Lexicon Pharmaceuticals(LXRX) - 2019 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q1 2019, total revenues were $9.2 million, down from $25.4 million in the prior-year period, primarily due to lower revenue from collaboration with Sanofi [30] - Net loss for Q1 2019 was $21.8 million or $0.21 per share, compared to a net loss of $41.8 million or $0.40 per share in the same period last year [33] - Cash and short-term investments at the end of Q1 2019 were approximately $133 million, down from $160.1 million as of December 31, 2018 [34] Business Line Data and Key Metrics Changes - US net sales of XERMELO reached $6.7 million in Q1 2019, representing a 24% increase from the same period in 2018 [14] - Research and development expenses decreased to $12 million from $47.7 million in the prior-year period, mainly due to lower external clinical development costs related to sotagliflozin [31] - Selling, general and administrative expenses were $14.1 million in Q1 2019, down from $14.9 million in the same period last year [32] Market Data and Key Metrics Changes - The approval of sotagliflozin in Type I diabetes in Europe marks the second product from the company's labs approved in a major region within 26 months [15] - The first Phase III study results for sotagliflozin in Type II diabetes are expected to be released in the current quarter [16] Company Strategy and Development Direction - The company aims to continue executing its growth strategy focused on the XERMELO business and advancing its pipeline for long-term sustainability [18] - The company is committed to exploring the therapeutic utility of telotristat ethyl in biliary tract cancer and advancing LX9211 for neuropathic pain [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of XERMELO, expecting 20% or greater growth in US net sales year-over-year [14][36] - The company is well-capitalized to execute its business growth, with a focus on managing resources effectively [17][35] Other Important Information - The company has concluded major Phase III investments in Type I diabetes and is nearing significant milestones for sotagliflozin in Type II diabetes [18] - The anticipated operating expenses for 2019 have been revised to a range of $115 million to $135 million, down from $120 million to $140 million [38] Q&A Session Summary Question: Anticipation of next steps after FDA interactions on Type I diabetes - Management indicated that they still anticipate data release for Type II diabetes this quarter but could not provide a specific timeline for FDA interactions [46][47] Question: Key endpoints for Phase III studies in Type II diabetes - Management highlighted renal impairment studies and a direct comparison with empagliflozin as key areas of focus [50][51] Question: Differentiation of sotagliflozin versus CREDENCE study conclusions - Management noted that A1C reduction will be a key differentiator, alongside renal and hemodynamic effects [59][60] Question: Updates on early-stage pipeline for neuropathic pain - The company is considering diabetic neuropathy as a lead indication for Phase II studies but has not finalized other indications yet [55] Question: Metrics around XERMELO in Q1 2019 - The company reported 104 new patient starts and a 17% growth in TRX for XERMELO in the first quarter [79]