Axsome Therapeutics(US:AXSM)2025-11-03 21:37Financial Performance - Total revenues for Q3 2025 reached $170.992 million, a 63.2% increase from $104.762 million in Q3 2024[15] - Product sales, net for the nine months ended September 30, 2025, were $439.101 million, up 66.1% from $264.352 million in the same period of 2024[15] - For the nine months ended September 30, 2025, total revenues were $442.5 million, a 65.7% increase from $266.9 million in the same period of 2024[148] - Total revenues for the three months ended September 30, 2025, were $171.0 million, up 63.5% from $104.8 million in the same period of 2024[148] - The company reported a net loss per common share of $0.94 for Q3 2025, an improvement from $1.34 in Q3 2024[12] - For the three months ended September 30, 2025, the net loss was $47.2 million, compared to a net loss of $64.6 million for the same period in 2024, representing a 26.5% improvement[12] - The segment net loss for the nine months ended September 30, 2025, was $154.615 million, down 27.2% from $212.304 million in the same period of 2024[169] Expenses - Operating expenses for Q3 2025 totaled $217.101 million, compared to $167.386 million in Q3 2024, reflecting a 29.7% increase[15] - Research and development expenses for the nine months ended September 30, 2025, were $134.488 million, slightly up from $132.071 million in the same period of 2024[15] - Research and development expenses totaled $40.2 million for the three months ended September 30, 2025, down from $45.4 million in 2024, and $134.5 million for the nine months ended September 30, 2025, slightly up from $132.1 million in 2024[202] - Selling, general and administrative expenses increased to $150.2 million for the three months ended September 30, 2025, compared to $95.6 million in 2024, and $401.3 million for the nine months ended September 30, 2025, up from $298.1 million in 2024[198] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $325.272 million, up from $315.353 million at the end of 2024[13] - Total assets increased to $669.250 million as of September 30, 2025, compared to $568.498 million at the end of 2024, representing an 18% growth[13] - The accumulated deficit increased to $1.277 billion as of September 30, 2025, from $1.123 billion at the end of 2024[13] - Cash flows from operating activities resulted in a net cash used of $74.752 million, compared to $102.208 million in the prior year, indicating a 27% improvement[21] Product Sales and Revenue Sources - Product sales for Auvelity reached $136.1 million in Q3 2025, a 69.5% increase from $80.4 million in Q3 2024[148] - The company reported a royalty revenue of $1.2 million for Sunosi sales in Q3 2025, compared to $1.0 million in Q3 2024, reflecting a 20% increase[151] - The primary sources of cash included proceeds from the sales of Auvelity, Sunosi, and Symbravo, as well as the issuance of common stock and debt[30] - The company generated revenue from license agreements and product sales, with sales recorded net of reserves for variable consideration[41] Debt and Financing - The Company entered into a loan agreement with Blackstone for up to $570 million, including a first lien senior secured term loan of $120 million funded on May 8, 2025[109] - The effective interest rate on the Term Loans was 9.58% for the nine months ended September 30, 2025[110] - The Company recorded a loss on debt extinguishment of approximately $10.4 million upon repaying its obligations under the Hercules Loan Agreement[116] - The Company has a minimum liquidity covenant of $30 million, tested quarterly under the Blackstone Loan Agreement[112] Research and Development - Research and development costs are expensed as incurred, with significant expenses related to employee-related costs and third-party services[80] - AXS-05 has received FDA Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation[178] - The Company has submitted a supplemental NDA for AXS-05 in Alzheimer's disease agitation, supported by four completed Phase 3 trials[178] - The company anticipates moderate increases in research and development costs through the end of 2025 and into 2026 as new development programs commence[203] Inventory and Receivables - As of September 30, 2025, accounts receivable, net increased to $196.5 million from $142.0 million as of December 31, 2024, representing a 38.3% increase[97] - Total inventory as of September 30, 2025, was $35.6 million, up from $26.3 million as of December 31, 2024, reflecting a 35.5% increase[98] Customer and Market Information - The company has three largest customers representing approximately 34%, 30%, and 26% of gross product sales for the nine months ended September 30, 2025[146] - The company expects fluctuations in revenues from Auvelity, Sunosi, and Symbravo based on demand quarter to quarter, and future revenue generation is contingent on successful product development and regulatory approval[186] Stock and Compensation - Total stock-based compensation expense for the nine months ended September 30, 2025, was $71.0 million, compared to $63.2 million for the same period in 2024[140] - The intrinsic value of restricted stock units (RSUs) that lapsed during the nine months ended September 30, 2025, was $17.2 million[134] - The Company granted 64,281 performance stock units (PSUs) in February 2025, with a grant date fair value of $94.39 per share[136]