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

Axsome Therapeutics (NASDAQ:AXSM) 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.

Auvelity Growth and Alzheimer’s Disease Agitation Launch

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.

Other Commercial Products

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 been positive, while payer access remains an important factor in the migraine market. Axsome increased the SYMBRAVO sales team from about 100 representatives to 150 representatives, with the impact of the additional personnel not yet reflected in the cited growth figures.

The company estimates SYMBRAVO could have annual peak sales of $500 million to $1 billion, Pizzie said.

Pipeline Milestones and Financial Position

Axsome has an NDA under FDA review for AXS-12 in narcolepsy, with a Prescription Drug User Fee Act date of May 1, Jacobson said. The company also recently initiated a Phase 3 smoking-cessation study of AXS-05, called SUMMIT, and two Phase 3 studies of solriamfetol in children and adolescents with ADHD, called FOCUS-2 and FOCUS-3.

Top-line results from the Phase 3 ENGAGE trial of solriamfetol in binge eating disorder are expected in the fourth quarter, Jacobson said. The company expects top-line results from a shift-work-disorder trial of sarampanadol next year.

• Seven clinical trials are ongoing, according to Axsome.
• The company is also pursuing programs in fibromyalgia, major depressive disorder with excessive sleepiness, schizophrenia, epilepsy and Tourette syndrome.
• Executives said they see the potential for approximately one NDA filing annually for the foreseeable future through 2031.

Pizzie said Axsome ended the second quarter with $320 million in cash, which he described as the company’s strongest financial position since inception. The company reported $46 million of research and development expense and $208 million of selling, general and administrative expense during the quarter.

Axsome expects selling, general and administrative spending to remain essentially level in the second half of the year, while research and development expense is expected to rise modestly as Phase 3 programs advance, Pizzie said. He added that the company is approaching cash-flow positivity and expects profitability to follow.

Jacobson also highlighted the company’s intellectual-property position, saying Auvelity exclusivity is expected to extend to early 2039 with pediatric exclusivity, while Sunosi’s established runway extends into 2040. He said SYMBRAVO patents extend to at least 2045, with work ongoing to establish its potential exclusivity period.

About Axsome Therapeutics (NASDAQ:AXSM)

Axsome Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for central nervous system (CNS) disorders. The company’s research programs address conditions with substantial unmet medical needs, including depression, migraine, narcolepsy, excessive daytime sleepiness, agitation associated with Alzheimer’s disease, and other neurological or psychiatric disorders.

Axsome’s commercial portfolio includes Auvelity, an oral medicine approved in the United States for the treatment of major depressive disorder in adults.