Axsome Therapeutics, Inc. Q4 FY2024 earnings call

• Axsome has a portfolio of three in-market products, three in regulatory submission stage, and ongoing Phase 3 trials, positioning to commercialize seven products by 2027.
• 2024 was a year of strong execution with total net product revenue of $386 million, driven by Auvelity and Sunosi growth.
• In 2025, expected growth supported by salesforce expansion for Auvelity, improved market access, and awareness of products. Received US approval of Symbravo on January 30th for acute migraine treatment.
• Pipeline updates: Plan to submit NDA for AXS-05 for Alzheimer's disease agitation in second half of 2025, NDA for AXS-12 for narcolepsy with cataplexy in second half of 2025, and expect to submit NDA for AXS-14 in fibromyalgia this quarter. Topline readouts anticipated from EMERGE, FOCUS, and PARADIGM Phase 3 trials in Q1 2025.
• Financials: Q4 2024 research and development expense $55 million, full year $187.1 million; selling, general and administrative expenses Q4 2024 $113.3 million, full year $411.4 million.
• Commercial update: Auvelity had ~158,000 prescriptions in Q4 2024, 10% q-o-q growth; Sunosi had ~49,000 prescriptions in Q4 2024, 4% q-o-q growth. Actively preparing for Symbravo commercial launch.

For the fourth quarter of 2024, total product revenues were $118.8 million, with net product sales of $117.3 million and royalty and milestone revenue of $1.4 million. For the full year 2024, total product revenues were $385.7 million, with net product sales of $381.7 million and royalty and milestone revenue of $4 million. Auvelity net product sales were $92.6 million in Q4 2024 and $291.4 million for the full year 2024, representing 89% and 124% year-over-year growth. Sunosi net product revenues were $26.2 million in Q4 2024 and $94.3 million for the full year 2024, with net product sales of $24.7 million and $90.3 million respectively and royalty and milestone revenue of $1.4 million and $4 million. Sunosi also had a one-time $0.5 million regulatory-based milestone in Q4 2024.

• Expect continued growth in 2025 supported by salesforce expansion for Auvelity, improved market access, and awareness. Auvelity on track to reach blockbuster potential.
• Plan to submit NDA for AXS-05 for Alzheimer's disease agitation in second half of 2025, NDA for AXS-12 for narcolepsy with cataplexy in second half of 2025, and submit NDA for AXS-14 in fibromyalgia this quarter.
• Topline readouts anticipated from EMERGE, FOCUS, and PARADIGM Phase 3 trials in Q1 2025. Enrollment progressing for ENGAGE and SUSTAIN studies with topline results in 2026.

• Forward-looking statements subject to change due to risks and uncertainties in regulatory, clinical, and market dynamics. Risks described in periodic filings with SEC, including uncertainties around NDA submissions, trial results, and commercialization.

Q: With respect to DTC promotional activities for Auvelity or Symbravo, can you comment on the cadence and strategies to optimize efficiency?

A: Intend to launch broad-based media outreach for Auvelity this year, considering calendar year seasonality. For Symbravo, will share more details in coming months.

Q: Color on salesforce expansion for Auvelity and synergy with Symbravo's prescriber base?

A: Added ~40 additional representatives to Auvelity sales team, ~10%-15% increase. Believe there's overlap with migraine treaters in primary care for synergy with Symbravo.

Q: Gating factors for AXS-05 NDA submission?

A: Building in the submission, top priority, will provide more granularity closer to second half.

Q: Will the Alzheimer's disease agitation filing be an NDA or sNDA? Have you had pre-NDA meeting for AXS-12?

A: Haven't communicated filing approach yet. Haven't confirmed timing of pre-NDA meeting for AXS-12 but will share when available.

Q: Clinically meaningful change on AISRS for ADHD trial and comparison to Qelbree?

A: Results pending, first study with Solriamfetol in ADHD, will look at data and compare to Qelbree when available.

Q: Expectations for PARADIGM study on Solriamfetol in MDD and positioning of product?

A: PARADIGM is first study with Solriamfetol in MDD, will learn from readout. Potential positioning for patients with comorbidities of excessive daytime sleepiness and depression.

Q: Symbravo uptake and factors impacting net price?

A: Optimistic about impact, targeted at headache specialists and neurology practices. Will have more to share on commercial launch, mindful of high rebate environment but confident in clinical profile.

Q: Thoughts on M&A/biz dev with existing commercial infrastructure?

A: Always looking for opportunities, open to complementing pipeline with assets, dedicated resources evaluating opportunities.

Q: Expenses this year and gating factors for AXS-12 NDA?

A: R&D spend peaked in Q4 2024, expected to moderate in 2025. AXS-12 NDA involves pre-NDA meeting and building submission, clinical program done, now back-office work.

Q: Patent settlement around Auvelity and impact on peak assumptions?

A: Dates were negotiated, will update and refine guidance as launch progresses with LOE day.

Q: Impact of Medicare Part D restructure on Auvelity revenues and mix of patients?

A: Don't expect significant impact, currently Auvelity is ~15% Medicare, no significant changes anticipated, but AXS-05 for Alzheimer's will have heavier Medicare focus.

Q: Timeline for AXS-05 in smoking cessation and differences between traditional vs e-cigarette users?

A: Phase 3 trial to start in 2025, initial trial for smokers, other nicotine users to be addressed later.