Financial Performance - Axsome Therapeutics reported quarterly losses of 47 cents per share, significantly better than the analyst consensus estimate of losses of $1.07 per share [1] - The company achieved quarterly sales of $150.04 million, exceeding the analyst consensus estimate of $140.33 million [1] Company Commentary - The CEO of Axsome Therapeutics highlighted strong underlying demand for their medicines, effective commercial execution, solid regulatory progress, and advancements in their neuroscience pipeline [2] - The recent approval and launch of SYMBRAVO for migraine, along with the accelerating performance of AUVELITY for depression and SUNOSI for excessive daytime sleepiness, were noted as positive developments [2] Stock Performance and Analyst Ratings - Following the earnings announcement, Axsome Therapeutics shares fell by 3.4% to trade at $102.89 [3] - Analysts have adjusted their price targets for Axsome Therapeutics, with RBC Capital maintaining an Outperform rating and raising the price target from $184 to $189, and B of A Securities maintaining a Buy rating with a price target increase from $173 to $176 [5]

Core Insights - Axsome Therapeutics reported an adjusted loss of $0.97 per share in Q2 2025, which is an improvement from a loss of $1.67 per share in the same quarter last year and better than the Zacks Consensus Estimate of a loss of $1.00 [1][6] - The company's total revenues increased by 72% year over year to $150 million in Q2 2025, surpassing the Zacks Consensus Estimate of $140 million, primarily driven by strong sales of Auvelity [1][6] Revenue Breakdown - Total revenues for Q2 2025 included product revenues from Auvelity, Sunosi, and Symbravo, along with royalty revenues, with net product revenues reaching $148.9 million compared to $86.5 million in the previous year [3] - Auvelity sales amounted to $119.6 million, reflecting an 84% year-over-year increase and a 24% sequential increase, exceeding the model estimate of $111.8 million [4][6] - Sunosi's net product sales were $30 million in Q2 2025, up 35% from the previous year, with total prescriptions growing 13% year over year to 50,000 [7] Pipeline Developments - Axsome is planning several late-stage studies and regulatory filings for AXS-05, AXS-12, AXS-14, and solriamfetol, including a supplemental new drug application for AXS-05 targeting Alzheimer's disease agitation [6][11] - AXS-12 is being developed for narcolepsy, with plans to submit a new drug application for treating cataplexy in Q4 2025 [12] - The company is also evaluating solriamfetol in phase III studies for ADHD and MDD, with studies expected to start in Q4 2025 [14][15] Financial Overview - Research and development expenses were $49.5 million, down 0.8% from the previous year, while selling, general, and administrative expenses rose by 25.8% to $130.3 million due to increased commercial activities [9][10] - As of June 30, 2025, Axsome had cash and cash equivalents of $303 million, slightly up from $300.9 million at the end of Q1 2025 [10]

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) The company reported **$150.0 million** in Q2 2025 revenues, a narrowed net loss of **$48.0 million**, and increased total assets to **$639.8 million** after refinancing debt with a new **$570.0 million** Blackstone loan Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $303,016 | $315,353 | | Accounts receivable, net | $198,825 | $142,001 | | Total current assets | $536,620 | $485,064 | | Total assets | $639,785 | $568,498 | | **Liabilities & Equity** | | | | Total current liabilities | $342,099 | $230,104 | | Loan payable, long-term | $117,540 | $180,710 | | Total liabilities | $566,710 | $511,483 | | Total stockholders' equity | $73,075 | $57,015 | Consolidated Statement of Operations Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total revenues** | **$150,042** | **$87,166** | **$271,505** | **$162,165** | | Product sales, net | $148,959 | $86,520 | $269,317 | $160,616 | | Loss from operations | ($36,714) | ($78,046) | ($93,696) | ($145,321) | | **Net loss** | **($47,973)** | **($79,345)** | **($107,386)** | **($147,702)** | | Net loss per share | ($0.97) | ($1.67) | ($2.18) | ($3.11) | Consolidated Statement of Cash Flows Highlights (Six months ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($75,798) | ($83,577) | | Net cash used in investing activities | ($351) | ($150) | | Net cash provided by financing activities | $63,812 | $13,191 | | **Net decrease in cash** | **($12,337)** | **($70,536)** | - The company's product portfolio includes FDA-approved treatments Auvelity® (for major depressive disorder), Sunosi® (for narcolepsy/obstructive sleep apnea), and the newly approved Symbravo® (for migraine), which became commercially available in June 2025[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes improved financial performance to strong product sales and the Symbravo launch, with net loss decreasing to **$48.0 million** and liquidity enhanced by a new **$570.0 million** Blackstone loan facility Revenue by Product (in thousands) | Product | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Auvelity | $119,642 | $65,025 | $215,873 | $118,420 | | Sunosi | $28,907 | $21,495 | $53,034 | $42,196 | | Symbravo | $410 | $0 | $410 | $0 | | **Total Product Sales, net** | **$148,959** | **$86,520** | **$269,317** | **$160,616** | - The increase in net product sales was primarily due to higher unit sales volume for both Auvelity and Sunosi, along with the commercial launch of Symbravo in June 2025[199](index=199&type=chunk) - Selling, general and administrative (SG&A) expenses increased to **$130.3 million** in Q2 2025 from **$103.6 million** in Q2 2024, driven by higher commercial activities for Auvelity and Symbravo and increased personnel costs[204](index=204&type=chunk) - In May 2025, the company entered into a new loan agreement with Blackstone for up to **$570.0 million** and used the initial proceeds to repay its existing debt with Hercules Capital, resulting in a one-time loss on debt extinguishment of **$10.4 million**[109](index=109&type=chunk)[116](index=116&type=chunk)[235](index=235&type=chunk) - The company believes its current cash position is sufficient to fund anticipated operations into cash flow positivity based on its current operating plan[223](index=223&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=47&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company identifies interest rate fluctuations, foreign currency exchange, and inflation as principal market risks, none of which are currently expected to materially affect financial results - The company's principal market risks are limited to interest rate fluctuations, foreign currency exchange risk, and inflation[242](index=242&type=chunk)[243](index=243&type=chunk)[245](index=245&type=chunk) - Management does not believe an immediate 100 basis point increase in interest rates or a 10% change in foreign currency exchange rates would have a material effect on the company's financial results or cash flows[242](index=242&type=chunk)[244](index=244&type=chunk) [Item 4. Controls and Procedures](index=47&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (June 30, 2025)[246](index=246&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect internal controls[247](index=247&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in ongoing legal proceedings, including a securities class action related to Symbravo® and patent infringement litigation concerning Sunosi® against generic drug manufacturers - **Securities Class Action:** A lawsuit alleging false statements regarding the NDA for AXS-07 (Symbravo®) is proceeding against the company and two officers after a motion to dismiss was partially denied in March 2025[251](index=251&type=chunk)[252](index=252&type=chunk) - **Shareholder Derivative Action:** A related derivative complaint against directors and officers is currently stayed pending the outcome of the Securities Class Action[253](index=253&type=chunk) - **Sunosi® Patent Litigation:** The company has filed patent infringement lawsuits against several generic drug manufacturers that submitted ANDAs for Sunosi®. Settlements have been reached with Unichem, Hikma, and Hetero, while actions against other defendants remain pending[254](index=254&type=chunk)[255](index=255&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, the need for additional funding, dependence on product commercial success, regulatory uncertainties for pipeline candidates, competition, reliance on third parties, intellectual property challenges, and compliance with complex healthcare laws - **Financial Risks:** The company has a history of significant losses (**$1.23 billion** accumulated deficit as of June 30, 2025) and may never achieve profitability. It may need additional funding, and its debt agreement with Blackstone contains restrictive covenants[261](index=261&type=chunk)[266](index=266&type=chunk)[269](index=269&type=chunk) - **Commercial & Development Risks:** The business is substantially dependent on the success of its three commercial products. There is no guarantee that pipeline candidates (like AXS-05 for AD agitation, AXS-12, AXS-14) will receive regulatory approval or be successfully commercialized. The company faces significant competition from major pharmaceutical companies[285](index=285&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) - **Third-Party & IP Risks:** The company relies on third parties for manufacturing, clinical trials, and other essential services. It also faces risks related to protecting its patents, potential infringement lawsuits, and the fact that some key intellectual property is licensed from an entity owned by its CEO[386](index=386&type=chunk)[393](index=393&type=chunk)[292](index=292&type=chunk) - **Regulatory & Legal Risks:** The company is subject to complex federal and state healthcare laws (e.g., Anti-Kickback, FCA), and failure to comply could result in substantial penalties. Changes in healthcare legislation, such as the Inflation Reduction Act (IRA), could adversely affect pricing and reimbursement[430](index=430&type=chunk)[446](index=446&type=chunk)[448](index=448&type=chunk) [Item 5. Other Information](index=112&type=section&id=ITEM%205.%20Other%20Information) The company did not adopt or terminate any Rule 10b5-1 trading arrangements, though two executive officers adopted new plans in June 2025 for future stock option exercises - The company did not adopt or terminate any Rule 10b5-1 trading arrangements for itself during Q2 2025[501](index=501&type=chunk) Executive Rule 10b5-1 Trading Plan Adoptions in Q2 2025 | Name | Title | Date of Adoption | Aggregate Shares to Be Sold | | :--- | :--- | :--- | :--- | | Herriot Tabuteau | Chief Executive Officer | June 13, 2025 | 524,000 | | Mark Jacobson | Chief Operating Officer | June 17, 2025 | 70,783 | [Item 6. Exhibits](index=112&type=section&id=ITEM%206.%20Exhibits) This section lists key exhibits filed with the Quarterly Report on Form 10-Q, including the Blackstone loan agreement, the 2025 Long-Term Incentive Plan, and standard CEO/CFO certifications - Key exhibits filed include the Loan Agreement with Blackstone dated May 8, 2025, and the company's 2025 Long-Term Incentive Plan documents[506](index=506&type=chunk)

Core Insights - Axsome Therapeutics reported $150.04 million in revenue for Q2 2025, a year-over-year increase of 72.1% [1] - The company’s EPS for the same period was -$0.92, an improvement from -$1.24 a year ago [1] - Revenue exceeded the Zacks Consensus Estimate of $139.61 million by 7.47%, and EPS also surpassed expectations by 8% [1] Revenue Breakdown - Royalty revenue was $1.08 million, below the nine-analyst average estimate of $1.74 million, reflecting a year-over-year increase of 67.7% [4] - Product sales, net totaled $148.96 million, exceeding the nine-analyst average estimate of $135.37 million, with a year-over-year increase of 72.2% [4] - Product sales for Sunosi reached $30 million, surpassing the six-analyst average estimate of $25.75 million [4] - Product sales for Auvelity were $119.6 million, compared to the $110.79 million average estimate from six analysts [4] Stock Performance - Axsome shares have returned -2.3% over the past month, while the Zacks S&P 500 composite increased by 0.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Core Viewpoint - Axsome Therapeutics reported a quarterly loss of $0.92 per share, which was better than the Zacks Consensus Estimate of a loss of $1, indicating an earnings surprise of +8.00% [1] - The company has shown consistent performance by surpassing consensus EPS estimates for four consecutive quarters [2] Financial Performance - Axsome's revenues for the quarter ended June 2025 were $150.04 million, exceeding the Zacks Consensus Estimate by 7.47%, and representing a significant increase from $87.17 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.75 on revenues of $163.39 million, and for the current fiscal year, it is -$3.28 on revenues of $612.93 million [7] Stock Performance - Since the beginning of the year, Axsome shares have increased by approximately 21.8%, outperforming the S&P 500's gain of 6.1% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Axsome belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, which may impact stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $150 million, representing a 72% increase year over year and a 24% increase quarter over quarter [6][14] - Net loss for the quarter was $48 million, or $0.97 per share, compared to a net loss of $59.4 million, or $1.22 per share in the previous quarter [17] - Cash and cash equivalents at the end of Q2 2025 were $300 million, down from $315.4 million at the end of Q2 2024 [17] Business Line Data and Key Metrics Changes - Avelity generated net product sales of $119.6 million, up 84% year over year and 24% quarter over quarter [14] - Sunosi net product revenues were $30 million, up 35% year over year and 19% quarter over quarter [15] - Zimbravo, launched on June 10, generated net sales of $410,000 in its partial quarter [15] Market Data and Key Metrics Changes - Avelity led the market in total prescriptions (TRx) growth, generating approximately 192,000 prescriptions in Q2, representing a 15% quarter over quarter growth [19] - Sunosi prescriptions exceeded 50,000 for the first time, representing a 9% sequential growth [20] - Coverage for Avelity now stands at 83% of lives across all channels, with 73% of commercial lives covered [20] Company Strategy and Development Direction - The company is focused on expanding its commercial portfolio with three marketed products and advancing its late-stage neuroscience pipeline [6][12] - AXS-five for Alzheimer's disease agitation is a key priority, with an sNDA submission expected this quarter [8] - The company aims to leverage its existing sales force for AXS-twelve and Sunosi, anticipating synergistic opportunities [114] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong demand for its products and the potential for continued growth in the second half of the year [6][23] - The company is encouraged by the early feedback on Cymbravo and expects to expand its coverage throughout the year [21][22] - Management highlighted the importance of market access and the positive signals from pharmacy benefit managers [28] Other Important Information - The company is advancing multiple late-stage development programs targeting significant unmet needs in neuroscience [6][12] - The launch of Cymbravo represents a significant milestone for the company, providing new treatment options for migraine patients [7] Q&A Session Summary Question: Payer coverage expansion for Avelity - Management clarified that the coverage expansion represents pull-through from previously announced GPO contracts and expects some acceleration in volume [28][30] Question: Market positioning of AXS-twelve against competitors - Management expressed optimism about AXS-twelve's profile in narcolepsy, highlighting its rapid action and efficacy in addressing key symptoms [35][36] Question: Utilization of Cimbravo through sampling - Management reported positive early utilization of sampling programs and patient savings programs, indicating strong initial access [42][43] Question: Revenue recognition for Cimbravo - Management explained that Q2 revenue recognition was based on initial stocking orders, with expectations for improved gross to net assumptions in future quarters [47][48] Question: Strategy for AXS-five in Alzheimer's agitation - Management plans to leverage existing sales forces and expand promotional efforts to target geriatric psychiatry and long-term care facilities [56][90] Question: Pediatric ADHD study details - Management indicated that the pediatric study would be a standard parallel group design, with confidence based on adult data translating to pediatric efficacy [110][111]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $150 million, reflecting a 72% increase year over year and a 24% increase quarter over quarter, driven by strong performance from Ovelity and Sunosi [6][14] - Net loss for the quarter was $48 million, or $0.97 per share, compared to a net loss of $59.4 million, or $1.22 per share in the previous quarter, and $79.3 million, or $1.67 per share in Q2 2024 [17] Business Line Data and Key Metrics Changes - Ovelity generated net product sales of $119.6 million, up 84% year over year and 24% quarter over quarter [14] - Sunosi net product revenues were $30 million, up 35% year over year and 19% quarter over quarter [15] - Zimbravo, launched on June 10, generated net sales of $410,000 for the partial quarter [15] Market Data and Key Metrics Changes - Avelity led the market in total prescriptions (TRx) growth, generating approximately 192,000 prescriptions in Q2, representing 15% quarter over quarter growth and 56% year over year growth [20] - Sunosi prescriptions exceeded 50,000 for the first time, representing 9% sequential growth and approximately 13% growth versus Q2 of last year [21] Company Strategy and Development Direction - The company is focused on advancing its late-stage neuroscience pipeline, with key priorities including AXS-five for Alzheimer's disease agitation and AXS-twelve for narcolepsy [8][10] - The launch of Cymbravo represents a significant milestone, providing new treatment options for migraine patients [7] - The company aims to expand its commercial infrastructure and enhance patient access to its medicines through strategic market access initiatives [19][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the accelerating trajectory of the commercial portfolio and the potential for significant long-term value creation [13] - The company anticipates continued strong commercial execution to drive momentum across its product portfolio in the second half of the year [23] Other Important Information - The company ended Q2 2025 with $300 million in cash and cash equivalents, down from $315.4 million at the end of Q2 2024 [17] - The company is on track to submit the sNDA for AXS-five this quarter and expects to initiate a Phase III trial for AXS-twelve in Q4 [9][10] Q&A Session Summary Question: Payer coverage expansion for Avelity - Management indicated that the coverage expansion represents pull-through from previously announced GPO contracts and expects some acceleration in volume [28][30] Question: Market positioning of AXS-twelve against competitors - Management expressed optimism about AXS-twelve's profile in narcolepsy, highlighting its rapid-acting nature and potential to address significant unmet needs [34][36] Question: Utilization of Cimbravo through sampling - Management reported positive early utilization of sampling programs and patient savings programs, indicating strong initial access [41][43] Question: Revenue recognition for Cimbravo - Management clarified that Q2 revenue recognition was based on initial stocking orders and that they expect to see more data on new patient starts in the coming quarters [46][48] Question: Strategy for AXS-five in Alzheimer's agitation - Management plans to leverage existing sales forces and expand promotional efforts to target geriatric psychiatry and long-term care facilities [54][56] Question: Growth drivers for Avelity - Management noted that GTN remained stable, with growth driven by higher demand and a favorable change in estimates related to liabilities [58][60] Question: Coverage expectations for Sunosi - Management aims to continue expanding coverage for Sunosi, which currently stands at approximately 83% of lives covered across channels [125] Question: Pediatric ADHD study details - Management indicated that the pediatric study will be a standard parallel group design, with confidence based on the efficacy observed in adult trials [110][112]

Financial Performance & Projections - Axsome reported Net Product Revenue of $150 million in 2Q 2025, a 72% increase compared to $872 million in 2Q 2024 [21] - AUVELITY Net Product Sales reached $1196 million in 2Q 2025, an 84% increase from $650 million in 2Q 2024 [21] - SUNOSI Net Product Revenue was $30 million in 2Q 2025, a 40% increase compared to $221 million in 2Q 2024 [21] - SYMBRAVO Net Product Sales were $04 million in 2Q 2025 [21] - The company estimates a combined peak sales potential of $165 billion across its differentiated portfolio [16] Clinical & Regulatory Milestones - The company commercially launched SYMBRAVO in the US in June 2025 [20] - Positive topline results were achieved from the EMERGE Phase 3 trial of SYMBRAVO in oral CGRP non-responders in 1Q 2025 [20] - Positive topline results were achieved from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults in 1Q 2025 [20] - Topline results were achieved from the PARADIGM Phase 3 trial of solriamfetol in MDD in 1Q 2025 [20] - An sNDA submission for AXS-05 in Alzheimer's disease agitation is expected in 3Q 2025 [20] - An NDA submission for AXS-12 in narcolepsy is expected in 4Q 2025 [20] Market & Pipeline - The company is developing new indications across approved products and has Phase 3 development programs ongoing [13] - The company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of solriamfetol in MDD with EDS in 4Q 2025 [20] - The company plans to initiate a Phase 3 trial of AXS-14 in fibromyalgia in 4Q 2025 [20] - The company plans to initiate a Phase 2/3 trial of AXS-05 in smoking cessation in 4Q 2025 [20]

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) This section provides an overview of Q2 2025 financial and operational achievements, including product performance and strategic pipeline advancements [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Axsome Therapeutics achieved robust financial and operational growth in Q2 2025, driven by significant product revenue increases and key pipeline advancements | Metric | 2Q 2025 Amount (Million USD) | YoY Growth | QoQ Growth | | :----------------------- | :--------------------------- | :--------- | :--------- | | Total Net Product Revenue | 150.0 | 72% | 24% | | AUVELITY Net Product Sales | 119.6 | 84% | 24% | | SUNOSI Net Product Revenue | 30.0 | 35% | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - AUVELITY market access expanded to an additional **28 million covered lives** in commercial channels[1](index=1&type=chunk) - SYMBRAVO secured its **first Group Purchasing Organization (GPO) contract**[1](index=1&type=chunk) - The supplemental New Drug Application (sNDA) for AXS-05 in Alzheimer's agitation is on track for submission in **Q3 2025**[1](index=1&type=chunk) - The New Drug Application (NDA) for AXS-12 for cataplexy in narcolepsy patients is anticipated for submission in **Q4 2025**[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Dr. Herriot Tabuteau emphasized strong Q2 2025 performance driven by robust product demand, commercial execution, regulatory progress, and a promising neuroscience pipeline - The company demonstrated strong performance in Q2 2025, attributed to robust demand for life-changing medicines, precise commercial execution, solid regulatory progress, and continued advancement of a differentiated neuroscience pipeline[4](index=4&type=chunk) - SYMBRAVO has been approved and successfully launched, while AUVELITY and SUNOSI show accelerated performance[4](index=4&type=chunk) - The sNDA for AXS-05 in Alzheimer's agitation and the NDA for AXS-12 in narcolepsy are on schedule for submission in Q3 and Q4, respectively[4](index=4&type=chunk) - The company possesses a late-stage development pipeline, including ADHD, binge eating disorder, shift work disorder, depression with excessive sleepiness, fibromyalgia, and smoking cessation, with potential first-in-class or best-in-class medicines addressing serious conditions affecting over **150 million US patients**[4](index=4&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) This section details Axsome Therapeutics' Q2 2025 financial performance, including key metrics, guidance, and consolidated financial statements [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) Axsome Therapeutics reported significant Q2 2025 revenue growth and a narrower net loss, driven by increased product sales and commercial activities, with sufficient cash reserves Q2 2025 Key Financial Data | Metric | 2Q 2025 (Million USD) | 2Q 2024 (Million USD) | YoY Growth | 1Q 2025 (Million USD) | QoQ Growth | | :----------------------------------- | :-------------------- | :-------------------- | :--------- | :-------------------- | :--------- | | **Revenue** | | | | | | | Total Net Product Revenue | 150.0 | 87.2 | 72% | 121.0 | 24% | | AUVELITY Net Product Sales | 119.6 | 65.0 | 84% | 96.4 | 24% | | SUNOSI Net Product Revenue | 30.0 | 22.1 | 35% | 25.2 | 19% | | SYMBRAVO Net Product Sales | 0.4 | - | - | - | - | | **Expenses** | | | | | | | Cost of Revenue | 13.4 | 8.1 | 65.4% | - | - | | Research and Development Expenses | 49.5 | 49.9 | -0.8% | - | - | | Selling, General and Administrative Expenses | 130.3 | 103.6 | 25.8% | - | - | | **Net Loss** | | | | | | | Net Loss | (48.0) | (79.3) | 39.5% | - | - | | Net Loss Per Share | (0.97) | (1.67) | 41.9% | - | - | | **Assets** | | | | | | | Cash and Cash Equivalents (as of June 30) | 303.0 | - | - | 315.4 (as of Dec 31) | -3.9% | | Common Shares Outstanding (as of June 30) | 49,815,301 | - | - | 48,667,587 (as of Dec 31) | 2.36% | [Financial Guidance](index=2&type=section&id=Financial%20Guidance) The company anticipates existing cash reserves will fund operations to positive cash flow, assuming no major changes to current plans - The company believes its existing cash is sufficient to fund operations until achieving positive cash flow, based on current operating plans[8](index=8&type=chunk) [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets and liabilities increased, driven by receivables, inventory, and short-term borrowings, with a slight rise in shareholder equity Consolidated Balance Sheets (as of June 30) | Item | June 30, 2025 (Thousand USD) | December 31, 2024 (Thousand USD) | | :----------------------------------- | :----------------------------- | :----------------------------- | | **Assets** | | | | Cash and Cash Equivalents | 303,016 | 315,353 | | Accounts Receivable, Net | 198,825 | 142,001 | | Inventory, Net | 18,441 | 15,732 | | Total Current Assets | 536,620 | 485,064 | | Total Assets | 639,785 | 568,498 | | **Liabilities** | | | | Accounts Payable | 91,628 | 71,997 | | Accrued Expenses and Other Current Liabilities | 170,902 | 147,987 | | Short-Term Borrowings | 70,000 | — | | Total Current Liabilities | 342,099 | 230,104 | | Long-Term Debt | 117,540 | 180,710 | | Total Liabilities | 566,710 | 511,483 | | **Stockholders' Equity** | | | | Common Stock | 5 | 5 | | Additional Paid-in Capital | 1,303,243 | 1,179,797 | | Accumulated Deficit | (1,230,173) | (1,122,787) | | Total Stockholders' Equity | 73,075 | 57,015 | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Axsome Therapeutics reported substantial revenue growth in Q2 and H1 2025, narrowing net losses despite increased operating expenses, driven by product sales and royalty income Consolidated Statements of Operations (as of June 30) | Item | 2Q 2025 (Thousand USD) | 2Q 2024 (Thousand USD) | H1 2025 (Thousand USD) | H1 2024 (Thousand USD) | | :----------------------------------- | :--------------------- | :--------------------- | :--------------------- | :--------------------- | | **Revenue** | | | | | | Product Sales, Net | 148,959 | 86,520 | 269,317 | 160,616 | | Royalty Revenue | 1,083 | 646 | 2,188 | 1,549 | | **Total Revenue** | **150,042** | **87,166** | **271,505** | **162,165** | | **Operating Expenses** | | | | | | Cost of Revenue | 13,448 | 8,055 | 23,237 | 14,352 | | Research and Development Expenses | 49,541 | 49,853 | 94,326 | 86,683 | | Selling, General and Administrative Expenses | 130,280 | 103,554 | 251,067 | 202,524 | | **Total Operating Expenses** | **186,756** | **165,212** | **365,201** | **307,486** | | Loss from Operations | (36,714) | (78,046) | (93,696) | (145,321) | | Net Loss | (47,973) | (79,345) | (107,386) | (147,702) | | Net Loss Per Share, Basic and Diluted | (0.97) | (1.67) | (2.18) | (3.11) | [Commercial Updates](index=2&type=section&id=Commercial%20Updates) This section provides commercial updates on AUVELITY, SUNOSI, and the successful launch of SYMBRAVO, detailing prescription growth and market access [AUVELITY](index=2&type=section&id=AUVELITY) AUVELITY, a unique rapid-acting oral treatment for MDD, demonstrated significant prescription growth and expanded market coverage in Q2 2025 - AUVELITY is the first and only rapid-acting oral NMDA receptor antagonist and sigma-1 receptor agonist approved in the US for the treatment of major depressive disorder[9](index=9&type=chunk) AUVELITY Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~192,000 | - | 56% | - | 15% | - As of July 1, AUVELITY's payer coverage in commercial channels expanded to an additional **28 million covered lives**; overall payer coverage across all channels is approximately **83%**, with commercial at approximately **73%** and government channels (Medicare and Medicaid) at approximately **100%**[11](index=11&type=chunk) [SUNOSI](index=3&type=section&id=SUNOSI) SUNOSI, a unique treatment for excessive daytime sleepiness, sustained prescription growth and high payer coverage in Q2 2025 - SUNOSI is the first and only dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea[12](index=12&type=chunk) SUNOSI Prescription Volume and Growth | Metric | 2Q 2025 | 2Q 2024 | YoY Growth | 1Q 2025 | QoQ Growth | | :------- | :------ | :------ | :--------- | :------ | :--------- | | Prescription Volume | ~50,000 | - | 13% | - | 9% | - SUNOSI's payer coverage across all channels is approximately **83%**, with commercial coverage at approximately **95%** and government channels at approximately **60%**[16](index=16&type=chunk) [SYMBRAVO](index=3&type=section&id=SYMBRAVO) SYMBRAVO successfully launched on June 10, 2025, quickly advancing commercialization with GPO contracts, initial payer coverage, and patient support - SYMBRAVO became available in US pharmacies on **June 10, 2025**, and active engagement with healthcare providers has commenced[16](index=16&type=chunk) - As of July 1, Axsome has contracted with one of the top three GPOs for potential formulary coverage of SYMBRAVO[16](index=16&type=chunk) - SYMBRAVO's payer coverage across all channels is currently approximately **38%**, with commercial at approximately **26%** and government channels at approximately **56%**[16](index=16&type=chunk) - The SYMBRAVO On My Side patient support program is fully operational, offering savings cards, educational resources, and HCP samples[16](index=16&type=chunk) [Development Pipeline](index=3&type=section&id=Development%20Pipeline) This section details the progress of Axsome's development pipeline, including AXS-05, Solriamfetol, AXS-12, and AXS-14, with upcoming regulatory and clinical milestones [AXS-05](index=3&type=section&id=AXS-05) AXS-05 progressed in Alzheimer's agitation with sNDA submission on track, and a pivotal trial for smoking cessation is imminent - AXS-05 has received **FDA Breakthrough Therapy designation** for Alzheimer's agitation[15](index=15&type=chunk) - Alzheimer's Agitation: The company plans to submit a supplemental New Drug Application (sNDA) for AXS-05 to the FDA in **Q3 2025**[17](index=17&type=chunk) - Smoking Cessation: The company plans to initiate a pivotal Phase 2/3 trial for AXS-05 in **Q4 2025**[17](index=17&type=chunk) [Solriamfetol](index=4&type=section&id=Solriamfetol) Solriamfetol is progressing in its pipeline for ADHD, MDD with EDS, BED, and SWD, with multiple Phase 3 trials underway or planned - Attention-Deficit/Hyperactivity Disorder (ADHD): The company plans to initiate a Phase 3 trial of solriamfetol in pediatric and adolescent ADHD patients in **Q4 2025**, following positive top-line results from the FOCUS Phase 3 trial in adult ADHD[21](index=21&type=chunk) - Major Depressive Disorder (MDD) with Excessive Daytime Sleepiness (EDS): The company plans to initiate a Phase 3 trial of solriamfetol in MDD patients with EDS in **Q4 2025**, following numerically greater improvement in depressive symptoms in a severe EDS patient subgroup in the PARADIGM Phase 3 proof-of-concept trial[21](index=21&type=chunk) - Binge Eating Disorder (BED): The ENGAGE Phase 3 trial is ongoing, with top-line results expected in **2026**[21](index=21&type=chunk) - Shift Work Disorder (SWD): The SUSTAIN Phase 3 trial is ongoing, with top-line results expected in **2026**[21](index=21&type=chunk) [AXS-12](index=4&type=section&id=AXS-12) AXS-12, with FDA Orphan Drug designation for narcolepsy, plans Q4 2025 NDA submission after positive clinical trial outcomes - AXS-12 has received **FDA Orphan Drug designation** for narcolepsy[19](index=19&type=chunk) - Narcolepsy: The company plans to submit an NDA for AXS-12 for the treatment of cataplexy in narcolepsy to the FDA in **Q4 2025**[19](index=19&type=chunk) - AXS-12 met its primary endpoints in three controlled Phase 2 and Phase 3 efficacy trials and a long-term safety trial, demonstrating rapid and significant reductions in cataplexy attacks, and improvements in excessive daytime sleepiness and cognitive function[19](index=19&type=chunk) [AXS-14](index=4&type=section&id=AXS-14) Axsome plans to initiate a new Phase 3 fixed-dose trial for AXS-14 in Q4 2025, addressing prior FDA feedback on its fibromyalgia NDA - Fibromyalgia: To address prior FDA Refusal to File (RTF) feedback for the AXS-14 NDA for the management of fibromyalgia, the company plans to initiate a Phase 3 fixed-dose 12-week trial in **Q4 2025**[20](index=20&type=chunk) [Corporate Information](index=5&type=section&id=Corporate%20Information) This section provides corporate updates, anticipated milestones, conference call details, company overview, forward-looking statements, and contact information [Corporate Updates](index=5&type=section&id=Corporate%20Updates) Axsome Therapeutics resolved SUNOSI patent litigation and hosted a successful "Brain Health R&D Day," highlighting its neuroscience leadership and innovative pipeline - In May 2025, Axsome resolved patent litigation with Hetero Labs Ltd. and its affiliates regarding generic versions of SUNOSI, allowing Hetero to begin selling its generic product after **September 1, 2040** (if pediatric exclusivity is obtained) or **March 1, 2040** (if pediatric exclusivity is not obtained)[26](index=26&type=chunk) - In July 2025, the company hosted a "Brain Health R&D Day" event, featuring six leading expert clinicians and key opinion leaders who discussed target indications for Axsome's late-stage pipeline and presented clinical data[26](index=26&type=chunk) [Anticipated Milestones](index=5&type=section&id=Anticipated%20Milestones) Axsome Therapeutics outlined key regulatory submissions, clinical trial results, and trial initiation plans for its product pipeline in upcoming quarters - Regulatory & Commercial: - AXS-05 sNDA submission for Alzheimer's agitation (**Q3 2025**) - AXS-12 NDA submission for narcolepsy (**Q4 2025**) - Clinical Trial Top-Line Results: - Solriamfetol Phase 3 ENGAGE trial for binge eating disorder (**2026**) - Solriamfetol Phase 3 SUSTAIN trial for shift work disorder (**2026**) - Clinical Trial Initiations & Progress: - AXS-05 pivotal Phase 2/3 trial initiation for smoking cessation (**Q4 2025**) - Solriamfetol Phase 3 trial initiation for pediatric and adolescent ADHD (**Q4 2025**) - Solriamfetol Phase 3 trial initiation for MDD with EDS (**Q4 2025**) - AXS-14 Phase 3 trial initiation for fibromyalgia (**Q4 2025**)[26](index=26&type=chunk) [Conference Call Information](index=5&type=section&id=Conference%20Call%20Information) Axsome Therapeutics provided details for its Q2 2025 financial results and business update conference call, including access information - The company is hosting a conference call and webcast today at **8:00 AM Eastern Time** to discuss its Q2 2025 financial results and business update[24](index=24&type=chunk) - To participate in the live conference call, dial **(877) 405-1239** (US Toll-Free) or **+1 (201) 389-0851** (International)[24](index=24&type=chunk) - A live webcast can be accessed on the "Investors" section of the company's website at axsome.com, under the "Webcasts & Presentations" page, with a replay available for approximately 30 days after the live event[24](index=24&type=chunk) [About Axsome Therapeutics](index=5&type=section&id=About%20Axsome%20Therapeutics) Axsome Therapeutics is a leading biopharmaceutical company focused on CNS disorders, developing differentiated products to improve patient outcomes and address severe neurological and psychiatric conditions - Axsome Therapeutics is a biopharmaceutical company dedicated to ushering in a new era of central nervous system (CNS) disorder treatment[25](index=25&type=chunk) - The company achieves scientific breakthroughs by identifying critical gaps in care and developing differentiated products with novel mechanisms of action to significantly improve patient outcomes[25](index=25&type=chunk) - Its neuroscience portfolio includes FDA-approved treatments for major depressive disorder, narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting a broad spectrum of serious neurological and psychiatric conditions affecting over **150 million people** in the US[25](index=25&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks and uncertainties regarding commercial success, clinical trials, regulatory approvals, and financial factors, with no obligation to update - Certain matters in this press release are "forward-looking statements," pertaining to the commercial success of the company's products (SUNOSI, AUVELITY, SYMBRAVO) and efforts to obtain additional indications for solriamfetol and/or AXS-05[27](index=27&type=chunk) - Forward-looking statements involve risks and uncertainties, including but not limited to the company's ability to maintain and expand payer coverage, the success, timing, and cost of ongoing and anticipated clinical trials, the timing and ability of regulatory agencies to grant approvals, the protection of intellectual property, capital requirements, and macroeconomic and regulatory developments[27](index=27&type=chunk) - The company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, and actual results and developments may differ materially from those expressed or implied in such statements[27](index=27&type=chunk) [Investor & Media Contacts](index=8&type=section&id=Investor%20%26%20Media%20Contacts) Contact information for Axsome Therapeutics' investor relations and media communications is provided - Investor Contact: Mark Jacobson, Chief Operating Officer, Phone: **(212) 332-3243**, Email: mjacobson@axsome.com[33](index=33&type=chunk) - Media Contact: Darren Opland, Director, Corporate Communications, Phone: **(929) 837-1065**, Email: dopland@axsome.com[33](index=33&type=chunk)

Core Insights - Axsome Therapeutics reported strong financial performance for Q2 2025, with total net product revenue of $150.0 million, reflecting a 72% year-over-year growth and a 24% sequential increase [4][9] - The company highlighted the successful launch of SYMBRAVO for migraine treatment and the continued growth of AUVELITY for depression and SUNOSI for excessive daytime sleepiness [3][4] - Axsome is on track for significant regulatory submissions, including AXS-05 for Alzheimer's disease agitation in Q3 2025 and AXS-12 for narcolepsy in Q4 2025 [3][4] Financial Highlights - Total net product revenue for Q2 2025 was $150.0 million, up from $87.2 million in Q2 2024 [4] - AUVELITY sales reached $119.6 million, an 84% increase year-over-year, while SUNOSI generated $30.0 million, a 35% increase [4] - The net loss for Q2 2025 was $48.0 million, or $(0.97) per share, compared to a net loss of $79.3 million, or $(1.67) per share, in Q2 2024 [9][29] Commercial Highlights - AUVELITY's market access expanded by 28 million new covered lives, achieving approximately 83% overall payer coverage [10] - SYMBRAVO launched on June 10, 2025, with initial sales of $0.4 million and a GPO contract signed for potential formulary coverage [4][10] - SUNOSI prescriptions increased by 13% year-over-year, with payer coverage at approximately 83% [10] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [13][15] - AXS-12 is targeted for cataplexy in narcolepsy, with an NDA submission anticipated in Q4 2025 [17] - The company is advancing multiple late-stage programs, including trials for ADHD, binge eating disorder, and fibromyalgia [12][14][18] Corporate Updates - Axsome resolved patent litigation with Hetero Labs regarding SUNOSI, allowing for future generic sales under specific conditions [22] - The company hosted a research and development day featuring expert discussions on its late-stage pipeline [22] - Axsome's cash and cash equivalents totaled $303.0 million as of June 30, 2025, down from $315.4 million at the end of 2024 [9][27]