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Good morning and welcome to the United Therapeutics Corporation Third Quarter 2018 Earnings call. My name is Shelby, and I will be your conference operator today. All participants are in a listen-only mode until the question-and-answer session portion of this earnings call.
I will now turn the conference call over to James Edgemond, Chief Financial Officer of United Therapeutics. Sir, you may begin.
Hi. Good morning. It is my pleasure to welcome you to the United Therapeutics Third Quarter 2018 Earnings Call. Accompanying me today on the earnings call are Dr. Martine Rothblatt, our Chairman and Chief Executive Officer; Mr. Michael Benkowitz, our President and Chief Operating Officer, and Mr. Andy Fisher, our Executive Vice President.
Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Form 10-K and 10-Q contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements.
Today's remarks may also include financial measures that were not prepared in accordance with U.S. Generally Accepted Accounting Principles. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website at www.unither.com.
Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website.
Now I will turn the call over to Dr. Rothblatt for an overview of our third quarter 2018 financial results and the business activities of United Therapeutics.
Thank you, James, and good morning, everybody dialing in to the United Therapeutics Third Quarter 2018 Earnings Call. My name is Martine Rothblatt. I'm the Chairman and CEO. And in addition to Mr. Edgemond, our Chief Financial Officer, I'm also joined on the call today by Michael Benkowitz, our President and Chief Operating Officer and Mr. Andrew Fisher, who is joining us for his last earnings call before his retirement after 20 years at United Therapeutics. Thank you, Andy, for all those years of service.
Well I've got a lot of good things to share on this call. First and foremost, I'm super excited that during the past quarter, we hit the second highest number of patients on our treprostinil franchise that we've ever had. That's over 7,000 patients across our Remodulin, Tyvaso, and Orenitram and it's very consistent with our expectations that we see our treprostinil franchise continuing to grow in terms of number of patient's health year-after-year through the 2019, 2020 and into the 2020s. And the reason for this notwithstanding the launch of generic Remodulin are the number of unique and differentiable factors that pertain to our various treprostinil products, Remodulin, Tyvaso and Orenitram.
Before I go into those differentiable aspects, let me mention the most important thing from a scientific standpoint is that our research has shown that treprostinil uniquely activates the EP2 receptor in the pulmonary vascular bed. And this is something which is not matched by other prostacyclin analogs or prodrugs of prostacyclin and it seems to have a significant pharmacodynamic impacts that are particularly relevant to the progress of pulmonary hypertension and the natural history of the disease. So we feel very fortunate that the treprostinil franchise, our home franchise, is one that uniquely activates this EP2 receptor in the pulmonary vasculature.
But now let me describe how our productization of that treprostinil franchise gives us some really exciting products and gives us the confidence to say that total patients on United Therapeutics treprostinil products are very, very likely and we are quite confident that they will continue to grow year-after-year for the coming years.
So, first let me talk about Remodulin, which was the first treprostinil product that we launched. There are four unique features to Remodulin as it is today and then there are four unique ways that Remodulin is going to advance above and beyond the entry point of any generic forms of Remodulin.
First, Remodulin has an established safety profile and 15-plus years of supply chain reliability that is recognized by prescribing physicians. By the way, speaking of supply chain, I would like people to know that we've got some tremendous and talented staff at United Therapeutics responsible for supply chain. Some of you may have had a chance to interact with Beth Rhodes, our Senior Vice President for Global Supply Chain. She reports to my colleague, Mike Benkowitz here right to my right and together they and their teams have done just a stellar job of ensuring a flawless supply chain for 15-plus years.
Second, Remodulin patient support services that generic manufacturers of Remodulin are not expected to offer. Third, physicians and payers have not historically encouraged substitution of existing lower cost PAH parenteral alternatives. And, number four, Remodulin will remain a highly differentiated product, will be delivered through multiple next generation drug delivery systems intended to enhance safety, tolerability and convenience for our patients. And next, fourth factor is a great launching point for me to talk about these four different ways that Remodulin will permutate over the next several years and remain a proprietary important branded product of United Therapeutics.
First and foremost, the implanted system for Remodulin or implantable system for Remodulin, ISR. This is a product that the FDA very graciously approved last year and is now going through a number of advancements to expand its reach beyond the initial patient population being helped out to the many thousands of patients that we, physicians and others believe are natural users of the implantable system for Remodulin.
Yesterday, we at United Therapeutics had one of our monthly or every other month town meetings and we were honored to have one of the implantable system for Remodulin patients come to speak to all of the gathered Unitherians as we like to call ourselves. And this patient (00:08:30) reasons I will leave unnamed has had the implantable system for Remodulin inside her for some six years. And she described the transformative experience that it had on her health.
And in the audience was our top Clinical Development Scientist responsible for this product, Dr. Lee Peterson (00:08:53). And when the patient was introduced to Dr. Lee Peterson (00:08:58), the patient leapt up from her seat, which is something that she had the energy to do, thanks to this kind of a product, and embraced Dr. Peterson (00:09:08) so strongly. And it was just a beautiful, beautiful sight to see, clinical drug developer meets patient whose life has been transformed through this product. So, many thousands of people I feel are (00:09:25) for the ISR product, which will be a major engine of treprostinil franchise's continued growth as we move through 2019 and into the 2020s.
Next up on the subcu side is RemUnity. RemUnity is this disposable, super high tech PatchPump invented by the famed inventor Dean Kamen. And with RemUnity, patients will be able to have a peace of mind that their drug is delivered with an accuracy that heretofore has not been possible through mechanically driven pumps, and also a level of convenience, which will save at least a dozen and perhaps as many as two dozen steps involved in their daily or every other day preparation of subcutaneous Remodulin for use. So we expect this was going to have a big effect on compliance to having an effect on convenience. And therefore we think many patients who might otherwise have stepped back from subcutaneous forms of Remodulin will in fact step forward. And this will be a second engine growing our continued number of patients on Remodulin.
Third and very similar to RemUnity, but different and also important way is SteadyMed's product, Trevyent. And we've mentioned in the Q that we filed today that we will be refiling the SteadyMed application for approval in the first half of 2019. And as many people who have filed the pulmonary hypertension space are aware, the SteadyMed product is a revolutionary piece of Israeli technology that allows perhaps the maximum of convenience because each pump has a fixed dose associated with it. And so there's no real need to have the added complexity in the pump of titrating to a different dose, because that's done in the cartridge that the patient receives in the mail and then throws away afterwards.
There has been a truly excellent market outreach done by the SteadyMed folks through their phenomenal programs, and we really look forward to integrating all of the great folks at SteadyMed into United Therapeutics, and relying on SteadyMed to fulfill its share of a several thousand additional patients on treprostinil that will be part of, that I mentioned this continued growth in United Therapeutics patients on treprostinil through 2019 and into the 2020s.
Next up, let me talk about the RemoLife (00:12:33) program. This is a tremendous partnership that we have with the manufacturer of all of our pumps today, Smiths Medical, certainly the leading name in the field of parenteral drug delivery technology. And our team together with the Smiths Medical folks have been hard at work developing this new RemoLife (00:12:59) pump, which is really quite breathtaking, because it's a first pump I've ever seen that's able to accommodate both intravenous as well as subcutaneous drug delivery. So it's a real ambidextrous player here. It's also going to be completely integrated with the patient's smartphone to allow data on the patients use of the drug to seamlessly pull it through the smartphone into the cloud, and there at the cloud, it can be accessed by their doctors, of course with prior consent from the patients, as well as the payers, again with prior consent, so that everybody is aware of exactly how much drug is in the patient's reservoir at any one point in time. This will lead to savings across the entire system, a reminders for the patient, a complete what we call the first-ever SmartPump system. And we're really excited about that strategic initiative with Smiths Medical.
Before I role onto why we'll get additional growth in Tyvaso and Orenitram, maybe just mention in transition the RemoPro product, which is a project to eliminate the subcutaneous site pain associated with Remodulin, which would also give rise to substantial additional thousands of patients accessing subcu Remodulin. And this RemoPro project has completed its first set of Phase I studies and we have successfully been able to mask the pain of the treprostinil molecule, which is known to cause subcu pain when passing through the dermis.
So a tremendous shout out to Dr. Ken Farris (00:14:55) and our other inventors at United Therapeutics, our Chemistry team under Dr. LeAnn Gou (00:14:59) who have been able to mask the subcutaneous pain and we now have additional iterations going forward that will aim to optimize the pharmacokinetic profile, so that we can demonstrate a bio-equivalence of our RemoPro drug with the Remodulin drug and thereby offer the patients via the RemUnity pump, via the SteadyMed pump, and via the Smiths Medical SmartPump subcutaneous version of it, a form of Remodulin which does not cause site pain.
So if those were the only sources of our growth in treprostinil patients, I'm confident that we will continue to grow treprostinil patients over years to come. But actually there's two more, frankly, even larger sources of growth (00:15:54) sequentially here. The next area is Tyvaso. I'm pleased to announce that we have completed the necessary number of events that we need for the unblinding of the BEAT trial, which is a combination of Tyvaso, esuberaprost trial meant to show that when Tyvaso is boosted with esuberaprost that there's a reduction in morbidity and mortality, that is great for the patients, those patients can use our drugs for longer period of time. And that unblinding is scheduled to occur at the end of March of 2019. And then we are queuing ourselves up for a filing on esuberaprost in combination with Tyvaso for the end of August 2019. So I do believe that that augurs very positively for Tyvaso.
Another amazing product that is going to cause many more patients to come onto Tyvaso is the MannKind product, what we call MannKind Technosphere. And this is an amazing device. Many of you in the pharma space I'm sure have seen their products used in the inhaled diabetes area. It's really just palm-able. It's the size of the smallest vaping device that as if you would tend to see, it's maybe not the smallest because I know some of these high school kids got things that the teachers can't see, but a step up from the small. It's definitely palm-able.
And it's so cool to watch it because it integrates with your smartphone via Bluetooth and there's actually like as you turn the MannKind device to the left or to the right, you actually see a cartoon of it on your smartphone, and the cartoon turns the same way that it turns, just like a picture on your smartphone will go the portrait or landscape. And when it's in the right orientation you get a green check, if wrong orientation you get like a red X and then you can even get like a curve, so that if you breathe along the curve you see that you're breathing just right. I mean this is gangbusters for compliance and for accurate deposition of Tyvaso for patient satisfaction.
And the team at MannKind is one of the absolute best groups of people that we've ever had the honor to work with. They are now fully integrated into our Clinical Drug Development Group over in Research Triangle Park. And I'm confident that once the MannKind device is approved that that will augur yet additional thousands of patients on Tyvaso, whichever – I don't know if it will be called Tyvaso or something else, but inhaled treprostinil is going to be called Tyvaso.
Another very exciting development in the area of Tyvaso is our PRN program with the European company MedSpray. And these guys are the leaders in a field of a nanosphere-based liquid powder deposition. And it's a device that requires no battery or electronic operation at all, you're able to have a deposition of this liquid powder that matches that that you get with Tyvaso. So this study is entering Phase I. Actually I believe the first patients are being randomized into Phase I in this quarter, and then we will have the final commercial product form delivered to us around the third quarter of next year and then move right into kind of a rapid Phase II, Phase III study at the end of 2019 and into 2020.
So very rapid advance in simultaneous dry powder with MannKind, liquid with MedSpray and the PRN showing that you throw esuberaprost on top of that, it all works longer and better. And anyway you add up one, two, and three, to me it's like 6,000 more patients. I don't know. Don't get hung up on the number 6,000, it could be much larger. So I think Tyvaso is another huge grower of United Therapeutics' patients on treprostinil.
I know I'm getting a little bit beyond the question time, so let me just wrap up very rapidly here with Orenitram, which is the third reason we believe that there will be many thousands of additional treprostinil patients. This is of course the Holy Grail of drug delivery, which is you pop a pill. We announced our FREEDOM-EV results. We did it right after unblinding because everybody was waiting for that. The most material data point is with the study positive or negative. Hell yeah, it was positive. It was damn positive, and there were a lot of high-fives and everybody is very excited.
The next step is that you prepare the NDA supplement and get the full dataset. I'm really happy to share with everybody that as we have gone through the full dataset, it is even better than we were able to announce immediately upon unblinding. I can't say anything more about the numbers because these things have to be peer reviewed and presented in the proper medical fora and whatnot, and of course the whole dataset going to the FDA. But I can tell you that right after you unblind you get deeper and deeper into the data. And on the most salient points of a study, the data is even better than what's originally announced. And I'm 100% confident that that is not a statement that will ever have to be walked back, so super excited about that.
Once physicians see not only the initial data, once the FDA blesses the initial data and it's something that is in the label and could be accurately said with regard to the drug, not to mention the full dataset, and once that's in the label and can be actively described to the physicians, I really think in most instances the physician will feel that – for the appropriate patient the only drug to prescribe would be Orenitram in combination with background therapy. Certainly, the only prostanoid to prescribe would be Orenitram. So that of course augurs many thousands of additional patients on treprostinil.
Well, thank you for joining me on the introductory portion of the call. I hope I've given you a sense of confidence, the data behind the confidence, the substance behind the confidence that we have, the United Therapeutics treprostinil franchise is going to continue to grow many thousands of patients more, year-after-year, after this very exciting reach of our second highest level of treprostinil patients ever, which we reached during this past quarter.
Now I'd like to open up the line for any questions to our Chief Financial Officer, Mr. James Edgemond; our President and Chief Operating Officer, Mr. Michael Benkowitz; and our wonderful Executive Senior VP and Associate Deputy General Counsel, Head of Strategic, Planning, Investor Relations, and many other things, that Andy has done with the best of spirits, and the best of abilities, over these years. Operator, please open up the call.
And our first question comes from Chris Shibutani from Cowen. Your line is now open.
Good morning. Thank you very much. Two questions, number one, Martine you're highlighting this patient number, which is something that we would really benefit from the ability to get a better sense of perspective on how to interpret that. Can you give us a little bit more background in terms of this, obviously there's been probably growth in the use of treatments at earlier stages, which might support a growing number of patients, but can you put some perspective, is there anything in terms of revenue per patient, or what do we do with this 7,000 number in terms of, I'm trying to figure out how to translate over to our view of how to think about the future? And then I have a follow-up question on expenses for James, but for you on the patient number, Martine.
Okay. So the drug industry has been critiqued for price increases, and I think that it's a dodgy but necessary statistic in terms of looking at how well a company is doing in terms of revenue, because a lot of companies they just keep increasing prices. Now fortunately that has been moderated in recent months, quarters, to the industry is trying to keep the price increases in the single-digits percentages. Just for the record, and not saying that we're better than anybody else, I just wanted to say what the fact is. United Therapeutics has never taken a double-digit price increase ever in our entire history. And so, we got to $1.5 billion a year in revenue the hard way, by doing good clinical trials, good clinical science, and explaining the results to doctors, and then doctors took the appropriate decision.
So if I was in your shoes, I would say, wow total number of patients on treprostinil, that is a really good metric for me to use to understand how well this company is doing, like if generics were eating their lunch, then by definition the total number of patients on treprostinil would be less, as you could see that's not happening here. Now we don't like to go into the minutia of how many patients are on this, that and the other version of our drug, and as you could tell from my introductory remarks we are in the process of kind of cloning three versions of our drugs into like 12 versions of our drugs. There will be four different flavors of Remodulin. There already are three different flavors. There will be four different flavors of Tyvaso, and I didn't have time to talk about what we're doing in terms of our Orenitram combo pill and our Orenitram once daily pill, but all that stuff is going forward as well.
So we're not going to go into the minutia of each particular product and how many thousands of patients are on each particular product. But I do think that I completely agree with you that the total number of United Therapeutics patients on treprostinil is an excellent barometer of how well the company is doing. Now in terms of pricing and in terms of what does that mean in terms of revenues, I think a kind of a rough metric that – and this is all based on publicly accessible information, every product has its own reimbursement profile, every product has its own rebate profile based on the Part B, Part D, Medicare, private, particular contracts with particular payers. Not to mention the fact that our products, unlike those of most of our competitors are titratable, which makes it yet more complicated to figure it out. But I think a conservative metric would be say, $150,000 per patient per year times the number of patients on the drug. It's going to be a rough estimate of what the company's net revenues are going to be. James, can you talk about the expense question?
Yeah. Hey Chris?
(00:28:52)
Yeah.
(00:28:54) know the expense question?
No, he was going to circle back on the expense question.
All right. Chris, do you have the expense questions ready? Operator, next call.
And our next question comes from Geoff Meacham from Barclay. Your line is now open.
Hey guys. Thanks so much for taking my call. This is Jason (00:29:11) on for Geoff. I was hoping if you could talk a little bit more broadly about – in thinking about the lifecycle management strategy, what the conversion rates would be like in moving patients over to all these various devices, especially given kind of the payer headwinds? What do you foresee the conversion rates being like? How do you anticipate managing them? And what do you ultimately expect those rates to be? Thanks so much.
Yeah. Thanks, Jason (00:29:45). I don't really think it's a lifecycle management question at all. I think it's a question of all of our existing products that patients are locked and loaded on those products. Very, very rare, as I mentioned in my introductory remarks for payers to rip a patient off a product that they are depending upon for sustaining their life. In the disease state, the patients just have a handful of expected years of life. Instead, I think it's a matter of a pipeline that's actually pouring forth a number of new products. The implantable system for Remodulin was the first such new product. The RemUnity is another new product. The Trevyent is another new product. And RemoPro is another is another new product. The RemoLife (00:30:34) with Smiths Medical is another new product. The esuberaprost is another new product and MannKind and so on and so forth.
So all of these products are not products that are swapping in and out of our existing patient base. All of the growth we are seeing is organic growth. We are eating into the Uptravi space. We are eating into the Opsumit space. We're eating into the newly diagnosed patient space. There are, every year, literally thousands of new patients diagnosed with pulmonary hypertension. I didn't have a chance in my introductory remarks to talk about the WHO Group 3 space, where we're conducting our Phase III trials in COPD and ILD forms of pulmonary hypertension; tens of thousands of patients which have gone untreated completely.
I didn't have a chance in my introductory remarks to talk about the WHO Group 2 space for patients with left heart failure, but with preserved ejection fraction, best estimates are well over 100,000 of those patients have been completely untreated. And so, it's the movement into these spaces with new products coming out of our pipeline. That's where the organic growth is coming from. Next question, please.
Thank you. And our next question comes from Terence Flynn from Goldman Sachs. Your line is now open.
Hi. Thanks for taking the question. I was just wondering, Martine, if you can comment on latest thoughts on capital allocation, specifically how you're thinking about repurchases versus business development and maybe expanding the pipeline beyond PAH. Thanks a lot.
Thanks, Terence, for that question. I'm going to pass it over to James as he's our Chief Financial Officer. I will just mention though, at the tail of the question, that we are expanding beyond pulmonary hypertension. And just to make sure everybody on the phone is aware during the past quarter we acquired the exclusive rights to a very, very exciting product for idiopathic pulmonary fibrosis, which is not associated with pulmonary hypertension. There is another subset of pulmonary fibrosis which is associated with pulmonary hypertension. We have a Phase III trial now enrolling patients called the PERFECT trial, and it's enrolling quite well. That's a growth opportunity for Tyvaso (00:33:05) thousands of new patients I mentioned before. But we also have this tremendous regenerative medicine type of product based on the Wnt pathway from Samumed in pulmonary fibrosis. Off in Phase I results, we're going to be taking it into Phase II and Phase III. But James, let me pass the baton over to you on the capital allocation question.
Good morning, Terence. Thanks for the question. And so Terence, our capital allocation priorities, I would say remain unchanged and consistent with what we've talked about previously. And so, we're first going to invest in R&D opportunities that support our business mission. And second, investing in value-creating business development activities. Martine mentioned some of those briefly just a moment ago. And third, historically we have done share repurchase, but that will be a third priority. So again, I think the framework that we've applied is been consistent. And I think if you go back to the third quarter, we've executed against that framework as we've discussed before.
Excellent, James. I'd like to add one last point, Terence, and that is we have not had a chance on our quarterly calls to talk very much about our oncology franchise. And it's probably something that I really take responsibility for. I should have provided the shareholders with more visibility into our oncology franchise.
It's a really beautiful drug because – and I'm talking here about Unituxin, in that based on the label it has reduced the death rate in the patients who end up dying from neuroblastoma by just about 50% in the subset of neuroblastoma patients to which it applies. That means that there are literally hundreds of kids that – thanks to Unituxin – are going to be able to grow up and live a normal life without a fear of cancer haunting them, without needing to take any continued drugs to keep their cancer in check. I wish it worked 100% of the time, but I'm grateful that it works 50% of the time. And we have a number of physicians that are beginning to test Unituxin in other GD2-responsive cancers, of which there are several dozen.
So we teamed up with a company called Precision Oncology to analyze all the different GD2 cancers and go through a comprehensive, precision medicine based set of assays to determine, which was our best shot for dinutuximab, and that's the proper chemical name of Unituxin. And anyway, the best shot turned out to be small cell lung cancer, followed by certain forms of glioma, followed by certain forms of melanoma. And so we embarked on first a Phase II, then the Phase III study of dinutuximab in small cell lung cancer. And we've now completed enrollment just this past quarter of over 450 patients, in that DISTINCT is the name of the Phase III study of dinutuximab for small cell lung cancer. Our business development, market research people have told me that they see this as a $2 billion market. So I think that's pretty impressive and it definitely is a strong step outside of pulmonary hypertension.
I'll also mention in that vein that there are forms of neuroblastoma for which Unituxin is not currently approved and we are pursuing approval on these additional forms of neuroblastoma for which it is not currently approved. There are some clinician testing of it in some soft tissue cancers, different types of sarcomas, so that's another significant opportunity. Finally, very recently we obtained exclusive rights from St. Jude to a humanized form of our dinutuximab molecule. And this coming quarter we'll be pretty much wrapping up the construction of our production facility for the humanized dinutuximab.
I have to say that the only drug we have or product that we have that I have not been able to keep the amount of inventory that I would like because of the size of our facilities and the amount of sales is dinutuximab. So with this new facility, we will be able to ramp up our production of humanized dinutuximab, which once we do the appropriate comparability studies and obtain FDA approval, I think it will be a gentler drug for the kids to take, and the adults for that matter and will really be a drug that can move our cancer franchise to its full $2 billion value proposition that I mentioned earlier. Next question?
And our next question comes from Liana Moussatos from Wedbush Securities. Your line is now open.
Thank you. What are the next steps and timing to get RemoPro approved? And do you plan to replace all subcutaneous products with RemoPro?
Thanks, Liana, so nice to hear your voice this morning. And (00:39:11) probably be the case, I would find it hard to understand why anybody would do a non-RemoPro version of treprostinil, when there was the RemoPro version available. You can see on the label that it's for regular treprostinil. I don't have the exact number, but something like 90% of the patients suffer subcutaneous site pain and erythema. So it's a very high proportion.
Some of those patients get used to it, some never do. I will tell you, I have tried it on myself and it hurts like hell. So I really – if you don't need to have it, I recommend you not do it. But if you have a pain-free way, that's the kind of thing that you get these hockey stick curves in terms of patient take up that if something causes pain, the doctor says, oh good news, I've got a painless version of your product, of your drug. It's like, okay, let's change yesterday. And in fact, it doesn't even have to be completely pain free. If you said to any normal human being I'll give you something that causes half the pain (00:40:40) half the pain. So I do believe, Liana, that the RemoPro product delivered through our RemUnity system and delivered through our Trevyent system, SteadyMed system, and delivered through the Smiths SmartPump, our RemoLife (00:40:59) system will be the overwhelming, almost exclusive way that people would take treprostinil subcutaneously. Next question?
And our last question comes from Jessica Fye from JPMorgan. Your line is now open.
Hi. This is (00:41:16) for Jessica. Thank you for taking our questions. Could you provide any color to when we expect Sandoz will begin launch of generic Remodulin? And what do you think maybe delaying the launch here? And then what about Teva, Par and Dr. Reddy's and is there a reason to think their product won't be approved to launch?
Well thank you for your question, and I'm joined today by our President and Chief Operating Officer, Mike Benkowitz. Among his many other responsibilities, Mike also oversees all commercial operations at Untied Therapeutics, all relationships with payers, many other key responsibilities. So, Mike, can you please help the JPMorgan analyst?
I'll try. At this point or at this date in time, we're not aware that Sandoz is launched. In fact we've heard they've not launched. And we really don't have additional information as to why they haven't launched or when they will launch. But we know that they could have launched back in June, (00:42:24). So as for the other companies, we're not aware that they received their approval either. So you probably have to talk to them to understand what the status is with their filings.
Super, Mike. Thank you so much, everybody, for joining our call. The bottom line here is the same as the top line. Second best number of patients on our treprostinil franchise ever, and the forecast is for continued growth in total patients on treprostinil through Remodulin, Tyvaso, Orenitram, and the ever-growing number of new forms of both molecules that will provide advantages to physicians and providing patient care, as well as growth outside of pulmonary hypertension now into pulmonary fibrosis and into small cell lunch cancer. Thank you very much.
Thank you for participating in today's United Therapeutics Corporation Conference Call. A rebroadcast will be available for replay for one week by dialing 1-855-859-2056 with international callers dialing 1-404-537-3406 and using access code 4179147.