Lexicon Pharmaceuticals(LXRX) - 2024 Q3 - Quarterly Report

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]