NASDAQ:UTHR United Therapeutics Q2 2026 Earnings Report $501.27 -10.45 (-2.04%) Closing price 08/13/2026 04:00 PM EasternExtended Trading$501.29 +0.02 (+0.00%) As of 08/13/2026 06:00 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 Massive. Learn more. ProfileEarnings HistoryForecast United Therapeutics EPS ResultsActual EPS$7.27Consensus EPS $6.86Beat/MissBeat by +$0.41One Year Ago EPS$6.41United Therapeutics Revenue ResultsActual Revenue$783.30 millionExpected Revenue$804.65 millionBeat/MissMissed by -$21.35 millionYoY Revenue Growth-1.90%United Therapeutics Announcement DetailsQuarterQ2 2026Date8/5/2026TimeBefore Market OpensConference Call DateWednesday, August 5, 2026Conference Call Time9:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by United Therapeutics Q2 2026 Earnings Call TranscriptProvided by QuartrAugust 5, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: United Therapeutics reported highly statistically significant results for the ADVANCE OUTCOMES study of ralinepag in PAH and submitted an NDA to the FDA, viewing the once-daily oral prostacyclin as a potential multibillion-dollar opportunity. Positive Sentiment: The company submitted an sNDA for nebulized Tyvaso in IPF after positive TETON results, with a potential 2027 approval; enrollment in the larger TETON PPF study is also nearly complete. Negative Sentiment: Second-quarter revenue was approximately $783 million, essentially flat sequentially and below management’s expectations. The company did not reaffirm or update its 2026 revenue-growth outlook, while nebulized Tyvaso remained pressured by increased competition. Positive Sentiment: Tyvaso DPI patient starts, referrals, total patients, and commercial patients reached record levels exiting the quarter, and a roughly doubled sales force began entering the field in July to improve physician reach and support second-half performance. Neutral Sentiment: United Therapeutics continues to advance its xenotransplantation pipeline, including UKidney, UThymoKidney, and EXPRESS-UHeart studies, while completing construction of commercial-scale facilities in Minnesota and Texas; however, these programs remain clinical-stage opportunities. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallUnited Therapeutics Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning. Welcome to the United Therapeutics Corporation Second Quarter 2026 Corporate Update. My name is JL, and I'll be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again. Please note that this call is being recorded. I'll now turn the webcast over to Harrison Silvers, investor relations at United Therapeutics. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:00:35Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation Second Quarter 2026 Corporate Update webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:01:29Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Strategic Development. Note that Martine Rothblatt, James Edgemond, and I will participate in a fireside chat and one-on-one meetings at the Wells Fargo Healthcare Conference, September 8th in Boston, the Cantor Fitzgerald Global Healthcare Conference in New York on September 9th. Pat Poisson will join us for the Morgan Stanley Global Healthcare Conference in New York on September 14th. Lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23rd. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:02:16Our scientific, commercial, and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona, September 5th through the 9th, and the American College of Chest Physicians CHEST 2026 annual meeting in Phoenix, October 18 through 21. I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine. Martine RothblattChairperson and CEO at United Therapeutics00:02:41We have slides available for reference. I encourage you to review those at your leisure. I'm not going to speak directly to the slides. The first half of 2026 has been one of the most consequential periods in United Therapeutics' history. First, we delivered exceptional clinical results from our ADVANCE OUTCOMES study, demonstrating ralinepag's potential to become a major new oral therapy for patients with PAH. We unblinded TETON-1, which surpassed the impressive TETON-2 results we reported last September. These results put us in an extraordinary position. A new molecule advancing toward the PAH market and a potential new indication for nebulized TYVASO in IPF, representing an opportunity meaningfully larger than our currently approved markets and a new option for patients. Martine RothblattChairperson and CEO at United Therapeutics00:03:44With these highly statistically significant clinical results, we recently submitted to the FDA what we believe are two of the most important new drug applications in rare pulmonary disease, the sNDA for nebulized TYVASO in IPF and the NDA for ralinepag in PAH. We are not stopping there. With additional filings planned later this year, including an IND for ralinepag DPI and an NDA for treprostinil SMI. We are moving with urgency toward what we believe will be a pivotal change in our growth trajectory as we plan to bring pioneering advanced inhalation technologies to patients. We expect potential approvals in 2027 for nebulized TYVASO in IPF, ralinepag in PAH, and the SMI device in PAH and PH-ILD. These are not incremental opportunities. Martine RothblattChairperson and CEO at United Therapeutics00:04:44We believe they are multibillion-dollar catalysts with the potential to redefine patient treatment paradigms, improve outcomes for patients, and fundamentally transform our growth profile and competitive position. Looking further ahead, enrollment in our TETON PPF trial is nearly complete, paving the way for another substantial phase III readout in the back half of 2027. Based on the successful TETON-1 and TETON-2 studies, as well as the similarities in underlying fibrosis and disease progression between IPF and PPF, we have a high degree of confidence in our ability to report another positive outcome. If successful, TETON PPF would open the door to an even larger opportunity, at least double that of IPF, and position nebulized TYVASO to become a leading therapy for patients with pulmonary fibrosis. Turning to our organ pipeline, we continue to make strong progress toward our goal of expanding the availability of transplantable organs. Martine RothblattChairperson and CEO at United Therapeutics00:05:53The UKidney EXPAND study continues to make great progress, with completion of the initial six-patient cohort expected later this year. In parallel, we soon anticipate initiating the UThymoKidney EXTEND registration enabling study. Lastly, with recent clearance from the FDA, we are working to commence our EXPRESS-UHeart study. Moreover, by the end of this year, we will complete construction of our two additional commercial-scale DPFs in Minnesota and Texas. With three authorized clinical trials, United Therapeutics is not just participating in the future of xenotransplantation, we are leading it. We believe this work can redefine organ transplantation, save countless lives, and create one of the most significant growth opportunities in our company's history. Our deep organ pipeline represents a bold and differentiated extension of United Therapeutics' mission, with the potential to transform how patients access life-saving organs and how United Therapeutics will create substantial value over the long term. Martine RothblattChairperson and CEO at United Therapeutics00:07:09We will be sharing with you more details about these programs as each moves through their development timelines. Our ability to pursue these opportunities is supported by a disciplined approach to capital allocation through our budget algorithm, which has positioned us near the top of our industry in operating efficiency. We have also been thoughtful in deploying capital toward internal growth objectives while remaining mindful of returning capital to shareholders. As an example, we recently deployed capital to acquire Thymmune Therapeutics, adding a promising thymus-based regenerative medicine platform that fits squarely within our mission. This acquisition broadens our organ alternative strategy and strengthens our ability to pursue therapies that could restore immune function for patients with serious diseases. We see tremendous potential ahead, and we're excited to welcome the Thymmune team to United Therapeutics. Martine RothblattChairperson and CEO at United Therapeutics00:08:15To close, we believe United Therapeutics is entering a defining era, one shaped by scientific ambition, innovative platforms, and a pipeline with the potential to transform care across some of the most challenging areas of medicine. As these opportunities advance, we see a future in which our impact on patients, our industry, and our growth trajectory can reach an entirely new level, making United Therapeutics a growth story unlike any other in biotech. With that, I'll turn the call over to our President, Michael Benkowitz, who will provide an overview of our commercial performance for the quarter. Mike? Michael BenkowitzPresident and COO at United Therapeutics00:09:01Thank you, Martine. Good morning, everyone. For the second quarter of 2026, we generated approximately $783 million in total revenue, essentially flat with the first quarter. While these results were below our expectations, they do not change our confidence in the strength of our business, the opportunities in front of us, or our ability to create substantial value over the coming years. I want to start by acknowledging something directly. Over the last several quarters, we understand investors have been looking for a faster acceleration in growth, and we recognize that confidence is earned through execution, not projections. Our focus is on improving results. As we evaluate the current state of the business, we believe the underlying fundamentals are strong, and we believe we are positioned to deliver improved performance in the second half of the year. Michael BenkowitzPresident and COO at United Therapeutics00:09:46Simply put, we exited the second quarter with considerably more momentum than the reported revenue line alone would suggest. Based on the trends we're seeing today, we expect the second half of 2026 to be stronger than the first half of 2026, and we remain focused on accelerating revenue growth as we move through the balance of the year. That said, we are not reaffirming or updating any prior revenue growth expectations for 2026 today. Turning to TYVASO, total revenue for the quarter was $453 million. Nebulized TYVASO remained pressured by competitive dynamics within the inhaled prostacyclin category as patients and providers evaluate an increasing number of treatment options. We expected this market to become more competitive over time, and that's precisely what we are seeing today. TYVASO DPI, meanwhile, continued to demonstrate growth and, more importantly, exited the quarter with what we view as significant underlying momentum. Michael BenkowitzPresident and COO at United Therapeutics00:10:42As we have discussed previously, quarterly sales are not always the best measure of underlying demand. Starts, referrals, total patients, and commercial patients all reached record levels exiting the quarter. Those metrics give us confidence not only in the durability of the franchise, but also in our ability to translate that momentum into stronger commercial performance over the second half of the year. We remain confident in the strength and long-term value of our existing commercial portfolio. Our conviction is grounded in what we believe are highly differentiated therapies that offer meaningful advantages in efficacy, convenience, dosing, and long-term tolerability. We continue to believe these characteristics matter deeply to patients and providers and position us well for sustained growth. Recognition of these benefits, particularly in a highly competitive environment, are taking time to crystallize with physicians. Michael BenkowitzPresident and COO at United Therapeutics00:11:31However, we believe our commercial strategy has us well positioned to accelerate that process. The underlying trends we are seeing reinforce our belief that we are moving in the right direction. As we discussed last quarter, we significantly expanded, that is, roughly doubled our sales force. Those representatives entered the field in early July and are already increasing our recent frequency of engagement with physicians across both PAH and PH-ILD. We recruited an exceptionally strong team with deep relevant experience. We expect their efforts to meaningfully enhance awareness of our therapies, accelerate adoption, and support stronger commercial performance over time. To round out this section, we believe the combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio, and growing physician awareness positions us well to accelerate performance in the second half of the year. Michael BenkowitzPresident and COO at United Therapeutics00:12:25At the same time, it's important to recognize that our story is not solely about the next quarter or the next year. We continue to believe that we have two potentially transformative opportunities in front of us. First, nebulized TYVASO and IPF. Second, ralinepag and PAH. Both represent areas of substantial unmet need. Both have the potential to become multi-billion dollar opportunities. Both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For TYVASO and IPF, we continue to see strong interest from physicians following the TETON results. We remain excited about the potential impact this therapy could have for patients with limited treatment options today. For ralinepag, we believe the opportunity to introduce the first once daily oral prostacyclin could represent a meaningful advancement for patients and providers seeking a differentiated treatment option. Michael BenkowitzPresident and COO at United Therapeutics00:13:21We have previously projected a $4 billion revenue run rate by the end of 2027 with our existing commercial portfolio. We still see a path to achieve this, although it has certainly narrowed. Factoring in some of the revenue from our anticipated IPF and ralinepag launches next year should get us there and beyond. Our strategy is straightforward. We are focused on executing and growing the business we have today while simultaneously preparing the organization for what we believe could be two important future launches. We do not view these future opportunities as replacing our current growth story. Rather, we view our current commercial portfolio as providing a strong, durable, and growing foundation, while TYVASO and IPF and ralinepag offer meaningful upside beyond that foundation. Michael BenkowitzPresident and COO at United Therapeutics00:14:05That combination gives us confidence not only in the long-term potential of United Therapeutics, but also in our ability to accelerate growth in the near term and create value across multiple time horizons. Before I close, I want to share with our investors something that is an important part of our culture and how we work. Across the company, we have a rallying cry called LTFI, which stands for Lock The F In. While there are certainly exciting opportunities on the horizon in 2027 and beyond, LTFI is a reminder that our responsibility is not to focus on future possibilities at the expense of present execution. We have patients, providers, shareholders, and fellow Unitherians counting on us today. LTFI is our commitment to all of those stakeholders. Michael BenkowitzPresident and COO at United Therapeutics00:14:49It's a reminder that while we are excited about what may come next, our focus remains on what we must deliver now, and we believe the trends we are seeing today position us to do exactly that. We are focused, we are accountable, we are committed to accelerating performance in the second half of the year, and we will continue to be LTFI as we deliver for patients, providers, our colleagues, and our shareholders. With that, I'll pass the call back to Harry to start our Q&A session. Harry? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:15:15Great. Thank you, Michael, and thank you, Martine, for the excellent overviews this morning. Before I give this over to JL to start the Q&A session, I would just like to remind those on the call asking questions, please try to limit yourself to one question with respect to the long queue that we have. JL, you can go ahead. Operator00:15:37Thank you. Again, if you have a question, please press star one on your telephone keypad to raise your hand and join the queue. If you wish to remove yourself from the queue, simply press star one again. One moment please for your first question. Your first question comes from line of Joseph Thome of TD Cowen. Your line is open. Joseph ThomeAnalyst at TD Cowen00:15:59Hi there. Good morning. Thank you for taking my question. Just as we're thinking about some of the other offerings, either ralinepag in PAH or the SMI in PAH and PH-ILD, how much do you think you're going to be able to kind of recapture maybe some of the momentum that you did lose by increased competition in the space? Just kind of your thoughts around that. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:16:24Thanks, Joe. I am going to pass it to Michael to answer that question. Michael BenkowitzPresident and COO at United Therapeutics00:16:28I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multi-billion dollar opportunity. We talked about the notion that this is a super prostacyclin. We think that the data that we saw in the ADVANCE OUTCOMES studies certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive. The combination of it not just it being a once-daily oral prostacyclin, which we think is differentiated in and of itself, but more importantly, actually, the clinical benefit that we saw in the trial, I think is really going to position us well for an exciting launch and, like we said, a multi-billion dollar opportunity. Michael BenkowitzPresident and COO at United Therapeutics00:17:15Similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications. I think we believe that it's going to be very well-received by both the physicians and the patients. We think there could be potentially some tolerability benefits. We look at that as really being, again, another way to differentiate ourselves relative to competition. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:17:47Next question, operator. Operator00:17:49Thank you. Your next question comes from the line of Roger Song of Jefferies. Your line is open. Roger SongAnalyst at Jefferies00:17:57Great. Thanks for taking the question. Along the line, in terms of those new product launch, appreciating the 2027 guidance reaffirmation, how should we think about the launch ramp up for those new products, including the nebulized IPF, TYVASO IPF, ralinepag and Tresmi? Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:18:22Thanks, Roger. Michael will answer that question for you. Michael BenkowitzPresident and COO at United Therapeutics00:18:24Sure. Roger, thanks for the question. I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027. I think we're working through that now. As we said, I think we certainly look at both as being multi-billion dollar opportunities. I don't think that's really in question. How quickly we get there, I think we're working through that. Obviously a lot of that's going to depend on when we're able to launch. Do we get priority review or not? I think as we get a little bit more information on the status of our regulatory filings and the timing of when we could see an approval, and just continue doing our work on the commercial side to prepare our launch trajectory. Michael BenkowitzPresident and COO at United Therapeutics00:19:11We'll have more information to share later this year, as I said. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:19:17Operator, next question. Operator00:19:19Your next question comes from the line of Jessica Fye of JPMorgan. Your line is open. Jessica FyeAnalyst at JPMorgan00:19:25Hey, guys. Good morning. Thanks for taking my question. This one's for Michael. Appreciate the comments on how you see the business set up for a stronger back half than first half. Just in the interest of getting consensus numbers in the right place for this period prior to the IPF launch. I think back half TYVASO consensus is for about $1.047 billion of revenue. Is that achievable based on the larger sales force and the other dynamics you mentioned, or should the Street be thinking about that number a little bit differently? Just want to make sure expectations are in the right place for the next couple quarters. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:20:02Thanks for the question, Jess. Good to hear from you this morning. We got Michael to answer that. Michael BenkowitzPresident and COO at United Therapeutics00:20:09Jess, as we said, we're not really reaffirming or updating anything at this point. As I said in my opening remarks, we expect the second half to be stronger than the first half. I think we're just going to leave it at that for right now. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:20:27Operator, next question. Operator00:20:29Your next question comes from the line of Roanna Ruiz of Leerink Partners. Your line is open. Analyst at Leerink Partners00:20:36Hey, guys. You have Ryan on for Roanna. Thanks for taking our question. Pivoting over to IPF. Coming out of ATS and your conversations with physicians, can you talk about your expectations for where you think TYVASO is going to be positioned in the IPF treatment landscape, in between nebulizer, DPI, and SMI? What do you think is really the main driver of future prescribing for this franchise? Thanks. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:21:00Hey, Ryan. Good morning. Thanks for the question. We got Michael again for you. Michael BenkowitzPresident and COO at United Therapeutics00:21:06Just to make sure everybody's clear, when we launch into IPF next year, we're just not launching with the nebulized TYVASO. We still have some engagement to do with the FDA to understand exactly what we're going to need to do to get approval in that indication for both DPI and SMI. The launch next year will solely be nebulized in IPF. I think the feedback we're getting is, as I said in my remarks, a lot of excitement around IPF, around the data, around the treatment option. I think as we've talked to some of the top KOLs, they said whether they use it first line or whether they add it on, it's really going to be patient-dependent. Michael BenkowitzPresident and COO at United Therapeutics00:21:52I think they all said ultimately it probably doesn't really even matter because I think what they're saying is IPF is moving towards what we're seeing in PAH in terms of a polytherapy approach to treating these patients. I think the vast majority of the docs we're talking about have said they're going to use TYVASO in combination with other products. Whether it's sequenced first or second, it kind of doesn't matter, but they're going to quickly get to polytherapy. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:22:25Great. JL, you can take the next one. Operator00:22:28Thank you. Your next question comes from the line of Ben Burnett of Wells Fargo. Your line is open. Ben BurnettAnalyst at Wells Fargo00:22:33Hey, thanks very much. I just wanted to follow up just on IPF and just what's your expectation for the type of data that you would need to generate to get the DPI and the SMI into IPF? Would this just be bridging data, or would you anticipate needing to generate any more efficacy data? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:22:54Hey, Ben. Thanks. I think for part of the question with the SMI, perhaps Pat can address that and maybe Leigh, if you want to add any commentary on bridging to the Tyvaso DPI. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:23:11Yeah. You want me to start, Harry? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:23:13Yeah. Pat PoissonEVP of Strategic Development at United Therapeutics00:23:14Yeah, we're engaged with FDA to have those discussions to understand what they need to see for TYVASO DPI. It's yet to be determined. I'll pass it over to Leigh to maybe add some color to the clinical approach. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:23:35Yeah. As Pat said, we're engaging with FDA. We have some good ideas for bridging, with regard to our current population that's enrolled, as far as potentially new starts. We have a proposed strategy that we'll be presenting to them, we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging. That goes for both SMI and DPI. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:24:10Great. Thank you both. JL, next question. Operator00:24:14Your next question comes from the line of Ash Verma of UBS. Your line is open. Ash VermaAnalyst at UBS00:24:20Hi. Yeah, thanks for taking our question. Can you talk about the sales force expansion heading into the IPF and ralinepag potential approval? How much of the sales force is already deployed? I'm assuming the physician calling point is a little bit different. How much does that help with the current TYVASO indications? Thanks. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:24:42Thanks for the question, Ash. Good to hear from you this morning. Michael can take that one for you. Michael BenkowitzPresident and COO at United Therapeutics00:24:47Sure. Ash. We've talked about in the past, and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. We've done that. We accelerated that process, made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1st, which we've essentially done. I mean, just looking at maybe one or two openings that we have to fill. Essentially, we've expanded the sales force. Now, of course, ralinepag and IPF are not approved indications, so they're not out detailing those two products or indications. We're using them, I think, to really get a little bit more leverage and a little bit greater reach and frequency to providers in our approved indications of PAH and PH-ILD. Michael BenkowitzPresident and COO at United Therapeutics00:25:47Like I said, we got them out in early July, and so they're out and starting to call on those physicians. I think your point on the call point is, it's a little bit different in the sense that with IPF, those patients are much more in the community than the academic centers, and that was really the rationale behind expanding the sales force in IPF, is because we knew we were going to have to go deeper into the community than we previously have had to because that's where those patients reside. It's not necessarily a different position, it's just a question of getting deeper into the community than we currently have. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:26:28That's a great overview. Thank you. Operator, next question. Operator00:26:32Thank you. Your next question comes from the line of Olivia Saunders of Cantor. Your line is open. Olivia Brayer SaundersAnalyst at Cantor00:26:37Hey, good morning, guys. Thank you for the question. Are you able to put some numbers around how big of a revenue opportunity you see IPF being, maybe overall franchise at peak? Just given how impressive JASCAYD's uptake has been so far, how does that impact the way that you guys are thinking about your own launch, just given some of the differences between JASCAYD and TYVASO? I also did want to see if there's anything you can say around baseline characteristics of the PPF patients enrolled so far, just given that you're hitting that 95%+ and whether you guys plan to publish those details after enrollment wraps. Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:27:18Thanks, Olivia, for your questions. I think Michael will address the commercial expectation side of it, maybe Leigh can answer the part on PPF patient characteristics. Michael BenkowitzPresident and COO at United Therapeutics00:27:31Yeah. I think Olivia, on your first question around terms of the opportunity, as I said, I think to an earlier question, I think we'll start to provide more information on all of that peak potential and ramp and trajectory and all of that as we get deeper into the second half of the year. Yeah, JASCAYD has had, I think, a very strong launch. There's no question. We're certainly looking at that. We're looking at what OFEV and Esbriet did, all of those things factor into how we're thinking about the TYVASO trajectory. Like I said, we'll have a lot more details to share on that as we get to later part of this year, early 2027. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:28:17Leigh, do you want to take that PPF question? Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:28:20Yeah. As we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up very shortly. Yeah. We will present the baseline characteristics of that patient population in upcoming conferences. Basically, that's your answer. Yeah. You will be seeing those. We look forward to sharing. Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:28:51Perfect. Thank you both. Operator, next one. Operator00:28:56Your next question comes from the line of Lisa Walter of RBC Capital Markets. Your line is open. Lisa WalterAnalyst at RBC Capital Markets00:29:03Oh, good morning. Thanks for taking our question. Just a quick one on the IPF sNDA filing. Wonder if you could share the date when it was filed and when we could hear about acceptance of the filing, and whether you think there is potential for a priority review. Any color here would be helpful. Thanks so much. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:29:23Thanks, Lisa. Always happy to take your questions. I think Leigh can answer that one. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:29:30Yeah. We submitted late June, we will be learning shortly if we're able to receive priority review. Probably, well, I can't really give a specific date on that. Again, that would be a six-month review period if that is received, and 10 months otherwise. That's basically what I can say right now. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:30:07I think that was perfect, Leigh. Operator, you can go ahead and wrap up the call. Operator00:30:15Thank you. Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for a replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com. That is ir.unither.com. You may now disconnect.Read moreParticipantsExecutivesHarrison SilversSenior Investor Relations ManagerMartine RothblattChairperson and CEOLeigh PetersonEVP of Product Development and XenotransplantationPat PoissonEVP of Strategic DevelopmentAnalystsMichael BenkowitzPresident and COO at United TherapeuticsJoseph ThomeAnalyst at TD CowenRoger SongAnalyst at JefferiesJessica FyeAnalyst at JPMorganAnalyst at Leerink PartnersBen BurnettAnalyst at Wells FargoAsh VermaAnalyst at UBSOlivia Brayer SaundersAnalyst at CantorLisa WalterAnalyst at RBC Capital MarketsPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) United Therapeutics Earnings HeadlinesUnited Therapeutics’s Q2 earnings call: Our top 5 analyst questionsAugust 12 at 1:46 PM | msn.comUnited Therapeutics (UTHR) Q2 2026 Earnings Call TranscriptAugust 12 at 1:46 PM | fool.comIran War Shock: What I Was Told In That Private MeetingYou’re Being LIED To About The Iran War Forget EVERYTHING you’ve heard about the Iran war. Especially the reasons why we’re bombing the country.August 14 at 1:00 AM | Banyan Hill Publishing (Ad)Liquidia, An IBD 50 Stock, Tops Sales Views Amid United Therapeutics RivalryAugust 12 at 10:31 AM | investors.comUnited Therapeutics (NASDAQ:UTHR) EVP Sells $4,291,515.00 in StockAugust 9, 2026 | americanbankingnews.comInsider Selling: United Therapeutics (NASDAQ:UTHR) CEO Sells $4,928,030.00 in StockAugust 9, 2026 | americanbankingnews.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) (NASDAQ: UTHR) is a biotechnology company dedicated to the development and commercialization of unique products to address life-threatening illnesses. The company’s primary focus has been on pulmonary arterial hypertension (PAH), where it has launched several therapies designed to improve functional capacity and quality of life for patients. Its marketed products include continuous infusion treprostinil (Remodulin), inhaled treprostinil (Tyvaso), oral treprostinil (Orenitram) and tadalafil (Adcirca), each tailored to different modes of administration and patient needs. In addition to its PAH portfolio, United Therapeutics markets dinutuximab (Unituxin) for high-risk neuroblastoma and continues to expand its therapeutic reach through ongoing clinical programs. Founded in 1996 and headquartered in Silver Spring, Maryland, United Therapeutics has combined its core expertise in vascular biology with innovative manufacturing technologies. Beyond pharmaceuticals, the company’s Lung Biotechnology PBC subsidiary explores regenerative medicine approaches, including decellularized and recellularized organ scaffolds and xenotransplantation methods aimed at addressing organ shortages. Its research pipeline encompasses next-generation agents for PAH, oncology, and transplant applications, reflecting a broad commitment to extending and improving life for patients with complex diseases. United Therapeutics operates globally, with commercial and clinical efforts spanning North America, Europe, and Asia. Its international infrastructure supports regulatory submissions and patient access programs in key markets such as the European Union and Japan. Under the leadership of founder and Chief Executive Officer Martine Rothblatt, the company emphasizes a multidisciplinary culture that integrates basic science, engineering and patient advocacy. This approach drives its mission to pioneer transformational therapies and sustainable organ manufacturing technologies for conditions with high unmet medical need.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 Latest Articles Nebius Just Exploded 34% on Blowout Earnings—Is It Time to Buy?SpaceX’s First Earnings Report Only Made Wall Street More DividedFranco-Nevada Earnings: Gold Is Rallying, But Does the Stock Even Care?Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not DemandLumentum Just Delivered the AI Growth Investors WantedCoreWeave's $129 Billion AI Backlog Changes the Bull CaseGE Vernova’s AI Power Boom Faces a Profit Test Upcoming Earnings BHP Group (8/17/2026)Palo Alto Networks (8/17/2026)Home Depot (8/18/2026)Medtronic (8/18/2026)Keysight Technologies (8/18/2026)Lowe's Companies (8/19/2026)TJX Companies (8/19/2026)Target (8/19/2026)Analog Devices (8/19/2026)NetEase (8/20/2026) Unlock superior investment research and tools. 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PresentationSkip to Participants Operator00:00:00Good morning. Welcome to the United Therapeutics Corporation Second Quarter 2026 Corporate Update. My name is JL, and I'll be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again. Please note that this call is being recorded. I'll now turn the webcast over to Harrison Silvers, investor relations at United Therapeutics. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:00:35Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation Second Quarter 2026 Corporate Update webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:01:29Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Strategic Development. Note that Martine Rothblatt, James Edgemond, and I will participate in a fireside chat and one-on-one meetings at the Wells Fargo Healthcare Conference, September 8th in Boston, the Cantor Fitzgerald Global Healthcare Conference in New York on September 9th. Pat Poisson will join us for the Morgan Stanley Global Healthcare Conference in New York on September 14th. Lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23rd. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:02:16Our scientific, commercial, and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona, September 5th through the 9th, and the American College of Chest Physicians CHEST 2026 annual meeting in Phoenix, October 18 through 21. I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine. Martine RothblattChairperson and CEO at United Therapeutics00:02:41We have slides available for reference. I encourage you to review those at your leisure. I'm not going to speak directly to the slides. The first half of 2026 has been one of the most consequential periods in United Therapeutics' history. First, we delivered exceptional clinical results from our ADVANCE OUTCOMES study, demonstrating ralinepag's potential to become a major new oral therapy for patients with PAH. We unblinded TETON-1, which surpassed the impressive TETON-2 results we reported last September. These results put us in an extraordinary position. A new molecule advancing toward the PAH market and a potential new indication for nebulized TYVASO in IPF, representing an opportunity meaningfully larger than our currently approved markets and a new option for patients. Martine RothblattChairperson and CEO at United Therapeutics00:03:44With these highly statistically significant clinical results, we recently submitted to the FDA what we believe are two of the most important new drug applications in rare pulmonary disease, the sNDA for nebulized TYVASO in IPF and the NDA for ralinepag in PAH. We are not stopping there. With additional filings planned later this year, including an IND for ralinepag DPI and an NDA for treprostinil SMI. We are moving with urgency toward what we believe will be a pivotal change in our growth trajectory as we plan to bring pioneering advanced inhalation technologies to patients. We expect potential approvals in 2027 for nebulized TYVASO in IPF, ralinepag in PAH, and the SMI device in PAH and PH-ILD. These are not incremental opportunities. Martine RothblattChairperson and CEO at United Therapeutics00:04:44We believe they are multibillion-dollar catalysts with the potential to redefine patient treatment paradigms, improve outcomes for patients, and fundamentally transform our growth profile and competitive position. Looking further ahead, enrollment in our TETON PPF trial is nearly complete, paving the way for another substantial phase III readout in the back half of 2027. Based on the successful TETON-1 and TETON-2 studies, as well as the similarities in underlying fibrosis and disease progression between IPF and PPF, we have a high degree of confidence in our ability to report another positive outcome. If successful, TETON PPF would open the door to an even larger opportunity, at least double that of IPF, and position nebulized TYVASO to become a leading therapy for patients with pulmonary fibrosis. Turning to our organ pipeline, we continue to make strong progress toward our goal of expanding the availability of transplantable organs. Martine RothblattChairperson and CEO at United Therapeutics00:05:53The UKidney EXPAND study continues to make great progress, with completion of the initial six-patient cohort expected later this year. In parallel, we soon anticipate initiating the UThymoKidney EXTEND registration enabling study. Lastly, with recent clearance from the FDA, we are working to commence our EXPRESS-UHeart study. Moreover, by the end of this year, we will complete construction of our two additional commercial-scale DPFs in Minnesota and Texas. With three authorized clinical trials, United Therapeutics is not just participating in the future of xenotransplantation, we are leading it. We believe this work can redefine organ transplantation, save countless lives, and create one of the most significant growth opportunities in our company's history. Our deep organ pipeline represents a bold and differentiated extension of United Therapeutics' mission, with the potential to transform how patients access life-saving organs and how United Therapeutics will create substantial value over the long term. Martine RothblattChairperson and CEO at United Therapeutics00:07:09We will be sharing with you more details about these programs as each moves through their development timelines. Our ability to pursue these opportunities is supported by a disciplined approach to capital allocation through our budget algorithm, which has positioned us near the top of our industry in operating efficiency. We have also been thoughtful in deploying capital toward internal growth objectives while remaining mindful of returning capital to shareholders. As an example, we recently deployed capital to acquire Thymmune Therapeutics, adding a promising thymus-based regenerative medicine platform that fits squarely within our mission. This acquisition broadens our organ alternative strategy and strengthens our ability to pursue therapies that could restore immune function for patients with serious diseases. We see tremendous potential ahead, and we're excited to welcome the Thymmune team to United Therapeutics. Martine RothblattChairperson and CEO at United Therapeutics00:08:15To close, we believe United Therapeutics is entering a defining era, one shaped by scientific ambition, innovative platforms, and a pipeline with the potential to transform care across some of the most challenging areas of medicine. As these opportunities advance, we see a future in which our impact on patients, our industry, and our growth trajectory can reach an entirely new level, making United Therapeutics a growth story unlike any other in biotech. With that, I'll turn the call over to our President, Michael Benkowitz, who will provide an overview of our commercial performance for the quarter. Mike? Michael BenkowitzPresident and COO at United Therapeutics00:09:01Thank you, Martine. Good morning, everyone. For the second quarter of 2026, we generated approximately $783 million in total revenue, essentially flat with the first quarter. While these results were below our expectations, they do not change our confidence in the strength of our business, the opportunities in front of us, or our ability to create substantial value over the coming years. I want to start by acknowledging something directly. Over the last several quarters, we understand investors have been looking for a faster acceleration in growth, and we recognize that confidence is earned through execution, not projections. Our focus is on improving results. As we evaluate the current state of the business, we believe the underlying fundamentals are strong, and we believe we are positioned to deliver improved performance in the second half of the year. Michael BenkowitzPresident and COO at United Therapeutics00:09:46Simply put, we exited the second quarter with considerably more momentum than the reported revenue line alone would suggest. Based on the trends we're seeing today, we expect the second half of 2026 to be stronger than the first half of 2026, and we remain focused on accelerating revenue growth as we move through the balance of the year. That said, we are not reaffirming or updating any prior revenue growth expectations for 2026 today. Turning to TYVASO, total revenue for the quarter was $453 million. Nebulized TYVASO remained pressured by competitive dynamics within the inhaled prostacyclin category as patients and providers evaluate an increasing number of treatment options. We expected this market to become more competitive over time, and that's precisely what we are seeing today. TYVASO DPI, meanwhile, continued to demonstrate growth and, more importantly, exited the quarter with what we view as significant underlying momentum. Michael BenkowitzPresident and COO at United Therapeutics00:10:42As we have discussed previously, quarterly sales are not always the best measure of underlying demand. Starts, referrals, total patients, and commercial patients all reached record levels exiting the quarter. Those metrics give us confidence not only in the durability of the franchise, but also in our ability to translate that momentum into stronger commercial performance over the second half of the year. We remain confident in the strength and long-term value of our existing commercial portfolio. Our conviction is grounded in what we believe are highly differentiated therapies that offer meaningful advantages in efficacy, convenience, dosing, and long-term tolerability. We continue to believe these characteristics matter deeply to patients and providers and position us well for sustained growth. Recognition of these benefits, particularly in a highly competitive environment, are taking time to crystallize with physicians. Michael BenkowitzPresident and COO at United Therapeutics00:11:31However, we believe our commercial strategy has us well positioned to accelerate that process. The underlying trends we are seeing reinforce our belief that we are moving in the right direction. As we discussed last quarter, we significantly expanded, that is, roughly doubled our sales force. Those representatives entered the field in early July and are already increasing our recent frequency of engagement with physicians across both PAH and PH-ILD. We recruited an exceptionally strong team with deep relevant experience. We expect their efforts to meaningfully enhance awareness of our therapies, accelerate adoption, and support stronger commercial performance over time. To round out this section, we believe the combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio, and growing physician awareness positions us well to accelerate performance in the second half of the year. Michael BenkowitzPresident and COO at United Therapeutics00:12:25At the same time, it's important to recognize that our story is not solely about the next quarter or the next year. We continue to believe that we have two potentially transformative opportunities in front of us. First, nebulized TYVASO and IPF. Second, ralinepag and PAH. Both represent areas of substantial unmet need. Both have the potential to become multi-billion dollar opportunities. Both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For TYVASO and IPF, we continue to see strong interest from physicians following the TETON results. We remain excited about the potential impact this therapy could have for patients with limited treatment options today. For ralinepag, we believe the opportunity to introduce the first once daily oral prostacyclin could represent a meaningful advancement for patients and providers seeking a differentiated treatment option. Michael BenkowitzPresident and COO at United Therapeutics00:13:21We have previously projected a $4 billion revenue run rate by the end of 2027 with our existing commercial portfolio. We still see a path to achieve this, although it has certainly narrowed. Factoring in some of the revenue from our anticipated IPF and ralinepag launches next year should get us there and beyond. Our strategy is straightforward. We are focused on executing and growing the business we have today while simultaneously preparing the organization for what we believe could be two important future launches. We do not view these future opportunities as replacing our current growth story. Rather, we view our current commercial portfolio as providing a strong, durable, and growing foundation, while TYVASO and IPF and ralinepag offer meaningful upside beyond that foundation. Michael BenkowitzPresident and COO at United Therapeutics00:14:05That combination gives us confidence not only in the long-term potential of United Therapeutics, but also in our ability to accelerate growth in the near term and create value across multiple time horizons. Before I close, I want to share with our investors something that is an important part of our culture and how we work. Across the company, we have a rallying cry called LTFI, which stands for Lock The F In. While there are certainly exciting opportunities on the horizon in 2027 and beyond, LTFI is a reminder that our responsibility is not to focus on future possibilities at the expense of present execution. We have patients, providers, shareholders, and fellow Unitherians counting on us today. LTFI is our commitment to all of those stakeholders. Michael BenkowitzPresident and COO at United Therapeutics00:14:49It's a reminder that while we are excited about what may come next, our focus remains on what we must deliver now, and we believe the trends we are seeing today position us to do exactly that. We are focused, we are accountable, we are committed to accelerating performance in the second half of the year, and we will continue to be LTFI as we deliver for patients, providers, our colleagues, and our shareholders. With that, I'll pass the call back to Harry to start our Q&A session. Harry? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:15:15Great. Thank you, Michael, and thank you, Martine, for the excellent overviews this morning. Before I give this over to JL to start the Q&A session, I would just like to remind those on the call asking questions, please try to limit yourself to one question with respect to the long queue that we have. JL, you can go ahead. Operator00:15:37Thank you. Again, if you have a question, please press star one on your telephone keypad to raise your hand and join the queue. If you wish to remove yourself from the queue, simply press star one again. One moment please for your first question. Your first question comes from line of Joseph Thome of TD Cowen. Your line is open. Joseph ThomeAnalyst at TD Cowen00:15:59Hi there. Good morning. Thank you for taking my question. Just as we're thinking about some of the other offerings, either ralinepag in PAH or the SMI in PAH and PH-ILD, how much do you think you're going to be able to kind of recapture maybe some of the momentum that you did lose by increased competition in the space? Just kind of your thoughts around that. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:16:24Thanks, Joe. I am going to pass it to Michael to answer that question. Michael BenkowitzPresident and COO at United Therapeutics00:16:28I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multi-billion dollar opportunity. We talked about the notion that this is a super prostacyclin. We think that the data that we saw in the ADVANCE OUTCOMES studies certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive. The combination of it not just it being a once-daily oral prostacyclin, which we think is differentiated in and of itself, but more importantly, actually, the clinical benefit that we saw in the trial, I think is really going to position us well for an exciting launch and, like we said, a multi-billion dollar opportunity. Michael BenkowitzPresident and COO at United Therapeutics00:17:15Similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications. I think we believe that it's going to be very well-received by both the physicians and the patients. We think there could be potentially some tolerability benefits. We look at that as really being, again, another way to differentiate ourselves relative to competition. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:17:47Next question, operator. Operator00:17:49Thank you. Your next question comes from the line of Roger Song of Jefferies. Your line is open. Roger SongAnalyst at Jefferies00:17:57Great. Thanks for taking the question. Along the line, in terms of those new product launch, appreciating the 2027 guidance reaffirmation, how should we think about the launch ramp up for those new products, including the nebulized IPF, TYVASO IPF, ralinepag and Tresmi? Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:18:22Thanks, Roger. Michael will answer that question for you. Michael BenkowitzPresident and COO at United Therapeutics00:18:24Sure. Roger, thanks for the question. I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027. I think we're working through that now. As we said, I think we certainly look at both as being multi-billion dollar opportunities. I don't think that's really in question. How quickly we get there, I think we're working through that. Obviously a lot of that's going to depend on when we're able to launch. Do we get priority review or not? I think as we get a little bit more information on the status of our regulatory filings and the timing of when we could see an approval, and just continue doing our work on the commercial side to prepare our launch trajectory. Michael BenkowitzPresident and COO at United Therapeutics00:19:11We'll have more information to share later this year, as I said. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:19:17Operator, next question. Operator00:19:19Your next question comes from the line of Jessica Fye of JPMorgan. Your line is open. Jessica FyeAnalyst at JPMorgan00:19:25Hey, guys. Good morning. Thanks for taking my question. This one's for Michael. Appreciate the comments on how you see the business set up for a stronger back half than first half. Just in the interest of getting consensus numbers in the right place for this period prior to the IPF launch. I think back half TYVASO consensus is for about $1.047 billion of revenue. Is that achievable based on the larger sales force and the other dynamics you mentioned, or should the Street be thinking about that number a little bit differently? Just want to make sure expectations are in the right place for the next couple quarters. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:20:02Thanks for the question, Jess. Good to hear from you this morning. We got Michael to answer that. Michael BenkowitzPresident and COO at United Therapeutics00:20:09Jess, as we said, we're not really reaffirming or updating anything at this point. As I said in my opening remarks, we expect the second half to be stronger than the first half. I think we're just going to leave it at that for right now. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:20:27Operator, next question. Operator00:20:29Your next question comes from the line of Roanna Ruiz of Leerink Partners. Your line is open. Analyst at Leerink Partners00:20:36Hey, guys. You have Ryan on for Roanna. Thanks for taking our question. Pivoting over to IPF. Coming out of ATS and your conversations with physicians, can you talk about your expectations for where you think TYVASO is going to be positioned in the IPF treatment landscape, in between nebulizer, DPI, and SMI? What do you think is really the main driver of future prescribing for this franchise? Thanks. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:21:00Hey, Ryan. Good morning. Thanks for the question. We got Michael again for you. Michael BenkowitzPresident and COO at United Therapeutics00:21:06Just to make sure everybody's clear, when we launch into IPF next year, we're just not launching with the nebulized TYVASO. We still have some engagement to do with the FDA to understand exactly what we're going to need to do to get approval in that indication for both DPI and SMI. The launch next year will solely be nebulized in IPF. I think the feedback we're getting is, as I said in my remarks, a lot of excitement around IPF, around the data, around the treatment option. I think as we've talked to some of the top KOLs, they said whether they use it first line or whether they add it on, it's really going to be patient-dependent. Michael BenkowitzPresident and COO at United Therapeutics00:21:52I think they all said ultimately it probably doesn't really even matter because I think what they're saying is IPF is moving towards what we're seeing in PAH in terms of a polytherapy approach to treating these patients. I think the vast majority of the docs we're talking about have said they're going to use TYVASO in combination with other products. Whether it's sequenced first or second, it kind of doesn't matter, but they're going to quickly get to polytherapy. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:22:25Great. JL, you can take the next one. Operator00:22:28Thank you. Your next question comes from the line of Ben Burnett of Wells Fargo. Your line is open. Ben BurnettAnalyst at Wells Fargo00:22:33Hey, thanks very much. I just wanted to follow up just on IPF and just what's your expectation for the type of data that you would need to generate to get the DPI and the SMI into IPF? Would this just be bridging data, or would you anticipate needing to generate any more efficacy data? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:22:54Hey, Ben. Thanks. I think for part of the question with the SMI, perhaps Pat can address that and maybe Leigh, if you want to add any commentary on bridging to the Tyvaso DPI. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:23:11Yeah. You want me to start, Harry? Harrison SilversSenior Investor Relations Manager at United Therapeutics00:23:13Yeah. Pat PoissonEVP of Strategic Development at United Therapeutics00:23:14Yeah, we're engaged with FDA to have those discussions to understand what they need to see for TYVASO DPI. It's yet to be determined. I'll pass it over to Leigh to maybe add some color to the clinical approach. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:23:35Yeah. As Pat said, we're engaging with FDA. We have some good ideas for bridging, with regard to our current population that's enrolled, as far as potentially new starts. We have a proposed strategy that we'll be presenting to them, we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging. That goes for both SMI and DPI. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:24:10Great. Thank you both. JL, next question. Operator00:24:14Your next question comes from the line of Ash Verma of UBS. Your line is open. Ash VermaAnalyst at UBS00:24:20Hi. Yeah, thanks for taking our question. Can you talk about the sales force expansion heading into the IPF and ralinepag potential approval? How much of the sales force is already deployed? I'm assuming the physician calling point is a little bit different. How much does that help with the current TYVASO indications? Thanks. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:24:42Thanks for the question, Ash. Good to hear from you this morning. Michael can take that one for you. Michael BenkowitzPresident and COO at United Therapeutics00:24:47Sure. Ash. We've talked about in the past, and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. We've done that. We accelerated that process, made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1st, which we've essentially done. I mean, just looking at maybe one or two openings that we have to fill. Essentially, we've expanded the sales force. Now, of course, ralinepag and IPF are not approved indications, so they're not out detailing those two products or indications. We're using them, I think, to really get a little bit more leverage and a little bit greater reach and frequency to providers in our approved indications of PAH and PH-ILD. Michael BenkowitzPresident and COO at United Therapeutics00:25:47Like I said, we got them out in early July, and so they're out and starting to call on those physicians. I think your point on the call point is, it's a little bit different in the sense that with IPF, those patients are much more in the community than the academic centers, and that was really the rationale behind expanding the sales force in IPF, is because we knew we were going to have to go deeper into the community than we previously have had to because that's where those patients reside. It's not necessarily a different position, it's just a question of getting deeper into the community than we currently have. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:26:28That's a great overview. Thank you. Operator, next question. Operator00:26:32Thank you. Your next question comes from the line of Olivia Saunders of Cantor. Your line is open. Olivia Brayer SaundersAnalyst at Cantor00:26:37Hey, good morning, guys. Thank you for the question. Are you able to put some numbers around how big of a revenue opportunity you see IPF being, maybe overall franchise at peak? Just given how impressive JASCAYD's uptake has been so far, how does that impact the way that you guys are thinking about your own launch, just given some of the differences between JASCAYD and TYVASO? I also did want to see if there's anything you can say around baseline characteristics of the PPF patients enrolled so far, just given that you're hitting that 95%+ and whether you guys plan to publish those details after enrollment wraps. Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:27:18Thanks, Olivia, for your questions. I think Michael will address the commercial expectation side of it, maybe Leigh can answer the part on PPF patient characteristics. Michael BenkowitzPresident and COO at United Therapeutics00:27:31Yeah. I think Olivia, on your first question around terms of the opportunity, as I said, I think to an earlier question, I think we'll start to provide more information on all of that peak potential and ramp and trajectory and all of that as we get deeper into the second half of the year. Yeah, JASCAYD has had, I think, a very strong launch. There's no question. We're certainly looking at that. We're looking at what OFEV and Esbriet did, all of those things factor into how we're thinking about the TYVASO trajectory. Like I said, we'll have a lot more details to share on that as we get to later part of this year, early 2027. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:28:17Leigh, do you want to take that PPF question? Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:28:20Yeah. As we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up very shortly. Yeah. We will present the baseline characteristics of that patient population in upcoming conferences. Basically, that's your answer. Yeah. You will be seeing those. We look forward to sharing. Thank you. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:28:51Perfect. Thank you both. Operator, next one. Operator00:28:56Your next question comes from the line of Lisa Walter of RBC Capital Markets. Your line is open. Lisa WalterAnalyst at RBC Capital Markets00:29:03Oh, good morning. Thanks for taking our question. Just a quick one on the IPF sNDA filing. Wonder if you could share the date when it was filed and when we could hear about acceptance of the filing, and whether you think there is potential for a priority review. Any color here would be helpful. Thanks so much. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:29:23Thanks, Lisa. Always happy to take your questions. I think Leigh can answer that one. Leigh PetersonEVP of Product Development and Xenotransplantation at United Therapeutics00:29:30Yeah. We submitted late June, we will be learning shortly if we're able to receive priority review. Probably, well, I can't really give a specific date on that. Again, that would be a six-month review period if that is received, and 10 months otherwise. That's basically what I can say right now. Harrison SilversSenior Investor Relations Manager at United Therapeutics00:30:07I think that was perfect, Leigh. Operator, you can go ahead and wrap up the call. Operator00:30:15Thank you. Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for a replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com. That is ir.unither.com. You may now disconnect.Read moreParticipantsExecutivesHarrison SilversSenior Investor Relations ManagerMartine RothblattChairperson and CEOLeigh PetersonEVP of Product Development and XenotransplantationPat PoissonEVP of Strategic DevelopmentAnalystsMichael BenkowitzPresident and COO at United TherapeuticsJoseph ThomeAnalyst at TD CowenRoger SongAnalyst at JefferiesJessica FyeAnalyst at JPMorganAnalyst at Leerink PartnersBen BurnettAnalyst at Wells FargoAsh VermaAnalyst at UBSOlivia Brayer SaundersAnalyst at CantorLisa WalterAnalyst at RBC Capital MarketsPowered by