Financial Data and Key Metrics Changes - In Q1 2025, the company reported collaboration revenue of $13.8 million, a 21% increase from Q4 2024 [15][18] - R&D expenses were $22.8 million, reflecting a 68% decrease compared to Q1 2024, and a nearly 40% decrease from Q4 2024 [16][17] - 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 [7][12] - The company generated $13.8 million in collaboration revenue for XERZUVEY, which is 50% of the net revenue reported by Biogen, marking a 21% increase from the previous quarter [15][18] - Over 70% of women prescribed XERZUVEY received it as their first new treatment for PPD [12][40] Market Data and Key Metrics Changes - The majority of prescriptions (almost 80%) in Q1 2025 came from OBGYNs, indicating a strong focus on peripartum care [12][26] - The total number of XERZUVEY writers 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 [6][8] - A strategic alternatives process is ongoing to evaluate opportunities for maximizing shareholder value [6] - The company has recalibrated its R&D approach to prioritize neuropsychiatry and neurodevelopmental disorders, with a focus on SAGE-319 and the NMDA receptor NAM platform [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercialization of XERZUVEY and the potential for significant growth in 2025 [11][18] - The cash runway is expected to support operations until mid-2027, with plans to create shareholder value through focused R&D and commercialization efforts [18][108] Other Important Information - The company has seen a paradigm shift in how healthcare providers are screening, diagnosing, and treating PPD [7][8] - The sales force expansion is complete, and management anticipates continued quarter-over-quarter growth in demand and revenue [12][39] 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 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 expressed confidence in the recalibrated R&D approach and the pharmacology of their drugs, believing they will create significant shareholder value if successful [31][33] 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 treatment, suggesting minimal obstacles to frontline use [40][41] Question: Can you speak about the concentrations of the sales force in particular regions? - Management confirmed that the sales force expansion is complete and they expect continued growth in regions where the sales force has been expanded [39] Question: How should we think about the acceleration in growth in shipments as the quarters progress? - Management reiterated their expectation of quarter-over-quarter growth and noted that they are not providing forward-looking forecasts [56][57] Question: What is the current awareness of XERZUVEY among OBGYNs and the expecting mother community? - Management reported approximately 90% aided awareness among physicians treating PPD, which is considered remarkably high for a product at this stage [65][66] Question: Has anything changed regarding Biogen's commitment to the product? - Management stated that there has been no change in the partnership with Biogen, and both parties are excited about the product's impact [72] Question: What is the persistence of prescribers for XERZUVEY? - Management indicated that once a healthcare provider prescribes XERZUVEY, they tend to become repeat writers, with no significant drop-off observed [114]

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]