Axsome Therapeutics(US:AXSM)2022-11-07 18:29Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was generated solely from Sunosi, amounting to U.S. net sales of $16.8 million, marking the first full quarter of sales for the product [14] - R&D expenses increased to $14.9 million from $13.2 million in Q3 2021, driven by personnel expenses and ongoing clinical trials [15] - SG&A expenses rose significantly to $40.9 million from $20.2 million in the comparable period, primarily due to commercial activities for Sunosi and pre-launch activities for Auvelity [15] - The net loss for Q3 2022 was $44.8 million or $1.07 per share, compared to a net loss of $34.9 million or $0.93 per share in Q3 2021 [16] - Cash and equivalents at the end of the quarter stood at $227.5 million, a substantial increase from $86.5 million at the end of 2021 [16] Business Line Data and Key Metrics Changes - Sunosi's total prescriptions grew 15% year-over-year, significantly outpacing the wake-promoting agent market, which grew only 1% [18] - The current prescription split for Sunosi is approximately 70% for obstructive sleep apnea (OSA) and 30% for narcolepsy [66] Market Data and Key Metrics Changes - Sunosi currently holds a 2% share of drug-treated OSA patients and a 7% share in drug-treated narcolepsy patients, indicating substantial growth potential [19] - Payer coverage for Sunosi remains robust, with 96% of commercial lives covered and 83% of total lives covered [19] Company Strategy and Development Direction - The company is focused on expanding the commercialization of Sunosi and has recently launched Auvelity for major depressive disorder (MDD), addressing a significant public health concern [9][10] - The pipeline includes several late-stage CNS products, with plans for NDA submissions for AXS-07, AXS-12, and AXS-14 in 2023 [11][12][13] - The company aims to leverage its Digital Centric Commercialization platform to enhance sales force productivity and market engagement for both Sunosi and Auvelity [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential for Sunosi and the early interest in Auvelity, despite it being only 12 days post-launch [10][20] - The company anticipates continued significant value creation from its pipeline and is preparing for clinical trial readouts and NDA filings in the near future [11][13] Other Important Information - The company utilized its ATM facility to realize net proceeds of $175 million during the third quarter [16] - The FDA approval of Auvelity allows access to up to $100 million under a $300 million term loan facility [16] Q&A Session Summary Question: What do you think is most attractive to prescribers regarding Auvelity's clinical profile? - Management indicated that the attractiveness lies in a combination of differentiated mechanism, onset, and limited side effects [25][26] Question: What feedback have you received from the FDA regarding the randomized withdrawal study? - Management noted that the design provides clear evidence of drug efficacy relative to control, and products have been approved based on such studies [27][28] Question: Can you provide insights on gross to net inventory changes for Sunosi? - Management expects gross to net to be around 50%, with no significant inventory impact during the quarter [33][35] Question: What is the current payer coverage for Auvelity? - Coverage is expected to evolve, with commercial payers typically blocking new therapies for clinical reviews post-launch [42][43] Question: What metrics will be reported regularly on earnings calls? - Management confirmed that they will report on scripts, HCP adoption, and payer coverage as they progress [72][74]