Q1 2024 Lexicon Pharmaceuticals Inc Earnings Call

Operator: Good day everyone, and welcome to the Lexicon Pharmaceuticals first 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, May 2nd, 2024. I'll now turn the call over to Lisa DeFrancesco, Head of Investor Relations and Strategy for Lexicon. Please go ahead, please.

Good day, everyone and welcome to the Lexicon Pharmaceuticals first quarter 2024 financial results Conference call.

At this time all participants are in a listen only mode.

Management's prepared remarks, we will hold a brief question and answer session.

As a reminder, this call is being recorded today may <unk> 2024.

I'll now turn the call over to leased at.

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Lisa M. DeFrancesco: Thank you, Jamie. Good afternoon, and welcome to the Lexicon Pharmaceuticals First Quarter 2024 Financial Results Conference Call. Joining me today are Lonnel Coats, Lexicon's Chief Executive Officer and Director, Jeff Wade, Lexicon's President and Chief Financial Officer, Dr. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer, and Tom Garner, Lexicon's Senior Vice President and Chief Commercial Officer. Earlier this afternoon, Lexicon issued a press release announcing financial results for the first quarter of 2024, which is available on our website at www.lexpharma.com and through our SEC filing.

Leased at: Thank you, Jamie and good afternoon, and welcome to the Lexicon Pharmaceuticals first quarter 2024 financial results Conference call. Joining me today are lienau coats Lexicons, Chief Executive Officer, and director, Jeff Wade Lexicons, President and Chief Financial Officer, Dr. Craig ran with lexicon, Senior Vice President and Chief Medical Officer.

Leased at: Tom Gardner Lexicon, senior Vice President and Chief Commercial Officer.

Earlier this afternoon lexicon issued a press release announcing financial results for the first quarter of 'twenty 'twenty, four which is available on our website at www dot lacks pharma dot com and to our SEC filings a webcast of this call along with the slide presentation is available on our website.

Lisa M. DeFrancesco: A webcast of this call, along with the slide presentation, is available on our website. During this call, we will review the information provided in the release, provide a corporate update, and then use the remainder of our time to answer your questions. Before we begin, let me remind you that we will be making forward-looking statements, including statements related to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of INPEPA, Zotigliflozin, Zinquista, LX-9211, LX-9851, and our other drug programs.

During this call we will be we will review the information provided in the release provide a corporate update and then use the remainder of our time to answer your question.

Lisa M. DeFrancesco: These statements may also include characterizations and projections relating to our commercial launch of Mpesa and 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, 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.

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 and pepper surgical flow then sequester. Alex 90 went one Alex 90, 851, and our other drug programs.

These statements May also include characterizations and projections relating to our commercial launch then pass on heart failure as well as the clinical development regulatory status and market opportunity for all of our trade programs.

This call May also contain forward looking statements relating to our growth and future operating results discovery and development of our drug candidates.

Leased at: [noise] 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 commercial launch then pepper, our discussions with the FDA and other regulatory authorities regarding our drug program, the timing and results of clinical trials and preclinical studies of our drug candidates.

Lisa M. DeFrancesco: These risks include uncertainties related to our commercial launch of MPEFA, our discussions with the FDA and other regulatory authorities regarding our drug programs, the timing and results of clinical trials and preclinical studies of our drug candidates, our dependence on 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 requirement of substantial funding to conduct our planned research, development, and commercialization activities. I would now like to turn the call over to Lonnel Coats. Lonnel?

Leased at: Our dependents, the hunt strategic Reliance's 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 requirement of substantial funding to conduct our planned research development and commercialization activities I would now like to turn the call over to lend out.

Lend: All right.

Lonnel Coats: Thank you, Lisa. Good afternoon, everyone, and thank you for joining us on the call. Now, before I begin our discussion of Lexicon's results for the first quarter of 2024, I want to acknowledge the press release that went out earlier this week announcing my retirement from Lexicon, which will be effective on my upcoming 10th anniversary with the company on July 7. I am truly blessed to have had the opportunity to spend the last decade leading this remarkable company.

Lend: Thank you Lisa good afternoon, everyone and thank you for joining us on the call.

Lend: Before I begin our discussion of electric cars results for the first quarter of 2024 I want to acknowledge a press release that went out earlier this week announcing my retirement from lexicon.

Speaker Change: Which will be effective on my upcoming 10th anniversary with the company.

Lend: On July 7th.

Speaker Change: I am truly blessed to have had the opportunity to spend the last decade, leading this remarkable company.

Lonnel Coats: I've had the privilege of working with an outstanding board that continues to support the company and the many amazing and talented employees who are dedicated to Lexicon's mission. It was important to me as I made the decision to embark on the next phase of my personal journey that I lead this company in the strongest possible position. I am happy to say Lexicon has never been stronger than it is today. As we outlined at our recent Investor Day, Lexicon has a significant portfolio and pipeline of exciting opportunities.

Lend: I had the privilege to work with an outstanding board that contains to support the company and the many amazing and talented employees, who are dedicated to lexicons mission.

Lend: It was important to me as I made the decision to embark on the next phase of my personal journey that I lead this company in the strongest possible position.

Lend: Im happy to say lexicon has never been stronger than it is today.

Lend: As we outlined at our recent Investor Day Lexicon has a significant portfolio and pipeline of exciting opportunities.

Lonnel Coats: We have a remarkably strong leadership team with the capital to execute on these opportunities to create value for stakeholders. With that, I'd like to turn this call over to our president and CFO, Jeff Wade, to begin our discussion of the results.

Lend: We have a remarkably strong leadership team with the capital to execute on these opportunities to create value for stakeholders.

Lend: With that I'd like to turn this call over to our president and CFO, Jeff wait to begin our discussions of the results.

Jeffrey L. Wade: Thank you Lonnie L.

Jeffrey L. Wade: As Lonnel mentioned, Lexicon has never been stronger than it is today, and we have made very substantial progress just in the past quarter. We continue to make progress on our heart failure launch with expanded market access, which we expect to broaden significantly starting mid-year and continuing thereafter, providing the key to potentially unlock a substantial inflection in our launch trajectory in the second half of this year. We see encouraging leading indicators supporting that potential, which Tom will discuss shortly.

Jeffrey L. Wade: As long as Al mentioned lexicon has never been stronger than it is today and we have made very substantial progress just in the past quarter.

Jeff: We continue to make progress on our heart failure lunch with expanded market access, which we expect to broaden significantly starting mid year and continuing thereafter, providing the key to potentially unlock a substantial inflection in our launch trajectory in the second half of this year.

Jeff: We see encouraging leading indicators supporting that potential which Tom will discuss shortly.

Jeffrey L. Wade: We achieved a path forward this past quarter for the resubmission of our new drug application for Zinquista for type 1 diabetes, offering the potential for another near-term and very substantial commercial opportunity for the company. We expect to be in a position to achieve a mid-year resubmission of the NDA, seeking approval of Zincuesta as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes and chronic kidney disease.

Jeff: We achieved a path forward this past quarter for Resubmission of our new drug application for <unk> for type one diabetes offering the potential for another near term and very substantial commercial opportunity for the company.

Tom Gardner: We expect to be in a position to achieve a mid year resubmission of the NDA seeking the approval of the sequester as an adjunct to insulin therapy to improve glycemic control in adults with type one diabetes and chronic kidney disease.

Jeffrey L. Wade: We believe the approval of Zinquista would help address significant unmet needs in a population with no real treatment options beyond insulin to manage their blood sugar. We have also begun our efforts to expand sodagliflozin's label to treat hypertrophic cardiomyopathy. Part of an overall strategy to seek medically important and high-value indications that are both unique to sotagluplosin among SGLT inhibitors and for which there is evidence for an advantage in inhibiting SGLT1. Startup activities for our Pivotal Phase III study in HCM are well underway, and we expect to begin patient enrollment around the middle of this year.

Jeff: We believe the approval of zinc cluster would help address significant unmet needs in a population with no real treatment options beyond insulin to manage their blood sugar.

Jeff: We have also begun our efforts to expand the pleasant label into hypertrophic cardiomyopathy part of an overall strategy to seek medically important and high value indications that are both unique to set a pleasure among U S gel T inhibitors and for which there is evidence for an advantage and inhibiting <unk>.

Jeff: One.

Jeff: Startup activities for our pivotal phase III study in HCM are well underway and we expect to begin patient enrollment around the middle of this year.

Jeffrey L. Wade: We are making continued good progress in the enrollment of our Phase 2b study of LX9211 for diabetic peripheral neuropathic pain, which continues to be on track for top-line data in the second quarter of 2025. We are increasingly confident in the opportunity for LX9211 to address a tremendous area of unmet need both in DPNP, the focus of this study, but also in neuropathic pain more broadly. At our Investor Day two weeks ago, we revealed LX9851, a promising new oral drug candidate for chronic weight management that addresses a novel target, ACSL5, with compelling biology.

Jeff: We are making continued good progress in the enrollment of our phase <unk> study of Alex 91, one for diabetic peripheral neuropathic pain.

Jeff: <unk> continues to be on track for topline data in the second quarter of 2025.

Jeff: We're increasingly confident in the opportunity for <unk> to one one to address a tremendous area of unmet need both in D. P. M. P. The focus of this study, but also in neuropathic pain more broadly.

Jeff: At our Investor day, two weeks ago, we revealed Alex 90, 851, a promising new oral drug candidate for chronic weight management that addresses a novel target Acs L five with compelling biology.

Jeffrey L. Wade: LX9851 provides additional evidence that Lexicon's unique Genome 5000 discovery platform, bound by a systematic approach to mammalian genetics, continues to produce. And, finally, but very importantly, we were able to raise $250 million in an oversubscribed offering with strong shareholder participation to support the execution of these exciting programs. I'll now turn the call over to Tom Garner, Lexicon's Chief Commercial Officer, to talk more about MPEPA for heart failure and where we are with the launch.

Jeff: Alex 95, one provides additional evidence that <unk> unique genome 5000 discovery platform founded in a systematic approach to mammalian genetics continues to produce.

Jeff: And finally, but very importantly, we were able to raise $250 million in an oversubscribed offering with strong shareholder participation to support the execution of these exciting programs.

Jeff: I'll now turn the call over to Tom Garner Lexicons, Chief commercial officer to talk more about in Peppa for heart failure, and where we are with the launch Tom.

Thomas A. Garner: Thank you, Jeff. And good afternoon, everyone.

Speaker Change: Thank you, Jeff and good afternoon, everyone. It's a pleasure to be able to speak with you all today.

Thomas A. Garner: It's a pleasure to be able to speak with you all today. As you will see, Q1 represented another quarter of continued positive progress with the ongoing launch of Impef. As a reminder, the commercial organization is fully aligned and focused on two key areas as it relates to the ongoing launch, namely driving awareness and demand for MPEFA amongst the cardiology community, while also working hard in parallel with major payers to secure profitable and equitable access for patients who can benefit from this medicine. We've also taken thoughtful and deliberate steps to evolve and significantly strengthen the commercial organization to ensure that we can maximize the opportunities that exist for MPEPA and, more broadly, Lexicon, in both the near and mid-term.

Speaker Change: As you will see Q1 represented another quarter of continued positive progress with the ongoing launch of in peso.

Thomas A. Garner: As a reminder, the commercial organization is fully aligned and focused on two key areas as it relates to the ongoing launch, namely driving awareness and demand for in peso amongst the cardiology community. While also working hard in parallel with major payers to secure profitable and equitable access for patients who can benefit from this medicine.

Thomas A. Garner: We have also taken thoughtful and deliberate steps to evolve and significantly strengthened the commercial organization to ensure that we can maximize the opportunities that exist for <unk> and more broadly lexicon in both the near and mid term.

Thomas A. Garner: Beginning on the next slide, you can see that heart failure remains a significant burden in the United States today. You can see that there are about seven million patients suffering from heart failure in the United States in 2019. This number is expected to grow by nearly 27% by the end of the decade to about eight and a half million patients, reflecting a growing and very substantial patient population where unmet needs remain.

Thomas A. Garner: Beginning on the next slide you can see the heartburn heart failure remains a significant burden in the United States today.

Speaker Change: You can see that there are about 7 million patients suffering with heart failure in the United States in 2019.

Speaker Change: This number is expected to grow by nearly 27% by the end of the decade, so about eight and a half million patients, reflecting a growing and very substantial patient population with unmet needs remain.

Thomas A. Garner: That anticipated growth is also projected to have a substantial impact on the healthcare system as a whole. At the start of the decade, heart failure costs were estimated to be about $44 billion, and by the end of the decade, this number is expected to increase to nearly $70 billion.

Speaker Change: As anticipated growth is also projected to have a substantial impact on the health care system as a whole.

Speaker Change: The decade heart failure costs are estimated to be about $44 billion by the end of the decade. This number is expected to increase to nearly $70 billion.

Thomas A. Garner: This clearly reflects a significant drain on resources, and we believe that Impefra is very well-positioned as a cost-effective solution, which brings me to the next slide. On slide 7, you can see how hospitalizations and readmissions are driving the majority of these heart failure-related costs. In fact, according to the latest estimates, hospitalizations account for nearly 80% of overall costs.

Speaker Change: This clearly reflects a significant drain on resources and we believe that <unk> is very well positioned as a cost effective solution, which brings me to the next slide.

Speaker Change: On slide seven you can see how hospitalizations and Readmissions are driving the majority of these heart failure related costs. In fact, according to the latest estimates hospitalizations account for nearly 80% of overall costs and when patients leave the hospital in many cases, they are readmitted very quickly with up to 25.

Thomas A. Garner: And when patients leave the hospital, in many cases, they are readmitted very quickly, with up to 25% returning within 30 days. As we've shared previously, much of our clinical data from PEPFAR, specifically from the SOLUIS trial, where the NNT was four and hospital readmissions were reduced by 50% at both 30 and 90 days, is received very positively, both by clinicians who are treating patients in the inpatient setting but also for those who are treating patients in the outpatient setting, with the goal of preventing readmissions, which is one of the objectives central to guideline-

Thomas A. Garner: Central resetting within 30 days.

Speaker Change: As we've shared previously much of all clinical data for <unk> peso, specifically from the soloist trial, where the N N T was full and hospital readmissions reduce by 50% at both 30 and 90 days is very is received very positively for clinicians who are treating patients in the inpatient setting, but also for those who are treating pain.

Thomas A. Garner: <unk> in the outpatient setting with the goal of preventing Readmissions, which is one of the objectives central to guidelines directed medical therapy.

Thomas A. Garner: Turning to the next slide, you can see that treatment with SGLTs is really in its infancy in terms of uptake for the treatment of heart failure. Impefra is now one of three SGLT medications that are referenced in the ACC guidelines. As the only dual inhibitor of SGLT-1 and SGLT-2, coupled with compelling clinical evidence, we believe that Impeffer offers significant value to HCPs, to patients, and to payers. However, despite the strong recommendation within the heart failure guidelines as one of the four pillars of guideline-directed medical therapy, the SGLT class still remains somewhat under-penetrated.

Thomas A. Garner: Turning to the next slide you can see the treatment with <unk> is really in its infancy in terms of uptake for the treatment of crop failure.

Thomas A. Garner: <unk> walnuts three S. J L. T medications that are referenced in the ACC guidelines as the only dual inhibitor of S. G. L. T. One and S. G. L T two couples with compelling clinical evidence, we believe that in peso offers significant value to hcp's to patients to payers.

Speaker Change: Despite the strong recommendation within the heart failure guidelines as one of the four pillars.

Thomas A. Garner: Directed medical therapy, the <unk> class still remains somewhat underpenetrated.

Thomas A. Garner: As of today, only around 11% of patients are actually being started on SGLT therapy for heart failure, representing a significant future opportunity for the class, including in PEPFAR. This is an area where the medical community is really pushing very hard. The American Heart Association has a Get With The Guidelines program for heart failure with the primary goal of ensuring the updated guidelines are consistently pulled through into clinical practice with the goal of improving patient care and outcomes.

Speaker Change: Today, only around 11% of patients are actually being started up nice G. L. T therapy for Australia, representing a significant future opportunity for the class including in peso.

Speaker Change: This is an area where the medical community is really pushing very hard the American Heart Association has to get with the guidelines program for heart failure with the primary goal of ensuring the updated guidelines are consistently cold through into clinical practice with the goal of improving patient care and outcomes.

Thomas A. Garner: Turning to slide 9, we're very excited about two recent additions to the joint guidelines established in 2022 by the American College of Cardiology, or ACC, the AHA, and the Heart Failure Society of America. Firstly, last year, the ACC released a consensus statement for the treatment of heart failure with preserved ejection fractures, which went even further than the 2022 Joint Guidelines in recommending STLT inhibitors as first-line foundational therapy for all patients who have hepatitis.

Thomas A. Garner: Turning to slide nine we're very excited about two recent additions to the joint guidelines established in 2022 by the American car T. A college of cardiology or ACC.

Thomas A. Garner: Hey on the heart failure Society of America first.

Speaker Change: Firstly last year, the ACC released a consensus statement for the treatment of heart failure with preserved ejection fraction, which went even further than the 2022 joint guidelines and recommending <unk> inhibitors as first line foundational therapy for all patients who have had passed and then just a few weeks ago. We're also.

Thomas A. Garner: And then just a few weeks ago, we were also very pleased to see the updated consensus statement for HEP REF, which reclassified the SGLT2 class as the SGLT class, in express recognition of MPEF's differentiated mechanism and action, inhibiting both SGLT1 as well as SGLT2.

Thomas A. Garner: Very pleased to see the updated consensus statement rats, which reclassified the <unk> two class C. S. T. L. T class acetyl T class in express recognition of in Perth is differentiated mechanism of action inhibiting both <unk> as well as S. G. L T. Two.

Thomas A. Garner: Taken together, we anticipate this continued support from experts in the heart failure community will result in continued growth and accelerating adoption for the SGLT inhibitor class as a whole, including in PEPFAR, across the spectrum of heart failure patients. Now pivoting to our results for the quarter, we continue to observe encouraging results from our efforts to accelerate adoption of Impefa for the treatment of heart failure. Awareness of Impeffer continues to trend positively upwards and has grown by nearly 10% since January and is now in the 88% range. At the same time, we are also seeing that intention to prescribe is increasing as more of our target customers are reached by our sales specialists and our non-personal efforts.

Thomas A. Garner: Taken together, we anticipate this continued support from experts in the heart failure community will result in continued growth and accelerating adoption for the <unk> inhibitor class as a whole including in peso across the spectrum of heart failure patients.

Thomas A. Garner: Now pivoting to our results for the quarter, we continued to observe encouraging results from our efforts to accelerate the adoption of the pepper for the treatment of heart failure.

Thomas A. Garner: Awareness of <unk> continues to trend positively upwards and has grown by nearly 10% since January and is now in the 88% range at the same time. We're also seeing that intention to prescribe is increasing as more of our target customers are reached by our sales specialists and our non personal efforts.

Thomas A. Garner: Encouragingly, once cardiologists have started a patient on Impeffer, they indicate very high product satisfaction, which is above similar benchmarks for comparable products in the cardiology space at this point in the product lifecycle. Taken together, these metrics give us confidence that Impeffer's differentiated value proposition and core messaging is resonating with our customers and demonstrates the great potential we see for continued growth throughout 2024 and beyond. Turning to slide 11, as a reminder, we have focused our in-person sales efforts on the highest volume heart failure prescribers with a team of highly tenured cardiovascular specialists.

Thomas A. Garner: Carriage in what was cardiologists have started a patient on impactful.

Thomas A. Garner: In ticket very high products, such as function, which is above similar benchmarks for comparable products in the cardiology space at this point to the product lifecycle.

Thomas A. Garner: Taken together these metrics give us confidence in Perth is differentiated value proposition and core messaging is resonating with our customers demonstrates the great potential we see for continued growth throughout 2024 and beyond.

Thomas A. Garner: Turning to slide 11, as a reminder, we have focused our in person sales efforts on the highest volume heart failure prescribers with a team of highly tenured its cardiovascular specialists.

Thomas A. Garner: The priority focus for this team is on segments A through C, where we see the highest volumes of heart failure patients, with the A and B targets alone accounting for more than 60% of the overall heart failure volume in the United States. As we move to the next slide, you will see that this focus strategy is starting to pay dividends. As you can see from the chart on the left, nearly 80% of the Impeffer script volume is currently coming from our A through C highest volume heart failure treaters.

Thomas A. Garner: The priority focus for this team is on the segments a through C, where we see the highest volumes of heart failure patients with the A&P targets alone accounting for more than 60% of the overall heart failure fall here in the United States.

Thomas A. Garner: As we move to the next slide you will see that this focused strategy is starting to pay dividends as you can.

Thomas A. Garner: Can see from the charts on the left nearly 80% of the impressive script volume is currently coming from our a through C highest volume heart failure treaters.

Thomas A. Garner: Moving to the chart on the right, you can see how we are penetrating each priority sector. Encouragingly, we are seeing increased adoption of Impeffer amongst these top-tier customers. We focused on the very most important Segment A and B customers.

Thomas A. Garner: Moving to the charts on the right you can see how we are penetrating each priority segments.

Thomas A. Garner: Encouragingly, we are seeing increased adoption of impact amongst these top tier customers.

Thomas A. Garner: We focused on the very most important segment A&P customers' adoption of in peso within this group grew by over 40% in Q1 versus Q4.

Thomas A. Garner: Adoption of Impeffer within this group grew by over 40% in Q1 versus Q4. While we continue to see increasing adoption, we should also note that we have significant room for continued growth across both of these segments, and this is something that the sales team is fully focused on continuing to deliver as we broaden the prescriber base. Moving to slide 13, you can see the continued progress we're making with the adoption of Ipefa across the entire cardiology community as a whole. Through the end of March, we had around 1,900 writers of Ipeffer, adding in excess of 600 new customers in the first quarter, representing an increase of over 45% versus the prior quarter.

Thomas A. Garner: While we countries continues to see increasing adoption. We should also note that we have significant room for continued growth across both of these segments and this is something that the team. The sales team is fully focused on continuing to deliver as we broaden the prescriber base.

Thomas A. Garner: Moving to slide 13, you can see the continued progress we are making with the adoption of it across the entire cardiology community as a whole.

Thomas A. Garner: Through the end of March we had around 1900 writers of peso.

Thomas A. Garner: In excess of 600, new customers in the first quarter, representing an increase of over 45% versus the prior quarter.

Thomas A. Garner: This positive momentum has continued through the early part of Q2. We're really pleased with this progress and expect it to continue as we further enhance our in-person promotional tools and our strengthened omni-channel approach, while also working hard to broaden access, which may still be viewed by customers as a barrier to product adoption at this point in the launch window. On slide 14, you will see that we are continuing to build ongoing prescription volumes even as we work to improve access conditions for MPEPA.

Thomas A. Garner: This positive momentum has continued through the early parts of Q2.

Thomas A. Garner: We're really pleased with this progress and expect it to continue as we further enhance our in person promotional tools. Our strengthened omnichannel approach. While also working hard to broaden access which may be still be viewed by customers as a barrier to product adoption at this point in the launch window.

Thomas A. Garner: We have seen encouraging upward momentum in TRX volumes throughout the quarter and have seen this trend continue into the early part of Q2. Accelerating and improving patient pull-through will remain a critical focus for the team to ensure that we not only continue to accelerate new-to-brand script demand but are able to continue and retain ongoing prescriptions for empefa prescribers and for their patients. The Impeffer Together program has been carefully designed to ensure that patients prescribed Impeffer can be appropriately started on their treatment journey, irrespective of their insurance type.

Thomas A. Garner: We have seen encouraging upward momentum in T. Rx volumes throughout the quarter and have seen this trend continue into the early parts of Q2.

Thomas A. Garner: So, as you can see from the previous slides, we are pleased with the continued positive momentum in leading indicators for Impeffer demand as customers become ever better acquainted with the clinical value proposition that Impeffer offers for their patients. It's worth noting that our overall access did not change considerably from roughly 40% as of last quarter, yet we have continued to see ongoing increases in total script volume. We're currently in the midst of the 2025 Medicare bid cycle, with the value and access team fully engaged in important and meaningful discussions with all major BBMs across both the commercial and Medicare books of business.

Thomas A. Garner: So as you can see from the previous slides, we are pleased with it.

Thomas A. Garner: We're pleased by the receptivity payers have shown for the product as they recognize there is clinical differentiation within PEPFAR and that the value proposition is compelling. They continue to express interest in reviewing IMPEFA for coverage and increasingly adding IMPEFA to their formularies. With that, I will hand over to Jeff to talk about Type 1 Zinc and

Jeffrey L. Wade: Thanks, Tom. It has been a particular passion of our company to improve the lives of people with type 1 diabetes. And we are pleased to have found a path forward for the resubmission of our NDA for Zinquista as an adjunct to insulin therapy for the substantial proportion of this population who also suffer from chronic kidney disease. Type 1 diabetes is a substantial opportunity in an area of high-end MET needs. Because type 1 diabetes involves complete insulin deficiency due to the autoimmune destruction of beta cells in the pancreas, people with type 1 diabetes rely entirely on insulin therapy, either multiple daily injections or insulin pumps to provide the insulin they need.

Jeff: Thanks, Tom.

Jeffrey L. Wade: But while insulin is lifesaving, it is also very challenging to manage, with the result that between 75% and 80% of people with type 1 diabetes fail to meet targets for A1C, a measure of average glucose. The difficulties in managing insulin therapy also mean that unmet needs for glycemic control in type 1 diabetes go far beyond A1c, with glucose variability and maintaining time and range being particular challenges. Maintaining good glucose control is important to the day-to-day lives and well-being of people with type 1 diabetes, but it is also important for reducing long-term complications, which include diabetic retinopathy, diabetic neuropathy, higher rates of cardiovascular disease, and chronic kidney disease. Notably, among the 1.7 million adults with type 1 diabetes, between 20 and 25 percent have chronic kidney disease, and many more are at risk for progression. Moving to slide 18.

Jeffrey L. Wade: Following a series of discussions with the FDA, we are preparing to resubmit our NDA for patients living with type 1 diabetes and chronic kidney disease in the middle of this year. In doing so, we are leveraging the extensive clinical data generated in what was and remains the largest ever phase three program of an oral adjunct to insulin in type 1 diabetes. We have the opportunity to reference a tremendous amount of additional supportive data that were generated after our original filing for approval in Type 1 diabetes, in a separate population but still relevant, providing evidence of benefits on cardiovascular death, heart failure, myocardial infarction, and stroke, and kidney protection.

Jeffrey L. Wade: And we have the benefit of recently published additional data from long term longitudinal studies that shows the importance of better glycemic control in slowing the progression of chronic kidney disease in the type 1 diabetes population. Together, these elements open the opportunity for our resubmission for the use of Zincuista as an adjunct to insulin with the potential to improve glycemic control for people living with type 1 diabetes and chronic kidney disease. On slide 19, the significant unmet needs in type 1 diabetes more broadly are shared by and often have particular importance in the population of people who also have chronic kidney disease. These needs include reaching A1C goals, reducing glycemic variability, including time and range. Controlling Complications and Reducing Weight Gain with the Overall Goal of Preventing Further Conditions or Complications, including Cardiovascular and Kidney-Related Diseases.

Jeffrey L. Wade: The data from our Phase 3 program of sotagliflozin and Type 1 diabetes provide compelling evidence addressing many of these unmet needs, with results consistent among the overall Type 1 diabetes population studied and also the subgroup with Type 1 diabetes and chronic kidney disease. On slide 20, you can see from the patient journey in type 1 diabetes that there are no real treatment options beyond insulin therapy to improve glycemic control and thus potentially prevent the complications that ultimately result from suboptimal glycemic control and that sonocomplosion has a unique opportunity to fill a gap and address an important area of need in this population.

Jeffrey L. Wade: I'd like to pivot, beginning with slide 21, to discuss our plans for a potential commercial launch. The treatment of type 1 diabetes is highly concentrated among endocrinologists, where the top 1,000 are treating about two-thirds of type 1 diabetes patients, and the top 3,000 are treating over 90%. The concentration of prescribers and their geographic distribution supports a focused, modest-sized field force, likely 120 or fewer in size.

Jeffrey L. Wade: We are continuing our planning and preparations for commercialization as we prepare to resubmit and post acceptance and through the review process and expect to hire the T1D focused field force very close to the potential launch early next year. Moving to slide 22, we are not the only ones who are enthusiastic about the opportunity for sonogliflozin to benefit people with type 1 diabetes. There are a number of studies, including some large studies, focused on outcomes beyond glycemic control in the T1D population that are utilizing sotagliflozin and from which we expect to add to our body of evidence over the next several years.

Jeffrey L. Wade: This includes a study called Sugar and Salt, which is designed to assess the outcomes of treatment with sotagliflozin in patients with type 1 diabetes and chronic kidney disease. SOPHIST, which looks at heart failure in type 1 diabetes, and STENO1, which looks at a reduction in cardiovascular risks in type 1 diabetes. To summarize, on slide 23, we expect to resubmit our NDA mid-year and, given the nature of the resubmission, anticipate a six-month review.

Jeffrey L. Wade: We expect to add to our body of evidence over the next several years. This includes a study called sugar and Salt, which is designed to assess the outcomes of treatment with sort of a pleasant and patients with type one diabetes and chronic kidney disease.

Jeffrey L. Wade: So first which looks at heart failure in type, one diabetes, and steno, one which looks at a reduction in cardiovascular risks and type one diabetes.

Jeffrey L. Wade: To summarize on slide 23, we expect to resubmit, our NDA mid year and given the nature of the Resubmission and anticipate a six month review.

Jeffrey L. Wade: Pre-launch planning activities are well underway, and we expect further investments related to the field force to occur closer to potential approval. There is a significant unmet need and substantial advocacy group support for treatments to manage glycemic control for people that have type 1 diabetes and chronic kidney disease, and we expect the body of evidence will continue to grow and expand over time. We couldn't be more excited here at Lexicon to be on this journey to bring surgical clothing to people with type 1 diabetes. I will now turn the call over to Craig to talk about hypertrophic cardiomyopathy and why we believe that this is a great opportunity to improve care for patients who still need better treatment options.

Jeffrey L. Wade: Prelaunch planning activities are well underway and we expect further investments related to field force to occur closer to potential approval.

Craig: There is a significant unmet need and substantial advocacy group support for treatment to manage glycemic control for people, who have type one diabetes and chronic kidney disease and we expect the body of evidence will continue to grow and expand over time.

Craig: Thank you Jeff.

Craig B. Granowitz: We shared a lot of detail on our rationale to pursue Soda Glyphosate and HCM at our recent Investor Day a couple weeks ago, which is still available for review on our website. So I'll just briefly summarize here.

Craig: We shared a lot of detail on our rationale to pursue sort of a posting an HCM at our recent investor day, a couple of weeks ago, which is still available for review on our website. So I'll just briefly summarize here are.

Craig B. Granowitz: Our enthusiasm about HCM as an opportunity for sotoglifosin was driven in part by a post hoc analysis of our scored data that demonstrated that sotoglifosin reduced the risk of cardiovascular events in patients with left ventricular hypertrophy without hypertension. This cohort shares phenotypic and physiologic traits of patients with HCM and may actually include undiagnosed cases of HCM. This analysis provides insight into the potential efficacy of sodaglifosin in patients with HCM. There is a lot of other physiology that would support the impact of SGLT1 expression on HCM and why sotaglifosin might work on the myocardium itself to achieve that end.

Craig B. Granowitz: This cohort shares phenotypic and physiologic traits of patients with HCM and May actually include on diagnosed cases of HCM.

Craig B. Granowitz: This analysis provides insight into the potential efficacy of <unk> in patients with HCM.

Craig B. Granowitz: <unk> <unk> expression on HCM, and why <unk> might work on the myocardium itself to achieve that in.

Craig B. Granowitz: After reviewing this data and discussing it with the FDA, we believe that sodaglifosin has the potential to address key unmet needs with the scientific rationale to support development. Timing of our study could also be beneficial, as heavy disease awareness efforts currently underway in the industry through new treatments could also provide additional benefits. We believe that the rate of diagnosis of HCM will likely outpace the growth of the disease itself.

Craig B. Granowitz: After reviewing this data and discussing with the FDA, we believe that sort of a post and has the potential to address key unmet needs.

Craig B. Granowitz: Moving to the study design on slide 26, our proposed indication is to improve symptoms and physical limitations, which is what all of the agents that are currently approved are designed to do. All the CMIs and all of the other agents have been designed and approved to improve physical functioning, not improve long-term outcomes. We have already demonstrated long-term CV outcomes from our vast heart failure clinical data, and importantly, we are including both obstructive and non-obstructive HCM patients in the upcoming trial. So we have a single 500 patient study with 200 patients each with obstructive and non-obstructive hypertrophic cardiomyopathy.

Craig B. Granowitz: Our KCCQ primary endpoint has been validated by the FDA as an endpoint for non-obstructive hypertrophic cardiomyopathy in registration trials of other agents. And importantly, a much broader group of patients are eligible to be included in our trial than those of the current CMIs because we're allowing patients to actually remain on a CMI, to remain on their beta blocker, and to be on their CCB, and we will allow an injection fraction inclusion criteria down to 50%, not the 60% that is in the CMI trials because the major risk of use of CMIs is that patients may develop heart failure and we're actually indicated to reduce the development of heart failure.

Craig B. Granowitz: Moving to slide 27, we believe that there are significant stakeholder needs and opportunities in the HCM treatment paradigm for which sotaglifosin can address. For patients, sotaglifosin has the potential for symptom improvement with very limited or no added side effects. It also has the potential to be cost effective without the need for significant patient monitoring. In this case, there would be no significant added burden to HCP offices and payers, and all stakeholders could potentially benefit.

Craig B. Granowitz: Because of the way that it will be studied, it would also be available for use across the treatment paradigm of HCM, regardless of their current therapy or obstructive or non-obstructive HCM status. Moving now to LX9211. We believe that LX9211 has a promising profile based on two completed proof-of-concept studies and a substantial market opportunity. It has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from diabetic peripheral neuropathic pain or DPNP on a daily basis.

Craig B. Granowitz: Because of the way that it will be studied it would also be available for use across the treatment paradigm of HCM, regardless of their current therapy, or OE, aw obstructive or non obstructive HCM status.

Craig B. Granowitz: Lexicon has been granted fast-track designation by the FDA for the development of LX9211 for DPNP. Diabetic peripheral neuropathic pain is a large and growing market with significant unmet medical need. It is estimated that more than 20 million Americans experience neuropathic pain, and approximately 5 million CPNP patients will be identified in the U.S. in 2022.

Craig B. Granowitz: Moving now to Alex 90 to one one we.

Craig B. Granowitz: We believe that Alex 91, one has a promising profile based on two completed proof of concept studies and a substantial market opportunity.

Craig B. Granowitz: Alex 91 has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from diabetic peripheral neuropathic pain or D. Pnp on a daily basis lexicon has been granted fast track designation by the FDA the development.

Craig B. Granowitz: <unk> nine to one one for <unk>.

Craig B. Granowitz: Diabetic peripheral neuropathic pain is a large and growing market with significant unmet medical need. It is estimated that more than 20 million Americans experience neuropathic pain, and approximately $5 million VPN P. Patients were identified in the U S. In 2022.

Craig B. Granowitz: LX9211 has the potential to be a first-to-market, novel, non-opioid therapy in a multibillion-dollar market. Our Progress Phase 2B study has an eight-week treatment duration and is enrolling adult patients with a diagnosis of type 1 or type 2 diabetes with moderate to severe diabetic peripheral neuropathic pain. It is a four-arm placebo-controlled study with approximately 400 patients, or 100 per arm. It also allows patients to remain on their underlying DPNP therapy, which reflects a more real-world use approach.

Craig B. Granowitz: Alex 91, one has the potential to be a first to market novel non opioid therapy in a multibillion dollar market.

Craig B. Granowitz: Our progress Phase <unk> study is an eight week treatment duration and is enrolling adult patients with a diagnosis of type one or type two diabetes with moderate to severe diabetic peripheral neuropathic pain.

Craig B. Granowitz: As a four arm placebo controlled study of approximately 400 patients or 100 per arm. It also allows patients to remain on their underlying <unk> therapy, which reflects a more real world use approach.

Craig B. Granowitz: As we have shared in previous updates, we have advanced LX9211 into late-stage development with a clinical program directed towards DPMP regulatory approval. The PROGRESS Study began enrollment in December. It is designed to be a dose optimization study in order to enable a more efficient phase three study execution, increased probability of success, as well as de-risked investment while maintaining overall development program costs and timelines. Enrollment remains on track, and we expect top-line data in Q2 2025.

Craig B. Granowitz: As we have shared in previous updates we have advanced Alex 91, one into late stage development with a clinical program directed towards D. Pnp regulatory approval. The progress study began enrollment in December.

Craig B. Granowitz: It is designed to be a dose optimization study in order to enable a more efficient phase III study execution increase probability of success as well as derisked investment, while maintaining overall development program costs and timelines enrollment remains on track and we.

Craig B. Granowitz: We expect the top line data in Q2 2025.

Craig B. Granowitz: Now moving on to LX9851 for obesity and weight management. Beginning on slide 34, we recently revealed an exciting pipeline opportunity, a novel oral development candidate for chronic weight management, which we are calling LX9851. With this ACS L5 inhibitor, we see the potential to address the significant opportunities beyond weight loss with GLP-1 receptor agonists, in Oral Agent. These include production of body fat that spares lean muscle mass, an improved metabolic profile, and benefits beyond weight loss, including potential in additional related indications such as metabolic syndrome and MASH.

Craig B. Granowitz: Now moving on to Alex 90, 851 for obesity and weight management.

Craig B. Granowitz: Beginning on slide 34, we recently revealed an exciting pipeline opportunity in.

Craig B. Granowitz: Novel Oral development candidate for chronic weight management, which we are calling L X 90 851.

Craig B. Granowitz: With this Acs L. Five inhibitor, we see the potential to address the significant opportunities beyond weight loss with <unk> one receptor agonist.

Craig B. Granowitz: An oral agent for.

Craig B. Granowitz: Reduction in body fat that spares lean muscle mass and improved metabolic profile and benefits beyond weight loss, including potential in additional related indications such as metabolic syndrome and mash.

Craig B. Granowitz: Our work here begins with an assessment of the compelling phenotype we observed in knocking out the ACSL5 gene in mice, representing what we might expect from a drug inhibiting the protein target encoded by that gene. The observed phenotype suggested that an ACSL-5 inhibitor had the potential to counter all aspects of metabolic syndrome, reduce obesity, improve glucose tolerance, and reduce cholesterol and triglycerides, among other metabolic benefits. In particular, as seen in slide 36, in our large-scale assessment of nearly 5,000 different genes, we saw much lower cholesterol and triglycerides and moderately lower body fat with no effect on lean body mass on a standard diet. And in slide 37, evaluating the effects of a high-fat diet revealed another important characteristic of the target, substantially lower body fat, 25% less with no difference in lean muscle mass.

Craig B. Granowitz: Our work here begins with an assessment of the compelling phenotype, we observed and knocking out the ACSF five gene in mice, representing what we might expect from a drug inhibiting the protein target encoded by that gene.

Craig B. Granowitz: The observed phenotype suggested that in ACSF five inhibitor has the potential to counter all aspects of metabolic syndrome.

Craig B. Granowitz: Our reduce obesity improved glucose tolerance and reduce cholesterol and triglycerides among other metabolic benefits.

Craig B. Granowitz: In particular as seen in slide 36 in our large scale assessment of nearly 5000 different genes, we saw much lower cholesterol and triglyceride and low and modest moderately lower body fat with no effect on lean body mass on a standard diet.

Craig B. Granowitz: And in slide 37, evaluating the effects of a high fat diet revealed another important characteristic of the target substantially lower body fat, 25% less with no difference in lean muscle mass.

Craig B. Granowitz: We have broadly reproduced these weight loss and metabolic effects with small molecular inhibitors of ACSL5, and our drug discovery efforts have now yielded a development candidate called LX9851. As we think about the opportunity for chronic weight management, the data from one of our more recent studies helped demonstrate that opportunity with LX9851 producing weight loss on its own but, importantly, also being additive to the weight loss scene with GLP-1 receptor agonist semaglutide, with the combination of LX9851 and semaglutide having a greater reduction in body fat overall than either agent on its own.

Craig B. Granowitz: We are broadly reproduce these weight loss and metabolic effects with small molecule inhibitors of ACSF five and our drug discovery efforts have now yielded a development candidate called <unk> 905, one as.

Craig B. Granowitz: As we think about the opportunity for chronic weight management the data from one of our more recent studies help demonstrate that opportunity with Alex 90, 851, producing weight loss on its own but importantly, also being additive to the weight loss seen with <unk>, one receptor agonist <unk> tied.

Craig B. Granowitz: With the combination of Alex 95, one and <unk>, having a greater reduction in body fat overall than either agent on its own.

Craig B. Granowitz: And in slide 39, as we consider the opportunity specifically for weight management after initial weight loss with a GLP-1 receptor agonist, you can see when we stopped treatment with semaglutide after day 14, we saw a return to baseline weight, similar to what has been seen in humans after discontinuation of a GLP-1 receptor agonist treatment. However, when we added 9851 after initial weight loss with semaglutide, we saw a preservation of weight loss

Craig B. Granowitz: And in slide 39, as we consider the opportunity specifically for weight management. After initial weight loss with a <unk> one receptor agonist you can see when we stopped treatment with <unk> After day 14.

Craig B. Granowitz: A return to baseline weight similar to what has been seen in humans. After discontinuation of the <unk> one receptor agonist treatment. However, when we added 905, one after initial weight loss with <unk>, we saw a preservation of weight loss.

Craig B. Granowitz: In summary, we have identified a promising new development candidate for chronic weight management addressing a novel target that is entering IND-enabling studies that address many of the most important opportunities beyond initial weight loss with a GLP-1 receptor agonist, an oral agent that reduces body fat and spares lean muscle mass, leading to an improved metabolic profile, and has benefits beyond weight loss and potential in additional related indications like metabolic syndrome and MAC. We presented these results at our Investor Day two weeks ago, with significant additional details, and we have already received a considerable amount of interest in the target and compound from potential partners. I'd now like to turn the call over to Jeff to take us through the financial results for the third quarter of 2024.

Craig B. Granowitz: In summary, we have identified a promising new development candidate for chronic weight management addressing a novel target that is entering IND, enabling studies that address many of the most important opportunities beyond initial weight loss with a <unk> one receptor agonist and oral agent that we are.

Jeff: <unk> body fat and spares lean muscle mass that leads to an improved metabolic profile and has benefits beyond weight loss and potential in additional related indications like metabolic syndrome and match with.

Jeff: Presented these results at our Investor day, two weeks ago with a signet with significant additional details and we have already received.

Jeff: Cyclical amount of interest in the target and compound from potential partners.

Craig B. Granowitz: I'd now like to turn the call over to Jeff to take us through the financial results for the third quarter of 2024.

Jeffrey L. Wade: Thank you, Craig. I will review some of the key elements of our first quarter 2024 financial results. You can find more financial details in the press release that we issued earlier today and in our 10-Q that's filed with the SEC. We ended the quarter with $355.6 million in cash and investments.

Jeff: Thank you Craig I will review some of the key elements of our first quarter 2024 financial results you can find more financial details in the press release that we issued earlier today and our 10-Q, that's filed with the SEC.

Jeffrey L. Wade: We ended the quarter with $355 6 million in cash and investments.

Jeffrey L. Wade: We believe that our existing capital resources provide us with the appropriate level of funding to support the commercial launch of MPEPA, to prepare for and potentially launch sequesta for type 1 diabetes, and to make planned investments in research and clinical development, including our Phase III study of psotocomposin in HCM and our Phase IIb study of LX9211 in diabetic peripheral neuropathic pain. We anticipate that our existing cash and investments, together with expected product revenues, will provide us with sufficient resources to manage our operations into 2026 and potentially significantly longer if we achieve the partnerships that may be optimal for certain programs, for example, enabling the Phase 3 global development of LX9211 across multiple types of neuropathic pain.

Jeffrey L. Wade: <unk> study <unk> nine to one one in diabetic peripheral neuropathic pain.

Jeffrey L. Wade: Global development of <unk> to one one across multiple types of neuropathic pain.

Jeffrey L. Wade: As indicated in our press release, we had $1.1 million in revenues in the first quarter of 2024, almost all from net sales of MPEPA, and had minimal revenues in the same period of 2023. Research and development expenses for the first quarter of 2024 increased to $14.4 million from $12 million for the corresponding period of 2023, primarily due to higher external R&D expenses. Selling general and administrative expenses for the first quarter of 2024 increased to $32.1 million from $19.1 million for the corresponding period in 2023, reflecting our investment in the commercial launch of MPEPA, including higher salaries and benefits associated with the addition of the MPEPA sales force and other increased primarily commercial headcount, as well as increased travel and marketing costs.

Jeffrey L. Wade: As indicated in our press release, we had $1 1 million in revenues in the first quarter of 2024, almost all from net salesman pepper and had minimal revenues in the same period in 2023.

Jeffrey L. Wade: Selling general and administrative expenses for the first quarter of 2024 increased to $32 1 million from $19 $1 million for the corresponding period in 2023, reflecting our investment in the commercial launch of <unk>, and pepper and putting higher salaries and benefits associated with the addition of the <unk> salesforce.

Jeffrey L. Wade: And other increased primarily commercial head count as well as increased travel and marketing costs.

Jeffrey L. Wade: In total, the net loss for the first quarter of 2024 was $48.4 million, or $0.20 per share, as compared to a net loss of $31.9 million, or $0.17 per share, in the corresponding period of 2023. For the first quarters of 2024 and 2023, the net loss included non-cash, stock-based compensation expense of $4.3 million and $3.4 million, respectively. As we typically do with our first quarter earnings, we are introducing our current view of our 2024 full-year expense guide.

Jeffrey L. Wade: And total net loss for the first quarter of 2024 was $48 4 million or <unk> 20 per share as compared to a net loss of 39 to $31 9 million or <unk> 17 per share in the corresponding period of 2023.

Jeffrey L. Wade: The first quarters of 2024 and 2023 net loss included noncash stock based compensation expense of $4 3 million and $3 4 million respectively.

Jeffrey L. Wade: As we typically do with our first quarter earnings we are introducing our current view of our 2020 for full year expense guidance.

Jeffrey L. Wade: This includes expected R&D expenses of between $70 and $80 million, SG&A expenses of between $140 and $155 million, and total operating expenses of between $210 to $235 million. These figures include non-cash expenses of $18 million to $20 million for stock-based compensation, depreciation, and amortization.

Jeffrey L. Wade: This includes expected R&D expenses of between 70 and $80 million SG&A expenses of between 140 and $155 million.

Jeffrey L. Wade: These figures include noncash expenses of 18 million to $20 million for stock based compensation depreciation and amortization.

Jeffrey L. Wade: As we near the end of our prepared remarks, I think it's worth highlighting the extent of our accomplishments to date and what remarkable opportunities we have ahead. We have an approved and marketed product, Empatha, that originated from our own discovery engine in a large and fast-growing market. In addition, we have a strong and deep pipeline encompassing label expansion and lifecycle management opportunities for sodagliflozin, along with promising drug candidates addressing novel targets in large markets with high-end met needs, like LX9211 for neuropathic pain and LX9851 for obesity and weight management.

Speaker Change: As we near the end of our prepared remarks, I think it's worth highlighting the extent of our accomplishments to date and what remarkable opportunities we have ahead.

Jeffrey L. Wade: And approved and marketed product and in Pampa that originated from our own discovery engine, and a large and fast growing market and.

Jeffrey L. Wade: Obesity and weight management.

Jeffrey L. Wade: Together, these assets offer remarkable opportunities, both for growth and for value-generating partnerships. As we wrap up on slide 45, you can see the significant number of potential catalysts that you'll be able to track and use to measure our progress over the next 18 to 24 months and the expected inflection in the Impepa launch in the second half of this year. Our NDA resubmission in type 1 diabetes and initiation of enrollment in our study in HCM, both in the middle of this year, expected completion of enrollment this year for LX9211 in diabetic peripheral neuropathic pain with top line data in the second quarter of 2025, and progress on our new development candidate for obesity and weight management. We are looking forward to a productive remainder of the year and to sharing our progress and achievements with our stakeholders. I would like to now open up the call to take your questions.

Jeffrey L. Wade: As we wrap up on slide 45, you can see the significant number of potential catalysts that you'll be able to track and used to measure our progress over the next 18 to 20 formats.

Jeffrey L. Wade: And inspected expected inflection in the Pep a launch in the second half of this year.

Jeffrey L. Wade: Our NDA resubmission in type, one diabetes and initiation of enrollment in our study in HCM both in the middle of this year.

Jeffrey L. Wade: Expected completion of enrollment this year for <unk> nine to one one in diabetic peripheral neuropathic pain with topline data in the second quarter of 2025 and progress on our new development candidate for obesity and weight management.

Speaker Change: We are looking forward to a productive remainder of the year and to sharing our progress and achievements with our stakeholders I would like to now open up the call to take your questions.

Operator: Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one on a touch-tone telephone. To withdraw your question, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality.

Speaker Change: Ladies and gentlemen at this time well begin the question and answer session.

Operator: Your question you May press Star two if.

Operator: You are using a speaker phone, we do ask that you. Please pick up the handset prior to pressing the key to ensure the best sound quality.

Operator: Again, that is the star, and then one to join the question queue will pause momentarily to assemble the roster. Our first question today comes from Yigal Nochomovitz from Citigroup. Please go ahead with your question.

Operator: And that will stall and then wanted to join the question queue.

Yigal Dov Nochomovitz: Pause momentarily to assemble the roster.

Yigal Dov Nochomovitz: Our first question today comes from.

Yigal Dov Nochomovitz: Mcconnell mechanics.

Yigal Dov Nochomovitz: Please go ahead with your question.

Amin An: Hi, team. This is Amin An for Yigal. Thank you for taking our questions. We have two here.

Yigal Dov Nochomovitz: Hi team. This is on for Yigal. Thank you for taking our questions.

Amin An: We have two here so the first one can you talk about.

Amin An: A bit more about the <unk> and <unk>.

Amin An: The main factors that will lead into the inflection in the second half and second question is on hypertrophic cardiomyopathy.

Amin An: So for the first one, for MPEFA, can you talk about a bit more about the granularity and the main factors that will lead to the inflection in the second half. And the second question is about hypertrophic cardiomyopathy. Can you talk about how, mechanistically, do you expect any differences in clinical outcomes between the obstructive and non-obstructive types of HCM?

Amin An: Can you talk about mechanically do you expect any different differences in clinical outcomes between the obstructive and non obstructive types of HCM.

Lonnel Coats: Thank you, Amin. Let me take the first question and turn it over to Tom. I believe it's, you know, what do we believe in terms of inflection and what's leading us to believe the inflection will happen in the second half? Let me start with the first part.

Speaker Change: Thank you and then let me take the first question and turn it over to Tom.

Lonnel Coats: I believe it's.

Lonnel Coats: You know, I've consistently said this consistently that we launched in the summer, and we launched off-cycle. So it's going to take time for us to build access and coverage. And we're now at that point where we're starting to get that access, and very shortly, we feel very confident we're going to gain even greater access. And to the point that Tom made earlier, we're seeing good growth in the absence of the kind of access that's going to need to accelerate.

Tom: You know I've said this consistently that we launched in the summer and.

Lonnel Coats: Access and coverage and we're now at that point, where we're starting to get that access and coming up very shortly we feel very confident we're going to gain even greater access and to the point that Tom made earlier, we're seeing good growth in the absence of the kind of access is going to need to accelerate but once we get it then that should be the few.

Lonnel Coats: But once we get it, then that should be the fuel that accelerates. But, Tom, I will turn it over to you to give more specificity. And then, Craig, if you can answer the question around HCM.

Lonnel Coats: The accelerates.

Tom: I will turn it over to you to have more to give more specificity and then Craig if you can answer the question around HCM Tom.

Thomas A. Garner: Thanks, Lonnel. I think you kind of summarized it well. Further comments were shared earlier on. So if we look at how we're kind of doing in terms of driving demand, you know, we are encouraged by some of the leading indicators that we see around just the customer perspective on Impeffer as a whole. Clearly, when our reps get in front of our customers, they are converting them into trial lists. And I think as we continue to broaden the adoption of the product, you know, with the numbers now increasing all the time, 2,000 writers, we're actually pleased with that kind of continued uptake.

Tom: So I think you kind of summarized it well.

Thomas A. Garner: Further covenant associated earlier on.

Thomas A. Garner: So if we if we look at how we're kind of doing in terms of driving demand. We are encouraged by some of the leading indicators that we see around just the customer perspective perspective on the impact for as a whole.

Thomas A. Garner: Clearly when our reps getting front of our customers. They are converting them into trials and I think as we continue to broaden the adoption for the product.

Thomas A. Garner: The number is now increasing all the time 2000, Reuters, we're actually pleased with that kind of continued uptake can we see on an ongoing basis, you know accelerating claims but also we're seeing now accelerating pull through in terms of the Trs Molina as well.

Thomas A. Garner: And we see on an ongoing basis, you know, accelerating claims, but we're also seeing now an accelerating pull through in terms of TRX volume as well. And per Lonnel's comments, the team is now very actively engaged with all of the payers given where we are with the 2025 bid cycle. So I think you take all of those factors together.

Thomas A. Garner: <unk> comments the team and I are very actively engaged with all of the payers given where we are with the <unk>.

Thomas A. Garner: One is to instruct bid cycles. So I think if you pull all of those factors together.

Thomas A. Garner: And just given what we're hearing from payers, in particular regarding the value proposition, and the fact that they do seem to be quite willing and open to considering adding Impeffer to their formularies with utilization management taken off the table, I think if we can do that, coupled with all of the efforts that we have and this growing prescriber base, we feel good about where we'll be in the second half of the year. So it's that combination of demand and access.

Thomas A. Garner: Just given what we're hearing from payers in particular regarding the value proposition and the fact that they do seem to be quite willing and open to be considering adding and pass it to their formularies with utilization management taken off the table I think if we can do that coupled with all the efforts that we have in this growing prescriber base that we feel.

Thomas A. Garner: Good where it will be in the second half of the year. So it's that combination of demand and access and as you're probably well aware you know those two those two things are always linked in a launch window access begets demand and demand.

Thomas A. Garner: And as you're probably well aware, those two things are always linked in a launch window: access begets demand, demand begets access. We're making sure that we're working very hard on both fronts to achieve that. So Craig, maybe I'll hand over to you about HTN. Thank you, Tom.

Craig: We're making sure that we're working very hard on both fronts to to achieve that.

Craig B. Granowitz: So I'll just restate the question that it was about: are there mechanistic differences that we believe are in place between obstructive and non-obstructive hypertrophic cardiomyopathy? Great question.

Craig B. Granowitz: And as a reminder, HCM is largely due to a number of gene defects, but most of them relate to actin and myosin and the interaction of actin and myosin. And that results in what is considered diastolic dysfunction. So largely, it is an issue of relaxation of the myocardium and limiting the ability of the myocardium to fill adequately in diastole. What is interesting is that a lot of the benefits that are seen mechanistically with sodaglyphosin are acting directly on the myocardium, which we believe will actually improve that basic underlying defect.

Craig B. Granowitz: <unk> HCM is largely due to a number of gene defects, but most of them relate to act in myosin and the interaction of actin and myosin.

Craig B. Granowitz: And that results in what is considered diastolic dysfunction. So largely it is an issue of relaxation of the myocardium and limiting the ability of the myocardium to fill adequately in diastole.

Craig B. Granowitz: What is interesting is that a lot of the benefits that are seen mechanistically with <unk>, our acting directly on the myocardium, which we believe will actually improve that.

Craig B. Granowitz: It's also important to note that in many patients with obstructive HCM that undergo septal reduction therapy, they often progress, and continue to symptomatically progress. And so again, we believe that there are more similarities in the underlying mechanism for which sotaglifosin might be uniquely beneficial than differences between what is obstructive and non-obstructive hypertrophic cardiomyopathy.

Craig B. Granowitz: Also important to note that in many patients with obstructive.

Craig B. Granowitz: <unk> that undergo septal reduction therapy, they often progress and continue to Symptomatically progress.

Craig B. Granowitz: So again, we believe that there are more similarities in the underlying mechanism for which sort of a thousand might be uniquely beneficial than our differences between what is obstructive and non obstructive hypertrophic cardiomyopathy.

Lonnel Coats: Okay, great. Thank you. Thank you for answering the questions and congratulations on your retirement, Lonnel.

Speaker Change: Okay, great. Thank you.

Lonnel Coats: Thank you for answering the questions.

Speaker Change: Congratulations on the retirement will announce.

Lonnel Coats: Thanks, I'm in. I appreciate it.

Lonnel Coats: Thanks, Amit I appreciate it.

Operator: Our next question comes from Yasmeen Rahimi of Piper Stanley. Please go ahead with your question.

Speaker Change: Our next question comes from mezzanine Romani.

Yasmeen Rahimi: Piper Sandler. Please go ahead with your question.

Jungjoo: Hey team, this is Jungjoo on behalf of Yas. I just first wanted to thank Lonnel on behalf of the PIPA team for your contribution. We have two questions. The first one is, in regards to 9851, what types of IND studies still need to be completed, and what duration tox package are you aiming to have before entering the clinic? And for the second question, considering there's actually a lot of off-label use for SDLT2s in non-obstructive patients, is there a biological basis why sotaglifosin's differentiating mechanism of action could possibly work better for these patients?

Operator: Hey, Dan This is Joe on for Yes, that's fair.

Jungjoo: Just wanted to thank lanell on behalf of the pipe became for your contribution.

Jungjoo: And we have two questions. The first one is in regards to 95, one what types of IMD study still need to be completed and what duration Tox package, India before entering the clinic.

Jungjoo: And for the second question, considering that I've seen a lot of off label use for <unk> in non obstructive patients as our biological reasons why vertical differentiated mechanism of action could actually possibly work better for these patients.

Craig B. Granowitz: Great two questions. Craig, why don't you start with the first one, HCM, and then we have our Head of Innovation available today to talk about 9851 to answer your first question. So, Craig, why don't we start with you?

Speaker Change: Greg two questions Craig why don't you start with the first one on HCM and then we have our.

Craig B. Granowitz: Our head of innovation available today to talk about $95. One to answer your first question. So correct, what we start with you.

Craig B. Granowitz: Yeah, thank you. If you could just, it got just a bit garbled at the end, so I didn't catch the whole question. Could you just restate the last part of that on the differences? I just missed the first part of it.

Speaker Change: Yes. Thank you if you could just talk just a bit garbled at the end so I didnt catch the whole question could you just restate the last part of that on the differences I just missed the first part of it.

Jungjoo: Yeah, but is there a biological basis why sodicliflozin's differentiated mechanism of action could possibly work better in these non-obstructive HCM patients?

Craig B. Granowitz: Yeah is there a biological basis, why political flows and differentiated mechanism of action kind of can you work, possibly better than not.

Jungjoo: Non obstructive HCM patients.

Craig B. Granowitz: Yeah, great, great question. As we said, in part to the last question, the fact that there are SGLT1 receptors on the myocardium itself, both at baseline, but are also induced during stress conditions, both experimentally and in patients, as well as Mendelian genetic studies that show that patients that have knockdown mutations in SGLT1 actually have less heart failure. We believe that the benefits that you'll see with sotaglifosin will be even better than those that you might see with an SGLT2 inhibitor.

Speaker Change: Yes, great Great question.

Craig B. Granowitz: As we said in part to the last question. The fact that there are <unk> one receptors on the myocardium itself. Both at baseline, but are also induced during stress conditions, both experimentally and in patients as well as our Mendelian genetics studies that.

Craig B. Granowitz: Show that patients that have knocked down mutations in SDLP, one actually have less heart failure.

Craig B. Granowitz: We believe that the benefits that youll see what <unk> will be even better than those that you might see with an <unk> two inhibitor. So the combination of both <unk> one.

Craig B. Granowitz: So the combination of both SGLT1 which is acting directly on the myocardium, and on the endothelium, and in the GI tract, as well as on the kidney, plus the more systemic effects that you see with SGLT2 inhibitors and lowering fluorine volume, increasing hemoglobin, and some other factors that you can get potentially two bangs for your buck with sotaglifosin, both of which would be beneficial in patients with HCM.

Craig B. Granowitz: Which is acting directly on the myocardium and on the endothelium and in the Gi tract as well as on the kidney plus the more systemic effects that you see with <unk>, two inhibitors, and lowering fluor and volume increasing hemoglobin and some other factors that you can get potentially two bangs for your Buck with surgical closing both of which.

Craig B. Granowitz: <unk> would be beneficial in patients with HCM.

Craig B. Granowitz: Alan, do you want to take the second question relative to 985.1 and IND work? Sure, absolutely. So we're just beginning the IND enabling work. The first part of that is manufacturing enough GMP material to do

Craig B. Granowitz: Alan, do you want to take the second question regarding 985.1 and IND work?

Craig B. Granowitz: Alan do you want to take the second question relative to 90 to 101 IND work.

Alan: Sure absolutely.

Alan: We're just beginning the IND enabling work.

Alan: The first part of that is manufacturing the.

Alan: Enough GMP material to do the.

Alan: Toxicology studies and safety studies, and we're planning to do a one month study in two species, so that will allow us to treat.

Craig B. Granowitz: The first patients for up to two one months.

Speaker Change: This is I think the <unk> that we've done at lexicon and so we have a.

Alan: A pretty well oiled machine to do the IND, enabling studies.

Alan: Thank you Ellen.

Operator: Our next question comes from Rwana Ruiz from New York Partners. Please go ahead with your question.

Speaker Change: Our next question comes from Rwanda release from Leerink Partners. Please go ahead with your question.

Rwana Ruiz: Great afternoon, everyone. For MPEFA, I was curious what feedback you are getting from physicians and reps in the field on MPEFA's clinical profile and differentiating features, and particularly what's attracting more prescribers to MPEFA?

Rwana Ruiz: Great afternoon, everyone.

Rwana Ruiz: First I was curious what feedback are you getting from physicians and reps in the field on and Pat This clinical profile and differentiating features and particularly what's attracting more prescribers to empower.

Thomas A. Garner: Great question. Tom, do you want to take that? Sure.

Rwana Ruiz: Great question, Tom do you want to take that.

Thomas A. Garner: Sure. So, you know, I think I mentioned some of the data earlier on. I mean, if you take the two main studies that we have, which are SOLOist and SCORD, obviously SOLOist was somewhat unique in that it was the only study of an SGLT in patients who had been hospitalized or recently hospitalized. And I think when customers see that data, in particular, the NNT of four, and as I mentioned, the fact that we reduce hospital admissions both at days 30 and at 90 by over 50%, I think that that's seen as very compelling when those two data points are taken together.

Thomas A. Garner: So.

Tom: I think I mentioned some of the data.

Thomas A. Garner: Earlier on I mean, if you take if you take the two studies that we have which is some interest in school, but obviously some of it was somewhat unique in that it was the the only study of <unk> in patients who have been hospitalized. So recently hospitalized so and I think one customer.

Thomas A. Garner: I think when they then look, when customers then see the score data on top, which is obviously more of the kind of patients who you'd be wanting to prevent coming into the hospital, they can clearly see that Impefa has a profile that actually fits across the entire range of heart failure patients, whether they be early heart failure patients, where you may be looking to prevent them entering the hospital, or they've actually had an episode of hospitalization and they've recently So I think that those kinds of key data sets taken together are seen as compelling.

Thomas A. Garner: Customers see that data in particular, the <unk> four and as I mentioned, the fact that we reduce hospital admissions both.

Thomas A. Garner: 30, and at 90 by over 50% I think that that's seen as very compelling when those two data points are taken together.

Thomas A. Garner: I think when they then look when customers don't see the school days from talk which is obviously more of the kind.

Thomas A. Garner: Patients, who you would be one thing to prevent coming into the hospital. They can clearly see the impact has a profile that actually fits across the entire range of heart failure patients whether they be.

Thomas A. Garner: Any heart failure patients, where you may be looking to prevent an uncertain the hospital or they've actually had a hospitalization and they've recently left or are about to leave he may want to prescribe the drug then or if they've been recently discharged.

Thomas A. Garner: And sure that they get the best possible treatment.

Thomas A. Garner: So I think those profile those kind of key dates taken together are seen as compelling the mode of action I think is also seen as compelling for those people who.

Thomas A. Garner: The mode of action, I think, is also seen as compelling for those people who appreciate the data that we have. And obviously, the evidence that we're continuing to generate around the products, specifically around areas like three-point mace and stroke, which we have data coming out of the ACC, is also seen as very differentiating versus the other SGLT treatments. So I think that that's the high-level story. On top of that, those messages are also resonating with payers, especially payers that are dealing with both the pharmacy and the medical benefit because, obviously, reducing and stopping these patients having to go back into the hospital after a period of hospitalization is something that is a priority across the board.

Thomas A. Garner: I appreciate that the data that we have and obviously the evidence that we are continuing to generate around the products specifically around areas like three point mace and stroke, which we.

Thomas A. Garner: We have data coming out of ACC has also seen this very differentiating versus the rest of the LTE treatment. So.

Thomas A. Garner: So thats the high level story.

Thomas A. Garner: On top of that.

Thomas A. Garner: Messages are also resonating with payers, especially payers that are dealing with both the pharmacy and the medical benefits.

Thomas A. Garner: Because obviously, reducing stocking these patients having to come back into the hospital extra period hospitalization is something that is.

Thomas A. Garner: The priority across the board so.

Thomas A. Garner: We're pleased with the general reaction to the profile on this on the whole.

Thomas A. Garner: So we're pleased with the general reaction to the profile on the whole. And as I mentioned earlier, we are making significant efforts to really bolster our commercialization efforts, both in terms of in-person selling but also thinking about third-party and omnichannel approaches as well.

Thomas A. Garner: And as I mentioned really wrong.

Thomas A. Garner: Making significant efforts to really bolster our commercialization efforts both in terms of in person selling.

Thomas A. Garner: But also thinking about third party and Omnichannel approaches as well.

Craig B. Granowitz: Interesting. Thanks. And one more from me. Given your upcoming phase three in HCM, could you just help frame why KCCQ is an important measure across both obstructive and non-obstructive HCM patients, particularly in the context of the fact that a lot of us are focused on other things like peak VO2 with some of the CMI trials and things like that?

Speaker Change: Interesting, thanks, and one more from me given your upcoming phase III in HCM could you just help frame why Keith accused in prime measure across both obstructive and non obstructive HCM patients are particularly in the context of the fact that a lot of us are focused on other things like pizza.

Craig B. Granowitz: Two with some of the CMI trials and things like that.

Craig B. Granowitz: Great question, Craig. Yeah, thank you, Lonnel. And again, I

Speaker Change: Great question Craig.

Craig B. Granowitz: Yeah, thank you, Lonnel. And again, I think, Royana, it's a great segue from ending the last question is that physicians who have already started using Impefa in the clinic have had really good results, and patients have been satisfied with the therapy. And as Tom mentioned in our prepared remarks, something on the order of over 90% of patients are satisfied, and healthcare providers are satisfied with the therapy. And I think that is really another foundational support for why we're so excited about what we're doing with HCM.

Speaker Change: Yes, Thank you and Alan and again I think it's a great segue from ending the last question is that physicians, who have already started using in pampa in the clinic have had really good results that the patients were satisfied with the therapy and is.

Craig B. Granowitz: Tom mentioned in our prepared remarks, something on the order of over 90% of patients are satisfied.

Craig B. Granowitz: Healthcare providers are satisfied with the therapy and I think that is really that another foundational support for why we're so excited about what we're doing with HCM.

Craig B. Granowitz: And as a reminder, what you hear from clinicians and experts is that all of these agents are approved for symptomatic relief, and the CMIs are not approved for long-term clinical benefit. And what you're seeing from providers and from the FDA is that some of these other physiologic markers, such as the six-minute walk or peak VO2, it's very hard to communicate that to patients and that to be a meaningful benefit. But when you ask them, is your life better? Can you walk another flight of stairs? Do you not get winded?

Craig B. Granowitz: And as a reminder, what you hear from clinicians and experts is that all of these agents are approved for symptomatic relief.

Craig B. Granowitz: Do you not have a lot of the symptomatic problems that bedevil the daily lives of patients? That's what's most meaningful. And I think that's why the FDA has evolved in their own thinking and in the more recent trials with these agents, they have allowed KCCQ as the primary endpoint. And as a reminder, the inclusion criteria for our study are all symptomatic patients with a KCCQ below 85. And so again, it's not a matter of saying, are we looking for another 10 meters to walk in a six minute walk test? I mean, we're really focusing on the activities of daily living.

Craig B. Granowitz: And as a reminder, the inclusion criteria for our study is all symptomatic patients with the KC CQ below 85.

Craig B. Granowitz: And I gotta give the FDA a lot of credit for evolving in their thinking about what is most important to patients. And importantly, we have at the key secondary endpoint the New York Heart Association, which is the counterpoint. So New York Heart is the healthcare provider assessment of patient functionality, and KCCQ is the patient self-assessment of functionality. And I think having it in that order, with the patient-reported outcome as the primary and the healthcare provider assessment as the key secondary, is a good way to go. And there's a lot of excitement in the field to participate in this trial.

Craig B. Granowitz: Endpoint, The New York Heart Association, which is the.

Operator: Our next question comes from Andrew Stide from Jeffries. Please go ahead with your question.

Andrew Stide: Hi, Thanks.

Andrew Stide: Congrats on the retirement best wishes to you on everything its been a pleasure.

Andrew Stide: A pleasure. Maybe the first question is about Empatha. You've directionally guided sales to accelerate in the second half of 2024. So just how much do you think sales can accelerate specifically in Q3 and Q4? Just curious how you would define an acceleration from the current sales trajectory? And then, secondly, would you need to rebuild or refocus on payer access again if type 1 diabetes was approved? Or can you leverage the work you've done in heart failure and apply it to type 1 diabetes? So, and I guess the question is just trying to gauge how much sales could accelerate even further immediately if you launched it for type 1 diabetes. Thanks.

Andrew Stide: Maybe the first question is about <unk> <unk>.

Andrew Stide: Directionally guided to sales to accelerate in the second half of 2024. So just how much do you think sales can inflect specifically in Q3 and Q4, just curious how you would define an acceleration from the current sales trajectory and then secondly would you need to rebuild our refocus on payer access again if tycho.

Andrew Stide: Diabetes was approved or can you leverage <unk>.

Andrew Stide: You've done heart failure and apply it to type one diabetes, so and ask the question is.

Lonnel Coats: Andrew, first, let me say thank you for the well wishes, and I'm looking forward to my retirement because of those tough questions. But I think Jeff has an answer to that, so let me turn it to him.

Speaker Change: I'm looking forward to my retirement, but.

Jeff: Because of those tough questions.

Jeffrey L. Wade: So, I think, you know, when you're looking at our overall coverage, it's around 40%, but a lot of that is subject to utilization management in terms of step edits, which in this area where step-through drugs have only been approved for heart failure relatively recently and are, you know, so early in the adoption curve, that's a pretty big obstacle.

Jeff: So I think when youre looking at our overall coverage.

Jeffrey L. Wade: It's around 40%, but a lot of that is subject to.

Jeffrey L. Wade: So early in the adoption curve, that's a pretty big obstacle and when we're negotiating and working with payers to get on formulary with contracted coverage, we're eliminating those step at it. So when you kind of looking at our Medicare being single digits.

Jeffrey L. Wade: And when we're negotiating and working with payers to get on formularies with contracted coverage, we're eliminating those step edits. So, when you're kind of looking at, you know, our Medicare being single digits, it has a chance to multiply many times over, so, and an opportunity to very significantly increase the commercial, as well, when you're thinking about access without those kind of restrictions. We think that there's an opportunity to really multiply the opportunity for, to multiply many times over what we're looking at in terms of the revenues that we're getting from MPEPA. So, that, I think, is an important element.

Jeffrey L. Wade: Chances to multiply.

Jeffrey L. Wade: Multiply.

Jeffrey L. Wade: Many fold.

Jeffrey L. Wade: We're looking at in terms of the.

Jeffrey L. Wade: The revenues that we're getting from our purpose. So that I think is an important element. The second thing is <unk>.

Jeffrey L. Wade: The second thing is type one diabetes, and this is to address your second question. Type 1 diabetes is kind of a different market, because unlike in heart failure, where we're competing, in type 1 diabetes, we're going to be potentially the only game in town. And it's also an area where payers are really interested. I mean, we're already having discussions.

Jeffrey L. Wade: Type one diabetes and this isn't the address your second question.

Jeffrey L. Wade: Type one diabetes is kind of a different market because unlike in heart failure, where we're competing in.

Jeffrey L. Wade: In type one diabetes, we're gonna be potentially the only game in town and.

Jeffrey L. Wade: And it's also an area where payers are really interested I mean, we're already having discussions is the minute that we announced that we were resubmitting. These payer discussions they are asking us about type one diabetes.

Jeffrey L. Wade: The minute that we announced that we were resubmitting these payer discussions, they were asking us about type 1 diabetes. We think that we will be able to have more favorable access to type 1 diabetes than we have in heart failure because it's not a competitive space in terms of, particularly as we think about the rebates required to be able to get access. And we're doing the groundwork now to be prepared for that launch. So we think that that is going to be an easier road by a good margin as it relates to access in type 1 diabetes. So hopefully, that answers your question.

Jeffrey L. Wade: We think that we will be able to have more favorable access in type one diabetes than we have in heart failure, because it's not a competitive space in terms of particularly as we think about.

Jeffrey L. Wade: The rebates required to be able to get access and we're doing the groundwork now to be prepared for for that launch. So we think that that is going to be an easier road.

Jeffrey L. Wade: By by a good margin and that is as it relates to access in type one diabetes. So hopefully that answers your question yes.

Lonnel Coats: Yeah, the only thing I would add is that we will leverage our infrastructure. We've built an incredibly talented team of people, both on the access side and the medical side. So that infrastructure will be leveraged to go into T1D. The most important decision we've made in the last eight, nine months was bringing an incredible executive like Tom, who knows how to bring all those pieces together well in advance of the launch. So we definitely will be leveraging the infrastructure along with the other things that Jeff laid out. Great.

Speaker Change: Yes, the only thing I would add is that.

Lonnel Coats: We will leverage our infrastructure, we've built an incredibly talented team of people.

Lonnel Coats: Both on the access side the medical side, so that infrastructure will be leveraged to go into the <unk>. Most important decision. We've made in the last eight nine months was bringing incredible executive like Tom.

Lonnel Coats: Who knows how to bring all those pieces together well in advance of the launch so we definitely will be leveraging the infrastructure along with the other things that Jeff laid out.

Lonnel Coats: Great. Okay. Thank you, guys. You bet, Andrew.

Speaker Change: Great. Okay. Thank you guys.

Speaker Change: You bet Andrew Thank you.

Lonnel Coats: Yes.

Operator: And our next question comes from Joseph Stringer from Needham & Company. Please go ahead with your question.

Lonnel Coats: And our next question comes from Joseph Stringer from Needham and company. Please go ahead with your question.

Operator: Yes.

Joseph Robert Stringer: Hi, thanks for taking our questions. You provided some data on the commercial opportunities for Zinquista and T1D. But I suppose, how should we think about your commercial strategy, targeting patient subgroups? Or how should we think about the stratification of patients that you would target? For example, what patients would you consider early adopters versus potential late adopters to the drug, assuming approval? And is it fair to think about it in terms of, say, the CKD stage? Or are there other important factors that we should think about? And then last one is pricing. Assuming approval for T1D, how should we think about price and pricing strategy?

Joseph Robert Stringer: Hi, Thanks for taking our questions.

Joseph Robert Stringer: Targeting patient subgroups or.

Joseph Robert Stringer: How should we think about the stratification of patients you would target for example, what patients would you consider early adopters versus potential late adopters to the drug.

Joseph Robert Stringer: Is it fair to think about it in terms of say <unk> stage or are there other important factors that we should think about and then.

Joseph Robert Stringer: Last one is on pricing assuming approval in <unk>, how should we think about price and pricing strategy. Thank you.

Jeffrey L. Wade: So I will I'm going to address the first question, which is how do we think about this market? So there are 1.7 million adults who have type 1 diabetes, and about 20 to 25% of those have chronic kidney disease. And most people who have type 1 diabetes are at risk for progression to chronic kidney disease. What I would encourage you to think about is that this is not about treating chronic kidney disease.

Jeffrey L. Wade: This market so.

Jeffrey L. Wade: There is $1 7 million adults, who have type one diabetes and about 20% 25% of those have chronic kidney disease and most people who have type one diabetes are at risk for progression of chronic kidney disease.

Jeffrey L. Wade: I would encourage you to think about is this is it does not.

Jeffrey L. Wade: About treating chronic kidney disease.

Jeffrey L. Wade: This is about providing benefits to patients who have type 1 diabetes to manage their blood glucose control who have chronic kidney disease, but that's one of multiple different things they're dealing with. And the benefit in this patient population is greater because they're at greater risk of progression of chronic kidney disease. But the benefits that are valued by the patient are really about, you know, improving their A1C, improving time and range, improving, you know, basically reducing their risk for complications across a broad range of areas.

Jeffrey L. Wade: Who have chronic kidney disease, but thats one of multiple different things, they're dealing with and the benefit in this patient population is greater because they are at greater risk of progression.

Jeffrey L. Wade: Ronit kidney disease, but the benefits that values that are valued by the patient.

Jeffrey L. Wade: It's really about.

Jeffrey L. Wade: Basically reducing their rest for a complications across a broad range of areas. So it's really about providing.

Jeffrey L. Wade: So it's really about providing benefits for glycemic control, addressing the core and met needs of type 1 diabetes patients in a population that's at greater risk for progression of chronic kidney disease. So that's the way I would encourage you to think about it. So one of the advantages in this market is that people with type 1 diabetes are very engaged in their own care. They have to be They don't really have a choice.

Jeffrey L. Wade: It's on glycemic control addressing the core unmet needs in type one diabetes patients.

Jeffrey L. Wade: In a population that's it.

Jeffrey L. Wade: Greater risk for progression of chronic kidney disease. So that's the way I would encourage you to think about it so.

Jeffrey L. Wade: And so obviously, people who are more engaged are probably more likely to be early adopters than people who are less engaged. But because people with type 1 diabetes, even the people who are less engaged, have to be pretty much engaged in their care, and because they want to avoid hypoglycemia, they want to feel better, they want to reduce glucose variability, we think that there's going to be an opportunity for pretty rapid uptake in this patient population.

Jeffrey L. Wade: One of the advantages in this market is that people with type one diabetes are very engaged in their own care.

Jeffrey L. Wade: They have to be they don't really have a choice.

Jeffrey L. Wade: So as that obviously people who are more engaged are probably more likely to be early adopters than people that are less engaged but because people with type one diabetes.

Speaker Change: I have a pretty rapid uptake.

Jeffrey L. Wade: But the important part, really, is to frame this as this is not a chronic kidney disease drug. This is a type one diabetes drug that would be indicated in the population that has chronic kidney disease. On pricing, we're still doing pricing work there.

Jeffrey L. Wade: This patient population.

Jeffrey L. Wade: But.

Jeffrey L. Wade: The important part really is to frame. This is this is not.

Jeffrey L. Wade: The chronic kidney disease drug this is the type one diabetes drug.

Jeffrey L. Wade: That is that would be indicated in the population that has chronic kidney disease.

Jeffrey L. Wade: On pricing, we're still doing pricing mark there.

Jeffrey L. Wade: We're going to, we'll, you know, do some refinement of that. But we think mostly that our net pricing is just going to be more favorable. That's the main thing that we think will be different. But we're going to do some additional work around how we look at wholesale acquisition costs and also about the level of rebates that would be required to answer your questions. Yeah, that's great.

Jeffrey L. Wade: Do some refinement of that but we think mostly that our net pricing is just going to be more favorable.

Jeffrey L. Wade: Gonna do some additional work around.

Jeffrey L. Wade: About the level of <unk>.

Jeffrey L. Wade: Rebates that would be required.

Jeffrey L. Wade: That answer your questions.

Joseph Robert Stringer: Yeah, that's great. Thank you for taking our question.

Speaker Change: Yeah, that's great. Thank you for taking our questions.

Speaker Change: Thank you Joey.

Operator: And ladies and gentlemen, at this time, to ensure there are no additional questions, I'll be turning the floor back over to Jeff Wade for any closing comments.

Jeffrey L. Wade: Well, thank you everyone for joining us on today's call and, really, for your continued support of Lexicon. And as we wrap up, I just want to reemphasize how Lexicon really has never been stronger. The company has never been in a better position to focus on the next steps. We have a strong management and leadership team in place committed to growth and expansion, and that includes seamless execution, targeted and smart capital allocation, and exploring and leveraging partnerships to add even more value to the Lexicon assets of the company. So we really appreciate you joining us, and thank you for your attention.

Jeffrey L. Wade: Well. Thank you everyone for joining us on today's call.

Jeffrey L. Wade: And.

Jeffrey L. Wade: And really for your continued support of <unk> com.

Jeffrey L. Wade: And as we wrap up.

Jeffrey L. Wade: He has never been out of their position to focus on next steps, we have a strong management and leadership team in place committed to growth and expansion and that includes seamless execution targeted and smart capital allocation.

Jeffrey L. Wade: And exploring and leveraging partnerships.

Jeffrey L. Wade: Yes.

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

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