The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on July 31. On the other hand, if they miss, the stock may move lower. Zacks Consensus Estimate Estimate Revisions Trend Earnings Whisper Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. How Have t ...

Core Insights - The company has two FDA-approved drugs for postpartum depression (PPD), Zulresso and Zurzuvae, with the latter being the first oral treatment for adults with PPD [1][10][14] - Sage Therapeutics is collaborating with Biogen for the commercialization of Zurzuvae, sharing profits and losses equally in the U.S. market [2][10] - Recent setbacks in clinical trials, particularly for major depressive disorder (MDD) and Parkinson's disease (PD), have raised concerns about the company's growth prospects [6][15][14] Drug Development and Market Position - Zulresso was approved in 2019 as the first treatment for adults with PPD [1] - Zurzuvae was approved in August 2023 and launched commercially in December 2023, aiming to establish itself as a first-line therapy for PPD [10][3] - The company is also developing dalzanemdor for cognitive dysfunction related to Huntington's disease and SAGE-324 for essential tremors, with ongoing studies expected to yield data soon [4][5][12] Financial Performance and Market Impact - Sage's shares have declined by 43.9% this year, contrasting with a 4% decline in the industry [11] - The company has faced a significant setback with the FDA's complete response letter regarding the MDD indication, which represents a larger market opportunity [6][14] - The company currently holds a Zacks Rank of 3 (Hold), indicating a cautious outlook [16]

Core Viewpoint - Sage Therapeutics announced that its phase II SURVEYOR study for dalzanemdor met its primary endpoint, but the company's shares fell by 2.8% following the announcement [1]. Group 1: Study Objectives and Results - The SURVEYOR study aimed to evaluate the safety of dalzanemdor, assess cognitive impairment in Huntington's disease (HD) patients compared to healthy participants, and understand the relationship between cognitive changes and functional changes [2]. - The study demonstrated a statistically significant difference in HD-Cognitive Assessment Battery (HD-CAB) composite scores between healthy participants and those with HD at baseline, with a small numerical difference observed between dalzanemdor and placebo at day 28 [3][7]. Group 2: Adverse Events and Future Studies - Eleven participants with HD experienced mild to moderate treatment-related adverse events, with no discontinuations due to these events [4]. - Sage is conducting a larger phase II DIMENSION study to evaluate the efficacy of dalzanemdor over a 12-week period, with data expected in late 2024 [8]. Additionally, dalzanemdor is being evaluated in the LIGHTWAVE study for Alzheimer's-related cognitive impairment, with top-line data expected later this year [10]. Group 3: Market Performance and Context - Sage's shares have decreased by 51.1% year-to-date, contrasting with a 6.4% decline in the industry [6]. - The company previously shared results from the PRECEDENT study on dalzanemdor in Parkinson's disease, which failed to meet its primary endpoint, leading management to halt further development for this indication [11].

NEW YORK, May 23, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Sage Therapeutics, Inc. ("Sage" or the "Company") (NASDAQ: SAGE). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Sage and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On April 17, 2024, Sage ...

Financial Data and Key Metrics Changes - ZURZUVAE generated $12.4 million in total revenue, with $6.2 million recognized as collaboration revenue during Q1 2024 [21][82] - The net loss for Q1 2024 was $108.5 million, with cash, cash equivalents, and marketable securities totaling approximately $717 million [82][83] - Operating expenses are expected to decrease in 2024 compared to 2023 [82] Business Line Data and Key Metrics Changes - There were over 1,200 prescriptions written for ZURZUVAE in Q1 2024, with 700 prescriptions shipped and delivered to patients [69][87] - The growth in prescriptions reflects strong interest and enthusiasm for ZURZUVAE in treating women with postpartum depression (PPD) [69][87] - The majority of prescriptions are coming from OB/GYNs, indicating a shift in treatment practice for PPD [29][51] Market Data and Key Metrics Changes - 65% of commercial lives are covered for ZURZUVAE, with most plans having no step therapy or complex prior authorization [88][131] - Almost half of the states have completed Medicaid reviews for ZURZUVAE, with favorable coverage decisions [71][132] - The company is seeing a trend of growing prescriptions each month, with repeat prescriptions from healthcare providers [17][52] Company Strategy and Development Direction - The strategy is to establish ZURZUVAE as the first-line therapy and standard of care for women with PPD, with plans to scale marketing efforts as success continues [46][65] - The company is focused on addressing unmet needs in brain health and plans to continue pipeline investments backed by data [97][100] - There is an emphasis on engaging with healthcare professionals and patient advocacy organizations to improve access to ZURZUVAE [48][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong launch of ZURZUVAE and the potential to help many women suffering from PPD [63][64] - There is a belief that the demand for PPD treatment is strong and continues to grow, with healthcare prescribers showing high interest [65][66] - Management acknowledged the challenges faced in the dalzanemdor program but remains committed to ongoing studies in other indications [62][91] Other Important Information - The company reported negative results from the PRECEDENT study in the dalzanemdor program, but remains hopeful for ongoing studies [62][75] - The company is actively working to optimize the specialty pharmacy process to expedite prescription processing for ZURZUVAE [87][132] Q&A Session Summary Question: Can you provide details on the KINETIC 2 study and its assumptions? - The KINETIC 2 study aims to assess the efficacy and safety of SAGE-324 for chronic administration, with a focus on achieving a benefit-risk profile suitable for Phase 3 [102][103] Question: What strategies are in place to increase awareness and prescribing among PCPs? - The company is focusing on educating clinicians through personal and non-personal promotion, with plans to expand direct-to-consumer (DTC) efforts when appropriate [122][125] Question: What are the reasons for diagnosed PPD patients not receiving prescriptions? - The company is addressing awareness and coverage issues, with ongoing efforts to educate healthcare providers and improve access to ZURZUVAE [129][131]

ZURZUVAE Launch & Market Access - Over 1,200 prescriptions of ZURZUVAE have been written[15] - More than 700 prescriptions of ZURZUVAE have been shipped/delivered[20] - OBGYNs accounted for the largest share of ZURZUVAE prescriptions, followed by psychiatrists and PCPs[20] - Over 65% of commercial lives are covered by payor policies in PPD with the majority having no step therapy or complex prior authorization for ZURZUVAE[20] Clinical Development Pipeline - Phase 2 data for dalzanemdor (SAGE-718) in Huntington's Disease (HD) and Alzheimer's Disease (AD) indications is expected in 2024[23] - Topline data from the SURVEYOR Study in HD is expected in mid-2024[25] - Topline data from the LIGHTWAVE Study in AD is expected in late 2024[25] - Topline data from the DIMENSION Study in HD is expected in late 2024[25] - Topline data from Phase 2 KINETIC 2 Study in Essential Tremor (ET) for SAGE-324 is expected in mid-2024[39] Financial Position - Sage Therapeutics reported a strong financial position with $717 million in cash at the end of Q1 2024[36] - Total revenue for Q1 2024 was $7.9 million, compared to $3.3 million in Q1 2023[36] - Net loss for Q1 2024 was ($108.5 million), compared to ($146.8 million) for Q1 2023[36]

[PART I – FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis of operations, market risk disclosures, and internal controls [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The company reported a net loss of **$108.5 million** in Q1 2024, an improvement from **$146.8 million** in Q1 2023, with total revenues rising to **$7.9 million** Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $172,653 | $70,992 | | Marketable securities | $544,360 | $682,192 | | **Total Assets** | **$767,600** | **$882,277** | | Total Liabilities | $61,799 | $82,747 | | **Total Stockholders' Equity** | **$705,801** | **$799,530** | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Product revenue, net | $1,690 | $3,294 | | Collaboration revenue - related party | $6,212 | $0 | | **Total Revenue** | **$7,902** | **$3,294** | | Research and development | $71,734 | $92,826 | | Selling, general and administrative | $52,574 | $65,708 | | **Loss from operations** | **($117,675)** | **($155,470)** | | **Net Loss** | **($108,483)** | **($146,828)** | | Net loss per share—basic and diluted | ($1.80) | ($2.46) | Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,832) | ($153,682) | | Net cash provided by investing activities | $139,436 | $194,867 | | Net cash provided by financing activities | $1,557 | $2,672 | | **Net increase in cash, cash equivalents and restricted cash** | **$103,161** | **$43,857** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section details the company's business, including ZURZUVAE's FDA approval for PPD, key collaborations, and the **August 2023 restructuring** that reduced workforce by **40%** - ZURZUVAE™ received FDA approval for PPD in August 2023, becoming commercially available in December, while zuranolone for MDD received a Complete Response Letter requiring further trials[28](index=28&type=chunk)[29](index=29&type=chunk) - The company has a collaboration with Biogen to jointly develop and commercialize ZURZUVAE and SAGE-324 in the U.S., sharing costs and profits/losses equally, with Biogen holding exclusive ex-U.S. rights[101](index=101&type=chunk)[105](index=105&type=chunk) - The August 2023 corporate reorganization included a **40% workforce reduction**, incurring **$32.8 million** in charges, with **$2.6 million** accrued as of March 31, 2024[153](index=153&type=chunk)[154](index=154&type=chunk) - A January 2024 stock option exchange program for non-executive employees resulted in **$1.7 million** in incremental stock-based compensation expense[134](index=134&type=chunk)[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the commercial launch of ZURZUVAE, pipeline advancements and setbacks, and the company's financial performance, including a reduced net loss and projected cash runway into **2026** [Overview](index=46&type=section&id=Overview) This overview details the company's focus on brain health, commercialization efforts for ZURZUVAE, pipeline progress including dalzanemdor and SAGE-324, and the expected cash runway into **2026** - ZURZUVAE™ became commercially available in the U.S. in December 2023 for the treatment of PPD, co-commercialized with Biogen[160](index=160&type=chunk) - The company is advancing dalzanemdor in Phase 2 trials for cognitive impairment in Huntington's disease (DIMENSION study) and Alzheimer's disease (LIGHTWAVE study), with topline data for both expected in late 2024[169](index=169&type=chunk)[172](index=172&type=chunk) - The PRECEDENT Phase 2 study of dalzanemdor for Parkinson's disease failed its primary endpoint in April 2024, leading to discontinuation of development in this indication[173](index=173&type=chunk) - The company anticipates existing cash and funding will support operations into **2026**[177](index=177&type=chunk)[233](index=233&type=chunk) [Results of Operations](index=61&type=section&id=Results%20of%20Operations) Total revenue increased to **$7.9 million** in Q1 2024, driven by ZURZUVAE collaboration revenue, while R&D and SG&A expenses decreased due to the **2023 restructuring** Comparison of Results for the Three Months Ended March 31 (in thousands) | Line Item | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Total revenue | $7,902 | $3,294 | $4,608 | | Cost of revenues | $1,269 | $230 | $1,039 | | Research and development | $71,734 | $92,826 | ($21,092) | | Selling, general and administrative | $52,574 | $65,708 | ($13,134) | | **Net loss** | **($108,483)** | **($146,828)** | **$38,345** | - Collaboration revenue of **$6.2 million** was recognized in Q1 2024 from the company's **50% share** of Biogen's ZURZUVAE net sales in the U.S[213](index=213&type=chunk) Research and Development Expenses Breakdown (in thousands) | Program | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | zuranolone (ZURZUVAE) | $1,053 | $23,139 | ($22,086) | | SAGE-324 | $7,899 | $6,256 | $1,643 | | dalzanemdor (SAGE-718) | $23,568 | $13,064 | $10,504 | | Net reimbursement from Biogen | ($5,657) | ($17,282) | $11,625 | | **Total R&D** | **$71,734** | **$92,826** | **($21,092)** | - SG&A expenses decreased primarily due to a **$6.1 million** reduction in personnel costs and a **$3.4 million** decrease in other expenses, both from the **August 2023 restructuring**[222](index=222&type=chunk) [Liquidity and Capital Resources](index=66&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company held **$717.0 million** in cash and equivalents, with net cash used in operations significantly reduced due to a **$75.0 million** Biogen milestone payment, extending the cash runway into **2026** - As of March 31, 2024, cash, cash equivalents, and marketable securities totaled **$717.0 million**[226](index=226&type=chunk)[426](index=426&type=chunk) - A **$75.0 million** milestone payment was received from Biogen in January 2024 for ZURZUVAE's first commercial sale for PPD in the U.S[225](index=225&type=chunk)[228](index=228&type=chunk) - Management anticipates that existing cash, along with funding from collaborations and estimated revenues, will support operations into **2026**[233](index=233&type=chunk)[431](index=431&type=chunk) - An 'at the market' (ATM) offering program for up to **$250.0 million** in common stock is in place, with no shares sold in Q1 2024[124](index=124&type=chunk)[127](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its **$717.0 million** in cash and equivalents, with no material impact expected due to short-term investments - The company's primary market risk is from interest rate fluctuations on its **$717.0 million** in cash, cash equivalents, and marketable securities[241](index=241&type=chunk) - The company does not believe that inflation had a material effect on its results of operations for the three months ended March 31, 2024 and 2023[244](index=244&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective at the reasonable assurance level[246](index=246&type=chunk) - No material changes were made to the company's internal control over financial reporting during the first quarter of 2024[247](index=247&type=chunk) [PART II – OTHER INFORMATION](index=52&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, significant risk factors, and other relevant disclosures [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings that would adversely impact its financial position or operations - The company is not currently a party to any material legal proceedings[249](index=249&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks, including dependence on ZURZUVAE commercialization, pipeline development uncertainties, a history of losses, the need for future capital, and impacts from healthcare reforms like the **Inflation Reduction Act** - The company's future prospects depend heavily on the successful commercialization of ZURZUVAE for PPD with Biogen, which faces risks of market acceptance, reimbursement, and competition[251](index=251&type=chunk)[252](index=252&type=chunk) - There is significant risk in the development of other product candidates, as the PRECEDENT study of dalzanemdor for Parkinson's disease failed its primary endpoint, and the FDA issued a CRL for zuranolone for MDD, requiring additional trials[257](index=257&type=chunk)[259](index=259&type=chunk) - The company has a history of significant operating losses, with a **$2.7 billion** accumulated deficit as of March 31, 2024, and anticipates needing to raise additional capital[426](index=426&type=chunk)[430](index=430&type=chunk) - Healthcare reforms, particularly the Inflation Reduction Act of 2022 (IRA), pose a risk through potential Medicare price negotiations, inflation-based rebates, and other cost-containment measures that could adversely affect product pricing and revenue[404](index=404&type=chunk)[410](index=410&type=chunk)[413](index=413&type=chunk)

Exhibit 99.1 Sage Therapeutics Announces First Quarter 2024 Financial Results and Highlights Pipeline and Business Progress Achieved $6.2 million in ZURZUVAE™ (zuranolone) collaboration revenue during the first quarter of 2024, representing 50% of the net revenues reported by Biogen Encouraging initial demand for ZURZUVAE; More than 700 prescriptions shipped and delivered in the first quarter of 2024 Payor coverage now in place for a majority of commercially covered lives for ZURZUVAE in the treatment of wo ...

SAGE Therapeutics, Inc. (NASDAQ:SAGE) Q4 2023 Earnings Conference Call February 14, 2024 8:00 AM ET Company Participants Barry Greene - President, CEO & Director Kimi Iguchi - CFO & Treasurer Laura Gault - Chief Medical Officer Chris Benecchi - Chief Business Officer Ashley Kaplowitz - Director, IR Conference Call Participants Matt Leskowitz - Goldman Sachs Anupam Rama - J.P. Morgan Ritu Baral - TD Cowen James Condulis - Stifel Tazeen Ahmad - Bank of America Brian Abraham - RBC Capital Markets Poorna Kannan ...

2 Chris Benecchi Chief Business Officer Laura Gault Chief Medical Officer Sage Therapeutics © 2024 3 ZURZUVAE First and only oral product approved by the FDA specifically for postpartum depression (second approved product) Sage Therapeutics © 2024 The COVID-19 Pandemic had a significant effect on perinatal mental health outcomes13-15 4 Strong financial foundation to help create value for sustained growth Important Safety Information ZURZUVAE may cause serious side effects, including decreased awareness and ...