Q3 2024 Phathom Pharmaceuticals Inc Earnings Call
and the other.
Speaker Change: Hello, and welcome to the Fathom Pharmaceuticals 3rd Quarter 2024 Earnings Results Call.
At this time, all participants are in listen-only mode.
After the presentation, there will be a question and answer session. If you would like to ask a question at this time, please press star 1 1 on your telephone keypad. Please be advised that today's call is being recorded. With that, I would like to turn the conference over to Eric Sciorilli, Fathom's Head of Investor Relations. Please go ahead.
Eric Sciorilli: Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's third quarter 2024 results.
Eric Sciorilli: 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. Azmin Abusi, 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.
Eric Sciorilli: Earlier this morning, we issued a press release detailing the results we will be discussing during the call.
Eric Sciorilli: 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.
Eric Sciorilli: Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation.
Eric Sciorilli: These forward-looking statements involve risks and uncertainties, many of which are beyond balance control.
Eric Sciorilli: 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 Fallon's common stock.
Eric Sciorilli: 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 FEC filings.
Eric Sciorilli: All forward-looking statements made on this call are based on the beliefs of Fathom as of this date, and Fathom disclaims any obligation to update these statements. With that, I will now turn the call over to Terrie Curran, Fathom's President and CEO, to kick us off. Terrie?
Terrie Curran: Thank you Eric and thank you to all those joining us on today's call. I'm excited to provide an update on Fathom's recent progress.
Eric Sciorilli: Successful commercial launch of the Quesna remains our top priority and I'm pleased to share that we're seeing growing interest from physicians and patients as well as increased coverage from payers.
Eric Sciorilli: Week-over-week and month-over-month, important key performance indicators have trended positively with respect to prescription data, market sentiment and patient access.
Eric Sciorilli: These outcomes inspire confidence that our launch strategies have been impactful. As we continue our launch journey, I'm confident that our teams are positioned appropriately to deliver on Vquesna's sizable market opportunity.
Eric Sciorilli: The third quarter of 2024 was momentous for FADM and the Quesna. We achieved several important milestones which advanced our commercial launch and strengthened our balance sheet to enable continued investment in our business.
Eric Sciorilli: On the commercial front, we secured FDA approval for Vekresna as a treatment for non-erosive GERD and greatly expanded commercial access, which has now surpassed 80% of lives covered.
Eric Sciorilli: On the financial side, we leveraged these achievements to successfully raise gross proceeds of $130 million in an equity follow-on, which we view as evidence that the capital markets have confidence in the opportunity that lies ahead.
Eric Sciorilli: In July, the Quesna was approved for the relief of heartburn associated with non-erosive GERD in adults. As the largest sub-category of GERD, this label expansion greatly increased the Quesna's addressable market to roughly 22 million US adults.
Eric Sciorilli: And since the non-erosive GERD market dynamics are nearly identical to those of erosive GERD, our teams have been able to quickly leverage the sales and marketing plans we already had in place for our erosive GERD launch.
The feedback so far has been tremendous.
Eric Sciorilli: Ultimately, with both major GERD indications now approved, we believe that Quesna can be a game changer with its rapid onset of action and durability of effect, providing relief to millions of patients who are dissatisfied with their existing treatment options.
Speaker Change: Thank you for watching. Please subscribe, like, and share. See you next time.
Speaker Change: In parallel, we have also made important progress on enhancing the Quesna's commercial coverage in the third quarter. Late in July, we announced the addition of the Quesna to CVS Caremark's national formularies, the largest of the country's three major pharmacy benefits managers.
Eric Sciorilli: Between this important accomplishment and several other formal replacements, over an estimated 120 million commercially insured lives now have access to the Quesna. And for the majority of those lives we successfully secured coverage subject to a single step through a generic TPI prescription.
Eric Sciorilli: One of our launch goals has always been to ensure the Quesna is widely accessible and affordable to commercial patients.
Eric Sciorilli: We feel we have done a good job in advancing this effort and we are both proud of the quantity and quality of the coverage we have earned.
Eric Sciorilli: In the months to come, we believe our commercial access will serve as a tailwind, increasing utilisation across both GERD indications.
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Eric Sciorilli: In fact, the effects of securing both non-erosive approval and broader commercial coverage are already having a positive impact on our results.
Speaker Change: We believe our third quarter 2024 launch data are impressive, highlighted by increasing the Quesna volume. In less than a year since launch, over 143,000 prescriptions have already been filled by patients.
Speaker Change: We believe the growth trajectory of this metric validates the unmet need in the market and serves as evidence that we are elevating brand awareness.
Speaker Change: With the fourth quarter underway, our goal is to improve on this momentum, expanding the number of the Quesnus prescribers and the number of the Quesnus scripts ultimately being filled by patients.
Speaker Change: Outside the quantitative data, I continue to be impressed by the recognition that Quesna has earned in the marketplace.
Speaker Change: In addition to the many patient and physician testimonials we receive on a weekly basis, the Quesna has recently won multiple industry awards touting its innovation.
Speaker Change: Media coverage for Quesna has also increased sharply, especially following our approval for non-erosive GERD.
Speaker Change: and on the medical front our team recently attended the American College of Gastroenterology conference where it was clear that the GI community and attending physicians continue to be excited by having the Quesna as a new option in their toolkit.
Speaker Change: Across these various sources of feedback, what I find most noteworthy is the consistency of the sentiment. Physicians, patients, care prenumerators, all describing a positive experience with sequesna, or reinforcing its potential to disrupt the TPI market.
Speaker Change: Turning now to our pipeline, we've begun reviewing McQuizner's early real-world non-erosive GERD data to understand consumer usage patterns and physician prescribing habits.
Speaker Change: Although additional data are needed, we believe these insights will help assess the value and potential timing of advancing a phase 3 program to validate the as-needs dosing of the Quesna for active heartburn episodes.
Speaker Change: Separately, we're in the final stages of obtaining FDA alignment on a Phase II program investigating Bequesna as a potential treatment for eosinophilic esophagitis, or EOE, which we now plan to initiate in the first half of 2025.
Speaker Change: On the financial side, Molly will further detail our third quarter 2024 results.
Speaker Change: for which we reported net revenues of $16.4 million and ended with $335 million in cash.
Speaker Change: We remain confident that our strength and balance sheet will enable us to continue delivering on our business strategies.
Speaker Change: I'm very happy with today's results. We believe our accomplishments in the third quarter were key steps in allowing Fathom to recognise the Quesna's full market opportunity.
Speaker Change: Our vision has always been focused on successfully executing our commercial strategy and I believe we're making terrific progress.
Speaker Change: We have appropriately invested in our people, technology and data to enable us to best understand and predict marketing levers that help drive growth.
Speaker Change: With recent approvals secured, commercial coverage expanded, and continued brand investment, I'm confident we can achieve the blockbuster opportunity we believe is possible for the Quesna. I'll now turn the call over to Martin to provide further details on our recent commercial updates.
Martin Gilligan: Thanks, Terrie, and hello, everyone. I'd like to start by echoing Terrie's comments that we're pleased with our third-quarter results.
Speaker Change: Following Boquesna's approval for non-erosive GERD and increased market access coverage, our teams have been working diligently to realize the expanded market opportunity.
Speaker Change: Today's results are clear evidence of the progress we've made. As we have done previously, I will begin with sharing updates on our launch data and follow with additional color on the efforts that have helped drive our successful third quarter.
Speaker Change: Now, turning to our metrics, I'd like to note that we are no longer reporting total demand, defined as the number of scripts written, even if not filled, as one of our quarterly data points.
Speaker Change: As we've mentioned in the past, demand was only meant to be an early launch metric. It was intended to serve as an indicator of market interest for Voquesna while we worked to establish commercial coverage.
Speaker Change: Now, given our widespread commercial access, we believe the fill prescriptions metric is an accurate measure of usage amongst prescribers and patients.
Speaker Change: With that being said, we have now surpassed 143,000 prescriptions filled by patients from launch through October 25th.
Speaker Change: This has more than doubled since our last report, displaying a growth of nearly 140%.
Speaker Change: In the third quarter specifically, we recorded approximately 69,000 filled Floquesna prescriptions.
Speaker Change: Also, just about doubling the amount we reported for the second quarter.
Speaker Change: We believe the recent label expansion for nonerosive GERD was the key driver of this growth. In fact, filled prescriptions for 10 mg, the approved dose for nonerosive GERD, increased by over 230% between Q2 and Q3.
Speaker Change: As a reminder, these figures include volumes filled through retail pharmacies, which are captured by IQVIA, as well as those filled through BlinkRx, one of our patient assistant programs.
Speaker Change: Consistent with our previous updates, as Bequezna's commercial coverage expanded, we expected the proportion of volume flowing through retail pharmacies to increase.
Speaker Change: As such, for the prescriptions filled in Q3, approximately 70% were filled through retail pharmacies and captured by IQVIA.
Speaker Change: In parallel, the total number of physicians who have written the filled script increased to over 13,600 as of October 18th.
Speaker Change: compared to over 8,200 as of our last report. We are pleased that the growth in BookWesner writers continues to indicate strong adoption.
Speaker Change: Through the end of Q3, about 12,400 cumulative prescribers have written a filled loquesna prescription up approximately 70% compared to Q2.
Speaker Change: Our data shows that repeat writing is growing, meaning those that prescribe Equestria are doing so often.
Speaker Change: Therefore, one of our key objectives has been to generate new writers with the aim that they will join those who write more frequently once they see the requisite benefit to their patients.
Speaker Change: I'm happy to report that this strategy is working and we're excited by the early results.
Speaker Change: All of this encouraging data stems from the widespread commercial access we have secured for Buquesna.
requiring only a single step through a generic prescription PPI.
Speaker Change: In the months following, downstream health plans have assigned because in a similar positioning on their formularies.
Speaker Change: Since the start of the third quarter, Foquesta has been added to formularies responsible for covering over 42 million commercial lives.
Speaker Change: And importantly, we see the significant growth in prescriptions for 10 mg as evidence that access is available for non-erosive GERD patients.
Speaker Change: With major payer wins secured, we're proud of the availability and affordability that we've set forth for commercial patients.
Speaker Change: In less than a year, we have successfully negotiated access for all approved indications with appropriate utilization management across the majority of plans for which Bequesna is covered.
Speaker Change: As a result, Bequezna's total covered population now captures over an estimated 120 million people, or more than 80% of all U.S. commercial lives.
Speaker Change: On the promotional front, we remain focused on increasing awareness with target physicians.
Speaker Change: In the early days of launch, gastroenterologists were first to embrace Wekwesna as they were largely aware of the new mechanism coming to the market.
Speaker Change: Since then, and accelerating with non-erosive GERD, we've been focused on growing the primary care prescriber base. In fact, Q3 was the first quarter since launch where the majority of new bequested prescribers were primary care physicians.
Speaker Change: These doctors are responsible for most SCIRT patient management decisions. So our aim is to make Voquesna a leading treatment option amongst this group.
Speaker Change: As for consumers, we know that positive feedback and direct requests can often impact physician prescribing choices.
Speaker Change: Fortunately, patient sentiment has been terrific and we believe that patients taking Vaquesna quickly notice the benefits and relay their experience back to their prescriber.
Speaker Change: In tandem, we continue to encourage patients to ask their physician about VoQuesna through further investment in our VoQuesna Can Kick Some Acid DTC campaign, which is expanded to include non-erosive GERD messaging.
Speaker Change: While the data is still maturing, our preliminary analysis has confirmed that the campaign is reaching the appropriate audience and that exposed consumers are converting to Vaquesna.
Speaker Change: As we approach the first anniversary of Equestria's initial launch for Erosive GERD and H. pylori, I'm confident in the foundation we've built and the momentum that has followed in these recent months.
Speaker Change: We continue to be excited by our quarterly progress, and I believe we are poised to continue delivering outstanding results.
Speaker Change: With the non-erosive GERD indication having launched not even four months ago, we believe there is opportunity for significant growth as we work toward displacing PPIs and getting Boquesna into patients' hands.
Speaker Change: I'll now pass it off to Molly to walk through our financial results. Molly?
Molly Henderson: Thank you, Martin, and hello to everyone on the call. I'm pleased to share our third quarter 2024 financial results with you today. Before going into the numbers, I'd like to note two items. First, during this call and similar to previous calls, we will not be providing financial guidance regarding projected revenues or earnings as we are still early into launch.
Speaker Change: 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.
Speaker Change: Turning to our results, during the third quarter and in September 30, 2024, we reported net revenues of $16.4 million, which represents an over 120% sequential quarter-for-quarter increase.
Speaker Change: In connection with the momentum from our non-erosive GERD launch, we believe the label expansion also contributed to the revenue growth in the third quarter.
Speaker Change: While we are still assessing inventory stocking patterns, early data following the launch of non-erosive GERD have remained largely consistent with previous quarters, signaling that wholesalers are holding about two weeks worth of retail product on hand.
Speaker Change: Regarding growth to net, discount rates are once again in line with the expectations we set forth pre-launch.
Speaker Change: We will continue to monitor the evolution of our GTN discount, especially in the fourth quarter, which will be our first full quarter to include the impacts of non-erosive GERD and commercial coverage above 80% for the entire quarter.
Speaker Change: Looking down the P&L to our operating expenses, we reported non-GAAP R&D spend of $7.4 million for the third quarter, which represents a 32% decrease compared to third quarter 2023. This also reflects a 22% increase sequentially compared to last quarter.
Speaker Change: The decrease compared to Q3 2023 reflects the wind-down of spend related to our completed Phase 3 non-erosive daily dosing trial, while the sequential quarterly increase reflects standard business operations related to our ongoing regulatory and clinical activities.
Speaker Change: As for SG&A, we reported non-GAAP expenses of $71.8 million for the third quarter of 2024. This represents an increase of $53.1 million relative to the same period in 2023, primarily driven by the build-out of our commercial infrastructure in support of the FOCWESNA launch in late 2023.
Speaker Change: Additionally, this period's SG&A expense included advertising costs of approximately $17.5 million in connection with our ongoing DTC campaign, which compares to $16.7 million reported last quarter.
Speaker Change: Going forward, we anticipate increased investments in our commercial activities for the remainder of 2024 and into 2025 based on the early results from our direct to consumer campaign.
Speaker Change: As for EPS, we reported non-gap adjusted net loss of $67.9 million for the third quarter 2024, or $1.05 loss per share compared sequentially to $73.3 million, or $1.25 loss per share for the second quarter of this year.
Speaker Change: Similar to previous quarters, the most significant reconciling item between GAAP and non-GAAP operating expenses was non-cash stock-based compensation. Other non-GAAP reconciling items included non-cash interest on a revenue interest financing liability and non-cash interest expense related to amortization of debt discounts.
Speaker Change: Turning to the balance sheet, as of September 30, 2024, cash and cash equivalents were $335 million. Up to an additional $125 million from our debt facility remains available, of which $25 million is available this year and $100 million is available next year, subject to achievement of certain revenue milestones.
Speaker Change: This cash balance includes proceeds received from the equity financing we closed upon in August.
Speaker Change: Following the approval of non-erosive GERD, our expanded commercial coverage, and strong Q2 results, we felt it was an opportune time to further strengthen the balance sheet. The August financing was initiated by reverse interest from select investors and resulted in gross proceeds of $130 million.
Speaker Change: Beyond enhancing our cash position, we felt our ability to complete a financing amidst challenging capital markets signaled confidence in our team's ability to deliver on Brook West's significant market opportunity.
Speaker Change: With this additional capital, we believe we have cash runway through cashflow positivity based on our current operating plan, estimated product revenues, and funds available under our term loan.
Speaker Change: I'd like to close by reiterating our solid third quarter 2024 results and highlighting our focus on the remainder of 2024 and start of 2025.
Speaker Change: We continue to believe we have a blockbuster opportunity with ProQuesna, and we are keenly focused on our capital allocation strategy, and to ensure we have a strong return on investments made in our commercial and our direct-to-consumer campaigns, as well as our R&D activities. We look forward to keeping the market updated on our strategy in these areas.
Speaker Change: With that, I would like to turn the call back over to Terrie for closing comments. Terrie?
Terrie Curran: Thank you, Molly, and thank you again to everyone joining us on today's call.
Terrie Curran: We're very happy with our third quarter accomplishments. Over the last few months we've launched for Quesna for non-erosive GERD, expanded commercial coverage for patients, and strengthened our balance sheet. Each of these milestones will play a major role in our ongoing commercialisation of the Quesna.
Terrie Curran: From the beginning, we focused on three goals that we felt would fuel a successful launch – communicating differentiation, driving brand awareness, and building commercial access. To date, we have made great progress on each of these pillars, as evidenced by our quarterly results.
Terrie Curran: In the fourth quarter, we'll continue to execute on our launch strategy and build upon our early launch success.
Terrie Curran: By expanding our DTC efforts, we believe we can enhance brand awareness among patients and physicians, ultimately fortifying the Questioner's position in the marketplace.
Terrie Curran: We believe the Quesna is still very much in its early phases of growth, and I'm confident that we're prepared to help it reach its full potential.
Terrie Curran: 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.
Speaker Change: Ladies and gentlemen, if you have a question or comment at this time, please press star one one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key.
Speaker Change: Again, if you have a question or comment at this time, please press star 11 on your telephone keypad.
Thank you. Thank you.
Speaker Change: Our first question or comment comes from the line of Annabelle Samimi from Stiefel. Ms. Samimi, your line is open.
Hi everyone, thanks for taking my questions and congratulations on
this great uptick.
So just wanted to try to...
Speaker Change: clarify a little bit. Your coverage uptake was really impressively rapid. And so, to what extent is the increased prescriptions from the actual access, because clearly you had blink, versus the uptake that you might have expected from the non-erosive GERD indications? You know, in other words, is this the inflection that we should start seeing from this NERD indication that we have? And what percent of prescriptions is now 60 days?
Speaker Change: Okay, thanks Annabelle. Martin, first of all, thanks for recognizing the rapid coverage that we have. I think you've heard us say before, it's a highlight for us and we couldn't be happier about it.
Martin Gilligan: In terms of the growth we're seeing, I'm going to say it's a mixture of both. More scripts are getting through, which is exactly what we intended, but we also know that we're seeing increased demand tied to the launch of non-erosive.
Terrie Curran: And so why do we know that we're seeing that demand? Well, 10 milligrams, you just saw an immediate rise that continues to grow. Now, 10 milligram can also be used for erosive GERD, but clearly that's tied to non-erosive. So it really is a mixture of the two.
Speaker Change: And then the last piece, I just want to make sure I have clarity, did you say what percent are 60 days?
Speaker Change: Yeah, I thought, so I think one of the things that we noted is that some of the prescriptions are 60 day prescriptions, so do you see a change in that pattern?
Speaker Change: Yeah, no, we're not seeing a change. So yeah, so scripts in general, most of the scripts are written for 30 days but there are some that are either for 60 or maybe 90. A lot of that's dictated by different health plans and what they require and or allow. But really it's driven mostly by the 30 days, but there is there is some that's a little bit more than that. Thanks. Okay, so it's more driven by health plans as opposed to
Speaker Change: You know, physician-feeling caution that, okay, you need to use this. We can prescribe this for two months as opposed to one.
Speaker Change: Yeah, it's a combination. I mean, if you were to go to your doctor today, it depends upon how they write refills. So that's step number one. And then step number two is what the plan allows.
Speaker Change: trial on an as-needed basis or to get it on the label because it's already being used that way.
Terrie Curran: Yeah, Annabelle, it's Terrie. I'll take that question. Yeah, so since we had
Speaker Change: the non-erosive indication approved. We've been evaluating real-world utilization and we really want to spend a couple of months just evaluating that data to ensure that we get good
Speaker Change: on that trial. So over the next couple of months we'll evaluate that and then, but what we have seen is that, even at ACG, the Phase 2 on-demand results were presented and the number of position papers.
have been published that incorporates...
Speaker Change: on-demand into the recommendation. So we're hearing from physicians that they...
Speaker Change: profile, the rapid response, they're really seeing it clinically and so we just want to really evaluate that data before we proceed with that so yeah.
Okay, great. Thank you so much. Congratulations again.
Speaker Change: Thank you. Our next question or comment comes from the line of Paul Choi from Goldman Sachs. Mr. Choi, your line is now open.
Speaker Change: Hi, thank you and good morning. Thanks for taking our questions and congrats on the progress. My first question is for Molly. If you'd maybe just sort of comment on your latest thinking on gross to net given the expansion in insurance coverage and the number of lives covered. I guess
Speaker Change: Any uptick that you're thinking of going into 2025, any color there would be helpful. And my second question maybe for Terrie is, can you update us on the status of your...
Speaker Change: gain application for linopresent monotherapy. What are sort of the gating factors there or sort of ongoing discussion points?
Speaker Change: and I guess what gives you conviction that the moiety will be covered under a non-infectious disease application such as NERD or erosive GERD. Thank you very much.
Speaker Change: Thanks, Bob. So Cher, as it relates to GTN, the range is coming, the results are coming right in the range of what we expected pre-launch, which was 50 to 65% discount. So if you do the math, you can calculate that we're right within that range.
Speaker Change: Because we're going into a holiday period with Q4 and then changing health plans going into next year, and as you pointed out with the inclusion of non-erosive, we expect to still stay within that range but we might see variability over the next couple quarters.
Speaker Change: All that being said, we continue to expect to tighten that range and be right within where we expected.
Terrie Curran: And Paul, it's Terrie. I'll take your question regarding the Orange Book. So yes, we are engaged in discussions with FDA regarding the exclusivity that's reflected in the Orange Book.
Speaker Change: Ultimately, we continue to firmly believe that the Orange Book listing for the Quesna should be updated to reflect the full 10 years of NCE exclusivity that the molecule received when the combo packs were approved as QIDP products.
Speaker Change: So our external council believes that our regulatory exclusivity should protect the Quesna from generic entries into 2032.
Speaker Change: and we're currently in the process of evaluating the best path forward to ensure
Speaker Change: The FDA does reflect this in the Orange Book and will provide updates if we have any material progress to report. But as it stands now, nothing has changed from our side. We're still operating under the assumption that the FDA should not accept.
Speaker Change: and Anne's replication from a generic until 2032 and we're very confident in that position.
Great, thank you very much.
Speaker Change: Thank you. Our next question or comment comes from the line of Mr. Joseph Stringer from Niederman Company. Mr. Stringer, your line is open.
Speaker Change: Hi, thanks for taking our questions. Can you comment on what you're seeing in terms of overall refill rates and how does this compare to say what is typically seen for prescription PPIs?
Thank you.
Speaker Change: Yeah, so Joey, the refill rate, so I don't have a specific rate to share with you, but what I will say, and it kind of echoes my comments, is we're seeing more physicians, right, and we've seen a really large increase in new writers, which just tells us that the business is really healthy and going in the right direction.
Speaker Change: So as you have new writers, they haven't had the opportunity to do the refills yet. That's all coming on board. But we do know for those that have started to write, that they're writing more.
Speaker Change: and what we do track and we're looking at is the persistency.
Speaker Change: And when you take a look at that and looking at patients that started earlier on in the launch and that are going back month after month, we're seeing refill rates that are healthy and reflect, as you just said, what you would expect to see in the PPI prescription market. So we feel really good about where we are.
Great, thank you very much.
Speaker Change: Thank you. Our next question or comment comes from the line of Yatin Suneha from Guggenheim. Ms. Suneha, your line is open.
Hey guys, good morning. Can you hear me?
Thank you.
Speaker Change: Very good. Congratulations on a very solid quarter. Just a couple from me. Could you maybe talk about how we should think about duration of therapy? Are you able to monitor sort of compliance and any comments there? So that's one.
Speaker Change: Second is, with regard to gross demand, I think if we assume 70-30 split between retail or IKEA versus Blink, I think we get to about a...
Speaker Change: and gross to net discount, at least on the retail of about 55, 56%. Is that sort of, is that not correct? I could maybe talk about that and how it should evolve, specifically in Q1 of next year, which I think is gonna be a little bit.
Speaker Change: we do have that one-time issues there. And then finally, any thoughts on establishing or thinking about establishing guidance? Thank you.
Speaker Change: So, thank you. I caught a couple of those and then I'll cover them, maybe not in the order that you had them, and then turn it over to Molly.
Speaker Change: So first on the duration, I think this is a little bit of what I was speaking to Joey's question. So what we're tracking right now is persistency.
Speaker Change: and when patients get drugged, how long are they on? And we're seeing that to be very consistent with what is happening with the PPI. So we've always said that the days of therapy are somewhere between that 140 and 160 on an annual basis. And we have no reason to believe right now that it's gonna be less than that, but we continue to study it as Terrie was mentioning earlier.
Speaker Change: And on the blink conversion, I think was another part of your question, or I call it that, is the, you know, the percent of scripts that are going through blink.
Speaker Change: As was commented earlier, you know, we moved from early on.
Speaker Change: About 50% of the prescriptions only being captured by IQVIA and the balance going through BlinkRx or CASH.
So if we're here, let's just call it cash.
Speaker Change: We've really progressed that over time, exactly like we said we would, is that that was going to evolve, and as access came on board, we would see, yes,
Speaker Change: less utilization of the patient support of cash. And that's what's really had us move through sequential quarters of actually getting down to 30% cash and 70% going through traditional retail. So we're making that progress. It'll continue to flow through as we move on. You do raise a good point though regarding Q1 next year. I think Molly was alluding to this a little bit earlier. Things change in Q1 for every company and every brand. You typically see a dip in prescriptions just early on.
Speaker Change: and then in the quarter, that rebounds. So what I will say is, you know, we expect that it would probably be something that follows trends in the industry. We obviously have the blink RX cash option for patients as they need it. And, you know, that's the reason the dip happens is because
Speaker Change: Patients are either changing plans, or their deductibles are resetting. So there's a little bit of burden for patients early on. But what I can tell you, and I'll just leave it at this before I turn it over to Molly, is that's common for every company, but what I do feel certain about is 2025 overall is going to be a big growth year for us.
Speaker Change: We want to make sure that we're very confident in whatever guidance we put out as it relates to revenue, so we'll continue to monitor trends and make sure it's something, when we do put out guidance, that it's something we can feel very comfortable with. So at this point, for the rest of this year, we'll continue to reiterate that we feel comfortable with the current full year 2024 consensus.
Speaker Change: and any comment on the gross total math that we did?
first enabled.
Thank you.
So we are getting about 55-56% for retail.
Speaker Change: Yeah, gross to net, sure, yeah. As the other question asked, we expect to continue to stay within the range that we provided prelaunch, which was at that 50 to 65% discount. And as you point out, we're right within that range. We expect some volatility going into the beginning of next year, as we indicated, but I continue to believe we'll stay within that range.
that's all I need.
Speaker Change: Thank you. Our next question or comment comes from the line of Chase Knickerbocker from Craig Howell. Knickerbocker, your line is now open.
Chase Knickerbocker: Good morning and congrats on the you know really impressive continued progress here.
Chase Knickerbocker: So I guess just first for me maybe just starting on kind of primary care with you know obviously the nerd launch in the quarter.
Speaker Change: Do you feel like it's still very early days from a standpoint of kind of your awareness level within primary care? What are you seeing from a demand level there? And again, do you think it's very early days and you really haven't seen that boost from primary care yet? I would love your thoughts there, Martin.
Chase, so I'll tell you.
Speaker Change: We had always said that primary care was going to be a big player for non-erosive, and it's certainly coming true.
Speaker Change: You know, you hit on three pieces. One is awareness. We have seen awareness grow amongst primary care, and if you think about it, you know, as I mentioned earlier in my comments, when we launched, gastroenterologists knew about PCABS and they knew something was coming, and that was lesser primary care. So we've seen that general awareness of Oquesna, since our sales force has been in place, out-talking to physicians grow.
Speaker Change: We've also seen a pop in the number of PCP prescribers. Our new writers in primary care have actually overtaken the new writers in gastroenterologists. So they are welcoming Boquesna, and I can tell you actually having...
Speaker Change: met some of these physicians, they're actually seeing the results that Terrie mentioned earlier is that rapid uptake in the durability, or I should say the rapid effect in the durability, the symptom relief. So we're definitely seeing that boost and the boost will continue.
Speaker Change: Great, then maybe just a little bit Martin about how you're tracking success there with your sales reps any kind of
you know, specific metrics that you're...
Speaker Change: kind of comping them too, as far as that awareness level with PCPs or just kind of like ordering primary care physicians within their territories. And then the last one from me to Molly would just be kind of, I guess, thoughts on potential guidance for 2025. You know, when that time comes kind of early next year, do you think that you guys will be in a position from a visibility perspective into your business that you'll be able to give kind of 2025 full year guidance? Thank you.
Speaker Change: So I'll go I'll go first, Chase. So what we're doing with the Salesforce is, you know, we're working with them, obviously, in providing direction and then taking their on the ground feedback as to what's happening. But what we what we focus on is who are they seeing?
Speaker Change: and I can tell you across all of those metrics, we feel really good. And then we also just do general awareness tracking as most brands do our physicians or intended prescribers or targets aware of our brand. And as I mentioned earlier, that continues to increase including primary care.
Speaker Change: Yeah, so as it relates to Guides for 25, Chase, as you pointed out, we're seeing some really nice trends in the script data. We'll want to make sure that we've got really good visibility and competence in whatever range and guidance we provide. But because we're still so early in the non-erosive, it's only been on the market four months now, I would expect that we continue to want to see several more months of the trends and the impact of non-erosive before we put out the guidance. But certainly it's something we're focused on and something we want to make sure that we provide a range that we can achieve once we do.
Great. Thanks, everyone.
Speaker Change: Thank you. Once again, ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. Our next question or comment comes from the line of Umar Rafat from Evercore ISI. Your line is open.
Speaker Change: Hi, good morning. This is Chen Xiangtong for OMER. Congrats on the quarter. A few questions, if I may. The first one is, we've seen the fill rate increase from around 30% to 50% in the last few quarters. I know you're no longer reporting written prescription, but could you give more color on what is the trend of fill rate in this quarter?
Speaker Change: And secondly, there is a clear inflection on the 10 milligram dose after the NERD launch. I know it's still early, but currently how much of the total volume is from NERD indication. And lastly, about the IEP. So the QIDP.
Speaker Change: is tied on the molecule. So just want to confirm that even if you get the new indication on QIDP, it does not give you another five-year exclusivity. Thank you.
Speaker Change: Yeah, so we'll all go first. In terms of the fill rate, yeah, and you said it, you called it out, right? So at this point, we've dropped tracking that as a key metric that we're reporting out on. But what I can tell you is that
Speaker Change: we had always intended that to be a very temporary, as we shared with you all, metric that we would be reporting. Because at the time, it was the right thing to do because we only had 38% commercial access. And now there were, you know, in excess of 80%. We feel the key metrics to look at are both the access, the growth in TRXs, and the growth in prescribers. What I can tell you is that the physician prescribing continues to grow to levels that we feel really good about and are consistent with successful launches. So hopefully that answers that. And then the 10 milligram inflection, I'm not sure I got the entire question, but we definitely have seen, upon approval of nonerose that an immediate uptake of the 10 milligram.
Speaker Change: I will remind you that 10 mg can also be used for non-erosive, but we also know that it's tied specifically to non-erosive, and it's really, we believe, making up the majority. We don't have a tieback specifically yet by ICD-10 codes, but we feel it's tied directly to non-erosive.
Terrie?
Speaker Change: And then regarding the regulatory exclusivity, so the five years for an NCE was for the Verquezna moiety and then the five years for QIDP is applied to the Verquezna chemical entity, so that's ten years to get to 2032.
Okay, thank you.
Speaker Change: Thank you. Our last question comes from the line of Matthew Caulfield from H.C. Wainwright. Mr. Caulfield, your line is now open.
Hey, good morning guys. Can you hear me okay?
Thank you.
Great, thank you, and congrats on the commercial progress.
Speaker Change: Just one follow-up from us. So thinking more broadly, are there any observations from the H. pylori side of the label? Clearly that's a smaller part of your focus, understandably, but has there been any change in prescriber engagement versus standard of care, and even as a potential gateway to getting those same patients ultimately onto erosive or non-erosive prescriptions?
Thanks a lot.
Yes.
Speaker Change: So, yeah, to answer the question on H. pylori, it's important for our business, but clearly the GERD market is so large that we tend to focus on that. So, I would say that what really works for H. pylori
Speaker Change: kind of ties into your last part of your question, is the benefits for GERD. It's that it really demonstrates that it's a potent acid suppressant.
Speaker Change: And that, when we speak to physicians, we tend to tie that message in so it has an ultimate payoff of the overall mechanism of action. So that's how it's tied into non-erosive, and there are some patients afterwards.
Speaker Change: when they are healed or their infection is eradicated, that might flip over to be a non erosive patient if in fact they continue to have GERD.
Speaker Change: But in terms of physicians, we do see that there are physicians who are starting to adopt H. pylori as their preferred treatment, that they are using both the dual and the triple pack. So I think it's made a welcome addition, and I think it's the differentiation that the Quesna brings to the treatment of H. pylori that is driving that.
Thank you very much.
Great, very helpful guys. Thank you and congrats again.
Speaker Change: Thank you very much. This concludes the Q&A session. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone have a wonderful day.
Speaker Change: and toward the flood lights It breaks my heart He can't fix It breaks my heart It breaks my heart
Speaker Change: and no no no no no no no no no NO NO NO
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Speaker Change: Based on the autobiography by Ernie Gardner Written and directed by Harold Cruz
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vocalist, technician, and artist.