Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2026 Corporate Update. My name is Krista, and I will be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question-and-answer portion of this earnings call. If you would like to ask a question during that time, simply press 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 will now turn the webcast over to Harry Silvers, Investor Relations at United Therapeutics.
Thank you, Krista. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation Third 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.
Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James 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 James Edgemond and I will participate in a fireside chat and one-on-one sessions at the UBS Global Biopharma Conference and Jefferies Global Healthcare Conference in London on November 16th and 17th, respectively. Additionally, members from our management team will participate in a fireside chat and one-on-one meetings at the 45th Annual J.P. Morgan Healthcare Conference in San Francisco in January of next year.
Our scientific, commercial, and medical affairs teams will be present at PHenomenal Hope 2026 on December 4th in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Bangkok in late January of next year. I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine.
Thank you, Harry, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. I am not going to speak directly to the slides. As we look back on the third quarter, I am incredibly proud of what our teams have accomplished. We executed at a high level across our business and across our company, delivering for patients while advancing one of the most ambitious growth strategies in biotechnology. The significance of this quarter extends beyond any individual result or milestone. It reflects the broader transformation underway at United Therapeutics as we build a comprehensive cardiopulmonary and respiratory medicine franchise capable of reaching dramatically more patients than ever before. For most of our history, UT has been known as a pulmonary hypertension company. Today, that legacy serves as the foundation for a much bigger UT.
Over the next several years, we expect to introduce wave after wave of innovation across multiple therapeutic and device platforms, from nebulized and dry powder therapies to soft mist inhalers, once-daily medicines, and combination products. We have 14 programs in development. Together, these advances are intended to address some of the largest unmet needs in pulmonary fibrosis and pulmonary hypertension. We are building an integrated portfolio designed around the needs of individual patients. Our strategy is to keep innovating so we can offer more patients the right therapy in the right format at the right time. The scale of that opportunity extends far beyond our historic pulmonary hypertension market. Across IPF, PPF, and PH-COPD alone, we are pursuing patient populations totaling approximately 1 million people in the United States. Supporting this strategy are significant and durable competitive advantages.
Our portfolio features extensive intellectual property protections, including fibrosis-related patents, device protections, and composition of matter protection for ralinepag, many of which extend into the 2040s. Just as important, our market advantages include decades of expertise, extensive engagement with physicians, specialized commercialization capabilities, manufacturing investments, and a proven ability to bring complex drug-device combinations to market. We are building on our strengths through the philosophy that has guided us for years: approve, then improve. We first establish a therapy as quickly as possible because our patients do not have time. Then, we continue to enhance convenience, administration, and treatment experience through new devices, formulations, and next-generation medicines. This disciplined approach creates a pipeline in which every new product builds on the foundation established by the last and provides improvements for the next.
As compelling as our cardiopulmonary and respiratory franchises are, they represent only one pillar of our long-term vision. In parallel, we continue to advance our manufactured organ alternatives programs and build the infrastructure we need to address one of medicine's greatest unmet needs. We believe this platform has the potential to revolutionize transplantation over the next decade, just as our therapies have revolutionized pulmonary hypertension over the past two decades. When I step back, I see a United Therapeutics stronger than at any point in our history, with a growing commercial business, late-stage assets of significant potential, multiple upcoming launches, and a clear strategy for creating value over the long term. In closing, thank you to our fellow Unitherians, patients, physicians, shareholders, and our other stakeholders for helping us fulfill our purpose.
And with that, I will turn the call over to our President, Michael Benkowitz, for an overview of our commercial performance for the quarter. Mike?
Thanks, Martine, and good morning, everybody. For the third quarter of 2026, we delivered record total revenue of $833 million and record Tyvaso revenue of $504 million, highlighted by strong sequential growth and underlying demand. Three months ago, I said confidence is earned through execution, not projections. This quarter's results, our best quarter ever, demonstrate that execution and reinforce our conviction that our business has regained meaningful momentum. A huge shout-out to all of our commercial operations, and medical teams for their hard work, persistence, and performance. Tyvaso's performance was driven by strong underlying demand, as the patient metrics we highlighted last quarter translated into commercial results.
Starts, referrals, patient demand, increased dosing, and physician engagement all continue to support growth and emphasize the value of differentiated products, disciplined execution, a clear understanding of physician and patient needs, and our expertise and support in the field of pulmonary hypertension. Most importantly, we see meaningful room to grow from here. The investments we made earlier this year in resources and sharpening our messaging are working as intended by expanding our reach, deepening physician engagement, increasing disease awareness, and driving greater penetration across PAH and PH-ILD. We have greater conviction in our strategy than ever. Elsewhere, the recent court decision upholding our intellectual property, together with the settlement we reached, provide important clarity and reinforce the long-term durability of our base business.
The terms of our settlement were highly favorable for United Therapeutics, ultimately removing PH-ILD from the YUTREPIA label, preventing its promotion and marketing into that indication, and prohibiting Liquidia from encouraging off-label usage, which we will be monitoring very closely. With no direct branded competition on the horizon, we can remain focused on growing the large, under-penetrated PH-ILD market. Based upon the provisions contemplated in the settlement and damages structure, near-term expectations for transitions from YUTREPIA to Tyvaso should be moderate. The larger opportunity in PH-ILD continues to remain focused on expanding physician awareness, identifying more eligible patients, and growing new prescriptions. That gives Tyvaso a long runway for largely uncontested growth. Stepping back, our story is not about stabilizing our business. It is about building on renewed momentum from our durable commercial foundation, with two of the most important potential launches in our history still ahead.
Once approved, we expect nebulized Tyvaso in IPF and ralinepag in PAH will each address significant unmet need. Both are supported by compelling clinical data, and both have the potential to become multi-billion dollar growth drivers for United Therapeutics. These opportunities do not replace our current growth story, they accelerate it. In closing, our base business is performing, our commercial strategy is working, our competitive position is strong, and we expect to enter 2027 with substantially more momentum than we had entering 2026. To highlight this continued momentum, we received over 1,000 referrals for a UT product in October, the most ever received in a single month. We remain focused, accountable, and committed to continue delivering compelling results. As proud as we are of this quarter, we believe we are just beginning the full scale of what we are determined to achieve.
And with that, I'll pass the call back to Harry to run the Q&A.
Thanks, Michael. Thanks, Martine. Great updates from both of you. Just before I pass the call back to the operator, please, just a reminder to everyone, try to limit yourself to one question. Operator, you can start.
Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, again, press star one. Your first question comes from Joseph Thome with TD Cowen. Please go ahead.
Hi there. Good morning. Congrats on the quarter, and thanks for taking my question. Maybe could you talk a little bit more about the patient switch dynamic, now that PH-ILD will be off the label for YUTREPIA? What are sort of your expectations of current YUTREPIA patients switching over? Maybe for new start markets, you mentioned that you are monitoring their off-label use potential. Can you just kind of go into how you're doing that in the field? Thank you.
Thanks for the question, Joe. Going to pass this one to Michael.
Sure. Yeah. Joe, thanks for the question. On the patient switch, per the terms of the settlement agreement, we sort of contemplated. Well, there was no requirement or expectation that patients would have to switch from YUTREPIA to Tyvaso DPI, and so we kind of contemplated that in the damages structure, as I mentioned. I think, obviously, we're going to continue to talk about the benefits and the differentiation of DPI relative to YUTREPIA, but it's really going to be, I think, a physician and patient decision as to whether or not they want to transition their existing patients over to Tyvaso DPI. But that's not something that's going to be required per the terms of the settlement.
So, like I said, I think what you're going to see is if you've got patients on YUTREPIA that, for whatever reason, are having issues, obviously, Tyvaso remains an option, you can switch. But I think if a patient's doing well on YUTREPIA, there's not really going to be, I think, a push on the part of doctors to switch patients over. So, as I said, the real opportunity here is with new prescriptions and continuing to penetrate the PH-ILD market, which we're starting to see with the benefit of the expanded sales force. In terms of monitoring that, I mean, look, I'm not going to really get into kind of sources and methods of how we're going to do that, but I think we have pretty good visibility into how things are playing out in terms of prescriptions and indications.
And we're just going to kind of keep an eye on that and see how that plays out along with what we're hearing in the market through our interactions with physicians.
Thanks, Michael. Operator, next question.
Your next question comes from the line of Olivia Brayer with Cantor. Please go ahead.
Hi. Good morning, guys. Thank you for the question. Michael, I just quickly wanted to follow up on PH-ILD. Are you guys actually seeing any acceleration in new starts on Tyvaso in the fourth quarter just on the back of that settlement, or do you really expect that to become more meaningful as patients come up for reauthorization in January? Just trying to kind of reconcile your comments around October trends. I'm sorry, Harry, but my real question is, on the soft mist inhaler program, where are you guys in the submission process at this point, and is a filing still on track for the end of the year?
And then as we think about soft mist, looking ahead to PH-COPD, what have you guys actually seen in the SMI product profile that's giving you so much confidence that it could succeed in this patient population, just given some of the challenges that others have experienced, right, with prior approaches? Thank you so much. Sorry to squeeze in two.
It sounded more like three. I will give Michael the first question, and then if you could pass it to Pat on the NDA expectations for SMI, and then perhaps Leigh can close it off with expectations in PH-COPD.
Yeah. Olivia, you never disappoint with your multi-question question. So thanks. So on PH-ILD, if you kind of think about the timeline of everything, as I said, I think, even before the settlement, right, going back to like mid-September, I think we saw this inflection in the referrals coming in, really across both indications, PAH and PH-ILD for Tyvaso, that has persisted through the end of October into November. In terms of working out the litigation decision, the settlement, I mean, all of that stuff really did not really get worked out until, I guess, what was that second, third week of October. So, still a little early to see, I think, another sort of inflection in terms of PH-ILD. I would expect that we are going to start to see that here over the next couple weeks, and into December, and then obviously the first part of the year.
That is kind of where things are right now. I mean, we do expect to see that. I have seen it. I kind of monitor daily referral trends. We had a couple days where we spiked, but I expect us to see kind of a new baseline in terms of referrals here over the next few weeks. Pat, you want to take the other question?
Yep. Thanks for the question, Olivia. We recently met with the FDA to discuss our NDA filing strategy, and that was pre-planned. Following that discussion, we've now determined that additional work is going to be needed to support the application. As a result of that, we now expect to submit the NDA in 2027 and not at the end of this year. We are actively working with our development partner to complete the necessary activities and establish an updated filing timeline. Leigh, I'll pass it on to you.
Yeah. As far as PH-COPD goes, our phase II trial, as you know, we have IND clearance for that study. In terms of the biological rationale for PH-COPD, I mean, the pharmacology of inhaled treprostinil is really well characterized with our commercially approved treatments for PH and PH-ILD. As you know, in these patients with WHO group three, with group three PH, such as ILD and COPD, the inhaled treprostinil, it directly targets more ventilated portions of the lungs. That can minimize the V/Q mismatch that's the concern with more systemic therapies that are also vasodilators.
It's really important to note that not only do we have a more robust design in our study, but we've really looked very carefully at the patient population that was enrolled into the prior study, PH-COPD, PERFECT study, and really worked hard with our steering committees to enrich this current population through the inclusion/exclusion criteria, to improve the chances of success as well as just decrease the risk of this program.
Thanks, Leigh. That was a great overview by all three of you. Operator, next question, please.
Your next question comes from the line of Ash Verma with UBS. Please go ahead.
Hey. Yeah, thanks for taking my question. On ralinepag, wanted to ask about this Official Action Indicated that you have mentioned in the Q about this API manufacturer. Can you talk about what is the contingency plan ahead of the potential regulatory approval for this? Thanks.
Thanks for the question, Ash. Pat, we will kick that over to you.
Yeah. Thanks, Ash. As you saw in the Q, our API supplier has an OAI compliance status as the result of an inspection earlier this year. We are actively working with them to remediate their compliance status so that it does not impact our PDUFA date, that is kind of priority one. We do have some alternative plans that are progressing in parallel. On a positive note, they have recently provided FDA updated information on their corrective actions, and there is open dialogue between the parties. We remain hopeful that this will get resolved fairly quickly, but we do have contingency plans in place.
Great. Thanks, Pat. Operator, next question.
Your next question comes from the line of Roger Song with Jefferies. Please go ahead.
Great. Thanks for taking the question. Maybe related to the triple oral pill, since the bioequivalence study is not sufficient for filing, what is the current plan for development and filing plan for the triple pill? Thank you.
Thanks for your question, Roger. Pat, can I ask you to answer this one again?
Yeah. So, we had a discussion with FDA, and they shared that that was their feedback to us. And so right now, we're looking at what our options are, really, if there's an alternate path that they would accept. That's going to take us a little while. So for right now, we're just treading water while we work on different options that we can present to them.
Thank you for that. Operator, next question.
Your next question comes from the line of Roanna Ruiz with Leerink Partners. Please go ahead.
Hey, everyone. Good morning. A quick question. Could you elaborate on what you saw as the biggest drivers behind the Tyvaso strength in the quarter, and if any could increase into year end? I'm specifically focused on if there was more traction from the upsized field force or any inventory or seasonal dynamics that we should consider in addition to underlying demand growth. Thanks.
Hey, Roanna. Good morning. Thanks for your question. This one will go to Michael.
Sure. Yeah, thanks for the question. So no inventory or seasonal dynamics really, I think, played into the quarter. I think it is really kind of a multifactorial thing. One is just, honestly, just great execution by the sales team. I think, we talked about the last quarter, came out of the quarter with really strong momentum. We have been able to maintain that even through October, as I talked about earlier. I think, as we have talked about on prior calls, I think some of the challenges we faced in the prior quarters are, we would have two really good months and then one soft month, and the two good months were not enough to offset the soft month, so we have been kind of flat for several quarters.
But now we have got, I think, really just consistent performance month to month to month, and so we are stacking good months on top of good months, and so that is really just, I think, plays into really strong execution by our commercial teams. I think the other thing that we have seen is, at the beginning of the year, we introduced an 80 microgram cartridge, so one breath gives you the equivalent of 15 nebulized breaths, and then some higher dose kits. I think there has been this misinformation out there that you cannot get to higher doses on TYVASO DPI. I think we have effectively debunked that. For patients that have started on TYVASO DPI since we introduced those cartridges, we introduced those higher strength kits, like one in three patients have achieved these higher doses, which is twice as what it was beforehand.
So, that is certainly, I think, played into the performance, is that we are getting patients to higher dose, which helps from a revenue standpoint, but also helps from a retention standpoint, because patients are obviously benefiting from the product. I think in terms of the effect of the sales force expansion, I think in terms of reach and frequency, that played a role in some of the consistent performance month to month. But in terms of what we have seen in terms of increase in referrals, increase in starts, I think, as I said, we start to see kind of this inflection point probably mid-September as a result of that. So, I do not think you can draw a straight line through to the revenue line for Q3. I think we will start to see the benefit of that here in Q4 and then heading into next year.
But it's clear that the expansion is working, and we're seeing the benefit of that. But probably limited revenue impact of that in Q3, but we certainly expect to see that, like I said, this quarter and heading into next year.
Great color. Thank you, Michael. Operator, next question.
Your next question comes from the line of Jessica Fye with J.P. Morgan. Please go ahead.
Hey, guys. Good morning. Thanks for taking the question. Congrats on the quarter. Really quick follow-up, I think it was one of Olivia's questions. Pat, can you just expand on what was new that's needed for the soft mist filing? Thank you.
Yeah, it's not necessarily anything new. It's just additional data in some areas that we need to provide. It's really just that. It wasn't anything they've asked us to do in addition to what we had already planned.
Okay. So, this is versus generating more data?
It's just generating additional data. I don't think we're particularly worried about it. It's just we need time to do it.
Thank you.
Great. Thanks, Jess, for the question and Pat for the answer. Operator, go ahead.
Your next question comes from the line of Ben Burnett with Wells Fargo. Please go ahead.
Hey, thank you. I want to ask about ralinepag and just what was behind the decision to buy out Arena's economics to ralinepag, and I guess, how did you value that transaction?
Thanks for the question, Ben. Going to pass this one to James.
Yeah. Thanks, Harry. Hi, Ben. Overall, this transaction to buy down the royalty demonstrates our confidence in the revenue opportunity for oral ralinepag, which, as you know, has a pending New Drug Application under review by the FDA for pulmonary arterial hypertension, which you know is a PDUFA date of June 24 of next year. In addition, the reason why we pursued this opportunity is we have conviction in the new dry powder inhalation formulations that we are developing for a variety of pulmonary indications going forward. I would say the price was the result of extensive negotiations, and we are not going to get into the details regarding that, but we looked at this more as an opportunistic use of capital, kind of in our overall capital allocation waterfall. Thanks for the question.
Thanks for that, James. Operator, we have time for one more question. Go ahead.
That question is going to come from the line of Lisa Walter at RBC. Please go ahead.
Oh, great. Good morning. Thanks for squeezing me in, and congrats on a strong quarter. Maybe another one on ralinepag DPI. Curious if plans have changed around developing this for PAH, or is PAH still part of the plan along with PH-ILD, IPF, and PPF? How are you thinking about the clinical development plans for ralinepag DPI in these indications? Any color here would be helpful. Thanks so much.
Yeah, absolutely. Good to hear your voice, Lisa. Going to pass this one over to Leigh to provide some color.
Yeah. Thanks for the question. We are in the process, as you know, of conducting the IND-enabling studies, as well as planning for the phase I study in healthy volunteers. That phase I study, pharmacokinetic study, safety, that will actually inform any other registrational study that we want to do. So, we're initially planning on doing a PH-ILD study, and either very, very soon thereafter or essentially at the same time, seeking approval for IPF, PPF. All of those will require some pivotal studies assessing the safety and efficacy. But again, we're confident that the mechanism, both of the very, very potent drug itself, the ralinepag being a very, very potent IP receptor agonist, as well as the inhaled route for these indications, where there's either some fibrosis or later for COPD, but that's not in the immediate plan.
Anyway, this inhaled route to minimize V/Q mismatch is really probably will make what we're calling Rali DPI a very transformative product in these larger indications.
Excellent overview, Leigh. That will conclude the Q&A, so I'll pass it back to the operator to close us out.
Thank you for participating in today's United Therapeutics Corporation's earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the Events and Presentation section of the United Therapeutics Investor Relations IR website at ir.unither.com. This now concludes today's call, and you may now disconnect.