Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $171 million, representing a 63% increase year over year [4][11] - Net product sales for Auvelity were $136.1 million, up 69% compared to the previous year [11] - Sunosi net product revenues were $32.8 million, reflecting a 35% increase year over year [11] - The net loss for the quarter was $47.2 million, or $0.94 per share, an improvement from a net loss of $64.6 million, or $1.34 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - Auvelity showed strong prescription growth with approximately 209,000 prescriptions written, a 46% year-over-year increase [15] - Sunosi had approximately 53,000 prescriptions, representing a 12% year-over-year growth [18] - Sembravo generated $2.1 million in net sales during its first full quarter on the market [11] Market Data and Key Metrics Changes - Commercial coverage for Auvelity increased from 73% to 75%, bringing total coverage to 85% of all lives across channels [15] - Payer coverage for Sunosi remains at approximately 83% of lives covered across channels [18] - Sembravo's overall payer coverage was approximately 52% of all lives as of October 1st [17] Company Strategy and Development Direction - The company aims to broaden patient access and drive awareness with clinicians for its products [5] - Axsome is advancing a robust pipeline with late-stage programs targeting Alzheimer's disease agitation, narcolepsy, and ADHD [5][10] - The company plans to initiate a phase 2/3 trial for AXS-05 in smoking cessation and target NDA submission for AXS-12 for cataplexy in narcolepsy [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth potential of Axsome, highlighting strong performance across its commercial portfolio [19] - The company anticipates meaningful activity across its late-stage programs in the coming months [5] - Management noted that the fundamentals of the business have never been stronger, positioning Axsome for substantial near and long-term value [10] Other Important Information - The company ended Q3 2025 with $325.3 million in cash and cash equivalents, an increase from $315.4 million at the end of 2024 [14] - Gross-to-net discounts for Auvelity and Sunosi were in the high 40% range, expected to increase to the low 50% range in Q4 [12] Q&A Session Summary Question: Insights on Sembravo's launch and prescribing depth - Management noted early positive responses from healthcare providers and patients, with a targeted approach focusing on top headache centers [22][23] Question: Growth driver for Auvelity in primary care - Management emphasized the importance of primary care as a growth driver, supported by sales force expansion and direct-to-consumer campaigns [26][27] Question: Expectations for AXS-05 adoption in Alzheimer's agitation - Management is optimistic about AXS-05's impact, planning to cover various specialties and settings of care [31][32] Question: Sales force expansion and cash flow positivity - Management confirmed plans for sales force expansion if AXS-05 is approved, with costs already included in cash flow positivity guidance [35][76] Question: Impact of DTC campaign on Auvelity prescriptions - Management indicated that significant impacts from the DTC campaign may be observed in 8-12 weeks, with early positive trends noted [77] Question: Regulatory interactions for AXS-05 - Management stated that interactions are ordinary course and that they are prepared for standard review by the FDA [87]

Core Insights - Avidity Biosciences, Inc. is set to be acquired by Novartis AG for $12 billion in an all-cash deal, marking a significant biotech acquisition of the year [1] Group 1: Acquisition Details - The acquisition offer is priced at $72 per share, representing a 46% premium over Avidity's closing price on October 24 and a 62% premium to its 30-day volume-weighted average price [3] - Avidity will spin out its early-stage precision cardiology programs into a new publicly traded company, funded with $270 million in cash, allowing shareholders to receive equity in the new entity alongside the cash offer [3] Group 2: Strategic Rationale - The acquisition aligns with Novartis' strategy to enhance its neuroscience and rare disease portfolio, focusing on Avidity's late-stage AOC pipeline, which includes treatments for Duchenne muscular dystrophy, myotonic dystrophy type 1, and facioscapulohumeral muscular dystrophy [4] Group 3: Analyst Perspectives - H.C. Wainwright downgraded Avidity to Neutral from Buy, setting a price target of $72, reflecting the cash offer from Novartis and indicating no expectation of a competing bid [2][5] - The price forecast is based on a combination of a $92 per share estimate using a 25× multiple of projected 2034 earnings and a discounted cash flow value of $51 per share [5][6] Group 4: Recent Financial Performance - Avidity reported a second-quarter loss of $1.21 per share, which was worse than analysts' expectations of a $1.00 loss, although sales increased significantly to $3.85 million, up 88% year over year [7]