Phathom Pharmaceuticals, Inc.

Hello and welcome to the Fathom Pharmaceutical second quarter 2025 earnings results call. At this time, all participants are on a listen-only mode. After this presentation, there will be a question and answer session. To raise your hand to ask a question, please press star 1-1. To lower your hand, please press star 1-1 again. Please be advised that today's call is being recorded. With that, I'd like to turn the call over to Eric Chiarelli, Fathom's head of investor relations. Please go ahead.

Thank you, Operator. Hello everyone and thank you for joining us this morning to discuss VADM's second quarter 2025 results. This morning's presentation will include remarks from Steve Bosta, our President and CEO, and Robert Breedlove, our VP of Finance and Principal Accounting Officer. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found under the News Releases section of our corporate website. The recording of today's webcast and the slides we'll be reviewing can be found under the events and presentation section of our corporate website. Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Fathom's control. Actual results may materially differ from the forward-looking statements, and any such risks may materially adversely affect our business and results of operations and the trading prices for Fathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filings. All forward-looking statements made on this call are based on the beliefs of Fathom out of this date, and Fathom disclaims any obligation to update these statements. With that, I will now turn the call over to Steve Bosta, Fathom's President and CEO, to kick us off. Steve?

Thank you, Eric, and thank you to everyone joining us on the call today. I'm pleased to share our second quarter results, which reflect the first step in our mission to build a growth-oriented and profitable GI company. We believe this quarter marks a meaningful inflection point for Fabbin. Let's begin with the key performance metrics. Launched through July 25, over 580,000 Vaquesna prescriptions have been filled, 49% growth in 14 weeks since our last report, In Q2, approximately 173,000 prescriptions were filled, reflecting 36% growth over Q1. Commercial access remains north of 80% of lives covered, with more than half of those requiring only a single step at it or less. BlinkRx continues to be a resource for both patients with coverage and for patients denied coverage who are then offered a cash pay option. Approximately 68% of Q2 Voquezna prescriptions were filled through the retail channel. This slight decrease in retail proportionality this quarter is due to the rollout of a cash pay option for Medicare patients through BlinkRx. This has brought in incremental new patients and helps to instill confidence among HCPs as more patients have positive access experiences. Importantly, both covered and cash pay segments are growing at healthy rates. Through July 18th, more than 29,300 unique HCPs have written a filled Voquezna script, approximately 24% more than at the time of our Q1 report. Although we expect the number of total writers to continue growing, our focus, beginning in Q3 this year, has shifted to driving more depth and frequency of writing more than to driving new writer conversions. We recently refreshed our Salesforce target list to prioritize gastroenterologists. Of note, about 70% of all Voquesna prescriptions written to date have come from GIs. Even though we've actually been spending more than 60% of our sales time in the last 12 months on primary care physician calls, We are clearly seeing, therefore, a higher return from our sales calls on GIs. Likely, this is because a greater percentage of PPI patients treated by GIs still experience GERD symptoms and need a new treatment option. In Q2, gastroenterology writers, on average, wrote more than twice the prescriptions per month as compared to primary care physician writers. which illustrates that our GI sales calls are more productive than our PCP sales calls. We believe that more time spent driving GI adoption will translate to accelerated revenue growth. Starting in July, our new sales target list now includes nearly all gastroenterologists. We've removed from the target list more than 20,000 PCP targets who had not yet started driving. The net effect of now including all gastroenterologists and removing unproductive PCP targets is to free up our reps' time to focus on GIs and to increase call frequency with these high-potential writers. This is a deliberate move to drive depth over breadth and to move prescribers up the adoption ladder from trialists to consistent writers to daily adopters. In making these changes, we are not discounting the significant future opportunity that exists with PCPs. Rather, we anticipate phased growth. Step one, GIs are the core riders with high awareness of Equestria today, delivering a greater return per sales call. Focusing on GIs is a clear and efficient path to our goal of growth and profitability. In time, primary care physicians will hear from their GERD patients how much better they feel on Vaquesna as they return from GI referrals. We believe that our reps will then be able to more efficiently convert and grow PCP adoption. We expect transitioning sales targets will take time to show benefit in our sales ramp. It takes several calls over months to move the needle with new physicians. I expect that we may start to see an acceleration of revenue within the next two to three quarters as we are able to call on GIs multiple times, leading to greater writing frequency in our core customer segment. Two notes on our reported metrics may be helpful. First, as we spend more time with existing customers to go deeper, our rate of converting new writers in future quarters will not be as high a priority. We may elect, therefore, to report different metrics in the future rather than writer counts due to this change in focus. Second, regarding the prescription numbers we've reported, IQVIA has implemented two recent restatements. All weekly Rx data from launch through July 4th have been revised. The launch to date and Q2 TRX numbers that we are reporting today therefore incorporate IQVIA's weekly restatements and some internal estimates of monthly data. The restatements have no impact on our actual revenues, which are not derived from the IQVIA numbers. Turning for a moment to exclusivity, we were pleased that we achieved a positive resolution to our citizens petition in early June. The FDA has now officially updated the Orange Book to reflect exclusivity for the Verquesna 10 milligram and 20 milligram tablets through May of 2032. It's important to clarify regarding timeline that this date of May 2032 marks the earliest point at which a generic ANDA can be filed, assuming that we do not have an Orange Book listed patent one year prior to that date. Therefore, We believe that the actual entry point of a generic venoprazan competitor should be no earlier than 2033, assuming a typical ANDA review cycle. Pediatric exclusivity, potential future IP, and multiple rounds of ANDA review for generic filers could potentially extend our exclusivity window even further. Confirming exclusivity into 2033 clearly enhances the NPV of the QuestNet. Following the citizen's petition decision, we have also revisited our development plans and near-term priority clinical studies. We've recently decided to move forward with a phase two trial in eosinophilic esophagitis, or EOE, which we expect to begin Q4 of this year. We believe Loquesna has the potential to be a first-line treatment in this indication, for which PPIs are commonly used today despite not being indicated for EOE. Additionally, the EOE program may provide a path to extend exclusivity by six months with future pediatric evaluation in this indication. Robert will provide more detailed financial updates shortly. But first, I'll highlight some key recent financial progress. We reported $39.5 million in revenue for Q2. which represents 39% growth over Q1 revenue. We started to implement our cost savings initiatives mid-quarter in Q2, and I've already shown a $12 million reduction in Q2 non-GAAP OpEx compared to Q1. We ended the quarter with approximately $150 million in cash. Based on our operating plan, with anticipated continued revenue growth and rigorous cost control efforts, We believe our current cash can be sufficient to reach profitability without requiring additional equity financing. Analyst consensus revenue for 2025 currently sits at approximately $160 million. We expect that we can achieve revenue north of current analyst estimates and are providing revenue guidance of $165 to $175 million for full year 2025. We're also on track with our expense reduction activities. We expect Q3 expenses to be below $60 million for the quarter and our Q4 expenses to be below $55 million, including the incremental cost associated with starting the EOE trial in Q4. Recall that this guidance is intended to reflect only cash operating expenses. That excludes stock-based compensation and other non-cash items. These expense reduction targets reflect our disciplined approach to spending while continuing to invest aggressively in key areas driving revenue growth. As a final note, we communicated last quarter that there could be a supply disruption in the Voquezna triple pack. The triple pack represents approximately 1% of our total revenue. The supply issue pertains specifically to the chlorithromycin tablets in the triple pack. We are in ongoing discussions with our supplier for these tablets and continue to actively monitor this situation. We have not experienced any commercial disruption to date. The Vapresna bottles and the Vapresna dual packs are not impacted, as they do not include chlorithromycin. We are prepared to quickly shift our H. pylori marketing emphasis fully to the dual pack if needed. Q2 was a strong quarter for Fathom. We're executing on our strategy, delivering results, and laying the foundation for long-term growth. We believe we're on track to reach profitability in 2026. Importantly, 30 to 40% of GERD patients still have symptoms while on PPIs or other common treatments. Vaquesna's rapid, potent, and durable acid suppression profile provides a meaningful treatment option for these patients. We receive numerous testimonials about the benefits of Vaquesna and how it's providing significant improvement in care for patients with GERD. It's a privilege to be part of a team that is making a significant difference for many thousands of patients today and potentially millions more patients in the years to come. I'll now turn the call over to Robert to walk through the financials in more detail.

Thanks, Steve, and hello, everyone. I appreciate you joining us today. We are pleased with our results for the quarter and the progress we have made both in terms of our revenue growth and cost savings. This morning, I'll be walking through our financial results for the second quarter of 2025, and I'll be commenting on both GAAP and non-GAAP financial measures. As always, detailed reconciliations between our non-GAAP results and the most directly comparable GAAP measures are included in this morning's press release and will also be discussed later in my remarks. As Steve mentioned, we reported net revenues of $39.5 million for Q2 2025, which represents a 39% increase compared to the prior quarter. This revenue growth was driven entirely by the increased adoption of OQUESNA, reflecting the success of our ongoing commercial efforts. As of quarter end, wholesaler inventory levels remain consistent with historical norms, averaging approximately two weeks of supply. Based on prescription trends and our revised sales strategy, we are providing full year 2025 revenue guidance of $165 to $175 million. Our gross to net discount rate for the quarter was within our expected range of 55 to 65%, and we expect the discount rate to remain within this range for the remainder of 2025. Now, turning to operating expenses, for Q2, we reported non-GAAP research and development expenses of $7.4 million and non-GAAP selling general and administrative expenses of $78.7 million. Compared to the same period in 2024, these represent increases of 23% and 11%, respectively. This year-over-year increase in R&D was primarily due to one-time personnel-related restructuring charges. while the increase in SG&A reflects continued commercial investment in support of the Voquezna launch. As part of our previously communicated cost-saving efforts, we achieved a meaningful reduction in spending this quarter compared to Q1 of 2025. Total non-GAAP operating expenses for Q2 2025 were $86.1 million, which is a $12 million decrease from Q1 2025. This decrease was driven by $18 million in savings, partially offset by approximately $6 million in one-time restructuring-related costs. We are encouraged by this early progress and we anticipate more substantial reductions in the second half of the year. To give some context, our Q2 non-GAAP operating expenses included approximately $15 million in pre-committed direct-to-consumer advertising spend, $7 million in project costs that could not be discontinued before Q3, and the aforementioned $6 million in one-time restructuring charges. We expect the reduction or elimination of spend in these areas to drive our continued cost saving efforts. Accounting for these items, we expect Q3 non-GAAP operating expenses to be below $60 million and Q4 non-GAAP operating expenses to be below $55 million. As a reminder, these projections reflect non-GAAP operating expenses. which excludes stock-based compensation and certain other non-cash items. We encourage our analysts and investors to account for this nuance in their modeling. Based on our Q2 results and anticipated second-half targets, we are lowering the upper range of our full-year 2025 non-GAAP operating expense guidance by $15 million to $290 million to $305 million. For the quarter ended June 30, 2025, we reported gross profit of $34.5 million, which equates to a gross margin of 87%, consistent with last quarter. After accounting for quarterly cash expenses, we reported a loss from operations, excluding stock-based compensation, of $51.7 million. That is a 30% improvement compared to the previous quarters. Our non-GAAP adjusted net loss for Q2 2025 was $56.5 million or $0.79 per share compared to a loss of $73.3 million or $1.25 per share for the same period in 2024 and a loss of $77.1 million or $1.07 per share for the first quarter of 2025. As with past quarters, reconciling items between GAAP and non-GAAP results included non-cash stock-based compensation, non-cash interest related to our revenue interest financing liability, and non-cash interest expense related to the amortization of debt discount. Lastly, as of June 30, 2025, our cash and cash equivalents totaled approximately $150 million. Based on our current revenue outlook and operating forecast, we expect our current cash balances can support operations through the point of achieving profitability in 2026, excluding stock-based compensation. and without the need for additional equity financing. We are encouraged by our results and remain confident in our ability to deliver strong revenue growth and maintain disciplined expense management through the second half of 2025. With that, I'll now turn the call back over to Steve for his closing remarks. Steve?

Thank you, Robert. And thank you again to everyone for joining us today. As you've heard throughout the call, we are executing with discipline and momentum. But Cuesna continues to demonstrate growth, and we believe our strategic pivot to focus on gastroenterologists will enable an acceleration of that growth. This targeted approach will deepen engagement with our highest-value prescribers and create an opportunity for increased adoption. At the same time, we are delivering on our commitment to financial discipline. We believe we have a clear path to profitability in 2026. We are building a business that is not only growing, but growing responsibly. With exclusivity anticipated into 2033 and our EOE Phase II trial set to begin later this year, we believe we are laying the groundwork for long-term value creation. To our patients, our team, and our shareholders, thank you. Your trust fuels our mission. We remain focused on our goal of delivering meaningful value through disciplined execution and durable growth. I'll now turn it over to the operator to facilitate a Q&A session. Operator?

Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered, you wish to move yourself from the queue, please press star 1-1 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Kristen Kluska with Cantor Fitzgerald. Your line is open.

Hi, good morning. Congrats on a great quarter and for your victory in the citizen petition. Good to put this behind you now. So in terms of the ways that you're going to drive more depth and frequency of writing prescriptions, can you give us a little bit more color about how the sales force will target that and how much of real world practice right now is some of these physicians trying it in a few of their patients first, hearing how well it is, and then recommending it to more patients under care?

Kristen, thanks so much for joining us and thanks for starting us off with what I think is actually the core topic for the transition that we're making, which is the focus on gastroenterology and the focus on depth and frequency of writing. It's actually really sort of quite simple and straightforward how we are targeting the sales reps. We've realigned all of the sales territories as of early July. So Q3 is All of our sales reps now have a new target list that is different from the target list on which they've been operating over the past several quarters. That drops out north of 20,000 primary care physicians that we were calling on that just hadn't converted and hadn't written. Now, we've obviously got a significant number of primary care physicians who have converted, but we were spending a lot of time trying to drive first adoption from physicians that would then write slowly. What we're seeing instead as we look at our metrics is that there is a very strong correlation between call frequency and frequency of prescribing within the gastroenterology community. We had previously only been calling on sort of the top half of the gastroenterology community decile based upon prescribing. We've now added all gastroenterologists into the call pattern, into the target list for the sales reps. And we are driving multiple sales calls per month into the key gastroenterology accounts that allows our sales team to spend enough time in the offices to get to know every prescriber in that office, to build comfort, build awareness, build experience with the product through sampling and through education of physicians that allows for an evolution of writing habits to much higher frequency writing. Our internal metrics, when we look at what happens as we spend more time in physician's offices, clearly indicate that's a strategy that works, that the tactics of spending time building those relationships, providing that education, grows utilization. Even in our top gastroenterology accounts, we are still a moderate percentage of their overall patient volume there is still growth even among the top accounts and then in the broader gastroenterology community where there's been some adoption there isn't yet daily or weekly writing practice among all of those physicians we're going to be able to achieve that by spending more time in those offices so it's it's time and relationships that drives depth and frequency and the real-world impact on that is as physicians get more comfortable with the product they prescribe it more often as they prescribe it more often It's a self-reinforcing positive psychology that emerges because they hear from their patients how much better they feel, and that creates an acceleration. We also think that there's going to be a bit of a broad community-based effect within gastroenterology, that as we get more gastroenterologists to write, they talk to more of their colleagues who also have positive experiences, and that creates an uplift within that entire community.

Thank you so much.

One moment for our next question. Our next question comes from Joseph Stringer with Needham & Company. Your line is open.

Hi, good morning. Thanks for taking our question. Congrats on the quarter. Just given your 2025 revenue guide of 165 to 175 in your comments on anticipated acceleration of revenue over the next few quarters, given your focus and traction with GI specialists. Is that acceleration already baked into the current revenue guide, or do you think this could be a driver to the upside?

I think absolutely long-term, it's a driver to the upside. What is hard to predict is how quickly it comes into our revenue numbers. And what I'm describing there is just, you know, as we add a significant number of new gastroenterology targets to the sales force, they start making sales calls. But we know that it can, in some cases, take seven, 10, 12 sales calls before a physician starts writing. And then it takes another several calls for them to start changing habits and to grow their habits. Now, that timeline is different for every physician. And for some of these physicians, they've already had a fair number of sales calls. So what I expect that we're going to see is that it may take one or two or three quarters before the new targeting strategy really starts to show a consistent acceleration in growth and revenue. But I think, again, our own metrics would suggest that that is going to happen. But it doesn't happen with the first sales call. It happens with multiple repeated visits to the office that happened gradually over a period of months. So in terms of our revenue guidance. I mean, the reason that we've provided guidance in a range that is above where panelists currently are. That's my expectation is that we're going to be in that 165 to 175 range. And I do believe that longer term we're going to get acceleration, whether the acceleration comes within this timeframe of the next two quarters or it's early in 2026. It's very hard for us to predict the date at which this new strategy really drives traction.

Great. Thank you for taking our question.

One moment for our next question. Our next question comes from Annabelle Samuel. Steve, your line is open.

Hi, thanks for taking my question, and thank you for the details on how you're targeting the GI docs. I guess my question is, and it makes total sense that you're focusing on the prescribers and at some point that transitions into primary care writers, but I am curious, the gas the the asset control market became blockbuster category um i believe through the primary care market so do you have any sense at what what is the tipping point between um you know the frequency of writing of the gastros and when that starts tipping into the primary care um what is that transition to get uh prescribing started in the primary care setting So I guess that's the first question, you know, what points that sort of, is there an inflection point that switches over to the primary care being the primary riders there? And maybe secondly, I did notice that you started this program to tap into the Medicare, Medicaid population. Is that going to, over time, impact your gross net some more? How much is going to start having to go through blank? I guess I'm trying to understand the longer-term dynamics of tapping into that market. Thanks.

So, in thinking about sort of the evolution from GI to primary care, in your question, there's almost a presumption that that we have to be in primary care for this to be a blockbuster product. I don't actually think that's true. I think that there is well north of a billion dollar revenue potential in GI alone. And that's also built on the precedent of the PPI experience that, um, there are multiple PPIs who reached that reach north of a billion dollars of revenue in GI before they made a broadening push into primary care. So there is sort of past history, in the reflux market that adoption first in GI has been a well-worn strategy that multiple products have used and that's driven the broader adoption and the GI market is a meaningful market in and of itself. It's also where there is the greatest concentration of need for our product. So if you think about the broad population of patients in a primary care office, the portion of patients who are experiencing the most discomfort from their heartburn, who are experiencing the most pain, get referred to GI. So the distribution of patients in GI needing a more potent reflux treatment is higher and is going to drive faster acceleration. So my expectation is this becomes a blockbuster product in GI alone. And then the PCP market is meaningfully additive. We have significant revenue potential and significant runway in GI. So I don't I don't perceive GI as a starting point and then it transitions to a primary focus on PCP. I view GI as a constant growth driver and then PCP to be meaningfully additive and expanding the market to add significant revenue on top of the GI opportunity. The second question regarding Medicare we're really viewing medicare as not the future revenue driver population because we still get a low percentage of medicare patients that achieve coverage the majority of medicare scripts that go through end up being cash pay scripts that run through the blink program the intent of creating the cash pay alternative for those um medicare patients that don't have coverage is really around both supporting patients, that there are patients who need our drug, and this provides them access to it, and supporting physicians to make it easier for a physician to prescribe the product and to be agnostic as to whether their patient is on commercial insurance or Medicare. We don't want the physician to have to think twice about, is my patient going to get this product covered? Do I want to prescribe it? We want them to just adopt the habit of prescribing. And for every patient that they perceive needs it, go ahead and prescribe it. Go ahead and send it through to Blink. If it's a commercial patient and they get covered, then that's a covered script. And if it's a Medicare patient and they need the cash pay option, Blink can provide the cash pay option. So it just makes it easier for an HCP to adopt the product and to do so broadly in their practice.

Okay, great. Thank you for the caller. Appreciate it.

One moment for our next question. Our next question comes from with Guggenheim. Your line is open.

Hey, guys. Thank you for taking my questions. Congratulations. Very nice quarter. And I must add, impressive above consensus guide because it's really helpful for us in light of all the cost cutting that you're doing. So the question for me is twofold. Number one, where exactly are you cutting costs and how might that impact growth trajectory be happening? And then when you talk about the $55 million cash OPEX in 4K, should that be considered a steady state as we go into 2026? Or maybe just help us understand how should we think about that? Because if that's the number, we think you could become profitable when the sales reach somewhere in the $70 to $75 million range. We just wanted to check if we are in the right OPEX. Thank you so much.

Terrific. Yeah, and thanks for the questions. I think those are going to be helpful in clarifying to a number of folks as they're thinking about modeling this for the future. So first, where we're cutting costs to get to the $60 million in Q3 and the $55 million in Q4 comes from several categories. The first and the biggest cost savings is actually eliminating our direct-to-consumer promotional program. That becomes a big line-item savings. and for context there on sort of how we're doing that and not impacting revenue is, you know, my own assessment of that program and our internal metrics would suggest that program was just run prematurely, that we ran that program at a time when there is not yet broad adoption in the primary care community, and if a DTC program is to work, it is intended to activate patients to drive them to primary care, but we don't have enough primary care physicians who are yet writing scripts. And so we were driving patients to physicians who don't know the drug and weren't writing, and we just weren't getting a return on it. So by reducing that spend, we're not expecting an adverse impact on revenue. We actually think that instead we're going to see more uplift in revenue because of the retargeting strategy on GIs, which improves Salesforce productivity. So that's the first sort of most significant area. Um, the, we did do a small restructuring, a modest sort of percentage of total, um, uh, headcount restructuring that will provide some savings as well. There are significant number of savings that come from third party vendor contracts that we are adjusting. And just across the board, we're creating fiscal discipline in how we are driving third party spend. So whether it's a marketing related vendor, that is developing marketing materials where we can do things more cost-effectively using AI or using internal resources rather than using an outside vendor. There's significant savings in that process. So just across the board in a number of areas, we've identified primarily third-party vendor costs that could be reduced and not adversely impact revenue. So we are seeing that already take effect. As Robert described, we effectively reduced costs by $18 million from Q1 to Q2 in terms of OpEx. Now that was offset by restructuring charges of 6 million that we took in, but you see already from Q1 to Q2 a significant operating reduction recognized. Those operating savings were implemented mid-quarter. So we're already at that you know, substantially toward that reduced run rate because we realized those cost savings. So the second half of the quarter, we've got clear line of sight visibility to get to the 60 million in Q3 and to get to the 55 million target in Q4 with, you know, rigorous investments still in our core sales tactics strategy. The second element of your question on sort of how to think about the 55 million in Q4 and the go forward, we haven't yet forecasted or published a 2026 OpEx run rate. Um, you should expect that our 2026 OpEx run rate will, will reflect the significant cost savings that we've had, but there may be some incremental investments that we choose to make in 2026. So we're not committing that we're going to hold exactly to the 55 million number. Um, there could be some things that we choose to do that either our revenue enhancing activities or the clinical trial activities. Obviously we're starting our EOE study, in Q4 that's built into the $55 million number, but that obviously will also have expenses into next year. So there may be some things that we add. The 2026 number might be a slightly higher run rate than that $55 million. We haven't communicated exactly what that magnitude is because we haven't built out our operating plan in that level of detail yet for 2026. But it will be substantially below where the company had been over past quarters.

Very helpful. Thank you. One moment for our next question. Our next question comes from Paul Choi with Goldman Sachs.

Your line is open. Paul, your line is open. You can ask your question.

Hi. Thank you. Congratulations on all the progress. It's good to see you guys going back into the clinic as well for EOE. Can you maybe comment just a little bit on what physician feedback is and in that sort of space between generic PPIs and other conventional therapies and the transition into biologics and just sort of what physicians would look for for an intermediate therapy potentially such as venoprazam there. And my second question is, can you maybe just sort of comment on how you're thinking about the timing for the pediatric study? It's been sort of something that's been in there in the background. I'm just wondering if that's something you would consider starting in 2026. Thanks for taking our questions.

I'm sorry, which study was that that you were asking about, Paul, the second one?

Pediatric, to get the additional exclusivity period, yes.

Got it, okay. So in thinking about the EOE opportunity, I think you've hit upon both elements of thinking strategically about the EOE opportunity. There's one element of it, which is the EOE market in and of itself represents an incremental revenue opportunity for us, There's a second element of it, which is that the EOE strategy potentially provides us a path to a written request and the pediatric exclusivity strategy. So the first part of it, in terms of the market opportunity, today, PPI therapy is first-line therapy in EOE patients. Even though there isn't a large clinical trial that has demonstrated efficacy, there are enough case reports or enough published experience studies there is enough experience on the part of physicians and mechanistic data that shows that modifying acid in the stomach has a beneficial impact on EOE, both the histology and the symptoms in that condition that standard PPI therapy has become standard of care first-line treatment. There is a meaningful opportunity to disrupt that and have venoprazan potentially become the first-line treatment rather than PPIs with meaningful clinical data that represents a significant large data set that shows efficacy, shows the magnitude of improvement. There are case reports from Japan that show significant improvement in histology with venoprazan. That underlying data set supports the thesis that we're going to be able to have a fundamental positive impact on these patients. through venoprazine therapy, and there's a possibility that this is, as you described, an intermediate step, that first-line therapies, PPIs, and then patients graduate to venoprazine. There's also a possibility that this becomes the first-line therapy and changes the nature of the treatment paradigm over time as we get clinical data that it actually gets adopted more broadly. But that's to be determined down the road as we get the clinical data from those studies. But that represents a meaningful upside revenue opportunity The second half of the value proposition of EOE is, as you described, the pediatric exclusivity extension. This first trial is going to be in adults only. So this is not going to provide the pediatric exclusivity extension, but it is intended to lead to an end of phase two meeting and a conversation with FDA about a written request. In our past conversations with FDA, they've indicated this could be a potential pediatric indication that would warrant that discussion, and so we're making no commitments about it because we don't have a commitment from the FDA in this regard, but we have had conversations where there's a possibility of getting a request associated with the Phase III program for EOE that would provide that six-month exclusivity extension, so that path will be determined at the end of the Phase II trial.

Great. Thank you. One moment for our next question. Our next question comes from with Evercore ISI. Your line is open.

Oh, hi. This is for . Thanks for taking our questions. Two questions, if I may. The first question is on strategy. I think the drug pricing letter was sent to a selected 17 companies, not the broad industry. And the scope looks like it's going to be limited within just Medicaid. So we don't know if this will change later. at least for now, the impact on your business is likely very small. So how are you thinking about your strategy in the ex-US market? And secondly, when I was looking at some of the historic data presented at the medical conferences, there were about 22% patients cycled through two lines of PPI, and another 14 to 17 cycled through more than three lines of PPI. I guess my question is, is this a result of the requirement on the step edits, or is this just a pattern of how the doctors are prescribing Moquizna, and is it going to change when more and more patients switch to Moquizna after just one line of PPI? Thank you.

So let's take each part of that separately. So the first part on the ex-US strategy, at the current time, we're just focused on the US market. We are not spending a significant amount of time thinking through what our launch strategy would be in Europe or in Canada. We have rights to venoprazine for three territories, for the US, for Europe and Canada. All of our commercial activities are focused on the US, all of the sort of focus of how do we drive our business focused on US. The European and Canadian opportunities represent potential upside opportunities, but they also come with the complications of the current market that you described. which is all of the issues around most favorite nations, pricing, et cetera. And so we're just not at this point anticipating any near-term activities in terms of our own launch in the European market. We have in the past had conversations with potential European partners around a potential launch. We might elect to do that at some point in time, but that's not a current strategy, but always a possibility that we might explore. The sort of second half of your question around sort of whether patients fail one PPI, two PPIs or three PPIs prior to getting venoprazan, that evolves over time as physicians get more and more comfortable with this therapy. So what you're seeing in terms of patients who have been on two PPIs for three PPIs, it's actually just a reflection of the fact that 30 to 40% of patients on PPI therapy are still experiencing pain. So it's interesting when we do market research and we look at what physicians report about who the patients are that are appropriate for venoprazine, some of them indicate a patient who's failed one round of PPI therapy. Some indicate a patient who's failed two rounds of PPI therapy. Some indicate a patient who's on PPI therapy and also adds antacids. Some indicate a patient who's on PPI therapy and now is double dosing. All of those are manifestations of exactly the same phenomenon, which is a patient who's been on PPI therapy and is still experiencing heartburn. That's our core patient. All of those strategies are different things that physicians have tried or have recommended to patients that they try to manage their ongoing heartburn, but the phenomenon is exactly the same, which is you've got a patient who's on a PPI who's not adequately resolving their heartburn, and they need something more, they need something better. That's the patient we're going to try to switch. And it will just vary by physician practice as to whether they have been through two or three PPI therapies over the time, over time, where I think that goes is it gravitates toward when you fail one PPI, why am I switching you from omeprazole to isomeprazole? That's not going to really do anything. If you're failing on omeprazole, you should be switching to our drug. That evolution and thinking is going to come over the course of the coming years of physician experience with this drug.

Thank you very much.

One moment for our next question. Our next question comes from Matthew Caulfield with AC Wainwright. Your line is open.

Hi. Good morning, guys, and congrats on the progress. So it was helpful to see the 68% retail pharmacy filled prescriptions with the remainder coming through the BlinkRx cash pay. So, I was wondering at this point, what is your sense of the steady state balance between those two? And can you also comment on the current average BlinkRx cash pay amount? Thanks again.

So, it's hard for us to predict what the future steady state average will be. Obviously, we're seeing both channels growing. And by the way, some of the retail-filled scripts actually have gone through Blink and then went to retail pharmacy. So we're seeing both the covered retail scripts growing and the Blink cash pay scripts growing. We don't try to manage the business to manage what that ratio is. We try to grow all scripts, and both channels will continue growing. And so our conversations with physicians are around driving prescription growth. And the guidance to a physician is if you just send it to Blink, it'll be easy. If it's a commercial script and it gets covered, you know, they'll help you with the PA. They'll run the process to try to make sure that this can run through smoothly. And so it streamlines the process for getting a patient the script if it gets covered. And it also streamlines the process for getting the patient the option to pay cash if it's not covered. And so that's a win-win for the physician and for the patient. So we're just trying to drive overall script volume and we don't try to manage to a ratio. We just try to grow both. And we don't consciously say we're growing cash pay or we're growing prescription or we're growing covered. We are growing scripts and then allowing the best outcome for the patient and for insurance coverage in that process. So there's not an active attempt to try to adjust those. Was there a second half to your question that I missed in that process?

No, that was very helpful. Yeah, the second part was just if there's a sense of the average BlinkRx cash pay amounts that patients could be paying in that category.

Oh, so Blink, the standard cash pay amount that they pay is $50. Gotcha, okay. So a patient will be offered... A $25 copay if they get insurance coverage so that they have a lower copay if they're covered. But if their insurance plan is not covering the product, then they're offered the $50 cash pay option.

Got it. Very helpful. Thank you, guys, and great to see the progress again.

And I'm not showing any further questions in the queue. And as such, this does conclude today's presentation. We thank you for your participation. You may all disconnect and have a wonderful day.