Financial Performance - Total revenues for the quarter ended March 31, 2023, were $94.576 million, with product sales of $28.569 million and license revenue of $65.735 million[14]. - Operating expenses for the same period were $100.950 million, significantly higher than $38.289 million in the previous year, driven by increased research and development costs[14]. - The net loss for the quarter was $11.218 million, a reduction from a net loss of $39.632 million in the same quarter of the previous year[14]. - Cash at the end of the period was $246.515 million, up from $200.842 million at the beginning of the period[20]. - The company reported a weighted average of 43,523,631 common shares outstanding for the quarter, compared to 38,323,167 shares in the same quarter last year[14]. - Interest expense for the quarter was $2.264 million, up from $1.343 million in the previous year[14]. - The company incurred net losses of $11.2 million for the three months ended March 31, 2023, compared to $39.6 million for the same period in 2022, with an accumulated deficit of $607.6 million as of March 31, 2023[182]. Research and Development - The company incurred research and development expenses of $17.793 million for the quarter, compared to $12.585 million in the same quarter last year, reflecting increased investment in product development[14]. - Research and development expenses for AXS-05 were $6.7 million in Q1 2023, an increase from $6.0 million in Q1 2022[199]. - The company aims to become a fully integrated biopharmaceutical company developing differentiated therapies for CNS disorders[25]. - Axsome Therapeutics is developing three not yet approved product candidates (AXS-07, AXS-12, and AXS-14) for CNS conditions, addressing significant market needs[24]. - The company is currently conducting a Phase 3 trial for AXS-12 in narcolepsy, referred to as the SYMPHONY study[180]. - The company achieved the primary endpoint in the Phase 2/3 ADVANCE-1 trial for AXS-05 in Alzheimer's disease agitation[177]. - AXS-07 achieved the co-primary endpoints in both the Phase 3 MOMENTUM and INTERCEPT trials for the acute treatment of migraine[177]. - The company has received a complete response letter from the FDA regarding AXS-07, primarily related to chemistry, manufacturing, and controls[177]. Commercialization and Licensing - In February 2023, the company announced a licensing agreement with Atnahs Pharma UK Limited to market Sunosi in Europe and certain countries in the Middle East/North Africa[24]. - The company entered into a license agreement with Pharmanovia in February 2023, receiving a non-refundable upfront payment of €62.0 million ($65.7 million) and is eligible for sales-based milestone payments totaling up to €94.5 million[159]. - The company sells Sunosi and Auvelity in the U.S. through wholesale distributors and internationally through local distributors[40]. - The company expects expenses to increase primarily due to the commercialization of Sunosi and Auvelity while further developing its pipeline assets[29]. - The company expects to incur significant commercialization expenses for Sunosi and Auvelity to support their growth[182]. - For the three months ended March 31, 2023, net product sales were $12.9 million for Sunosi and $15.7 million for Auvelity[40]. - The company will receive a royalty percentage in the mid-twenties on net sales of the licensed products in the territory[191]. Assets and Liabilities - As of March 31, 2023, the company had an accumulated deficit of $607.6 million[28]. - The company recorded goodwill and an intangible asset as a result of the Sunosi acquisition, with goodwill deemed to have an indefinite life and tested annually for impairment[58]. - The fair value of the contingent consideration related to the Sunosi acquisition is recorded as $35.1 million as of March 31, 2023, down from $37 million at the end of 2022[105]. - The Company’s intangible asset net book value was $58.1 million as of March 31, 2023, with an estimated future amortization expense of $6.4 million for 2023[102]. - The total inventory as of March 31, 2023, was $22.4 million, compared to $18.0 million at December 31, 2022, reflecting an increase in raw materials and finished goods[111]. - The company reported net accounts receivable of $44.8 million as of March 31, 2023, an increase from $37.7 million at December 31, 2022[97]. - The company’s total outstanding debt increased to $150,000 million as of March 31, 2023, up from $95,000 million as of December 31, 2022, reflecting a 57.9% increase[129]. Future Outlook - The company expects revenues from Sunosi and Auvelity to fluctuate based on demand quarter to quarter[189]. - The company may continue to incur substantial operating losses even as it begins to generate revenues from its product candidates[28]. - The company has not recorded any allowances for doubtful accounts receivable as of March 31, 2023, despite receivables from the three largest customers totaling 47%, 24%, and 24% of the accounts receivable net balance[66]. - The company expects to pay up to $165 million based on revenue milestones and $1 million based on development milestones related to the Sunosi acquisition[87]. - The company must maintain a minimum cash requirement of $30 million as part of the loan agreement[117]. - The company is required to achieve at least 60% of net product revenue from specific products, including AXS-05, AXS-07, and Sunosi, starting from the reporting period ended June 30, 2023[121]. Stock and Compensation - The company has extended the maturity date of its loan agreement to January 1, 2028, with the possibility of extending to January 1, 2029, if certain revenue targets are met[117]. - The total compensation cost not yet recognized related to unvested Restricted Stock Units (RSUs) was $29.3 million as of March 31, 2023, expected to be recognized over a weighted-average period of 3.1 years[150]. - The Company reported total stock-based compensation expense of $12.9 million for the three months ended March 31, 2023, compared to $7.6 million for the same period in 2022, indicating a year-over-year increase of approximately 69.7%[152]. - The weighted average grant date fair value of options granted in the first quarter of 2023 was $51.44 per option, with a total unrecognized compensation cost related to non-vested stock options amounting to $160.3 million, expected to be recognized over 3.1 years[148]. - The Company has 1,241,793 shares available for issuance under its 2015 Omnibus Incentive Compensation Plan as of March 31, 2023[146]. - The outstanding warrants increased to 69,520 as of March 31, 2023, from 50,796 at the end of 2022, with a weighted average exercise price of $48.97[154].

Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q4 2022 Earnings Conference Call February 27, 2023 8:00 AM ET Company Participants Mark Jacobson - COO Herriot Tabuteau - Chairman & CEO Nick Pizzie - CFO Lori Englebert - EVP, Commercial and Business Development Hunter Murdock - General Counsel Conference Call Participants Charles Duncan - Cantor Fitzgerald Marc Goodman - SVB Securities Vikram Purohit - Morgan Stanley Jason Gerberry - Bank of America David Amsellem - Piper Sandler Joon Lee - Truist Securities Joseph ...

Table of Contents a UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-37635 AXSOME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or ...

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