Sage Therapeutics(US:SAGE)2021-11-02 19:05Financial Data and Key Metrics Changes - The company recorded $1.4 million in net revenue for Q3 2021 from the sale of ZULRESSO, a decrease from $1.6 million in the same period of 2020 [57] - Research and development expenses increased to $83.5 million in Q3 2021 from $74.1 million in Q3 2020, reflecting planned expansion of the pipeline [59] - Selling, general and administrative expenses rose to $48.7 million in Q3 2021 compared to $35.1 million in Q3 2020, driven by increased hiring and launch readiness activities [60] - The net loss for Q3 2021 was $130.2 million, including $34 million of non-cash stock-based compensation, compared to a net loss of $105.7 million in Q3 2020 [61] - The company expects to have a cash balance of more than $1.7 billion at the end of 2021 [62] Business Line Data and Key Metrics Changes - The zuranolone program has shown significant clinical progress, with four positive studies supporting the NDA filing [9][11] - The company is preparing to initiate a Phase 2 dose-ranging study for SAGE-324, which is aimed at treating essential tremor and other neurological disorders [21][45] - SAGE-718 received fast track designation for Huntington's disease, with plans for a Phase 2 study in early to moderate Huntington's disease expected to begin this year [22][50] Market Data and Key Metrics Changes - The MDD market is estimated to have 19 million sufferers annually, indicating a significant opportunity for zuranolone if approved [36] - The company is actively engaging with key opinion leaders (KOLs) to discuss the potential of zuranolone in clinical practice [18] Company Strategy and Development Direction - The company aims to submit an NDA for zuranolone in MDD in the second half of 2022 and for PPD in the first half of 2023 [9] - The strategic focus is on building a robust data package to support the launch of zuranolone and to educate physicians on its use [19][36] - The company is expanding its neurology franchise with SAGE-324 and SAGE-718, targeting significant unmet needs in neurological disorders [20][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to execute on strategic goals and become a leader in brain health [31] - The management highlighted the importance of rapid relief of depressive symptoms as a key differentiator for zuranolone compared to traditional antidepressants [19][114] - The company is optimistic about the potential of its pipeline and the impact it can have on patients suffering from brain health disorders [55] Other Important Information - The company announced the departure of its Chief Medical Officer, Steve Kanes, who will pursue a CEO role at a private biotech company [28] - The company welcomed new executives to its leadership team, indicating a focus on strengthening its organizational capabilities [26] Q&A Session Summary Question: About the CORAL primary endpoint change - Management confirmed that the change was driven by feedback from the FDA to demonstrate rapid relief of depressive symptoms early in clinical trials [66][67] Question: Importance of seeing a separation from placebo at later time points - Management emphasized that the totality of data across multiple studies will be important for physicians, rather than focusing on individual studies [73] Question: Final sample size of CORAL and FDA conversations - Management indicated that statistical significance at later time points is not required, focusing instead on consistent and durable impact [81][84] Question: Day 3 placebo responses and filing data - Management explained that the day 3 data will be beneficial for educating physicians about zuranolone's rapid onset of action [91][92] Question: SAGE-324 Phase 2 study details - Management confirmed that the Phase 2 study will be a dose-ranging study to find an appropriate balance between efficacy and tolerability [97] Question: KOL conversations and potential launch concerns - Management noted that treating physicians are increasingly recognizing the differentiated profile and safety of zuranolone compared to traditional treatments [106][109] Question: Linkage between day 3 separation and remission rates - Management highlighted the clinical significance of rapid relief of depressive symptoms and the importance of the CORAL study in demonstrating this [114]