Earnings Call Transcript - LXRX Q1 2023

Operator, Operator

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. After today's presentation, there will be an opportunity to ask questions. Please also note this event is being recorded. And at this time, I would now like to turn the conference over to Carrie Siragusa. Ma'am, please go ahead.

Carrie Siragusa, Head of Investor Relations

Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals first quarter 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; and Dr. Craig Granowitz, Lexicon's 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 the 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 sotagliflozin, 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 in 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 Lonnel Coats.

Lonnel Coats, CEO

Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. The first quarter of 2023 was another significant period for Lexicon, as we continue to advance in both of our lead programs, sotagliflozin, 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 the LX9211 program for neuropathic pain, as many of you know, we reported on the results of two Phase 2 proof-of-concept studies last year in diabetic peripheral neuropathic pain and postherpetic neuralgia. Bolstered by these results, we have continued to progress with the development plan for late-stage development and expect to receive feedback from the FDA on these plans in the second quarter of this year. Turning to sotagliflozin, as shared in our last quarterly call, we had our late-cycle review meeting with the FDA in late February for NDA for the treatment of heart failure. The agency indicated that there were no substantial review issues and again confirmed that it has no plans to hold an Advisory Committee Meeting. We believe everything remains on track for our PDUFA target date on May 27th. 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 pre-approval information exchanges with payers across national and regional accounts, government and institutions, the recruitment of experienced cardiovascular sales professionals, with the majority already onboard, presentations at two major medical meetings, including a featured presentation on the time to clinical benefit of sotagliflozin, which Dr. Granowitz will speak further about shortly. Finally, we are 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 during the review period and are planning to commercially launch sotagliflozin in the U.S. in the second quarter promptly following regulatory approval. I will now turn the call over to Jeff to review the sotagliflozin program and to further review the status of our commercial launch preparations.

Jeff Wade, President and CFO

Thanks, Lonnel. 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 for the healthcare system, with annual costs from heart failure 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, there is 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 the American College of Cardiology, starting patients on therapy at the time of hospital discharge results in a 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 sotagliflozin's effects in reducing cardiovascular mortality and the risk of hospital admissions at 30 and 90 days following discharge and from the ACC meeting in March regarding sotagliflozin's time to clinical benefit and consistent effects across left ventricular ejection fraction.

Dr. Craig Granowitz, SVP and Chief Medical Officer

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. Just last week, the ACC issued a new document in the April edition of JAK entitled 2023 ACC Expert Consensus Decision Pathway 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 sotagliflozin in recently hospitalized patients resulted in significantly lower total number of deaths from cardiovascular causes, 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 sotagliflozin, given its unique data showing a significant impact on that transition of care patient population. Turning to the next slide, as you can see, this group of patients from the SOLOIST 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 SOLOIST 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. They were approximately 50% of patients in each of those two categories. As you can see in this slide, 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. This finding is unsurpassed within the SGLT inhibitor class. The objective of the post hoc analysis presented by Dr. Bert Pitt at last year's American Heart Association Scientific Sessions was to evaluate the efficacy of sotagliflozin 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. You can see the sotagliflozin arm in blue begins to separate from the placebo arm in red very early on, showing that treatment with sotagliflozin resulted in a statistically relevant risk reduction versus placebo of approximately 50% for readmission, for non-fatal heart failure events, 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 and underscore the benefit of early initiation of evidence-based heart failure therapy. Sotagliflozin 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 sotagliflozin 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 referenced. We believe that these data support and further extend the 30-day reduction in readmission results for sotagliflozin presented at the 2022 AHA meeting, demonstrating that treatment with sotagliflozin 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.

Jeff Wade, President and CFO

Thank you, Craig. As Lonnel referenced earlier, commercial launch preparations for sotagliflozin have been underway for well over a year and have progressed meaningfully throughout Q1. We have invested significantly in 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 full market access and medical teams who have been having appropriate pre-approval information exchanges with key stakeholders since late last year. As we noted last quarter, we brought on our sales leadership team towards the end of last year, and 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 in the U.S., and we are well prepared to deploy comprehensive patient support programs to provide appropriate assistance when needed as we ramp up our access during launch. 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 sotagliflozin bolstered by three key factors: first, updated heart failure treatment guidelines; second, a growing unmet medical need with SGLT adoption still in the early part of the adoption curve; and third, a unique data set for sotagliflozin specifically addressing 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, hospital systems, and payers that bear the cost of hospitalizations and rehospitalizations. 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 is independent of the opioid pathway. In Phase 1 studies, LX9211 was shown to be well tolerated with a pharmacokinetic profile supportive of once daily dosing. Lexicon has been granted fast track designation by the FDA for diabetic peripheral neuropathic pain. From a market perspective, the neuropathic pain market is expected to grow by more than 13% worldwide between 2020 and 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 is 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 Phase 2 studies in two distinct types of neuropathic pain that were reported last year.

Dr. Craig Granowitz, SVP and Chief Medical Officer

Thank you, Jeff. As we discussed during our last quarterly call, the primary endpoint of the RELIEF-DPN-1 study was achieved with a statistically significant reduction in the average daily pain score or ADPS at week 6 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. The 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. We also noted during the blinded five-week placebo runoff period that there was a gradual tapering of efficacy in both treatment arms, with no evidence of rebound pain or withdrawal symptoms. There were no observed differences in treatment-emergent adverse events between the treatment and placebo arms during the runoff period, and no drug-related serious adverse events or deaths were reported in the trial. As we also discussed in our last quarterly call, our second Phase 2 proof-of-concept study in postherpetic neuralgia, RELIEF-PHN-1, demonstrated that 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-PHN-1 trial were frequently 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 curve. In conclusion, we have now completed two Phase 2 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 for those suffering 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 rapid advancement of LX9211 into late-stage development for 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 efficiently as possible. I'd now like to turn the call back to Jeff to take us through the financial results for the first quarter 2023.

Jeff Wade, President and CFO

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 10-Q 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 sotagliflozin 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 sotagliflozin, 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 sotagliflozin 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 for the corresponding period in 2022. This was primarily due to increases in headcount and in professional and consulting fees relating to preparations for the commercial launch of sotagliflozin in heart failure. In total, net loss for the first quarter of 2023 was $23.5 million or $0.16 per share in the corresponding period in 2022. For the first quarters of 2023 and 2022, net loss included non-cash stock-based compensation expense of $3.4 million and $2.8 million respectively. 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 sotagliflozin 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.

Operator, Operator

Ladies and gentlemen, we will now begin the question-and-answer session. Our first question today comes from Andrew Tsai from Jefferies. Please go ahead with your question.

Andrew Tsai, Analyst

Thanks for sharing the updates. Really appreciate you taking my questions. So, the first one is, I noticed in your prepared remarks, it sounded like you’re in very productive labeling discussions. So, if or when sotagliflozin 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, what we can expect to see on a front patient label claim?

Lonnel Coats, CEO

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. Therefore, what you should expect is a broad label for the drug. As Craig has mentioned very clearly during this call, sotagliflozin works across left ventricular ejection fraction, including HFpEF. You should expect us to move in that direction as well. 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.

Andrew Tsai, Analyst

Great. If it gets approved, do you think there is an immediate opportunity for 100 sales reps to pursue right away? Additionally, as we look ahead to 2023 and 2024, what do you see as the main factors that will drive sales growth? What needs to be accomplished to ensure a strong adoption? Thank you.

Lonnel Coats, CEO

Yes, 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 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 inside the hospital. That's where we have very unique data. I think that is our opportunity to not only impact patients but also have an impact on systems and bringing costs down. We will spend most of our time doing 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 and how well we are able to penetrate into Medicare and get coverage. We've been out in the market in appropriate conversations trying to lock and load and get ready for that. What we're going to lay out for you when we get approval is one of the metrics that you should really look for. Number one will be our ability to penetrate and get coverage in 2023. If we do that well, 2024 will be all about net sales at that time.

Andrew Tsai, Analyst

And last one is, will IQVIA sales be trackable or the scripts?

Lonnel Coats, CEO

Jeff, I'll turn it over to you.

Jeff Wade, President and CFO

We expect that IQVIA will be able to track sales in terms of the scripts. But again, a lot of this is what we are going to be focused on, which is getting access and getting formulary coverage.

Operator, Operator

And our next question comes from Yigal Nochomovitz from Citigroup. Please go ahead with your question.

Yigal Nochomovitz, Analyst

Hi, Lonnel and Jeff and team, thanks for taking the question. On LX9211, I'm just curious, you mentioned you are going to have feedback from the FDA in this quarter on the path forward. Could you talk a little bit more about what you expect there? Have you proposed a specific Phase 3 plan for both indications? What additional validation or clearance are you expecting from the FDA with regard to those two diseases? And also regarding partnering, I know you have talked about partnering this in the past. Can you just give us an update there on how that's going?

Lonnel Coats, CEO

Okay, great questions. Yigal, let me turn it over to Jeff.

Jeff Wade, President and CFO

We are outlining with the FDA to keep elements of the plan going forward into late-stage development. This is 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. In addition to that, we are continuing dialogue with potential partners, and we will 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. We are committed to doing that going forward, and we will do that with the feedback that we get from the agency later this quarter.

Yigal Nochomovitz, Analyst

So, you would wait for a partner before starting a Phase 3 or not necessarily you might look at it yourself?

Jeff Wade, President and CFO

So, we are pushing forward with development and doing the work to advance it. Frankly, we believe that the way to create the greatest value in a partnership is to continue to develop the drug and push it forward in development.

Yigal Nochomovitz, Analyst

Okay. But you are focusing on DPN?

Lonnel Coats, CEO

Yes. Yigal, I think for us DPN is the biggest opportunity. To Jeff's point, we are not going to wait for a partner because we will be 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 are aligned around that feedback, and keep developing the program so that we can be in the best position to achieve the value we think this drug will have going forward. DPN will be our focus. I think what a partnership really provides for us, if we should achieve that, is it allows us to go broader than DPN. 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 DPN, which is our current goal.

Yigal Nochomovitz, Analyst

Okay, great. In terms of heart failure, we have a significant day coming up in about 25 days. I would like to explore this segment of the market, specifically regarding the transition of care in patients with worsening heart failure. Could you provide more details on the extent of this opportunity concerning existing competitors? What insights have you gathered from market evaluations regarding whether SGLT is being utilized off-label? Do you believe this is an area where you can swiftly gain market share due to your unique value proposition supported by the guidelines and robust data presented at AHA? Additionally, you mentioned some initial conversations with integrated delivery networks, reimbursement, and Medicare. How receptive have they been to the value proposition of addressing this treatment gap that you have identified?

Jeff Wade, President and CFO

To address your first question, SGLT inhibitors are beginning to be used in hospitals, but the extent of their use varies by institution. We are still in the early stages of adopting SGLT inhibitors for patients transitioning from hospital care. The main reason for this approach is that initiating therapy in the hospital or at discharge increases the likelihood that patients will continue their treatment. We plan to present our unique data demonstrating benefits on critical endpoints in this environment, which will support the commercial launch of sotagliflozin as our primary focus. Regarding the second part of your question about receptivity among payers and hospital systems, I would describe that receptivity as very encouraging. We have a distinctive value proposition in that area. We will publish data on cost-effectiveness and discuss our added value, but the unique findings from the SOLOIST trial are particularly significant for hospital systems and payers, considering their costs related to readmissions. The evidence we have from studies, especially with SOLOIST, demonstrating the benefits in reducing hospital readmissions is quite compelling.

Lonnel Coats, CEO

Just to add a couple of other points to what Jeff was saying. It's important to put in context how recent these guideline changes are. The first guidelines issued by the European cardiovascular societies came out less than two years ago. The U.S. combined guidelines on the use of SGLT inhibitors really only came out a year and a half ago. This consensus statement in the HFpEF area only came out last week. When you consider that the penetration of SGLT inhibitors is less than 10% currently, while beta blockers are at 90%, and the SGLT class is now the only class of agents recommended at a 1A level of recommendation across the entire class of HFrEF and HFpEF, the opportunity set for SGLT inhibitors as a class is quite profound, with a substantial tailwind at our back. Additionally, the value proposition for sotagliflozin in that transition of care patient population, which is the highest unmet need, is significant. With 25% of these patients returning to the hospital within 30 days and 65% within a year, the high rate of rehospitalizations presents a clear opportunity. Payers are aware of this issue, and our data set is unparalleled; there is no other SGLT that can offer similar data in this patient group, strengthening our confidence in the market demand for sotagliflozin.

Dr. Craig Granowitz, SVP and Chief Medical Officer

The only thing I'd add, and I think my colleagues have been very clear, is that there are only three SGLTs in this class competing for this segment. We know Jardiance is one, and dapagliflozin is another, with sotagliflozin being the third. Why is that significant? Because we were able to demonstrate powerful data even before submitting our application; our unique data has already influenced recent European guidelines and appears in U.S. recommendations, even without having received approval. The significance of these guidelines adds to our market advantage as we prepare to launch sotagliflozin. We're feeling encouraged and remain focused on the imminent review process with the FDA, as we believe we have a remarkably unique compound that can significantly improve patient lives with our innovation.

Operator, Operator

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 remarks.

Lonnel Coats, CEO

As always, I want to thank everyone for joining us. This is an incredible opportunity for Lexicon and our stakeholders this year. LX9211 will advance into late-stage development, and we are feeling confident about that. We will receive FDA feedback shortly, which will help us determine how to best progress LX9211. I feel assured that if we pursue a partnership, it will embrace terms that are important for us to generate value for our stakeholders. For sotagliflozin, we are optimistic, we have made significant investments, our staff is prepared, and we have had remarkably productive conversations with the FDA. We are just a short period away from revealing what we have always believed: that we have a uniquely powerful compound that can enter the market and enhance patients' lives through innovation. Thank you, and I look forward to the next call.

Operator, Operator

Ladies and gentlemen, with that, we will conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.