Diverse group of stakeholders aligned around the importance of elevating public awareness of need for new treatments for chronic pain and the need to expand the Alternatives to PAIN ActTHE WOODLANDS, Texas, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Yesterday, Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) hosted and participated in a roundtable discussion with experts to explore how to enhance current and future legislative and policy efforts to better meet the needs of Americans suffering from chronic pain. The pers ...

Lexicon Pharmaceuticals (LXRX) Conference Summary Company Overview - **Company**: Lexicon Pharmaceuticals (LXRX) - **Date of Conference**: September 03, 2025 - **Key Speakers**: Mike Exton (CEO), Craig Granowitz (CMO) Key Points and Arguments Company Evolution and Pipeline Focus - Lexicon Pharmaceuticals has shifted back to a pure R&D focus, emphasizing its pipeline development [4][5] - The company has made significant progress with three main assets in its pipeline [4] Licensing and Collaborations - In Q1 2025, Lexicon licensed LX9851, a preclinical asset for obesity, to Novo Nordisk, a leader in obesity treatment [4] Clinical Trials and Data - The PROGRESS Phase 2b study for pilovapitan, a non-opioid treatment for diabetic peripheral neuropathic pain, has shown promising results, with plans to move into Phase 3 trials in early 2026 [5][6] - The company is preparing for a busy September with multiple data rollouts at medical meetings [6] Heart Failure and HCM Programs - Lexicon continues to market sotagliflozin for heart failure under PEPFAR, maintaining sales levels from the previous year [6] - The SONARDA trial for hypertrophic cardiomyopathy (HCM) is progressing well, with full patient enrollment expected by 2026 [7] Data Analysis and Findings - A pooled analysis of over 12,000 patients in heart failure studies showed consistent responses across age groups, particularly in elderly patients [10] - The analysis indicated a 50% reduction in hospital readmissions and cardiovascular death at various time points, highlighting the efficacy of sotagliflozin compared to other SGLT inhibitors [12][14] Differentiation in Treatment - Lexicon's approach to treating HFpEF and non-obstructive HCM is unique, as sotagliflozin addresses underlying metabolic disorders in the myocardium [29] - The company aims to position sotagliflozin as the first-line treatment for both HFpEF and HCM, leveraging its efficacy and safety profile [35] Trial Design and Regulatory Engagement - The SONARDA trial is designed to include both obstructive and non-obstructive HCM patients, with a primary endpoint focused on symptom relief [40] - Lexicon is in discussions with the FDA to finalize the design for Phase 3 trials, aiming for a straightforward approval process based on previous Phase 2 data [62][66] Financial and Partnership Strategy - Lexicon plans to partner for the Phase 3 program, seeking a partner that is committed to long-term investment in the drug's development [78] - The company is exploring various partnership structures, aiming for a worldwide deal [79] Upcoming Events - The Arrowhead meeting in October will feature data presentations across Lexicon's Phase 2 programs, which are expected to inform the end of Phase 2 meeting with the FDA [81] Additional Important Insights - The analysis of the MAPLE trial indicated that beta blockers may cause harm, suggesting a potential shift in treatment paradigms for HCM [34] - The company is focused on simplifying trial designs to reduce variability and enhance the clarity of results [68] This summary encapsulates the key discussions and insights from the Lexicon Pharmaceuticals conference, highlighting the company's strategic focus on R&D, clinical advancements, and market positioning in the biopharmaceutical landscape.

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $3,580 million, down approximately 2% year-over-year, but operational revenue growth was approximately 3% when excluding the impact from Indoor [27][28] - Adjusted gross margin for the quarter was 56.6%, consistent with expectations, and operating expenses decreased due to planned cost-saving initiatives [31][32] - Free cash flow generated in the quarter was $167 million, with an adjusted figure of $241 million when excluding transaction-related costs [32] Business Line Data and Key Metrics Changes - In developed markets, brand performance helped offset the Indoor impact, with European business growing approximately 2% and brands portfolio growing approximately 3% [28] - North American business decreased 11% year-over-year, primarily due to Indoor impact and competition, while Emerging Markets saw a 1% increase driven by Turkey and Emerging Asia [29] - Greater China net sales grew 9%, benefiting from proactive patient choice and customer purchasing patterns [30] Market Data and Key Metrics Changes - The company serves approximately one billion patients worldwide each year, with a global supply chain supporting patient access [13] - The U.S. market is expected to see continued growth in generics, although moving additional manufacturing of non-complex generics to the U.S. is deemed difficult in the short term [14][15] - The company anticipates no material impact from proposed U.S. tariffs on its 2025 financial picture, while monitoring developments closely [12][35] Company Strategy and Development Direction - The company is focused on driving strong commercial execution, advancing its late-stage pipeline, and exploring strategic business development opportunities [6][11] - The enterprise-wide strategic review aims to position the company for sustainable growth in 2026 and beyond, with updates expected in the Q3 earnings call [11][54] - The company is committed to returning capital to shareholders through dividends and share buybacks, having returned over $630 million year-to-date [10][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, citing a strong business foundation and a maturing late-stage pipeline [15][16] - The company reiterated its 2025 financial guidance, expecting to be in the top half of the range for revenue and adjusted EPS [15][34] - Management acknowledged the challenges posed by tariffs but does not anticipate a material financial impact in 2025 [48][35] Other Important Information - Five of the six anticipated Phase III readouts have shown positive results, reinforcing the strength of the company's pipeline [7][18] - The company is making progress on remediation efforts at its Indoor facility, with plans to discuss reinspection with the FDA [11][69] - The company has received FDA approval for dorunavir tablets manufactured at its Nashik facility, indicating positive operational progress [12][70] Q&A Session Summary Question: Capital allocation priorities and growth expectations - Management emphasized a balanced approach to capital allocation, focusing on returning capital to shareholders while building a growth portfolio through strategic business development [40][41] Question: Impact of tariffs on revenue from India versus EU - Management stated that it is monitoring the situation closely and does not anticipate a material financial impact from tariffs in 2025 [48] Question: Performance of the China business - The China business saw a 9% operational growth, with expectations for moderate growth in the future, driven by strong brand equity and proactive patient demand [55][56] Question: Contribution from new products in developed markets - Management expects to generate approximately $450 million to $550 million from new product revenue, with a back-half weighting based on approval and launch timing [61][62] Question: Commercial strategy for meloxicam - The company is in the midst of launch planning for meloxicam, focusing on market research and positioning, with expectations for significant opportunity in the acute pain market [66][67]

Financial Data and Key Metrics Changes - For Q2 2025, Lexicon Pharmaceuticals reported revenues of $28.9 million, a significant increase from $1.6 million in Q2 2024, primarily driven by $27.5 million in licensing revenue from Novo Nordisk [24] - The net income for Q2 2025 was $3.3 million, or $0.01 per share, compared to a net loss of $53.4 million, or $0.17 per share, in the same period of 2024 [25] - Total operating expenses decreased by $31.9 million quarter over quarter, reflecting the company's strategic repositioning as an R&D-focused entity [27] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 decreased to $15.7 million from $17.6 million in Q2 2024, mainly due to lower external research expenses on the PROGRESS clinical trial [25] - Selling, general, and administrative expenses decreased to $9.4 million in Q2 2025 from $39.2 million in 2024, attributed to reduced marketing efforts for MPEFA [25] Market Data and Key Metrics Changes - The company is actively pursuing regulatory approvals for sotagliflozin in various international markets, including the UAE, Saudi Arabia, Canada, Australia, New Zealand, and several Southeast Asian countries [31] - The ongoing Phase III SONATA study for sotagliflozin is the only registrational trial currently evaluating treatment in both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [20] Company Strategy and Development Direction - Lexicon is focused on advancing its innovative portfolio of potential medicines, with a strategic pivot towards R&D that has taken shape in 2025 [6] - The company aims to maximize the potential of its drug candidates through partnerships, particularly with Novo Nordisk for LX9851 and Viatris for sotagliflozin [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of their R&D programs and the potential for pilavapitan to become a transformative therapy for patients with neuropathic pain [14] - The company anticipates presenting full progress data for pilavapitan in Q3 2025 and is preparing for an end-of-Phase II meeting [33] Other Important Information - The company ended Q2 2025 with $168 million in cash and short-term investments, down from $238 million at the end of 2024 [26] - Lexicon expects to recognize the remaining $17.5 million of licensing revenue from the Novo agreement in the second half of 2025 [26] Q&A Session Summary Question: Can you walk us through the SOTA CROSS trial and its design? - Management explained that the SOTA CROSS trial is designed to evaluate therapeutic options for non-obstructive HCM, with a crossover design allowing patients to serve as their own control [42] Question: How does the company plan to take advantage of the push for non-opioid pain medications? - Management highlighted their engagement with legislative efforts supporting non-opioid medications and expressed optimism about the potential for pilavapitan in this context [48] Question: What is Novo's plan for the Phase I study in obesity? - Management indicated that Novo is expected to vigorously pursue the Phase I program for LX9851, with a focus on oral and combination therapies [56] Question: How does the recent Vertex announcement impact confidence in the pain market? - Management expressed increased confidence in their own neuropathic pain program, citing successful Phase II results with pilavapitan [72] Question: Will an echo be required for patients if sotagliflozin is approved? - Management stated that while an echo will be part of the study protocol, it may not be a major impediment for patient suitability if approved [78]

Pipeline Development - Pilavapadin (LX9211) Phase 2b PROGRESS study identified the 10 mg dose as the most clinically meaningful for DPNP[13], with post-hoc analysis showing statistically significant pain reduction compared to placebo (p = 0.04) in combined 10 mg dosing arms[16] - The PROGRESS study enrolled 496 patients[12], and the 10 mg dose had a completion rate of 87.8%[18], similar to the placebo group's 87.9%[18] - LX9851 IND-enabling studies are underway for obesity and related metabolic disorders[6], showing potential for weight loss maintenance after semaglutide discontinuation in preclinical studies[34] - SONATA-HCM Phase 3 trial is enrolling globally to evaluate sotagliflozin in both obstructive and non-obstructive HCM patients[21, 29] Sotagliflozin & INPEFA - Sotagliflozin has shown a 0.77 hazard ratio (95% CI 0.65-0.91, p=0.0020) for reduced major adverse cardiovascular events (MACE) in patients with T2D, CKD, and high CV risk[23] - Approximately 1.1 million people in the U.S. have HCM[26, 27], presenting a significant market opportunity for sotagliflozin[26] - Viatris is undertaking ex-US, ex-EU registration and regional development of sotagliflozin[21] Market Opportunity & Partnerships - Approximately 9 million U.S. patients have progressive DPNP[20], with 60% experiencing moderate-to-severe pain and low satisfaction with current treatments[20] - Lexicon entered an exclusive licensing agreement with Novo Nordisk for LX9851, receiving $75 million in upfront and near-term milestones, with potential for up to $1 billion in aggregate payments[40] - Lexicon entered an exclusive licensing agreement with Viatris for sotagliflozin outside the U.S. and Europe, receiving $25 million upfront, with potential for almost $200 million in milestone payments[40]

Core Insights - Lexicon Pharmaceuticals presented a post-hoc analysis showing that treatment with sotagliflozin, when added to optimized insulin therapy, resulted in a reduction of hypoglycemic events in patients with type 1 diabetes (T1D) without increasing risk [1][5][6] Group 1: Clinical Findings - The analysis indicated that sotagliflozin significantly reduced hypoglycemic events, particularly in patients with blood glucose levels ≤55 mg/dL [1][5] - Chronic kidney disease (CKD) is a notable risk factor for hypoglycemia in T1D, with 20% to 40% of T1D patients developing CKD [3] - The study evaluated the effect of kidney function on hypoglycemia risk using data from two Phase 3 clinical trials, inTandem 1 and inTandem 2, which compared sotagliflozin to placebo [4][5] Group 2: Treatment Efficacy - Results showed that sotagliflozin maintained a consistent trend of reduced hypoglycemia across different estimated glomerular filtration rate (eGFR) subgroups [5] - The treatment led to lower rates of severe hypoglycemia compared to placebo, reinforcing its potential as a safer adjunct therapy for T1D patients [5][6] Group 3: Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to discover therapeutic targets [7] - The company has a diverse pipeline of drug candidates in various stages of development, addressing conditions such as neuropathic pain, hypertrophic cardiomyopathy, and obesity [7]

Core Insights - Lexicon Pharmaceuticals is set to present data on sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients at the 85th Scientific Sessions of the American Diabetes Association on June 22, 2025 [1][3] - The company will also present topline data from the PROGRESS Phase 2b study on pilavapadin (LX9211) for diabetic peripheral neuropathic pain during the same event [1][3] Sotagliflozin Presentation - The presentation titled "Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function" will take place on June 22, 2025, from 4:00-4:15 p.m. CT [3] - Clinical efficacy data for sotagliflozin will be segmented by kidney function subgroups based on Estimated Glomerular Filtration Rate (eGFR) [2] PROGRESS Study Overview - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe diabetic peripheral neuropathic pain [6] - The study is placebo-controlled, focusing on changes in pain levels over an 8-week period with various dosages of pilavapadin [6][7] About Sotagliflozin - Sotagliflozin is an oral inhibitor targeting SGLT2 and SGLT1 proteins, which are involved in glucose regulation [5] - The drug has been studied in approximately 20,000 patients across various conditions, including heart failure and chronic kidney disease [5] About Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes affecting around 9 million patients in the U.S., causing symptoms like burning pain and numbness [8]

Summary of Lexicon Pharmaceuticals Conference Call Company Overview - **Company**: Lexicon Pharmaceuticals - **Industry**: Biopharmaceuticals, focusing on cardiometabolic and associated disorders - **Key Products**: LX9851 (obesity treatment), pilovapitan (neuropathic pain), sotagliflozin (hypertrophic cardiomyopathy) Core Points and Arguments 1. **Licensing Agreement**: Lexicon signed an exclusive worldwide license for LX9851 with Novo Nordisk, providing significant financial terms and flexibility on the balance sheet for a preclinical asset [3][4] 2. **Pilovapitan Development**: The Phase 2b study for pilovapitan in diabetic peripheral neuropathic pain (DPNP) showed a significant reduction in pain scores compared to placebo, with a 1.5 to nearly 2-point drop from baseline within 6 to 8 weeks [4][14] 3. **Sotagliflozin Progress**: Enrollment for sotagliflozin in hypertrophic cardiomyopathy (HCM) is progressing well, with data readouts expected in 2027. The drug is positioned to target both obstructive and non-obstructive HCM [4][34] 4. **FDA Engagement**: Lexicon is preparing to meet with the FDA for pilovapitan's Phase 3 study, expecting to submit a complete data package by late Q3 to early Q4 [18][19] 5. **Partnerships**: The partnership with Viatris is validating for sotagliflozin, with plans to file in challenging markets like Canada and Australia [10][34] 6. **Financial Position**: Lexicon ended Q1 with approximately $195 million in cash, sufficient to fund ongoing projects, but the Phase 3 program will be funded in partnership [28][29] 7. **Market Positioning**: Sotagliflozin is expected to be prescribed widely due to its known safety profile and ease of use, potentially becoming the first indicated new medicine in non-obstructive HCM [34][35] Additional Important Insights 1. **Clinical Need**: There is a significant need for non-opioid medications for chronic neuropathic pain, as current options are inadequate [12] 2. **Trial Design**: The Phase 3 trial for pilovapitan will have a single active dose versus placebo design to minimize placebo effects [22][23] 3. **Market Dynamics**: The ability to charge a higher price for sotagliflozin in HCM is contingent on being the first approved medicine for that indication, similar to previous experiences with Zynquista [36][37] 4. **Milestone Payments**: Lexicon expects to receive $30 million in near-term milestone payments from the Novo partnership, with the first being the submission of the IND [46][48] This summary encapsulates the key points discussed during the conference call, highlighting Lexicon's strategic direction, product pipeline, and market positioning.

Core Insights - Lexicon Pharmaceuticals is conducting a pivotal Phase 3 clinical trial named SONATA-HCM to evaluate the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [1][2] - The study aims to enroll 500 patients globally, with a primary efficacy endpoint focused on symptom improvement as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score [3][4] - The trial is expected to support a supplemental new drug application for sotagliflozin, addressing a significant unmet need in the treatment of non-obstructive HCM [2][4] Study Design and Objectives - SONATA-HCM is a randomized, double-blind, placebo-controlled multicenter trial [3] - The study will include 250 patients with obstructive HCM and 250 with non-obstructive HCM [3] - The primary endpoint is the change in symptoms from baseline to week 26, assessed through the KCCQ CSS survey [3] Clinical Significance - There is a notable lack of approved therapies for non-obstructive HCM, highlighting the importance of this study [4] - Sotagliflozin has shown potential benefits in heart failure patients, which may extend to HCM patients if proven effective [4] - The drug's dual inhibition of SGLT1 and SGLT2 is associated with reduced risk of major adverse cardiovascular events, as noted in recent publications [4] Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines that transform patients' lives, utilizing a unique genomics target discovery platform [7][8] - The company has a pipeline of drug candidates in various stages of development, including treatments for HCM, neuropathic pain, obesity, and metabolic disorders [8]

Financial Data and Key Metrics Changes - For Q1 2025, revenue from sales of MPEFA was reported at $1.1 million, compared to $1.1 million for Q1 2024 [25] - Research and development expenses increased to $15.3 million from $14.4 million year-over-year, reflecting expenses associated with late-stage development programs [25] - Selling, general, and administrative expenses decreased significantly to $11.6 million from $32.1 million, primarily due to strategic repositioning efforts [25] - The net loss for Q1 2025 was $25.3 million or $0.07 per share, compared to a net loss of $48.4 million or $0.20 per share for the same period in 2024 [25] - Cash and short-term investments at the end of Q1 2025 were $194.8 million, down from $238 million at the end of 2024 [26] Business Line Data and Key Metrics Changes - The company announced an exclusive license agreement with Novo Nordisk for LX9851, which includes potential milestone payments of up to $1 billion and tiered royalties on future net sales [5][6] - The Phase 2b study of pilavapitan showed a well-tolerated dose with clear evidence of effect, paving the way for Phase 3 studies [7][9] - Enrollment in the global pivotal Sonata HCM study of sotagliflozin is on track, with expectations for all Phase III sites to be operational by Q3 2025 [13][18] Market Data and Key Metrics Changes - Approximately 9 million people in the U.S. are currently affected by diabetic peripheral neuropathic pain (DPNP), with projections to grow to 13 million by 2035 [10] - In the U.S., there are over 1 million people with hypertrophic cardiomyopathy (HCM), with a significant portion having non-obstructive HCM [14] Company Strategy and Development Direction - The company is focused on advancing its R&D programs and has restructured its cost base to support this pivot [7][8] - The partnership with Novo Nordisk is seen as a validation of the science behind LX9851 and aims to maximize its market potential [6][20] - The company is committed to advancing pilavapitan for DPNP and sotagliflozin for HCM, with plans for further regulatory engagement and data presentations [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pilavapitan to be the first novel oral non-opioid DPNP medication in over two decades, highlighting the significant unmet need in this market [9][11] - The company anticipates stable U.S. MPEFA revenues despite limited promotional activity and expects lower cash usage in subsequent quarters [26][27] - Management is optimistic about the upcoming catalysts and the potential for new partnerships to enhance the value of its pipeline [28][30] Other Important Information - The company has revised its operating expense guidance for 2025, expecting total operating expenses between $135 million and $145 million [27] - The partnership with Beatrice for sotagliflozin includes a $25 million upfront payment and potential milestone payments of up to $200 million [21] Q&A Session Summary Question: Can you discuss the intended trial designs for the pain program? - The plan is to run two parallel trials with similar designs, one U.S.-only and the other worldwide, with approximately 300-350 patients per arm [34] Question: How are the IND enabling studies for LX9851 progressing? - The IND enabling studies are on track for completion this year, with a strong collaborative relationship with Novo Nordisk [43] Question: Is the end of Phase II meeting a gating factor for strategic discussions? - It is not seen as a gating factor; discussions with strategic partners will continue concurrently [52] Question: What additional data will be presented at medical meetings? - Additional detail on secondary analyses related to pain quality and functionality will be shared, along with pharmacokinetic data [55] Question: How is the Sonata trial designed to create a homogeneous population? - The trial focuses on symptomatic disease, which is reflective of diastolic dysfunction, and is powered for both obstructive and non-obstructive HCM [59][66]