Company Participants

Lisa DeFrancesco – Senior Vice President, Investor Relations and Corporate Strategy
Mike Exton – Chief Executive Officer and Director
Scott Coiante – Senior Vice President and Chief Financial Officer
Craig Granowitz – Senior Vice President and Chief Medical Officer

Conference Call Participants

Joseph Stringer – Needham & Co.
Joe Pantginis – H.C. Wainwright
Andrew Tsai – Jefferies

Operator

Welcome to the Lexicon Pharmaceuticals Fourth Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a brief question-and-answer session. As a reminder, this call is being recorded today, March 6, 2025.

I will now turn the call over to Lisa DeFrancesco, SVP, Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.

Lisa DeFrancesco

Thank you, Gigi. Good afternoon and welcome to the Lexicon Pharmaceuticals fourth quarter and full year 2024 financial results conference Call. Joining me today for prepared remarks are Dr. Mike Exton, Lexicon’s Chief Executive Officer and Director; and Scott Coiante, Senior Vice President and Chief Financial Officer; Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer, will also join us for Q&A.

Earlier this afternoon, Lexicon issued a press release announcing our financial results for the fourth quarter of 2024, which are available on our website at www.lexiconpharma.com and through our SEC filing. A webcast of this call, along with a slide presentation, is also 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 related to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of pilavapadin, LX9851, sotagliflozin and our other drug programs, as well as our business generally. These statements may also include characterizations and projections, relating to the clinical development, regulatory status, and market opportunity for our drug programs, and the commercial performance of INPEFA for heart failure.

This call may also contain forward-looking statements, related to our growth and future operating results, discovery and development of our drug candidates, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements, and we refer you to our most recent Annual Report on Form 10-K and other SEC filings, for detailed information describing such risks.

I would now like to turn the call over to Mike Exton. Mike?

Mike Exton

Great. Thanks Lisa, and good afternoon everyone. Thanks for joining the call.

Look, we’ve had a busy start to 2025 already, including our announcement on Monday of top line results from our PROGRESS Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain or DPNP.

But as we take a moment to look back, and reflect on 2024, I’m immensely proud of the resilience and adaptability of the team in keeping our pipeline of novel medicines moving forward, and advancing our Lead to Succeed strategy. Last year we strategically repositioned Lexicon, to focus the company and its resources on our clinical development programs.

And some key highlights from these programs included the early completion of enrollment, for our PROGRESS study, great progress in our pivotal Phase 3 SONATA HCM study of sotagliflozin in hypertrophic cardiomyopathy HCM, where we continue to enroll patients as planned, advancing IND enabling studies of LX9851 in obesity and related cardiovascular disorders. And lastly, we reinvigorated our business development efforts including a significant licensing agreement with Viatris, the sotagliflozin outside of the U.S. and Europe.

Now, I want to begin today’s overview, with our most recent significant development. On Monday, we issued a press release and held a conference call, to discuss the top line results for PROGRESS the Phase 2b dose findings study of pilavapadin, our oral non-opioid drug candidate for DPNP.

Now the two most important takeaways from our top line announcement this week are first, in all doses in the PROGRESS study including placebo, we observed a clear separation in ADPS from baseline with the 10 mg dose, also showing meaningful improvement compared to placebo. Secondly, all pilavapadin treated arm showed improved tolerability, when compared with our previous RELIEF DPN study.

Indeed, the 10 milligram dose of pilavapadin showed particularly better tolerability, as compared to RELIEF. For these reasons, we successfully achieved our corporate objectives, for PROGRESS with the 10 milligram dose. And so these data, in combination with the data from the RELIEF study, give us greater confidence in the potential of pilavapadin, to be the first novel oral, non-opioid DPNP medication in more than two decades, and we’re moving forward with a 10 milligram dose.

As you can see in this slide, pilavapadin 10 milligrams performed strongly, improving ADPS of week eight, reducing it by 1.74 points from baseline. Now, as we continue to analyze the data, there are already signals that give us even greater confidence, to advance the 10 milligram dose into pivotal trials, tooling the two arms that utilize 10 milligrams, the 10 milligram dose plus the 10, plus the 20, plus 10 arm. This PROGRESS post-hoc analysis shows an approximately 0.6 ADPS reduction versus placebo early as week two, which is maintained throughout the treatment period.

Interestingly, while the pain reduction curve of the placebo arm appears, to flatten out in the last four weeks of the trial, the 10 milligram dose continues to consistently reduce ADPS scores, suggesting that in pivotal trials of 12 weeks duration, further separation may be achievable. Furthermore, as we outlined on Monday, the 10 milligram dose was well tolerated.

In PROGRESS, as many patients with 10 milligram pilavapadin, as with placebo completed the trial, conclusively ascribing the tolerability performance in the previous RELIEF study to the day one ten-fold loading dose. This gives us confidence in the tolerability of 10 milligrams of pilavapadin in Phase 3 trials. We continue to analyze further data and look forward, to presenting the full findings from the PROGRESS study at a future medical meeting.

So now, I want to talk about what pilavapadin can potentially mean for patients. DPNP is a large and growing condition that impacts approximately 9 million people in the U.S. It’s a chronic and progressive pain disorder that severely impairs people’s quality of life, with the majority of patients experiencing moderate to severe pain.

When we speak with patients and physicians, it’s truly devastating to hear, how it impacts their everyday life, their ability to sleep at night, their mental health and their relationships. DPNP can also lead to loss of sensation, loss of balance, falls and fractures, and a wealth of other complications. But importantly, currently available treatments, simply don’t provide adequate RELIEF.

It’s estimated about 60% of patients, have tried multiple therapies and only a third are somewhat satisfied with their treatment. Now market research, we heard numerous HCPs and patients report an immense need for new treatment options, and in particular a simple, easy to use non-opioid treatment options for DPNP.

And finally, with about a third of DPNP patients, still resorting to short-term opioid use for pain RELIEF, even today, when we know the potentially devastating effects of these treatments, this space is primed for reform. HCPs, legislators and policymakers via initiatives such as the Alternatives to PAIN Act, provide tailwinds to support movement towards new non-opioid options.

Next, I’d like to discuss LX9851, where we are continuing to advance IND-enabling studies. LX9851 is our first in class oral ACSL5 inhibitor, for the treatment of obesity and related cardiometabolic disorders. In November, we presented clinical in vivo efficacy data from two studies, related to LX9851 at ObesityWeek.

The first study showed that the treatment with LX9851, resulted in significant reductions in weight, food intake and fat mass in diet induced obese mice, and that LX9851 mitigated weight regain, following discontinuation of the GLP-1 analog semaglutide.

The second study characterized the novel mechanism of action of LX9851, and how it activates the ileal brake, to induce satiety and lower desire for additional food consumption. We remain on track for an IND submission for LX9851 in 2025, as we evaluate potential partnership opportunities for this innovative mechanism.

So now I want to briefly touch on the current status of sotagliflozin. We have a significant potential opportunity to expand our label in hypertrophic cardiomyopathy, a disease state with high unmet need that impacts about 1 million patients in the U.S. We’re currently enrolling SONATA HCM, a global pivotal Phase 3 study including patients with both obstructive and non-obstructive HCM.

Upon completion of the HCM study, with additional evidence and data in hand, we will revisit the totality of the sotagliflozin asset potential in the U.S. In terms of what we’re doing today though, as we bridge to this future opportunity. As you can recall, we made the necessary decision to cease all promotion of INPEFA in the U.S. for heart failure, due to the difficult market access environment, dominated by two major SGLT2 inhibitors.

Currently, sotagliflozin is available on the U.S. market, with our continued commitment to maintain awareness, and provide tools to support patients in an extremely cost effective approach. Outside of the U.S. and Europe, we’re actively working with our exclusive licensee Viatris, on supporting their efforts towards registration, and regional development.

Our medical affairs data generation and publication activities remain ongoing, and we continue to engage with the scientific community through numerous investigator initiated third-party funded studies, to build upon our compelling body of medical evidence in CV conditions, and outcomes and support sotagliflozin as a differentiated inhibitor of both SGLT1 and 2.

Now to that end, I wanted to briefly acknowledge a notable recent publication in The Lancet Diabetes & Endocrinology, which highlighted the effects of sotagliflozin to reduce major adverse cardiovascular events or MACE, myocardial infarction and stroke among patients with type 2 diabetes, chronic kidney disease and high cardiovascular risk. The findings show that sotagliflozin significantly, and meaningfully reduces MACE versus placebo, demonstrating early and broad cardiovascular protection in this population.

This research also highlighted that sotagliflozin is the only SGLT inhibitor, to show significant reductions in both MI and stroke, indicating the potential role of SGLT1 inhibition in reducing ischemic events, an important distinction from selective SGLT2 inhibitors.

As I shared just a moment ago, this supports our goal of demonstrating differentiation of sotagliflozin, and presents compelling additional support as Viatris on regulatory submissions in key ex U.S. and ex-European markets throughout 2025.

I’ll now turn it over to Scott, to walk you through our financial results for the quarter, and the year ended December 31, 2024.

Scott Coiante

Thanks Mike.

Lexicon ended 2024 with $238 million in cash, cash equivalents and short-term investments, as compared to $170 million as of December 31, 2023. As noted in this afternoon’s press release, we reported $26.6 million in revenue in the fourth quarter and $31.1 million in revenue for the full year 2024.

Revenues for INPEFA were $1.7 million in the fourth quarter of 2024, and $6 million for the full year 2024. Total revenues for both the fourth quarter and full year, include an upfront payment of $25 million received in connection with the Viatris licensing agreement.

Research and development expenses, for the fourth quarter increased to $26.7 million from $14.8 million in the fourth quarter of 2023. Full year 2024 research and development expenses increased to $84.5 million in 2023, primarily due to our investments in Phase 2 and Phase 3 clinical trials, including the SONATA Phase 3 study of sotagliflozin in HCM and the PROGRESS Phase 2b study of pilavapadin in DPNP.

Selling, general and administrative expenses, for the fourth quarter of 2024 of $32.3 million, were comparable to the $32.6 million of SG&A expenses in the fourth quarter of 2023. Full year 2024, SG&A expenses increased to $143.1 million from $114 million in 2023.

This increase in 2024 reflects higher marketing costs, related to the commercialization of INPEFA and increased employee salaries and benefit costs, prior to the reduction in our field sales force in late 2024, as well as severance costs associated with our strategic repositioning.

Net loss for the fourth quarter of 2024, was $33.8 million or $0.09 per share as compared to a net loss of $49.8 million or $0.20 per share in the corresponding period in 2023, and net loss for the full year 2024 was $200.4 million or $0.32 per share in 2024, as compared to a net loss of $177.1 million or $0.80 per share, for the same period in 2023.

During 2024, Lexicon took steps, to first reduce and then to eliminate all proportional efforts for INPEFA. These included a significant reduction of employees and elimination of all promotional efforts for INPEFA and heart failure in the U.S. We believe these steps, will reduce operating expenses moving forward.

For 2025, we expect total operating expenses to be in the range of $135 million to $145 million. We expect research and development expenses, to be in the range of $100 million to $105 million and G&A expenses to be in the range of $35 million to $40 million.

Research and development expenses include costs associated with the ongoing development of sotagliflozin for HCM, preparations for the Phase 3 development of pilavapadin and preclinical costs associated with preparations for the IND filing of LX9851.

Research and development expenses for 2025, do not include the cost of pivotal Phase 3 trials for pilavapadin, as the size and scope of these trials will be determined as part of our end of Phase 2 review discussions with the FDA.

I’ll now turn it back to Mike, for closing remarks.

Mike Exton

Yes, thanks Scott.

And look, in summary, we’ve got a full and exciting year ahead. The work we did in 2024, really set the foundation and we look forward to updating you all, as the year progresses. For pilavapadin, we’ve got a number of important upcoming catalysts including disclosure of the full PROGRESS data set, the end of Phase 2 meeting with the FDA, and data presentations at upcoming endocrinology and pain focused medical meetings.

In addition to the important upcoming milestones, we discussed today, we’re also very actively engaged in partnership discussions that, enhance our clinical and commercial capabilities, and help us maximize the potential of all of our novel therapies. This will be critical focus for of the company in the coming months. So with that Scott, Craig and I have time, to take all of your questions.

So I’ll turn it back to you, operator.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Joseph Stringer from Needham & Co.

Joseph Stringer

Hi, thanks for taking our questions from us. Want to ask on the 9851 oral obesity asset and kind of the clinical development plan there? A couple of questions on that. Is that only being considered as a combo therapy with say a GLP drug, or is there an option for monotherapy? And then what are the potential indications and/or trial designs that you’re thinking of for an initial Phase 1? And then lastly, if a decision is made to ultimately partner that program, how much clinical data do you think you need to generate before it would make sense to engage, or turn it over to a potential partner?

Craig Granowitz

So Joey, it’s Craig. I’ll answer the first two questions and probably turn it back over to Mike for the third. We really see this molecule as being developed both as monotherapy and combination therapy. Monotherapy alone or monotherapy after discontinuation of an injectable or other GLP-1 agonist. Knowing with the data that’s come in with the injectables at least that a vast majority of patients don’t remain on therapy for more than a year. In fact, the median duration is somewhere between six and 12 months.

So what we’ve demonstrated in the animal models, is the activity of the drug is independent and additive on top of semaglutide, even maximum dose semaglutide. And if you withdraw the semaglutide and then add the 9851 that you largely maintain the weight loss. Whereas if you don’t add the 9851, weight returns very quickly to baseline, which is also situation in patients.

So we see that there’s an opportunity in both mono and combination therapy. The second question on the clinical program, I think the Phase 1 program is going to be pretty standard. What we’ve communicated before, is we have a few critical goals that would be a part of the Phase 1 clinical program. First and most importantly, is do patients actually lose weight, similar to what we see in the animal models?

The second is the tolerability of the therapy. Because again, you always have to wonder in these treatments. The question is, will it be well tolerated, especially with the novel mechanism of action like the ileal brake? We haven’t seen anything in the animal models, to suggest that would be an issue with tolerability, but that would be an important component.

And the third is to demonstrate that there – is a clear mechanistic differentiation, from the GLP-1 mechanism. So I think those would really be the three critical goals that, we’ve certainly thought about in running the Phase 1 program. And I’ll turn it back over to Mike for the last part of your question.

Mike Exton

Yes, no thanks for the question. And as you could imagine, with a completely novel and orthogonal mechanism to the GLP-1 and incretin-based mechanisms, there’s a number of companies that have not only been interested in this particular asset, but have engaged in the data over the last month. We’ve been talking to a number of players, and what it would take to move into a partnership, from a data perspective is really quite varied.

And we’re prepared if we do have the right partner, with the right conditions at any particular time, to move into partnership. Because ultimately we believe that this program is best served with a partner, to really capitalize on the breadth of indications, again with the potential for indications beyond obesity, as well as the commercialization of this particular mechanism ultimately. So that’s where we’re at with 9851 and potential partnering opportunities.

Joseph Stringer

Great. Thank you so much for taking our questions.

Mike Exton

Okay.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler.

Unidentified Analyst

Hi, this is [Heena] on for Yas. Thank you for taking our questions. My first question, is could you kindly provide some color on how enrollment is progressing into your SONATA study, and when you expect enrollment completion? And with that, how soon could you engage with the FDA, for the end of Phase 2 meetings for Pilavapadin and start planning for Phase 3? And finally, what are some of the rate limiting steps to complete for the IND filing for 9851, which was previously discussed? Thank you.

Mike Exton

Three great questions on three different programs. I’ll let Craig have a stab at those.

Craig Granowitz

Thanks Heena. I’ll answer them in order. On the HCM program. We’ve been really pleased by the feedback we’ve gotten. We’ve had a number of investigator meetings, both in the U.S. and outside the U.S. We focus first and initially on opening sites in the U.S. We’ve communicated that we’re targeting about 30 sites in the United States, 120 sites overall with a target enrollment of about 500 patients, 250 each stratified for obstructive and non-obstructive.

I can say that we’ve made outstanding progress, in getting all the government approvals necessary, to have those conversations in countries outside the U.S., and we have sites open in non-U.S. countries right now. Again, we have not been forthcoming, with exactly what those are. But we can say that we are opening sites on plan. We have patients that are actively in screening, and actively in treatment today, similar to the timelines we’ve set.

The timelines I think we’ve talked about is that we’re looking to have final study results towards the end of ’26, which means that we would be filing with the FDA probably sometime in first quarter of ’27. Those are our current timelines. Obviously, its early days in the trial, but those are the timelines that we’ve put forward. And there’s nothing at this point that, we think is going to be significantly changing those timelines at the moment.

So if that answers your questions on HCM, I’ll move forward to Pilavapadin. For Pilavapadin, we’ve communicated. I’m sorry, I didn’t mean to cut you off. For Pilavapadin, we’re really, as Mike mentioned and I think we mentioned in the call on Monday, we’re really looking to get down to the FDA and have the end of Phase 2 meeting sometime in the second half of this year, with the possibility of starting Phase 3, Phase 3 program before the end of 2025.

Obviously, that will be dependent on a number of other factors, but those are the timelines that we feel comfortable at. And just to reiterate, what Mike said, is that we are more confident than ever in that 10 milligram dose, as being the right dose and that the PROGRESS study, really clarified the open issues that we had, going into the study about what is the best dose to go into Phase 3, balancing both safety and efficacy, and do you need the loading dose or not?

So we feel quite strongly positive now, to move to the end of Phase 2, publish the data this year and then move into Phase 3. On 9851, we’ve mentioned, and I think Mike talked about, that our plan is to have all of the IND enabling studies done this year, to get down to the FDA and have that meeting, and be ready to start the first in human studies before the end of the year.

That’s the timelines that we continue to track to. We’re doing all of the IND enabling studies right now. We had to do the dose finding from the animal studies, to do the final toxicology studies that, are required as part of the standard IND package. And we’re working actively against those targets.

Unidentified Analyst

Thank you so much.

Mike Exton

Thanks, Heena.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Joe Pantginis from H.C. Wainwright.

Joe Pantginis

Hi, everybody. Good afternoon. Thanks for taking the questions, two questions if you don’t mind. So for Pilavapadin data that you just put out, sort of a looking forward question. Craig on the call earlier said some broad strokes, as to what the Phase 3 program might look – like. Can you discuss anything right now with regard to what you feel might be the key open questions and/or, wish lists that you might have going into the FDA meeting? And of course, they could absolutely change tomorrow?

Craig Granowitz

Yes, Joe, great question. I think we mentioned perhaps at least in passing on Monday, some of the critical things that we’re going to look at, as we get the final data set. In a couple of them, we really talked about some of the key secondary endpoints that, we think are most meaningful to patients as Mike talked about, is particularly sleep interruption and burning pain.

So those are going to be important endpoints that, we want to take a look at, as we get the full data set in. Another one that we believe, is pretty important to look at, is the use of the acetaminophen rescue protocol, as you remember from RELIEF, that correlated really nicely with response that, there was much greater and earlier use, of the acetaminophen rescue in the placebo arm than in the active arm.

And we feel comfortable that those three, particularly are going to be important elements that will be consistent, or hopefully consistent with the primary endpoint data that we shared, and we’re certainly consistent in the RELIEF study. I think the other area that we have an interest, and I know a number of people that have asked have interest is what was the response regardless of the underlying single DPNP medication use.

And as a reminder in RELIEF we demonstrated activity independent, from the underlying DPNP medication and on top of the DPNP medication. So I think that is going to be another important question, because I think going into Phase 3, if we could demonstrate we have activity both with, or without underlying DPNP medication use, I think that will be very important for patients, healthcare providers and payers to know.

We’ll also continue, to look at some of the additional safety parameters, in reference to DPNP use. Looking at that in some of the demographic factors, as I think we mentioned, there were some notable differences in the demographics. Particularly the representation of black Americans in the trial was nearly double. So we will continue to look at some of those factors as well. I hope that wasn’t too long a list, Joe.

Joe Pantginis

No, no, that’s fantastic. I appreciate that color. And then just quickly, I guess a financial logistical question, if you will. Just wanted to make sure have the INPEFA one-time charges worked through the system already, or should we expect any for the first quarter?

Scott Coiante

Hi, Joe, it’s Scott. No, I would say that it’s safe assumption that all the costs were accrued. Certainly accrued as of the end of the year.

Joe Pantginis

Perfect. Thanks for all the color, guys.

Mike Exton

Thanks, Joe.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andrew Tsai from Jefferies.

Andrew Tsai

Hi, thanks. Good afternoon. Appreciate all the updates. Maybe two questions on pain on my side, for the upcoming FDA and the Phase 2 meeting. Could it make sense to ask them if this Phase 2b counts as a supporting pivotal and by extension, do you have a base case, or upside case internally? And then secondly at this juncture, do you think you would be powering the Phase 3s, to what you saw in the Phase 2a, or the Phase 2b for the 10 mg dose? Thank you.

Craig Granowitz

Yes, Andrew, thanks for the question. Certainly that would be an upside in our current scenario planning, of having this trial be counted as a pivotal. We would see it counting strongly as a supportive trial, but our base assumption would not be that this was a pivotal trial. And I think, as we previously shared our current thinking, which obviously will be impacted by FDA, is that we’d be looking at two pivotal trials going into the Phase 3 program, each one of which would have, roughly 300 to 400 patients in size.

And to your question, we would probably power it, similar that we powered both of these current trials for the statistics of a 0.6 drop on a placebo adjusted basis. And I wanted to reaffirm one of the points that Mike made in passing, is that we demonstrated in the PROGRESS study that at the 10 milligram dose, the pain scores continue to decline at a linear rate that, was really consistent from week three on.

So you saw a sharp drop in the first couple weeks, and then the slope of the curve changed, but remain pretty consistent from week three, or so to week eight. We don’t see any reason why that would particularly mitigate, between week eight and week 12. And if you sort of straight line that out, we think that that pain score is going, to continue to significantly drop.

If you look at the placebo and what has traditionally been seen in pain studies with placebo, is that that tends to plateau at somewhere between four and eight weeks. And you can already see hints of that in this trial, and in the RELIEF trial that the plateau – that the placebo is beginning to plateau.

So we feel quite confident, or comfortable that that wedge, that growing wedge of difference from the placebo in pain score to the drug will continue to grow between week eight and week 12 and that that 0.6 drop is something that, we think is we can comfortably achieve.

Andrew Tsai

Thanks, appreciate it.

Mike Exton

Thanks, Andrew.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Roanna Ruiz from Leerink Partners.

Unidentified Analyst

Hi all, this is Maisie on for Roanna. We just had two commercialization questions kind of around sotagliflozin and HCM. So for one what are your thoughts around partnership, and commercialization for that asset? And it’s kind of a two-parter, and the second part being how does that differ across different regions, where CMI use may be impacted? In countries of – in Africa and Asia I think that we are seeing that use is a lot less, and so just kind of wanted your insights around that please? Thanks.

Craig Granowitz

No, great, great question. So firstly for HCM ex U.S. and ex-Europe that, is entirely licensed to Viatris, our sotagliflozin partner. So in if you like rest of world Viatris and we’re closely connected with them, to help them in the registration process et cetera for HCM, as well as the other indications. But for the U.S. and well for Europe. I think we’ve mentioned before, we don’t have any intention in expanding our presence, and certainly not our commercial presence outside of the U.S.

So, we would be seeking a partner for Europe, where there is pretty substantial CMI use as you know. And then it comes to the U.S., and really we feel we’ve got the expertise and capabilities to commercialize HCM sotagliflozin for HCM. And as we’ve mentioned before, it’s going to be a very different payer situation for HCM, as the first and only SGLT inhibitor approved for HCM, to what we see for INPEFA heart failure.

And so that will provide us, with a much different potential commercialization trajectory. Now, one interesting and final aspect to that commercialization approach is unlike the CMIs, and I think this will continue both with currently approved and future approved CMIs that, will be used in a pretty focused way in centers of excellence that, treat HCM patients, general cardiology see HCM patients and are able to diagnose.

And the SGLT as a class, is very well known by general cardiologists. And so, really there’s an opportunity. Although we certainly see ourselves playing a significant role commercially in the U.S. There may be other partnering opportunities, as we move forward, but we will hold a very significant if not sole approach, to commercializing that in the U.S.

Unidentified Analyst

Oh, great. Okay. Thanks for the added color. Actually to follow-up on that then. As we think about the baseline characteristics for SONATA, are there any targets for the amount of patients that could be on background beta blocker or CMI therapy?

Craig Granowitz

Great question, Maisie. We have not put the limitations on any baseline or background therapy. We took a very similar approach to what we did with the SCORED and SOLOIST trials, where we included all patients with heart failure in those trials, regardless of whether they were HFrEF or HFpEF. In this trial, we’re taking all patients that remain symptomatic, as defined by a baseline KCCQ score.

So they can be on any underlying medication, including a CMI in that regard. And what we really care most about is that they have an adequately low KCCQ score at baseline. That’s really the major criteria. As a reminder also, the ejection fraction that we allow is an EF down to 50%. So I think the opportunity, will include both obstructive, non-obstructive background therapies that exist including CMIs and an EF down to 50% as well as having primary endpoint as KCCQ.

The secondary endpoint is New York Heart, and no requirement for all of the echoes that the CMIs require. That has all of the other physiologic testing, the peak VO2 and others that, really make it very difficult to enroll those trials, and limit the number of centers in those trials. We believe that our trial offers a number of different upsides in that regard.

Unidentified Analyst

Very helpful. Thank you all for the added color.

Mike Exton

Yes, thanks Maisie.

Operator

Thank you. At this time, I would now like to turn the conference back over to Mike Exton, for closing remarks.

Mike Exton

Well, thanks everyone for joining us this afternoon. It was great to have you all here, and give you a complete update across the three pretty significant programs that we have for sotagliflozin, for pilavapadin and LX9851. We’ve got a busy quarter ahead of us, and really look forward to updating you as we progress throughout the quarter, and indeed throughout the year. So thank you very much operator, and see everyone later.

Operator

This concludes today’s conference call. Thank you for participating. You may now disconnect