Axsome Therapeutics (NASDAQ:AXSM) executives said the company is preparing for a June launch of AUVELITY in Alzheimer’s disease agitation while continuing to expand its push in major depressive disorder, citing broad payer access, a larger sales force and what they described as a differentiated clinical profile.
Speaking at a company presentation, Chief Operating Officer Mark Jacobson and Chief Financial Officer Nick Pizzie discussed the recent approval of the new AUVELITY indication, the company’s commercial strategy and updates on other assets including SYMBRAVO and SUNOSI.
AUVELITY Launch Strategy Centers on Overlap With Depression Market
Jacobson said the new label for Alzheimer’s disease agitation is “incredibly clean” and gives Axsome’s commercial team room to educate prescribers across both the new indication and AUVELITY’s existing major depressive disorder, or MDD, indication. He said Alzheimer’s disease agitation represents a serious unmet need, while also creating commercial overlap with depression treatment.
Pizzie said AUVELITY is 14 quarters into its MDD launch. Axsome began that launch with 160 sales representatives, later expanded to 260 and then 300, and has now increased the field force to 630 representatives ahead of the Alzheimer’s disease agitation launch and in response to the trajectory in MDD.
According to Pizzie, AUVELITY has 86% payer access in MDD, with 56% either first line or first switch. He said the product currently has 0.2% of the total antidepressant market and is annualizing at more than $600 million, while holding 0.3% of the NBRx market.
Jacobson said the company’s internal view of synergy between indications is based less on analogs from other central nervous system drugs and more on prescriber-level analysis. He said long-term care is a key area of overlap because of high rates of depression among residents and among patients with Alzheimer’s disease agitation.
“Fifty percent to 80% of individuals in long-term care facilities are depressed, and that’s not an area that we’ve actively educated in the past or detailed in,” Jacobson said.
Company Highlights Differentiation in Alzheimer’s Disease Agitation
Asked about the competitive position of AUVELITY in Alzheimer’s disease agitation, Jacobson said the drug’s differentiation starts with its mechanism, which he described as targeting NMDA and sigma-1. He said that profile is distinct from on- and off-label pharmacotherapies currently used in the patient population.
Jacobson said the label includes parallel-group efficacy data showing that the product works quickly, with separation seen at two to three weeks, as well as relapse-prevention data demonstrating duration of effect over longer periods. He also emphasized tolerability, citing low rates of adverse events and saying the label does not include a boxed warning for this patient population.
“We didn’t see sedation. We don’t see a mortality signal. We don’t see a fall signal,” Jacobson said, adding that the most common adverse events listed for the patient population are dizziness and dyspepsia.
Jacobson said the 630-person sales force will promote both Alzheimer’s disease agitation and MDD, with targeting decisions driven by provider type, account mix and geography. Each account manager will have a blend of targets focused on MDD, Alzheimer’s disease agitation or both.
Medicare Part D Coverage Expected to Support Launch
Pizzie said Axsome expects about 80% of Alzheimer’s disease agitation prescriptions to fall under Medicare Part D. He said the company currently has 100% covered lives in Part D, with 75% of those lives having no prior authorization and first-line or first-switch access. For the remaining 25%, Pizzie said the company expects most prior authorizations to be limited to confirmation of indication.
On gross-to-net dynamics, Pizzie said Axsome expects net price in Part D to be slightly better than in the commercial channel because copay coverage is not allowed in Part D.
For long-term care, Pizzie said a portion of the 630 representatives will be dedicated to that channel and will function more like key account managers than traditional specialty or primary care representatives. He said their role will include educating facilities about payer access and building relationships with pharmacies and health care professionals who support the centers.
Jacobson added that Axsome has been preparing supply chain infrastructure through its existing MDD business to ensure prescriptions can be filled when written.
MDD Growth Plan Includes Primary Care and DTC Investment
In MDD, Jacobson said the company’s long-term expectations are based on current trends in primary care adoption, patient performance and clinician feedback. He said Axsome is investing further in primary care and does not view its targets as dependent on a narrow patient profile.
Pizzie noted that the company has exclusivity through early 2039 with pediatric indications and said AUVELITY is still early in its commercial life. He said Axsome has been “laying the roots and the foundation” and is now increasing investment with the larger sales team and direct-to-consumer advertising.
On DTC spending, Pizzie said Axsome began advertising in the fourth quarter of last year and has learned more about the mix between traditional linear television and digital TV. A new campaign began in March and is expected to continue through the rest of the year, though Pizzie said spending will remain disciplined.
Jacobson said the company still views the sales force as its best return-on-investment opportunity, with DTC and other promotional channels serving as supporting elements.
Updates on SYMBRAVO and SUNOSI
Discussing SYMBRAVO, Pizzie said an inflection in revenue recognition is expected to come as payer access improves. He cited a “nice win” in the first quarter and said sequential prescription growth was about 36% quarter over quarter. He said feedback on the product has been positive, including on efficacy and safety, and noted that Axsome is expanding the SYMBRAVO sales effort from an average of roughly 100 representatives.
Jacobson said SYMBRAVO operates in a market that is different from depression, particularly in access and treatment dynamics, and that Axsome has been using a data-driven approach to understand clinician feedback and market operations before investing further.
On SUNOSI in attention-deficit/hyperactivity disorder, Jacobson said adult trial efficacy was in line with stimulants on an absolute-change basis and that the product has a distinct tolerability and scheduling profile. He said Axsome is starting two trials in children and adolescents and will provide updates during the year.
“We just have to finish the clinical program,” Jacobson said.
About Axsome Therapeutics (NASDAQ:AXSM)
Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.
Axsome's pipeline includes several late-stage and approved product candidates.
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