United Therapeutics Corporation
Q1 2015 Earnings Call Transcript

Published: 28 Apr 2015

[Operator:]

Good morning. My name is Andrew and I’ll be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation’s First Quarter 2015 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Remarks today concerning United Therapeutics Corporation will include forward-looking statements, representing the company's expectations or beliefs regarding future events. The company cautions that such statements involve risks and uncertainties that may cause actual results to differ materially from those projected in the forward-looking statements. Please see the company’s latest forms 10-K and 10-Q and subsequent filings with the SEC for additional information on these risks and uncertainties. There can be no assurance that the actual results, events, or developments referenced in these statements will occur or be realized. The company assumes no obligation to update forward-looking statements to reflect actual results, new information or changes in underlying assumptions. Today’s remarks are intended to educate investors about the company. This may include reporting on the progress and the results of clinical trials or other developments with respect to the company’s products. Today’s remarks are not intended to promote the company’s products to suggest that they are safe and effective for any other use 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 products available on the company’s website at www.unither.com. Thank you, and Dr. Rothblatt. You may begin your conference.

[Martine Rothblatt:]

Thank you, operator. Good morning everybody and welcome to our United Therapeutics quarterly conference call. I will start off by providing some overview top line information and then open up the call in a couple of moments for your questions. I’m joined on the calls today by our Co-Chief Executive Officer and President of the company, Dr. Roger Jeffs; our Chief Financial Officer, Mr. James Edgemond; and our Chief Strategy Officer who also receives all of our intellectual property portfolio Mr. Andrew Fisher. So with regard to the top-line information, we reported revenues of just over $327 million for the quarter. Our GAAP net loss was $16.6 million. To understand that you really have to realize that that reflects the accounting treatment required for what we call our share tracking awards program. These are sort of shadow stock options effectively that are settled in cash by the company and we’ll having a stock option plan. And these combined with the stock options that also are issued pursuant to the stock option plan have an accounting treatment which have to be – has to be mark-to-market each quarter. So in periods of time when the company’s stock price rises relatively rapidly such as during the first quarter of this year then those share tracking award program or STAP as we call them for short get marked up in a way that makes some look through much more expensive, conversely in the quarter when the company stock price declines, sometimes the GAAP profit looks much better because there’s actually a negative value or a lower value that can be assigned to the STAPs. So because of this confusing accounting treatment or let me just say somewhat you know obscuring accounting treatment with regard to underlying operations of the STAPs, we also report non-GAAP earnings and these non-GAAP earnings were $135 million for the past quarter or about $2.55 per diluted share. So those are strikingly positive numbers. And a little bit of color on how we’re trying to bridge this bit of disconnect between the net loss and the strong non-GAAP profit. We intend and subject to the board of directors approval to ask shareholders to authorize a new stock option plan within ISS boundary parameters that we’re hopeful we’ve get a positive recommendation from them and then we could start gravitating away from the STAPs hopefully ending them completely over a period of a few years, and only offering stock options, which are accounted for in a more conventionally understood way with regard to our peers. So, that’s one thing that I think is gong to bridge that difference. And we also have an ongoing stock buyback program, which has helped our diluted share count continue to decrease. And we are still well in the midst of that buyback continuing to buyback shares everyday pursuant to board’s resolution or pricing committee’s resolution to buyback shares up to a price of $200 per share. So we’re continuing that buyback, which also helps on the diluted shares. Now to provide a bit of color on the operations, as I said, these – the staff accounting can somewhat obscure the affects of operations. We’re reporting revenues for four different products

[Operator:]

[Operator Instructions] Our first question for the day comes from the line of Joseph Schwartz from Leerink. Your line is open.

[Joseph Schwartz:]

Great, thanks so much for taking the question. I was wondering if you could give us an update on the implantable pump program with Medtronic and in particular where does this stand with the FDA relative to the RTF latter and consent degree that they received for the – from the FDA?

[Martine Rothblatt:]

Let me refer that question to Dr. Jeff.

[Roger Jeffs:]

Yes, thanks for the question Joe. So we just learned of the consent degree when the market did which was yesterday afternoon. So we’re not really fully informed on the aspects from the degree, which was specific to their neuromodulation unit and whether or not that will then have sort of tangible impact on the Remodulin implantable system in the PMA filing that Medtronic did late last year. So the good news is we had already had a scheduled meeting. Medtronic and UT are going to conduct together with both CDER, the drug division, and CDRH, the device division for early May and we’re going to see further clarity on the true impact of the consent degree of any on the filing. And if there is material impact on that we’ll update next quarter. The refusal to file was more of an administrative refusal on our NDA. Remember, we were going to submit as a label supplement, the FDA asked us to submit that as an NDA. When it – that beats up the application and required that we submit the study reports that – for the trials that Medtronic have conducted. Those were in – what’s called CDRH acceptable formats of the device division has a format that they like to see. They are in ICH format, so we submitted those with understanding we thought from CDER that that was the format that they wanted to see them and it turns out that was not. They want to see them in CDER specific format. So we’re reformatting those documents as we speak. So the refusable file was around that. We don’t think that will have a material impact and certainly whether or not the consent degree impacted some of that and they’re waiting to have the face-to-face meeting with us or not is going to be a part of the conversation. So that’s the impact. We really don't know what the impact is. We will seek some clarity and as Martine said it's an important platform that both physicians and patients are eager to see progress. So that’s something we’re fully supporting.

[Joseph Schwartz:]

Okay. Great, thanks for all the color.

[Martine Rothblatt:]

Thank you, Joseph. Thanks Roger. Operator, next question please.

[Operator:]

Thank you. Our next question comes from the line of Hartaj Singh from BTIG. Your line is open.

[HartajSingh:]

Hi. Thanks for the question. I actually want to ask about a program that you had not mentioned, Martin, the UNITUXIN program. I know that’s got approval in the U.S. and then it’s going through the process in the EU. Can you just kind of walk me through the launch and then how quickly you would expect to have those patients in the U.S. and EU in the second half of this year and in 2016? Thank you.

[Martine Rothblatt:]

Yes, thank you very much for the question, sir. I’d like to direct that question to Dr. Jeffs.

[Roger Jeffs:]

Thanks Martine. Thanks for the question, Hartaj. So, hopefully, everybody knows UNITUXIN was approved in this quarter in the U.S. at the GD2 binding monoclonal antibody indicated in combination with combination with GM-CSF and interleukin-2, and 13-cis-retinoic acid for the treatment of pediatric patients with high-risk neuroblastoma who have achieved at least a partial response prior to first line multi-agent, multi-nodal therapy. It does have also some black box warnings, so it's going to used in special pediatric oncologist because of life-threatening potential for infusion [indiscernible] and some neuropathy. So I want to make sure people understand that there's a black box to that as well. The – we are progressing the launch in the states. It really won't take much of the sales force let’s say fairly discrete population of patients of between 350 and 500 in the U.S. Most of those patients are – who do present with this – the indication that I described are receiving UNITUXIN as part of an open label trial now. So the addressable market is mostly captured. And we don't think that it won’t change necessarily because we’re not going to promote which is going to serve that market and assist them with getting commercial supply of our manufactured antibody. We will launch in the second half of the year in the U.S. and we expect revenues to come forward during the second half of the year. We’re still working on pricing, so we won't really give you a number that we attempt to – we were going to attempt to receive this year, but we think the addressable market globally is around 75 million to 100 million equally distributed between the U.S. and the EU. As to the EU, pleased to report that we have responded to their comments, so the clock has restarted so there 180 day clock it’s progressing. That means very quickly within 30 days basically we’re going to have a final opinion from the CHMP and that will then lead to a final commission decision in late July. So, we should add some action in the coming months and we can provide clarity through press release if we were approved or not accordingly. That launch will be probably delayed – not delayed but will occur in 2016 once we get the logistics sorted for pricing and country by country specific labeling that need to occur translations, et cetera, is a bit more of an effort because of the different cultures that will receive that therapy. So all is progressing very nicely with UNITUXIN, we’re very pleased to have launched our pediatric oncology franchise with UNITUXIN as our lead and look to build out that franchise in the coming years.

[Martine Rothblatt:]

Thank you, Roger. And thank you for the question regarding UNITUXIN. Operator, next question, please.

[Operator:]

Thank you. Our next question comes from the line of Phil Nadeau from Cowen and Company. Your line is open.

[Phil Nadeau:]

Good morning and thanks for taking my question, also one on the implantable pump. Can you give us some idea of the FDA’s thinking in reclassifying the filing from a label supplement to an NDA. What was it about the filing that that made them want to do that? And then second, just generally on a consent decree process, I understand that you don’t have complete clarity on what’s happening with Medtronic, but generally in a consent decree process like senior [indiscernible] situation that there is a point in the consent decree where new approvals can start happening, again I think it’s after the company summits the remediation plan to the FDA. Is that your understanding to and where Medtronic is in that process? Thanks.

[Martine Rothblatt:]

Okay, well, thanks for the questions from Cowen. And I’d like to ask Roger to please project those.

[Roger Jeffs:]

And so Phil, I will answer the first of your question, which is what – why an NDA versus labeling supplements, it’s really administrative and something we accepted I think it’s good for the Remodulin and fusion system franchise that NDA from our point of view. I think it gives CDER a little bit more of foot in the game so to speak. It’s not simply a device approval when it’s an NDA, it’s also now a drug approval. So put the drug in the device on sort of equal footing. It’s truly – it’s simply administrative that as to the ramifications of the consent decree as I said we just learned of this yesterday. I’m sure Medtronic is quite capably handling a response to that and has clearly taken the decree very seriously based on what we’ve seen today. We’ll work with them closely to get a better understanding and understand the impact of any on the Remodulin and in fusion system. And they’re keen to work with us as well. We’ve been very good partners with them and we expect that to continue. But we can’t comment on anything other than that at this point.

[Martine Rothblatt:]

Thanks, Roger for the answer and count for the question. And operator next question please.

[Operator:]

Sure. Our next question comes from the line of Liana Moussatos from Wedbush Securities. Your line is open.

[Liana Moussatos:]

Thank you for taking my question. Can you update us on the status of Remodulin sales in China and Japan?

[Martine Rothblatt:]

Thanks, Liana. I’d like to ask Roger to address that question please.

[Roger Jeffs:]

And if I could – the James Edgemond is here with me if you don’t mind.

[Martine Rothblatt:]

Sure, no problem, James.

[James Edgemond:]

Thanks.

[Roger Jeffs:]

Got to give him something to talk about.

[Martine Rothblatt:]

Yes. Absolutely, he is the CFO; he is accounting the Chinese and Japanese incomes.

[James Edgemond:]

Thanks Roger. Thank you for the question. So, a couple of things, one just to be clear we expect our revenues will continue to be primarily generated from the U.S. sales. So I just want to make sure that’s clear. But also from a China and even at Japan standpoint, we typically refrain from offering guidance on new product launches and product launches in countries. I think we’re going to stick to that approach. But the observation is that the uptake of new drugs in an EPH market tends to be a gradual process. And so, we just want to keep that in mind going forward about revenue contributions.

[Martine Rothblatt:]

Thank you very much James. And we are – sorry not to able to provide you with the real specific communicative guidance on that. Operator, next question?

[Operator:]

Thank you. Our next question comes from the line of Mark Schoenebaum from Evercore ISI. Your line is open.

[Salim Syed:]

Hey, guys. Thanks so much for the question. This is Salim in for Mark. Just one question on Orenitram, Martine. So I know you mentioned all the details and thank you for that that was very helpful. I’m still confused of why is there – why was there a little quarter-over-quarter growth? I mean [Indiscernible] have been titrated up, there should be still some growth quarter-over-quarter, right. So may be if you could give us some color into that. And then on just your subcutaneous semi-disposable pump and how should we think about that pump in light of the study med competitions. Thanks.

[Martine Rothblatt:]

Yes, so the quarter-to-quarter is the numbers are so small that you’re not going to be able to really get any insight from something that’s going $6 million to $7 million to $8 million. Those are just fluctuations in ordering patterns from the distributor. As mentioned April is at $8.5 million and that’s just the normal sort of growth that you’re going to see. You’re going to see. You’re going to have some people moving back and forth that they go to Orenitram and perhaps their condition worsens and they need to go back to Remodulin. So when you’re down here at the single-digit millions per month, there is nothing to read into the flat quarter-to-quarter there. What’s significant is that there are now basically 300 additional patients now actually a little bit more than that on Orenitram now than they were at the beginning of the quarter. And those 300 patients are overwhelmingly patients, who are coming in at their low dose and ramping up to higher and higher dose. And hence once they get the – they will move up through 100k, 150k, 200k a year. And furthermore an additional 100 patients are coming on to Orenitram each month. So the total momentum, the total vector is in the direction of right now something like between $150 million to $200 million revenue run rate once those patients get the full dose. But from just like when we’re at the very beginning of the curve, it’s – there is no significance in the differences month-to-month. As to the second question about the study meds, it’s kind of like – now it’s like a talk about people and then I hear so I really can’t say anything about study med. What I can say is that with the DEKA system which we call the unity pump is analogically, which in different, another way to say it continuously variable in its dosage across the entire spectrum of doses that people with pulmonary hypertension require from treprostinil. And this is – this is very important from a manufacturing standpoint, ultimately from the approval standpoint and from a patient and physician utilization standpoint. So, there is just as much continuous adjustability in the dosage that is available from the unity pump which we are doing with DEKA as there was in the legacy CAD pumps and even old MiniMed pumps that we were using previously for subcutaneous Remodulin. So from a user standpoint, from a regulatory standpoint, from a patient treatment standpoint there is like no difference. It’s the subcu pump that they – that has always worked brilliantly for everybody, but now it’s just like way more than advanced and way more convenient. And the patients don’t have to worry about changing out there the medicine with these 20 mill vials and whatnot. So it’s – I would say and I’m not really doing any hyperbole, in terms of a subcu pump it would be very hard to imagine something there could be A. easier to use; and B) more continuously dosable and this – then this device which we would hope to launch in the 2017 timeframe.

[Salim Syed:]

Great, thank you.

[Martine Rothblatt:]

Sure. We have time for one last question operator.

[Operator:]

Okay, our last question for today is from the line of Robyn Karnauskas from Deutsche Bank. Your line is open.

[Evan Siegerman:]

Hi, this is Evan on for Robyn. Thank you for taking my question. On Tyvaso, so with the combination study is this Phase III enrollment hitting commercial revenues at all?

[Martine Rothblatt:]

I don’t believe it is. The first reason for that is that the total size of the study is only about 240 patients or 250 patients I can’t remember the exact number but something like that. And that is just opposed by they are being something like 3,500 patients on Tyvaso. So you could see that it’s a very small percentage of the total number of patients. And then those 3,500 patients are themselves represent not even a third of the target market for Tyvaso, which has been pegged at 10,000 patients for a quite a number of years. So we’re making good and steady progress in penetrating those 10,000 patients. But I think what is needed is to amplify the efficacy of that therapy by providing the triple advantages that these protocol offers. Those triple advantages are first of all better pharmacokinetics because it got systematic pharmacokinetics that balance the in filled pharmacokinetics. Secondly, better pharmacodynamics because you’re now impacting the disease state – the animal proliferation in the tiny capillaries just off the alveoli. You’re impacting them systemically from esuberaprost and then you’re impacting them coming from the airway side with Tyvaso. So you’re really able to be – attacking those occluded tiny, tiny millions of arterials from both directions, which is an important pharmacodynamic enhancement. And then finally, you’re able to add this really unique and interesting ability to address and refresh different sets of prostacyclin receptors because both the treprostinal molecule in Tyvaso and the esuberaprost molecule addressed overlapping, but different sets of receptors. So things such as ultimately saturation of receptors can get more of a refresh and we can get what is our hypothesis to test a more potent overall response. That in turn, we believe we will allow us to build the Tyvaso market up from where it is right now in the 3000 I mentioned during introductory remarks up to a target of at least 50% of its target market, 5000 patients and with the stacked revenues of Tyvaso and esuberaprost, that’s a second billion dollar revenue pipeline in addition to the billion dollar revenue pipeline associated with Orenitram.

[Evan Siegerman:]

Great, thank you for taking my question.

[Martine Rothblatt:]

Sure, thanks, my pleasure. Well, I’ll ask the operator to wrap-up the call, I know that you can meet face-to-face with Roger and I at various healthcare conferences as well as with James Edgemond, Dr. Jeffs will be – I believe at the Deutsche Bank Conference and I believe I’ll be in New York at the Wedbush conference. So we look forward to seeing you over the next few months in person. Operator, feel free to wrap-up the call.

[Operator:]

Thank you. Thank you again ladies and gentlemen for participating in today’s United Therapeutics Corporation’s conference call. This call will be available for replay beginning at 8.30 a.m. Eastern Standard Time today through 11.59 p.m. Eastern Standard Time on Tuesday May 5. The conference ID number that you will need to use to connect to the replay is 28256741. The number to dial for the replay is [phone]. Alternatively you can dial [phone]. Thank you again for your participation and have a great day.