Q4 2024 Phathom Pharmaceuticals Inc Earnings Call
Speaker Change: Hello, and welcome to the Phathom Pharmaceuticals fourth quarter and full year 2024 earnings results call.
Speaker Change: At this time, all participants are in a listen only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again.
Please be advised that today's call is being recorded.
Speaker Change: With that, I would like to turn the conference over to Eric Sciorilli, Phathom's head of investor relations. Please go ahead.
Speaker Change: Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Staten's fourth quarter and four year 2024 results. This morning's presentation will include remarks from Terrie Curran, our president and CEO , Martin Gilligan, Archive Commercial Officer, and Molly Henderson, Archive Financial Officer.
Eric Sciorilli: Azmi Nabulsi, our chief operating officer will also be joining the team during the Q&A portion of today's call.
Eric Sciorilli: 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.
Eric Sciorilli: A copy of that press release can be found under the news releases section of our corporate website.
Eric Sciorilli: Further, the recording of today's webcast can be found under the events and presentation section of our corporate website.
Eric Sciorilli: Before we begin, let me remind you that we will be making a number of forward booking statements throughout today's presentation.
Eric Sciorilli: He's followed looking statements involved risks and uncertainties, many of which are beyond
Eric Sciorilli: Actual results can materially differ from the forward looking statements. Any such risks can materially adversely affect the business, the results of operations, and the trading prices for thousands come and start.
Eric Sciorilli: The discussion of these statements and risk factors is available on the current safe harbor slide, as well as in the risk factor section of today's 1-10 kit.
Speaker Change: All forward-looking statements made on this call are based on the beliefs of Thadam as of this date, and Thadam disclaims any obligation to update these statements. With that, I will now turn the call over to Terrie Curran, Adam is present in the EO. Take a guess off. Terrie.
Terrie Curran: Thank you, Eric, and thank you to all those joining us on today's call and excited to report on the great progress we made during 2024 and the work that's underway to ensure 2025 is a year of strong growth.
Terrie Curran: Throughout our first full year of product availability, we reported many accomplishments and consistently exceeded expectations.
Terrie Curran: Most noteworthy with secured board commercial access, launched a full-scale consumer campaign and received FDA approval for non-erosive goods.
Terrie Curran: As I reflect on the past year, it's clear that we've built a strong foundation with each of our accomplishments serving as key building blocks.
Terrie Curran: Feedback from positions, testimonials from patients, and continued demand give us confidence that the weather is a game-changing product and they will successfully bring it to market.
Terrie Curran: We're proud of the work we've done so far, but this is just the beginning. We'll continue building off this strong foundation and focus on pivotal growth drivers in 2025. We fully believe that the clinic can reach blockbuster status.
Terrie Curran: Importantly, our launch data reinforced this story, commercial coverage has held consistently above 120 million lives.
Terrie Curran: with the majority of these lives being able to access the prisoner after stepping through only one generic PTI prescription, a pre-satisfied criteria for most acid reflux patients.
Terrie Curran: and, with either 300,000 descriptions filled today, the poultry from this coverage is evident.
Terrie Curran: Without a doubt, the non-erosive approval sparked an inflection in our launch, and we believe that the momentum will continue throughout 2025 and beyond.
Terrie Curran: Looking more broadly at Phathom's future, there is so much to be excited about related to our ongoing launch and upcoming development goals.
Terrie Curran: On the commercial front, we will continue to invest with the objective of making the quesna a household name.
Terrie Curran: The prolettes physicians and patients think of when they think of happening.
Terrie Curran: In fact, I'm pleased to share that we'll soon be rolling out an exciting new consumer campaign, expanding upon the quesna kin kick some acid, and am that further enhancing brand awareness.
Terrie Curran: In parallel, ourselves forth, we focused on reaching primary care physicians who are the largest group of good treaters.
Terrie Curran: We build amazing awareness with GIs, but PCPs are where we can make a big difference.
Terrie Curran: Every year there are hundreds of thousands of PCPs who write PPI's for their patients.
Terrie Curran: We're seeing adding the quizzes to their toolkit to materially help the way they treat good.
Terrie Curran: For now, we're focused on driving roads by calling on the highest volume PCTs with increased frequency.
Terrie Curran: Our reps are working to ensure these positions recognized by the Clevver Brand, understand the clinical benefits, and know that the access process is often as easy as checking a box.
Terrie Curran: We believe this is the path to displacing PPI's, and that will share more on these efforts later in the call.
Terrie Curran: On the development front, we've always viewed the equipment as a pipeline and a product. And we believe Eeson Affilico-Sophagitis, or ELE, can be the next indication to expand the label. In fact, we recently finalised the phase 2 design with the FDA.
Terrie Curran: This is a space we're excited about because we think the president can make a difference [inaudible]
Terrie Curran: EOA is a chronic employment tree condition of the Asophagus, which is drawing increased attention from the medical community as both the incidents and prevalence of growing in recent years.
Terrie Curran: Although compared to good ELE is a smaller market, we believe it could be a unique opportunity given the importance of the condition, the need for lifelong management and the overlap with the Guestor Entrology market.
Terrie Curran: Patients with AOE usually present with heartburn symptoms and difficulty swallowing. The unmet needed significance given the current treatment options are limited.
Terrie Curran: Although an approved corticosteroid and biologic offered two options, TBI's continue to be first blind therapy, despite not being approved this indication.
Terrie Curran: The rationale is that PPIs are meant to reduce the sovideal inflammation and neutralize acid
Terrie Curran: Based on this, we believe the potency of the questioner, they potentially provide an alternative first-line therapy, ahead of PPI, biologics and corticosteroids.
Terrie Curran: Our study will be the first large, well-controlled study in A&E for either acid-secretary class, PPIs or PCAMS.
Terrie Curran: It will include approximately 150 subjects with both adult and adolescent segments.
Terrie Curran: Equestrian's Effort to See Will Be Compared to Buscebo, and we anticipate the top line readout in 2027.
Terrie Curran: Although data on the efficacy of PKADS for ELE is limited, reviews of retrospective data from Japan show the promise that not presents potential impact.
Terrie Curran: Recently, we've also been working on the development of an hourly disintegrating tablet for ODT formulation for the question.
Terrie Curran: This is another key color to our development strategy that complements the work we are doing in ELE.
Terrie Curran: Once available, an OTT formulation could present a root of administration more desirable for patients with difficulty swallowing, which is the core symptom among most suffering from ELE, and also a common among pediatric and elderly patients. [inaudible]
Terrie Curran: Additionally, an ODC formulation offers the opportunity for new intellectual property potentially further protecting the brand.
Terrie Curran: An ODC formulation could be a longer term source of differentiation from over-the-counsive equation of product. In fact, we believe the equation is uniquely suited for a prescription over-the-counter or ODC switch.
Such an if you could create a long-term, durable revenue stream.
Terrie Curran: The total OTC asset control market generates approximately $3 billion in annual sales.
Terrie Curran: PPI specifically account for roughly a third of those sales with branded products making up about 35% of the corresponding PPI unit volume.
Terrie Curran: We believe the question is rapid, potent, and durable asset suppression profile supports the potential to capture market share by providing rapid and complete heartburn relief as needed.
Terrie Curran: However, there's work to be done before we can achieve that vision. Throughout 2025, we'll be analysing your teaching market opportunity and developing our long-term strategy.
Terrie Curran: Separately, we're exploring real world data to understand the prevalence of good symptoms among the increasing wave of GOP1 users and the utilization of as in suppressants to relieve such symptoms.
Terrie Curran: Our review will help us to determine if further efforts are warranted to evaluate the potential of the equipment revived relief to those patients.
Speaker Change: Before turning the call over to Martin, I'd like to take a moment to mention our active citizen petition to the FDA and potential outcomes.
Speaker Change: On December 11, 2024, we submitted a citizen petition for CP to the FTI requesting that they update the orange book.
Speaker Change: to reflect a 10-year period of new chemical entity exclusivity for our 10 milligram and 20 milligram bottles.
Speaker Change: based on the fact that the underlying drug substance across all the clothing products contains the same new active moiety for not present.
Speaker Change: We continue to feel confident in the strength of our legal position as outlined in the CP.
Speaker Change: We are now just about halfway through the 180-day period, the FDA's review and provider response.
Speaker Change: If the FDA grants us DP on or before the June deadline, we expect the orange book to be quickly updated to reflect regulatory exclusivity through May 2032 for all the equivalent of products.
Speaker Change: However, even in the case where the FDA rules against our CP request, we are equally confident in our patent position.
Speaker Change: Our composition of matter-patent is strong and we expect its expiry will be extended to at least mid-2030, pending the granting of our requested patent to an extension under the Hatch-Wexman Act.
Additionally, we have a separate pattern to represent formulation. So, this is the formulation.
Speaker Change: Lastly, on the financial side, Molly will further detail our fourth course of 2024 results later in the call, for which we reported net revenues of 29.7 million and ended with 297 million in cash.
Speaker Change: We remain confident that our balance sheet and the available capital under our dinner agreement can support the investment needed to pursue our launch and development plans.
Speaker Change: In 2024, we build a strong foundation. We are now leveraging our commercial and development expertise to grow the launch and continue exploring new opportunities for the quid in the franchise.
Speaker Change: We're here at Phathom of Passionate Resilient and Determined to Deliver on the Queensland's blockbuster potential. We're just getting started and excited by the opportunities that lie ahead in 2025.
Speaker Change: I'll now turn the call over to Martin to provide further details on our recent commercial updates, Martin.
Speaker Change: Thanks, Terrie, and hello everyone. As you've heard Terrie mention, we are extremely happy with the progress we made in 2024. Our results continue to prove we're successfully executing on our strategy, and I'm incredibly proud of the Thadam team.
Speaker Change: Launching the drug is hard. Launching a retail focused drug and disrupting a massive, genericized market is even harder. However, that is what we set out to do and I believe we're doing it well.
Speaker Change: I will begin with sharing updates in our key performance metrics since we last spoke. However, today you will also hear me share a few additional data points that highlight new information we've learned from being on the market for a little over a year.
Speaker Change: I'd like to note ahead of time that not all of these are necessarily metrics that we will share on a recurring basis. However, we feel they are important to share at this stage to provide a view into 2024 results.
Speaker Change: Starting with the latest on the present prescriptions, we have now surpassed 300,000 scripts filled by patients from launch through February 21st.
Speaker Change: Over the 17 weeks since our last report, this figure has more than doubled displaying growth of approximately 110%.
Speaker Change: And the fourth quarter specifically, we recorded approximately 118,000 fills with question prescriptions, equating to a growth of over 70% compared to our third
Speaker Change: As always, these figures include volumes filled through retail pharmacies, which are captured by Acuvia, as well as those filled through BlinkRx, one of our patient assistant programs.
Speaker Change: Consistent with previous quarters, the proportion of scripts in Q4 flowing through retail pharmacies and captured by Accuvia continue to increase now reaching a approximately 75%.
Speaker Change: As we begin 2025, it's worth noting that branded products typically experience seasonal slowness to start the year.
Speaker Change: The effects of holidays, patient health plan changes and deductible resets are felt industry-wide
Speaker Change: As such, we anticipate the impact from these events will reflect historical trends as it relates to Q1 field script growth and the ratio of retail field prescriptions.
Speaker Change: That being said, we believe previous trends will quickly return after the first couple months of the year.
Speaker Change: Furthering this belief is the fact that we have seen total demand continue to increase over the last two months.
Speaker Change: To us, this signals a growing opportunity to fill book business scripts, which we believe should materialize after the standard volatility in early year fulfillment diminishes.
Speaker Change: Separately, we've also been monitoring Book President's refill rate. Amongstrips filled in the fourth quarter, we observed about 70% being filled by patients continuing Book President Therapy. [inaudible]
Speaker Change: They said where we are in launch, I'm pleased with this ratio, especially considering we're attracting in line with other successful launches.
Speaker Change: It implies that patients are initiating because of treatment and remaining on therapy. In fact, what gives more confidence is our preliminary duration of therapy analysis which complements these refill patterns.
Speaker Change: Now that we're a year into the question of availability, we've had the chance to monitor usage among some of our earliest cohorts of patients.
Speaker Change: Specifically, we looked at patients who initiated therapy on the 10 milligram or 20 milligram in the second quarter of 2024 and tracked the number of bottle prescriptions they filled over the subsequent six months.
Speaker Change: In that time frame, an average of 3.5 equipment prescriptions were filled, implying a run rate above pre-launch expectations.
Speaker Change: Again, paired with refill data, this is very encouraging. We are seeing patients initiate treatment and continue on therapy in line with PPI usage.
Speaker Change: This very early data is sourced from a relatively small sample given the proximity to launch, but we're happy with the preliminary results, and we plan to continue monitoring patients, persistency and compliance over longer periods.
Speaker Change: In parallel, the total number of physicians who have written the field script has increased to over 20,000 as of February 14, compared to over 13,600 as of our last report, demonstrating continued adoption among new writers.
Speaker Change: Through the end of Q4, about 17,800 cumulative prescribers have written a filled request of prescription of nearly 45% Q3.
Speaker Change: In addition to the growing number of writers, we're equally excited about the proportion who continue to write Vocuesna signaling their positive experience among all Vocuesna writers about 75% have written more than once. We're really excited about the proportion of Vocuesna's positive experience among all Vocuesna writers about 75% have written more than once.
Speaker Change: From physician feedback and patient testimonials, we know that a question is having a positive impact on patient slides.
Terrie Curran: This repeat writer's statistic validates that once positions begin for Scrabbing Book Buzna, they continue writing As Terrie said, our goal is to bring on more new writers to continue this pattern and we believe focusing on primary care is a clear path to achieving this
Terrie Curran: As we think about the book, Pleasant Opportunity, PCPs are the area where we can drive the most growth and we are determined to increase adoption among this group.
Terrie Curran: In fact, we're starting to see writer trends shift, especially following the approval of Non-Aros of GERD.
Terrie Curran: Our market research shows that primary care awareness of a question that has almost doubled since the launch in mid-July and just recently we observed a total number of cumulative TCP writers surpassed the total number of GI writers.
Terrie Curran: We knew this would be the case, given the difference in population sizes and the skew of our target panel. However, to see it come to fruition so quickly after the non-arosa launch is encouraging.
There is still more work to do on this front.
Terrie Curran: Right now, although smaller in size, our G.I. base makes up the majority of total rating.
Terrie Curran: By focusing on primary care, we aim to increase both the number of writers and the frequency of their writing Ultimately, our goal is for the volume being written by PCPs to surpass that of GIs
Terrie Curran: Meanwhile, the ability of patients to access Buchezna and an affordable price when their physician rights is equally important. On the commercial front, despite the usual shifting of formularies to start the year, Buchezna remains above 80% covered, equating to over 120 million lives.
Terrie Curran: On the Medicare and Medicaid front, we continue to have limited coverage, but we're working on ways to enhance access for government patients.
Terrie Curran: Importantly, we remain pleased with the quality of our commercial coverage.
Terrie Curran: For the majority of covered lives, we have secured access subject to a single step through a generic DTI prescription.
Terrie Curran: In practice, this takes the form of a simple PA or prior authorization, and we are working to educate prescribers on this process.
Terrie Curran: New branded products are often expected to be difficult to access. We want to disrupt that perception, whether it be through the completion of a simple TA or the use of BlinkRx, our patient assistance program, we are working to help physicians understand how easy it can be to get bookwesna to the commercial patients.
Terrie Curran: The communication of this message by our Salesforce, especially to PCP's, is a key focus area for 2025.
Terrie Curran: In the meantime, we've been pleased to see that a presence place in therapy so far is exactly where we plan. Among a representative sample of a
Terrie Curran: This is evidence that a quesna is not being reserved only for patients that have tried and failed multiple PPI's.
Terrie Curran: Physicians are thinking of Apple Quesna as an early alternative to PPI's as opposed to exhausting all possible options.
Terrie Curran: This aligns with a formulary positioning and this one step market segment is not small by any means.
Terrie Curran: On the consumer front, it is equally important to have patients aware of the brand and to motivate them to ask their doctors for a quesna.
Terrie Curran: This is one of our top priorities in 2025. Our initial investment in the book, the Equasinist can check the massive campaign is working.
Terrie Curran: Since its televised launch in April last year, there's been a 55% growth in the proportion of positions who report receiving a request for Vokvezna.
Terrie Curran: And among physicians aware of a quesna, our market research indicates that nearly three out of four are likely to write a prescription at the ask by a patient
Terrie Curran: Based on this data and other internal metrics, we have chosen to increase our investment in DTC efforts, especially in the first half of 2025. We are doubling down a consumer brand awareness. Our investments will focus on ensuring that our reach and frequency is comprehensive.
Terrie Curran: Additionally, we are working on an exciting new campaign that will further enhance our powerful messaging and distinctive look by leveraging a unique real book questioner patient to drive greater engagement in demand.
Terrie Curran: We are planning to go live on digital media in the next few weeks and anticipate reaching broadcast TV early in the second quarter. And stay tuned, we expect there to be some buzz
Terrie Curran: Overall, we feel our early launch performance has been impressive, and we're looking forward to growing demand in 2025.
Terrie Curran: We have several key focus areas, increasing primary care adoption, ensuring awareness of the simple PA process, and expanding DTC promotion. We believe these will be pivotal drivers of growth, the foundation is set, and now we push for acceleration on the heels of the nonarrows of launch.
Terrie Curran: I'll now pass it off to Molly to walk through our financial results Molly Molly
Molly Henderson: Thanks, Martin. Hello, everyone, and thanks for joining us. I'm pleased to share our fourth quarter until year 2024 financial results with you today.
Molly Henderson: Similar to previous quarters, I'd like to note that I will be commenting on both gaps and non-GAAP financial measures.
Molly Henderson: Supporting schedules with detailed reconciliation 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.
Molly Henderson: Turning to our results. For the fourth quarter, 2024, we reported net revenues of 29.7 million, which represents a sequential quarter-over-quarter increase of 81%.
Molly Henderson: Strauneple, Pleasant Demand, resulting from the approval of non-arrows of Guards last July was one of the primary drivers of our growth.
Molly Henderson: For the full year, 2024, we reported net revenues of $55.3 million. Most notably, during each quarter of 2024, we saw strong revenue growth, and we are pleased with our financial results from the first full year of launch of a growth of GERD and partial year launch of a non-a growth GERD. And we are pleased with our financial results from the first full year of launch of a non-a growth GERD.
Molly Henderson: Regarding growth to net, discount rates are once again in line with our expectations we set forth pre-launch. The last three quarters of 2024 are a growth to net discount approximated 57%.
Molly Henderson: Based on this trend, resetting deductibles and evolving payer rebating levels over time, we are narrowing the range of our GTN discount rate guidance to be between 55 and 65% for 2025.
Molly Henderson: For the quarter ended December 31, 2024, we reported gross profit of 25.8 million, which equates to gross margin 87% and increase of 155 basis points over the third quarter.
Molly Henderson: For the full year, we reported gross profit of 47.3 million and a gross margin of 86%.
Molly Henderson: Moving down the PNU for our average expenses. For R&D, we reported gap expenses of 8.6 million for the fourth quarter, which represents a 36% decrease compared to this period in 2023.
Molly Henderson: The year-over-year change is driven primarily by lower stock-based compensation expense in 2024, compared to the fourth quarter of 2023, which included a one-time investing event for performance shares tied to the erosive herd approval.
Molly Henderson: As for SGNA, we reported gap expenses of 76.7 million for the fourth quarter of 2024. This represents an increase in 19.7 million compared to the fourth quarter of 2023, primarily driven by the ongoing expansion of our commercial efforts in support of the Poisona launch. [inaudible]
Terrie Curran: As for our projected operating expenses for 2025, there are a couple items to keep in mind. As Terrie mentioned, we plan to initiate our phase to East Nephila, Cassava,
Terrie Curran: We anticipate this trial and other investments in life cycle management opportunities will lead to increased R&D spend throughout the year.
Terrie Curran: and on the SNA side, you heard Martin talk about the positive impact our DTC campaign is having on brand awareness.
Terrie Curran: and the first staff of 2025 who plan to increase our investment to support the expansion of these DTC efforts.
Terrie Curran: In the second half of the year, we will evaluate the effectiveness metrics from the enhanced campaign to inform our continued capital allocation strategy in this area.
Terrie Curran: Overall, with the initiation of the EOE trial and growing DTC efforts, we are estimating our non-GAAP operative expenses for 2025 to range between $360 million and $390 million for the full year.
Terrie Curran: We anticipate the split between R&D and SG&A will be similar to 2024 for R&D accounted for about 10% of the total spend compared to SG&A's 90% contribution.
Terrie Curran: We have provided non-GAAP fund guidance as we believe it provides a more transparent view in the inter-anticipated use of cash.
Terrie Curran: As for EPS, we reported get net loss for the fourth quarter, 24 of 74.5 million, or $1.5cent loss per share compared to 79.6 million, or $1.39cent loss per share for the fourth quarter of 2023.
Terrie Curran: Nan Gapaget, Nalboss, for the fourth quarter, 2024, with 56.4 million, or 79 cent loss per share, compared to 46 million, or 80 cent loss per share, and the fourth quarter of 2023.
Terrie Curran: Similar to previous quarters, the most significant reconcelling items between Gap and Nong Gap operating expenses was non-cash stock-based compensation.
Terrie Curran: Other non-GAAP , reconciling items include non-cash interest on our revenue interest financing liability, and non-cash interest expense related to amortization of debt discounts.
Terrie Curran: Turning to cash. As of December 31, 2024, cash and cash equivalents were 297 million. Up to an additional 100 million from our desperately remains available this year, subject to the achievement of certain revenue milestones.
Terrie Curran: based on a current operating plan, estimated product revenues, and funds available under our term loan, we remain confident that we have run right through cash flow positivity.
Lastly, Looking ahead to 2025 Revenue.
Terrie Curran: As is common in our industry, we note that the first quarter is often a soft quarter. This dynamic stems from lingering impacts of holidays, a shortened month, patient health plan changes, conductual resets, and working through year and stockings.
Terrie Curran: Specifically, as it relates to inventory, we've known an elevated level of stocky buyer wholesalers at the end of 2024.
Terrie Curran: Approximating about three weeks of inventory on hand compared to the typical two weeks we've been seeing.
Terrie Curran: As a result of all these dynamics, we are anticipating soft and first quarter revenues, but on a full year basis, we are comfortable with a current 2025 consensus revenues of approximately 155 million.
Terrie Curran: Overall, we are pleased with our 2024 financial results and look forward to leveraging our strong foundation to ensure a successful 2025.
Terrie Curran: They continue to view Vocaisna as a blockbuster opportunity and we are allocating capital strategically to recognize this vision.
Terrie Curran: With investments in our pipeline, expanded DTC marketing and ongoing position promotion we are excited about Batham's future. We look forward to keeping the market updated and our progress throughout the year.
Terrie Curran: With that, I'll turn the call back over to Terrie for closing remarks. Terrie?
Terrie Curran: Thank you, Molly, and thank you again to everyone joining us on today's call. With the great progress of 2024 in the review, we look forward to all that's ahead in 2025.
Terrie Curran: Our focus is on leveraging our highly experienced teams to drive growth.
Terrie Curran: From a commercial perspective, we plan to further disrupt the GERD market with our large established field course and expanded DTC efforts. And on the development front, we're excited to investigate new indications and formulations with the goal of better setting patients with acid-related disorders.
Terrie Curran: So now, I'm filliering the path to pick the quiz and adoption is our top priority.
Terrie Curran: Based on the tremendous feedback we're hearing from patients and physicians, we believe we're on track to to place PPI's in this very large market.
This is an element we think is currently being underappreciated.
Terrie Curran: The dynamics of the good market, the quevenous benefits of the patients and the importance of commercial execution have not changed.
Terrie Curran: Our story remains time to delivery, and we are prepared to demonstrate continued success in 2025.
Terrie Curran: With the Non-Arosing Good Lord still in its early days, this is just the beginning of our journey.
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: As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Our first question comes from Yatin Suneja with Guggenheim
Yatin Suneja: Hey guys, thank you for taking my question. Two questions from me. First one is on this citizen petition. Could you maybe help us understand the timelines around it?
Yatin Suneja: I think our understanding is in June , but given some of the political stuff happening at the FDA, the FDA has to sort of give you an opinion by June , so that's one.
Yatin Suneja: and then if in a scenario the decision doesn't go in your favor, what are certain options that you have?
Yatin Suneja: The second one is on Q1 specifically. Thank you for flagging the inventory in land and other dynamics.
Yatin Suneja: But just to confirm, you do expect growth in Q1, that it took Q4, or are you trying to imply that it could be a downquarter. Thank you.
Terrie Curran: Thanks, your turn. It's Sherry here. I'll take you first question on the CP and then I'll hand over to Molly regarding Q1.
Terrie Curran: So, with the CP, we submitted, you're correct, we submitted in December , so the timeline there is 180 days within that timeline, the FTA is required to respond to us, so we anticipate.
Terrie Curran: Are a response from them on that day or if not before the hundred and only days.
Terrie Curran: We don't see the changes within the FTA impacting that timeline.
Terrie Curran: We're very pleased with the progress that we're making on the CP. It's as expected, we're proactively involved with key influential stakeholders in Washington and industry groups and we're also pleased to see on the CP Docket.
Terrie Curran: that we have posts from KOLs as well as industry and patient groups so...
Terrie Curran: Very pleased with the progress we're making and remain very confident. Thank you very much.
in that petition. [inaudible]
Terrie Curran: If it does not go as anticipated, we will evaluate next steps but most likely pursue litigation as we believe we have a very strong legal position.
Terrie Curran: Sure, hi, Yatin. Sure, as it relates to Q1, as we've been signaling that industry dynamics certainly point to a softened Q1. We haven't provided any more specifics, but I think it's safe to assume we're still two thirds through the quarter. So we have some more work to do, but it's safe to assume that it will be a bit softer than obviously industry as it industry is showing. So we're still two thirds through the quarter. We're still two thirds through the quarter. We're still two thirds through the quarter.
Dr. Raffat, Dr.
Our next question comes from Joseph Stringer with Needham.
Joseph Stringer: Hi, good morning. Thanks for taking our questions. For the Phase 3 on-demand trial, when do you think you'll have enough real-world data to make a go-no-go decision there and when can we potentially anticipate an announcement on this? [inaudible]
Thanks.
Speaker Change: Yes, yes, thanks, Joey. We're continuing to evaluate the real world utilization of the Equipment Area on demand as well as.
Speaker Change: The publication of white papers and guidelines that are already starting to incorporate the utilisation or recommendation of the quesner as an on-demand option because of its profile.
Speaker Change: So, I would say by mid-year we'll have enough information to make a decision and determine whether we proceed with that study.
Our next question comes from Annabel Samimy with Steeple.
Speaker Change: Thank you for joining us. Thank you. Have a great day.
and other campaign, and then think about the...
Speaker Change: Cash and, I guess, runway to profitability and how this is all balanced at what point do you pull back on some of the DTC to sort of drive the profitability, I guess, and some timing around that is possible.
Morgan Annabel, Martin
Speaker Change: I guess one thing I just want to clarify in your question is…
Speaker Change: The campaign is an evolution of our current campaign, so what it tells us is that we've got a super strong campaign that's really motivating patients to go in and ask
Speaker Change: Physicians, Four Request, no matter the fact, we've seen a 55% increase in the number of physicians who have received requests, and as I said earlier, about three out of four will grant faith solely on that request.
Speaker Change: So it's told us that the combination of the sales reps that are creating demand.
Speaker Change: The Growth in Primary Care Prescribers that have now passed cumulatively GI and patients going in that it's the right time to invest in DTC. We know it's reaching the intended audience.
Speaker Change: We know that it's motivating them to take action, and what we're doing is we're monitoring things such as impact on TRXs, as I mentioned before, request rates and those still rates.
Speaker Change: So it's definitely the right time. We've got a great campaign coming up that will really be an evolution and creatively take it to the next level.
Investment from a DTC perspective.
Great. Thank you.
Thank you.
Our next question comes from Christine Kluska with Cantor Fitzgerald
Kristen Kluska: Good morning. Can you please speak to some of the early metrics you're seeing on refill trend and usage for nerd specifically now that you have a few more months of sales under your belt and how you might also anticipate that moving forward is more awareness is out there? Yeah.
or happy to take that, Christine.
Speaker Change: So first let me take the refill and then I'll, you know, address the part about non-erosive because definitely it's connected. Excuse me, it's still very early and I often have to remind myself that we're only.
Speaker Change: 7 months into launch and non-erosive. But we are absolutely right where we should be in this stage of launch.
Speaker Change: I had given some specifics earlier in my comments about our refills but when we look at that we compare that to other small molecule chronic medication refills.
Speaker Change: and we're right where we need to be in terms of tracking to that. And the other thing that makes us feel really good is we believe we're tracking to the persistency and it's in line with PPI's. You know, we always set prior to launch at the PPI's what we know. There are total days of therapy on an annual basis or 140 to 160.
Speaker Change: Day of the Year, and given the information I shared previously, we're tracking directly towards that.
Speaker Change: Now, contributing to that is the combination of both the roasts of Ann Nano-Rosive.
Speaker Change: What I'm happy to share is that we're seeing consistent refill rates amongst the 10 milligram and the 20 milligram .
Speaker Change: The 10 milligram can be used and is used for maintenance, but we know that there was a
Speaker Change: Significant increase in 10 milligram is growing even faster than 20 milligram because of the non-erosive so we see the two going hand in hand and we're actually getting feedback from physicians that tell us that their patients are doing so well that they're continuing.
Speaker Change: So I think I answered everything, the refills as well as how it's tied to Non-Arosive.
Thank you.
Our next question comes from Umer Raffat with Evercore [inaudible]
Speaker Change: Oh, hey, good morning, Mr. Zhunxiang, Arthur Omer.
Speaker Change: Thank you so much for taking our question and also thank you for providing additional data points. It's really helpful.
Speaker Change: I think just want to focus on the new patient's start number. So if you look at the NBRX data, it's kind of stabilized around 2000 every week since I think October last year, and with the new consumer campaign, what should we expect going to this year in 2025? And on that point, how important is the blink ARX right now considering the coverage has improved and over 80 percent?
Um, yeah, so again, this is Martin and I'll take a. Like, uh,
Speaker Change: I think I'll do those in order. The first one regarding the NBRX, we are definitely seeing an increase in new patient starts and what we're able to see
Speaker Change: are not only new patients going through retail slash acuvia, but also patients who are going through link Rx.
Speaker Change: So the combination of that tells us that there's definitely an increase in growing new patients who are starting up a quesna I will just refer back to as Molly was referring to earlier as with every brand it's not unique to a quesna there is some softness during q1
Speaker Change: but we feel that new patients are coming on board and one of the drivers as I mentioned earlier and you put into your question was regarding the DTC and the consumer driving that.
Speaker Change: So we believe it's a combination of a couple things that are increasing the new patients or NBRXs, it's a combination of new primary care doctors who are starting to adopt
Speaker Change: We're seeing increase in number of physicians on a weekly basis. We're also seeing physicians do reputers are prescribing on more patients, and then lastly the consumer going in and asking
Speaker Change: I might have, I'm not sure if I answered everything, I might have missed the specifics of your blank question.
with the importance of blank. So I would say blank remains. [inaudible]
Speaker Change: Very important for us. We brought a link on board specifically to make sure that we're supporting patients.
It's been a very good experience.
Speaker Change: and it's very much focused on our commercial patients and what the intent is to get commercial patients on Book President as a physician intended. We also see that when a patient goes to blink our ex, they're more likely to have increased refill. So overall it's been a great partnership and physicians have been adopting it widely.
Thank you so much.
Our next question comes from Paul Choi with Goldman Sachs.
Paul Choi: Thank you. Good morning and thanks for taking our question.
Paul Choi: I want to ask about the ODT formulation that you're developing and just with regard to the IP strategy, would you initially seek the pediatric extension that would come with that potentially first or would you likely see the formulation patent issued first?
Paul Choi: There, just any clarity on sort of the sequence of how that would be developed would be helpful. And then my second question is
Paul Choi: Molly's earlier comment on the roughly 57% growth to that. You may just remind us which channels are being included in that calculation, is that excluding free drug, any other or specific channels just helping us understand that.
Paul Choi: Relative to your guidance to range of 55 to 65% would be helpful. Thank you very much.
Yeah Paul, I'll take the… I'll take the…
Paul Choi: I'll take the patent question. They're independent of each other. So the OGT has broader obligations and just pediatric because it can be used in the OE on demand as well as
Paul Choi: as a pediatric, but also for OTC as well. So they will be running in peril. So I see a scenario where we attain the patent.
for that formulation before the society.
Speaker Change: Anything that goes through retail slash IQVIA, it's at the WAC price, which is now a little over $680 a bottle versus the Blink channel, which has a WAC price of $50.
Speaker Change: So it's important that you use those two dynamics. You can actually get pretty close to that 57% that we reported. So I would say that's the most important element of calculating growth in that free. Some of the samples and so forth do not go through. That's more of a marketing expense. So the lion's share of what you see in growth in that is really the rebating as well as the whole Taylor Disgums.
[inaudible]
Speaker Change: Okay, great, thanks for that. If I could just ask a quick follow up for the ODT, what that in your best estimate would sort of potentially take the IP out to? Okay.
Speaker Change: Well, I mean, it will be a full protection. That will be in, you know, 20 years or so.
Speaker Change: Again, I cannot be so specific because we're working on this matter now, but it will be a full protection for the formulation for different aspects, the multiple aspects of the formulation.
Okay, great. Thank you.
Our next question comes from Matthew Caufield with H.C. Wainwright
Matthew Caulfield: Hey, good morning guys, and thanks for the updates. Just quickly from our end. For those new prescriptions, would you say any greater potential resistance comes from prescriber acceptance of the novel mechanism itself or any remaining initial coverage pushback at this stage? Thanks again.
Matthew Caulfield: Interesting question, Matt. No, I think, and even resistance, I'm not sure we get resistance at all to Boquesna.
Matthew Caulfield: I mean, they're really welcoming the new mechanism. They recognize immediately that it's different than a PPI and that it has definitely a place in therapy. I think what you see is as we bring on more primary care physicians. I think it's different.
Matthew Caulfield: What you see over time is they first need to get a couple patients started to have their first experience and then what we hear from the physicians is they start repeating back to us the story and the stories that we're hearing are really tied to two things is and it's all rooted in the rapid potent durable profile is that how quickly it worked.
Matthew Caulfield: and that it actually lasted the full 24 hours in the patients to having a real life-changing experience being able during the night to last through night without any heartburn or disruption.
That's helpful, thank you.
I'm showing no further questions in queue at this time.
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Matthew Caulfield: This documentary focuses on the protection of marine environments and the United States Marine Conservatism. For more information visit www.naranglen.com
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