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Phathom Pharmaceuticals, Inc. Q4 FY2023 Earnings Call

Phathom Pharmaceuticals, Inc. (PHAT)

Earnings Call FY2023 Q4 Call date: 2024-03-07 Concluded

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Operator

Hello and welcome to the Phathom Pharmaceuticals Fourth Quarter and Full Year 2023 Earnings Conference Call. Please be advised today's conference is being recorded. With that, I would like to turn the conference over to Eric Sciorilli, Phathom's Head of Investor Relations. Please go ahead.

Eric Sciorilli Head of Investor Relations

Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Phathom's fourth quarter and full year 2023 results. This morning's presentation will include remarks from Terrie Curran, our President and CEO; Martin Gilligan, our Chief Commercial Officer; and Molly Henderson, our Chief Financial Officer. Azmi Nabulsi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. 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. Further, the recording of today's webcast can be found under the Events and Presentations 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 Phathom's control. Actual results can materially differ from the forward-looking statements, and any such risks can materially adversely affect the business, the results of operations, and trading prices for Phathom'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 Phathom as of this date, and Phathom disclaims any obligation to update these statements. Also included today are non-GAAP financial measures which should be considered only as supplemental to, and not a substitute for or superior to, GAAP measures. To the extent applicable, please refer to the tables at the end of this morning's press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures. With that, I will now turn the call over to Terrie Curran, Phathom's President and CEO, to kick us off. Terrie?

Thank you, Eric, and thanks to everyone joining us on today's call. This marks our first earnings call as a commercial company. I'm eager to share the progress we've made in the fourth quarter of 2023 and the beginning of 2024. In this brief timeframe, we have accomplished numerous regulatory, manufacturing, financial, and commercial milestones that showcase the significant dedication of our teams. In November, we set three primary goals for the early stages of our launch: to highlight VOQUEZNA's clinical superiority over PPIs, to raise awareness among physicians, and to enhance access for commercial patients. I'm pleased to report that we are achieving these goals; prescribers have quickly acknowledged VOQUEZNA's unique mechanism of action. Our representatives are even relaying stories of physicians noting VOQUEZNA's rapid and effective acid suppression profile. This excitement is translating into demand, with thousands of prescriptions written since the product's availability. After more than 30 years since the approval of the first PPI, there is a strong demand for innovation. Moreover, the number of patients who have utilized VOQUEZNA is increasing daily. For me, one of the most rewarding aspects of our launch has been hearing stories of patients who have suffered for so long and are now experiencing significant improvements with VOQUEZNA. We are working diligently to ensure that as many patients as possible can access VOQUEZNA and benefit from it. With our recent success with Express Scripts, we are on track to secure extensive coverage for commercial patients. These positive indicators, along with the impressive commercial success of vonoprazan in Japan, reinforce my confidence in VOQUEZNA's promising future in the U.S. With an erosive GERD market of about 7 million adults in the U.S., favorable feedback from physicians and patients, and expected label expansions, we believe VOQUEZNA has the potential to achieve annual peak revenues exceeding $3 billion. From our initial launch data, I'm happy to report that over 3,800 prescriptions for VOQUEZNA have been filled. This number includes prescriptions counted by IQVIA and those filled through BlinkRx. We mention filled prescriptions because we have also been tracking total demand, which we believe provides a comprehensive view of the growing interest in prescribing VOQUEZNA. We estimate that more than 14,000 total prescriptions have been written since the launch. We are pleased with this level of demand and view it as a positive sign for VOQUEZNA as we seek broad payer coverage. Last month, VOQUEZNA was included in Express Scripts' national formularies for commercial patients. As part of our strategy, we secured placement with a straightforward step edit through a generic PPI. Consequently, VOQUEZNA's accessibility has expanded to approximately 60 million commercially covered lives. We believe our rapid acquisition of commercial formulary placement with one of the largest PBMs indicates that our pricing and access strategy is well-received by payers. We are actively engaging with other major PBMs and health plans, expecting further expansion of commercial coverage throughout 2024. As this coverage develops, we expect the gap between total demand and filled prescriptions to narrow significantly. While we continue with the launch, our R&D team is focused on advancing pipeline opportunities for vonoprazan. In December, we announced that the FDA accepted our NDA for non-erosive GERD daily dosing and set a PDUFA target action date of July 19, 2024. We are just four months from that decision date. Non-erosive GERD represents the largest subset of GERD, affecting about 15 million adults in the U.S. annually. If approved, this indication will greatly expand VOQUEZNA's target population and likely accelerate adoption. The review of our application is progressing as anticipated, and we are preparing for a July launch in this substantial indication. Looking ahead, we plan to initiate a Phase III trial for as-needed Non-Erosive GERD and a Phase II trial for Eosinophilic Esophagitis later this year. We believe vonoprazan's distinct mechanism of action positions us well for success in these trials. If approved, these additional label extensions will further set vonoprazan apart from PPIs and expand the total addressable market for VOQUEZNA. We are enthusiastic about these initiatives and look forward to sharing more updates on our progress. Later in the call, Molly will provide further details on our fourth quarter and full-year 2023 financials, where we reported revenues of $682,000 and ended the year with $381 million in cash. We believe our robust balance sheet will support us in executing our launch and development strategies. I have previously highlighted several essential factors for a potential blockbuster drug—such as a significant target market, clear unmet patient needs, demonstrated superiority, and physician demand. The positive feedback from the early months of our launch has strengthened our belief that these elements are present in the GERD market. It ultimately comes down to our execution, and this team is well-equipped to deliver. These are exciting times for Phathom as we advance on both commercial and development fronts. This year is sure to bring new milestones and lay a strong foundation for VOQUEZNA's future. Our goal of becoming the leading acid suppressant prescribed in the U.S. is off to a promising start, and we are committed to pursuing our strategy for significant market expansion. I will now turn the call over to Martin to provide further insights into our launch progress. Martin?

Speaker 3

Thanks, Terrie, and hello, everyone. I'd like to first echo Terrie's comments that we're very happy with how the launch of VOQUEZNA has started. We're progressing as anticipated, and our pre-launch research is being validated by the feedback we're hearing from physicians and patients. During today's call, I'll touch on both quantitative and qualitative elements from our launch. But I know many of you on this call are most keen to hear about our script data, so let's start there. Today, we're reporting script data as of February 23 from both IQVIA and BlinkRx, which represents our latest available information. With the second half of our sales force entering the field in early January, this reflects about seven weeks of our full promotional efforts. This has translated to achieving over 3,800 filled prescriptions, which have reached patients' hands. As our reps continue to promote to physicians and garner the backing of strengthened commercial coverage, we expect positive script momentum to continue. Additionally, our KPIs indicate that over 1,200 unique prescribers have written VOQUEZNA prescriptions that have ultimately been filled. Among those writers, we are already seeing repeat prescribing, which builds our confidence that physicians recognize VOQUEZNA's value for patients. We are encouraged by the initial breadth of this prescriber base and anticipate it will grow as we further engage with high-volume targets. Another important metric that Terrie mentioned was total demand. We estimate that upwards of 14,000 prescriptions have been written since the start of launch. We believe the significant amount of demand to be indicative of the high level of unmet need in the market. It demonstrates that patients are interested in trying something new and physicians are willing to write for VOQUEZNA. As you've heard us say historically, providing access to patients is key to converting demand. As with all new products, negotiating coverage with payers is an essential step in achieving a successful launch, and this process often takes time. In anticipation, we established a patient support program through BlinkRx, which has meaningfully expanded patient access, resulting in an increased number of filled prescriptions. Early data shows the use of BlinkRx growing consistently, accompanied by positive feedback. However, there are still physicians sending prescriptions to their patients' long-established retail pharmacies. Although this has led to a proportion of early VOQUEZNA prescriptions not being filled, we believe we are well positioned to convert more of these prescriptions over time. In the near term, our sales force continues to emphasize the availability of BlinkRx to physicians as it often represents the best option for getting VOQUEZNA into patients' hands. And ultimately, future contracting with PBMs and health plans will increase payer access and narrow the gap between total demand and filled prescriptions. In fact, with VOQUEZNA now on formulary at the first of the three major PBMs, we are already making progress on that front. The first major PBM contracting win was with Express Scripts, often referred to as ESI. About three weeks ago, we announced the positioning of VOQUEZNA on ESI's National Formulary. This was a key accomplishment for Phathom, expanding VOQUEZNA's availability to roughly 23 million additional commercial lives. Our team was able to secure non-preferred brand status with a single step edit exactly as intended. The single step is with respect to the use of generic PPI prescriptions within the last 130 days. These criteria will be evaluated at the pharmacy counter electronically, avoiding any administrative burden for physicians or office staff. Alternatively, if the patient used over-the-counter PPIs instead of prescriptions during that time period, they could also satisfy the single step by means of prior authorization with attestation by their doctor. This latter avenue for access is a significant development as it means ESI patients could potentially access VOQUEZNA as a first-line treatment. As intended, this formulary position provides physicians a straightforward path to accessing VOQUEZNA for the broadest patient population. VOQUEZNA's total commercial coverage now reflects an estimated 60 million commercial covered lives. Achieving this level of commercial access less than three months into product availability is fantastic, but we know there is still work to be done. We believe our progress so far bodes well for our other ongoing negotiations, where we remain focused on securing VOQUEZNA coverage with a similar formulary position. We are confident in our strategy and believe it will continue to yield expanded coverage, resulting in an uptick in filled prescriptions throughout the remainder of 2024. Shifting to our promotional efforts, the sales reps continue to report back that VOQUEZNA is generating enthusiasm with prescribers. Physicians are articulating patients' unmet need and recognizing VOQUEZNA's value as a treatment option. The reps are focused on their reach and frequency among our full call panel of approximately 52,000 targets. In parallel, we are working diligently to reach patients suffering from the conditions for which VOQUEZNA is approved. In these early days, we are happy to see that we appear to be making an impact. To date, we've had over 185,000 visits to our consumer website, and we're hearing from physicians' offices that patients are asking for VOQUEZNA. Patient requests are a key component of our demand strategy, and market research conducted with 200 of our target physicians indicates almost 80% stated they would grant VOQUEZNA upon request for their Erosive GERD patients. With this in mind, we plan to initiate a new branded consumer campaign which has been met with positive and motivating feedback from test audiences. This campaign speaks directly to Erosive GERD patients and their symptoms. Most notably, this will include TV commercials on popular streaming services. So if you suffer from Erosive GERD, keep an eye out for VOQUEZNA on your devices, starting later this month. In closing, I'm extremely happy with the commentary we're hearing from prescribers and how it translates into demand. We are successfully executing our launch strategy with continued promotion to physicians, a broadened consumer campaign, and expanded commercial coverage; we anticipate significant growth in filled prescriptions over the course of 2024. Our teams are energized and committed to our belief in the blockbuster potential for VOQUEZNA. I'll now pass it off to Molly to walk through our financial results. Molly?

Thank you, Martin, and hello to everyone on the call. I'm happy to share our fourth quarter and full year 2023 financial results with you today. This is a momentous earnings call for Phathom as it is the first time we are reporting net revenues for our VOQUEZNA products. Although revenues reflect about a month of launch activity, we are pleased with the initial results. I'd like to note two items before going into the numbers. First, during this call, we will not be providing financial guidance regarding projected annual revenues, spend, or earnings, as we are still in the early months of launch. Additionally, I will be commenting on both GAAP and non-GAAP financial measures. Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section and can be found in this morning's press release. Now, turning to the numbers. For the fourth quarter of 2023, we reported net revenues of $682,000, driven by the initial stocking of wholesalers in December. This reflects a partial quarter of sales given that VOQUEZNA bottles became commercially available as of November 28, and VOQUEZNA Paks as of mid-December. Additionally, we reported gross profit of $515,000 for the fourth quarter of 2023, which equates to a gross margin of approximately 76%. The cost of revenues includes royalties owed to Takeda and excludes certain inventory costs that were expensed prior to receiving FDA approval. Note that the royalties owed as part of our revenue interest financing agreement are not captured in cost of revenues but rather in other interest expense. Moving down the P&L to our spend, we reported non-GAAP R&D expenses of $6.1 million for the fourth quarter of 2023, compared to $14.3 million for the same period in 2022. As for SG&A, we reported non-GAAP expenses of $39.7 million for the fourth quarter of 2023, compared to $25.7 million for the fourth quarter of 2022. On a full-year basis, we reported non-GAAP R&D expenses of $37.6 million for 2023, compared to $65.9 million for 2022. And for SG&A, our non-GAAP expense was $85.2 million for 2023, compared to $82.4 million for 2022. On a full-year and quarterly basis, the decrease in R&D expenses was primarily related to lower clinical trial costs as we concluded our Phase III Non-Erosive GERD daily dosing trial during 2023. Regarding SG&A, our increase in spend was driven by the build-out of our commercial infrastructure and initiation of marketing activities in support of the commercial launch of VOQUEZNA. Additionally, the most significant reconciling item between GAAP and non-GAAP operating expenses for the period was noncash stock-based compensation, largely associated with the vesting of performance shares upon the approval of Erosive GERD. Other non-GAAP reconciling items include noncash interest on our revenue interest financing liability and noncash interest expense related to the amortization of debt discount. Turning to EPS, we reported a GAAP net loss for the fourth quarter of 2023 of $79.6 million or $1.39 loss per share compared to $55 million or $1.33 loss per share for the fourth quarter of 2022. Non-GAAP adjusted net loss for the fourth quarter of 2023 was $46 million or $0.80 loss per share compared to $42.2 million or $1.02 loss per share for the same period in 2022. As of December 31, 2023, cash and cash equivalents were $381 million. This includes $175 million received during the fourth quarter of 2023 from our revenue interest financing agreement upon the approval of Erosive GERD. Also during the fourth quarter, we announced the expansion of our existing term loan facility with Hercules Capital. The amendment provides access to more favorable terms and an additional $100 million in non-dilutive capital, subject to achievement of certain revenue milestones. With this amendment, we now have a total of $160 million available via our debt facility. We believe we are in a solid financial position and reaffirm our expectation that we have cash runway through the end of 2026 based on our current operating plan, expected product revenues, and funds available under our term loan. Lastly, as we shared previously, we expect nominal revenues during these first couple of quarters of launch while payer coverage is materializing. Additionally, I mentioned our fourth quarter 2023 revenues mostly represented inventory stocking by wholesalers. We expect the sell-through of the stocking to take place during the first quarter of 2024, reinforcing our previous comments regarding nominal revenues during these first couple of quarters of launch. With that, I'll now turn the call back over to Terrie for closing comments. Terrie?

Thank you, Molly, and thank you again to everyone joining us on today's call. Phathom's accomplishments in 2023 were nothing short of amazing, and I'm extremely proud of this team. As we round out Q1 and approach Q2, our primary focus is set on securing formulary placement with payers. We've made great progress on that front so far and anticipate expanded commercial coverage throughout the year. As for the back half of 2024, we believe the planned launch of Non-Erosive GERD daily dosing in July, pending FDA approval, will serve as another key catalyst for driving adoption. We believe VOQUEZNA represents a blockbuster opportunity, and this launch is off to an exciting start. The enthusiasm here at Phathom is tremendous, and there is much to look forward to in 2024. Thank you again for joining us today. We appreciate your continued interest and support. I'll now turn it over to the operator to facilitate a 10-minute question-and-answer session.

Operator

And our first question comes from Yatin Suneja with Guggenheim.

Speaker 5

A couple for me. Could you just talk about the reason for not filling the scripts other than coverage? And how long does it take for BlinkRx patients to get the coverage?

Speaker 3

Yes, this is Martin and I’ll address that question. Regarding our coverage, we are very pleased with the Express Scripts win. As we’ve discussed before, our goal was to secure one step through a PPI, allowing us to access the widest market possible. Additionally, if a patient has only used OTC options, their physician can attest and initiate access to VOQUEZNA. Since this news was recently announced and the product just became available, we expect to see an increase in the number of scripts being processed. We are also in advanced discussions with other major payers, so we anticipate seeing additional progress as we move into Q2 and throughout the year. Furthermore, we have been actively supporting this initiative through BlinkRx. Our focus was to ensure that customers have a positive experience, to address initial coverage gaps, and to ensure that commercial patients on VOQUEZNA receive the treatment as intended by their physicians. Lastly, it was crucial for us to establish a program that guarantees refills for patients transitioning from patient support to commercial coverage through standard channels.

Speaker 5

Got it. And then, just maybe a follow-up and a really quick one. I understand you are in the early phase of a launch and not providing sort of guidance. Could you just talk about your comfort with the consensus out there, which is around 40 million to 45 million? And then also, if you can talk about the GTN dynamics, where we are? And how do you think it's going to evolve and where do you expect to end up in 2024?

Sure. Yatin, I'll take that. It's Molly. Overall, as you mentioned, we are not providing specific revenue guidance, but we want to reiterate our previous comments that we anticipate very minimal revenues for the first couple of quarters post-launch as we establish payer coverage and manage the stocking mentioned in Q4. Regarding GTN, we are not making comments on our status based on ongoing discussions with payers. However, we have previously stated, and will continue to give some guidance on, the run rate. We expect a normalized run rate between 50% and 65% on a steady state. Those are the only areas we are providing guidance on at this early stage of the launch.

Operator

And our next question is going to come from the line of Joseph Stringer with Needham & Company.

Speaker 6

Gave some very helpful infill on the contribution to film scripts from BlinkRx since launch. But just curious if you can comment on the relative proportion so that Blink/IQVIA split. Was it higher or lower in Q4 2023 than what it is in the first quarter of this year to date? And maybe as a follow-up to that, can you provide any qualitative guidance on how you see that relative split trending as the launch goes on and, of course, more coverage is carried? Would you expect that to trend down and reach a steady state level at some point?

Speaker 3

Yes, I'll address the first part of your question. There are two components here. The utilization of BlinkRx is increasing over time, which is what we anticipated and have been communicating to everyone. We're effectively informing physicians that it’s the best option for insured patients to access VOQUEZNA. You might expect that since the launch and continuing into 2023, the utilization of BlinkRx has been growing. However, I want to clarify an important point regarding the filled scripts. When you examine the scripts reported by IQVIA, those were filled at retail. Any additional figures we mention are related to the fills that occurred at BlinkRx. We believe that the current split between retail and BlinkRx will stay consistent and will gradually shift more towards retail as we achieve more successes.

Operator

Our next question is going to come from the line of Paul Choi with Goldman Sachs.

Speaker 7

I just want to maybe follow up a little bit on the previous question with regard to the pace of conversion between Blink and filled scripts and so forth. And just, I guess, as you think about that ratio over the course of the next 12 to 18 months, do you expect it to evolve more linearly? Or do you sort of see step function changes as coverage is added here, including like when such as the recent Express Scripts add? And then I had a pipeline question.

Speaker 3

Yes, Paul, I'll address that question again. You'll notice changes over time based on access. Initially, during the early weeks of our launch, we had no access, so what went into Blink was entirely based on patients who received a prescription and utilized our patient support program. Moving forward, as we gain more access and achieve more successes with payers, those prescriptions will be quickly recognized as having commercial coverage and will be filled at retail.

Speaker 7

Okay, got it. And then, a pipeline question. The EOE program is really interesting. I noticed in the press release, you referenced PPI as off-label or unapproved treatment. But I'm just curious how you're thinking about the study population, particularly in the recent light of budesonide being approved for that population as well as Dupixent, and so I'm just curious, are you thinking about this study as a treatment-naive population or a post-steroid, post-biologics population as your initial study population and maybe subsequent studies and other populations down the road?

Paul, thanks for your question. I'll kick it off and then I'll pass it over to Azmi. So we're finalizing the protocol for the Eosinophilic Esophagitis Phase II. We're really excited about that. And as you know, PPIs are utilized first line but are not approved, and our positioning in the treatment paradigm would be prebiologic first line. And so that's what we're pursuing there. We intend to initiate that Phase II by year-end. Maybe Azmi, do you have any other comments?

Yes. I mean, we're definitely targeting first line. We're looking at a broader population because remember, this is a Phase II. So we need to understand the performance in the different population segments, but the intent is to be first-line prebiologic as patients will start with a similar treatment that hopefully we'll be able to show is effective.

Operator

And our next question is going to come from the line of Umer Raffat with Evercore.

Speaker 9

I have a couple here, if I may. First, could you remind us, there was some confusion on whether the uptick in IMS, especially was observed in January, was that a function of IMS just doing a better job capturing Blink? Or was that completely exclusive? Maybe a different way of answering that is the significant sort of acceleration we saw almost tripling in TRx heading into January, February. Was that also seen in the prescriptions to date you guys saw? And I have a couple of follow-ups.

Speaker 3

Yes. So I think what your question was specifically asking about the IQVIA data and any uptick or anything else in January. What that is, is any script that has gone through a retail channel is being picked up by IQVIA. So that's all scripts realized through normal retail channels.

Speaker 9

It's all scripts. But I guess just to clarify, the acceleration seen in prescription pickup, which is over a doubling of TRx. Was that something also observed in the prescription fill rate that you guys were seeing as well or the overall prescriptions?

Speaker 3

Yes, we're seeing the same patterns between Blink and anything that's filled by Blink and anything that's filled by IQVIA. But what you're seeing on a weekly basis through IQVIA are all scripts that are filled through retail means.

Speaker 9

Okay, got it. That's great. Now the next one is really around some of the stuff, the data points you guys shared. So we know by IQVIA, the total prescriptions reported so far are just under 2,000 or so. You guys implied 3,800 have been filled. So is it reasonable to assume that the IQVIA to Blink ratio is about 1:1 right now? Is that reasonable?

Speaker 3

Yes. I think it's a pretty good assumption.

Speaker 9

Got it. And I guess the last point would be, how do you think about the prescriptions being filled up? Is that because of some payment issue? Because presumably, through Blink, people are able to pay $50 or $75 and get it. So why would there be 10,000 or so prescriptions not picked up?

Speaker 3

Yes. Physicians have the ability to send prescriptions anywhere, which is an important point since VOQUEZNA is available at all retail pharmacies. Blink is a new service that is creating change. We are observing growth in utilization and weekly demand at Blink, with new and repeat physicians increasing. As more physicians begin to use Blink, we expect the gap to narrow over time. Additionally, as we achieve more wins, the gap will continue to narrow. We are in the early weeks of a launch, so we are experiencing a lot of variation during this period. Looking ahead, we anticipate seeing more variation in this context.

Operator

And our next question is going to come from the line of Matthew Caufield with H.C. Wainwright.

Speaker 10

Congrats on the launch progress. So based on the current erosive labeling, do you have a sense of whether any non-erosive patients or patients that are possibly unconfirmed if their disease is erosive or non-erosive are included in the current script launch numbers, either IQVIA or the BlinkRx numbers?

Speaker 3

Yes, thank you for the question. Currently, we are not tracking by indication. I want to clarify that we are not promoting for non-erosive conditions, and therefore, we are not measuring any utilization in that area.

Speaker 10

That's helpful. And then just one quick follow-up. So with the range of the 140 scripts written to date and the 3,800 plus that were filled, is that spread at least at this stage, in line with what you would have expected for this part of the launch?

Speaker 3

Yes. Just to clarify, you say nationwide. Yes, we're noticing a similar increase across the U.S. and not seeing any regional differences. Our representatives are engaging with 52,000 physicians, and they're receiving very similar positive feedback. We're witnessing an increase in all the various targets we're pursuing, and we're very satisfied with the demand. We've noted 14,000 written prescriptions, and considering our full sales force has only been operational for seven weeks, it demonstrates that there is a significant unmet need. Physicians are reporting that their patients are experiencing quick healing results within hours.

Operator

And our next question is going to come from the line of Chase Knickerbocker with Craig-Hallum.

Speaker 11

Obviously, great to see with the ESI win. I guess, Martin, what's your confidence level in kind of recreating the structure there, particularly around how the PA is structured? Pretty simple PA process if it's a simple automated pull if they were on Rx PPIs in the last 6 months or so and then a simple attestation on the OTC PPIs. Is that something that you think you can recreate kind of broadly in all your contracts?

Speaker 3

Yes. I would say that we are absolutely confident that scripts will be accepted for Express Scripts' national formulary. Additionally, as Terrie mentioned in her opening remarks, we have made significant progress with major payers regarding access for VOQUEZNA. All of these discussions are focused on a similar strategy involving a step through a PPI. As we have previously discussed, this is the largest segment, as most patients are already on a PPI and there is considerable switching among different PPIs. There are also many OTC add-on options. Therefore, we believe we have been successful in reaching the broadest population possible.

Speaker 11

But particularly regarding the structure of the PA and how it functions, that's something you believe can be replicated with other large formularies. Additionally, I would like to explore the characteristics of the early writers. So far, they are primarily GI doctors. Should we consider them to be higher volume? Clearly, it's only a few prescriptions filled per prescriber at this point. Some additional insights would be beneficial.

Speaker 3

Yes. So I'll take the first part of the question in terms of the OTC; the PA associated with that. So listen, this is clearly something that's on the table for discussion. And our best case was and will always be one step through a PPI. I would take that addition of a PA for an OTC patient as beyond the best case. So I feel really confident about our best case and very hopeful that we can also get that additional PA. In terms of utilization thus far, our sales force has been very focused on calling on the highest volume physicians in the category. And as you can imagine, when you lay all that out, the majority of them who fit in the highest volume are gastroenterologists. So as a result, what we're seeing out of the gate is our largest group of prescribers are GIs. However, I'll say what's really nice in there is they've got a real strong base in those offices of nurse practitioners or physician assistants. We're seeing uptake among them. They're actually often the first-line prescriber as well as those who are accountable for switches. And then we're just starting to see prescriptions amongst primary care as we start reaching out to that group.

Speaker 11

Got it. That makes sense. And then lastly, just one for Molly. Quite a bit of stock-based comp in the quarter. Is that kind of onetime new employee sort of stock comp? And then that's it for me.

Chase, yes. So that's related to the PSUs associated with the approval of Erosive GERD. So 19.3% of that was, I'd characterize as a onetime event.

Operator

And our last question is going to come from the line of Yatin Suneja with Guggenheim.

Speaker 5

Just one follow-up, which is around the spend rate, obviously, with the DTC campaign. Just curious if you can articulate how should we model the spend in 2024.

Yes. So we're not providing any additional commentary as it relates to guidance on spend, Yatin. But what we can say with confidence is that the spend that we're anticipating for DTC is well within our guidance for the cash runway, and we feel comfortable that we still have runway through 2026.

Operator

Thank you. This does close today's question-and-answer session. Ladies and gentlemen, this also does conclude today's conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.