United Therapeutics Corp (UTHR) 2014 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Good morning. My name is Eric, and I will be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation fourth quarter and annual 2014 financial results conference call.

  • (Operator Instructions)

  • Remarks today concerning United Therapeutics Corporation will include forward-looking statements representing the Company's expectations or beliefs regarding future events. The Company cautions that such statements involve risks and uncertainties that may cause actual results to differ materially from those projected in the forward-looking statements. Please see the Company's latest Forms 10-K and 10-Q and subsequent filings with the SEC for additional information on these risks and uncertainties.

  • There can be no assurance that the actual results, events, or developments referenced in these statements will occur or be realized. The Company assumes no obligation to update forward-looking statements to reflect actual results, new information, or changes in underlying assumptions.

  • Today's remarks are intended to educate investors about the Company. This may include reporting on the progress and results of clinical trials or other developments with respect to the Company's products. Today's remarks are not intended to promote the Company's products to suggest that they are safe and effective for any other use than what is consistent with their FDA approved labeling, or to provide all available information regarding the products, their risks, or related clinical trial results.

  • Anyone seeking information regarding the use of one of the Company's products should consult the full prescribing information for the product available on the Company's website at www.UniTher.com.

  • Thank you. Dr. Rothblatt, you may begin your conference.

  • Martine Rothblatt - Chairman & Co-CEO

  • Thank you, Eric, for that nice introduction. Good morning, everybody. I'm joined on the call this morning by my co-CEO, Dr. Roger Jeffs; and also our Chief Financial Officer, John Ferrari; and our Chief Strategy Officer, Andy Fisher.

  • I'd like to start off by noting that John Ferrari, who has been our longest-standing CFO, more than six years, is at long last retiring, having hit the big 6-0. This will be John's last conference call with us. John, thank you so much for the past six years of service as Chief Financial Officer. Subsequent to John's retirement, our new Chief Financial Officer will be James Edgemond, whom many, if not most of you on this call, have had an opportunity to meet have had various healthcare conferences and has been overseeing the Investor Relations area as well for the past year or so. Starting with the next call, James Edgemond will be the Chief Financial Officer and answering questions in that area.

  • All right. Our overall revenues and profits grew significantly from 2013 to 2014, and we are pleased to see continued growth in the number of patients helped by each of our products. The fourth quarter was especially distinguished by Orenitram which exceeded 25% of Adcirca sales and 17% of Tyvaso sales despite the fact that December was only the seventh month of Orenitram's launch, whereas those other two products were launched way back in 2009. This affirms our belief that Orenitram is on track to become our best selling product.

  • Let me just break a couple of those stats down for everybody so we can all appreciate the significance. It took about 10 years for Remodulin to reach approximately a half billion dollars a year in sales. As Dr. Jeffs as pointed out previously, it took only about half that amount of time, approximately five years, for Tyvaso to reach approximately half billion dollars a year in sales. That's no doubt largely because of the much easier delivery mechanism of Tyvaso compared to Remodulin.

  • Now it's taken just about half a year for Orenitram to reach somewhere between a sixth and a fifth of the level of the sales of those other products. If you go ahead and you multiply that, say, a sixth by a six, you should come out with -- it should take about three years for Orenitram to reach that same approximate revenue run rate. That's why we feel confident that Orenitram is on track to become our best-selling product. It's obviously much easier to take a pill than even to do a four-times-a-day nebulizer session, which in turn is much easier than putting up with the subcutaneous or intravenous delivery route.

  • Once Orenitram matches the Tyvaso, Remodulin realm of revenues at $500 million a year, we remain very confident that Orenitram will continue its growth to over $1 billion a year. That would require just about 5,000 patients, which by the way is itself only a sixth of the currently prescribed and treated pulmonary hypertension patients in the US; and that the rate of growth in the pulmonary hypertension market, 5,000 patients will represent only a seventh, maybe only an eighth of all the patients by the time Orenitram gets up to there. Things are looking very bright for Orenitram.

  • Another interesting statistic that you can glean out of today's annual numbers is that this is the first time in 10 years that we've had significant quarter-to-quarter growth in revenues for all four quarters of the year. I think it's a reflection of the growing diversity of our revenue base, as well as a recent expansion of our sales forces deeper into the community prescriber level. Revenues first quarter, second quarter, third quarter, fourth quarter, there were growth in revenues every sequential quarter. The level that they were this year, we haven't seen that in our entire 10-year history. There's been a couple of times when there was some incremental growth but not as strong as this.

  • Again, I think that's it's probably a testament to something Dr. Jeffs has said frequently, which is that it's time to look at total treprostinil revenues. When you look at the total treprostinil revenues and add Adcirca into that as well, you're able to transcend through some of the quarterly fluctuations that have been seen in the past. I probably rambled on long enough here with some insight into the statistic.

  • Let me ask the operator to kindly open up the phones, and I'll try to sort the questions amongst myself, Dr. Jeffs, John Ferrari, and Mr. Fisher. Operator?

  • Operator

  • (Operator Instructions)

  • Liana Moussatos, Wedbush Securities.

  • Liana Moussatos - Analyst

  • Thank you for taking my question, and congratulations on the quarter. Could you update us on pipeline products like implantable pump and the antibody for neuroblastoma?

  • Martine Rothblatt - Chairman & Co-CEO

  • Yes, thanks very much, Liana, for your question. Those two particular projects have been ones that have been marshaled by our Co-CEO, Roger Jeffs, so Roger, could you provide Liana and the other listeners with some insight into the implantable pump and neuroblastoma projects?

  • Roger Jeffs - President & Co-CEO

  • Yes, thank you, Martine. Thank you for the question, Liana. I'm very pleased to answer that one as it's been a particular rich year for pipeline development at United Therapeutics. I think when you look at the pipeline, the two biggest components of that are the fact we're in Phase III with both Orenitram and our beraprost analogue as one to enhance the FREEDOM-EV trials, to enhance the Orenitram label. The beraprost is novel chemical entity looking to augment inhalation therapy with an oral adjunct.

  • Those are both in Phase III and progressing well, and I think particularly with regard to FREEDOM-EV it has a number of attributes that are attractive, one, that it will augment the US label as I mentioned. It could support European approval of Orenitram, given its morbidity mortality as a primary end point.

  • It will provide more clinical data with respect to combination use. We certainly have some now, but this will further add to that spectrum of data, particularly with regard to delay in clinical worsening, and we'll get additional data with the TID regimen used from the start of therapy. Those are all important attributes of the FREEDOM-EV trial, and again and enrollment is progressing both in the beraprost BEAT study and the FREEDOM-EV study for both of those products.

  • I think the other important developments in 2014 related to Remodulin, one was the implantable pump that development with Medtronic was filed in December as a PMA, and that is on track. We have also done a labeling supplement in January, so that we expect some time in late 2015 to have approval of the implantable platform which will really benefit patients from a safety standpoint. It will eradicate in essence the risk of septicemia, and it will also allow once a month or even more prolonged filling which is a tremendous convenience advantage to patients and something that patients have already clamored for.

  • In addition, late in 2014 we announced a new semi-disposable subcutaneous pump platform in collaboration with DEKA. What that is, is a novel pre-filled pump administration of subcutaneous Remodulin.

  • The only way to use that pump technology will be through United Therapeutics because it's pre-filled. The bladder or the cartridge that contains Remodulin will be disposable, and the brains of the pump will be controlled by iPhone type technology. Smartphone technology to control the flow rate will be retained by the patient, but even that would be disposable on pretty much a monthly basis.

  • Those are, again, important portfolio management programs in the sense that it takes a product that's been in the market for over 10 years and gives it a renaissance and a reinvigoration in terms of what we're able to do for patients, both from a safety and convenience aspect.

  • Further to that, and you mentioned it is a huge part of 2014 for us, was branching out into the oncology space. We filed in late 2013 what we're calling Unituxin, which is our chimeric 14.18 anti-GD2 monoclonal antibody, which is an immunotherapeutic treatment for children with high risk neuroblastoma. We filed that at the EMA in late 2013, and then in second quarter of 2014, we filed that application with the FDA.

  • The action date for the FDA BLA is in March, so we're very close to having a definitive answer on that application. Then in Europe, we expect an answer in the second quarter, at least an opinion. Then post the opinion, there will be basically a 90-day clock to work out labeling and other aspects of that application.

  • We are hopeful that in 2015, we will launch our first oncology product into a market with high, high unmet need with a molecule that has shown very significant and robust performance in clinical trials, not only improving event-free survival but improving survival as well in these children that have had a very burdensome and rigorous course of therapy. It's a horrible disease.

  • Then in terms of other platforms, we continue to progress. In antiviral program, we're in Phase I with one of our products there, UV 4. We're doing a number of other things with terms of advancing our long programs, both with regard to xenotransplantation and tissue engineering, but those are certainly farther reach programs. Regardless, we continue to progress those entities as well. I think, unless you have other questions, Liana, that's all I'll give on that today

  • Liana Moussatos - Analyst

  • Thank you very much.

  • Martine Rothblatt - Chairman & Co-CEO

  • Doctor, that's a terrific review. Thank you very much. Operator, next question.

  • Operator

  • Terence Flynn, Goldman Sachs.

  • Irene Lau - Analyst

  • Hi. This is Irene in for Terence. Thanks for taking the question. For Orenitram, could you provide us with the number of patients on [drug], and the breakdown between [these starts] versus Tyvaso and Remodulin switches, and maybe how that changed from last quarter, if any? If not, can you offer insight in the average dose of Orenitram? Also, how does the breadth of prescriber base compare to Tyvaso? Thanks

  • Martine Rothblatt - Chairman & Co-CEO

  • Okay. Thank you for the question. We cannot provide the breakdowns that you identified in the first part of your question.

  • With regard to the second part of your question, there's been an increasingly rapid evolution of the dosing of the patients from the BID to the TID modality. Basically, if you want a long-term perception the maximum dose that's targeted in our FREEDOM-EV registration trial for Orenitram, seeking a morbidity and mortality end point is 6 milligrams TID. That's a reasonable target to look toward as a long-term, steady-stage dosing level for Orenitram.

  • Thanks for your question. Next question please?

  • Operator

  • Mark Schoenebaum, Evercore ISI.

  • Mark Schoenebaum - Analyst

  • Hi, guys. Thanks so much for taking the question. I really appreciate it. Roger, I was wondering the selexipag data coming up. I was wondering what you'll be looking for in the data to understand how that molecule is going to play into the market.

  • The second question was on FREEDOM-EV, the outcome [start] that you were just speaking about, I understand it's on top of one oral. There have been some physicians that have expressed concern that it's on top of two orals, and that might therefore impact enrollment. I was wondering if you could comment on that and give us an update on enrollment. Thanks a lot

  • Roger Jeffs - President & Co-CEO

  • Sure, Mark. Thanks for the question. Maybe I'll sound a bit like a broken record here on selexipag. I believe it's been more than eight months since they announced their initial data, and I think we all still await the publication of a broader set of data. They've been very quiet on the data released, but I do understand that it's going to be at March at ACC they're going to have a more complete review of that data.

  • In terms of questions, that I would like to see answered, and I think again it's not just me, I think this comes from the clinical community in general that treats patients with PAH, is that while they've shown a relative risk reduction in morbidity and mortality, I think people want to see the Kaplan-Meier plot that undermines that or supports that risk reduction, and certainly look at the absolute risk reduction. Further, it'd be nice to see breakdown by background therapy because they had a component of those patients, I believe upwards of 25%, that were naive to treatment, so basically a monotherapy treatment, and whether or not that subsegment of the population drove the results similar to what happens if you looked at their (inaudible) data. A lot of that effect was driven by the treatment naive patient population, and then to look at how did it perform both on single and/or double background therapy, which I do understand they had a very small portion of patients on dual background therapy.

  • The second thing I would like to see is a lot more clarity on the six-minute distance effect, not just placebo corrected, but look at it in the active group. In the commercial setting, you don't get the benefit of giving nothing. You have to just perform as an active moiety, so it be interesting to see what was the active group improvement in six-minute walk distance.

  • Then secondarily to that, it would then be important over their [eight-fold] dose range to see if there was a dose response. What I've heard through the grapevine is that the active group improvement was small, in the single-digit range. If that's true then it's obviously going to be very hard to show a dose response, if not impossible.

  • A third question would be, what's the overall tolerability profile. I think Actelion's made a lot of claim that having an IP 1 selective agonist [approach] would improve the tolerability profile, but we've also heard and I think they've announced actually that they were 14% of the patients that dropped out. That's nearly one in six that dropped out to prostacyclin related side effects.

  • That's a very high number just for that, and then obviously there are dropouts for other reasons. Their dropout rate must be pretty high. By comparison, if you look at the FREEDOM-M study, our label, we had 4% dropouts due to prostacyclin related side effects, and the placebo comparative group was 3%, so much lower level of dropouts, again, and that was on a BID regimen.

  • As Martine said, our market has moved to TID which appears to be much better tolerated given that the retention of patients in the commercial setting is very, very good. Those are the types of things that I'd want to see.

  • I think further on dose, it'd be interesting to see because they have a dose ceiling. Did patients track to the highest dose? Are those the patients that are then dropping out because of intolerance?

  • How do dropouts correlate with the dose applied? That's a very important metric to look at because I think one of the things that they're asserting is they're going to give this low and known dose at a maintenance dose to support patients on (inaudible).

  • That actually disadvantages patients in my opinion because the hallmark of prostacyclin therapy is that it's infinitely titratable to effect. What you want to do is dose the drugs to effect, so to have a limitation in that regard to me limits clinical utility of the therapy and actually undermines the clinical value of that moiety.

  • Again, those are the types of things that I would like to see. Whether or not they show them, who knows? Hopefully, the audience will ask all those questions because those are the answers that are going to define their outcome, both in terms of a regulatory review as well as if they're successful there in the commercial setting.

  • Martine Rothblatt - Chairman & Co-CEO

  • Thank you, Roger. Thanks for that great comprehensive answer. Operator, Eric, next question?

  • Operator

  • Jessica Fye, JPMorgan.

  • Unidentified Participant - Analyst

  • Hi. This is Ryan for Jess. Thanks for taking my question, and congratulations on the quarter. Maybe you could give us a little bit of color on the expense outlook for 2015. Thanks.

  • Martine Rothblatt - Chairman & Co-CEO

  • Sure, thanks for that question and for the congratulations on the quarter. As we have John Ferrari here for his last conference call, after 6 times, [24], excellent conference calls, John, if you can give some insight on R&D expense looking into 2015?

  • John Ferrari - CFO

  • Without giving specific numbers, in general, I would expect that R&D expenses may increase slightly in 2015 over 2014 because we have two big clinical trials going on, EV and BEAT, well as the developmental work that we're doing still on the Mini-Med pumps Remodulin, infusion system, the disposable pump, and other things like that. We're investing in the pipeline which is investing in our future.

  • Sales and marketing could be flat to maybe just a slight increase since we do have four products that we are now marketing and trying to sell. Then SG&A tends to go up year-over-year just because the support services and things that we need to do to for our growing Company, but I don't see any significant increases in the SG&A line item that would be noteworthy.

  • Then our cost of goods product sales, actually will decrease year-over-year now because we're not paying a 10% royalty to Glaxo for the treprostinil based products.

  • Martine Rothblatt - Chairman & Co-CEO

  • John, that is really important, that last point that you mentioned. Significantly, with the big drop in COGS by I guess would be somewhat close to 10%, 10% drop in COGS, that's really significant. I apologize for misspeaking. It's been eight years that you've been CFO, 32 quarters not six years.

  • Our profit picture continues to look good. In addition to that, we're continuing to execute our share buybacks. Not only are earnings on their own likely to grow because of growth in sales and flat to downward trends in expenses including COGS, but significantly, earnings per share should increase yet further because of our reduction in outstanding shares. Indeed, that's why we think that's a good use of money demonstrating our confidence going forward in financials. Next question, Eric?

  • Operator

  • Michael Yee, RBC Capital Markets.

  • Judy Liu - Analyst

  • Good morning. Thank you for taking my questions. This is actually Judy Liu on for Michael Yee. I had a question of about Orenitram, if you don't mind. I was wondering if you could give us a little bit more on your thoughts of what timeframe would you expect Orenitram to be your biggest product?

  • Would you expect most of the patients converting to be coming from other products you are offering, or from non-UTHR products? Also if you could perhaps explain or just state what impact, if any, this would have on sales of Orenitram, the impact that the pump would have, that would be great. Thank you.

  • Martine Rothblatt - Chairman & Co-CEO

  • Yes, as was indicated earlier, we think that we're looking at less than a handful of years until we match with Orenitram the level of revenues that we see with Tyvaso. You can see that, as I mentioned in my introductory remarks, at the rate that we've launched out of the starting block here is quite brisk and significant. Basically, you're looking on something like a handful of years until it becomes the Company's best-selling product, were there no growth in the other products, and maybe a year or so after that if there were growth.

  • Now, we don't really believe that the growth in Orenitram is mostly coming from UTHR products. It's actually patients who are not already on UTHR products. That would be the source of most of the growth.

  • As I mentioned, there are 30,000 and growing numbers of pulmonary hypertension patients. The number of those patients in the US who are on our products currently are something in like the 7,000 patient range.

  • The vast majority of pulmonary hypertension patients don't yet have access to prostacyclin therapy. In fact, a fast statistic is that about half the patients who die from pulmonary hypertension never have access to prostacyclin therapy. Again, it's mostly related to the fact that it's a big challenge and a big difficulty for many patients to take the [preferential] therapy or even the nebulization therapy.

  • Many patients are seen at community centers. In fact, more than half patients are seen at community centers, and those community centers may simply not be able to support the complexities associated with Remodulin or Tyvaso. However, prescribing a pill is something that can be handled very widely, including at the community centers, and hence we have new specialists focusing on those centers.

  • I think most of the growth in Orenitram is going to come from patients who are naive to prostacyclin therapy. In other words, they have been newly diagnosed, or they have been on a [PDE-5] background therapy or ETRA background therapy, and now the doctor believes that it's important to get them on what has been considered a gold standard, prostacyclin branch of therapy.

  • It's also important to remember that the patients with pulmonary hypertension have been shown in clinical studies to have diminished levels of prostacyclin metabolized, and that's the whole logic behind prostacyclin therapy. It's because of the somatic genetic mutations in these patients, they don't make the same amount of prostacyclin as healthy people make. The whole logic behind Orenitram and Tyvaso and Remodulin is to provide the patients with that additional prostacyclin that their bodies cannot make on their own.

  • In summary, I'd like to mention that the way to think about pulmonary hypertension and the introduction of Orenitram is that pulmonary hypertension is a disease of low incidence, but due to better and better therapies and care, growing prevalence. It's really a fascinating case study that the incidence is simply on the level of a few per million people per year, but the prevalence has grown from 3,000 patients at the time we launched our Company to over 30,000 patients today and continuing to grow, and this is because patients are living longer and longer with the therapies approved for pulmonary hypertension.

  • At our recent national sales meeting in February, I had the honor to meet a pulmonary hypertension patient who's now going on four decades of life diagnosed with pulmonary hypertension. She was tremendously inspiring and courageous.

  • Her doctor said she is like a history book of pulmonary hypertension therapies. I believe patients like her are going to be the type of patients that will live longer and longer and contribute to the growing prevalence of pulmonary hypertension. Next question?

  • Operator

  • Geoff Meacham, Barclays.

  • Geoff Meacham - Analyst

  • Hi. Good morning, guys. Thanks for taking the question. I wanted to ask on Adcirca hoping you guys can talk a little bit about the sequential trends seen in the fourth quarter. Was there an impact on the Gilead data and with Letairis?

  • Then on the patent side, you guys have obviously had extension strategies for Tyvaso and Remodulin. I'm just wondering if there's any opportunity for Adcirca extension beyond 2017? Thank you.

  • Martine Rothblatt - Chairman & Co-CEO

  • Thanks so much for that question. Adcirca had a terrific quarter, and it's really very helpful for us because Adcirca is pretty much the sales force responsible for it as the trailblazer for all of our prostacyclin based oral therapies. The way we think about it is that if we can successfully represent a product until there are even in an orphan disease 15,000, 16,000, 17,000,18,000 patients taking the drug, if we could do that with Adcirca than we can do that with our oral prostacyclin therapies esuberaprost and Orenitram. Once esuberaprost would be approved and Orenitram's label would be expanded with the FREEDOM-EV study.

  • Of course, the physicians and the patients appreciate the numerous benefits of Adcirca. It's a therapy which it is taken once a day. As most of the people on the call probably know, it is a rebranded form of Cialis, one of the most widely prescribed drugs in the marketplace that people feel very comfortable about in terms of its safety profile.

  • There has been the recent outcome of the study of Adcirca combined with Letairis, the Gilead product, and that data will be presented I believe at the upcoming ATS (inaudible) meetings, and certainly in peer review publications. It was interesting that it was publicly announced that the combination of those two drugs had a significant effect in terms of achieving the end point, the end point being a delay of morbidity and mortality, combined end point. That information is out there for the experts to peruse.

  • It's also quite interesting that similar results were not achievable with sildenafil combined with Tracleer, so again, nobody compared the two exactly one to the other. I don't think that you're really seeing a mapping over of the AMBITION study data. That's the Adcirca plus ambrisentan. You're not seeing that mapped over to Opsumit, Tracleer, or sildenafil.

  • Now another very fascinating point about the Adcirca growth is that payers are realizing that this is well worth paying for and significant because it largely competes against sildenafil, which is largely generic at this point, but sildenafil has to be taken three times a day compared to the one time at a day for Adcirca. Of course, as noted just previously sildenafil was not included in the AMBITION study that produced such positive results.

  • All of this harkens very well for Adcirca, and we're certainly aiming to try to get that up to 20,000 patients on therapy. That would be about two out of every three pulmonary hypertension patients. To the best of my knowledge, that would be the highest penetration that any single product ever achieved in the pulmonary hypertension space, very significant.

  • In terms of the patent situation, the therapy is one that we licensed from Eli Lilly and Company, and the ball is really completely in Eli Lilly's court with regard to every aspect of IP strategy and even the economics relating to Adcirca. We would just have to defer questions in that whole area to Eli Lilly. We have time for two last questions here.

  • Operator

  • Robyn Karnauskas, Deutsche Bank.

  • Evan Seigerman - Analyst

  • Hi, this is Evan on for Robyn. Congratulations on a great year. I want to turn the focus to the antibody for the neuroendocrine tumors. With the approval coming up, how should we start thinking about the market?

  • I know there's about 650 patients in the United States who are diagnosed with the specific tumor condition every year. How many of those should we estimate would be eligible for treatment? Thank you.

  • Martine Rothblatt - Chairman & Co-CEO

  • Thanks, Evan. Thank you for your congratulations, and congratulations to your overall bank on the recent [Valiant] transaction. That was quite significant as well. I'd like to ask my Co-CEO, Dr. Jeffs, to address the questions on neuroblastoma. He's much more on top of that than I am.

  • Evan Seigerman - Analyst

  • Great

  • Roger Jeffs - President & Co-CEO

  • Sure. Thanks for the question, Evan. I think the way we've estimated the market is there's approximately 500 patients that would match the indication claim of high risk refractory neuroblastoma. We, based on what we think we will price this, we haven't disclosed, but that would predict about a $75 million or so market in the United States with an analogous market in Europe. I think one of the good things about having a chimeric monoclonal antibody is the price tolerance in Europe is going to be almost equal or at parity to what the price target here will be here in the States, so the markets are very comparable both in terms of size and expectation with revenues.

  • That's probably as much color as we can give you at this time. Again, we're waiting for approvals. It's near-term. We certainly are optimistic that we will get approval.

  • There might be some commitments to that approval in terms of doing further studying, and quote, unquote, validation of some of the science pre-clinically even. We'll just have to wait and see, but the ramp to that revenue is another important aspect of it, and it should be actually quite quick.

  • The reason I say that is we're already probably treating upwards of 65% to 75% of that market through our open label studies. It's going to be the first and only approved therapy specifically for patients with neuroblastoma. Its uptake will be rapid it's such a known entity. There's a few centers of excellence. Most of them, if not all of them, participated in the trial through the Children's Oncology Group and the NCI that developed this therapy. We're their manufacturing and commercial partner for this.

  • Then we're going to do other supported trials and some branch point type opportunities like osteosarcoma, and maybe in other types of neuroblastoma regiments to augment further the benefit that was previously observed. I think the uptake will be quick to those revenue streams that I talked about

  • Evan Seigerman - Analyst

  • Excellent. Is there potential for more dosing beyond the five cycles I saw in the trials?

  • Roger Jeffs - President & Co-CEO

  • Yes, that's a great question. We've had some advisory boards with the physicians that treat these kids that are suffering, and it won't be indicated for subsequent courses initially. I think what appears to happen is they take the five courses. Then some patients can further relapse. They are then retreated.

  • That's not universally true, but it does happen and will happen. I don't think payers will reject that quote, unquote, off-label use of the therapy that's used in this manner. It's something clearly we will not promote, but given the dire situation for the kids, it's something we will want to study through whether or not additional courses of therapy would benefit the patients.

  • Evan Seigerman - Analyst

  • Excellent. Thank you so much

  • Martine Rothblatt - Chairman & Co-CEO

  • Thank you. Next question.

  • Operator

  • Phil Nadeau, Cowen and Company.

  • Phi Nadeau - Analyst

  • Good morning. Thanks for fitting in my question. I had a question on the concentration of the Remodulin formulation. We've heard that you've recently I believe doubled the concentration versus the marketed formulation. I guess my question is, one, is that true?

  • Two, what are your plans for that formulation? Was that filed with the implantable pump? Then three, if it was filed with the implantable pump, what proportion of the market can you now address? In the past people had worried that the volume in the pump would be too small for some of the more severe patients. Then lastly, what was the IP of that new formulation?

  • Martine Rothblatt - Chairman & Co-CEO

  • Thanks, Phil, for the question, and since the question is pretty much all in the IP domain, we can ask our Chief Strategy Officer, Andy Fisher, to address that question.

  • Andy Fisher - CSO

  • Hi, Phil. Thanks for the question. The very short answer to the question is we're not making any comment about formulations or anything else relevant to the Remodulin implantable pump system. Typically, when we have a pending new regulatory filing, we refrain from comment on it until it's actually acted on or approved by the FDA, so we do not have a response on this right now.

  • Phi Nadeau - Analyst

  • Thank you.

  • Martine Rothblatt - Chairman & Co-CEO

  • All right. That's was the last of the three questions. I want to thank everybody for attending the conference call.

  • We do plan to be present at a number of different healthcare conferences coming up in the next few months. James, Roger, or myself look forward to seeing you at those healthcare conferences. Eric, thanks for your services as operator. You can wrap up the call.

  • Operator

  • Thank you for participating in today's United Therapeutics Corporation conference call. This call will be available for replay beginning at 8:30 AM Eastern Standard Time today through 11:59 PM Eastern Standard Time on Tuesday, March 3. The conference ID number for the replay is 738 43546. The number to dial for the replay is 855-859-2056 or 404-537-3406. Thank you, and have a great day.