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]
Sage Therapeutics(SAGE) - 2024 Q1 - Earnings Call Transcript