Axsome (AXSM) Q1 2025 Earnings Call Transcript

Motley Fool Transcribing, The Motley Fool

Mon, May 4, 2026 astatine 10:35 AM CDT 39 min read

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DATE

Monday, May 5, 2025 astatine 8:00 a.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Dr. Herriot Tabuteau

• Chief Financial Officer — Nick Pizzie

• Chief Commercial Officer — Ari Maizel

• Chief Operating Officer — Mark Jacobson

• General Counsel — Hunter Murdock

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Full Conference Call Transcript

Turning to today's agenda. Dr. Herriot Tabuteau, our CEO, volition unfastened today's treatment with an overview of our show and cardinal upcoming catalysts; Nick Pizzie, our Chief Financial Officer, volition reappraisal our fiscal results for the quarter; Ari Maizel, our Chief Commercial Officer, volition past supply a commercialized update; Mark Jacobson, our Chief Operating Officer; and Hunter Murdock, our General Counsel, volition beryllium joining america for Q&A. And with that, I volition crook the telephone implicit to Herriot.

Herriot Tabuteau: Thank you, Darren and bully morning, everyone. Axsome entered 2025 with beardown momentum crossed the business. In the archetypal quarter, we delivered year-over-year full gross maturation of 62%, driven by robust underlying request for Auvelity and Sunosi. In addition, the caller FDA support of Symbravo, our 2nd internally developed product, reflects Axsome's committedness to delivering innovative medicines with the imaginable to meaningfully amended upon the standards of attraction for patients surviving with superior CNS conditions. Our portfolio contiguous is distinctively diversified and strategically positioned to thrust durable growth. Earlier this year, I outlined cardinal priorities related to our pipeline. The archetypal was to beforehand our 3 caller NDA signifier merchandise candidates toward regulatory filings.

These see AXS-14 for the absorption of fibromyalgia, AXS-05 successful Alzheimer's illness agitation and AXS-12 for the attraction of cataplexy and narcolepsy. The 2nd was to successfully execute crossed our aggregate Phase III objective programs that broaden the imaginable of our existent products and merchandise candidates, including AXS-05, Solriamfetol and Symbravo. Since conscionable the opening of this year, we've made important advancement connected some fronts, which underscores the agility and operational excellence of our organization. Starting with AXS-14 for the attraction of fibromyalgia. We person submitted our NDA to the FDA for AXS-14, and expect a determination connected the acceptance of the filing successful the 2nd quarter.

Fibromyalgia is simply a chronic and often debilitating the imaginativeness characterized by wide pain, fatigue, slumber disturbance and cognitive impairment. Recent probe suggests that determination are implicit 17 cardinal radical successful the U.S. who are surviving with fibromyalgia. Despite this prevalence, determination has been nary meaningful therapeutic innovation successful much than 15 years portion presently disposable attraction options connection adaptable efficacy and bash not code each cardinal symptoms of this condition. AXS-14 has the imaginable to code this unmet aesculapian request successful the attraction of fibromyalgia if approved. Turning present to AXS-05 for the attraction of Alzheimer's illness agitation.