NASDAQ:PHAT Phathom Pharmaceuticals Q1 2024 Earnings Report $2.76 -0.60 (-17.86%) Closing price 05/2/2025 04:00 PM EasternExtended Trading$2.81 +0.05 (+1.81%) As of 05/2/2025 07:58 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Phathom Pharmaceuticals EPS ResultsActual EPS-$1.42Consensus EPS -$1.43Beat/MissBeat by +$0.01One Year Ago EPSN/APhathom Pharmaceuticals Revenue ResultsActual Revenue$1.91 millionExpected Revenue$2.76 millionBeat/MissMissed by -$850.00 thousandYoY Revenue GrowthN/APhathom Pharmaceuticals Announcement DetailsQuarterQ1 2024Date5/9/2024TimeN/AConference Call DateThursday, May 9, 2024Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Phathom Pharmaceuticals Q1 2024 Earnings Call TranscriptProvided by QuartrMay 9, 2024 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Hello, and welcome to Fabin Pharmaceuticals First Quarter 20 24 Earnings Results Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. With that, I would like to turn the conference call over to Eric Chiarelli, Phantom's Head of Investor Relations. Please go ahead. Speaker 100:00:35Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's Q1 2024 results. This morning's presentation will include remarks from Terry Curran, our President and CEO Martin Gilligan, our Chief Commercial Officer and Molly Henderson, our Chief Financial Officer. Asmin Abulsi, our Chief Operating Officer will also be joining the team during the Q and A portion of today's call. Just a couple of logistical items before we get started. Speaker 100:01:01Earlier 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 Fathom's control. Speaker 100:01:30Actual results can materially differ from the forward looking statements Speaker 200:01:34and Speaker 100:01:34any such risks can materially adversely affect the business, the results of operations and trading prices for Fathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide as well as in the Risk Factors section of our most recent Form 10 ks and subsequent SEC filings. 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 Teri Curran, Fathom's President and CEO, to kick us off. Teri? Speaker 300:02:07Thank you, Eric, and thank you to all those joining us on today's call. I'm excited to report on the great progress we've made since the start of 2024. Throughout our 1st full quarter of launch, our team continued to deliver on our 3 main launch goals: communicating McQuizzan's clinical superiority versus the PPI, driving brand awareness and building access to commercial patients. Most importantly, the increased enthusiasm surrounding the Quezna is clear. I'm pleased to share that there are now upwards of 43,000 prescriptions written and launched to date, a notable increase relative to the number we reported just 2 months ago. Speaker 300:02:49This latest demand metric is evidence of how our teams have been successfully executing. I'll now share more on the progress we've made on each of our launch goals. Beginning with communicating superiority versus the PPI, our sales force has made great strides to inform target physicians of the clinical differentiation that the Quezna can offer patients. With each incremental sales call, we see our promotional messages due to real world patient experiences. On several occasions, we received unsolicited comments from both patients and doctors telling us how the Grezna has delivered improved symptom relief. Speaker 300:03:40Patients are describing life changing effects, especially for those that have suffered from this condition for many years. We're proud to be able to help these patients, and we know these types of testimonials encourage physicians to expand their prescribing behaviors. From the outset, we've been determined to drive brand awareness with both physicians and consumers. At the end of March, we expanded these efforts in a significant way, launching a new direct to consumer or DTC campaign titled bequesna kick some asset. Our market research indicates that patient requests are a major driver of the prescribing decision. Speaker 300:04:21So we crafted a television commercial aimed at motivating the Quezna. Later in the call, Martin will share more about the campaign and the early positive receptivity we're hearing from the marketplace. On the access front, we announced the addition of the Equisna to the Express Scripts or ESI National Formalary Midway Through Q1. This early outcome validated the belief that our access strategy would resonate with large payers. Now, midway through Q2, I'm proud to share that the Quezna was recently added to the Cigna Healthcare Formalaries with a single step edit similar to ESI. Speaker 300:05:04As a result, approximately 72,000,000 commercially insured lives now have access to VEQUESNA. We continue to negotiate coverage with other major payers with the aim to expand in commercial access throughout 2024. Earlier, I touched on how delivering our strategy has generated growth in total demand. I'm equally happy to report that still the Quezna prescriptions, meaning those that reach the hands of patients, have also significantly increased. We recorded over 17,500 bequesna prescriptions being filled launch to date. Speaker 300:05:42These volume metrics are very exciting early indicators. With anticipated expansion in commercial coverage, ongoing rollout of our DTC efforts and a potential approval of non erosive GERD, we remain steadfast in our belief of the blockbuster opportunity for Bequaza. Focusing now more closely on non erosive GERD, We're anticipating this potential label expansion to be an important catalyst in the second half of twenty twenty four. This indication represents the largest subcategory of GERD, more than doubling that of its cirrhosis counterpart, with an estimated 15,000,000 U. S. Speaker 300:06:22Adults diagnosed and treated for the disease annually. Despite the difference in the population size, the patient journey from symptom onset to receiving treatment is largely identical. More importantly, the doctors providing care are the same for both indications. We believe that this means our sales force is appropriately sized and already building relationships with these prescribers. If approved, our goal is for our current commercial team to be able to communicate nonarosa GERD commercial messages within days of the FDA's decision. Speaker 300:07:01With the July 19 PDUFA target action date, we're excited to soon be able to offer potential new treatment option to these patients. In parallel with our launch journey, we continue to advance development opportunities for vinoprazine. Later this year, we are planning to initiate a Phase 3 trial for as needed dosing in non erosive GERD. We believe that this study will build on the positive results we observed from our previous Phase 2 trial. Additionally, we are planning to initiate a Phase 2 trial for eosinophilic esophagitis, or EoE, later this year. Speaker 300:07:38Subject to trial success, phenoprazan could be positioned as a first line replacement of PPIs, which are the current standard of care. Phenoprazan's rapid, potent and durable acid suppression profile is the foundation for exploring these GI conditions. Our aim for both programs is to further differentiate venoprazan from PPIs, which are not approved for either of these indications. If approved, both label enhancements would further expand the total addressable market for the Questner products. On the financial side, Molly will further detail our Q1 2024 results later in the call, for which we reported revenues of $1,900,000 and ended with $322,000,000 in cash. Speaker 300:08:26We remain confident that our strong balance sheet will enable us to continue delivering on our launch and development strategies. As you've likely heard me say, the key elements of a potential blockbuster launch are present in this market. It now comes down to execution. And in this Q1 of 2024, our teams have continued to deliver. This launch is still in its infancy. Speaker 300:08:52The end of March marked only our 1st full quarter of launch, yet the progress we've made is impressive. We will continue to promote superiority in erosive GERD and leverage our full scale DTC efforts to reach the millions of patients suffering from this condition. In tandem, we're working diligently to pair awareness with broad commercial coverage, which we expect to expand throughout the remainder of 2024. These tactics, in conjunction with the anticipated launch of non erosive GERD, give us confidence that the Quezna's launch ramp is only just beginning. I'll now turn the call over to Martin to dive deeper into recent commercial updates. Speaker 300:09:38Martin? Speaker 400:09:39Thanks, Terry, and hello, everyone. Let me first echo that we believe the launch of Aquezna is off to a great start. Our sales team continues to share positive feedback from their conversations with physicians. The breadth and depth of their outreach among high volume prescribers increases daily. And beyond the doctors, the sentiment among patients is also very positive. Speaker 400:09:59We're now seeing some of the early users of Ocresna come back for refills, further signaling their positive experiences. At the end of March, we significantly elevated our DTC efforts with the goal of increasing brand awareness among consumers and empowering them to request VEQUESNA. We've also made progress on the commercial coverage front to best ensure those who want VEQUESNA can get VEQUESNA. I'll dive into each of these items in more detail, but let me start by providing an update on our most recent launch metrics. Today, we're reporting our latest available written and filled prescription data as of April 26, which is just 9 weeks removed from our previously reported data. Speaker 400:10:41In roughly 2 months, the number of Ocwenet prescriptions written has grown by 207% to over 43,000, while the number of filled prescriptions has grown by 361 percent to over 17,500. As you've heard us say, it takes time to disrupt long established behaviors, but these latest metrics are an exciting testament to the willingness to physicians and patients to try something new and different. Looking more closely at the over 17,500 prescriptions filled, we're also seeing notable growth on a monthly basis. In fact, filled OQUEZADA prescriptions for each month of the Q1 increased sequentially by more than 100%. Keep in mind that these figures reflect prescriptions flowing through retail pharmacies, which are captured by IQVIA, as well as those flowing through our $50 cash pay assistance program, which are captured by BlinkRx. Speaker 400:11:40Within Q1, we recorded roughly 9,500 filled VEQUESTA prescriptions, of which approximately 60% were filled through retail pharmacies and captured by IQVIA. In tandem with growing volume, the number of physicians writing VEQUESNA has also increased. As of April 19, upwards of 3,800 physicians have written a VEQUESTA prescription that has been filled. This reflects a growth of over 2 15 percent relative to what we previously reported as of mid February. This includes writing by a mix of our target specialties favoring GIs more heavily during these early phases of launch. Speaker 400:12:19Importantly, our latest data shows a strong degree of repeat writers. Over 50% of the question prescribers have written multiple times, which we see as an encouraging lead indicator. Doctors are witnessing the impact of healing and 24 hour heartburn relief on patients' lives, which we believe bolsters their intent to prescribe. We anticipate this early breadth and depth of our prescriber base will grow the increasing brand awareness and further engagement by our sales force. Beyond filled LUKESNA prescriptions, I mentioned earlier that over 43,000 total prescriptions have been written by physicians. Speaker 400:12:54This is a strong gauge of the existing and growing total demand in the marketplace. Recall that the metrics we shared during our last earnings call did not yet reflect any impact from the addition of Aquezna to ESI's National Formularies. With that coverage in place, we are now starting to see a narrowing of the proportional gap between written and filled prescriptions. As commercial coverage is secured, we anticipate closing the gap further, therefore realizing more and more of the revenue opportunity associated with this level of total demand. On that note, we continue to make good progress on our goal of securing widespread access for patients with commercial insurance. Speaker 400:13:35I'm happy to expand upon Terry's earlier Cigna update. As of May 1, vopresna was added to Cigna Formularies, which provides coverage to over 9,000,000 commercially insured people. Importantly, we were successful in negotiating access subject to a single step in it exactly as intended. With this inclusion, approximately 72,000,000 commercial lives now have access to bequestana. As we move deeper into 2024, we anticipate that an increasing number of plans will initiate bequesna coverage, including other major payers with which we are actively negotiating. Speaker 400:14:12While access is a key driver in converting full prescriptions, our promotional efforts are essential to increasing overall demand. In March, we rolled out our full scale direct to consumer campaign, which you heard Terry mention. The VEQUESTA can kick some acid campaign initially went live across several consumer facing platforms, most notably in the form of a television commercial on popular streaming services such as Hulu and Prime. We're extremely proud of this effort, which tested very well while in development with target audiences. Consumers told us the campaign is different, memorable and motivating. Speaker 400:14:48Our intent with the commercial is to raise awareness that VEQUESNA is the 1st and only treatment of its kind, helps heal erosions and maintain healing and provides 24 hour heartburn relief. Between the unique approach and strong messaging, we aim to motivate consumers to ask their physician for VEQUESNA. The end market feedback thus far has been tremendous and we're excited to announce the commercial is now airing more broadly across major television networks as of late April. The Q1 of 2024 included several meaningful steps in the Aquezna. Our progress in the marketing and promotional front was significant. Speaker 400:15:25We saw notable increases in total demand generated and the number of prescriptions filled. The ramp of commercial coverage was strengthened by the addition of aquezna to Cigna formularies and remains on track with positive inflection points anticipated throughout the remainder of this 1st year of launch. We believe the pairing of expanded coverage and widespread promotional efforts plus the nearing potential entry into the non erosive GERD market serve as fundamental drivers of continued growth. With each additional building block, we get closer to our goal of displacing PPIs and realizing the blockbuster opportunity for Vopresna. I'll now pass it off to Molly to walk through our financial results. Speaker 400:16:07Molly? Speaker 500:16:08Thanks, Martin, and hello to everyone on the call. I'm happy to share our Q1 2024 financial results with you today. As you've heard from Terry and Martin, we've made important progress related to launch of Aquezna in such a short period of time. Before going into the numbers, I'd like to note 2 items. 1st, during this call and similar to last quarter, we will not be providing financial guidance regarding projected revenues, spend or earnings as we are still early stages of launch. Speaker 500:16:35Additionally, 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 measure will be discussed later in my section and can be found in this morning's press release. Now turning to the numbers. For the Q1 2024, we reported net revenues of 1,900,000 dollars Keeping in mind that this was our 1st full quarter of launch, this represents a 180% sequential quarterly increase. Growing demand in filled prescriptions led the way to inventory restocking by wholesalers. Speaker 500:17:10Although it's difficult to estimate stocking behaviors this early into launch, we anticipate being able to get a better sense of stocking patterns over the next couple of quarters. On the gross to net discount front, we would like to flag that our gross to net discount this quarter was better than expected. This resulted from a 3 week period during the Q1 where our patient copay savings card was unavailable due to the changed health care cyber attack. For the quarter ended March 31, 2024, we reported gross profit of $1,500,000 dollars which equates to a gross margin of 78 percent, a sequential quarterly increase of about 2 20 basis points. Moving down the P and L to our operating expenses. Speaker 500:17:51We reported non GAAP R and D spend of $8,200,000 for the Q1 of 2024, which represents 16% reduction in spend compared to the Q1 of 2023. The decrease in R and D expenses was primarily related to lower clinical trial costs associated with the wind down of activities related to our Phase 3 non erosive daily dosing trial, which we read out last year. As for SG and A, we reported non GAAP expenses of $57,600,000 for the Q1 of 2024. This represents an increase over 3 30 percent relative to the same period in 2023. The increase was largely driven by the build out of our commercial and marketing activities in support of the commercial launch of Opezna. Speaker 500:18:34Most notably, the Q1 of 2024 includes nearly a complete quarter of costs related to our full strength sales force. Additionally, this quarter's SG and A expenses included advertising costs, which approximated $6,800,000 and were primarily related to the initiation of our roquesnekinkiximacid DTC campaign. For both spend categories, the most significant reconciling item between GAAP and non GAAP operating expenses for these periods was non cash stock based compensation. 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 discount. Turning to EPS. Speaker 500:19:15We reported non GAAP adjusted net loss of $64,800,000 for the Q1 of 2024 or $1.11 loss per share compared sequentially to $46,000,000 or $0.80 loss per share for the Q4 of 2023. As of March 31, 2024, cash and cash equivalents were $322,000,000 up to an additional $150,000,000 remains available via our debt facility, of which $50,000,000 is available this year and $100,000,000 is available next year, subject to achievement of certain revenue milestones. We believe that 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. Overall, our 1st full quarter of launch yielded results that were in line with our expectations. We saw a proportional increase in filled scripts and a better than expected gross to net discount due to certain one time events. Speaker 500:20:15We continue to diligently manage our spend while ensuring we invest appropriately to enable brand awareness and commercial access for patients in need of Okezna. With notable milestones on the horizon, we're excited about continuing to meet our goals for the rest of 2024. With that, I'll now turn the call back over to Terri for closing comments. Terri? Speaker 300:20:35Thank you, Molly, and thank you again to everyone joining us on today's call. When the Quezna was approved, I share this slide to outline our perceived path to a potential blockbuster opportunity. Now, 6 months into our journey, we have delivered according to the plan. Our Q1 results demonstrate that Fathom is off to a strong start in 2024. We've made significant progress in growing demand, accelerating filled prescriptions and expanding brand awareness. Speaker 300:21:06Our launch metrics are proof that the of equesner is resonating with both physicians and consumers. In upcoming quarters, we'll look to continue efforts on all of these fronts with an acute focus on establishing widespread commercial coverage throughout 2024. Simultaneously, we're nearing closer to the potential approval and label expansion of Aquezna for the daily dosing of non erosive GERD. We believe the large patient population in this indication and similar commercial dynamics with erosive GERD create an important catalyst. Internally, when we think about the potential for the Kreuzner, our bar is high, and we're committed to realizing this opportunity. Speaker 300:21:49We remain focused on our goal of displacing PPIs in this very large market and we look forward to sharing our progress throughout the remainder of the year. Thank you 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? Operator00:22:09Thank you. At this time, we will conduct a question and answer session. Our first question comes from Yatin Suneja of Guggenheim. Your line is open. Speaker 200:22:36Hey guys, thank you for taking my question. Very nice update today. A couple for me and real quick one. Could you I don't know if you just mentioned this, but could you talk about the split between BLINK, Rx and IMS? It seems like the fill rate has really improved to almost 41% now versus, let's say, 27 ish percent when you reported last time. Speaker 200:22:59Where you are on the fill rate? If you can talk about that specifically for Blink RX, that would be great. And you just touched on, and I'd love to hear from you, how should we think about inflection when you get that label? Thank you. Speaker 400:23:20Okay. Good morning, Yatin. I'll cover all those. This is Martin. So first, let me talk about, BLINK and IQVIA. Speaker 400:23:26I think your percentages are pretty spot on in terms of the split. And I think as we always said in the past is that as we gained more access moving through the process, you would start to see a shift more towards covered scripts going to blank versus cash. So I think our awareness of blank is really growing and we're seeing it heavily utilized. But I just want to make sure for everyone on the line that we're really clear when we're talking about blink. I think many people just think of it as the cash component of it. Speaker 400:23:53There we're offering that patient support that I mentioned earlier. But as you see more coverage come on board as we just have, you'll probably see less scripts being filled over time there. And then I'll just remind you that any script that is going to blink, that is covered is going to a partner pharmacy that is picked up by IQVIA. So that drives the rates that you're seeing and the fill rates. And then I think the last part of your question was regarding the inflection. Speaker 400:24:19So we envision as we said both on the access front that we expect inflections during Q2 and Q3 as we grow our coverage, just like you saw, as we had with Cigna announcing today. And then I think the other inflection we'll be expecting is upon the approval and we'll start marketing for non erosive curd. Operator00:24:45Thank you. One moment for our next question. Our next question comes from Umer Raffat of Evercore. Umer, your line is open. Speaker 600:24:57Hi. This is Chen Shan on for Umer. Thanks for taking our question. I guess first one on gross to net. How much improvement should we expect throughout the year, especially towards the end of the year? Speaker 600:25:08And second question is on the potential indication expansion. Do you expect an inflection in terms of volume in the second half or it will be a more gradual ramp? Speaker 500:25:22Sure. I'll take the gross to net and then turn it over to Martin on So as we said, we experienced a somewhat better than expected gross to net for the Q1 because of our co pay assistance program not being available due to the cyber attack. We're not specifically commenting on our growth in that projections for the rest of the year as we're still in negotiations with a couple of other payers. But at this point, we're not seeing significant variations from our expectations. And then I'll turn it over to Martin for the inflection on there. Speaker 400:25:51Yes. So I think as I mentioned a little early, a question before is that we do expect an inflection for non erosive GERD. And so what we're seeing is we're going to be entering a much larger market. Erosive GERD is 7,000,000 patients and that non erosive is 15,000,000 patients who are both diagnosed and treated. We really feel that we're not going to be starting this launch at 0 like we did back in January. Speaker 400:26:15We have the same sales force calling on the same physicians, while the patients have different diagnoses. Their symptoms are the same, the journeys are the same and we hear the same level of dissatisfaction, the same level of discussion in terms of switching PPIs and adding on. So we know that the category is searching for a new mechanism and we believe that PEQUEZADA is that mechanism for them as it's playing out for erosive curd. So we believe that our we've started our momentum and the erosive experience we have thus far will really benefit us moving into the non erosive launch. Speaker 600:26:48Thanks. Just want to follow-up. How much of the reported sales was inventory? Speaker 500:26:57If I understood that way, it's inventory. So the majority of the sales for the Q1 would have been demand related, related to those prescriptions that were filled. We're still a little bit early in the cycle to see stocking behavior, but what we're seeing so far is pretty commensurate with what you'd see in the stocking patterns. Speaker 700:27:22All right. Speaker 600:27:23Thank you so much. Operator00:27:24Thank you very much. One moment for our next question. Our next question comes from Joseph Springer of Needham and Company. Joseph, your line is open. Speaker 700:27:36Hi, good morning. Thanks for taking our questions. I just want a clarifying question on the Link IQVIA split. If we kind of back into the numbers based on the TRx metrics you provided, I think since your last update in early March, there have been around 13,700 TRx filled and around 7,300 IQVIA scripts. So that implies, like a 5,000 three-forty seven split or roughly 1 to 1 IQVIA to blank since the last update. Speaker 700:28:04So is that a fair assessment? Question number 1. And then then that one to one split is similar to what you provided in March. Just want to get clarification on that. And then secondly, on the potential label expansion to NERD daily dosing. Speaker 700:28:31Can you talk a little bit about the different market access dynamics, in particular from a payer perspective between the current launch in ROSA GERD and the potential launch in NERD. For example, you're securing coverage for the bottle right now as we understand it. So when it comes time for label expansion to the NERD indication, it's not a separate negotiation with payers for the indication. Is that also a fair assumption? Speaker 400:29:06Hey, Joey. So I'll split into 2 parts. I just want to make sure on the first one I understand the question. Your question is you were estimating that in our last earnings call, the ratio between BLINK and IQVIA was 1:1. And you're asking if it's sixty-forty now, is that correct? Speaker 400:29:28Yes. So I might have lost you. So the answer to that question is yes. I want to make sure I understood it. So right now what we're reporting is that about 50% of the scripts are going through what I'll call the retail channel versus going through our cash support, which is exactly I think that we set out when we spoke in the last earnings call that as more access comes on board, you would expect that our those be a shift in ratio between what you see in IQVIA versus cash scripts and we anticipate that continues as we get more coverage, which leads into the second part of your question in terms of non erosive in the daily dosing. Speaker 400:30:01We are expecting the approval with our PDUFA of July 2019. And right now, generally, as we look at a coverage for pack is always for packaging or presentation, not by indication and this is how payers work. So when we've been reporting our data as of right now today of 72,000,000, that's all about the bottle. So we would anticipate that that bottle coverage will carry forward for non erosive. And it's our expectation that we would see the same type of coverage after approval with non erosive that we have prior to. Speaker 700:30:42Great. That's very helpful. Thank you for taking our questions. Operator00:30:46Thank you very much. One moment for our next question. Our next question comes from Paul Chille of Goldman Sachs. Paul, your line is open. Speaker 800:30:59Hi, good morning team and thanks for taking our questions. I have 2. The first one is, Martin, I want to follow-up a little bit on your comments in your prepared remarks regarding refills. And can you maybe just comment or help us quantify what percentage of patients who are getting a script filled come back and are able to stick with get a second bottle just to help us understand how many patients are sticking with the treatment from with Vopresin from treatment onto the maintenance space. Any quantification there would be helpful. Speaker 800:31:34And my second question is, as you look at the mix between the bottle and the packs, at least as expressed by the IQVIA data, do you think that's a fair proxy for what the mix will look like in the indications, going forward here, as you expand into NERDA as well? Thanks for taking our questions. Speaker 400:31:56Absolutely. So the first one on the refills, yes. So we are seeing 2 things that are also related to refills as we're seeing more patients come back now and continuing on therapy. So I'm not ready to quantify that for you today, but I can tell you that that's exactly what's happening and you see that in our TRx numbers as those TRx has continued to increase. We also know that more physicians are writing and as I just said before they're also writing for more patients. Speaker 400:32:23So I think that's what you're seeing reflective in the TRx data. And then, your question on the mix of bottle versus packs, yes, the packs it's about 10% and our planning that's what we always assume to see in our mix and you should expect that to carry forward. Speaker 800:32:39Great. Okay. Thank you. Operator00:32:42Thank you very much. One moment for our next question. Our next question comes from Chase Knickerbocker of Craig Hallum. Chase, your line is open. Speaker 800:32:54Hi, good morning, everyone. This is Abhir Hoot on for Chase here. Just one from us for BloomcarX. So when should we expect the volume that is under blinkrx here to become really fairly small amount over of the overall volume, let's say, less than 20%, should we think of that kind of being in the latter half of twenty twenty four? Or do you think it doesn't that won't happen until 2025? Speaker 400:33:25So Chase, I think it's hard to put a number on that. I think what you can expect is that that's going to as I've been saying is that that's going to decline over time. We've got an interesting launch and a positive launch. We're bringing on new physicians. We're bringing on new payers and we're in the middle of a launch and we're getting ready for a launch. Speaker 400:33:44So as this continues to grow, you're just going to see a lot of movement on a lot of metrics given all those factors. I think the key signal to us are 2 things. You heard today the increase in access, and you heard, as we said last time, start to see that shift, what would be the patient support or cash that goes through BLINK. So, don't have a number to give you today. I think there's a lot of movement in the market for us. Speaker 400:34:08That's all very positive, as I just mentioned, and you'll continue to see that decline during the year. Speaker 200:34:17Thank you. Operator00:34:19Thank you very much. One moment for our next question. Our next question comes from Annabel Samimy of Stifel. Annabel, your line is open. Speaker 900:34:31Hi, all. Thanks for taking my question. I guess I'm going to get just a little bit more granular on Blink for a minute. So you said that it's going to decrease over time, but is there a scenario where you have increased demand faster than you get payers on board and perhaps you have the percentage going through BLINK increasing before it decreases? I guess that's the first question. Speaker 900:34:52And as far as coverage is concerned and what the tail of BLINK might be, is there a steady state of coverage that you think that you'll get to like 70% or 80% of that and on that tail end, is BLINK going to stop and then those patients just don't get prescriptions fulfilled? And so just trying to understand the go forward dynamics there. Thanks. Speaker 400:35:22Yes. So Annabel, there were a couple of questions there, but they're all have a common thread and related. So, I think I'm going to hit them all here. Is there a case where demand might grow faster than payer coverage? That's an interesting question. Speaker 400:35:36I think we've seen a steady growth and that's what we feel good about. Our demand is it's steadily growing. So I think you'll continue to see that. And we're far along in negotiations with the other major payers, which will be continuing through Q2 and Q3. So, I don't think that's going to be the case. Speaker 400:35:54I think we're going to have, coverage come on board as we see growth in prescriptions. And I think the next part of that was would we see an increase in cash Blynk covered scripts before we saw a decrease? I'm not prepared to say that that's correct or incorrect, but it's not what we're expecting. I think you saw a big change from our last earnings call, where we had that 1 to 1 versus sixty-forty. So our anticipation is that will continue to decline. Speaker 400:36:24And then, will we continue BLINK? I mean, we'll always look to do the right things for patients. There will always be some level of coverage that doesn't exist. And we want to make sure that we do the right things for patients. So we'll always be in there. Speaker 400:36:38And then in terms of I think one of your other questions was steady state for coverage. I think we're going to see it continue to grow, as I just said a moment ago between going into Q2, which we're in and you've already seen it. So we've kind of kept that statement that we made in the last earnings call that we expected to see more growth in Q2 and Q3. So we've already had our first step in Q2 and we believe there's more to come in Q2 and Q3. Speaker 900:37:03Okay. Thank you. Operator00:37:05Thank you very much. One moment for our next question. Our next question comes from Matthew Caulfield of H. C. Wainwright. Operator00:37:15Matthew, your line is open. Speaker 1000:37:18Hi, good morning, guys. So for the launch, is there any granularity that you can share at this stage between the prescriptions coming from GI or primary care? And do you anticipate 1 or the other being a greater target or contributor for growth? Thanks. Speaker 400:37:36So I'm sorry, did you finish? Speaker 800:37:40Yes. Speaker 400:37:40Okay. I'm sorry. I thought I cut you off. Just want to make sure. So, yes, so right now we're seeing not to our surprise that the percentage of scripts are leaning heavier towards GI. Speaker 400:37:52So what's the rationale for that? I know we've spoken in the past that when we sent our sales force out, their objective was to start at the higher deciles, would be the higher volume physicians. So really starting on those decile tens and working down to 9, 8, etcetera. And that's where you see the imbalance between the GIs being the higher decile and the primary care being lower. So yes, so right now at this point, we're seeing a higher slant towards gastroenterologists, but we're actually seeing primary care come on board. Speaker 400:38:21So it's playing out exactly as we thought it would. Speaker 1000:38:26Very helpful. Thank you. And then maybe if I could just ask one more quick question. In regards to the current fill rate, do you know how that kind of stacks up against something like a more established PPI? Presumably not all the PPI prescriptions are getting filled either, but just curious how that could compare possibly? Speaker 400:38:43Yes. So I think that's a hard comparison. I think when you're looking at something that's a generic product that's been around for 30 some odd years and is also OTC, I think a better way to look at it is our fill rate as it compares to a launch product and where we are. And what you heard today was a rate we have of 41%. And we know looking at other launches that not only is that consistent, but it's actually in a really good position right now at our place of launch. Speaker 400:39:16So, and a lot of that's kind of driving in terms the coverage we have right now has come on board, as we announced today with Cigna, and that fill rate will only go up moving forward. Speaker 1000:39:28Great. Very helpful guys. I appreciate it.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallPhathom Pharmaceuticals Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Phathom Pharmaceuticals Earnings HeadlinesPhathom Pharmaceuticals, Inc. (NASDAQ:PHAT) Given Average Rating of "Buy" by BrokeragesMay 4 at 1:57 AM | americanbankingnews.comPhathom Pharmaceuticals, Inc. (PHAT) Q1 2025 Earnings Call TranscriptMay 3 at 3:57 AM | seekingalpha.comGold Alert: The Truth About Fort Knox Is ComingOwning physical gold isn’t the best way to profit. I’ve found a better way to invest in gold—one that’s already performing nearly twice as well as gold this year and looks ready to go much higher. If you wait for the news to hit, you’ll already be too late.May 4, 2025 | Golden Portfolio (Ad)Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT) Q1 2025 Earnings Call TranscriptMay 2 at 12:51 PM | msn.comPhathom Pharmaceuticals Inc (PHAT) Q1 2025 Earnings Call Highlights: Strong Revenue Growth Amid ...May 2 at 7:49 AM | finance.yahoo.comRetail Interest in Phathom Soars As Firm Pledges Profit Path, Cuts Costs After Q1 MissMay 2 at 7:49 AM | msn.comSee More Phathom Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Phathom Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Phathom Pharmaceuticals and other key companies, straight to your email. Email Address About Phathom PharmaceuticalsPhathom Pharmaceuticals (NASDAQ:PHAT), biopharmaceutical company, focuses on developing and commercializing treatments for gastrointestinal diseases. The company has the rights in the United States, Europe, and Canada for an investigational potassium-competitive acid blocker (P-CAB) that blocks acid secretion in the stomach. It is also developing vonoprazan for the treatment of erosive gastroesophageal reflux disease; and in combination with antibiotics for the treatment of Helicobacter pylori infection. The company was incorporated in 2018 and is headquartered in Florham Park, New Jersey.View Phathom Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Amazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback PlanMicrosoft Crushes Earnings, What’s Next for MSFT Stock?Qualcomm's Earnings: 2 Reasons to Buy, 1 to Stay AwayAMD Stock Signals Strong Buy Ahead of Earnings Upcoming Earnings Palantir Technologies (5/5/2025)Vertex Pharmaceuticals (5/5/2025)Realty Income (5/5/2025)Williams Companies (5/5/2025)CRH (5/5/2025)Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 11 speakers on the call. Operator00:00:00Hello, and welcome to Fabin Pharmaceuticals First Quarter 20 24 Earnings Results Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. With that, I would like to turn the conference call over to Eric Chiarelli, Phantom's Head of Investor Relations. Please go ahead. Speaker 100:00:35Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's Q1 2024 results. This morning's presentation will include remarks from Terry Curran, our President and CEO Martin Gilligan, our Chief Commercial Officer and Molly Henderson, our Chief Financial Officer. Asmin Abulsi, our Chief Operating Officer will also be joining the team during the Q and A portion of today's call. Just a couple of logistical items before we get started. Speaker 100:01:01Earlier 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 Fathom's control. Speaker 100:01:30Actual results can materially differ from the forward looking statements Speaker 200:01:34and Speaker 100:01:34any such risks can materially adversely affect the business, the results of operations and trading prices for Fathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide as well as in the Risk Factors section of our most recent Form 10 ks and subsequent SEC filings. 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 Teri Curran, Fathom's President and CEO, to kick us off. Teri? Speaker 300:02:07Thank you, Eric, and thank you to all those joining us on today's call. I'm excited to report on the great progress we've made since the start of 2024. Throughout our 1st full quarter of launch, our team continued to deliver on our 3 main launch goals: communicating McQuizzan's clinical superiority versus the PPI, driving brand awareness and building access to commercial patients. Most importantly, the increased enthusiasm surrounding the Quezna is clear. I'm pleased to share that there are now upwards of 43,000 prescriptions written and launched to date, a notable increase relative to the number we reported just 2 months ago. Speaker 300:02:49This latest demand metric is evidence of how our teams have been successfully executing. I'll now share more on the progress we've made on each of our launch goals. Beginning with communicating superiority versus the PPI, our sales force has made great strides to inform target physicians of the clinical differentiation that the Quezna can offer patients. With each incremental sales call, we see our promotional messages due to real world patient experiences. On several occasions, we received unsolicited comments from both patients and doctors telling us how the Grezna has delivered improved symptom relief. Speaker 300:03:40Patients are describing life changing effects, especially for those that have suffered from this condition for many years. We're proud to be able to help these patients, and we know these types of testimonials encourage physicians to expand their prescribing behaviors. From the outset, we've been determined to drive brand awareness with both physicians and consumers. At the end of March, we expanded these efforts in a significant way, launching a new direct to consumer or DTC campaign titled bequesna kick some asset. Our market research indicates that patient requests are a major driver of the prescribing decision. Speaker 300:04:21So we crafted a television commercial aimed at motivating the Quezna. Later in the call, Martin will share more about the campaign and the early positive receptivity we're hearing from the marketplace. On the access front, we announced the addition of the Equisna to the Express Scripts or ESI National Formalary Midway Through Q1. This early outcome validated the belief that our access strategy would resonate with large payers. Now, midway through Q2, I'm proud to share that the Quezna was recently added to the Cigna Healthcare Formalaries with a single step edit similar to ESI. Speaker 300:05:04As a result, approximately 72,000,000 commercially insured lives now have access to VEQUESNA. We continue to negotiate coverage with other major payers with the aim to expand in commercial access throughout 2024. Earlier, I touched on how delivering our strategy has generated growth in total demand. I'm equally happy to report that still the Quezna prescriptions, meaning those that reach the hands of patients, have also significantly increased. We recorded over 17,500 bequesna prescriptions being filled launch to date. Speaker 300:05:42These volume metrics are very exciting early indicators. With anticipated expansion in commercial coverage, ongoing rollout of our DTC efforts and a potential approval of non erosive GERD, we remain steadfast in our belief of the blockbuster opportunity for Bequaza. Focusing now more closely on non erosive GERD, We're anticipating this potential label expansion to be an important catalyst in the second half of twenty twenty four. This indication represents the largest subcategory of GERD, more than doubling that of its cirrhosis counterpart, with an estimated 15,000,000 U. S. Speaker 300:06:22Adults diagnosed and treated for the disease annually. Despite the difference in the population size, the patient journey from symptom onset to receiving treatment is largely identical. More importantly, the doctors providing care are the same for both indications. We believe that this means our sales force is appropriately sized and already building relationships with these prescribers. If approved, our goal is for our current commercial team to be able to communicate nonarosa GERD commercial messages within days of the FDA's decision. Speaker 300:07:01With the July 19 PDUFA target action date, we're excited to soon be able to offer potential new treatment option to these patients. In parallel with our launch journey, we continue to advance development opportunities for vinoprazine. Later this year, we are planning to initiate a Phase 3 trial for as needed dosing in non erosive GERD. We believe that this study will build on the positive results we observed from our previous Phase 2 trial. Additionally, we are planning to initiate a Phase 2 trial for eosinophilic esophagitis, or EoE, later this year. Speaker 300:07:38Subject to trial success, phenoprazan could be positioned as a first line replacement of PPIs, which are the current standard of care. Phenoprazan's rapid, potent and durable acid suppression profile is the foundation for exploring these GI conditions. Our aim for both programs is to further differentiate venoprazan from PPIs, which are not approved for either of these indications. If approved, both label enhancements would further expand the total addressable market for the Questner products. On the financial side, Molly will further detail our Q1 2024 results later in the call, for which we reported revenues of $1,900,000 and ended with $322,000,000 in cash. Speaker 300:08:26We remain confident that our strong balance sheet will enable us to continue delivering on our launch and development strategies. As you've likely heard me say, the key elements of a potential blockbuster launch are present in this market. It now comes down to execution. And in this Q1 of 2024, our teams have continued to deliver. This launch is still in its infancy. Speaker 300:08:52The end of March marked only our 1st full quarter of launch, yet the progress we've made is impressive. We will continue to promote superiority in erosive GERD and leverage our full scale DTC efforts to reach the millions of patients suffering from this condition. In tandem, we're working diligently to pair awareness with broad commercial coverage, which we expect to expand throughout the remainder of 2024. These tactics, in conjunction with the anticipated launch of non erosive GERD, give us confidence that the Quezna's launch ramp is only just beginning. I'll now turn the call over to Martin to dive deeper into recent commercial updates. Speaker 300:09:38Martin? Speaker 400:09:39Thanks, Terry, and hello, everyone. Let me first echo that we believe the launch of Aquezna is off to a great start. Our sales team continues to share positive feedback from their conversations with physicians. The breadth and depth of their outreach among high volume prescribers increases daily. And beyond the doctors, the sentiment among patients is also very positive. Speaker 400:09:59We're now seeing some of the early users of Ocresna come back for refills, further signaling their positive experiences. At the end of March, we significantly elevated our DTC efforts with the goal of increasing brand awareness among consumers and empowering them to request VEQUESNA. We've also made progress on the commercial coverage front to best ensure those who want VEQUESNA can get VEQUESNA. I'll dive into each of these items in more detail, but let me start by providing an update on our most recent launch metrics. Today, we're reporting our latest available written and filled prescription data as of April 26, which is just 9 weeks removed from our previously reported data. Speaker 400:10:41In roughly 2 months, the number of Ocwenet prescriptions written has grown by 207% to over 43,000, while the number of filled prescriptions has grown by 361 percent to over 17,500. As you've heard us say, it takes time to disrupt long established behaviors, but these latest metrics are an exciting testament to the willingness to physicians and patients to try something new and different. Looking more closely at the over 17,500 prescriptions filled, we're also seeing notable growth on a monthly basis. In fact, filled OQUEZADA prescriptions for each month of the Q1 increased sequentially by more than 100%. Keep in mind that these figures reflect prescriptions flowing through retail pharmacies, which are captured by IQVIA, as well as those flowing through our $50 cash pay assistance program, which are captured by BlinkRx. Speaker 400:11:40Within Q1, we recorded roughly 9,500 filled VEQUESTA prescriptions, of which approximately 60% were filled through retail pharmacies and captured by IQVIA. In tandem with growing volume, the number of physicians writing VEQUESNA has also increased. As of April 19, upwards of 3,800 physicians have written a VEQUESTA prescription that has been filled. This reflects a growth of over 2 15 percent relative to what we previously reported as of mid February. This includes writing by a mix of our target specialties favoring GIs more heavily during these early phases of launch. Speaker 400:12:19Importantly, our latest data shows a strong degree of repeat writers. Over 50% of the question prescribers have written multiple times, which we see as an encouraging lead indicator. Doctors are witnessing the impact of healing and 24 hour heartburn relief on patients' lives, which we believe bolsters their intent to prescribe. We anticipate this early breadth and depth of our prescriber base will grow the increasing brand awareness and further engagement by our sales force. Beyond filled LUKESNA prescriptions, I mentioned earlier that over 43,000 total prescriptions have been written by physicians. Speaker 400:12:54This is a strong gauge of the existing and growing total demand in the marketplace. Recall that the metrics we shared during our last earnings call did not yet reflect any impact from the addition of Aquezna to ESI's National Formularies. With that coverage in place, we are now starting to see a narrowing of the proportional gap between written and filled prescriptions. As commercial coverage is secured, we anticipate closing the gap further, therefore realizing more and more of the revenue opportunity associated with this level of total demand. On that note, we continue to make good progress on our goal of securing widespread access for patients with commercial insurance. Speaker 400:13:35I'm happy to expand upon Terry's earlier Cigna update. As of May 1, vopresna was added to Cigna Formularies, which provides coverage to over 9,000,000 commercially insured people. Importantly, we were successful in negotiating access subject to a single step in it exactly as intended. With this inclusion, approximately 72,000,000 commercial lives now have access to bequestana. As we move deeper into 2024, we anticipate that an increasing number of plans will initiate bequesna coverage, including other major payers with which we are actively negotiating. Speaker 400:14:12While access is a key driver in converting full prescriptions, our promotional efforts are essential to increasing overall demand. In March, we rolled out our full scale direct to consumer campaign, which you heard Terry mention. The VEQUESTA can kick some acid campaign initially went live across several consumer facing platforms, most notably in the form of a television commercial on popular streaming services such as Hulu and Prime. We're extremely proud of this effort, which tested very well while in development with target audiences. Consumers told us the campaign is different, memorable and motivating. Speaker 400:14:48Our intent with the commercial is to raise awareness that VEQUESNA is the 1st and only treatment of its kind, helps heal erosions and maintain healing and provides 24 hour heartburn relief. Between the unique approach and strong messaging, we aim to motivate consumers to ask their physician for VEQUESNA. The end market feedback thus far has been tremendous and we're excited to announce the commercial is now airing more broadly across major television networks as of late April. The Q1 of 2024 included several meaningful steps in the Aquezna. Our progress in the marketing and promotional front was significant. Speaker 400:15:25We saw notable increases in total demand generated and the number of prescriptions filled. The ramp of commercial coverage was strengthened by the addition of aquezna to Cigna formularies and remains on track with positive inflection points anticipated throughout the remainder of this 1st year of launch. We believe the pairing of expanded coverage and widespread promotional efforts plus the nearing potential entry into the non erosive GERD market serve as fundamental drivers of continued growth. With each additional building block, we get closer to our goal of displacing PPIs and realizing the blockbuster opportunity for Vopresna. I'll now pass it off to Molly to walk through our financial results. Speaker 400:16:07Molly? Speaker 500:16:08Thanks, Martin, and hello to everyone on the call. I'm happy to share our Q1 2024 financial results with you today. As you've heard from Terry and Martin, we've made important progress related to launch of Aquezna in such a short period of time. Before going into the numbers, I'd like to note 2 items. 1st, during this call and similar to last quarter, we will not be providing financial guidance regarding projected revenues, spend or earnings as we are still early stages of launch. Speaker 500:16:35Additionally, 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 measure will be discussed later in my section and can be found in this morning's press release. Now turning to the numbers. For the Q1 2024, we reported net revenues of 1,900,000 dollars Keeping in mind that this was our 1st full quarter of launch, this represents a 180% sequential quarterly increase. Growing demand in filled prescriptions led the way to inventory restocking by wholesalers. Speaker 500:17:10Although it's difficult to estimate stocking behaviors this early into launch, we anticipate being able to get a better sense of stocking patterns over the next couple of quarters. On the gross to net discount front, we would like to flag that our gross to net discount this quarter was better than expected. This resulted from a 3 week period during the Q1 where our patient copay savings card was unavailable due to the changed health care cyber attack. For the quarter ended March 31, 2024, we reported gross profit of $1,500,000 dollars which equates to a gross margin of 78 percent, a sequential quarterly increase of about 2 20 basis points. Moving down the P and L to our operating expenses. Speaker 500:17:51We reported non GAAP R and D spend of $8,200,000 for the Q1 of 2024, which represents 16% reduction in spend compared to the Q1 of 2023. The decrease in R and D expenses was primarily related to lower clinical trial costs associated with the wind down of activities related to our Phase 3 non erosive daily dosing trial, which we read out last year. As for SG and A, we reported non GAAP expenses of $57,600,000 for the Q1 of 2024. This represents an increase over 3 30 percent relative to the same period in 2023. The increase was largely driven by the build out of our commercial and marketing activities in support of the commercial launch of Opezna. Speaker 500:18:34Most notably, the Q1 of 2024 includes nearly a complete quarter of costs related to our full strength sales force. Additionally, this quarter's SG and A expenses included advertising costs, which approximated $6,800,000 and were primarily related to the initiation of our roquesnekinkiximacid DTC campaign. For both spend categories, the most significant reconciling item between GAAP and non GAAP operating expenses for these periods was non cash stock based compensation. 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 discount. Turning to EPS. Speaker 500:19:15We reported non GAAP adjusted net loss of $64,800,000 for the Q1 of 2024 or $1.11 loss per share compared sequentially to $46,000,000 or $0.80 loss per share for the Q4 of 2023. As of March 31, 2024, cash and cash equivalents were $322,000,000 up to an additional $150,000,000 remains available via our debt facility, of which $50,000,000 is available this year and $100,000,000 is available next year, subject to achievement of certain revenue milestones. We believe that 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. Overall, our 1st full quarter of launch yielded results that were in line with our expectations. We saw a proportional increase in filled scripts and a better than expected gross to net discount due to certain one time events. Speaker 500:20:15We continue to diligently manage our spend while ensuring we invest appropriately to enable brand awareness and commercial access for patients in need of Okezna. With notable milestones on the horizon, we're excited about continuing to meet our goals for the rest of 2024. With that, I'll now turn the call back over to Terri for closing comments. Terri? Speaker 300:20:35Thank you, Molly, and thank you again to everyone joining us on today's call. When the Quezna was approved, I share this slide to outline our perceived path to a potential blockbuster opportunity. Now, 6 months into our journey, we have delivered according to the plan. Our Q1 results demonstrate that Fathom is off to a strong start in 2024. We've made significant progress in growing demand, accelerating filled prescriptions and expanding brand awareness. Speaker 300:21:06Our launch metrics are proof that the of equesner is resonating with both physicians and consumers. In upcoming quarters, we'll look to continue efforts on all of these fronts with an acute focus on establishing widespread commercial coverage throughout 2024. Simultaneously, we're nearing closer to the potential approval and label expansion of Aquezna for the daily dosing of non erosive GERD. We believe the large patient population in this indication and similar commercial dynamics with erosive GERD create an important catalyst. Internally, when we think about the potential for the Kreuzner, our bar is high, and we're committed to realizing this opportunity. Speaker 300:21:49We remain focused on our goal of displacing PPIs in this very large market and we look forward to sharing our progress throughout the remainder of the year. Thank you 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? Operator00:22:09Thank you. At this time, we will conduct a question and answer session. Our first question comes from Yatin Suneja of Guggenheim. Your line is open. Speaker 200:22:36Hey guys, thank you for taking my question. Very nice update today. A couple for me and real quick one. Could you I don't know if you just mentioned this, but could you talk about the split between BLINK, Rx and IMS? It seems like the fill rate has really improved to almost 41% now versus, let's say, 27 ish percent when you reported last time. Speaker 200:22:59Where you are on the fill rate? If you can talk about that specifically for Blink RX, that would be great. And you just touched on, and I'd love to hear from you, how should we think about inflection when you get that label? Thank you. Speaker 400:23:20Okay. Good morning, Yatin. I'll cover all those. This is Martin. So first, let me talk about, BLINK and IQVIA. Speaker 400:23:26I think your percentages are pretty spot on in terms of the split. And I think as we always said in the past is that as we gained more access moving through the process, you would start to see a shift more towards covered scripts going to blank versus cash. So I think our awareness of blank is really growing and we're seeing it heavily utilized. But I just want to make sure for everyone on the line that we're really clear when we're talking about blink. I think many people just think of it as the cash component of it. Speaker 400:23:53There we're offering that patient support that I mentioned earlier. But as you see more coverage come on board as we just have, you'll probably see less scripts being filled over time there. And then I'll just remind you that any script that is going to blink, that is covered is going to a partner pharmacy that is picked up by IQVIA. So that drives the rates that you're seeing and the fill rates. And then I think the last part of your question was regarding the inflection. Speaker 400:24:19So we envision as we said both on the access front that we expect inflections during Q2 and Q3 as we grow our coverage, just like you saw, as we had with Cigna announcing today. And then I think the other inflection we'll be expecting is upon the approval and we'll start marketing for non erosive curd. Operator00:24:45Thank you. One moment for our next question. Our next question comes from Umer Raffat of Evercore. Umer, your line is open. Speaker 600:24:57Hi. This is Chen Shan on for Umer. Thanks for taking our question. I guess first one on gross to net. How much improvement should we expect throughout the year, especially towards the end of the year? Speaker 600:25:08And second question is on the potential indication expansion. Do you expect an inflection in terms of volume in the second half or it will be a more gradual ramp? Speaker 500:25:22Sure. I'll take the gross to net and then turn it over to Martin on So as we said, we experienced a somewhat better than expected gross to net for the Q1 because of our co pay assistance program not being available due to the cyber attack. We're not specifically commenting on our growth in that projections for the rest of the year as we're still in negotiations with a couple of other payers. But at this point, we're not seeing significant variations from our expectations. And then I'll turn it over to Martin for the inflection on there. Speaker 400:25:51Yes. So I think as I mentioned a little early, a question before is that we do expect an inflection for non erosive GERD. And so what we're seeing is we're going to be entering a much larger market. Erosive GERD is 7,000,000 patients and that non erosive is 15,000,000 patients who are both diagnosed and treated. We really feel that we're not going to be starting this launch at 0 like we did back in January. Speaker 400:26:15We have the same sales force calling on the same physicians, while the patients have different diagnoses. Their symptoms are the same, the journeys are the same and we hear the same level of dissatisfaction, the same level of discussion in terms of switching PPIs and adding on. So we know that the category is searching for a new mechanism and we believe that PEQUEZADA is that mechanism for them as it's playing out for erosive curd. So we believe that our we've started our momentum and the erosive experience we have thus far will really benefit us moving into the non erosive launch. Speaker 600:26:48Thanks. Just want to follow-up. How much of the reported sales was inventory? Speaker 500:26:57If I understood that way, it's inventory. So the majority of the sales for the Q1 would have been demand related, related to those prescriptions that were filled. We're still a little bit early in the cycle to see stocking behavior, but what we're seeing so far is pretty commensurate with what you'd see in the stocking patterns. Speaker 700:27:22All right. Speaker 600:27:23Thank you so much. Operator00:27:24Thank you very much. One moment for our next question. Our next question comes from Joseph Springer of Needham and Company. Joseph, your line is open. Speaker 700:27:36Hi, good morning. Thanks for taking our questions. I just want a clarifying question on the Link IQVIA split. If we kind of back into the numbers based on the TRx metrics you provided, I think since your last update in early March, there have been around 13,700 TRx filled and around 7,300 IQVIA scripts. So that implies, like a 5,000 three-forty seven split or roughly 1 to 1 IQVIA to blank since the last update. Speaker 700:28:04So is that a fair assessment? Question number 1. And then then that one to one split is similar to what you provided in March. Just want to get clarification on that. And then secondly, on the potential label expansion to NERD daily dosing. Speaker 700:28:31Can you talk a little bit about the different market access dynamics, in particular from a payer perspective between the current launch in ROSA GERD and the potential launch in NERD. For example, you're securing coverage for the bottle right now as we understand it. So when it comes time for label expansion to the NERD indication, it's not a separate negotiation with payers for the indication. Is that also a fair assumption? Speaker 400:29:06Hey, Joey. So I'll split into 2 parts. I just want to make sure on the first one I understand the question. Your question is you were estimating that in our last earnings call, the ratio between BLINK and IQVIA was 1:1. And you're asking if it's sixty-forty now, is that correct? Speaker 400:29:28Yes. So I might have lost you. So the answer to that question is yes. I want to make sure I understood it. So right now what we're reporting is that about 50% of the scripts are going through what I'll call the retail channel versus going through our cash support, which is exactly I think that we set out when we spoke in the last earnings call that as more access comes on board, you would expect that our those be a shift in ratio between what you see in IQVIA versus cash scripts and we anticipate that continues as we get more coverage, which leads into the second part of your question in terms of non erosive in the daily dosing. Speaker 400:30:01We are expecting the approval with our PDUFA of July 2019. And right now, generally, as we look at a coverage for pack is always for packaging or presentation, not by indication and this is how payers work. So when we've been reporting our data as of right now today of 72,000,000, that's all about the bottle. So we would anticipate that that bottle coverage will carry forward for non erosive. And it's our expectation that we would see the same type of coverage after approval with non erosive that we have prior to. Speaker 700:30:42Great. That's very helpful. Thank you for taking our questions. Operator00:30:46Thank you very much. One moment for our next question. Our next question comes from Paul Chille of Goldman Sachs. Paul, your line is open. Speaker 800:30:59Hi, good morning team and thanks for taking our questions. I have 2. The first one is, Martin, I want to follow-up a little bit on your comments in your prepared remarks regarding refills. And can you maybe just comment or help us quantify what percentage of patients who are getting a script filled come back and are able to stick with get a second bottle just to help us understand how many patients are sticking with the treatment from with Vopresin from treatment onto the maintenance space. Any quantification there would be helpful. Speaker 800:31:34And my second question is, as you look at the mix between the bottle and the packs, at least as expressed by the IQVIA data, do you think that's a fair proxy for what the mix will look like in the indications, going forward here, as you expand into NERDA as well? Thanks for taking our questions. Speaker 400:31:56Absolutely. So the first one on the refills, yes. So we are seeing 2 things that are also related to refills as we're seeing more patients come back now and continuing on therapy. So I'm not ready to quantify that for you today, but I can tell you that that's exactly what's happening and you see that in our TRx numbers as those TRx has continued to increase. We also know that more physicians are writing and as I just said before they're also writing for more patients. Speaker 400:32:23So I think that's what you're seeing reflective in the TRx data. And then, your question on the mix of bottle versus packs, yes, the packs it's about 10% and our planning that's what we always assume to see in our mix and you should expect that to carry forward. Speaker 800:32:39Great. Okay. Thank you. Operator00:32:42Thank you very much. One moment for our next question. Our next question comes from Chase Knickerbocker of Craig Hallum. Chase, your line is open. Speaker 800:32:54Hi, good morning, everyone. This is Abhir Hoot on for Chase here. Just one from us for BloomcarX. So when should we expect the volume that is under blinkrx here to become really fairly small amount over of the overall volume, let's say, less than 20%, should we think of that kind of being in the latter half of twenty twenty four? Or do you think it doesn't that won't happen until 2025? Speaker 400:33:25So Chase, I think it's hard to put a number on that. I think what you can expect is that that's going to as I've been saying is that that's going to decline over time. We've got an interesting launch and a positive launch. We're bringing on new physicians. We're bringing on new payers and we're in the middle of a launch and we're getting ready for a launch. Speaker 400:33:44So as this continues to grow, you're just going to see a lot of movement on a lot of metrics given all those factors. I think the key signal to us are 2 things. You heard today the increase in access, and you heard, as we said last time, start to see that shift, what would be the patient support or cash that goes through BLINK. So, don't have a number to give you today. I think there's a lot of movement in the market for us. Speaker 400:34:08That's all very positive, as I just mentioned, and you'll continue to see that decline during the year. Speaker 200:34:17Thank you. Operator00:34:19Thank you very much. One moment for our next question. Our next question comes from Annabel Samimy of Stifel. Annabel, your line is open. Speaker 900:34:31Hi, all. Thanks for taking my question. I guess I'm going to get just a little bit more granular on Blink for a minute. So you said that it's going to decrease over time, but is there a scenario where you have increased demand faster than you get payers on board and perhaps you have the percentage going through BLINK increasing before it decreases? I guess that's the first question. Speaker 900:34:52And as far as coverage is concerned and what the tail of BLINK might be, is there a steady state of coverage that you think that you'll get to like 70% or 80% of that and on that tail end, is BLINK going to stop and then those patients just don't get prescriptions fulfilled? And so just trying to understand the go forward dynamics there. Thanks. Speaker 400:35:22Yes. So Annabel, there were a couple of questions there, but they're all have a common thread and related. So, I think I'm going to hit them all here. Is there a case where demand might grow faster than payer coverage? That's an interesting question. Speaker 400:35:36I think we've seen a steady growth and that's what we feel good about. Our demand is it's steadily growing. So I think you'll continue to see that. And we're far along in negotiations with the other major payers, which will be continuing through Q2 and Q3. So, I don't think that's going to be the case. Speaker 400:35:54I think we're going to have, coverage come on board as we see growth in prescriptions. And I think the next part of that was would we see an increase in cash Blynk covered scripts before we saw a decrease? I'm not prepared to say that that's correct or incorrect, but it's not what we're expecting. I think you saw a big change from our last earnings call, where we had that 1 to 1 versus sixty-forty. So our anticipation is that will continue to decline. Speaker 400:36:24And then, will we continue BLINK? I mean, we'll always look to do the right things for patients. There will always be some level of coverage that doesn't exist. And we want to make sure that we do the right things for patients. So we'll always be in there. Speaker 400:36:38And then in terms of I think one of your other questions was steady state for coverage. I think we're going to see it continue to grow, as I just said a moment ago between going into Q2, which we're in and you've already seen it. So we've kind of kept that statement that we made in the last earnings call that we expected to see more growth in Q2 and Q3. So we've already had our first step in Q2 and we believe there's more to come in Q2 and Q3. Speaker 900:37:03Okay. Thank you. Operator00:37:05Thank you very much. One moment for our next question. Our next question comes from Matthew Caulfield of H. C. Wainwright. Operator00:37:15Matthew, your line is open. Speaker 1000:37:18Hi, good morning, guys. So for the launch, is there any granularity that you can share at this stage between the prescriptions coming from GI or primary care? And do you anticipate 1 or the other being a greater target or contributor for growth? Thanks. Speaker 400:37:36So I'm sorry, did you finish? Speaker 800:37:40Yes. Speaker 400:37:40Okay. I'm sorry. I thought I cut you off. Just want to make sure. So, yes, so right now we're seeing not to our surprise that the percentage of scripts are leaning heavier towards GI. Speaker 400:37:52So what's the rationale for that? I know we've spoken in the past that when we sent our sales force out, their objective was to start at the higher deciles, would be the higher volume physicians. So really starting on those decile tens and working down to 9, 8, etcetera. And that's where you see the imbalance between the GIs being the higher decile and the primary care being lower. So yes, so right now at this point, we're seeing a higher slant towards gastroenterologists, but we're actually seeing primary care come on board. Speaker 400:38:21So it's playing out exactly as we thought it would. Speaker 1000:38:26Very helpful. Thank you. And then maybe if I could just ask one more quick question. In regards to the current fill rate, do you know how that kind of stacks up against something like a more established PPI? Presumably not all the PPI prescriptions are getting filled either, but just curious how that could compare possibly? Speaker 400:38:43Yes. So I think that's a hard comparison. I think when you're looking at something that's a generic product that's been around for 30 some odd years and is also OTC, I think a better way to look at it is our fill rate as it compares to a launch product and where we are. And what you heard today was a rate we have of 41%. And we know looking at other launches that not only is that consistent, but it's actually in a really good position right now at our place of launch. Speaker 400:39:16So, and a lot of that's kind of driving in terms the coverage we have right now has come on board, as we announced today with Cigna, and that fill rate will only go up moving forward. Speaker 1000:39:28Great. Very helpful guys. I appreciate it.Read morePowered by