AXSM Q2 2025: Auvelity adds 28M covered lives, fuels 24% rev growth
- Strong Commercial Execution and Expanded Market Access: Management highlighted robust prescription growth for Auvelity and Sunosi, with Auvelity benefiting from the addition of 28 million newly covered lives and achieving 83% coverage across channels, while maintaining stable gross-to-net margins, which underscores effective market penetration and revenue growth potential.
- Diverse, Differentiated Product Portfolio and Pipeline: The Q&A emphasized a diversified portfolio—with strong performance from existing products and promising pipeline assets such as AXS-five for Alzheimer’s agitation and AXS-twelve for narcolepsy. The multi‐mechanistic approach of Cymbravo in acute migraine also received encouraging early feedback, underlining potential future value drivers.
- Efficient Sales Force and Synergistic Strategies: Executives pointed to the impact of a focused and expanded sales force—with dedicated teams across products—enhancing new patient starts and leveraging existing infrastructure (e.g., using the Sunosi team to support AXS-twelve), which demonstrates operational excellence and scalability for sustained long-term growth.
- Regulatory and clinical uncertainties: Several questions raised concerns about the robust translation of adult efficacy data to the pediatric population for products such as AXS-twelve and the design requirements for confirming efficacy in both children and adolescents, which introduces potential delays or setbacks in regulatory approvals.
- Margin and revenue recognition pressures: Discussions on evolving gross-to-net (GTN) dynamics, potential adjustments in liability estimates, and future pricing negotiations—such as the anticipated IRA pricing for Avelity—raise concerns over margin pressures and revenue volatility.
- Commercial execution risks for new launches: Early feedback on products like Cimbravo highlighted uncertainties around conversion rates from sampling to prescription and overall market acceptance, which could hamper sustained revenue growth in a competitive landscape.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
R&D Expenses | Q2 2025 | Expected to increase in Q2 2025 due to a new Phase III trial and NDA fee | No specific R&D expense guidance provided | no current guidance |
SG&A Expenses | Q2 2025 | Expected to increase in Q2 2025 due to SYMBRAVO hiring and DTC campaign launch | No specific SG&A guidance provided | no current guidance |
Cash Flow Positivity / Cash Balance | Q2 2025 | Current cash balance of $300.9 million is sufficient | No cash flow or balance update provided | no current guidance |
GTN Discounts | FY 2025 | GTN discounts for Auvelity and Sunosi anticipated in the mid‑50% range | No FY 2025 GTN guidance provided (though later Cimbravo is mentioned separately) | no current guidance |
Peak Sales for Auvelity | FY 2025 | Quantitative range of $1 billion to $3 billion | Qualitative update: expects continued growth progress with incremental lift from a planned national DTC campaign | changed from quantitative to qualitative |
AXS‑05 for Alzheimer’s Disease Agitation | Q2 2025 | No prior guidance | Plans to submit the sNDA in the current quarter | no prior guidance |
AXS‑05 for Smoking Cessation | Q4 2025 | No prior guidance | Expected initiation of a Phase 2/3 trial in Q4 2025 | no prior guidance |
AXS‑12 for Narcolepsy with Cataplexy | Q4 2025 | No prior guidance | NDA submission to the FDA slated for Q4 2025 | no prior guidance |
AXS‑14 for Fibromyalgia | Q4 2025 | No prior guidance | Expected initiation of a Phase 3 trial in Q4 2025 | no prior guidance |
Solriamfetol Clinical Programs | Q4 2025*/Next Year | No prior guidance | Includes a pediatric Phase 3 trial for ADHD and a Phase 3 trial for MDD with EDS in Q4 2025, plus ENGAGE trial readout next year | no prior guidance |
Commercial Strategy for AXS‑05 | Q2 2025 | No prior guidance | Preparing for a potential launch and expanding promotional efforts (including targeting geriatric psychiatry, neurodegenerative specialists and long‑term care) | no prior guidance |
Cimbravo – Gross‑to‑Net Outcome | FY 2025* | No prior guidance | Expects gross‑to‑net to remain high for the remainder of the year | no prior guidance |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Pipeline Development and Regulatory Milestones | Discussed across Q1 2025 ( ), Q4 2024 ( ), and Q3 2024 ( ) with consistent emphasis on multiple assets and upcoming NDA/sNDA filings. | Q2 2025 updates ( ) reinforce progress on AXS-05, AXS-12, AXS-14, and solriamfetol along with clear milestone dates. | Consistent focus with increased prioritization and clearer regulatory timelines. |
Commercial Execution and Expanded Market Access | Q1 2025 ( ), Q4 2024 ( ), and Q3 2024 ( ) highlighted strong demand and expanding payer coverage across products. | Q2 2025 ( ) emphasizes strong performance of Auvelity, Sunosi, and the new launch of Cymbravo with further expanded market access. | Sustained robust performance with expanded access and additional product launch momentum. |
Sales Force Expansion and Synergistic Strategies | Q1 2025 ( ), Q4 2024 ( ), and Q3 2024 ( ) demonstrated investments in expanding teams and leveraging synergies for launches. | Q2 2025 ( ) maintains the focus through continued sales force expansion and notes synergistic opportunities (e.g., leveraging Sunosi’s sales team for AXS-12). | Ongoing emphasis with reinforced synergy opportunities and consistent expansion. |
Regulatory and Clinical Uncertainties | Addressed in Q1 2025 ( ), Q4 2024 ( ) and Q3 2024 ( ) regarding filing strategies and pediatric study plans. | Q2 2025 ( ) focuses on sNDA timelines for AXS-05, NDA plans for AXS-12, and confirms pediatric trial guidance. | Well-managed and steady progression with clear timelines and confidence in data packages. |
Margin Pressures and Revenue Recognition Dynamics | Not mentioned in Q1 2025, Q4 2024, or Q3 2024 (N/A). | Q2 2025 ( ) introduces detailed commentary on GTN discounts, revenue recognition for Cimbravo, Auvelity, and Sunosi plus IRA pricing considerations. | A new emphasis in the current period, adding depth on financial metrics and pricing outlook. |
Competitive Landscape and Generic Competition Risks | Discussed in Q1 2025 ( ), Q4 2024 ( ) and Q3 2024 ( ) with focus on patent settlements and market performance against generics. | In Q2 2025 there is no mention (N/A). | Reduced focus on competition and generic risks in the current update. |
Patent and Exclusivity Developments Impacting Long-Term Revenue | Q1 2025 ( ) and Q4 2024 ( ) mentioned the Teva settlement and LOE dates; Q3 2024 had no discussion (N/A). | Q2 2025 does not mention these topics (N/A). | Discussion has tapered off in the current period. |
DTC Campaign Execution and High Commercial Investment Risks | Q1 2025 ( ) and Q4 2024 ( ) provided details on upcoming national DTC campaigns and related SG&A pressures; Q3 2024 did not cover it (N/A). | Q2 2025 ( ) notes no national DTC campaign has been launched yet, with plans to execute later, and no explicit high-risk discussion. | Consistent rollout plans with a mild de‐emphasis on associated risks in the current period. |
Delayed Clinical Study Timelines and New Launch Execution Risks | Q3 2024 ( ) mentioned a delay in the FOCUS study and Q4 2024 ( ) provided indirect insights; Q1 2025 had minimal mention. | Q2 2025 does not mention delays or new launch risks (N/A). | Lack of discussion suggests potential resolution or reduced concern in the current period. |
Increased R&D and SG&A Expenses Impacting Profitability | Discussed in Q1 2025 ( ), Q4 2024 ( ) and Q3 2024 ( ) with rising expenses offset by operational leverage. | Q2 2025 ( ) highlights increased SG&A due to commercialization while showing improved net loss metrics; R&D expenses are relatively stable. | Continued investment with controlled expense growth and improving profitability metrics. |
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Avelity Coverage
Q: How will new covered lives boost Avelity volume?
A: Management noted that previously announced GPO contracts add 28 million new covered lives, which are expected to accelerate patient volume while keeping the GTN in the mid-50s range. -
Avelity Revenue
Q: What factors drove Avelity’s revenue increase?
A: Improved GTN, modest inventory effects, and a small liability adjustment contributed to the 24% revenue growth from the prior quarter. -
Auvelity Growth
Q: When will Auvelity TRx growth inflect?
A: New patient starts began rising late Q1; with an eventual DTC launch, incremental growth is expected, and the average treatment duration is around 6–7 prescriptions annually. -
AXS-five Adoption
Q: How will AXS‑five perform against Rexulti?
A: AXS‑five is positioned with a strong efficacy and safety profile, particularly in Medicare, offering a compelling alternative to Rexulti and off‑label antipsychotics. -
AXS‑twelve Profile
Q: How does AXS‑twelve compare to current narcolepsy treatments?
A: The product is seen as rapid‑acting with significant reductions in cataplexy; its NDA package will include three controlled trials plus a long‑term safety extension. -
CINBRAVO Revenue
Q: Will early CINBRAVO scripts improve revenue recognition?
A: Early stocking orders in this short quarter generated revenue at a GTN in the low‑80s, with expectations to maintain similar performance without inventory distortions. -
CINBRAVO Sampling
Q: What is the early utilization of CINBRAVO samples?
A: The sampling program shows positive uptake, with samples effectively converting into prescriptions and supporting early market access. -
CINBRAVO Differentiators
Q: How does CINBRAVO differentiate from other migraine treatments?
A: Its multi‑mechanistic approach and rapid onset have resonated well among patients and clinicians, with GTN remaining in the low‑80s. -
FDA Alignment
Q: Has the FDA confirmed data sufficiency for AXS‑five?
A: The pre‑NDA meeting held last spring confirmed alignment on the data package for Alzheimer’s agitation, with the submission on track this quarter. -
AXS‑five Strategy
Q: What is the future commercial plan for AXS‑five?
A: The company plans to target high‑value prescribers, particularly in community and long‑term care segments, with no current indication of an advisory committee. -
Head‑to‑Head Design
Q: Will a direct trial be run against bupropion?
A: The registration study for AXS‑five inherently includes a bupropion arm to demonstrate component contribution, effectively serving as a head‑to‑head comparison. -
Sales Force Allocation
Q: What is the sales force split across products?
A: There are 300 representatives for Auvelity and 100 each for both Sunosi and CINBRAVO, supporting distinct commercial strategies. -
Precision Medicine
Q: How does the precision approach apply across patient ages?
A: The strategy uses clinical presentation and underlying pathophysiology to tailor treatment for MDD, with expectations that benefits seen in adults will extend to pediatric patients. -
Auvelity Usage Mix
Q: What is the current clinical mix for Auvelity prescriptions?
A: Auvelity maintains roughly 50% early‑line usage and steady penetration into primary care without needing sales force expansion at this time. -
Pediatric ADHD Study
Q: What design will the pediatric ADHD study follow?
A: A standard parallel‑group design using a pediatric scale is planned, though added complexity exists to ensure precise regulatory alignment for a Q4 initiation. -
Narcolepsy Synergies
Q: How will Sunosi’s team support AXS‑twelve launch?
A: There is near complete overlap between the patient populations, allowing the existing Sunosi team to effectively drive AXS‑twelve’s commercial launch. -
Seasonality & Pricing
Q: What about summer seasonality and IRA pricing impacts?
A: Typical summer seasonality is expected across indications; ADA pricing will mirror Auvelity’s current WAC of $11.77, with negotiations projected around 2029–2030. -
Sunosi Performance
Q: What drove Sunosi’s strong quarterly performance?
A: Strong prescriber engagement, increased productivity, and achieving 83% commercial coverage are credited with driving Sunosi’s performance. -
Pediatric Trial Strategy
Q: Is one pediatric trial sufficient for regulatory approval?
A: The company believes a combined study covering both children and adolescents can adequately inform dosing and safety, building on the adult efficacy profile.
Research analysts covering Axsome Therapeutics.