Sage Therapeutics(US:SAGE)2021-08-03 19:00Financial Data and Key Metrics Changes - The company recorded $1.6 million in net revenue for Q2 2021 from ZULRESSO sales, an increase from $1.1 million in Q2 2020 [33] - Selling, general and administrative expenses rose to $43.3 million in Q2 2021 from $38.2 million in the same period of 2020 [34] - Research and development expenses decreased to $66.2 million in Q2 2021 from $73.3 million in Q2 2020, reflecting a reduction due to reimbursements from Biogen [35] - The net loss for Q2 2021 was $107.2 million, improved from a net loss of $136.3 million in Q2 2020 [35] - The company expects to end 2021 with a cash balance of over $1.7 billion [37] Business Line Data and Key Metrics Changes - The depression franchise, led by zuranolone, has shown consistent and differentiated data, with positive outcomes in pivotal studies [22][23] - The neurology franchise, led by SAGE-324, reported a 36% reduction in upper tremor amplitude from baseline in a recent study [27] - The neuropsych franchise is advancing SAGE-718, which has shown positive impacts on cognitive function in Parkinson's disease patients [30] Market Data and Key Metrics Changes - The company highlighted the increasing rates of depression, with over 19 million adults in the U.S. experiencing at least one major depressive episode annually [15] - The COVID-19 pandemic has exacerbated depressive symptoms, indicating a growing need for effective treatments [15] Company Strategy and Development Direction - The company aims to become a leader in brain health and a top-tier biopharmaceutical company by focusing on innovative treatments for brain disorders [7] - There is a strong emphasis on building a best-in-class commercialization program for zuranolone to meet patient needs [16] - The company is committed to expanding its pipeline and accelerating development across its three franchises [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory path for zuranolone, citing sufficient efficacy data for filing an NDA [41][44] - The company is optimistic about the potential of zuranolone to revolutionize depression treatment with rapid onset and sustained effects [51] - Management acknowledged the challenges posed by the pandemic but remains focused on advancing their pipeline and achieving key milestones [31] Other Important Information - The company announced the termination of the Phase III study evaluating brexanolone for COVID-19-related ARDS due to enrollment issues [31] - Ongoing studies are expected to provide additional data to support the efficacy and safety of zuranolone [25] Q&A Session Summary Question: Clarification on regulatory strategy and study terminations - Management confirmed that sufficient efficacy data exists for filing and that the termination of certain studies will not hinder the NDA filing process [41][42] Question: Additional steps for Phase II dose-ranging study for SAGE-324 - Management indicated that they are working with Biogen to finalize the design of the next dose-frequency study [46][47] Question: Investor feedback on WATERFALL readout - Management noted positive feedback indicating a paradigm shift in depression treatment, emphasizing the rapid efficacy of zuranolone [50][51] Question: Discontinued RAINFOREST study and sleep benefits - Management reassured that existing data indicates improvements in sleep patterns among patients, which will be communicated during label negotiations [60][61] Question: SHORELINE study patient data - Management reported that over 500 patients are currently enrolled in the SHORELINE study, with high retention rates and positive response metrics [66][67]