Good morning. My name is Elvis, 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 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 represent United Therapeutics' expectations or beliefs regarding future events based on current assumptions. United Therapeutics cautions that such statements involve risks and uncertainties that may cause actual results to differ materially from those in forward-looking statements.
Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in 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 recognized.
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.
Good morning everyone and welcome to the yearend 2007, and fourth quarter 2007, financial reporting of United Therapeutics. I am joined on the conference call today by our Chief Financial Officer, John Ferrari; and our President and Chief Operating Officer, Dr. Roger Jeffs.
I'd like to start off, with the great pleasure to report record revenues for 2007 of $211 million, and record EBITDASO or earnings before interest, taxes, depreciation, and stock options, of $4 per share. GAAP profits of course, came in lower at $20 million for the year, but EBITDASO better reveals our great operating leverage. We can see this operating leverage most clearly in the fourth quarter '07 results.
For the fourth quarter, our revenues came in at about $60 million, our highest quarterly level ever, of which, nearly $25 million was EBITDASO. This 42% operating leverage is likely to improve yet further in 2008, because we have reduced our basic spending against previous year revenues by 5%. So for 2008 we should see even greater operating leverage than 2007.
With regard to the difference between EBITDASO and GAAP, the primary difference is of course stock options, and during 2007, stock option expense increased significantly compared to 2006, because we follow a strict pay for performance metric in compensating the Chief Executive in particular, as well as the rest of the company.
Until the Chief Executives' stock option compensation program, stock options are awarded only for increases in market capitalization, for years when there is no increase in market capitalization, no stock options are awarded. In 2007, we nearly doubled our market capitalization, and as a result stock option expense went up accordingly.
In addition to all of this great news, we have some fantastic news flow geared up for 2008 as well. Specifically in the next quarter, second quarter of 2008, we expect our inhaled Treprostinil NDA to be filed with the FDA.
I am following that in the second half of 2008, we expect to unwind our oral Treprostinil study, the FREEDOM-C study. And finally, by the end of 2008, we expect to file with the European central filing system our inhaled Treprostinil registration package seeking approval of inhaled Treprostinil in Europe.
So it's been a year of fantastic financial results, our best fourth quarter ever, a fourth quarter that pegs us solidly at almost $0.25 billion a year revenue run rate. We can see clearly that we are also nowhere near the peak revenues from our parenteral franchise, and we have much greater franchises, with inhaled and oral very close at hand.
It's now my pleasure to open up the lines for any questions that can be directed to me, our Chief Financial Officer, or Dr. Jeffs. Operator?
(Operator Instructions). Your first question comes from the line of Geoffrey Meacham.
Hi, guys, thanks for taking my question.
I have a question for you on Remodulin, just a couple of questions on the quarter. First, can you talk a little bit about the growth that you've seen outside the US, and then the second part is, where are you with the IV Remodulin launch in Europe?
Our growth continues to be very strong in Europe as well as the US, we've been tracking for quite a while somewhere between 10% and 15% of US revenues come from Europe. And that's despite the fact that with regard to SubQ Remodulin, we've had a tactical switch to a country-by-country approval process, which is certainly slowing down the commercialization effort.
With regard to intravenous Remodulin, we've just received a notification that we'll have to wait longer before we have approval for commercial approval for intravenous Remodulin, because the regulatory for this in France, with whom we are working, are still not satisfied with the filing that we've put forth.
As some of you may recall, we went through a very similar obstacle course with regard to SubQ Remodulin, but fortunately after perseverance and patients and performance. In our case performance in terms of providing all of the documentation that the Europeans requested differentially from the Americans. We ultimately were able to get SubQ Remodulin approved, and we feel confident that eventually we will be able to have commercial approval for intravenous Remodulin in at least some of the countries in Europe.
An important point to keep in mind with regard to parenteral Remodulin in Europe, is that Parenteral Prostacyclin has never been the success story in Europe that it was in the United States. And in fact most patients in Europe who are on Prostacyclin therapy are on inhaled Prostacyclin therapy, specifically inhaled Iloprost, whereas most patients who are on Prostacyclin therapy in the United States are on Parenteral Prostacyclin therapy.
So it's basically just a difference in terms of the way different routes of administration developed between Europe and the US, and different prescribing preferences on behalf of the key opinion leaders in Europe and the US. But the bottom line is, that we continue to sell Parenteral Prosta Remodulin in Europe. It makes a healthy contribution to revenues and earnings and we expect to continue to do so for many years.
And just a follow up if I may on Viveta, the filing in Europe is there anything different that has to be done from a regulatory standpoint compared to the US filing?
Sure, I am 100% positive that there will be, because in every respect with most drugs the Europeans are going to have different preferences than the US. But they are really good, so there are a number of things which I think augur well for a substantial increase in the percentage of our inhaled revenues that come from Europe, as compared to the parenteral revenues.
First of all, as I just mentioned, in Europe inhalation is the preferred way to take Prostacyclin, and so the fact that we'll have an inhaled product augurs very well for us. Secondly, with regard to inhaled Treprostinil we are going to go with the centralized filing method, so we'll be able to get approval for like all countries at one time rather than the country-by-country approach that went with parenteral Prostacyclin. So, that's definitely going to grease the skids tremendously.
Finally there is a clear recognition already that actually originated from Europe and from the KOLs in Europe, key opinion leaders in Europe that inhaled Treprostinil is very, very safe, does not involve any of the kind of issues that parenteral Prostacyclin entails, which has been things that have given Europeans pause.
And secondly that did actually have differential efficacy and dosing flexibility compared to inhaled Iloprosts. So, it's actually objectively a superior way to provide Prostacyclin and for those reasons we think that the regulatory process will not be identical in Europe and the US. It will go quite smoothly.
Great. Thank you.
Your next question comes from the line of Bret Holley.
Just a question on the Remodulin and FREEDOM trials if you continue to be satisfied on that front and I guess another question would be whether you have seen a continued low discontinuation rates among patients with a new low dose loading dose?
Good question. I am going to refer to Dr. Jeffs to give the details, but I can say that we have had great enrollment on FREEDOM and it's really a great tribute to the way that Roger's team has carried out that study, but Roger can you provide some details.
Certainly Martine. Yeah, I would agree with Martine, I think this is our greatest period of enrollment. We certainly have more sites than ever enrolling in the study. In the FREEDOM 301 study that's the combination trial, so that's with the oral Remodulin added on top of background therapy.
We're nearly 80% enrolled with 235 or the 300 patients enrolled into the study. In the FREEDOM monotherapy study where this is front line therapies, we are also doing fantastically in terms of enrollment, with almost with two-thirds of the patients enrolled a 100 of the 150 are now enrolled.
What that augurs well for is that particularly for the combination trial, given we're 80% enrolled, we believe we can complete enrollment in the second quarter of 2008, and then easily meet our own milestone of providing data in the fourth quarter of 2008 on the combination trial.
I think what's exciting about that is certainly that is the tougher test of the drug. I think we all believe if it works in combination it certainly will work as a monotherapy trail. But to me, the true test of the therapy is this combination trial.
One thing that will make that a successful test as you asked about is, do we have the dose that is well tolerated and can we escalate that dose. So since we introduced the 0.5 milligram into the clinical trials back in July of 2007, we've had very few, less than a handful of patients that has dropped out for Prostacyclin related adverse events.
So I think the drop out rate is largely solved by the 0.5 milligram tablet. We are also able dose escalate a little bit easier with a smaller dose increment. So that is going well so we are achieving the range of target doses that we need to achieve. So I think if all things continue along this path we will be well positioned for a successful trail later in the year.
Thank you. Next question please.
Your next question comes from the line of Matt Kaplan.
Hi. Good morning. Thanks for taking my questions.
Sure, Matt nice to hear from you.
You too. Could you give us an update in terms of what to you expect at the ATS meeting coming up in May of this year in terms of data presented?
Great, well I mentioned Roger is in-charge of all the clinical programs. So Roger can you give us a snap shot.
I will Martine and good morning Matt.
One thing we promised the investigative group is that we really won't divulge the data in advance of the ATS meeting. So Valerie McLaughlin is going to present the data at ATS. Her presentation has been chosen for oral presentation. It will be presented on Wednesday, May 21st at the New Concepts in Treatment of Pulmonary Hypertension session, which is in the afternoon from 1.30 to 4.15.
So other than what we have already told you, we are not going to say anything additional in terms of giving you a little bit more color on the data. Valerie will give you color on all the end points, all the different permutations of analysis, and I think you will find that the data is consistent, the data is supportive of the primary end point findings and the data is robust.
So well in the grand picture that's what you will see and I think you'll get great comfort from what you present. I really won't go into this specifics of that.
Okay, fair enough. And then one quick question could you give us a sense of the R&D expenses going forward in '08 with a wind down of the OvaRex programs and related programs?
Sure when we decided to terminate the OvaRex program, at that point of time we basically decided to ratchet back our overall spending across the board by 5%. That is mentioned in my opening remarks and even though we had a great fourth quarter and a great 2007 both in terms, not only revenues but also in terms of earnings and operating leverage. I think things will improve yet further in 2008, because pretty much across the board R&D. We will reduce our percentage spend as against revenues by about 5%, and effectively that will increase overall company operating leverage by about that amount.
Your next question comes from the line of Jennifer Chao.
Great, thanks for taking the questions.
Hi, Jennifer long time no hear from you.
Yes hi, Martine and gang, good to talk to you. First Martine, I am just wondering if you can just discuss any changes to trends that we're seeing in the rate of conversion to Remodulin from sub Flolan and Ventavis and any important considerations. And in fact at least Martine if you could just give us an update on the sepsis investigation follow-up and then any expected inventory changes in 2008?
Sure, I think probably the best person to answer the first two questions would be Roger because we've been doing very, very well in growing our franchise. For example, when you take a look at our current total revenues right now of around 200 and then a revenue run rate of around $240 million a year, and you compare that to what is generally discussed as the Flolan annual revenue run rate of around $60 million.
You can see pretty clearly that Remodulin has become about the 80% market leader in parenteral Prostacyclin and if one includes Ventavis revenues in there, we have about a 60% market share in terms of all three Prostacyclin therapies. So really happy to have over 2,000 just occurred during 2007 and we became both the number one parenteral number one, Prostacyclin in general and for that matter the market leader just in severe pulmonary hypertension.
But let me ask Roger to give a little bit more color on individual transition stories from Flolan and from Ventavis and then for the third question, John, if you could be queued up and ready to answer Jeniffer's questions about inventory.
Right, good morning, Jennifer. As to conversions, I think a couple of things, I would echo what Martine said, that it's exactly true that we have continued to gain share in the parenteral market. I think one of the very discomforting things is that the Flolan share is declining, so there is less opportunity to switch patients, but still a bountiful level of business there.
The other transition base that we are focused on, is obviously the Ventavis base. Given that the average patient retention on that therapy is between 6 months and 8 months, that's a low hanging fruit of patients that we would like to transition to Parenteral Remodulin.
In that regard, also at the ATS meeting in May, we are presenting two abstracts that are specific to transition, one is a rapid switch protocol from intravenous Epoprostenol, where we look at quality of life and treatment comparisons. So for the first time you will see some quality of life measures that show not only kind of the patients being maintained when they switch, without any acute change in their clinical status as well as a long-term follow up that shows that they maintain their status. But you will see that the quality of life of those patients has improved when they do that.
So, I think that's an important piece, that's particularly important to patients. Since they have a rare and life threatening disease. Intravenous therapy can be a burdensome therapy, but this will show that being on intravenous Remodulin provides a better quality of life. So, that's one important abstract.
The second one is a retrospective multi-center transition experience where we've looked at data from a number of centers that has transitioned these patient that just aren't well managed on Ventavis, and then switched to intravenous Remodulin, and we will show data to show the those transitions go well, that the patients do well and that there's benefits to those patients who are declining on the Ventavis therapy and managed on Remodulin. So, two important I think pieces of work that will continue to improve our transition experience and maintain the growth in that subset of patients.
The number of questions we get about sepsis now is minimal. I think the revenues somewhat speaks to themselves and that they are marketed in large parts, that doesn’t view sepsis as a particularly unique concern with Remodulin. The SLC has met and they are producing and that's the Scientific Leadership Committee of the Pulmonary Hypertension Association
I think under the direction of Ray Benza, who is from UAB, they are going to produce a guidance document on good catheter care and maintenance. And one of the aspects that they will speak to is the use of what's called a closed hub system. It has become clear that the infection risk is not related to the product. And I would say that's true for Flolan or Remodulin, and that the risk of infection is a contamination risk, and one entry point for water particularly for gram negative infection would be at the catheter hub.
So use of a closed hub system minimizes the intrusion of water into the line, and it seems that when that happens, you can nearly eradicate the rate of gram negative infection in there. The real leader in that effort has been Dr. Dunbar Ivy, at Children's Hospital in Denver. He has taken these kids, which like to shower, swim and do lot of things that introduce water into these lines and taken their rate of infection to almost zero, use of a closed hub system. He showed that data with the SLC and there are going to envelop his data as part of their guidance statement.
In addition to that we've also worked with our distributors to educate them about this practice and they are widely distributing knowledge to those patients and physicians about the use of closed hub systems as well as all of the other appropriate prophylactic techniques that one must use when intravenous therapies are delivered.
So I think that the sepsis issue remains a minimal issue and I think it will become even more minimal in the future as a better job is done with catheter care and maintenance.
Yes, so John, I will turn it over to you now.
Hi. With regards to the inventories for 2008, my crystal ball is a little cloudy on that but my expectation would be that inventory levels should only grow as the patient demand grows and patient accounts grow. We've seen for the last three quarters inventory levels relatively stable and only growing as the patient demand grows.
Thanks John, thank you Jennifer. It's nice hearing from you.
Your next question comes from the line of Liana Moussatos.
When do you think you will have data from the FREEDOM-M trial and then for oral Remodulin assuming that all the data goes well? When do you think you would be filing, and finally what percent of Remodulin sales in Q4 were from the IV?
Thanks, Liana. Roger you want to take those three questions?
Yeah. So it's a little bit hard to predict when we will have data from the Freedom-M trial, but it’s a 12 week study. So from the last patient in it will take three months to get the last patient out, and then I think you can reasonably add six to eight weeks to lock the database. So, from the last patient and you're talking of five months from there. So I think probably a reasonable expectation would be in the first half of 2009, we would have data from Freedom-M study and certainly we are pushing to get that as early in first half of '09 as we can.
Then the filing would be probably in the third quarter of '09, that type of timeframe or second half of '09 for sure. So we would look to hopefully have and so it's again from Freedom-C the combination trial in the fourth quarter first half has to take to commit to first or second quarter, but so is the first half of '09 for the Freedom-M and then the filing in the later half of '09 with an approval there, 10 months from then, so an approval in 2010.
And what percent of Q4 Remodulin sales were from IV?
Yeah. I will take that. So we don’t necessarily break the sales out by out by route, SubQ to IV, but historically our trends have been close to 50-50 with a slight lean in favor of SubQ actually given its longer life in the market. But I think it's approximating a 50-50 usage pattern.
Next question please.
Your next question comes from the line of Biren Amin.
Thanks for taking my question. I was wondering when investors should expect the virgin data from the Aradigm inhaler program.
Right, well I think it's realistic that we could have some good proof of concept data relatively soon in this year Biren, and that would give us basically complete confidence that the treprostinil drug is delivered commensurately with the Aradigm unit as it would be with our current Optineb device the company Nebu-Tec.
Now the term bridging could be a little bit ambiguous because different people might have different meanings of that and frankly ultimately the only person who's meeting really matters is the FDA and the EMEAs meeting. And we don't yet really know exactly what kind of course "bridging data" they may want in terms of expediting the approval of the MDI.
I'd like emphasize that our current Optineb device works extremely well, is very well received by patients, and because it allows patients to drastically shrink their inhalation time down to only about four minutes a day from close to an hour a day with the Ventavis product. The Optineb has been a real life saver for our patients. But what we are interested in doing is reaching to broader market segments and finally, we are like totally focused on the goal that no pulmonary hypertension patients should be without Prostacyclin therapy, because of its great benefits.
Of course it's difficult to ask a patient who is just in the early stages of pulmonary hypertension to put up with an indwelling catheter or to breathe in from a nebulizer even four times a day, even for a minute at a time. It's much easier if you can offer the patients something like a pill or something like an MDI that can be put in their pocket, much like an asthma inhaler.
So we are confident that there will be a good market for the Optineb and a larger market in the future for an MDI based device. There will be a place for both. Exactly how we bridge from one to the other in terms of regulatory data, we are going to have to wait and get clear guidance from FDA and EMEA and I do feel quite confident that we will have that guidance around the middle to the third quarter of this year and we will definitely announce it at that time.
Great, thank you.
Sure. Yeah, we have time for one last question, operator.
And your last question comes from the line of Joseph Schwartz.
Great, thanks very much. I was wondering if you could provide us with some insight into help us appreciate the development hypothesis for oral Remodulin some more. Just because when I look at the past presentations, it appears that around a milligram of oral Remodulin, achieves about a fifth of the plasma concentration of IV and SubQ therapeutic doses. So now that you are looking at even lower doses, how do you expect oral Remodulin to potentially succeed? Thank you.
Well, fortunately, we've got the world foremost expert or at least the boss of the world foremost expert on the line Roger can you answer that question?
Yes, sure Joe, good question. So, I think maybe clarify sort of how Prostacyclin are dosed, or at least remind people how they are dosed. So the goal of the one milligram initially was to provide a start dose, that was well tolerated and equivalent to about a 5 ng/kg/min infusion rate over the eight to 10 hours that its release would be profiled.
So, it turns out that the one milligram in a patient was more equivalent to about 10 ng/kg/min. And that was why that start dose was somewhat in tolerated by some patients. So, that's why we went back to the 0.5 milligram to get back in line where we intended to be from the beginning. And as I said earlier once we did that the drop out rates have declined to a bare minimum.
So, that's goal the goal of the tablet strength, the initial tablet strength, and in fact we are producing a 0.25 milligram tablet to release to the clinic. So, that we can even mange the handful of patients that are intolerant to the 0.5 and then as you look down the line as we are progressing to pediatric populations, it's conceivable that they wouldn't eat even lower doses to start and then increment with.
So, that's the rationale behind choosing a dose, or a tablet strength to start with. But then when you talk about therapeutic equivalency, we think the business end of this drug where you start seeing therapeutic benefit is between 15 ng/kg/min or 20 ng/kg/min or greater overtime and some patients take more and some patients take less. But on average I would say that's where you start seeing the therapeutic benefit of the drug.
So the goal of the oral dosing paradigm is to increase the number of tablets that a patient takes over the course of the clinical trial to achieve a target dose that's therapeutic. The beauty of a dose escalation protocol is that you can individually dose titrate, so that each and every patient should be able to titrate to a therapeutic dose for them, which is also well tolerated for them. And it maybe different, but again on average we think that it would be at least 20 ng/kg/min or more.
So that would equate to about two milligrams twice a day or more. So when we look at the conduct of the study, what we're trying to achieve in the clinical study is to make sure that the patients are dosed at least to about two milligrams BID or more at the end of the 12 week or 16 week treatment period, or whatever it might be for the study.
So that's the goal of the protocol, so I think when you look at equivalency, all we really have tried to do is equate the tablet strength to an initial start dose, and then allow a strengthen that would allow for discrete dose increments overtime, because you don't want to also increase the dose too rapidly. That can lead to intolerance as well.
So all factors point that we have it right now, and again we have to do the studies, and we have to do placebo control studies, but at least anecdotally, I see things seem to be going quite well, but we won't know till we unblind.
Thanks Roger. That's a fantastic answer. And thanks also to the two key members of your team, Drs. Mottola and Ferris for their work on the oral formulation, which has made possible what has been called the holy grill of Prostacyclin therapy, to be able to get Prostacyclin down into an oral pill that can be provided to the entire population of pulmonary hypertension patients. So I really appreciate the work that they have done.
Well for those of you who may have joined the call late, I would like to reiterate a few highlights from the call before closing. We had a great year with our best revenues yet of $211 million EBITDASO, $4 per share. Revealing about 40% operating leverage and also record fourth quarter '07 revenues and EBITDASO, showing that we are solidly positioned for 2008.
And speaking of 2008 we are very, very clear that we are quite a long ways from the peak of parenteral revenues, there are many more patients who are not responding to oral treatments and inhaled treatments in need of parenteral treatment. In the parenteral market, where we now have about an 80% market share, we are quite confident that growth can continue at the pass rates for at least another a year or two before a peak is reached. And by the time that peak is reached Prostacyclin revenues can growth yet further with inhaled treatment, which has a market potential for of at least doubled the parenteral market. And then long before that peak is reached there would be hopefully the available of oral Treprostinil product, which can support yet another doubling of the inhaled market peak.
So with intravenous, subcutaneous, inhaled, and oral routes of Treprostinil delivery, I think it could be confidently said that we at United are uniquely positioned to capture the great market potential of Prostacyclin therapy and we are firmly focused on that goal for 2008, '09 and '10.
Thank you so much for joining our call this morning and we look forward to seeing you at the ATS of other healthcare conferences in the coming months. Thank you very much.
Thank you for participating in today's United Therapeutic Corporation fourth quarter earnings conference call. This call will be available for replay beginning at 11:35 am Eastern today through 11:59 pm Eastern on Tuesday February 26, 2008. The conference ID number for the reply is 33422885. Again the conference ID number for the reply is the 33422885. The number to dial for the reply is 1800-642-1687 or 706-645-9291 you may disconnect at this time.
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