Axsome Therapeutics (NASDAQ:AXSM) executives said the company is seeing accelerating prescription growth for AUVELITY following its sales-force expansion and the recent launch of the drug in Alzheimer’s disease agitation, while management expects operating expenses to remain relatively stable in the second half of the year.
Speaking at Morgan Stanley’s Global Healthcare Conference, Chief Financial Officer Nick Pizzie said the majority of AUVELITY prescription growth in the second quarter was tied to major depressive disorder and the expanded commercial organization. More recently, however, the Alzheimer’s disease agitation indication has begun to contribute more meaningfully to new-to-brand prescription trends.
Pizzie said AUVELITY reached a record 3,800 weekly new-to-brand prescriptions on the Friday before the conference. Average weekly new-to-brand prescriptions were about 2,400 in the first quarter and 3,000 in the second quarter, he said. The company had also recorded three consecutive weeks of its highest new-to-brand prescription levels.
AUVELITY Launch Metrics and Sampling
Chief Operating Officer Mark Jacobson said Axsome expects the commercial effects of both its expanded field force and Alzheimer’s disease agitation launch to emerge over one to two quarters, rather than produce an immediate jump in overall prescription data.
He said the company is focused on new-to-brand prescriptions and new prescribers as earlier indicators of adoption, which it expects eventually to translate into total prescription growth. Jacobson added that physician feedback on AUVELITY in Alzheimer’s disease agitation has been encouraging, with prescribers reporting that the product is working well and demonstrating a favorable tolerability profile.
The company is using a sampling program that includes a three-week titration pack for Alzheimer’s disease agitation. Jacobson said sample conversion rates can fluctuate during the early launch period, including because some patients transitioning from other therapies may be titrated more slowly or receive maintenance-dose samples.
Axsome has not disclosed sample conversion rates and does not plan extensive commentary on its sampling strategy, Jacobson said. Still, he said the company is seeing samples convert into prescriptions and expects its third-quarter results to provide a more complete view of the launch. Pizzie said Axsome is considering providing investors with additional launch metrics when it reports its first full quarter of results for the new indication.
Commercial Opportunity and Market Access
Management reiterated its long-term $8 billion peak-sales model for AUVELITY, including $4 billion each in major depressive disorder and Alzheimer’s disease agitation. Pizzie characterized the assumptions underlying that outlook as conservative.
In major depressive disorder, AUVELITY had captured approximately 26 basis points of the overall antidepressant market as of the end of the second quarter, according to Pizzie. He said that level of market share corresponded with a run rate approaching three-quarters of a billion dollars, while 1% of the total market would represent more than $3 billion in sales.
For Alzheimer’s disease agitation, Pizzie cited more than 20 million prescriptions and said that roughly 99% of the market had previously consisted of generic, off-label treatments. Jacobson said the company’s model uses lower persistence assumptions for Alzheimer’s disease agitation than it uses in depression, despite clinical results showing durable responses and low discontinuation rates.
Axsome has more than doubled its commercial team and added a long-term-care team, Pizzie said. The company has 89% coverage of total covered lives, including 100% Medicare coverage, and has first-line or first-switch positioning in a majority of covered plans, he added. The expanded organization is intended to deepen coverage among high-decile prescribers while expanding outreach to primary care providers.
Pipeline, Spending and Cash Flow
Jacobson highlighted several development programs for solriamfetol, with attention focused on attention-deficit/hyperactivity disorder, major depressive disorder with excessive sleepiness, binge eating disorder and shift work disorder. Two pediatric ADHD studies are underway, and positive results from both could support a filing, he said. A completed adult ADHD study was positive, according to Jacobson.
The company expects a fourth-quarter readout from the ENGAGE trial in binge eating disorder. Jacobson said Axsome would likely need an additional study for a filing if ENGAGE is positive. For shift work disorder, he said the company expects that one positive study could support an application because of the condition’s relationship to solriamfetol’s existing approved uses.
For AXS-12 in cataplexy and narcolepsy, Jacobson said Axsome sees a $500 million to $1 billion commercial opportunity. He cited daytime dosing, a distinct safety and tolerability profile, and clinical benefits in cataplexy, sleep, excessive daytime sleepiness and cognition as potential differentiators. Pizzie said the PDUFA date is May 1, 2027.
Pizzie said selling, general and administrative expense of $208 million in the second quarter should be a reasonable reference point for the back half of the year, as the cost of the sales-force expansion was largely included in that figure. Research and development expense, which was $46 million in the second quarter, is expected to rise modestly as the company runs five Phase 3 trials.
Management said revenue is expected to grow faster than operating expenses, creating operating leverage. Pizzie declined to specify the quarter in which Axsome expects to reach cash-flow positivity, but said the company has a “very clear path” toward positive cash flow and profitability thereafter.
Jacobson also said Axsome plans to continue investing in commercial execution and pipeline development, including label-expansion efforts for marketed products. The company recently began the Phase 3 SUMMIT trial of AUVELITY in smoking cessation and is evaluating other potential indications across its portfolio.
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.
