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May. 7, 2026 12:30 PM
Lexicon Pharmaceuticals, Inc. (LXRX)

Lexicon Pharmaceuticals, Inc. (LXRX) 2026 Q1 Earnings Call Transcript

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Craig: approved, Zynqvisto would be the first and only oral adjuvant to insulin therapy ever approved for glycemic control in type 1 diabetes. Our final cardiometabolic program is LX9851, our first-in-class non-incretin oral small molecule inhibitor of ACS L5 in development for obesity and associated metabolic disorders. Global development by our licensee, Novo Nordisk, continues to advance and LX9851 is now in the clinic following Novo's initiation of a phase one study in March. We are pleased by Novo's continued enthusiasm for this candidate and its novel mechanism and how swiftly Novo has advanced this program into clinical development. Now turning to our chronic pain program, like Sotaglifosin, pilavapidin has broad pipeline in a pill potential. Pilla is a novel investigative therapy targeting AAK1. Beyond DPNP, we believe that there are a number of potential applications for pilavapidin. The AAK1 pathway is central to a number of cellular processes, such as synaptic signaling between neurons involved in pain signaling and also spasticity. With this in mind, we are conducting IND enabling work in multiple additional neuroscience indications. Last month, we presented two additional data sets at the AAN annual meeting that further validate the development of pilavapidin in DPMP as well as other neuroscience indications. First, we shared additional efficacy data from the PROGRESS III Phase IIb study supporting the selection of pilavapidin 10 milligrams for Phase III development in DPMP. Following the top line results from the PROGRESS Phase II study last year, We knew we needed to deepen our understanding of these results through additional analyses. The data presented at AAN provided additional validation needed to advance pilivapidin 10 milligrams, as well as a deeper understanding of the profile of this novel mechanism. The data we have seen to date give us further confidence that pilivapidin is phase three ready in DPNP. Second, we presented preclinical evidence supporting pilavapidin as a novel oral therapy for spasticity, including evaluation in preclinical models of multiple sclerosis and spinal cord injury. The data shared at AAN underscore the opportunity to expand the potential of pilavapidin beyond EPMP, consistent with a pipeline in a pill opportunity that we have discussed. I'll now turn it over to Scott to provide an update on the company's financials.

Michael Heaney: Michael Heaney Thank you, Craig. I'll begin with a summary of our results for the first quarter of 2026. Total revenues were $21.1 million for the quarter compared to $1.3 million for the corresponding period in 2025. Revenues for the first quarter of 2026 include two $10 million milestones recognized from the Novo Nordisk Agreement and net sales of MPEFA of $1.1 million. Research and development expenses for the first quarter of 2026 were 12.8 million compared to 15.3 million in the corresponding period of 2025, reflecting lower external research expense in 2026 due to the completion of our progress phase 2B clinical trial and the licensing of LX9851 to Novo Nordisk. Selling, general, and administrative expenses for the first quarter of 2026 were 9.2 million compared to $11.6 million in the corresponding period of 2025. The decrease in 2026 reflects reduced marketing efforts and lower personnel costs. Net loss for the first quarter of 2026 was $1.0 million, or less than a penny per share, compared to a net loss of $25.3 million, or seven cents per share, in the corresponding period of 2025. Net loss for the first quarter of 2026 included non-cash stock-based compensation expense of $3.1 million. As of March 31st, 2026, Lexicon had $199.7 million in cash, cash equivalents, short-term investments, and restricted cash as compared to $125.2 million as of December 31st, 2025. Total debt as of March 31st, 2026, was $49.7 million as compared to $54 million as of December 31st, 2025. I'd like to now highlight a few items from the first quarter. As I mentioned, revenue for the first quarter included two $10 million milestones recognized under our NOVA Nordisk Licensing Agreement. Quarter over quarter, our operating expenses decreased by $4.8 million, reflecting our continued operational discipline and the strategic repositioning we began implementing in late 2024. We are also reaffirming our full year 2026 outlook for operating expenses. Earlier this week, we took steps to improve our balance sheet and enhance our financial flexibility. We announced a $100 million debt facility with Hercules Capital. Under the terms of this agreement, an initial tranche of $55 million was funded at closing and was utilized to repay our existing loan facility with Oxford Finance. A second $20 million tranche is available for draw at lexicon's option subject to the achievement of certain clinical, regulatory, and financial milestones and specified time requirements. A third $25 million tranche is available for draw at lexicon's option subject to Hercules' consent and specified timing requirements. The loan facility provides for an initial interest-only period of 18 months with the potential for two six-month extensions. We are incredibly pleased with our financial accomplishments thus far in 2026, including the completion of our capital raise in February and our new loan facility with Hercules. We have strengthened our balance sheet and improved our financial flexibility while remaining prudent with our expenses ahead of our important milestones in the back half of this year. I will now turn it back to Mike for closing remarks.

Mike Exton: Yeah, thanks, Scott. Now, before we turn to Q&A, I just want to reiterate just how pivotal a year 2026 is for Lexicon. To ensure success for the year and to get us to this point where in H2 we will have a number of important things happen for the company, we've done two things. We've taken steps, firstly, to strengthen our financial foundation over the last few months. And second, we've executed incredibly well. And as a result, we've many significant milestones just weeks away. I'm excited for how the opportunities are really shaping up for us, both with our own actions, but also importantly within the external environment, which is favoring our approach across the board for all of our programs. For HCM as the field evolves, an awareness of both obstructive and now importantly non-obstructive disease really advance. We are well positioned with a therapy that has the potential for a strong benefit risk profile and ease of use at a time where market awareness will be high and the need will clearly remain significant. In T1D, we haven't given up. Indeed, our resolve is strengthened by the ongoing constructive dialogue with the FDA. Indeed, we're close to being able to submit new clinical data that we believe demonstrates a strong benefit risk with people with T1D supported by high unmet need and strong patient support for approval. With pilobapidin, we're pursuing the right strategic partner to allow for the greatest potential for this novel asset at a time when the pain therapeutic space and legislative and regulatory environment are increasingly in our favor of new novel non-opioid approaches. And finally, with Alex 9851, our licensee, Nova Nordis, continues to prioritize the clinical development of the asset. And indeed, just yesterday, highlighted 9851 in their earnings call. So by next quarter, even in just the next few weeks, we believe we'll be able to share a number of positive developments. And we thank you for your continued attention and support. And with that, I'll turn it back to you, operator, to guide us through the Q&A.

Operator: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press star, then the number one on your telephone keypad. And your first question comes from the line of Andrew Che with Jefferies. Please go ahead.

Brian: Hey, it's Brian here, on for Andrew. Just given the Acacia data in non-obstructive that just hit, without a Campton, How does that make you feel about your own sonata phase three? And if you can just talk about potential differentiation there as well, please.

Mike Exton: Yeah. No, thanks, Brian. Appreciate the question. So, look, I think first and foremost, it's really an exciting time to be in the field of HCM. I think there's a lot of enthusiasm and a lot of patient need. And what we saw yesterday from the Acacia study really gives us a lot of confidence that we have an asset where we believe we will have an incredibly strong benefit-risk profile. We know the safety of Sotagliflozin through many years of study and many thousands of patients' exposure. And if Sonata is positive, we believe that represents a strong benefit-risk profile. And really, the opportunity, particularly in non-obstructive is incredibly large, and so we're really buoyed by that, and it gives us confidence in our step moving forward, particularly because with a strong benefit-risk profile, together with that simple once-a-day oral dosing, we really see ourselves positioned particularly in non-obstructive as a first-line therapy. It makes a ton of sense where you don't have a REMS, you're a simple, well-known, safe product, that provide significant symptom relief that a first-line asset can work very well for us. And importantly, really, these are two very different mechanisms. And like many types of cardiometabolic disease, using multiple mechanisms for shots on golem to relieve symptoms and improve outcomes is typically done. So we're incredibly pleased that we have a strong opportunity in non-obstructive and obstructive disease.

Craig: Yeah, I'll just add, Brian, a couple other points. Thank you, Mike, for your comments. As Mike mentioned, the mechanisms of action here are not in conflict. In fact, they're probably complementary. I think the general feeling in the field is that CMIs are acting primarily as hemodynamic agents. And as I tried to mention in my prepared remarks, so does acting. as a hemodynamic agent in a different manner, really acting on the cardiorenal axis and also improving a number of other parameters, some weight loss, increase in hemoglobin, decrease in blood pressure, all of which are beneficial for the heart in any heart failure state. And in addition, we believe that the SGLT1 effects with SGLT1 receptors upregulated, particularly in the myocardium, that acting directly on the heart muscle tissue in a way that is novel and distinct from a CMI is important. As we've mentioned in prior calls, we have not excluded patients on CMIs in this trial. And I can tell you that we are enrolling symptomatic patients on CMIs. Obviously, they're all Mavacamptan because that was the only product that's been commercially available heretofore. I also think that the results from Acacia had I would say, at least on a median basis, a relatively modest effect on KCCQ score. And if the patients had baseline KCCQ scores similar to what was seen in the Odyssey, my guess is a number of those patients will still remain symptomatic and will require additional therapy, which is consistent with what we're seeing in our trial enrollment, that all the patients that are on CMIs remain symptomatic. I think in that regard, as Mike said, the biggest issue in non-obstructive is going to be patient identification because people have not been looking for non-obstructive disease, and I think historically have just sort of lumped them into a slightly different variant of PEPF. And I think that differentiation of a much thicker left ventricular wall has probably not been appreciated to date, and having another company out there really talking about the importance of non-obstructive HCM as a separate disease state from HFPEF, I think will be extraordinarily important for the field and for Lexicon.

Operator: We'll take our next question. Your next question comes from the line of with Citigroup. Please go ahead.

Caroline: Hey, this is Caroline on . Thanks for taking our question. We're wondering if you can tell us what percent of enrollment in the Phase 3 Sonata HCM study has been completed, and how is the split in enrollment trending between obstructive and nonobstructive patients? You know, is there a risk of too many nonobstructive patients relative to obstructive patients, given some obstructive patients are currently being treated with CMIs, which you've mentioned before? You know, what does... if the enrollment is weighted more towards one group over the other. Thanks.

Craig: Yeah, great questions. I'll answer them in the order that you asked them. We haven't given exact numbers of enrollment, but I can say confidently that we reaffirmed the timelines that we have with enrollment middle of this year in terms of last patient first visit of 500 target patients. We've seen as expected as all the sites come online, the expected and dramatic uptick in enrollment as the sites open and become familiar with the study and its availability. The distribution of patients, again, I don't want to comment too early before we finalize enrollment. I think, as we've said, the need is larger in the non-obstructive group, since there is obstructive therapy available with CAMS-ISOS during the duration of the trial. but we are enrolling significant numbers of both obstructive and nonobstructive patients in the trial.

Operator: Thank you. Again, if you would like to ask a question, press star 1 on your telephone keypad. And your next question comes from the line of Yasmin Rahimi with Piper signed. Please go ahead.

Dominic: Hi, this is Dominic on for Yaz. Thank you for the update and congrats on the great quarter. We just had a few questions and then kind of going along with some of the conversation about enrollment. At the time of enrollment completion in mid 2026 for Sonata, would you potentially unveil baseline demographics? And then kind of in line with that, do you have any thoughts on how similar Sonata's patient population will look to Acacia for the recent readout? We have one more question just on what would be clinically meaningful difference in KCCQ and what did you power Sonata for on this endpoint? Thank you so much.

Mike Exton: Yeah, thanks, Dominic. Let me start up and then Craig can take some of the detailed Sonata questions as well. So we haven't finalized exactly the information that we will release at the time of enrollment. But we're certainly committed and understand that there's interest across a number of parameters. Of course, this split is given by the questions that are coming. This split of obstructive, non-obstructive is of interest and to really get the final baseline DEMs to compare that to Sonata. So we're very cognizant of that and we will determine over the coming weeks exactly what we will release when so we haven't sort of finalized but we will be providing updates because we are we are cognizant that that's important for the folks to understand um as it comes to the sort of uh the the sonata specific questions i might let you um take those greg yeah thanks mike um i hope i have your questions correct i'll answer the the one on demographics first again we're still enrolling the trial and um

Craig: Keisha has not really, to my knowledge, given details on the demographics, some of what was done with Odyssey since Odyssey is now already published. But I think we're seeing a patient population similar to what has been reported for Odyssey. You're really looking at population in their mid-50s to 60, pretty symptomatic disease. A good distribution by gender, equal distribution of gender. So we have a population I think was very consistent with what we expected, particularly the demographic and the geography that we're enrolling in this trial, which is U.S. and across Europe. But I think in that regard, we've not seen anything unexpected. We haven't looked at detail yet at the KCCQ scores or anything else, but certainly, We know that patients are symptomatic that are coming into the disease. And broadly similar entry criteria, right? Yeah, exactly, Mike. Yeah, thank you. Very similar entry criteria to the other trials. The clinically meaningful KCCQ score, I think the field is generally focused on five, four to five as the number. You know, I think there may be a rethinking of that in light of some of the more recent study results that have come out. but certainly historically that has been seen as an important threshold for clinical meaningfulness. And that's how we powered our trial is based on that range. Again, we haven't given the exact statistical plan that we're using, but we can certainly detect in that range comfortably with a high degree of probability of success. And I do think that is going to be a real point of discussion in the field of risk benefit with modest improvements in KCCQ, but with, you know, potential for safety concerns and monitoring. I think those are going to be important discussions that the field will be having as the field of non-obstructive HCM is further discussed at upcoming medical meetings and probably also with payers and regulatory authorities.

Mike Exton: Great, thank you so much.

Operator: And there are no further questions at this time. I will now turn the call back over to Mike Exton for closing remarks.

Mike Exton: Thanks so much, everyone. Thanks for tuning in and listening to our update. As I mentioned, the team has really worked incredibly hard to put us in a strong financial and strategic position and to execute across all of our programs. We're really looking forward to H2 here in 2026. I think, as you see from our remarks, we've got many things that we've been working on diligently over the last wee while that are going to come to fruition. And so I really look forward to updating you with a lot more information in the not too near future. So have a great day and look forward to speaking with you all again soon. Thank you very much.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.