Earnings Labs

United Therapeutics Corporation (UTHR)

Q1 2017 Earnings Call· Wed, Apr 26, 2017

$566.69

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Transcript

Operator

Operator

Good morning. My name is Chanel, and I will be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation 2017 First Quarter Financial Results. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Remarks today concerning United Therapeutics will include forward-looking statements representing the company's expectations or beliefs regarding future events. The company cautions that these statements involve risks and uncertainties that may cause actual results to differ materially. Please see the company's latest SEC filings, including Forms 10-K and 10-Q for additional information on these risks and uncertainties. The company assumes no obligation to update forward-looking statements. Today's remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles. Reconciliation of non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures can be found in our earnings release available on our website at www.unither.com. Finally, please note that today's remarks may include reporting on the progress and results of clinical trials or other developments with respect to the company's products. These remarks are intended solely to educate investors about the company and are not intended to promote the company's products, to suggest that they are safe and effective for any use other than what is consistent with their FDA approved labeling, or to provide all available information regarding the products, their risks, or related clinical trial results. Anyone seeking information regarding the use of one of the company's products should consult the full prescribing information for the product, available on the company's website at www.unither.com. Thank you. Dr. Rothblatt, you may begin your conference.

Martine A. Rothblatt - United Therapeutics Corp.

Management

Thank you, operator. Good morning, everybody. Welcome to United Therapeutics' first quarter 2017 earnings call. My name is Martine Rothblatt. I'm the Chairman and CEO, and I'm joined on the call by our Chief Financial Officer James Edgemond and our Chief Strategy Officer Andrew Fisher, who is also known as our IP guru. I've got a few introductory remarks, and then we'll open up the lines for questions that can be directed to Andy, James or myself. This past quarter, we saw a continuation of the transient, temporary phenomenon of too few patients coming onto our therapies to offset the loss of our patients to either transplantation or death. This phenomenon is the result of patients remaining longer on AMBITION therapy than they have in the past, plus some diversion to Uptravi therapy, while duration on our true prostacyclin therapies, which are generally used after an initial challenge with either oral PDE-5 or oral ETRA therapies, has remained largely unchanged. I say this is a transient and temporary phenomena because the numbers of patients who need to be on our therapy are building up on the AMBITION protocol like an ever-larger backlog, and when they do break through to needing true prostacyclin therapy, which will be in the coming quarters, we expect to see a significant jump in Orenitram, Tyvaso and Remodulin revenues. Indeed, in the past quarter, the first quarter of this year, we saw for the first time since Uptravi's launch our decline of patients have stopped, stabilized and has begun growing again. So that's a huge good sign of what we can expect to see in the quarters to come. Now, whether these patients who are now moving onto United Therapeutics' therapies go onto Orenitram first and then Tyvaso, or Tyvaso first and then Remodulin, or straight…

Operator

Operator

Thank you. And our first question comes from the line of Geoff Meacham of Barclays. Your line is now open.

Evan Seigerman - Barclays Capital, Inc.

Analyst

Hi, all. This is Evan, on for Geoff. Thanks for taking the question. Just one about the interim look on the FREEDOM-EV study. What do you view as a reasonable bar for commercial viability and differentiation versus the competition? And does it matter if a patient is on one or more therapies? So basically, what's the role of combination therapy going forward?

Martine A. Rothblatt - United Therapeutics Corp.

Management

Thanks, Evan. Two insightful questions, indeed. So first of all, we've got an incredible biostatistics team here at United Therapeutics, and we assessed carefully the question of the interim work on the FREEDOM-EV study. And once we came to the conclusion that we were more likely than not to succeed with that interim look – of course there's no guarantee or assurance – but that we were more likely to succeed or not, we always ask ourselves at this company what's the right thing to do? And the right thing to do is, of course, avail patients of a therapy that could reduce their morbidity and mortality as soon as possible. So since the statistics dictated a greater than 50% likelihood of success, we chose to go for the interim look and that will occur later this year. The bar, I believe, is to show a reduction in morbidity and mortality which would then put it on par from a label sense in terms of efficacy, for sure, with Uptravi. Now, with regard to the second question, I think everybody would love for there to be a silver bullet for pulmonary hypertension, and Lord knows we continue to search for that. It would take way more time than I would have this morning to go into some of the very interesting, early, early-stage pipeline activities that we're looking at about new molecular entities that are capable of addressing two of the five pathways of pulmonary hypertension that have been left unaddressed despite 20 years of drug development. There are these five pathways that have been well-known for a generation: the prostacyclin pathway, the nitric oxide pathway, the endothelin pathway. Those, of course, have combined across them some 13 approved drugs. But then there's also the thromboxane pathway and the serotonin…

Evan Seigerman - Barclays Capital, Inc.

Analyst

Great. Thanks for taking the questions.

Martine A. Rothblatt - United Therapeutics Corp.

Management

Sure thing.

Operator

Operator

Thank you. And our next question comes from the line of Martin Auster of UBS. Your line is now open.

Mark Connolly - UBS Securities LLC

Analyst

Hi. This is Mark Connolly on for Marty. Thanks for taking my call. So following up with FREEDOM-EV, we noticed in the queue that some approval timelines were adjusted from previous guidance. And can you comment specifically on FREEDOM-EV, which was pushed to 2020 from 2019 and what that might mean related to the interim analysis planned this summer?

Martine A. Rothblatt - United Therapeutics Corp.

Management

Yeah, Mark, the guidance we'd give is that we have a group of projects that we call in the nearer-term guideline, in the nearer-term pipeline. And the only guidance that we're providing are that these products which are in the nearer-term pipeline will be launched in the four-year period 2018, 2019, 2020, and 2021. I don't have the whole list of them, but certainly FREEDOM-EV, which we go by the product name OreniPlus, because it's Orenitram plus background therapy. That's the study design, okay, that's something that will be launched in the 2018 to 2021 pipeline. And it's just too arbitrary to be able to parse the particular launch timeframe within a quarter or even within the break of an annual year. So with regard to the launch of OreniPlus, that would be nearer-term, sometime between 2018 and 2021.

Mark Connolly - UBS Securities LLC

Analyst

Okay, great. Thanks for taking my question.

Martine A. Rothblatt - United Therapeutics Corp.

Management

Sure thing, Mark.

Operator

Operator

Thank you. And our next question comes from the line of Terence Flynn of Goldman Sachs. Your line is now open. Terence Flynn - Goldman Sachs & Co.: Hi. Thanks for taking the question. Martine, just based on your pipeline review during your prepared remarks, is it fair to assume that you're content with your pipeline as it currently stands? Or should we expect more collaborations along the lines of the bio-printing agreement? Or would you even perhaps consider any mid-stage clinical assets outside of PAH? Thanks.

Martine A. Rothblatt - United Therapeutics Corp.

Management

Yes, Terence, we're not content. We at United Therapeutics looked at ourselves as like a restless engine, and we are always on the prowl for new opportunities. In fact, we find a lot of companies want to work with us and even would like to be acquired by us because the culture and the atmosphere at UT is so awesome. I know you're like a big statistics guy, like one stat figure is that the voluntary turnover at United Therapeutics is way less than it is at other biotech companies and pharma companies in our peer group. So people definitely want to be acquired, and we're interested in acquiring new technologies, new therapies. We're interested in both early-stage assets, such as those that are active in the thromboxane and serotonin pathways. We're interested in more advanced methods of current pathways. During the past quarter, we closed a deal with a terrific company named Respira, who was referred to us by one of the leading pulmonary hypertension physicians, Dr. Adaani Frost, down in Houston, and we're really excited about this IBAR [26:10] therapy, as I mentioned in my prepared remarks. In addition, we are – I think we're liked a lot by all of the major banks, including yours, Goldman Sachs, and as a result, the investment banking side of those firms bring to us these beautiful binders that are like at least an inch thick. And in them are pages upon pages of different companies that would they think could be good opportunities for us to acquire them. And we are in a very nice situation because we have the best and brightest minds from Goldman and JPMorgan and Wells Fargo and Citibank and what have you, have the best and brightest minds bringing us all of their cool ideas…

Operator

Operator

Thank you, and our next question comes from Liana Moussatos of Wedbush Technology. Your line is now open.

Liana Moussatos - Wedbush Securities, Inc.

Analyst

Thank you for taking my question. What are the next steps to get the 3D print transplant organs to the market?

Martine A. Rothblatt - United Therapeutics Corp.

Management

Yeah, Liana, thank you for that question. It's a step-by-step process and what I like about it is that it's now an engineering process. It isn't something that any longer requires fundamental breakthroughs in physics, something that doesn't require new inventions. It requires a step-by-step improvement of the engineering of our current technologies. So for example, today we have literally an assembly line of porcine lung decellularized scaffolds. And when I say an assembly line, we are decellularizing over 500 scaffolds a year, so that would be, once cellularized, that would increase the supply of lung transplants 25% in the entire country right now. We also have a parallel assembly line in another lab where we recellularize these scaffolds with allogenic cells, that is with human cells. So when the final organ is completed, it looks to the patient recipient just like a human lung, even though at its collagen skeleton, if you will, these are proteins that were originated in the – by instructions from a pig's DNA. Over time they will get completely replaced by human DNA-directed collagen. It will be a completely human lung. So these same technologies of scaffold management and recellularization of these scaffolds are exactly the same technologies that will apply to the 3D printed scaffold. Of course the great benefit of the 3D printed scaffold is that we can make these in any size and shape that is necessary for different patients' chest size. And another great benefit is that we can scale up the number of scaffolds far greater than we can do with the porcine decellularization process. And finally, it looks like it will be much less expensive as well. So the process is to begin printing the scaffolds with our partners at 3D Systems, basically branch by branch. There are,…

Liana Moussatos - Wedbush Securities, Inc.

Analyst

Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Alethia Young of Credit Suisse. Your line is now open. Alethia Young - Credit Suisse Securities (USA) LLC (Broker): Hey, thanks for taking my question. Just one on the timing of how you're thinking about when revenues might return back to some of the advanced therapies. I know if you look at AMBITION it seems like kind of the rate in which people had events was very slow in the combination arm, so I just wondered if you could talk about maybe what you're seeing in the real world and how that applies to your business maybe over the rest of this year. Thanks.

Martine A. Rothblatt - United Therapeutics Corp.

Management

Sure, I'm glad to. And this will be the last question, operator. So it's not a kind of a thing that you can be super precise about because we're in the realm of human affairs and there's thousands of patients on these AMBITION therapies. But what can be said, largely because we're dealing with relatively large numbers of people, is that about 15%, say one out of every seven patients or so, who are on combination therapies experience a morbidity or mortality event each year. Now, that does not ipso facto automatically mean that the patient is going to be immediately moved onto an advanced therapy. I think in the best case, at the largest treatment hospitals, that would ordinarily be what one would do, because it definitely is a bad sign to be suffering these morbidity events, which are things like requiring hospitalization, dropping in New York Heart Association functional class, significant decrement in six-minute walk distance, or significant deterioration in cardio-hemodynamics. But there are thousands of patients with PAH. They're seen all over the country. Many people live in rural areas. Not everybody can, like, get switched to a new therapy right away. So in real life, sometimes the rate of patients moving onto the more advanced therapies may be a little bit slower. On the other hand, in clinical trials, patients are monitored very intensively and are basically under a kind of, I would say, a subliminal encouragement to remain on therapy, whereas, what's usually the case in the real world is patients do worse on therapies than they do in clinical trials. So that's a factor kind of tending to move patients more to our therapies more rapidly. I have a chart that was prepared for me. It was very interesting. It showed that from the…