Company Mission and Pipeline - Sage's mission is to be a top-tier biopharmaceutical company in the next 5 years, focusing on brain health[17] - The company has a rich pipeline across 3 franchises, including 3 late-stage programs and 5 NCE development programs across 12+ indications[17] - Sage aims for 2 or more IND-enabling programs per year by 2023[17] Zuranolone (SAGE-217) Development - Zuranolone is being developed for Major Depressive Disorder (MDD), Postpartum Depression (PPD), Treatment Resistant Depression, Generalized Anxiety Disorder, and Bipolar Depression[20, 21] - Clinical trials show consistent and rapid improvement in depressive symptoms with zuranolone[48] - Approximately 70% of participants with positive response to the initial 2-week course of zuranolone required only one or two courses of treatment during the 12-month SHORELINE study[54] - Shionogi's Phase 2 study in Japan achieved primary endpoints at both 20 mg and 30 mg doses, showing significant improvement over placebo from Day 3 to Day 15[71] SAGE-324 Development - SAGE-324 is being developed for Essential Tremor and Parkinson's Disease[23] - In an open-label, phase 1 study, a single dose of SAGE-324 resulted in nearly 50% tremor reduction in ET patients[97] - The KINETIC Study showed a statistically significant reduction from baseline in Upper Limb Tremor Score at Day 29 with SAGE-324[101] SAGE-718 Development - SAGE-718 is being developed for Huntington's Disease Cognitive Dysfunction, Parkinson's Disease Cognitive Dysfunction, and Alzheimer's Disease Mild Cognitive Impairment and Mild Dementia[24, 25] - In the Phase 2a open-label PARADIGM Study, patients with mild cognitive impairment due to Parkinson's disease showed performance improvements from baseline on multiple tests in the cognitive domain of executive function during the 14 days of treatment[132] Financial Position - Sage has over $1.8 billion in capital to fund efforts to accelerate and advance medicines[17] - The company anticipates a cash balance of more than $1.7 billion at the end of 2021[155] - Third quarter 2021 revenue from Zulresso was $1.4 million[155]

Financial 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]

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, 2021 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 incorp ...

Financial 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]

Investor Presentation August 2021 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 ...

☐ 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 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, 2021 OR Sage Therapeutics, Inc. (Exact name of registrant as specified in its Charter) (State or other jurisdiction of incorporati ...

SAGE Therapeutics, Inc. (NASDAQ:SAGE) Q1 2021 Earnings Conference Call May 4, 2021 8:00 AM ET Company Participants Jeff Boyle - Investor Contact Barry Greene - President, CEO & Director Stephen Kanes - Chief Medical Officer Kimi Iguchi - CFO & Treasurer Jim Doherty - Chief Research Officer Conference Call Participants Andrew Tsai - Jefferies Ritu Baral - Cowen and Company Tazeen Ahmad - Bank of America Merrill Lynch Yasmeen Rahimi - Piper Sandler & Co. Turner Kufe - JPMorgan Chase & Co. Laura Chico - Wedbus ...

Company Overview - Sage Therapeutics aims to be a top-tier biopharmaceutical company in the next 5 years[18] - The company has a rich pipeline across 3 franchises and goals of 2 or more IND-enabling programs per year by 2023[18] - Sage Therapeutics has over $2 billion in capital to fund efforts to impact an estimated >450 million patients globally[18] Depression Franchise (Zuranolone) - Approximately 70% of participants with positive response to an initial 2-week zuranolone treatment required at most one additional treatment during the 12-month SHORELINE study[34, 56] - In the SHORELINE study (30mg cohort), 42.9% of responders to initial treatment required only one course of zuranolone, while 25.6% needed 2 courses, 11.9% needed 3 courses, 10.8% needed 4 courses, and 8.8% needed 5 courses[56] - In the SHORELINE study, 23.9% exited the study with the primary reason of not achieving response in the first course of treatment[43] - In the 199 patients who received zuranolone 50 mg only, approximately 80.5% achieved response and 43.2% achieved remission after the initial 2-week treatment period[49, 52] Neurology Franchise (SAGE-324) - It's estimated that nearly 135 million people globally suffer from essential tremor (ET) or Parkinson's disease (PD)[67] - In an open-label, phase 1 study, a single dose of SAGE-324 resulted in nearly 50% tremor reduction in ET patients[69] - In the Phase 2 KINETIC Study, somnolence occurred in 68%, dizziness in 38%, balance disorder in 15%, diplopia in 12%, dysarthria in 12%, and gait disturbance in 12% of patients in the SAGE-324 treatment group[75] Neuropsychiatry Franchise (SAGE-718) - The 2020 economic burden of Alzheimer's disease in the US is estimated at ~$305 billion, compared to ~$200 billion in 2000[87]

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, 2021 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 Therapeutics, Inc. (NASDAQ:SAGE) Q4 2020 Earnings Conference Call February 8, 2021 8:00 AM ET Company Participants Barry Greene - CEO Jeff Boyle - Head-Investor Relations Mike Cloonan - Chief Operating Officer Kimi Iguchi - Chief Financial Officer Steve Kanes - Chief Medical Officer Conference Call Participants Laura Chico - Wedbush Securities Andrew Tsai - Jefferies Paul Matteis - Stifel Yatin Suneja - Guggenheim Partners Jay Olson - Oppenheimer Salveen Richter - Goldman Sachs Tazeen Ahmad - Bank of ...