Lexicon Pharmaceuticals(LXRX) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2022 with $136.2 million in cash and investments, including net proceeds of $94.3 million from a public offering and private placement [29] - Research and development expenses decreased to $10.6 million from $15.7 million in Q3 2021, primarily due to lower external clinical research expenses [32] - Selling, general and administrative expenses increased to $12.6 million from $7.3 million in Q3 2021, mainly due to increased personnel and external expenses related to the commercial launch preparations [33] - The net loss for Q3 2022 was $23.4 million, or $0.13 per share, compared to a net loss of $23.1 million, or $0.16 per share, in Q3 2021 [33] Business Line Data and Key Metrics Changes - The company is actively developing two lead programs: sotagliflozin for heart failure and LX9211 for neuropathic pain [8] - Sotagliflozin is positioned to enter the heart failure market, with a PDUFA target action date anticipated in May 2023 [9] - LX9211 has shown positive top-line results in a Phase II proof-of-concept study for painful diabetic neuropathy, with final data to be presented at an upcoming summit [10][27] Market Data and Key Metrics Changes - Over 6 million people in the U.S. are living with heart failure, with about 1 million new cases diagnosed each year, indicating a large and growing market [11] - Heart failure is the leading cause of hospitalization for Americans over 65, with approximately 1 million hospitalizations annually [12] Company Strategy and Development Direction - The company aims to differentiate sotagliflozin in the heart failure market through unique data from the SOLOIST-WHF trial, which demonstrated significant effects on reducing cardiovascular mortality and hospital readmissions [9][18] - The company is exploring potential partnerships for LX9211 to advance its development and is engaged in discussions to find a strategic fit [26][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming regulatory review for sotagliflozin, noting no significant issues were raised during the mid-cycle review meeting with the FDA [8][37] - The company anticipates launching sotagliflozin in the U.S. in the first half of 2023, contingent on regulatory approval [66] Other Important Information - The company has been granted fast track designation by the FDA for LX9211 in diabetic peripheral neuropathic pain [20] - The final results of the RELIEF-DPN trial will be presented at the 16th Annual Pain Therapeutic Summit, providing further insights into the efficacy of LX9211 [27] Q&A Session Summary Question: Did the FDA request additional data during the mid-cycle review? - Management confirmed that the FDA did not request any new data, indicating a comprehensive submission package [37] Question: Can you elaborate on the potential unique label for sotagliflozin? - Management indicated confidence in obtaining label elements for recent worsening heart failure, as this was the population studied in the SOLOIST trial [39] Question: What differentiates sotagliflozin from other SGLT2 inhibitors? - Management highlighted that other SGLT2 data did not show significant separation until 90 days, while sotagliflozin demonstrated a 52% reduction in all-cause death or heart failure-related events at 90 days [50] Question: What are the plans for LX9211 beyond diabetic neuropathy? - Management noted that preclinical data supports exploring other types of neuropathic pain and potential applications in spasticity [61]