• Total Product Revenue: $118.8 million for Q4 2024; $385.7 million for full year 2024, representing 66% and 88% year-over-year growth, respectively.
• Auvelity Net Product Sales: $92.6 million for Q4 2024; $291.4 million for full year 2024, representing 89% and 124% year-over-year growth.
• Sunosi Net Product Revenues: $26.2 million for Q4 2024; $94.3 million for full year 2024, representing 16% and 26% year-over-year growth.
• Cost of Revenue: $10.5 million for Q4 2024; $33.3 million for full year 2024.
• Research and Development Expense: $55 million for Q4 2024; $187.1 million for full year 2024.
• Selling, General and Administrative Expenses: $113.3 million for Q4 2024; $411.4 million for full year 2024.
• Net Loss: $74.9 million for Q4 2024; $287.2 million for full year 2024.
• Cash and Cash Equivalents: $315.4 million at the end of 2024.
• Auvelity Prescriptions: Approximately 158,000 in Q4 2024, representing 10% quarter-over-quarter growth.
• Sunosi Prescriptions: Approximately 49,000 in Q4 2024, representing 4% sequential growth.

• Warning! GuruFocus has detected 5 Warning Signs with CC.

Release Date: February 18, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Axsome Therapeutics Inc (NASDAQ:AXSM) reported strong financial performance with total net product revenue of $386 million for 2024, reflecting high double-digit year-over-year growth.
• The company received US approval for Symbravo, a novel oral acute treatment for migraine, and is preparing for its commercial launch.
• Axsome Therapeutics Inc (NASDAQ:AXSM) has a robust late-stage pipeline with plans to submit NDAs for AXS-05, AXS-12, and AXS-14 in 2025.
• Auvelity and Sunosi showed significant demand growth, with Auvelity achieving 89% and 124% year-over-year growth in net product sales for the fourth quarter and full year, respectively.
• The company ended 2024 with $315.4 million in cash and cash equivalents, which is expected to fund operations into cash flow positivity.

Negative Points

• Axsome Therapeutics Inc (NASDAQ:AXSM) reported a net loss of $287.2 million for the full year of 2024, an increase from the previous year.
• Research and development expenses increased significantly to $187.1 million for the full year of 2024, impacting overall profitability.
• The company anticipates a slower growth rate in Q1 2025 due to negative seasonality effects.
• There are uncertainties regarding the regulatory filing strategy for AXS-05 in Alzheimer's disease agitation, which could impact timelines.
• The high rebating environment for oral CGRPs presents challenges for the net pricing strategy of Symbravo.

Q & A Highlights

Q: With respect to DTC promotional activities for Auvelity or Symbravo, can you comment on the cadence and strategies for optimizing efficiency? A: Herriot Tabuteau, CEO: We plan to launch a broad-based media outreach for Auvelity in the coming months, ensuring sufficient spend to drive awareness. We will consider calendar year seasonality to optimize media investment. For Symbravo, commercial plans will be shared soon.

Q: Can you provide details on the sales force expansion for Auvelity and its synergy with Symbravo's prescriber base? A: Herriot Tabuteau, CEO: We added about 40 representatives to the Auvelity sales team, a 10-15% increase. There is expected synergy with Symbravo, especially among migraine treaters in primary care, due to overlapping comorbidities with depression.

Q: Will the Alzheimer's disease agitation filing be an NDA or sNDA, and have you had the pre-NDA meeting for AXS-12 for narcolepsy? A: Mark Jacobson, COO: We haven't communicated the filing approach for Alzheimer's yet. For AXS-12, we haven't confirmed the timing for the pre-NDA meeting but will share updates once available.

Q: What are the expectations for the seasonal cadence of scripts and revenues for Auvelity in 2025, especially in Q1? A: Herriot Tabuteau, CEO: We expect Q1 to be a growth quarter, albeit slower than the back half of the year. The sales force expansion is showing positive indicators, and we anticipate incremental growth in new patient starts by the end of Q1.

Q: How are you thinking about M&A and business development given the exclusivity runway for Auvelity and cash generation? A: Nick Pizzie, CFO: We are open to opportunities that complement our pipeline, including earlier-stage assets. We have dedicated resources to evaluate potential opportunities.

Q: Can you provide insights into the PARADIGM study for solriamfetol in MDD and its positioning relative to Auvelity? A: Herriot Tabuteau, CEO: The PARADIGM study is the first with solriamfetol in MDD. If positive, it could be positioned for patients with both excessive daytime sleepiness and depression, leveraging its unique mechanism of action.

Q: How should we think about the launch trajectory and uptake for Symbravo in the migraine market? A: Ari Maizel, CCO: We expect uptake similar to recent oral CGRP launches. Symbravo has a unique clinical profile, and we are targeting headache specialists and neurology practices, which represent 70% of the branded market.

Q: What are the regulatory and commercial considerations for the Alzheimer's disease agitation filing strategy? A: Mark Jacobson, COO: The filing strategy involves considerations across branding, IP, market access, and regulatory aspects. We will provide specific details on our approach soon.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.