NASDAQ:UTHR United Therapeutics Q1 2023 Earnings Report $284.82 +0.51 (+0.18%) Closing price 04:00 PM EasternExtended Trading$285.75 +0.93 (+0.33%) As of 07:35 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast United Therapeutics EPS ResultsActual EPS$4.86Consensus EPS $4.26Beat/MissBeat by +$0.60One Year Ago EPS$5.03United Therapeutics Revenue ResultsActual Revenue$506.90 millionExpected Revenue$514.37 millionBeat/MissMissed by -$7.47 millionYoY Revenue Growth+9.70%United Therapeutics Announcement DetailsQuarterQ1 2023Date5/3/2023TimeBefore Market OpensConference Call DateWednesday, May 3, 2023Conference Call Time9:00AM ETUpcoming EarningsUnited Therapeutics' Q1 2025 earnings is scheduled for Tuesday, April 29, 2025, with a conference call scheduled on Friday, May 2, 2025 at 6:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfilePowered by United Therapeutics Q1 2023 Earnings Call TranscriptProvided by QuartrMay 3, 2023 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Good morning, and welcome to the United Therapeutics Corporation First Quarter 2023 Earnings Webcast. My name is Danielle, 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 the earnings call. Please note this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Speaker 100:00:40Thank you, Danielle, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation Q1 2023 earnings webcast. Accompanying me 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 and then Pat Poisson, our Executive Vice President of Technical Operations and finally, Doctor. Lee Peterson, our Senior Vice President of Product Development. Speaker 100:01:10Remarks today will include forward looking and 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 ks and 10 Q, contain additional information on these risks and uncertainties, and we assume no obligation to update these forward looking statements. Today's remarks also may discuss the progress and results 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. Speaker 100:01:52Full prescribing information for these products are available on the product's website. Now I will turn the webcast over to Speaker 200:02:08Thank you, Dewey. Very excited to welcome everyone to another great quarter at United Therapeutics. We are thrilled to continue on course toward our mid decade goals of 25,000 patients being treated for pulmonary hypertension and the doubling of our revenue run rate. This quarter, we moved toward those goals with double digit revenue growth From Q1 'twenty two to Q1 'twenty three and that also includes, by the way, nearly 40 I think our double digit growth rate remains a solid forecast, even with the possibility of new FDA approvals of sotatercept or Liquidia. The reason is that sotatercept Systemic drugs are generally contraindicated there due to them causing VQ or ventilation perfusion mismatch. Speaker 200:03:17In the disease tabricep was tested in group 1 pulmonary arterial hypertension, we expect it to be complementary to either our Orenitram, Syvaso or Remodulin products. So we don't forecast a realistic threat from sotatercept to our growth. The season Liquidia, if approved, also does not challenge our projected double digit growth It's because it's not a generic product, but is instead a strongly differentiated drug device product, requiring 65% more drug to even match Tyvaso's effect based on their own clinical trial data. Also exciting to report this quarter is the robust progress in our pipeline. We are spot on target to fully enroll our current big Phase III trials by the end of next year, each of which have their own $1,000,000,000 potential. Speaker 200:04:20In other words, the pipeline alone embeds more than double our current Total revenues and then there is the aforementioned organic doubling of our revenues from our existing products already commercialized And now entering the market, such as Tyvaso DPI, RemUnity and our new Orenitram dose titration kit. I'm also very excited to report big news on the use of capital front. We have allocated a $500,000,000 to a new Tyvaso DPI manufacturing facility in Research Triangle Park, North Carolina with 50,000 patient capacity. And by the way, this is an addition to our existing nearly $100,000,000 allocation of capital to our new clinical xenotransplantation facility in Virginia. By the way, speaking about transplant, I'd like to thank the dozens of shareholders and other stakeholders who sent me Amy Silverstein's superb story of her heroism in the face of heart transplants and immunosuppressants. Speaker 200:05:35In that vein, I wanted to take a moment to update everyone on what we at United Therapeutics are doing to effectuate Amy's quest. In our own labs At our company, we reprogrammed differentiated cells from patients back to stem cells called iPSCs or inducible By the end of this year, we'll be creating iPSCs from 2 patient donors every single month. In our own labs, we differentiate cells into different types of cells needed for cellularizing Different organs, such as lung, including stromal cells and the alveolar cells and different types of alveolar cells. In our own labs, we grow differentiated cells in 3 d chambers into the billions of cells needed to cover each organ. Indeed, in our own labs, over the past 3 years, we have produced about 2 trillion cells every year. Speaker 200:06:41Also in our own labs, we cellularize our organ scaffolds with the cells that we have expanded. Indeed, last month, we achieved a kind of leahawk level of proof of concept for 1 of our own cellularized lungs provided a pig model with the level of oxygen considered acceptable for human lung transplants. Again, in our own labs, we produce, this time under GMP conditions, about 500 lung scaffolds every year and are now working on 3 d printing kidney and liver scaffolds in partnership with 3 d Systems. In short, Amy's vision of an immunosuppressant free organ transplant is realistic for this decade, the 2020s. Kidneys and livers in the clinic within 5 years. Speaker 200:07:47Parts could also be done. No immunosuppressants would be needed So it is really the best of times here at United Therapeutics with record revenues, another $500,000,000 quarter, Record pipeline potential, dollars 2,000,000,000 plus opportunities and record deployment of capital and Business Expansion. At UT, our mantra is go big or go home. We are going big on pulmonary hypertension. We are going big on pulmonary fibrosis, and we are going big on creating an unlimited supply Transplantable Tolerable Organs. Speaker 200:08:35Mike Benkowitz, our President and Chief Operating Officer, will now give you a deeper dive into the business. Mike? Speaker 300:08:43Thanks, Martine, and good morning, everyone. We're pleased to report yet another quarter of meaningful growth for our treprostinil business. And as Martine said, we're really excited to have quarterly revenues of more than $500,000,000 for the 2nd time in our company's history. As usual, I'm going to provide some color around what we're seeing with respect to each of our treprostinil products, Tyvaso, Remodulin and Orenitram. For Tyvaso and Tyvaso DPI, underlying physician and patient demand for Tyvaso remained exceptionally strong in the Q1. Speaker 300:09:15As we continue to grow our Trivaso active patients at a clip consistent with the patient growth trends for the prior three quarters. We saw a record number of referrals, which is what we call prescriptions and new patient starts during the Q1. We also continue to increase the breadth and depth of Tyvaso prescriber base. Since the PH ILD launch in 2021, We have now doubled the number of Tyvaso prescribers. That's our breadth metric. Speaker 300:09:43And in terms of prescribing depth, I've mentioned on prior calls that our key metric here is the number of prescribers with 3 or more Tyvaso patients. I'm really happy to report that we've doubled the number of prescribers in this category. The 3 plus Tyvaso prescribers now represent about 40% of all prescribers, which means we still have an opportunity to expand depth, which should pave the way to further accelerate Tyvaso growth over time. The Q1 performance for Tyvaso saw the usual early year seasonality with respect to patient discontinuations due to insurance changes And also as usual, discontinuations returned to normal levels in February, March April. Importantly, discontinuations for Tyvaso DPI So overall, we believe the underlying strength of the Tyvaso business is great. Speaker 300:10:43Looking at Q1 revenue, as I said in the past, due to the nature of our business, we regularly encourage investors to look at longer term revenue trends compared to quarterly revenue fluctuations. With that said, there were 3 main factors that impacted Tyvaso revenue in the Q1, given that we're essentially in the middle of 2 product launches within the Tyvaso franchise, PHILD and then Tyvaso DPI. First, and as we discussed last quarter, Specialty Pharmacies made significant orders of nebulized Tyvaso in anticipation of increased PHIL D demand without fully appreciating the potential for Tyvaso DPI demand. Moving to the Q4 of last year and the Q1 of this year, We saw unexpectedly strong demand for Tyvaso DPI relative to nebulized Tyvaso and the specialty pharmacies needed to reduce its nebulized inventory, which reduced Tyvaso revenue well under patient well under actual patient demand in the Q4 of 2022 Q1 of this year. 2nd, we're seeing a higher level of PAP utilization for Tyvaso DPI than we expected. Speaker 300:11:58We believe this is a short term phenomenon and will subside to a large degree when the Medicare changes that are part of the Inflation Reduction Act go into effect starting next year. Finally, due to the incredible demand for DPI and the fact that we launched immediately upon approval without building inventory, We have not been able to allow specialty pharmacies to up to their contractual minimum inventories each month. Based on our DPI demand trends and forecast, This is something that could persist for the balance of the year. Having said that, we are taking steps to increase DPI production capacity in both the short and medium term. First, our partner MannKind is activating a second production line and additional kitting capacity from which we expect to see increased DPI supply as soon as this quarter. Speaker 300:12:482nd and in parallel, MannKind is also on track to significantly expand Manufacturing capacity in the first half of next year to support up to 25,000 Tyvaso DPI patients a year. And finally, as Martine mentioned, we have initiated a construction project to build a new UT owned and operated Tyvaso DPI manufacturing facility. That facility is intended to provide enough capacity to support an additional 50,000 DPI patients per year and with expansion capacity for up to 75,000 DPI patients. Turning to Remodulin. This business continues to be incredibly resilient even though it's faced a generic competitor for almost 4 years now. Speaker 300:13:30We saw the 2nd highest number of referrals for Remodulin in the Q1. And after a small dip in active patients following the generic launch subcutaneous version of Remodulin, our active patients are back to pre generic levels. RemUnity continues to gain traction in the market as it is the only subcutaneous pump widely available for new Remodulin patient starts with RemUnity representing over half of our monthly subcu Remodulin shipments during the quarter. Finally, OrenoTram had a very solid quarter achieving a record number of patients on therapy and record revenues. We launched a 90 day titration kit during the Q1, which simplifies dosing and titration for new patients. Speaker 300:14:11While still early, physician and patient feedback has been very positive around the convenience of these new kits. There continues to be a lot of buzz in the physician community around the expedite data we top lined last October, demonstrating that prostacyclin induction with Remodulin can lead to double the average Orenitram dose when patients shift to oral therapy and in a shorter period of time as compared to patients who do not have a Remodulin induction. We expect to publish a peer reviewed manuscript detailing this study in the coming months. To wrap up, we're very pleased with the overall treprostin business led by the incredible demand for Tyvaso DPI and we believe we're on our way to hitting our goal of a $4,000,000,000 revenue run rate. With that, I'll turn the call back over to Martine to start the Q and A session. Speaker 200:15:01Thank you so much, Mike. Those were Terrific insights into every one of the products. Really appreciate that call that you shared with everyone. Operator, could you please open the phones and Operator00:15:20We will now begin the question and answer session. At this time, we'll pause momentarily to assemble the roster. The first question comes from Joseph Thome of TD Cowen, please go ahead. Speaker 400:15:51Mike, I know you mentioned that the Tyvaso DPI Maybe what are the expectations for The Tyvaso DPI average time on therapy versus what you were seeing with the nebulizer. And as we see Sotatercept potentially long launching Maybe next year, do you expect the Tyvaso time on therapy could actually increase as these patients kind of continue To do maybe better than they did without Sotatercept or would they instead maybe ramp down their process like when you use? How do you expect that to kind of play out? Thank you. Speaker 200:16:28It looks like I don't direct his question to you. Speaker 300:16:33Sure. Thanks, Joe. So I think overall, We're really encouraged by the lower level of discontinuation rates with Tyvaso DPI and we do think that that offers well for increased time on therapy. To put a number on that, I think it's still a little early to kind of say definitively what that's going to be. But certainly, a Patient satisfaction has been really high with Tyvaso DPI. Speaker 300:16:59I think it's led to better adherence, better compliance And that leads to patients doing better and then that will ultimately lead to patients staying on therapy longer. So I think your premise or your hypothesis that Time on therapy will increase with DPI over time is absolutely right. That's something we're certainly expecting. Similarly, I think sotatercept probably helps in that regard as well. If you look at the underlying data in the sotatercept study, 70% of the patients in that We're on a background on prostacyclin. Speaker 300:17:34So as Martine said in her opening comments, we think there's a lot of complementary effects between prostacyclin and sotatercept. And so we would Expect that when sotatercept is launched to the market, that will continue and patients will experience A nice benefit between the two products as well as the other products on background therapy and should continue to lead to increased time on therapy. Speaker 200:18:00Thanks, Mike. Operator, next question please. Operator00:18:04The next question comes from Hartaj Singh of Oppenheimer. Please go ahead. Speaker 500:18:10Great. Thank you. Nice update everybody and thanks for the question. You just had a question on ORTRAM and the EXPEDITE I know at ERS last year in Barcelona, really big updates there and educating the patient physician community. Seems like at ATS this year again you will kind of delve into that. Speaker 500:18:29If you can just talk to us a little bit about what the patient flow is? Are patients mostly starting on Remodulin then going Orinstram, are they still starting on Orinstram or what's the breakdown? And then how can we expect sort of That to benefit Orenshram going forward. I know it already is, but could that add even more going forward? Thank you. Speaker 200:18:49Great question, Hartaj. Good choice Mike, I think you'd be again be the best person to address that question. Speaker 300:18:57Sure. Thanks, Hartaj, for the question. So in terms of Kind of the mix of patients between starting de novo on Orenitram and transitioning from rojulant, I think it's roughly 65 call Two thirds roughly, two thirds of patients are starting de novo on Orenitram right now. And as I mentioned in my comments, I think the fact that We've got that titration kit, new titration kit. I think that's going to continue to help patients titrate up on I Still believe that there will be patients that will start to deliver on our enantiomer over time once we really fully, I think, take advantage of the expedite data. Speaker 300:19:38But I also think it's true that Tyvaso DPI is proving to be so convenient for patients. It's almost sort of your gateway drug to So I think over time you're going to see a higher number higher percentage of patients initiate prostacyclin Cyclotherapy on DPI even over the orals both orenitram and selexipag. And so the thing that we really like about The EXPEDITE data and then the ARTISAN study, which we've talked about on prior calls is it's an opportunity to take these Maybe functional class, 3 patients or even 4 patients in the case of ARTISAN and start them on remodulin, get their hemodynamic Hemodynamics down to closer to normal levels and then you can flip them over to Orenitram and really use Orenitram as our maintenance drug And continue to titrate up as you need. And if they continue if over time they decline, you can obviously switch them back to Remodulin. But we really see that as sort of a key position for our Renitaram as we move forward over the next several years. Speaker 300:20:48And In sum, it really just kind of speaks to the flexibility of treprostinil and the fact that we've got these different delivery options. And so it really just, I think allows us to kind of meet the patient, the physician where the patient is in their disease progression. Operator00:21:04Great. Speaker 200:21:04Thanks so much, Mike. That was really beautiful the way you're able to describe that with Artisan and Expedite and the whole rapid transition to oral, We're able to get patients into a stable equilibria, if you will, with their pulmonary artery pressures down around, I would say below 40 millimeters of mercury. And there's like an increasing volume of data out there, well over A dozen scientific papers that have shown that patients with pulmonary hypertension who are managed In this kind of potential well between 30 millimeters and 40 millimeters of mercury, are able to achieve very long term survival, 10, 20 years out to the limit of the papers of the data that the papers had access to. And those are papers by independent physicians, not from us. So we really believe that our initial Mission of the company of being able to keep patients with pulmonary hypertension living with pulmonary hypertension Instead of dying from pulmonary hypertension, has been very largely achieved with the combination of parenteral Prostacycline to rapidly get their pressures down and then oral prostacycline orenitram Operator00:22:40The next question comes from Jessica Fye of JPMorgan. Please go ahead. Speaker 600:22:45Hey, guys. Good morning. Thanks for taking my question. On the plans to increase Capacity for Tyvaso DPI that sounds pretty bullish with respect to the anticipated demand trends there and it sounds like you're seeing nice net Patient adds as well. But can you just confirm whether there's any capacity constraint on DPI right now that's at all limiting to patient adds? Speaker 600:23:07Or is it that you're keeping up with patient demand and then in the near term the capacity is maybe just keeping the specialty pharmacies from reaching target inventory levels? And just related to that, I think you said Tyvaso net patient adds were in line with the past three quarters. Can you just remind me what that run rate was that you're tracking in line with? Thank you. Speaker 200:23:28Okay. Thanks so much for the questions, Jeff, and good to hear your voice this morning. There were several questions there. So let me start with the production expansion questions. And then Mike, if you could queue up your responses to the rest of the questions that Jeff asked there. Speaker 200:23:51So, Jeff, yes, so we are pretty bullish On our forecast for Tyvaso DPI and the maximum capacity of the MannKind facility up in Danbury, Connecticut, will be by the beginning of next This year will be for 25,000 DPI patients. So we'll be entering 24 with a capacity for 25,000 patients. Now as I mentioned in my introductory remarks, Our company's goals for the middle of the decade are 25 being able to treat 25,000 Pulmonary hypertension patients. So if a large proportion of those 25,000 patients are on high basal DPI, Which is, I think reasonable. Then it would be like, well, where is the production Capacity for the go big on pulmonary fibrosis, where is the production capacity for what we think the pulmonary fibrosis market will be? Speaker 200:25:04Well, best as we can tell, we expect the pulmonary fibrosis market to actually be For Tyvaso DPI, even larger than the pulmonary hypertension market. So we would need more than an additional 20 hypotheses that we have for Tyvaso DPI In pulmonary fibrosis is such that we could easily expect to have 50,000 Pulmonary hypertension patients. So that's the reason why we need to start now deploying a substantial amount Capital to build this brand new Tyvaso DPI production facility in Research Triangle Park, North Carolina. As Mike mentioned, even that facility, even though its launch capacity will be 50,000 patients, it will have a surge capacity So we think between the 25,000 at MannKind, The 50,000 in North Carolina, the surge to 75,000 in North Carolina. As we enter the 2026 timeframe, we then have a capacity to support 75,000 to 100,000 DPI patients, which would cover our needs for both group 1 pulmonary hypertension, group 3 pulmonary hypertension, idiopathic pulmonary fibrosis and additional forms of pulmonary fibrosis that go under the rubric of Proliferative progressive pulmonary fibrosis, which in fact we are embarking on the other additional Phase III trial for. Speaker 200:27:11So Mike, with those comments in terms of the production capacity, can you answer the other questions that Jeff sent? Speaker 300:27:21Absolutely. So Jeff, I think your question around your first part of your question was around So patient demand versus SP demand to build up their inventory. So we're definitely in the category of the latter. So we're not having To halt or delay patient starts on DPI, we're making enough to meet the patient demand. I think that The issue that I was referencing in my opening comments is typically specialty pharmacy, they have an algorithm for figuring out how much How they order every month, they typically try to order up to have Call it roughly 2 months of inventory on hand and then over the course of the month we'll get down to about 30 days. Speaker 300:28:08So they generally like to keep at least always be in a position where they have at a minimum 30 days of inventory on hand. So due to the demand, we're not able to kind of meet that need on the part of specialty pharmacy. Like I said, we have some additional production capacity coming online as soon as this quarter. That will start to open things up a little bit. But I think really between As we're continuing to grow over the balance of the year, we're probably going to be in this situation where they're not going to be able to order up to the levels they're accustomed to ordering up to. Speaker 300:28:40Until as Martine said, we get that the significant expansion next year to get up to 25,000 patients. The second part of your question was just Sort of the average, I guess, the run rate in terms of patient adds. So if you look back over the last this quarter or the prior three quarters, it's kind of averaged out to around 500 patient adds 500 patient adds per quarter on Tyvaso, and that's between both DPI and nebulized. Speaker 200:29:06Perfect, Mike. Thanks so much. Operator, we're ready for your next question. Operator00:29:12The next question comes from Eun Yang from Jefferies. Please go ahead. Speaker 700:29:17Thank you. I have a question on TETAN trial. So we are expecting data in 2025. So based on the Phase III INCREASE trial in a subgroup of patients with the underlying IPF, We saw benefits on FOVC up to 16 weeks. So TETAN trial is a 52 week time point. Speaker 700:29:41So do you expect Benefits on FOVC to continue to increase to 52 weeks and then can you comment on powering assumptions for the TITAN trial. Thank you. Speaker 200:29:55Thanks. Good morning, Yoon. Nice to hear your questions. I think it would be best to have Doctor. Petersen, she is in charge of running the Chetan trial, answer your questions. Speaker 800:30:09Yes. Hi, everyone. Thank you for your question. Yes, so in fact, the INCREASE study, Indeed, the main study, the placebo controlled study was 16 weeks as you mentioned. However, we do have an open label extension study of the increased data where we've looked to see how the patients do over the longer period of time, including the 52 week time period. Speaker 800:30:37And we still see benefits of patients on Tyvaso in the increased population. So we feel confident that that will translate to the longer period in the TETON studies. And as far as the TETON study, they are Definitely powered, I mean we have 90% power to detect The difference that we've seen in the increased studies with regard to AbbVie, S and P. So we have sufficient power to see the difference over the 52 week period. So again, we feel confident on that. Speaker 200:31:25So awesome. Thank you so much, Lee. Operator, we're ready for your next question. Operator00:31:31The next question comes from Andreas Argeraj of Wedbush Securities. Please go ahead. Speaker 900:31:38Good morning and thanks for taking my question and congrats on the quarter. When thinking so quickly, first, what's the status of the organ manufacturing programs and when can we expect 1st program to enter a clinical trial? And then how should we think about spend when it comes to organ manufacturing? And I have one follow-up. Speaker 200:31:59Okay. We won't be able to take your follow-up. And Andreas, thanks for the congrats on the quarter. Your line broke up a little bit, but That's the results of the organ manufacturing to enter into clinical trials. And I think you asked something about the capital associated with other spending. Speaker 200:32:25So the organ manufacturing program is a broad, multifaceted, multiple So there are multiple shots on gold program. So it won't be really realistic to give an overview of everything beyond the really exciting Things I mentioned this morning that in response to Amy Silverstein's passionate arguments That part of our organ manufacturing program is strongly focused on organs that would not require In other words, autologous organs that are manufactured with the cells downstream from a patient's own donated cells and we within different laboratories at United Therapeutics, We currently produce iPSC cells. In other words, we reprogram PBMCs and other differentiated from patients back into stem cells. We then used techniques proprietary to the company to then differentiate those stem cells into the different types of cells that we would cellularize organs with. Other programs at other laboratories within United Therapeutics are based on allogeneic cell lines that we are able to MHC segment. Speaker 200:33:53Patients could expect a much lighter immunosuppressant load than if they were just And then let me get to your question about the So the organs we have closest to clinical trials are our Xeno hearts and Xeno kidneys. These are Hearts and kidneys from donor animals that have been grown under the equivalent of good manufacturing practices conditions, what are called pathogen free conditions, and they have 10 genetic modifications that we believe will allow them to surmount hyperacute and acute rejection With no more than the normal commercially available immunosuppressants today and be able to continue on to Long term duration in the recipient's body with the management of chronic rejection as is done today with allografts. So those organs are currently in what's called by the FDA a pivotal preclinical program. That means it's the last preclinical program before going into a human study. And that Hopefully, we will be able to complete that program by the end of 'twenty four And be able to then enter into the first clinical trials in 'twenty five. Speaker 200:35:36So that would be kind of the bottom line answer to your question that the first manufactured kidneys and hearts, Hopefully, knock on wood, should be able to enter into clinical trials in 'twenty five. Operator, we've got time for one last question. Operator00:35:53The next question comes from Ash Varma of UBS. Please go ahead. Speaker 1000:35:58Hi, good morning. Thanks for taking my question. I had one on sotatercept impact. So the feedback that we've heard from physicians indicates that Merck's product positioning and The reception can have an important bearing on what part of your portfolio may get impacted. In your view, does that matter and like what is the assumption that you have on competitors pricing in line of therapy positioning? Speaker 1000:36:25Thank you. Speaker 200:36:25Okay. Thanks for the questions, Ash. Like a frontline question and then Mike will I mean answer, then Mike will give you more of a definitive answer. But as I noted in our introductory remarks, We don't see sotatercept having any effect whatsoever on the growth guidance that we've provided for our company. And the reason for that is a lot of people are not completely clear that there are 2 different diseases That are treated with drugs such as ours that sound very similar and it's easy to get them So the disease that sotatercept was tested in and the disease that all of our drugs are All of our non cancer drugs are approved for is called Group 1 Pulmonary Arterial Hypertension and the acronym is PAH. Speaker 200:37:30A different disease is called Group 3 Pulmonary hypertension or just group 3 PH. Sotatercept has never been tested, at least in anything published That we're aware of, in group 3 pulmonary hypertension, the only drug approved for group 3 pulmonary hypertension is Tyvaso, including Tyvaso DPI. And as Mike described very well, Most of our growth in the coming years, we expect to come from Group 3 pulmonary hypertension. So by definition, sotadustep cannot have any effect on that growth trajectory whatsoever. In addition to that, within the Group 1 pulmonary arterial hypertension, where we do continue to have growth across our franchise, I think Mike mentioned we had our highest quarterly sales of Orenitram ever. Speaker 200:38:29We expect sotatercept to be complementary. And Mike, would you like to expand on that? Speaker 300:38:36Sure. I'll just kind of pick up right there, which is, I think I said in response to an earlier question around this, we definitely look at Sotatercept as complementary to our drug and the other drugs that are currently on the market Treat Group 1 PAH, it's another pathway. So now we have a drug to treat 4 different pathways associated with pulmonary arterial hypertension. If you look at the as I said, if you look at the data in So, TATACEP trial, 70%, 70%, 70% of those patients were on prostacyclin therapy. So clearly, there appears to be a complementary or synergistic effect between prostacyclin and satatercept. Speaker 300:39:20We think that all of the drugs will continue to be used. I know some physicians that we've talked to have talked about this sort of 4 corners approach Of creatine PAH, so you have a drug to treat each of the 4 pathways. How that gets sequenced In the grand scheme of things, it doesn't really matter, because I think it's still a progressive disease. There was nothing in the Sisatercept data really suggest that it's a cure or even a disease modifying agent, I know there were some speculation that that might be the case, but that I don't think that's borne out So clearly patients are benefiting from it, but I think it's a combination with the other drugs. And so we think over time It's another drug that physicians could add to their treatment on Rheumatarium, but it doesn't appear to be something that's going to replace or displays our products. Speaker 200:40:14Thanks so much, Mike, and thank you, operator, and everybody for joining our Q1 conference call. Due to the great work of Dewey Steadman, we'll be presenting at various and sundry healthcare conferences during the balance of the year, and we look forward to Operator00:40:40Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available For replay for 1 week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir. Uniter.com.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallUnited Therapeutics Q1 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) United Therapeutics Earnings HeadlinesBrokerages Set United Therapeutics Co. (NASDAQ:UTHR) Target Price at $388.25April 12 at 2:21 AM | americanbankingnews.com2 of Wall Street’s Favorite Stocks to Target This Week and 1 to QuestionApril 11, 2025 | finance.yahoo.comCrypto’s crashing…but we’re still profitingMost traders are panicking right now. Bitcoin’s dropping. Altcoins are bleeding. The stock market’s a mess. The news is screaming fear. But while most traders watch their portfolios tank…April 15, 2025 | Crypto Swap Profits (Ad)United Therapeutics Co. (NASDAQ:UTHR) Director Sells $1,138,200.00 in StockApril 11, 2025 | americanbankingnews.comLiquidia: United Therapeutics Has The Last LaughApril 7, 2025 | seekingalpha.comUnited Therapeutics Named to ‘100 Best Companies to Work For’ in 2025 by Fortune Media and Great Place to WorkApril 2, 2025 | finance.yahoo.comSee More United Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like United Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on United Therapeutics and other key companies, straight to your email. Email Address About United TherapeuticsUnited Therapeutics (NASDAQ:UTHR), a biotechnology company, engages in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases in the United States and internationally. The company offers Tyvaso DPI, an inhaled dry powder via pre-filled and single-use cartridges; Tyvaso, an inhaled solution via ultrasonic nebulizer; Remodulin (treprostinil) injection to treat patients with pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise; Orenitram, a tablet dosage form of treprostinil, to delay disease progression and improve exercise capacity in PAH patients; and Adcirca, an oral PDE-5 inhibitor to enhance the exercise ability in PAH patients. It also markets and sells Unituxin (dinutuximab) injection, a monoclonal antibody for treating high-risk neuroblastoma; and Remunity Pump, which contains a pump and separate controller for Remodulin. In addition, the company engages in developing RemoPro and Ralinepag for the treatment of PAH; Aurora-GT, a gene therapy product to rebuild the blood vessels in the lungs; and Nebulized Tyvaso, for the treatment of idiopathic pulmonary fibrosis, as well as xenografts, which are development-stage organ products. It has licensing and collaboration agreements with DEKA Research & Development Corp. to develop a semi-disposable system for the subcutaneous delivery of treprostinil; MannKind Corporation to develop and license treprostinil inhalation powder and the Dreamboat device; and Arena Pharmaceuticals, Inc. to develop Ralinepag. The company was incorporated in 1996 and is headquartered in Silver Spring, Maryland.View United Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s NextAfter Massive Post Earnings Fall, Does Hope Remain for MongoDB?Semtech Rallies on Earnings Beat—Is There More Upside? 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There are 11 speakers on the call. Operator00:00:00Good morning, and welcome to the United Therapeutics Corporation First Quarter 2023 Earnings Webcast. My name is Danielle, 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 the earnings call. Please note this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Speaker 100:00:40Thank you, Danielle, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation Q1 2023 earnings webcast. Accompanying me 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 and then Pat Poisson, our Executive Vice President of Technical Operations and finally, Doctor. Lee Peterson, our Senior Vice President of Product Development. Speaker 100:01:10Remarks today will include forward looking and 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 ks and 10 Q, contain additional information on these risks and uncertainties, and we assume no obligation to update these forward looking statements. Today's remarks also may discuss the progress and results 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. Speaker 100:01:52Full prescribing information for these products are available on the product's website. Now I will turn the webcast over to Speaker 200:02:08Thank you, Dewey. Very excited to welcome everyone to another great quarter at United Therapeutics. We are thrilled to continue on course toward our mid decade goals of 25,000 patients being treated for pulmonary hypertension and the doubling of our revenue run rate. This quarter, we moved toward those goals with double digit revenue growth From Q1 'twenty two to Q1 'twenty three and that also includes, by the way, nearly 40 I think our double digit growth rate remains a solid forecast, even with the possibility of new FDA approvals of sotatercept or Liquidia. The reason is that sotatercept Systemic drugs are generally contraindicated there due to them causing VQ or ventilation perfusion mismatch. Speaker 200:03:17In the disease tabricep was tested in group 1 pulmonary arterial hypertension, we expect it to be complementary to either our Orenitram, Syvaso or Remodulin products. So we don't forecast a realistic threat from sotatercept to our growth. The season Liquidia, if approved, also does not challenge our projected double digit growth It's because it's not a generic product, but is instead a strongly differentiated drug device product, requiring 65% more drug to even match Tyvaso's effect based on their own clinical trial data. Also exciting to report this quarter is the robust progress in our pipeline. We are spot on target to fully enroll our current big Phase III trials by the end of next year, each of which have their own $1,000,000,000 potential. Speaker 200:04:20In other words, the pipeline alone embeds more than double our current Total revenues and then there is the aforementioned organic doubling of our revenues from our existing products already commercialized And now entering the market, such as Tyvaso DPI, RemUnity and our new Orenitram dose titration kit. I'm also very excited to report big news on the use of capital front. We have allocated a $500,000,000 to a new Tyvaso DPI manufacturing facility in Research Triangle Park, North Carolina with 50,000 patient capacity. And by the way, this is an addition to our existing nearly $100,000,000 allocation of capital to our new clinical xenotransplantation facility in Virginia. By the way, speaking about transplant, I'd like to thank the dozens of shareholders and other stakeholders who sent me Amy Silverstein's superb story of her heroism in the face of heart transplants and immunosuppressants. Speaker 200:05:35In that vein, I wanted to take a moment to update everyone on what we at United Therapeutics are doing to effectuate Amy's quest. In our own labs At our company, we reprogrammed differentiated cells from patients back to stem cells called iPSCs or inducible By the end of this year, we'll be creating iPSCs from 2 patient donors every single month. In our own labs, we differentiate cells into different types of cells needed for cellularizing Different organs, such as lung, including stromal cells and the alveolar cells and different types of alveolar cells. In our own labs, we grow differentiated cells in 3 d chambers into the billions of cells needed to cover each organ. Indeed, in our own labs, over the past 3 years, we have produced about 2 trillion cells every year. Speaker 200:06:41Also in our own labs, we cellularize our organ scaffolds with the cells that we have expanded. Indeed, last month, we achieved a kind of leahawk level of proof of concept for 1 of our own cellularized lungs provided a pig model with the level of oxygen considered acceptable for human lung transplants. Again, in our own labs, we produce, this time under GMP conditions, about 500 lung scaffolds every year and are now working on 3 d printing kidney and liver scaffolds in partnership with 3 d Systems. In short, Amy's vision of an immunosuppressant free organ transplant is realistic for this decade, the 2020s. Kidneys and livers in the clinic within 5 years. Speaker 200:07:47Parts could also be done. No immunosuppressants would be needed So it is really the best of times here at United Therapeutics with record revenues, another $500,000,000 quarter, Record pipeline potential, dollars 2,000,000,000 plus opportunities and record deployment of capital and Business Expansion. At UT, our mantra is go big or go home. We are going big on pulmonary hypertension. We are going big on pulmonary fibrosis, and we are going big on creating an unlimited supply Transplantable Tolerable Organs. Speaker 200:08:35Mike Benkowitz, our President and Chief Operating Officer, will now give you a deeper dive into the business. Mike? Speaker 300:08:43Thanks, Martine, and good morning, everyone. We're pleased to report yet another quarter of meaningful growth for our treprostinil business. And as Martine said, we're really excited to have quarterly revenues of more than $500,000,000 for the 2nd time in our company's history. As usual, I'm going to provide some color around what we're seeing with respect to each of our treprostinil products, Tyvaso, Remodulin and Orenitram. For Tyvaso and Tyvaso DPI, underlying physician and patient demand for Tyvaso remained exceptionally strong in the Q1. Speaker 300:09:15As we continue to grow our Trivaso active patients at a clip consistent with the patient growth trends for the prior three quarters. We saw a record number of referrals, which is what we call prescriptions and new patient starts during the Q1. We also continue to increase the breadth and depth of Tyvaso prescriber base. Since the PH ILD launch in 2021, We have now doubled the number of Tyvaso prescribers. That's our breadth metric. Speaker 300:09:43And in terms of prescribing depth, I've mentioned on prior calls that our key metric here is the number of prescribers with 3 or more Tyvaso patients. I'm really happy to report that we've doubled the number of prescribers in this category. The 3 plus Tyvaso prescribers now represent about 40% of all prescribers, which means we still have an opportunity to expand depth, which should pave the way to further accelerate Tyvaso growth over time. The Q1 performance for Tyvaso saw the usual early year seasonality with respect to patient discontinuations due to insurance changes And also as usual, discontinuations returned to normal levels in February, March April. Importantly, discontinuations for Tyvaso DPI So overall, we believe the underlying strength of the Tyvaso business is great. Speaker 300:10:43Looking at Q1 revenue, as I said in the past, due to the nature of our business, we regularly encourage investors to look at longer term revenue trends compared to quarterly revenue fluctuations. With that said, there were 3 main factors that impacted Tyvaso revenue in the Q1, given that we're essentially in the middle of 2 product launches within the Tyvaso franchise, PHILD and then Tyvaso DPI. First, and as we discussed last quarter, Specialty Pharmacies made significant orders of nebulized Tyvaso in anticipation of increased PHIL D demand without fully appreciating the potential for Tyvaso DPI demand. Moving to the Q4 of last year and the Q1 of this year, We saw unexpectedly strong demand for Tyvaso DPI relative to nebulized Tyvaso and the specialty pharmacies needed to reduce its nebulized inventory, which reduced Tyvaso revenue well under patient well under actual patient demand in the Q4 of 2022 Q1 of this year. 2nd, we're seeing a higher level of PAP utilization for Tyvaso DPI than we expected. Speaker 300:11:58We believe this is a short term phenomenon and will subside to a large degree when the Medicare changes that are part of the Inflation Reduction Act go into effect starting next year. Finally, due to the incredible demand for DPI and the fact that we launched immediately upon approval without building inventory, We have not been able to allow specialty pharmacies to up to their contractual minimum inventories each month. Based on our DPI demand trends and forecast, This is something that could persist for the balance of the year. Having said that, we are taking steps to increase DPI production capacity in both the short and medium term. First, our partner MannKind is activating a second production line and additional kitting capacity from which we expect to see increased DPI supply as soon as this quarter. Speaker 300:12:482nd and in parallel, MannKind is also on track to significantly expand Manufacturing capacity in the first half of next year to support up to 25,000 Tyvaso DPI patients a year. And finally, as Martine mentioned, we have initiated a construction project to build a new UT owned and operated Tyvaso DPI manufacturing facility. That facility is intended to provide enough capacity to support an additional 50,000 DPI patients per year and with expansion capacity for up to 75,000 DPI patients. Turning to Remodulin. This business continues to be incredibly resilient even though it's faced a generic competitor for almost 4 years now. Speaker 300:13:30We saw the 2nd highest number of referrals for Remodulin in the Q1. And after a small dip in active patients following the generic launch subcutaneous version of Remodulin, our active patients are back to pre generic levels. RemUnity continues to gain traction in the market as it is the only subcutaneous pump widely available for new Remodulin patient starts with RemUnity representing over half of our monthly subcu Remodulin shipments during the quarter. Finally, OrenoTram had a very solid quarter achieving a record number of patients on therapy and record revenues. We launched a 90 day titration kit during the Q1, which simplifies dosing and titration for new patients. Speaker 300:14:11While still early, physician and patient feedback has been very positive around the convenience of these new kits. There continues to be a lot of buzz in the physician community around the expedite data we top lined last October, demonstrating that prostacyclin induction with Remodulin can lead to double the average Orenitram dose when patients shift to oral therapy and in a shorter period of time as compared to patients who do not have a Remodulin induction. We expect to publish a peer reviewed manuscript detailing this study in the coming months. To wrap up, we're very pleased with the overall treprostin business led by the incredible demand for Tyvaso DPI and we believe we're on our way to hitting our goal of a $4,000,000,000 revenue run rate. With that, I'll turn the call back over to Martine to start the Q and A session. Speaker 200:15:01Thank you so much, Mike. Those were Terrific insights into every one of the products. Really appreciate that call that you shared with everyone. Operator, could you please open the phones and Operator00:15:20We will now begin the question and answer session. At this time, we'll pause momentarily to assemble the roster. The first question comes from Joseph Thome of TD Cowen, please go ahead. Speaker 400:15:51Mike, I know you mentioned that the Tyvaso DPI Maybe what are the expectations for The Tyvaso DPI average time on therapy versus what you were seeing with the nebulizer. And as we see Sotatercept potentially long launching Maybe next year, do you expect the Tyvaso time on therapy could actually increase as these patients kind of continue To do maybe better than they did without Sotatercept or would they instead maybe ramp down their process like when you use? How do you expect that to kind of play out? Thank you. Speaker 200:16:28It looks like I don't direct his question to you. Speaker 300:16:33Sure. Thanks, Joe. So I think overall, We're really encouraged by the lower level of discontinuation rates with Tyvaso DPI and we do think that that offers well for increased time on therapy. To put a number on that, I think it's still a little early to kind of say definitively what that's going to be. But certainly, a Patient satisfaction has been really high with Tyvaso DPI. Speaker 300:16:59I think it's led to better adherence, better compliance And that leads to patients doing better and then that will ultimately lead to patients staying on therapy longer. So I think your premise or your hypothesis that Time on therapy will increase with DPI over time is absolutely right. That's something we're certainly expecting. Similarly, I think sotatercept probably helps in that regard as well. If you look at the underlying data in the sotatercept study, 70% of the patients in that We're on a background on prostacyclin. Speaker 300:17:34So as Martine said in her opening comments, we think there's a lot of complementary effects between prostacyclin and sotatercept. And so we would Expect that when sotatercept is launched to the market, that will continue and patients will experience A nice benefit between the two products as well as the other products on background therapy and should continue to lead to increased time on therapy. Speaker 200:18:00Thanks, Mike. Operator, next question please. Operator00:18:04The next question comes from Hartaj Singh of Oppenheimer. Please go ahead. Speaker 500:18:10Great. Thank you. Nice update everybody and thanks for the question. You just had a question on ORTRAM and the EXPEDITE I know at ERS last year in Barcelona, really big updates there and educating the patient physician community. Seems like at ATS this year again you will kind of delve into that. Speaker 500:18:29If you can just talk to us a little bit about what the patient flow is? Are patients mostly starting on Remodulin then going Orinstram, are they still starting on Orinstram or what's the breakdown? And then how can we expect sort of That to benefit Orenshram going forward. I know it already is, but could that add even more going forward? Thank you. Speaker 200:18:49Great question, Hartaj. Good choice Mike, I think you'd be again be the best person to address that question. Speaker 300:18:57Sure. Thanks, Hartaj, for the question. So in terms of Kind of the mix of patients between starting de novo on Orenitram and transitioning from rojulant, I think it's roughly 65 call Two thirds roughly, two thirds of patients are starting de novo on Orenitram right now. And as I mentioned in my comments, I think the fact that We've got that titration kit, new titration kit. I think that's going to continue to help patients titrate up on I Still believe that there will be patients that will start to deliver on our enantiomer over time once we really fully, I think, take advantage of the expedite data. Speaker 300:19:38But I also think it's true that Tyvaso DPI is proving to be so convenient for patients. It's almost sort of your gateway drug to So I think over time you're going to see a higher number higher percentage of patients initiate prostacyclin Cyclotherapy on DPI even over the orals both orenitram and selexipag. And so the thing that we really like about The EXPEDITE data and then the ARTISAN study, which we've talked about on prior calls is it's an opportunity to take these Maybe functional class, 3 patients or even 4 patients in the case of ARTISAN and start them on remodulin, get their hemodynamic Hemodynamics down to closer to normal levels and then you can flip them over to Orenitram and really use Orenitram as our maintenance drug And continue to titrate up as you need. And if they continue if over time they decline, you can obviously switch them back to Remodulin. But we really see that as sort of a key position for our Renitaram as we move forward over the next several years. Speaker 300:20:48And In sum, it really just kind of speaks to the flexibility of treprostinil and the fact that we've got these different delivery options. And so it really just, I think allows us to kind of meet the patient, the physician where the patient is in their disease progression. Operator00:21:04Great. Speaker 200:21:04Thanks so much, Mike. That was really beautiful the way you're able to describe that with Artisan and Expedite and the whole rapid transition to oral, We're able to get patients into a stable equilibria, if you will, with their pulmonary artery pressures down around, I would say below 40 millimeters of mercury. And there's like an increasing volume of data out there, well over A dozen scientific papers that have shown that patients with pulmonary hypertension who are managed In this kind of potential well between 30 millimeters and 40 millimeters of mercury, are able to achieve very long term survival, 10, 20 years out to the limit of the papers of the data that the papers had access to. And those are papers by independent physicians, not from us. So we really believe that our initial Mission of the company of being able to keep patients with pulmonary hypertension living with pulmonary hypertension Instead of dying from pulmonary hypertension, has been very largely achieved with the combination of parenteral Prostacycline to rapidly get their pressures down and then oral prostacycline orenitram Operator00:22:40The next question comes from Jessica Fye of JPMorgan. Please go ahead. Speaker 600:22:45Hey, guys. Good morning. Thanks for taking my question. On the plans to increase Capacity for Tyvaso DPI that sounds pretty bullish with respect to the anticipated demand trends there and it sounds like you're seeing nice net Patient adds as well. But can you just confirm whether there's any capacity constraint on DPI right now that's at all limiting to patient adds? Speaker 600:23:07Or is it that you're keeping up with patient demand and then in the near term the capacity is maybe just keeping the specialty pharmacies from reaching target inventory levels? And just related to that, I think you said Tyvaso net patient adds were in line with the past three quarters. Can you just remind me what that run rate was that you're tracking in line with? Thank you. Speaker 200:23:28Okay. Thanks so much for the questions, Jeff, and good to hear your voice this morning. There were several questions there. So let me start with the production expansion questions. And then Mike, if you could queue up your responses to the rest of the questions that Jeff asked there. Speaker 200:23:51So, Jeff, yes, so we are pretty bullish On our forecast for Tyvaso DPI and the maximum capacity of the MannKind facility up in Danbury, Connecticut, will be by the beginning of next This year will be for 25,000 DPI patients. So we'll be entering 24 with a capacity for 25,000 patients. Now as I mentioned in my introductory remarks, Our company's goals for the middle of the decade are 25 being able to treat 25,000 Pulmonary hypertension patients. So if a large proportion of those 25,000 patients are on high basal DPI, Which is, I think reasonable. Then it would be like, well, where is the production Capacity for the go big on pulmonary fibrosis, where is the production capacity for what we think the pulmonary fibrosis market will be? Speaker 200:25:04Well, best as we can tell, we expect the pulmonary fibrosis market to actually be For Tyvaso DPI, even larger than the pulmonary hypertension market. So we would need more than an additional 20 hypotheses that we have for Tyvaso DPI In pulmonary fibrosis is such that we could easily expect to have 50,000 Pulmonary hypertension patients. So that's the reason why we need to start now deploying a substantial amount Capital to build this brand new Tyvaso DPI production facility in Research Triangle Park, North Carolina. As Mike mentioned, even that facility, even though its launch capacity will be 50,000 patients, it will have a surge capacity So we think between the 25,000 at MannKind, The 50,000 in North Carolina, the surge to 75,000 in North Carolina. As we enter the 2026 timeframe, we then have a capacity to support 75,000 to 100,000 DPI patients, which would cover our needs for both group 1 pulmonary hypertension, group 3 pulmonary hypertension, idiopathic pulmonary fibrosis and additional forms of pulmonary fibrosis that go under the rubric of Proliferative progressive pulmonary fibrosis, which in fact we are embarking on the other additional Phase III trial for. Speaker 200:27:11So Mike, with those comments in terms of the production capacity, can you answer the other questions that Jeff sent? Speaker 300:27:21Absolutely. So Jeff, I think your question around your first part of your question was around So patient demand versus SP demand to build up their inventory. So we're definitely in the category of the latter. So we're not having To halt or delay patient starts on DPI, we're making enough to meet the patient demand. I think that The issue that I was referencing in my opening comments is typically specialty pharmacy, they have an algorithm for figuring out how much How they order every month, they typically try to order up to have Call it roughly 2 months of inventory on hand and then over the course of the month we'll get down to about 30 days. Speaker 300:28:08So they generally like to keep at least always be in a position where they have at a minimum 30 days of inventory on hand. So due to the demand, we're not able to kind of meet that need on the part of specialty pharmacy. Like I said, we have some additional production capacity coming online as soon as this quarter. That will start to open things up a little bit. But I think really between As we're continuing to grow over the balance of the year, we're probably going to be in this situation where they're not going to be able to order up to the levels they're accustomed to ordering up to. Speaker 300:28:40Until as Martine said, we get that the significant expansion next year to get up to 25,000 patients. The second part of your question was just Sort of the average, I guess, the run rate in terms of patient adds. So if you look back over the last this quarter or the prior three quarters, it's kind of averaged out to around 500 patient adds 500 patient adds per quarter on Tyvaso, and that's between both DPI and nebulized. Speaker 200:29:06Perfect, Mike. Thanks so much. Operator, we're ready for your next question. Operator00:29:12The next question comes from Eun Yang from Jefferies. Please go ahead. Speaker 700:29:17Thank you. I have a question on TETAN trial. So we are expecting data in 2025. So based on the Phase III INCREASE trial in a subgroup of patients with the underlying IPF, We saw benefits on FOVC up to 16 weeks. So TETAN trial is a 52 week time point. Speaker 700:29:41So do you expect Benefits on FOVC to continue to increase to 52 weeks and then can you comment on powering assumptions for the TITAN trial. Thank you. Speaker 200:29:55Thanks. Good morning, Yoon. Nice to hear your questions. I think it would be best to have Doctor. Petersen, she is in charge of running the Chetan trial, answer your questions. Speaker 800:30:09Yes. Hi, everyone. Thank you for your question. Yes, so in fact, the INCREASE study, Indeed, the main study, the placebo controlled study was 16 weeks as you mentioned. However, we do have an open label extension study of the increased data where we've looked to see how the patients do over the longer period of time, including the 52 week time period. Speaker 800:30:37And we still see benefits of patients on Tyvaso in the increased population. So we feel confident that that will translate to the longer period in the TETON studies. And as far as the TETON study, they are Definitely powered, I mean we have 90% power to detect The difference that we've seen in the increased studies with regard to AbbVie, S and P. So we have sufficient power to see the difference over the 52 week period. So again, we feel confident on that. Speaker 200:31:25So awesome. Thank you so much, Lee. Operator, we're ready for your next question. Operator00:31:31The next question comes from Andreas Argeraj of Wedbush Securities. Please go ahead. Speaker 900:31:38Good morning and thanks for taking my question and congrats on the quarter. When thinking so quickly, first, what's the status of the organ manufacturing programs and when can we expect 1st program to enter a clinical trial? And then how should we think about spend when it comes to organ manufacturing? And I have one follow-up. Speaker 200:31:59Okay. We won't be able to take your follow-up. And Andreas, thanks for the congrats on the quarter. Your line broke up a little bit, but That's the results of the organ manufacturing to enter into clinical trials. And I think you asked something about the capital associated with other spending. Speaker 200:32:25So the organ manufacturing program is a broad, multifaceted, multiple So there are multiple shots on gold program. So it won't be really realistic to give an overview of everything beyond the really exciting Things I mentioned this morning that in response to Amy Silverstein's passionate arguments That part of our organ manufacturing program is strongly focused on organs that would not require In other words, autologous organs that are manufactured with the cells downstream from a patient's own donated cells and we within different laboratories at United Therapeutics, We currently produce iPSC cells. In other words, we reprogram PBMCs and other differentiated from patients back into stem cells. We then used techniques proprietary to the company to then differentiate those stem cells into the different types of cells that we would cellularize organs with. Other programs at other laboratories within United Therapeutics are based on allogeneic cell lines that we are able to MHC segment. Speaker 200:33:53Patients could expect a much lighter immunosuppressant load than if they were just And then let me get to your question about the So the organs we have closest to clinical trials are our Xeno hearts and Xeno kidneys. These are Hearts and kidneys from donor animals that have been grown under the equivalent of good manufacturing practices conditions, what are called pathogen free conditions, and they have 10 genetic modifications that we believe will allow them to surmount hyperacute and acute rejection With no more than the normal commercially available immunosuppressants today and be able to continue on to Long term duration in the recipient's body with the management of chronic rejection as is done today with allografts. So those organs are currently in what's called by the FDA a pivotal preclinical program. That means it's the last preclinical program before going into a human study. And that Hopefully, we will be able to complete that program by the end of 'twenty four And be able to then enter into the first clinical trials in 'twenty five. Speaker 200:35:36So that would be kind of the bottom line answer to your question that the first manufactured kidneys and hearts, Hopefully, knock on wood, should be able to enter into clinical trials in 'twenty five. Operator, we've got time for one last question. Operator00:35:53The next question comes from Ash Varma of UBS. Please go ahead. Speaker 1000:35:58Hi, good morning. Thanks for taking my question. I had one on sotatercept impact. So the feedback that we've heard from physicians indicates that Merck's product positioning and The reception can have an important bearing on what part of your portfolio may get impacted. In your view, does that matter and like what is the assumption that you have on competitors pricing in line of therapy positioning? Speaker 1000:36:25Thank you. Speaker 200:36:25Okay. Thanks for the questions, Ash. Like a frontline question and then Mike will I mean answer, then Mike will give you more of a definitive answer. But as I noted in our introductory remarks, We don't see sotatercept having any effect whatsoever on the growth guidance that we've provided for our company. And the reason for that is a lot of people are not completely clear that there are 2 different diseases That are treated with drugs such as ours that sound very similar and it's easy to get them So the disease that sotatercept was tested in and the disease that all of our drugs are All of our non cancer drugs are approved for is called Group 1 Pulmonary Arterial Hypertension and the acronym is PAH. Speaker 200:37:30A different disease is called Group 3 Pulmonary hypertension or just group 3 PH. Sotatercept has never been tested, at least in anything published That we're aware of, in group 3 pulmonary hypertension, the only drug approved for group 3 pulmonary hypertension is Tyvaso, including Tyvaso DPI. And as Mike described very well, Most of our growth in the coming years, we expect to come from Group 3 pulmonary hypertension. So by definition, sotadustep cannot have any effect on that growth trajectory whatsoever. In addition to that, within the Group 1 pulmonary arterial hypertension, where we do continue to have growth across our franchise, I think Mike mentioned we had our highest quarterly sales of Orenitram ever. Speaker 200:38:29We expect sotatercept to be complementary. And Mike, would you like to expand on that? Speaker 300:38:36Sure. I'll just kind of pick up right there, which is, I think I said in response to an earlier question around this, we definitely look at Sotatercept as complementary to our drug and the other drugs that are currently on the market Treat Group 1 PAH, it's another pathway. So now we have a drug to treat 4 different pathways associated with pulmonary arterial hypertension. If you look at the as I said, if you look at the data in So, TATACEP trial, 70%, 70%, 70% of those patients were on prostacyclin therapy. So clearly, there appears to be a complementary or synergistic effect between prostacyclin and satatercept. Speaker 300:39:20We think that all of the drugs will continue to be used. I know some physicians that we've talked to have talked about this sort of 4 corners approach Of creatine PAH, so you have a drug to treat each of the 4 pathways. How that gets sequenced In the grand scheme of things, it doesn't really matter, because I think it's still a progressive disease. There was nothing in the Sisatercept data really suggest that it's a cure or even a disease modifying agent, I know there were some speculation that that might be the case, but that I don't think that's borne out So clearly patients are benefiting from it, but I think it's a combination with the other drugs. And so we think over time It's another drug that physicians could add to their treatment on Rheumatarium, but it doesn't appear to be something that's going to replace or displays our products. Speaker 200:40:14Thanks so much, Mike, and thank you, operator, and everybody for joining our Q1 conference call. Due to the great work of Dewey Steadman, we'll be presenting at various and sundry healthcare conferences during the balance of the year, and we look forward to Operator00:40:40Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available For replay for 1 week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir. Uniter.com.Read moreRemove AdsPowered by