Commercial Performance of ZURZUVAE - In Q1 2025, over 3,000 shipments of ZURZUVAE were made to women with PPD[13] - Approximately 80% of ZURZUVAE prescriptions in Q1 2025 were written by OBGYNs[15] - More than 70% of women prescribed ZURZUVAE received it as their first new treatment for PPD[17] - The company is strategically investing in the commercialization of ZURZUVAE in the PPD market[12] Financial Results (Q1 2025) - Total revenue was $14.1 million, compared to $7.9 million in Q1 2024[23] - Collaboration revenue was $13.8 million, compared to $6.2 million in Q1 2024[23] - Net loss was ($62.2 million), compared to ($108.5 million) in Q1 2024[23] - Research and Development (R&D) expenses were $22.8 million, compared to $71.7 million in Q1 2024[23] - Cash and marketable securities totaled $0.4 billion, compared to $0.7 billion in Q1 2024[23] Pipeline and Strategic Focus - The company is focused on developing novel programs in diseases with high unmet needs in Neurodevelopmental Disorders & Neuropsychiatry[12] - The company is evaluating potential indications for SAGE-324, including seizures in developmental and epileptic encephalopathies (DEEs), with an update expected in mid-2025[24]

Company Performance - Sage Therapeutics reported a quarterly loss of $1.01 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.99, and an improvement from a loss of $1.80 per share a year ago [1] - The company posted revenues of $14.06 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 0.67%, but showing growth from $7.9 million in the same quarter last year [2] - Over the last four quarters, Sage Therapeutics has not surpassed consensus EPS estimates, although it has topped consensus revenue estimates twice [2] Stock Performance - Sage Therapeutics shares have increased by approximately 43.1% since the beginning of the year, contrasting with a decline of 6% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.95 on revenues of $17.11 million, and for the current fiscal year, it is -$3.38 on revenues of $81.59 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Sage Therapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Data and Key Metrics Changes - The company reported collaboration revenue of $13.8 million for Q1 2025, a 21% increase from Q4 2024 [16][18] - R&D expenses were $22.8 million, reflecting a 68% decrease compared to Q1 2024, and a nearly 40% decrease from Q4 2024 [17][18] - The net loss for Q1 2025 was $62.2 million, down from a net loss of $95.8 million in Q4 2024 [18] Business Line Data and Key Metrics Changes - XERZUVEY was shipped to over 3,000 women with postpartum depression (PPD) in Q1 2025, representing a 22% increase from Q4 2024 [8][12] - The company generated $13.8 million in collaboration revenue from XERZUVEY, which is 50% of the net revenue reported by Biogen [16][18] - Over 70% of women prescribed XERZUVEY received it as their first new treatment for PPD [12][42] Market Data and Key Metrics Changes - The majority of prescriptions (almost 80%) came from OBGYNs, indicating strong engagement from healthcare providers [12][26] - The total number of prescribers for XERZUVEY increased by over 20% in Q1 2025 [12] Company Strategy and Development Direction - The company is focused on establishing XERZUVEY as the standard of care for women with PPD and is actively working to expand its reach [8][9] - A strategic review process is ongoing to evaluate opportunities for maximizing shareholder value [7] - The company has recalibrated its R&D approach to focus on neuropsychiatry and neurodevelopmental disorders, prioritizing programs with strong scientific rationale [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of XERZUVEY and the potential for continued quarter-on-quarter revenue growth throughout 2025 [25][54] - The company anticipates that its existing cash and marketable securities will support operations until mid-2027 [18][113] Other Important Information - The company has seen a significant increase in awareness of XERZUVEY among healthcare providers, with approximately 90% aided awareness reported [66] - The sales force expansion is complete, and management expects this will lead to continued growth in prescriptions and revenue [41][112] Q&A Session Summary Question: What kind of early pull through are you seeing from your Salesforce initiatives? - Management noted strong first-quarter growth of over 20% in both demand and revenue, attributing this to the expanded sales force [25][26] Question: Could you provide some additional color on the pipeline and your upcoming catalysts? - Management emphasized confidence in the pharmacology of their pipeline drugs and the potential for significant shareholder value if successful [32][34] Question: What do you believe are the key factors for prescribers and patients deciding not to use XERZUVEY as their first-line treatment? - Management indicated that over 70% of women prescribed XERZUVEY are receiving it as their first new treatment, suggesting minimal obstacles to frontline use [42][44] Question: How should we look at inventory levels now? - Management stated that inventory levels fluctuate due to wholesalers' purchasing habits, but emphasized focusing on demand trends rather than inventory [48][60] Question: What is the current penetration in the OBGYN market? - Management did not disclose specific numbers but indicated ongoing growth in new prescribers and repeat prescribing [98][100] Question: What is the persistence of prescribers for XERZUVEY? - Management confirmed that once healthcare providers prescribe XERZUVEY, they tend to become repeat prescribers, indicating strong retention [118]

Financial Position - As of March 31, 2025, the company's total cash equivalents amounted to $42.139 million, a decrease from $80.239 million as of December 31, 2024[80][81]. - The total marketable securities held by the company as of March 31, 2025, were valued at $378.630 million, down from $423.397 million as of December 31, 2024[80][83]. - The company held cash, cash equivalents, and marketable securities totaling $423.9 million as of March 31, 2025[267]. - The company does not expect significant impact from fluctuations in interest rates on its financial condition due to the short-term nature of its cash and marketable securities[267]. - The company has exposure to foreign currency exchange rate fluctuations but considers this exposure to be immaterial[268]. - Inflation has not materially affected the company's results of operations during the three months ended March 31, 2025, and 2024[270]. Marketable Securities and Investments - The company reported unrealized losses of $82,000 on its marketable securities as of March 31, 2025, attributed to interest rate increases[84]. - The fair value of U.S. corporate bonds held by the company was $253.414 million as of March 31, 2025, compared to $269.013 million as of December 31, 2024[82][83]. - The company had accrued interest receivable of $2.7 million related to available-for-sale securities as of March 31, 2025[83]. - All marketable securities held by the company had remaining contractual maturities of one year or less, except for U.S. corporate bonds and international corporate bonds with a fair value of $40.0 million and maturities of one to two years as of March 31, 2025[85]. - The company did not experience any impairments of assets measured and carried at fair value during the three months ended March 31, 2025[87]. - The company performed validation procedures on fair value measurements and did not adjust any provided by pricing services as of March 31, 2025[79]. Legal and Regulatory Matters - The Company is involved in a federal securities class action lawsuit alleging violations of U.S. securities laws, with unspecified damages sought for stock purchases made between April 12, 2021, and July 23, 2024[89]. - The Company received a subpoena from the SEC regarding zuranolone for MDD treatment, and is cooperating with the investigation[90]. - The Company is unable to predict the outcome of ongoing legal proceedings or reasonably estimate potential losses[93]. Collaborations and Revenue - The Company entered a strategic collaboration with Shionogi for zuranolone, with an upfront payment of $90 million and potential milestone payments of up to $485 million[95]. - The Company achieved a $75 million milestone for the first commercial sale of ZURZUVAE for treating women with PPD in the U.S. in Q4 2023[106]. - The Biogen Collaboration Agreement allows for potential milestone payments of up to $1.6 billion, but the Company will not receive $150 million for MDD due to halted development[106]. - The Company is eligible for tiered royalties on net sales of SAGE-217 products in the Biogen Territory, ranging from high teens to low twenties percentage rates[108]. - The Biogen Collaboration Agreement will continue until royalty terms expire in the Biogen Territory, with Biogen responsible for development and commercialization costs[112]. - The Company maintains exclusive rights to develop and commercialize zuranolone outside the Shionogi Territory[95]. - In Q4 2023, the Company recognized $75 million in license and milestone revenue related to the first commercial sale of ZURZUVAE for the treatment of women with PPD in the U.S.[119]. - For the three months ended March 31, 2025, collaboration revenue from Biogen was $13.8 million, compared to $6.2 million for the same period in 2024[123]. - The Company recorded a collaboration receivable of $10.7 million as of March 31, 2025, representing net reimbursement amounts due[123]. Stock-Based Compensation and Equity - The Company has an ATM Sales Agreement allowing for the sale of up to $250 million in common stock, with no shares sold under this agreement as of March 31, 2025[131][136]. - The 2024 Equity Incentive Plan was approved, allowing for the grant of up to 16,502,166 shares of common stock[138]. - As of March 31, 2025, the total number of shares underlying outstanding awards under the 2024 Plan, the 2014 Plan, and the 2016 Plan was 8,782,994, with 6,214,108 shares available for future issuance under the 2024 Plan[142]. - The Company granted 1,493,452 time-based restricted stock units during the three months ended March 31, 2025, compared to 857,084 in the same period of 2024[147]. - The total unrecognized stock-based compensation expense related to time-based restricted stock units was $15.8 million, expected to be recognized over a remaining weighted average vesting period of 3.57 years[148]. - The Company recorded stock-based compensation expense of $6.9 million for the three months ended March 31, 2025, down from $13.7 million in the same period of 2024[161]. - As of March 31, 2025, the total unrecognized stock-based compensation expense related to performance restricted stock units was $34.4 million[154]. - The Company accepted for exchange eligible options to purchase a total of 3,079,608 shares, granting replacement options for a total of 1,483,113 shares with an exercise price of $22.20 per share[144]. - The Company expects to incur a total of $1.7 million of additional stock-based compensation expense as a result of the Option Exchange, to be recognized over the 18-month vesting period[145]. Financial Performance - The net loss for the three months ended March 31, 2025, was $62.2 million, resulting in a basic and diluted net loss per share of $1.01, compared to a net loss of $108.5 million and a loss per share of $1.80 in 2024[163]. - Revenues for the three months ended March 31, 2025, were $14,063,000, a 77.5% increase from $7,902,000 in the same period of 2024[172]. - Net loss for the three months ended March 31, 2025, was $(62,214,000), a significant improvement compared to $(108,483,000) in the same period of 2024, reflecting a reduction of 42.7%[172]. - Program expenses for zuranolone (ZURZUVAE) increased to $12,010,000 in Q1 2025 from $5,257,000 in Q1 2024, representing a 128.5% increase[172]. - Non-program expenses decreased to $19,258,000 in Q1 2025 from $22,131,000 in Q1 2024, indicating a reduction of 12.6%[172]. - Total restructuring charges incurred through March 31, 2025, amounted to $32.9 million, with no related expenses recorded during the three months ended March 31, 2025[165]. - Total charges related to the 2024 Restructuring incurred through March 31, 2025, are $22.8 million, which is the total expected amount to be incurred[167].

Exhibit 99.1 "We delivered strong growth in revenue and shipments of ZURZUVAE during the first quarter of 2025 through the team's disciplined execution and unwavering commitment to bringing ZURZUVAE to more women with postpartum depression," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "We remain focused on establishing ZURZUVAE as the standard of care for women with postpartum depression and driving our business strategy forward with the goal of creating value for shareholders." First Q ...

Core Viewpoint - Kaskela Law LLC is investigating Sage Therapeutics, Inc. on behalf of long-term investors due to a securities fraud complaint filed against the company [1][2]. Summary by Relevant Sections Allegations of Misconduct - The complaint alleges that during the Class Period (April 12, 2021 to July 23, 2024), Sage and its senior executives concealed significant risks and adverse information regarding the development of three key pharmaceuticals: zuranolone (SAGE-217/BIIB125), SAGE-718, and SAGE-324 [3]. FDA Findings and Impact - By the end of the Class Period, it was revealed that the FDA denied approval for zuranolone for treating major depressive disorder (MDD) due to its lack of long-term efficacy and its performance being no better than a placebo. The FDA's guidance from 2018 indicated a need for a more effective treatment for MDD [4]. - The FDA approved zuranolone for postpartum depression (PPD) but noted an increased incidence of suicidal ideation and behavior in MDD patients, which was not observed in PPD patients [4]. - Sage also abandoned the development of SAGE-718 and SAGE-324 due to negative clinical trial results, leading to Biogen terminating its collaboration and licensing agreement for SAGE-324 [4]. Investigation Focus - The investigation aims to determine if Sage's board of directors violated securities laws or breached fiduciary duties related to the alleged misconduct [5].

Driven Brands Holdings, Inc. - A securities fraud class action complaint against Driven Brands has survived the defendants' motion to dismiss, indicating that the allegations were sufficiently pleaded [1][4] - The complaint alleges that certain officers and directors made materially false and misleading statements regarding the company's ability to integrate acquired businesses and the performance of its car wash segment [3] - Long-term shareholders who held Driven Brands shares since before October 27, 2021, can seek corporate reforms and a court-approved incentive award at no cost [2][5] Mercury Systems, Inc. - A securities fraud class action complaint against Mercury Systems has also survived the motion to dismiss, with key allegations being adequately pleaded [6][9] - The complaint claims that the company misled investors about its growth by using improper revenue recognition practices and misrepresenting the status of its projects [8] - Current shareholders who held shares since before February 3, 2021, can seek corporate reforms and a court-approved incentive award at no cost [7][9] Playstudios, Inc. - A securities fraud class action complaint against Playstudios has survived the motion to dismiss and has reached a settlement [10][14] - The complaint alleges that shareholders paid artificially inflated prices for their securities due to the defendants' wrongful conduct [13] - Shareholders who purchased or acquired Playstudios shares prior to August 11, 2021, can seek corporate reforms and a court-approved incentive award at no cost [11][15] Sage Therapeutics, Inc. - An investigation is underway regarding claims against Sage Therapeutics, focusing on whether certain officers and directors breached their fiduciary duties [15] - The underlying complaint alleges that the company made materially false and misleading statements about the effectiveness of its treatments and the prospects for FDA approval [17] - Shareholders who purchased Sage Therapeutics shares prior to April 12, 2021, can seek corporate reforms and a court-approved incentive award at no cost [16][18]

Financial Data and Key Metrics Changes - In Q4 2024, collaboration revenue from ZURZUVAE sales was $11.4 million, a 4% increase from Q3 2024, with full-year revenue at $36.1 million [27] - R&D expenses were $37 million, SG&A expenses were $54 million, and one-time restructuring expenses were $22.5 million in Q4 2024 [28] - The net loss for Q4 2024 was $95.8 million, with existing cash and equivalents of $504 million expected to support operations until mid-2027 [30] Business Line Data and Key Metrics Changes - ZURZUVAE saw nearly 2,500 prescriptions shipped in Q4 2024, representing a 21% increase from Q3 2024, with over 6,600 prescriptions shipped throughout 2024 [18][11] - More than 70% of ZURZUVAE patients received it as their first new treatment for PPD, with 60% of targeted healthcare providers writing repeat prescriptions [21][20] Market Data and Key Metrics Changes - Greater than 95% of commercial and Medicaid lives are covered for ZURZUVAE, with most having no step edits or complex prior authorizations [23] - The company noted a promotionally responsive market for PPD treatments, indicating significant growth potential [25] Company Strategy and Development Direction - The company aims to establish ZURZUVAE as the standard of care for PPD, with plans to invest in 2025 to fuel revenue growth [10] - A recalibrated R&D approach will focus on neuropsych and neurodevelopmental disorders, with ongoing development of SAGE-319 and SAGE-324 [13][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial momentum of ZURZUVAE and the potential for blockbuster growth in PPD treatment [12] - The company is committed to maintaining financial discipline while enhancing shareholder value, despite the unsolicited acquisition proposal from Biogen [14][15] Other Important Information - The company is exploring partnerships and out-licensing opportunities for clinical and preclinical compounds [35] - The strategic review initiated by the Board aims to evaluate opportunities to maximize shareholder value [15] Q&A Session Summary Question: Can you elaborate on the sales force expansion and marketing efforts? - Management confirmed an aligned commercialization plan with increased sales force and investment in marketing, including social media campaigns [40][41] Question: What are the inventory dynamics for the quarter? - Management explained that revenue is recorded when product moves to wholesalers, and inventory dynamics can fluctuate based on channel management [52][54] Question: How do you anticipate the first quarter will perform? - Management expects continued quarter-on-quarter growth, citing strong demand and effective reimbursement strategies [59][60] Question: What proportion of patients are receiving ZURZUVAE as first-line therapy? - Over 70% of patients are receiving ZURZUVAE as their first treatment, with historical bias being a challenge for broader adoption [148][150] Question: Can you provide insights on the collaboration with Shionogi in Japan? - Management indicated that a decision on MDD from the Japanese FDA is expected later this year, with potential regulatory and commercial milestones [126][128]

Fourth Quarter and Full Year 2024 Financial Results February 11, 2025 − We may encounter unexpected safety or tolerability issues with respect to any of our product candidates or marketed products; we may encounter different or more severe adverse events at higher doses, different frequency or length of dosing or in new indications. − At any stage, regulatory authorities may ask for additional clinical trials, non-clinical studies or other data in order for us to proceed further in development or to file fo ...

Financial Performance - Sage Therapeutics reported a quarterly loss of $1.56 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.45, and a significant increase from a loss of $0.55 per share a year ago [1] - The company posted revenues of $12.82 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 11.20%, and a decline from year-ago revenues of $77.97 million [2] - Over the last four quarters, the company has not surpassed consensus EPS estimates [2] Stock Performance - Sage Therapeutics shares have increased approximately 33.7% since the beginning of the year, outperforming the S&P 500's gain of 3.1% [3] - The current status of estimate revisions for Sage Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.16 on revenues of $15.55 million, and for the current fiscal year, it is -$3.87 on revenues of $87.12 million [7] - The outlook for the Medical - Biomedical and Genetics industry, where Sage Therapeutics operates, is favorable, ranking in the top 26% of over 250 Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8] Industry Comparison - IDEAYA Biosciences, another company in the same industry, is expected to report a quarterly loss of $0.67 per share, reflecting a year-over-year change of -28.9%, with revenues anticipated to be $7 million, up 78.6% from the previous year [9]