Axsome Therapeutics Highlights Auvelity Growth, Pipeline Progress at H.C. Wainwright Conference

Axsome Therapeutics executives highlighted growth across its commercial portfolio, an expanded sales force and multiple late-stage clinical programs during the H.C. Wainwright 28th Annual Global Investment Conference. Chief Operating Officer Mark Jacobson said the company has three marketed products: Auvelity for major depressive disorder and Alzheimer’s disease agitation; Sunosi for excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy; and SYMBRAVO for the acute treatment of migraine. The company also has six product candidates in development across 10 psychiatry and neurology indications, he said.

Chief Financial Officer Nick Pizzie said Axsome reported second-quarter revenue of $218.4 million, representing 46% year-over-year growth and 14% sequential growth. Auvelity generated more than $180 million of that total, while Sunosi contributed $36 million and SYMBRAVO produced $2.3 million.

Executives emphasized Auvelity’s commercial opportunity following its recently approved indication for agitation associated with Alzheimer’s disease. Jacobson said the launch began in the summer and became more fully operational in June, alongside the completion of an expansion of the company’s community sales force.

Pizzie said Axsome expanded its sales organization from fewer than 300 representatives to more than 600, or roughly 630 when including its long-term-care team. The company added the long-term-care-focused team after receiving the Alzheimer’s disease agitation indication, according to Jacobson. “We expect to see that growth begin essentially now,” Jacobson said, referring to expected effects from the field-force expansion, market-access developments and the new indication.

Pizzie said the company estimates Auvelity’s annual peak-sales potential at more than $8 billion, split roughly between major depressive disorder and Alzheimer’s disease agitation. He said the product’s annualized revenue based on second-quarter results was about $750 million, representing what he characterized as a small share of the broader antidepressant market. The company said all Medicare Part D participants have access to Auvelity for Alzheimer’s disease agitation, with more than 85% of patients not requiring prior authorization and having unrestricted or first-line access, according to Pizzie.

Sunosi, which Axsome acquired and markets for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, continues to grow steadily, Jacobson said. Pizzie cited estimated peak-sales potential of $300 million to $500 million for the product. For SYMBRAVO, Pizzie said revenue rose 30% sequentially in the second quarter. Executives said demand and feedback have bee...