Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 13, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Entity File Number | 001-37635 | ||
Entity Registrant Name | AXSOME THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-4241907 | ||
Entity Address, Address Line One | One World Trade Center | ||
Entity Address, Address Line Two | 22nd Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10007 | ||
City Area Code | 212 | ||
Local Phone Number | 332-3241 | ||
Title of 12(b) Security | Common Stock, Par Value $0.0001 Per Share | ||
Trading Symbol | AXSM | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 47,374,375 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001579428 | ||
Amendment Flag | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 2.8 | ||
Auditor Firm ID | 34 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | Morristown, New Jersey | ||
Documents Incorporated by Reference | Portions of the registrant's definitive proxy statement for its 2024 Annual Meeting of Stockholders (the "Proxy Statement"), to be filed within 120 days of the registrant's fiscal year ended December 31, 2023, are incorporated by reference in Part III of this Annual Report on Form 10-K. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement is not deemed to be filed as part of this Annual Report on Form 10-K. | ||
Ernst & Young LLP | |||
Document Information [Line Items] | |||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | New York, New York |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 386,193 | $ 200,842 |
Accounts receivables, net | 94,820 | 37,699 |
Inventories, net | 15,135 | 4,320 |
Prepaid and other current assets | 8,115 | 2,781 |
Total current assets | 504,263 | 245,642 |
Equipment, net | 846 | 722 |
Right-of-use asset - operating lease | 6,772 | 420 |
Goodwill | 12,042 | 10,310 |
Intangible asset, net | 53,286 | 59,661 |
Non-current inventory and other assets | 11,027 | 14,721 |
Total assets | 588,236 | 331,476 |
Current liabilities: | ||
Accounts payable | 40,679 | 38,605 |
Accrued expenses and other current liabilities | 90,501 | 51,631 |
Operating lease liability, current portion | 1,267 | 425 |
Contingent consideration, current | 6,407 | 5,900 |
Total current liabilities | 138,854 | 96,561 |
Contingent consideration, non-current | 73,300 | 31,100 |
Loan payable, long-term | 178,070 | 94,259 |
Operating lease liability, long-term | 7,035 | |
Total liabilities | 397,259 | 221,920 |
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) | ||
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,351,363 and 43,498,617 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively) | 5 | 4 |
Additional paid-in capital | 1,026,543 | 705,885 |
Accumulated deficit | (835,571) | (596,333) |
Total stockholders’ equity | 190,977 | 109,556 |
Total liabilities and stockholders’ equity | $ 588,236 | $ 331,476 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 47,351,363 | 43,498,617 |
Common stock, shares outstanding | 47,351,363 | 43,498,617 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues [Abstract] | |||
Revenue | $ 270,600 | $ 50,037 | |
Operating expenses: | |||
Cost of revenue (excluding amortization and depreciation) | 26,065 | 5,198 | |
Research and development | 97,944 | 57,947 | $ 58,061 |
Selling, general and administrative | 323,123 | 159,254 | 66,646 |
Loss in fair value of contingent consideration | 48,918 | 3,298 | |
Intangible asset amortization | 6,375 | 4,139 | |
Total operating expenses | 502,425 | 229,836 | 124,707 |
Loss from operations | (231,825) | (179,799) | (124,707) |
Interest expense, net | (6,453) | (7,335) | (5,696) |
Loss before income taxes | (238,278) | (187,134) | (130,403) |
Income tax expense | (960) | ||
Net loss | $ (239,238) | $ (187,134) | $ (130,403) |
Net loss per common share, basic | $ (5.27) | $ (4.60) | $ (3.47) |
Net loss per common share, diluted | $ (5.27) | $ (4.60) | $ (3.47) |
Weighted average common shares outstanding, basic | 45,425,212 | 40,655,941 | 37,618,599 |
Weighted average common shares outstanding, diluted | 45,425,212 | 40,655,941 | 37,618,599 |
Product Sales | |||
Revenues [Abstract] | |||
Revenue | $ 202,460 | $ 50,037 | |
License Revenue | |||
Revenues [Abstract] | |||
Revenue | 65,735 | ||
Royalty Revenue | |||
Revenues [Abstract] | |||
Revenue | $ 2,405 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2020 | $ 113,793 | $ 4 | $ 705,885 | $ (596,333) |
Balance (in shares) at Dec. 31, 2020 | 43,498,617 | |||
Stock-based compensation | 20,803 | 20,803 | ||
Issuance of common stock upon exercise of options | 4,402 | 4,402 | ||
Issuance of common stock upon exercise of options (in shares) | 326,219 | |||
Issuance of common stock upon vesting of RSUs (in shares) | 6,191 | |||
Issuance of common stock upon financing | 7,212 | 7,212 | ||
Issuance of common stock upon financing (in shares) | 110,296 | |||
Shares tendered for withholding taxes | (176) | (176) | ||
Net loss | (130,403) | (130,403) | ||
Ending balance at Dec. 31, 2021 | 15,631 | $ 4 | 424,826 | (409,199) |
Balance (in shares) at Dec. 31, 2021 | 37,816,794 | |||
Stock-based compensation | 37,726 | 37,726 | ||
Issuance of common stock upon exercise of options | 6,251 | 6,251 | ||
Issuance of common stock upon exercise of options (in shares) | 340,149 | |||
Issuance of common stock upon vesting of RSUs (in shares) | 21,214 | |||
Issuance of common stock upon financing | 236,788 | 236,788 | ||
Issuance of common stock upon financing (in shares) | 5,320,460 | |||
Issuance of warrants | 826 | 826 | ||
Shares tendered for withholding taxes | (532) | (532) | ||
Net loss | (187,134) | (187,134) | ||
Ending balance at Dec. 31, 2022 | $ 109,556 | $ 4 | 392,585 | (278,796) |
Balance (in shares) at Dec. 31, 2022 | 43,498,617 | 37,374,088 | ||
Stock-based compensation | $ 65,357 | 65,357 | ||
Issuance of common stock upon exercise of options | $ 12,419 | 12,419 | ||
Issuance of common stock upon exercise of options (in shares) | 358,760 | 358,760 | ||
Issuance of common stock upon vesting of RSUs (in shares) | 43,986 | |||
Issuance of common stock upon financing | $ 243,083 | $ 1 | 243,082 | |
Issuance of common stock upon financing (in shares) | 3,450,000 | |||
Issuance of warrants | 1,635 | 1,635 | ||
Shares tendered for withholding taxes | (1,835) | (1,835) | ||
Net loss | (239,238) | (239,238) | ||
Ending balance at Dec. 31, 2023 | $ 190,977 | $ 5 | $ 1,026,543 | $ (835,571) |
Balance (in shares) at Dec. 31, 2023 | 47,351,363 | 47,351,363 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | |||
Net loss | $ (239,238) | $ (187,134) | $ (130,403) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 62,620 | 37,726 | 20,803 |
Amortization of intangible asset | 6,375 | 4,139 | |
Amortization of debt discount | 2,574 | 1,483 | 1,077 |
Depreciation | 459 | 263 | 76 |
Loss in fair value of contingent consideration | 48,918 | 3,298 | |
Non-cash lease expense | 1,450 | 1,162 | 1,079 |
Change in operating lease liability | 154 | (1,118) | (1,182) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (57,121) | (37,699) | |
Inventories, net | (8,156) | (1,331) | |
Prepaid expenses and other current assets | (5,335) | (2,735) | 103 |
Non-current inventory and other assets | 3,694 | (3,944) | (6) |
Accounts payable | 2,074 | 25,456 | (355) |
Accrued expenses and other current liabilities | 36,452 | 43,923 | 582 |
Net cash used in operating activities | (145,080) | (116,511) | (108,226) |
Cash flows from investing activities | |||
Purchases of equipment | (582) | (702) | (308) |
Cash paid for business combination | (53,000) | ||
Net cash used in investing activities | (582) | (53,702) | (308) |
Cash flows from financing activities | |||
Proceeds from draw down of debt | 85,000 | 45,000 | |
Payment of debt issuance costs | (1,442) | (487) | (309) |
Proceeds from issuance of common stock upon financing | 258,750 | 243,763 | 7,436 |
Cash paid for common stock issuance costs | (15,668) | (6,975) | (223) |
Proceeds from issuance of common stock upon exercise of options | 12,419 | 6,251 | 4,402 |
Payment of contingent consideration | (6,211) | (2,438) | |
Payments of tax withholdings on stock award | (1,835) | (532) | (176) |
Net cash provided by financing activities | 331,013 | 284,582 | 11,130 |
Net (decrease) increase in cash | 185,351 | 114,369 | (97,404) |
Cash at beginning of period | 200,842 | 86,473 | 183,877 |
Cash at end of period | 386,193 | 200,842 | 86,473 |
Supplemental disclosures of cash flow information: | |||
Interest paid | 16,730 | 7,686 | $ 4,625 |
Operating lease right-of-use asset obtained in exchange for operating lease liability | 7,802 | 561 | |
Supplemental non-cash investing activities: | |||
Fair value of contingent consideration in a business combination | 79,707 | 37,000 | |
Supplemental disclosures of non-cash financing activity: | |||
Issuance of warrants in connection with debt financing | $ 1,635 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (239,238) | $ (187,134) | $ (130,403) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the fourth quarter of 2023, the following Rule 10b5-1 trading arrangements (as defined in Item 408(a)(1)(i) of Regulation S-K) and non-Rule 10b5-1 trading arrangements (as defined in Item 408(c) of Regulation S-K) intended to satisfy the affirmative defense of Rule 10b5-1(c) of the Exchange Act were adopted or terminated by our directors and/or executive officers: Name Title Date of Adoption of Rule 10b5-1 Trading Arrangement (1) Scheduled Expiration Date of Rule 10b5-1 Trading Arrangement Aggregate Number of Securities to Be Sold Roger Jeffs Director December 14, 2023 (2) September 16, 2024 Up to 32,323 shares of common stock pursuant to the exercise of non-qualified stock options Mark Saad Director December 14, 2023 (2) November 19, 2025 Up to 89,699 shares of common stock pursuant to the exercise of non-qualified stock options (1) Date of adoption of Rule 10b5-1 trading arrangements is in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations. (2) The first trade pursuant to the Rule 10b5-1 trading arrangement will be, in accordance with both the Company’s insider trading policy and applicable SEC rules and regulations, on a date after the date of adoption of the Rule 10b5-1 trading arrangement. During the fourth quarter of 2023, the Company did not adopt or terminate a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K). |
Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Roger Jeffs [Member] | |
Trading Arrangements, by Individual | |
Name | Roger Jeffs |
Title | Director |
Rule 10b5-1 Arrangement Adopted | true |
Non-Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | December 14, 2023 |
Rule 10b5-1 Arrangement Terminated | true |
Non-Rule 10b5-1 Arrangement Terminated | true |
Termination Date | September 16, 2024 |
Aggregate Available | (32,323) |
Mark Saad [Member] | |
Trading Arrangements, by Individual | |
Name | Mark Saad |
Title | Director |
Rule 10b5-1 Arrangement Adopted | true |
Non-Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | December 14, 2023 |
Rule 10b5-1 Arrangement Terminated | true |
Non-Rule 10b5-1 Arrangement Terminated | true |
Termination Date | November 19, 2025 |
Aggregate Available | 89,699 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | Note 1. Nature of Business and Basis of Presentation Axsome Therapeutics, Inc. (“Axsome” or the “Company”) is a biopharmaceutical company developing and delivering novel therapies for central nervous system (“CNS”) conditions that have limited treatment options. By focusing on this therapeutic area, the Company is addressing significant and growing markets where current treatment options are limited or inadequate. The Company was incorporated on January 12, 2012 in the State of Delaware. The Company aims to become a fully integrated biopharmaceutical company that develops and commercializes differentiated therapies that expand the treatment options available to caregivers and improve the lives of patients living with CNS disorders. The Company’s CNS portfolio includes three not yet approved product candidates, AXS-07, AXS-12, and AXS-14, which are being developed for multiple indications, and two approved products - Auvelity® (the components of which are referred to as “AXS-05”) and Sunosi® - both of which are also being developed for further indications. The Company refers herein to Sunosi, Auvelity, AXS-07, AXS-12, AXS-14 and its programs to develop additional indications for AXS-05 and solriamfetol as the Company’s products. The Company acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals plc (“Jazz”) in May 2022 and worldwide ex-U.S. rights (excluding certain Asian markets) from Jazz in November 2022 (collectively, the “Acquisition”). Sunosi is a product approved by the U.S. Food and Drug Administration (the “FDA”) and marketed in the U.S. to improve wakefulness in adult patients with excessive daytime sleepiness (“EDS”) associated with narcolepsy or obstructive sleep apnea. Sunosi was approved in Europe in January 2020 by the European Commission. In February 2023, the Company announced a licensing transaction with Atnahs Pharma UK Limited (“Pharmanovia”) to market Sunosi in Europe and certain countries in the Middle East / North Africa. In August 2022, the Company announced the FDA approval of Auvelity, and in October 2022, the U.S. commercial availability of Auvelity for the treatment of major depressive disorder in adults. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All material intercompany accounts and transactions have been eliminated during the consolidation process. Liquidity and Capital Resources The Company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable. As of December 31, 2023, the Company had an accumulated deficit of $ 835.6 million. The Company’s primary sources of cash have been proceeds from the sales of Sunosi and Auvelity, the issuance and sale of its common stock in public offerings and the issuance of debt. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties. The Company may continue to incur substantial operating losses even as it continues to generate revenues from its products. The Company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. During that time, the Company expects that its expenses will increase primarily due to the commercialization of Sunosi and Auvelity while continuing to further develop the Company's pipeline assets. The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs. The Company’s common stock is listed on The Nasdaq Global Market and trades under the symbol “AXSM.” |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Significant Risks and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise additional capital. If the Company's commercialization of its products is not financially successful, it will be unable to generate sufficient recurring product revenue to achieve and maintain profitability. The Company currently has two commercially approved products, Auvelity and Sunosi, and there can be no assurance that the Company’s research and development efforts will result in successfully commercialized products in addition to Auvelity and Sunosi. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. Use of Estimates Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense; determination of fair value of warrants; accounting for research and development costs; accounting for acquisitions; impairments of goodwill and the intangible asset; determination of fair value of contingent consideration; chargebacks, cash discounts, sales rebates, returns and other adjustments; and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Revenue Recognition In accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”) the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. Transfer of control is based on contractual performance obligations, which occurs upon transfer of the title along with the physical transfer of the Company's goods to the customer, as that is when the customer has obtained control of significantly all of the economic benefits and the Company obtains a right of payment. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product sales, see Product Sales, net (below) and Note 15 - Revenues . License Agreements The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones and royalties on sales of products. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. Contingent milestones at contract inception are estimated to the extent that it is probable that a significant revenue reversal would not occur and are included in the transaction price using the most likely amount method. Milestone payments that are not within the Company's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received, and, therefore, the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that a significant revenue reversal would not occur and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment. For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied). Product Sales, net The Company sells Sunosi and Auvelity in the United States to wholesale distributors with whom the Company has entered into formal agreements (collectively, the “Distributors”). The Company sells Sunosi internationally through wholesale distributors for delivery primarily to retail pharmacies and on a product supply basis to Pharmanovia for distribution in licensed territories. See Note 15 - Revenues for further breakout of product sales, net. Reserves for Variable Consideration The Company's estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. These reserves reflect the Company's best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligation to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses customer segment utilization mix data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Amounts accrued for rebates, discounts, and other incentives are adjusted when trends indicate that adjustment is appropriate and to reflect actual experience. Trade Discounts and Allowances - The Company generally provides discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its distributors for distribution services and data. These payments have been recorded as a reduction to product sales as well as a reduction to accounts receivables, net on the consolidated balance sheets. Product Returns - The Company generally offers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product sale is recognized, as well as a component of accrued expense and other current liabilities. The Company currently estimates product return liabilities using available industry data, historical product sales information and actual returns experience. Chargebacks and Discounts - Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to distributors. Distributors charge the Company for the difference between what they pay for the product and the ultimate selling price. These reserves are established in the same period that the related product sales are recognized, resulting in a reduction to product sales and accounts receivables, net. Rebates - Rebates apply to: Medicaid, managed care, and supplemental rebates to all applicable states as defined by the statutory government pricing calculation requirements under the Medicaid Drug Rebate Program. Tricare rebates to the TRICARE third-party administrator are based on the statutory calculation defined in the agreement with the Defense Health Agency. Part D and Commercial Managed Care rebates are paid based on the contracts with Pharmacy Benefit Managers (“PBMs”) and Managed Care Organizations. Rebates are paid to these entities upon receipt of an invoice from the contracted entity which is based on the utilization of the product by the members of the contracted entity. Allowances for rebates also include amounts due under the Inflation Reduction Act of 2022 for Medicare Part D. The Company estimates these rebates and records such estimates in the same period the related product sales is recognized, resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities. Coverage Gap - The Medicare Part D coverage gap is a period of consumer payment for prescription medication costs which lies between the initial coverage limit and the catastrophic-coverage threshold, when the patient is a member of a Medicare Part D prescription-drug program administered by the Centers for Medicare & Medicaid Services. The Company estimates the percentage of goods sold under Coverage Gap and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities. Other Incentives - Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product sales as well as a component of accrued expenses and other current liabilities. The Company makes significant estimates and judgments that materially affect its recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts frequently are submitted to the Company significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. The Company will adjust its estimates based on new information, including information regarding actual rebates, chargebacks and discounts for its products, as it becomes available. Cost of Revenue The Company's cost of revenue consists of cost of product sales and a fee sharing expense related to the upfront license revenue received. Cost of product sales primarily include direct costs (inclusive of material, shipping, handling and manufacturing costs), overhead and product royalties. Cost of product sales excludes depreciation and amortization. The cost of product sales for both Sunosi and Auvelity were $ 26.1 million and $ 5.2 million for the years ended December 31, 2023 and 2022 , respectively. In the first quarter of 2023, the Company recorded a $ 5.0 million license sharing expense related to the upfront license revenue received. The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals Co. Ltd. (“SK”) and Aerial Biopharma, LLC (“Aerial”). SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company's sales of Sunosi, and the Company is committed to pay up to $ 165 million based on revenue milestones and $ 1 million based on development milestones. Additionally, the Company pays a royalty to Antecip Bioventures II LLC (“Antecip”), an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board of Directors (the “Board”), Herriot Tabuteau, M.D., equal to 3.0 % of Auvelity net sales. Foreign Currency Translation Revenues and expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date they are incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the Statements of Operations and is not material to the Company’s consolidated financial statements. Segment Information Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders. Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. The Company’s cash and cash equivalents includes holdings in checking and overnight sweep accounts. The Company’s cash equivalents, which are money market funds held in a sweep account, are measured at fair value on a recurring basis. As of December 31, 2023, the balance of cash and cash equivalents was $ 386.2 million, which approximates fair value and was determined based upon Level 1 inputs. The sweep account is valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1 on the fair value hierarchy. Concentration of Risk Concentration of Credit Risk - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains its cash at financial institutions, which cash exceeds insured limits. At December 31, 2023 , the majority of the Company’s cash was held by two financial institutions, and amounts on deposit were in excess of government-provided insurance limits. The Company places its cash and cash equivalents in what it believes to be high credit quality banks and money market funds and has not recognized any losses from credit risks on such accounts since inception. See Accounts Receivables, net below for further information. Concentration of Risk, Other- The Company has a limited number of contract manufacturers for its products. At times the Company may have only one manufacturer or supplier for its products. Business Combination The Company accounted for the Acquisition as a business combination using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing the intangible asset include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates. As a result of the Acquisition, the Company recorded goodwill and an intangible asset. Goodwill Goodwill is deemed to have an indefinite life and therefore not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or more frequently if events or changes in circumstances indicate that the asset might be impaired. When reviewing goodwill for impairment, the Company first evaluates the qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the qualitative factors determine it is necessary to complete a goodwill impairment test, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. The Company completes its annual goodwill assessment as of December 31. As of December 31, 2023 , the Company has determined that it has one reporting unit. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during the fiscal year ended December 31, 2023. Intangible Asset The Company's intangible asset is amortized using the straight-line method over its estimated period of benefit of ten years. The Company evaluates recoverability of the intangible asset periodically by considering events or changes in circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of the intangible asset during the year ended December 31, 2023 . Contingent Consideration Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). The royalty payments due to Jazz are a high single-digit royalty on the Company's U.S. net sales of Sunosi in the current indication and a mid single-digit royalty on the Company's U.S. net sales of Sunosi for future indications. Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations during such period a change is recognized. The Company estimates the fair value of the contingent consideration as of the acquisition date and reporting periods thereafter using the probability weighted income approach using significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates and discount rates. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded within total liabilities in the consolidated balance sheets. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three‑level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. An asset's or liability's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments are cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other liabilities, contingent warrant liability, current and long-term debt and current and non-current contingent consideration. The Company's Level 1 financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other liabilities. They are considered Level 1 as the carrying values reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities. The carrying value of debt on the Company’s balance sheet is estimated to approximate its fair value. The Company's Level 3 financial instruments include contingent warrant liability and current and non-current contingent consideration due to the significant unobservable inputs required in determining their respective fair values. The Company categorized the fair value of contingent consideration liabilities as Level 3 within the fair value hierarchy as the estimate is based on significant unobservable inputs requiring management judgment. The fair value of contingent consideration liabilities is estimated by using the probability weighted income approach using significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success and discount rates. Contingent consideration liabilities are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 8 - Fair Value of Financial Instruments for further detail. The Company estimated the fair value of the warrant liabilities using the Black-Scholes model based on key assumption and inputs. The Company utilizes a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement (as defined below) warrants and allocated the probability of occurrence percentage to the fair values calculated, and, therefore, is considered Level 3 within the fair value hierarchy. The Company accounts for warrants anticipated to be issued in the future under the Loan Agreement as liabilities and measures them at fair value using the Black-Scholes valuation model. The warrants are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 8 - Fair Value of Financial Instruments for further detail. Accounts Receivable, net The Company’s accounts receivable, net, arise from product sales. They are generally stated at the invoiced amount and do not bear interest. Accounts receivable allowances result from chargebacks, prompt pay discounts, and distribution fees. Payment terms are typically 60 days or less . The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in the customers’ credit profiles. During the first quarter of 2023, the Company began distributing products through wholesale customers. The Company estimates expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. The Company has not historically experienced significant credit losses. Based on its assessment, as of December 31, 2023 , the Company has no t recorded any allowances for doubtful accounts receivable. Receivables from the Company's three largest customers totaled 38 %, 32 % and 28 % of the Company's accounts receivable, net balance as of December 31, 2023 . Debt Issuance Costs Debt issuance costs consist of costs incurred in obtaining long-term financing. These costs are classified on the consolidated balance sheet as a direct deduction from the carrying amount of the related debt liability. These expenses are deferred and amortized as part of interest expense in the consolidated statement of operations using the effective interest rate method over the term of the debt agreement. Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The remaining inventory associated with the Acquisition is stated at fair value due to purchase accounting. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of revenue. The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory levels are evaluated for amounts that would be sold within one year. If the level of inventory exceeds the estimated amount that would be sold beyond the next 12 months, the Company classifies the estimate of such inventory as non-current. Equipment, net Equipment consists primarily of computer equipment and is recorded at cost. Equipment is depreciated on a straight‑line basis over its estimated useful life, which the Company estimates to be three years . When equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist primarily of employee-related expenses, including salaries, benefits, travel and stock-based compensation expense, contract services, costs incurred to third-party service providers for conducting research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. Research, preclinical and clinical study expenses are estimated based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on the Company’s behalf, including discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, accruals are adjusted accordingly. Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternative future use are expensed as incurred. Advertising Costs Advertising costs are included in selling, general and administrative expenses and are expensed as incurred. The Company considers advertising costs as expenses related to the promotion of the Company's commercial products. For the years ended December 31, 2023 and 2022, |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2023 | |
Business Combinations [Abstract] | |
Business Combination | Note 3. Business Combination Acquisition of Assets of Jazz Pharmaceuticals On March 25, 2022, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Jazz, pursuant to which the Company was to acquire commercial and development rights with respect to Sunosi from Jazz in certain U.S. and ex-U.S. markets. The Acquisition occurred in two separate closings. The sale and purchase of specified initial assets contemplated by the Purchase Agreement occurred on May 9, 2022 (the “Initial Closing”), following the satisfaction or waiver of the closing conditions under the Purchase Agreement. The sale and purchase of specified ex-U.S. assets contemplated by the Purchase Agreement occurred on November 14, 2022 following the satisfaction or waiver of the closing conditions under the Purchase Agreement (the “Final Closing”). The Company accounted for the Initial Closing as a business combination using the acquisition method of accounting, and the Company accounted for the Final Closing as an asset acquisition. Under the terms of the Purchase Agreement, the Company received from Jazz worldwide commercial, development, manufacturing, and intellectual property rights to Sunosi, except for certain Asian markets. Jazz received from the Company a total upfront payment of $ 53 million. In addition, Jazz will receive a high single-digit royalty on the Company's U.S. net sales of Sunosi in the current indication, and a mid single-digit royalty on the Company's U.S. net sales of Sunosi in future indications. The Company also assumed the commitments of Jazz to SK and Aerial. SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets as stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company's sales of Sunosi, and additionally, the Company is committed to pay up to $ 165 million based on revenue milestones and $ 1 million based on development milestones. The Company financed the transaction via its existing term loan facility with Hercules Capital, Inc. The purchase consideration consisted of the following: Cash at settlement $ 53,000 Fair value of contingent consideration 36,140 Total $ 89,140 The allocation of the fair value of the Acquisition is shown in the table below: Amounts recognized as of acquisition date (as previously reported) Measurement period adjustments (1) Purchase price allocation Inventory $ 10,601 $ — $ 10,601 Other current assets 3,551 1,587 5,138 Intangible asset 63,800 — 63,800 Goodwill 11,897 145 12,042 Accrued expenses and other current liabilities ( 709 ) ( 1,732 ) ( 2,441 ) Total $ 89,140 $ — $ 89,140 (1) The adjustment to goodwill resulted from rebates and returns during the post-acquisition period, which were provisionally recorded as an asset and liability, respectively, as of the acquisition date. The net assets were recorded at their estimated fair value. In valuing acquired assets and liabilities, fair value estimates were based primarily on future expected cash flows, market rate assumptions for contractual obligations, and appropriate discount rates. Inventories acquired included raw materials, work in process and finished goods for Sunosi. Inventories were recorded at their estimated fair values categorized as Level 3. The fair value of finished goods was determined based on the estimated selling price, net of selling costs and a margin on the selling activities. The fair value of work in process was determined based on estimated selling price, net of selling costs and costs to complete the manufacturing, and a margin on the selling and manufacturing activities. The fair value of raw materials was estimated to equal the replacement cost. A step-up in the value of inventory of $ 1.1 million was originally recorded in connection with the Acquisition and is being amortized through cost of revenue as the underlying product is sold. Other current assets acquired were sample inventory and the rebates for Sunosi sales by the Company after the Initial Closing to be covered by Jazz. The intangible asset is acquired developed technology. Fair value was determined by applying the income approach, which recognizes that the fair value of an asset is premised upon the expected receipt of future economic benefits such as earnings and cash inflows based on current sales projections and estimated direct costs, using a discount rate of 43.5 % that reflects the return requirements of the market. The intangible asset is being amortized over an estimated useful life of 10 years. Goodwill is considered an indefinite-lived asset and relates primarily to intangible assets that do not qualify for separate recognition, such as the assembled workforce and synergies between the entities. The Company expects that the entire amount of the purchase price allocated to goodwill will be deductible for U.S. income tax purposes over a 15-year period. Accrued expenses and other current liabilities acquired were the Company's assumed sales returns liability for Sunosi after the transaction close date related to Sunosi sales recorded by Jazz prior to the Initial Closing. Pro Forma Consolidated Financial Information (Unaudited) The following unaudited pro forma summary presents consolidated information of the Company, including Sunosi, as if the business combination had occurred on January 1, 2021, the earliest period presented herein: Year ended December 31, 2022 2021 Net revenues $ 74,065 $ 51,670 Net loss ( 211,571 ) ( 283,831 ) |
Accounts Receivable, net
Accounts Receivable, net | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Accounts Receivable, net | Note 4. Accounts Receivable, net Accounts receivable, net, consisted of the following: December 31, December 31, Trade receivables $ 107,320 $ 46,796 Less: Reserves for variable consideration ( 12,500 ) ( 9,097 ) Accounts receivable, net $ 94,820 $ 37,699 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 5. Inventory Inventory consisted of the following: December 31, December 31, Raw materials $ 5,534 $ 2,473 Work in process 10,287 13,965 Finished goods 9,643 1,590 Total $ 25,464 $ 18,028 There were no material inventory reserves or write downs of any excess and obsolete inventory as of December 31, 2023. Non-current inventory, which consists of raw materials and work in progress inventory, is included in Non-current inventory and other assets on the accompanying consolidated balance sheets. Non-current inventory is anticipated to be consumed beyond the Company's normal operating cycle. The following table summarizes the balance sheet classification of the Company's inventory for each of the periods indicated: December 31, December 31, Balance sheet classification Inventories, net $ 15,135 $ 4,320 Non-current inventory and other assets 10,329 13,708 Total $ 25,464 $ 18,028 |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill [Abstract] | |
Goodwill | Note 6. Goodwill The following table provides the Company’s carrying amount of goodwill as of December 31, 2023. Goodwill Balance at December 31, 2022 $ 10,310 Measurement period adjustment 1,732 Balance at December 31, 2023 $ 12,042 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Intangible Assets [Abstract] | |
Intangible Asset | Note 7. Intangible Asset The following table provides the Company's carrying amount of the intangible asset for each of the periods indicated. Gross carrying amount Accumulated amortization Net carrying amount Remaining weighted-average useful life Balance at December 31, 2022 Finite-lived intangible asset $ 63,800 $ 4,139 $ 59,661 10 -years Balance at December 31, 2023 Finite-lived intangible asset $ 63,800 $ 10,514 $ 53,286 9 -years Amortization expense was approximately $ 6.4 million and $ 4.1 million for the years ended December 31, 2023 and 2022, respectively. Based on the finite-lived intangible asset recorded as of December 31, 2023, and assuming the underlying asset will not be impaired and that we will not change the expected life of the asset, future amortization expenses over the next five years and periods thereafter are estimated to be as follows: Estimated amortization expense 2024 $ 6,392 2025 6,375 2026 6,375 2027 6,375 2028 6,392 Thereafter 21,377 Total $ 53,286 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Note 8. Fair Value of Financial Instruments In connection with the Acquisition, the Company pays royalty on net sales of Sunosi to Jazz. The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. The fair value of the contingent consideration is reflected as current accrued contingent consideration of $ 6.4 million and non-current contingent consideration liability of $ 73.3 million in the consolidated balance sheet as of December 31, 2023. The fair value of financial instruments measured on a recurring basis is as follows: December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents - money market funds $ 251,768 $ — $ — $ 251,768 Liabilities: Contingent consideration $ — $ — $ 79,707 $ 79,707 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents - money market funds $ 195,475 $ — $ — $ 195,475 Liabilities: Contingent consideration $ — $ — $ 37,000 $ 37,000 Contingent Consideration Liabilities The fair value of the contingent consideration liabilities is marked-to-market each reporting period and was remeasured at December 31, 2023. Changes in fair value of the contingent consideration liabilities as of December 31, 2023 are as follows: Contingent consideration Balance at December 31, 2022 $ 37,000 Adjustment to fair value 48,918 Payments ( 6,211 ) Balance at December 31, 2023 (Level 3) $ 79,707 The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs: As of December 31, 2023 As of December 31, 2022 Valuation methodology Significant unobservable input Weighted average (range, if applicable) Weighted average (range, if applicable) Contingent consideration Probability weighted income approach Discount rate 13.2 % 12.0 % Revenue discount rate 16.4 % - 19.4 % 20.9 % The Company's fair value measurement of contingent consideration liabilities has been classified as level 3 as its valuation requires substantial judgment and estimation of factors which requires use of unobservable inputs. The fair value of contingent consideration liabilities are estimated by using the probability weighted income approach using significant assumptions including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates, and discount rates. If significant changes are made to one or more of these assumptions, the estimated fair value of contingent consideration liabilities may result in a significantly higher or lower fair value measurement. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | Note 9. Accrued Expenses and Other Current Liabilities A ccrued expenses and other current liabilities consisted of the following: December 31, December 31, Accrued research and development $ 6,503 $ 4,714 Accrued compensation 20,457 11,284 Accrued selling, general and administrative 9,242 6,596 Accrued sales discounts, rebates and allowances 46,713 26,545 Accrued royalties 5,927 1,617 Accrued interest 1,659 875 Total $ 90,501 $ 51,631 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | Note 10. Loan and Security Agreement Hercules Capital, Inc. Fourth Amendment to the Loan Agreement On May 8, 2023, the Company entered into the Waiver and Fourth Amendment (the “Fourth Amendment”) to its Loan and Security Agreement, dated as of September 25, 2020 (as amended by that certain First Amendment to Loan and Security Agreement, dated as of October 14, 2021, as further amended by the Second Amendment to Loan and Security Agreement, dated as of March 27, 2022, and as further amended by the Third Amendment to Loan and Security Agreement, dated as of January 9, 2023) (the “Loan Agreement”) with Hercules Capital, Inc., a Maryland corporation (“Hercules”), in its capacity as administrative agent and collateral agent, and the other financial institutions or entities party thereto as lenders. The Fourth Amendment increased the amount of cash that could be held by Axsome Malta Ltd. (“Axsome Malta”) outside of the United States from $ 3.0 million to $ 15.0 million for a 45-day period after the closing of the Fourth Amendment and to $ 10.0 million thereafter. The Fourth Amendment also waived any purported default with respect to the amount of cash held by Axsome Malta prior to the date of the Fourth Amendment. In August 2023, Hercules granted the Company a waiver to the Fourth Amendment, permitting Axsome Malta to hold up to $ 12.5 million in Cash outside of the United States until December 31, 2023. Third Amendment to the Loan Agreement On January 9, 2023, the Company entered into a Third Amendment (the “Third Amendment”) to the Loan Agreement with Hercules, in its capacity as administrative agent and collateral agent, and the other financial institutions or entities party thereto as lenders. The Third Amendment amended the terms of the Loan Agreement to, among other things: • Extend the maturity date to January 1, 2028, unless the Company meets certain revenue targets as described in the Loan Agreement, in which case the Company can extend the maturity date to January 1, 2029; • Increase the aggregate principal amount under the Loan Agreement from $ 300.0 million to $ 350.0 million; • Subject to the terms and conditions in the Loan Agreement, change the term loan advance amounts and dates available under the tranche 1 advance through tranche 5 advance, including increasing the tranche 1 advance from one tranche of $ 95.0 million to five sub-tranches of $ 95.0 million, $ 55.0 million, $ 30.0 million, $ 35.0 million and $ 35.0 million, respectively, changing the tranche 2 advance from three sub-tranches of $ 35.0 million, $ 35.0 million and $ 30.0 million to one tranche of $ 25.0 million, changing the tranche 3 advance from two sub-tranches of $ 15.0 million and $ 5.0 million to one tranche of $ 75.0 million and removing the tranche 4 advance and tranche 5 advance entirely; • Revise the interest rate applicable to extensions of credit under the Loan Agreement to equal (a) if the prime rate is greater than or equal to 7.00 %, the greater of either (i) the prime rate plus 2.20 %, and (ii) 9.95 %, but in no event greater than 10.70 %, and (b) if the prime rate is less than 7.00 %, 9.70 %; • Increase the minimum cash requirement of the Company to $ 30.0 million; and • Require the Company to pay a facility fee equal to 0.75 % of the amount of principal actually funded pursuant to the tranche 1B advance, tranche 1C advance, tranche 1D advance, tranche 1E advance, tranche 2 advance and tranche 3 advance. The Company allowed tranche 1D to expire undrawn. On October 14, 2021, the Company entered into a First Amendment to the Loan and Security Agreement with Hercules. On March 27, 2022, in connection with the Acquisition (as described above), the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) with Hercules. The Second Amendment closed on May 9, 2022 concurrently with the closing of the Acquisition. As collateral for the obligations, the Company has granted to Hercules a senior security interest in all of the Company’s right, title, and interest in, to and under all of the Company’s property, inclusive of intellectual property, which includes one of the Company’s existing license agreements (the “License Agreement”) with Antecip, an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., subject to limited exceptions. Antecip consented to the collateral assignment of the License Agreement, among other things, under a direct agreement (the “Direct Agreement”) with the Company, Antecip and Hercules. The Loan Agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens (including a negative pledge on intellectual property and other assets), guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes. At the initial closing, there were no applicable financial covenants contained in the Loan Agreement. Effective upon closing of the Third Amendment of the Loan Agreement in January 2023, the following limited financial covenants applied: • Effective upon closing of the Third Amendment of the Loan Agreement, the Company at all times thereafter must maintain cash in an account or accounts in which Hercules has a first priority security interest, in an aggregate amount greater than or equal to $ 30.0 million, plus the amount of the Company’s accounts payable under U.S. GAAP not paid after the 180th day following the invoice for such account payable (such amount, the “Qualified Cash A/P Amount”). • The Company must meet, beginning June 30, 2023, any of the following conditions: (A) ensure that at all times its market capitalization exceeds $ 1.5 billion, and that it maintains cash in an account which Hercules has a first priority security interest in an amount not less than 50 % of the sum of the outstanding principal amount of the term loan advances plus the Qualified Cash A/P Amount, (B) ensure that at all times that it maintains cash in an account which Hercules has a first priority security interest in an amount not less than 95 % of the sum of the outstanding principal amount of the term loan advances plus the Qualified Cash A/P Amount, or (C) achieve at least 60 % of the net product revenue per the Board approved forecast solely from the sale of AXS-05, AXS-07, and Sunosi (which may include royalty, profit sharing, or sales-based milestone revenue recognized in accordance with GAAP, but will not include any upfront or non-sales-based milestone payments under business development or licensing transactions), measured on a trailing six-month basis as of the date of the Company’s most recent quarterly financial statement, determined on a quarterly basis. • Axsome Malta, a company organized under the laws of the Republic of Malta, shall not hold cash outside of the United States in excess of $ 3.0 million in the aggregate at any time. This amount, however, was increased by the Fourth Amendment to $ 15.0 million for a 45-day period after the closing of the Fourth Amendment and to $ 10.0 million thereafter. Furthermore, in August 2023, Hercules granted the Company a waiver to the Fourth Amendment, permitting Axsome Malta to hold up to $ 12.5 million in Cash outside of the United States until December 31, 2023. • Restrictions on the Company’s ability to incur additional indebtedness, pay dividends, encumber its intellectual property, or engage in certain fundamental business transactions, such as mergers or acquisitions of other businesses, with certain exceptions. The Company’s obligations under the Loan Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, insolvency and a material adverse change in the Borrower’s business, operations or financial or other condition. In addition, the Company is required to pay certain end of term charges, including (A) an initial end of term charge of $ 4.45 million and (B) a subsequent end of term charge of (i) 1.10 % of the aggregate amount of all tranche 1A advances plus (ii) 4.95 % of the aggregate amount of all term loan advances (other than tranche 1A advances) funded. The end of term charges are being accreted into interest expense using the effective interest rate method over the term of the loan. If certain maturity extension conditions are satisfied, the Company must pay an extension end of term charge equal to 1.00 % of the aggregate amount of all term loan advances outstanding as of the date on which the maturity extension conditions are satisfied, in addition to the end of term charges described above. The Company may, at its option prepay the term loans in full or in part, subject to a prepayment penalty equal to (i) 2.0 % of the principal amount prepaid if the prepayment occurs prior to February 1, 2024, (ii) 1.5 % of the principal amount prepaid if the prepayment occurs on or after February 1, 2024 but prior to February 1, 2025, and (iii) 1.0 % of the principal amount prepaid if the prepayment occurs on or after February 1, 2025 but prior to February 1, 2026. The Company evaluated whether the Third Amendment entered into in January 2023 represented a debt modification or extinguishment in accordance with ASC 470-50, Debt – Modifications and Extinguishments . As the present value of the cash flows under the terms of the Third Amendment is less than 10 % different from the remaining cash flows under the terms of the Second Amendment, the Third Amendment was accounted for as a debt modification. The unamortized balance of debt discount costs incurred in connection with those loans and additional debt discount costs incurred in connection with entry into the Third Amendment are being amortized through maturity in January 2028 utilizing the effective interest rate method. Long-term debt and unamortized debt discount balances are as follows: December 31, December 31, Total outstanding debt $ 180,000 $ 95,000 Add: accreted final payment fee 2,610 1,363 Less: unamortized debt discount, long-term ( 4,540 ) ( 2,104 ) Less: current portion of long-term debt — — Loan payable, long-term $ 178,070 $ 94,259 The book value of debt approximates its fair value given its variable interest rate. Year ended December 31, 2023 2022 2021 Interest expense $ 17,514 $ 8,176 $ 4,617 Amortization of final payment fee 1,197 668 554 Amortization of debt discount related issuance costs and warrants 1,324 815 523 Scheduled principal payments on outstanding debt, as of December 31, 2023, are as follows: 2024 $ — 2025 — 2026 — 2027 — 2028 180,000 Thereafter — Total principal payments outstanding $ 180,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 11. Commitments and Contingencies Operating Leases Leases are accounted for under ASC Topic 842. The Company made an accounting policy election not to apply the recognition requirements to short-term leases. The Company recognizes the lease payments for short-term leases in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term, and variable lease payments in the period in which the obligation for those payments is incurred. Therefore, the Company is not recognizing a lease liability or right-of-use asset for any lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to extend the term or purchase the underlying asset that the Company is reasonably certain to exercise. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company has entered into a lease agreement for the Company’s principal executive offices located in New York, New York. The lease does not include any restrictions or covenants that had to be accounted for under the lease guidance. In February 2023 , the Company entered into a ten-year agreement to sublease office space at One World Trade Center, beginning April 2023. Based on the Company's past experience and current expectation for administrative office needs, the Company determined the lease term to be five years . As of December 31, 2023 , the remaining lease term for the Company's operating lease was 4.3 years with a discount rate of 12.0 %. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. The Company entered into a lease for the previous office space at 22 Cortlandt St, New York, NY and extended the lease through April 30, 2023 . The lease ended in April 2023 . Rent expense incurred during the years ended December 31, 2023, 2022 and 2021 was $ 2.2 million, $ 1.3 million, and $ 1.2 million, respectively. Operating lease expenses recognized were as follows: Year ended December 31, 2023 2022 2021 Total operating lease expense $ 2,173 $ 1,208 $ 1,148 Future minimum lease payments of our operating leases as of December 31, 2023, were as follows: 2024 $ 1,240 2025 1,932 2026 2,521 2027 2,521 2028 3,231 Thereafter — Total lease payments 11,445 Less imputed interest ( 3,143 ) Present value of operating lease liabilities $ 8,302 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Note 12. Stockholders’ Equity Public Offerings At-the-Market Offerings In December 2019, the Company entered into a sales agreement (the “December 2019 Sales Agreement”) with SVB Securities LLC (now known as Leerink Partners LLC) (“Leerink”), pursuant to which the Company may sell up to $ 80 million in shares of the Company’s common stock from time to time through Leerink, acting as the Company’s sales agent, in one or more at-the-market offerings utilizing an automatic shelf registration statement (the “2019 Shelf Registration Statement”) the Company filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 5, 2019 for the issuance of common stock, preferred stock, warrants, rights, debt securities and units. Leerink is entitled to receive a commission of 3.0 % of the gross proceeds for any shares sold under the December 2019 Sales Agreement. The December 2019 Sales Agreement was replaced by the March 2022 Sales Agreement (as defined below). In March 2022, the Company entered into a sales agreement (the “March 2022 Sales Agreement”) with Leerink, pursuant to which the Company may sell up to $ 200 million in shares of the Company’s common stock from time to time through Leerink, acting as the Company’s sales agent, in one or more at-the-market offerings utilizing the 2019 Shelf Registration Statement. Leerink is entitled to receive a commission of up to 3.0 % of the gross proceeds for any shares sold under the March 2022 Sales Agreement. The March 2022 Sales Agreement supersedes the December 2019 Sales Agreement, dated December 5, 2019, by and between the Company and Leerink. The Company exhausted sales of its shares of the Company’s common stock under its prior at-the-market offering program. In August 2022, the Company filed a prospectus supplement to the 2019 Shelf Registration Statement for the issuance and sale, if any, of up to an additional $ 250 million in shares of the Company’s common stock. The Company will pay Leerink a commission of up to 3.0 % of the gross sales proceeds of any shares sold through Leerink, acting as sales agent, under the March 2022 Sales Agreement. In December 2022, in connection with the 2022 Shelf Registration Statement (as defined below), the Company filed a new sales agreement prospectus to replace the prior prospectus supplement filed in August 2022 associated with the expired 2019 Shelf Registration Statement. The new sales agreement prospectus covered the issuance and sale by the Company of up to the same $ 250 million of our common stock that may be issued and sold from time to time through SVB Securities, as the Company’s sales agent, under the March 2022 Sales Agreement. The Company did no t utilize the March 2022 Sales Agreement with Leerink during the year ended December 31, 2023. Under the December 2019 Sales Agreement and March 2022 Sales Agreement, the Company received approximately $ 238.8 million in gross proceeds through the sale of 5,167,973 shares, of which net proceeds were approximately $ 231.8 million for the year ended December 31, 2022. Under the December 2019 Sales Agreement, the Company received approximately $ 7.4 million in gross proceeds through the sale of 110,296 shares, of which net proceeds were approximately $ 7.2 million for the year ended December 31, 2021. Upon the closing of the Second Amendment, which occurred in March 2022, Hercules also purchased 152,487 of the Company’s unregistered common stock for a total consideration of $ 5.0 million at a share price equal to $ 32.79 per share, pursuant to a share transfer agreement. The holders of shares of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders and written actions in lieu of meetings. The holders of shares of common stock are entitled to receive dividends, if and when declared by the Board. June 2023 Public Offering In June 2023, the Company completed an underwritten public offering of its common stock (the “June 2023 Public Offering”). The Company sold 3.0 million shares of its common stock at a public offering price of $ 75.00 per share. The net proceeds were $ 211.3 million, net of underwriting discounts and commissions of $ 13.5 million and other offering costs of $ 0.2 million. Additionally, in connection with this public offering, in July 2023, the underwriters fully exercised their option to purchase 450,000 additional shares of the Company's common stock at a public offering price of $ 75.00 per share. The net proceeds from the exercise of the option were $ 31.7 million, net of underwriting discounts and commissions of $ 2.0 million and other minimal offering costs. Shelf Registration Statement On December 2, 2022, the Company filed an automatic shelf registration statement (the “2022 Shelf Registration Statement”) with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units. It became effective upon filing with the SEC and is currently the Company’s only active shelf registration. Under SEC rules, the 2022 Shelf Registration Statement allows for the potential future offer and sale by the Company, from time to time, in one or more public offerings of an indeterminate amount of the Company’s common stock, preferred stock, debt securities, and units at indeterminate prices. At the time any of the securities covered by the 2022 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. Equity Incentive Plan In November 2015, the 2015 Omnibus Incentive Compensation Plan (the “2015 Plan”) was adopted by the Company’s stockholders. As of December 31, 2023 , there were 2,168,858 shares available for future grant under the 2015 Plan. Stock Options The following table sets forth stock option activity as of December 31, 2023: Number Weighted Weighted Aggregate Outstanding at December 31, 2022 6,617,728 $ 31.80 Granted 2,529,767 67.40 Exercised ( 358,760 ) 34.52 Forfeited/Canceled ( 326,441 ) 53.23 Outstanding at December 31, 2023 8,462,294 $ 41.48 7.1 $ 323,159 Vested and expected to vest at December 31, 2023 8,462,294 $ 41.48 7.1 $ 323,159 Exercisable at December 31, 2023 4,523,493 $ 28.30 5.7 $ 232,383 The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The expected term of the Company’s stock options has been determined utilizing the “simplified” method as described in the SEC’s Staff Accounting Bulletin No. 107 relating to stock-based compensation. The simplified method was chosen because the Company has limited historical option exercise experience due to its short operating history. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for a period approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does no t expect to pay any cash dividends in the foreseeable future. In prior years, expected volatility was based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. Currently, expected volatility is based on historical volatility information of the Company's common stock since the Company's initial public offering in 2015. The relevant data used to determine the value of the stock option grants is as follows: Black-Scholes option valuation assumptions 2023 2022 2021 Risk-free interest rates 3.34 - 4.88 % 1.46 - 4.31 % 0.63 - 1.47 % Dividend yield — — — Volatility 93 - 99 % 90 - 95 % 89 - 93 % Weighted average expected term 5.0 - 6.11 years 5.0 - 6.11 years 5.0 - 6.17 years The weighted average grant date fair value of options granted was $ 53.07 , $ 28.18 and $ 39.64 per option for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023 , there was $ 162.0 million of total unrecognized compensation cost related to non‑vested stock options which is expected to be recognized over a weighted average period of 2.8 years. These amounts do not include 6,169 options outstanding as of December 31, 2023, which are performance‑based and vest upon the achievement of certain corporate milestones. Stock‑based compensation will be measured and recorded if and when it is probable that the milestone will occur. Restricted Stock Units The fair value of RSUs is determined on the date of the grant based on the market price of its shares of common stock as of that date. The fair value of the RSUs is recognized as an expense ratably over the vesting period of four years . As of December 31, 2023 , total compensation cost not yet recognized related to unvested RSUs was $ 25.9 million, which is expected to be recognized over a weighted-average period of 2.5 years. The intrinsic value of RSUs lapsed during the years ended December 31, 2023, 2022 and 2021 was $ 4.9 million, $ 1.5 million and $ 0.4 million, respectively. The following table sets forth the RSU activity for the year ended December 31, 2023: Number Weighted Outstanding at December 31, 2022 686,375 $ 31.80 Granted 343,020 56.26 Vested ( 194,425 ) 32.78 Forfeited ( 30,820 ) 48.37 Outstanding at December 31, 2023 804,150 $ 41.36 Employee Stock Purchase Plan The ESPP allows employees to purchase shares of the Company’s common stock. The purchase price is equal to 85 % of the lower of the closing price of the Company’s common stock on (1) the first day of the offering period or (2) the last day of the offering period. The Company commenced the first offering pursuant to the ESPP on June 1, 2023, and such offering will end on May 31, 2024. During the year ended December 31, 2023 , no shares of common stock were purchased pursuant to the ESPP, and $ 1.1 million of expense was recorded for the same period. Stock-based Compensation Expense Stock‑based compensation expense recognized was as follows: Year ended December 31, 2023 2022 2021 Research and development $ 14,080 $ 8,604 $ 7,456 Selling, general and administrative 48,540 29,122 13,345 Total $ 62,620 $ 37,726 $ 20,801 Stock-based compensation expense capitalized into inventory totaled $ 2.7 million and $ 1.3 million for the years ended December 31, 2023 and 2022, respectively. The Company started capitalizing stock-based compensation to inventory in the third quarter of 2022. Capitalized stock-based compensation is recognized as an expense in cost of revenue when the related product is sold or in selling, general and administrative expense when the related product is dispensed as a physician sample. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2023 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Note 13. Warrants The following table summarizes warrant activity for the years ended December 31, 2023, 2022, and 2021: Warrants Weighted average Outstanding at December 31, 2020 15,541 $ 80.43 Issued — — Exercised — — Outstanding at December 31, 2021 15,541 80.43 Issued 35,255 31.91 Exercised — — Outstanding at December 31, 2022 50,796 46.75 Issued 28,424 74.75 Exercised — — Outstanding at December 31, 2023 79,220 $ 56.80 Outstanding Warrants In connection with the entry into the Third Amendment, Hercules received warrants to purchase an aggregate of 18,724 shares of the Company’s common stock at an exercise price of $ 55.01 per share, and in connection with the draw down of the tranche 1C advance, Hercules received warrants to purchase 9,700 shares of the Company's common stock at an exercise price of $ 77.31 per share (collectively, the “2023 warrants”). In connection with the entry into the Second Amendment, Hercules received warrants to purchase an aggregate of 35,255 shares of the Company’s common stock at an exercise price of $ 31.91 per share (the “2022 warrants”), and in connection with the first advance of the 2020 Term Loan, Hercules received warrants to purchase an aggregate of 15,541 shares of the Company’s common stock at an exercise price of $ 80.43 per share (the “2020 warrants”). The 2023 warrants, 2022 warrants and 2020 warrants were priced using the volume weighted average price of the Company’s common stock over the ten -day trading period immediately preceding the initial closing, subject to certain limited adjustments as specified in the warrant. The warrants are exercisable for seven years from the date of issuance. The warrants were classified as a component of stockholders’ equity. The relative fair value of the warrants of approximately $ 1.6 million for the 2023 warrants, $ 0.8 million for the 2022 warrants and $ 0.9 million for the 2020 warrants at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The discount on the debt is being amortized to interest expense over the term of the debt utilizing the effective interest rate method. The initial fair value of warrants outstanding was estimated using the Black‑Scholes option pricing model with the following assumptions: Black-Scholes option valuation assumptions 2023 2022 2020 Risk-free interest rate 3.6 - 3.9 % 3.1 % 0.5 % Dividend yield — — — Volatility 92 - 95 % 94 % 88 % Weighted average contractual term 7 years 7 years 7 years |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Note 14. Net Loss per Common Share The following table sets forth the computation of basic and diluted net loss per common share: Year ended December 31, 2023 2022 2021 Basic and diluted net loss per common share: Net loss $ ( 239,238 ) $ ( 187,134 ) $ ( 130,403 ) Weighted average common shares outstanding—basic and diluted 45,425,212 40,655,941 37,618,599 Net loss per common share—basic and diluted $ ( 5.27 ) $ ( 4.60 ) $ ( 3.47 ) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti‑dilutive: December 31, 2023 2022 2021 Stock options 8,462,294 6,617,728 5,090,377 Restricted stock units 804,150 686,375 326,625 Warrants 79,220 50,796 15,541 ESPP 56,760 — — Total 9,402,424 7,354,899 5,432,543 |
Revenues
Revenues | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Note 15. Revenues The Company sells Sunosi and Auvelity in the United States through the Distributors. The Company sells Sunosi internationally through local distributors for delivery primarily to retail pharmacies and hospitals. License revenue consists of the recognition of the upfront payment the Company received from Pharmanovia in February 2023, and royalty revenue is related to sales of Sunosi by Pharmanovia in certain ex-U.S. markets. The following table presents a summary of total revenues by product: By Product Year ended December 31, 2023 2022 Product sales, net Auvelity $ 130,072 $ 5,168 Sunosi 72,388 44,869 Total product sales, net 202,460 50,037 Sunosi license revenue 65,735 — Sunosi royalty revenue 2,405 — Total revenues $ 270,600 $ 50,037 The following table presents a summary of total revenues by geographic location: By Geographic Location Year ended December 31, 2023 2022 Product sales, net United States $ 197,224 $ 49,132 Outside of the United States 5,236 905 Total product sales, net 202,460 50,037 License revenue Outside of the United States 65,735 — Royalty revenue Outside of the United States 2,405 — Total revenues $ 270,600 $ 50,037 For the year ended December 31, 2023, product sales, net includes adjustments for provisions for product sales made in 2022 resulting from changes in estimates of $ 0.1 million for Sunosi and $ 0.8 million for Auvelity. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
License Agreements | Note 16. License Agreements License Agreement with Pharmanovia In February 2023, Axsome Malta, a Malta limited company and a wholly-owned subsidiary of the Company, entered into an exclusive license agreement with Pharmanovia (the “Pharmanovia License Agreement”) to commercialize and further develop Sunosi in Europe and certain countries in the Middle East and North Africa (the “Territory”). Under the terms of the Pharmanovia License Agreement, the Company retains its existing interest in Sunosi intellectual property and licenses those rights in the Territory to Pharmanovia. Pharmanovia is solely responsible for the clinical development and commercialization of Sunosi in the Territory. The Company will continue to manufacture Sunosi and provide product supply to Pharmanovia for an indefinite period of time, and the Company will recognize revenue as a component of product sales, net, when product is supplied to Pharmanovia. In consideration for entering the Pharmanovia License Agreement, the Company received a non-refundable upfront payment of € 62.0 million ($ 65.7 million). The Company also will receive a royalty percentage in the mid-twenties on Sunosi net sales in the Territory and is eligible to receive sales-based milestone payments totaling up to € 94.5 million. The Company evaluated the Pharmanovia License Agreement under ASC 606 and concluded that Pharmanovia represents a customer in the transaction. The initial transaction price consisted of the non-refundable upfront payment, which was recognized as License Revenue in the first quarter of 2023 upon transfer of the license to Pharmanovia, as the requirement for revenue recognition under ASC 606 were met. The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. The Company evaluated the constraint on variable consideration and concluded that the milestone payments are dependent on regulatory approvals and actions of third parties, and thus are highly susceptible to factors outside the Company’s influence. Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur. Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met. All other development or regulatory milestones will be recognized as revenue immediately in the period the underlying milestone is achieved. Any consideration related to sales-based royalties will be recognized when the related sales occur. For the year ended December 31, 2023, the Company recognized royalty revenue of $ 2.4 million, related to Pharmanovia sales of Sunosi. No other development or sales-based milestones were recognized during the year ended December 31, 2023. Exclusive License Agreement with Pfizer In January 2020, the Company entered into an exclusive license agreement with Pfizer Inc. (“Pfizer”) for Pfizer’s clinical and nonclinical data, and intellectual property for reboxetine, the active pharmaceutical ingredient in AXS-12 which the Company is developing for the treatment of narcolepsy. The agreement also provides the Company exclusive rights to develop and commercialize esreboxetine, a new late-stage product candidate referred to as AXS-14, in the U.S. for the treatment of fibromyalgia. Under the terms of the agreement, Pfizer received 82,019 shares of the Company’s common stock having a stated value of $ 8.0 million, based on the average closing price of the Company’s common stock for the ten prior trading days of $ 97.54 , in consideration for the license and rights and also received an upfront cash payment of $ 3.0 million. The Company determined that the fair value of each share of common stock granted to Pfizer on the closing date of January 9, 2020 was $ 87.24 , based on the closing price of the Company’s stock on that date. As a result, the fair value of the stock issued was $ 7.2 million and, therefore, the total research and development expense recognized was $ 10.2 million related to the Pfizer license agreement during the year ended December 31, 2020. Pfizer can also receive up to $ 323 million in regulatory and sales milestones and tiered mid-single to low double-digit royalties on future sales related to the licensed products. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14. During the years ended December 31, 2023 and 2022 , no milestone payments or royalties were paid to Pfizer by the Company. Exclusive License Agreements with Antecip In 2012, the Company entered into three exclusive license agreements with Antecip, an entity owned by the Company's Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., in which the Company was granted exclusive licenses to develop, manufacture and commercialize Antecip’s patents and applications related to the development of AXS-05 (now marketed as Auvelity) and two product candidates no longer under active development, anywhere in the world for human therapeutic, veterinary, and diagnostic use. Pursuant to the agreements, the Company is required to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize these product candidates. Under the terms of the agreements, the Company is required to pay to Antecip a royalty equal to 3.0 % for AXS-05 (and 1.5 % or 4.5 % for the other two product candidates no longer under active development), of net sales of products containing the licensed technology by the Company, its affiliates, or permitted sublicensees. These royalty payments are subject to reduction by an amount up to 50.0 % of any required payments to third parties. Unless earlier terminated by a party for cause or by the Company for convenience, the agreements shall remain in effect on a product-by-product and country-by-country basis until the later to occur of (i) the applicable product is no longer covered by a valid claim in that country or (ii) 10 years from the first commercial sale of the applicable product in that country. Upon expiration of the agreements with respect to a product in a country, the Company’s license grant for that product in that country will become a fully paid-up, royalty-free, perpetual non-exclusive license. If Antecip terminates any of the agreements for cause, or if the Company exercises its right to terminate any of the agreements for convenience, the rights granted to the Company under such terminated agreement will revert to Antecip. The Company began recording royalty payments to Antecip along with the initiation of sales of Auvelity (the components of which are referred to as “AXS-05”) in the fourth quarter of 2022. For the year ended December 31, 2023 , the Company recorded royalty expense of $ 3.9 million for royalty due to Antecip, which is equal to 3.0 % of net sales of Auvelity. This is considered to be a related party transaction. In connection with the Loan Agreement, the Company entered into the Direct Agreement with Antecip and Hercules, pursuant to which Antecip consented to the collateral assignment of the License Agreement under the Loan Agreement, among other things. |
Royalty Agreements
Royalty Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
Royalty Agreements | Note 17. Royalty Agreements Pursuant to the Purchase Agreement, the Company agreed to make non-refundable, non-creditable royalty payments to Jazz equal to a (A) high single-digit royalty for any current indication, or (B) mid single-digit royalty for any future indication of net sales in the U.S. Territory made during the applicable royalty term. There are no royalty payments due to Jazz for Net Sales outside of the U.S. Territory. At the Initial Closing, the Company assumed all of the commitments of Jazz to SK and Aerial. SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company’s sales of Sunosi, and additionally, the Company is committed to pay up to $ 165 million based on revenue milestones and $ 1 million based on development milestones. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 18. Income Taxes As of December 31, 2023, the Company has U.S. federal net operating loss (“NOL”) carryforwards of approximately $ 547 million and foreign NOL carryforwards of $ 0.7 million. U.S. federal NOLs amounting to $ 60 million generated before the 2018 tax year will start expiring beginning 2032 , and the NOLs of approximately $ 487 million generated in 2018 and later have an indefinite carryforward period. The NOL carryforwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and state tax authorities. NOL carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The components of the Company’s deferred tax assets and deferred tax liabilities are as follows: December 31, 2023 December 31, 2022 Deferred tax assets: Net federal operating loss carryforward $ 114,889 $ 96,156 Net foreign operating loss carryforward 697 2,795 Net state operating loss carryforward 34,365 32,029 Non-cash compensation 20,007 11,028 Research and development credits 21,034 15,016 Interest expense 1,327 319 Intangible asset 4,242 10,422 Accrued expenses 6,058 2,113 Section 174 capitalization 22,248 14,541 Other 315 110 Deferred tax asset, excluding valuation allowance 225,182 184,529 Deferred tax liabilities: Fixed assets ( 78 ) — Lease asset ( 1,661 ) ( 104 ) Deferred tax liability, excluding valuation allowance ( 1,739 ) ( 104 ) Less valuation allowance ( 223,443 ) ( 184,425 ) Net deferred tax assets $ — $ — A valuation allowance is provided for deferred tax assets where the recoverability of the assets is uncertain. The determination to provide a valuation allowance is dependent upon the assessment of whether it is more likely than not that sufficient future taxable income will be generated to utilize the deferred tax assets. Based on the weight of the available evidence, which includes the Company’s historical operating losses and forecast of future losses, the Company provided a full valuation allowance against the deferred tax assets resulting from the tax loss and credits carried forward. The valuation allowance increased $ 39.0 million, $ 26.9 million and $ 49.6 million, in 2023, 2022 and 2021, respectively, as a result of the increase of the deferred tax assets. The Company recorded $ 1.0 million of income tax expense related to its foreign operations primarily due to a one-time payment received in connection with the Pharmanovia License Agreement. There was no income tax expense or benefit recorded by the Company in any other jurisdiction due to its net loss tax position and full valuation allowance during the years ended December 31, 2022 and 2021. As of December 31, 2023, the Company does not believe any material uncertain tax positions are present. A reconciliation of the statutory federal income tax rate to the Company’s annual effective tax rate as reflected in the consolidated financial statements is as follows: December 31, 2023 December 31, 2022 December 31, 2021 U.S. federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.6 4.5 14.0 Foreign Rate Differential ( 1.8 ) 1.2 — Stock based compensation - Excess tax benefit 0.7 1.0 1.8 162(m) Limitation ( 1.4 ) — — Other permanent differences ( 0.4 ) ( 0.3 ) ( 0.1 ) Tax credit 1.9 ( 0.6 ) 1.3 Deferred tax adjustment — ( 2.9 ) — GILTI ( 2.0 ) — — Change in valuation allowance ( 21.0 ) ( 23.9 ) ( 38.0 ) Effective tax rate ( 0.4 )% — % — % The Company is currently under examination by the IRS for the Company's 2021 U.S. income tax return. The Company is not currently under examination at the state level. The Company’s U.S. federal and state net operating losses have occurred since its inception in 2012 and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company has elected to account for Global Intangible Low-Taxed Income (GILTI) in the period in which it is incurred, and therefore has not provided deferred tax impacts of GILTI in its consolidated financial statements. |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Note 19. Related Party Transactions From the Company’s inception, Herriot Tabuteau, M.D. has been the Company’s founder, Chief Executive Officer, Chairman of the Company’s Board, and the beneficial owner of more than 5 % of the outstanding shares of the Company’s common stock. In connection with the formation of the Company, in January 2012, the Company issued to Antecip Bioventures II LLC, an entity controlled by Dr. Tabuteau, an aggregate of 7,344,500 shares of the Company’s common stock for nominal consideration. Additionally, since the launch of Auvelity in the fourth quarter of 2022, the Company recorded royalty expense of $ 3.9 million and $ 0.2 million for the years ended December 31, 2023 and 2022 , respectively, which equal 3.0 % of net sales for those respective years. The Company is a party to three exclusive license agreements with Antecip Bioventures II LLC, an entity owned by Dr. Tabuteau. See Note 16 - License Agreements for further information regarding the license agreements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Significant Risks And Uncertainties | Significant Risks and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise additional capital. If the Company's commercialization of its products is not financially successful, it will be unable to generate sufficient recurring product revenue to achieve and maintain profitability. The Company currently has two commercially approved products, Auvelity and Sunosi, and there can be no assurance that the Company’s research and development efforts will result in successfully commercialized products in addition to Auvelity and Sunosi. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property. |
Use of Estimates | Use of Estimates Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense; determination of fair value of warrants; accounting for research and development costs; accounting for acquisitions; impairments of goodwill and the intangible asset; determination of fair value of contingent consideration; chargebacks, cash discounts, sales rebates, returns and other adjustments; and the recoverability of the Company’s net deferred tax assets and related valuation allowance. |
Revenue Recognition | Revenue Recognition In accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”) the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. Transfer of control is based on contractual performance obligations, which occurs upon transfer of the title along with the physical transfer of the Company's goods to the customer, as that is when the customer has obtained control of significantly all of the economic benefits and the Company obtains a right of payment. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product sales, see Product Sales, net (below) and Note 15 - Revenues . |
License Agreements | License Agreements The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones and royalties on sales of products. If a license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. Contingent milestones at contract inception are estimated to the extent that it is probable that a significant revenue reversal would not occur and are included in the transaction price using the most likely amount method. Milestone payments that are not within the Company's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received, and, therefore, the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that a significant revenue reversal would not occur and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment. For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied). Product Sales, net The Company sells Sunosi and Auvelity in the United States to wholesale distributors with whom the Company has entered into formal agreements (collectively, the “Distributors”). The Company sells Sunosi internationally through wholesale distributors for delivery primarily to retail pharmacies and on a product supply basis to Pharmanovia for distribution in licensed territories. See Note 15 - Revenues for further breakout of product sales, net. Reserves for Variable Consideration The Company's estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. These reserves reflect the Company's best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligation to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses customer segment utilization mix data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Amounts accrued for rebates, discounts, and other incentives are adjusted when trends indicate that adjustment is appropriate and to reflect actual experience. Trade Discounts and Allowances - The Company generally provides discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its distributors for distribution services and data. These payments have been recorded as a reduction to product sales as well as a reduction to accounts receivables, net on the consolidated balance sheets. Product Returns - The Company generally offers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product sale is recognized, as well as a component of accrued expense and other current liabilities. The Company currently estimates product return liabilities using available industry data, historical product sales information and actual returns experience. Chargebacks and Discounts - Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to distributors. Distributors charge the Company for the difference between what they pay for the product and the ultimate selling price. These reserves are established in the same period that the related product sales are recognized, resulting in a reduction to product sales and accounts receivables, net. Rebates - Rebates apply to: Medicaid, managed care, and supplemental rebates to all applicable states as defined by the statutory government pricing calculation requirements under the Medicaid Drug Rebate Program. Tricare rebates to the TRICARE third-party administrator are based on the statutory calculation defined in the agreement with the Defense Health Agency. Part D and Commercial Managed Care rebates are paid based on the contracts with Pharmacy Benefit Managers (“PBMs”) and Managed Care Organizations. Rebates are paid to these entities upon receipt of an invoice from the contracted entity which is based on the utilization of the product by the members of the contracted entity. Allowances for rebates also include amounts due under the Inflation Reduction Act of 2022 for Medicare Part D. The Company estimates these rebates and records such estimates in the same period the related product sales is recognized, resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities. Coverage Gap - The Medicare Part D coverage gap is a period of consumer payment for prescription medication costs which lies between the initial coverage limit and the catastrophic-coverage threshold, when the patient is a member of a Medicare Part D prescription-drug program administered by the Centers for Medicare & Medicaid Services. The Company estimates the percentage of goods sold under Coverage Gap and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities. Other Incentives - Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product sales as well as a component of accrued expenses and other current liabilities. The Company makes significant estimates and judgments that materially affect its recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts frequently are submitted to the Company significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. The Company will adjust its estimates based on new information, including information regarding actual rebates, chargebacks and discounts for its products, as it becomes available. |
Cost of Revenue | Cost of Revenue The Company's cost of revenue consists of cost of product sales and a fee sharing expense related to the upfront license revenue received. Cost of product sales primarily include direct costs (inclusive of material, shipping, handling and manufacturing costs), overhead and product royalties. Cost of product sales excludes depreciation and amortization. The cost of product sales for both Sunosi and Auvelity were $ 26.1 million and $ 5.2 million for the years ended December 31, 2023 and 2022 , respectively. In the first quarter of 2023, the Company recorded a $ 5.0 million license sharing expense related to the upfront license revenue received. The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals Co. Ltd. (“SK”) and Aerial Biopharma, LLC (“Aerial”). SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company's sales of Sunosi, and the Company is committed to pay up to $ 165 million based on revenue milestones and $ 1 million based on development milestones. Additionally, the Company pays a royalty to Antecip Bioventures II LLC (“Antecip”), an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board of Directors (the “Board”), Herriot Tabuteau, M.D., equal to 3.0 % of Auvelity net sales. |
Foreign Currency Translation | Foreign Currency Translation Revenues and expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date they are incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the Statements of Operations and is not material to the Company’s consolidated financial statements. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating segment and reporting unit, which is the business of developing and delivering novel therapies for the management of CNS disorders. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. The Company’s cash and cash equivalents includes holdings in checking and overnight sweep accounts. The Company’s cash equivalents, which are money market funds held in a sweep account, are measured at fair value on a recurring basis. As of December 31, 2023, the balance of cash and cash equivalents was $ 386.2 million, which approximates fair value and was determined based upon Level 1 inputs. The sweep account is valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1 on the fair value hierarchy. |
Concentration of Risk | Concentration of Risk Concentration of Credit Risk - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains its cash at financial institutions, which cash exceeds insured limits. At December 31, 2023 , the majority of the Company’s cash was held by two financial institutions, and amounts on deposit were in excess of government-provided insurance limits. The Company places its cash and cash equivalents in what it believes to be high credit quality banks and money market funds and has not recognized any losses from credit risks on such accounts since inception. See Accounts Receivables, net below for further information. Concentration of Risk, Other- The Company has a limited number of contract manufacturers for its products. At times the Company may have only one manufacturer or supplier for its products. |
Business Combination | Business Combination The Company accounted for the Acquisition as a business combination using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing the intangible asset include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates. As a result of the Acquisition, the Company recorded goodwill and an intangible asset. Goodwill Goodwill is deemed to have an indefinite life and therefore not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or more frequently if events or changes in circumstances indicate that the asset might be impaired. When reviewing goodwill for impairment, the Company first evaluates the qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the qualitative factors determine it is necessary to complete a goodwill impairment test, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. The Company completes its annual goodwill assessment as of December 31. As of December 31, 2023 , the Company has determined that it has one reporting unit. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during the fiscal year ended December 31, 2023. Intangible Asset The Company's intangible asset is amortized using the straight-line method over its estimated period of benefit of ten years. The Company evaluates recoverability of the intangible asset periodically by considering events or changes in circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of the intangible asset during the year ended December 31, 2023 . |
Contingent Consideration | Contingent Consideration Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). The royalty payments due to Jazz are a high single-digit royalty on the Company's U.S. net sales of Sunosi in the current indication and a mid single-digit royalty on the Company's U.S. net sales of Sunosi for future indications. Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations during such period a change is recognized. The Company estimates the fair value of the contingent consideration as of the acquisition date and reporting periods thereafter using the probability weighted income approach using significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates and discount rates. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded within total liabilities in the consolidated balance sheets. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three‑level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. An asset's or liability's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments are cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other liabilities, contingent warrant liability, current and long-term debt and current and non-current contingent consideration. The Company's Level 1 financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other liabilities. They are considered Level 1 as the carrying values reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities. The carrying value of debt on the Company’s balance sheet is estimated to approximate its fair value. The Company's Level 3 financial instruments include contingent warrant liability and current and non-current contingent consideration due to the significant unobservable inputs required in determining their respective fair values. The Company categorized the fair value of contingent consideration liabilities as Level 3 within the fair value hierarchy as the estimate is based on significant unobservable inputs requiring management judgment. The fair value of contingent consideration liabilities is estimated by using the probability weighted income approach using significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success and discount rates. Contingent consideration liabilities are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 8 - Fair Value of Financial Instruments for further detail. The Company estimated the fair value of the warrant liabilities using the Black-Scholes model based on key assumption and inputs. The Company utilizes a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement (as defined below) warrants and allocated the probability of occurrence percentage to the fair values calculated, and, therefore, is considered Level 3 within the fair value hierarchy. The Company accounts for warrants anticipated to be issued in the future under the Loan Agreement as liabilities and measures them at fair value using the Black-Scholes valuation model. The warrants are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 8 - Fair Value of Financial Instruments for further detail. |
Accounts Receivable, net | Accounts Receivable, net The Company’s accounts receivable, net, arise from product sales. They are generally stated at the invoiced amount and do not bear interest. Accounts receivable allowances result from chargebacks, prompt pay discounts, and distribution fees. Payment terms are typically 60 days or less . The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in the customers’ credit profiles. During the first quarter of 2023, the Company began distributing products through wholesale customers. The Company estimates expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. The Company has not historically experienced significant credit losses. Based on its assessment, as of December 31, 2023 , the Company has no t recorded any allowances for doubtful accounts receivable. Receivables from the Company's three largest customers totaled 38 %, 32 % and 28 % of the Company's accounts receivable, net balance as of December 31, 2023 . |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs consist of costs incurred in obtaining long-term financing. These costs are classified on the consolidated balance sheet as a direct deduction from the carrying amount of the related debt liability. These expenses are deferred and amortized as part of interest expense in the consolidated statement of operations using the effective interest rate method over the term of the debt agreement. |
Inventory | Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The remaining inventory associated with the Acquisition is stated at fair value due to purchase accounting. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of revenue. The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory levels are evaluated for amounts that would be sold within one year. If the level of inventory exceeds the estimated amount that would be sold beyond the next 12 months, the Company classifies the estimate of such inventory as non-current. |
Equipment, net | Equipment, net Equipment consists primarily of computer equipment and is recorded at cost. Equipment is depreciated on a straight‑line basis over its estimated useful life, which the Company estimates to be three years . When equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist primarily of employee-related expenses, including salaries, benefits, travel and stock-based compensation expense, contract services, costs incurred to third-party service providers for conducting research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. Research, preclinical and clinical study expenses are estimated based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on the Company’s behalf, including discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, accruals are adjusted accordingly. Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternative future use are expensed as incurred. |
Advertising Costs | Advertising Costs Advertising costs are included in selling, general and administrative expenses and are expensed as incurred. The Company considers advertising costs as expenses related to the promotion of the Company's commercial products. For the years ended December 31, 2023 and 2022, advertising costs were $ 100.3 million and $ 35.3 million, respectively. The Company did not have commercial products in 2021. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position as well as consideration of the available facts and circumstances. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. In the event the Company determines that accrual of interest or penalties are necessary in the future, the amount will be presented as a component of income tax expense. |
Stock-Based Compensation | Stock-Based Compensation For stock options issued, the Company estimates the grant date fair value of each option using the Black‑Scholes option pricing model. The Black-Scholes model takes into account the expected volatility of the Company’s common stock, the risk-free interest rate, the estimated life of the option, the closing market price of the Company’s common stock and the exercise price. The estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application of management’s judgment. In addition, the Company recognizes expense for equity award forfeitures as they occur. For restricted stock units (“RSUs”), the Company issues them in the form of Company common stock. The fair market value of these awards is based on the market closing price per share on the grant date. The Company recognizes the grant date fair value of the stock options and RSUs over the requisite service period, which is generally the vesting term. For awards only subject to service-based vesting conditions, the Company elected to recognize stock-based compensation expense on a straight-line basis. For awards subject to performance-based vesting conditions, the Company recognizes stock-based compensation expense using the accelerated attribution method when the achievement of the performance condition becomes probable. The expense related to the stock-based compensation is recorded within the same financial statement line item as the grantee’s cash compensation. The Company’s policy upon exercise of stock options and RSUs is that shares will be issued as new shares drawing on the Company’s 2015 Omnibus Incentive Compensation Plan share pool that was adopted by the stockholders in November 2015. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options, RSUs and/or common stock pursuant to the 2023 Employee Stock Purchase Plan (the “ESPP”), which would result in the issuance of incremental shares of common stock. As the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for the years ended December 31, 2023 and 2022 . |
Leases | Leases The Company determines if an arrangement is a lease at contract inception. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. When evaluating whether a contract contains a lease, the Company considers whether (1) the contract explicitly or implicitly identifies assets that are contractually defined and (2) the Company obtains substantially all of the economic benefits from the use of that underlying asset and directs how and for what purpose the asset is used during the term of the contract. The Company’s lease agreements contain lease and non-lease components. Non-lease components primarily include payments for maintenance and utilities. The Company has applied the practical expedient to combine fixed payments for non-lease components with lease payments and account for them together as a single lease component, which increases the amount of lease assets and corresponding liabilities. Payments under the Company’s lease arrangements are primarily fixed, however variable payments, are expensed as incurred and not included in the operating lease asset and liability. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses the interest rate implicit in the contract when such rate is readily determinable and uses the Company’s incremental borrowing rate when the rate implicit in the contract is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments. The Company’s operating leases are reflected in the right-of-use operating asset; operating lease liability, current portion; and operating lease liability, long-term portion in the Company’s consolidated balance sheets. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, and do not include an option to extend the term or purchase the underlying asset that the Company is reasonably certain to exercise, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In October 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-08, Business Combinations (Topic 805). This update requires that an entity (acquirer) recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC 606, Revenue from Contracts with Customers. At the acquisition date, an acquirer should account for the related revenue contracts in accordance with ASC 606 as if it had originated the contracts. This differs from the current requirement to measure contract assets and contract liabilities acquired in a business combination at fair value. The amendments in this update should be applied prospectively, and are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted this standard as of January 1, 2023 and concluded it did not have a material impact on the Company's financial statements. See Note 3 - Business Combination for further information. In November 2023, the FASB issued ASU 2023-07, Segment reporting, which requires disclosure of incremental segment information on an annual and interim basis. The standard is effective for years beginning after December 15, 2023, and interim periods beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to income tax disclosures, which requires disclosure of disaggregated income taxes paid by jurisdiction, enhances disclosures in the effective tax rate reconciliation and modifies other income tax-related disclosures. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements. |
Business Combination (Tables)
Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Business Combinations [Abstract] | |
Schedule of Purchase Consideration | The purchase consideration consisted of the following: Cash at settlement $ 53,000 Fair value of contingent consideration 36,140 Total $ 89,140 |
Schedule of Allocation of Fair Value | The allocation of the fair value of the Acquisition is shown in the table below: Amounts recognized as of acquisition date (as previously reported) Measurement period adjustments (1) Purchase price allocation Inventory $ 10,601 $ — $ 10,601 Other current assets 3,551 1,587 5,138 Intangible asset 63,800 — 63,800 Goodwill 11,897 145 12,042 Accrued expenses and other current liabilities ( 709 ) ( 1,732 ) ( 2,441 ) Total $ 89,140 $ — $ 89,140 (1) The adjustment to goodwill resulted from rebates and returns during the post-acquisition period, which were provisionally recorded as an asset and liability, respectively, as of the acquisition date. |
Schedule of Unaudited Pro Forma Summary Presents Consolidated Information | The following unaudited pro forma summary presents consolidated information of the Company, including Sunosi, as if the business combination had occurred on January 1, 2021, the earliest period presented herein: Year ended December 31, 2022 2021 Net revenues $ 74,065 $ 51,670 Net loss ( 211,571 ) ( 283,831 ) |
Accounts Receivable, net (Table
Accounts Receivable, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Receivables [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net, consisted of the following: December 31, December 31, Trade receivables $ 107,320 $ 46,796 Less: Reserves for variable consideration ( 12,500 ) ( 9,097 ) Accounts receivable, net $ 94,820 $ 37,699 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, December 31, Raw materials $ 5,534 $ 2,473 Work in process 10,287 13,965 Finished goods 9,643 1,590 Total $ 25,464 $ 18,028 |
Summary of Balance Sheet Classification of Inventory | The following table summarizes the balance sheet classification of the Company's inventory for each of the periods indicated: December 31, December 31, Balance sheet classification Inventories, net $ 15,135 $ 4,320 Non-current inventory and other assets 10,329 13,708 Total $ 25,464 $ 18,028 |
Goodwill (Tables)
Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill [Abstract] | |
Schedule of Goodwill | The following table provides the Company’s carrying amount of goodwill as of December 31, 2023. Goodwill Balance at December 31, 2022 $ 10,310 Measurement period adjustment 1,732 Balance at December 31, 2023 $ 12,042 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Intangible Assets [Abstract] | |
Schedule of Carrying Amount of Intangible Asset | The following table provides the Company's carrying amount of the intangible asset for each of the periods indicated. Gross carrying amount Accumulated amortization Net carrying amount Remaining weighted-average useful life Balance at December 31, 2022 Finite-lived intangible asset $ 63,800 $ 4,139 $ 59,661 10 -years Balance at December 31, 2023 Finite-lived intangible asset $ 63,800 $ 10,514 $ 53,286 9 -years |
Schedule of Finite Lived Intangible Assets Future Amortization Expenses | Based on the finite-lived intangible asset recorded as of December 31, 2023, and assuming the underlying asset will not be impaired and that we will not change the expected life of the asset, future amortization expenses over the next five years and periods thereafter are estimated to be as follows: Estimated amortization expense 2024 $ 6,392 2025 6,375 2026 6,375 2027 6,375 2028 6,392 Thereafter 21,377 Total $ 53,286 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of financial instruments measured on a recurring basis | The fair value of financial instruments measured on a recurring basis is as follows: December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents - money market funds $ 251,768 $ — $ — $ 251,768 Liabilities: Contingent consideration $ — $ — $ 79,707 $ 79,707 December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents - money market funds $ 195,475 $ — $ — $ 195,475 Liabilities: Contingent consideration $ — $ — $ 37,000 $ 37,000 |
Schedule of changes in fair value of contingent consideration liabilities | The fair value of the contingent consideration liabilities is marked-to-market each reporting period and was remeasured at December 31, 2023. Changes in fair value of the contingent consideration liabilities as of December 31, 2023 are as follows: Contingent consideration Balance at December 31, 2022 $ 37,000 Adjustment to fair value 48,918 Payments ( 6,211 ) Balance at December 31, 2023 (Level 3) $ 79,707 |
Schedule of fair value measurements of contingent consideration recurring include significant unobservable inputs | The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs: As of December 31, 2023 As of December 31, 2022 Valuation methodology Significant unobservable input Weighted average (range, if applicable) Weighted average (range, if applicable) Contingent consideration Probability weighted income approach Discount rate 13.2 % 12.0 % Revenue discount rate 16.4 % - 19.4 % 20.9 % |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | A ccrued expenses and other current liabilities consisted of the following: December 31, December 31, Accrued research and development $ 6,503 $ 4,714 Accrued compensation 20,457 11,284 Accrued selling, general and administrative 9,242 6,596 Accrued sales discounts, rebates and allowances 46,713 26,545 Accrued royalties 5,927 1,617 Accrued interest 1,659 875 Total $ 90,501 $ 51,631 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Debt and Unamortized Debt Discount Balances | Long-term debt and unamortized debt discount balances are as follows: December 31, December 31, Total outstanding debt $ 180,000 $ 95,000 Add: accreted final payment fee 2,610 1,363 Less: unamortized debt discount, long-term ( 4,540 ) ( 2,104 ) Less: current portion of long-term debt — — Loan payable, long-term $ 178,070 $ 94,259 |
Schedule of debt approximates its fair value given its variable interest rate | The book value of debt approximates its fair value given its variable interest rate. Year ended December 31, 2023 2022 2021 Interest expense $ 17,514 $ 8,176 $ 4,617 Amortization of final payment fee 1,197 668 554 Amortization of debt discount related issuance costs and warrants 1,324 815 523 |
Schedule of Principal Payments | Scheduled principal payments on outstanding debt, as of December 31, 2023, are as follows: 2024 $ — 2025 — 2026 — 2027 — 2028 180,000 Thereafter — Total principal payments outstanding $ 180,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease Expense | Year ended December 31, 2023 2022 2021 Total operating lease expense $ 2,173 $ 1,208 $ 1,148 |
Schedule of Future Minimum Lease Payments of Operating Leases | Future minimum lease payments of our operating leases as of December 31, 2023, were as follows: 2024 $ 1,240 2025 1,932 2026 2,521 2027 2,521 2028 3,231 Thereafter — Total lease payments 11,445 Less imputed interest ( 3,143 ) Present value of operating lease liabilities $ 8,302 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table sets forth stock option activity as of December 31, 2023: Number Weighted Weighted Aggregate Outstanding at December 31, 2022 6,617,728 $ 31.80 Granted 2,529,767 67.40 Exercised ( 358,760 ) 34.52 Forfeited/Canceled ( 326,441 ) 53.23 Outstanding at December 31, 2023 8,462,294 $ 41.48 7.1 $ 323,159 Vested and expected to vest at December 31, 2023 8,462,294 $ 41.48 7.1 $ 323,159 Exercisable at December 31, 2023 4,523,493 $ 28.30 5.7 $ 232,383 |
Summary of Black-Scholes Option Valuation Assumptions | The relevant data used to determine the value of the stock option grants is as follows: Black-Scholes option valuation assumptions 2023 2022 2021 Risk-free interest rates 3.34 - 4.88 % 1.46 - 4.31 % 0.63 - 1.47 % Dividend yield — — — Volatility 93 - 99 % 90 - 95 % 89 - 93 % Weighted average expected term 5.0 - 6.11 years 5.0 - 6.11 years 5.0 - 6.17 years |
Schedule of RSU Activity | The following table sets forth the RSU activity for the year ended December 31, 2023: Number Weighted Outstanding at December 31, 2022 686,375 $ 31.80 Granted 343,020 56.26 Vested ( 194,425 ) 32.78 Forfeited ( 30,820 ) 48.37 Outstanding at December 31, 2023 804,150 $ 41.36 |
Schedule of Stock-Based Compensation Expense Recognized | Stock‑based compensation expense recognized was as follows: Year ended December 31, 2023 2022 2021 Research and development $ 14,080 $ 8,604 $ 7,456 Selling, general and administrative 48,540 29,122 13,345 Total $ 62,620 $ 37,726 $ 20,801 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Class of Warrant or Right [Line Items] | |
Schedule of Warrant Activity | The following table summarizes warrant activity for the years ended December 31, 2023, 2022, and 2021: Warrants Weighted average Outstanding at December 31, 2020 15,541 $ 80.43 Issued — — Exercised — — Outstanding at December 31, 2021 15,541 80.43 Issued 35,255 31.91 Exercised — — Outstanding at December 31, 2022 50,796 46.75 Issued 28,424 74.75 Exercised — — Outstanding at December 31, 2023 79,220 $ 56.80 |
Schedule of fair value measurements of contingent consideration recurring include significant unobservable inputs | The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs: As of December 31, 2023 As of December 31, 2022 Valuation methodology Significant unobservable input Weighted average (range, if applicable) Weighted average (range, if applicable) Contingent consideration Probability weighted income approach Discount rate 13.2 % 12.0 % Revenue discount rate 16.4 % - 19.4 % 20.9 % |
Warrants | |
Class of Warrant or Right [Line Items] | |
Schedule of fair value measurements of contingent consideration recurring include significant unobservable inputs | The initial fair value of warrants outstanding was estimated using the Black‑Scholes option pricing model with the following assumptions: Black-Scholes option valuation assumptions 2023 2022 2020 Risk-free interest rate 3.6 - 3.9 % 3.1 % 0.5 % Dividend yield — — — Volatility 92 - 95 % 94 % 88 % Weighted average contractual term 7 years 7 years 7 years |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Common Share | The following table sets forth the computation of basic and diluted net loss per common share: Year ended December 31, 2023 2022 2021 Basic and diluted net loss per common share: Net loss $ ( 239,238 ) $ ( 187,134 ) $ ( 130,403 ) Weighted average common shares outstanding—basic and diluted 45,425,212 40,655,941 37,618,599 Net loss per common share—basic and diluted $ ( 5.27 ) $ ( 4.60 ) $ ( 3.47 ) |
Schedule of Potentially Dilutive Securities | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti‑dilutive: December 31, 2023 2022 2021 Stock options 8,462,294 6,617,728 5,090,377 Restricted stock units 804,150 686,375 326,625 Warrants 79,220 50,796 15,541 ESPP 56,760 — — Total 9,402,424 7,354,899 5,432,543 |
Revenues (Tables)
Revenues (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Disaggregation of Product Sales | The following table presents a summary of total revenues by product: By Product Year ended December 31, 2023 2022 Product sales, net Auvelity $ 130,072 $ 5,168 Sunosi 72,388 44,869 Total product sales, net 202,460 50,037 Sunosi license revenue 65,735 — Sunosi royalty revenue 2,405 — Total revenues $ 270,600 $ 50,037 The following table presents a summary of total revenues by geographic location: By Geographic Location Year ended December 31, 2023 2022 Product sales, net United States $ 197,224 $ 49,132 Outside of the United States 5,236 905 Total product sales, net 202,460 50,037 License revenue Outside of the United States 65,735 — Royalty revenue Outside of the United States 2,405 — Total revenues $ 270,600 $ 50,037 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets | The components of the Company’s deferred tax assets and deferred tax liabilities are as follows: December 31, 2023 December 31, 2022 Deferred tax assets: Net federal operating loss carryforward $ 114,889 $ 96,156 Net foreign operating loss carryforward 697 2,795 Net state operating loss carryforward 34,365 32,029 Non-cash compensation 20,007 11,028 Research and development credits 21,034 15,016 Interest expense 1,327 319 Intangible asset 4,242 10,422 Accrued expenses 6,058 2,113 Section 174 capitalization 22,248 14,541 Other 315 110 Deferred tax asset, excluding valuation allowance 225,182 184,529 Deferred tax liabilities: Fixed assets ( 78 ) — Lease asset ( 1,661 ) ( 104 ) Deferred tax liability, excluding valuation allowance ( 1,739 ) ( 104 ) Less valuation allowance ( 223,443 ) ( 184,425 ) Net deferred tax assets $ — $ — |
Schedule of Income Tax Rate Reconciliation | A reconciliation of the statutory federal income tax rate to the Company’s annual effective tax rate as reflected in the consolidated financial statements is as follows: December 31, 2023 December 31, 2022 December 31, 2021 U.S. federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 2.6 4.5 14.0 Foreign Rate Differential ( 1.8 ) 1.2 — Stock based compensation - Excess tax benefit 0.7 1.0 1.8 162(m) Limitation ( 1.4 ) — — Other permanent differences ( 0.4 ) ( 0.3 ) ( 0.1 ) Tax credit 1.9 ( 0.6 ) 1.3 Deferred tax adjustment — ( 2.9 ) — GILTI ( 2.0 ) — — Change in valuation allowance ( 21.0 ) ( 23.9 ) ( 38.0 ) Effective tax rate ( 0.4 )% — % — % |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Details) $ in Thousands | Dec. 31, 2023 USD ($) Product | Dec. 31, 2022 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of not yet approved product candidates | 3 | |
Number of approved products | 2 | |
Accumulated deficit | $ | $ (835,571) | $ (596,333) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 25, 2022 USD ($) Market | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) Customer Market Institution ReportingUnits Segment | Dec. 31, 2022 USD ($) | |
Segment and Geographic Information | ||||
Number of operating segments | Segment | 1 | |||
Cash Equivalents | ||||
Cash Equivalents | $ 386,200,000 | |||
Concentration of Credit Risk | ||||
Number of financial institutions that hold the Company's cash | Institution | 2 | |||
Business Combination | ||||
Number of reporting units | ReportingUnits | 1 | |||
Accounts Receivable, net | ||||
Accounts receivable, Allowance for credit loss | $ 0 | |||
Equipment, net | ||||
Estimated useful life | 3 years | |||
Cost of Product Sales | ||||
Payment terms | 60 days or less | |||
Number of customers | Customer | 3 | |||
Advertising costs | $ 100,300,000 | $ 35,300,000 | ||
Customer Concentration Risk | Accounts Receivable | Customer One | ||||
Accounts Receivable, net | ||||
Concentration risk, percentage | 38% | |||
Customer Concentration Risk | Accounts Receivable | Customer Two | ||||
Accounts Receivable, net | ||||
Concentration risk, percentage | 32% | |||
Customer Concentration Risk | Accounts Receivable | Customer Three | ||||
Accounts Receivable, net | ||||
Concentration risk, percentage | 28% | |||
License Fee | ||||
Cost of Product Sales | ||||
Cost of product sales | $ 5,000,000 | |||
Sunosi | ||||
Cost of Product Sales | ||||
Number of Asian markets | Market | 12 | |||
Revenue milestones | $ 165,000,000 | $ 165,000,000 | ||
Development milestones | $ 1,000,000 | $ 1,000,000 | ||
Sunosi | Jazz Pharmaceuticals Plc | ||||
Cost of Product Sales | ||||
Number of Asian markets | Market | 12 | |||
Auvelity | ||||
Cost of Product Sales | ||||
License agreement royalty as a percent of net sales | 3% | |||
Sunosi and Auvelity | ||||
Cost of Product Sales | ||||
Cost of product sales | $ 26,100,000 | $ 5,200,000 |
Business Combination - Addition
Business Combination - Additional Information (Details) $ in Millions | 12 Months Ended | ||
Mar. 25, 2022 USD ($) Market | Dec. 31, 2023 USD ($) Market | Dec. 31, 2022 | |
Business Acquisition [Line Items] | |||
Intangible assets, Estimated period of benefit | 9 years | 10 years | |
Jazz Pharmaceuticals Plc | |||
Business Acquisition [Line Items] | |||
Business combination purchase price allocated to goodwill deductible in number of years | 15 years | ||
Sunosi | |||
Business Acquisition [Line Items] | |||
Number of Asian markets | Market | 12 | ||
Revenue milestones | $ 165 | $ 165 | |
Development milestones | 1 | $ 1 | |
Inventory step-up fair value | 1.1 | ||
Sunosi | Jazz Pharmaceuticals Plc | |||
Business Acquisition [Line Items] | |||
Upfront payment | $ 53 | ||
Number of Asian markets | Market | 12 | ||
Intangible assets, Estimated period of benefit | 10 years | ||
Sunosi | Jazz Pharmaceuticals Plc | Measurement Input Discount Rate | |||
Business Acquisition [Line Items] | |||
Percentage of discount rate intangible asset measurement input | 43.50% |
Business Combination - Schedule
Business Combination - Schedule of purchase consideration (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Mar. 25, 2022 | Dec. 31, 2022 | |
Business Acquisition [Line Items] | ||
Cash at settlement | $ 53,000 | |
Sunosi | Jazz Pharmaceuticals Plc | ||
Business Acquisition [Line Items] | ||
Cash at settlement | $ 53,000 | |
Fair value of contingent consideration | 36,140 | |
Total | $ 89,140 |
Business Combination - Schedu_2
Business Combination - Schedule of Allocation of the Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 25, 2022 |
Business Acquisition [Line Items] | |||
Goodwill | $ 12,042 | $ 10,310 | |
Sunosi | Jazz Pharmaceuticals Plc | |||
Business Acquisition [Line Items] | |||
Inventory | $ 10,601 | ||
Other current assets | 5,138 | ||
Intangible asset | 63,800 | ||
Goodwill | 12,042 | ||
Accrued expenses and other current liabilities | (2,441) | ||
Total | 89,140 | ||
Sunosi | Jazz Pharmaceuticals Plc | Previoiusly Reported | |||
Business Acquisition [Line Items] | |||
Inventory | 10,601 | ||
Other current assets | 3,551 | ||
Intangible asset | 63,800 | ||
Goodwill | 11,897 | ||
Accrued expenses and other current liabilities | (709) | ||
Total | 89,140 | ||
Sunosi | Jazz Pharmaceuticals Plc | Restatement Adjustment | |||
Business Acquisition [Line Items] | |||
Other current assets | 1,587 | ||
Goodwill | 145 | ||
Accrued expenses and other current liabilities | $ (1,732) |
Business Combination - Schedu_3
Business Combination - Schedule of Unaudited Pro Forma Summary Presents Consolidated Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||
Net revenues | $ 74,065 | $ 51,670 |
Net loss | $ (211,571) | $ (283,831) |
Accounts Receivable, net - Sche
Accounts Receivable, net - Schedule of Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Receivables [Abstract] | ||
Trade receivables | $ 107,320 | $ 46,796 |
Less: Reserves for variable consideration | (12,500) | (9,097) |
Accounts Receivable, net | $ 94,820 | $ 37,699 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 5,534 | $ 2,473 |
Work in process | 10,287 | 13,965 |
Finished goods | 9,643 | 1,590 |
Total | $ 25,464 | $ 18,028 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Mar. 25, 2022 | |
Inventory [Line Items] | ||
Inventory write down | $ 0 | |
Sunosi | ||
Inventory [Line Items] | ||
Inventory step-up fair value | $ 1,100,000 |
Inventory - Summary of Balance
Inventory - Summary of Balance Sheet Classification of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Inventories, net | $ 15,135 | $ 4,320 |
Non-current inventory and other assets | 10,329 | 13,708 |
Total | $ 25,464 | $ 18,028 |
Goodwill - Schedule of Goodwill
Goodwill - Schedule of Goodwill (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Goodwill [Abstract] | |
Goodwill, beginning balance | $ 10,310 |
Measurement period adjustment | 1,732 |
Goodwill, ending balance | $ 12,042 |
Intangible Asset - Schedule of
Intangible Asset - Schedule of Carrying Amount of Intangible Asset (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Intangible Assets [Abstract] | ||
Gross carrying amount | $ 63,800 | $ 63,800 |
Accumulated amortization | 10,514 | 4,139 |
Net carrying amount | $ 53,286 | $ 59,661 |
Remaining Weighted-Average Useful Life | 9 years | 10 years |
Intangible Asset - Additional I
Intangible Asset - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Intangible Assets [Abstract] | ||
Amortization expense | $ 6,375 | $ 4,139 |
Intangible Asset - Schedule o_2
Intangible Asset - Schedule of Finite Lived Intangible Assets Future Amortization Expenses (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Intangible Assets [Abstract] | |
2024 | $ 6,392 |
2025 | 6,375 |
2026 | 6,375 |
2027 | 6,375 |
2028 | 6,392 |
Thereafter | 21,377 |
Total | $ 53,286 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Accrued contingent consideration, current | $ 6,407 | $ 5,900 |
Contingent consideration liability, non-current | 73,300 | $ 31,100 |
Sunosi | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Accrued contingent consideration, current | 6,400 | |
Contingent consideration liability, non-current | $ 73,300 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Fair Value of Financial Instruments Measured on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Liabilities: | ||
Contingent consideration | $ 79,707 | $ 37,000 |
Money Market Funds | ||
Assets: | ||
Cash and cash equivalents | 251,768 | 195,475 |
Level 1 | Money Market Funds | ||
Assets: | ||
Cash and cash equivalents | 251,768 | 195,475 |
Level 3 | ||
Liabilities: | ||
Contingent consideration | $ 79,707 | $ 37,000 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Schedule of Changes in Fair Value of Contingent Consideration Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Abstract] | ||
Beginning Balance | $ 37,000 | |
Adjustment to fair value | 48,918 | $ 3,298 |
Payments | (6,211) | |
Ending Balance (Level 3) | $ 79,707 | $ 37,000 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Schedule of Fair Value Measurements of Contingent Consideration Recurring Include Significant Unobservable Inputs (Details) - Probability weighted income approach - Contingent consideration - Level 3 | Dec. 31, 2023 | Dec. 31, 2022 |
Measurement Input Discount Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.132 | 0.12 |
Revenue Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.209 | |
Revenue Discount rate | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.194 | |
Revenue Discount rate | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.164 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued research and development | $ 6,503 | $ 4,714 |
Accrued compensation | 20,457 | 11,284 |
Accrued selling, general and administrative | 9,242 | 6,596 |
Accrued sales discounts, rebates and allowances | 46,713 | 26,545 |
Accrued royalties | 5,927 | 1,617 |
Accrued Interest | 1,659 | 875 |
Total | $ 90,501 | $ 51,631 |
Loan and Security Agreement - A
Loan and Security Agreement - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Jan. 09, 2023 | Dec. 31, 2023 | Aug. 31, 2023 | May 08, 2023 | |
Third Amendment To Loan and Security Agreement | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | $ 350,000 | |||
45-day Period after Closing of Fourth Amendment to Loan and Security Agreement | ||||
Line Of Credit Facility [Line Items] | ||||
Cash | $ 10,000 | |||
Maximum | Fourth Amendment To Loan and Security Agreement | ||||
Line Of Credit Facility [Line Items] | ||||
Cash | $ 12,500 | |||
Prepayment Occurs Prior to First Anniversary of Closing Date | Third Amendment To Loan and Security Agreement | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 300,000 | |||
Tranche One | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 95,000 | |||
Tranche One Sub Tranche One | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 95,000 | |||
Tranche One Sub Tranche Two | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 55,000 | |||
Tranche One Sub Tranche Three | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 30,000 | |||
Tranche One Sub Tranche Four | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 35,000 | |||
Tranche One Sub Tranche Five | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 35,000 | |||
Tranche Two Sub Tranche One | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 35,000 | |||
Tranche Two Sub Tranche Two | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 35,000 | |||
Tranche Two Sub Tranche Three | ||||
Line Of Credit Facility [Line Items] | ||||
Line of Credit Facility, Current Borrowing Capacity | 30,000 | |||
Tranche Two Sub Tranches To One Tranche | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 25,000 | |||
Tranche Three Sub Tranche One | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 15,000 | |||
Tranche Three Sub Tranche Two | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 5,000 | |||
Tranche Three Sub Tranches to One Tranche | ||||
Line Of Credit Facility [Line Items] | ||||
Maximum loan amount | 75,000 | |||
Term Loan 2020 | ||||
Line Of Credit Facility [Line Items] | ||||
Cash | $ 3,000 | |||
Debt instrument maturity, month and year | 2028-01 | |||
Interest rate basis | 9.70% | |||
Base interest rate | 9.95% | |||
Minimum different from remaining percentage of cash flow | 10% | |||
Final payment fee | $ 4,450 | |||
Percentage of final payment fee | 1.10% | |||
Increase in minimum cash requirement amount | $ 30,000 | |||
Percentage of facility fee to be paid | 0.75% | |||
Term Loan 2020 | Fourth Amendment To Loan and Security Agreement | ||||
Line Of Credit Facility [Line Items] | ||||
Cash | $ 15,000 | |||
Term Loan 2020 | Minimum | ||||
Line Of Credit Facility [Line Items] | ||||
Base interest rate | 7% | |||
Term Loan 2020 | Maximum | ||||
Line Of Credit Facility [Line Items] | ||||
Interest rate basis | 10.70% | |||
Term Loan 2020 | Prime Rate | ||||
Line Of Credit Facility [Line Items] | ||||
Interest rate basis | 2.20% | |||
Term Loan 2020 | Prime Rate | Maximum | ||||
Line Of Credit Facility [Line Items] | ||||
Interest rate basis | 7% | |||
Term Loan 2020 | Outstanding principle and advances under the loans agreement exceeds 55 million | ||||
Line Of Credit Facility [Line Items] | ||||
Minimum cash to be maintain as a first priority security interest | $ 30,000 | |||
Term Loan 2020 | Outstanding principle and advances under the loans agreement exceeds 65 million | ||||
Line Of Credit Facility [Line Items] | ||||
Minimum amount of market capital to be maintained | $ 1,500,000 | |||
Minimum percentage of cash to be maintained as a security following market capitalization condition | 50% | |||
Minimum percentage of cash to be maintained as a security | 95% | |||
Term Loan 2020 | Outstanding principle and advances under the loans agreement exceeds 65 million | AXS-05 and AXS-07 | ||||
Line Of Credit Facility [Line Items] | ||||
Minimum product revenue percent | 60% | |||
Term Loan 2020 | Prepayment Occurs Prior to February 1, 2024 | ||||
Line Of Credit Facility [Line Items] | ||||
Percentage of prepayment penalty | 2% | |||
Term Loan 2020 | Prepayment Occurs On or After February 1, 2024 but Prior to February 1, 2025 | ||||
Line Of Credit Facility [Line Items] | ||||
Percentage of prepayment penalty | 1.50% | |||
Term Loan 2020 | Prepayment Occurs On or After February 1, 2025 but Prior to February 1, 2026 | ||||
Line Of Credit Facility [Line Items] | ||||
Percentage of prepayment penalty | 1% | |||
Term Loan Advances Other Than Tranche 1A | ||||
Line Of Credit Facility [Line Items] | ||||
Percentage of final payment fee | 4.95% | |||
Term Loan Advances | ||||
Line Of Credit Facility [Line Items] | ||||
Percentage of final payment fee | 1% |
Loan and Security Agreement - S
Loan and Security Agreement - Schedule of Outstanding Debt and Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Total outstanding debt | $ 180,000 | $ 95,000 |
Add: accreted final payment fee | 2,610 | 1,363 |
Less: unamortized debt discount, long-term | (4,540) | (2,104) |
Loan payable, long-term | $ 178,070 | $ 94,259 |
Loan and Security Agreement -_2
Loan and Security Agreement - Schedule of debt approximates its fair value given its variable interest rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Line of Credit Facility [Line Items] | |||
Interest expense | $ 17,514 | $ 8,176 | $ 4,617 |
Amortization of final payment fee | 1,197 | 668 | 554 |
Amortization of debt discount related issuance costs and warrants | 2,574 | 1,483 | 1,077 |
Warrants | |||
Line of Credit Facility [Line Items] | |||
Amortization of debt discount related issuance costs and warrants | $ 1,324 | $ 815 | $ 523 |
Loan and Security Agreement -_3
Loan and Security Agreement - Schedule of Principal Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
2028 | $ 180,000 | |
Total principal payments outstanding | $ 180,000 | $ 95,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||||
Lessee, operating lease, description | The Company entered into a lease for the previous office space at 22 Cortlandt St, New York, NY and extended the lease through April 30, 2023. The lease ended in April 2023 | |||
Lessee, operating lease, existence of option to extend [true false] | true | |||
Lessee, operating lease, option to extend | extended the lease through April 30, 2023 | |||
Rent expense | $ 2.2 | $ 1.3 | $ 1.2 | |
Operating lease, remaining lease term | 4 years 3 months 18 days | |||
Operating lease, discount rate | 12% | |||
Sublease agreement term | 10 years | |||
Lease term | 5 years | |||
22 Cortlandt Street Lease | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease, expiration month and year | 2023-02 | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease term | 12 months |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Operating Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | |||
Total operating lease expense | $ 2,173 | $ 1,208 | $ 1,148 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Lease Payments of Operating Leases (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
2024 | $ 1,240 |
2025 | 1,932 |
2026 | 2,521 |
2027 | 2,521 |
2028 | 3,231 |
Total lease payments | 11,445 |
Less imputed interest | (3,143) |
Present value of operating lease liabilities | $ 8,302 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||
Jul. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | Aug. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2019 USD ($) | Dec. 31, 2023 USD ($) Vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Expected cash dividend | $ 0 | |||||||
Expense | 62,620 | $ 37,726 | $ 20,801 | |||||
Stock-based compensation expense capitalized | 2,700,000 | 1,300,000 | ||||||
Proceeds from Issuance of Common Stock | $ 258,750,000 | $ 243,763,000 | $ 7,436,000 | |||||
Common stock, voting right per share | Vote | 1 | |||||||
Weighted average grant date fair value | $ / shares | $ 53.07 | $ 28.18 | $ 39.64 | |||||
Unrecognized compensation cost related to non-vested stock options expected to be recognized | $ 162,000,000 | |||||||
Expected vesting period for non-vested share-based compensation | 2 years 9 months 18 days | |||||||
Non-vested options outstanding | shares | 6,169 | |||||||
Common Stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Issuance of common stock | shares | 3,450,000 | 5,320,460 | 110,296 | |||||
Restricted Stock Units | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Vesting period | 4 years | |||||||
Compensation cost not yet recognized related to unvested RSUs | $ 25,900,000 | |||||||
Weighted average contractual term | 2 years 6 months | |||||||
Intrinsic value lapsed | $ 1,500,000 | $ 4,900,000 | $ 1,500,000 | $ 400,000 | ||||
2015 Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares available for future grant | shares | 2,168,858 | |||||||
June 2023 Public Offering | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Proceeds from Issuance of Common Stock | $ 31,700,000 | $ 211,300,000 | ||||||
Underwriting discounts and commissions | $ 2,000,000 | 13,500,000 | ||||||
Other offering costs | $ 200,000 | |||||||
June 2023 Public Offering | Common Stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share Price | $ / shares | $ 75 | $ 75 | ||||||
Issuance of common stock | shares | 450,000 | 3,000,000 | ||||||
Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Purchase price of common stock percent | 85% | |||||||
Expense | $ 1,100,000 | |||||||
Employee Stock Purchase Plan | Common Stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares issued | shares | 0 | |||||||
Leerink | December 2019 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Proceeds from issuance of common stock, gross | $ 7,400,000 | |||||||
Shares issued | shares | 110,296 | |||||||
Proceeds from issuance of common stock, net | $ 7,200,000 | |||||||
Common stock sales agreement, commission percentage | 3% | |||||||
Leerink | December 2019 and March 2022 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Proceeds from issuance of common stock, gross | $ 238,800,000 | |||||||
Shares issued | shares | 5,167,973 | |||||||
Proceeds from issuance of common stock, net | $ 231,800,000 | |||||||
Leerink | March 2022 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock sales agreement, authorized amount | $ 250,000,000 | |||||||
Proceeds from Issuance of Common Stock | $ 0 | |||||||
Maximum | Leerink | December 2019 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock sales agreement, authorized amount | $ 80,000,000 | |||||||
Maximum | Leerink | March 2022 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock sales agreement, authorized amount | $ 250,000,000 | $ 200,000,000 | ||||||
Common stock sales agreement, commission percentage | 3% | 3% | ||||||
Hercules Capital Inc | March 2022 Sales Agreement | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares issued | shares | 152,487 | |||||||
Proceeds from issuance of common stock, net | $ 5,000,000 | |||||||
Share Price | $ / shares | $ 32.79 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Number of shares | |
Number of shares, Outstanding, beginning balance | shares | 6,617,728 |
Number of shares, Granted | shares | 2,529,767 |
Number of shares, Exercised | shares | (358,760) |
Number of shares, Forfeited/Canceled | shares | (326,441) |
Number of shares, Outstanding, ending balance | shares | 8,462,294 |
Number of shares, Vested and expected to vest | shares | 8,462,294 |
Number of shares, Exercisable | shares | 4,523,493 |
Weighted average exercise price | |
Weighted average exercise price, Outstanding, beginning balance | $ / shares | $ 31.8 |
Weighted average exercise price, Granted | $ / shares | 67.4 |
Weighted average exercise price, Exercised | $ / shares | 34.52 |
Weighted average exercise price, Forfeited/Canceled | $ / shares | 53.23 |
Weighted average exercise price, Outstanding, ending balance | $ / shares | 41.48 |
Weighted average exercise price, Vested and expected to vest | $ / shares | 41.48 |
Weighted average exercise price, Exercisable | $ / shares | $ 28.3 |
Weighted average contractual term | |
Weighted average contractual term, Outstanding | 7 years 1 month 6 days |
Weighted average contractual term, Vested and expected to vest | 7 years 1 month 6 days |
Weighted average contractual term, Exercisable | 5 years 8 months 12 days |
Aggregate intrinsic value | |
Aggregate intrinsic value, Outstanding | $ | $ 323,159 |
Aggregate intrinsic value, Vested and expected to vest | $ | 323,159 |
Aggregate intrinsic value, Exercisable | $ | $ 232,383 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Black-Scholes Option Valuation Assumptions (Details) - Stock Options | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Black-Scholes option valuation assumptions | |||
Risk-free interest rate, minimum | 3.34% | 1.46% | 0.63% |
Risk-free interest rate, maximum | 4.88% | 4.31% | 1.47% |
Volatility, minimum | 93% | 90% | 89% |
Volatility, maximum | 99% | 95% | 93% |
Minimum | |||
Black-Scholes option valuation assumptions | |||
Weighted average expected term | 5 years | 5 years | 5 years |
Maximum | |||
Black-Scholes option valuation assumptions | |||
Weighted average expected term | 6 years 1 month 9 days | 6 years 1 month 9 days | 6 years 2 months 1 day |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of RSU Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Number of shares | |
Number of shares, Outstanding, beginning balance | shares | 686,375 |
Number of shares, Granted | shares | 343,020 |
Number of shares, Vested | shares | (194,425) |
Number of shares, Forfeited | shares | (30,820) |
Number of shares, Outstanding, ending balance | shares | 804,150 |
Weighted average grant date fair value | |
Weighted average grant date fair value, Outstanding, beginning balance | $ / shares | $ 31.8 |
Weighted average grant date fair value, Granted | $ / shares | 56.26 |
Weighted average grant date fair value, Vested | $ / shares | 32.78 |
Weighted average grant date fair value, Forfeited | $ / shares | 48.37 |
Weighted average grant date fair value, Outstanding, ending balance | $ / shares | $ 41.36 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Stock-Based Compensation Expense Recognized (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 62,620 | $ 37,726 | $ 20,801 |
Research and Development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 14,080 | 8,604 | 7,456 |
Selling General and Administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 48,540 | $ 29,122 | $ 13,345 |
Warrants - Schedule of Warrant
Warrants - Schedule of Warrant Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |||
Warrants outstanding beginning balance | 50,796 | 15,541 | 15,541 |
Issued | 28,424 | 35,255 | 0 |
Exercised | 0 | 0 | 0 |
Warrants outstanding ending balance | 79,220 | 50,796 | 15,541 |
Weighted average exercise price, Beginning balance | $ 46.75 | $ 80.43 | $ 80.43 |
Issued | 74.75 | 31.91 | 0 |
Exercised | 0 | 0 | 0 |
Weighted average exercise price, Ending balance | $ 56.8 | $ 46.75 | $ 80.43 |
Warrants - Additional Informati
Warrants - Additional Information (Details) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Dec. 31, 2023 USD ($) Days $ / shares shares | Dec. 31, 2022 $ / shares | Dec. 31, 2021 $ / shares | Dec. 31, 2020 $ / shares | |
Class Of Warrant Or Right [Line Items] | ||||
Exercise price of warrants (in dollars per share) | $ 56.8 | $ 46.75 | $ 80.43 | $ 80.43 |
Warrants | Hercules Capital Inc | Third Amendment To Loan and Security Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock to be issued if warrants are exercised (in shares) | shares | 18,724 | |||
Exercise price of warrants (in dollars per share) | $ 55.01 | |||
Warrants | 2023 Warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock to be issued if warrants are exercised (in shares) | shares | 9,700 | |||
Exercise price of warrants (in dollars per share) | $ 77.31 | |||
Fair value | $ | $ 1.6 | |||
Warrants | 2022 warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock to be issued if warrants are exercised (in shares) | shares | 35,255 | |||
Exercise price of warrants (in dollars per share) | $ 31.91 | |||
Fair value | $ | $ 0.8 | |||
Warrants | 2020 Warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Common stock to be issued if warrants are exercised (in shares) | shares | 15,541 | |||
Exercise price of warrants (in dollars per share) | $ 80.43 | |||
Trading days | Days | 10 | |||
Term of warrants (in years) | 7 years | |||
Fair value | $ | $ 0.9 |
Warrants - Summary of Initial F
Warrants - Summary of Initial Fair Value of Warrants Estimated using Black - Scholes Option Pricing Model (Details) | Dec. 31, 2023 |
2023 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
2022 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
2020 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
Risk Free Interest Rate | 2023 Warrants | Minimum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.036 |
Risk Free Interest Rate | 2023 Warrants | Maximum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.039 |
Risk Free Interest Rate | 2022 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.031 |
Risk Free Interest Rate | 2020 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.005 |
Dividend Yield | 2023 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0 |
Dividend Yield | 2022 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0 |
Dividend Yield | 2020 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0 |
Volatility | 2023 Warrants | Minimum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.92 |
Volatility | 2023 Warrants | Maximum | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.95 |
Volatility | 2022 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.94 |
Volatility | 2020 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.88 |
Net Loss per Common Share - Com
Net Loss per Common Share - Computation of Basic and Diluted Net Loss per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (239,238) | $ (187,134) | $ (130,403) |
Weighted average common shares outstanding, basic | 45,425,212 | 40,655,941 | 37,618,599 |
Weighted average common shares outstanding, diluted | 45,425,212 | 40,655,941 | 37,618,599 |
Net loss per common share, basic | $ (5.27) | $ (4.60) | $ (3.47) |
Net loss per common share, diluted | $ (5.27) | $ (4.60) | $ (3.47) |
Net Loss per Common Share - Pot
Net Loss per Common Share - Potentially Dilutive Securities Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 9,402,424 | 7,354,899 | 5,432,543 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 8,462,294 | 6,617,728 | 5,090,377 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 804,150 | 686,375 | 326,625 |
Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 79,220 | 50,796 | 15,541 |
ESPP | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 56,760 |
Revenues - Additional Informati
Revenues - Additional Information (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Sunosi [Member] | |
Contract With Customer Liability [Line Items] | |
Prior period adjustments for product sales resulting from changes in estimates | $ 0.1 |
Auvelity [Member] | |
Contract With Customer Liability [Line Items] | |
Prior period adjustments for product sales resulting from changes in estimates | $ 0.8 |
Revenues - Schedule of Disaggre
Revenues - Schedule of Disaggregation of Product Sales (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 270,600 | $ 50,037 |
Product Sales | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 202,460 | 50,037 |
Product Sales | United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 197,224 | 49,132 |
Product Sales | Outside of the United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 5,236 | 905 |
Product Sales | Auvelity | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 130,072 | 5,168 |
Product Sales | Sunosi | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 72,388 | $ 44,869 |
License Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 65,735 | |
License Revenue | Outside of the United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 65,735 | |
License Revenue | Sunosi | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 65,735 | |
Royalty Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 2,405 | |
Royalty Revenue | Outside of the United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 2,405 | |
Royalty Revenue | Sunosi | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 2,405 |
License Agreements - Additional
License Agreements - Additional Information (Details) $ / shares in Units, € in Millions | 1 Months Ended | 12 Months Ended | ||||||
Jan. 31, 2020 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) Item shares | Dec. 31, 2023 EUR (€) Item | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2012 Item | Jan. 09, 2020 USD ($) $ / shares | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
Number of common shares | shares | 47,351,363 | 43,498,617 | ||||||
Value of common stock | $ 5,000 | $ 4,000 | ||||||
Research and development expense recognized | 97,944,000 | 57,947,000 | $ 58,061,000 | |||||
License Agreement | Antecip | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
Milestone payments or royalties | 3,900,000 | $ 200,000 | ||||||
Accrued royalty payments | $ 3,900,000 | |||||||
Number of exclusive license agreements | Item | 3 | 3 | 3 | |||||
License agreement royalty as a percent of net sales | 3% | 3% | 3% | |||||
License agreement royalty, maximum reduction percent as a result of required third party payments | 50% | |||||||
License agreement term, from first commercial sale | 10 years | |||||||
License Agreement | Antecip | AXS-05 | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
License agreement royalty as a percent of net sales | 3% | |||||||
License Agreement | Antecip | Other Two Products | Minimum | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
License agreement royalty as a percent of net sales | 1.50% | |||||||
License Agreement | Antecip | Other Two Products | Maximum | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
License agreement royalty as a percent of net sales | 4.50% | |||||||
Pfizer Inc | License Agreement | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
Number of common shares | shares | 82,019 | |||||||
Value of common stock | $ 8,000,000 | |||||||
Prior trading days | 10 days | |||||||
Share price | $ / shares | $ 97.54 | |||||||
Upfront cash payment | $ 3,000,000 | |||||||
Fair value share price | $ / shares | $ 87.24 | |||||||
Fair value of common stock | $ 7,200,000 | |||||||
Research and development expense recognized | $ 10,200,000 | |||||||
Future milestone payments | $ 323,000,000 | |||||||
Milestone payments or royalties | 0 | $ 0 | ||||||
Pharmanovia | License Agreement | ||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||
Non-refundable upfront payment received | 65,700,000 | € 62 | ||||||
Eligible to receive sales-based and other milestones | € | € 94.5 | |||||||
Royalty revenue | 2,400,000 | |||||||
Other development and sales based milestones recognized | $ 0 |
Royalty Agreements - Additional
Royalty Agreements - Additional Information (Details) - Sunosi $ in Millions | 12 Months Ended | |
Mar. 25, 2022 USD ($) | Dec. 31, 2023 USD ($) Market | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Number of Asian markets | Market | 12 | |
Revenue milestones | $ 165 | $ 165 |
Development milestones | $ 1 | $ 1 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||
NOL carryforwards | $ 547,000,000 | ||
Foreign NOL carryforwards | 700,000 | ||
Increase in valuation allowance | 39,000,000 | $ 26,900,000 | $ 49,600,000 |
Income tax expense (benefit) | 960,000 | ||
Other Jurisdiction | |||
Operating Loss Carryforwards [Line Items] | |||
Income tax expense (benefit) | $ 0 | $ 0 | |
Tax Year 2017 | |||
Operating Loss Carryforwards [Line Items] | |||
NOL carryforwards | 60,000,000 | ||
NOL carryforwards expiration year | 2032 | ||
Tax Year 2018 | |||
Operating Loss Carryforwards [Line Items] | |||
NOL carryforwards | $ 487,000,000 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net federal operating loss carryforward | $ 114,889 | $ 96,156 |
Net foreign operating loss carryforward | 697 | 2,795 |
Net state operating loss carryforward | 34,365 | 32,029 |
Non-cash compensation | 20,007 | 11,028 |
Research and development credits | 21,034 | 15,016 |
Interest expense | 1,327 | 319 |
Intangible asset | 4,242 | 10,422 |
Accrued expenses | 6,058 | 2,113 |
Setion 174 capitlization | 22,248 | 14,541 |
Other | 315 | 110 |
Deferred tax asset, excluding valuation allowance | 225,182 | 184,529 |
Deferred tax liabilities: | ||
Fixed assets | (78) | |
Lease asset | (1,661) | (104) |
Deferred tax liability, excluding valuation allowance | (1,739) | (104) |
Less valuation allowance | $ (223,443) | $ (184,425) |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
U.S. federal statutory income tax rate | 21% | 21% | 21% |
State taxes, net of federal benefit | 2.60% | 4.50% | 14% |
Foreign Rate Differential | (1.80%) | 1.20% | |
Stock based compensation - Excess tax benefit | 0.70% | 1% | 1.80% |
162(m) Limitation | (1.40%) | ||
Other permanent differences | (0.40%) | (0.30%) | (0.10%) |
Tax credit | 1.90% | (0.60%) | 1.30% |
Deferred tax adjustment | (2.90%) | ||
GILTI | (2.00%) | ||
Change in valuation allowance | (21.00%) | (23.90%) | (38.00%) |
Effective tax rate | (0.40%) |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2012 shares | Dec. 31, 2023 USD ($) Item | Dec. 31, 2022 USD ($) | Dec. 31, 2012 Item | |
Antecip | ||||
Related Party Transaction [Line Items] | ||||
Shares issued | shares | 7,344,500 | |||
Antecip | License Agreement | ||||
Related Party Transaction [Line Items] | ||||
Royalty expense | $ | $ 3.9 | $ 0.2 | ||
License agreement royalty as a percent of net sales | 3% | 3% | ||
Number of exclusive license agreements | Item | 3 | 3 | ||
Minimum | Dr. Tabuteau | ||||
Related Party Transaction [Line Items] | ||||
Beneficial ownership percentage | 5% |