Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 21, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
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 | 22 Cortlandt Street | ||
Entity Address, Address Line Two | 16th 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 | 43,516,501 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001579428 | ||
Amendment Flag | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 1.2 | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | New York, New York | ||
Documents Incorporated by Reference | Portions of the registrant's definitive proxy statement for its 2023 Annual Meeting of Stockholders (the "Proxy Statement"), to be filed within 120 days of the registrant's fiscal year ended December 31, 2022 , 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. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 200,841,955 | $ 86,472,854 |
Accounts receivables, net | 37,698,868 | |
Inventories, net | 4,319,921 | |
Prepaid and other current assets | 2,780,665 | 45,286 |
Total current assets | 245,641,409 | 86,518,140 |
Equipment, net | 722,515 | 283,846 |
Right-of-use asset - operating lease | 420,298 | 660,162 |
Goodwill | 10,310,000 | |
Intangible asset, net | 59,660,772 | |
Non-current inventory and other assets | 14,721,101 | 322,910 |
Total assets | 331,476,095 | 87,785,058 |
Current liabilities: | ||
Accounts payable | 38,605,312 | 13,149,329 |
Accrued expenses and other current liabilities | 51,630,813 | 9,295,180 |
Operating lease liability, current portion | 424,673 | 620,675 |
Contingent consideration, current | 5,900,000 | |
Total current liabilities | 96,560,798 | 23,065,184 |
Contingent consideration, non-current | 31,100,000 | |
Loan payable, long-term | 94,258,888 | 49,089,522 |
Total liabilities | 221,919,686 | 72,154,706 |
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding at December 31, 2022 and December 31, 2021, respectively) | ||
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 43,498,617 and 37,816,794 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively) | 4,350 | 3,782 |
Additional paid-in capital | 705,884,795 | 424,825,655 |
Accumulated deficit | (596,332,736) | (409,199,085) |
Total stockholders’ equity | 109,556,409 | 15,630,352 |
Total liabilities and stockholders’ equity | $ 331,476,095 | $ 87,785,058 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 43,498,617 | 37,816,794 |
Common stock, shares outstanding | 43,498,617 | 37,816,794 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues [Abstract] | |||
Product sales, net | $ 50,037,106 | ||
Revenue, Product and Service [Extensible Enumeration] | us-gaap:ProductMember | ||
Operating expenses: | |||
Cost of product sales (excluding amortization and depreciation) | $ 5,197,595 | ||
Cost, Product and Service [Extensible Enumeration] | us-gaap:ProductMember | ||
Research and development | $ 57,947,447 | $ 58,060,725 | $ 70,244,579 |
Selling, general and administrative | 159,253,661 | 66,646,205 | 28,896,749 |
Loss in fair value of contingent consideration | 3,298,230 | ||
Intangible asset amortization | 4,139,228 | ||
Total operating expenses | 229,836,161 | 124,706,930 | 99,141,328 |
Loss from operations | (179,799,055) | (124,706,930) | (99,141,328) |
Interest expense, net | (7,334,596) | (5,696,062) | (2,565,838) |
Tax credit | 53,578 | ||
Loss on extinguishment of debt | (1,247,012) | ||
Net loss | $ (187,133,651) | $ (130,402,992) | $ (102,900,600) |
Net loss per common share, basic | $ (4.60) | $ (3.47) | $ (2.77) |
Net loss per common share, diluted | $ (4.60) | $ (3.47) | $ (2.77) |
Weighted average common shares outstanding, basic | 40,655,941 | 37,618,599 | 37,206,928 |
Weighted average common shares outstanding, diluted | 40,655,941 | 37,618,599 | 37,206,928 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | License Agreement | Common Stock | Common Stock License Agreement | Additional Paid-in Capital | Additional Paid-in Capital License Agreement | Accumulated Deficit |
Beginning balance at Dec. 31, 2019 | $ 178,722,389 | $ 3,693 | $ 354,614,189 | $ (175,895,493) | |||
Balance (in shares) at Dec. 31, 2019 | 36,933,217 | ||||||
Stock-based compensation | 14,756,206 | 14,756,206 | |||||
Issuance of common stock upon exercise of options | 1,049,849 | $ 13 | 1,049,836 | ||||
Issuance of common stock upon exercise of options (in shares) | 127,778 | ||||||
Exercise of warrants | 6 | $ 6 | |||||
Exercise of warrants (in shares) | 63,831 | ||||||
Issuance of warrants upon debt financing | 884,216 | 884,216 | |||||
Issuance of common stock upon financing | 14,125,506 | $ 7,155,337 | $ 17 | $ 8 | 14,125,489 | $ 7,155,329 | |
Issuance of common stock upon financing (in shares) | 167,243 | 82,019 | |||||
Net loss | (102,900,600) | (102,900,600) | |||||
Ending balance at Dec. 31, 2020 | 113,792,909 | $ 3,737 | 392,585,265 | (278,796,093) | |||
Balance (in shares) at Dec. 31, 2020 | 37,374,088 | ||||||
Stock-based compensation | 20,801,380 | 20,801,380 | |||||
Issuance of common stock upon exercise of options | 4,402,400 | $ 33 | 4,402,367 | ||||
Issuance of common stock upon exercise of options (in shares) | 326,219 | ||||||
Issuance of common stock upon vesting of RSUs | 1 | $ 1 | |||||
Issuance of common stock upon vesting of RSUs (in shares) | 6,191 | ||||||
Issuance of common stock upon financing | 7,212,367 | $ 11 | 7,212,356 | ||||
Issuance of common stock upon financing (in shares) | 110,296 | ||||||
Shares tendered for withholding taxes | (175,713) | $ 0 | (175,713) | ||||
Net loss | (130,402,992) | 0 | (130,402,992) | ||||
Ending balance at Dec. 31, 2021 | $ 15,630,352 | $ 3,782 | 424,825,655 | (409,199,085) | |||
Balance (in shares) at Dec. 31, 2021 | 37,816,794 | 37,816,794 | |||||
Stock-based compensation | $ 37,726,158 | 37,726,158 | |||||
Issuance of common stock upon exercise of options | $ 6,251,173 | $ 34 | 6,251,139 | ||||
Issuance of common stock upon exercise of options (in shares) | 340,149 | 340,149 | |||||
Exercise of warrants | $ 826,153 | 826,153 | |||||
Issuance of common stock upon vesting of RSUs | 0 | $ 2 | (2) | ||||
Issuance of common stock upon vesting of RSUs (in shares) | 21,214 | ||||||
Issuance of common stock upon financing | 236,788,056 | $ 532 | 236,787,524 | ||||
Issuance of common stock upon financing (in shares) | 5,320,460 | ||||||
Shares tendered for withholding taxes | (531,832) | (531,832) | |||||
Net loss | (187,133,651) | (187,133,651) | |||||
Ending balance at Dec. 31, 2022 | $ 109,556,409 | $ 4,350 | $ 705,884,795 | $ (596,332,736) | |||
Balance (in shares) at Dec. 31, 2022 | 43,498,617 | 43,498,617 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | |||
Net loss | $ (187,133,651) | $ (130,402,992) | $ (102,900,600) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 37,726,158 | 20,801,380 | 14,756,206 |
Non-cash research and development license expense | 7,155,337 | ||
Amortization of Intangible Assets | 4,139,228 | ||
Loss on extinguishment of debt | 1,247,012 | ||
Amortization of debt discount | 1,482,678 | 1,077,015 | 786,750 |
Depreciation | 263,440 | 76,350 | 23,864 |
Loss in fair value of contingent consideration | 3,298,230 | ||
Amortization of operating lease right-of-use asset | 1,161,505 | 1,079,313 | 53,854 |
Change in operating lease liability | (1,117,643) | (1,181,620) | 8,967 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (37,698,868) | ||
Inventories, net | (1,330,916) | ||
Prepaid expenses and other current assets | (2,735,379) | 103,087 | 264,722 |
Non-current inventory and other assets | (3,944,196) | (5,535) | (177,500) |
Accounts payable | 25,455,983 | (354,693) | 2,560,697 |
Accrued expenses and other current liabilities | 43,922,633 | 581,931 | (2,235,878) |
Net cash used in operating activities | (116,510,798) | (108,225,764) | (78,456,569) |
Cash flows from investing activities | |||
Purchases of equipment | (702,109) | (307,549) | (45,891) |
Cash paid for business combination | (53,000,000) | ||
Net cash used in investing activities | (53,702,109) | (307,549) | (45,891) |
Cash flows from financing activities | |||
Proceeds from draw down of debt | 45,000,000 | 50,000,000 | |
Payment of debt issuance costs | (487,160) | (309,340) | (1,102,609) |
Repayment of principal on term loan | (21,660,000) | ||
Proceeds from issuance of common stock upon financing, net | 236,788,056 | 7,212,367 | 14,125,506 |
Proceeds from issuance of common stock upon exercise of options | 6,251,173 | 4,402,400 | 1,049,849 |
Payment of contingent consideration | (2,438,230) | ||
Payments of tax withholdings on stock award | (531,831) | (175,713) | |
Net cash provided by financing activities | 284,582,008 | 11,129,714 | 42,412,746 |
Net (decrease) increase in cash | 114,369,101 | (97,403,599) | (36,089,714) |
Cash at beginning of period | 86,472,854 | 183,876,453 | 219,966,167 |
Cash at end of period | 200,841,955 | 86,472,854 | 183,876,453 |
Supplemental disclosures of cash flow information: | |||
Interest paid | 7,686,292 | $ 4,625,208 | 2,097,292 |
Operating lease right-of-use asset obtained in exchange for operating lease liability | 561,380 | 1,793,328 | |
Supplemental non-cash investing activities: | |||
Fair value of contingent consideration in a business combination | $ 37,000,000 | ||
Supplemental disclosures of non-cash financing activity: | |||
Issuance of warrants in connection with debt financing | $ 884,216 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
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’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® (also referred to as "AXS-05") and Sunosi® - both of which are also being developed for further indications. In May 2022, the Company acquired Sunosi from Jazz Pharmaceuticals ("Jazz") for sale in the U.S. and in November 2022, following the ex-U.S. assets acquisition from Jazz, the Company began selling Sunosi in certain ex-U.S. markets. Sunosi is a product approved by FDA and marketed in the U.S. to improve wakefulness in adult patients with EDS ("excessive daytime sleepiness") associated with narcolepsy or obstructive sleep apnea, and also approved in Europe in January 2020 by the European Commission. In August 2022, the Company announced the FDA approval of Auvelity and in October 2022, the U.S. commercial availability of Auvelity. Auvelity is indicated for the treatment of major depressive disorder in adults. 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 refers herein to Sunosi, Auveity, AXS-05, AXS-07, AXS-12, AXS-14, solriamfetol, and its programs to develop additional indications for Sunosi and Auvelity, as the Company’s products. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. 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 for the foreseeable future and may never become profitable. As of December 31, 2022, the Company had an accumulated deficit of $ 596.3 million. The Company’s primary sources of cash have been proceeds from the issuance and sale of its common stock in public offerings and the issuance of debt. Sales of Sunosi and Auvelity recently initiated. 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. The Company may continue to incur substantial operating losses even if it begins to generate revenues from its product candidates. The Company believes its current cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for its product candidates. 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 in light 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”. Impact of COVID-19 In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that has now spread globally. On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency. The Secretary of Health and Human Services declared a public health emergency in the United States on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 outbreak. On March 11, 2020, the WHO declared COVID-19 a global pandemic. The full impact of the ongoing COVID-19 pandemic is still unknown and rapidly evolving. While the potential economic impact brought by and over the duration of the COVID-19 pandemic may be difficult to assess or predict, the COVID-19 pandemic has resulted in significant disruption of global financial markets, which could in the future negatively affect the Company’s liquidity. In addition, a recession or market volatility resulting from the COVID-19 pandemic could affect the Company’s business. Given the nature and type of the Company’s short-term investments, the Company does not believe the COVID-19 pandemic has had or will have a material impact on the Company’s current investment liquidity. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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, if approved; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products, if approved; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, if approved; and the Company’s ability to raise additional financing. 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 the 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; the determination of the fair value of the warrants; the accounting for research and development costs; accounting for acquisitions; impairments goodwill and intangible assets; 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 ASC Topic 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. The reported results for the year ended December 31, 2022 reflect the application of ASC Topic 606. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 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 Topic 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 Topic 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). Payment terms are typically 90 days or less . Product Sales, net In 2022, the Company sold Sunosi and Auvelity in the United States through a single third-party logistic provider ("3PL"), which takes title and control of the goods. The 3PL distributed the product to wholesale distributors (collectively the "Distributors") with whom the Company has entered into formal agreements for delivery to retail pharmacies. The company sells Sunosi internationally through local distributors for delivery primarily to retail pharmacies and hospitals. For the year ended December 31, 2022, Product sales, net were $ 44.8 million for Sunosi, including $ 0.9 million in ex-U.S. markets, and $ 5.2 million for Auvelity. 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 our 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. 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 - Consistent with industry practice, 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 sales 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 and its own sales information. 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 based on the statutory calculation defined in the agreement with 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. 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 expense 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 expense 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 expense 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. Foreign Currency Translation Expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date the expense is 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 financial statements. Segment and Geographic 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 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, 2022, the balance of cash and cash equivalents was $ 200.8 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. 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 at times, exceed federally insured limits. At December 31, 2022, the majority of the Company’s cash was held by one financial institution and the amount on deposit was in excess of Federal Deposit Insurance Corporation insurance limits. The Company has not recognized any losses from credit risks on such accounts since inception and does not believe that it is exposed to any significant credit risk with respect to cash and cash equivalents. See Accounts Receivables, net below for further information. Concentration of Risk, Other- We have a limited number of contract manufacturers for our products. At times we may have only one manufacturer or supplier for a product. Business Combination The Company accounted for the Sunosi 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 certain intangible assets 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 of Sunosi from Jazz, 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. The Company performs a one-step test in its evaluation of the carrying value of goodwill if qualitative factors determine it is necessary to complete a goodwill impairment test. In the evaluation, 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 intends to complete its annual goodwill assessment in the first quarter. As of December 31, 2022, 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 year ended December 31, 2022. Intangible Assets Intangible assets are amortized using the straight-line method over their estimated period of benefit of ten years. The Company evaluates the recoverability of intangible assets 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 intangible assets during the year ended December 31, 2022. 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 estimated future cash outflows based on future sales. 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 liabilities, current and long-term debt, current and non-current contingent consideration. The carrying values for cash, accounts payable and accrued liabilities reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities, and therefore considered Level 1 within the fair value hierarchy. The carrying value of debt on the Company’s balance sheet (see Note 6 – Loan and Security Agreement), is estimated to approximate its fair value as the interest rate approximates the market rate for loans with similar terms and risk characteristics, and therefore considered Level 1 within the fair value hierarchy. The key assumptions used to determine the fair value of acquisition-related assets and liabilities are estimated by management, not observable in the market and, therefore considered Level 3 inputs within the fair value hierarchy. 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. 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. In 2022, primarily all of the Company's accounts receivables, net, was generated from the Company's contracted 3PL. Outside of the U.S., accounts receivables are derived from a variety of customers spread across different geographic areas. 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, 2022, the Company has no t recorded any allowances for doubtful accounts receivable. As of December 31, 2022, there is $ 9.1 million of reserves for Variable Consideration recorded as an allowance against Accounts Receivable, net primarily due to Trade Discounts and Allowances and Chargebacks. 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 average cost or estimated net realizable value. The remaining inventory associated with the Sunosi 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 product sales. 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. Cost of Product Sales The Company's cost of product sales relates to sales of Sunosi and Auvelity. 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. Cost of product sales were $ 5.2 million for the year ended December 31, 2022. There were no sales in 2021. The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals (“SK)” and Aerial Biopharma (“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. The Company pays a royalty to Antecip equal to 3.0 % of Auvelity net sales. 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 the conduct of research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. We estimate research, preclinical and clinical study expenses based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on our behalf. We estimate these expenses based on 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, we will adjust the accrual 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. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. 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 year ended December 31, 2022, advertising costs were $ 35.3 million. The Company did not have commercial products in 2021 and 2020. 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 estimates an annual effective tax rate of 0 % for the year ending December 31, 2022 and has no t recorded an income tax benefit for the year ended December 31, 2022 and 2021 since it determined that a full valuation allowance is required against the Company’s deferred tax assets. 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. As of December 31, 2022, the Company does not believe any material uncertain tax positions are present. 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 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. For awards subject to service-based vesting conditions, the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period, which is generally the vesting term. For awards subject to performance-based vesting conditions, the Company recognizes stock-based compensation expense using the accelerated attribution method when it is probable that the performance condition will be achieved. 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 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, and RSUs, 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 year ended December 31, 2022 and 2021. 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 agreement contains 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 arrangement 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 t |
Business Combination
Business Combination | 12 Months Ended |
Dec. 31, 2022 | |
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 Sunosi from Jazz (the “Acquisition”) in certain U.S. and ex-U.S. markets. The Acquisition occurred in two separate closings. The sale and purchase of Specified Initial Assets as defined and contemplated by the Purchase Agreement occurred on May 9, 2022 (“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 (“Final Closing” or “Ex-U.S. Closing”), and primarily consisted of inventory. The Company accounted for the Initial Closing as a business combination using the acquisition method of accounting and the Ex-U.S. 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 Biopharmaceuticals (“SK)” and Aerial Biopharma (“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 $ 300 million term loan facility with Hercules Capital, Inc. In conjunction with the Acquisition, the Company incurred approximately $ 0.5 million in transaction costs, which were expensed as selling, general, and administrative expense in the consolidated statement of operations during the year ended December 31, 2022. The Company's results of operations associated with Sunosi for the year ended December 31, 2022, include $ 44.8 million of net product sales and $ 13.1 million of net loss. This is included in the Company's consolidated statement of operations for the year ended December 31, 2022. Preliminary purchase consideration consisted of the following: Cash at settlement $ 53,000,000 Fair value of contingent consideration 36,140,000 Total $ 89,140,000 The preliminary allocation of the fair value of the Sunosi acquisition is shown in table below: Amounts Recognized as of Acquisition Date (as previously reported) Measurement Period Adjustments Purchase Price Allocation Inventory $ 10,601,000 $ — $ 10,601,000 Other current assets 3,551,000 1,587,000 (1) 5,138,000 Developed technology 63,800,000 — 63,800,000 Goodwill 11,897,000 ( 1,587,000 ) (1) 10,310,000 Accrued expenses and other current liabilities ( 709,000 ) — ( 709,000 ) Total $ 89,140,000 $ — $ 89,140,000 (1) The adjustment to goodwill resulted from rebates covered by Jazz during the post acquisition period which were provisionally recorded as an asset as of the acquisition date. The above allocation of the purchase price is based upon certain preliminary valuations and other analyses that have not been finalized as of the date of this filing. As such, the purchase price amount and allocations for this transaction are preliminary estimates including developed technology, goodwill and contingent consideration, which may be subject to change within the measurement period. 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 product sales 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. Intangible assets include acquired developed technology. The fair value of the acquired developed technology asset 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. Goodwill of $ 10.3 million was established as a result of the Acquisition. 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 expense and other current liabilities acquired were the Company's assumed sales returns liability for Sunosi after the transaction close date related to Jazz sales 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 $ 74,065,000 $ 51,670,000 Net Loss ( 211,571,000 ) ( 283,831,000 ) These pro forma results are illustrative only and not indicative of the actual results of operations that would have been achieved nor are they indicative of future results of operations. |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill [Abstract] | |
Goodwill | Note 4. Goodwill Goodwill of $ 10.3 million was recorded in connection with the Sunosi acquisition as described in Note 3 Business Combination. The adjustment to goodwill resulted from rebates covered by Jazz during the post acquisition period which were provisionally recorded as an asset as of the acquisition date. The following table provides the Company’s goodwill as of December 31, 2022. Goodwill Balance at December 31, 2021 $ — Goodwill from Sunosi Acquisition 11,897,000 Measurement period adjustment ( 1,587,000 ) Balance at December 31, 2022 $ 10,310,000 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Intangible Assets [Abstract] | |
Intangible Asset | Note 5. Intangible Asset The gross carrying amount and net book value of the Company's intangible asset are as follows: Estimated fair value Remaining Weighted-Average Useful Life Balance at December 31, 2021 $ — Gross Carrying Amount 63,800,000 10 -years Accumulated Amortization ( 4,139,228 ) Net Book Value at December 31, 2022 $ 59,660,772 Based on finite-lived intangible assets recorded as of December 31, 2022, and assuming the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses were estimated as follows: Estimated Amortization Expense 2023 6,374,760 2024 6,392,226 2025 6,374,760 2026 6,374,760 Thereafter 34,144,266 Total $ 59,660,772 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 6. Fair Value Measurements In connection with the Sunosi acquisition, the Company pays an uncapped royalty on U.S. 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 $ 5.9 million and non-current contingent consideration liability of $ 31.1 million in the consolidated balance sheet as of December 31, 2022. The fair value of financial instruments measured on a recurring basis is as follows: May 9, 2022 Level 1 Level 2 Level 3 Total Liabilities: Contingent consideration $ — $ — $ 36,140,000 $ 36,140,000 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Contingent consideration $ — $ — $ 37,000,000 $ 37,000,000 Total $ — $ — $ 37,000,000 $ 37,000,000 The fair value of the contingent consideration was remeasured at December 31, 2022. The fair value of the financial instruments as of December 31, 2022 is as follows: Contingent Consideration Balance at December 31, 2021 $ — Initial estimate (Level 3) 36,140,000 Loss in fair value of contingent consideration 3,298,230 Payments ( 2,438,230 ) Balance at December 31, 2022 (Level 3) $ 37,000,000 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, 2022 As of May 9, 2022 Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable) Weighted Average (range, if applicable) Contingent Consideration Probability weighted income approach Discount rate 12.0 % 11.7 % Revenue Required Metric Risk Premium rate 20.9 % 20.8 % The fair value measurement of the contingent consideration is sensitive to the change in discount rates. As of December 31, 2022, if the discount rate increases or decreases by approximately 1%, the fair value of the contingent consideration would range from $ 35.3 million to $ 38.8 million. As of December 31, 2022, if the revenue discount rate increases or decreases by approximately 1%, the fair value of the contingent consideration would range from $ 35.8 million to $ 38.3 million. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 7. Inventory Inventory consists of the following: December 31, Raw materials $ 2,473,058 Work in process 13,964,402 Finished goods 1,590,350 Total $ 18,027,810 As of December 31, 2022, inventories included $ 1.0 million related to the purchase accounting inventory fair value step-up on inventory acquired in the Sunosi Acquisition for the U.S. Territory. There were no material inventory reserves as of December 31, 2022. Non-current inventory, which consists of raw materials and work in progress inventory, is included in non-current inventory and other assets in the Company's consolidated balance sheets. Non-current inventory is anticipated to be consumed beyond our normal operating cycle. The following table summarizes the balance sheet classification of the Company's inventory for each of the periods indicated: December 31, Balance sheet classification Inventories, net $ 4,319,921 Non-current inventory and other assets 13,707,889 Total $ 18,027,810 |
Net Loss per Common Share
Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | Note 11. 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, 2022 2021 2020 Basic and diluted net loss per common share: Net loss $ ( 187,133,651 ) $ ( 130,402,992 ) $ ( 102,900,600 ) Weighted average common shares outstanding—basic and diluted 40,655,941 37,618,599 37,206,928 Net loss per common share—basic and diluted $ ( 4.60 ) $ ( 3.47 ) $ ( 2.77 ) The following potentially dilutive securities outstanding at December 31, 2022, 2021, and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti‑dilutive: December 31, 2022 2021 2020 Stock options 6,617,728 5,090,377 3,733,916 Restricted stock units 686,375 326,625 136,067 Warrants 50,796 15,541 15,541 Total 7,354,899 5,432,543 3,885,524 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | Note 8. Accrued Expenses and Other Current Liabilities At December 31, 2022 and 2021, accrued expenses consisted of the following: December 31, December 31, Accrued research and development $ 4,714,388 $ 2,416,897 Accrued compensation 11,283,646 4,050,236 Accrued selling, general and administrative 6,596,409 2,442,700 Accrued sales discounts, rebates and allowances 26,544,510 — Accrued royalties 1,616,541 — Accrued interest 875,319 385,347 Total $ 51,630,813 $ 9,295,180 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | Note 9. Loan and Security Agreement Hercules Capital, Inc. Second Amendment to the Loan Agreement 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 Capital, Inc., or Hercules. The Second Amendment closed on May 9, 2022 concurrently with the closing of the Acquisition. The Second Amendment amends the terms of that certain Loan and Security Agreement, dated as of September 25, 2020 (as amended by the First Amendment to the Loan and Security Agreement, dated of October 14, 2021) (the “Loan Agreement”). The changes in the Term Loan Advances (as defined in the Loan Agreement) amounts and dates are as follows: (i) increasing the Tranche 1 (as defined in the Loan Agreement) from $ 60.0 million to $ 95.0 million, whereby $ 45.0 million was drawn upon the Second Amendment closing date (ii) changing the Tranche 2 Advances to three sub-tranches of $ 35.0 million, $ 35.0 million and $ 30.0 million, respectively, for a same total value of $ 100.0 million, which is now accessible at the Company's option upon the achievement of the approval of AXS-05 (iii) changing the Tranche 3 Advance to two sub-tranches of $ 15.0 million and $ 5.0 million, respectively, for the same total value of $ 20.0 million, upon approval of AXS-07 (iv) decreasing the Tranche 4 Advance from $ 55.0 million to $ 50.0 million, available upon achievement of certain combined sales and outstanding debt criteria and (v) decreasing the Tranche 5 Advance from $ 75.0 million to $ 35.0 million, subject to the approval from Hercules. The outstanding balance of the debt bears interest at a floating rate based on the greater of (a) 8.95 % or (b) US WSJ Prime + 5.70 %) to not exceed 10.70 %. As collateral for the obligations, the Company has granted to Hercules a senior security interest in all of Company’s right, title, and interest in, to and under all of Company’s property, inclusive of intellectual property, which includes one of the Company’s existing license agreements (the “License Agreement”) with Antecip Bioventures II LLC (“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 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. Only after additional amounts are drawn down by the Company in the future, if the Company decides to do so, under the terms set forth in the Loan Agreement, there will be certain limited financial covenants that will apply, including: • Effective upon closing of the Second 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 $ 40.0 million, plus the amount of the Company’s accounts payable under U.S. GAAP not paid after the 180 th day following the invoice for such account payable (such amount, the “Qualified Cash A/P Amount”). The $ 40.0 million threshold decreased to $ 25.0 million upon achievement of the AXS-05 milestone. • Effective upon the (i) the last calendar month of the calendar quarter that is nine months following the earlier of (x) the date that the First Milestone is achieved (y) the date that the Second Milestone is achieved, or (z) the final closing date of the Sunosi acquisition (A) ensure that at all times its market capitalization exceeds $ 1.0 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 85 % 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 of directors 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. • 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 a final payment fee equal to (A) $ 2,910,000 in connection with the drawn amount of Tranche 1A plus (B) 4.5 % on the draw down of Tranche 1B and the aggregate amount of all term future loan advances. The final payment fee is being accreted and amortized into interest expense using the effective interest rate method over the term of the loan. 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 the first anniversary of the First Amendment Closing Date, (ii) 1.5 % of the principal amount prepaid if the prepayment occurs on or after the first anniversary and prior to the second anniversary of the First Amendment Closing Date, and (iii) 1.0 % of the principal amount prepaid if the prepayment occurs on or after the second anniversary and prior to the third anniversary of the First Amendment Closing Date. These percentages are unchanged from the First Amendment to the Loan Agreement. The Company evaluated whether the Hercules Term Loan entered into in March 2022 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 Second Amendment to the Hercules Agreement is less than 10 % different from the remaining cash flows under the terms of the First amendment, the Second 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 Hercules Second Amendment to the Loan Agreement, are being amortized through maturity in October 2026 utilizing the effective interest rate method. In January 2023, the Company entered into a Third Amendment (the "Third Amendment") to its Loan and Security Agreement (the “Loan Agreement”) with Hercules. The Third Amendment increases the size of the Term Loan Advance (as defined in the Loan Agreement) to $ 350,000,000 , reduces the interest rate, and extends the maturity and interest-only period of the Loan Agreement. $ 55.0 million was drawn upon the Third Amendment closing date. See Note 18 - Subsequent Events for further information. The Third Amendment amended the terms of the Loan Agreement to, among other things, (i) 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; (ii) increase the aggregate principal amount under the Loan Agreement from $ 300,000,000 to $ 350,000,000 ; (iii) subject to the terms and conditions in the Loan Agreement, change the Term Loan Advance amounts and dates available under the Tranche 1 Advance (as defined in the Loan Agreement) through Tranche 5 Advance (as defined in the Loan Agreement), including increasing the Tranche 1 Advance from one tranche of $ 95,000,000 to five sub-tranches of $ 95,000,000 , $ 55,000,000 , $ 30,000,000 , $ 35,000,000 and $ 35,000,000 , respectively, changing the Tranche 2 Advance (as defined in the Loan Agreement) from three sub-tranches of $ 35,000,000 , $ 35,000,000 and $ 30,000,000 to one tranche of $ 25,000,000 , changing the Tranche 3 Advance (as defined in the Loan Agreement) from two sub-tranches of $ 15,000,000 and $ 5,000,000 to one tranche of $ 75,000,000 , and removing the Tranche 4 Advance (as defined in the Loan Agreement) and Tranche 5 Advance entirely; (iv) revise the interest rate applicable to extensions of credit under the Loan Agreement to equal the greater of 9.95 % per annum or the prime rate plus 2.20 % per annum, to not exceed 10.70 % (v) increase the minimum cash requirement of the Company to $ 30,000,000 ; and (vi) 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 (as defined in the Loan Agreement), Tranche 1C Advance (as defined in the Term Loan), Tranche 1D Advance (as defined in the Loan Agreement), Tranche 1E Advance (as defined in the Term Loan), Tranche 2 Advance and Tranche 3 Advance. Silicon Valley Bank In March 2019, the Company entered into a $ 24.0 million growth capital term loan facility (the “2019 Term Loan”) with Silicon Valley Bank, or SVB and West River Innovation Lending Fund VIII, L.P., or WestRiver. In September 2020, the Company used a portion of the 2020 Term Loan to terminate and repay all amounts outstanding under the 2019 Term Loan and recorded a loss on extinguishment of the 2019 Term Loan. Further information on warrants issued related to the debt financings and amendments are disclosed in Note 13 - Warrants. Long-term debt and unamortized debt discount balances are as follows: December 31, December 31, Total Outstanding Debt $ 95,000,000 $ 50,000,000 Add: accreted liability of final payment fee 1,362,733 706,407 Less: unamortized debt discount, long-term ( 2,103,845 ) ( 1,616,885 ) Less: current portion of long-term debt — — Loan payable, long-term $ 94,258,888 $ 49,089,522 The book value of debt approximates its fair value given its variable interest rate. Year ended December 31, 2022 2021 2020 Interest Expense $ 8,176,264 $ 4,616,597 $ 2,362,083 Amortization of final payment fee 668,051 554,493 469,676 Amortization of debt discount related issuance costs and warrants 814,627 522,522 317,074 Scheduled Principal Payments on Outstanding Debt, as of December 31, 2022, are as follows: 2022 — 2023 — 2024 — 2025 15,202,884 2026 79,797,116 Total principal payments outstanding $ 95,000,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10. 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. The Company entered into a lease for office space at 22 Cortlandt St, New York, NY consisting of the 16 th floor effective August 1, 2020 . In August 2022, the Company entered into an agreement to extend the lease of 22 Cortlandt Street through April 30, 2023 . Rent expense incurred during the years ended December 31, 2022, 2021 and 2020 was $ 1,255,165 , $ 1,175,139 , and $ 870,275 . Operating lease expenses recognized for the years ended December 31, 2022, 2021, and 2020 was as follows: Year ended December 31, 2022 2021 2020 Total operating lease expense $ 1,207,837 $ 1,147,692 $ 47,821 Future minimum lease payments of our operating leases as of December 31, 2022, were as follows: 2023 427,875 2024 — 2025 — Thereafter — Total lease payments 427,875 Less imputed interest ( 3,202 ) Present value of operating lease liabilities $ 424,673 As of December 31, 2022, the remaining lease term for our operating lease was 0.3 years with a discount rate of 6.0 %. 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. In February 2023, the Company entered into a sub-lease agreement for new corporate and executive office space, commencing March 2023 . See Note 18 - Subsequent Events for further information. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Note 12. Stockholders’ Equity Capital Structure In December 2019, the Company entered into a sales agreement (the “December 2019 Sales Agreement”) with SVB Securities LLC (formerly known as SVB Leerink LLC) (“SVB Securities”), pursuant to which the Company may sell up to $ 80 million in shares of the Company’s common stock from time to time through SVB Securities, acting as the Company’s sales agent, in one or more at-the-market offerings utilizing the automatic shelf registration statement that the Company previously filed with the SEC on December 5, 2019 (the “2019 Shelf Registration Statement”). SVB Securities 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 (see below). In March 2022, the Company entered into a sales agreement (the “March 2022 Sales Agreement”) with SVB Securities, pursuant to which the Company may sell up to $ 200 million in shares of the Company’s common stock from time to time through SVB Securities, acting as the Company’s sales agent, in one or more at-the-market offerings utilizing the 2019 Shelf Registration Statement. SVB Securities 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 SVB Securities. 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 under the March 2022 Sales Agreement. The Company will pay SVB Securities a commission of up to 3.0 % of the gross sales proceeds of any shares sold through SVB Securities, 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. Under the December 2019 Sales Agreement and March 2022 Sales Agreement, for the year ended December 31, 2022, 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. Upon the closing of the Second Amendment, 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 of directors. Shelf Registration Statement On December 2, 2022, the Company filed an automatic shelf registration statement (“2022 Shelf Registration Statement”) with the Securities and Exchange Commission (“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. Through the date of this report, the Company has no t issued common stock pursuant to such shelf registration statement. 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 Plans The Company had granted stock options under its 2013 Equity Compensation Plan (the “2013 Plan”), which was adopted for employees and consultants for the purpose of advancing the interests of the Company's stockholders by enhancing its ability to attract, retain and motivate persons who are expected to make important contributions to the Company. In November 2015, the 2015 Omnibus Incentive Compensation Plan (the “2015 Plan”) was adopted by the Company’s stockholders . The 2015 Plan is the successor to the Company's 2013 Plan. In conjunction with the adoption of the 2015 Plan, no additional grants were made from the 2013 Plan and options from the 2013 Plan remain outstanding. As of December 31, 2022, there were 2,944,176 shares available for future grant under the 2015 Plan. Modification and Cancellation of Stock Awards In June 2020, in connection with the decision not to stand for re-election by a member of the Company’s Board of Director’s, the vesting of stock options covering 21,666 shares of common stock was accelerated. As a result of this modification, the Company recorded incremental stock-based compensation expense of approximately $ 1.3 million for the year ended December 31, 2020. In November 2020, certain employee Stock Options and Restricted Stock Units were cancelled. Stock options to purchase an aggregate of 38,267 shares of common stock were cancelled, and the Company recognized non-cash stock-based compensation expense of $ 2.1 million related to this cancellation for the year ended December 31, 2020. Restricted Stock Units for an aggregate of 11,735 shares of common stock were cancelled, and the Company recognized non-cash stock-based compensation expense of $ 0.5 million related to this cancellation for the year ended December 31, 2020. Stock Options The following table summarizes stock option activity as of December 31, 2022: Number Weighted Weighted Aggregate Outstanding at December 31, 2021 5,090,377 $ 28.89 Granted 2,222,866 38.62 Exercised ( 340,149 ) 18.38 Forfeited ( 317,942 ) 39.50 Expired ( 37,424 ) 54.76 Outstanding at December 31, 2022 6,617,728 $ 31.80 7.3 $ 300,653,467 Vested and expected to vest at December 31, 2022 6,617,728 $ 31.80 7.3 $ 300,653,467 Exercisable at December 31, 2022 3,470,813 $ 21.43 5.8 $ 193,768,216 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 not expect to pay any cash dividends in the foreseeable future. Expected volatility is based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. The relevant data used to determine the value of the stock option grants for the years ended December 31, 2022, 2021, and 2020 is as follows: Black-Scholes option valuation assumptions 2022 2021 2020 Risk-free interest rates 1.46 - 4.31 % 0.63 - 1.47 % 0.3 - 1.7 % Dividend yield — — — Volatility 90 - 95 % 89 - 93 % 67 - 99 % Weighted average expected term 5.0 - 6.11 years 5.0 - 6.17 years 3.51 - 6.14 years The weighted average grant date fair value of options granted was $ 28.18 , $ 39.64 , and $ 36.77 per option for the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31, 2022, there was $ 95.7 million of total unrecognized compensation cost related to non‑vested stock options which is expected to be recognized over a weighted average period of 2.9 years. These amounts do not include 6,169 options outstanding as of December 31, 2022, 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. The intrinsic value of stock options exercised during the years ended December 31, 2022, 2021 and 2020 was $ 13.2 million, $ 13.5 million, and $ 9.4 million, respectively. Restricted Stock Units In 2020, the Company began granting RSUs covering an equal number of its shares of common stock to employees. 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, 2022, total compensation cost not yet recognized related to unvested RSUs was $ 17.5 million, which is expected to be recognized over a weighted-average period of 2 .9 years. The intrinsic value of RSUs lapsed during the year ended December 31, 2022 and 2021 was $ 1.5 million and $ 0.4 million, respectively. The following table sets forth the RSU activity for the year ended December 31, 2022: Number Weighted Outstanding at December 31, 2021 302,764 $ 42.93 Granted 533,134 27.18 Vested ( 81,639 ) 42.49 Forfeited ( 67,884 ) 30.20 Outstanding at December 31, 2022 686,375 $ 31.80 Stock‑based compensation expense recognized for the years ended December 31, 2022, 2021, and 2020 was as follows: Year ended December 31, 2022 2021 2020 Research and development $ 8,604,408 $ 7,456,049 $ 3,953,939 Selling, general and administrative 29,121,750 13,345,331 10,802,267 Total $ 37,726,158 $ 20,801,380 $ 14,756,206 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Note 13. Warrants The following table summarizes warrant activity as of December 31, 2022, 2021, and 2020: Warrants Weighted average Outstanding at December 31, 2019 69,656 $ 7.21 Issued 15,541 80.43 Exercised ( 69,656 ) 7.21 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 Outstanding Warrants In connection with the entry into the Second Amendment, Hercules received warrants to purchase an aggregate 35,255 shares of the Company’s common stock at an exercise price of $ 31.91 per share ("2022 warrants") and in connection with the first advance of the 2020 Term Loan, Hercules received warrants to purchase an aggregate 15,541 shares of the Company’s common stock at an exercise price of $ 80.43 per share ("2020 warrants"). Both the 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 $ 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 outstanding warrants of 69,656 as of December 31, 2019 were fully exercised by Life Sciences Loans and WestRiver Innovation Lending during year ended December 31, 2020. These warrants were issued during 2016, 2018 and 2019 in connection with the Company's previous debt facility with SVB. The initial fair value of the warrants was estimated using the Black‑Scholes option pricing model with the following assumptions: Black-Scholes option valuation assumptions 2022 2020 2019 2018 2016 Risk-free interest rate 3.1 % 0.5 % 2.8 % 3.0 % 1.8 % Dividend yield — — — — — Volatility 94 % 88 % 97 % 85 % 73 % Weighted average contractual term 7 years 7 years 7 years 7 years 7 years |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
License Agreements | Note 14. License Agreements 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 now 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 $ 97.538 , 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 twelve months 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. 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, 2022, 2021 and 2020, no milestone payments or royalties were paid to Pfizer by the Company. In 2012, the Company entered into three exclusive license agreements with Antecip Bioventures II LLC, or Antecip, an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., in which it was granted exclusive licenses to develop, manufacture, and commercialize Antecip’s patents and applications related to the development of AXS‑05 and two product candidate that are not currently in development, anywhere in the world for veterinary and human therapeutic and diagnostic use. Pursuant to the agreements, the Company is required to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize AXS‑05. Under the terms of the agreements, the Company is required to pay to Antecip a royalty equal to 3.0 % for AXS‑05, 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. In connection with the 2020 Term Loan, the Company entered into a Direct Agreement with Antecip pursuant to which Antecip consented to the collateral assignment of the License Agreement to Hercules, among other things. Due to the sales of Auvelity in the fourth quarter of 2022, the Company recorded an accrual for royalty payments to Antecip equal to 3.0 % of net sales. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 15. Income Taxes As of December 31, 2022, the Company has U.S. federal net operating loss (“NOL”) carryforwards of approximately $ 458 million and foreign NOL carryforwards of $ 7.8 million. U.S. federal NOLs amounting to $ 60 million generated before the 2018 tax year will start expiring beginning 2032 , and the NOL of approximately $ 398 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 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, 2022 December 31, 2021 Deferred tax assets: Net federal operating loss carryforward $ 96,156,250 $ 76,470,431 Net foreign operating loss carryforward 2,794,785 88,480 Net state operating loss carryforward 32,029,378 47,672,157 Non-cash compensation 11,027,745 13,228,425 Research and development credits 15,015,642 14,455,797 Interest Expense 318,798 4,117,655 Intangible Assets 10,422,110 — Accrued expenses 2,113,054 1,479,728 Section 174 Capitalization 14,540,848 — Other 109,988 219,760 Deferred tax asset, excluding valuation allowance 184,528,598 157,732,433 Deferred tax liabilities: Lease Asset ( 104,001 ) ( 224,958 ) Deferred tax liability, excluding valuation allowance ( 104,001 ) ( 224,958 ) Less valuation allowance ( 184,424,597 ) ( 157,507,475 ) 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 $ 26.9 million, $ 49.6 million, and $ 39.7 million, in 2022, 2021, and 2020, respectively, as a result of the increase of the deferred tax assets. There was no income tax expense (benefit) recorded by the Company due to its net loss tax position and full valuation allowance during the years ended December 31, 2022, 2021, and 2020. A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements is as follows: December 31, 2022 December 31, 2021 December 31, 2020 U.S. federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 4.5 14.0 13.7 Foreign Rate Differential 1.2 — — Stock based compensation - Excess tax benefit 1.0 1.8 1.8 Other permanent differences ( 0.3 ) ( 0.1 ) ( 0.6 ) Tax credit ( 0.6 ) 1.3 2.5 Deferred tax adjustment ( 2.9 ) — — Change in valuation allowance ( 23.9 ) ( 38.0 ) ( 38.4 ) Effective tax rate — % — % — % The Company is not currently under examination at the federal or state levels and as of the date of the consolidated financial statements, there were no known assessments. 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 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, 2022 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Note 16. 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 of directors, 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, due to the sales of Auvelity in the fourth quarter of 2022, the Company recorded an accrual of $ 0.2 million for royalty payments to Antecip equal to 3.0 % of net sales. The Company is a party to three exclusive license agreements with Antecip Bioventures II LLC, an entity owned by Dr. Tabuteau. See Note 14 – License Agreements for further information regarding the license agreements. |
Royalty Agreements
Royalty Agreements | 12 Months Ended |
Dec. 31, 2022 | |
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 (as defined in the Purchase Agreement), or (B) mid-single digit royalty for any Future Indication (as defined in the Purchase Agreement), of Net Sales (as defined in the Purchase Agreement) in the U.S. Territory (as defined in the Purchase Agreement) made during the applicable Royalty Term (as defined in the Purchase Agreement). 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 the Product 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. The Company is required to pay Antecip Bioventures II LLC, or Antecip, an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., a royalty equal to 3.0 % for AXS‑05 (Auvelity), of net sales of products containing the licensed technology by the Company, its affiliates, or permitted sublicensees. Effective in the fourth quarter of 2022, the Company began recording royalty expense to Antecip as a component of cost of product sales. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 18. Subsequent Events On January 9, 2023, the Company entered into a Third Amendment to its Loan and Security Agreement with Hercules Capital Inc. The Third Amendment increased the size of the aggregate principal amount under the Loan Agreement from $ 300 million to $ 350 million reduced the interest rate, and extended the maturity and interest-only period of the Loan Agreement. $ 55.0 million was drawn upon the Third Amendment closing date. On February 21, 2023, the Company entered into a sublease agreement for office space for the Company's corporate and executive offices. On February 21, 2023, Axsome Malta Ltd., a Malta limited company (“Axsome Malta”), a wholly-owned subsidiary of the Company, entered into a License Agreement (the “License Agreement”) with Atnahs Pharma UK Limited (Pharmanovia), a company organized and existing under the laws of England and Wales (the “Licensee”), pursuant to which Axsome Malta will license certain Licensed Intellectual Property (as defined in the License Agreement) to the Licensee and grant an exclusive license to Licensee in the Territory (as defined in the License agreement to include Europe and certain countries in the Middle East and Africa) for use of the Licensed Intellectual property for the development and commercialization of the Company’s Licensed Products (as defined in the License Agreement and which includes the Company’s product Sunosi). The Company received an upfront payment of € 62.0 million ($ 66.2 million) and is eligible to receive sales-based and other milestones totaling up to € 94.5 million ($ 101.1 million). The Company will receive a royalty percentage in the mid-twenties on net sales of the Licensed Products (as defined in the License Agreement) in the Territory (as defined in the License Agreement). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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, if approved; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products, if approved; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, if approved; and the Company’s ability to raise additional financing. 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 the 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; the determination of the fair value of the warrants; the accounting for research and development costs; accounting for acquisitions; impairments goodwill and intangible assets; 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 ASC Topic 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. The reported results for the year ended December 31, 2022 reflect the application of ASC Topic 606. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 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 Topic 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 Topic 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). Payment terms are typically 90 days or less . Product Sales, net In 2022, the Company sold Sunosi and Auvelity in the United States through a single third-party logistic provider ("3PL"), which takes title and control of the goods. The 3PL distributed the product to wholesale distributors (collectively the "Distributors") with whom the Company has entered into formal agreements for delivery to retail pharmacies. The company sells Sunosi internationally through local distributors for delivery primarily to retail pharmacies and hospitals. For the year ended December 31, 2022, Product sales, net were $ 44.8 million for Sunosi, including $ 0.9 million in ex-U.S. markets, and $ 5.2 million for Auvelity. 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 our 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. 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 - Consistent with industry practice, 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 sales 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 and its own sales information. 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 based on the statutory calculation defined in the agreement with 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. 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 expense 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 expense 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 expense 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. |
Foreign Currency Translation | Foreign Currency Translation Expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date the expense is 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 financial statements. |
Segment and Geographic Information | Segment and Geographic 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 Equivalents | 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, 2022, the balance of cash and cash equivalents was $ 200.8 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. |
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 at times, exceed federally insured limits. At December 31, 2022, the majority of the Company’s cash was held by one financial institution and the amount on deposit was in excess of Federal Deposit Insurance Corporation insurance limits. The Company has not recognized any losses from credit risks on such accounts since inception and does not believe that it is exposed to any significant credit risk with respect to cash and cash equivalents. See Accounts Receivables, net below for further information. Concentration of Risk, Other- We have a limited number of contract manufacturers for our products. At times we may have only one manufacturer or supplier for a product. |
Business Combination | Business Combination The Company accounted for the Sunosi 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 certain intangible assets 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 of Sunosi from Jazz, 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. The Company performs a one-step test in its evaluation of the carrying value of goodwill if qualitative factors determine it is necessary to complete a goodwill impairment test. In the evaluation, 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 intends to complete its annual goodwill assessment in the first quarter. As of December 31, 2022, 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 year ended December 31, 2022. Intangible Assets Intangible assets are amortized using the straight-line method over their estimated period of benefit of ten years. The Company evaluates the recoverability of intangible assets 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 intangible assets during the year ended December 31, 2022. |
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 estimated future cash outflows based on future sales. 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 liabilities, current and long-term debt, current and non-current contingent consideration. The carrying values for cash, accounts payable and accrued liabilities reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities, and therefore considered Level 1 within the fair value hierarchy. The carrying value of debt on the Company’s balance sheet (see Note 6 – Loan and Security Agreement), is estimated to approximate its fair value as the interest rate approximates the market rate for loans with similar terms and risk characteristics, and therefore considered Level 1 within the fair value hierarchy. The key assumptions used to determine the fair value of acquisition-related assets and liabilities are estimated by management, not observable in the market and, therefore considered Level 3 inputs within the fair value hierarchy. |
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. 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. In 2022, primarily all of the Company's accounts receivables, net, was generated from the Company's contracted 3PL. Outside of the U.S., accounts receivables are derived from a variety of customers spread across different geographic areas. 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, 2022, the Company has no t recorded any allowances for doubtful accounts receivable. As of December 31, 2022, there is $ 9.1 million of reserves for Variable Consideration recorded as an allowance against Accounts Receivable, net primarily due to Trade Discounts and Allowances and Chargebacks. |
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 average cost or estimated net realizable value. The remaining inventory associated with the Sunosi 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 product sales. 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. |
Cost of Product Sales | Cost of Product Sales The Company's cost of product sales relates to sales of Sunosi and Auvelity. 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. Cost of product sales were $ 5.2 million for the year ended December 31, 2022. There were no sales in 2021. The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals (“SK)” and Aerial Biopharma (“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. The Company pays a royalty to Antecip equal to 3.0 % of Auvelity net sales. |
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 the conduct of research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. We estimate research, preclinical and clinical study expenses based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on our behalf. We estimate these expenses based on 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, we will adjust the accrual 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. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. |
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 year ended December 31, 2022, advertising costs were $ 35.3 million. The Company did not have commercial products in 2021 and 2020. |
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 estimates an annual effective tax rate of 0 % for the year ending December 31, 2022 and has no t recorded an income tax benefit for the year ended December 31, 2022 and 2021 since it determined that a full valuation allowance is required against the Company’s deferred tax assets. 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. As of December 31, 2022, the Company does not believe any material uncertain tax positions are present. 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. For awards subject to service-based vesting conditions, the Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period, which is generally the vesting term. For awards subject to performance-based vesting conditions, the Company recognizes stock-based compensation expense using the accelerated attribution method when it is probable that the performance condition will be achieved. 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, and RSUs, 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 year ended December 31, 2022 and 2021. |
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 agreement contains 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 arrangement 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 implicit interest rate when readily determinable and uses the Company’s incremental borrowing rate when the implicit rate 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 minimum 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 Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers. At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 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 ASU for fiscal year ended December 31, 2022 and concluded it did not have a material impact on the Company's financial statements. See Note 3 - Business Combination for further information. |
Business Combination (Tables)
Business Combination (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combinations [Abstract] | |
Schedule of Preliminary Purchase Consideration | Preliminary purchase consideration consisted of the following: Cash at settlement $ 53,000,000 Fair value of contingent consideration 36,140,000 Total $ 89,140,000 |
Schedule of Preliminary Allocation of Fair Value | The preliminary allocation of the fair value of the Sunosi acquisition is shown in table below: Amounts Recognized as of Acquisition Date (as previously reported) Measurement Period Adjustments Purchase Price Allocation Inventory $ 10,601,000 $ — $ 10,601,000 Other current assets 3,551,000 1,587,000 (1) 5,138,000 Developed technology 63,800,000 — 63,800,000 Goodwill 11,897,000 ( 1,587,000 ) (1) 10,310,000 Accrued expenses and other current liabilities ( 709,000 ) — ( 709,000 ) Total $ 89,140,000 $ — $ 89,140,000 (1) The adjustment to goodwill resulted from rebates covered by Jazz during the post acquisition period which were provisionally recorded as an asset 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 $ 74,065,000 $ 51,670,000 Net Loss ( 211,571,000 ) ( 283,831,000 ) |
Goodwill (Tables)
Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill [Abstract] | |
Schedule of Goodwill | The following table provides the Company’s goodwill as of December 31, 2022. Goodwill Balance at December 31, 2021 $ — Goodwill from Sunosi Acquisition 11,897,000 Measurement period adjustment ( 1,587,000 ) Balance at December 31, 2022 $ 10,310,000 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Intangible Assets [Abstract] | |
Schedule of Net Book Value of our Intangible Asset | The gross carrying amount and net book value of the Company's intangible asset are as follows: Estimated fair value Remaining Weighted-Average Useful Life Balance at December 31, 2021 $ — Gross Carrying Amount 63,800,000 10 -years Accumulated Amortization ( 4,139,228 ) Net Book Value at December 31, 2022 $ 59,660,772 |
Schedule of Finite Lived Intangible Assets Future Amortization Expense | Based on finite-lived intangible assets recorded as of December 31, 2022, and assuming the underlying assets will not be impaired and that we will not change the expected lives of the assets, future amortization expenses were estimated as follows: Estimated Amortization Expense 2023 6,374,760 2024 6,392,226 2025 6,374,760 2026 6,374,760 Thereafter 34,144,266 Total $ 59,660,772 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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: May 9, 2022 Level 1 Level 2 Level 3 Total Liabilities: Contingent consideration $ — $ — $ 36,140,000 $ 36,140,000 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Contingent consideration $ — $ — $ 37,000,000 $ 37,000,000 Total $ — $ — $ 37,000,000 $ 37,000,000 |
Schedule of fair value of the contingent consideration remeasured | The fair value of the contingent consideration was remeasured at December 31, 2022. The fair value of the financial instruments as of December 31, 2022 is as follows: Contingent Consideration Balance at December 31, 2021 $ — Initial estimate (Level 3) 36,140,000 Loss in fair value of contingent consideration 3,298,230 Payments ( 2,438,230 ) Balance at December 31, 2022 (Level 3) $ 37,000,000 |
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, 2022 As of May 9, 2022 Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable) Weighted Average (range, if applicable) Contingent Consideration Probability weighted income approach Discount rate 12.0 % 11.7 % Revenue Required Metric Risk Premium rate 20.9 % 20.8 % |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consists of the following: December 31, Raw materials $ 2,473,058 Work in process 13,964,402 Finished goods 1,590,350 Total $ 18,027,810 |
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, Balance sheet classification Inventories, net $ 4,319,921 Non-current inventory and other assets 13,707,889 Total $ 18,027,810 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 2021 2020 Basic and diluted net loss per common share: Net loss $ ( 187,133,651 ) $ ( 130,402,992 ) $ ( 102,900,600 ) Weighted average common shares outstanding—basic and diluted 40,655,941 37,618,599 37,206,928 Net loss per common share—basic and diluted $ ( 4.60 ) $ ( 3.47 ) $ ( 2.77 ) |
Schedule of Potentially Dilutive Securities | The following potentially dilutive securities outstanding at December 31, 2022, 2021, and 2020 have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti‑dilutive: December 31, 2022 2021 2020 Stock options 6,617,728 5,090,377 3,733,916 Restricted stock units 686,375 326,625 136,067 Warrants 50,796 15,541 15,541 Total 7,354,899 5,432,543 3,885,524 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Schedule of Accrued Expenses | At December 31, 2022 and 2021, accrued expenses consisted of the following: December 31, December 31, Accrued research and development $ 4,714,388 $ 2,416,897 Accrued compensation 11,283,646 4,050,236 Accrued selling, general and administrative 6,596,409 2,442,700 Accrued sales discounts, rebates and allowances 26,544,510 — Accrued royalties 1,616,541 — Accrued interest 875,319 385,347 Total $ 51,630,813 $ 9,295,180 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
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 $ 95,000,000 $ 50,000,000 Add: accreted liability of final payment fee 1,362,733 706,407 Less: unamortized debt discount, long-term ( 2,103,845 ) ( 1,616,885 ) Less: current portion of long-term debt — — Loan payable, long-term $ 94,258,888 $ 49,089,522 | |
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, 2022 2021 2020 Interest Expense $ 8,176,264 $ 4,616,597 $ 2,362,083 Amortization of final payment fee 668,051 554,493 469,676 Amortization of debt discount related issuance costs and warrants 814,627 522,522 317,074 | |
Schedule of Principal Payments | Scheduled Principal Payments on Outstanding Debt, as of December 31, 2022, are as follows: 2022 — 2023 — 2024 — 2025 15,202,884 2026 79,797,116 Total principal payments outstanding $ 95,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease Expense | Year ended December 31, 2022 2021 2020 Total operating lease expense $ 1,207,837 $ 1,147,692 $ 47,821 |
Schedule of Future Minimum Lease Payments of Operating Leases | Future minimum lease payments of our operating leases as of December 31, 2022, were as follows: 2023 427,875 2024 — 2025 — Thereafter — Total lease payments 427,875 Less imputed interest ( 3,202 ) Present value of operating lease liabilities $ 424,673 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity as of December 31, 2022: Number Weighted Weighted Aggregate Outstanding at December 31, 2021 5,090,377 $ 28.89 Granted 2,222,866 38.62 Exercised ( 340,149 ) 18.38 Forfeited ( 317,942 ) 39.50 Expired ( 37,424 ) 54.76 Outstanding at December 31, 2022 6,617,728 $ 31.80 7.3 $ 300,653,467 Vested and expected to vest at December 31, 2022 6,617,728 $ 31.80 7.3 $ 300,653,467 Exercisable at December 31, 2022 3,470,813 $ 21.43 5.8 $ 193,768,216 |
Summary of Black-Scholes Option Valuation Assumptions | The relevant data used to determine the value of the stock option grants for the years ended December 31, 2022, 2021, and 2020 is as follows: Black-Scholes option valuation assumptions 2022 2021 2020 Risk-free interest rates 1.46 - 4.31 % 0.63 - 1.47 % 0.3 - 1.7 % Dividend yield — — — Volatility 90 - 95 % 89 - 93 % 67 - 99 % Weighted average expected term 5.0 - 6.11 years 5.0 - 6.17 years 3.51 - 6.14 years |
Schedule of RSU Activity | The following table sets forth the RSU activity for the year ended December 31, 2022: Number Weighted Outstanding at December 31, 2021 302,764 $ 42.93 Granted 533,134 27.18 Vested ( 81,639 ) 42.49 Forfeited ( 67,884 ) 30.20 Outstanding at December 31, 2022 686,375 $ 31.80 |
Schedule of Stock-Based Compensation Expense Recognized | Stock‑based compensation expense recognized for the years ended December 31, 2022, 2021, and 2020 was as follows: Year ended December 31, 2022 2021 2020 Research and development $ 8,604,408 $ 7,456,049 $ 3,953,939 Selling, general and administrative 29,121,750 13,345,331 10,802,267 Total $ 37,726,158 $ 20,801,380 $ 14,756,206 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Class of Warrant or Right [Line Items] | |
Schedule of Warrant Activity | The following table summarizes warrant activity as of December 31, 2022, 2021, and 2020: Warrants Weighted average Outstanding at December 31, 2019 69,656 $ 7.21 Issued 15,541 80.43 Exercised ( 69,656 ) 7.21 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 |
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, 2022 As of May 9, 2022 Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable) Weighted Average (range, if applicable) Contingent Consideration Probability weighted income approach Discount rate 12.0 % 11.7 % Revenue Required Metric Risk Premium rate 20.9 % 20.8 % |
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 the warrants was estimated using the Black‑Scholes option pricing model with the following assumptions: Black-Scholes option valuation assumptions 2022 2020 2019 2018 2016 Risk-free interest rate 3.1 % 0.5 % 2.8 % 3.0 % 1.8 % Dividend yield — — — — — Volatility 94 % 88 % 97 % 85 % 73 % Weighted average contractual term 7 years 7 years 7 years 7 years 7 years |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022 December 31, 2021 Deferred tax assets: Net federal operating loss carryforward $ 96,156,250 $ 76,470,431 Net foreign operating loss carryforward 2,794,785 88,480 Net state operating loss carryforward 32,029,378 47,672,157 Non-cash compensation 11,027,745 13,228,425 Research and development credits 15,015,642 14,455,797 Interest Expense 318,798 4,117,655 Intangible Assets 10,422,110 — Accrued expenses 2,113,054 1,479,728 Section 174 Capitalization 14,540,848 — Other 109,988 219,760 Deferred tax asset, excluding valuation allowance 184,528,598 157,732,433 Deferred tax liabilities: Lease Asset ( 104,001 ) ( 224,958 ) Deferred tax liability, excluding valuation allowance ( 104,001 ) ( 224,958 ) Less valuation allowance ( 184,424,597 ) ( 157,507,475 ) Net deferred tax assets $ — $ — |
Schedule of Income Tax Rate Reconciliation | A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements is as follows: December 31, 2022 December 31, 2021 December 31, 2020 U.S. federal statutory income tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 4.5 14.0 13.7 Foreign Rate Differential 1.2 — — Stock based compensation - Excess tax benefit 1.0 1.8 1.8 Other permanent differences ( 0.3 ) ( 0.1 ) ( 0.6 ) Tax credit ( 0.6 ) 1.3 2.5 Deferred tax adjustment ( 2.9 ) — — Change in valuation allowance ( 23.9 ) ( 38.0 ) ( 38.4 ) Effective tax rate — % — % — % |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Details) | Dec. 31, 2022 USD ($) Product | Dec. 31, 2021 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of not yet approved product candidates | 3 | |
Number of approved products | 2 | |
Accumulated deficit | $ | $ (596,332,736) | $ (409,199,085) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |||
Mar. 25, 2022 USD ($) Market | Dec. 31, 2022 USD ($) Institution ReportingUnits Segment Market | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Segment and Geographic Information | ||||
Number of operating segments | Segment | 1 | |||
Revenue Recognition | ||||
Product sales, net | $ 50,037,106 | |||
Cash Equivalents | ||||
Cash Equivalents | $ 200,800,000 | |||
Concentration of Credit Risk | ||||
Number of financial institutions that hold the Company's cash | Institution | 1 | |||
Business Combination | ||||
Intangible assets, Estimated period of benefit | 10 years | |||
Number of reporting units | ReportingUnits | 1 | |||
Accounts Receivable, net | ||||
Accounts receivable, Allowance for credit loss | $ 0 | |||
Accounts receivable, reserves for variable consideration | $ 9,100,000 | |||
Equipment, net | ||||
Estimated useful life | 3 years | |||
Cost of Product Sales | ||||
Cost of product sales | $ 5,200,000 | |||
Payment terms | 90 days or less | |||
Sales | $ 0 | |||
Advertising costs | $ 35,300,000 | |||
Income Taxes | ||||
Effective tax rate | 0% | |||
Income tax benefit | $ 0 | $ 0 | $ 0 | |
Ex-U.S. Markets | ||||
Cost of Product Sales | ||||
Sales | 900,000 | |||
Sunosi | ||||
Revenue Recognition | ||||
Product sales, net | 44,800,000 | |||
Cost of Product Sales | ||||
Sales | $ 44,800,000 | |||
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 | ||||
Business Combination | ||||
Intangible assets, Estimated period of benefit | 10 years | |||
Cost of Product Sales | ||||
Number of Asian markets | Market | 12 | |||
Auvelity | ||||
Cost of Product Sales | ||||
Sales | $ 5,200,000 | |||
License agreement royalty as a percent of net sales | 3% |
Business Combination - Addition
Business Combination - Additional Information (Details) | 12 Months Ended | |||
Mar. 25, 2022 USD ($) Market | Dec. 31, 2022 USD ($) Market | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Business Acquisition [Line Items] | ||||
Product sales | $ 50,037,106 | |||
Type of Revenue [Extensible List] | us-gaap:ProductMember | |||
Net loss | $ (187,133,651) | $ (130,402,992) | $ (102,900,600) | |
Intangible assets, Estimated period of benefit | 10 years | |||
Goodwill | $ 10,310,000 | |||
Hercules Capital Inc | Term Loan | ||||
Business Acquisition [Line Items] | ||||
Line of credit | $ 300,000,000 | |||
Selling General And Administrative Expenses | ||||
Business Acquisition [Line Items] | ||||
Business combination, transaction costs | $ 500,000 | |||
Sunosi | ||||
Business Acquisition [Line Items] | ||||
Number of Asian markets | Market | 12 | |||
Revenue milestones | 165,000,000 | $ 165,000,000 | ||
Development milestones | 1,000,000 | 1,000,000 | ||
Product sales | $ 44,800,000 | |||
Type of Revenue [Extensible List] | us-gaap:ProductMember | |||
Net loss | $ 13,100,000 | |||
Inventory step-up fair value | 1,100,000 | 1,000,000 | ||
Goodwill | $ 10,300,000 | |||
Jazz Pharmaceuticals Plc | ||||
Business Acquisition [Line Items] | ||||
Business combination purchase price allocated to goodwill deductible in number of years | 15 years | |||
Jazz Pharmaceuticals Plc | Sunosi | ||||
Business Acquisition [Line Items] | ||||
Upfront payment | $ 53,000,000 | |||
Number of Asian markets | Market | 12 | |||
Intangible assets, Estimated period of benefit | 10 years | |||
Goodwill | $ 10,310,000 | $ 10,300,000 | ||
Jazz Pharmaceuticals Plc | Sunosi | 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 Preliminary purchase consideration (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Business Acquisition [Line Items] | |
Cash at settlement | $ 53,000,000 |
Jazz Pharmaceuticals Plc [Member] | Sunosi | |
Business Acquisition [Line Items] | |
Cash at settlement | 53,000,000 |
Fair value of contingent consideration | 36,140,000 |
Total | $ 89,140,000 |
Business Combination - Schedu_2
Business Combination - Schedule of Preliminary Allocation of the Fair Value (Details) - USD ($) | Dec. 31, 2022 | Mar. 25, 2022 |
Business Acquisition [Line Items] | ||
Goodwill | $ 10,310,000 | |
Sunosi | ||
Business Acquisition [Line Items] | ||
Goodwill | 10,300,000 | |
Jazz Pharmaceuticals Plc | Sunosi | ||
Business Acquisition [Line Items] | ||
Inventory | $ 10,601,000 | |
Other current assets | 5,138,000 | |
Developed technology | 63,800,000 | |
Goodwill | $ 10,300,000 | 10,310,000 |
Accrued expenses and other current liabilities | (709,000) | |
Total | 89,140,000 | |
Jazz Pharmaceuticals Plc | Sunosi | Previoiusly Reported | ||
Business Acquisition [Line Items] | ||
Inventory | 10,601,000 | |
Other current assets | 3,551,000 | |
Developed technology | 63,800,000 | |
Goodwill | 11,897,000 | |
Accrued expenses and other current liabilities | (709,000) | |
Total | 89,140,000 | |
Jazz Pharmaceuticals Plc | Sunosi | Measurement Period Adjustments | ||
Business Acquisition [Line Items] | ||
Other current assets | 1,587,000 | |
Goodwill | $ (1,587,000) |
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 | $ 51,670,000 | $ 74,065,000 |
Net Loss | $ (283,831,000) | $ (211,571,000) |
Goodwill - Additional Informati
Goodwill - Additional Information (Details) | Dec. 31, 2022 USD ($) |
Goodwill [Line Items] | |
Goodwill | $ 10,310,000 |
Sunosi | |
Goodwill [Line Items] | |
Goodwill | $ 10,300,000 |
Goodwill - Schedule of Goodwill
Goodwill - Schedule of Goodwill (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Goodwill [Abstract] | |
Goodwill from Sunosi Acquisition | $ 11,897,000 |
Measurement period adjustment | (1,587,000) |
Goodwill, Ending Balance | $ 10,310,000 |
Intangible Asset - Schedule of
Intangible Asset - Schedule of Net Book Value of our Intangible Asset (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Intangible Assets [Abstract] | |
Gross Carrying Amount | $ 63,800,000 |
Accumulated Amortization | (4,139,228) |
Net Book Value at December 31, 2022 | $ 59,660,772 |
Remaining Weighted-Average Useful Life | 10 years |
Intangible Asset - Schedule o_2
Intangible Asset - Schedule of Finite Lived Intangible Assets Future Amortization Expense (Details) | Dec. 31, 2022 USD ($) |
Intangible Assets [Abstract] | |
2023 | $ 6,374,760 |
2024 | 6,392,226 |
2025 | 6,374,760 |
2026 | 6,374,760 |
Thereafter | 34,144,266 |
Total | $ 59,660,772 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Dec. 31, 2022 USD ($) |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Accrued contingent consideration, current | $ 5,900,000 |
Contingent consideration liability, non-current | 31,100,000 |
Fair value of contingent consideration | 37,000,000 |
Maximum | Discount Rate Increases or Decreases by Approximately 1% | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of contingent consideration | 38,800,000 |
Maximum | Revenue Discount Rate Increases or Decreases by Approximately 1% | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of contingent consideration | 38,300,000 |
Minimum | Discount Rate Increases or Decreases by Approximately 1% | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of contingent consideration | 35,300,000 |
Minimum | Revenue Discount Rate Increases or Decreases by Approximately 1% | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of contingent consideration | 35,800,000 |
Sunosi | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Accrued contingent consideration, current | 5,900,000 |
Contingent consideration liability, non-current | $ 31,100,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Of Financial Instruments Measured On Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) | Dec. 31, 2022 | May 09, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | $ 37,000,000 | |
Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | 37,000,000 | $ 36,140,000 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 37,000,000 | |
Level 3 | Contingent consideration | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Contingent consideration | $ 37,000,000 | $ 36,140,000 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule Of Fair Value Of The Contingent Consideration Remeasured (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Abstract] | |
Initial estimate (Level 3) | $ 36,140,000 |
Loss in fair value of contingent consideration | 3,298,230 |
Payments | (2,438,230) |
Ending Balance (Level 3) | $ 37,000,000 |
Fair Value Measurements - Sch_3
Fair Value Measurements - Schedule Of Fair Value Measurements Of Contingent Consideration Recurring Include Significant Unobservable Inputs (Details) - Probability weighted income approach - Contingent consideration - Level 3 | Dec. 31, 2022 | May 09, 2022 |
Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.120 | 0.117 |
Revenue Required Metric Risk Premium rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration, measurement input | 0.209 | 0.208 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) | Dec. 31, 2022 USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials | $ 2,473,058 |
Work in process | 13,964,402 |
Finished goods | 1,590,350 |
Total | $ 18,027,810 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | Dec. 31, 2022 | Mar. 25, 2022 |
Inventory [Line Items] | ||
Inventory reserves | $ 0 | |
Sunosi | ||
Inventory [Line Items] | ||
Inventory step-up fair value | $ 1,000,000 | $ 1,100,000 |
Inventory - Summary of Balance
Inventory - Summary of Balance Sheet Classification of Inventory (Details) | Dec. 31, 2022 USD ($) |
Inventory Disclosure [Abstract] | |
Inventories, net | $ 4,319,921 |
Non-current inventory and other assets | 13,707,889 |
Total | $ 18,027,810 |
Net Loss per Common Share - Com
Net Loss per Common Share - Computation of Basic and Diluted Net Loss per Common Share (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (187,133,651) | $ (130,402,992) | $ (102,900,600) |
Weighted average common shares outstanding, basic | 40,655,941 | 37,618,599 | 37,206,928 |
Weighted average common shares outstanding, diluted | 40,655,941 | 37,618,599 | 37,206,928 |
Net loss per common share, basic | $ (4.60) | $ (3.47) | $ (2.77) |
Net loss per common share, diluted | $ (4.60) | $ (3.47) | $ (2.77) |
Net Loss per Common Share - Pot
Net Loss per Common Share - Potentially Dilutive Securities Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 7,354,899 | 5,432,543 | 3,885,524 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 6,617,728 | 5,090,377 | 3,733,916 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 686,375 | 326,625 | 136,067 |
Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities | 50,796 | 15,541 | 15,541 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued research and development | $ 4,714,388 | $ 2,416,897 |
Accrued compensation | 11,283,646 | 4,050,236 |
Accrued selling, general and administrative | 6,596,409 | 2,442,700 |
Accrued sales discounts, rebates and allowances | 26,544,510 | |
Accrued royalties | 1,616,541 | |
Accrued Interest | 875,319 | 385,347 |
Total | $ 51,630,813 | $ 9,295,180 |
Loan and Security Agreement - A
Loan and Security Agreement - Additional Information (Details) - USD ($) | 12 Months Ended | |||||||
Jan. 31, 2023 | Oct. 14, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 09, 2023 | Mar. 27, 2022 | Mar. 31, 2019 | |
Line Of Credit Facility [Line Items] | ||||||||
Loss on extinguishment of debt | $ 1,247,012 | |||||||
Interest expense | $ 8,176,264 | $ 4,616,597 | 2,362,083 | |||||
Amortization of debt issuance costs | 668,051 | 554,493 | 469,676 | |||||
Amortization of debt discount | 1,482,678 | 1,077,015 | 786,750 | |||||
Third Amendment To Loan and Security Agreement | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 350,000,000 | |||||||
Warrants | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Amortization of debt discount | 814,627 | $ 522,522 | $ 317,074 | |||||
Hercules Capital Inc | Term Loan | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 350,000,000 | $ 350,000,000 | ||||||
Hercules Capital Inc | Third Amendment To Loan and Security Agreement | Term Loan | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 55,000,000 | $ 55,000,000 | ||||||
Prepayment Occurs Prior to First Anniversary of Closing Date | Third Amendment To Loan and Security Agreement | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 300,000,000 | |||||||
Term Loan 2020 | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Debt instrument maturity, month and year | 2026-10 | |||||||
Base interest rate | 8.95% | |||||||
Final payment fee | $ 2,910,000 | |||||||
Percentage of final payment fee | 4.50% | |||||||
Minimum different from remaining percentage of cash flow | 10% | |||||||
Term Loan 2020 | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Base interest rate | 9.95% | |||||||
Increase in minimum cash requirement amount | $ 30,000,000 | |||||||
Percentage of facility fee to be paid | 0.75% | |||||||
Term Loan 2020 | Prime Rate | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Interest rate basis | 5.70% | |||||||
Term Loan 2020 | Prime Rate | Subsequent Event | ||||||||
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 | 10.70% | |||||||
Term Loan 2020 | Prime Rate | Maximum | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Interest rate basis | 10.70% | |||||||
Term Loan 2020 | Hercules Capital Inc | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 300,000,000 | |||||||
Term Loan 2020 | Prepayment Occurs Prior to First Anniversary of Closing Date | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Percentage of prepayment penalty | 2% | |||||||
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 | $ 40,000,000 | |||||||
Period of unpaid invoices amount maintain as security | 180 days | |||||||
Long term debt upon milestone achievement amount | $ 25,000,000 | |||||||
Long term debt increase decrease threshold amount | 40,000,000 | |||||||
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 | $ 1,000,000,000 | |||||||
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 | 85% | |||||||
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 on or After First Anniversary and Prior to Second Anniversary of the Closing Date | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Percentage of prepayment penalty | 1.50% | |||||||
Term Loan 2020 | Prepayment Occurs on or After Second Anniversary and Prior to Third Anniversary of Closing Date | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Percentage of prepayment penalty | 1% | |||||||
Tranche One | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 95,000,000 | |||||||
2020 Warrants | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 60,000,000 | |||||||
Remaining credit facility to be drawn | $ 95,000,000 | |||||||
2020 Warrants | Second Amendment To Loan and Security Agreement | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 45,000,000 | |||||||
Term loan 2020 tranche two | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 100,000,000 | |||||||
Term loan 2020 tranche three | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 20,000,000 | |||||||
Term loan 2020 tranche four | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 55,000,000 | 50,000,000 | ||||||
Term loan 2020 tranche five | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Remaining credit facility to be drawn | $ 75,000,000 | |||||||
2019 Term Loan | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 24,000,000 | |||||||
Tranche One Sub-Tranche One | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 95,000,000 | |||||||
Tranche One Sub Tranche Two | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 55,000,000 | |||||||
Tranche One Sub Tranche Three | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 30,000,000 | |||||||
Tranche One Sub Tranche Four | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche One Sub Tranche Five | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche Two Sub Tranche One | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche Two Sub Tranche One | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche Two Sub-Tranche Two | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche Two Sub-Tranche Two | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 35,000,000 | |||||||
Tranche Two Sub-Tranche Three | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 30,000,000 | |||||||
Tranche Two Sub-Tranche Three | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 30,000,000 | |||||||
Tranche Three Sub Tranche One | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 15,000,000 | |||||||
Tranche Three Sub Tranche One | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 15,000,000 | |||||||
Tranche Three Sub Tranche Two | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 5,000,000 | |||||||
Tranche Three Sub Tranche Two | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 5,000,000 | |||||||
Tranche Two Sub Tranches To One Tranche | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | 25,000,000 | |||||||
Tranche Three Sub Tranches to One Tranche | Subsequent Event | ||||||||
Line Of Credit Facility [Line Items] | ||||||||
Maximum loan amount | $ 75,000,000 |
Loan and Security Agreement - S
Loan and Security Agreement - Schedule of Outstanding Debt and Unamortized Debt Discount Balances (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Total Outstanding Debt | $ 95,000,000 | $ 50,000,000 |
Add: accreted liability of final payment fee | 1,362,733 | 706,407 |
Less: unamortized debt discount, long term | (2,103,845) | (1,616,885) |
Loan payable, long-term | $ 94,258,888 | $ 49,089,522 |
Loan and Security Agreement -_2
Loan and Security Agreement - Schedule of debt approximates its fair value given its variable interest rate (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Line of Credit Facility [Line Items] | |||
Interest expense | $ 8,176,264 | $ 4,616,597 | $ 2,362,083 |
Amortization of final payment fee | 668,051 | 554,493 | 469,676 |
Amortization of debt discount related issuance costs and warrants | 1,482,678 | 1,077,015 | 786,750 |
Warrants | |||
Line of Credit Facility [Line Items] | |||
Amortization of debt discount related issuance costs and warrants | $ 814,627 | $ 522,522 | $ 317,074 |
Loan and Security Agreement -_3
Loan and Security Agreement - Schedule of Principal Payments (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2025 | $ 15,202,884 | |
2026 | 79,797,116 | |
Total principal payments outstanding | $ 95,000,000 | $ 50,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Contingencies [Line Items] | ||||
Lease commencement date | Aug. 01, 2020 | |||
Lessee, operating lease, description | The Company entered into a lease for office space at 22 Cortlandt St, New York, NY consisting of the 16th floor effective August 1, 2020. In August 2022, the Company entered into an agreement to extend the lease of 22 Cortlandt Street through April 30, 2023. | |||
Lessee, operating lease, existence of option to extend [true false] | true | |||
Lessee, operating lease, option to extend | extend the lease of 22 Cortlandt Street through April 30, 2023 | |||
Rent expense | $ 1,255,165 | $ 1,175,139 | $ 870,275 | |
Operating lease, remaining lease term | 3 months 18 days | |||
Operating lease, discount rate | 6% | |||
Forecast | ||||
Loss Contingencies [Line Items] | ||||
Lessee, Operating Lease, Lease Not yet Commenced, Commencement Date | 2023-03 | |||
Maximum | ||||
Loss Contingencies [Line Items] | ||||
Lease term | 12 months |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Operating Lease Expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Contingencies [Line Items] | |||
Total operating lease expense | $ 1,207,837 | $ 1,147,692 | $ 47,821 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Lease Payments of Operating Leases (Details) | Dec. 31, 2022 USD ($) |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | |
2023 | $ 427,875 |
Total lease payments | 427,875 |
Less imputed interest | (3,202) |
Present value of operating lease liabilities | $ 424,673 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Dec. 02, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Aug. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | Nov. 30, 2020 shares | Jun. 30, 2020 USD ($) shares | Dec. 31, 2019 USD ($) $ / shares | Dec. 31, 2022 USD ($) Vote $ / shares shares | Dec. 31, 2021 USD ($) $ / shares | Dec. 31, 2020 USD ($) $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 46.75 | $ 7.21 | $ 46.75 | $ 80.43 | $ 80.43 | |||||
Common stock, voting right per share | Vote | 1 | |||||||||
Stock-based compensation expense | $ 37,726,158 | $ 20,801,380 | $ 14,756,206 | |||||||
Stock option to purchase shares of common stock cancelled | shares | 317,942 | |||||||||
Weighted average grant date fair value | $ / shares | $ 28.18 | $ 39.64 | $ 36.77 | |||||||
Unrecognized compensation cost related to non-vested stock options expected to be recognized | $ 95,700,000 | $ 95,700,000 | ||||||||
Expected vesting period for non-vested share-based compensation | 2 years 10 months 24 days | |||||||||
Non-vested options outstanding | shares | 6,169 | 6,169 | ||||||||
Intrinsic value of stock options exercised | $ 13,200,000 | $ 13,200,000 | $ 13,500,000 | $ 9,400,000 | ||||||
Stock Options | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Stock option to purchase shares of common stock cancelled | shares | 38,267 | |||||||||
Non-cash stock-based compensation expense related to plan cancelled | 2,100,000 | |||||||||
Restricted Stock Units | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Non-cash stock-based compensation expense related to plan cancelled | $ 500,000 | |||||||||
Stock option to purchase shares of common stock cancelled | shares | 11,735 | |||||||||
Vesting period | 4 years | |||||||||
Compensation cost not yet recognized related to unvested RSUs | 17,500,000 | $ 17,500,000 | ||||||||
Weighted average contractual term | 10 months 24 days | |||||||||
Intrinsic value lapsed | $ 1,500,000 | $ 1,500,000 | $ 400,000 | |||||||
Director | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Vesting of stock options | shares | 21,666 | |||||||||
Stock-based compensation expense | $ 1,300,000 | |||||||||
2013 Plan | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Shares available for future grant | shares | 0 | 0 | ||||||||
2015 Plan | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Shares available for future grant | shares | 2,944,176 | 2,944,176 | ||||||||
2022 Shelf Registration | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Share issued, value | $ 0 | |||||||||
Proceeds from issuance of common stock, gross | $ 0 | |||||||||
SVB Securities | December 2019 Sales Agreement | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Common stock sales agreement, commission percentage | 3% | |||||||||
SVB Securities | December 2019, August 222 and March 2022 Sales Agreement | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Share issued, value | $ 238,800,000 | |||||||||
Shares issued | shares | 5,167,973 | |||||||||
Proceeds from issuance of common stock, gross | $ 238,800,000 | |||||||||
Proceeds from issuance of common stock, net | $ 231,800,000 | |||||||||
SVB Securities | March 2022 Sales Agreement | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Common stock sales agreement, authorized amount | $ 250,000,000 | |||||||||
SVB Securities | Maximum | December 2019 Sales Agreement | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Common stock sales agreement, authorized amount | $ 80,000,000 | |||||||||
SVB Securities | Maximum | 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 | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Shares issued | shares | 152,487 | |||||||||
Share Price | $ / shares | $ 32.79 | $ 32.79 | ||||||||
Proceeds from issuance of common stock, net | $ 5,000,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Number of shares | |
Number of shares, Outstanding, beginning balance | shares | 5,090,377 |
Number of shares, Granted | shares | 2,222,866 |
Number of shares, Exercised | shares | (340,149) |
Number of shares, Forfeited | shares | (317,942) |
Number of shares, Expired | shares | (37,424) |
Number of shares, Outstanding, ending balance | shares | 6,617,728 |
Number of shares, Vested and expected to vest | shares | 6,617,728 |
Number of shares, Exercisable | shares | 3,470,813 |
Weighted average exercise price | |
Weighted average exercise price, Outstanding, beginning balance | $ / shares | $ 28.89 |
Weighted average exercise price, Granted | $ / shares | 38.62 |
Weighted average exercise price, Exercised | $ / shares | 18.38 |
Weighted average exercise price, Forfeited | $ / shares | 39.50 |
Weighted average exercise price, Expired | $ / shares | 54.76 |
Weighted average exercise price, Outstanding, ending balance | $ / shares | 31.80 |
Weighted average exercise price, Vested and expected to vest | $ / shares | 31.80 |
Weighted average exercise price, Exercisable | $ / shares | $ 21.43 |
Weighted average contractual term | |
Weighted average contractual term, Outstanding | 7 years 3 months 18 days |
Weighted average contractual term, Vested and expected to vest | 7 years 3 months 18 days |
Weighted average contractual term, Exercisable | 5 years 9 months 18 days |
Aggregate intrinsic value | |
Aggregate intrinsic value, Outstanding | $ | $ 300,653,467 |
Aggregate intrinsic value, Vested and expected to vest | $ | 300,653,467 |
Aggregate intrinsic value, Exercisable | $ | $ 193,768,216 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Black-Scholes Option Valuation Assumptions (Details) - Stock Options | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Black-Scholes option valuation assumptions | |||
Risk-free interest rate, minimum | 1.46% | 0.63% | 0.30% |
Risk-free interest rate, maximum | 4.31% | 1.47% | 1.70% |
Volatility, minimum | 90% | 89% | 67% |
Volatility, maximum | 95% | 93% | 99% |
Minimum | |||
Black-Scholes option valuation assumptions | |||
Weighted average expected term | 5 years | 5 years | 3 years 6 months 3 days |
Maximum | |||
Black-Scholes option valuation assumptions | |||
Weighted average expected term | 6 years 1 month 9 days | 6 years 2 months 1 day | 6 years 1 month 20 days |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of RSU Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Number of shares | |
Number of shares, Outstanding, beginning balance | shares | 302,764 |
Number of shares, Granted | shares | 533,134 |
Number of shares, Vested | shares | (81,639) |
Number of shares, Forfeited | shares | (67,884) |
Number of shares, Outstanding, ending balance | shares | 686,375 |
Weighted average grant date fair value | |
Weighted average grant date fair value, Outstanding, beginning balance | $ / shares | $ 42.93 |
Weighted average grant date fair value, Granted | $ / shares | 27.18 |
Weighted average grant date fair value, Vested | $ / shares | 42.49 |
Weighted average grant date fair value, Forfeited | $ / shares | 30.20 |
Weighted average grant date fair value, Outstanding, ending balance | $ / shares | $ 31.80 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Stock-Based Compensation Expense Recognized (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 37,726,158 | $ 20,801,380 | $ 14,756,206 |
Research and Development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 8,604,408 | 7,456,049 | 3,953,939 |
Selling General and Administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 29,121,750 | $ 13,345,331 | $ 10,802,267 |
Warrants - Additional Informati
Warrants - Additional Information (Details) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Dec. 31, 2022 USD ($) Days $ / shares shares | Dec. 31, 2020 $ / shares shares | Dec. 31, 2021 $ / shares shares | Dec. 31, 2019 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | ||||
Warrants outstanding | shares | 50,796 | 15,541 | 15,541 | 69,656 |
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||
Exercise price of warrants (in dollars per share) | $ / shares | $ 46.75 | $ 80.43 | $ 80.43 | $ 7.21 |
Warrants exercised | shares | 69,656 | |||
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) | $ / shares | $ 80.43 | |||
Trading days | Days | 10 | |||
Term of warrants (in years) | 7 years | |||
Fair value | $ | $ 0.9 | |||
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) | $ / shares | $ 31.91 | |||
Trading days | Days | 10 | |||
Term of warrants (in years) | 7 years | |||
Fair value | $ | $ 0.8 |
Warrants - Schedule of Warrant
Warrants - Schedule of Warrant Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2020 | |
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants outstanding beginning balance | 15,541 | 69,656 |
Issued | 35,255 | 15,541 |
Exercised | (69,656) | |
Warrants outstanding ending balance | 50,796 | 15,541 |
Weighted average exercise price, Beginning balance | $ 80.43 | $ 7.21 |
Issued | 31.91 | 80.43 |
Exercised | 7.21 | |
Weighted average exercise price, Ending balance | $ 46.75 | $ 80.43 |
Warrants - Summary of Initial F
Warrants - Summary of Initial Fair Value of Warrants Estimated using Black - Scholes Option Pricing Model (Details) | Dec. 31, 2022 |
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 |
2019 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
2018 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
2016 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrant term | 7 years |
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 |
Risk Free Interest Rate | 2019 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.028 |
Risk Free Interest Rate | 2018 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.030 |
Risk Free Interest Rate | 2016 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.018 |
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 |
Volatility | 2019 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.97 |
Volatility | 2018 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.85 |
Volatility | 2016 Warrants | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Warrants and Rights Outstanding, Measurement Input | 0.73 |
License Agreements - Additional
License Agreements - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Jan. 31, 2020 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2022 USD ($) Item shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | 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 | 43,498,617 | 43,498,617 | 37,816,794 | ||||
Value of common stock | $ 4,350 | $ 4,350 | $ 3,782 | ||||
Research and development expense recognized | $ 57,947,447 | $ 58,060,725 | $ 70,244,579 | ||||
License Agreement | Antecip | |||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | |||||||
Number of exclusive license agreements | Item | 3 | 3 | |||||
License agreement royalty as a percent of net sales | 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% | 3% | |||||
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 | $ 97.538 | ||||||
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 | $ 323,000,000 | |||||
Milestone payments or royalties | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | |||
NOL carryforwards | $ 458,000,000 | ||
Foreign NOL carryforwards | 7,800,000 | ||
Increase in valuation allowance | 26,900,000 | $ 49,600,000 | $ 39,700,000 |
Income tax expense (benefit) | $ 0 | 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 | $ 398,000,000 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net federal operating loss carryforward | $ 96,156,250 | $ 76,470,431 |
Net foreign operating loss carryforward | 2,794,785 | 88,480 |
Net state operating loss carryforward | 32,029,378 | 47,672,157 |
Non-cash compensation | 11,027,745 | 13,228,425 |
Research and development credits | 15,015,642 | 14,455,797 |
Interest Expense | 318,798 | 4,117,655 |
Intangible Assets | 10,422,110 | |
Accrued expenses | 2,113,054 | 1,479,728 |
Setion 174 Capitlization | 14,540,848 | |
Other | 109,988 | 219,760 |
Deferred tax asset, excluding valuation allowance | 184,528,598 | 157,732,433 |
Deferred tax liabilities: | ||
Lease Asset | (104,001) | (224,958) |
Deferred tax liability, excluding valuation allowance | (104,001) | (224,958) |
Less valuation allowance | $ (184,424,597) | $ (157,507,475) |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
U.S. federal statutory income tax rate | 21% | 21% | 21% |
State taxes, net of federal benefit | 4.50% | 14% | 13.70% |
Foreign Rate Differential | 1.20% | ||
Stock based compensation - Excess tax benefit | 1% | 1.80% | 1.80% |
Other permanent differences | (0.30%) | (0.10%) | (0.60%) |
Tax credit | (0.60%) | 1.30% | 2.50% |
Deferred tax adjustment | (2.90%) | ||
Change in valuation allowance | (23.90%) | (38.00%) | (38.40%) |
Effective tax rate | 0% |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Jan. 31, 2012 shares | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) Item | Dec. 31, 2012 Item | |
Antecip | ||||
Related Party Transaction [Line Items] | ||||
Shares issued | shares | 7,344,500 | |||
Antecip | License Agreement | ||||
Related Party Transaction [Line Items] | ||||
Accrued royalty payments | $ | $ 0.2 | $ 0.2 | ||
License agreement royalty as a percent of net sales | 3% | |||
Number of exclusive license agreements | Item | 3 | 3 | ||
Minimum | Dr. Tabuteau | ||||
Related Party Transaction [Line Items] | ||||
Beneficial ownership percentage | 5% | 5% |
Royalty Agreements - Additional
Royalty Agreements - Additional Information (Details) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 25, 2022 USD ($) | Dec. 31, 2022 | Dec. 31, 2022 USD ($) Market | Dec. 31, 2012 | |
License Agreement | Antecip | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
License agreement royalty as a percent of net sales | 3% | |||
AXS-05 | License Agreement | Antecip | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
License agreement royalty as a percent of net sales | 3% | 3% | ||
Sunosi | ||||
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 |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) € in Millions | Feb. 21, 2023 USD ($) | Feb. 21, 2023 EUR (€) | Jan. 31, 2023 USD ($) | Jan. 09, 2023 USD ($) | Oct. 14, 2021 USD ($) |
Term Loan 2020 | Hercules Capital Inc | |||||
Subsequent Event [Line Items] | |||||
Maximum loan amount | $ 300,000,000 | ||||
Subsequent Event | Hercules Capital Inc | Term Loan | |||||
Subsequent Event [Line Items] | |||||
Maximum loan amount | $ 350,000,000 | $ 350,000,000 | |||
Subsequent Event | Third Amendment To Loan and Security Agreement | |||||
Subsequent Event [Line Items] | |||||
Maximum loan amount | 350,000,000 | ||||
Subsequent Event | Third Amendment To Loan and Security Agreement | Hercules Capital Inc | Term Loan | |||||
Subsequent Event [Line Items] | |||||
Maximum loan amount | $ 55,000,000 | $ 55,000,000 | |||
License Agreement | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
upfront payment received | $ 66,200,000 | € 62 | |||
Eligible to receive sales-based and other milestones | $ 101,100,000 | € 94.5 |