Q1 2023 Lexicon Pharmaceuticals Inc Earnings Call
Participants
Carrie Siragusa
Craig B. Granowitz; Senior VP & Chief Medical Officer; Lexicon Pharmaceuticals, Inc.
Jeffrey L. Wade; President & CFO; Lexicon Pharmaceuticals, Inc.
Lonnel Coats; CEO & Director; Lexicon Pharmaceuticals, Inc.
Joseph Robert Stringer; Senior Analyst; Needham & Company, LLC, Research Division
Lin Tsai; Equity Analyst; Jefferies LLC, Research Division
Yigal Dov Nochomovitz; Director; Citigroup Inc., Research Division
Presentation
Operator
Good day, everyone, and welcome to the Lexicon Pharmaceuticals First Quarter 2023 Financial Results Conference Call. (Operator Instructions). Please also note that today's event is being recorded.
And at this time, I'd like to turn the floor over to Carrie Siragusa. Ma'am, please go ahead.
Carrie Siragusa
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 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 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
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, sotagliflozin, our dual SGLT1/2 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 2 Phase II proof-of-concept studies last year in diabetic peripheral neuropathic pain and postherpetic 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 sotagliflozin. As shared in our last quarterly call, we had our late cycle review meeting with FDA late February for our 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 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 launch-ready for PDUFA, including, but not limited to, very productive label discussions and negotiations with the FDA, appropriate and preapproval 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 2 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 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?
Jeffrey L. Wade
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 1 year.
Hospital readmissions are burdensome not only for patients but also to the health care 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 2 recent major scientific meetings, from the AHA meeting late last year regarding sotagliflozin'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 sotagliflozin's time to clinical benefit and consistent effects across left ventricular ejection fraction.
Craig B. Granowitz
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. 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 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 suggest 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. As a reminder, the SOLOIST trial enrolled approximately 1,200 patients who have been hospitalized for heart failure and were 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 2 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 4 patients for 1 year to avoid 1 endpoint event, a finding which 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 2 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 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 nonfatal 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. They also 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 recently 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 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 patients with worsening heart failure.
I'll now turn the call back over to Jeff to share more about our commercial launch preparations.
Jeffrey L. Wade
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 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 preapproval 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., 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: one, updated heart failure treatment guidelines; two, a growing unmet medical need with SGLT adoption still in the early part of the adoption curve; and three, a unique data set for sotagliflozin specifically addressing the effectiveness in patients hospitalized for heart failure. Capitalizing on those 3 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.
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 I 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 a 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 II studies in 2 distinct types of neuropathic pain that read out last year.
Craig B. Granowitz
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. High dose arm achieved a reduction from baseline of 1.27 points with a p-value of 0.03 compared to placebo, narrowly missing a 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. 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 II proof-of-concept study in postherpetic neuralgia, RELIEF-PHN-1, 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. Though 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 and another neuropathic pain condition.
The results of the RELIEF-PHN-1 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 9 to May 11.
Notably, as you can see on the slide, LX9211 has shown consistent results across these 2 studies. 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 II 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 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.
I'd now like to turn the call back to Jeff to take us through the financial results for the first quarter 2023.
Jeffrey L. Wade
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 $32.3 million or $0.17 per share as compared to a net loss of $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 noncash 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.
Question and Answer Session
Operator
(Operator Instructions) Our first question today comes from Andrew Tsai from Jefferies.
Lin Tsai
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 sota 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 the front page label claim?
Lonnel Coats
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. 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.
Lin Tsai
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 and 2024, what would be the key drivers for sales to accelerate? What needs basically to be done to ensure a robust uptake?
Lonnel Coats
Yes, 2 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. It's really going to be in that transition of care, a 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, 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 in markets and appropriate conversations, trying to lock and load and get ready for that. And so 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.
Lin Tsai
And last one is, will IQVIA sales be trackable or the scripts?
Lonnel Coats
Jeff, I'll turn it over to you.
Jeffrey L. Wade
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 is going to be in terms of what we talk about. We'll be talking about getting access and getting formulary coverage.
Operator
Our next question comes from Yigal Nochomovitz from Citigroup.
Yigal Dov Nochomovitz
On 9211, 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 III plan for both indications? What additional validation or clearance that you're expecting from the FDA with regard to those 2 diseases? And also regarding partnering, I know you've talked about partnering this in the past. Can you just give us an update there on how that's going?
Lonnel Coats
Okay. Great questions, Yigal. Let me turn it over to Jeff.
Jeffrey L. Wade
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.
Yigal Dov Nochomovitz
So you would wait for a partner for starting a Phase III or not necessarily? You might go ahead yourself.
Jeffrey L. Wade
We are pushing forward with the development and doing the work to push forward in development and advancing that. And 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.
Yigal Dov Nochomovitz
Okay. But you're focusing on DPN? Yes.
Lonnel Coats
Yes, Yigal, I think for us, DPN is the biggest opportunity. And to Jeff's point, we're not going to -- we shouldn't wait for a partner. We'd 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.
I think 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 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.
Yigal Dov Nochomovitz
Okay. Great. And then on heart failure, so obviously a big day coming up in the, I guess, 25 days. So I wanted to drill down a little bit into the slice of the market, this transition of care in the recently worsening heart failure. I just want to get a better understanding. I mean how much of a white space is this in terms of entrenched competitors? What are you hearing from the channel checks as far -- 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 what's been the -- you mentioned some early discussions, as you said, with the IDNs and the reimbursement in the Medicare and so on. What's been the receptivity so far in terms of the value proposition to covering this and filling this gap in the treatment channel that you've talked about?
Jeffrey L. Wade
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 end points 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.
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 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 SOLOIST in particular, that shows this benefit in hospital readmissions and not only overall, but also the 30- and 90-day hospital readmission data that were presented to AHA 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.
Craig B. Granowitz
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 U.S. combined guidelines around use of SGLT inhibitors at all really only came out 1.5 years ago. And this consensus statement in the HFpEF 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 sotagliflozin 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 is a really strong class rationale, market need and attributes of sotagliflozin as a new agent that support its uptake in use.
Lonnel Coats
The only thing I would add, and I think my colleagues have been very clear, is in that class, there's only 3 SGLTs that's going to be in this classified in this fight. We know Jardiance is one, and the other one certainly would be dapagliflozin. And the third one will be sotagliflozin. Why is that unique is that in the European guidelines, we were spoken about, and we hadn't even submitted the drug. That's how powerful the data is.
We get to the U.S. guidelines, once again, there is a specificity to sotagliflozin, and we hadn't received an approval. And so already sotagliflozin and the uniqueness of this data is falling into these guidelines absent the drug even being approved. And so we will have these guidelines and a way 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.
Operator
(Operator Instructions) Our next question comes from Joseph Stringer from Needham & Company.
Joseph Robert Stringer
Just going back to the potential label scenarios for sota, you kind of outlined your base case broad label scenario. I guess do you feel that you need to have that base case broad label in order to be differentiated from the approved competitor drugs and be commercially successful? Or if sota 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?
Lonnel Coats
Thank you, Joseph. Let me first say, I'm pretty confident the scenario I gave you is a 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 in 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.
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.
Lonnel Coats
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. I feel confident that if we move into partnership, it would 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 a remarkably unique compound that we can bring to the market and begin to live our mission, and that's 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.
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 lines.
