SAGE Therapeutics, Inc. (NASDAQ:SAGE) Q3 2023 Earnings Conference Call November 7, 2022 8:00 AM ET Company Participants Ashley Kaplowitz - Director, IR Barry Greene - President, CEO & Director Christopher Benecchi - Chief Business Officer Kimi Iguchi - CFO & Treasurer Laura Gault - Chief Medical Officer Conference Call Participants Ritu Baral - TD Cowen Anupam Rama - JPMorgan Chase & Co. Tazeen Ahmad - Bank of America Merrill Lynch Salveen Richter - Goldman Sachs Group Jay Olson - Oppenheimer Ami Fadia - Ne ...

2023 Financial Results • Forward-looking statements in this presentation include statements regarding: plans and goals for commercialization of ZURZUVAE as a treatment for women with PPD and expected timelines; our belief in the potential benefit and profile of ZURZUVAE in the treatment of PPD; our plans, goals, and expectations regarding access to ZURZUVAE for women with PPD and reimbursement; the potential for success of our other product candidates in various indications, including the potential profile ...

l 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, 2023 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 in ...

Summary of Sage Therapeutics Business Update Call Company and Industry Overview - **Company**: Sage Therapeutics, Inc. (NASDAQ:SAGE) - **Industry**: Biopharmaceuticals, specifically focusing on mental health treatments, particularly postpartum depression (PPD) and major depressive disorder (MDD) Key Points and Arguments 1. **FDA Approval of ZURZUVAE**: Sage Therapeutics and Biogen received FDA approval for ZURZUVAE (zuranolone) as the first and only oral treatment specifically indicated for adults with PPD, addressing a significant unmet need for approximately 500,000 women affected annually in the U.S. [5][8][19] 2. **Launch Plans**: ZURZUVAE is expected to be commercially available in Q4 2023, following DEA scheduling, which is anticipated within 90 days of approval [8][19][28]. 3. **Clinical Data**: The approval is based on the NEST clinical development program, including the SKYLARK and ROBIN studies, which demonstrated statistically significant improvement in depressive symptoms as early as day three and maintained effects at day 45 [13][14]. 4. **Safety Profile**: ZURZUVAE has a box warning for driving impairment, advising patients not to drive for at least 12 hours post-dose. Common adverse reactions include somnolence, dizziness, and urinary tract infections [15][16]. 5. **Commercial Strategy**: Sage plans to implement a focused launch strategy targeting high-prescribing healthcare providers (HCPs) and leveraging omnichannel capabilities to reach both HCPs and women with PPD [21][22][28]. 6. **Market Access**: Approximately 55% of U.S. births are covered by commercial insurance, and Sage aims to ensure access to ZURZUVAE for all women with PPD, regardless of financial circumstances [27][28]. 7. **Financial Position**: Sage reported $1 billion in cash as of June 30, 2023, and anticipates that current resources will support operations into 2025. However, the company is refining its strategy and evaluating resource allocation following the CRL for MDD [29][30]. 8. **Impact of MDD CRL**: The company received a complete response letter (CRL) from the FDA for zuranolone as a treatment for MDD, expressing disappointment and reviewing feedback for next steps [6][41][53]. Additional Important Content 1. **Unmet Need in PPD**: The call emphasized the significant burden of PPD on new mothers and the generational impact on children, highlighting the importance of ZURZUVAE as a new treatment option [9][25]. 2. **Patient Access Programs**: Sage plans to implement co-pay assistance programs to ensure that women with PPD can access ZURZUVAE regardless of their financial situation [24][27]. 3. **Collaboration with Biogen**: The partnership with Biogen is crucial for the launch of ZURZUVAE, with both companies committed to addressing the needs of women with PPD [72][76]. 4. **Future Developments**: Sage is evaluating the potential for future studies and resubmission efforts for MDD, with a focus on maintaining a robust pipeline and exploring partnerships for ongoing development [66][68]. This summary encapsulates the critical updates and strategic directions discussed during the Sage Therapeutics business update call, focusing on the launch of ZURZUVAE and the implications of the recent FDA decisions.

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, 2023 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 incorpora ...

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q1 2023 Earnings Conference Call May 2, 2023 8:00 AM ET Company Participants Helen Rubinstein - Director of Investor Relations Barry Greene - Chief Executive Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - Chief Financial Officer Laura Gault - Chief Medical Officer Conference Call Participants Anupam Rama - JPMorgan Ritu Baral - PD Cowen Yasmeen Rahimi - Piper Sandler Jay Olson - Oppenheimer Paul Matteis - Stifel Sum ...

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, 2023 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 incorpor ...

Sage Therapeutics, Inc. (NASDAQ:SAGE) Q4 2022 Earnings Conference Call February 16, 2023 8:00 AM ET Company Participants Helen Rubinstein - Director of Investor Relations Barry Greene - Chief Executive Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - Chief Financial Officer Laura Gault - Chief Medical Officer Conference Call Participants Tazeen Ahmad - Bank of America Salveen Richter - Goldman Sachs Anupam Rama - JPMorgan Ritu Baral - Cowen Eason Lee - Ne ...

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 ...