Phathom Pharmaceuticals, Inc. (PHAT) Earnings Call Transcript & Summary
June 11, 2024
Earnings Call Speaker Segments
Kyuwon Choi
analystOkay. Good afternoon. We'll continue with the next session. I'm Paul Choi, and I cover the mid-cap biotech sector here at the firm. It's my pleasure to welcome Phathom to this session. To my immediate left is Martin and at the far end is Molly, CFO. Martin runs Commercial. Maybe what we'll do is I'll turn it over to either Molly or Martin, to maybe to kick it off with some introductory high-level remarks and then we'll get to Q&A. [Operator Instructions] But otherwise, I'll turn it over to Molly to may be kick it off for some overview. Thank you.
Molly Henderson
executiveThanks, Paul, and thanks for the invite to here in Miami. I appreciate the invitation. So maybe a little bit on why we're excited and what we've got to look forward to for the rest of year. So here at Phathom, as many of you know, we launched our first product in erosive GERD and H. pylori at the end of last year. So we're about 6 months into launch. As of our Q1 report, which was at the end of April, we indicated that we had over 43,000 scripts written to date. Very excited about that. 17,500 have been filled. So obviously, that translates into revenue. And then on the heels of that, we're really excited about our nonerosive approval date, which is about 5 weeks from now. So lots to be excited here at Phathom, and we're happy with what we've seen so far.
Kyuwon Choi
analystOkay. Great. So maybe let's start with the commercial piece since you've talked about the launch a little bit here. And both with GERD and HP, you've made a lot of progress in terms of expanding the coverage footprint versus when the product initially got approved in HP a while back. So can you maybe just tell us where you are in terms of coverage overall for both indications? Just what sort of the commercial side and the government side stands at? And maybe we'll start with that.
Martin Gilligan
executiveYes. So the -- let's first take the H. pylori packs. So we have 63% commercial coverage right now. And we got -- obviously, because we had the approval earlier, we got started. We had more time on that. Where we are with the bottle or VOQUEZNA itself, which would be for GERD. We're at 49% commercial lives covered. And what I always tell everyone is we just launched GERD this calendar year, typically takes 6 to 9 months to get your -- to get a good source of reimbursement. So the fact that we're at 49%, says we're doing really well. Express Scripts and Cigna happened really early in our process, and we anticipate some inflections coming forward as we finish out Q2 and going into Q3.
Kyuwon Choi
analystOkay. So a few more major national payers that check the box on over the next 6 to 9 months.
Martin Gilligan
executiveYes.
Kyuwon Choi
analystOkay. Great. And then on the government side?
Martin Gilligan
executiveYes. So on the government side, we do have some scripts going through. All -- like all new brands, products coming to market, there's always a lag before government. There's a whole process that you follow with Medicare that's very calendar driven as opposed to launch date driven. So we've never anticipated in terms of our reimbursement that we would have government being a core part of our business. We've always really based the VOQUEZNA value really upon the commercial patients.
Kyuwon Choi
analystOkay. One of the questions I frequently get from investors is just can you explain to me what is BlinkRx? How does the company utilize it? Where are the mechanics there? What is the script going through Blink mean versus a script going through a regular retail channel like at a pharmacy? Can you maybe just walk us at a high level through the mechanics there and how you guys are using Blink?
Martin Gilligan
executiveYes. So BlinkRx is our patient support service. I know many brands, especially biologics or specialty brands go to specialty pharmacies. And what happens in those cases is most of the time, it's a free goods. And when someone goes into that process, it's very hard for that patient to be extracted from there for many operational issues. So we opted to go with BlinkRx, which is a digital pharmacy or digital fulfillment center. So what we always tell physicians is, VOQUEZNA is available at all retail pharmacies. But your best option to get VOQUEZNA filled is if you send it to BlinkRx, which is right in their prescribing. So when they go on and do their e-prescribing, it pops up like any other pharmacy. And so I always suggest people think of that as a highway. So the first fork in the road is whether you're a government patient as you were just asking our commercial patient. We can't provide support for government patients and nor can any brand. So right there, that patient would go off that highway because they can't get the patient support. The commercial patient continues down the road and then there's another fork in the road. If they already have coverage. So for example, we're on Express Scripts national formulary. If that script goes there, BlinkRx triages that prescription into all electronic right over to one of their partner retail mail pharmacies. And that goes out directly from there. They pay a normal co-pay, and that prescription is picked up by IQVIA. However, that was one fork in the road. The other fork is, I'm a commercial patient, but I don't have coverage yet. What happens there is BlinkRx will offer that patient VOQUEZNA for $50 for a 30-month supply, and that's our patient support. And our objective there were 2 things. One is with -- if a doctor intended for the patient to get VOQUEZNA, we want the best option for them to be able to get it. And then also, as I talked about earlier, as people getting in these patient support programs, every time that prescription comes in for a refill, they do another check. And when they get to that fork in the road, if they suddenly have reimbursement, they go over to a traditional commercial fill. So I'll just summarize in two things. If it's a support -- cash support prescription, that is not picked up by IQVIA, and we report that on a quarterly basis. If it is triaged over to a pharmacy that has picked up by IQVIA.
Kyuwon Choi
analystOkay. Great.
Martin Gilligan
executiveDoes that help?
Kyuwon Choi
analystYes, it does. I think that's still a bit of confusion, I think, for investors or maybe -- at least for those who are new to the story. And so the other sort of dimension of that is you're talking about written scripts versus filled scripts, right? And so can you maybe just understand what's the ratio then, at least in terms of what you've reported over the past couple of quarters? And maybe if you can provide a bit of an update on how that has been trending since you last reported your quarterly results?
Martin Gilligan
executiveYes. So what we've been providing are several metrics, but 2 of them are the number of prescriptions that have actually been written and filled. Means, patient went to the pharmacy, prescription filled versus scripts that were written and just didn't get through the system. And what we know is that differential between the 2 tells us 2 things. First of all, there's a really high demand. The number of prescriptions being written is very high and then obviously due to excess, there's that gap. We see that gap closing. So in -- when we reported Q4, which is at the beginning of this calendar year, only 17% of those prescriptions were actually getting filled. As we progressed several months in when we did our last earnings, it's 49% are being -- excuse me, 42% are being filled. So over time, what you'll see is the closing of the gap between the doctor who wrote and the prescription was filled and not filled.
Kyuwon Choi
analystOkay. Great. And that was just for people's reference, that was just 2 months later, if I recall, in terms of the give or take...
Martin Gilligan
executiveYes, our last piece of data referenced mid-April.
Kyuwon Choi
analystOkay. Great. Molly, maybe if you could just sort of remind us as with all new product launches, often some of the metrics in terms of where we -- what we watch in terms of coverage and reimbursement and things like that. I'm just trying to understand gross to net, and you sort of talked about industry benchmarks, let's say, for PPIs and things like that. Can you maybe just remind us where historical averages have been for like GI drugs such as PPIs, and just kind of where you are and where you think the longer-term trajectory might be for VOQUEZNA?
Molly Henderson
executiveSure. So maybe starting with where we are. So what we indicated going into launch is that we would expect gross to net to be around 75% discount for the first couple of quarters and then on a steady state, 50% to 65% discount. And we indicated that while we're in negotiations with payers, we probably won't provide much more of an update. We don't want to negotiate against ourselves necessarily. But what we're seeing at this point doesn't necessarily deviate too far from what we expected going into launch. And as it relates to how it compares to other drugs, it's generally within the same. Obviously, as you know, there hasn't been a GI drug, at least in the GERD space launched in many, many years. But as it relates to other drugs, similar environments with going into a competing genericized market, I think you'd see a standard within that range of 50% to 65%.
Kyuwon Choi
analystOkay. Great. Martin, maybe come back to you and just -- you talked a little bit about BlinkRx being sort of in the toolkit of physicians in terms of their EMRs and things like that. Could you maybe speak a little bit to the patient experience as well as the physician experience in terms of getting prescriptions through, let's say, a road block comps in the middle of a prescription, even they're just -- how does the patient follow up to maybe get it through and push it, does it require the physicians back office to do a fair amount of leg work, maybe just some of the processes there.
Martin Gilligan
executiveYes. So that's the, I'll say, the positive of what we're experiencing unlike some other brands that I've worked on. To date, there's really no forms to be filled out to get VOQUEZNA, no paperwork. It really is prescribing that goes to the pharmacy and for the most part, that coverage has picked up electronically. So whether it goes to a Walgreens, CVS or Blink, it's a ping of the system that provides whether [indiscernible] our finding is that more scripts get filled through, meaning approved and filled through BlinkRx. We're seeing that more physicians are using BlinkRx, and they're sending more prescriptions there and more get through. So as time goes on, you're seeing that physicians -- it was new for them as well, right? But it wasn't a barrier or an objection, it was just new. So as time goes on, we're seeing more utilization. And of course, that's based upon their own experience that if it's working for them, and it's not creating an effort for them, there's no objection.
Kyuwon Choi
analystOkay. Great. To the degree you have information on this, can you maybe comment a little bit on the median patient you're seeing? Are they typically refractory to 1 or 2 PPIs? Are you seeing de novo patients who may be newly diagnosed? Is that potentially working? Or are the step edits potentially sort of very strictly being enforced? Any color there would be great.
Martin Gilligan
executiveYes. So no matter what brand I've worked on and done a launch, I'll always say, out of the gate, you always get the worst patient. So we're no different there. I'm not saying it's all our patients, so we have some of those. The positive news out of that is that we're hearing that it's working. The consistent thing we're hearing from all customers throughout the entire country, the physicians and office staff and we're not placing those words, we're hearing back game changer. We're hearing really quick relief, we're hearing patients who have been suffering for a while. And within hours, they're getting that heartburn relief. We're actually getting pictures of patients with their esophagus cleared. So that's really positive.
Kyuwon Choi
analystOkay. Great. Like real scope...
Martin Gilligan
executiveYes. Proactively doctors like, here's my before and after. I'm so excited about this. Again, this is a game changer. So it tells us that the promise we have for VOQUEZNA is holding true. So what -- who are the patients we're seeing besides kind of those worst-case scenarios, what we're seeing is exactly what we thought and what our intention and strategy is, is that patient who's been on a PPI, which by the way, is the majority of the market, who's been on the PPI. And at some point during their journey and the reason they're at the doctor's office is because I'm still having breakthrough, I'm sleeping with pillows. We just spoke to someone today who was on a PPI and says I never drink coffee in the afternoon because I know I'll be tossing and turning all night long, not from jittery caffeine, but from heartburn. So that's what it is. And these are people who not only are taking the PPI, maybe switching, but maybe keeping TUMS on the desk or on the nightstand. And that's exactly what we expected. And that's the basis of our reimbursement being one step through a PPI, which we've been able to successfully achieve thus far with the payer contracts.
Kyuwon Choi
analystOkay. Great. Maybe a little bit in terms of your commercial plan. You talked about sort of a tiering strategy in terms of -- you focusing on high-volume prescribers. Maybe you can comment on where you are in terms of addressing that initial target opportunity of high-volume prescribers? And when does the potential to move into the second or third tranche of prescribers maybe start to open itself up?
Martin Gilligan
executiveYes. So I'll back up a little bit and just let everyone know, we're calling right now our target is 52,000 high-volume PPI prescribers. It's a mix of gastroenterologists, primary care, and nurse practitioner physician assistants. And for those of you who are aware in the industry, we decile physicians. So a decile 10, top of the pyramid, small group of doctors, highest volume and you work your way down. In general, at the top of the pyramid are a very heavy gastroenterologist focused in primary care as you move through. So as you can imagine, that's where our rep started. So most of the experience they've had in terms of frequency has been with gastroenterologists. And then to no surprise, right now, our biggest group of physicians prescribing are the GIs, followed by nurse practitioner physician assistants. They're a really fast-growing group. In the area of GERD, they tend to be diagnosers first-line treatment switches, but they're a fast-growing group. And as we go through the pyramid, which we're calling on them, we just don't have that frequency yet only given the calendar date takes time, is primary care.
Kyuwon Choi
analystOkay. I know you're only a couple of quarters into the launch. Could you also maybe comment on what you've seen in terms of repeat prescribing patterns? I know probably for many of these physicians, it's just one or -- just a handful of patients. But how many repeat prescribers are you seeing? And are you able to quantify that to date?
Martin Gilligan
executiveYes. So to your point about our timing. So our full sales force was in place at the end of January. And so here we are, first -- or like a second week of June. So it's really early in launch. We are seeing those physicians who write a prescription of VOQUEZNA, are also repeat prescribers. So we're seeing two things. We're seeing more physicians write and those that write, writing more prescriptions.
Kyuwon Choi
analystOkay. Great. In terms of the last commercial piece, I guess, here is, you talked a little bit at the beginning about sort of a few more quarters before the major insurance coverage is sort of complete as well as some of the government stuff. But you've talked about a potential inflection resulting once the coverage is a little more established across both at a national level and the government level. And so I guess as you think about that as a barrier to sort of broader adoption for VOQUEZNA here, I guess what is sort of -- how would you characterize the pent-up demand, I guess? And what is -- I guess, in your mind, as you guys do your game planning, just thinking about what does that slope of the trajectory look like? Because I think that's what a lot of investors are waiting for. We monitor the TRx data on a weekly or monthly basis, and it's definitely growing, but just kind of understanding when that big sort of moment and spend in the curve could start to occur?
Martin Gilligan
executiveYes. So we have -- so clearly, reimbursement is going to be a key driver. And it was only a few months ago, we were at 27% commercial lives covered and now we're at 49%. So we would expect as we move forward as within -- finishing Q2 going into Q3, as we have more lives covered then more prescriptions would get through. So going back to our conversation a few minutes ago, that difference between scripts written and scripts filled, that's what's going to drive that gap to close. And then clearly, as more prescriptions go through with ease, I think that's an additional accelerator for physicians themselves, to say, well, not only did I write it, but I also see it getting through. So that's why we talk about kind of a key driver being reimbursement and then we also have the nonerosive PDUFA coming up in July.
Kyuwon Choi
analystOkay. Great. I want to talk a little bit about NERD, the nonerosive opportunity here. And it's interesting additive opportunity for you guys. Can you maybe just remind us how are those patients currently treated? And just sort of how do you size up that opportunity, roughly speaking, versus the GERD opportunity or erosive esophagitis opportunity? Just kind of what's the potential there?
Molly Henderson
executiveSure. So I'll talk a little bit about market size and the dynamics from the patient journey is very similar, but I'll turn it over to Martin for that. So from a patient size perspective, if you look at the total GERD umbrella, it represents 22 million patients that are diagnosed and treated every year. So 15 million of that is nonerosive and 7 million is erosive. So that's that 7 million we have under our belts today. And now as of -- hopefully, July 19, we'll have this additional 15 million. So 22 million patients will get open to us. When you talk about that inflection, we're essentially going to be at least doubling, if not tripling our market opportunity within the next several weeks. And then as far as the patient journey, it's very similar, but I'll turn over to Martin.
Martin Gilligan
executiveYes. As Molly said, the journey is the same, right? They probably start with an OTC, probably end up on a PPI OTC. They'll go to a primary care doctor. From the primary care doctor, if they start that marry go around or circling of PPIs and adding things on, then they might send off to a gastroenterologist. Where at that point, they would probably get that endoscopy which would finally indicate whether they're erosive or nonerosive. And then most of those patients actually come back to the primary care for long-term maintenance. So the way we've approached that market is, these 52,000 physicians we call on, they are the same doctors who prescribe for both erosive and nonerosive. And the symptoms for those patients, the heartburn symptoms, their burden is very similar between the two. So the way we address them as consumers or potential patients is the same way, and then the physicians we're talking to are the same.
Kyuwon Choi
analystOkay. Great. You brought up actually a point out which is -- touches my next question, which is, I talked about patients cycling through PPIs and often with this class of medicine for GI medicines [indiscernible] for the treatment period, but not necessarily, and they feel better in terms of their symptoms. But they don't necessarily feel better -- after they feel better, they don't necessarily [indiscernible] they don't necessarily stick with the maintenance experience. So I guess one question is, obviously, patients stuck trough it [indiscernible] patient stuck with their therapy through the maintenance period through their clinical trial. But maybe how do you guys think about what the real world experience might be like. I'm sure patients will probably stick through the treatment phase, but just what is the adherence in the maintenance phase look like?
Martin Gilligan
executiveOkay. So listen, it's like any other chronic medication, right? You have patients who are hyper compliant and patients who are poor compliant. What we think about is what we know from the PPI data on average, patients take 160 tablets, PPI -- 160 PPI tablets a year, and they take multiple years. So if that's the average of 160, you're going to have some patients who hit both ends of the spectrum. And we hear this from patients. I live and die by my acid [ suppressant ]. I can't go a day without it. I'm afraid to go a day without it. I need it every day. And then you're going to have other patients, as you described, of, "hey, I'm feeling pretty good, I've been on this for x number of weeks, maybe I'll go off for a while until I need it." We call that the maybe intermittent patient versus the more compliant patients. So I think it's a mix of both of them. But what we do know is this is an impressive category in terms of the number of patients who take PPIs and are fairly adherent to PPIs.
Kyuwon Choi
analystMaybe one for both of you and Molly. Molly, you talked about the NERD opportunity being potentially significantly -- a significant expansion in terms of the addressable patient pool. And so in terms of your commercial footprint and ability to target that on top of your existing indications, how do you guys think about your existing commercial footprint versus what you might potentially need for a NERD launch in a few weeks here?
Molly Henderson
executiveYes, from a spend perspective.
Kyuwon Choi
analystYes.
Molly Henderson
executiveYes. So I think as you might have seen, we launched our DTC campaign at the end of the first quarter. So that will be a key catalyst into going into the nonerosive launch, but we continue to expect to invest in the DTC component, get the awareness out, especially now with this broaden market opportunity. So from a spend perspective, you can expect to see an increase in DTC spend, again, also given the fact that it just launched during the first quarter, especially at the end of the first quarter. So it's safe to assume that it will continue to increase, not just in Q2 and then throughout this year. And as you'd expect, we've continued to invest even getting into next year because that is a big patient driver and awareness component of our strategy.
Martin Gilligan
executiveAnd I should kind of -- I just thought, we've been spending a lot of time. I have been talking about PPIs. I want to be clear that VOQUEZNA is not a PPI. And that's why being a P-CAB, we have 320 reps who are placed in the field, and that footprint does not change with nonerosive because, again, it's the same physicians. But there's no one who's been playing in this market, promoting in this market for about 10 years. So that like -- that's because coming with VOQUEZNA, a first-in-class, best-in-class product that's completely different mechanism of action than P-CAB. We can really be efficient in calling on those physicians with 320.
Kyuwon Choi
analystThat's right. Yes, it's been the first new product in the category since Dexilant, if memory served.
Martin Gilligan
executiveCorrect.
Kyuwon Choi
analystOkay. I want to talk a little bit about life cycle management. I mean we're talking about your first additional post-approval indication potentially with NERD here, but you're also working on some other things like on-demand use. Can you maybe remind us how that trial is progressing? And just kind of when top line data for that might potentially come and just sort of what regulatory steps might be involved after that.
Molly Henderson
executiveSure. So to your point, we anticipate initiating an on-demand study later this year. The current study that is contemplated by the FDA for July is daily dosing. So this would be an as-needed approach. And based upon the positive Phase II data, we're very optimistic going into that Phase III. We're currently still in discussions with the FDA on the design. But what we've indicated from a guidance perspective is that we plan to initiate by the end of this year.
Kyuwon Choi
analystOkay. And can you maybe just remind us what the Phase II data looked like maybe at a high level and how that might figure in your Phase III discussions here?
Molly Henderson
executiveYes. Sure. So what we've indicated is that by -- even as quick as 1 hour, we start to see separation from the placebo and the primary endpoint in that Phase II was 3 hours relief -- a proportion of 3-hour relief of symptoms and sustained for 24 hours. So that's the key element of what we would intend to just show in the Phase III.
Kyuwon Choi
analystMaybe one more on that before we move on is just -- you talked about placebo-controlled data. But I suspect maybe a lot of patients currently in terms of real-world practice maybe take OTC products on demand, not necessarily a PPI, but some sort of OTC product. And so does an active comparator maybe make sense just in terms of like understanding or improving physician's receptivity potentially down the road to an on-demand indication?
Martin Gilligan
executiveYes. So I would say no. Here's what we hear about the on-demand or as needed opportunity. First of all, physicians like the concept. What they really like about it is I can take a patient, put them on VOQUEZNA, get them controlled on daily dosing. And then if they need it or if they desire it, they can go to it as needed. So what we hear is it gives me more reasons to switch more patients to this new product, this new category that's rapid. That's why it adds needed work, it's rapid, potent and durable. So it gives them more reason to move more patients. What we are -- what we don't see as a strategy is moving patients off their couches who are taking OTCs to then enter their prescription space. Not saying that, that won't happen, we believe it will. But our strategy is less about growing and bringing more patients in, but moving more patients over. Patients are highly, highly motivated about the concept of as needed. So you marry that with the physicians who really like the concept in a motivated patient group, and it's really a recipe for success.
Kyuwon Choi
analystOkay. Great. Maybe staying on the topic of life cycle management. You've also, in the past, talked about the EoE opportunity, which is pretty attractive, but also targeted by several other companies who either have clinical stage assets and/or approved assets potentially for EoE. So can you maybe just remind us, first, what is the market opportunity there in your mind, or as you model it? And then second, what are the clinical development plans for vonoprazan in this particular area?
Molly Henderson
executiveSo starting with the last question first. So we also plan to initiate a Phase II and EoE by the end of this year. And what we're seeing is standard practices that PPIs are used as standard of care, even though they're not indicated as such. So we believe there's a tremendous opportunity to introduce a drug that's actually indicated in this space. And what we've seen based upon the results of the PPIs but there's efficacy and we continue to expand on that as we design out our Phase II.
Kyuwon Choi
analystOkay. I guess any other, I guess, either life cycle management programs that I haven't called out that you think probably would represent additional opportunities here for vonoprazan beyond on-demand and EoE that you think would be potentially additive to the franchise?
Molly Henderson
executiveI think another area that we're looking into is ODT, like an orally dissolving tablet. I think as we look at end of life cycle management, that OTC component would be a key catalyst and having this ODT approach. So we're currently looking at that, and we think that would be a nice additive to the end of life cycle.
Kyuwon Choi
analystOkay. I guess as you think about expanding the franchise beyond vonoprazan and just maybe thinking about either internally developed assets and/or externally acquired assets. The topic of BD and so forth, doesn't often frequently come up because you're still relatively early in your launch, just a relatively new commercial stage company. But could you maybe speak to your philosophy and just thinking about what are the adjacent opportunities either in the GI space or if not in the GI space, what would sort of be potentially synergistic with what Phathom does currently?
Molly Henderson
executiveYes. So what we're developing is not just a GI footprint, but a PCP footprint. So from a value perspective, we see that there's tremendous amount of synergies that could be had by having another asset under our belt, whether it be a GI space or ones that treated by PCPs. That being said, the next 12 to 18 months are really focused on launch. So with 6 months into launch on erosive with nonerosive on the tail with on-demand, they're coming after that. We're focused on these assets. But certainly, within the 18 months, we'll continue to look and see what else is there in the market, not just from a commercial standpoint, but we also have a very strong regulatory in development that we feel we could leverage with other assets.
Kyuwon Choi
analystOkay. I also want to ask about other geographies. Obviously, Takeda sells TAKECAB in Japan. You guys now have the approval here in the U.S., but additional markets, whether you would want to potentially go it alone in key geographies, let's say, in the key parts of Europe or and/or through a distributor or partnership relationship, how do you guys think about that given the landscape there -- in those key markets?
Molly Henderson
executiveYou're right. So we have licensed rights in both EU and in Canada. We've got a lot of inbound interest since we received erosive approval at the end of last year. We're assessing those. I think from an economic standpoint, that will always be the driver as to when and how we approach that market, but our strategy has always been to partner in those regions, just because of the complexities that requires between access and distribution.
Kyuwon Choi
analystOkay. And then maybe from a regulatory standpoint, you guys obviously completed the Phase III that supported here your U.S. approval. But just what would be potentially required from either a clinical trial or regulatory perspective for those markets?
Molly Henderson
executiveYes. So in erosive GERD, we did have sites in our Phase III in Europe, so that could certainly be leveraged. Nonerosive would be a little bit different. So there need to be some supporting studies to help bridge that. But I think the other big asset that we have under our belts and compared to other P-CABs as well as our strong safety database with the Takeda and the millions of patients that have been prescribed this in Japan alone.
Kyuwon Choi
analystSo what would potential next steps be for MAA or moving forward with the EMA, that's something that you guys have been a little quiet on for a while. I'm just sort of curious how you guys are thinking about potential timing for that? What are sort of next steps for proceeding with the EMA?
Molly Henderson
executiveYes. Because of the economics, as I mentioned, the price points are so much lower. So what really matters in Europe is volume. So having nonerosive is going to open up, to a point, a lot of additional opportunity to really drive market adoption within Europe. So that's a key catalyst for us to get secured is the nonerosive in the U.S. And then it comes down to assessing the economics, like I said. So I think there's no timeline that we're in, the time -- clock starts ticking once we file with EMA. So at this point, it's all assessing the opportunities as they come in and determine what makes the most sense.
Kyuwon Choi
analystOkay. So just to make sure I'm clear, your plans in Europe are largely -- it sounds like you want to get the NERD trial completed to support an MAA there with EMA, and that would be the key determinant of our advancing in Europe?
Molly Henderson
executiveRight. And the partner would leverage -- we would leverage our partner to do all the regulatory...
Kyuwon Choi
analystOkay. Great. Maybe as you think about the longer-term opportunity for both vonoprazan in your existing indications and future opportunities, you and I have often talked about a blockbuster opportunity there. And as you look at sort of street numbers over the longer term, numbers are in that ballpark. And I guess, as you think about -- also the shape of the company and your investment to support the launch right now, how do you think about the transition to either reaching breakeven, sort of what the rough time frame for that might potentially be and then attaining sustained profitability?
Molly Henderson
executiveYes. So we haven't provided that specificity. What we have indicated is that our current cash plus the cash available and our debt facility gets us through 2026. We also have indicated that we, to your point, believe that is blockbuster potential, which we believe has opportunity of over $3 billion in revenues on an annualized basis. So if you typically see a typical time to peak of 4 to 6 years, you could model that out and you'd assume within several years that we'll certainly reach that point. I always caveat it that we will continue to invest in the asset. And to your point on BD, it's important that we continue to have a pipeline of sustainable products and leverage the infrastructure that we've built so far.
Kyuwon Choi
analystRight. And maybe can you remind us where TAKECAB is currently tracking, annualizing that. And remember, some of the early years were sort of restricted by prescription volumes, which didn't make the year 1 or year 2 of the launch necessarily look particularly compelling. But in terms of more recent performance, where is the asset tracking there in Japan?
Martin Gilligan
executiveSo they're currently the market leader. So it's very interesting. The dynamics are very similar to what we experienced in the U.S., where there have been PPIs for a long time. And it enters a new class, and it's called TAKECAB in Japan, but VOQUEZNA here. And they pulled all of their -- all their share came directly from generic PPIs. And they're now the volume market leader, which is really significant for them. They continue to grow. And they're getting the patients kind of through that same concept of high unmet need and almost that power positioning of having a compound that's more rapid, potent and durable versus standard of care.
Kyuwon Choi
analystAnd that's just on the GERD indication, correct? There's no NERD approval, if I recall correctly.
Martin Gilligan
executiveCorrect. Yes. They have erosive GERD. They have H. pylori. They do not have nonerosive indication as we will. They also have what would be indications, which are very small here in the U.S., but larger in Japan, such as coadministration with an NSAID or with aspirin or duodenal ulcers. Those are very -- have become very small markets in the U.S. in the past decade, but they have that over in Japan.
Kyuwon Choi
analystOkay. Great. Well, thanks, Molly and Martin for joining us. We're almost out of time here, so we'll end it on that note. Thank you very much.
Martin Gilligan
executiveThanks, Paul.
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