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Axsome Therapeutics, Inc. (AXSM)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 net product revenue rose 66% YoY to $118.8M, driven by Auvelity +89% YoY ($92.6M) and Sunosi +16% YoY ($26.2M); FY 2024 net product revenue grew 88% to $385.7M .
  • Non-GAAP drivers: Q4 included a one-time $2.5M Sunosi sales-based milestone in cost of revenue and $35.9M non-cash charges (stock comp, contingent consideration, amortization), tempering margins (Q4 net loss $(74.9)M, $(1.54) per share) .
  • Commercial execution remains strong: Auvelity ~158k Rx in Q4 (+10% QoQ), coverage ~78% of lives (commercial ~63%; government 100%); Sunosi ~49k Rx (+4% QoQ), coverage ~83% (commercial ~95%; government ~60%) .
  • 2025 catalysts: Symbravo approved Jan 30, 2025 with U.S. launch targeted in ~4 months; AXS‑05 (AD agitation) and AXS‑12 (narcolepsy) NDA submissions targeted 2H 2025; Phase 3 readouts for solriamfetol in ADHD/MDD and Symbravo EMERGE in 1Q 2025 .

What Went Well and What Went Wrong

What Went Well

  • Auvelity momentum: Q4 sales rose 89% YoY to $92.6M; ~158k Rx in Q4 (+10% QoQ), with expanding payer coverage and salesforce expansion to 300 completed .
  • Diversified growth: Sunosi net product revenue up 16% YoY to $26.2M; ~49k U.S. Rx (+4% QoQ); coverage stable at ~83% of lives .
  • Pipeline progress: Symbravo approved in U.S.; AXS‑05 AD agitation Phase 3 program successfully completed; AXS‑12 ENCORE Phase 3 positive; near-term Phase 3 readouts planned (ADHD, MDD; Symbravo EMERGE) .
    • CEO: “2024 was another defining year… strong commercial growth and a rapidly advancing late-stage pipeline… U.S. approval of Symbravo… well positioned to continue delivering innovative new medicines” .

What Went Wrong

  • Profitability still pressured: Q4 operating loss $(72.6)M and net loss $(74.9)M (EPS $(1.54)), with SG&A at $113.3M and R&D at $55.0M in the quarter .
  • One-time costs and non-cash items weighed on margins: Q4 included a $2.5M Sunosi milestone in cost of revenue and $35.9M of non-cash charges (incl. $22.0M stock comp and $11.0M contingent consideration) .
  • Gross-to-net headwinds ahead: Management flagged seasonal GTN discount step-up into Q1 (“mid-50s” for Auvelity and Sunosi), which can pressure net sales recognition early in the year .

Financial Results

Quarterly trend (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($M)87.166 104.762 118.766
Net Product Sales ($M)86.520 103.736 117.325
Royalty & Milestone Rev ($M)0.646 1.026 1.441
Cost of Revenue ($M)8.055 8.437 10.514
R&D Expense ($M)49.853 45.388 55.006
SG&A Expense ($M)103.554 95.564 113.271
Loss from Operations ($M)(78.046) (62.624) (72.617)
Net Loss ($M)(79.345) (64.602) (74.912)
Diluted EPS ($)(1.67) (1.34) (1.54)
Operating Margin %(89.6%)[a] (59.8%)[a] (61.1%)[a]
Net Margin %(91.0%)[a] (61.6%)[a] (63.1%)[a]

[a] Operating/Net margin computed from cited revenues and losses.

YoY comparison

MetricQ4 2023Q4 2024
Total Revenues ($M)71.531 118.766
Net Loss ($M)(98.651) (74.912)
Diluted EPS ($)(2.08) (1.54)

Product/Segment breakdown (oldest → newest)

ProductQ2 2024Q3 2024Q4 2024
Auvelity Net Sales ($M)65.0 80.4 92.6
Sunosi Net Product Revenue ($M)22.1 24.4 26.2
Total Net Product Revenue ($M)87.2 104.8 118.8

KPIs (oldest → newest)

KPIQ2 2024Q3 2024Q4 2024
Auvelity Prescriptions~123,000 ~144,000 ~158,000
Auvelity Coverage (Total Lives)~76% ~78% ~78%
Auvelity Coverage (Commercial/Gov’t)60% / ~100% 63% / 100% 63% / 100%
Sunosi Prescriptions (U.S.)~45,000 ~47,000 ~49,000
Sunosi Coverage (Total Lives)~83% ~83% ~83%
Sunosi Coverage (Commercial/Gov’t)95% / — 95% / 60% 95% / 60%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti‑yearSufficient to fund operations into cash flow positivity (Q3 view) Sufficient to fund operations into cash flow positivity (Q4 view) Maintained
Auvelity & Sunosi GTNQ1 seasonality—GTN “mid‑50s” expected in Q1 (negative seasonality) New granularity
R&D spend cadence2025—R&D peaked in Q4; expected to moderate in 2025 New
SG&A vs sales2025—SG&A to increase vs Q4, but sales expected to grow faster, supporting path to cash flow positivity New
Symbravo launch timing2025—U.S. commercial availability anticipated ~4 months post‑approval (approved Jan 30, 2025) New

Earnings Call Themes & Trends

TopicQ-2 (Q2’24)Q-1 (Q3’24)Current (Q4’24)Trend
Market access & GTNCommercial lives for Auvelity rose to 60% (total ~76%); GTN low‑mid 50s Auvelity total lives ~78%; GTN ~50% in Q3 Auvelity total lives ~78%; GTN to mid‑50s in Q1 Stable access; seasonal GTN headwind ahead
Salesforce expansionEarlier expansion aided primary care growth Second Auvelity expansion planned for Q1’25 Expansion to 300 completed; synergy with Symbravo expected Increasing reach/frequency
Pipeline milestonesAXS‑07 NDA resubmitted; multiple Phase 3 readouts guided 2H’24 AXS‑05/12 readouts 4Q; ADHD/MDD 1Q’25 Symbravo approved; AXS‑05/12 NDA 2H’25; ADHD/MDD/EMERGE 1Q’25 Execution continued
Regulatory/legalSunosi generic settlement (Unichem) —Auvelity generic settlement with Teva; licensed entry 2038/2039 IP strengthened
Pricing/rebates——Symbravo to enter high‑rebate category; balancing access and profitability Managed approach

Management Commentary

  • “Based on the recent performance, Auvelity is on track to reach blockbuster potential.” – CEO Herriot Tabuteau .
  • “We believe that our current cash balance is sufficient to fund anticipated operations into cash flow positivity based on the current operating plan.” – CFO Nick Pizzie .
  • “Approximately 158,000 prescriptions were written for Auvelity in the fourth quarter… and payer coverage… is at approximately 78% of all covered lives.” – Management commentary .
  • On Symbravo launch: “This is a high rebate category… we… engage in access discussions… while maintaining long‑term profitability.” – Management .

Q&A Highlights

  • DTC and media cadence: Broad-based Auvelity media planned in coming months with seasonality-aware timing; Symbravo go‑to‑market details forthcoming .
  • Salesforce & Symbravo synergy: Auvelity team expanded 10–15% (+40 reps) with overlap expected among migraine treaters in primary care; efficiencies from comorbidities with depression .
  • AXS‑05 (AD agitation) filing: Second half 2025 targeted; gating factor is building the submission (not stability testing); NDA vs sNDA path under evaluation across branding/IP/access dimensions .
  • GTN guidance: Q1 GTN expected mid‑50s for Auvelity/Sunosi due to seasonality; Q4 GTN ~50% .
  • OpEx trajectory: R&D peaked in Q4 and should moderate in 2025; SG&A to increase vs Q4, but sales growth expected to outpace, supporting cash flow positivity .
  • Symbravo pricing/access: Entering a high-rebate market; strategy informed by oral CGRP launches; payer engagement underway to balance access and profitability .
  • IP: Auvelity ANDA litigation settled; Teva licensed generic entry 2038/2039 .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS and forward quarters was unavailable at query time due to data access limits. As a result, we cannot assess beat/miss vs consensus for Q4 2024 or provide current forward estimates. Values from S&P Global were not retrievable at this time.

Key Takeaways for Investors

  • Commercial momentum is intact: Auvelity continues to scale across both psychiatry and primary care with stable/improving access; Sunosi remains steady with broad commercial coverage .
  • Margins are improving vs mid‑year but remain negative; Q4 included one‑time and non‑cash items that depressed profitability; watch GTN seasonality in Q1 .
  • 2025 is catalyst-rich: Symbravo launch; AXS‑05 and AXS‑12 NDA filings; multiple Phase 3 readouts (ADHD, MDD, EMERGE) – all potential stock drivers .
  • Balance sheet supports execution: $315.4M cash at year-end; management guides runway into cash flow positivity under current plan .
  • Access and payer dynamics remain central: Continued Auvelity coverage progress and prudent approach to Symbravo access in a high‑rebate category should shape net pricing and uptake .
  • IP visibility improved: Auvelity settlement with Teva provides long runway (licensed entry 2038/2039), reducing LOE uncertainty .
  • Watch operating leverage: Management expects sales growth to outpace OpEx in 2025; R&D moderation post-peak should aid cash burn trajectory .
Sources: Q4 2024 press release and 8‑K, earnings call transcript; prior quarter releases/calls. All figures and statements are cited inline.