United Therapeutics Corp

NASDAQ:UTHR

Earnings Call Transcript 2020-Q4

[Operator]

Good morning, and welcome to the United Therapeutics Corporation, Fourth Quarter 2020 Earnings Call. My name is Kenzie, and I will be your conference operator today. [Operator Instructions]

I will now turn the conference call over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics.

[Dewey Steadman, Head, IR]

Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation fourth quarter 2020 earnings call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairman 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, 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 Form 10-K and 10-Q, contain additional information on these risks and uncertainties. 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. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found at our earnings release available on our website at www.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 these products are available on our website.

Now, I'll turn the call over to Dr. Rothblatt for an overview of the fourth quarter and full year 2020 financial results and business activities of United Therapeutics. Dr. Rothblatt?

[Martine Rothblatt, Chairman and CEO]

Thank you, Dewey. Good morning, everyone.

Welcome to the 2020 full year and fourth quarter earnings call of United Therapeutics. We are going to have a really great call today. UT is a pulmonary hypertension Company, now becoming both a pulmonary hypertension and a pulmonary fibrosis Company.

We expect our products for these two markets to generate double-digit growth for several years to come. For example, today we report that our fourth quarter 2020 revenues grew by double-digits, about 24% from fourth quarter 2019 and even excluding a one-time 2019 operation in the distributor order patterns, revenue still grew over 10%, fourth quarter year-over-year with Tyvaso posting a 27% growth fourth quarter year-over-year and Orenitram posting a UT record 30% growth.

Let me now go into some detail on why we expect strong growth in Treprostinil patient counts to continue. Starting with our pulmonary hypertension activities, we believe organic growth from our existing three commercialized products as well as new products emerging from our pipeline will drive double-digit growth.

Organic growth from our three existing products includes, first of all, the increasing use of Remodulin, as part of our Remunity protocol to drive pulmonary artery pressures down below 40 millimeters of mercury, before rapidly switching the patients for long-term management on Orenitram.

Several top pulmonary hypertension experts have recently shown that this kind of protocol is associated with much longer patient survival than the conventional approaches. Second of all, substantial organic growth is coming from Tyvaso, based on data from our increased pivotal trial that was published this past quarter in the New England Journal of Medicine. This kind of growth is visible in the 24% year-to-year financials mentioned above.

And third of all, organic growth is also coming from Orenitram, based on ever greater awareness of its ability to reduce mortality and morbidity based on data from our FREEDOM pivotal study. This is clear in the 30% growth rate from fourth quarter 2019 to fourth quarter 2020.

Now, we also expect growth to be driven by new products emerging from our pipeline. These for pulmonary hypertension includes, first of all, our just launched Remunity device, secondly, our expected launch of our Implantable System for Remodulin or ISR product, jointly developed and promoted together with Medtronic, and third, our expected launch by the end of this year of our dry powder inhaler form of Tyvaso which we call Tyvaso DPI.

Then, just around the corner, during 2022 to 2024, we expect to advance through late stage clinical development and launch for pulmonary hypertension. First of all, our Trevyent product optimized for dexterity challenged patients, which is in fact just awaiting resubmission to the FDA.

Second of all, our once-daily alternative to Uptravi called ralinepag. Thirdly. our once-daily version of Orenitram, and fourthly a thin, reduced form of Remodulin called RemoPro. So all told, you add up the ones that are on the market and about to come, we have ten parallel pathways to propel double-digit growth in pulmonary hypertension, three on the market, three next up to the market, and four in queue behind that.

Now in addition to all of that, as mentioned at the beginning of the call, we have now built the bridge to evolve from just a pulmonary hypertension Company to also being a pulmonary fibrosis Company.

This evolution was made possible by the beautiful results from our increased trial reported in the New England Journal of Medicine that showed Tyvaso in ILD-PH, or also known as WHO Group 3 disease patients, in that all of its primary and all of its secondary endpoints in patients with pulmonary fibrosis induced pulmonary hypertension.

This new indication representing - it's over 30,000 U.S. patients has no approved therapies and nearly all existing pulmonary hypertension treatments are in fact strongly contraindicated in it. You know, it's funny for me to reflect on this, but roughly speaking, it is like pending FDA approval in April, which our fingers are all crossed on.

It's like starting UT's revenue climb from the birth of the Company, all over again, but this time without competition from Actelion, Pfizer or Glaxo. Now our bridge in the pulmonary fibrosis is being even further strengthened with our Phase 3 TETON trial of Tyvaso in patients with pure pulmonary fibrosis. That is, no pulmonary hypertension.

In this trial, we will test the hypothesis that Tyvaso is a disease-modifying drug on top of existing pulmonary fibrosis treatments. That hypothesis already indicated by benchtop studies received strong confirmatory data in the INCREASE trial, because the patients on Tyvaso had improved forced vital capacity outcomes or FVC as compared to just a reduced rate of decline in FVC seen in the conventionally treated group.

Now this patient population, the pure pulmonary fibrosis patients numbers about 100,000 in the U.S. and are easily accessible since they are being treated already with either Pirfenidone, also known as Esbriet, or Nintedanib also known as Ofev.

So between the Group 3 population of 30,000 patients I mentioned before, that we hoped to get approval for in April and the TETON population, we hope to show success in by the end of next year, numbering about 100,000 patients, there will be plenty of Tyvaso patients to drive double-digit growth for several years to come.

I should also add that we expect our approval of our Tyvaso DPI, I mentioned that earlier to include a label, not only for pulmonary hypertension patients, but very importantly, also for pulmonary fibrosis patients. In summary, without even getting into our Phase 3 trial in COPD associated pulmonary hypertension or a registration trial for pulmonary hypertension gene therapy, UT's prospects have never looked better.

With a total of 12 other vectors to double-digit patient growth, some in pulmonary fibrosis, some in pulmonary hypertension, some on the market, some soon to be launched, we feel very confident that the most important growth phase of United Therapeutics is just about to begin.

I'd like to open up the lines for questions. We have a number of experts joining me on the phone. So if you ask me the question, I'll forward it either to Mike Benkowitz on all business questions to James Edgemond for all financial questions to Dr. Leigh Peterson for scientific questions and to Dewey Steadman for any IT questions.

Operator, please feel free to open the lines.

[Operator]

[Operator Instructions] Our first question comes from the line of Joseph Thome with Cowen and Company. Please go ahead, your line is open.

[Joseph Thome, Cowen and Company]

Thank you for taking my question and congratulations on all the progress. I want to discuss the hopeful integration of the DPI, a little bit. Can you give us your thoughts on how you expect to transition in, or start patients on the DPI and PAH? And then for PH- ILD because the DPI could launch reasonably quickly after the formal label expansion, how are you thinking over the next 12 months to 18 months, integrating PH-ILD patients on the DPI versus the nebulized Tyvaso version? Thank you.

[Martine Rothblatt, Chairman and CEO]

Yes. Thanks so much for those good questions. You know, they're both really in the realm of business questions that Mike Benkowitz and his very talented team have already been working on and interacting with physicians on. So Mike, could you take that question?

[Michael Benkowitz, President and COO]

Sure. I think the answer applies really, I think to both indications. And we're really excited about the progress we've made with Tyvaso DPI. We're looking forward to the filing as Martine said in April. And with the priority review voucher, we purchased at the end of last year, are hopeful that just assuming everything goes well with the FDA we'll be able to launch that into both indications by the end of this year.

And I'll tell you that there is both and with PAH docs and with PH-ILD docs, there is a lot of excitement and enthusiasm around having a dry powder inhaler. And so, we're preparing to aggressively launch that product and make it available to as many patients as are wanting to either start initiating therapy on Tyvaso as well as transition over.

And so, I think at this point we're very encouraged by the feedback we're hearing from the physicians, very optimistic that there will be a - I think, there will be a relatively speaking in PAH, a quick transition for those patients that want to transition to DPI to be able to do so, very soon after launch.

[Martine Rothblatt, Chairman and CEO]

Thanks, Mike. Operator, next question please?

[Operator]

Our next question comes from the line of Liana Moussatos with Wedbush. Please go ahead, your line is open.

[Liana Moussatos, Wedbush]

Thank you for taking my question. So for Remunity launch, how should we think about Q1 revenues?

[Martine Rothblatt, Chairman and CEO]

Thanks, Liana. Nice to hear your voice this morning. Again another business question, I'd like to forward that to Mike Benkowitz.

[Michael Benkowitz, President and COO]

Yes. So Liana, I think with the Remunity launch, you're looking at, I think another product where there's a lot of excitement in the market as Martine said. We launched that earlier this month. We're pleased to see the really early enthusiasm from physicians around Remunity. We're already seeing referrals come in. So we expect to get those patients on therapy in the coming weeks, months and into the future.

We're not going to break out Remunity versus the MS 3 pump revenues. We're still continuing to try and report that as Remodulin revenues. But we certainly believe that with the Remunity Pump, we have an opportunity to continue to kind of maintain our Remodulin business over the long term and grow it by virtue of the Remunity Pump as well as the next generations of that, the machine filled pump and as Martine talked about, the RemoPro which is our pain free version of Remodulin.

[Martine Rothblatt, Chairman and CEO]

Thanks so much, Mike. You know, I'm so excited about Remunity, Liana, I can't actually hold myself back from sharing the anecdote that flowed in just the past couple of days ago. There is - you know, an important pulmonary hypertension center that had regularly put patients on IV Remodulin, but was very resistant to putting patients on subcu Remodulin.

They actually have become the first center to put patients on Remunity. They were so impressed with the differences of Remunity compared to subcu Remodulin, that this center that had not put patients on subcu Remodulin for a long time was now switching patients over or starting new patients on Remunity, whereas they wouldn't have done that for subcu Remodulin. So I just think that, that anecdote is a very positive indicator of things to come for Remunity.

Operator, next question?

[Operator]

Our next question comes from the line of Eun Yang with Jefferies. Please go ahead, your line is open.

[Eun Yang, Jefferies]

Thank you. Questions on Tyvaso DPI. So once it's approved, you owe double-digit percentage of royalty to MannKind. Are there any regulatory or sales-related milestones? And with that, do you expect the gross margin to kind of settle around mid to high 80s? Thank you.

[Martine Rothblatt, Chairman and CEO]

Okay. Thank you, Eun so much for the question. That sounds to me like pretty much of a financial question. So I'm going to ask our CFO James Edgemond to please handle that one.

[James Edgemond, CFO and Treasurer]

Yes. Thank you, Martine and good morning Eun. You're right, we do owe MannKind royalties related to patients that use the DPI going forward. And as you've probably recognized and noted in the financial statements, we have historically made milestone payment and we achieved these milestones under our agreement with MannKind.

Going forward, there are limited milestones with respect to pursuing other indications. So our main financial obligation as you kind of referred to is fully around our royalty obligation for new patients going to DPI. And as for kind of your question around gross margin, you're getting very specific in terms of what it would be acting overall, because we don't necessarily anticipate breaking out Tyvaso or DPI versus the current nebulizer.

So in your modeling, I think if you take the royalty obligations that we owe MannKind, within your model, you're going to come out to something based upon how you're splitting the revenue. But we don't anticipate doing that on a going forward basis. So thanks for your question and Martine back to you.

[Martine Rothblatt, Chairman and CEO]

Thank you so much, James. Appreciate it. Operator, could you please receive the next question?

[Operator]

Our next question comes from the line of Jessica Fye with JPMorgan. Please go ahead, your line is open.

[Jessica Fye, JPMorgan]

Good morning. Thanks so much for taking the question. My question is on the Tyvaso, PH-ILD launch and in the press release, how - you kind of reiterated the hope to double the number of Tyvaso patients in the near-term. I think in the past you suggested maybe looking at about 18 months. When we think about that growth in patients, should we think of that as sort of straight line growth or is this something that could have an initial bolus or conversely something that might start slow and then sort of inflect over time?

[Martine Rothblatt, Chairman and CEO]

Thanks, Jessica for your question. Nice hearing your voice this morning. That's a very squarely a business question, so I'll pass that one to Mike.

[Michael Benkowitz, President and COO]

Yes, thanks. Thanks, Jess. It's a great question. As we talked about when we did the INCREASE call, investor call last month. I think our belief is that it probably won't be straight line. We do think that there may be an initial bolus, I can't really quantify what that is right now, because I think we're still gathering that data through interactions with our physicians.

So there may be an initial bolus, and then it may - it could dip a little bit, and then start to ramp back up. But I think it's - my belief based on what we're hearing right now is, I think it will be thinking about a big picture, a little bit slower than ramping up over the next 18 month period of time.

And that's really just a function of getting the patients and getting them strained, getting them echoed on, getting the right heart cath. And I think there is still some - but there's scheduling, there's logistics and all of that stuff has to happen, and then you have to get the referrals, I think, get patients initiated on therapy.

So that's really the reason for that. It has nothing to do I think with lack of awareness or lack of enthusiasm for Tyvaso indication. As we talked about last month there's certainly a lot of excitement about being able to have this to treatment armamentarium for pulmonary hypertension ILD.

[Martine Rothblatt, Chairman and CEO]

Thanks so much, Mike. Operator, next question please?

[Operator]

Your next question comes from the line of Marty Auster with Credit Suisse. Please go ahead, your line is open.

[Martin Auster, Credit Suisse]

Thanks Martine. I think this one is going to fall into the business question category as well. But I just wanted to check in with Mike, Tyvaso had some nice growth this year and obviously there's a lot of awareness and interest in the Group 3 PH-ILD indication that we're all hoping for approval on the PDUFA date coming up in April. Curious if you can maybe talk a little bit about, did you see any sort of increasing in terms of the breadth of prescribers of Tyvaso this year, where you're just seeing kind of a little - kind of better depth and uptake of existing base?

Just curious if you could kind of comment as we're trying to think about how much - kind of how much of that growth is reflecting some early enthusiasm for the broadened indication. Thanks.

[Martine Rothblatt, Chairman and CEO]

Thanks, Marty. Great hearing your voice again today as well. You guessed it. Mike?

[Martin Auster, Credit Suisse]

Having earned my paycheck today, that feels great. Yeah, so it's a little bit difficult to know the extent to which there is off-label used as a result of the increased data. All that we're able to track is the - is who is writing the referral. So to your point about being the prescriber base, that hasn't changed. The folks that are being writing Tyvaso, are our typical PAH prescribers. We have not seen a material change in that. We haven't seen really an uptick in new prescribers yet.

We do expect that that's going to - that's going to occur after we had label expansion. So within that prescriber base, our usual prescriber base to the extent that they're seeing ILD patients, they could be writing for the indication. But by and large, the performance of Tyvaso is within our traditional PAH stocks.

I think a lot of it has to do with the buzz around Tyvaso, the New England Journal and I think it's just a lot on the PAH side, just reminding physicians of what a great drug that is for PAH patients.

[Martine Rothblatt, Chairman and CEO]

Awesome. Thanks, Mike. Thank you, Marty. Operator, next question please?

[Operator]

Our next question comes from the line of Hartaj Singh with Oppenheimer. Please go ahead, your line is open.

[Hartaj Singh, Oppenheimer]

Great. Thank you for the question. Just a financial question. In 2020, you had a dip in your sales from losing Adcirca. James, I know you always talk about OpEx spend as being 50% of previous year's sales. However, in 2021, you're going to have potential launches, a lot of things going on. Just how to think about that, and then going forward also. Thank you for the question.

[Martine Rothblatt, Chairman and CEO]

Thanks Hartaj. Great hearing you online today. Hopefully, winter is not treating you too bad there in New York. And James, solid financial question.

[James Edgemond, CFO and Treasurer]

Yes. Thank you, Martine. Good morning, Hartaj. And as always good to hear your voice. Thanks for the question. So the budget algorithm that we have talked about historically that you referred to this morning where we plan our budget in a current year, for example 2021 based upon 50% of prior year revenues in total. So to your point around the decrease in sales, if you use Adcirca as an example, overall, we still need to maintain our budgets and our financial discipline with respect to our total revenues.

So as revenues grow going forward, that means Unitarians in terms of their budgets will get additional funds for projects. With respect to your specific question on 2021, we still need to stay within our budget algorithm with all the activity that Martine and Michael talked about in terms of product launches and clinical development. We still need to make sure we stay within that budget algorithm. So our 2021 budgets are based upon 2020 revenues.

And that's how we've built them and that's how we'll execute across the course of 2021. And all Unitherians know that in order to get more in additional budget dollars, we need to all grow revenue across the firm and that's what Martine talked about double-digit growth going forward. And that really is objective across United Therapeutics. So thanks for your question, Hartaj and Martine back to you.

[Martine Rothblatt, Chairman and CEO]

Thanks, James for your great answer. And it's really beautiful hearing you describe the budget algorithm because the vision that I have in my head is that we have not a 100 people rowing to grow the business of the Company like just the sales and marketing force, but we have a 1,000, the total head count of United Therapeutics all rowing in the same direction.

The product development, the research and development, legal, financial, everybody is focused on a singular goal of growing the Company so that everybody there, everybody in the Company can have additional resources available to grow the projects that are nearest and dearest and center to their own career development experience.

So that budget algorithm has had a excellent effect of kind of - you know, magnetically aligning all 1,000 Unitherians in the same positive direction. Thanks for bringing up that question. Operator, next question please?

[Operator]

Our next question comes from the line of Terence Flynn with Goldman Sachs. Please go ahead, your line is open.

[Terence Flynn, Goldman Sachs]

Good morning. Thanks for taking the questions. Maybe two for me. Martine, you talked about double-digit revenue growth. Just wondering, you know that I think, for 2021 that how sustainable is that longer-term and then on ralinepag, another important late-stage program for you guys, maybe any update on enrollment there and the potential timing of the data? Thank you.

[Martine Rothblatt, Chairman and CEO]

Sure. Thanks. I'm going to answer the first question, which is kind of, I guess more of like a strategic overall question and then I'm going to pass it to Dr. Peterson to answer the scientific question relating to ralinepag.

So as to the durability of our revenue growth, I think it looks really strong, and that was the reason I wanted to kind of highlight in the introductory remarks that we're not talking about growing within kind of a single small finite crowded pond, which is a bit how I would describe Group 1 pulmonary hypertension, about ten approved drugs, roughly speaking, 50,000 U.S. patients.

We are going to grow in that Group 1 pulmonary hypertension. But the durability of our growth, you know, throughout the 2020 doesn't depend just on Group 1 pulmonary hypertension. We've been on top of that, have this Group 3 community, which is one of their feet are in pulmonary fibrosis, which is the cause of their disease, and the other of their feet is in pulmonary hypertension which we know very well. And now, we are - we've done the necessary pivotal trial, executed to a level of scientific rigor and confidence that it enjoyed publication in the New England Journal of Medicine, and hopefully to be approved in April.

Now with that launch, we would go into a patient population of approximately 30,000 patients who are almost are already being treated for their pulmonary fibrosis, but virtually none of them are being treated for their pulmonary hypertension because there was no drug approved to treat that.

And that's why I mentioned at the beginning of the call, this is to me like you know kind of a very beautiful scenario. It's like when we started the Company a decade or two ago, there were maybe 20,000 pulmonary hypertension patients, and we were competing with Glaxo on the [frontier] side. We were competing with Actelion on the oral side. We were competing with another drug called Iloprost on the inhaled side.

And those actually fragmented and then we had ten different competitors as we do to date, but still growing organically within Group 1. But in Group 3 there is none of that. There's 30,000 patients in need of a therapy and hopefully knock on wood, the - we will get approved in April and then we have an awesome therapy for them in Tyvaso.

And then Mike just - you know, a year later, absolutely revolutionary therapy with the Tyvaso DPI product. So I think that's going to drive our growth for well beyond 2021, in fact for several years.

And then, you know, one more thing, which I mentioned in the introductory remarks, is this pure pulmonary fibrosis population of 100,000 patients in the U.S., all being managed with a drug, which unfortunately reduces the rate of decline in their forced vital capacity, but does not improve it, does not modify the disease and we've got this very promising data from the INCREASE study that builds upon earlier bench-top data that shows actually there is disease modifying capability in Tyvaso for patients with pulmonary fibrosis. We need to now validate that hypothesis with the prospective study, which is what our TETON study is currently enrolling.

So you add up the Group 1, the Group 3, the pulmonary fibrosis, not to mention the PERFECT study, and I think this growing our patients by double-digit rates is something that can be reasonably anticipated for the balance of the 2020. So with that answer to your business question or strategic question, let me shift over to Dr. Peterson to address the scientific question.

[Leigh Peterson, VP, Product Development]

Yes. So basically you were asking about the ralinepag studies, and in spite of the pandemic, the enrollment in those studies especially the outcome study is going quite well. We still have a few sites that are open due to the pandemic, but of those sites, the majority of the sites are open and again they are enrolling quite well.

This is - the outcome study is an international trial. So we have sites all over the world. And we have pretty - we have good enrollment, both in the U.S. as well as outside of the U.S. We're still planning to have the outcome study enrolled in 2022 and then have a readout in 2024.

Now remember this study is endpoint driven, hence the name, outcome study. And so, not only do we have - need to have the patients enrolled, but we need to follow them and collect data on the disease progression of these patients, and then compare that in the two groups.

So we expect a 2024 readout and a 2025 launch. We're also enrolling our [indiscernible] study. Now that study isn't endpoint driven it's change in peak VO2 from baseline to week 28, and we'll be enrolling 193 patients in that study, and that allows for dropout. And so if we don't have as many dropouts as maybe we put into the initial calculations, we could finish that trial sooner. But we're counting on them both to be finishing around the same time, at this point. We'll know more as enrollment progresses and the sites continue to open up.

[Martine Rothblatt, Chairman and CEO]

Thank you so much, Dr. Peterson. Operator, we have time for one last question.

[Operator]

We have no telephone questions in queue at this time.

[Martine Rothblatt, Chairman and CEO]

Okay. Thank you so much. Well everybody, I would really like to express our appreciation for you participating in this quarterly earnings call covering the fourth quarter of 2020, full year 2020. As promised at the beginning, it's going - it was going to be a really great call, and it was. We had so many good questions. And it's been the pleasure of Mike Benkowitz, James Edgemond, Dewey and Dr. Peterson and myself to join you this morning. Have a great day.

[Operator]

Thank you for participating in today's United Therapeutics Corporation conference call. A rebroadcast will be available for replay for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code 8999095.