Good morning, everyone. I'm Dewey Steadman with United Therapeutics, and I'm happy today to host, or at least introduce Jessica Fye from J.P. Morgan, who will be hosting our fireside chat with the management team today. Before we start, I just wanna remind you that we may make forward-looking statements today, and any risks and uncertainties are listed in our SEC filings, including forms 10-K and 10-Q. With that, I'll turn it over to Jess.
Great. Thanks, Dewey, and welcome everyone. Happy New Year. I'm Jessica Fye. I'm a Biotech Analyst at J.P. Morgan. Delighted to be joined today by United Therapeutics' senior management team, including the company's Chairperson and CEO, Dr. Martine Rothblatt, as well as the company's President and COO, Michael Benkowitz. Thank you so much for spending this time with us this morning. Martine, I wanted to start out talking about your goals for the year ahead. Maybe with that, you can outline some of the recent progress with United Therapeutics and then just share what you're looking forward to this year.
Okay. Thanks, Jessica, and Happy New Year to you and to everybody else on the call. With regard to 2021, I think we accomplished a lot of really great goals. I think, you know, 1st and foremost is we had achieved our goal of approval of Tyvaso for Group 3 pulmonary hypertension. That's the 1st approval ever for Group 3 pulmonary hypertension. That was huge. Secondly, we got all but approval totally queued up for imminent approval of our DPI form of Tyvaso for not only Group 3 but also Group 1 and Group 3. That's really huge. We experienced back to double-digit patient growth and put us strongly on track for wrapping up the year this coming year with 6,000 Tyvaso patients.
That was a goal we set at the beginning of 2021 to have the double-digit patient growth, and we definitely experienced it. We started a phase III trial in pulmonary fibrosis. First time we've ever been in that indication. A whole lot of additional pipeline R&D. So it's just, you know, a huge number of things that were accomplished in 2021. With regard to 2022, Jess, I think it's going to be a year of fulfillment for UT, and I would spell fulfillment as like F-U-L-L, full-fillment. Fulfillment. The reason I use that mnemonic is because in 2022, we expect to have full enrollment of our COPD phase III trial. We expect to have full enrollment of our outcomes trial of ralinepag.
We expect to have full approval of our DPI product, full commercial launch of our Remunity product, and then full achievement of the 6,000 patient goal that we had set out for ourselves for Tyvaso. It's a whole lot of fulfillment in 2022.
Okay, great. Maybe to now look farther ahead, I also wanted to spend some time talking about your 2025 goal, your 25 by 25 goal. 25,000 patients, it's a lofty number, clearly one you see as achievable. I guess I wanna understand how you accomplish that and what we envision the business looking like when you do. I guess 1st, just thinking about the baseline where we are now, how many patients are on Tyvaso, Remodulin and Orenitram today?
Yeah. Great question, and one that the whole, you know, team at United Therapeutics is really focused on. We do feel confident in our ability to achieve 25,000 patients by 2025. Right now we are north of 10,000 patients, so you know, roughly speaking, 40% of the way there. The basic breakdown of the numbers that you ask for and how we would get from these numbers to the 25,000 patient numbers goes like this. Right now we have something north of 4,000 patients on Remodulin, and we expect to more than double that by 2025, principally through the launch of Remunity, and then after Remunity, RemoPro, which is our painless form of Remodulin.
That's one of the products that I mentioned at the beginning. It's in our active pipeline R&D that will go into human trials very soon, within the next 2 or 3 months. The next building block toward 25 is our oral products. Right now we have north of 3,000 patients on our oral products, and we expect to double that to over 6,000 patients by 2025. That's gonna be accomplished principally through the launch of ralinepag, but also through continued organic growth in ralinepag. Finally, the 3rd major building block, Jess, to get us to 25,000 is Tyvaso. Right now we are somewhere north of 4,000 patients on Tyvaso.
We expect to triple that by 2025 through the organic growth of Tyvaso in WHO Group 1, Group 3, the launch of the DPI product this year in Group 1 and Group 3, and then the subsequent launches of our COPD product. I mentioned at the beginning that we expect to have full enrollment of the COPD phase III this year, as well as the launch of our IPF product. I mentioned that that phase III trial is underway. With all of that phase III activity and with all of those launched products and just about launched products and imminently launched products, I feel it is quite achievable to close the 60% gap between the 10,000 that we're at right now and the 25,000 goal by 2025.
Okay, great. We talked about kind of the near term, talked about the long term a little bit. I wanna drill down on Tyvaso, now your largest product after the very successful early start to the PH-ILD launch. I guess 1st, you've talked about adding these 3,000 patients by the end of 2022. Can you tell us how many patients were added in the Q4 ? And just to confirm, do you still expect to meet that 3,000 patient add target?
Yeah. Thanks, Jess. You know, just so I don't like hog all the time from my keynoter or firesider, Mike, would you like to jump in and talk for a while?
Sure. Happy to do so. Yeah. You know, Jess, I think as you know, we and as Martine mentioned at the beginning of 2021, we set out the goal for Tyvaso to double the number of patients from 3,000 to 6,000 by the end of 2022. You know, I always kinda wanna remind folks of sort of some of the cautionary language around that, which is that it probably not going to be a linear path to get there, but we feel confident that we will get there. Then obviously, you know, with COVID still lingering, there's a little bit of a risk factor out there, but we haven't, you know, knock on wood, up till now, not really experienced any impact as a result of COVID.
At the end of in terms of how we're progressing towards that goal, at the end of Q3, we announced that we are at approximately 4,000 patients on Tyvaso. As Martine said, we're north of that now. I think we'll probably wait till our earnings call to provide a final number on number of patients on Tyvaso as of the end of the quarter. We're still kinda crunching through some of that data. The bottom line is we do feel very confident that we will be able to achieve the doubling or the 6,000 patients by the end of 2022.
Okay, great. I guess related to that, can you walk us through where things stand with CMS reimbursement for Tyvaso in PH-ILD? Tell us maybe how you plan to communicate that to investors once it's received.
Sure. You know, we started the process for CMS reimbursement, really like weeks after we received approval back in April. Submitted our application in May. Really we're sort of at the mercy of the government in terms of receiving the policy update. I think the guidance or the requirement is that they have up till a year after receiving the application to make a decision. You know, that kinda puts an outer bound of, I guess it would be May of this year. You know, I think we were optimistically thinking that process would go fairly quickly in 2021, and that we would receive approval shortly after our application. That turned out not to be the case.
They opened their comment period, I think, at the end of Q3. That wrapped up in the middle of November. At least in terms of what we saw from comments, really no issue there. We feel extremely confident that we will get the policy. We will get a positive coverage decision, we just can't predict when. As of now, we're still waiting for CMS to update the policy. As I said, we certainly expect that will happen here, you know, between now and, you know, certainly May at the outer band.
Okay. To the extent you have some government pay patients currently receiving free Tyvaso, when could they start being reimbursed?
I think if I kind of think about it sort of bifurcating, and I'll come back specifically to the current patients that are receiving free drugs. Once the policy update is completed and it's effective, any new patients coming in with CMS will become commercial paying patients under Medicare. With respect to patients that are currently in our patient assistance program, you know, the law says that, you know, for CMS patients, once they enter your patient assistance program, they have to stay in for the calendar year.
Those patients that are currently in our patient assistance program, given that the calendar rolled over to January, you know, if we were to get a coverage decision tomorrow, you know, unfortunately from a, you know, from a revenue standpoint, those patients need to stay in patient assistance through the balance of 2022, then they roll into commercial in 2023. But, you know, at the end of the day, as Martine said, we're really kind of focused on the long term and our 25 by 25 goal, which is why we opened up our patient assistance program to these patients because, you know, we, you know, we feel it's the right thing to do to help these patients with this therapy, particularly given that there's no other alternative.
You know, just from a down the road revenue standpoint, it's certainly much easier if we've already have them on therapy and in the system to convert them over.
Got it. You've alluded a couple times to maybe some anecdotal reports of a warehousing dynamic where some physicians are waiting for CMS reimbursement to kick in before going through the process of initiating a patient on Tyvaso. Can you elaborate a little bit on that?
Yeah, I mean, I think it's important. I think the key word there is anecdotal because it's really hard for us to quantify what that looks like. I think, but just in having conversations with physicians, particularly ILD treaters that are new to Tyvaso, you know, I think, you know, they have been going through the process of understanding how they're gonna screen, how they're gonna diagnose, where are they gonna send patients to get a right heart cath if they don't have that capability within their, you know, within their community clinic or their institution. Then there's, you know, the whole, you know, process of going through the referral process and all the things you have to actually start a patient on therapy.
We have heard from a number of physicians that are new to Tyvaso that, despite the fact that the patients have the ability to apply for patient assistance, they're, I guess, taking the path of least resistance, which is they're just gonna wait for CMS coverage. Rather than have to go through the process of approving or applying for PAP and then going back and applying for insurance coverage, they said they're waiting. I'm hoping that's gonna start to kind of break down a little bit after the 1st of the year, given that, you know, the CMS coverage is taking a little bit longer than expected. You know, we'll see.
In any event, we do think that there are some patients that are just kinda sitting there that I think will kinda come through the system once we have the CMS coverage.
Can you give us a breakdown of how you see the number of PAH versus PH-ILD patients currently on Tyvaso and how you think about that changing over time?
Yeah, I mean, it's hard for me to give you specifics just because of the way the data comes in to us. I mean, I think what you can sort of think about it in terms of round numbers is we were, you know, we were at 3,000 patients at the beginning of the year before approval. So, you know, assume those are all group one. As we said, we added, you know, about 1,000 plus now through the course of 2022. I think the vast majority of those are probably PH-ILD. Not all of them. I mean, I think we're just continuing to kind of grow Tyvaso and PAH. But, you know, assume most of this. It's, you know, probably somewhere around, you know, 75 to 25 right now between the group one and group 3. I mean, that's rough.
Again, the data's a little messy when it comes in, but that's just sort of, you know, my estimation. I think as we move forward, certainly that tilts more towards, I think, group 3, right? Just given the fact that you've got a 30,000 patient population, no treatment, no other treatment option besides Tyvaso. Not to mention, I think DPI, you know, certainly plays into that and provides a catalyst for even more patients coming on board. I think, you know, that will start to tilt more. That mix will start to tilt more towards PH-ILD, and I think the majority will be in PH-ILD. Again, I think with DPI, there's still an opportunity for us to see some growth with Tyvaso in group one as well.
Okay. Got it. How are you thinking about the Tyvaso franchise outside of the U.S.? What do you need to do to get approved in Europe? Would you potentially pursue a partner?
We have pursued a partner. We have engaged with a partner. In fact, we just before the holiday signed an agreement with our current European partner, Ferrer, to commercialize Tyvaso for PH-ILD in the European markets. You know, the terms of that is it's a 50/50 revenue share between Ferrer and us, plus, you know, we'll get a payment for COGS to make the product. In terms of the process and what needs to happen, hopefully we'll have more information to share as we get into Q2. We're actually going through the EMA scientific advice process right now to understand what exactly they're gonna require, what steps we need to go through and what the timing looks like for approval for PH-ILD.
Okay. Got it. I think there were some headlines over the holidays on this, but what's the latest status of the Tyvaso litigation with Liquidia?
You want me to keep going, Martine?
Sure. I'll give you a break now. Jess, we really don't get into the details of litigation for all the obvious reasons. You know, lawyers don't want to try their cases in public. We're just not gonna comment on the status of the litigation other than I can say that there are multiple patents which we feel are being infringed. These patents are being litigated through a mix of fora, the patent office, fora, the IPR process, the federal court system. There's just like a kinda layers and layers of patent disputes going on, and I think that they will go on for quite some time to come.
Okay. Maybe switching to Tyvaso DPI. Can you talk about how you see sales of Tyvaso or that franchise evolving with the introduction of the DPI?
Yes. I think that DPI will be popular. There's always a lot of excitement over a product that is an improvement on the existing product. On the other hand, what we see in pulmonary hypertension is that there is tremendous loyalty to the legacy products. I'll tell you that I find it surprising myself that I meet patients every so often who are still on intravenous Flolan. For those listeners who are newer to the story, that was the very first product approved by the FDA back in the 1990s. This product has a very short half-life of, like, 1 to 2 minutes. If the flow is interrupted, the patient is at essentially immediate risk of fatal rebound hypertension. In addition, it is.
It requires an indwelling Hickman catheter, which has shown itself to be prone to septicemic infection, and in fact, that's on the label of the product. Finally, the pump is a 1990s legacy pump, which is big and bulky and needs to be surrounded with ice. I'm like, "Why are you still on Flolan?" I of course, I'm very respectful to the patient and, you know, their decisions and whatnot. When I ask them that question because I'm not, like, pushing our products, I'm just kind of thinking of the patient, "Why are you still doing this?" They express a sentiment that, you know, "This product has saved my life. This product
I'm alive because of this product." Because of that, I think there's an inherent human nature aspect of loyalty to whatever has saved your life and has become, like, in some ways, your closest friend. In fact, many people name their pumps and whatnot. It's the same sort of story with the inhaled product. There are many patients, I mean, actually, as Mike just said, you know, thousands of patients to whom they feel that the Tyvaso product with its Optineb nebulizer, if not, you know, per label, having saved their life, has at least been life-changing for them and has given them back a great deal of their life.
I think for patients who have had this very positive experience with the Tyvaso Optineb, there would be a natural reluctance to just, like, chuck it off to the side and grab the, you know, the new kid on the block. For newly diagnosed patients, I think those newly diagnosed patients would definitely preferentially along the percentage splits that Mike referred to earlier, although he was talking Group 3, Group 1, I would say something like that 75/25 could also very likely be the case with Tyvaso versus the legacy Optineb. The long and short answer to your question, Jess, is that I do not believe the legacy Optineb is, like, going away. As with all of United Therapeutics products, we are, like, obsessed on supply chain.
We were obsessed on supply chain before the whole country and world was obsessed on supply chain. We have a multi-year inventory of our drugs, of all of the devices. All of our devices and our drugs, they're made in the United States. We store them at multiple different locations that are hundreds of miles away from each other. I think that you're gonna see continued use of Tyvaso nebulizer or Optineb in addition to Tyvaso DPI.
Okay. Got it. Bit of a specific question, but now that you have resubmitted the NDA as of December, any inclination yet as to whether you expect FDA to classify it as a Class 1 or Class 2 response?
We don't know at the moment. We're waiting for, like, a bureaucratic step at the FDA, so you know, we should know that within a month or so.
Can you tell us if the resubmission was based on resolving the inspection with the 3rd-party vendor, or did you move that function they were providing elsewhere in order to resubmit?
Yeah, we did move that function, Jess. You know, I really have to give huge kudos to our manufacturing quality assurance and regulatory teams that we were able to successfully move that entire process within 69 days. I know the people who aren't like, you know, I mean, like, I totally geek out on all this, but a lot of people aren't this deep in at all. It's like, okay, you move the process. It's so much vastly more complicated than you just move the process. These are, you know, highly regulatorily controlled processes for the assays and tests. Everybody is very busy right now. Everybody is short-staffed. But these are multi-part processes, but our team successfully accomplished this.
You know, I'd go out on a limb, and I would say it would be extremely rare in our wonderful pharmaceutical industry that these type of tasks could go from, like, zero to everything is checked out and done and submitted to the FDA in 69 days through Thanksgiving and all of that sort of stuff. We did it.
Right. We just got an investor question popping up here that's relevant to this topic, but do you need any inspection at the facility that you moved this function to?
You know, I don't know the specific answer to that level of question. If it's required, I can assure you that we are on it like peanut butter on bread.
Great. Maybe last one on Tyvaso DPI. I'm curious how you think about emerging competition like Insmed's TPIP, which is early but might have the potential for less frequent dosing.
Sure. Mike, do you want me to keep talking, or do you wanna talk?
I mean, I can take it if you want. Sure. I mean, I think, you know, from our standpoint, there's always a lot of, I think, emerging things in this space that, you know, we're certainly keeping our eye on. A lot of this, I think, is still, you know, pretty early. I think until these things get a little bit further along, you know, we tend not to get too excited about it, 'cause it's a long row to hoe. Stepping back, I think what I would, you know, just sort of remind everybody is that we have, you know, pretty big markets that we're playing in, right?
You take group 1, which is the most competitive market that we play in, right? Roughly 50,000 patients diagnosed with Group 1 PAH. You still only have about a quarter of those patients that are on a prostacyclin therapy. There's really, I think, a lot of room for growth, not only with our products, but even with, you know, other products that come into the market. I think the patient size there, the patient population is there to support multiple players. When you move into Group 3, you look into PH-ILD, there, like I said before, you've got 30,000 patients, no competition yet, but we've got, you know, exclusivity through 2024.
We have that market to ourselves for a few years and an opportunity to really, I think, kind of establish ourselves as the premier product in that space. If our PERFECT study is positive for Tyvaso PH-COPD, we would expect to get another probably a 3-year exclusivity for that patient population, which, you know, we estimate to be about 100,000 patients. Then, you know, finally, if the TETON study in IPF is successful, that's another 100,000 patients, and we believe we'll get orphan designation there, so 7 years.
You know, I think it's certainly interesting, and we're keeping an eye on emerging technology, but I think we're really kind of focused on the markets we're in, the markets we're going into, and we feel like we've got, you know, we've got a lot of runway from an exclusivity standpoint ahead of us there.
Okay. Makes sense. Maybe switching to the Remodulin franchise, what's the feedback you're hearing from physicians and patients using Remunity? Martine, at the beginning, you kind of alluded to a full launch for Remunity this year. Can you just elaborate a little bit on what that means relative to what was happening in 2021?
Yeah. I'll take that one, Martine. So I think, you know, overall I think the feedback from the physicians and the patients that have had experience with Remunity has been quite positive. If you just kinda recall and remind, just to remind everybody, you know, the differentiators relative to the MS3, I mean, start with the technology. I mean, the MS3 is, you know, I guess 25, almost 30 years old right now. It's still, you know, a great pump and works really well. You know, one of the things that Remunity does is it brings 21st-century technology to a pump that was designed, you know, specifically for use with Remodulin.
You know, one of the kinda cool things, if you wanna geek out on these, you know, there's actually no motors in the pump. It uses acoustic volume sensing technology to control the Remodulin flow rates without the use of a motor. You know, so tech-wise, it's pretty cool. I think from a patient standpoint, the things that they really appreciate about the technology are the size. I mean, the form factor, the profile is really, really small. It's much more discreet than what they're used to with the MS3 or certainly the CADD-Legacy in the case of IV patients. It's prefilled, so patients are getting prefilled cassettes shipped to them every couple weeks.
All they have to do is really kinda, you know, snap out their old cartridge, snap in their new cartridge, they're good to go. They do that every 2 to 3 days. Then I think the other thing that patients really appreciate is the fact that it's water resistant, so they're not having to go through, you know, a big rigmarole if they wanna, you know, take a shower or jump in the pool, of having to like cover things up and deal with, you know, those issues like they are with the MS 3. I think there's a lot of attributes, a lot of things that patients and physicians are really excited about.
You know, one of the things that, you know, Jess, you and I have talked about, I think on prior calls, is that logistically, this is probably one of the most complicated launches we've had just because of the fact that you have specialty pharmacy having to fill the cassettes and they're having to package cassettes and then ship those to patients. You know, when we launched in 2021, we went through sort of a kind of a phased launch because what we wanted to make sure happened is that those logistical issues worked as smoothly and seamlessly as we needed them to because we wanted the patients to have a great experience and love the pump as much as we do.
That process worked well. We learned some things along the way. One of the things that we've learned along the way is that, I guess the other feature about the pump that I didn't mention is that, it has a wider array of notifications and alerts. From a safety standpoint, it's really great because if something goes wrong, the patient's gonna know. It turns out that I think some of those alerts are more sensitive than what we were expecting, not to the point of creating a safety issue. I think for patients that had started on Remunity for the most part, not enough for them to say, "I don't like this pump.
I'm gonna go back to the old one." There was enough noise around that to where we were like, "Hey, you know what? We need to maybe kind of tweak the settings on these alerts," because it was. I would put it in a category of an annoyance. Again, from our standpoint, we want our customers to have an amazing experience. Our patients have an amazing experience with this pump. You know, we kind of, you know, kind of slowed down bringing patients onto Remunity until we, you know, we kind of changed the settings on this, on the pump around these alarms. That process is ongoing.
We believe with our partner DEKA, we fixed that and so we'll kind of, you know, here as we get probably to the middle of the Q1 , move back into, you know, bringing patients back on at the same rate or faster than we were in 2021.
Okay. I guess looking ahead, understanding there's probably a mix of new patient starts and switches to Remunity, what makes someone eligible or likely to be switched from Remodulin in its current form or current pump onto Remunity and why?
Yeah. I mean, I think from an eligibility standpoint, whether it's existing patient or new patient, I mean, I would say both are technically eligible to start on Remunity. I would refer back to what you know, Martine said or explained about some of the loyalty, the loyalty that patients have to their existing devices when we were talking about the Tyvaso nebulizer versus the Tyvaso DPI. I think that's that dynamic exists here with Remodulin, maybe more so because again, you're dealing with you know, sicker patients typically. You know, if you're on Remodulin, you're typically a sicker patient than maybe if you're on an oral and you're on an inhaled prostacyclin.
If you know, if a patient is feeling like they have their disease under control, they're managing it, I think there's you know the reluctance to switch to a new technology may be greater. Certainly with newer patients, I think they're gonna be much more inclined to start on Remunity just because of all the features I described. We will see patients transition, and we have seen patients transition from the MS 3 over to the Remunity. I think that will continue. I think that transition will just play out over a longer period of time. Ultimately, we you know we expect the vast majority of patients to be on Remunity over the long term.
Then certainly with the next version or the next few versions, when you have the manufacturing filled version of Remunity and then eventually RemoPro, which Martine mentioned earlier, would expect all patients to be on Remunity.
Yeah. Maybe that's a good time to turn to RemoPro. What exactly is the status there and how much larger of a patient population do you think it could capture compared to Remodulin?
Yeah. Thanks, Jess. The status is that we take RemoPro into human testing in, like I said, within the next couple of months. Then we will do a formal bioequivalence study, very analogous to what we did with DPI and the Optineb. I believe all of that activity is consistent with us being able to file for RemoPro approval either in late 2023 or worst case, early 2024, and then have a full year or, you know, more than a full year of our product launch to help contribute to our 25 by 25 goals. The potential of it per our 25 by 25 goals is to contribute to more than a doubling of our current 4,000 Remodulin patients upward 8,000.
It would end up really carrying a lot of the water in terms of that, you know, roughly 30 to 33% contribution to the 25 by 25. Another thing to mention in that regard is we're pretty also obsessive about continuing to improve our products. The way we look at things at United Therapeutics is that, like in manufacturing, we say the process is the product. It's something similar to that, you know, from the patient standpoint. There's the API. Then there is the device to deliver the API, then the whole supply chain to get the device to deliver the API. For example, Mike was talking about what we're doing to make sure that our patients have an awesome experience with Remunity.
One, you know, complicated logistic that he mentioned was the need for the pharmacies to fill the cassettes. We are right now midstream in a process to implement a machine, what we call a machine fill process of filling the cassettes that would, you know, eliminate the need for the pharmacies to be in the middle. I guess it's been over a year now, we signed an agreement with Philips to use their technology to build an automated Remunity machine fill plant down in our Jacksonville facility.
That RemoPro product will be able to be delivered through a complete streamlined supply chain with all of the filling of the Remunity cassette being done at our own factory plant, where we also are making the product itself in conjunction with this very nice Philips technology. All of that combined, I think, puts us on very solid ground for Remunity being a product together with RemoPro that has really long legs. The technology and the patents behind the Remunity delivery system, including the Philips technology for the machine fill version of it, go way into the late 2030s.
This product, as seen by the patient, is something that from United Therapeutics standpoint, is all part of patent-protected technology going out to the late 2030s and provides a vital benefit to the patients as, I think, the best way to parenterally deliver treprostinil.
Got it. You mean sticking with the pipeline opportunities, you partially answered this one earlier, but can you just provide a status update on both the TETON and PERFECT studies? Talk about how enrollment's going and when we could see data.
Yes. That's part of our goals for 2022 is to have full enrollment of the PERFECT study. I believe we should reach just about 50% enrollment on the TETON study. Those are things that we're doing in 2022. I would say that's probably like my personal number one goal and responsibility just as Mike's is on the commercialization side. We are doing a really good job of it. I think that we are progressed in terms of PERFECT with the enrollment, the randomization, blah, blah, all that kind of stuff to achieve full enrollment by the end of this year. The study has a 6-minute walk endpoint, standard pulmonary hypertension endpoint.
That's good because we won't have to wait forever for the data. If the last patient is in, you know, by the end of this year, I think it's, you know, quite reasonable to expect data in the middle of 2023. Then the team would work very hard to get the NDA filed before Christmas so that we could launch that product in 2024. I know we probably sound like broken records here and contribute to our 25 by 25 goal in 2025, but that's what we're all focused on. All of these multifaceted activities all feed into that 25 by 25 goal. With regard to TETON, we're off and running. We're building a lot of new relationships.
You know, we were not previously dealing with the pulmonologists that treat just pulmonary fibrosis. So we are making a lot of those solid relationships. We're randomizing patients. In fact, things are going so well that we decided to launch an international complement to the U.S. study. As Mike said, we expanded, you know, our long-standing good partnership with Ferrer. So we're really excited about the worldwide potential in pulmonary fibrosis. So we launched a 2nd study, TETON 2, with a top CRO that in fact had just been deeply involved in another IPF study. So we have super relationships throughout the world, and I think that will allow us to, like, jump out of the starting block faster than ever on TETON 2.
Okay, great. Maybe one more question in the pipeline before we wrap up, because we're running out of time here. I'm curious for the PERFECT study how similar or different the PH that COPD patients get is from the PH that ILD patients get, and whether the increased results read across to success in PH-COPD and why or maybe why not?
Like it's a great question. It's scientifically a very interesting question, but of course, the only real answer to that will be to see the outcome of the PERFECT study, to see to what extent those results are correlative with the ones from, say, INCREASE in ILD. I will say that the reason we launched this study was because of the phase II work that we had funded that showed the largest improvements in 6-minute walk that we had ever seen were in the Group 3 patients with ILD and then separately in the Group 3 patients with COPD. You know exactly why that is, what exactly is the mechanism of action, you know, you're getting kind of a little bit into the black box of biology there that I don't think anybody really knows.
I could talk about this pathway and that pathway, but I think I would just be like talking. You know, biology is gonna do its own thing. As an empiricist, I would say the phase II data was, like, you would be an idiot not to go ahead and develop this into phase III. We did develop it into phase III. The patient uptake has been good. The physician uptake has been excellent. When physicians are excited, that is a good positive sign that they understand and believe in the mechanism of action. More than that, it's not too long to wait now, just about 11 more months and we'll be fully enrolled.
Great. Maybe just to wrap up, we kind of talked about near-term business opportunities. We talked about longer term pipeline opportunities. I was hoping you could tie it all together and talk about your long-term vision for the company and what we should be looking forward to.
Thanks, Jess. You know, it's always very interesting to be asked that type of a question because that also is very much of a black box. Like, you know, which directions will a company go into? It would have been hard to predict a few years ago that we would be so committed to the IPF indication as we are now. We were led there by the data that came out of the research that we were doing in other fields.
The way that Mike and I really run the company is that our goal is forward looking, let's say, 5 or 10 years down the road, to have thousands of people working at United Therapeutics and as many of them as possible feel that they are having the absolute best career development experience of their life working on therapies and medicines that can save the lives of thousands of other people. That's, you know, that's the vision that we work toward. Right now, we're at 1,000 employees. I think, you know, several years down the road, we'll be at several thousand employees. Right now, we're one of the places that people love to work at more than any of our peers and as reflected in all kinds of surveys and whatnot.
We wanna be able to, you know, scale that to having thousands of people feeling they are having their best career development experience, creating medicines to help save the lives of thousands of other people.
Great. Well, we'll leave it there. Thank you so much, Martine, Michael, and James and Dewey, for joining us today. A Happy New Year, everyone.
Happy New Year to you.
Happy New Year. Thanks, Jess.