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spk07: Good day, everyone, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one using a touchtone telephone. To withdraw your questions, you may press star and two. Please also note that today's event is being recorded. And at this time, I'd like to turn the floor over to Terri Siragusa. Ma'am, please go ahead.
spk04: Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. Joining me today are Lynelle Coates, Lexicon's Chief Executive Officer, Jeff Wade, Lexicon's President and Chief Financial Officer, and Dr. Craig Granowitz, Lexicon Senior Vice President and Chief Medical Officer. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the first quarter of 2023, which is available on our website at www.lexpharma.com and through our SEC filings. A 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 you that we will be making forward-looking statements, including statements relating to the safety, efficacy, regulatory status, and therapeutic and commercial potential of Sotagliflozin LX9211 and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of Sotocliflozin, LX9211, and our other drug candidates and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, launch and commercialization plans for any approved products, strategic alliances, and intellectual property, as well as other matters that are not historical facts or information. Various 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 NDA for Sotagliflozin and heart failure, and our discussions with the FDA regarding Sotagliflozin, LX9211, and our other drug candidates. the success of our commercialization efforts with respect to any approved products, the timing and results of clinical trials and preclinical studies of Sotagliflozin, LX9211, and our other 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. For a list and description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. I would now like to turn the call over to Lynelle Coates.
spk05: Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. First quarter of 2023 was another significant period for Lexicon. As we continue to advance in both of our lead programs, Sotagiflozin, our dual SGLT1 and 2 inhibitor that we're developing for heart failure, and LX9211, our AAK1 inhibitor that we're developing for neuropathic pain. Starting with LX9211 program for neuropathic pain, as many of you know, we reported on the results of two phase two proof of concept studies last year in diabetic peripheral neuropathic pain and post-hepatic neuralgia. Bolstered by these results, we have continued to move forward with development plans for late stage development and expect to have feedback from the FDA on these plans in the second quarter of this year. Turning to Sotica-Flozen, as shared in our last quarterly call, we had our late cycle review meeting with FDA in late February for NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues and again confirm that it has no plans to hold an advisory committee meeting. So we believe everything remains on track for our PDUFA target date on May 27th. Now, since our last call, we also wanted to highlight the significant progress we have made across all functions of the company to be launch ready for PDUFA, including but not limited to very productive label discussions and negotiations with the FDA. Appropriate and pre-approval information exchanges with payers across national and regional accounts, government, and institutions. The recruitment of experienced cardiovascular sales professionals, of which the majority are already on board with the company. Presentations at two major medical meetings, including a feature presentation on the time to clinical benefit of Sotagliflozin, which Dr. Granowitz will speak further about shortly. And finally, we finalized, we're finalizing wholesaler and distribution agreements to be ready to ship product within the U.S. shortly following approval. We look forward to continuing to work with the FDA over the next few weeks and during the review period and are planning to commercially launch Sotocoflozin in the U.S. in the second quarter promptly following regulatory approval. I will now turn the call over to Jeff to review the Sotocoflozin program and to further review the status of our commercial launch preparations.
spk10: Jeff? Thanks, Lionel. There are nearly 7 million people in the United States living with heart failure, a number that is expected to increase to 8 million by 2030. Heart failure is the leading cause of hospitalization for Americans over 65, with approximately 1.3 million hospitalizations for heart failure annually. Patients who are hospitalized for heart failure are highly likely to return with approximately 25% of patients being readmitted to the hospital within 30 days of discharge and 65% within one year. Hospital readmissions are burdensome not only for patients but also to the healthcare system. Annual costs from heart failure are expected to increase to nearly $70 billion by 2030 with 80% of those costs due to hospitalizations. There is a substantial unmet need for better treatment options for patients, and as these data make clear, a strong incentive for providers, hospitals, and payers to identify new approaches to reduce hospital readmissions. We also know that it is important to prioritize when patients are started on therapy in order to increase the likelihood that they remain on therapy following a hospitalization. As you can see from the data shown on this slide from the Journal of American College of Cardiology, starting patients on therapy at the time of hospital discharge results in significantly higher percentage of patients receiving appropriate treatment at 60 and 90 days and at 12 months follow-up. I will now turn the call over to Craig to discuss recent updates to the heart failure treatment guidelines and decision pathways prioritizing SGLT inhibitors, and to review important data from two recent major scientific meetings. From the AHA meeting late last year regarding Sotocliflozin's effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 and 90 days following discharge, and from the ACC meeting in March regarding Sotocliflozin's time to clinical benefit and consistent effects across left ventricular ejection fraction.
spk09: Thank you, Jeff. Heart failure is a multi-billion dollar market that is poised for substantial growth. Along with the increasing disease prevalence, this anticipated growth is being driven by new guidelines recently issued by major cardiovascular societies in the United States and Europe recommending the use of SGLT inhibitors as a pillar of care for treating heart failure.
spk03: In addition, just last week, ACC issued a new document in the April edition of JAG entitled 2023 ACC Expert Consensus Decision Pathway
spk09: on the management of heart failure with preserved ejection fraction. The consensus recommended that SGLT inhibitors should be initiated in all individuals with HFPEF lacking contraindications. Considered together with the previous consensus guidelines, the SGLT class is the only medical therapy recommended in all HF patients, regardless of ejection fraction. It is also important to note that the soloist worsening heart failure study of sodaglifosin in recently hospitalized patients resulted in significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo, regardless of left ventricular ejection fraction. Currently, of those 1.3 million hospitalizations a year, due to heart failure, data suggests that fewer than 10% of these patients are currently discharged with a prescription for an SGLT inhibitor. This provides an exceptional opportunity for Sotilifosin, given its unique data showing its significant impact on that transition of care patient population. Turning to the next slide, as you can see, this group of patients from the SOLOIS trial while improving in their clinical journey remains at risk for future heart failure events, as Jeff has noted in prior slides. As a reminder, the SOLOIS trial enrolled approximately 1,200 patients who had been hospitalized for heart failure and were transitioning out of the hospital. Double-blind randomized treatment began either in the hospital or within three days following their discharge. there were approximately 50% of patients in each of those two categories. As you can see in this slide, and as a reminder, the primary endpoint of the trial was achieved with a statistically significant and clinically meaningful reduction of 33% in the composite total cardiovascular death, hospitalization for heart failure, and urgent heart failure visits with the need to treat only four patients for one year to avoid one endpoint event, a finding which is unsurpassed within the SGLT inhibitor class. The objective of the post hoc analysis presented by Dr. Burke-Pitt at last year's American Heart Association Scientific Sessions was to evaluate the efficacy of sodaliposin versus placebo at reducing hospital readmissions and mortality within 30 and 90 days after discharge from a heart failure hospitalization among the patients who began study treatment on or before the date of discharge. As a reminder, there were no differences between these two groups of patients for baseline characteristics or the primary endpoint. Presented here are the results for cardiovascular death and heart failure related events for 30 and 90 days post discharge.
spk03: You can see the sodaglifosin arm in blue begins to separate from the placebo arm in red very early on and showed that the treatment was Soda glyphosate resulted in a statistically relative risk reduction versus placebo. of approximately 50% for readmission for non-fatal heart failure events.
spk09: and for the composite of cardiovascular death and readmission for heart failure at both 30 and 90 days following hospital discharge. These findings are unique. They also underscore the benefit of early initiation of evidence-based heart failure therapy. Sodaglifosin is the first compound to demonstrate a reduction on both mortality and heart failure events for treatment initiated during a heart failure hospitalization. Finally, we wanted to highlight key data just presented at the American College of Cardiology 72nd Annual Scientific Session held in March of 2023 on the time to clinical benefit of Sotagliflozin, which has also been published in the Journal of the American College of Cardiology shortly thereafter. The study authors concluded that treatment with Pseudoglyphosin led to a statistically significant reduction in the risk of the primary outcome by day 27 post-randomization. These results were consistent across the left ventricular ejection fraction range, a finding that aligns with the recent ACC consensus statement that was just recently referenced. We believe that these data support and further extend the 30-day reduction in readmission results for Sotaglifosin presented at the 2022 AHA meeting that treatment with Sotaglifosin results in an early and significant reduction in heart failure events and cardiovascular death in the high-cost, high-risk, recently hospitalized patient with worsening heart failure. I'll now turn the call back over to Jeff to share more about our commercial launch preparations.
spk10: Thank you, Craig. As Lonnell referenced earlier, commercial launch preparations for citagliflozin have been underway for well over a year and have progressed meaningfully throughout Q1. We have invested significantly in the infrastructure to support a commercial launch in heart failure in the U.S. in the first half of 2023, and we have the required resources currently in place. This includes the full market access and medical teams who have been having the appropriate pre-approval information exchanges with key stakeholders since late last year.
spk03: As we noted last we brought on our sales leadership team towards the end of last year. As of today we have filled the majority of the sales representative positions to be ready for deployment following approval. Further, We have substantially completed contracting with the major wholesaler and distribution networks. And we are well prepared to deploy comprehensive patient support programs to provide appropriate assistance. needed as we ramp up our access during launch.
spk10: Based on all the foundational work done to date, we feel confident that we have the right talent and resources to be ready for a very successful commercial launch following regulatory approval in the coming weeks. To summarize, we believe we have a tremendous opportunity for sodium plosive bolstered by three key factors. One, updated heart failure treatment guidelines, two, a growing medical need with SGLT adoption still in the early part of the adoption curve, and three, a unique data set for psoriasis specifically addressing the effectiveness in patients hospitalized for heart failure. Capitalizing on those three factors, we are making launch preparations with a focused commercial strategy using targeted messaging based on areas of clinical differentiation and where our value proposition is expected to have the most impact, including with cardiologists and hospital systems and payers that bear the cost of hospitalizations and re-hospitalizations. We will now turn briefly to our LX9211 program. LX9211 is a potent, highly selective small molecule inhibitor of a novel target, adapter-associated kinase 1 or AAK1. In a number of relevant animal models of neuropathic pain, LX9211 has demonstrated consistent, significant reductions in pain scores, even when compared to positive controls such as gabapentin. LX9211 achieves high levels of drug in the CNS, and importantly, the mechanism of action of LX9211
spk03: independent of the opioid pathway. And phase one studies, LX19, was shown to be well-treated with a pharmacokinetic profile supportive of one has been granted designation by the FDA. peripheral neuropathic pain. From a market perspective, market is expected to grow by more than 13% worldwide between 2020
spk10: in 2026 and is projected to be worth more than $13.2 billion. Currently available therapies are limited by lack of efficacy, side effects, and potential for abuse. As a result, there's a tremendous opportunity for new and innovative treatments such as LX9211 to enter this growing market with a great unmet need. I will now turn the call back to Craig to briefly review the key results from our base two studies in two distinct types of neuropathic pain that read out last year.
spk01: Thank you, Jeff.
spk09: As we discussed during our last quarterly call, the primary endpoint of the relief DPN1 study was achieved with a statistically significant reduction in the average daily pain score, or ADPS, at week six compared to placebo in the low-dose arm. There was an absolute reduction in ADPS from baseline of 1.39 points, with a p-value of 0.007, compared to placebo. High-dose arm, achieved a reduction from baseline of 1.27 points with a p-value of 0.03 compared to placebo, narrowly missing the significant threshold in the study of 0.028, but showing consistent effects.
spk03: You also noted during the blinded five-week placebo runoff period, there was a Gradual tapering of that in arms. with no evidence of rebound pain or withdrawal symptoms. There were no differences in treatment urgent adverse events between the treatment and Most people arms during the period and no drug related serious adverse events or deaths. were reported in the trial. As you also discussed in our last quarterly call, our second phase two proof of concept study
spk09: in postherpatic neuralgia, relief PHN1, LX9211 achieved a reduction in the average daily pain score of 2.42 points from baseline at week 6 compared to a reduction of 1.62 points in the placebo arm with a placebo-adjusted difference of 0.8 points and a p-value of 0.12. Although these results did not achieve statistical significance on the primary endpoint of the study, overall results demonstrated clear evidence of effect and achieved our goal for this small 79-patient study to support the further development of LX9211 in another neuropathic pain condition. The results of the relief PHN1 trial were recently presented at the emerging science section of the American Academy of Neurology annual meeting on April 24th of this year, and will also be presented at the British Pain Society 56th annual scientific meeting taking place in Glasgow from May 9th to May 11th. Notably, as you can see on the slide, LX9211 has shown consistent results across these two studies. When placing the graphs from the two studies side by side, the separation from placebo and the mean change from baseline create the same shaped curves. In conclusion, we have now completed two phase two proof of concept studies of LX9211 that support AAK1 inhibition as a potential new mechanism of action for treating neuropathic pain. We believe that LX9211 has the potential to overcome many of the shortcomings of current therapies and could be a welcome new innovation.
spk03: from neuropathic pain on a daily basis. This is a large and growing market with a high unmet medical need. As a result, we are pursuing the advancement of LX9211 into the late stage development of the treatment of neuropathic pain. We are continuing the work to identify and optimize proper dosing regimens. And we are preparing to receive feedback from the FDA in Q2. on how best to advance the program into late stage development as quickly and as efficiently as possible. I'd now like to turn the I'll back to Jeff to take us through the financial results for the first quarter 2023.
spk10: Thank you, Craig. I will review some key aspects of our first quarter 2023 financial results. More financial details can be found in the press release that we issued earlier today and our 10Q that will be filed shortly with the SEC. We ended the quarter with $105.9 million in cash and investments. We believe that our existing capital resources provide us with the right level of funding to support continued commercial preparations and make appropriate investments in research and clinical development. Our loan facility with Oxford Finance, which provides up to $100 million in additional borrowing capacity, gives us substantial financial flexibility as we prepare to embark upon the expected launch of Sotoflozin in the second quarter of this year. We just recently executed an amendment with Oxford that allows us to draw up to $75 million upon approval of Sotocliflozin, the proceeds of which we would use to further fund our planned launch. We anticipate that our existing cash and investments together with capacity under the loan facility will provide us with sufficient resources to manage our operations well into the anticipated launch of Sotocliflozin into the market. As indicated in our press release this afternoon, we had minimal revenues for the first quarters of both 2023 and 2022. Research and development expenses for the first quarter of 2023 decreased to $12.1 million from $14.9 million for the corresponding period in 2022, primarily due to lower external research and development costs and professional and consulting fees in 2023. SELLING GENERAL AND ADMINISTRATIVE EXPENSES FOR THE FIRST QUARTER OF 2023 INCREASED TO $19.5 MILLION FROM $8.5 MILLION THE CORRESPONDING IN 2022. THIS WAS
spk03: primarily due to increases in headcount and professional and consulting fees relating to preparations for the commercial launch of soda was . In total, net loss for the first quarter of 2023 was 32%. $3 million or $0.17 per share as compared to 2010. That was a loss of $23.5 million or $0.16 share in the corresponding period in 2022. For the first quarters of 2023 and 2022, Net loss included non-cash, stock-based compensation expense, $3.4 million and $2.8 million, respectively.
spk10: Before we transition to Q&A, I'd like to take this opportunity to reiterate the great progress we have made since our last call in preparation for the launch of Cerciflozin into the heart failure market. Across every function of the company, we have made considerable progress to prepare for our PDUFA date of May 27th, and if approved, a prompt launch into the market in Q2 2023. I would like to pause now and ask the operator to open up the call to take your questions.
spk07: Ladies and gentlemen, we'll now begin the question and answer session. To ask a question, you may press star and then 1 on your touch-tone phones. If you are using a speakerphone, we do ask that you please pick up your handsets before pressing the keys. To withdraw your questions, you may press star and 2. Once again, that is star and then 1.
spk01: To join the question queue, pause momentarily to assemble the roster. Our first question today comes from Andrew Sy from Jefferies.
spk07: Please go ahead with your question.
spk02: Great. Thanks. Hi, team. Thanks for sharing the updates. I really appreciate you taking my question. So the first one is I noticed in your prepared remarks it sounded like you're in very productive labeling discussion. So if or when soda does get approved, is there anything in the label that you would encourage investors to pay attention to and Maybe talk about, if you can, you know, what we can expect to see on front page label claim.
spk05: Great question, Andrew. Yes, I think you've characterized it correctly. We've had some outstanding conversations with the FDA. I think what you can expect is we've made a pretty powerful argument that this drug works for heart failure. This will be a cardiovascular drug and nothing else. meaning that we believe that the drug will work across heart failure regardless of diabetes.
spk03: And therefore, what you should expect is a broad label for the drug. Craig has mentioned very clearly during his call. Sotica flows and works across left ventricular ventricular ejection fraction including HEPF. You should expect us to move in that direction as well. And so I think those are the two broad perspectives I would say investors should look for. when we turn the cards over and finish our negotiations with the agency. Great. Let's just say it does get approved. First, do you think there's a low-hanging fruit of patience that you're... I believe hundreds of sales reps can tackle right off the bat.
spk02: And then secondly is, you know, what would you say for, as we think about 2023 to 2024, what would be the key drivers for sales to accelerate? What needs basically to be done to ensure a robust uptake? Thank you.
spk05: Yeah, two things. One is that given that 90% of the market is still absent SGLTs regardless of the guidelines, so I think that's a huge low-hanging fruit for us to try to achieve. The place we're going to focus is not in the broader area of cardiovascular competition and heart failure. It's really going to be in that transition of care, patient that's inside the hospital. That's where we have very unique data. And I think that is our opportunity to not only have impact on patient, but also have impact on systems and bringing costs down. And therefore, you know, we will spend most of our time to do that. In 2023, it'll be less about how much net sales you move. It'll be more about how well we're able to penetrate the IDNs, how well we're able to penetrate into Medicare and get coverage. And so we've been out in markets and appropriate conversations trying to lock and load and get ready for that. And so what we're going to lay out for you when we get approval is what are the metrics that you should really look for? Number one will be our ability to penetrate and get coverage in 2023. We do that well, 2024 will be all about net trade sales at that time.
spk02: And last one is, Will IQVIA sales be trackable for the scripts? Jeff, I'll turn it over to you.
spk10: We expect that IQVIA will be able to track sales in terms of the scripts. But again, a lot of this is what we're going to be focused on. It's going to be in terms of what we talk about. We'll be talking about getting access and getting...
spk03: formulary coverage. Right. Makes sense. Thank you. Very helpful. Thank you, Andrew. Next question comes from from Citigroup. Please go ahead with your question. Hi, Linnell. We're taking the questions. On 19-1-1, I'm just curious to mention you're going to have feedback from the FDA in the next quarter on the path forward. Could you talk a little bit more about what you expect there? Have you proposed a specific phase three plan for both indications? What additional validation or clearance are you expecting from the FDA with regard to diseases and also regarding partnering.
spk01: I know you've talked about partnering just in the past.
spk08: Can you just give us an update there on how that's going?
spk05: Thanks. Okay, great questions, Ugal. Let me turn it over to Jeff.
spk10: We are outlining with FDA the key elements of the plan going forward into late-stage development. And it's mostly focused on the largest of these indications, which is diabetic peripheral neuropathic pain and other work that we need to do to advance the program going forward. So that's really been the area of focus. And we... In addition to that, we're continuing dialogue with potential partners, and we'll be proceeding with those discussions as we get further into the development. But in the meantime, we are continuing to take steps to push this forward into development. And we're committed to doing that going forward, and we'll do that with the feedback that we get from the agency later this quarter.
spk08: So you would wait for a partner for starting a phase three or not necessarily? You might go ahead yourself.
spk10: We are pushing forward with development and doing the work to push forward in development and advancing that. Frankly, we believe that the way to create the greatest value in partnership is to continue to develop the drug and to push it forward in development.
spk08: Okay. But you're focusing on DPN?
spk05: Yeah. Yeah, I think for us, DPN is the biggest opportunity. And to Jeff's point, we shouldn't wait for a partner. We've been waiting forever trying to negotiate the proper value I think we can achieve with this program. The best way to do this is to get the FDA feedback, make sure that we're aligned around that feedback, and keep developing the program forward so that we can be in the best position to achieve the value we think this drug provides.
spk03: this drug will have going forward. So DPM will be our focus. I think what a partnership really provides is a high source of should achieve that is it allows us to go beyond DPN to PHN, which is why we did that work, and pursue a broader neuropathic pain indication. But in the absence of that, Lexicon can advance this compound for deep pain, which is what is our current goal. Okay. Great. And then on heart failure, so obviously a big day coming up. I guess 25 days. So I want to drill down. down a little bit into this into this slice of the market this transition of care in the recent worsening heart failure I just want to get a better understanding I mean How much of a white space is this in terms of French competitors?
spk08: What are you hearing from the channel checks as far as, are SGLTs being used off-label here, or is this really an area where you're just going to come in and be able to take share quickly given the unique value proposition that you've outlined both with the guidelines as well as with the strong data at AHA. And, you know, what's been the – you mentioned some early discussions, as you said, with the IDNs and reimbursement and the Medicare and so on. What's been the receptivity so far in terms of the value proposition there? to covering this and filling this gap in the treatment channel that you've talked about?
spk10: So to answer the first part of your question, SGLT inhibitors are starting to be used in the hospital setting. And it's variable among institutions as to how widely they're being used. But we're still, at this point, early in the adoption curve for use of SGLT inhibitors for that transition of care patients. And most of the argument for it has been that it's better to get people on therapy at hospital or upon discharge because they're likely to stay on therapy if that happens. We're going to bring our unique data that shows benefits on hard endpoints into that setting. And that's what we're going to leverage as we proceed with the commercial launch of pseudodiplosion as our area of focus. But it's already starting to pick up. in that area. The second part of the question was receptivity among payers and hospital systems. I would say, I would characterize that receptivity as being very encouraging. We have a unique value proposition there. We will be publishing data about cost effectiveness and be talking about, you know, the value that we bring, but the unique data from Soloist
spk03: has a benefit that uniquely is important to hospitals, systems, and the payers. As we think about the people are really bearing those costs of that re-hospitalization and then the proof that we have from the studies that we ran and from soloists in particular that shows this benefit and hospital admissions and not only overall but also so that the 30- and 90-day hospital remission data that were presented to AHA last year. So that value proposition, what can bring to the table from an economic perspective for payers and hospital systems has been resonating very well.
spk09: Yeah, you know, I'll just add a couple other points to what Jeff was saying. I think it's important to put in context how recent these guideline changes are, that the first guidelines that were the European guidelines only came out less than two years ago. The U.S. combined guidelines around use of SGLT inhibitors at all really only came out a year and a half ago. And this consensus statement in the HFPAF category only came out last week. I think when you think about the fact, as Jeff mentioned, the penetration of SGLT inhibitors is less than 10% currently. And if you think about beta blockers being at 90%, and the fact that the SGLT class now is the only class of agents that's now recommended at a 1A level of recommendation across the entire class of HFREF and HFPEF, I think the opportunity set for the SGLT inhibitors as a class is quite profound and a huge tailwind at our back. I think on top of that, the value proposition with Sotilifosin in that transition of care patient, which is the highest unmet need, 25% of these patients coming back to the hospital in 30 days, 65% within a year, 100 events per 100 patient years in that group of patients. The payers all know there's a problem there, and our data set, is unparalleled. There is no other SGLT that can present a data set like ours in that group of patients. So we think that there's a really strong class rationale, market need, and attributes of pseudoglyphosate as a new agent that support its uptake and use.
spk05: The only thing I would add, and I think my colleagues have been very clear, is in that class, there's only three SGLTs
spk03: He's just going to be in this class fighting this fight. We know Jardine's is one. And the other one certainly would be the pack of flows. And the third one would be Why is that unique? Is that the European guidelines, we were spoken about, and we hadn't even submitted the drug. That's our problem. offer the data. We get to the U.S. guidelines. Once again, there's a specificity to the SOTGF closing, and we hadn't we hadn't received approval. And so already the drug even being approved. And so we will have these guidelines and the way that these guidelines pretty much as a significant value proposition as we go into market.
spk05: That is remarkably unique. And so we're feeling pretty confident at this stage. It's about locking and loading and getting ready for what we believe the FDA will deliver to us and for us. And we'll certainly have a lot more to say once that happens.
spk01: Great. Thank you, Lionel and team. Thank you. You bet.
spk07: Once again, if you would like to ask a question, please press star and 1. To remove yourself from the question queue, you may press star and 2. Our next question comes from Joseph Stringer from Needham & Company. Please go ahead with your question.
spk06: Hi. Thanks for taking our question. Just going back to the potential label scenarios for SODA, you kind of outlined your best case broad label scenario. I guess do you feel that you need to have that best case broad label in order to be differentiated from the approved competitor drugs and be commercially successful? Or if Soda does get approved with a more narrow label, do you still think that you could be differentiated and capture market share and ultimately be commercially successful?
spk05: Thank you, Joseph. Let me first say I'm pretty confident the scenario I gave you is the scenario it should be. However, I would say that patients are going to cycle on these compounds. And given the growth rate and the size of this market, the CAGR that we see, just the cycling of these compounds, we will have a significant opportunity. But the uniqueness of our data, should we achieve what I've already laid out to you, will indeed create a significant opportunity for soda flows and quite a large product over time. So I'm pretty confident in my view around what I believe, where we're going to land, and that's going to be the optimistic scenario.
spk03: Great. Thanks for taking that question. You bet. Ladies and gentlemen, with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to the management team for any closing questions. As always, I want to thank everyone for joining us. This is such an awesome hour. opportunity for Lexicon and our stakeholders this year. LX9211 will advance to late stage development. We're feeling pretty good about that. We'll get the FDA feedback here shortly. And we'll know exactly how we want to advance. I'm confident that If we move into partnership, it will be on the terms that we think is important for us to generate value for all of our stakeholders. The second one is for We're feeling pretty bullish.
spk05: And therefore, we have made the investments. Our people are on board. They're ready to go. The conversations with the FDA has been remarkably productive. And we're feeling, as I said, pretty confident. that we are a short period away from turning the cards over and sharing with you what we've always believed is that we have a remarkably unique compound that we can bring to the market and begin to live our mission and ask to ensure that patients have an opportunity to improve their lives with one of our innovations. With that, I'll thank you and look forward to the next call.
spk07: Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.
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