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Executives

Martine Rothblatt - Chairman and CEO

Roger Jeffs - President and COO

Analysts

Biren Amin - Stanford Group

Jim Birchenough - Barclays Capital

Jeff Meacham – JPMorgan

Brett Holley - Oppenheimer & Company

Phil Nadeau - Cowen and Company

Joseph Schwartz - Leerink Swann

Mark Schoenebaum - Deutsche Bank

United Therapeutics Corporation (UTHR) Q4 2008 Earnings Call February 17, 2009 9:00 AM ET

Operator

Please standby we are about to begin. Good morning, my name is Michelle and I will be your conference operator today. At this time, I'd like to welcome everyone to the United Therapeutics Corporation Fourth Quarter and Annual 2008 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 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 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

Thank you very much, operator and good morning to everybody. Thank you for joining us on our conference call for 2008 fourth quarter and annual financial results. I'm joined today on the conference call by Dr. Roger Jeffs, our President and Chief Operating Officer; and by John Ferrari, our Chief Financial Officer. After couple of our brief opening remarks I am going to open the lines to questions which can be directed to any of the three of us.

We are very happy that our revenues for 2008 grew in excess of 30% for the seventh consecutive year, reaching a total of $281.5 million.

In addition to these fantastic results on revenues the news continues to actually, portend fantastic results for 2009 because we have two additional products up for FDA approval in the next few inhaled treprostinil and oral tadalafil. The inhaled treprostinil PDUFA date with the FDA is at the end of April. And the oral tadalafil PDUFA date is towards the end of May.

We believe that together with the continued growth in organic revenues that we have from [prerenal] Remodulin as demonstrated by our seventh consecutive year of 30% growth. That revenue source together with new revenues from inhaled treprostinil and oral tadalafil will allow us to continue this growth trajectory in to the foreseeable future.

We are also announcing today that we are going to be rewickering a bit oral treprostinil programs with an amendment to our FREEDOM-M study for oral treprostinil and with a new FREEDOM-C squared second combination oral trials. And the goal of these trials is to develop our treprostinil molecule in to an oral dosage form.

Now we do not believe that the oral dosage form will be able to meaningfully contribute to revenues for several years, probably not until about 2014. But it is I think excellent evidence of United Therapeutics firm commitment to developing better and better therapies for pulmonary hypertension.

For both the physicians and the patients can continue to have hope in looking to United Therapeutics for a better and easier to take treatments for their condition.

But during the years between now and 2014 we have three very exciting sources of growth. And three very exciting sources of therapies that physicians and patients can use.

Perenal Remodulin in both its intravenous and subcutaneous forms which today are pretty much split 50-50 between subcutaneous and intravenous and on subject to FDA approval inhaled treprostinil and then oral tadalafil each of which have shown in their pivotal registration studies key values better than 0.001 so highly statically significant results on with the standard, goal standard end points and pulmonary hypertension of six minute walk.

Ladies and gentlemen with our track record of growth which is unprecedented in North America and with our two new engines being strapped on that can provide even larger amounts of growth in the years to come. I am very proud to say that the company amounted the lead has one of the best prospects of profitability and revenue growth and new therapies for pulmonary hypertension of any company around.

So with those worlds of introduction let me now open to you telephone lines. So that you can ask questions regarding business, clinical, sales and marketing or other questions of Roger, John and myself, Operator?

Question-and-Answer-Session

Operator

(Operator Instructions) First question will go to Biren Amin with Stanford.

Biren Amin - Stanford Group

Hi Martine, hope you feel better today, I was just wondering if you could maybe discuss deign of this new FREEDOM study. We see similar primary end points with the six minute walk and the new FREEDOM file?

Martine Rothblatt

Sure, Roger can you answer that question?

Roger Jeffs

Yeah, certainly Martine, and thank you for the question. I will preface my comments with echoing what Martine said in just reminding the caller that, note that oral is now an early Phase III program and with the scenarios that I will describe at best on blinding will be in about two years and material revenues will not contribute for full years and more. Having said that what our intention is with the ongoing FREEDOM-M or the monotherapy study which currently has 171 patients enrolled is will add about 140 patients. So that will take sample size to around 310 patients.

All of the 140 patients that we will add will be added with in to the 0.25 milligram starting dose. So all of those patients will have access to 0.25 for both dose start and dose increment.

In total given the patents had access to the 0.25 of the 171 that are already enrolled that will give us around 200 patients that had exposure from the beginning of the study to 0.25 milligram tablet and throughout the study that will give us a 90% power to detect of 45 meter difference at the P less than 0.01 level and certainly if successful we would have a single study that potentially would be a regulatory interest for filing.

So that’s our intention the amendment will be sent to the FDA shortly, and then we will begin the study probably in the April timeframe once the FDA approves the amendment and IRB and ethic committees around the world also approve the amendment. We were the reason, I gave the two year scenario for data is we were doing about 8 to 10 patients per month at the end of the FREEDOM-M study when, of the 171 patients enroll. So that would predict around 14 months enrollment three months with to conduct the study and then a couple of months to do the data analysis cleaning and unbinding, so that's were the two year window comes from around FREEDOM-M.

I would also point out that we are going to do this FREEDOM-C squared study or the repeat of FREEDOM-C that will be about 300 patient study starting in June. We are going to power that study for 30 meter difference at 90% P less than 05, and that would also take roughly two or more years to enroll and then unbind. And whether or not we need one or two studies certainly will depend on the data. So, that’s what I can give you today about the current status of the oral program.

Biren Amin - Stanford Group

And will you be looking at six minute walk as primary endpoint with the FREEDOM-C squared?

Roger Jeffs

Yes certainly, so the both FREEDOM studies, the endpoint will be peak six minute walk. And then we will have all of the secondary endpoints that are now common for these trails trough levels, Borg Dyspnea Score quality of life Hemodynamics etcetera that are nothing new in terms of what the primary endpoint focus is or should be.

Biren Amin - Stanford Group

Great, thanks.

Martine Rothblatt

Next question please.

Operator

Our next question comes from Jim Birchenough with Barclays Capital.

Jim Birchenough - Barclays Capital

Hi, thanks for taking the question, and congratulations on the Q2 2008 results.

Martine Rothblatt

Thanks, Jim.

Jim Birchenough - Barclays Capital

So, just wondering if you could characterize your discussion with FDA currently around the inhaled Remodulin whether you are in labeling discussions, and if not, when you expect those discussion to begin?

Roger Jeffs

Sure, Jim. Our experience is that are labeling discussions are really the very last thing that ends up getting talked with the agency about. In the past it has been basically about 45 days or so from approval until those discussions come up.

And so we have not have back and forth with regard to labeling. The back in forth that we have had with the agency so far on Triumph has been very routine sorts of questions, there is probably at least one email a week that goes between our Head of Regulatory Affairs and the FDA.

There have been no surprises. On one email that got forwarded to me, for example, because it was particularly interesting what the agency had asked. What would our numbers look like if the following patients were cut out of the statistics and we did that and the results were still highly statistically significant.

So these are just normal in customary sort of stress testing of the data that the agency does, and I can say very confidently that everything has let us to believe that proceeding through a very normal and timely review. And we remain quite confident that the PDUFA date can be met.

Jim Birchenough - Barclays Capital

All right thanks for taking the question.

Roger Jeffs

Sure.

Operator

We will take our next question from Jeff Meacham with JPMorgan.

Jeff Meacham – JPMorgan

Hi, I also want to offer my congrats for the year, and thanks for taking the question.

Martine Rothblatt

Hey, Jeff, good to hear from you.

Jeff Meacham – JPMorgan

So question, two questions one on oral. Was the plan for two studies based on your discussions with FDA, or was it just you are de-risking the program, and then what do you think of the probability of filing on an upsize FREEDOM-M trail alone?

Martine Rothblatt

Roger?

Roger Jeffs

Yeah. Hi, good morning Jeff. The two studies is our idea. So while we are bullish about FREEDOM-M we do want to de-risk the program as you said, so that if the study FREEDOM-M for example was less than 05, but greater than 01 the filing would require a second study, and we would be well positioned at that point in time to deliver second results.

I think the other statement, we have always trying to do here at United Therapeutics also is to really study the drug in its appropriate patient population. And by that I mean, we fully expected that this drug will be used in combination with existing PD5 inhibitors like to Tadalafil or endothelin receptor antagonist.

So we want to produce data to show that there is an added benefit to doing adding Oral Treprostinil to those background regiment, because we feel that’s the right thing to do. It will offset obviously sub-serve as the secondary study if we so need it. So it really is 100% Jeff.

Jeff Meacham – JPMorgan

Okay and just a very quick follow-up if I can on the Inhaled program? How do you guys see this initial launch trajectory? Now that you are pretty close to the PDUFA date do you anticipate switching, do you capturing vast majority of new starts help us with a large carrier if you can?

Roger Jeffs

But we are moving forward on the launch preparations, Jeff, with a combined effort in terms of market research, prepping the sales team, developing sales on promotional materials. We are for example already committing dollars to the printing of labels with alternative product names though we are not actually printing the labels, but we are signing the contracts because the exact product name is something decided by the FDA at the last minute.

So we are doing everything we possibly can, because of our confidence in the late April PDUFA date, we want to get as good start as possible. Our current launch plan is to launch in the first part of June, which is pretty much as close after the PDUFA date days as we get final labels and everything is printed and done.

In terms of the market entry point for Inhaled it's really interesting, because we think that this drug has actually three separate market entry points. Each of which are going to be very attractive, and while it being a midyear launch, it's not realistic to look forward to any material amount of revenues from inhaled treprostinil in 2009.

2010, we defiantly expected to make a material contribution, and that's simply because of the arithmetic of you launch something in June and by the time we get patients on it and reimbursement through it, you have pretty much start by the quarter of revenues when all is said and done.

Now to get to some of your specific questions. First of all, any patient who is on background all therapy is going to be a prime patient for the marketing team to approach. And that's because of our expectations that the label would be something in the vain of this drug is indicated for patients who either PD5 or ETRA therapy for pulmonary hypertension. I mean that would be sort of a conservative label, because that would be almost verbatim the results of their registration study that we submitted for the drug.

So certainly patients who are not doing their best in ETRA or not doing their best on PD5 inhibitor, those would be prime patients for the positioning of this drug. And on that point, let me just refresh everybody that the registration studies for Tracleer and registration study for Revatio, both showed that in fact more than half the patients did not improve during the conduct of those studies.

And that data sort of borne out by some excellent research that the Medicor Leerink Swann group has done showing that the average time the patients remain on the single oral drug is actually less that the year now. So all that shows that there is a huge market potential for people who are on one of the oral drugs and needs to do better. So, that’s certainly is primary market trust for this drug.

Now, a secondary market drugs are for the patients who are on Ventavis. Of course the vast majority of those patients on Ventavis are also on either PD5 inhibitor or Tracleer, but it is separate population because these are people who already been self that they were not doing that well and in old drug and needed a inhalation therapy as an adjunct.

From everything we have seen, we believe that inhaled personal presents a pretty compelling posture these of the inhaled Treprostinil presents a pretty compelling posture vis-à-vis inhaled Ventavis. There is a lot of data to show that should personal molecule has great efficacy and does the right things at the biochemical level that you want to have drug to get a great clinical effect.

There is also the remarkably greater convenience. Basically the patient goes from fix eight, nine and more a long duration net nebulization with Ventavis to simply four, one minute sessions with inhaled to personal.

And unfortunately with this disease compliances is crucial. And I know many of us who are all perfectly healthy think that "Well, if you had like a life threatening disease you would be fastidious about compliance.]

But in the real world that's not held its in the real world people miss doses, people forget to take things and doing some four times a day is markedly better than six, eight or more times a day. And especially if those four times a day are as fast as a minute. So we think that all across the board patients on Ventavis are going to asking their physicians to switch to Treprostinil and forget some data and support that.

Roger and his team are doing a very innovative multinational, multi-center Ventavis switch study, that's Ventavis switched to Inhaled Treprostinil which is already enrolled a number of patients and is continuing to enroll more as new IRB centers have rolled out.

Finally you asked the questions about naïve patient, and we have to really see what the FDA label says. We are a company that is very, very conservative in our attitude towards legal and regulatory compliance.

So we have to see what the label says, but certainly there are going to be instances were patients present as a Class III patients. And the physician is of the point of view that there is an important role played by prostacyclin class drugs in affecting the natural history of that disease. And I would say it’s quite likely is not inevitable that there will be number of those newly presenting Class III patients who are initially diagnosed with a combination of say tadalafil and treprostinil or [litaris] and treprostinil.

To give them a combination of the synergies of a combination therapy right from the start now that's something that, data is still being developed on synergies of combination therapies. But my impression from talking with doctors all the time is that the mind share in favor of combination therapy earlier rather then latter is growing and so therefore I think a third market entry point for treprostinil is for the class three patient to be given a shock at the power of prostacyclin from their very initial diagnosis and perhaps together with the synergistic benefits of the PDE5 or ETRA.

Jeff Meacham – JPMorgan

Great thanks Martine for the detail.

Martine Rothblatt

My pleasure.

Operator

Our next question comes from Brett Holley with Oppenheimer & Co.

Brett Holley - Oppenheimer & Company

Hi, thanks for taking my question. Roger, I was wondering what risks you see to the amendment to FREEDOM-M trials towards the FDAs point of view and what data analysis plan do you have on the primary end point for the revised study?

Roger Jeffs

No the risk would be Brett, that they do not except our proposed changes and would ask us to do a new study from the start which would potentially delay us maybe four or five months in terms of when we completed its study. I do not think its material in that respect. But there is some precedent that other companies have done this, I think as long as you are informed from an independent study without having looked at any of the cards so to speak of the current and ongoing study then this is an acceptable thing to do in terms of the amending the sample size and also amending the primary analysis to be only the patients the 200 or so patients that had access to the 0.25 milligram from the start of the study.

So, the risk is that the FDA does not accept that and we have to then go through an alternative plan which is to start that 200 patient study from scratch and that would mean that the current FREEDOM-M study would be unblinded sometime in March. But we don't anticipate that to be the outcome of our discussions. But certainly the FDA no doubt will want to talk us once we file the amendment.

In terms of the analysis, I think again as long as we haven't turned over any cards in the current study, this should be an acceptable strategy. The FDA is interested in showing are looking at data based on the dosing regiment that one would label which would be the 0.25 milligram start and the 0.25 milligram available as an increment. So I think that would be the primary analysis so that would be most interested in and why would be acceptable to them.

Brett Holley - Oppenheimer & Company

So, I guess, one question I have is, if they kind of showed kind of a middle ground and said okay, you can add the additional patients to the trial. But you have to look at the trial on it and to treat basis with all the patients included, how would the powering look on to that scenario?

Roger Jeffs

It still obviously will be very strong, because you would have a sample size now of 315 patients versus 200 in your primary analysis. I think irrespective of what we do on the primary, we are going to have to look at the total population at the secondary analysis and we have written amendment to do so. But you can always even within any study share alpha. So if the alpha is 0.05 another, again this is just a hybrid, not something we're intended to do, we could share the alpha between the overall population of 315 and then the quote/unquote, sub group that only had access to 0.25 but we could share that alpha evenly if you will.

But we do not really think we need to do that, we think we can spend of the alpha on the primary 0.25 milligram group and just redefine who the primary analysis group is because we think the way, the reasons that we are doing that are legitimate, but certainly there is a risk that will have some profession.

Brett Holley - Oppenheimer & Company

Okay. Thanks very much.

Roger Jeffs

Sure.

Operator

Our next question from Phil Nadeau with Cowen and Company.

Phil Nadeau - Cowen and Company

Good morning. Thanks for taking my question. My question is actually financial one. Are you prepared to give any guidance for 2009 this morning and particular on the R&D line even excluding the payment to really it's seems like R&D was heavier than we have seen in the past is that something we should expect later into the future?

Roger Jeffs

We do not generally give guidance forward-looking however what we do provide to the street which I think is actually better than some traditional forms of guidance is one, two, as people looking for track record seven consecutive years of revenue growth in excess of 30% and as you heard in our remarks earlier today we think that our perenal Remodulin definitely allow us to continue growing it's revenues plus the contribution of inhaled and tadalafil. And then we are pretty open about the fact that we try to follow a pretty simple budgeting rule of spending less money than we make. And in particular we aim to spend in successive years upwards of about 80% or so of the revenues that we earned in the previous.

And that's when you run those numbers through, it translates into their being in expectation that most spending category can increase by something like 20% to 30% from a one year to the next. And that's actually been our historical record. There of course will be blips up and down, here and there and SG&A and R&D. And of course I am not excluding, I am excluding extraordinary one time things like the in license from Lilly of tadalafil.

But we have no extraordinary R&D programs other than the one-third disclosed in our 10-Ks and have been these FREEDOM trials the, inhaled treprostinil switch study. The continued development of treprostinil and other indications we have a oncology study in nuroplastoma that’s going to begin this year in 2009.

We continue to do work on our antiviral platform with lipid encapsulated glycobiology agents. We've got a pretty robust R&D program that continues but it should not be anything that would cause our spending to go outside of the envelope that you have seen in the previous year.

Phil Nadeau - Cowen and Company

And what about earned SG&A do you need to add any infrastructure to launch inhaled remodulin and tadalafil?

Roger Jeffs

No I think we have our infrastructure well in place. We will add a few more people around the margins. But the basic infrastructure has been in place for a year now. And those reps have been visiting all the physicians to whom we would expect to be the preponderant writers of prescriptions for tadalafil and inhaled treprostinil and we know them pretty well. I think we are perfectly prepared as we are.

Phil Nadeau - Cowen and Company

Thank you.

Operator

And our next question will go to Joseph Schwartz with Leerink Swann.

Joseph Schwartz - Leerink Swann

Hi, good morning, thanks for taking the question. I was wondering how much clarity you expect to get from the FDA regarding the proposed amendment. Just based on your experience with how they operate. How clear do you think that they will be when advising you to go ahead or not go ahead with the amendment?

Roger Jeffs

This is Roger. I think it will be a simple guess its okay or now we need to discuss it further. Those in fact simple, that occurs actually with any protocol that you would submit to the agency. I do not think it would be unique necessarily to this amendment in fact this is about the fifth amendment for this study protocol there is always during the course of studies amendment to either in the inclusion or exclusion criteria or rather same. So I think this would be either a yes or a simple let's talk.

Joseph Schwartz - Leerink Swann

Okay and do you have a meaning set up and how might we expect to learn from the outcome?

Roger Jeffs

We do not have, we have not submitted the amendment as of yet eminent we choose the 30 day review and or so and certainly with discussions. But I think it would just be at our next earnings call we would update you that we have commenced enrolling the amendment or not.

Joseph Schwartz - Leerink Swann

Okay great and can you discuss the sights that you are considering using in the other two studies of oral remodulin?

Roger Jeffs

No, I am not sure about the other two studies so that the FREEDOM-M study is the sites that we are currently participating in the FREEDOM-M study and then the FREEDOM-C square the repeat combination study is many of the same sites. If not all, from the original study group. We are endeavoring to add further other centers to FREEDOM-M study in particular, and that effort is ongoing as we speak.

Joseph Schwartz - Leerink Swann

Great. Thanks.

Martine Rothblatt

Operator, we have time for one more question.

Operator

Mark Schoenebaum with Deutsche Bank.

Mark Schoenebaum - Deutsche Bank

Thanks for slipping me in, I appreciate it.

Martine Rothblatt

Well, you are the man. You got the last slot out here.

Mark Schoenebaum - Deutsche Bank

Okay. Excellent. Martine, you were kind enough in the last conference call, I think to give an estimate of revenue potential of tadalafil, kind of over longer term perspective, I was wondering if you would be willing to give us that kind of perspective on the inhaled treprostinil and if time, I had a housekeeping?

Martine Rothblatt

What about the housekeeping?

Mark Schoenebaum - Deutsche Bank

Just housekeeping question.

Martine Rothblatt

Okay. So the inhaled treprostinil I answered the previous question that pointed out these three separate market entry point. So the next step in the analysis would really be to ask how many patients are being treated with either ETRA or PDE5 and there is a couple of ways to get some insight into those numbers one way to get some insight into the number is by procuring IMS data. However IMS data really only covers drugs that are filled at a local pharmacy. You can't really get to IMS data for specialized pharmaceutical such as ETRAs. From what we have been able to learn from the IMS data.

There is probably something in the order of magnitude of 10,000 patients being treated with a PDE5 inhibitor. And with regard to the ETRAs you can get a fair amount of insight by dividing out [hepthilion] which are overwhelmingly due to Tracleer by the known price of Tracleer, and come up with some estimate that there is again rough order of magnitude something like 20,000 patients are being treated with Tracleer.

So, some of that are going to be treated with both and there is no real easy way but to tell whether they are being treated with one or two. But if you take a conservative figure of 10,000 patients to just be very conservative being treated with one of the two as monotherapy and again very conservatively you assume that the drug is prescribed only in accordance with it's label which we do not know what the label is.

But if the label exactly track the study which was the study one of the other therapy then you might say that there would be an addressable market for inhaled treprostinil of something on the order of 10,000 patients. And how many of those patients would actually be captured by inhaled treprostinil would depend upon how many patients needed something in addition to their oral drugs.

Well, as I mentioned in response to an earlier question based on the registration study it looks like more than half the patients need something in addition to their drug. The latest data from mediocre at Leerink Swann is also highly consistent with that.

So again just to pick a conservative factor if you pick something like 5000 patients are going to be captured by inhalation therapy than it’s a toss up between Ventavis and inhaled treprostinil I think from any objective sense the benefits back up pretty heavily in favor of inhaled treprostinil vis-à-vis Ventavis. Its premature to know exactly what the pricing would be by the price comparably to Ventavis you would be looking at revenues, around order of magnitude in the $500 million a year range.

Mark Schoenebaum - Deutsche Bank

Okay great and then can you just update us quickly on status, and that was actually very helpful, so thank you. Status of the Japanese and European filings?

Martine Rothblatt

Yes Roger is responsible for the regulatory department duty. So Roger if you can brief everybody on the great relationship with Mochida and our going about on the centralized EMEA approach and the benefits that's accretive to us. As result of that the orphan drug status and so on.

Roger Jeffs

Yeah sure Martine. So as Martine mentioned in Mochida Pharmaceutical Company is our partner for Japan for subcutaneous and intravenous approval. They will initiate patient studies, they have done patient bridging studies recently and now are going to move in to formal dosing studies in patients starting this quarter.

It takes a while to get studies completed there, so it should be another couple of years before they complete that. But Mochida should be generating revenues in the 2012, 2013 timeframe. In Europe for inhaled, we have we did file in December our inhaled application as Martine mentioned via the centralized process to the EMEA that filing was validated and accepted for review in January. So that is currently under active review and all things going well, we predict probably a best possible approval time of late 2009. In addition, we have been engaged with French on the ongoing intravenous application, so it has been a busy time for, both the inhaled and intravenous application in Europe.

Mark Schoenebaum - Deutsche Bank

That and the French Discussions are going well?

Roger Jeffs

The French discussions are ongoing, and they have been ongoing for times.

Mark Schoenebaum - Deutsche Bank

Okay.

Roger Jeffs

I had to take the character.

Mark Schoenebaum - Deutsche Bank

Okay sir, Thanks a lot for let me speaking, I appreciate that guys.

Martine Rothblatt

Great. Well thank you how much for your coverage. We really appreciate it, and as a couple of wrap up remark I know some people may have joined the call late. We had a record year of revenues for 2008, our seventh consecutive year of growing in excess of 30% according to our outside consultants, and company that actually met or beat any other US filed technology company's record currently.

In addition, we spoke quiet a bit about the time shifting of the oral Treprostinil program out to the 2013 to 2014 timeframe. I therefore review the story with UT has evolved to be one of inhaled treprostinil, oral tadalafil and continued to strong growth in the on core perennial Remodulin business.

That’s core organic Remodulin business remain strong because the number of patients who are living longer with preliminary hypertension continues to increase. Specifically the number of patients with New York Heart Association Class IV Pulmonary Hypertension continuous to increase year-after-year, and that is a our prime market for Remodulin.

In fact our data shows upwards of 90% of the patients with Class IV some form of prostacyclin and with regard to inhaled Treprostinil another interesting 90% staff has mentioned earlier is that Dr. Ray Benza from University of Pittsburgh medical center recently reported data showing that in the one-year open label follow-up study from the Triumph's pivotal study that 90% of the patients who were in that study required no therapy in addition to there inhaled Treprostinil and whatever pre-existing background therapy they were on after a year.

Again, very struggling confirmation and beautiful confirmation of Dr. Lew Rubin and Dr. Werner Seeger's initial insights that molecule met ideal delivery method when Treprostinil met the NEBU-TEC inhaler. And then last but not least, our exciting in-license tadalafil, the active molecule Cialis for pulmonary hypertension, exclusive license to United Therapeutics as a part of a broader strategic relationship with Lilly.

And pursuant to this agreement, we will be promoting subject to FDA approval and selling to tadalafil for its label, and we believe we have to have question in this call on to tadalafil. But I would say if you would take look at the data which has recently been presented it's to me, absolutely in the sweet spot of drugs for patients newly diagnosed with pulmonary hypertension in particular in that it's got six minute walk distances that are equal or better than those of either the ETRAs or PD5. It's got a fantastic safety track record its one of the most largely prescribed drugs in the world.

It's marketed price Cialis less than that which is charged for Revatio which will be the only to directly comparable. And then most important what has been pointed out to me by several KOLs is that the difference between TID dosing with Revatio and the once a dosing with tadalafil is really huge.

And it really a more consistent delivery are highlighted likely for the compliance. The last thing you want with the pulmonary hypertension patients is for their pulmonary hypertension pressures to be cycling through the days from lower points to higher points. tadalafil is likely to be very helpful in showing optimum compliance in this patients population.

We have got really embracement of Richard. We are extremely proud that companies physicians and patients have been trusted us to do so much in pulmonary hypertension and we are all fired up and ready to go to make 2009 our best year ever. Thanks so much for joining us and look forward to seeing you guys at conferences during the course of the year. Thank you.

Operator

Thank you for participating in today's United Therapeutics Corporation fourth quarter and annual 2008 financial results conference call. This call will be available for replay beginning at approximately 11.35 AM Eastern Standard Time, today through 11.59 PM Eastern Standard Time on Wednesday, February 25th.

The conference ID number for the replay is 6654716. The number to dial for the replay is 1-888-203-1112 or 719-457-0820. Thank you for participating and have a great day.

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Source: United Therapeutics Corporation Q4 2008 Earnings Call Transcript
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