United Therapeutics Corporation (UTHR) Q4 2009 Earnings Report, Transcript and Summary

Good morning, my name is Melissa, and I will be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation fourth quarter earnings conference call. (Operator instructions) Remarks today concerning United Therapeutics will include forward-looking statements, which represent 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 occur 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.

Thank you, operator and welcome everybody to our fourth quarter 2009 and 2009 annual financial results conference call being held here both in Washington with our Chief Financial Officer, John Ferrari and myself; and across the pond in London with Dr Roger Jeffs, our President and Chief Operating Officer. I hope everybody had a nice three-day weekend, and I know for many of us in the Mid-Atlantic area, it has been more like a two-week weekend with all of the blizzards and bases without work. But we at United Therapeutics have worked hard all through the weekend to do our regular business and also to be prepared for this call. So, we look forward to questions after a few opening remarks. I would like to start off by saying that I am really pleased that our revenues for 2009 grew in excess of 30% for the eighth consecutive year now totaling just about $370 million. So, really it is like a skin-pinching number for us. We could have scarcely believed eight years ago, when we were back at $20 million, that we would be able to continue at 30% growth rate year after year. We were warned that there is a law of large numbers that prevents companies from being able to grow at sort of our targeted PE figure too many years. But, in the case of United Therapeutics, I think we have trumped, at least for the foreseeable future, the law of large numbers with the law of great drugs, and along with the continuing positive trend relative to Remodulin, we are excited about the potential to reach even more pulmonary hypertension patients in 2010 with Tyvaso and Adcirca. So, this is going to be our first calendar year with three fantastic medicines and those are our three great drugs that we can trump the law of large numbers with and hopefully notch our targeted growth rate for a ninth year at the end of 2010. Going back to 2009 though, we are also really excited that we turned around our GAAP loss from 2008 into a $19 million GAAP profit in 2009. So that was really exciting but perhaps much more meaningful is the fact that our earnings before non-cash charges climbed up to $140 million in 2009. That is 25% more than the $120 million we did in 2008, and I think, if I had to boil down this entire financial report to the two most salient numbers, they would be $370 million total revenues, just about $150 million cash profits, we are really excited, those are impressive numbers. And going forward into 2010, as mentioned, we hope to continue this growth rate by the additional strength of Tyvaso and Adcirca and for those of you who are more interested in what is really around the corner, 2010 is also really exciting because it is the last year before our anticipated unblinding of the most transformative drug in our entire history, oral treprostinil, which we hope to have that unblinding in 2011. So, both from a number standpoint, from the patients treated standpoint, from a new drug standpoint, and from a pipeline standpoint, it is a great time here at United Therapeutics, and I would like to now ask the operator to please open up the phone lines and we will take the calls in the order received.

Thank you. (Operator instructions) At this time, we will take our first question from Geoff Meacham of JP Morgan. Geoff Meacham – JP Morgan: Great. Thanks for taking the question Martine.

Good morning Geoff, and it looks like that God of numbers is really on your side because I actually understand that you turned 40 today, Happy Birthday. Geoff Meacham – JP Morgan: Thanks.

So, somehow the God of numbers made you first in the queue, so Happy Birthday and fire away. Geoff Meacham – JP Morgan: Right, I appreciate it, just want to talk to you about the Tyvaso launch metrics, I am wondering if you can give us a sense for the patients exiting the quarter, and maybe help us characterize them in terms of maybe de novo starts versus switches from Ventavis versus parenteral patients from Remodulin.

Great question, Geoff. Yes, we are doing really, really well. The team here thinks it is best for me not to give out a precise number but I can tell you that we are basically virtually kissing, to use a Valentine’s Day analogy, the 1000 patients figure that we had mentioned as our goal for the beginning of the quarter. So, we are as close to being in terms of number of patients scripted, number of unique patients scripted, and it is off to exactly the kind of start that we had anticipated. Based on that, we are even more confident than we were back in the fourth quarter that we will be able to achieve our goal of having 80% market share of the inhaled pulmonary hypertension space by the time that Ventavis goes off patent two or three years from now, because even in terms of patients, we are right now, I don’t really know the exact number of patients, but I would say there are about as many patients being scripted for Treprostinil or Tyvaso as there are for Ventavis. So it is off to a fantastic start. With regard to the make-up of those patients, you basically can read into my just completed sentence that we are not seeing a whole lot of patients being transitioned from Ventavis to Tyvaso. The majority of the patients are de novo patients who are not well optimized on the oral drugs, and the next place that they are stopping is Tyvaso. In the past, they probably would have stopped at Ventavis but now, they are predominantly stopping at Tyvaso. And it is not really all that unsurprising if you consider the fact that there are probably upwards of 20,000 patients being treated with either PD5 or endothelin receptor antagonists, and that on average patients will stay on those drugs before progressing to a new medicine, something like two or three years. So, you know, if you divide that number into that 20,000 maybe even 25,000 patients treated, and I am just talking about the US here, you can see the largest pool of patients is going to come from that pool. Having said that, we are getting Ventavis transitions. They are the minority of the patients. We have even had a handful of patients transitioned from parenteral on to Tyvaso although that is such a small handful it is really an anecdotal category. But the main engine of growth of Tyvaso is twofold. First of all, it is a fact that patients seem to stay on Tyvaso a lot longer. We are seeing very, very few drops from Tyvaso. On the other hand, the generally reported information is that the mean duration of a patient on Ventavis is probably in the nine-month category. And as you may recall, even after two years, we had not reached the 50% level of patients in the open label extension study on Tyvaso. So, this drug has a lot of sticking power, a lot of staying power. The second main driver is the ever-increasing number of patients who have been placed on oral drugs, Letairis, Persantin [ph], Sildenafil and now Tadalafil, and it is just unfortunately the relentlessly progressive nature of pulmonary hypertension is that the vast majority of the patients do progress and Tyvaso is now an extremely nice parking spot, only four times a day, couple of minutes per inhalation, and the unique mechanism of action of Trepostinil, which seems to be pulmonary selective and of course has a very long half life, is going to kind of exponentially increase the Tyvaso patient count. And that is why we are able to report that we have virtually achieved our goal that we quoted at the fourth quarter. Geoff Meacham – JP Morgan: Okay, thanks a lot. Thanks for the color.

Sure.

We will go next to Bret Holley of Oppenheimer & Company. Bret Holley – Oppenheimer & Company: Yes, hi, thanks for taking the question.

Bret, I don’t think it is your birthday today, right? Bret Holley – Oppenheimer & Company: No, it is not my birthday at all.

You are just lucky. Bret Holley – Oppenheimer & Company: Exactly. I am curious about your comment that the number of patients on Tyvaso at this point is approximately the same as the number of patients on Ventavis. Does that imply that essentially kind of within a couple of months here that the inhaled market has crossed the double as far as number of patients?

I think that is an excellent conclusion. I think it is a spot-on conclusion. Bret Holley – Oppenheimer & Company: Okay, and then just a second question is, how do you feel that your market share for Adcirca is lining up versus Revatio?

I can share for Adcirca doing really well and that we have kind of got a three-engine rocket system here with Remodulin, Tyvaso, and Adcirca and as we promised everybody back in 2009, we would break out the quarterly contributions of each drug separately. So, going ahead and taking a look at how Adcirca has done for the fourth quarter compared to the full year, you can see that it is growing at an increasing rate and that is what we expect. Our goal for Adcirca is calibrated similarly to the goal on Tyvaso, which in both cases we feel are kind of under-promising over-achieved goals, and that is true with Adcirca. We want to have 80% of the PD5 space by the time that Sildenafil or Revatio goes off patent and that is a little bit sooner towards the end of 2012, but that is okay because Adcirca is a much easier drug to prescribe. It is just a pill, it is a once-a-day pill. It is the only PD5 that has been able to show an ability to delay time to clinical worsening and doctors are really, really pleased to script it. So, if you kind of, you know, draw a linear path, that will take us to 80% market share. We will be there by the end of 2012 when Sildenafil goes off patent. Bret Holley – Oppenheimer & Company: Right. Thanks very much for the color.

Thank you.

We will go next to Liana Moussatos of Wedbush Securities. Liana Moussatos – Wedbush Securities: Thank you. You talked about Tyvaso being a nice parking spot for the Class III patients. How does that impact parenteral Remodulin over time? They have this really nice convenient prostacyclin that is available now, and do you see resistance going on to parenteral, and therefore, as more patients are around Tyvaso, fewer patients over time would be on the parenteral? And then, you also mentioned oral Treprostinil coming onboard in a couple of years and what kind of impact will that have on Tyvaso and parenteral Remodulin?

Those are like the $69,000 questions that all of us at UT will be scratching our heads about because we are not soothsayers and these are (inaudible) questions and we don’t really know what the future holds. So we have been monitoring things really closely quarter by quarter, and so far we are really excited and cheering for Remodulin. You can see comparing Remodulin fourth quarter ’09 over fourth quarter ’08 substantial growth, almost 20% range growth, so it is continuing to grow and be a contributor to the company’s overall growth. Even if you compare say third quarter ’09 to fourth quarter ’09, Remodulin held its own, which is traditionally what it has done third quarter to fourth quarter if you go back to third quarter of ’08, fourth quarter ’08, third quarter ’07, fourth quarter ’07, it pretty much is flat quarter to quarter as distributors rationalize their end-of-year inventory. So things continue to look very good for Remodulin. Now, the reason why I think that there is good reason to think that things will continue to look good for Remodulin going forward is that even though Tyvaso is a great parking spot, it is not a cure, and I wish it was a cure but it is not a cure. And therefore, the expectation is that patients will progress, and in the words of one of the great KOLs in the field, Dr Lewis Rubin, there comes a point in time when many patients need to be virtually “based” in a prostanoid. And of course, those are pretty much the Class IV patients, Class III, IV patients. So, when you need that “bathing” in a prostanoid, I think parenteral is the only one that is going to give you that sort of delivery. Now, I will caveat that statement by saying that we do know with oral treprostinil that we are achieving pharmacokinetic levels that are comparable to what is achieved with parenteral Treprostinil. Just to give you a little anecdote, the current trials the FREEDOM-M, the FREEDOM-C trials, the squared trials that we are doing for oral treprostinil, patients exiting those studies are by and large at a dosage level that correlates to 30 nanograms per kilo per minute, which is the dosage level which is a common place for patients on subcut or IV Remodulin to be on. So, it may be possible that we could achieve this sort of bathing of the patients in prostacyclin by gradual upward titration of the doses from oral treprostinil. But you know, realistically we hope to unblind FREEDOM-M in 2011, FREEDOM-C 2 in 2012 and then it is going to take like half year to get the NDA filed and then like a year for the FDA to decide, and then it is going to take another two or three years of experience before people really know whether or not oral treprostinil is a substitute for parenteral. So at least until the 2013, 2014 timeframe, I think that parenteral Remodulin will continue to be a strong reliable engine in the United Therapeutics rocket. Liana Moussatos – Wedbush Securities: Thank you.

We will go next to Terence Flynn of Lazard Capital Markets. Terence Flynn – Lazard Capital Markets: Hi, thanks for taking the questions.

Hi Terence. Terence Flynn – Lazard Capital Markets: Had a few quick questions, first on the SG&A front, I was wondering, if I look at SG&A as a percentage of revenue excluding stock option expense, I think you read about 36% for the fourth quarter versus 28% for the third quarter, just wondering how we should think about those two percentages here as we head into 2010 and then just a follow-up question on tax rate.

Sure. With regard to the SG&A, sales and marketing guys are really great at spending money, they spend it very wisely, they spend it smartly, but materials are expensive and we are launching two drugs in one year while continuing to add additional promotional materials on Remodulin. One interesting thing that we have done in Remodulin, we have kind of cloned all of our materials into Spanish, which is something we really should have done earlier, but better late than never. With each one of these materials, you have got to have New York advertising agencies involved and then extensive regulatory submission process and approval process. It is insanely expensive. And then you have got to double that again for Adcirca and then again for Tyvaso. So I am not the least bit surprised that SG&A crept up in 2009 compared to previously. I do think however that we are going to rest back down towards the traditional rates that we were at and that is really because of the fantastic leverage that is built into the three-drug United Therapeutics model. While there are certain expenses that are incremental with each additional drug, as the drug matures on its launch path, more and more expenses, a preponderance of expenses become common. As you know, we have a common sales force detailing all three drugs, so I do think that you are going to see those numbers climb back down [ph] in 2010. Terence Flynn – Lazard Capital Markets: Okay, great, and then on the tax rate, can you give us any idea when do you expect to be paying taxes on a cash basis?

I am going to refer that question to our tax guru, Chief Financial Officer, John Ferrari.

We are actually paying some cash taxes now. We do on a state level and to a certain extent we do pay a little bit on the federal because we are limited on the amount of business credits that we can take in any given year. But we still have a fair amount of business credit so it will be several years before we will be a full tax payer on the corporate end. Terence Flynn – Lazard Capital Markets: Okay, and maybe just one last question on –

Actually there are more people – we get complaints from people who cannot get the call, so two questions – Terence Flynn – Lazard Capital Markets: Okay, thanks a lot.

Sorry.

We will go to Mark Schoenebaum of Deutsche Bank. Mark Schoenebaum – Deutsche Bank: Hi Martine, my birthday was in December.

Happy Birthday. Mark Schoenebaum – Deutsche Bank: Thank you very much.

Happy Belated Birthday, hopefully it was not the 40. Mark Schoenebaum – Deutsche Bank: No, no, I appreciate it. I was wondering maybe if Roger is on the line –

Yes. Mark Schoenebaum – Deutsche Bank: To get an update on the oral Remodulin, because I cannot pronounce the other one, trials, can you remind us why the probability – why we should believe that the probability of success in FREEDOM-M and FREEDOM-C 2 is higher than in the trial that red out in late ’08 please?

Sure Mark, thanks for the question, glad to have one to answer. I think the rationale that Martine was alluding to is in the terms of the dosing and the dose of a [ph] current patient is an important consideration and probably the fundamental consideration when trying to assess the probability of a success here. As you know, previously when we only had the 1 milligram tablet, we had difficulty getting patients over a 1 milligram threshold over a 12 to 16-week period, that is not the case now that we have introduced the 0.25 milligram tablet, and in fact most of the patients that are exiting the double-blind study while we remain blinded to their drug treatment are achieving a dose of 3 milligrams or greater, which would equate to the 30 nanograms per kilogram per minute infused parenteral infusion rates that Martine alluded to. That is a very robust amount of treprostinil given in a fairly short period of time and augurs well that when patients get the drug, they will respond to the drug and the trial will be eventually successful. I think the other thing to consider from the previous experience that governs the effect size that was observed was the number of dropouts. Again, we are seeing a completely different story with regards to dropouts. So we could end between the earlier experience of 0.25 and the two studies over a 100 patients or more on the current 0.25 dose regimen where we start at 0.25 and then titrate patients up by 0.25 milligram increments. And we have only had, I believe, one or two dropouts in total. So we have changed not only the ability to initiate and titrate the drug but also the ability to tolerate the drug over the period of the study. So, given those dosing facts from our belief that is very, very positive results and something that speaks very positively about the potential outcome of the study. Mark Schoenebaum – Deutsche Bank: Okay that is super helpful, thanks a lot. I will get back in the queue.

Thanks, next question please.

Eun Yang of Jefferies & Company. Eun Yang – Jefferies & Company: Thanks very much. On 1000 patients on Tyvaso, can you give us a little bit more breakdown on what percent of patients are continuing from clinical trials and what percent of patients are actually kind of warehoused in anticipation of a Tyvaso approval?

Yes. So, prescriptions have been written for 1000 patients, just about 1000 patients, of those around 150 went on the drug as a continuation from the previous studies, and maybe another 100 or so were, to the best of our knowledge, kind of holding back and were part of like the bolus that we announced in our last conference call. So, another way to say all of this is that two times more patients or three times more patients have been scripted Tyvaso after launch than upon launch. Eun Yang – Jefferies & Company: That is very helpful, thank you. When you say one script, is that one month supply of Tyvaso?

No, that is a year, every time I say script, it is a patient, the script is the patient, the same thing. Eun Yang – Jefferies & Company: Okay, thank you.

We will go to Salveen Kochnover of Collins Stewart. Brent Kelly – Collins Stewart: Hi, thanks for taking the question, this is Brent Kelly in for Salveen. I know historically you guys have given comments around operating expenses as a function of previous year’s revenue, is that something that you guys can give us for this year?

Yes, we give that kind of guidance and we are looking at our cash budget for 2010 as being approximately 80% of our spending of our pharmaceutical revenues from 2009. Brent Kelly – Collins Stewart: Okay, that is very helpful.

It is not a number that I would use as a scalpel [ph] because there are certain adjustments that we make to that number, for example, our cost of goods sold, because we are selling more and more drugs each year, we have to pay like an increasing royalty, an increasing amount of drug products, so it is not an exact kind of scalpel, but I think it gives you a good guidance that you are very unlikely to see R&D and SG&A spending increase in excess of 80% of previous year revenue. Brent Kelly – Collins Stewart: Thank you.

Sure. Next question?

Matt Kaplan, Ladenburg. Matt Kaplan – Ladenburg: Right, thanks for taking the question.

Hi Matt, glad you got in. Matt Kaplan – Ladenburg: Yes. Couple of things, first, can you give us any guidance in terms of what you expect in the number of scripts for the end of second quarter and then a question for Roger in terms of the rest of the pipeline, you have had some recent announcements with (inaudible) and then the oral bovine collagen and what we should expect for the pipeline?

Yes, with regard to the second quarter, we are going to stay away from continuing to provide that kind of guidance. We wanted to make sure that people were like roughly on track back in the fourth quarter because we saw revenue targets for Tyvaso in 2010 of like $20 million and $30 million, which did not really make any sense. And instead, I think, if you want to definitely be on the safe side and not have a downside surprise, take a 1000 patients and multiply it by three quarters by something like $120 K or so per patient and after that some kind of linear ramp for the first quarter, and you will end up with a revenue figure north of $60 million and you will not end up with a downside surprise on the second quarter after that. So that is an answer to your first question and Roger, you want to answer the second question.

Sure. The recent announcements around (inaudible) and the collagen bovine products was sort of an early look at products that we think are high potential in pulmonary indications that would be synergistic with our selling ability. So most of those are early. With the IP, we think there is a possibility a doing a quick Phase II studies going to higher doses too rapidly (inaudible) decision on that without incurring too much spend. And the immune works deal I think is an earlier stage opportunity which again will not cost us a lot going forward to get to some going over our decisions, but the beautiful thing about each of these opportunities is the cost of obtaining the license was very low and the opportunities very high, so it is a very nice profile. I think the other thing to highlight in terms of our research portfolio within United Therapeutics is we have ongoing studies in patients with critical ischemia and intermittent claudication with the oral Remodulin construct and that Phase II dosing studies even though we are now looking at (inaudible) for example, and then we had a Phase II program in neuroblastoma, which is going to be the building block of our oncology platform as we look to take both our 3F8 antibody and our 8H9 antibody, which would look at metastatic brain cancers, for example, into an oncology field. So most of our efforts, as we have said, is focused on the oral Remodulin trials reporting in the markets of both Remodulin and Tyvaso and then certainly with Stage IV type studies in granting of studies that support the market agents. The Phase III FREEDOM-C and FREEDOM-M studies, which are global trials, we have taken a very aggressive position in terms of resourcing for these trials with recent expanding the number of centres that we have in China and India, we will have more than 80 sites when all this is said and done because we want to make sure that we unblind these trials on the timelines that Martine actually articulated. So, I think in a nutshell, those are kind of the initiatives that we have. We remain focused on the oral Remodulin and we are beginning to take peeks at other indications so that we can expand beyond pulmonary hypertension per se without distracting ourselves.

Great exchange there. We have time for one last question, operator.

We will go to Matt Duffy, BDR Research. Matt Duffy – BDR Research: Good morning, congratulations, and thanks for taking my call.

Thank you Matt, glad you got in. Matt Duffy – BDR Research: Thanks. Just two things on the promotional side. Number one, can you give us a little more color on how your field forces are directed? What the sort of weighting is between Remodulin, Adcirca and Tyvaso? And then also, are you sampling Adcirca?

Let me ask Roger who also oversees all the companies sales and marketing efforts, so Roger, could you provide the answers to the last two questions?

Sure, certainly. I will start with the last one first, we are not sampling Adcirca. I know that Pfizer is sampling Revatio quite heavily now as a perhaps a competitive measure to our launch of Adcirca, but we do not feel that is something that we need to do and for patients that are unable to pay for the travel, we certainly have patient assistance programs that will provide for them. We are not trying to deny patients drugs. We just do not think of sampling programs that is necessary or perhaps appropriate in this market. In terms of the weighting of our sales force, I think you would say our number one weighting now is on Tyvaso with Remodulin and Adcirca quickly behind that. So they are not that different in terms of their waiting, but I think what we are trying to really do is retain the Remodulin revenues and continue to grow it, and then take these new product launches and Martine said, try to consume 80% of the market share before their competitive molecules go off patent, which is what we are tracking towards. So, all three are important to our growth, but certainly as you can see from this quarter’s number, for example, the revenue that Tyvaso is bringing to the company is significant and it is weighted appropriately within our incentive compensation plan. Matt Duffy – BDR Research: Okay, great. Thank you.

Thanks to all of you so much for joining our 2009 annual results and fourth quarter conference call. It was really great to hear a lot of familiar names on the call. There is a busy calendar of healthcare conferences during the balance of 2010, and our Corporate and Investor Relations teams look forward to seeing you guys at those conferences and clearing your questions then, and providing you additional updates during the year. Thanks so much and operator, you can wrap up the call now.

Thank you for participating in today's United Therapeutics Corporation fourth quarter earnings conference call. This call will be available for replay beginning at 12 pm Eastern time today through 11:59 pm Eastern time on Tuesday, February 23. The conference ID number for the replay is 5260604. The number to dial in for the replay is 1-888-203-1112 or 719-457-0820. This will conclude today’s conference call.