Okay. Good afternoon. We'll continue with the next session. I'm Paul Choi, and I cover the SMIDCap biotech sector here at the firm. So my pleasure to welcome Phathom to this session. To my immediate left is Martin, and to our 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 kick it off with some introductory high-level remarks, and then we'll get to Q&A. If there are any questions from the audience, please feel free to raise your hands, and happy to pass the mic to you. But otherwise, I'll turn it over to,
Great.
Molly.
Yeah.
Maybe to kick it off with some overview.
Thanks, Paul.
Thank you.
Thanks for the invite to be 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 the year. So here at Phathom, as many of you know, we launched our first products in Erosive GERD H. pylori at the end of last year. So we're about six 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. I was very excited about that. 17,500 had been filled. So obviously that translates into revenue. And then on the heels of that, we're really excited about our non-erosive approval date, which is about five weeks from now. So lots to be excited here at Phathom, and we're happy with what we've seen so far.
Okay. Great. So maybe let's start with the commercial piece, since you've talked about the launch a little bit here. Both with GERD and HP, you know, you've made a lot of progress in terms of expanding the coverage footprint.
Mm-hmm.
versus, you know, when the product initially got approved in H. pylori a while back. So can you maybe just, you know, 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.
Yeah. So, 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 the Voquezna itself, which would be for GERD, we're at 49% commercial lives covered. And, you know, what I always tell everyone is we just launched GERD this calendar year. Typically takes 6-9 months 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, you know, finish out Q2 and going into Q3.
Okay. So a few more major national payers to check, check the box on over the next 6-9 months.
Yes.
Okay. Great. And then on the government side?
Yeah. 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.
Okay. One of the questions I, I frequently get from investors is just, you know, can you explain to me what is BlinkRx? How does the company utilize it? What are the mechanics there?
Yeah.
You know, what does a 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, you know, how you guys are using Blink?
Yeah. 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 free goods. And when someone goes into that process, it's very hard for that patient to become extracted from there for many operational issues. So we opted to go with BlinkRx, which is a digital pharmacy, a digital fulfillment center. So what we always tell physicians is Voquezna's 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 it a bit as a highway.
So the first fork in the road is whether you're a government patient, as you were just asking, or a commercial patient. We can't provide support for government patients, nor can any brand. So right there, you know, that, that patient would go off that highway 'cause 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, and it's all electronic, right over to one of their partner retail mail pharmacies. And that goes out directly from there. They pay a normal copay, 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. Our objective there were two 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. 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. 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 IQVA, and we report that on a quarterly basis. If it is triaged over to a pharmacy, that is picked up by IQVA.
Okay. Great.
Does that help?
Yes, it does. You know, I think that's still a bit of confusion, I think, for investors or maybe at least 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?
Yeah.
So can you maybe just understand, you know, what's the ratio been, at least in terms of what you've reported over the past couple of quarters? Maybe if you can provide a bit of an update on how that has been trending since you last reported your quarterly results.
Yeah. So what we've been providing are, well, several metrics, but two 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. What we know is that differential between the two tells us two things. First of all, there's a really high demand. The number of prescriptions being written is very high. Then obviously due to access, there's that gap. We see that gap closing. So, 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%, excuse me, 42%, are being filled.
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.
Okay. Great. And that was just for people's reference. That was just two months later, if, if I recall, in terms of the give or take, right?
Yeah. Our last piece of data referenced mid-April.
Okay. Great.
Yeah.
Molly, maybe if you could just sort of remind us, you know, as with all new product launches, often, you know, some of the metrics in terms of where we, what we watch in terms of coverage and reimbursement and things like that are just trying to understand gross to net. And you sort of talked about industry benchmarks, you know, 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?
Mm-hmm.
Just kind of where you are and where you think the longer-term trajectory might be for Voquezna?
Sure. 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%-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 wanna negotiate against ourselves necessarily.
Sure.
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, similar environments with going into a competing genericized market, I think you'd see standard within that range of 50%-65%.
Okay. Great. Martin, maybe coming 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 roadblock comes in the middle of a prescription, you know, and they're just, you know, how does the patient follow up?
Yeah.
You know, to maybe get it through and, you know, push, push it? You know, does it require, the physician's back office to do a fair amount of legwork?
Mm-hmm.
Maybe just some of the processes there?
Yeah. So that's 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 is picked up electronically. So whether it goes to a Walgreens, CVS, or Blink, it's a ping of the system that, you know, provides whether 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.
As time goes on, we're seeing more utilization. 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.
Okay. Great. To the degree you have information on this, can you maybe comment a little bit on the, the median patient you're seeing? Are they typically, you know, refractory to one or two PPIs? Are you seeing de novo patients, you know, who are maybe newly diagnosed? You know, is that potentially working? Or are, are the step edits potentially, you know, sort of very strictly being enforced?
Yeah.
Maybe any color there would be great.
Yeah. 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, but 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, both 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 who, you know, their esophagus cleared. So that's really positive.
Oh, that's great. Like.
Yeah.
Real soap.
Yeah. Like doc pro, proactively, doctor's like, "Here's my before and after. I'm so excited about this.
Okay. Exciting.
This is, again, this is a game changer. So it tells us that the promise we have for Voquezna is holding true. So what are 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, has been on a 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's on a PPI and says, "I never drink coffee in the afternoon 'cause I know I'll be, you know, tossing and turning all night long, not from jittery caffeine, but from heartburn." So that's, that's what it is.
And these are people who not only are taking the PPI, maybe switching, but maybe keeping Tums on their desk or on their nightstand. That's exactly what we expected. 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.
Okay. Great. Maybe a little bit in terms of your, your commercial plan. You know, you, you, you talked about, sort of a tiering strategy in terms of you're focusing on high-volume prescribers.
Mm-hmm.
Maybe you can comment on where you are in terms of addressing that initial target opportunity of high-volume prescribers?
Mm-hmm.
You know, when does the potential to move into that second or third tranche of prescribers maybe start to open itself up?
Yeah. So, I'll back up a little bit and just, you know, 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 very heavy gastroenterologists 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 category 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. So 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 as primary care.
Okay. I know you're only a couple 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 you know, how many repeat prescribers are you seeing? And are you able to quantify that to date?
Yeah. 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, I guess, second week of June. So it's really early in launch. We are seeing those physicians who write a prescription Voquezna are also repeat prescribers. So we're seeing two things. We're seeing more physicians write and those that write, writing more prescriptions.
Okay. Great. In terms of the last commercial piece, I guess, you talked a little bit at the beginning about sort of, you know, a few more quarters of 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, you know, you know, what is sort of the how would you characterize the pent-up demand, I guess?
You know, 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? 'Cause I think that's what a lot of investors are waiting for. We monitor the TRx data on a weekly or monthly basis.
Mm-hmm.
It's definitely growing, but just kind of understanding when that big, you know, sort of moment and, you know, bend in the curve could start to occur.
Yeah. So we have, so clearly reimbursement is gonna be a key driver. And, you know, it was only a few months ago we were at 27% commercial lives covered, and now we're at 49%. So we wouldn't, we would expect, as we move forward, as within Q 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 gonna 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 non-erosive PDUFA coming up in July.
Okay. Great. I wanna talk a little bit about NERD, the non-erosive opportunity here. And, you know, it's a interesting additive opportunity for you guys. Can you maybe just remind us how are those patients currently treated and just, you know, sort of how do you size up that opportunity, roughly speaking, versus the GERD opportunity or erosive esophagitis opportunity?
Sure.
Just kind of what's the potential there?
Sure. So I'll talk a little bit market size and the dynamics from the patient journey is very similar, but I'll turn 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 non-erosive and 7 is erosive. So that's that 7 we have under our belts today. And now, as of hopefully July 19th, we'll have this additional 15. So 22 million patients will get open to us. So when you talk about that inflection, you know, we're essentially gonna 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 for the question.
Yeah. As Molly said, the journey's 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 merry-go-round or circling of PPIs and adding things on, then they might be sent off to a gastroenterologist where at that point they would probably get that endoscopy, which would, you know, finally indicate whether they're erosive or non-erosive. 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 non-erosive. And the symptoms for those patients, the heartburn symptoms, their burden, is very similar between the two.
So the way we, you know, address them as consumers or potential patients is the same way. And then the physicians we're talking to are the same.
Okay. Great. You brought up actually a point that touches on my next question, which is talked about patients cycling through PPIs. And you know, often with this class of medicines or GI medicines, for the treatment period, but necessarily don't and they feel better in terms of their symptoms.
Mm-hmm.
But they don't necessarily feel better. After they feel better, they don't necessarily stick with the maintenance.
Yeah.
Apologize. They don't necessarily stick with the maintenance period. So, I guess one question is, obviously, patients stuck through it during the maintenance period here and there.
Okay. Patients stuck with their therapy through the maintenance period through their clinical trial. But maybe, you know, how do you guys think about what the real-world experience might be, might be like? I'm sure patients will probably stick through the treatment phase, but just, you know, what does the adherence during the maintenance phase look like?
Yeah. Am I trying to use—do I need the handheld?
I'm good.
Okay. So, listen, it's like any other chronic medication, right? You have patients who are hypercompliant 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 gonna 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 gonna 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 till I need it." We call that the maybe intermittent patient, versus the more compliant patient. 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.
Maybe one for both you and Molly is, you know, Molly, you talked about the NERD opportunity being, you know, potentially 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, you know, your existing commercial footprint versus what you might potentially need for a NERD launch in a few weeks here?
Yeah. From a spend perspective.
Yeah.
Yeah. So I think as you might have seen, we launched our DTC campaign at the end of the first quarter. So that'll be a key catalyst into going into the non-erosive launch. But we continue to expect to invest in the DTC component, component, get the awareness out, especially now with this broad 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'll continue to increase, not just in Q2 and then throughout this year. And, and as you'd expect, we'd continue to invest even going into next year, because that is a big patient driver and awareness component of our strategy.
And I should, I should kind of respect. I just thought, I mean, we've been spending a lot of time. I have been talking about PPIs. I wanna 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. Net footprint does not change with non-erosive 'cause, 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 why that's because coming in 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.
That's right.
Yeah. It's been the first new product in the category since. Excellent, if, if memory serves.
Correct.
Okay. I wanna talk a little bit about lifecycle management. I mean, we're already 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, you know, 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?
Sure. So to your point, we anticipate in 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 as 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 it by the end of this year.
Okay. And can you maybe just remind us, you know, what the phase II data looked like maybe at a high level, and, you know, how that might figure in your phase III discussions here?
Yeah. 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.
Okay. Maybe 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, you know, physician receptivity potentially down the road to an on-demand indication?
Go ahead.
Yeah. So I would say no. You know, 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 as-needed works. It's rapid, potent, and durable. So it gives them more reason to move more patients. 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.
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. You marry that with the physicians who really like the concept and a motivated patient group, and it's really a recipe for success.
Okay. Great. Maybe staying on the topic of lifecycle management, you've also, in the past, talked about the EOE opportunity, which is pretty attractive but also targeted by, you know, several other companies, whether have clinical stage assets and/or approved assets, potentially for EOE. So can you maybe just remind us, you know, first, you know, 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?
Mm-hmm. So starting with the last question first, we also plan to initiate a phase II in EOE by the end of this year. What we're seeing is that in standard practice 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. What we've seen based upon the results of the PPI is that there's efficacy. We continue to expand on that as we design out our phase II.
Okay. I guess any other, I guess either lifecycle management programs that I haven't called about 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?
Yeah. I think another area that we're looking into is ODT, like an orally disintegrating tablet. I think as we look at end-of-lifecycle management, that OTC component would be a key catalyst in having this ODT approach. So we're currently looking at that, and we think that would be a nice additive to the end of our lifecycle.
Okay. 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, atop the topic of BD and so forth doesn't often frequently come up because you're still relatively early in your launch, just and, you know, 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 necessarily in the GI space, what would sort of be potentially synergistic with what Phathom does currently?
Yeah. 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 a tremendous amount of synergies that could be had by having another asset under our belts, whether it's the GI space or ones that are treated by PCPs. That being said, the next 12-18 months are really focused on launch. So with, you know, 6 months into launch on erosive with non-erosive on its heels 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 and development that we feel we could leverage with other assets.
Okay. I also want to ask about other geographies. Obviously, Takeda sells Takecab in Japan. You guys now have the approval in the US, but additional markets, whether you would want to, you know, 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?
You're right. So we have license 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.
Okay. And then maybe from a regulatory standpoint, you guys obviously completed the phase III that's supported here, your U.S. approval, but just what would be potentially required, from either a clinical trial or regulatory perspective for those markets?
Yeah. So in Erosive GERD, we did have sites in our phase III in Europe, so that could certainly be leveraged. Non-erosive would be a little bit different. So there didn't need to be some supporting studies to help bridge that. But I think the other big asset that we have on our belts and compared to other P-CABs as well is our strong safety database, with the Takecab and the millions of patients that have been prescribed this in Japan alone.
Okay. So what would potential next steps be for MAA or, you know, 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?
Yeah. Because of the economics, as I mentioned, the price points are so much lower. So what really matters in Europe is volume. So having non-erosive is gonna open up, to your 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 non-erosive 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.
Okay. So just to make sure I'm clear, your plans in Europe are largely it sounds like you wanna get the NERD trial completed.
Right.
Support to support an MAA there with EMA. That would be the key determinant of the advancing in Europe.
Right. And we would leverage a partner to do all the regulatory aspects of that.
Okay. Great. Maybe as you think about the longer-term opportunity for both vonoprazan, you know, in your existing indications and future opportunities, you know, you and I have often talked about, you know, 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, you know, 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, you know, reaching break-even, sort of what the rough timeframe for that might potentially be, and then attaining sustained profitability?
Yep. So we haven't provided that specificity. What we have indicated is that our current cash plus the cash available under our debt facility gets us through 2026. We also have indicated that we, to your point, believe that it's 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, you know, 4-6 years, you could model that out, and you'd assume within, you know, 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.
Right. 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, you know, which didn't make the year one or year two of the launch necessarily look particularly compelling. But in terms of more recent performance, where's the asset tracking there in Japan?
Yeah. So they're currently the market leader. It's very interesting. The dynamics are very similar to what we experienced in the U.S. where there had been PPIs for a long time. And in enters a new class, and it's called Takecab in Japan, but Voquezna here. And all of their share came directly from generic PPIs, and they are now the volume market leader, which is, you know, 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.
Okay. And that's just on the GERD indication, correct? There's no NERD approval, if I recall correctly?
Correct. Yeah. They have erosive GERD. They have H. pylori.
Okay.
They do not have non-erosive 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 co-administration with an NSAID or with aspirin or duodenal ulcers. Those have become very small markets in the U.S. in the past decades. So they have that over in Japan.
Okay. Great. My 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.