Financial Data and Key Metrics Changes - In Q2, Axsome Therapeutics achieved a milestone of $150 million in net sales for the first time, with $120 million from Avelity and $30 million from Sunosi, indicating strong growth potential [5] - The company has a robust balance sheet with over $300 million in cash, positioning it for cash flow positivity [5] Business Line Data and Key Metrics Changes - Avelity is on track for annualized sales of half a billion, with significant growth observed since its launch [5][37] - Sunosi generated $30 million in sales, with a focus on expanding its market presence in obstructive sleep apnea and narcolepsy [68] - The launch of Symbravo for migraine treatment is in early stages, with positive feedback on its efficacy and tolerability [54][56] Market Data and Key Metrics Changes - The market for Alzheimer's disease agitation shows substantial unmet need, with potential peak sales for Avelity estimated between $1 billion to $3 billion [11] - Avelity is currently capturing about 0.16% of the total market share, indicating significant room for growth [50] Company Strategy and Development Direction - The company is focused on expanding its sales force and enhancing its commercialization strategy, particularly for Avelity and the upcoming Alzheimer's indication [33][41] - Axsome is exploring additional indications for Sunosi, including ADHD and MDD associated with excessive daytime sleepiness, which could drive future growth [69][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Avelity, citing a strong sales force and increased market access as key drivers [38][41] - The company aims to prioritize top-line growth while also improving cash flow, with a significant reduction in losses year-over-year [90] Other Important Information - Axsome has a patent portfolio for Symbravo extending to 2041, providing a competitive edge in the market [65][66] - The company is in dialogue with the FDA regarding its clinical trial designs and submission strategies for various products, ensuring alignment with regulatory expectations [21][25] Q&A Session Summary Question: Are you still on track to file an sNDA for Alzheimer's disease agitation in Q3? - Yes, the company is on track to file [6][7] Question: What is the commercial opportunity in Alzheimer's agitation? - There is substantial unmet need, with potential peak sales estimated at $1 billion to $3 billion [11] Question: How is the sales force being optimized for Avelity? - The sales force has expanded to approximately 300 reps, with plans to integrate Alzheimer's agitation into their strategy [33][34] Question: What are the goals for the launch of Symbravo? - The focus is on gathering clinician feedback and improving access for patients [54][56] Question: What is the expected gross to net discount for Avelity? - The company expects to maintain a mid-50s range for gross to net discounting [52][53] Question: What is the potential market for ADHD indications? - The peak sales potential for ADHD is estimated at $1 billion to $3 billion [77]

Core Viewpoint - Axsome Therapeutics has shown a positive trend in its stock performance, with a 19.2% increase over the past month, outperforming the S&P 500, leading to speculation about the sustainability of this trend ahead of its next earnings release [1]. Financial Performance - In Q2 2025, Axsome reported an adjusted loss of $0.97 per share, which was narrower than the Zacks Consensus Estimate of a loss of $1.00, and a significant improvement from a loss of $1.67 per share in the same quarter last year [2]. - Total revenues surged 72% year over year to $150 million, exceeding the Zacks Consensus Estimate of $140 million, primarily driven by strong sales of Auvelity [3]. - Product revenues reached $148.9 million in Q2, compared to $86.5 million in the previous year, with royalty revenues contributing an additional $1.1 million [4]. Product Sales Breakdown - Auvelity sales amounted to $119.6 million, reflecting an 84% year-over-year increase and a 24% sequential increase, with approximately 192,000 prescriptions recorded, marking a 15% sequential and 56% year-over-year increase [5]. - Sunosi's net product sales were $30 million, up 35% from the previous year, with total prescriptions growing 13% year over year to 50,000 [6]. - Symbravo, launched in June, generated $0.4 million in sales during its partial quarter [6]. Expense Analysis - Research and development expenses were $49.5 million, down 0.8% from the previous year, attributed to the completion of label expansion studies [7]. - Selling, general, and administrative expenses totaled $130.3 million, up 25.8% year over year, driven by increased commercial activities for Auvelity and ongoing launch activities for Symbravo [8]. Cash Position - As of June 30, 2025, Axsome had cash and cash equivalents of $303 million, slightly up from $300.9 million as of March 31, 2025 [8]. Market Outlook - Estimates for Axsome have been trending downward, indicating a potential shift in market sentiment, with a Zacks Rank of 3 (Hold) suggesting an expectation of in-line returns in the coming months [12]. Industry Comparison - Axsome operates within the Zacks Medical - Biomedical and Genetics industry, where Regeneron reported revenues of $3.68 billion in its last quarter, reflecting a year-over-year increase of 3.6% [13].

Core Viewpoint - Axsome Therapeutics has shown strong stock performance, with a 20.2% increase over the past month, significantly outperforming the industry and the S&P 500 [1][7]. Sales Performance - The lead drug, Auvelity, has generated $215.9 million in sales during the first half of 2025, marking an 82.3% year-over-year increase, primarily due to higher unit sales volume [3][7]. - Auvelity is expected to maintain a compound annual growth rate (CAGR) of approximately 42.7% over the next three years [3]. Drug Development and Pipeline - Axsome is expanding Auvelity's indications for other CNS disorders, including Alzheimer's disease agitation and smoking cessation, with plans to submit a supplemental new drug application (sNDA) later in Q3 2025 [4]. - The company is also advancing its other drugs, such as Sunosi, which generated $53 million in sales in H1 2025, reflecting a 25.6% year-over-year increase [8]. - New migraine drug Symbravo was approved in January 2025 and launched in June, enhancing Axsome's market presence [9]. Competitive Landscape - Competition exists in the CNS market, with companies like Acadia Pharmaceuticals developing similar treatments [11]. - Sunosi may face competition from Jazz Pharmaceuticals' sleep disorder drugs, which have a strong market share [12]. Regulatory Challenges - Axsome received a Refusal to File letter from the FDA regarding its NDA for AXS-14, which could delay potential approval and market entry [13]. Valuation Metrics - Axsome's shares are trading at a price-to-sales (P/S) ratio of 12.16, significantly higher than the industry average of 2.12, although below its five-year mean of 14.93 [14]. Earnings Estimates - The Zacks Consensus Estimate for 2025 loss per share has widened from $3.26 to $3.41, while 2026 earnings per share estimates have decreased from $1.36 to $0.92 [16]. Conclusion - The strong sales performance of Auvelity and the progress of other drugs are positive indicators for Axsome's stock [17]. - However, competition and potential regulatory setbacks pose risks to growth prospects [17].

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]