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Axsome Therapeutics (NasdaqGM:AXSM) FY Conference Transcript
2026-02-25 20:02
Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on February 25, 2026 Core Business and Product Performance - **Product**: Auvelity for Major Depressive Disorder (MDD) - **Sales Achievement**: Over $500 million in sales in 2025, three years post-launch [2] - **Salesforce Expansion**: Increased from 300 to 600 sales representatives to enhance market penetration, particularly in primary care [4] - **Market Access**: Improved access with 86% of covered lives, including 100% in the government channel [7][8] - **First Line Prescriptions**: 50% of total prescriptions are for first line or first switch patients [8] Market Dynamics and Growth Drivers - **Uptake Drivers**: Increased awareness, trial engagement, and a differentiated product profile leading to positive patient outcomes [9] - **Retention Rates**: Currently tracking in line with typical antidepressant persistence, with over 50% of patients being first line or first switch [11][12] - **Alzheimer's Disease Agitation (ADA) Opportunity**: Anticipation of FDA's PDUFA date on April 30, 2026, for Auvelity's indication in Alzheimer's agitation [15] Clinical Data and Regulatory Insights - **Clinical Trials**: Four controlled trials conducted, with three positive outcomes supporting efficacy and safety [22][23] - **Safety Profile**: No significant safety concerns noted, particularly regarding falls or mortality in the elderly population [24] - **Market Size for ADA**: Approximately 5 million Alzheimer's patients experience agitation, with 20 million scripts written annually, predominantly off-label [20] Go-to-Market Strategy - **Pre-launch Activities**: Non-branded campaigns to raise awareness about Alzheimer's agitation and education for healthcare providers [27] - **Reimbursement Strategy**: Full coverage anticipated for Medicare Part D, which constitutes over 70% of total scripts for Alzheimer's agitation [28] - **Expected GTN Improvement**: Anticipated better gross-to-net (GTN) for ADA scripts compared to MDD due to the nature of Medicare Part D [28] Future Catalysts and Pipeline - **Upcoming Trials**: Ongoing trials for binge eating disorder (BED) and shift work disorder, with top-line results expected in the second half of 2026 [35][36] - **New Product AXS-12**: NDA submission imminent, leveraging existing sales force for potential launch in narcolepsy [39] - **New Asset AXS-17**: Recently in-licensed for epilepsy, complementing the existing CNS pipeline [42] Financial Outlook - **Cash Flow Positivity**: Near-term expectations for cash flow positivity remain unchanged, with recent quarters showing close to cash flow positive results [53][54] - **Sales Projections**: Peak sales for Auvelity projected between $2.5 billion and $6 billion, viewed as achievable based on current market dynamics [34] Conclusion - Axsome Therapeutics is positioned for significant growth with its product Auvelity, particularly in the MDD and Alzheimer's agitation markets. The company is actively expanding its sales force, improving market access, and preparing for upcoming product launches and regulatory approvals. The financial outlook remains positive, with a focus on achieving cash flow positivity and leveraging its robust pipeline for future growth.
AXSM Q4 Loss Wider Than Expected, Revenues Surge Y/Y on Auvelity Sales
ZACKS· 2026-02-24 18:11
Key Takeaways AXSM reported a Q4 loss of 71 cents, missing estimates even as revenues rose 65% to $196M.Auvelity sales climbed 68% Y/Y to $155.1M, with prescriptions up 42% year over year in Q425.Axsome's Sunosi sales rose 40% Y/Y, while newly launched Symbravo generated $4.1M in Q4.Axsome Therapeutics (AXSM) incurred a loss of 71 cents per share in the fourth quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 70 cents. The company had incurred a loss of 96 cents per share in the year-ago ...
Axsome Therapeutics, Inc. Q4 2025 Earnings Call Summary
Yahoo Finance· 2026-02-23 17:31
Achieved 66% annual revenue growth driven by Auvelity's rapid uptake, which surpassed $500,000,000 in net sales in its third full year of launch. Attributed Auvelity's outperformance to its distinct clinical profile and fast onset of action, allowing it to grow 42% year-over-year while the broader antidepressant market remained flat. Expanded the primary care prescriber base for Auvelity, which now represents approximately one-third of all prescribers and is the fastest-growing segment. Initiated a ...
Here's What Key Metrics Tell Us About Axsome (AXSM) Q4 Earnings
ZACKS· 2026-02-23 17:00
For the quarter ended December 2025, Axsome Therapeutics (AXSM) reported revenue of $196 million, up 65% over the same period last year. EPS came in at -$0.71, compared to -$0.96 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $193.01 million, representing a surprise of +1.55%. The company delivered an EPS surprise of -1%, with the consensus EPS estimate being -$0.70.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall ...
Axsome Therapeutics(AXSM) - 2025 Q4 - Earnings Call Transcript
2026-02-23 14:02
Financial Data and Key Metrics Changes - Total revenue for Q4 2025 increased 65% year-over-year to $196 million, and for the full year increased 66% to $639 million [6][12] - Net product sales of Auvelity for Q4 were $155.1 million, up 68% compared to the prior year, and total sales for Auvelity reached $507.1 million, representing a 74% year-over-year increase [12][13] - Net loss for Q4 was $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share for Q4 2024 [16] - Net loss for the full year was $183.2 million, or $3.68 per share, compared to a net loss of $287.2 million, or $5.99 per share for 2024 [17] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth in prescriptions [6][19] - Sunosi generated net product revenue of $36.7 million for Q4, a 40% increase compared to Q4 2024, and $124.8 million for the full year, representing a 32% increase [13] - Symbravo generated $4.1 million in net sales for Q4 and $6.6 million for the full year, following its second full quarter of launch [13] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [19] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [20] - Symbravo's overall payer coverage is approximately 52% at the start of the year [22] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications [6] - Plans to conduct two Phase 3 trials in ADHD, one in children and one in adolescents, are on track for initiation in the first half of the year [9] - The company aims to expand its sales force to approximately 600 representatives to support growth in MDD and potential launch in Alzheimer's disease agitation [21][59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver new treatment options for patients living with CNS disorders, supported by a scalable commercial platform [6][11] - The company anticipates that its current cash balance is sufficient to fund operations into cash flow positivity based on the current operating plan [17] - Management is optimistic about the potential impact of the upcoming launch for Alzheimer's disease agitation, with preparations underway [69] Other Important Information - The company has made significant progress with its NDA package for AXS-12 in narcolepsy and expects to submit that imminently [8] - The acquisition of AZD7325, a novel oral GABA A alpha-2/3 receptor positive allosteric modulator, is planned for evaluation in epilepsy [10] Q&A Session Summary Question: Implications of the new FDA publication on the one trial policy - Management is assessing the implications and will continue to vet clinical plans with the FDA [28] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the focus is currently on preparing for Phase II readiness [33] Question: Coverage evolution for Auvelity post-ADA label approval - Existing coverage should generally apply to the new indication, but there may be additional efforts needed for Medicare coverage [36] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access across OSA and narcolepsy markets [44] Question: Sales force expansion rationale - The expansion aims to accelerate growth in MDD and prepare for potential Alzheimer's agitation indication [59] Question: Coverage evolution for Symbravo - The secured contract with a third large GPO allows for active negotiation with payers, with optimism for increased coverage [63]
Axsome Therapeutics(AXSM) - 2025 Q4 - Earnings Call Transcript
2026-02-23 14:02
Axsome Therapeutics (NasdaqGM:AXSM) Q4 2025 Earnings call February 23, 2026 08:00 AM ET Company ParticipantsAndrew Tsai - Managing DirectorAri Maizel - Chief Commercial OfficerAshley Dong - Director of Investor RelationsDavid Hong - Senior Portfolio ManagerGraig Suvannavejh - Managing DirectorHerriot Tabuteau - CEOMark Jacobson - COOMatthew Harrison - Equity Research AssociateNick Pizzie - CFOPete Stavropoulos - Director of Biotech Equity ResearchSean Laaman - Executive DirectorConference Call ParticipantsA ...
Axsome Therapeutics(AXSM) - 2025 Q4 - Earnings Call Transcript
2026-02-23 14:00
Financial Data and Key Metrics Changes - Total revenue for Q4 2025 increased 65% year-over-year to $196 million, and for the full year increased 66% to $639 million [4][11] - Net product sales of Auvelity for Q4 were $155.1 million, up 68% compared to the prior year, and total sales for Auvelity reached $507.1 million for the full year, representing a 74% year-over-year increase [12][15] - Net loss for Q4 was $28.6 million, or $0.56 per share, compared to a net loss of $74.9 million, or $1.54 per share for Q4 2024 [15] - Net loss for the full year of 2025 was $183.2 million, or $3.68 per share, compared to a net loss of $287.2 million, or $5.99 per share for 2024 [16] Business Line Data and Key Metrics Changes - Auvelity achieved sales of over $500 million in its third full year of launch, with significant growth contributing to overall revenue [4] - Sunosi generated net product revenue of $36.7 million for Q4, a 40% increase compared to Q4 2024, and $124.8 million for the full year, representing a 32% increase [12] - Symbravo generated $4.1 million in net sales for Q4 and $6.6 million for the full year, following its second full quarter of launch [12] Market Data and Key Metrics Changes - Auvelity prescriptions grew by 42% year-over-year, with over 225,000 prescriptions written in Q4 [18] - Payer coverage for Auvelity increased from 75% to 78%, bringing total coverage to 86% of all lives across channels [19] - Symbravo's overall payer coverage is approximately 52% at the start of the year, with 49% in commercial and 57% in government channels [21] Company Strategy and Development Direction - The company is advancing a broad CNS pipeline with 5 novel product candidates across 9 high-impact indications, including a planned phase 2/3 trial of AXS-05 in smoking cessation [5][6] - AXS-12's NDA submission for narcolepsy is expected imminently, with significant progress made following positive FDA pre-NDA meeting minutes [6] - The company plans to expand its sales force to approximately 600 representatives to support growth in MDD and potential Alzheimer's disease agitation [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver upon vast opportunities for the growing portfolio of CNS medicines, supported by a scalable commercial platform [4][18] - The company anticipates continued momentum in its commercial business and expects to generate significant value through disciplined investment and performance across its CNS portfolios [104] Other Important Information - The company ended the year with $323 million in cash and cash equivalents, compared to $315 million at the end of 2024, indicating sufficient funds to support operations into cash flow positivity [17] - Gross and net discounts for Auvelity and Sunosi are expected to increase due to typical Q1 dynamics, with Symbravo's gross net discount remaining elevated during the launch phase [13] Q&A Session Summary Question: Implications of the new FDA publication on the one trial policy - Management is assessing the implications and will continue to vet clinical plans with the FDA, indicating potential for supportive evidence in ongoing studies [26][27] Question: Development plan for AXS-17 in epilepsy - The product has been studied in various indications, and the company is closely assessing different types of epilepsy for potential clinical success [31][33] Question: Auvelity payer coverage evolution post-ADA label addition - Existing coverage is expected to apply to the new indication, with efforts ongoing to ensure sufficient coverage and utilization management [35][36] Question: Initial launch cadence for Alzheimer's agitation - The company is preparing for a launch within a quarter post-approval, with metrics to be shared regarding script percentages from the ADA space [39][69] Question: Growth drivers for Sunosi - Growth is driven by both volume and improved access, with steady performance in both OSA and narcolepsy markets [44] Question: DTC campaign progress for Auvelity - The national TV campaign launched in late 2025 has generated positive impacts on new patient starts, with ongoing optimization of media spend [46][48] Question: Coverage expectations for Auvelity at steady state - The goal is to secure access for as many patients as possible, with steady progress in increasing covered lives anticipated [50][52] Question: AXS-12 opportunity in narcolepsy - AXS-12 offers compelling treatment options for patients, with strong data in cataplexy and potential benefits in excessive daytime sleepiness [72][74]
Factors You Need to Know Ahead of TechnipFMC's Q4 Earnings Release
ZACKS· 2026-02-16 17:35
Core Viewpoint - TechnipFMC plc (FTI) is set to announce its fourth-quarter fiscal 2025 results on February 19, with earnings estimated at 51 cents per share and revenues at $2.55 billion [1] Group 1: Recent Performance - In the last reported quarter, FTI achieved adjusted earnings of 75 cents per share, surpassing the Zacks Consensus Estimate of 65 cents, driven by strong performance in the Subsea segment [2] - FTI's revenues for the last quarter were $2.6 billion, exceeding the Zacks Consensus Estimate by 1.2% [2] - FTI has beaten the Zacks Consensus Estimate in three of the last four quarters, with an average surprise of 20.16% [3] Group 2: Fourth Quarter Expectations - The Zacks Consensus Estimate for fourth-quarter fiscal 2025 earnings has remained unchanged, indicating a 5.56% year-over-year decrease, while revenue estimates suggest a 7.58% increase from the previous year [3] - FTI's revenue is expected to improve due to strong contributions from the Subsea segment, which is projected to generate $2.2 billion, reflecting an 8.7% year-over-year increase [4][5] - The company holds a $16.8 billion backlog, which, along with the ongoing industrialization of its Subsea business, is expected to positively influence fourth-quarter earnings [6] Group 3: Cost Considerations - Rising costs may negatively impact FTI's bottom line, with total costs and expenses increasing by 8.8% in the last quarter, a trend expected to continue [7] - The increase in costs is attributed to the inflationary environment and a tight labor market [7] Group 4: Earnings Prediction - The model predicts an earnings beat for FTI, supported by a positive Earnings ESP of +1.61% and a Zacks Rank of 2 (Buy) [10][11]
Factors You Need to Know Ahead of ProPetro's Q4 Earnings Release
ZACKS· 2026-02-13 15:01
Core Insights - ProPetro Holding Corp. (PUMP) is expected to report a fourth-quarter 2025 loss of 13 cents per share with revenues of $283.28 million, indicating a challenging performance outlook [1][8] Financial Performance - In the last reported quarter, PUMP recorded an adjusted loss per share of 2 cents, which was better than the Zacks Consensus Estimate of a loss of 11 cents, attributed to a 44.4% year-over-year decrease in costs and expenses [2] - Revenues for the last quarter were $294 million, surpassing the consensus estimate of $258 million [2] - The Zacks Consensus Estimate for fourth-quarter 2025 earnings shows a significant year-over-year decrease of 1,200%, while revenues are projected to decline by 11.63% compared to the previous year [3] Revenue and Cost Projections - PUMP's total revenues are anticipated to decline, with hydraulic fracturing services expected to generate $201.1 million, down from $236.9 million in the same quarter last year [4] - Wireline revenues are projected to decrease by 3.8%, and cementing revenues are expected to fall by 5.2% year-over-year [4] - Total costs and expenses for the fourth quarter are expected to be $302.4 million, reflecting a 10.8% decrease from the prior year, driven by reductions in general and administrative expenses (down 18.4%) and depreciation and amortization (down 19.7%) [5][8] Earnings Prediction - The Zacks model does not predict an earnings beat for PUMP, as the Earnings ESP is -5.88%, indicating a lack of favorable conditions for a positive earnings surprise [6]
1 High-Flying Stock With More Upside Ahead
Yahoo Finance· 2026-02-03 17:05
Core Insights - Axsome Therapeutics has shown significant market performance over the past five years, driven by clinical and regulatory advancements, and is approaching large-cap status [1] - There remains potential for further investment in Axsome Therapeutics due to ongoing growth and new product developments [1] Group 1: Sales Growth - Axsome's revenue for the third quarter reached $171 million, reflecting a 63% increase compared to the same period last year [2] - The company's current product lineup includes Auvelity for depression, Sunosi for narcolepsy-related daytime sleepiness, and Symbravo for migraines, all contributing to strong sales growth [2][3] Group 2: Future Approvals - Axsome is pursuing new approvals and label expansions, including a new indication for Auvelity in treating Alzheimer's disease agitation, which has shown positive results in phase 3 studies and is under FDA consideration [4] - Sunosi has completed a phase 3 study for ADHD in adults, with plans for additional late-stage trials in related markets [5] Group 3: New Product Pipeline - The company is developing several other products, such as AXS-12 for cataplexy in narcolepsy and AXS-14 for fibromyalgia, which could significantly enhance sales potential [6] - The addressable market for Alzheimer's agitation is substantial, with over 5 million patients in the U.S. and currently only one FDA-approved treatment available [7]