Planned activities and anticipated timelines | --- | --- | --- | --- | |-------------------------------------------------------------------------------------|--------------------------|--------------------------|-------| | NDA development and related processes | FDA Advisory Committee* | DEA Scheduling Period^ | | | Medical affairs, health economics, value and access, and commercialization planning | | | | FDA = U.S. Food and Drug Administration; DEA = Drug Enforcement Administration; MDD = major depressive ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36544 Sage Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 27-4486580 (State or Other Jurisdictio ...

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q3 2022 Earnings Conference Call November 8, 2022 8:00 AM ET Company Participants Helen Rubinstein - Director, IR Barry Greene - Chief Executive Officer Kimi Iguchi - Chief Financial Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Jeff Jonas - Chief Innovation Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Ritu Baral - Cowen Salveen Richter - Goldman Sachs Paul Matteis - Stifel Laura Chico - Wedbush Jay Olson ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-36544 Sage Therapeutics, Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of inco ...

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q2 2022 Earnings Conference Call August 2, 2022 8:00 AM ET Company Participants Helen Rubinstein - IR Barry Greene - CEO Albert Robichaud - Chief Scientific Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - CFO Conference Call Participants Ritu Baral - Cowen Paul Matteis - Stifel Ami Fadia - Needham Jay Olson - Oppenheimer Swapnil Malekar - Piper Sandler Yatin Suneja - Guggenheim Marc Goodman - SVB Leerink Gospel Enyindah-Asonye - Morgan Stanley Gary Nachman ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36544 Sage Therapeutics, Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorporati ...

Financial 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]

Investor Presentation May 2022 Safe Harbor Statement • The slides presented today and the accompanying oral presentations contain forward-looking statements, which may be identified by the use of words such as "may," "might," "will," "should," "can,","expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "opportunity", "goal", "mission", "potential," "target", or "continue," and other similar expressions. • Forward-looking statements in this presentation include statements reg ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36544 Sage Therapeutics, Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorporat ...

SAGE-718 Clinical Studies Overview - The DIMENSION study is a Phase 2 placebo-controlled study evaluating SAGE-718 in patients with early Huntington's Disease (HD)[2, 5] - The primary endpoint of the DIMENSION study is the change from baseline in the Composite score of the Huntington's Disease Cognitive Assessment Battery (HD-CAB)[4] - The SURVEYOR study is a Phase 2 placebo-controlled study in patients with early HD, with a Healthy Participant (HP) Comparator Arm[13, 16] - The primary endpoint of the SURVEYOR study is baseline measures of the Huntington's Disease Cognitive Assessment Battery (HD-CAB) cognitive composite score[15] - The PRECEDENT study is a Phase 2 placebo-controlled study in patients with Mild Cognitive Impairment (MCI) due to Parkinson's Disease (PD)[20, 26] - The primary endpoint of the PRECEDENT study is the change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding test[20] Dosing and Study Design - In the DIMENSION study, participants receive either SAGE-718 (1.2 mg oral daily from days 1 to 27; 0.9 mg oral daily from days 28 to 84) or placebo[8, 5] - In the SURVEYOR study, HD participants receive either SAGE-718 (1.2 mg oral daily) or placebo[17, 18] - In the PRECEDENT study, participants receive either SAGE-718 (1.2 mg oral daily) or placebo[24, 22] Inclusion Criteria for HD Studies - Participants in the DIMENSION and SURVEYOR studies must have genetically confirmed HD with huntingtin gene CAG expansion ≥36[6, 18] - Participants in the DIMENSION and SURVEYOR studies must have a UHDRS-Total Functional Capacity (TFC) score >6 and <13[6, 18] - Participants in the DIMENSION and SURVEYOR studies must have a Montreal Cognitive Assessment (MoCA) score <26 at screening[6, 18] Inclusion Criteria for PD-MCI Study - Participants in the PRECEDENT study must be between 50 and 75 years old at screening[23] - Participants in the PRECEDENT study must have a confirmed diagnosis of idiopathic PD according to 2015 MDS clinical diagnostic criteria[23] - Participants meeting Level 1 PD-MCI criteria must have a MoCA score of 20 to 25 (inclusive) at Screening, while those meeting Level 2 PD-MCI criteria must have a MoCA score of 18 to 25 (inclusive) at Screening[23]