Core Insights - Lexicon Pharmaceuticals has elected Ivan H. Cheung to its Board of Directors, marking a significant moment in the company's history [1][4] - Mr. Cheung brings over 25 years of experience in the healthcare industry and has a strong track record in shareholder value creation [2][3] - The appointment coincides with the retirement of Robert J. Lefkowitz, who served on the board for 23 years [4][5] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has commercially launched INPEFA® (sotagliflozin) in the United States and has a pipeline of drug candidates in various stages of development for conditions such as neuropathic pain, diabetes, and metabolism [5]

Financial Performance - Revenues for the three months ended September 30, 2024, were approximately $1.8 million, a significant increase from $0.2 million in the same period in 2023, and for the nine months ended September 30, 2024, revenues were $4.5 million compared to $0.5 million in 2023, primarily driven by sales of INPEFA[67] - The net loss for the three months ended September 30, 2024, was $64.8 million, or $0.18 per share, compared to a net loss of $50.5 million, or $0.21 per share, in the same period in 2023[81] - The company reported a net loss of $166.6 million for the nine months ended September 30, 2024, which included non-cash charges of $6.9 million related to stock-based compensation[89] Expenses - Research and development expenses for the three months ended September 30, 2024, increased by 47% to $25.8 million from $17.6 million in 2023, and for the nine months, they rose by 31% to $57.8 million from $44.1 million[69] - Selling, general and administrative expenses for the three months ended September 30, 2024, increased by 23% to $39.6 million from $32.2 million in 2023, and for the nine months, they rose by 36% to $110.8 million from $81.4 million[74] - Interest and other expenses increased to $4.6 million for the three months ended September 30, 2024, from $3.9 million in 2023, reflecting additional borrowing under the Oxford Term Loans[79] Cash and Funding - As of September 30, 2024, the company had $258.4 million in cash, cash equivalents, and short-term investments, compared to $170.0 million as of December 31, 2023[89] - The company entered into a loan and security agreement with Oxford providing up to $150 million in borrowing capacity, with $100 million funded under the first three tranches as of September 30, 2024[84] - The company is required to maintain a minimum unrestricted cash and investments balance of $10 million until specified net sales are achieved, increasing to $25 million upon funding of the fourth tranche[85] Future Outlook - The company expects to continue incurring significant research and development costs and selling, general and administrative expenses, necessitating higher revenues to achieve profitability[65] - The company expects to continue substantial capital resources for the commercialization of INPEFA and the launch of ZYNQUISTA, with current cash and investment balances projected to fund operations for at least the next 12 months[93] - Future capital requirements will depend on the success of commercialization efforts and ongoing research and development, with potential needs for additional liquidity through collaborations or equity sales[92] Product Development - The company is commercializing INPEFA (sotagliflozin) in the U.S. to reduce cardiovascular risks in adults with heart failure or type 2 diabetes[55] - The company is pursuing regulatory approval for ZYNQUISTA™ (sotagliflozin) for type 1 diabetes, with a New Drug Application currently under review by the FDA, expected to be completed by December 20, 2024[56] - Research and development efforts include ongoing Phase 3 trials for sotagliflozin in hypertrophic cardiomyopathy and Phase 2b trials for LX9211 in diabetic peripheral neuropathic pain[57][58] - An exclusive license agreement with Viatris was signed for the development of sotagliflozin, resulting in an upfront payment of $25 million[88] - Upon regulatory approval of sotagliflozin, the company will make royalty payments totaling $4.5 million in three annual installments[90] Market and Currency Exposure - The company has operated primarily in the U.S., with all sales made in U.S. dollars, resulting in no material exposure to foreign currency fluctuations[97] Accumulated Deficit - The company has an accumulated deficit of $1.9 billion as of September 30, 2024, primarily due to research and development costs and selling, general and administrative expenses[65]

3Q24 Earnings Presentation ‹#› Forward-Looking Statements • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of INPEFA® (sotagliflozin), ZYNQUISTA™ (sotagliflozin ...

Financial Data and Key Metrics Changes - The company reported revenues of $1.8 million for Q3 2024, primarily from net sales of INPEFA, with a net loss of $64.8 million, or $0.18 per share, compared to a net loss of $50.5 million, or $0.21 per share, in the same period last year [35][36] - R&D expenses increased to $25.8 million from $17.6 million year-over-year, driven by investments in late-stage development programs [35] - Selling, general, and administrative expenses rose to $39.6 million from $32.2 million, reflecting higher marketing costs and severance costs due to a strategic repositioning [36] Business Line Data and Key Metrics Changes - INPEFA net sales for Q3 2024 were $1.7 million, representing an 8% quarter-on-quarter growth, with year-to-date sales of $4.5 million [18] - The filled TRx volumes for INPEFA improved, with gross unit volume increasing by 26%, despite a 50% reduction in the field force [19] Market Data and Key Metrics Changes - The company noted that 80% of patients with T1D and CKD are treated by a concentrated group of approximately 4,000 endocrinologists, allowing for significant impact with the existing field team [16] - Approximately 50% of lives are covered in the U.S. for INPEFA, with many patients requiring prior authorization or to try other SGLT-2 inhibitors before being prescribed [68] Company Strategy and Development Direction - The company is focusing on the commercial launch of ZYNQUISTA and has completed a strategic repositioning to promote INPEFA to targeted high prescribers [9][11] - A licensing agreement was established with Viatris for sotagliflozin outside the U.S. and Europe, indicating a renewed emphasis on business development and partnerships [11][40] - The company is preparing for multiple outcome scenarios as it approaches the PDUFA date for ZYNQUISTA on December 20, 2024 [14][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for ZYNQUISTA to address unmet needs in the T1D and CKD population, despite challenges faced during the FDA advisory committee meeting [12][13] - The company anticipates top-line data for LX9211 in the first quarter of 2025, with a focus on redefining the standard of care in diabetic peripheral neuropathic pain [25][27] - Management highlighted the importance of the upcoming IND filing for LX9851 by mid-2025, emphasizing its potential in obesity and associated cardiometabolic disorders [43][72] Other Important Information - The company ended the quarter with $258.4 million in cash and investments, excluding the $25 million upfront payment from the licensing agreement with Viatris [34] - The company is actively discussing potential partnerships for LX9211 and LX9851 to realize their full value and potential [41][72] Q&A Session Summary Question: Confidence in receiving a skinnier label for ZYNQUISTA - Management remains engaged with the FDA and is committed to the December 20 target date, but further comments would be premature [46] Question: Expectations for pain program efficacy - Management hopes for better efficacy based on intent-to-treat analysis and improved tolerability compared to previous studies [49] Question: Data on pain program efficacy and safety - Limited blinded data is available, focusing on safety and overall results regarding dropouts and tolerability [51] Question: Alignment with FDA on HCM trial endpoints - Management feels confident in the KCCQ primary endpoint and has discussed it with the FDA prior to trial initiation [53] Question: INPEFA trajectory and investment levels - Modest growth is anticipated for INPEFA, with ongoing engagement with payers and a focus on increasing prescriber depth [68] Question: Future partnerships and prioritization - The company is prioritizing partnerships for LX9211 and LX9851, with a focus on realizing their commercial opportunities [72]

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -5.88%. A quarter ago, it was expected that this drugmaker would post a loss of $0.18 per share when it actually produced a loss of $0.17, delivering a surprise of 5.56%.Over the last four quarters, the company has ...

Exhibit 99.1 LEXICON PHARMACEUTICALS REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe Completed ZYNQUISTA™ FDA Advisory Committee Meeting; PDUFA Goal Date December 20, 2024 Concluded Enrollment Screening For Phase 2b PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP); Topline Data Expected in Q1 2025 Executed Repositioning of INPEFA (sotagliflozin ...

Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe Completed ZYNQUISTA™ FDA Advisory Committee Meeting; PDUFA Goal Date December 20, 2024 Concluded Enrollment Screening For Phase 2b PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP); Topline Data Expected in Q1 2025 Executed Repositioning of INPEFA® (sotagliflozin); Net Sales of $1.7 Million in Q3 2024 Conference Call and Webcast at 5:00pm ET THE WOODLANDS, Texas, Nov. 12 ...

People with T1D and CKD treated with sotagliflozin and insulin had similar lowering effects on glycated hemoglobin (HbA1c), the primary endpoint, as people with T1D who do not have CKD Sotagliflozin was associated with a lower to neutral risk of severe hypoglycemia and did not significantly increase the risk of diabetic ketoacidosis (DKA) among a small number of DKA events THE WOODLANDS, Texas, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the peer-reviewed J ...

THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted ...

THE WOODLANDS, Texas, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Jeff Wade, president and chief operating officer, has decided to step down to pursue new opportunities outside of Lexicon, effective September 30, 2024. A search for a new chief financial officer is ongoing. For the past 25 years, Mr. Wade has served in a series of finance, corporate development, administrative and legal leadership positions at Lexicon, serving most recently as presiden ...