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`FINAL TRANSCRIPT
`Q2 2010 United Therapeutics Earnings Conference Call
`
`EVENT DATE/TIME: 07/28/2010 09:00 AM GMT
`
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1142 , p. 1 of 13
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
`
`CORPORATE PARTICIPANTS
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
` Roger Jeffs United Therapeutics - President & COO
`
` John Ferrari United Therapeutics - CFO
`
`
`CONFERENCE CALL PARTICIPANTS
`
` Laura Ekas Collins Stewart - Analyst
`
` Geoffrey Meacham JPMorgan - Analyst
`
` Michael Yee RBC Capital Markets - Analyst
`
` Eun Yang Jefferies & Co. - Analyst
`
` Bret Holley Oppenheimer & Co. - Analyst
`
` Mark Schoenebaum ISI Group - Analyst
`
` Matt Kaplan Ladenburg Thalmann & Company Inc. - Analyst
`
` Liana Moussatos Wedbush Morgan Securities, Inc. - Analyst
`
`
` Joseph Schwartz Leerink Swann & Company - Analyst
` Jon Stephenson Summer Street Partners - Analyst
`
` Jim Birchenough Barclays Capital - Analyst
`
` Matt Duffy Black Diamond Research - Analyst
`
`
`PRESENTATION
`
`Operator
`
`
`
`Good morning. My name is Jonathan, and I will be your conference operator today. At this time, I would like to welcome everyone to the
`United Therapeutics Corporation's second quarter 2010 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 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 assumption, or changes in factors affecting such forward-looking statements. Thank you. Dr. Rothblatt, you may begin
`your conference.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Good morning everybody, and welcome to the United Therapeutics second quarter 2010 financial results conference call. I'm joined this
`morning by Dr. Roger Jeffs, our President and Chief Operating Officer; and Mr. John Ferrari, our Chief Financial Officer. Together the three
`of us will answer your questions after I start off with some introductory remarks.
`
`The quarter has been a great one for us. Revenues for the second quarter were $137 million, up from $84 million in the second quarter of
`2009. Net income for the second quarter of 2010 was $37.7 million, or $0.67 per basic share, compared to a modest net loss a year ago. So,
`the business is doing very well indeed. Our strong performance for this quarter, and indeed for the whole first half of 2010, has been
`highlighted by continued top line growth. These results, which were principally driven by the increase in demand for our therapies, affirmed
`that the patient base benefiting from our medicines is expanding along the entire range of the pulmonary arterial hypertension continuum.
`Indeed, that's been exactly our strategy in beginning with the parenteral therapies with Remodulin, expanding into the class III population
`with the inhaled treprostinil, and then with Adcirca being able to address the entire continuum of pulmonary hypertension class II, III, and IV
`patients. All of the therapies are experiencing substantial growth in their market segments, and have either achieved market leadership or are
`on their way to.
`
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
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`Starting with Remodulin, we remain overwhelmingly the therapy of choice for parental prostanoid therapy, having a clear majority of
`prescriptions and revenue market share compared to Flolan and its generic alternatives. In the inhaled market space, we are really excited to
`announce on this call that we are right on target to our goal of achieving 80% market share of inhaled prostanoids, because as of this call we
`now have crusted over 60% market share. This is especially significant when you consider we started from a dead halt nine months ago when
`we launched in September, and already six out of every ten patients using any form of inhaled prostanoid in the US are using our Tyvaso.
`
`And then our goal for Adcirca is similarly right on track. There our goal is to achieve 80% market share by the time that REVATIO, the
`alternative PDE5 inhibitor goes off patent at the end of 2012. There too, we started from a debt start with its launch one year ago, and I'm just
`really impressed that one year later we're already at over 20% market share in the PDE5 space among pulmonary hypertension patients. So,
`just following that curve, I remain confident that Adcirca will become the treatment of choice along -- right on the schedule that we've
`projected it to be. We've -- for each of the individual products, we've had some either some slight variances from consensus with regard to --
`let me start with GAAP earnings. We're aware that we're about 50% better than consensus, so I think a lot of that relates to people still
`understanding the -- the stock option structure accounting for that. But really great result on GAAP earnings per share.
`
`In terms of Remodulin revenues, we are off about $3 million, off a couple million dollars on Tyvaso, and then up $2 million on Adcirca. So,
`these differences of $2 million or $3 million one way or the other are completely insignificant, given the level of revenues that we're talking
`about and the continued growth of patients in each of these three product lines. So with those introductory remarks behind me, let me now
`open up the lines and either myself, Dr. Jeffs, or John Ferrari will be glad to take your calls.
`
`QUESTIONS AND ANSWERS
`
`Operator
`
`
`
`(Operator instructions)
`
`Our first question comes from Salveen Kochnover from Collins Stewart. Your question please.
`
`
`
` Laura Ekas Collins Stewart - Analyst
`
`Good morning. This is Laurie Ekas on behalf of Salveen. I was just wondering if you could give us some additional insight into -- or as to
`how we should think about the quarter-over-quarter increase in Remodulin sales, given that you took a price increase and that there was no
`inventory stocking in the first quarter? How should we think about the growth trajectory going forward from here?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Yes, thanks for your question. I think you should think positively about the growth trajectory. Year-to-year we're looking at about 20%
`growth on Remodulin, and I think that's a reasonable sort of curve, looking forward. The total number of patients with pulmonary
`hypertension continues to grow.
`
`Total spending in the hypertension market has a (inaudible) around 20%, so there's a lot of growth in the market. The vast majority of that
`growth is at the front end, with the patients who are being treated simply with oral therapies such as Adcirca. But for most of the patients, the
`condition is inexorably progressive, and the patients end up requiring parenteral therapy at the later stages of the conditions. And amongst the
`parenteral therapies, Remodulin is the clear choice of physicians throughout the country. It's got the very long half life, which is completely
`unique to it, and the greatest convenience. And finally, the physicians have the alternative modes of administration and delivery, whether
`subq or IV, which again gives a lot of flexibility to the patients. So, as these ever-growing numbers of pulmonary hypertension patients
`progress toward the latter stages of the disease, the numbers of patients on Remodulin are going to continue to increase. And that's what
`we've seen here, year over year. And I think you could continue to see it.
`
`Now, it's interesting that there has been some little bit of cannibalization from Remodulin to Tyvaso. For example, as best as we can track,
`about 6% of our Tyvaso patients have actually come from Remodulin. This is not something that we encourage. In fact, it's something that a
`number of leading physicians caution against. But in the hands of the skilled physician, that transition for an appropriate patient can certainly
`be accomplished, and has been successfully accomplished. And for those patients, it's certainly a big sense of liberation going from a 24-hour
`a day therapy to a therapy that only takes eight minutes a day in the case of Tyvaso. Yet the fact that there's been such modest transition from
`
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
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`Remodulin to Tyvaso shows that that's not a very big factor affecting Remodulin's growth.
`
`So, I think Remodulin is going to continue to grow. It's going to probably grow at the same rate that you've seen year-over-year. And it's
`interesting, it's in its eighth year and actually getting stronger and stronger. And if you ask me, Martine, what is the main reason why
`Remodulin continues to get stronger and stronger, it's because in the first few years of the drug, there was a lot of uncertainty on how to
`manage the site pain, which afflicts upwards of 90% of the patients who start the drug. And doctors don't want to hurt their patients. And so
`many people recoiled from subq. Dr. Jeffs led the brilliant effort to develop IV Remodulin, and very quickly we regathered all that steam
`with IV Remodulin. But in the intervening years, physicians figured out if you leave your subq needle in place beyond three days, the site
`pain for the great majority of patients greatly diminishes. And in some -- many patients, all but disappears. So, there has been an evolving
`practice of keeping the subq needle in place for upwards of three weeks, maybe a few more days.
`
`And the long and short of it is the subq patient suffers site pain for two or three days, but for the rest of the month is pretty much free of the
`pain, and has the much greater freedom associated with subq. That has led to a situation where the majority of our Remodulin patients are
`now subq patients, which was a flip from -- at one point it was a majority IV. And that's continuing drive the aggressive growth of
`Remodulin into more and more of the pulmonary hypertension patient population.
`
`
`
` Laura Ekas Collins Stewart - Analyst
`
`Okay, great.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Next question?
`
`Operator
`
`
`
`Thank you, our next question comes from the line of Geoff Meacham from JPMorgan. Your question please.
`
`
`
` Geoffrey Meacham JPMorgan - Analyst
`
`Yes, thanks. Thanks guys for taking the question. On Tyvaso, wondering Martine if you can talk about, or maybe Roger, the breakout of
`patients. I think last quarter you talked about de novo versus Ventavis switches versus Remodulin switches, and you just gave a number
`recently, or the 6% number. How does that distribution -- has that changed from 4Q last year to 1Q to 2Q?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Yes, I'll start off answering the question and then invite Roger to provide some additional color. Things have -- the bottom line is things have
`not changed from the fourth quarter. The mix of patients is very similar to -- the mix we saw initially. And as mentioned in my introductory
`remarks, it's actually beginning to gain significant steam here in the second quarter and moving to the third quarter. Roughly speaking, about
`10% of the patients come on to Tyvaso actually from parenteral therapies. Either Remodulin or Flolan or the other generic parenteral
`therapies. Maybe a tad less than 10%.
`
`About 20% of the patients, maybe a little bit more than 20%, come on to our therapy from Ventavis, and then the majority, the large
`majority, around 70%, come on to our therapy after not really achieving the results desired with either oral or more commonly dual oral
`therapies. That is PDE5 plus an ETRA. So, that's pretty much as you recall the situation as we reported last year. The majority of patients are
`coming from the oral therapies rather than at the expense of Ventavis. And what I find really fascinating about that is it actually validates a
`thesis of our VP of strategic planning, Dr. Oster, who has actually long highlighted the fact that there is this huge population of patients on
`orals, upwards of 15,000 on PDE5s, maybe a little bit lesser number on ETRAs who -- only a small fraction of those patients are also on
`some form of prostacyclin therapy. And yes, those patients are overwhelmingly going to progress. And unfortunately, when there's no
`prostacyclin therapy that the patient wants to go on, all too often the patient ends up expiring without ever getting the benefits of prostacyclin
`therapy. And a lot of surveys have shown that to be a common end result with pulmonary hypertension.
`
`What Dr. Oster's pointed out is the much greater convenience and efficacy, the safety associated with Tyvaso allows prostacyclin therapy to
`move upstream into this large patient population who are previously on orals. And indeed, that's exactly what we are seeing. Because to the
`best of our calculations, our achievement of 60% market share in the inhaled prostanoid space has come not so much at the expense of
`
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
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`Ventavis per se as it has come through moving upstream into patients who were previously treated on dual oral therapies. That's a very, very
`positive message for all concerned. And it's why my introductory remarks I said our revenue growth reflects our growth along the entire
`continuum of pulmonary arterial hypertension. Roger, would you like to add any color to those remarks?
`
`
`
` Roger Jeffs United Therapeutics - President & COO
`
`No, I think that's a very eloquent response, Martine. The only thing I would add is that over time, the payer acceptance, and I would even say
`the payer preference for Tyvaso is emerging, and I think that continues to change the profile of patients started on Tyvaso versus Ventavis,
`which speaks to the share that we gained. So, I think it's an additive benefit to everything that you have said.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Great. Thanks.
`
`
`
` Geoffrey Meacham JPMorgan - Analyst
`
`Can I ask a follow-up or do you want me to get back in the queue?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`I think you should get back in queue because -- there's a lot of people in line right now.
`
`
`
` Geoffrey Meacham JPMorgan - Analyst
`
`Okay, thanks.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Thanks.
`
`Operator
`
`
`
`Thank you. Our next question comes from the line of Michael Yee, from RBC Capital.
`
`
`
` Michael Yee RBC Capital Markets - Analyst
`
`Hey, thanks Martine. A question on inventories. Were there any slight changes in inventory on Remodulin or Tyvaso? And then can you
`remind us how much inventory the wholesalers actually keep on hand, say weeks or days? Because based on our calculations, a couple days
`of change is even worth a few million of Remodulin, right? So that could impact things.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`This is John Ferarri. You are actually correct on the -- I guess change in patient days would have a change in potential revenues on it. For --
`let me start with Remodulin. We did see a decline, a slight decline in the value of inventory held by US distributors at the end of June. But
`we saw a decline in the patient days held, probably about three or four days at the end of June. What -- by contract, they are supposed to hold
`approximately 30 days, patient days of inventory, at any point in time. So, Remodulin was around the contractual terms as we expected. Now
`for Tyvaso, we actually saw a significant decrease in both the dollar value of the inventory and the patient days held by our distributors for
`Tyvaso. So, we are working with the distributors to make sure that their ordering patterns are such that it complies with our contractual
`arrangements.
`
`
`
` Michael Yee RBC Capital Markets - Analyst
`
`Great. Thanks, John.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Thanks.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Next question.
`
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
`
`Operator
`
`
`
`Thank you, our next question comes from Eun Yang from Jeffries. Your question please.
`
`
`
` Eun Yang Jefferies & Co. - Analyst
`
`Thanks. A question on Tyvaso. (Inaudible) reported of Ventavis's sales for the second quarter. In terms of the dollar amount in the US, it's
`similar to what Tyvaso had generated for the same quarter. (Inaudible) was sold there, Ventavis's sales grew quarter-over-quarter about 20%,
`so is it fair to assume that in terms of a new patient, getting onto inhaled therapy, Tyvaso captures about 80% and Ventavis captures about
`20%?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`It's an interesting analysis. You know, it would be hard -- I'd rather stick with our total market share number, because that's the one that I
`carefully due diligence before the call, rather than making an off-the-cuff confirmation of your number. I can say with confidence that right
`now we've got six out of 10, roughly speaking, inhaled patients, people on inhaled prostanoids. So that's - and that means that Ventavis has
`about four out of 10. And our - the trending is continuing strongly in our favor. And there are a couple of reasons for that.
`
`First of all, we are continuing to register strong triple-digit patient starts every month. And the rate actually is tracking upwards. So, that's a
`very positive factor. The second positive factor is that we lose many fewer patients than Ventavis loses. The published information on
`Ventavis that the persistent of the average Ventavis patient is about six months. In fact, we surveyed doctors, and that's what blinded surveys
`of doctors report. So, for the patients, they get on, they lose one in the same year.
`
`Our drug hasn't been out a whole year, so we can't provide annual persistence data. But there is the published open label data from the
`Triumph study, which showed significantly greater persistence on Tyvaso than on Ventavis, and as of right now, from all the patients who've
`started on Tyvaso, 80% -- actually about 86%, little bit more than I mentioned just before, are on the drug right now. So we're seeing some
`really impressive persistence. When you combine the triple-digit new starts, continuing to -- very strong and steady as a heartbeat, with the
`greater persistence, it's an inexorable trend that will end up at that 80% figure. Exactly when, I'd rather not predict but that's definitely where
`we're going.
`
`
`
` Eun Yang Jefferies & Co. - Analyst
`
`Thank you.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Sure. Next question please.
`
`Operator
`
`
`
`Certainly. Our next question comes from the line of Bret Holley from Oppenheimer. Your question please.
`
`
`
` Bret Holley Oppenheimer & Co. - Analyst
`
`Yes, hi. Thanks for taking the question. I'm wondering if you can give us any update on the dropout rate (inaudible) for Freedom C. Are you
`still maintaining a trend where it's in the low single digits as you reported in February?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Thanks, Bret. Nice to hear your voice on the call. I'm going to forward that question to Dr. Jeffs.
`
`
`
` Roger Jeffs United Therapeutics - President & COO
`
`Good morning, Bret. So, obviously on dropout rates we're not going to provide exquisite details while the trial's ongoing, and we certainly
`will provide all of that detail when we unblind. But just to speak more generally about it, I'd say the dropouts that we are seeing today are
`encouraging to us in terms of the lack of dropouts in general due to prostacyclin-like side effects. Which is presenting a very different profile
`than what we had seen previously in Freedom C, the first Freedom C study. Our dropout rates now are considerably lower and within the
`bounds of what you are expressing, a single digit or low single digit. So, we remain very enthusiastic.
`
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`I think I would also add that we are pleased with the current patient enrollment. We have over 70 centers active around the globe for both
`Freedom C and Freedom M. The clinical team is exquisitely focused on robust -- yet what I think is important appropriate patient enroll.
`We've recently been notified of approval in China by the SFDA, and that will further positively impact enrollment. Particularly the Freedom
`M study, which as you know the mono therapy setting is a more difficult trial to enroll. Given all this, we're very bullish about the Freedom
`studies and the prospects for oral treprostinil. We remain confident that we can unblind these trials in 2011, and we think the drug profile,
`particularly the dropout rate today, is a very positive one that makes us enthusiastic about the potential outcome of these studies.
`
`
`
` Bret Holley Oppenheimer & Co. - Analyst
`
`Thanks a lot Roger.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Thanks Bret. Good hearing from you. Next call please?
`
`Operator
`
`
`
`Certainly. Our next question comes from the line of Mark Schoenebaum from ISI Group. Your question please.
`
`
`
` Mark Schoenebaum ISI Group - Analyst
`
`Hey, thanks for taking the question. Appreciate it, guys. My question was fall to you, you said strong triple-digit ads for Tyvaso. So, I guess
`that means at least 300 gross ads in the quarter, patient ads for Tyvaso. I just was wondering if I'm doing that math right. And then can you
`give us any sense of what the net ads were? Or what the total patient numbers are?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Yes. No. I actually -- painted myself into a corner by giving the triple-digit figure. The ads each month are in the -- the starts each month are
`in the 100s. So it's -- the exact figure varies to be 170, 140, 150. It bounces all around the place but it's not 300 starts each month.
`
`
`
` Mark Schoenebaum ISI Group - Analyst
`
`But I mean at least 300 over the course of the quarter though, right?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Oh yes, definitely. I'm sorry, you said per quarter? Oh okay, I was talking about per month. I'm sorry, I didn't catch that. Positively, we have
`never had a quarter with less than 300 starts.
`
`
`
` Mark Schoenebaum ISI Group - Analyst
`
`And then for Roger, is there any chance the Freedom trials come this year? Is there any chance of that? Thanks.
`
`
`
` Roger Jeffs United Therapeutics - President & COO
`
`No. We're predicting 2011 and that's what we are going to stick with.
`
`
`
` Mark Schoenebaum ISI Group - Analyst
`
`Fair enough. Thanks a lot.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Okay. Good hearing from you, Mark.
`
`
`
` Mark Schoenebaum ISI Group - Analyst
`
`Thank you.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Next call?
`
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`means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
`
`Operator
`
`
`
`Our next question comes from the line of Matt Kaplan from Ladenburg. Your question please.
`
`
`
` Matt Kaplan Ladenburg Thalmann & Company Inc. - Analyst
`
`Hey guys, thanks for taking my question. Two things. First, for John Ferarri, could he talk a little bit about taxes? And what you expect this
`year's tax rate to be? And then number two, to give us an update with respect to the next generation for Tyvaso?
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Just to be fair to the other --
`
`
`
` Matt Kaplan Ladenburg Thalmann & Company Inc. - Analyst
`
`For Roger.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Only one question per person until we get back in line.
`
`
`
` Matt Kaplan Ladenburg Thalmann & Company Inc. - Analyst
`
`Okay. Fair enough.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Yes, we disclosed in our Q our estimated effective tax rate for the year, which is what we used to book our tax expense. So, right now, we are
`estimating it to be 35%. Give or take a percentage for 2010.
`
`
`
` Matt Kaplan Ladenburg Thalmann & Company Inc. - Analyst
`
`Okay. Thank you.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Thanks. Just bounce back in the queue, and hopefully we'll be able get back around to you. Next question?
`
`Operator
`
`
`
`Certainly. Our next question comes from the line of line of Liana Moussatos from Wedbush Securities.
`
`
`
` Liana Moussatos Wedbush Morgan Securities, Inc. - Analyst
`
`Thank you. What percentage of Q2 Remodulin sales were subcutaneous?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`I don't have -- we don't have it that precise, but it's -- as mentioned previously it's over 50% of the patients are subq patients. Now, I realize
`that's not exactly your question. I would -- to a rough approximation, Liana, I would guess and it really is a guess because the same vials are
`sold for IV patients and subq patients. But I would guess that it's over 50% of the revenues on Remodulin are IV, even though over 50% of
`the patients are subq. And the reason for that is that even though we've established with some really great work managed by our clinical
`development team, that there is a really true statistically true bioequivalent between the subq and the IV routes of administration.
`
`Nevertheless, when things get down to the clinicians' practice, there is a tendency to dose more aggressively with the IV than the subq. And I
`think it probably has to do with the perception, Liana, which we've not really been able to shake, that the acutely suffered but chronically
`disappearing site pain associated with treprostinil is somehow dose responsive. And the more you give, the more pain you're going to get. So,
`if you start a patient, and they start suffering from pain, you don't want to ramp up the Remodulin dose, even though it would help him
`clinically. You don't cause him more pain. We actually don't believe that it does cause him any more pain, but it's hard to actually persuade
`people overall of that. If someone is having pain, the natural tendency is to stop whatever you're doing that's causing the pain, not increase it.
`
`So, as a result of that, IV tends to be dosed more aggressively and subq tends to be dosed more cautiously. And hence the average revenue
`
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1142 , p. 8 of 13
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`07/28/2010 09:00 AM GMT, Q2 2010 United Therapeutics Earnings Conference Call
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`coming from an IV patient is average that the - is higher than the revenue coming from the subq patient. But I would say it's all within pretty
`much that 60/40 band. It's nothing outside of that 60/40 band.
`
`
`
` Liana Moussatos Wedbush Morgan Securities, Inc. - Analyst
`
`And do you expect it to stay at this rate's steady state over time?
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Liana, I'm going to move onto the next question, but while the operator's getting the next question. As mentioned, we see the Remodulin
`market continuing grow at the current rate ,and the mix of the patient patients remaining constant as well.
`
`
`
` Liana Moussatos Wedbush Morgan Securities, Inc. - Analyst
`
`Thank you.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Next question?
`
`Operator
`
`
`
`Certainly. Our next question from the line of Joseph Schwartz from Leerink Swann. You question please.
`
`
`
` John Ferrari United Therapeutics - CFO
`
`Leerink Swann. Get the advertisement right. Hey Joe, how's it going?
`
`
`
` Joseph Schwartz Leerink Swann & Company - Analyst
`
`Very well, thanks. I was wondering if you could update us on your E- regulatory activities for both parenteral and inhaled Remodulin.
`
`
`
` Martine Rothblatt United Therapeutics - Chairman & CEO
`
`Great. Roger manages a global regulatory group as well as several other activities. So Roger, pass that ball to you.
`
`
`
` Roger Jeffs United Therapeutics - President & COO
`
`Thanks for the question, Jeff. With regarding Tyvaso, we're in the midst of discussions, a scientific advice meeting with the EMEA regarding
`trial design. And as we've stated previously, our preference is to conduct a smaller trial than the Triumph program. Possibly a study of
`Tyvaso in the in the treatment naive setting, which if successful would enable EU approval and possible label extension in the US as an
`added benefit. But those negotiations, if you will, in that protocol are ongoing, with the intent we will begin this study next year.
`
`With regarding IV, that is also now under act of review for the remainder of this year. And if successful for intravenous Remodulin, we think
`the first quarter of 2011 is a reasonable target date to expect approval for intravenous Remodulin in the EU. But as we've all seen, that date
`tends to slip based on holds and reviews and requests for more information. So, if all went well, the first quarter 2011 would be a reasonable