Earnings Labs

United Therapeutics Corporation (UTHR)

Q2 2008 Earnings Call· Thu, Jul 31, 2008

$571.66

+0.45%

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Transcript

Operator

Operator

Good morning, my name is Tim and I will be your conference operator today. At this time, I'd like to welcome everyone to the United Therapeutics Corporation second quarter earnings 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 will include forward-looking statements which represents United Therapeutics' expectations or beliefs regarding future events based on current assumptions. United Therapeutics cautions that such statements involve risk and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in the United Therapeutics' periodic and other reports filed with the SEC. There can be no assurance that the actual results, events or developments referenced in such forward-looking statements will assure or be realized. United Therapeutics assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions, or changes in factors affecting such forward-looking statements. Thank you. Dr. Rothblatt, you may begin your conference.

Martine Rothblatt

Management

Good morning, everyone and pleased to show to you our second quarter 2008 financial results today. The United Therapeutics team on the call today really spans quite a bit of the globe and over eight time zones. I'm in California this morning for my niece's Bat Mitzvah; and Roger Jeffs, our President Chief Operating Officer is in the U.K., both on a well deserved vacation, but still managing our sales marketing and clinical development efforts via the wizardry of digital technology; and John Ferrari, our Chief Financial Officer, is minding the store at our Silver Spring headquarters, ensuring that all of the confluent [ph] companies, all of the sheckles coming in to the company are being counted to exacting GAAP standards. So, the three of us are here today to answer your questions and after I give a brief introduction, we'll open up the lines to provide you any color or additional information on things that might be of interest to you. On most quarterly conference calls, we assess how we've been doing in terms of our what we call our three main thrusters, those being revenues, profits, and milestones, and I'm glad to report that we're doing absolutely great. All of three thrusters are firing, I would say, at optimal capacity. For example, starting with revenues, revenues this quarter are up 32% from the matching quarter previously, topping over $68 million. Profits are up 125% from the matching quarter in 2007, and in addition, our earnings before non-cash charges are up over 70% from the matching quarter. So, the financial metrics are looking really, really good here and for me it's extremely gratifying that we're on track to grow our annual revenues in excess of 30% for the sixth consecutive year and it's –- all of us just –-…

Operator

Operator

(Operator instructions) Your first question will come from the line of Jeff Meacham. Jeff Meacham – J.P. Morgan: Hi, can you hear me?

Martine Rothblatt

Management

Yes, Jeff. Good to hear your voice this morning. How are you doing? Jeff Meacham – J.P. Morgan: Good. Thanks, Martine. Hey, a question for you on the FREEDOM-M trial. Just wanted to know where you guys were with enrollment when you're set to have sites activated and in the end what impact do you think this could have on the enrollment term?

Martine Rothblatt

Management

Sure. Doctor Jeffs would you like to fill that question?

Roger Jeffs

Analyst

Yes. Happy to, Martine. Good morning and good afternoon, Jeff. The FREEDOM-M is moving along nicely. The patient enrollment number now is 128 and while that hasn't moved too much from the last call, I think the important thing as you alluded to is that we have five of the six centers in India are currently active, so they have steady drug and are screening or enrolling patients. We've had our first patient enrolled last week from one of the centers. We are actually going on a fairly governed and measured approach initially to make sure that they entered the first patients correctly, performed all of the initial procedures, including the important walk test as it should be done. And then, we're going to allow the gates to open, if you will, and let more patients in. We have one center, for example, that has seven patients waiting to go into the study, but we're having them do one patient first before they entered the other six. So, I think with this – with this six Indian centers, as well as the continued effort from the centers in the U.S. and Mexico, we are confident that we can enroll that trial late in the third-quarter of this year or early part of fourth-quarter of this year, which then, as Martine said, should provide an unblinding from the monotherapy trial in the first half of 2009. Jeff Meacham – J.P. Morgan: Thank you.

Operator

Operator

Your next question will come from the line of Jim Urchno [ph].

Jim Urchno

Analyst

Hi, Martine. Just want to add my congratulations for the quarter.

Martine Rothblatt

Management

Thanks so much. We appreciate it.

Jim Urchno

Analyst

So, just a question on the overall prostacyclin market. Could you maybe give us an update on where we're at in terms of the prostacyclin market? What kind of growth we're seeing in prostacyclin use? Where Remodulin is in terms of market share and how much more room do you think you have to grow as, I guess, the big question?

Martine Rothblatt

Management

Sure. Great question. The prostacyclin market is a really fun and exciting market to look at because it's segmented really so nicely and therefore it's something that you should really take a look at different market shares. We– as you can tell from our financial results this quarter, we're getting very very close to tracking at just about $300 million a year in terms of sales for Remodulin and that's split pretty much 50-50 between IV and subcu Remodulin. To the best of our ability to determine, neither each of, let me say, each of the Ventavis sales and Flolan sales are each below $100 million per year. And therefore, by sort of, anyway that you slice and dice the market, it's clear that Remodulin is the leading form of prostacyclin, at least in the United States today. Now, in terms of continued growth, the growth that we have seen is mostly what I would call organic growth. Meaning that it's mostly growth from all non-responders coming into Remodulin. And indeed, the message, when we survey doctors in the field, the key information that is coming back from the specialist in treating pulmonary hypertension is that at the first sign of the decline, meaning decline from a patient who's been treated with Tracleer or Revatio, or Vicares [ph], at the first sign of decline put the patient on Remodulin and that seems to be the key message which is out there right now. Now, to the best of our ability to discern, there's something north of 20,000 patients currently being treated with oral meds for pulmonary hypertension. Again, either an ETRA [ph] or PD5 [ph] or combination of the two. And, on the other hand, there is less than one out of – less than 20% as many patients are…

Jim Urchno

Analyst

Okay. Thanks for taking the question.

Martine Rothblatt

Management

Sure. Good question.

Operator

Operator

Your next question will come from the line of Yuan Wang. Eun Yang – Jefferies & Co.: Hi. This is Eun Yang from Jefferies. What inhaled and oral versions of prostacyclin are on the market? I'm just wondering in terms of the combination used, how would you position those two drugs? Like to get your thinking on the strategy.

Martine Rothblatt

Management

Trepostinil One is the combination study which we call Freedom-C and that's one I indicated would be unblinded during the next quarters. So very, very important, and interesting, and fascinating news event. And then another study of it is monotherapy

Analyst

So, it will be a– we'll be able to answer that question very precisely with the outcomes of the FREEDOM trial. But let me say that the– whether the outcome is that it's used mostly as solo monotherapy or if the outcome is that it should be used preferentially just as combination therapy, United Therapeutics wins either way, and the reason for that is that there are already more than 20,000 patients on oral background therapy. The PD5 inhibitors such as Tadalafil or the ETRA's, and that's a huge number of patients compared to the number of patients on Remodulin, for example. And if the only market that we address was the combination market, adding inhale Trepostinil and oral Trepostinil on top of the meds taken by the currently treated 20,000 patients, you will see a multi-fold increase in United Therapeutics revenues. And, it's for that reason that all of us at United Therapeutics feel that we're very honored and favored to have an opportunity to build this biotechnology company that simply through doing a good and rigorous job of making prostacyclin therapy easier to take, that we can broaden the market and therefore allow many more people to get the benefits of what all the prescribers agree is the gold standard in pulmonary hypertension treatment, namely, prostacyclin therapy. Eun Yang – Jefferies & Co.: Thanks very much for the clarification.

Martine Rothblatt

Management

Sure, good question.

Operator

Operator

Your next question will come from the line of Bret Holley. Bret Holley – Oppenheimer & Co.: Yeah. Hi. Thanks. Thanks for the back [ph] question and good morning everyone.

Martine Rothblatt

Management

Hey, Bret. How's it going? Bret Holley – Oppenheimer & Co.: Alright. How are you?

Martine Rothblatt

Management

Good. Bret Holley – Oppenheimer & Co.: I have a question. I'm just wondering if your kind of reiterating your expectation for a 10% to 15% dropout rate and FREEDOM-C That's kind of what you were talking about May, and I'm just wondering if there's any update on your thinking on that?

Martine Rothblatt

Management

Let me ask Dr. Jeffs to talk about that clinical question.

Roger Jeffs

Analyst

Sure Bret. Good morning. Yeah, I think we're still in the range. Probably, going to trend a little bit towards the upper end of that range. I think, as the last patients to complete the study, as you know, the last patient will exit the study in mid September, so its a little hard to predict exactly what the final percent drop-out will be. But roughly speaking, it will be in the sort of upper end of the range that you talked about. Some of the reasons for drop-out has been more towards clinical worsening than they ease, and we think that's a good thing. So, we don't get too concerned if drop-outs got to the upper end of the range, particularly if it happened to be – if it turns out to be in the placebo group more preferentially than the active group in this later half of the study. So, the good news is we're not too far away from unblinding and knowing where the drop-out fall and then seeing what the impact of those drop-outs are on the effect size and the statistic. So, I think in general speaking, the range that we said in the last quarter is still true, although I would – I would maybe target you guys to the upper end of that range. Bret Holley – Oppenheimer & Co.: Okay. So, upper end meaning around 15% then?

Roger Jeffs

Analyst

Exactly. Bret Holley – Oppenheimer & Co.: Okay. And then, one other question I have was what was – is – has been the feedback from the European regulators going into the filing for inhaled in Europe. Obviously they're not filed yet, but what is the feedback been about the single trial and that approach, at least, in terms of European approval?

Roger Jeffs

Analyst

Yes, we've – that's a good question. So, we've had this similar types of discussions that one would have in the U.S. in terms of Pre-NDA meetings. So, we've had a discussion about the filing – the contents of the filing and that was fine. They were more than happy with the single study filing and the statistic that we presented to them that the study provided. We did talk about some of the data a little bit more in depth in the pre-filing meeting than we did at the FDA and with that, I think they had additional comfort with the study and its design and the data that was provided from the study. We've even been assigned at rapators [ph], it's a centralized filings, so a little bit different than what we did for intravenous and sub – than we did for subcu. What we found that by mutual recognition, this one went through, is going to go through a central filing so it will be a one stop approval across all countries which we think is a much better approach for the inhaled filing and those rapators have been assigned. So, we're doing some of the things that one must do in Europe which includes writing a pediatric plan. There's a risk management plan as well that one does, just talks about how we are going to assess the post marketing situation. And all of those pieces are being put in place as we head towards the December filing. So, in general, the electronic filing for Europe is fairly similar to what you see in the States although the format can be a little bit different so that's why it's taken sometime. In addition, we need to do these pediatric and risk management plans along with it. So, I would say everything is 100% on target for an end of the year filing. Bret Holley – Oppenheimer & Co.: Okay. Thanks very much, Roger.

Roger Jeffs

Analyst

Sure.

Operator

Operator

Your next question will come from the line of Matt Kaplan. Matthew Kaplan – Ladenburg Thalmann & Co.: Hi. Good morning. Thanks for taking my question and congratulations on the great quarter.

Martine Rothblatt

Management

Thanks, Matt. Matthew Kaplan, Ladenburg Thalmann & Co.: Could you talk a little bit about the quarter in terms of what happened during the quarter, specifically in the revenue side, 0-inventory levels et cetera? Why you did such a good job?

Martine Rothblatt

Management

Sure. John Ferrari, our CFO, can give you a really good analytic breakdown of the different components there. John?

John Ferrari

Analyst

Hey, Matt. How are you doing? Matthew Kaplan, Ladenburg Thalmann & Co.: Doing good.

John Ferrari

Analyst

I think the quarters – if you take a look at them previous quarters, I mean, most of the growth there has been through increases in patient counts and just use of Remodulin. So, I mean, that's the primary reason why revenues have grown. Inventory has been wrote – but patient count, actually, for the quarter, inventory levels went down but nothing significant. So, it's really just organic growth from patients. Matthew Kaplan, Ladenburg Thalmann & Co.: Great. And then, just a follow-up on the questions that were asked previously on account of dynamics of the current– in the current market, in the current business. And just some insight in terms of with the introduction of the inhaled product and then the potential introduction of oral product, how is that going to affect your current based business in the parenteral therapies, and then with the introduction the oral products, how will that impact the potential introduction of oral product, how would that impact the inhaled business?

John Ferrari

Analyst

Right. So, I really don't think that there's going to be anything but a positive impact from the introduction of those two therapies on our revenues and here's the reasons why. By the very nature of it's therapy, parenteral therapies are reserved for patients who have not been able to achieve success with earlier therapies, and to give you an example of a market which is more mature than the U.S. market in terms of inhaled therapy, inhalation therapy has been used in Germany for as long as Flolan has been used here, upwards of 10 years. And when patients are no longer responsive to inhalation therapy, inhaled Iloprost, they are transitioned to parenteral Iloprost or IV Iloprost therapy, and sometimes this is done if a bridge to transplantation mode, and sometimes this is done basically just to be able to get a better quality of life, better exerciseability, move a patient that is perhaps thinking toward Class 4 status back up into Class 3 status. And that's the role the parenteral therapy seems to play best in terms of prostacyclin therapy. But with oral and inhaled, we're going to be trying to push the curve, if you will, push this prostacyclin therapy earlier in the stage of disease. So even though our IV and subcu therapies have a label indication of Class 2, 3. or 4 New York Heart Association class. In practice, because it's such a invasive therapy, walking around with the catheter for the rest of your life, dwelling into your abdomen or into your chest, it's something that by its very nature doctors going to reserve for New York Heart Association class 3 or 4 patients. But with a inhalation therapy, this is something that can be pushed forward in the differential treatment algorithm [ph] for…

John Ferrari

Analyst

Sure.

Operator

Operator

Your next question will come from the line of Lucy Lu. Lucy Lu – Citigroup: Great. Thank you. Martine, your planning an oral Remodulin and dosage [ph] ranging study that would explore the relationship between dose and therapeutic effect. My question is that, if you already know how well oral Remodulin and dosages translate into IV subcu equivalent, what additional information are you hoping to get from the study? Can you just provide some details?

Martine Rothblatt

Management

Sure Dr. Lu. Thanks for the question. Glad you can attend the call this morning and let me ask Roger to give you that color.

Roger Jeffs

Analyst

Yes. Certainly. Good morning, Lucy. I think, it's really more if, to think about the dose ranging study, I would think of it as a labeling study. So in essence, what we're trying to do, and it speaks somewhat to our confidence in the current trials, is it's a Phase 4 study done pre-approval. So one of the issues that comes up with prostacyclin in general, and this could be for a Trepostinil or Trepostinil, is that there is no– in this labeling, there is no upper dose described and in fact the dosing information is patient centric and patient specific such that it really doesn't describe how (inaudible) doses, week by week, or month by month, or year by year. It just says, “Dose to clinical benefit and tolerance.” So, that can make some regulators uncomfortable that there is no upper limit. So what we are trying to do with the dose ranging study is to show that if you pre-assign patients to this very specific indiscreet dose cohort [ph], either no dose, very low dose, or a higher dose, that the patients that got the higher dose did better and that would support the thesis that's always been employed with prostacyclin that giving more does lead to better benefits. So, in a way, it's somewhat – mostly addressing what I would say as a labeling issue, and it's also an issue that, for example, the FDA wants to know – has some interest in – they get uncomfortable with this open-ended dose ranging labels so what we said, “Well, we'll give you some clarity around that and show that there is a dose response to the therapy.” That's a very difficult answer to get out of the Titration studies that we have employed both with subcu and now…

Roger Jeffs

Analyst

No. So, it's not even part of our filing pieces. So, I think, technically, if we had– as we have with inhaled, that the combination came in at less than 01 and was robust at less than 01, we'd have a single study that was worthy of the filing and potentially be registrable. The fact that we have a second monotherapy study that Martine's described so close to unblinding, I think agencies should be keen to see that data at least during the review. So, those two studies, I think, are requisite for the approval of oral Remodulin. This other study, again, is – we could have waited till later to do it and shown that going low – you just lowered dose strength. Going lower, going slower was as good as going a little bit harder as we did in the trials. But we just decided we'd go ahead and start generating Phase 4 data earlier. I think you'll also see, once we unblind in the – in the fourth quarter of this year and our successes that will potentially start other Phase 4 type studies exploring patients with other types of pulmonary hypertension, like chronic thromboembolic, HIV associated, and really start getting the jump on expanding the usage of our product throughout the entire PAH continuum. Lucy Lu – Citigroup: Alright. Thank you.

Roger Jeffs

Analyst

Sure.

Martine Rothblatt

Management

Great. Operator, we have time for one more question.

Operator

Operator

Thank you. Your final question will come from the line of Liana Moussatos. Ms. Moussatos, your line is open. Liana Moussatos – Pacific Growth Equities: Hi. Thank you. I just want to make sure that I heard correctly that you expect to unblind Freedom-C in November and the last patient is mid-September?

Roger Jeffs

Analyst

That's correct. Liana Moussatos – Pacific Growth Equities: Okay. Thank you.

Martine Rothblatt

Management

Great. I'd like to thank everybody for participating on our conference call this morning. Its – as you could see from the results and we really appreciate the congratulations. It's been a fantastic quarter. It's one where U.K talk continues to keep exactly to its growth targets and not only in terms of looking backwards, but, looking forwards. We have a really exciting set of milestone coming up in the second half of this year and the first half of next year. And, its a real pleasure, on behalf of the entire United Therapeutics team, to share with you our confidence and satisfaction with the revenues, profits, and milestones push portions of our company with our ability to continue our growth rate in revenues and profits going forward, and continue on blinding exciting scientific results that can open if they bring the power of prostacyclin to every single pulmonary hypertension patient. Thanks so much for visiting in this morning, I look forward to seeing you at the upcoming investment conferences in September, October, and there after. Thank you very much.

Operator

Operator

.: .: