Financial Data and Key Metrics Changes - In Q4 2024, collaboration revenue from XERZUVE sales was $11.4 million, a 4% increase from Q3 2024, with full-year revenue at $36.1 million [19] - The net loss for Q4 2024 was $95.8 million, with R&D expenses at $37 million and SG&A expenses at $54 million [20][21] - The company anticipates overall operating expenses to substantially decrease in 2025 compared to 2024 due to reductions in R&D and G&A from pipeline prioritization [20] Business Line Data and Key Metrics Changes - XERZUVE saw nearly 2,500 prescriptions shipped in Q4 2024, representing a 21% increase from Q3 2024, with over 6,600 prescriptions shipped throughout 2024 [13][14] - More than 70% of XERZUVE patients received it as their first new treatment for PPD, with about 60% of targeted healthcare providers writing repeat prescriptions [15][16] Market Data and Key Metrics Changes - Over 95% of commercial and Medicaid lives are covered or have a path to coverage for XERZUVE, with the majority having no step edits or complex prior authorizations [17] - The company is seeing a promotionally responsive market, with a 33% growth rate in patient shipments in territories where the sales force was expanded [18] Company Strategy and Development Direction - The company plans to build on XERZUVE's commercial momentum, recalibrate its R&D approach, and maintain financial discipline to enhance shareholder growth [7] - The focus for 2025 includes establishing SERGEUVA as a standard of care for PPD and prioritizing the pipeline for neuropsych and neurodevelopmental disorders [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercialization of XERZUVE and the potential for significant growth in 2025, supported by strong demand and a favorable reimbursement environment [11][12] - The company is committed to maintaining a strong financial position with a cash runway expected to last until mid-2027 [21] Other Important Information - The Board rejected Biogen's unsolicited acquisition proposal, stating it undervalued the company and initiated a strategic review to maximize shareholder value [12] - The company is exploring partnerships and out-licensing opportunities for clinical and preclinical stage compounds [24] 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 [28][30] Question: What are the inventory dynamics for the quarter? - Management explained that revenue is influenced by inventory management at specialty pharmacies and wholesalers, emphasizing that demand is the key metric to assess performance [34][36] Question: How do you anticipate the first quarter will perform given historical seasonality? - Management expects continued quarter-on-quarter growth, noting that the reimbursement structure does not present typical first-quarter issues [42][43] Question: What proportion of patients are receiving XERZUVE as their first-line therapy? - Over 70% of patients are receiving XERZUVE as their first-line treatment, with historical bias being a challenge for those on other medications [115][117] 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 amounting to approximately $55 million [96][97] Question: How sensitive is the market to marketing efforts? - Management noted that the market is promotionally responsive, with both physician engagement and patient awareness contributing to prescription growth [104][106]

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 ...

Sage Therapeutics, Inc. (SAGE) closed the last trading session at $6.14, gaining 9.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $8.72 indicates a 42% upside potential.The average comprises 18 short-term price targets ranging from a low of $4 to a high of $17, with a standard deviation of $3.54. While the lowest estimate indicates a decline of 34.9% from the current price leve ...

Sage Therapeutics, Inc. (SAGE) shares rallied 12.2% in the last trading session to close at $5.61. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 3.1% gain over the past four weeks.The company recently announced a strategic reorganization wherein it decided to focus on the commercialization of its depression drug Zurzuvae (zuranolone), which is marketed in partnership with Biogen. Zurzuvae is the first and o ...

Sage Therapeutics’ (SAGE) phase II study evaluating its neuropsychiatric candidate, dalzanemdor (SAGE-718), for treating cognitive impairment (CI) associated with Huntington’s Disease (HD) failed to meet the primary endpoint.The double-blind, placebo-controlled DIMENSION study evaluated the effects of dalzanemdor in participants with CI associated with HD.Top-line data from the study showed that dalzanemdor failed to demonstrate a statistically significant difference from baseline compared to placebo on the ...

Sage Therapeutics, Inc. (SAGE) reported a loss of $1.53 per share for the third quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.52. The company had reported a loss of $2.81 per share (excluding the restructuring expenses) in the year-ago quarter. Revenues in the third quarter totaled $11.8 million, significantly up from $2.7 million reported in the year-ago period. The upside can be attributed to sales of new depression drug Zurzuvae (zuranolone), which is marketed in partnership wi ...