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]

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 ...

Financial Performance - Lexicon Pharmaceuticals reported Q3 2024 revenues of $1.8 million, a significant increase from $0.2 million in Q3 2023, primarily driven by product sales of INPEFA[10] - The company achieved net sales of $1.7 million for INPEFA in Q3 2024, with an 18% increase in active prescribers[6] - Lexicon reported a net loss of $64.8 million, or $0.18 per share, in Q3 2024, compared to a net loss of $50.5 million, or $0.21 per share, in Q3 2023[13] - Selling, general and administrative expenses increased to $39.6 million in Q3 2024, compared to $32.2 million in Q3 2023, reflecting higher marketing costs and severance expenses[12] - Research and development expenses rose to $25.8 million in Q3 2024, up from $17.6 million in Q3 2023, due to investments in clinical trials[11] - The company has $258.4 million in cash and investments as of September 30, 2024, up from $170.0 million at the end of 2023[14] Product Development and Regulatory Updates - An exclusive licensing agreement with Viatris for sotagliflozin was announced, including a $25 million upfront payment and potential additional milestones of $197 million[3] - Topline data from the Phase 2b PROGRESS study of LX9211 is expected in Q1 2025[8] - The PDUFA target action date for ZYNQUISTA is set for December 20, 2024, following a recent FDA Advisory Committee meeting[4] - The company is conducting a pivotal Phase 3 study (SONATA) for sotagliflozin in hypertrophic cardiomyopathy (HCM) with a target enrollment of 500 patients[7] Safety and Efficacy Concerns - INPEFA may increase the risk of hypoglycemia when combined with insulin or insulin secretagogues, necessitating a lower dose of these medications[26] - Reports of Fournier's Gangrene have been identified in patients with diabetes receiving SGLT2 inhibitors, requiring immediate treatment and monitoring[27] - INPEFA increases the risk of genital mycotic infections, which should be monitored and treated appropriately[28] - Co-administration of INPEFA 400 mg with digoxin increases digoxin exposure, requiring appropriate patient monitoring[29] - INPEFA is not recommended during the second and third trimesters of pregnancy or while breastfeeding[30] - Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension[30] - INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and showed a consistent safety profile across eGFR subgroups[30] - There was an increase in volume-related adverse events in patients with eGFR < 30 mL/min/1.73 m² compared to the overall safety population[30] - INPEFA is not recommended in patients with moderate or severe hepatic impairment[30] - Urinary glucose tests are not reliable for patients taking SGLT2 inhibitors; alternative testing methods should be used[28]

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 ...

Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin TIR measures approach target set by American Diabetes Association Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated tha ...

THE WOODLANDS, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Lexicon management will participate in the following investor conferences taking place in September: H.C. Wainwright 26th Annual Global Investment Conference – Tuesday, September 10, 2024 at 12:30pm ET 2024 Cantor Fitzgerald Global Healthcare Conference – Tuesday, September 17, 2024 at 8:35am ET A simultaneous webcast for these events will be available in the "Events" section of the Lex ...