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Good morning and welcome to the United Therapeutics Corporation Second Quarter 2021 Earnings Webcast. My name is Stephanie and I will be your conference operator today. [Operator Instructions] I will now turn the webcast over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.
Good morning and it’s my pleasure to welcome you to the United Therapeutics Corporation second quarter 2021 earnings webcast. Accompanying me on today’s webcast are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Mr. Michael Benkowitz, our President and Chief Operating Officer; Mr. James Edgemond, our Chief Financial Officer and Treasurer; and Dr. Leigh Peterson, our Senior Vice President of Product Development.
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 and we assume no obligation to update these forward-looking statements. Today’s remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles or GAAP. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found on our earnings release available on our website at ir.unither.com.
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 our products are available on our website.
Now, I will turn the webcast over to Dr. Rothblatt for a review of our second quarter 2021 financial results and business activities of United Therapeutics. Martine?
Thanks, Dewey. Good morning, everyone and thank you for joining us on our quarterly earnings call. We have a lot of good news to share today. So, it’s going to be a very fun call. You have read in the press release the outstanding financial results. And in a moment, I am going to turn the mic over to Mike Benkowitz, who will speak a little bit more about the commercial success that we are experiencing.
I would like to talk a little bit about our pipeline, which is quite robust and doing very well. We have a number of studies in Phase 3. I’d like to highlight a few of them. Two of our studies are outside of Group 1 PAH, the PERFECT study in COPD, specifically a form of COPD that’s associated with pulmonary hypertension and another Phase 3 study in idiopathic pulmonary fibrosis, also known as IPF. That study is called the TETON study within United Therapeutics. In addition to those Phase 3 studies, we have additional Phase 3 studies within Group 1 pulmonary hypertension. Two of those Phase 3 studies are using our once a day drug called ralinepag and both of those studies are going quite nicely. In addition, we have a lot of next-generation treprostinil development activity that will be in – some of its in Phase 1 and then moving into bioequivalence testing over the next year or two. So, that will provide an ongoing pipeline of next-generation treprostinil products for Group 1 and possibly also Group 3 pulmonary hypertension.
Looking a little bit at the longer term, we are working on cures for pulmonary hypertension, either through gene therapy. And we do have a gene therapy trial also in Phase 3 or actually manufactured lungs, lungs that are manufactured in our laboratories and then transplanted into patients to completely cure either their pulmonary hypertension, pulmonary fibrosis, or many other end-stage lung diseases. In the meantime, on the clinical side, there is increasing evidence that current medicines dosed appropriately may in fact convert pulmonary hypertension into a lifelong manageable condition.
And a lot of these data are coming from Europe and Japan. I think you are going to soon see more reports from the United States, but it’s really startling to see reports with patients, more than 90% of the patients in the cohort living 20 years, over 10 years with the current medications, but dosed differently than kind of the traditional dosing, dosing – dosed according to a very specific protocol. So, that’s tremendously exciting for us in the pulmonary hypertension field, to be able to convert pulmonary hypertension into a lifelong manageable condition. And indeed, the goal of our next-generation treprostinil products is to make these kind of lifelong, manageable protocols as easy as possible for the patients because they will be on them for literally decades.
Well, with that introduction to our pipeline and clinical development activities, I’d like to pass the microphone over to Mike Benkowitz to talk about the commercial operations. Mike?
Thanks, Martine and good morning, everyone. The second quarter was a very exciting quarter for United Therapeutics on the commercial front as we began our push into new rare lung disease indications outside of pulmonary arterial hypertension. I am pleased to report that we achieved several milestones in the second quarter at a treprostinil franchise level. First, we ended the second quarter with a record number of U.S. patients on our treprostinil therapies marking the fourth consecutive quarter of total treprostinil patient growth. Second, we achieved an all-time high in two of our key underlying U.S. demand metrics, total treprostinil prescriptions and total treprostinil actual patient starts. Finally, while we always caution that revenues don’t necessarily reflect underlying demand for our products due to the ordering patterns of our specialty pharmacy and distribution partners, we are excited to have achieved record treprostinil revenue in the quarter.
Now, I’d like to spend a few minutes talking about individual product performance. Of course, we are very excited to have launched Tyvaso into pulmonary hypertension associated with interstitial lung disease at the beginning of the second quarter. Earlier this year, we established a goal to double the number of patients on Tyvaso by the end of next year, assuming no COVID-related impact to HCP access and patient initiation of therapy, and importantly, recognizing that the path to doubling may not be linear. In the first quarter of the launch, we have established strong momentum and as of the end of Q2, we are already more than one-sixth of the way to our goal of doubling the number of patients on Tyvaso through the PH-ILD label expansion. We are also very encouraged by the prescription and start patterns in Q2, which are double or more than double the quarterly referral and start levels in 2020.
On the reimbursement front, we continue to work with CMS to update their policy to cover Tyvaso for the treatment of PH-ILD. We remain confident that this update will happen, but cannot predict its timing due to the government’s processes and procedures. In the meantime, Medicare Medicaid patients can apply and have been applying to our patient assistance program. If they meet our patient assistance program eligibility criteria, they can initiate Tyvaso therapy immediately. Once CMS updates their coverage policy, Medicare Medicaid patients will be able to start on commercial drug.
Moving on to Remodulin, we were very pleased to see in Q2 the highest number of prescriptions and starts for Remodulin in the past 12 years. We believe there are several factors contributing to this. First, as we mentioned last year, Remodulin therapy initiation was most impacted by the pandemic for a period of time as many patients were unable to come into the hospital to start on Remodulin. We believe this created a so-called warehousing of patients that started to open up in Q3 of last year and continued into Q2. In addition, there is renewed appreciation of the clinical benefits of Remodulin for PAH patients, for example, the ability to move patients to a low-risk status and then potentially transition to oral prostacyclin, such as Orenitram and as Martine mentioned, recently published retrospective data showing that use of Remodulin can reduce mPAP or mean pulmonary arterial pressure and if mPAP is reduced below 40 millimeters of mercury, there can be a dramatic improvement in long-term survival.
The competitive landscape did change in the second quarter for Remodulin as the generic form of subcutaneous treprostinil became available. At this point, the subcu generic launch looks very similar to the IV generic launch we saw in 2019. There has been an initial bolus of subcu Remodulin patients, similar in quantity to what we saw with IV and primarily these dual-eligible Medicare Medicaid patients that have been switched to generic treprostinil. However, the base of patients we have now is higher than when IV generic launched, we still see that PAH docs prefer branded Remodulin over the generic alternative when they are filling out their prescriptions and we have yet to see widespread payer management of these patients.
It’s also important to note some of the potential limitations around generic subcu availability. It’s our understanding that this product is only being offered by one of the specialty pharmacies that distribute PAH medicines. It’s also our understanding that the subcu pumps that are currently being used with generic treprostinil are limited in supply. Meanwhile, we have invested in the supply of pumps and disposables, including the new Remunity pump and believe that we are well positioned to serve Remodulin patients for the long-term. Orenitram also had a strong quarter, posting new prescriptions with starts in the second quarter that were one of the highest since the product’s launch and total patients on therapy that were the highest ever.
As mentioned in previous calls and investor conferences that while we saw an uptick on Orenitram following the FREEDOM-EV label expansion, the launch trajectory was blunted by COVID. In the second quarter of this year, we were able to have consistently more robust interactions with prescribers about FREEDOM-EV and the total Orenitram value proposition. And we believe that translated into the underlying demand performance we are seeing. If we can maintain this momentum going forward, we expect this to show up on the revenue line in subsequent quarters as patients titrate to an efficacious dose and ordering by specialty pharmacies, which often lags underlying demand catches up.
With respect to Unituxin, we are extremely pleased to see second quarter demand continue at a similar pace to the first quarter. We have limited visibility into how the drug is being used, but we know use has increased in the U.S. Moreover, Unituxin was approved in Japan in the second quarter with an indication that’s actually broader than the U.S. label. Consequently, our Japanese distribution partner, Ohara ordered a larger than expected amount of Unituxin in the quarter.
Finally, we are excited about our pending applications at FDA for Tyvaso DPI. We’re pleased that the PAI and general facility inspection at our partner, MannKind’s Danbury, Connecticut facility has commenced as scheduled and is ongoing. Our PDUFA action date is in October of this year, and we’re working hard to build launch quantities and mobilizing our commercial teams to support a launch soon after approval. So there is a lot of positive things happening on the commercial front. We remain focused on executing against our plans through the second half of the year and importantly, making progress toward our near-term goal of doubling the number of patients on Tyvaso by the end of 2022.
With that, Martine, I’ll turn the call back over to you.
Thanks so much, Mike. Great review. So operator, we can now open up the lines for any questions. And whatever questions come in, I’ll direct them either to James, our CFO, to Mike, our President or any questions of a scientific medical technical nature to Dr. Peterson. Operator?
Thank you. [Operator Instructions] And your first question is from the line of Jessica Fye with JPMorgan.
Hey, nice quarter this morning. You guys said you’re well on your way to the goal of doubling the number of patients on Tyvaso, but also said the path may not be linear. So can you share the latest thinking on the shape of the curve to get to that year-end ‘22 goal? And related to that, you also mentioned that ordering patterns can factor into revenue, not perfectly aligning with patient demand. So how should we think about that dynamic going forward in the back half of the year? Thank you.
Thanks, Jess. Nice to hear your voice this morning. Both of those questions seem to be squarely in Mike’s daily work.
Sure. I think on the first part of the question around the shape of the curve, I think we’re still trying to get better visibility into what that looks like. And I think the question that we’re still trying to get some insight into is the patients that are residing with the PH-ILD treaters and how quickly those patients are getting referred – either getting referred over to PAH clinic or these PH-ILD treaters are starting to activate and treat patients on their own and so that – we’re still getting insights on that. We don’t have perfect clarity. I think I’m hoping to get through Q3 into Q4, we will get a better sense of that. So that’s still why I’m still thinking that it’s maybe not going to necessarily be a linear and maybe potentially more hockey stick as we get into 2022, but I think we will have a little bit better visibility on that as we get into – later into the second half of the year. On the ordering patterns, I mean it’s – this is always an issue we’ve always had. The specialty pharmacies have days on inventory requirements for our contracts that they have to keep on hand. They have an algorithm they look at that takes into account historical shipment data as well as prospective estimated demand. And with that, we’ve got and agree upon level of wording that has to happen. And so beyond that, it’s really just sort of kind of normal course of business. And so as we start to kind of see referrals start on the Tyvaso side of things pick up, I would expect the orders to pick up as we go on.
Perfect. Thanks so much, Mike. Next question, please?
Your next question is from the line of Hartaj Singh with Oppenheimer & Company.
Hi, good morning.
Hey, good morning, Martine. Good to hear your voice. Thank you for the question and nice quarter. The question I had was on COPD and IPF, Martine, you pointed those out at the beginning in terms of the prepared script. Could you just talk a little bit about the scientific rationale behind Tyvaso inhaler for COPD and IPF? And then specifically, when do you expect the readouts for both the patient enrollment to complete and readouts to happen for COPD and IPF? Thank you.
Yes. Great question, Hartaj, I’ll speak for a moment or two about the Group 3 COPD pulmonary hypertension and let – while I’m doing that, Dr. Peterson, if you could queue up your thoughts on the scientific rationale in IPF, which is unique in the sense that it has nothing to do with pulmonary hypertension at all. And Dr. Peterson has studied that scientific rationale quite a bit. So with regard to the COPD, we’re not treating the COPD per se, but we’re treating only the pulmonary hypertension that those patients have who also have COPD. We’re doing this based on previous work from Dr. Waxman and others that showed that when Group 3 patients with COPD were treated off label with Tyvaso, they have dramatically improved 6-minute walk test, Hartaj. And it was based on that data that we were able to size our PERFECT study. It’s about roughly 100 patients, a bit more than 100 patients and felt very confident with that sizing because of the very dramatic data that had come out earlier. So it is the mechanism of action is the same as it would be for treating any other type of pulmonary hypertension. We’ve got the ability of treprostinil to, for example, dilate the smooth muscles in the pulmonary arteries, which are causing the vasal constriction. And we also have the ability of Tyvaso inhaled to reduce the platelet aggregation in those tiny arterials, which also contribute to ultimately a afterload in the right heart and actually spells a worse morbidity and mortality picture for the COPD patients who have pulmonary hypertension than for those who don’t. There are a lot of patients Hartaj, with the COPD form of pulmonary hypertension, in fact, over 100,000 in the U.S. alone. So there is a real great opportunity for us to do good there. And I think the scientific rationale, the empirical data upon which we sized and based the PERFECT study was very solid, and we have high expectations for success. Dr. Peterson, would you like to talk about the scientific rationale in pulmonary fibrosis because that’s something really very new.
Yes. Yes, sure. Thanks, Martine, and thanks for the question. So really what came – one of the things that came out of the INCREASE study in addition to meeting our primary endpoints and everything that’s been published so far, including New England Journal, is that we published a paper in the Lancet recently, and it describes the surprise sort of that we saw, which was that we saw an improvement in FVC, which is forced vital capacity. And this indicated that Tyvaso might not only work on the pulmonary hypertension component of the disease, but it might actually work on the fibrotic disease in patients with PH-ILD. And that’s actually supported by – so we saw this clinically, and that’s actually supported by non-clinical evidence where there is been several studies that have shown the anti-fibrotic effect of treprostinil. So that together made a design, think about what’s going on, and think that possibly this could also work in patients with IPF without pulmonary hypertension, so again, evidenced an increase and evidence in non-clinical studies, both in vitro and in vivo. And just to reiterate what Martine just said. So for PH-ILD and PH-COPD, obviously, as mentioned, there is a common pathogenesis for the PH component. But in fact, due to these other effects of treprostinil, treprostinil binds multiple receptors on multiple cell types and has multiple mechanisms of action. There are additional actions such as the fibrosis that can work specifically in patients with fibrotic lung disease. And there is even a bronchodilation effect that could also help the patients with obstructive lung conditions, such as COPD.
Perfect. Thanks so much, Dr. Peterson. Operator, next question, please.
Your next question is from the line of Joseph Thome with Cowen & Company.
Good morning and thank you for taking my question, and congratulations on the great progress. Maybe one more just a little bit on the reimbursement environment for PH-ILD, if you can comment a little bit more on that, how many kind of patients are prescribed therapy, are they able to actually get Tyvaso right now for the most part? And obviously, we know this is essentially the first, they are formally approved in this indication. Are you seeing any sort of considerations for prior therapies that patients have seen or specific levels of disease burden?
Yes. Thanks for the question. It’s all of our strategic operations and managed markets activities report into Mike. So Mike, if you could provide some insight on that question?
Sure. Joe, so in terms of disease severity or prior therapies, we’re not seeing any requirements there. As I think you know this is really the first and only treatment that’s on the market to treat the pulmonary hypertension associated with the ILD, the other drugs are treating underlying lung disease. So we’re not seeing any issues there. I would say on the kind of the private payer side of things, those prescriptions that are coming in for PAH, ILD patients are going through with little to no issue. And then on the – like I said, on the CMS side, we’re waiting for the CMS approval, which that process is ongoing that accepted our application, they are just going through there, like I said, their policies and procedures, and we’re optimistic and hopeful that that’s coming shortly. So those patients, like I said, are eligible to apply for a patient assistance program. And then if they are eligible, they can come in and start and then once we have CMS approval, presumably, they could become a commercial patient.
Perfect. Thanks so much, Mike. Operator, next question, please.
Your next question is from the line of Eun Yang of Jefferies.
Thank you. Great quarter. Congrats. Recently, J&J received approval of intravenous UPTRAVI. So I want to ask you how do you see this might or might not impact your marketing franchise? Thank you.
Thanks for the question, Eun. Nice to hear your voice this morning and thanks for the congratulations. We, at present, really would have no idea to comment about what kind of impact intravenous UPTRAVI might have. We do feel that the intravenous route is important, although the same amount of efficacy can be achieved with the subcutaneous route. And that’s, of course, ordinarily much easier on the patient and certainly much easier on their ongoing lifestyle. So, that’s really the question to be assessed there. In terms of over the longer term, I think what Mike was referring to and I was referring to earlier is that the patients tend to have the best experience according to these recent reports from both Europe and Japan, when they are on the parenteral route for relatively short period of time, in order to aggressively reduce their pressures down below 40 millimeters of mercury and relieve the after load on the right heart. So, whatever goes on there is, I would say, not part of the biggest picture of pulmonary hypertension because the total amount of time on the parenteral therapy is relatively short compared to the total amount of time on Orenitram or another oral therapy. So hopefully, that gives you a little bit of insight into what might be going on in the parenteral optionality space. Next question, please.
Your next question is from the line of Terence Flynn with Goldman Sachs.
Hi. Thanks so much for taking the question. I was just wondering if you could comment at all about the breadth of prescribing you are seeing in the PH-ILD side, are you seeing a mix of both new prescribers or existing prescribers? And then the second part of the question is just how should we think about the treatment duration for the PH-ILD setting relative to PAH for Tyvaso? Thanks so much.
Yes. Great question. Mike, do you like to handle that one?
Sure. On the prescribing breadth, I mean, as it stands right now, I am not surprising and I think this got a little bit, I think looking into Jess’s question around whether the uptick is linear or not, if it’s more heavily weighted. So, the answer is, we are getting both PAH and PH-ILD. I would say, as we sit here today, it’s more constant. The weight is more towards the PAH side. But we fully expect that as the launch evolves, as we continue to engage with physicians that will start to even out and maybe even potentially shift to the PH-ILD. I think it’s really going to depend on the center where the physicians are. Do they have a PAH clinic and do those PH-ILD physicians want to actually treat versus refer. From our standpoint, we don’t really care who treats. We do want to make sure that those patients were getting caught earlier in their disease because we think that and this gets into the second part of your question, we think that the earlier they start on Tyvaso the more and the longer they can benefit. And so from a timing standpoint, in terms of duration of therapy, it’s really going to, I think be a question of where they are in their disease progression and what’s sort of the dominant part of the disease, is it the ILD, is it the pulmonary hypertension. And so if you have got really severe ILD, less on the PAH, they go on Tyvaso. I think those patients probably won’t be on as long versus patients that are – it’s really more PAH, less on the ILD, where I think we would expect to see duration of treatment along the lines of what we see in, if not longer in PAH.
Perfect. Thanks so much, Mike. Excellent response and very comprehensive. So operator, we have got time for just one more question.
Your final question is from the line of Geoff Meacham from Bank of America.
Good morning. This is Jason on for Geoff. Thanks so much for taking our question and congratulations on the quarter. Just thinking ahead in terms of the second half of the year, I know you were projecting growth, but there were some, obviously, some one-time benefits, including Unituxin, the Japanese order and OUS Remodulin. And just wanted to get your sense of how confident you are in kind of moving forward on the trajectory for the second half of the year? Thanks so much.
Okay, Geoff. So basically, you are just asking what we expect to see from here towards the end of the year?
Well, sure. I was looking at the 10-Q, that the continued revenue growth in the second half of 2021 compared to 2020, given the one-time benefits of this quarter, the confidence in growth trajectory of the second half of 2021.
Yes. I don’t think – I wouldn’t really buy into the hypothesis about a huge amount of one-time growth benefits this quarter. I know Mike kind of referred to the warehousing of the Remodulin patients, but I wouldn’t like translate that into being a one-time benefit, because those patients have to book their appointments with the doctors and come in and there is going to be a continual upward swell coming from patients who were pushed back due to COVID. So, I don’t see this as a one-time event. I really see it more as what Mike has been talking about, and we have been talking about that we are building steadily toward our goals of doubling the number of Tyvaso patients by the end of next year and having 25,000 patients by the end of 2025. And any given quarter, there is of course, always ups and downs. But what you are seeing, I think, in this quarter is the new revenue track for United Therapeutics going forward, a revenue track, which is consistent with doubling the number of Tyvaso patients by the end of next year and a revenue track that’s consistent with having 25,000 patients by the end of 2025.
Got it. Thanks so much for the color.
Excellent. Mike, did you want to add something about Unituxin on that last question?
Yes. I would just say – I would just add maybe two maybe granular points. So, the Unituxin, I wouldn’t look as necessarily being a one-time event, as Martine mentioned. The larger – when I referenced the larger order from Japan, that really was a function of the fact that we have larger than what we were forecasting because we weren’t expecting a broader label of what we got. So, now that we have the broader label, I think the orders that we expect from Japan would be on par with what we saw in this quarter over time. I would also say on the international side, we always see some lumpiness there. Part of what we saw last year with the generic entrant into Europe was Ferrer, our partner having to draw down their inventory. So, that’s been gone down. And I think we will still see lumpy orders internationally, but over the course of a year, I think that will level out.
Exactly, Mike. Totally agree. Operator, you can please now wrap up, and we would like to thank everybody for participating in our second quarter earnings call. It’s been an extremely exciting quarter with all of the top level results that Mike reported on, best in numerous different categories, solidly on track for our announced goals and a very exciting pipeline to continue propelling our growth through the balance of the 2020s. Operator, you can now wrap up.
Thank you. Thank you for participating in today’s United Therapeutics Corporation Earnings Webcast. A rebroadcast of the webcast will be available for replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com.