Earnings Call Transcript - LXRX Q3 2024

Operator, Operator

Good day, and welcome to the Lexicon Pharmaceuticals Third Quarter 2024 Results Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Lisa DeFrancesco, Head of Investor Relations and Corporate Communications. Please go ahead.

Lisa DeFrancesco, Head of Investor Relations and Corporate Communications

Thank you, Dave. Good afternoon, and welcome to the Lexicon Pharmaceuticals third quarter 2024 financial results conference call. Joining me today are Dr. Mike Exton, Lexicon's Chief Executive Officer and Director; Tom Garner, Senior Vice President and Chief Commercial Officer; Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer; and Dr. Alan Main, Executive Vice President, Innovation and Chemical Sciences. Earlier this afternoon, Lexicon issued a press release announcing our financial results for the third quarter of 2024, which is available on our website 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 INPEFA, ZYNQUISTA, LX9211, LX9851, and our other drug programs, as well as our business generally. These statements may also include characterizations and projections relating to our commercial launch of INPEFA in heart failure, as well as the clinical development, regulatory status, and market opportunity for all of our drug programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovering 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. 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 Exton, CEO

Thanks, Lisa, and good day, everyone. Thanks for joining us on the call. Before we begin our discussion on Lexicon’s results and business update for the third quarter of 2024, I’d like to discuss the progress we’ve made throughout this year, specifically over the last quarter, where there have been a considerable number of important achievements. Summarizing just the last few months, we’ve completed the resubmission of our NDA for ZYNQUISTA for glycemic control in people with type 1 diabetes and chronic kidney disease. The FDA held an advisory committee meeting for our NDA on October 31, and we’re continuing to work toward the PDUFA goal date of December 20 of this year. We’re planning for multiple outcome scenarios as we approach the PDUFA date in a few weeks. We also completed a strategic repositioning and continued focus promotion of INPEFA to targeted high prescribers. Furthermore, we have two major assets undergoing late stage clinical development, and we’re making excellent progress in the development of both. A Phase 3 study for sotagliflozin in hypertrophic cardiomyopathy, or HCM, is underway, and the study is making good progress in sites open and enrolling patients. A Phase 2b study for LX9211 in diabetic peripheral neuropathic pain, or DPNP, has crossed a major milestone by completing enrollment screening earlier than anticipated. Now we anticipate top-line data in the first quarter of 2025. From our earlier clinical pipeline, we’ve made progress with our exciting novel drug candidate LX9851, an oral therapy with IND-enabling studies underway for obesity and associated cardiometabolic disorders. Lastly, we’re able to share important data on this asset at Obesity Week. We believe LX9851 has the potential to become an innovative next-generation treatment, and we also know, booming and yet evolving market. We’ve taken steps to reinvigorate our business development efforts with a substantial near-term focus on partnering. One result of these efforts was the recent exclusive licensing agreement we completed for sotagliflozin outside of the U.S. and Europe with Viatris, a company with strong cardiometabolic expertise and a successful track record of commercializing medicines. So I’m going to begin our business overview today by sharing an update on ZYNQUISTA, following our recent AdCom. The committee voted 11 to 3 that the benefits of ZYNQUISTA do not outweigh the risks in adults with T1D and CKD. Now, importantly, following the vote of the initial population, there are additional robust discussions surrounding the benefit risks of ZYNQUISTA in the 60 to 90 population, which was predefined and discussed at length during both the Lexicon and FDA presentations. As part of the discussion, additional committee members expressed support for sotagliflozin in this subpopulation where they believe the benefits potentially outweigh the risks. Indeed, we saw an overwhelming outpouring of support, reflective of the unmet need that exists in this population. The meeting was widely attended by patient communities, advocates, and healthcare professionals, and included 23 presentations shared during the public hearing, and a total of 148 submissions to the MDAC docket. Though there have been few advancements in insulin and CGM technology, the vast majority of people with T1D struggle to maintain glycemic control. Glycemic control is especially critical in the higher-risk population of people with both T1D and CKD to slow the progression of kidney disease, heart failure, and death. Although the Lexicon team remains hard at work towards our PDUFA date of December 20, and while we work towards the PDUFA date and remain committed to launch readiness to bring ZYNQUISTA to patients if approved, we’re vigilant about our cash position and spending. Accordingly, we’re preparing for all PDUFA outcome scenarios, with each plan mindful of cash and focusing resources on the opportunities provided by our strong pipeline. Presently, we’ve paused any new spending related to launch preparation until we have more clarity on the path forward. However, in the event that we do have a successful outcome at PDUFA, our goal is to make ZYNQUISTA available to the appropriate patients as quickly as possible, and as early as the first quarter of 2025. We’ve done a significant amount of planning in preparation for this launch and have a number of key tailwinds, including an established supply chain and manufacturing capabilities ready to scale, given our prior launch of sotagliflozin, as INPEFA for heart failure, proven commercial leadership expertise, and a highly experienced team with significant launch experience, and operating in a highly concentrated market, knowing that 80% of people with T1D and CKD are treated by a concentrated group of approximately 4,000 endocrinologists, which will give us the opportunity to have a significant impact with our existing field team. Most importantly, ZYNQUISTA has the potential to be the first and only adjunct therapy to insulin for glycemic control. There’s been a dearth of innovation for this patient population, despite the significant need, and we believe ZYNQUISTA could satisfy a strong pent-up demand if and when we align with the FDA on the right patient population to benefit from this therapy. So moving on now next to briefly discuss INPEFA for heart failure. Net sales for the third quarter of 2024 were $1.7 million, which represents an 8% quarter-on-quarter growth, yielding $4.5 million year-to-date for 2024. Through Q3, we saw improvements in filled TRx volumes across both commercially insured and Medicare patients, with gross unit volume increasing by 26%, driven predominantly by increased depth of prescribing among the growing base and repeat INPEFA prescribers. This progress continues to be driven by the focused efforts of our sales team, even with the strategic repositioning that included a 50% reduction in field force, which was effective in September. Continuing with the discussion of sotagliflozin, which remains a pipeline and appeal opportunity for Lexicon, we have made significant progress in our clinical development strategy for patients with symptomatic HCM. Enrollment is now underway for SONATA HCM, a pivotal Phase 3 placebo-controlled study, with a targeted enrollment of 500 patients with obstructive or non-obstructive HCM. The primary endpoint of the study is change from baseline in KCCQ score, an endpoint that has been accepted by the FDA as the primary endpoint in this and other label-enabling HCM trials, and with which we’ve previously achieved success in our SOLOIST heart failure trial. Importantly, SONATA HCM is studying a broader patient population than that studied in other ongoing trials in HCM, as we allow patients to be on cardiac myosin inhibitors, as well as allowing the use of beta blockers and calcium channel blockers. If approved, this clinical approach would potentially enable broad adoption and ease of use, as there would be no need necessarily to change the current treatment regimen. We’ve obtained feedback from the FDA that success in this single study could support a broad label for sotagliflozin in HCM. Once again, this fits our Lead to Succeed strategy as an important area of growing unmet need where we have the potential to be the only indicated SGLT inhibitor. Current estimates suggest that approximately one million patients in the U.S. today have HCM. Many are not diagnosed, in part given the non-specific nature of HCM symptoms, but diagnostic rates have been rising rapidly, a trend which is expected to continue over the next decade with increased awareness and understanding of this disease. Looking further into our pipeline, I really want to spend some time today on LX9211, as we’re near the finish line of our Phase 2b study. LX9211 is another pipeline and appeal opportunity for Lexicon, with what we believe to be multi-blockbuster potential across numerous possible therapeutic applications in important areas of need. These include diabetic peripheral neuropathic pain, which is currently under evaluation, but also in other forms of neuropathic pain, such as post-hepatic neuralgia and potentially in forms of spasticity. LX9211 offers the opportunity to potentially redefine the standard of care in DPNP. Targeting the enzyme AAK1, LX9211 is a non-opioid medication and has the potential to be the first new oral treatment for neuropathic pain in more than two decades. LX9211 has received fast-track designation from the FDA for development in DPNP. As you can tell, we’re really excited about the potential of this program. Our progress Phase 2b dose optimization study completed screening for enrollment this past quarter. That’s significantly ahead of schedule. We now anticipate top-line data in the first quarter of 2025, so that’s really right around the corner for us. We believe this study was well designed. Like our previous proof-of-concept study, it’s placebo-controlled and allows patients to remain on a stable dose of standard of care therapy rather than removing all pain medications. That’s consistent with how novel DPNP drugs are likely to be used in real-world practice. There are approximately 20 million patients in the U.S. suffering from neuropathic pain, and about 5 million of those have diabetic peripheral neuropathic pain. If approved, we believe that LX9211 could offer real benefit to patients and to the clinical community who are looking for better options to improve outcomes for patients with various types of neuropathic pain. We’re really looking forward to these results. The protocol of the study was also designed to find the correct dose and optimize the Phase 3 program both in terms of length and overall study size. While Lexicon is well positioned to continue the clinical development for DPNP, we’ve been actively discussing potential partnerships to realize the full value and potential for this asset. Our newest drug candidate is LX9851, a novel compound currently in preclinical studies for obesity and associated metabolic disorders. We believe that LX9851 has the potential, like our other assets, to be developed in additional indications and to be used as a potential combination therapy. LX9851 is a small molecule inhibitor of the novel target ACSL5, an enzyme that is highly expressed in the intestinal mucosa. Its unique ileal break mechanism appears to provide benefit versus known limitations of GLP1s, such as lean muscle loss, dose-related adverse GI side effects, and weight rebound post-discontinuation. We believe 9851 could be administered orally for chronic weight management, alone or in combination with incretin mechanisms, with a target product profile that reduces body fat and improves overall metabolic profile. On the next couple of slides here, I’d like to show some preclinical data which was presented last week at Obesity Week. The first slide shows the significant reduction in body weight observed with diet-induced obese, or DIO, mice that are on a high-fat diet. Notably, the addition of LX9851 to semaglutide resulted in significantly greater weight loss than that achieved by semaglutide alone. Furthermore, we also presented data on what happens to weight loss if semaglutide is discontinued and then LX9851 treatment is initiated. Here you’ll see the blue line that shows weight loss associated with the administration of semaglutide. Importantly, when semaglutide treatment is withdrawn after day 14, it quickly rebounds back to baseline. If, however, LX9851 treatment commences upon semaglutide discontinuation, the green line shows how weight loss is substantially maintained. We’re really enthused about the promise of these early results and other preclinical data we’ve generated demonstrating improvements in cholesterol, triglycerides, and insulin sensitivity, which may pave the way for additional related indications in metabolic syndrome and MASH. As we know, the obesity and weight management space is an area of tremendous interest in the industry, and we’re very excited about the potential for an oral therapy that complements and enhances current therapies alone or in combination. We continue to advance our IND-enabling studies and are actively preparing for IND filing by mid-2025. In summary, we’ve made great progress across every one of our invested pipeline assets as we explore the potential applications of our novel unique products. We’re focused on making progress across the board on this pipeline in 2025. Let’s now touch on the financials for the quarter, and then I’ll talk a little bit more in-depth about our partnering strategy. We ended the quarter with $258.4 million in cash and investments, not including the upfront payment of $25 million that we received from the licensing agreement with Viatris, which was received in the fourth quarter. As indicated in our press release this afternoon, we had $1.8 million in revenues in the third quarter of ’24, almost all from net sales of INPEFA. R&D expenses for the third quarter of ’24 increased to $25.8 million from $17.6 million for the corresponding period of 2023. That was primarily due to investments in our late-stage development programs, including the commencement of SONATA Phase 3 study of sotagliflozin in HCM and the earlier recognition of expenses related to the Progress Phase 2b due to the enrollment acceleration. Selling general and administrative expenses for the third quarter increased to $39.6 million from $32.2 million for the corresponding period in 2023. That reflects higher marketing costs in conjunction with the commercialization of INPEFA and launch planning for ZYNQUISTA, as well as severance costs resulting from the strategic repositioning announced in August, which included a 50% reduction in the field force at that time. In total, net loss for the second quarter of 2024 was $64.8 million, or $0.18 a share, compared to a net loss of $50.5 million, or $0.21 a share, in the corresponding period of last year. For the third quarters of ’24 and ’23, net loss included non-cash stock-based compensation expense of $2.8 million and $3.9 million, respectively. Let me now pivot and talk a little bit more about our strategy for partnering, which, as I mentioned earlier, is going to be a key value driver for Lexicon going forward. We’ve reinvigorated our business development efforts over the last quarter, and that’s going to be a key part of our Lead to Succeed strategy moving forward. We have three key priorities when evaluating partnership opportunities to create value: augmenting our commercial capabilities, advancing our pipeline in any or all potential indications, and expanding access to new geographies or territories to deliver on the innate value of our products. Importantly, any partnerships would be a major source of non-dilutive capital to invest in our future. A fantastic lead example of this strategy in action is the exclusive licensing arrangement we announced this quarter with Beatrice, a company with strong cardiometabolic expertise, global commercial capability, and a successful track record of launching medicines in new territories. This deal represents an exclusive opportunity to expand the reach of sotagliflozin across all indications to patients in other markets outside of the U.S. and outside of the EU. The deal included a $25 million cash upfront payment and close to $200 million in potential regulatory and sales milestone payments, as well as tiered royalties from the low double digit to high teens. We’re excited to work with Beatrice, and even in these early weeks, they’ve already been an engaged and motivated partner. We’re confident that they are the right collaborator for sotagliflozin in these territories. With a renewed emphasis on business development, we’ve reshaped our BD team who are laser focused on our pipeline and potential near-term partnering opportunities. Both LX9211 and LX9851 are focused on disease areas with proven or clearly articulated multi-blockbuster potential for new medicines. We continue our engagement with potential partners in this space, and we’re sharing important data as they progress. Importantly, we also now have a focused lead generation program against additional undisclosed targets from Genome5000 in preclinical validation within the cardiometabolic and neuroscience spaces. 2024 has been transformative for Lexicon, and the next 12 to 18 months promises to be just as pivotal. We have several important potential catalysts coming in the relatively near term. We’ll know for certain whether we have the ability to launch ZYNQUISTA in just a few short weeks. As I stated earlier, we’re ready today for multiple scenarios. Our SONATA Phase 3 study of sotagliflozin in HCM is well underway, and we look forward to continuing to enroll patients. We expect our PROGRESS Phase 2b study of LX9211 in DPNP will report top-line data in the early part of next year. The IND-enabling studies of LX9851 in the rapidly evolving area of obesity and associated cardiometabolic disorders are underway, with an IND filing anticipated in the middle of next year. Each of these opportunities has large potential in areas of significant unmet need and clearly represent large commercial opportunities. Any one of these successful outcomes has the potential to redefine Lexicon’s future and create significant value for stakeholders, including the patients we are also committed to. With that said, I’ll turn the call back to the operator and look forward to your questions.

Operator, Operator

We will now begin the question-and-answer session. The first question comes from Andrew Tsai with Jeffries. Please go ahead.

Andrew Tsai, Analyst

Hi, good afternoon. Thanks so much for taking my questions. I appreciate the updates. So after the AdCom, what would you say is your confidence that you will be getting a skinnier label within that 60 to 90 CKD subgroup? And is there anything you can do in the coming weeks, maybe sharing some more data or anything else to help convince the FDA to grant approval? Thanks.

Mike Exton, CEO

Yes, great. Thanks, Andrew. I’ll let Craig comment initially.

Craig Granowitz, Chief Medical Officer

Yes, thanks, Andrew. We remain involved and engaged with the FDA after the MDEC process, and I think really at this point all we can say is that we’ve continued our engagement with them, and we remain committed to the target date of December 20th. I think anything further at this point would be premature for us to comment on one way or the other. Thanks.

Mike Exton, CEO

Andrew, just to add a little bit of flavor, you know, both the FDA and us did call out the 60 to 90 group as a population that may have improved benefit-risk, and indeed that doesn’t represent a skinnier label. In fact, compared to the indication that we submitted in our briefing document, it represents a population with another 15% to 20% of eligible CKD patients. So we don’t think that would represent a skinnier label, and we’re going to continue to work with the FDA on potential scenarios.

Andrew Tsai, Analyst

Yes. Thanks for the clarification. And then secondly, for the pain program, obviously the data is coming faster than what we had expected. So at the end of the day, are you expecting a larger placebo-adjusted efficacy separation than what you saw in the prior Phase 2a, and why? Thanks.

Craig Granowitz, Chief Medical Officer

Yes, Andrew, it’s Craig Granowitz again, thank you for the question. As we’ve mentioned, we always analyze our data not from a completer’s analysis standpoint but on an intent-to-treat basis. If the data holds up and the percentage of patients that are completing the trial is greater than the dropout rates that we saw in the 201 study, the pilot study, one might expect that the response rates might be greater, and certainly that’s what we’re hoping for—was to have a better efficacy-safety profile. The dizziness signal we saw was really a C-max effect that was very much correlated to that initial handful loading dose on day one. I think, as we’ve shared in prior calls, we’ve seen a very different profile, again, all blinded data, but a very different profile in the tolerability of treatment during this study. While I don’t want to overstate the case, analyzing the data on an intent-to-treat basis, the more drugs patients get in, assuming the drug is active, the more likely it is that we will see an enhancement of relative efficacy compared to placebo.

Andrew Tsai, Analyst

Okay, that's very encouraging. Thank you.

Craig Granowitz, Chief Medical Officer

Thanks, Andrew.

Operator, Operator

The next question comes from Yasmeen Rahimi with Piper Sandler. Please go ahead.

Unidentified Analyst, Analyst

Hey, team. This is Jung-Goo on behalf of Yas. Thank you for taking our questions. For the pain program, could you comment on what types of data you're privy to on a blinded basis across efficacy and safety? And secondly, is it reasonable to expect a dose response in the study as well?

Craig Granowitz, Chief Medical Officer

Yeah, so the data we get is extraordinarily limited, and again, it's all blinded data, so we don't know which patients are on drug or not on drug, and it's driven totally around safety. We continue to monitor that because patient safety is our most important priority, and we continue to do that ongoing regarding all the patients that are enrolled. The overall results in terms of dropouts and tolerability are the only things we can comment on. So I really can't say anything other than what I've already shared is that the profile in the blinded data seems somewhat different than what we saw in the pilot trial, and I think I really can't comment more than that on the overall profile of the drug.

Unidentified Analyst, Analyst

Got it. Thank you.

Operator, Operator

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

Joseph Stringer, Analyst

Hi. Thanks for taking our questions. Question on the Phase 3 HCM trial. Are you aligned with the FDA on the KCCQ primary endpoint, and what would you consider a successful placebo-adjusted change in the KCCQ? Is there a bar for success here on this endpoint, the dataset?

Craig Granowitz, Chief Medical Officer

Yes, Joey, it’s Craig Granowitz again. We feel quite confident in this endpoint. We did have this discussion with the FDA prior to initiating the trial, both in terms of the endpoint, the magnitude of the benefit, the statistical plan, the powering of the study, and the inclusion of both obstructive and non-obstructive in the relative numbers that are included in the trial. All the parameters we’ve shared previously on the trial design and endpoints, we feel confident in. We’ve not shared the overall expected KCCQ delta achieved in the trial, but as Mike mentioned in the prepared remarks, this is an endpoint that we feel quite confident we can reach based on what we’ve seen in the SOLOIST trial. The inclusion criteria are for patients with symptomatic disease with a maximum KCCQ of 85 at enrollment, which means the median will be somewhat lower than that. Based on our prior experience and the fact that FDA has allowed approval of other studies as label-enabling studies running in non-obstructive HCM, we feel confident in the endpoint, as well as the expected outcomes using this instrument with sotagliflozin in a group of patients with symptomatic heart failure.

Joseph Stringer, Analyst

Great. Thank you very much.

Operator, Operator

The next question comes from Joe Pantginis with H.C. Wainwright. Please go ahead.

Joe Pantginis, Analyst

Hey, everybody. Good afternoon. Thanks for taking the questions. So I know Craig mentioned that you might be further restricted in your comments around the AdCom, but just curious how much the targeted population plays into your current FDA discussions. More importantly, if you do get another CRL and the FDA suggests another study in that defined population, are you prepared to do it yourself?

Mike Exton, CEO

Yeah. It’s an intriguing and insightful question, as always, Joe. At this stage, we’re going to await the results of the PDUFA to make any concrete decisions. We’ve been pursuing this with the FDA for over six years, and it would be very difficult to think about continuing to do more studies, especially when we have a ton of evidence we presented at the AdCom. It makes it a tough proposition to pursue further investments, particularly when it’s hard to have confidence that it would be sufficient. So never say never, but it would be a tough one.

Craig Granowitz, Chief Medical Officer

Yes, Joe. We did have that specific discussion during the Q&A, as some of the MDAC advisors asked us about that. I’ll just very briefly remind the group that we did three large independently blinded trials, all of which achieved the primary and secondary endpoints. The 60 to 90 group was a predefined group prior to the initiation of the study, which we showed previously and again at the meeting that achieved statistical significance in all three of those trials. There was never a discussion at the advisory committee, did we achieve the endpoint which was A1C reduction, or all of the key secondary endpoints, blood pressure control, weight management, time and range, reduction, and level two hypo. We felt at the time of the last CRL and particularly in this population that there is no basis to re-run the efficacy trials. We think that has been definitively established as has the safety profile and the mitigation strategies that have been widely adopted across the medical community for dealing with diabetic ketoacidosis. The initiating and mitigation factors are the same regardless of SGLT inhibitors. And as we reminded the MDAC, 50% of the patients, whether they were on drug or not on drug, restarted the therapy during treatment. There’s no basis to run a study looking at the mitigation of DKA based on these international consensus guidelines that have been widely adopted. So, from a medical standpoint, we just don’t see any rationale or need to run another efficacy trial for glycemic management.

Joe Pantginis, Analyst

Very fair answers. I appreciate it and also the reminders. A quick question, and then my second question. For the HCM study with sotagliflozin, just curious about patient competition with approved products for HCM as well as developmental assets. And then for 9211, since we’re approaching data, if you could remind everyone publicly, since this could be the first non-opioid approved for DPNP, what are some of the key benchmarks we’d be looking at when the data come out?

Craig Granowitz, Chief Medical Officer

I'll answer your first question on enrollment and competitive enrollment for the HCM trials. We've opened a number of sites in the U.S. We presented data on the trial design at the HFSA meeting and at the HCM meeting from the study PIs. The sites that we're opening in the U.S. like the protocol, and they are interested in participating. We expanded the number of study sites in the U.S. as we previously shared, and we are in the process of getting approvals for all the other countries right now. The other country approvals are on track or ahead of schedule of what we had anticipated at the time to get those government approvals to initiate the trial. We feel pretty good on the design. Just like our 9211 trial, it's a pragmatic trial design that's easy to follow. You don’t have to do all the echoes with the other trials. The duration is short. The endpoint is simple. You don’t need to do VO2 testing or complicated physiologic testing. The feedback we've had at the investigator meeting has been very favorable. It's a pretty easy study to do.

Joe Pantginis, Analyst

Great job, Craig. Thank you.

Craig Granowitz, Chief Medical Officer

Maybe I'll turn it back over to Mike on benchmarks for the 9211 study.

Mike Exton, CEO

I assume Joe, you’re talking about the primary endpoint and the delta we might see in pain scores.

Joe Pantginis, Analyst

Yeah, primary and secondary benchmarks.

Craig Granowitz, Chief Medical Officer

Great question. When you look at a pain program, you have to look at two parameters: the placebo-adjusted reduction in pain score and the baseline to maximum reduction in pain score because patients don’t get treated compared to placebo—they get treated compared to their baseline. These patients have a significant placebo effect regardless. The reductions in pain score of patients to their baseline are quite significant in all these trials, and we did hear from our clinical experts and the FDA that the reduction in pain score we were achieving in the pilot study, both in the DPNP and in the PHN study, were clinically meaningful compared to placebo, looking in the range of 0.65 to 0.8. In the PHN study, the reduction in median pain score is even larger than in the DPNP trial. I think it’s evidenced by the fact that there was tremendous uptake of the trial, and we completed it many weeks early.

Mike Exton, CEO

The beauty of this trial, as Craig mentioned, is pragmatism and association with how it’s likely patients are going to be treated for DPNP when and if this gets approved. Any new pain medicine will be stepped through generic medicines, both from the physician and managed care perspectives. This study enrolls more quickly than expected, and we think that it is scientifically the most valid way to show the efficacy over and above the standard of care. It also helps physicians and payers to feel confident about the efficacy of LX9211.

Joe Pantginis, Analyst

Very, very helpful. Thanks for all the answers and good luck going into next month.

Mike Exton, CEO

Thanks, Joe.

Operator, Operator

The next question comes from Yigal Nochomovitz with Citigroup. Please go ahead.

Yigal Nochomovitz, Analyst

Yes, hi. Thanks for taking the question. Could you spend some time talking about how you’re thinking about the INPEFA trajectory going forward into 2025 in terms of the quarterly growth and what the appropriate level of investment should be in that launch? Also, which types of patients are receiving it, and how many had to have gone through prior authorization or needed to try one of the other SGLT-2s? Thanks.

Tom Garner, Chief Commercial Officer

Hi, it's Tom Garner. So I’ll take that one first and then anything else that you want to add. As we looked at Q3, and I think as Mike mentioned earlier on, we saw some encouraging and continued modest growth of INPEFA even post the restructure that took place during the quarter. If you look at our overall dispense volume, that was about 40% quarter over quarter, the number of unique prescribers grew by about 20%, and our new-to-brand share actually grew by about 20% as well. I guess the corresponding question may be why did the net revenues not follow those trends? That was due to a significant growth to net true-up at the start of the quarter, which impacts overall net revenues. The dynamics within the heart failure marketplace skew heavily part B. Our med D exposure is around 60% and commercial makes up about 30% with Medicaid and others making up the remaining 10%. In terms of our access and coverage, we have roughly 50% of lives covered in the US, noting again that most of those patients required some kind of step-through utilization management regarding heart failure medication—potentially having to step through another SGLT before being prescribed. Our value and access team are continuing to engage very heavily with the payer community regarding INPEFA, and we're hopeful for several outstanding bids for Medicare and commercial that we are hoping to pull through. We’re beginning to see some clarity on the overhang we saw this year with the IRA, as three major competitors were listed on that top 10 drug list. This is giving payers clarity on how things look moving forward. We’ll continue to push INPEFA with our target prescribers, growing the prescriber base, and we have refocused our sales force. Our primary focus is pushing increased depth amongst our writers. We anticipate modest growth quarter-over-quarter moving forward. It's also worth noting that this will be largely the same customer base we’ll be talking to regarding HCM.

Mike Exton, CEO

The only additional add here is, when we did the restructure in September, we were very focused and targeted in how we created the new field and commercial organization with the balance of ZYNQUISTA and INPEFA. We will continue to evaluate that with all scenarios as we move forward towards December 20.

Yigal Nochomovitz, Analyst

Thank you very much.

Operator, Operator

The next question comes from Roanna Ruiz with Leerink Partners. Please go ahead.

Roanna Ruiz, Analyst

Great, thanks. Afternoon, everyone. Could you elaborate on what drove the recent Viatris agreement for sotagliflozin? Considering your focus on partnering, what is your outlook on how to prioritize future partnerships across sotagliflozin or the other pipeline assets and different regions globally as well?

Mike Exton, CEO

Hi, Roanna. It’s nice to speak with you again. For Viatris and the global partnership, clearly, our focus as a company is the U.S. in terms of our commercial footprint at the moment. We were looking for a strong global partner with the ability to commercialize in those rest of world markets, and Viatris came to the top of the pile when we considered that. The engagement we had was a good negotiation back and forth, and I think we reached a win-win out of it. We expect this to be a fruitful partnership in actuality, and as we mentioned already, they're highly engaged, and we’re highly engaged. This provides significant additional value to the company that we wouldn't have realized by ourselves. Regarding prioritizing the pipeline, I think for both LX9211 and LX9851, they lend themselves to partnering significantly. I wouldn’t necessarily differentiate between the two. LX9211 being a late Phase 2b asset will be a strong value creator if successful. There are many pharma companies with an interest in pain franchises, and also others showing interest in neuroscience or adjacent interests in pain. The number of recent deals in weight management, weight loss, and engaged partners we’ve been discussing with presents opportunities for partnering. Thus, over the next 3 to 6 months, we will be doubling down in those discussions.

Craig Granowitz, Chief Medical Officer

Roanna, I wanted to add one more thing about Beatrice. They have deep experience in cardiovascular medicine, both historically and currently. Many of their important drugs are cardiovascular, and they've shown a deep experience in that area. The recent deals they’ve done have also been in the cardiovascular space, so we have a partner that has a lot of shared vision around heart and heart failure.

Roanna Ruiz, Analyst

Makes sense. And as my second question, could you elaborate on your thoughts on LX9851 fitting into the treatment paradigm? I know you've talked about obesity, but also I think you've alluded to cardiometabolic disorders as well. As you sort of interrogate that product, what sort of differentiating features do you hope will shine through for this asset?

Mike Exton, CEO

I think there are a number of critical features, and as we know, this whole space is evolving rapidly, with many companies involved. A couple of unique features that are distinct from the general field are that it’s a small molecule; it’s going to be an oral once-a-day medicine, which many patients prefer. Secondly, this is not a GLP-1 or GIP; it's a completely different mechanism. The data we presented demonstrates preservation of lean body mass, which is potentially important as we learn more about current treatment paradigms. It can be used in combination therapies, as in diabetes and other cardiometabolic diseases—it's all about combination therapies. A few years down the road, we could foresee LX9851 being a very valuable addition to a portfolio of different types of assets targeting patient lifestyles. We see it as a complementary mechanism with potential value for partners.

Roanna Ruiz, Analyst

Got it. Thanks.

Operator, Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Mike Exton for any closing remarks.

Mike Exton, CEO

Firstly, thanks a lot for the insightful questions, everyone. It’s a unique time, not only between now and December 20, where we will get some clarity on how we move forward with ZYNQUISTA, but beyond that as we progress these three important pipeline opportunities with sotagliflozin in HCM, the upcoming readout of LX9211 in the PROGRESS Phase 2b study, and continuing to execute with Alan and the team to finalize the IND enabling studies for LX9851. While we are focused on the near term, we have many things to look forward to, and we’re excited about the opportunity. We appreciate everyone listening in, and we look forward to catching up with some of you again later. Thanks very much, and back to you, operator.

Operator, Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.