Lexicon Pharmaceuticals Q1 2023 Earnings Call Transcript

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May 2, 2023

There are 8 speakers on the call.

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 Please also note that today's event is being recorded. And at this time, I'd like to turn the floor over to Cary Saragusa. Ma'am, please go ahead.

Speaker 1

Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals Q1 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 Doctor. 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 Q1 of 2023, which is available on our website atwww.lexpharma.com and through our SEC filings.

Speaker 1

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.

Speaker 1

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 Coase.

Speaker 2

Thank you, Carrie. Good afternoon, everyone, and thank you for joining us on the call. Q1 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 in diabetic peripheral neuropathic pain and pulse herpatic 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 Q2 of this year.

Speaker 2

Turning to sotagliflozin. 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. We believe everything remains on track for our PDUFA target date on May 27. Now since our last call, we also wanted to highlight the significant progress we have made across all functions of the company to be launched 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.

Speaker 2

Presentations at 2 major medical meetings, including a feature presentation on the time to clinical benefit of sotagliflozin, which Doctor. Granowitz will speak further about shortly. And finally, we're finalizing wholesaler and distribution agreements to be ready to ship product within the U. S. Shortly following approval.

Speaker 2

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 sotagliflozin in the U. S. In the Q2 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?

Speaker 3

Thanks, Lonnel. There are nearly 7,000,000 people in the United States living with heart The number that is expected to increase to $8,000,000 by 2,030. Heart failure is the leading cause of hospitalization for Americans over 65 with approximately 1,300,000 hospitalizations for heart failure annually. Patients who are hospitalized for heart failure are highly likely to return with approximately 25% of patients being Hospital readmissions are burdensome not only for patients, but also to the healthcare system. Annual costs from heart failure are expected to increased nearly $70,000,000,000 by 2,030 with 80% of those costs due to hospitalizations.

Speaker 3

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 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 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 2 recent major scientific meetings. From the meeting late last year Regarding sotagliflozin's effects in reducing cardiovascular mortality and the risk of hospital readmissions at 30 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.

Speaker 4

Thank you, Jeff. Heart failure is a multibillion 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. In addition, just last week, ACC Issued a new document in the April edition of JACC 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.

Speaker 4

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 of left ventricular ejection fraction. Currently of those 1,300,000 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 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 SOLOIST trial While improving in their clinical journey remains at risk for future heart failure events as Jeff has noted in prior slides.

Speaker 4

As a reminder, the SOLOIST trial enrolled approximately 1200 patients who have been hospitalized for heart failure And we're transitioning out of the hospital. Double blind randomized treatment began either in the hospital or within 3 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 and urgent heart failure visits with the need to treat only 4 patients for 1 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 Doctor.

Speaker 4

Burk 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 90 days post discharge. You can see the sotagliflozin arm in blue Begins to separate from placebo arm in red very early on and showed the treatment with sotagliflozin resulted in a statistically relative 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 90 days following hospital discharge. These findings are unique.

Speaker 4

They also underscore the benefit of early initiation of evidence based heart failure therapy. Sotagliflozin is the 1st 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 recently referenced.

Speaker 4

We believe that these data support and further extend the 30 day reduction in readmission results For sotagliflozin presented at the 2022 meeting 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.

Speaker 3

Thank you, Craig. As Lonnel referenced earlier, commercial launch preparations for Flosum have been underway for well over a year and have progressed meaningfully throughout Q1. We have significantly in the infrastructure to support a commercial launch in heart failure in the U. S. In the first half of twenty twenty three, and we have the required resources currently in place.

Speaker 3

This includes the full market access and medical teams We have been having the 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. 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.

Speaker 3

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 3 key factors: 1, updated heart failure treatment guidelines 2, a growing unmet medical need with SGLT adoption still in the early part of the adoption curve. And 3, a unique data set for sotagliflozin 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 rehospitalizations.

Speaker 3

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 AK1. 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 achieved 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.

Speaker 3

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 20202026 and is projected to be worth more than $13,200,000,000 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 Phase 2 studies in 2 distinct types of myrifabic pain that read out last year.

Speaker 4

Thank you, Jeff. As we discussed during our last quarterly call, The primary endpoint of the RELIEF DPN-one 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 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. We also noted during the blinded 5 week placebo runoff period, there was a gradual tapering of efficacy in both treatment arms with no evidence of rebound pain or withdrawal symptoms.

Speaker 4

There were no 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 post herpatic neuralgia, relief PHN1, LX9211 achieved a reduction in the average daily pain score of 2.42 points from baseline at week 6 compared to 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 seventy nine patient study to further to support the further development of LX9211 in another neuropathic pain condition. The results of the RELIEF PHN1 trial were frequently presented at the Emerging Science section The American Academy of Neurology Annual Meeting on April 24 this year and will also be presented at the British Pain Society 56th Annual Scientific Meeting taking place in Glasgow from May 9 to May 11. Notably, as you can see on the slide, LX9211 has shown consistent results across these two studies.

Speaker 4

When placing the graphs from the 2 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 2 Phase 2 proof of concept Studies for of LX9211 that support AAK1 inhibition as a potential new mechanism of action for 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 the 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 as efficiently as possible.

Speaker 4

I'd now like to turn the call back to Jeff to take us through the financial results for the Q1 2023.

Speaker 3

Thank you, Craig. I will review some key aspects of our Q1 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 $105,900,000 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.

Speaker 3

Our loan facility with Oxford Finance, which provides up To $100,000,000 in additional borrowing capacity gives us substantial financial flexibility as we prepare to embark upon the expected launch of sotagliflozin in the Q2 of this year. We just recently executed an amendment with Oxford that allows us to draw up $75,000,000 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 sotiflozin into the market. As indicated in our press release this afternoon, we had minimal revenues for the 1st quarters of both 20232022. Research and development expenses for the Q1 of 2023 decreased to $12,100,000 from $14,900,000 for the corresponding period in 2022, primarily due to lower external research and development cost and professional and consulting fees in 2023.

Speaker 3

Selling, general and administrative expenses for the Q1 of 2023 increased to $19,500,000 from $8,500,000 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 and heart failure. In total, net loss for the Q1 of 2023 was $32,300,000 or $0.17 per share as compared to a net loss of $23,500,000 or $0.16 per share and the corresponding period in 2022. For the 1st quarters of 20232022, Net loss included non cash stock based compensation expense of $3,400,000 $2,800,000 respectively. Before we transition to Q and 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 cetagliflozin into the heart failure market.

Speaker 3

Across every function of the company, we have made considerable progress to prepare for our PDUFA date of May 27 and if approved, a prompt launch into the market in Q2 2023.

Operator

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

Speaker 5

Great. Thanks. Hi, team. Thanks for sharing the updates. Really appreciate you taking my questions.

Speaker 5

So the first one is, I noticed in your prepared remarks, It sounded like you're in very productive labeling discussion. So if Or1 soda does get approved, is there anything And 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 front page label Claim?

Speaker 2

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.

Speaker 2

And 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. And so I think those are the 2 broad perspectives I would say investors should look for when we turn the cards over and finish our negotiations with the agency.

Speaker 5

Great. And so let's just say, it does get approved. First, do you think there is a low hanging fruit of patients that your, I believe 100 sales reps can tackle right off the bat. And then secondly is, 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?

Speaker 5

Thank you.

Speaker 2

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 try to achieve. The place we're going to focus is not in the broader area of cardiovascular Competition in heart failure is 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.

Speaker 2

And therefore, We will spend most of our time to do that. In 2023, it will be less about how much net sales you move. It will 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 end 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 It's one of the metrics that you should really look for.

Speaker 2

Number 1 will be our ability to penetrate and get coverage in 2023. We do that well. 2024 will be all about Net Trace sales at that time.

Speaker 5

And last one is, Will IQVIA sales be trackable for the scripts?

Speaker 2

Jeff, I'll turn it over to you.

Speaker 3

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 talked about. We'll be talking about getting access and getting Formulary coverage.

Speaker 5

Right. Makes sense. Thank you. Very helpful.

Speaker 2

You bet. Thank you, Andrew.

Operator

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

Speaker 6

Hi, Lonnel and Jeff and team. Thanks for taking the questions. On 9,211, I'm just curious, you mentioned you're 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 to diseases.

Speaker 6

And also regarding partnering, I know you've talked about partnering this in the past. Can you just give us an update there and how that's going? Thanks.

Speaker 2

Okay. Great questions, Yigal. Let me turn it over to Jeff.

Speaker 3

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.

Speaker 3

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.

Speaker 6

So you would wait for a partner for starting a Phase 3 or not necessarily, you might go ahead yourself?

Speaker 3

So 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 drag and to push it forward in development.

Speaker 6

Okay. But you're focusing on DPN,

Speaker 2

Yes, Yigal, I think for us DTN is the biggest opportunity. And to Jeff's point, we're not going to we shouldn't wait for a partner. We'll 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'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 will have going forward. So DPN will be our focus.

Speaker 2

I think what we what a partnership really provides for us if we should achieve that is it allows us to go broader than DPN. It allow us to go beyond DPN PN 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 what is our current goal.

Speaker 6

Okay, great. And then on heart failure, so obviously a big day coming up in, I guess, 25 days. So I wanted to drill down a little bit into this slice of the market, this transition of care and the recently worsening heart failure. I just want to get a better understanding. How much of a white space is this in terms of entrenched competitors?

Speaker 6

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 And what's been the you mentioned some early discussions as you said with the IDNs and reimbursement Karen, so on. What's been the receptivity so far in terms of the value proposition to covering this And I'm filling this gap in the treatment channel that you've talked about.

Speaker 3

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 sotagliflozin as our area of focus. But it's already starting to pick up in that area.

Speaker 3

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.

Speaker 2

We

Speaker 3

have a unique value proposition there. We will be publishing data about cost effectiveness and be talking about The value that we bring, but the unique data from SOLOIST has a benefit That uniquely is important to hospital systems and to payers. As we think about the people who are really bearing those Costs of that rehospitalization and the proof that we have from the studies that we ran and from SOLOS in particular that shows this benefit in hospital readmissions and not only overall, but also The 30 90 day hospital readmission data that were presented to last year. So that value proposition, what we can bring to the table from an Economic perspective for payers and hospital systems has been resonating very well.

Speaker 4

Yes, Yushal, I'll just add a couple of 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 2 years ago. The Lines around use of SGLT inhibitors at all really only came out a year and a half ago. And this consensus statement And the HFpEF category only came out last week.

Speaker 4

I think when you think about the fact, as Jeff mentioned, the penetration of The SGLT class now is the only class of agents that's now recommended at a 1A level of recommendation across the Higher class of HFrEF and HFpEF, I think the opportunity set for the SGLT inhibitors as a class It's quite profound and a huge tailwind at our back. I think on top of that, the value proposition With sotagliflozin in that transition of care patient, which is the highest unmet need, 25% of these patients 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 is a really strong class Now market need and attributes of sotagliflozin as a new agent that support its uptake in use.

Speaker 2

The only thing I would add, and I think my colleagues have been very clear, is in that class, there's only 3 is going to be in this class fighting this fight. We know Jardiance is 1 and the other one certainly would be dupagliflozin. And the third one, be stotagliflozin. Why is that unique? Is that in the European guidelines, we were spoken about and we hadn't even submitted the drug.

Speaker 2

That's how powerful the data is. We get to the U. S. Guidelines. Once again, there's a specificity to sotagliflozin and we hadn't received an approval.

Speaker 2

And so already, and the uniqueness of his data is falling into these guidelines absent the drug even being approved. And so we will have these guidelines and the weight of these guidelines Pretty much as a significant value proposition as we go into market. 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.

Speaker 6

Great. Thank you, Anil and team. Thank you. You

Operator

Our next question comes from Joseph Stringer from Needham and Company. Please go ahead with your question.

Speaker 7

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.

Speaker 2

I guess do you

Speaker 7

feel that you need to have that best case broad label in order to be differentiated from The approved competitor drugs and the commercially successful or if sort of it does get approved with a More than they are on label, do you still think that you could be differentiated and capture market share and ultimately be commercially successful?

Speaker 2

Thank you, Joseph. Let me first say I'm pretty confident the scenario I gave you is the scenario that 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 sotagliflozin and quite a large product over time.

Speaker 2

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.

Speaker 7

Great. Thanks for taking my question.

Speaker 2

You bet.

Operator

And 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.

Speaker 2

Well, as always, I want to thank everyone for joining us. This is such an awesome opportunity for Lexicon and our stakeholders this year. LX9211 will advance into 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 LX9211.

Speaker 2

I feel confident that if we move into partnership will be under the terms that we think is important for us to generate value for all of our stakeholders. The second one is for sotagliflozin. We're feeling pretty bullish. 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 remarkably unique compound that we can bring to the market and begin to live our mission and as to ensure that patients have an opportunity to improve their lives with one of our innovations.

Speaker 2

With that, I'll thank you and look forward to the next call.

Operator

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

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