Axsome Therapeutics (AXSM) Q2 2024 earnings summary

Executive summary

• Achieved total net product revenue of $87.2 million in Q2 2024, up 87% year-over-year, driven by strong Auvelity and Sunosi sales growth and expanded payer coverage.

• Advanced late-stage CNS pipeline, including NDA resubmission for AXS-07 (migraine), progress toward NDA submission for AXS-14 (fibromyalgia), and initiation of multiple Phase 3 trials.

• Multiple pivotal Phase 3 trial readouts expected in the second half of 2024 and 2025, supporting future growth.

• Auvelity and Sunosi remain the only commercial products, with ongoing development of additional CNS therapies.

• Recent clinical milestones include positive data for AXS-12 in narcolepsy and expanded commercial coverage for Auvelity.

Financial highlights

• Total net product revenue reached $87.2 million in Q2 2024, up from $46.7 million in Q2 2023.

• Auvelity net sales were $65 million (135% year-over-year growth); Sunosi net revenue was $22.1 million (16% year-over-year growth).

• Net loss was $79.3 million ($1.67 per share), compared to $67.2 million ($1.54 per share) in Q2 2023, including $26 million in non-cash charges.

• R&D expenses rose to $49.9 million (from $20.6 million in Q2 2023), reflecting increased clinical activity and personnel costs.

• SG&A expenses increased to $103.6 million (from $78.9 million), mainly due to commercialization and organizational growth.

Outlook and guidance

• Current cash balance of $315.7 million as of June 30, 2024, is expected to fund operations into cash flow positivity under the current plan.

• Anticipates top-line results from multiple Phase 3 trials (ADVANCE-2, ACCORD-2, FOCUS, AXS-07, AXS-05, solriamfetol) in the second half of 2024.

• NDA submission for AXS-14 in fibromyalgia expected in Q3 2024.

• Expects continued commercial coverage expansion and evolving market access for Auvelity.

• Expenses projected to increase as commercialization and clinical development activities expand.