Axsome Therapeutics' Q3 2025 Earnings Call: Contradictions in Sales Force Expansion, Reboxetine Strategy, and AXS-05 Commercialization Plans

Date of Call: November 3, 2025

Financials Results

• Revenue: $171.0M total product revenue, up 63% YOY; AUVELITY $136.1M, up 69% YOY; SUNOSI $32.8M, up 35% YOY; SYMBRAVO $2.1M (first full quarter)
• EPS: Net loss $47.2M or $0.94 per share, compared to net loss $64.6M or $1.34 per share in Q3 2024

Guidance:

• Submitted sNDA for AXS-05 (Alzheimer's agitation); awaiting FDA acceptance decision.
• Target NDA submission for AXS-12 (cataplexy in narcolepsy) in Q4 2025.
• Initiate Phase II/III smoking cessation trial for AXS-05 this quarter.
• Initiate pediatric Phase III for solriamfetol (ADHD) in Q4 and a Phase III for MDD with EDS this quarter.
• Expect ENGAGE (binge eating) and SUSTAIN (shift work) topline readouts next year.
• Launch AXS-14 Phase III in fibromyalgia before year-end.
• AUVELITY and SUNOSI gross-to-net expected to rise from high-40% in Q3 to low-50% in Q4; SYMBRAVO GTN to remain mid-70s during launch.
• Cash $325.3M; management believes this funds operations into cash-flow positivity and includes anticipated ADA sales-force expansion costs.

Business Commentary:

* Revenue Growth and Market Performance: - Axsome Therapeutics reported total revenue of $171 million in Q3 2025, representing a 63% increase year-over-year. - The growth was driven by strong performance in its three marketed products, particularly AUVELITY and SUNOSI.

• Product Performance and Market Share:
• AUVELITY generated $136.1 million in net product sales, up 69% year-over-year, demonstrating strong demand and market traction in major depressive disorder.

• The increase was attributed to continued high underlying demand, strategic commercial investments, and expanded sales force efforts.

• Product Launches and Strategic Execution:

• SUNOSI recorded $32.8 million in net product sales, with 35% year-over-year growth.

• Growth was supported by strong demand in the wake-promoting agent market and increasing adoption among clinicians.

• Pipeline and Late-Stage Development:

• Axsome submitted a supplemental NDA for AXS-05 in Alzheimer's disease agitation, marking a significant milestone for its late-stage pipeline.
• The company expects multiple registrational trials and anticipates data readouts in key areas like narcolepsy and ADHD, driving value through diverse neuroscience indications.

Sentiment Analysis:

Overall Tone: Positive

• Management: "delivered strong revenue growth with total revenue of $171 million... a 63% increase year-over-year." CEO: "The fundamentals of our business have never been stronger." CFO: cash balance "sufficient to fund anticipated operations into cash flow positivity." Multiple references to advancing late-stage pipeline and commercial momentum.

Q&A:

• Question from Leonid Timashev (RBC Capital Markets): Can you extrapolate SYMBRAVO Q3 trends into Q4/2026, comment on depth of prescribing and what you'd like to see before investing more in the launch?
  Response: Early SYMBRAVO launch is performing as expected with positive HCP/patient response; focus is on penetrating top 150 headache centers and improving market access, and expansion/investment decisions will follow observed real-world uptake.

• Question from Basma Radwan Ibrahim (Leerink Partners LLC): Is primary care a key growth driver for AUVELITY and how will you grow this segment—through sales force expansion or other tactics?
  Response: Yes—primary care is critical (now ~1/3 of prescribers); growth driven by targeted sales-force coverage, improved market access easing PAs, and DTC efforts that are already lifting patient requests.

• Question from Pete Stavropoulos (Cantor Fitzgerald & Co.): Given AXS-05's profile versus antipsychotics, what adoption do you expect if approved and how will you drive uptake across channels; any learnings from REXULTI?
  Response: Expect multi-specialty adoption (primary care, geriatric psych, neurology, long-term care); will leverage existing sales force, add dedicated long-term care promotion if approved, and incorporate relevant external launch learnings.

• Question from Sean Laaman (Morgan Stanley): How much capacity remains in the current sales force given SG&A bump, when might you add reps, and how does this affect time to cash-flow positivity?
  Response: Current force is driving significant growth; incremental reps are planned for ADA upon approval with final sizing early 2026, SG&A rise reflects DTC and SYMBRAVO launch, and there is no change to the cash-flow positivity outlook.

• Question from Ashwani Verma (UBS Investment Bank): How many days past filing are you for the AD agitation sNDA, could you be past 60 days for priority review, and any shutdown impact on review timing?
  Response: We haven't disclosed submission date; FDA typically notifies up to ~74 days on acceptance; we do not expect the government shutdown to affect timing and await the acceptance decision.

• Question from Lin Tsai (Jefferies LLC): For SUNOSI Phase III readouts (binge eating, shift work), describe study designs and what positive data would entail for sNDA filing timing.
  Response: Binge-eating uses a standard parallel-group design; one positive study is first step but two trials are needed for filing—plans reflect that cadence; other solriamfetol programs (e.g., ADHD pediatric) are being initiated.

• Question from Ami Fadia (Needham & Company, LLC): Strategically, will you add assets to drive operational efficiencies or focus on executing your deep late-stage pipeline?
  Response: Current marketed products and late-stage pipeline provide ample near-term opportunity; no urgent need to add assets, but inbound opportunities will be evaluated selectively to complement the portfolio.

• Question from David Amsellem (Piper Sandler & Co.): Thoughts on reboxetine commercial opportunity versus emerging orexin-2 agents—competitive dynamics and sizing?
  Response: Reboxetine targets norepinephrine pathways complementary to orexin approaches; strong Phase III efficacy/tolerability profile and high commercial synergy with SUNOSI infrastructure suggest sizeable opportunity despite new entrants.

• Question from Joon Lee (Truist Securities, Inc.): Where is SUNOSI demand coming from (NT1/NT2/IH/OSA) and thoughts on combining SUNOSI with AXS-12 versus keeping separate?
  Response: Majority demand is from OSA (~two-thirds); narcolepsy contributes as well; combination use is clinically plausible for some patients, but priority remains obtaining approvals and providing clinicians data to guide individualized treatment.

• Question from Raghuram Selvaraju (H.C. Wainwright & Co): After the initial 150 headache centers for SYMBRAVO, what centers will you target next and when might you start DTC for SYMBRAVO?
  Response: Next expansion would move into primary-care migraine-treating prescribers; DTC timing is premature and contingent on achieving prescriber coverage, market access and sales-force scale similar to AUVELITY's approach.

• Question from Dina Ramadane (BofA Securities): For AXS-05 ADA, what clinical bar is needed for priority review/AdCom and what will long-term care promotion look like?
  Response: Base case is standard review; FDA decisions on priority/AdCom are not reducible to a single quantitative efficacy bar; long-term care promotion requires a dedicated team engaging nursing staff, pharmacy and medical directors plus community clinicians.

• Question from Yatin Suneja (Guggenheim Securities, LLC): Do you expect an AdCom for the ADA submission given REXULTI had one?
  Response: AdCom necessity is determined upon FDA acceptance and cannot be predicted now; stay tuned to the acceptance decision.

• Question from Graig Suvannavejh (Mizuho Securities USA LLC): Q3 AUVELITY GTN moved from mid-50s to high-40s—what drove that and what further coverage/GTN moves do you expect from recent contracting?
  Response: Improved net price and GTN in Q3 were driven by 28 million additional covered lives coming online; total coverage ~85% and signing of a third large GPO should expand lives covered further, though timing and final GTN impact remain uncertain.

• Question from David Hoang (Deutsche Bank AG): For an ADA launch, can you bookend the minimum reps needed and is that expansion already contemplated in guidance/cash-flow positivity?
  Response: Headcount sizing is still being determined and will be set if approved; costs for anticipated expansion are already included in current cash-flow forecasts.

• Question from Troy Langford (TD Cowen): How many quarters until AUVELITY DTC materially impacts prescriptions—inflection or gradual growth?
  Response: DTC effects are typically observable in ~8–12 weeks; early trends show increases in weekly new patient starts, but it's still early to call a major inflection.

• Question from Myles Minter (William Blair & Company L.L.C.): Will the third GPO move AUVELITY commercial coverage from 75% to mid-90% and affect GTN similarly; any change in FDA interactions after uniQure news?
  Response: Too early to quantify GTN effect from the new contract; management remains optimistic on coverage gains; regulatory dialogues are currently status quo with no material change reported.

• Question from Madison Wynne El-Saadi (B. Riley Securities, Inc.): Is AUVELITY growth from higher per-prescriber activity versus new prescribers, and will the four Phase IIIs launching this quarter start in parallel or sequentially?
  Response: Growth is driven by both increased prescriptions per existing writer and addition of new prescribers; the four Phase III initiations are on track for Q4 but will start in a staged cadence rather than all on the same day.

• Question from Craig (Wells Fargo) (on behalf of Benjamin Burnett): How have regulatory interactions for the AXS-05 ADA sNDA differed from past programs, and what is driving apparent expansion in narcolepsy epidemiology?
  Response: Regulatory engagement is in ordinary course for this submission; rising awareness and improved diagnostics as more products enter the space likely explain growing epidemiology estimates—company models ~185,000 U.S. narcolepsy patients.

Contradiction Point 1

Sales Force Expansion and Market Penetration Strategy

It involves the company's approach to expanding its sales force and strategies for market penetration, which are crucial for revenue growth and market share.

How do you view your current sales team’s capacity and when will expansion be needed? - Sean Laaman (Morgan Stanley)

2025Q3: The sales force is performing well, but additional representatives are planned to support Alzheimer’s agitation approval. Expansion details will be finalized in early 2026. - Ari Maizel(CMO), Nick Pizzie(CFO)

Could you provide details on the reimbursement coverage expansion for Auvelity? What are the expected volume dynamics for the second half of the year? - Leonid Timashev (RBC Capital Markets)

2025Q2: We expect higher number of prescribers and specialty pharmacies over the remainder of the year, with little or no additional sales force headcount. - Ari Maizel(CMO)

Contradiction Point 2

Reboxetine Commercial Opportunity

It pertains to the company's assessment of the commercial opportunity for reboxetine, which impacts strategic decisions and investor expectations.

What are your thoughts on reboxetine's commercial potential? - David Amsellem (Piper Sandler & Co.)

2025Q3: Reboxetine's focus on norepinephrine reuptake inhibition aligns with the orexin pathway in narcolepsy. Clinical trials show efficacy in cataplexy and nonstimulant daytime treatment. - Herriot Tabuteau(CMO), Ari Maizel(CMO)

How does AXS-12 position against oxybate and potential orexin 2 agonists? What data will be included in the NDA filing? - Sean M. Laaman (Morgan Stanley)

2025Q2: Reboxetine might be interesting for some of the companies with a strategy of going after the orphan indications. - Ari Maizel(CMO)

Contradiction Point 3

Sales Force Expansion and Growth Strategy

It involves the company's strategy for expanding its sales force and the timing and focus of its growth, which are critical for achieving commercial success and meeting revenue expectations.

How do you assess the capacity of your current sales force, and when will you need to expand? - Sean Laaman (Morgan Stanley, Research Division)

2025Q3: Expansion details will be finalized in early 2026. - Ari Maizel(CMO)

What details can you provide about the ADA pre-NDA meeting? What are the expectations for additional meetings? When will guidance on Auvelity for MDD be provided? - Joon Lee (Truist Securities, Inc., Research Division)

2025Q1: The field force continued to grow significantly during the quarter with the expansion of our primary care sales force, which more than doubled in size this quarter. - Ari Maizel(CMO)

Contradiction Point 4

Commercial Strategy for AXS-05 in Alzheimer's Disease Agitation

It involves the company's strategic approach to the commercialization of AXS-05 for Alzheimer's disease agitation, which will impact market penetration and revenue forecasts.

What are your expectations for AUVELITY adoption if approved for Alzheimer's agitation, and how will you drive uptake? - Pete Stavropoulos (Cantor Fitzgerald)

2025Q3: AUVELITY's focus will be on primary care, geriatric psychiatrists, neurologists, and LTC facilities. - Ari Maizel(CMO)

Is the Alzheimer's agitation filing an NDA or sNDA? Have you had a pre-NDA meeting for AXS-12 narcolepsy, and what are the leading scenarios? - Asim Rana (Truist Securities)

2024Q4: We believe we have a strong case for phase 3 data combined with the Phase 2 data. We'll be coming to you with a filing strategy after our pre-NDA meeting. - Mark Jacobson(COO)

Contradiction Point 5

DTC Promotion and Timing

It involves the company's strategy and timeline for Direct-to-Consumer (DTC) promotional activities, which are crucial for driving product awareness and sales.

What’s next for SYMBRAVO’s geographic expansion and DTC timeline? - Raghuram Selvaraju (H.C. Wainwright)

2025Q3: The focus in the next phase is on expanding into primary care settings. The DTC timing for SYMBRAVO is uncertain, similar to AUVELITY, focusing on market access and sales force strength. - Ari Maizel(CMO)

Regarding DTC promotional activities for Auvelity or Symbravo, can you comment on the timing of their initiation? - Raghuram Selvaraju (H.C. Wainwright)

2024Q4: We intend to launch a broad-based media outreach plan for Auvelity this year in the coming months. - Ari Maizel(CMO)