Group 1 - Lexicon Pharmaceuticals will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference on June 5 at 12:50 p.m. ET [1] - The event will be accessible live and as a replay on the Company's website [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The Genome5000™ program has enabled Lexicon to study nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential [2] - The company has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development for conditions such as heart failure, neuropathic pain, obesity, cardiology, and diabetes [2]

Financial Data and Key Metrics Changes - The company reported approximately $195 million in cash and investments as of the end of March [3] - In Q1, the company generated about $1.4 million in sales for its heart failure drug, Impefa, maintaining sales levels from previous quarters despite a scaled-down commercial footprint [20] Business Line Data and Key Metrics Changes - The Phase 2b PROGRESS study for pilovaparin demonstrated that the 10 mg daily dose outperformed the 20 mg dose, supporting its efficacy for diabetic peripheral neuropathic pain [12] - The company has seen no sales growth for Impefa this year but expects to maintain sales in the U.S. while pursuing regulatory approvals in other countries [20][21] Market Data and Key Metrics Changes - There are approximately 9 million people in the U.S. diagnosed with diabetic peripheral neuropathic pain, indicating a significant market opportunity for new treatments [5] - The company is actively pursuing regulatory approvals in the UAE, Saudi Arabia, and Canada for Impefa, which could lead to meaningful sales growth outside the U.S. [21] Company Strategy and Development Direction - The company is focusing on partnerships to enhance the development and commercialization of its assets, particularly pilovaparin, which has potential for multiple indications [17] - The company aims to maintain its presence in the market for Impefa while building evidence for its efficacy through ongoing studies [22] Management's Comments on Operating Environment and Future Outlook - Management highlighted the desperate need for new non-opioid treatments in the context of the opioid crisis, particularly for diabetic peripheral neuropathic pain [6] - The company is optimistic about the upcoming catalysts, including data presentations and regulatory meetings, which are expected to drive value for its development pipeline [45] Other Important Information - The company has entered into a partnership with Novo Nordisk for its obesity asset, receiving $75 million in upfront payments and potential future milestones totaling up to $1 billion [38] - The SONata HCM clinical trial for sotagliflozin is designed to include both obstructive and nonobstructive hypertrophic cardiomyopathy, with regulatory approvals obtained in 20 countries [33][34] Q&A Session Summary Question: Can you provide insights on pilovaparin's next regulatory steps? - The company plans to present data from the Phase 2b study at major medical meetings and will have an end-of-Phase 2 meeting with the FDA to finalize Phase 3 designs [14][15] Question: What are the commercial prospects for soragliflozin? - The company has maintained sales of Impefa in the U.S. and is pursuing regulatory approvals in other countries, expecting meaningful sales growth as these approvals are granted [20][21] Question: What is the rationale for evaluating sotagliflozin in both forms of HCM? - The underlying pathophysiology of HCM is similar in both obstructive and nonobstructive forms, making sotagliflozin a promising candidate for treatment [24][25] Question: How is the partnership with Novo Nordisk structured? - The partnership allows Novo to take over the IND submission process after Lexicon completes the IND enabling studies, which are expected to be finished this year [41][42]

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 Performance - Revenues for Q1 2025 were approximately $1.3 million, up from $1.1 million in Q1 2024, primarily from sales of INPEFA[79]. - Research and development expenses increased by 6% to $15.3 million in Q1 2025 from $14.4 million in Q1 2024, driven by a 12% rise in third-party services[81]. - Selling, general and administrative expenses decreased by 64% to $11.6 million in Q1 2025 from $32.1 million in Q1 2024[82]. - 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, in Q1 2024[86]. - The company had an accumulated deficit of approximately $2.0 billion as of March 31, 2025[77]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $194.8 million as of March 31, 2025, down from $238.0 million at the end of 2024[90]. - Current unrestricted cash and investments amount to approximately $194.8 million as of March 31, 2025, sufficient to fund operations for at least the next 12 months[101]. - The company has approximately $194.8 million in cash and cash equivalents, with limited market and credit risk exposure[104]. Debt and Financing - The company entered into an Open Market Sale Agreement with Jefferies LLC for the potential sale of up to $75 million in common stock[91]. - A seventh amendment to the loan agreement with Oxford included a prepayment of $45 million and modifications to financial covenants[92]. - The company repaid $45 million to Oxford in April 2025, with additional payments of $20.2 million, $30.2 million, and $11.6 million due in the fiscal years ending December 31, 2027, 2028, and 2029 respectively[93]. - As of March 31, 2025, the company maintained a minimum cash balance of $29 million in a blocked account, in compliance with its debt covenants[94]. - The outstanding Oxford Term Loans bear interest at a floating rate tied to the 1-month CME Term SOFR rate, maturing by March 2029[105]. - If liquidity needs arise, the company may seek additional financing through collaborations or selling equity, which could dilute stockholder value[102]. Regulatory and Collaboration Updates - The company received Fast Track designation from the FDA for pilavapadin in diabetic peripheral neuropathic pain[74]. - The company is pursuing regulatory approval for ZYNQUISTA (sotagliflozin) for type 1 diabetes, with ongoing proceedings related to its NDA[70]. - The company entered into an exclusive license agreement with Novo Nordisk A/S in March 2025, receiving an upfront payment of $45 million and potential milestone payments totaling up to $960 million[95]. - An exclusive license agreement with Viatris for the development of sotagliflozin resulted in an upfront payment of $25 million in October 2024[96]. - Upon regulatory approval of sotagliflozin, the company will make royalty payments totaling $4.5 million in three annual installments of $1.5 million[97]. Future Outlook - The company expects substantial future capital requirements, influenced by ongoing R&D success and new collaborations[100].

Group 1 - Lexicon Pharmaceuticals reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.10, and an improvement from a loss of $0.20 per share a year ago, resulting in an earnings surprise of 30% [1] - The company posted revenues of $1.26 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 23.52%, compared to year-ago revenues of $1.13 million [2] - Lexicon shares have declined approximately 8.8% since the beginning of the year, while the S&P 500 has seen a decline of -0.6% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.09 on revenues of $2.37 million, and for the current fiscal year, it is -$0.37 on revenues of $15.43 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 35% of over 250 Zacks industries, indicating a favorable outlook for the industry [8] - Lexicon has a Zacks Rank of 2 (Buy), suggesting that the stock is expected to outperform the market in the near future [6]

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]

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 costs associated with late-stage development programs [26] - Selling, general, and administrative expenses decreased significantly to $11.6 million from $32.1 million, primarily due to strategic repositioning efforts [26] - 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 [26] - Cash and short-term investments at the end of Q1 2025 were $194.8 million, down from $238 million at the end of 2024 [27] 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 [6][20] - The Phase 2b study of pilavapitan showed a well-tolerated dose with clear evidence of effect, paving the way for Phase 3 studies [7][10] - 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 [19][31] 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 rise to 13 million by 2035 [11] - 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 [8] - The partnership with Novo Nordisk is seen as a validation of the science behind LX9851 and aims to maximize its market potential [5][20] - The company is committed to developing pilavapitan as a novel oral treatment for DPNP, addressing a significant unmet need in the market [13] 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 need for new treatment options [10][12] - The company anticipates sharing full data from the PROGRESS study in Q3 and is preparing for an end-of-Phase II meeting with the FDA [30][31] - Management emphasized the importance of focusing on areas with significant unmet needs and leveraging partnerships to enhance the value of their assets [29] Other Important Information - The company expects stable U.S. MPEFA revenues despite limited promotional activity and has reiterated its operating expense guidance for 2025 [27][28] - The company is actively engaging in discussions with potential partners for pilavapitan to unlock its global value across multiple indications [23] 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 [36] Question: How are the IND enabling studies for LX9851 progressing? - The IND enabling studies are on track for completion this year, with strong collaboration with Novo Nordisk [44] Question: Will the end of Phase II meeting be a gating factor for strategic discussions? - It is not seen as a gating factor; discussions 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 [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 to see effects in both obstructive and non-obstructive HCM [60][62]

Financial Performance - Revenues for Q1 2025 increased to $1.3 million from $1.1 million in Q1 2024, representing an increase of approximately 18.6%[9] - 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, in Q1 2024[11] - Cash and investments as of March 31, 2025, totaled $194.8 million, down from $238.0 million as of December 31, 2024[12] Research and Development - Research and Development (R&D) expenses rose to $15.3 million in Q1 2025 from $14.4 million in Q1 2024, reflecting continued investment in clinical trials[9] - The Phase 2b PROGRESS study confirmed the 10 mg dose of pilavapadin for advancement into Phase 3 development for diabetic peripheral neuropathic pain[3] - Enrollment is underway for the SONATA Phase 3 study of sotagliflozin, targeting 500 patients with hypertrophic cardiomyopathy[13] - Lexicon plans to build on the evidence of sotagliflozin for heart failure and drive enrollment in the SONATA-HCM study in 2025[3] Operational Efficiency - Selling, General and Administrative (SG&A) expenses decreased significantly to $11.6 million in Q1 2025 from $32.1 million in Q1 2024, a reduction of approximately 63.8%[10] - The company aims to optimize operational spending in 2025, achieving a reduction in total operating expenses of approximately 40%[3] Strategic Partnerships - Lexicon entered an exclusive licensing agreement with Novo Nordisk for LX9851, potentially worth up to $1 billion in milestone payments, including $75 million in upfront payments[7]

Core Insights - Lexicon Pharmaceuticals has made significant progress in 2025, focusing on R&D and achieving key milestones, including an exclusive licensing agreement with Novo Nordisk for LX9851 and positive results from the Phase 2b PROGRESS study for pilavapadin [1][3][4] Financial Performance - Revenues for Q1 2025 increased to $1.3 million from $1.1 million in Q1 2024, primarily driven by product sales of INPEFA® (sotagliflozin) [9] - Research and development expenses rose to $15.3 million in Q1 2025 from $14.4 million in Q1 2024, reflecting ongoing investments in clinical trials [10] - Selling, general and administrative expenses decreased significantly to $11.6 million in Q1 2025 from $32.1 million in Q1 2024 due to strategic repositioning and reduced marketing efforts [11] - 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, in Q1 2024 [12] Pipeline Developments - Pilavapadin (LX9211) is advancing towards Phase 3 development for diabetic peripheral neuropathic pain (DPNP), with the 10 mg dose showing meaningful pain reduction in the Phase 2b PROGRESS study [7][4] - LX9851, a novel oral candidate for obesity, is in preclinical development, with Lexicon eligible for up to $1 billion in milestone payments from Novo Nordisk [7][3] - The SONATA-HCM study for sotagliflozin in hypertrophic cardiomyopathy (HCM) is underway, targeting 500 patient enrollments [6][7] Cash Position - As of March 31, 2025, Lexicon had $194.8 million in cash and investments, down from $238.0 million at the end of 2024, partly due to severance payments related to strategic changes [13][20]

Group 1 - Lexicon Pharmaceuticals will participate in a fireside chat at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at 9:30 a.m. ET [1] - The event will be accessible live and as a replay on the company's website [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The company has developed a unique genomics target discovery platform called Genome5000™, studying nearly 5,000 genes and identifying over 100 protein targets with therapeutic potential [2] - Lexicon has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development for conditions such as heart failure, neuropathic pain, obesity, cardiology, and diabetes [2]