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].

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]

Sage Therapeutics (SAGE) Q4 2024 Earnings Call February 11, 2025 04:30 PM ET Company Participants Ashley Kaplowitz - Director of Investor RelationsBarry Greene - CEOChris Benecchi - COOLaura Gault - Chief Medical OfficerShrunatra Mishra - AssociatePaul Matteis - Managing Director, Head of Therapeutics ResearchTazeen Ahmad - MD - US Equity ResearchKevin Meli - Equity Research AssociateDylan Shindler - Equity Research AssociateDouglas Tsao - Managing DirectorUy Ear - Vice PresidentSumant Kulkarni - Managing D ...

Market Opportunity and Product Development - The company aims to establish ZURZUVAE as the standard of care for women with postpartum depression (PPD) and expand market growth in this area [12]. - The estimated number of women with PPD is significant, with the company projecting a substantial market opportunity for ZURZUVAE [12]. - The company expects to commercialize ZURZUVAE as a treatment for postpartum depression (PPD) and aims to establish it as the standard of care, targeting a significant market opportunity [12]. - The estimated number of women with PPD is substantial, and the company anticipates a strong market access strategy to help all prescribed patients gain access to ZURZUVAE quickly [12]. - The company plans to announce data from a Phase 1 multiple ascending dose study of SAGE-319 by late 2025 [12]. - The company plans to announce data from a Phase 1 study of SAGE-319 by late 2025, with potential implications for behavioral symptoms associated with neurodevelopmental disorders [12]. - The company is focused on developing additional product candidates, including SAGE-324 for seizures, with updates expected in mid-2025 [12]. Strategic Relationships and Collaborations - The company is dependent on successful collaborations with Biogen and Shionogi for the development and commercialization of its product candidates [19]. - The company emphasizes the importance of maintaining strong relationships with collaborators like Biogen and Shionogi to ensure successful product development and commercialization [19]. - The company has rejected an unsolicited acquisition proposal from Biogen, which may impact its relationship and commercialization efforts for ZURZUVAE [18]. - The company is exploring strategic alternatives and has rejected an unsolicited acquisition proposal from Biogen, which may impact their collaboration and commercialization efforts [18]. Financial Considerations and Risks - The company anticipates potential cost savings from a corporate reorganization in October 2024, although these may not meet expectations [19]. - The company anticipates potential cost savings from a corporate reorganization planned for October 2024, which may affect cash runway and future funding needs [19]. - The company may need to raise additional funding, which may not be available on acceptable terms [19]. - The company faces risks related to the commercialization of ZURZUVAE, including market acceptance and competition [18]. - The company acknowledges risks related to the commercialization of ZURZUVAE, including market acceptance and competition, which could affect revenue generation [18]. - The company faces uncertainties regarding the regulatory approval of its product candidates, which could materially impact business prospects [18]. - The company is subject to healthcare laws and regulations that could impact its business and financial performance [19]. - The company is subject to healthcare laws and regulations that could expose it to various risks, including potential sanctions and penalties [19].

Revenue and Sales Performance - In Q4 2024, nearly 2,500 prescriptions of ZURZUVAE were shipped, representing a 21% increase from Q3 2024, with over 6,600 prescriptions shipped for the full year[4] - Collaboration revenue from ZURZUVAE was $11.4 million in Q4 2024 and $36.1 million for the full year, accounting for 50% of net revenues recorded by Biogen[4] - The company anticipates a significant topline revenue growth in 2025 due to commercialization investments, including joint sales force expansions and digital marketing campaigns[3] - The company reported a strong repeat prescription rate of about 60% among targeted healthcare providers after prescribing ZURZUVAE[4] - Total revenues for the year ended December 31, 2024, were $41,243 thousand, a decrease of 52% compared to $86,455 thousand in 2023[20] - Product revenue, net for the three months ended December 31, 2024, was $442 thousand, down 78% from $1,985 thousand in the same period of 2023[20] - Collaboration revenue from related parties increased significantly to $36,087 thousand for the year ended December 31, 2024, compared to $824 thousand in 2023[20] Financial Position and Cash Flow - Cash, cash equivalents, and marketable securities totaled $504 million as of December 31, 2024, with a cash runway expected to support operations until mid-2027[1] - Cash, cash equivalents, and marketable securities decreased to $504,418 thousand as of December 31, 2024, down from $753,184 thousand in 2023, representing a decline of approximately 33%[18] - Total stockholder's equity decreased to $465,089 thousand as of December 31, 2024, down from $799,530 thousand in 2023, reflecting a decline of about 42%[18] Expenses and Losses - Research and development expenses decreased to $37.0 million in Q4 2024 from $64.3 million in Q4 2023, reflecting cost-saving measures and pipeline prioritization[10] - Selling, general and administrative expenses were $54.0 million in Q4 2024, a slight decrease from $55.1 million in Q4 2023, due to reorganization cost savings[13] - Net loss for Q4 2024 was $95.8 million, compared to $32.7 million in Q4 2023, with a total net loss of $400.7 million for the full year[13] - Research and development expenses for the year ended December 31, 2024, were $225,895 thousand, a reduction of 37% from $356,235 thousand in 2023[20] - The net loss for the year ended December 31, 2024, was $400,666 thousand, compared to a net loss of $541,489 thousand in 2023, indicating an improvement of approximately 26%[20] - Operating costs and expenses for the year ended December 31, 2024, totaled $473,613 thousand, a decrease of 29% from $666,304 thousand in 2023[20] - The company reported a net loss per share of $6.59 for the year ended December 31, 2024, compared to $9.05 in 2023, showing a reduction in loss per share of approximately 27%[20] Future Outlook and Challenges - The company expects to provide updates on SAGE-319 and SAGE-324 in mid-2025, focusing on potential treatments for neurodevelopmental disorders and seizures[5][7] - The company anticipates potential challenges in achieving anticipated cost savings from its reorganization and pipeline prioritization efforts scheduled for October 2024[20] - More than 70% of ZURZUVAE patients received it as their first new treatment for postpartum depression (PPD)[9]

Wall Street expects a year-over-year decline in earnings on lower revenues when Sage Therapeutics, Inc. (SAGE) reports results for the quarter ended December 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on February 11, 2025, might help the stock move higher if these key numbers are b ...

Sage Therapeutics (SAGE) announced that its board of directors has rejected the unsolicited, non-binding proposal offer from drug giant Biogen (BIIB) to acquire the remaining shares of SAGE.Per Sage Therapeutics, the BIIB offer significantly undervalues the company and is not in the best interest of shareholders.SAGE’s board of directors has now started exploring strategic alternatives and evaluating other options to maximize its shareholders’ value.Shares of SAGE were up 4.8% on Jan. 27 following the news ...

Sage Therapeutics, Inc. (SAGE) shares soared 35.1% in the last trading session to close at $7.50. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 3.1% gain over the past four weeks.The stock rallied after the company announced that its partner Biogen had made an unsolicited, non-binding proposal offer to acquire SAGE shares that it does not already own for $7.22 per share. The offer price represented a premium of 30% on Sage Ther ...