Sage Therapeutics(US:SAGE)2022-05-03 17:54Financial Data and Key Metrics Changes - The net loss for Q1 2022 was $122.1 million, with cash, cash equivalents, and marketable securities totaling $1.6 billion at the end of the quarter [54] - R&D expenses increased to $78 million in Q1 2022 from $58.1 million in the same period of 2021, driven by advancements in the pipeline beyond zuranolone [54] - SG&A expenses rose to $46.5 million in Q1 2022 compared to $39.8 million in Q1 2021, primarily due to hiring for ongoing activities in anticipation of future product launches [56] Business Line Data and Key Metrics Changes - The depression franchise is advancing with the rolling NDA submission for zuranolone in MDD, supported by six positive clinical trials [31][32] - The neuropsych franchise, led by SAGE-718, is progressing with six ongoing and planned Phase II studies targeting cognitive disorders [26][28] - The neurology franchise, led by SAGE-324, has initiated the Phase 2b KINETIC 2 study for essential tremor [51][52] Market Data and Key Metrics Changes - The prevalence of depression has increased significantly, with a three to fourfold rise in symptoms since the COVID-19 pandemic began [12] - Approximately one in eight mothers in the U.S. report experiencing symptoms of postpartum depression (PPD) each year, highlighting a substantial market need [13] Company Strategy and Development Direction - The company aims to become a leader in brain health and a top-tier biopharmaceutical company, focusing on innovative treatments for MDD and PPD [8][9] - There is a commitment to pioneering solutions for brain health, with a focus on partnerships with stakeholders to prepare for the market launch of zuranolone [18][19] - The strategy includes a fit-for-purpose launch for zuranolone, emphasizing data-driven insights and stakeholder engagement [19] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing brain health pandemic and the urgent need for novel therapies in mental health [8][10] - The company is optimistic about the potential of zuranolone to address unmet needs in treating MDD and PPD, with plans for NDA submissions in 2022 and early 2023 [15][33] - Management expressed confidence in the progress made across the pipeline and the potential for long-term value creation for patients and stakeholders [54][59] Other Important Information - The company recorded $20 million in reimbursement from Biogen related to their collaboration, which supports ongoing investments in their pipeline [57] - The company anticipates having approximately $1.3 billion in cash, cash equivalents, and marketable securities by the end of 2022, supporting operations into 2025 [58] Q&A Session Summary Question: Clinical rationale for extending the eligible window for SKYLARK study - Management explained that extending the window to 12 months allows for a wider patient enrollment without significantly changing the population characteristics [61][63] Question: Safety profile for zuranolone regarding somnolence - Management indicated that somnolence rates are dose-dependent, with low to high teens percentages observed, and noted that some degree of somnolence could be beneficial for patients with sleep challenges [68][71][72] Question: Physician feedback on SAGE-718 at AAN - Feedback was overwhelmingly positive, with excitement about the potential impact of SAGE-718 on patients suffering from cognitive impairment due to various neurological conditions [75][78] Question: Differences in trial design for SAGE-718 studies - Management highlighted that the PRECEDENT study is a placebo-controlled study with a longer dosing duration compared to earlier studies, designed to provide more robust data [83][85] Question: Rolling submission for zuranolone and labeling considerations - Management discussed the NDA rolling submission process and indicated that discussions with the FDA will focus on the treatment of MDD and PPD, with ongoing evaluations of potential labeling specifics [89][91]