous year. This continued strong commercial execution in what is normally a seasonally challenging quarter was driven by record patient shipments and near-record referrals and starts, largely on par with the previous quarter. The sequential decline in Tyvaso revenue from 3Q to 4Q was primarily driven by a larger gross to net that we've been highlighting for the last few quarters. Our investment in these contracting efforts was conducted to help position nebulized Tyvaso and Tyvaso DPI at parity with current and potential future competitor products. As we have previously noted, these new contracts became effective over the third and fourth quarters of 2024, and we saw this impact primarily in the fourth quarter. At this point, we believe these additional investments and rebates have largely been pulled through, creating a new base from which Tyvaso can continue to grow. Moving to Orenitram, we reported 28% revenue growth in the fourth quarter of 2024 to $108 million, largely in line with the third quarter of 2024 and again what is normally a seasonally weak fourth quarter for specialty pharmacy ordering. In the fourth quarter, we saw record patient shipments for Orenitram. Close to 50% of Orenitram starts are now coming from Remodulin transitions, indicating to us that our educational efforts around use with intermediate high-risk patients needing additional PAH treatment along with scientific discussions about the EXPEDITE study are influencing Orenitram use. Moving to Remodulin, we reported fourth-quarter worldwide revenue of $135 million, up 17% from the prior year period. US revenue grew 11%, setting another record for patient shipments. We continue to see strong referral and start trends for Remodulin. In January, our partner, DEKA, received FDA clearance for the new RemUnity Pro pump. RemUnity Pro is the next generation in subcutaneous pump technology optimized and designed for patients with PAH. RemUnity Pro builds on our unique RemUnity pump platform with features designed with input from PAH practitioners and patients to further simplify daily use. Compared to RemUnity, RemUnity Pro offers broader accessibility through intuitive technology, incorporates a touchscreen remote with step-by-step guidance, streamlined alerts, simplified patient filling, and automatic pump-driven priming. We expect to launch RemUnity Pro later this year. Finally, Unituxan achieved record revenue of $68 million for the fourth quarter, up 25% from the prior year quarter. US revenue for Unituxan was $62 million, driven by both price and volume increases. This growth demonstrates the product's strong market presence and the effectiveness of our commercial strategy. To wrap up, we are extremely proud of our team's accomplishments this quarter as the underlying dynamics of our business remain very strong. And with the recent investment in our commercial contracting efforts, we believe we are well-positioned to continue providing our important medicines to patients while delivering value to our shareholders. Martine, I'll turn things back to you to run the Q&A.

Thank you very much, Mike. Operator, please open the lines to any questions.

You are using a speakerphone, before pressing the keys. At this time, we will pause momentarily to assemble our roster. Our first question comes from Roger Song of Jefferies. Go ahead, please.

Great. Congrats for the quarter. Maybe start with the top-line commercial franchise, given you don't provide 2025 sales guidance, we understand the growth trajectory for the year. Then also you mentioned some seasonality for Q1. How should we think about this year, in the upcoming quarters, and then I have one or two pipeline questions. Thank you.

Thank you, Roger, for the kudos, and I'll bounce that question to Mike.

Sure. So I think as you kind of think about 2025 and beyond as it relates to our what we call our foundational business, which is our commercial portfolio products. You know, I think what we've been saying for the last few quarters, last couple of years really, is that we expect to continue to grow double digits onto mid-decade. And then, you know, obviously, with expected Ralinepag and IPF approval for Tyvaso, you know, we could, you know, that growth projection should inflect in a meaningful way. So, really, even with the contracting efforts, we employed over the last couple of quarters or that went into effect over the last couple of quarters. We really see no change in that perspective in terms of the base business for the next year to two years. So we're just going to continue to execute commercially. And, like I said, deliver that double-digit revenue growth performance.

Perfect answer, Michael. Thank you. Operator, next question.

The next question comes from Jessica Fye of JPMorgan. Go ahead, please.

Great. Good morning. Thanks for taking my question. So with the first transplant for the uKidney clinical trial expected mid-year, can you talk about what you'll be looking for to support proceeding to the next transplant? I think there's a waiting period in between the first and the second. And then just talk about what proof points in that program would on gate larger scale investment in additional DPF facilities. Thank you.

Thanks, Jessica. Nice to hear your voice this morning, and I'll flip that question over to Doctor Peterson, our EVP of Xenotransplantation.

Yep. Hi. Yeah. So as you mentioned, we have this is a single-phase less study. And it starts with a cohort of six participants. And then we have a twelve-week review period where we will be involving well, we're actually involving our DSMB, which is our independent data safety monitoring committee as well as our steering committee throughout the study because it's open label. But we'll have a formal review of all of the data, safety data, and as well as patient and graft survival data at that point. And determine the risk-benefit ratio of going forward into the remainder of the what we have a plan of up to fifty patients. And as far as the endpoints or the demonstration of success, we're going to be looking again at a six-month graft survival rates, patient survival rate, as well as several parameters of kidney function and then, of course, of safety, which includes transmission of infections, including potential zoonotic infections.

Lee, that's a great answer. Thank you so much. And Jessica, in terms of additional spending on DPF facilities, it's premature to speculate on that, but it will just be something that we'll consider as the trial proceeds. Operator, next question.

The next question comes from Ash Verma of UBS. Hi. Thanks for taking my question. I wanted to wonder where to your business. Is this study finished earlier than expected?

And in the past, I understand that you've talked about that the Wind River, late line, and common courtesy used with some of your products was encapsulating your PAH position. But now that Wind River moves earlier line and faster than expected, can Tyvaso still grow on the PAH side?

Thank you, Ash, for dialing in this morning. Mike, I think you would be the best person to answer that question.

Sure. So I think in terms of the Hyperion study, I mean, obviously, we'll see how that plays out over the next couple of quarters. I remain, you know, as I said in the answer to the first question, we still expect that we're going to continue to grow double digits across our franchise. I do not think, you know, as we said all along, Wind River is not a cure. It's definitely an addition to the PAH treatment armamentarium, which is great for patients. It doesn't replace prostacyclin. I think what we've seen, you know, up till now is that's being aged in combination with prostacyclin. I think that will continue to be the case. If for whatever reason physicians start to move, you use Wind River ahead of prostacyclin, you know, over the long term. I think that's immaterial because PAH continues to be a progressive disease and whether patients start on prostacyclin before or after Wind River, eventually they're going to get to a prostacyclin. So as we think about our business over the long term, we think the impact is going to be really be immaterial.

Excellent, Michael. Operator, next question.

The next question comes from Joseph Thome of TD Cowen. Go ahead, please.

Hi there. Good morning. Thank you for taking my question and congrats on the progress. Maybe another on the xenotransplant. Can you put into context the baseline disease severity of the first patient that will be enrolled maybe as it relates to kind of the baseline disease severity of Tuatulunie? And then related to that, we've obviously been able to follow these patients' progress through either press releases from the hospitals themselves or news sources. I guess, do you expect this to continue in the formal clinical study as early as yesterday? It seems like Miss Luzine was able to return home. We can kind of watch this as it happens. Is that going to be the case in the formal study as well? Thank you.

Thank you, Joe. I think Doctor Peterson could give you a very good answer on that question.

Yeah. So I think your second question was about how we will follow our clinical study patients with regard to the news and what's been shown with Miss Luzine. We will not be doing that. But for clinical studies, the data are there's patient privacy. There we will it will not be the same as what you've seen with this EINB case. It'll be more like a traditional clinical study where you don't have names and, you know, follow that. As far as the eligibility, our eligibility includes two populations of patients. One are patients who are not eligible for the current kidney transplant waitlist. But they don't have several comorbidities. Like, very they're not very, very sick patients. Probably, like, you're asking specifically about the first two heart patients. Our patients won't have severe cardiovascular comorbidities, as well as several others. So they'll but, again, they won't be eligible for the list due to medical reasons. And then we also have a second population, which probably Miss Luzine would fall into, which is that they are not expected to get an allo transplant due to things such as HLA sensitization or other factors type O blood, or a combination of these factors, they're not expected to get an allo transplant for at least five years. And so this is the second population where, again, they're on the list. But they're not expected to really have a good chance of receiving an allo transplant. So I hope that gives you a little bit of an indication. Follow her status, which is really great. We're really happy to help patients like her. And probably the second category is very similar to what you understand and what we understand. Where she is.

Thank you, Doctor Peterson. Superb three hundred sixty-degree answer. Next question, operator.

The next question comes from Roanna Ruiz of Leerink. Go ahead, please.

Great. Morning, everyone. So question about Tyvaso in PHILD. Could prescribing growth on the ILD side plus increase in commercial volumes under Part D redesign possibly outweigh some seasonality trends from Q1 going to Q2? Just curious if any color on that.

Very interesting question, Roanna. Michael, can you answer that?

Sure. I think in terms of the first part of the question around PHILD growth, you know, as you recall, we expanded our sales force coming into 2024. Really to try and drive the drive prescribing growth in the PHILD or in the I'm sorry, in the ILD treaters, those physicians that are seeing the PHILD patients. So it'll be a prior to that. Or at least at launch and up till then, I think what we were seeing is, you know, the vast majority of PHILD patients were being referred to pulmonary hypertension clinics and it was those physicians that were prescribing Tyvaso. And so, you know, our but, yeah, as a kind of think of the patient population, that really wasn't a sustainable model going forward if we really were going to have an impact and be able to penetrate the market. So that was really sort of the idea behind the expansion was to really start to continue to educate the ILD treaters on, you know, not only the disease, but how to use Tyvaso, how to start, you know, and treat patients. So I will say that that so far has paid off in spades. You know, if you look at our prescriber growth over the course of 2024, the majority of that growth is in the ILD treating community. So we are starting to get the breadth of prescribers in that group. And then actually starting to make some mends on the depth. I talk often about the three plus doctors that get to three plus patients, you know, then they quickly jump up to six, seven, eight, nine, ten patients. So we're having a lot of success both in terms of the growth of the breadth of the prescribers and starting to get more depth among those prescribers. And so I think we just expect that to continue as we move on into 2025 and beyond. And, you know, I was just looking at, you know, calculating if you look at, you know, patient growth between PHILD and PAH. The nice thing is with Tyvaso is we're actually growing on both indications. So in 2024, we grew roughly I think there's about 37%, 35 to 40%. In PHILD, still mid-teen growth. In PAH. So it's nice to see that we're growing in both indications. The yeah. So I think, hopefully, that addresses the first part of your question around prescriber growth and then growth in PHILD versus PAH. As it relates to Part D impact, I think as we said for the last couple of quarters, I think that largely played out last year. You know, we saw in Q1, we saw more patients or patient assistance patients convert over to commercial paying patients in Q1 of 2024, and then that continued over the course of the year and we kind of settled in at about, you know, about roughly 90% of our patients are commercial paying patients. And then 10% are in our roughly 10% are PAP program. I would expect that that's going to be kind of the new normal or the baseline going forward. Could shift, you know, bounce around a little bit quarter to quarter just depending on the type of patient we're getting in. But generally, I would expect to kind of settle in around that. So I'm not expecting to see much of an impact in Q1 or Q2 as a result of the Part D redesign.

Excellent. Michael, your encyclopedic knowledge is a benefit to all of us. Thank you so much. Really appreciate it. Operator, we only have time for one last question and whoever that may be, maybe it'll be a question for our Chief Financial Officer since this is an earnings call. Next question, operator?

Okay. The next question comes from Andreas Argyrides. Go ahead, please.

Thanks. Good morning and thanks for taking our question. And, Martine, apologies. You put me on the spot on the financial question. I don't think I had that one teed up here, but, first of all, kudos to the team here, and also to the milestone on getting the IND clearing and, you know, you're leading the way. That's it's pretty fascinating and interesting going forward here. And following to one of the progress here. Hearing this is resume daily activities is a kudos for the team. My question was really just quickly around Tyvaso and IPF. Getting a sense of the intellectual property moat that you've built around that, how long you can expect exclusivity and then quickly on contracting and some of the competitive dynamics behind that. I don't know if I squeezed you in there, but apologies for that.

Yeah. Okay. Well, thank you, Andreas. We appreciate your kudos. You're off the hook on the question for James. We don't really like to discuss publicly the issues relating to IP and whatnot and about out of time, so I'm going to ask just Michael if he could talk about the contracting aspects of our anticipated launch into IPF. Michael?

Yeah. So, Andre, I'm not sure if the question was related directly to contracting an IPF or just contracting generally or what we've done thus far. But really, I think the philosophy that we and the strategy we employed last year was to start to lock in payers with some additional rebates in anticipation of future competitors. And then the idea behind that is if we start to have those rebate dollars flowing through, then, you know, regardless of where a potential competitor comes in with rebates, we have dollars flowing through. And that puts us, I think, we think, in a stronger position keeps us at parity. I think, payers will be less reluctant I'm sorry, less likely, more reluctant to, you know, enter into contracts that would disadvantage us because, you know, at that point, they'd basically be turning off as big as the rebate collar. So that was really the idea behind the payer strategy, which is, you know, get the rebates in place, start to get those dollars flowing, keep us at parity with competitors, and then we feel like if we're really, you know, if and then have the discussion with the clinicians around what's the better product for their patients, and we feel very strongly that we're better positioned and very well positioned to succeed on that front.

Thank you, Mike. Perfect answer. Operator, you may now wrap up 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 presentation section of the United Therapeutics Investor Relations website at ir.unither.com. Thank you.