NASDAQ:LXRX Lexicon Pharmaceuticals Q3 2023 Earnings Report $0.71 +0.01 (+0.71%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$0.71 +0.01 (+0.79%) As of 04/25/2025 07:56 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 Lexicon Pharmaceuticals EPS ResultsActual EPS-$0.21Consensus EPS -$0.22Beat/MissBeat by +$0.01One Year Ago EPSN/ALexicon Pharmaceuticals Revenue ResultsActual Revenue$0.16 millionExpected Revenue$1.49 millionBeat/MissMissed by -$1.33 millionYoY Revenue GrowthN/ALexicon Pharmaceuticals Announcement DetailsQuarterQ3 2023Date11/8/2023TimeN/AConference Call DateWednesday, November 8, 2023Conference Call Time8:00AM ETUpcoming EarningsLexicon Pharmaceuticals' Q1 2025 earnings is scheduled for Thursday, May 1, 2025, with a conference call scheduled at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Lexicon Pharmaceuticals Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 8, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good day, and welcome to the Lexicon Pharmaceuticals Third Quarter 2023 Financial Results Conference Call. Today, all participants will be in a listen only mode. Conference Specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. Please note that today's event is being recorded. Operator00:00:38I would now like to turn the conference over to Keri Sarabusa. Please go ahead. Speaker 100:00:44Thank you, Chris. Good morning, and welcome to the Lexicon Pharmaceuticals Q3 2023 financial results conference call. Joining me today are Lonnel Coats, Lexicon's Chief Executive Officer Jeff Wade, Lexicon's President and Chief Financial Officer Doctor. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer and Tom Garner, Lexicon's Senior Vice President and Chief Commercial Officer. Earlier this morning, Lexicon issued a press release announcing our financial results for the Q3 of 2023, which is available on our website at www.lexpharma.com and through our SEC filings. Speaker 100:01:23A webcast of this call, along with a slide presentation, is available on our website. During this call, we will review the information provided in the release, provide a corporate update and then use the remainder of our time to answer your questions. Before we begin, let me remind review that we will be making forward looking statements, including statements relating to the safety, efficacy, clinical development, regulatory status and therapeutic and commercial potential of IMpepha, LX9211 and our other drug programs. These statements may will include characterizations and projections relating to our commercial launch of Empefa in heart failure as well as the clinical development, regulatory status and market opportunity for all of our drug programs. This call may also contain forward looking statements relating to our growth and future operating results, discovery and development of our drug candidates, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Speaker 100:02:24Various risks may cause our actual results to differ materially from those expressed or implied in such forward looking statements. These risks include uncertainties related to our commercial launch of Empefa, our discussions with the FDA and other regulatory authorities regarding our drug programs, the timing and results of clinical trials and preclinical studies of our drug candidates, our dependence upon strategic alliances and other third party relationships, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our planned research, development and commercialization activities. I would now like to turn the call over to Lonnel Coats. Speaker 200:03:07Thank you, Carrie. Good morning, everyone, and thank you for joining us on the call. The 3rd quarter represents the 1st full quarter of the AMPEPHA launch. While it is still early, the market is what we expected, full of near term challenges, coupled with substantial near and long term opportunities. As expected, market access has proven to be a near term restraint on early launch growth. Speaker 200:03:33We have dedicated enormous effort to break through secure broad formulary access. Encouragingly, we have been seeing increasing prescription demand and clinical utilization for ONPEPA and notwithstanding limited access are now starting to see major formulary wins with some of the more notable becoming effective on November 1. With EMPEPA's significant clinical share of voice in publications and medical meetings, coupled with additional expected formulary wins and increasing uptake from a broadening base of priority physicians, we are confident The momentum behind Empefa will continue to accelerate as we enter 2024. Our new Chief Commercial Officer, Tom Garner, will walk you through the early launch dynamics in more detail shortly. Turning to LX9211, We have commenced late stage development in diabetic peripheral neuropathic pain with patient enrollment expected to begin this quarter and a Phase 2b dose optimization clinical trial. Speaker 200:04:41ALX9211 could become the first new non opioid drug from neuropathic pain in over 2 decades. Neuropathic pain represents a significant market opportunity. We have lined our development plan with recently received FDA feedback to move forward with a strategy that is designed to optimize development time and efficiency, while also maximizing the likelihood of a successful path to regulatory approval. I will now turn the call over to Tom Garner, who recently joined Lexicon as Chief Commercial Officer to provide his perspective on the commercial launch of EMPEPA. Speaker 300:05:23Thank you, Lonnel, and good morning, everyone. It's a pleasure to speak with you all today. So starting with heart failure market dynamics, the updated treatment guidelines and growing clinical evidence continue to help fuel the growth of heart failure indicated SGLT for that indication. SGLT inhibitor use in heart failure has grown by 70 3% year over year through August of 2023, with the entire heart failure branded market growing by almost 40% from 2021 to 2022, representing a rapidly growing opportunity of at least $3,000,000,000 Even with this significant momentum, the utilization of SGLT inhibitors for the treatment of heart failure was only around 10% last year, providing tremendous opportunity for a new treatment like IMpepha, which has compelling and differentiated data in this specific patient population. On the next slide, you will see 2 critical focus areas for the Impella launch, namely demand generation and formulary access. Speaker 300:06:32We are encouraged by the momentum that we are building on both of these fronts. As we look at demand generation, our teams have been focused on driving awareness in trial of IMpepha with high volume writers who treat the majority of heart failure patients in the United States. As a result of these efforts, the number of unique prescribers for Impella has grown throughout Q3 and will remain a key strategic area of focus for our cross and teams moving forward. Importantly, we are seeing meaningful increases in IMpepho demand as evidenced by submitted claims data that has outpaced filled prescriptions, which is expected as formulary access continues to build. It's worth noting that as we close out the 1st full quarter of our commercial launch, we have seen an acceleration in our paid prescription data, reflecting improving access conditions for Impella. Speaker 300:07:27In terms of formulary access, the team has been focused on discussions with both national and regional payer plans and has successfully engaged with all targeted plans with multiple layers of engagements throughout Q3. As we announced in our press release this morning, key formulary access contracts were executed in Q3 in both Medicare and commercial channels, and we expect access to continue throughout Q4. We will also share more information today about integrated delivery networks or IDNs, which also remain a strategic focus given the uniqueness of the SOLOIST patient population and valuable rehospitalization data for IMpepha. Turning to additional quarterly launch metrics, you will see here a view of ex factory shipments to wholesalers, data on prescriptions and unique prescribers and a summary of demand data. Ex factory shipments continued through the Q3 as wholesalers used up the initial orders received in June, trends that we have continued to see accelerate throughout the quarter. Speaker 300:08:33As mentioned previously, we are hyper focused on growing the unique prescriber base for Impella, which has expanded nearly 500 healthcare professionals through the quarter. The majority of which are from key high priority, high prescriber targets. We have been encouraged to see the growing clinical demand data outpacing our full prescription data by a ratio of nearly 5:one. With contracted access continuing to build with large national payers, we believe that this growing clinical demand will lead to additional filled prescriptions as Impella achieves greater formulary coverage. As you will see on the next slide, filled prescriptions continued to grow week over week throughout Q3 2023 with an acceleration in the last few weeks of the quarter. Speaker 300:09:21It's also worth noting that this number reflects prescriptions being reported directly through IQVRA and Symphony alongside those that are going through our specialty pharmacy, which are not invisible to 3rd party agencies. As mentioned on the prior slide, top line demand has outpaced the number of prescriptions filled with nearly 5,000 submitted claims through Q3, clearly demonstrating the impacts of our field teams and customer belief in the clinical value offered by AMPEPHA. Turning to our progress on payer coverage, we have been pleased to see coverage for Empefa grow throughout Q3 across both commercial and Medicare formularies. The additions to Medicare plans are particularly significant given that these are early additions outside of the normal contracting process with major national payers. We do expect additional plan coverage to be added through Q4 into next year. Speaker 300:10:19Turning to IDNs. IDN integrated delivery networks remain a key component of our launch strategy. Given the typical new to market block for IDN formery additions, our primary focus in Q3 has been on building the foundations for coverage. The team has initiated contract negotiations with all 4 major group single organizations, 2 of which have already been fully executed. The executed contracts represents around 60% of heart failure lives in our targeted institutions. Speaker 300:10:53Once GPO contracting is completed, IDN Systems will be able to evaluate both clinically and financially during their formative product reviews, which we expect to begin later this year and into 2024. In summary, Q3 was an important quarter for the launch of IMpetha with meaningful progress made on the execution of the launch strategy across the entire commercial organization. We are pleased by the positive reception given by the clinical community to IMpepha as the only SGLT-onefour inhibitor indicated for the treatment of heart failure. The team remains laser focused on further accelerating the positive momentum we have begun to build since launch and helping even more patients with worsening heart failure wherever they may be cared for. I will now turn the call over to Craig to give an overview of the most recent scientific and medical data releases for IMpepha. Speaker 400:11:51Thank you, Tom, and great to have you on the team. We're continuing to communicate meaningful and differentiated scientific and medical data on AMPEPA to the broad scientific community. As you can see on this slide, our data presentations over the last several months have focused on 4 key differentiating areas for AMPEPA, clinical analyses, real world evidence, pharmacoeconomic data including both cost effectiveness and budget impact and mechanism of action. Quite recently, we supported a post hoc analysis of our Phase 3 SCORED study at the Heart Failure Society of America Annual Scientific Meeting that looked at the reduction in the risk of cardiovascular events in patients with left ventricular hypertrophy without hypertension. This data is of particular interest to heart failure specialists and to Lexicon as we evaluate future opportunities for broadening the use of INPEPA. Speaker 400:12:51At the American Managed Care Pharmacy Nexus 2023 meeting, we presented cost effectiveness data and budget impact modeling data for AMPEFA, which were also published in the Journal of Managed Care and Specialty Pharmacy. These studies serve as evidence that AMPEPHA is an affordable treatment that offers important clinical value for heart failure patients and significant value for payers. Last weekend, the American Society of Nephrology held its annual kidney week meeting where Lexicon supported several presentations addressing the challenges and complications of diabetes and chronic kidney disease. Of note, ASN itself selected one of the presentations for a featured independent press release and highlighted the analysis of sotagliflozin and kidney and cardiorenal outcomes from the SCORE trial. We are proud of this independent recognition from ASN as we continue to study the clinical benefits of sotagliflozin And we at Lexicon are committed to working diligently to inform broadly the scientific evidence demonstrated. Speaker 400:14:02Now turning to the future, we are also looking forward to the American Heart Association scientific sessions that are starting in just a few days. We will be supporting data presentations across all domains we have identified as differentiating that is clinical, real world evidence, pharmacoeconomic data and the Impella mechanism of action. We expect that the oral presentation of data assessing sotagliflozin's effect on early clinical benefit for heart failure and atherosclerotic events will be of particular interest to the scientific and medical communities. While I have just shared with you data that Lexicon and our academic collaborators have been publishing on Mpepha, I'd now like to share with you data that the academic community itself has published independently of Lexicon regarding the opportunity that exists in addressing the needs of patients with heart failure. A recent publication in the Journal of the American Heart Association entitled Acute Heart Failure is a Malignant Process, but We Can Induce Permission. Speaker 400:15:11Noted that acute heart failure due to both increasing prevalence in early readmission and death rates of greater than 30% annually make heart failure, a malignant condition. Beyond the poor medical outcomes of heart failure patients, the publication also noted that acute heart failure represents one of the largest drivers of healthcare costs globally. The publication also examined Several studies recently published in the peer review literature, which have demonstrated that remission in this malignant process can be induced if therapy is instituted rapidly. It is important to note that 2 studies from the SGLT class were included in this analysis, including the SOLOIST WHF study of INPEFA that is seen in panel A of the figure. Data from the SOLOIST WHF study, which included stabilized patients hospitalized for heart failure were included in this composite figure and show the evidence of sotagliflozin's early benefit in this at risk population. Speaker 400:16:19This represents a key differentiating aspect and our promotional strategy. The publication concludes that there is an urgent call for all stakeholders to come together to address the gaps and implementation and enable healthcare providers to induce durable remissions in patients with acute heart failure. We strongly support this messaging and we'll continue to support the community by providing continuing medical education about the importance of the early initiation of SGLT inhibitors like Empefa at discharge or promptly following an acute heart failure event. Now we will turn briefly to an update on LX9211. We believe LX9211 has a promising profile based on 2 completed proof of concept studies and a substantial market opportunity. Speaker 400:17:14LX9211 has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from diabetic peripheral neuropathic pain or DPNP on a daily basis. This large and growing market with high unmet medical need of more than 20,000,000 Americans experiencing neuropathic obtained an approximately $5,000,000 with DPNP in the U. S. In 2022 alone. As a reminder, Lexicon has been granted fast track designation by the FDA for the development of LX9211 in DPNP. Speaker 400:17:54As we have shared in previous updates, we are advancing LX9211 into late stage clinical development with a program directed toward PMP regulatory approval. Our plan is reflective of the feedback we recently received from FDA, including ADPS remaining the primary endpoint of future studies and targeting a DPNP population similar to that enrolled in our Phase 2 proof of concept study. The FDA also agreed with the potential for inclusion of the phrase Operator00:18:27Early Speaker 400:18:27onset pain relief with persistent effect in the label if supported by clinical evidence and our approach for dose selection of the Phase 3 studies. Speaker 200:18:37The 1st Speaker 400:18:38late stage trial named PROPRS will be a dose optimization study with an extension designed to satisfy ICH guidelines for long term exposure requirements that will run-in parallel with the planned next stage Phase 3 trials. As a reminder, the progress study was specifically designed to enable a more efficient Phase 3 study execution as well as to derisk investment while maintaining overall program timelines and costs. Finally, turning to the progress study design, it will have an 8 week treatment duration and will enroll adult patients with either type 1 diabetes or type 2 diabetes who have moderate to severe diabetic peripheral neuropathic pain. Our teams have been hard at work completing the start ups of the study throughout Q3 and we expect initiation of dosing in early December 2023 and early data readout expected in Q2 2025. I'd now like to turn the call over to Jeff to take us through the financial results for the Q3 of 2023. Speaker 500:19:49Thank you, Craig. I will review some key aspects of our Q3 2023 financial results. More financial details can be found in the press release that we issued earlier today and then our 10 Q that will be filed shortly with the SEC. We ended the quarter with $218,400,000 in cash and investments. We believe that our existing capital resources provide us with the appropriate level of funding to support the commercial launch of Bempepah and to make our planned investments in research and clinical development. Speaker 500:20:22Our loan facility with Oxford Finance, which offers up to $50,000,000 in additional borrowing capacity provides financial flexibility as we continue the launch of Mpepho. We anticipate that our existing cash and investments together with capacity under the loan facility will provide us sufficient resources to manage our operations well into 2020 As indicated in our press release this morning, we had $160,000 in revenues in the Q2 of 2020 3 compared to minimal revenues in 2022. And PEPA net revenues from launch in late June through September 30th totaled approximately $400,000 Research and development expenses for the Q3 of 2023 increased to $17,600,000 from $10,600,000 for the corresponding period in 2022, primarily due to higher manufacturing costs and higher external R and D expenses related to the LX9211 program, partially offset by lower professional and consulting fees. Selling, general and administrative expenses for the Q3 of 2023 increased to $32,200,000 from 12.6 relating to the commercial launch of EMPEPA. In total, net loss for the Q3 of 2023 was $50,500,000 or $0.21 per share as compared to a net loss of $23,400,000 or $0.13 per share in the corresponding period in 2022. Speaker 500:22:06For the 3rd quarters of 2023 2022, net loss included non cash stock based compensation expense of $3,900,000 $2,600,000 respectively. As with the prior quarter, we are also including a view of are 2023 full year expense guidance. This includes expected R and D expenses of between $60,000,000 $70,000,000 SG and A expenses of between $110,000,000 $120,000,000 and total operating expenses of This includes non cash expenses of $17,000,000 to $18,000,000 for stock based compensation, depreciation and amortization. Operator00:23:05We will now begin the question and answer session. Today's first question comes from Yigal Nochomovitz with Citi. Please proceed. Speaker 600:23:42Hi, team. This is Carly on for Yigal. Thanks for taking our questions. We just wanted to drill down a bit on the market access side. You mentioned about 25% of lives covered, I think, at the end of the quarter, and that's expected to increase further in the Q4. Speaker 600:23:59Just curious when you would expect to really have the vast majority of lives covered and we could potentially really see an inflection point in the launch? Thank you. Speaker 200:24:13Carly, that's a great question. If you recall from the last conference call, we said you should pay very close attention to the Q1 of next year. I think based on the rate that we're moving on at this point in time, I think where you'll see probably the vast majority of the opportunity for us to capture coverage will be in the first half of next year. I think that's when you'll start to see the real shift happen for the brand. To the point that Tom made, we're very encouraged that the demand is there. Speaker 200:24:45We know that. The access has to match the demand. And when that happens, then you have a we should have a Very significant bend in the curve. And so my projection would be we'll have the majority of what we need to have covered by the Q2 of next year. Speaker 600:25:01Okay, got it. That's helpful. And then just as a follow-up, curious if there's any insight that you have into the profile of The initial patients that are being prescribed in PEFA, if there's any subgroup or consistency in terms of patient characteristics where you feel like the demand is particularly strong? Thank you. Speaker 200:25:26I'll turn it over to Tom. Speaker 300:25:27Yes. Good morning. Thanks for the question. I think, I mean, the initial profile seems To be as you would expect kind of the heart failure patient who is either recently out of hospital or could be being discharged from hospital. I mean that's where obviously SOLOS data, I think speaks most loudly. Speaker 300:25:46But if you look at kind of strategically where we've been focused, I mean, it's in both inpatient and outpatient as we consider kind of where those patients sit today and how they move through the system. So Nothing specific at this point in time that's kind of calling out an IMpeper patient versus a majority and sort of Farxiga patient, but I think we will learn considerably more over coming period. Speaker 600:26:10Okay, great. That's helpful. Thank you for taking the questions. Operator00:26:17The next question comes from Andrew Tsai with Jefferies. Please proceed. Speaker 700:26:23Hey, good morning. Thanks for taking our questions. So maybe two questions. The first one is more about the Q3 sales breakdown. How much inventory build or drawdown was there in the quarter? Speaker 700:26:39And then secondly, what were the gross to nets like? Were they below 50%? And then secondly, interestingly, in one of your slides. It looks like there are 5,000 claims as of Q3, whereas 1,000 have been filled. So the question is what percentage of those 5,000 would or could get converted and how quickly could they get converted? Speaker 700:27:03Thanks. Speaker 200:27:05Great question. Jeff, let me have you take the first part of that. Speaker 500:27:09Okay. So gross to net is same as it was last quarter, it's in the low 40% range. And we So that's like the first part of your question, the Speaker 400:27:31Inventory. Speaker 500:27:32The inventory actually the inventory has been drawn down quite a bit. And so basically we started off with an inventory build. So that We're now towards a more steady state in terms of where we are right now. That a lot of what got filled out of in the Q3 was a drawdown of the inventory build. But we're replacing that on a regular basis now. Speaker 500:28:04And so that's were kind of at this point, I would say after that initial fill of the channel, then it's probably closer to steady state now. Speaker 300:28:15Maybe I'll take the second question. So in relation to the 5,000 claims, so as we mentioned, we're encouraged by the fact that Doctors are putting pen to paper. They clearly see the value for Impella and they want to try for heart failure. So that's very encouraging. As we stated, as we exited Q3, our coverage was about 25% within the quarter as we exited. Speaker 300:28:40And that didn't obviously reflect some of the bigger wins that we've announced over the last few weeks. So that number is going to improve Pretty dramatically. We do anticipate through this quarter and then beyond. So rather than being a 20% conversion rate, that will continue tick upwards into the 30s 40s and even higher as we gain further wins. So we do anticipate that that will continue to grow pretty Quickly, quite frankly, especially with ESI going live last week, which is a pretty major win and we have others on the way as well. Speaker 300:29:13So That's kind of how we see this developing over time. Speaker 700:29:20Great. Thank you very much. Speaker 200:29:23Thank you, Andrew. Operator00:29:27The next question is from Joseph Stringer with Needham and Company. Please proceed. Speaker 700:29:34Hi. Thanks for taking my questions. Just a follow-up on the gross to net commentary. You mentioned that it's in the low 40% range for Q3. Is this the expectation for what you would expect it to look like at steady state, maybe some additional color there? Speaker 700:29:52And then just quickly on the Phase IIb pain trial, Can you remind us how similar the patients are going into the Phase IIb relative to the Phase IIa trial in terms of inclusion, exclusion criteria and guidance for top line results from the Phase 2b? Thanks. Speaker 200:30:12Joe, I'll take that first part and just say it's too early to give you steady state on gross to net. We're negotiating agreements every day. And so I think as we get Another quarter or 2 under our belt and we'll be able to give you some clear guidance. But at this moment, lots of negotiations are ongoing with the intent of broadening access. So stay tuned on that one. Speaker 200:30:312nd part, I'll turn it over to Craig. Speaker 400:30:33Yes. Thank you, Joey. Great question. And this was one that we spent a lot of time thinking about with our study sites who are the high performing sites from our 2A DPNP program that enrolled the majority of the patients and we're including all of our best performing sites. They're all excited to dissipate in the program again as well as feedback from Tore, consultants as well as FDA itself. Speaker 400:30:58And we really want to focus on those patients similar to the 2A with longstanding DPNP stable in their diabetes care, whether it's type 1 or type 2 diabetes, but with significant pain. We're also allowing like the Phase 2a study those to be on an underlying DPNP medication. And we learned a lot in terms of some of the PROs and other metrics that we're putting into the study. So we're really going with a population that has significant unmet medical need, which is also a very large Amount of the market, there is a large number of these patients with significant need that is not being met by current care. And we feel confident based on all of the work that we've done that we can enroll the study in the timeframe that we've set out. Speaker 400:31:51And the second part of your question related to the timing is that we're really looking to have 1st patient enrolled, as I've already mentioned in early December, all the site validation work and site initiation work has been completed. IRBs are approving the protocol and we expect to have data from that 8 week treatment period, Q2 of 2025. As I mentioned, all the patients will be the have the opportunity to roll over into a long term follow-up study on drug, which allows us both to have additional data, But also is a good inducement to get patients to participate in a blinded study with a placebo. So we've really tried to optimize based on what we've learned from our study sites, from the patients and from the FDA. Speaker 200:32:38Yes. The only thing I will add to that is We're operating in a non COVID environment now. And so we learned a lot. The last time we did this, we were head on inside the COVID environment that slowed that trial. So we've learned a lot from that and I think that'll help us with some of our acceleration. Speaker 200:32:56And the second thing is when you have proven you've got a proven concept, which we have proven in the first study, it's easier to the point that Craig has made to get that IRB support as well as to get this study up and rolling and encourage sites to come on board. So we should have a much more valid opportunity to move a greater speed than we did the first time. Speaker 700:33:21Great. Thank you for taking our questions. Speaker 200:33:23You bet. Operator00:33:28The next question comes from Yasmeen Rahimi with Piper Sandler. Please proceed. Speaker 700:33:34Hi, team. This is Jin Liu on for Yas today. Thanks for taking our questions. We have 2 on our end. First, could you describe the geographies that are high focus currently? Speaker 700:33:44And our second question is, how are you thinking about partnership interest for LX9211 or in peso outside of the United States? Speaker 200:33:54The first question was geography of the sales team? Yes, correct. For prescribing? Okay. Speaker 300:34:02Yes, yes. So as per most Major cardiac conditions of which heart failure is 1. You do tend to see a clustering around major metropolitan centers. So if you kind of look at our Geographic distribution, both of the sales team and of prescribers today, as you would imagine, there's a clustering within kind of The Eastern seaboard of the U. S. Speaker 300:34:25And along the West Coast as well. Although I would also add that as you move from East To us, we do see significant opportunity within major centers there as you move kind of through the Midwest. So Encouragingly, we're seeing usage from across the country, both in larger academic institutions, But also within the community setting as well, which I think again talks to the value of the Impella clinical story that we're able to share and the fact that our Clinicians really do understand the differentiated profile that we have in this specific population. So, obviously, it's early days, 5,000 claims as you've heard with from around 500 writers. We do anticipate that that number is going to increase pretty markedly through this quarter and we look forward to be able Share more information with you in early next year. Speaker 200:35:17I would add on the second question on LX9211 in terms of partnering. There remains very good interest in LX9211. From our perspective is we have to think about how do we continue to develop this to maximize value for our stakeholders. From my perspective, we have an effective dose. We already know that. Speaker 200:35:38What we're doing now is to create an optimal dose that allows us to have an efficient Phase 3 program. And I think in doing that, that then sets us up to have an asset that I think has broader and bigger value, Particularly if we want to expand beyond just DPNP because I think the drug has application in all of their not all of them, but a Big part of neuropathic pain. In order to do that, we would then need a partner. But for DPNP, I think this next step, it needs to stay in our hands for us to get that optimal dose and doing that should we be successful. I think that opens up a much broader and bigger opportunity for us. Speaker 200:36:17If we move, I think too fast on this, then I think we will be less optimal in terms of what value we will achieve with it. So At this point in time, I think we need to execute well on this study, get on the other side of it and keep the partners at bay until we get that done. Operator00:36:45At this time, we are showing no further questioners in the queue. And this does conclude our question and answer session. I would now like to turn the conference back over to Mr. Lonnel Coats for any closing remarks. Speaker 200:36:58Well, let me say thank you to everyone for joining us on the call today Yes, and your continued support of Lexicon. Let me close out by summarizing our upcoming key milestones and events. First, we are on target with the late stage development plans we share for LX9211 and diabetic peripheral nerve path pain. This is another large and growing market still in need of innovative treatments and we expect the progress study to begin enrollment in December of this year. 2nd, we are highly focused on delivering on a successful launch of Empeza. Speaker 200:37:32We have a focused commercial strategy that leverages our unique clinical data and we're entering a market that is just beginning to reflect the growth driven by the new treatment guidelines, which include SGLTs as a pillar of heart failure treatment. We are pursuing market access for Empeza across all channels and have been able to see early access additions throughout this quarter and expect to be able to share incremental news as we move into 2024. I remain remarkably encouraged and I'm very pleased that Tom Joyner Tom Joyner Tom Garner has chosen to join us as we make efforts to accelerate this launch in 2024. Finally, importantly, Lexicon is in a strong cash position with the ability to fund operations well into 2025. Thank you very much. Operator00:38:27The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLexicon Pharmaceuticals Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Lexicon Pharmaceuticals Earnings HeadlinesLexicon Pharmaceuticals to Present at the 24th Annual Needham Virtual Healthcare ConferenceApril 2, 2025 | globenewswire.comLexicon stock soars on Novo Nordisk licensing dealMarch 29, 2025 | za.investing.comReal Americans Don’t Wait on Wall Street’s Next MoveWhat's happening in the markets right now should concern every freedom-loving American who's worked hard and saved smart. Your 401(k) doesn't deserve to be dragged through the mud by tariffs, trade wars, reckless spending, and political standoffs. And you don't have to stand by while Wall Street plays roulette with your future.April 27, 2025 | Premier Gold Co (Ad)Lexicon announces exclusive license agreement with Novo Nordisk for LX9851March 29, 2025 | markets.businessinsider.comLexicon announces exclusive license agreement with Novo Nordisk for LX9851March 29, 2025 | markets.businessinsider.comWhat 6 Analyst Ratings Have To Say About Lexicon PharmaceuticalsMarch 29, 2025 | benzinga.comSee More Lexicon Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Lexicon Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Lexicon Pharmaceuticals and other key companies, straight to your email. Email Address About Lexicon PharmaceuticalsLexicon Pharmaceuticals (NASDAQ:LXRX), a biopharmaceutical company, focuses on the discovery, development, and commercialization of pharmaceutical products. Its orally-delivered small molecule drug candidates under development comprise Sotagliflozin that completed Phase III clinical trials for the for the treatment of heart failure and type 1 diabetes; and LX9211, which is in Phase II clinical development for the treatment of neuropathic pain and LX2761, which is in Phase I clinical development for gastrointestinal tract. Lexicon Pharmaceuticals, Inc. has strategic collaboration and license agreements with Bristol-Myers Squibb Company and Genentech, Inc. 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There are 8 speakers on the call. Operator00:00:00Good day, and welcome to the Lexicon Pharmaceuticals Third Quarter 2023 Financial Results Conference Call. Today, all participants will be in a listen only mode. Conference Specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. Please note that today's event is being recorded. Operator00:00:38I would now like to turn the conference over to Keri Sarabusa. Please go ahead. Speaker 100:00:44Thank you, Chris. Good morning, and welcome to the Lexicon Pharmaceuticals Q3 2023 financial results conference call. Joining me today are Lonnel Coats, Lexicon's Chief Executive Officer Jeff Wade, Lexicon's President and Chief Financial Officer Doctor. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer and Tom Garner, Lexicon's Senior Vice President and Chief Commercial Officer. Earlier this morning, Lexicon issued a press release announcing our financial results for the Q3 of 2023, which is available on our website at www.lexpharma.com and through our SEC filings. Speaker 100:01:23A webcast of this call, along with a slide presentation, is available on our website. During this call, we will review the information provided in the release, provide a corporate update and then use the remainder of our time to answer your questions. Before we begin, let me remind review that we will be making forward looking statements, including statements relating to the safety, efficacy, clinical development, regulatory status and therapeutic and commercial potential of IMpepha, LX9211 and our other drug programs. These statements may will include characterizations and projections relating to our commercial launch of Empefa in heart failure as well as the clinical development, regulatory status and market opportunity for all of our drug programs. This call may also contain forward looking statements relating to our growth and future operating results, discovery and development of our drug candidates, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Speaker 100:02:24Various risks may cause our actual results to differ materially from those expressed or implied in such forward looking statements. These risks include uncertainties related to our commercial launch of Empefa, our discussions with the FDA and other regulatory authorities regarding our drug programs, the timing and results of clinical trials and preclinical studies of our drug candidates, our dependence upon strategic alliances and other third party relationships, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our planned research, development and commercialization activities. I would now like to turn the call over to Lonnel Coats. Speaker 200:03:07Thank you, Carrie. Good morning, everyone, and thank you for joining us on the call. The 3rd quarter represents the 1st full quarter of the AMPEPHA launch. While it is still early, the market is what we expected, full of near term challenges, coupled with substantial near and long term opportunities. As expected, market access has proven to be a near term restraint on early launch growth. Speaker 200:03:33We have dedicated enormous effort to break through secure broad formulary access. Encouragingly, we have been seeing increasing prescription demand and clinical utilization for ONPEPA and notwithstanding limited access are now starting to see major formulary wins with some of the more notable becoming effective on November 1. With EMPEPA's significant clinical share of voice in publications and medical meetings, coupled with additional expected formulary wins and increasing uptake from a broadening base of priority physicians, we are confident The momentum behind Empefa will continue to accelerate as we enter 2024. Our new Chief Commercial Officer, Tom Garner, will walk you through the early launch dynamics in more detail shortly. Turning to LX9211, We have commenced late stage development in diabetic peripheral neuropathic pain with patient enrollment expected to begin this quarter and a Phase 2b dose optimization clinical trial. Speaker 200:04:41ALX9211 could become the first new non opioid drug from neuropathic pain in over 2 decades. Neuropathic pain represents a significant market opportunity. We have lined our development plan with recently received FDA feedback to move forward with a strategy that is designed to optimize development time and efficiency, while also maximizing the likelihood of a successful path to regulatory approval. I will now turn the call over to Tom Garner, who recently joined Lexicon as Chief Commercial Officer to provide his perspective on the commercial launch of EMPEPA. Speaker 300:05:23Thank you, Lonnel, and good morning, everyone. It's a pleasure to speak with you all today. So starting with heart failure market dynamics, the updated treatment guidelines and growing clinical evidence continue to help fuel the growth of heart failure indicated SGLT for that indication. SGLT inhibitor use in heart failure has grown by 70 3% year over year through August of 2023, with the entire heart failure branded market growing by almost 40% from 2021 to 2022, representing a rapidly growing opportunity of at least $3,000,000,000 Even with this significant momentum, the utilization of SGLT inhibitors for the treatment of heart failure was only around 10% last year, providing tremendous opportunity for a new treatment like IMpepha, which has compelling and differentiated data in this specific patient population. On the next slide, you will see 2 critical focus areas for the Impella launch, namely demand generation and formulary access. Speaker 300:06:32We are encouraged by the momentum that we are building on both of these fronts. As we look at demand generation, our teams have been focused on driving awareness in trial of IMpepha with high volume writers who treat the majority of heart failure patients in the United States. As a result of these efforts, the number of unique prescribers for Impella has grown throughout Q3 and will remain a key strategic area of focus for our cross and teams moving forward. Importantly, we are seeing meaningful increases in IMpepho demand as evidenced by submitted claims data that has outpaced filled prescriptions, which is expected as formulary access continues to build. It's worth noting that as we close out the 1st full quarter of our commercial launch, we have seen an acceleration in our paid prescription data, reflecting improving access conditions for Impella. Speaker 300:07:27In terms of formulary access, the team has been focused on discussions with both national and regional payer plans and has successfully engaged with all targeted plans with multiple layers of engagements throughout Q3. As we announced in our press release this morning, key formulary access contracts were executed in Q3 in both Medicare and commercial channels, and we expect access to continue throughout Q4. We will also share more information today about integrated delivery networks or IDNs, which also remain a strategic focus given the uniqueness of the SOLOIST patient population and valuable rehospitalization data for IMpepha. Turning to additional quarterly launch metrics, you will see here a view of ex factory shipments to wholesalers, data on prescriptions and unique prescribers and a summary of demand data. Ex factory shipments continued through the Q3 as wholesalers used up the initial orders received in June, trends that we have continued to see accelerate throughout the quarter. Speaker 300:08:33As mentioned previously, we are hyper focused on growing the unique prescriber base for Impella, which has expanded nearly 500 healthcare professionals through the quarter. The majority of which are from key high priority, high prescriber targets. We have been encouraged to see the growing clinical demand data outpacing our full prescription data by a ratio of nearly 5:one. With contracted access continuing to build with large national payers, we believe that this growing clinical demand will lead to additional filled prescriptions as Impella achieves greater formulary coverage. As you will see on the next slide, filled prescriptions continued to grow week over week throughout Q3 2023 with an acceleration in the last few weeks of the quarter. Speaker 300:09:21It's also worth noting that this number reflects prescriptions being reported directly through IQVRA and Symphony alongside those that are going through our specialty pharmacy, which are not invisible to 3rd party agencies. As mentioned on the prior slide, top line demand has outpaced the number of prescriptions filled with nearly 5,000 submitted claims through Q3, clearly demonstrating the impacts of our field teams and customer belief in the clinical value offered by AMPEPHA. Turning to our progress on payer coverage, we have been pleased to see coverage for Empefa grow throughout Q3 across both commercial and Medicare formularies. The additions to Medicare plans are particularly significant given that these are early additions outside of the normal contracting process with major national payers. We do expect additional plan coverage to be added through Q4 into next year. Speaker 300:10:19Turning to IDNs. IDN integrated delivery networks remain a key component of our launch strategy. Given the typical new to market block for IDN formery additions, our primary focus in Q3 has been on building the foundations for coverage. The team has initiated contract negotiations with all 4 major group single organizations, 2 of which have already been fully executed. The executed contracts represents around 60% of heart failure lives in our targeted institutions. Speaker 300:10:53Once GPO contracting is completed, IDN Systems will be able to evaluate both clinically and financially during their formative product reviews, which we expect to begin later this year and into 2024. In summary, Q3 was an important quarter for the launch of IMpetha with meaningful progress made on the execution of the launch strategy across the entire commercial organization. We are pleased by the positive reception given by the clinical community to IMpepha as the only SGLT-onefour inhibitor indicated for the treatment of heart failure. The team remains laser focused on further accelerating the positive momentum we have begun to build since launch and helping even more patients with worsening heart failure wherever they may be cared for. I will now turn the call over to Craig to give an overview of the most recent scientific and medical data releases for IMpepha. Speaker 400:11:51Thank you, Tom, and great to have you on the team. We're continuing to communicate meaningful and differentiated scientific and medical data on AMPEPA to the broad scientific community. As you can see on this slide, our data presentations over the last several months have focused on 4 key differentiating areas for AMPEPA, clinical analyses, real world evidence, pharmacoeconomic data including both cost effectiveness and budget impact and mechanism of action. Quite recently, we supported a post hoc analysis of our Phase 3 SCORED study at the Heart Failure Society of America Annual Scientific Meeting that looked at the reduction in the risk of cardiovascular events in patients with left ventricular hypertrophy without hypertension. This data is of particular interest to heart failure specialists and to Lexicon as we evaluate future opportunities for broadening the use of INPEPA. Speaker 400:12:51At the American Managed Care Pharmacy Nexus 2023 meeting, we presented cost effectiveness data and budget impact modeling data for AMPEFA, which were also published in the Journal of Managed Care and Specialty Pharmacy. These studies serve as evidence that AMPEPHA is an affordable treatment that offers important clinical value for heart failure patients and significant value for payers. Last weekend, the American Society of Nephrology held its annual kidney week meeting where Lexicon supported several presentations addressing the challenges and complications of diabetes and chronic kidney disease. Of note, ASN itself selected one of the presentations for a featured independent press release and highlighted the analysis of sotagliflozin and kidney and cardiorenal outcomes from the SCORE trial. We are proud of this independent recognition from ASN as we continue to study the clinical benefits of sotagliflozin And we at Lexicon are committed to working diligently to inform broadly the scientific evidence demonstrated. Speaker 400:14:02Now turning to the future, we are also looking forward to the American Heart Association scientific sessions that are starting in just a few days. We will be supporting data presentations across all domains we have identified as differentiating that is clinical, real world evidence, pharmacoeconomic data and the Impella mechanism of action. We expect that the oral presentation of data assessing sotagliflozin's effect on early clinical benefit for heart failure and atherosclerotic events will be of particular interest to the scientific and medical communities. While I have just shared with you data that Lexicon and our academic collaborators have been publishing on Mpepha, I'd now like to share with you data that the academic community itself has published independently of Lexicon regarding the opportunity that exists in addressing the needs of patients with heart failure. A recent publication in the Journal of the American Heart Association entitled Acute Heart Failure is a Malignant Process, but We Can Induce Permission. Speaker 400:15:11Noted that acute heart failure due to both increasing prevalence in early readmission and death rates of greater than 30% annually make heart failure, a malignant condition. Beyond the poor medical outcomes of heart failure patients, the publication also noted that acute heart failure represents one of the largest drivers of healthcare costs globally. The publication also examined Several studies recently published in the peer review literature, which have demonstrated that remission in this malignant process can be induced if therapy is instituted rapidly. It is important to note that 2 studies from the SGLT class were included in this analysis, including the SOLOIST WHF study of INPEFA that is seen in panel A of the figure. Data from the SOLOIST WHF study, which included stabilized patients hospitalized for heart failure were included in this composite figure and show the evidence of sotagliflozin's early benefit in this at risk population. Speaker 400:16:19This represents a key differentiating aspect and our promotional strategy. The publication concludes that there is an urgent call for all stakeholders to come together to address the gaps and implementation and enable healthcare providers to induce durable remissions in patients with acute heart failure. We strongly support this messaging and we'll continue to support the community by providing continuing medical education about the importance of the early initiation of SGLT inhibitors like Empefa at discharge or promptly following an acute heart failure event. Now we will turn briefly to an update on LX9211. We believe LX9211 has a promising profile based on 2 completed proof of concept studies and a substantial market opportunity. Speaker 400:17:14LX9211 has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from diabetic peripheral neuropathic pain or DPNP on a daily basis. This large and growing market with high unmet medical need of more than 20,000,000 Americans experiencing neuropathic obtained an approximately $5,000,000 with DPNP in the U. S. In 2022 alone. As a reminder, Lexicon has been granted fast track designation by the FDA for the development of LX9211 in DPNP. Speaker 400:17:54As we have shared in previous updates, we are advancing LX9211 into late stage clinical development with a program directed toward PMP regulatory approval. Our plan is reflective of the feedback we recently received from FDA, including ADPS remaining the primary endpoint of future studies and targeting a DPNP population similar to that enrolled in our Phase 2 proof of concept study. The FDA also agreed with the potential for inclusion of the phrase Operator00:18:27Early Speaker 400:18:27onset pain relief with persistent effect in the label if supported by clinical evidence and our approach for dose selection of the Phase 3 studies. Speaker 200:18:37The 1st Speaker 400:18:38late stage trial named PROPRS will be a dose optimization study with an extension designed to satisfy ICH guidelines for long term exposure requirements that will run-in parallel with the planned next stage Phase 3 trials. As a reminder, the progress study was specifically designed to enable a more efficient Phase 3 study execution as well as to derisk investment while maintaining overall program timelines and costs. Finally, turning to the progress study design, it will have an 8 week treatment duration and will enroll adult patients with either type 1 diabetes or type 2 diabetes who have moderate to severe diabetic peripheral neuropathic pain. Our teams have been hard at work completing the start ups of the study throughout Q3 and we expect initiation of dosing in early December 2023 and early data readout expected in Q2 2025. I'd now like to turn the call over to Jeff to take us through the financial results for the Q3 of 2023. Speaker 500:19:49Thank you, Craig. I will review some key aspects of our Q3 2023 financial results. More financial details can be found in the press release that we issued earlier today and then our 10 Q that will be filed shortly with the SEC. We ended the quarter with $218,400,000 in cash and investments. We believe that our existing capital resources provide us with the appropriate level of funding to support the commercial launch of Bempepah and to make our planned investments in research and clinical development. Speaker 500:20:22Our loan facility with Oxford Finance, which offers up to $50,000,000 in additional borrowing capacity provides financial flexibility as we continue the launch of Mpepho. We anticipate that our existing cash and investments together with capacity under the loan facility will provide us sufficient resources to manage our operations well into 2020 As indicated in our press release this morning, we had $160,000 in revenues in the Q2 of 2020 3 compared to minimal revenues in 2022. And PEPA net revenues from launch in late June through September 30th totaled approximately $400,000 Research and development expenses for the Q3 of 2023 increased to $17,600,000 from $10,600,000 for the corresponding period in 2022, primarily due to higher manufacturing costs and higher external R and D expenses related to the LX9211 program, partially offset by lower professional and consulting fees. Selling, general and administrative expenses for the Q3 of 2023 increased to $32,200,000 from 12.6 relating to the commercial launch of EMPEPA. In total, net loss for the Q3 of 2023 was $50,500,000 or $0.21 per share as compared to a net loss of $23,400,000 or $0.13 per share in the corresponding period in 2022. Speaker 500:22:06For the 3rd quarters of 2023 2022, net loss included non cash stock based compensation expense of $3,900,000 $2,600,000 respectively. As with the prior quarter, we are also including a view of are 2023 full year expense guidance. This includes expected R and D expenses of between $60,000,000 $70,000,000 SG and A expenses of between $110,000,000 $120,000,000 and total operating expenses of This includes non cash expenses of $17,000,000 to $18,000,000 for stock based compensation, depreciation and amortization. Operator00:23:05We will now begin the question and answer session. Today's first question comes from Yigal Nochomovitz with Citi. Please proceed. Speaker 600:23:42Hi, team. This is Carly on for Yigal. Thanks for taking our questions. We just wanted to drill down a bit on the market access side. You mentioned about 25% of lives covered, I think, at the end of the quarter, and that's expected to increase further in the Q4. Speaker 600:23:59Just curious when you would expect to really have the vast majority of lives covered and we could potentially really see an inflection point in the launch? Thank you. Speaker 200:24:13Carly, that's a great question. If you recall from the last conference call, we said you should pay very close attention to the Q1 of next year. I think based on the rate that we're moving on at this point in time, I think where you'll see probably the vast majority of the opportunity for us to capture coverage will be in the first half of next year. I think that's when you'll start to see the real shift happen for the brand. To the point that Tom made, we're very encouraged that the demand is there. Speaker 200:24:45We know that. The access has to match the demand. And when that happens, then you have a we should have a Very significant bend in the curve. And so my projection would be we'll have the majority of what we need to have covered by the Q2 of next year. Speaker 600:25:01Okay, got it. That's helpful. And then just as a follow-up, curious if there's any insight that you have into the profile of The initial patients that are being prescribed in PEFA, if there's any subgroup or consistency in terms of patient characteristics where you feel like the demand is particularly strong? Thank you. Speaker 200:25:26I'll turn it over to Tom. Speaker 300:25:27Yes. Good morning. Thanks for the question. I think, I mean, the initial profile seems To be as you would expect kind of the heart failure patient who is either recently out of hospital or could be being discharged from hospital. I mean that's where obviously SOLOS data, I think speaks most loudly. Speaker 300:25:46But if you look at kind of strategically where we've been focused, I mean, it's in both inpatient and outpatient as we consider kind of where those patients sit today and how they move through the system. So Nothing specific at this point in time that's kind of calling out an IMpeper patient versus a majority and sort of Farxiga patient, but I think we will learn considerably more over coming period. Speaker 600:26:10Okay, great. That's helpful. Thank you for taking the questions. Operator00:26:17The next question comes from Andrew Tsai with Jefferies. Please proceed. Speaker 700:26:23Hey, good morning. Thanks for taking our questions. So maybe two questions. The first one is more about the Q3 sales breakdown. How much inventory build or drawdown was there in the quarter? Speaker 700:26:39And then secondly, what were the gross to nets like? Were they below 50%? And then secondly, interestingly, in one of your slides. It looks like there are 5,000 claims as of Q3, whereas 1,000 have been filled. So the question is what percentage of those 5,000 would or could get converted and how quickly could they get converted? Speaker 700:27:03Thanks. Speaker 200:27:05Great question. Jeff, let me have you take the first part of that. Speaker 500:27:09Okay. So gross to net is same as it was last quarter, it's in the low 40% range. And we So that's like the first part of your question, the Speaker 400:27:31Inventory. Speaker 500:27:32The inventory actually the inventory has been drawn down quite a bit. And so basically we started off with an inventory build. So that We're now towards a more steady state in terms of where we are right now. That a lot of what got filled out of in the Q3 was a drawdown of the inventory build. But we're replacing that on a regular basis now. Speaker 500:28:04And so that's were kind of at this point, I would say after that initial fill of the channel, then it's probably closer to steady state now. Speaker 300:28:15Maybe I'll take the second question. So in relation to the 5,000 claims, so as we mentioned, we're encouraged by the fact that Doctors are putting pen to paper. They clearly see the value for Impella and they want to try for heart failure. So that's very encouraging. As we stated, as we exited Q3, our coverage was about 25% within the quarter as we exited. Speaker 300:28:40And that didn't obviously reflect some of the bigger wins that we've announced over the last few weeks. So that number is going to improve Pretty dramatically. We do anticipate through this quarter and then beyond. So rather than being a 20% conversion rate, that will continue tick upwards into the 30s 40s and even higher as we gain further wins. So we do anticipate that that will continue to grow pretty Quickly, quite frankly, especially with ESI going live last week, which is a pretty major win and we have others on the way as well. Speaker 300:29:13So That's kind of how we see this developing over time. Speaker 700:29:20Great. Thank you very much. Speaker 200:29:23Thank you, Andrew. Operator00:29:27The next question is from Joseph Stringer with Needham and Company. Please proceed. Speaker 700:29:34Hi. Thanks for taking my questions. Just a follow-up on the gross to net commentary. You mentioned that it's in the low 40% range for Q3. Is this the expectation for what you would expect it to look like at steady state, maybe some additional color there? Speaker 700:29:52And then just quickly on the Phase IIb pain trial, Can you remind us how similar the patients are going into the Phase IIb relative to the Phase IIa trial in terms of inclusion, exclusion criteria and guidance for top line results from the Phase 2b? Thanks. Speaker 200:30:12Joe, I'll take that first part and just say it's too early to give you steady state on gross to net. We're negotiating agreements every day. And so I think as we get Another quarter or 2 under our belt and we'll be able to give you some clear guidance. But at this moment, lots of negotiations are ongoing with the intent of broadening access. So stay tuned on that one. Speaker 200:30:312nd part, I'll turn it over to Craig. Speaker 400:30:33Yes. Thank you, Joey. Great question. And this was one that we spent a lot of time thinking about with our study sites who are the high performing sites from our 2A DPNP program that enrolled the majority of the patients and we're including all of our best performing sites. They're all excited to dissipate in the program again as well as feedback from Tore, consultants as well as FDA itself. Speaker 400:30:58And we really want to focus on those patients similar to the 2A with longstanding DPNP stable in their diabetes care, whether it's type 1 or type 2 diabetes, but with significant pain. We're also allowing like the Phase 2a study those to be on an underlying DPNP medication. And we learned a lot in terms of some of the PROs and other metrics that we're putting into the study. So we're really going with a population that has significant unmet medical need, which is also a very large Amount of the market, there is a large number of these patients with significant need that is not being met by current care. And we feel confident based on all of the work that we've done that we can enroll the study in the timeframe that we've set out. Speaker 400:31:51And the second part of your question related to the timing is that we're really looking to have 1st patient enrolled, as I've already mentioned in early December, all the site validation work and site initiation work has been completed. IRBs are approving the protocol and we expect to have data from that 8 week treatment period, Q2 of 2025. As I mentioned, all the patients will be the have the opportunity to roll over into a long term follow-up study on drug, which allows us both to have additional data, But also is a good inducement to get patients to participate in a blinded study with a placebo. So we've really tried to optimize based on what we've learned from our study sites, from the patients and from the FDA. Speaker 200:32:38Yes. The only thing I will add to that is We're operating in a non COVID environment now. And so we learned a lot. The last time we did this, we were head on inside the COVID environment that slowed that trial. So we've learned a lot from that and I think that'll help us with some of our acceleration. Speaker 200:32:56And the second thing is when you have proven you've got a proven concept, which we have proven in the first study, it's easier to the point that Craig has made to get that IRB support as well as to get this study up and rolling and encourage sites to come on board. So we should have a much more valid opportunity to move a greater speed than we did the first time. Speaker 700:33:21Great. Thank you for taking our questions. Speaker 200:33:23You bet. Operator00:33:28The next question comes from Yasmeen Rahimi with Piper Sandler. Please proceed. Speaker 700:33:34Hi, team. This is Jin Liu on for Yas today. Thanks for taking our questions. We have 2 on our end. First, could you describe the geographies that are high focus currently? Speaker 700:33:44And our second question is, how are you thinking about partnership interest for LX9211 or in peso outside of the United States? Speaker 200:33:54The first question was geography of the sales team? Yes, correct. For prescribing? Okay. Speaker 300:34:02Yes, yes. So as per most Major cardiac conditions of which heart failure is 1. You do tend to see a clustering around major metropolitan centers. So if you kind of look at our Geographic distribution, both of the sales team and of prescribers today, as you would imagine, there's a clustering within kind of The Eastern seaboard of the U. S. Speaker 300:34:25And along the West Coast as well. Although I would also add that as you move from East To us, we do see significant opportunity within major centers there as you move kind of through the Midwest. So Encouragingly, we're seeing usage from across the country, both in larger academic institutions, But also within the community setting as well, which I think again talks to the value of the Impella clinical story that we're able to share and the fact that our Clinicians really do understand the differentiated profile that we have in this specific population. So, obviously, it's early days, 5,000 claims as you've heard with from around 500 writers. We do anticipate that that number is going to increase pretty markedly through this quarter and we look forward to be able Share more information with you in early next year. Speaker 200:35:17I would add on the second question on LX9211 in terms of partnering. There remains very good interest in LX9211. From our perspective is we have to think about how do we continue to develop this to maximize value for our stakeholders. From my perspective, we have an effective dose. We already know that. Speaker 200:35:38What we're doing now is to create an optimal dose that allows us to have an efficient Phase 3 program. And I think in doing that, that then sets us up to have an asset that I think has broader and bigger value, Particularly if we want to expand beyond just DPNP because I think the drug has application in all of their not all of them, but a Big part of neuropathic pain. In order to do that, we would then need a partner. But for DPNP, I think this next step, it needs to stay in our hands for us to get that optimal dose and doing that should we be successful. I think that opens up a much broader and bigger opportunity for us. Speaker 200:36:17If we move, I think too fast on this, then I think we will be less optimal in terms of what value we will achieve with it. So At this point in time, I think we need to execute well on this study, get on the other side of it and keep the partners at bay until we get that done. Operator00:36:45At this time, we are showing no further questioners in the queue. And this does conclude our question and answer session. I would now like to turn the conference back over to Mr. Lonnel Coats for any closing remarks. Speaker 200:36:58Well, let me say thank you to everyone for joining us on the call today Yes, and your continued support of Lexicon. Let me close out by summarizing our upcoming key milestones and events. First, we are on target with the late stage development plans we share for LX9211 and diabetic peripheral nerve path pain. This is another large and growing market still in need of innovative treatments and we expect the progress study to begin enrollment in December of this year. 2nd, we are highly focused on delivering on a successful launch of Empeza. Speaker 200:37:32We have a focused commercial strategy that leverages our unique clinical data and we're entering a market that is just beginning to reflect the growth driven by the new treatment guidelines, which include SGLTs as a pillar of heart failure treatment. We are pursuing market access for Empeza across all channels and have been able to see early access additions throughout this quarter and expect to be able to share incremental news as we move into 2024. I remain remarkably encouraged and I'm very pleased that Tom Joyner Tom Joyner Tom Garner has chosen to join us as we make efforts to accelerate this launch in 2024. Finally, importantly, Lexicon is in a strong cash position with the ability to fund operations well into 2025. Thank you very much. Operator00:38:27The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.Read morePowered by