Skip to main content

Axsome Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 10, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 10, 2026

AXSM$133.96+1.2%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Item 1. Financial Statements

Consolidated Balance Sheets

June 30,2026December 31,2025
(Unaudited)
Assets
Current assets:
Cash and cash equivalents$319,850$322,933
Accounts receivable, net277,459224,464
Inventories, net37,88327,938
Prepaid and other current assets21,37713,651
Total current assets656,569588,986
Equipment, net874562
Right-of-use asset - operating lease19,15720,858
Goodwill12,04212,042
Intangible asset, net37,35840,519
Non-current inventory and other assets35,44726,838
Total assets$761,447$689,805
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable$78,969$65,537
Accrued expenses and other current liabilities299,632232,853
Operating lease liability, current portion646434
Contingent consideration, current11,19910,012
Short-term borrowings70,00070,000
Total current liabilities460,446378,836
Contingent consideration, non-current69,13577,540
Loan payable, long-term117,958117,746
Operating lease liability, long-term21,57423,182
Finance lease liability, long-term9,0304,206
Total liabilities678,143601,510
Stockholders’ equity:
Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding)——
Common stock, $0.0001 par value per share (150,000,000 shares authorized, 52,299,889 and 50,882,766 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively)55
Additional paid-in capital1,505,1161,394,251
Accumulated deficit(1,421,817)(1,305,961)
Total stockholders’ equity83,30488,295
Total liabilities and stockholders’ equity$761,447$689,805

Consolidated Statements of Operations (Unaudited)

Three months ended June 30,Six months ended June 30,
2026202520262025
Revenues:
Product sales, net$216,355$148,959$405,755$269,317
Royalty revenue and milestone revenue2,0201,0833,8232,188
Total revenues218,375150,042409,578271,505
Operating expenses:
Cost of revenue (excluding amortization and depreciation)13,56413,44828,28923,237
Research and development46,22749,54198,90494,326
Selling, general and administrative208,137130,280393,133251,067
Gain in fair value of contingent consideration(1,496)(8,102)(906)(6,590)
Intangible asset amortization1,5891,5893,1613,161
Total operating expenses268,021186,756522,581365,201
Loss from operations(49,646)(36,714)(113,003)(93,696)
Interest expense, net(1,540)(1,834)(2,725)(4,265)
Loss on debt extinguishment—(10,385)—(10,385)
Loss before income taxes(51,186)(48,933)(115,728)(108,346)
Income tax benefit (expense)(128)960(128)960
Net loss$(51,314)$(47,973)$(115,856)$(107,386)
Net loss per common share, basic and diluted$(0.99)$(0.97)$(2.25)$(2.18)
Weighted average common shares outstanding, basic and diluted51,799,70849,442,00151,500,69049,158,159

Consolidated Statements of Stockholders’ Equity (Unaudited)

(In thousands, except share amounts)

Common stock · Additional paid-in · Accumulated · Totalstockholders’
SharesAmountcapitaldeficitequity
Balance at December 31, 202448,667,58751,179,797(1,122,787)57,015
Stock-based compensation——23,647—23,647
Issuance of common stock upon exercise of options331,853—17,035—17,035
Issuance of common stock upon vesting of RSUs60,835————
Issuance of common stock upon financing156,484—19,257—19,257
Shares tendered for withholding taxes——(4,336)—(4,336)
Net loss———(59,413)(59,413)
Balance at March 31, 202549,216,75951,235,400(1,182,200)53,205
Stock-based compensation——24,954—24,954
Issuance of common stock upon exercise of options and under employee stock purchase plan276,280—11,661—11,661
Issuance of common stock upon vesting of RSUs15,776————
Issuance of common stock upon financing306,486—32,116—32,116
Shares tendered for withholding taxes——(888)—(888)
Net loss———(47,973)(47,973)
Balance at June 30, 202549,815,30151,303,243(1,230,173)73,075
Balance at December 31, 202550,882,76651,394,251(1,305,961)88,295
Stock-based compensation——23,906—23,906
Issuance of common stock upon exercise of options412,310—9,981—9,981
Issuance of common stock upon vesting of RSUs89,567————
Issuance of common stock upon financing35,802—6,248—6,248
Shares tendered for withholding taxes——(9,301)—(9,301)
Net loss———(64,542)(64,542)
Balance at March 31, 202651,420,44551,425,085(1,370,503)54,587
Stock-based compensation——27,625—27,625
Issuance of common stock upon exercise of options and under employee stock purchase plan755,644—41,968—41,968
Issuance of common stock upon vesting of RSUs28,979————
Issuance of common stock upon financing54,644—13,272—13,272
Issuance of common stock upon exercise of warrants40,177————
Shares tendered for withholding taxes——(2,834)—(2,834)
Net loss———(51,314)(51,314)
Balance at June 30, 202652,299,889$5$1,505,116$(1,421,817)$83,304

Consolidated Statements of Cash Flows (Unaudited)

(In thousands)

Six months ended June 30,
20262025
Cash flows from operating activities
Net loss$(115,856)$(107,386)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense50,58647,919
Amortization of intangible asset3,1613,161
Amortization of debt discount323984
Loss on debt extinguishment—10,385
Depreciation259269
Gain in fair value of contingent consideration(906)(6,590)
Gain from lease modification—(2,250)
Non-cash lease expense1,7011,432
Right-of-use asset amortization for finance lease1,834949
Changes in operating assets and liabilities:
Accounts receivable, net(52,995)(56,824)
Inventories, net(9,000)(2,026)
Prepaid expenses and other current assets(7,726)(4,360)
Non-current inventory and other assets(907)(3,223)
Accounts payable13,43219,631
Accrued expenses and other current liabilities63,83922,322
Operating lease liability(1,397)(191)
Net cash used in operating activities(53,652)(75,798)
Cash flows from investing activities
Purchases of equipment(571)(351)
Net cash used in investing activities(571)(351)
Cash flows from financing activities
Proceeds from draw down of debt140,000190,000
Payment of debt issuance costs—(3,638)
Repayment of debt(140,000)(191,988)
Payments on principal portion of finance lease obligation(1,882)(919)
Proceeds from issuance of common stock upon financing19,81752,283
Cash paid for common stock issuance costs(297)(910)
Proceeds from issuance of common stock upon exercise of options and under employee stock purchase plan51,94928,696
Payment of contingent consideration(6,312)(4,488)
Payments of tax withholdings on stock awards(12,135)(5,224)
Net cash provided by financing activities51,14063,812
Net decrease in cash(3,083)(12,337)
Cash at beginning of period322,933315,353
Cash at end of period$319,850$303,016
Supplemental disclosures of cash flow information:
Interest paid$5,969$8,359
Operating lease right-of-use asset obtained in exchange for operating lease liability—23,869
Finance lease right-of-use asset obtained in exchange for finance lease liability10,4272,360
Decrease in operating lease right-of-use asset due to lease modification—5,349
Decrease in operating lease liability due to lease modification—7,599

Notes to Consolidated Financial Statements (Unaudited)

Note 1. Nature of Business and Basis of Presentation

Axsome Therapeutics, Inc. (“Axsome” or the “Company”), based in New York, New York, is a biopharmaceutical company dedicated to the development and commercialization of innovative medicines to improve the brain health of individuals living with central nervous system (“CNS”) conditions. Axsome has a broad and diverse commercial portfolio of four U.S. Food and Drug Administration (“FDA”) approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease (AADDAD), excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and migraine. Additionally, Axsome is advancing a deep pipeline of numerous novel product candidates in early- to late-stage development targeting a range of serious, underserved conditions across psychiatry and neurology that collectively impact over 150 million people in the United States.

SUNOSI® is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea or narcolepsy. SUNOSI was approved by the FDA in March 2019, by the European Commission in January 2020, and by Health Canada in May 2021. The Company acquired the U.S. rights to SUNOSI in May 2022 and, in November 2022, acquired worldwide ex-U.S. rights, excluding certain Asian markets. In February 2023, the Company announced a licensing transaction with Atnahs Pharma UK Limited (“Pharmanovia”) to market SUNOSI in Europe and certain countries in the Middle East / North Africa.

AUVELITY® (dextromethorphan-bupropion), also referred to as “AXS-05”, was developed by the Company and approved by the FDA in August 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder in adults (MDD). The Company initiated the commercial availability of AUVELITY in October 2022. In April 2026, the FDA approved AUVELITY for the treatment of AADDAD. The Company initiated the commercial launch of AUVELITY for the treatment of AADDAD in June 2026.

SYMBRAVO® (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist that was developed by the Company and approved by the FDA in January 2025 for the acute treatment of migraine with or without aura in adults. The Company initiated the commercial availability of SYMBRAVO in June 2025.

In November 2025, the Company acquired global rights to AXS-17, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM). The Company plans to evaluate AXS-17 as a potential treatment for epilepsy. In December 2025, the Company acquired global rights to deuterium-stabilized S-bupropion. In the first quarter of 2026, the Company acquired AXS-20, a selective PDE10A inhibitor. The Company plans to initially develop AXS-20 in schizophrenia and Tourette syndrome.

The Company refers herein to AUVELITY, SUNOSI, SYMBRAVO (also referred to as “AXS-07”), AXS-12, AXS-14, AXS-17, AXS-20 and its programs to develop additional indications for AXS-05 and solriamfetol as the Company’s products.

The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 23, 2026.

In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the full fiscal year or any future period.

Liquidity and Capital Resources

The Company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable. As of June 30, 2026, the Company had an accumulated deficit of $1,421.8 million.

The Company’s primary sources of cash have been proceeds from the sales of AUVELITY, SUNOSI, and SYMBRAVO, the issuance and sale of its common stock in public offerings, and the issuance of debt. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties. The Company may continue to incur substantial operating losses even as it continues to generate revenues from its products.

The Company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. During that time, the Company expects that its expenses will increase primarily due to the commercialization of AUVELITY, SUNOSI, and SYMBRAVO while continuing to further develop the Company’s pipeline assets. The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.

The Company’s common stock is listed on The Nasdaq Global Market and trades under the symbol “AXSM.”

Note 2. Summary of Significant Accounting Policies

Significant Risks and Uncertainties

The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise additional capital. If the Company’s commercialization of its products is not financially successful, it will be unable to generate sufficient recurring product revenue to achieve and maintain profitability.

The Company currently has three commercial products, AUVELITY, SUNOSI, and SYMBRAVO. There can be no assurance that the Company’s research and development efforts will result in additional successfully commercialized products. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.

Use of Estimates

Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense; determination of fair value of warrants; accounting for research and development costs; accounting for acquisitions; impairments of goodwill and the intangible asset; determination of fair value of contingent consideration; chargebacks, cash discounts, sales rebates, returns and other adjustments; and the recoverability of the Company’s net deferred tax assets and related valuation allowance.

Revenue Recognition

In accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. Transfer of control is based on contractual performance obligations, which occurs upon transfer of the title along with the physical transfer of the Company’s goods to the customer, as that is when the customer has obtained control of significantly all of the economic benefits and the Company obtains a right of payment.

To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product sales, see Product Sales, net and Note 13. Revenues.

License Agreements

The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones and royalties on sales of products.

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights and are accounted for as separate performance obligations.

Contingent milestones at contract inception are estimated to the extent that it is probable that a significant revenue reversal would not occur and are included in the transaction price using the most likely amount method. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received, and, therefore, the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that a significant revenue reversal would not occur and, if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.

For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied).

Product Sales, net

Revenues from product sales are recorded net of reserves for variable consideration. These reserves reflect the Company’s best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts. The Company sells AUVELITY, SUNOSI, and SYMBRAVO in the United States to wholesale distributors with whom the Company has entered into formal agreements (collectively, the “Distributors”). These Distributors subsequently resell the Company’s products to retail pharmacies. The Company also sells SUNOSI to Distributors in Canada and on a product supply basis to Pharmanovia. SUNOSI is subsequently sold by Pharmanovia in certain ex-U.S. markets. The Company does not sell products under consignment arrangements, and the collection of proceeds from product sales is not contingent upon customers’ sale of the goods to third parties. The Company received FDA approvals for SYMBRAVO and AUVELITY to treat AADDAD in January 2025 and April 2026, respectively, and commenced commercial sales in June 2025 and June 2026, respectively. See Note 13. Revenues for a further breakout of product sales, net.

Reserves for Variable Consideration

The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. These reserves reflect the Company’s best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts and are classified as reductions to accounts receivable, net if payable to a customer or accrued expenses and other current liabilities if payable to a third-party. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligation to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses customer segment utilization mix data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Amounts accrued for rebates, discounts, and other incentives are adjusted when trends indicate that adjustment is appropriate and to reflect actual experience.

Trade Discounts and Allowances - The Company generally provides discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its distributors for distribution services and data. These payments have been recorded as a reduction to product sales as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Product Returns - The Company generally offers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product sale is recognized, as well as a component of accrued expense and other current liabilities. The Company currently estimates product return liabilities using available industry data, historical product sales information, and actual returns experience.

Chargebacks and Discounts - Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to distributors. Distributors charge the Company for the difference between what they pay for the product and the ultimate selling price. These reserves are established in the same period that the related product sales are recognized, resulting in a reduction to product sales and accounts receivable, net.

Rebates - Rebates apply to: Medicaid, managed care, and supplemental rebates to all applicable states as defined by the statutory government pricing calculation requirements under the Medicaid Drug Rebate Program. Tricare rebates to the TRICARE third-party administrator are based on the statutory calculation defined in the agreement with the Defense Health Agency. Part D and Commercial Managed Care rebates are paid based on the contracts with Pharmacy Benefit Managers (“PBMs”) and Managed Care Organizations. Rebates are paid to these entities upon receipt of an invoice from the contracted entity which is based on the utilization of the product by the members of the contracted entity. Allowances for rebates also include amounts due for Medicare Inflation Based Rebates resulting from the Inflation Reduction Act of 2022, which includes measures requiring manufacturers to pay rebates where price increases exceed the rate of inflation. The Company estimates these rebates and records such estimates in the same period the related product sales are recognized, resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.

Medicare Part D Program Redesign - Effective January 1, 2025, the Medicare Part D coverage gap program was replaced with a redesigned program under the Inflation Reduction Act of 2022. The standard Part D benefit now comprises three phases: the deductible phase, the initial coverage phase and the catastrophic coverage phase. Applicable dispensed drugs will be subject to manufacturer discounts of 10% during the initial coverage phase and 20% during the catastrophic coverage phase. The Company estimates the percentage of goods sold to patients in the initial coverage and catastrophic coverage phases and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.

Other Incentives - Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. The reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product sales as well as a component of accrued expenses and other current liabilities.

The Company makes significant estimates and judgments that materially affect its recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts frequently are submitted to the Company significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. The Company will adjust its estimates based on new information, including information regarding actual rebates, chargebacks and discounts for its products, as it becomes available.

Cost of Revenue

The Company’s cost of revenue consists of cost of product sales. Cost of product sales primarily include direct costs (inclusive of material, shipping, handling, and manufacturing costs), overhead and product royalties. Cost of product sales excludes depreciation and amortization.

The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals Co. Ltd. (“SK”) and Aerial Biopharma, LLC (“Aerial”). SK is the originator of SUNOSI and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to SUNOSI excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company’s sales of SUNOSI, and the Company is committed to pay up to $162.5 million based on revenue milestones and $1.0 million based on development milestones. Additionally, the Company pays a royalty to Antecip Bioventures II LLC (“Antecip”), an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board of Directors (the “Board”), Herriot Tabuteau, M.D., equal to 3.0% of AUVELITY net sales.

Foreign Currency Translation

Revenues and expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date they are incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the statements of operations and is not material to the Company’s consolidated financial statements.

Segment Information

Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business asone operating and reporting segment, which is the business of developing and delivering novel therapies for the management of CNS disorders. See Note 19. Segment Information for further information.

Cash and Cash Equivalents

The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. The Company’s cash and cash equivalents include 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 June 30, 2026, the balance of cash and cash equivalents was $319.9 million, which approximates fair value and was determined based upon Level 1 inputs. The sweep account is valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1 on the fair value hierarchy.

Concentration of Risk

Concentration of Credit Risk - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains its cash deposits at financial institutions, which cash deposits exceed insured limits. At June 30, 2026, the majority of the Company’s cash was held bytwo financial institutions, and amounts on deposit were in excess of government-provided insurance limits. The Company places its cash and cash equivalents in what it believes to be high credit quality banks and money market funds and has not recognized any losses from credit risks on such accounts since inception. See Note 3. Accounts Receivable, net below for further information.

Concentration of Risk, Other-The Company has a limited number of contract manufacturers for its products. At times, the Company may have only one manufacturer or supplier for its products.

Business Combination

The Company accounted for the acquisition of SUNOSI (the “Acquisition”) as a business combination using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing the intangible asset include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates.

As a result of the Acquisition, the Company recorded goodwill and an intangible asset.

Goodwill

Goodwill is deemed to have an indefinite life and therefore not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or more frequently if events or changes in circumstances indicate that the asset might be impaired. When reviewing goodwill for impairment, the Company first evaluates the qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the qualitative factors determine it is necessary to complete a goodwill impairment test, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. The Company completes its annual goodwill assessment as of December 31. As of June 30, 2026, the Company has determined that it hasone reporting unit. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during thesix months ended June 30, 2026. The balance of goodwill was $12.0 million at both June 30, 2026 and December 31, 2025.

Intangible Asset

The Company’s intangible asset is amortized using the straight-line method over its estimated period of benefit of ten years. The Company evaluates recoverability of the intangible asset periodically by considering events or changes in circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of the intangible asset during the six months ended June 30, 2026.

Asset Acquisition

Acquisitions that do not qualify as a business combination are accounted for as an acquisition of an asset. The cost of the acquisition is allocated to the assets acquired and liabilities assumed. At acquisition, in process research and development projects with no alternative future use are recorded as research and development expense. Direct and incremental transaction costs are included in the cost of the acquisition. Contingent consideration obligations relating to development, regulatory and commercial milestones are not recognized at the acquisition date and instead are recorded when it is probable they will occur and can be reasonably estimated.

Contingent Consideration

Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). The royalty payments due to Jazz are a high single-digit royalty on the Company’s U.S. net sales of SUNOSI in the current indication and a mid-single-digit royalty on the Company’s U.S. net sales of SUNOSI for future indications. Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations during such period a change is recognized. The Company estimates the fair value of the contingent consideration as of the acquisition date and reporting periods thereafter using the probability weighted income approach and makes significant assumptions, including estimated future sales of SUNOSI in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates, and discount rates. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded within total liabilities in the consolidated balance sheets.

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three‑level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:

Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly.

Level 3—Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. An asset’s or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The Company’s financial instruments are cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other liabilities, short-term and long-term debt, and current and non-current contingent consideration. The Company’s Level 1 financial instruments include cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses and other liabilities. They are considered Level 1 as the carrying values reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities. The carrying value of debt on the Company’s balance sheet is estimated to approximate its fair value. The Company’s Level 3 financial instruments include current and non-current contingent consideration due to the significant unobservable inputs required in determining their respective fair values.

The Company categorized the fair value of contingent consideration liabilities as Level 3 within the fair value hierarchy as the estimate is based on significant unobservable inputs requiring management judgment. The fair value of contingent consideration liabilities is estimated by using the probability weighted income approach using significant assumptions, including estimated future sales of SUNOSI in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success and discount rates. Contingent consideration liabilities are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 6. Fair Value of Financial Instruments for further detail.

Accounts Receivable, net

The Company’s accounts receivable, net arise from product sales and represent amounts due from its customers. They are generally stated at the gross sales amount, less reserves resulting from trade discounts and allowances and chargebacks. Accounts receivable typically has a standard payment term of 60 days or less anddoes not bear interest.

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. 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. As of June 30, 2026, the Company didnot have an allowance for doubtful accounts balance and did not experience any significant credit losses. For further information about accounts receivable, see Note 3. Accounts Receivable, net.

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 and subsequently amortized as interest expense in the consolidated statement of operations using the effective interest rate method. Costs that are directly attributable to the issuance of revolving credit facilities are capitalized and ratably amortized over the term of the revolving credit facility.

The Company evaluates amendments to its debt instruments in accordance with ASC 470-50, Debt – Modifications and Extinguishments (“ASC 470”) to determine whether the amendment should be accounted for as a modification or an extinguishment. An amendment may be considered modified when the terms of the new debt and original instrument are not “substantially different” (as defined in the debt modification guidance in ASC 470). Amendments that are considered modifications are accounted for prospectively as yield adjustments, based on the revised terms, and lender fees and costs directly incurred with third parties, to the extent material, are recorded as debt discount and amortized to interest expense using the effective interest rate method.

Inventory

The Company values its inventories at the lower of cost or estimated net realizable value. The remaining inventory associated with the Acquisition is stated at fair value due to purchase accounting. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within the cost of revenue.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign.

Inventory levels are evaluated for amounts that would be sold within one year. If the level of inventory exceeds the estimated amount that would be sold after 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 bethree years. When equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development expenses consist primarily of employee-related expenses, including salaries, benefits, travel and stock-based compensation expense, contract services, costs incurred to third-party service providers for conducting research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. In addition, research and development costs also include costs related to asset acquisitions involving clinical development programs that have not yet received regulatory approval. Research, preclinical and clinical study expenses are estimated based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on the Company’s behalf, including discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, accruals are adjusted accordingly. Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternative future use are expensed as incurred.

Advertising Costs

Advertising costs are included in selling, general and administrative expenses, and are expensed as incurred. The Company considers advertising costs as expenses related to the promotion of the Company’s commercial products. For the three and six months ended June 30, 2026, advertising costs were $55.1 million and $114.5 million, respectively. For thethree and six months ended June 30, 2025, advertising costs were $36.0 million and $63.7 million, respectively.

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 recorded a tax expense of $0.1 million for thethree and six months ended June 30, 2026, primarily related to its Canadian operations. The tax expense for Canada was calculated using a separate estimated annual effective tax rate. The Company maintains full valuation allowances against its deferred tax assets in its other material jurisdictions and does not expect to realize a tax benefit from its projected annual losses. Accordingly, no income tax benefit was recognized for year-to-date losses in those jurisdictions.

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 June 30, 2026, 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.

The Company issues restricted stock units (“RSUs”) and performance stock units (“PSUs”) 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 and for certain awards that are subject to a post-vesting holding period, an illiquidity discount is also applied.

The Company recognizes the grant date fair value of the stock options and RSUs over the requisite service period, which is generally the vesting term. For awards only subject to service-based vesting conditions, the Company elected to recognize stock-based compensation expense on a straight-line basis. For PSUs, the Company recognizes stock-based compensation expense when the achievement of the performance condition becomes probable. Stock-based compensation expense for PSUs with cliff-vesting terms is recognized on a straight-line basis. At the end of each reporting period, the Company reassesses the probability of achieving the performance condition and adjusts the stock-based compensation expense accordingly.

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, vesting of RSUs and PSUs is that the Company will issue shares as new shares drawing on the Company’s 2025 Long-Term Incentive Plan share pool that the Board adopted in April 2025 and the stockholders approved in June 2025. In addition, the Company accounts for equity award forfeitures as they occur.

Basic and Diluted Net Loss per Common Share

Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options, RSUs, PSUs, and/or common stock pursuant to the 2023 Employee Stock Purchase Plan (the “ESPP”), which would result in the issuance of incremental shares of common stock. As the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for the three and six months ended June 30, 2026 and 2025.

Leases

The Company determines if an arrangement is a lease at contract inception. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. When evaluating whether a contract contains a lease, the Company considers whether (1) the contract explicitly or implicitly identifies assets that are contractually defined and (2) the Company obtains substantially all of the economic benefits from the use of that underlying asset and directs how and for what purpose the asset is used during the term of the contract.

The Company’s lease agreements contain lease and non-lease components. Non-lease components primarily include payments for maintenance and utilities. The Company has applied the practical expedient to combine fixed payments for non-lease components with lease payments and account for them together as a single lease component, which increases the amount of lease assets and corresponding liabilities. Payments under the Company’s lease arrangements are primarily fixed, however, variable payments are expensed as incurred and not included in the operating lease asset and liability.

Lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses the interest rate implicit in the contract when such rate is readily determinable and uses the Company’s incremental borrowing rate when the rate implicit in the contract is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments.

Leases are accounted for under ASC 842, Leases (“ASC 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 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 toextend 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 evaluates amendments to its lease arrangements in accordance with ASC 842.

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. Operating lease expense is recognized on a straight-line basis over the lease term and included in selling, general and administrative expenses. Finance leases are included in the non-current inventory and other assets; accrued expenses and other current liabilities; and finance lease liability, long-term in the Company’s consolidated balance sheets. Assets under the finance leases are amortized on a straight-line basis over the lease term and included in selling, general and administrative expenses. 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

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. The guidance is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements.

Note 3. Accounts Receivable, net

Accounts receivable, net consisted of the following:

June 30,2026December 31,2025
Trade receivables$305,990$246,674
Less: Reserves for variable consideration(28,531)(22,210)
Accounts receivable, net$277,459$224,464

Note 4. Inventory

Inventory consisted of the following:

June 30,2026December 31,2025
Raw materials$12,493$10,377
Work in process16,82917,836
Finished goods19,39711,280
Total$48,719$39,493

There wereno material inventory reserves or write downs of any excess and obsolete inventory as of June 30, 2026. Non-current inventory, which consists of raw materials and work in process inventory, is included in non-current inventory and other assets on the accompanying consolidated balance sheets. Non-current inventory is estimated to be consumed beyond the next 12 months.

The following table summarizes the balance sheet classification of the Company’s inventory for each of the periods indicated:

June 30,2026December 31,2025
Balance sheet classification
Inventories, net$37,883$27,938
Non-current inventory and other assets10,83611,555
Total$48,719$39,493

Note 5. Intangible Asset

The following table provides the Company’s carrying amount of the intangible asset for each of the periods indicated.

Gross carrying amountAccumulated amortizationNet carrying amountRemaining weighted-average useful life
Finite-lived intangible asset$63,800$23,281$40,5197-years
Finite-lived intangible asset$63,800$26,442$37,3586-years

Based on the finite-lived intangible asset recorded as of June 30, 2026, and assuming the underlying asset will not be impaired and that the Company will not change the expected life of the asset, future amortization expense over the next five years and periods thereafter are estimated to be as follows:

Estimated amortization expense
2026$3,214
20276,375
20286,392
20296,375
20306,375
Thereafter8,627
Total$37,358

Note 6. Fair Value of Financial Instruments

In connection with the Acquisition, the Company pays 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 $11.2 million and non-current contingent consideration liability of $69.1 million in the consolidated balance sheet as of June 30, 2026.

The fair value of financial instruments measured on a recurring basis is as follows:

Level 1Level 2Level 3Total
Assets:
Cash and cash equivalents - money market funds$155,545$—$—$155,545
Liabilities:
Contingent consideration$—$—$80,334$80,334
Level 1Level 2Level 3Total
Assets:
Cash and cash equivalents - money market funds$173,111$—$—$173,111
Liabilities:
Contingent consideration$—$—$87,552$87,552

Contingent Consideration Liabilities

The fair value of the contingent consideration liabilities is marked-to-market at each reporting period and was remeasured at June 30, 2026. Changes in fair value of the contingent consideration liabilities as of June 30, 2026 are as follows:

Contingent consideration
Balance at December 31, 2025$87,552
Adjustment to fair value(906)
Payments(6,312)
Balance at June 30, 2026 (Level 3)$80,334

The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs:

As of June 30, 2026 · As of December 31, 2025
Valuation methodologySignificant unobservable inputWeighted average (range, if applicable)Weighted average (range, if applicable)
Contingent considerationProbability weighted income approachDiscount rate18.7%14.9%
Revenue discount rate16.4% - 19.4%17.2% - 20.2%

The Company’s fair value measurement of contingent consideration liabilities has been classified as Level 3 as its valuation requires judgment and estimation of factors which requires use of unobservable inputs. The fair value of contingent consideration liabilities is estimated by using the probability weighted income approach using significant assumptions including estimated future sales of SUNOSI in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates, and discount rates. If significant changes are made to one or more of these assumptions, the estimated fair value of contingent consideration liabilities may result in a significantly higher or lower fair value measurement.

Note 7. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

June 30,2026December 31,2025
Accrued research and development$10,833$8,654
Accrued compensation32,93736,938
Accrued selling, general, and administrative37,23826,423
Accrued sales discounts, rebates, and allowances204,632150,247
Accrued royalties8,4647,902
Accrued interest4343
Accrued taxes—101
Finance lease liability, current5,4852,545
Total$299,632$232,853

Note 8. Loan and Security Agreement

Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C.

For the purposes of this Note 8, capitalized terms used but not otherwise defined herein shall have the meanings assigned to them in the Blackstone Loan Agreement (as defined below).

On May 8, 2025 (the “Closing Date”), the Company entered into a loan agreement (the “Blackstone Loan Agreement”) with Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C. (collectively, the “Blackstone Representative” and referred to herein as “Blackstone”), certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, National Association, in its capacity as administrative agent, collateral agent and security trustee (“Wilmington Trust”), and the lenders from time to time party thereto (collectively, the “Lenders”). The Blackstone Loan Agreement provides for loans in an aggregate principal amount of up to $570.0 million, consisting of (i) a first lien senior secured term loan in an aggregate principal amount of $120.0 million funded to the Company on the Closing Date, (ii) a $180.0 million senior secured term loan available to the Company at its option, of which $90.0 million was available until May 31, 2026 and the remaining $90.0 million is available until May 31, 2027 (the “Term Loans”), and (iii) a super senior revolving credit facility in an aggregate principal amount of up to $70.0 million available at the Company’s option (the “Revolver” and, together with the Term Loans, the “Loans”). The Blackstone Loan Agreement also permits the Company, subject to the consent of the Lenders, to request incremental term loans in an aggregate principal amount of up to $200.0 million at any time and on the same terms as the initial Term Loans, except that any call protection will be determined at the time the incremental term loans are incurred.

On June 26, 2026, the Company entered into a First Incremental Revolving Credit Commitment Supplement and Amendment to the Blackstone Loan Agreement (the “First Incremental Supplement”) with Blackstone, Wilmington Trust and the Lenders party thereto, pursuant to which the aggregate principal amount of Revolving Credit Commitments under the Blackstone Loan Agreement was increased by $20.0 million, from $70.0 million to $90.0 million, and the Company’s Permitted Indebtedness (as defined in the Loan Agreement) was increased by $10.0 million, from $10.0 million to $20.0 million. The proceeds of the Term Loans were used, together with cash on hand, to repay in full the Company’s obligations under the Hercules Loan Agreement (as defined below). As of June 30, 2026, there were $120.0 million and $70.0 million of outstanding principal amounts under the Term Loans and Revolver facilities, respectively. The Company had allowed the Term Loan commitment of $90.0 million, which remained available to the Company at its option until May 31, 2026, to expire undrawn. The remaining $90.0 million of Term Loan commitment is available to the Company at its option until May 31, 2027. As of June 30, 2026, $20.0 million remained available and undrawn under the Revolver, representing the difference between the $90.0 million of Revolving Credit Commitments and the outstanding balance thereunder. The outstanding balance under the Revolver was classified as short-term based on the Company’s intent and ability to repay this amount in the next twelve months, and included in short-term borrowings on the accompanying consolidated balance sheets. In July 2026, the Company repaid the entire outstanding balance as of June 30, 2026 under the Revolver.

The Term Loans bear interest at a rate equal to the Term SOFR (“Secured Overnight Financing Rate”) plus a margin of 4.75%. The effective interest rate on the Term Loans was 9.58% for both thesix months ended June 30, 2026 and 2025. The Revolver bears interest at SOFR plus a margin of 4.00%. If an Event of Default occurs and is continuing, all amounts outstanding under the Blackstone Loan Agreement will bear an additional 2.00% interest. The weighted-average interest rate on the Revolver was 7.73% and 7.67% as of June 30, 2026 and December 31, 2025, respectively. The Loans mature and the principal amount (including any interest and fees) must be repaid on the date that is five years from the Closing Date. Fees and costs that were directly attributable to the Revolver have been capitalized as deferred assets and will be ratably expensed over the life of the Revolver. Deferred assets are included in non-current inventory and other assets on the accompanying consolidated balance sheets. As of June 30, 2026, the remaining unamortized balance of deferred assets was $0.9 million.

The Loans are subject to mandatory prepayment provisions that may require prepayment upon a change of control, the incurrence of certain additional indebtedness, certain asset sales, or an event of loss, subject to certain conditions set forth in the Blackstone Loan Agreement. The Company may prepay the Loans in whole at its option at any time, subject to certain yield protection premiums. The obligations under the Blackstone Loan Agreement are guaranteed by the Company’s subsidiaries party thereto as guarantors and are secured by a first lien security interest in certain assets of the Company and the guarantors.

The Blackstone Loan Agreement contains customary representations and warranties, affirmative and negative covenants, and events of default applicable to the Company and the guarantors. The Blackstone Loan Agreement also contains a minimum liquidity covenant of $30.0 million, tested quarterly. If an event of default occurs and is continuing, the Lenders may declare all amounts outstanding under the Blackstone Loan Agreement to be immediately due and payable.

Concurrent with the closing of the Blackstone Loan Agreement, Blackstone purchased $15.0 million of the Company’s common stock at a purchase price of $107.14 per share in a private placement transaction. The purchase agreement for the private placement contains customary representations, warranties, and covenants, and includes a lock-up period that generally prohibits, without the prior written consent of the Company, the sale, transfer, pledge, or other disposition of the securities through the period ending 120 days from the Closing Date.

In connection with the Blackstone Loan Agreement, Antecip consented to the collateral assignment of one of the license agreements, among other things, under a direct agreement among the Company, Antecip, a related party, and Blackstone. This new direct agreement superseded the prior direct agreement among the Company, Antecip and Hercules Capital, Inc. (“Hercules”) that had been entered into in connection with the Hercules Loan Agreement, which terminated automatically upon repayment of the Hercules loan obligations in full on May 8, 2025.

Hercules Capital, Inc.

In September 2020, the Company entered into a Loan and Security Agreement for a term loan with Hercules, a Maryland corporation, in its capacity as administrative agent and collateral agent, and as a lender, and the other financial institutions that from time to time act as lenders (the “Hercules Loan Agreement”, as amended).

Borrowings under the Hercules Loan Agreement bore interest at a rate equal to: (a) if the prime rate was greater than or equal to 7.00%, the greater of either (i) theprime rate plus 2.20%, and (ii)9.95%, but in no event greater than 10.70%, and (b) if theprime rate was less than 7.00%,9.70%. In addition, the Company was required to pay certain end of term charges, including (A) an initial end of term charge of $4.45 million and (B) a subsequent end of term charge of (i)1.10% of the aggregate amount of all Tranche 1A Advances (as defined in the Hercules Loan Agreement) plus (ii)4.95% of the aggregate amount of all term loan advances (other than Tranche 1A Advances) funded minus (iii) any charges paid by the Borrower (as defined in the Hercules Loan Agreement) to Hercules related to partial prepayments of the outstanding Secured Obligations (as defined in the Hercules Loan Agreement). The end of term charges were accreted into interest expense using the effective interest rate method over the term of the loan. If certain maturity extension conditions were satisfied, the Company was required to pay an extension end of term charge equal to 1.00% of the aggregate amount of all Term Loan Advances (as defined in the Hercules Loan Agreement) outstanding as of the date on which the maturity extension conditions were satisfied, in addition to the end of term charges described above. The Company could, at its option, prepay the term loans in full or in part, subject to a prepayment penalty equal to (i)2.0% of the Advance (as defined in the Hercules Loan Agreement) amount prepaid if the prepayment occurred prior to February 1, 2024, (ii)1.5% of the Advance amount prepaid if the prepayment occurred on or after February 1, 2024 but prior to February 1, 2025, and (iii)1.0% of the Advance amount prepaid if the prepayment occurred on or after February 1, 2025 but prior to February 1, 2026.

Debt issuance costs and the value of warrants issued in connection with the Hercules Loan Agreement were recorded as a debt discount and amortized to interest expense using the effective interest method over the expected term of the borrowing.

On May 8, 2025, the Company repaid in full its obligations under the Hercules Loan Agreement using proceeds from the Blackstone Loan Agreement. Upon repayment, the Company recorded a loss on debt extinguishment of $10.4 million in the Company’s consolidated statement of operations. As of June 30, 2026, there areno outstanding obligations under the Hercules Loan Agreement.

Loan Interest Expense and Amortization

Long-term debt and unamortized debt discount balances are as follows:

June 30,2026December 31,2025
Total outstanding debt, long-term$120,000$120,000
Less: unamortized debt discount, long-term(2,042)(2,254)
Loan payable, long-term$117,958$117,746

The book value of debt approximates its fair value given its variable interest rate.

Interest expense, amortization of the final payment fee, and amortization of the debt discount related to the issuance costs and warrants for the Company’s debt are as follows:

Three months ended June 30,Six months ended June 30,
2026202520262025
Interest expense$2,736$3,639$5,504$8,117
Amortization of final payment fee—134—527
Amortization of debt discount related issuance costs and warrants164183323457

Scheduled principal payments on outstanding debt, long-term, as of June 30, 2026, are as follows:

2026$—
2027—
2028—
2029—
2030120,000
Thereafter—
Total principal payments outstanding$120,000

Note 9. Commitments and Contingencies

Leases

In February 2023, the Company entered into a sublease agreement (the “Sublease”) for the previous office space located at One World Trade Center.

In January 2025, the Company entered into an amended sublease agreement (the “First Amendment”) to terminate the existing space in its corporate office and commence occupancy of different space within the same building. The First Amendment was treated as a lease modification to the Sublease which resulted in the recognition of a gain on modification of $2.3 million which is included in selling, general and administrative expenses. The Company also recorded a right-of-use asset and corresponding lease liability of $23.9 million during the first quarter of fiscal year 2025. Based on the Company’s past experience and current expectations for administrative office needs, the Company determined the lease term to be approximatelysix years. As of June 30, 2026 and December 31, 2025, the remaining lease term for the Company’s operating lease was 4.8 years and 5.3 years, respectively, and the discount rate was 7.12% as of each date. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment.

The Company entered into a fleet lease program beginning the first quarter of 2024. The lease agreement includes an initial 12-month noncancelable period with monthly renewal options thereafter. Lease terms range from approximately 40 to 50 months and are classified as finance leases. During thesix months ended June 30, 2026, the Company recognized a right-of-use asset and lease liability, both, of $10.4 million in connection to this lease. As of June 30, 2026, right-of-use asset and lease liability related to the finance lease were both $14.5 million, and the weighted average remaining lease term was 2.9 years, with a weighted average discount rate of 9.15%. As of December 31, 2025, right-of-use asset and lease liability related to the finance lease were $6.6 million and $6.8 million, respectively, and the weighted average remaining lease term was 2.8 years, with a weighted average discount rate of 9.6%.

Lease expenses recognized were as follows:

Three months ended June 30,Six months ended June 30,
2026202520262025
Operating lease expense$1,261$1,247$2,522$2,218
Finance lease expense:
Amortization of right-of-use assets1,1555371,834949
Interest on lease liabilities301130465243

Future minimum lease payments of the Company’s leases as of June 30, 2026 were as follows:

Operating lease · Finance lease
2026$(189)$3,375
20274,7915,807
20284,8074,769
202911,2842,400
20305,0324
Thereafter1,285—
Total lease payments27,01016,355
Less: imputed interest(4,790)(1,840)
Present value of lease liabilities$22,220$14,515

Legal Proceedings

The Company may be involved in various claims, litigation and legal proceedings from time to time. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Because of uncertainties related to claims, litigation and legal proceedings, accruals are based on the Company’s best estimates based on available information. The Company records accruals for outstanding legal matters if a matter is both probable to result in material liability and the amount of loss or a range of possible loss can be reasonably estimated. If a loss contingency is not both probable and reasonably estimable, the Company does not establish an accrued liability.

Stockholder Derivative Action

On July 21, 2022, Daniel Engel filed a stockholder derivative complaint captioned Engel v. Herriot Tabuteau, et al. in the SDNY District Court against the Company’s then-current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant). On January 27, 2023, Kyle Guterba filed a stockholder derivative complaint captioned Guterba v. Tabuteau, et al. in the SDNY District Court against the Company’s then-current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant). The SDNY derivative complaints arise out of similar allegations as those made in a now-resolved securities class action relating to the Company’s AXS-07 product (the “Securities Class Action”). The plaintiffs assert claims for breach of fiduciary duties against all of the defendants and for contribution for violations of Section 10(b) and 21D of the Exchange Act. The plaintiffs seek unspecified damages, fees, interest, and costs, as well as corporate governance changes. The Engel and Guterba matters were consolidated on February 28, 2023 and were stayed pending further proceedings in the Securities Class Action. On November 25, 2025, the plaintiffs filed an amended complaint. On February 13, 2026, the defendants moved to dismiss the amended complaint. The motion to dismiss is fully briefed and the parties await the Court’s decision.

On September 23, 2025, John Wickstrom filed a stockholder derivative complaint captioned Wickstrom v. Herriot Tabuteau, et al. in the Court of Chancery of the State of Delaware against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant). On September 29, 2025, John Gildea filed a stockholder derivative complaint captioned Gildea v. Herriot Tabuteau, et al. in the Court of Chancery of the State of Delaware against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant). The Delaware derivative complaints arise out of similar allegations as those made in the Securities Class Action and the SDNY derivative action. The plaintiffs assert claims for breach of fiduciary duties, unjust enrichment, and corporate waste against all of the defendants. The plaintiffs seek unspecified damages, fees, interest, and costs, as well as corporate governance changes. On November 6, 2025, the court consolidated the actions and designated the complaint in the Wickstrom action as the operative complaint. On February 2, 2026, the defendants moved to dismiss the complaint. On July 9, 2026, the court granted defendants’ motion and dismissed the complaint with prejudice.

SUNOSI Paragraph IV Litigation

On September 13, 2023, the Company commenced a patent infringement action against six generic drug companies relating to each company’s Abbreviated New Drug Application (“ANDA”) for SUNOSI. The generic drug companies were: Hikma Pharmaceuticals USA, Inc. (“Hikma”); Unichem Laboratories Ltd. (“Unichem”); Sandoz Inc (“Sandoz”); Hetero USA, Inc., Hetero Labs Limited Unit-V, and Hetero Labs Ltd. (collectively, “Hetero”); Alkem Laboratories Ltd. (“Alkem”); and Aurobindo Pharma USA, Inc. and Aurobindo Pharma Limited (collectively, “Aurobindo”). This action was captioned Axsome Malta Ltd. & Axsome Therapeutics, Inc. v. Alkem Laboratories Ltd., et al. No. 2:23-cv-20354 in the U.S. District Court for the District of New Jersey, or the NJ District Court. Between December 2023 and February 2026, the Company commenced several additional related patent infringement actions against the defendants.

The Company has executed settlement agreements with all current ANDA filers. Each ANDA filer agrees not to launch its generic solriamfetol product until September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, or earlier under certain circumstances. Specifically, the Company entered into settlement agreements with Unichem on June 4, 2024, with Hikma on March 2, 2025, with Hetero on May 21, 2025, with Alkem on February 13, 2026, and with Aurobindo on June 2, 2026. Additionally, on August 21, 2024, the Company reached an agreement to dismiss the actions pending against Sandoz Inc. No actions remain pending.

SYMBRAVO Paragraph IV Litigation

On September 26, 2025, the Company commenced a patent infringement action against Apotex Inc. (“Apotex”) relating to Apotex’s ANDA for SYMBRAVO. This action is captioned Axsome Therapeutics, Inc. v. Apotex, Inc., No. 1:25-cv-16038 in the NJ District Court. On March 10, 2026, Apotex filed a motion for judgment on the pleadings to dismiss certain of the asserted patents. The motion is fully briefed, but the Court has not yet ruled on Apotex’s motion. The action is currently in fact discovery.

The Company believes that its assertions in pending legal proceedings have merit and does not believe that any of these matters, individually or in the aggregate, will have a material adverse effect on its financial position. As of June 30, 2026, there wereno potential material losses from claims, asserted or unasserted, or legal proceedings that the Company determined were both probable and reasonably estimable.

Note 10. Stockholders’ Equity

Public Offerings

At-the-Market Offerings

In March 2022, the Company entered into a sales agreement (the “March 2022 Sales Agreement”) with Leerink Partners LLC (“Leerink”) and filed a prospectus supplement. The March 2022 Sales Agreement supersedes the sales agreement, dated December 5, 2019, by and between the Company and Leerink. The Company exhausted sales of shares of our common stock under our sales agreement, dated December 5, 2019.

Under the March 2022 Sales Agreement, for the three months ended June 30, 2026, the Company received approximately $13.5 million in gross proceeds through the sale of 54,644 shares, of which net proceeds were approximately $13.3 million. For the six months ended June 30, 2026, the Company received approximately $19.8 million in gross proceeds through the sale of 90,446 shares, of which net proceeds were approximately $19.5 million under the March 2022 Sales Agreement.

Blackstone Securities Purchase Agreement

In May 2025, the Company entered into a securities purchase agreement with Blackstone, and its affiliates, for the private placement (the “Private Placement”) of an aggregate of 140,000 shares of the Company’s common stock, at a purchase price of $107.14 per share. Gross proceeds from the Private Placement were approximately $15.0 million. The closing of the Private Placement occurred contemporaneously with the closing of the Blackstone Loan Agreement.

Shelf Registration Statement

On November 3, 2025, the Company filed an automatic shelf registration statement (File No. 333-291228) (the “2025 Shelf Registration Statement”) with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units. It became effective upon filing with the SEC and is currently the Company’s only active shelf registration.

Under SEC rules, the 2025 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 unlimited 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 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Equity Incentive Plan

In October 2015, the Board adopted the 2015 Omnibus Incentive Compensation Plan, as amended from time to time (the “2015 Plan”) and the Company’s stockholders approved the 2015 Plan in November 2015. In April 2025, the Board adopted the Company’s 2025 Long-Term Incentive Plan (“2025 Plan”) and the Company’s stockholders approved the 2025 Plan in June 2025. The Company will make all future equity awards from the 2025 Plan and the Company does not intend to grant any future equity awards from the 2015 Plan. As of June 30, 2026, there were 1,993,655 shares available for future grant under the 2025 Plan.

Stock Options

The following table sets forth stock option activity as of June 30, 2026:

Numberof sharesWeightedaverageexercise priceWeightedaveragecontractualterm (years)Aggregateintrinsicvalue
Outstanding at December 31, 20257,034,278$51.98
Granted——
Exercised(1,061,762)42.96
Forfeited/Canceled(70,937)79.90
Outstanding at June 30, 20265,901,579$53.275.4$1,130,181
Vested and expected to vest at June 30, 20265,901,579$53.275.4$1,130,181
Exercisable at June 30, 20264,771,457$45.335.0$951,605

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 option exercise history 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 doesnot expect to pay any cash dividends in the foreseeable future. In prior years, expected volatility was based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. Currently, expected volatility is based on historical volatility information of the Company’s common stock since the Company’s initial public offering in 2015.

As of June 30, 2026, there was $68.3 million of total unrecognized compensation cost related to unvested stock options which is expected to be recognized over a weighted average period of 1.6 years.

Restricted Stock Units

The fair value of the RSUs is recognized as an expense ratably over the vesting period offour years. As of June 30, 2026, total compensation cost not yet recognized related to nonvested RSUs was $157.0 million, which is expected to be recognized over a weighted-average period of 3.0 years. The intrinsic value of RSUs lapsed during thesix months ended June 30, 2026 was $34.1 million.

The following table sets forth the RSU activity for thesix months ended June 30, 2026:

Numberof sharesWeightedaveragegrant datefair value
Nonvested at December 31, 20251,012,809$90.93
Granted695,719162.32
Vested(328,316)72.31
Forfeited(45,917)123.29
Nonvested at June 30, 20261,334,295$131.62

Performance Stock Units

In February 2025, the Company granted PSUs to the executive officers. Vesting of these PSUs is subject to achievement of specified performance goals, which include achieving revenue, clinical, and regulatory targets over athree-year performance period.

In April 2026, the Company granted an additional award of PSUs to its executive officers. Vesting of these PSUs is subject to achievement of specified performance goals, which include achieving revenue and commercialization targets over athree-year performance period.

For both awards, the actual number of common shares that would ultimately be issued is calculated by multiplying the number of PSUs granted by a payout multiplier ranging from 0 to 2. Achievement of the performance goals will ultimately be determined by the Compensation Committee or the Board at the end of the vesting term, which is approximately 3 years from the grant date. As of June 30, 2026, total compensation cost not yet recognized related to nonvested PSUs was $9.5 million, which is expected to be recognized over a weighted-average period of 2.2 years.

The following table sets forth the PSU activity for thesix months ended June 30, 2026:

Numberof sharesWeightedaveragegrant datefair value
Nonvested at December 31, 202564,281$94.39
Granted55,386138.42
Vested——
Forfeited——
Nonvested at June 30, 2026119,667$114.77

Employee Stock Purchase Plan

The ESPP allows eligible employees to purchase shares of the Company’s common stock. The purchase price is equal to 85% of the lower of the closing price of the Company’s common stock on (1) the first day of the offering period or (2) the last day of the offering period. The ESPP has consecutive offering periods that begin on or about June 1st of each year with a duration of 12 months. The Company commenced the third offering period pursuant to the ESPP on June 1, 2025, and such offering ended on May 31, 2026.

During the six months ended June 30, 2026,68,643 common shares have been purchased and issued pursuant to the ESPP, and $0.6 million and $1.2 million of expenses were recorded for thethree and six months ended June 30, 2026. During the six months ended June 30, 2025,59,607 common shares have been purchased and issued pursuant to the ESPP, and $0.5 million and $0.8 million of expenses were recorded for the three and six months ended June 30, 2025.

Stock-based Compensation Expense

Stock-based compensation expense recognized was as follows:

Three months ended June 30,Six months ended June 30,
2026202520262025
Research and development$7,739$6,941$14,642$13,400
Selling, general and administrative19,40917,67035,94434,519
Total$27,148$24,611$50,586$47,919

Stock-based compensation expense capitalized into inventory totaled $0.4 million and $0.9 million for thethree and six months ended June 30, 2026, respectively, and $0.3 million and $0.7 million for thethree and six months ended June 30, 2025, respectively. Capitalized stock-based compensation is recognized as an expense in cost of product sales when the related product is sold or in selling, general and administrative expense when the related product is dispensed as a physician sample.

Note 11. Warrants

The following table summarizes warrant activity for thesix months ended June 30, 2026:

WarrantsWeighted averageexercise price
Outstanding at December 31, 202579,220$56.80
Issued——
Exercised(50,796)46.75
Outstanding at June 30, 202628,424$74.75

In connection with the entry into the Third Amendment to the Hercules Loan Agreement, which the Company entered into in January 2023, Hercules received warrants to purchase an aggregate of 18,724 shares of the Company’s common stock at an exercise price of $73.43 per share, and in connection with the draw down of the Tranche 1C Advance, Hercules received warrants to purchase 9,700 shares of the Company’s common stock at an exercise price of $77.31 per share (collectively, the “2023 warrants”). In connection with the entry into the Second Amendment, Hercules received warrants to purchase an aggregate of 35,255 shares of the Company’s common stock at an exercise price of $31.91 per share (the “2022 warrants”), and in connection with the first advance of the 2020 Term Loan, Hercules received warrants to purchase an aggregate of 15,541 shares of the Company’s common stock at an exercise price of $80.43 per share (the “2020 warrants”).

The 2023 warrants, 2022 warrants and 2020 warrants were priced using the volume weighted average price of the Company’s common stock over theten-day trading period immediately preceding the initial closing, subject to certain limited adjustments as specified in the warrant. The warrants are exercisable forseven years from the date of issuance. The warrants were classified as a component of stockholders’ equity. The relative fair value of the warrants of approximately $1.6 million for the 2023 warrants, $0.8 million for the 2022 warrants and $0.9 million for the 2020 warrants at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. Upon full repayment of the Company’s obligations under the Hercules Loan Agreement, no additional warrants are issuable under the Hercules Loan Agreement.

During the six months ended June 30, 2026, Hercules exercised the 2020 warrants and the 2022 warrants on a cashless basis in accordance with the net issuance provisions of the warrants, resulting in the net issuance of 40,177 shares of the Company’s common stock. The Company received no cash proceeds in connection with the exercise. The 2023 warrants remained outstanding as of June 30, 2026.

Note 12. Net Loss per Common Share

The following table sets forth the computation of basic and diluted net loss per common share:

Three months ended June 30,Six months ended June 30,
2026202520262025
Basic and diluted net loss per common share:
Net loss$(51,314)$(47,973)$(115,856)$(107,386)
Weighted average common shares outstanding—basic and diluted51,799,70849,442,00151,500,69049,158,159
Net loss per common share—basic and diluted$(0.99)$(0.97)$(2.25)$(2.18)

The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:

June 30,
20262025
Stock options5,901,5798,090,273
Restricted stock units1,970,6311,526,153
Performance stock units119,66764,281
Warrants28,42479,220
ESPP55,12192,598
Total8,075,4229,852,525

Note 13. Revenues

The Company sells AUVELITY, SUNOSI, and SYMBRAVO in the United States through the Distributors. The Company also sells SUNOSI to Distributors in Canada and on a product supply basis to Pharmanovia. SUNOSI is subsequently sold by Pharmanovia in certain ex-U.S. markets. For the six months ended June 30, 2026, the Company’sthree largest customers represented approximately 38%,27%, and 24% of the Company’s gross product sales.

Royalty revenue is related to the sales of SUNOSI by Pharmanovia in certain ex-U.S. markets and milestone revenue consists of $0.5 million related to an achievement of a regulatory milestone for AUVELITY recorded in the first quarter of 2026 and $0.5 million related to an achievement of a developmental milestone for SUNOSI recorded in the second quarter of 2026.

The following table presents a summary of total revenues by product:

Three months ended June 30,Six months ended June 30,
2026202520262025
Product sales, net
AUVELITY$180,282$119,642$332,978$215,873
SUNOSI33,82028,90766,45153,034
SYMBRAVO2,2534106,326410
Total product sales, net216,355148,959405,755269,317
AUVELITY milestone revenue——500—
SUNOSI milestone revenue546—546—
SUNOSI royalty revenue1,4741,0832,7772,188
Total revenues$218,375$150,042$409,578$271,505

The following table presents a summary of total revenues by geographic location:

Three months ended June 30,Six months ended June 30,
2026202520262025
Product sales, net
United States$215,367$146,446$404,239$265,859
Outside of the United States9882,5131,5163,458
Total product sales, net216,355148,959405,755269,317
Royalty and milestone revenue
United States——500—
Outside of the United States2,0201,0833,3232,188
Total revenues$218,375$150,042$409,578$271,505

For the six months ended June 30, 2026, product sales, net includes adjustments for provisions for product sales made in previous fiscal years resulting from changes in estimates of $1.2 million for AUVELITY, $2.4 million for SUNOSI, and $0.1 million for SYMBRAVO. For thesix months ended June 30, 2025, product sales, net includes adjustments for provisions for product sales made in previous fiscal years resulting from changes in estimates of $1.1 million for AUVELITY and $0.9 million for SUNOSI.

Note 14. License Agreements

License Agreement with Pharmanovia

In February 2023, Axsome Malta, a Malta limited company and a wholly owned subsidiary of the Company, entered into an exclusive license agreement with Pharmanovia (the “Pharmanovia License Agreement”) to commercialize and further develop SUNOSI in Europe and certain countries in the Middle East and North Africa (the “Territory”). Under the terms of the Pharmanovia License Agreement, the Company retains its existing interest in SUNOSI intellectual property and licenses those rights in the Territory to Pharmanovia. Pharmanovia is solely responsible for the clinical development and commercialization of SUNOSI in the Territory. The Company will continue to manufacture SUNOSI and provide product supply to Pharmanovia for an indefinite period of time, and the Company will recognize revenue as a component of product sales, net, when product is supplied to Pharmanovia.

In consideration for entering the Pharmanovia License Agreement, the Company received a non-refundable upfront payment of €62.0 million ($65.7 million). The Company also will receive a royalty percentage in the mid-twenties on SUNOSI net sales in the Territory and is eligible to receive sales-based milestone payments totaling up to €94.5 million.

The Company evaluated the Pharmanovia License Agreement under ASC 606 and concluded that Pharmanovia represents a customer in the transaction. The initial transaction price consisted of the non-refundable upfront payment, which was recognized as License Revenue in the first quarter of 2023 upon transfer of the license to Pharmanovia, as the requirement for revenue recognition under ASC 606 was met. The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. The Company evaluated the constraint on variable consideration and concluded that the milestone payments are dependent on regulatory approvals and actions of third parties, and thus are highly susceptible to factors outside the Company’s influence. Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur. Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met. All other development or regulatory milestones will be recognized as revenue immediately in the period the underlying milestone is achieved. Any consideration related to sales-based royalties will be recognized when the related sales occur. The Company recognized royalty revenue of $1.5 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively, and $2.8 million and $2.2 million for the six months ended June 30, 2026 and 2025, respectively, related to Pharmanovia’s sales of SUNOSI. No other development or sales-based milestones were recognized during thethree and six months ended June 30, 2026 and 2025.

Exclusive License Agreement with Pfizer

In January 2020, the Company entered into an exclusive license agreement with Pfizer Inc. (“Pfizer”) for Pfizer’s clinical and non-clinical data, and intellectual property for reboxetine, the active pharmaceutical ingredient in AXS-12 which the Company is developing for the treatment of narcolepsy. The agreement also provides the Company exclusive rights to develop and commercialize esreboxetine, a new late-stage product candidate referred to as AXS-14, in the United States 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 theten prior trading days of $97.54, in consideration for the license and rights and also received an upfront cash payment of $3.0 million. The Company determined that the fair value of each share of common stock granted to Pfizer on the closing date of January 9, 2020 was $87.24, based on the closing price of the Company’s stock on that date. As a result, the fair value of the stock issued was $7.2 million and, therefore, the total research and development expense recognized was $10.2 million related to the Pfizer license agreement during the year ended December 31, 2020.

Pfizer can also receive up to $323 million in regulatory and sales milestones, and tiered mid-single to low double-digit royalties on future sales related to the licensed products. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14. During thethree and six months ended June 30, 2026 and 2025, no milestone payments or royalties were paid to Pfizer by the Company.

Exclusive License Agreements with Antecip

In 2012, the Company entered into three exclusive license agreements with Antecip, an entity owned by the Company’s Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., in which the Company was granted exclusive licenses to develop, manufacture and commercialize Antecip’s patents and applications related to the development of AXS-05 (now marketed as AUVELITY) and two product candidates no longer under active development, anywhere in the world for human therapeutic, veterinary, and diagnostic use. Pursuant to the agreements, the Company is required to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize these product candidates. Under the terms of the agreements, the Company is required to pay to Antecip a royalty equal to 3.0% for AXS-05 (and 1.5% or 4.5% for the other two product candidates no longer under active development), of net sales of products containing the licensed technology by the Company, its affiliates, or permitted sublicensees. These royalty payments are subject to reduction by an amount up to 50.0% of any required payments to third parties. Unless earlier terminated by a party for cause or by the Company for convenience, the agreements shall remain in effect on a product-by-product and country-by-country basis until the later to occur of (i) the applicable product is no longer covered by a valid claim in that country or (ii)10 years from the first commercial sale of the applicable product in that country. Upon expiration of the agreements with respect to a product in a country, the Company’s license grant for that product in that country will become a fully paid-up, royalty-free, perpetual non-exclusive license. If Antecip terminates any of the agreements for cause, or if the Company exercises its right to terminate any of the agreements for convenience, the rights granted to the Company under such terminated agreement will revert to Antecip. The Company began recording royalty payments to Antecip along with the initiation of sales of AUVELITY (the components of which are referred to as “AXS-05”) in the fourth quarter of 2022. The Company recorded royalty expense due to Antecip of $5.3 million and $3.6 million for the three months ended June 30, 2026 and 2025, respectively, and $9.9 million and $6.5 million for thesix months ended June 30, 2026 and 2025, respectively, which is equal to 3.0% of net sales of AUVELITY. This is considered to be a related party transaction.

In connection with the Blackstone Loan Agreement, Antecip consented to the collateral assignment of one of the license agreements, among other things, under a direct agreement among the Company, Antecip, a related party, and Blackstone. This new direct agreement superseded the prior direct agreement among the Company, Antecip and Hercules that had been entered into in connection with the Hercules Loan Agreement, which terminated automatically upon repayment of the Hercules loan obligations in full on May 8, 2025.

Note 15. Acquisitions

In the first quarter of 2026, the Company acquired the global rights to balipodect (AXS-20), a selective PDE10A Inhibitor for the treatment of schizophrenia and other neuropsychiatric conditions, from Takeda Pharmaceutical Company Limited (Takeda), for $10.4 million, inclusive of transaction costs. Takeda is eligible to receive up to $260.0 million in development, regulatory and sales-based milestones and a mid single-digit royalty on potential global net sales of balipodect.

The Company accounted for the transaction as an acquisition of an asset, as substantially all the fair value of the assets acquired were concentrated in balipodect. The Company recorded a charge of $10.4 million in research and development expense, inclusive of the upfront payment and direct transaction costs.

Note 16. Royalty Agreements

On March 25, 2022, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Jazz, pursuant to which the Company was to acquire commercial and development rights with respect to SUNOSI from Jazz in certain U.S. and ex-U.S. markets. The Acquisition occurred in two separate closings. The sale and purchase of specified initial assets contemplated by the Purchase Agreement occurred on May 9, 2022 (the “Initial Closing”), following the satisfaction or waiver of the closing conditions under the Purchase Agreement. The sale and purchase of specified ex-U.S. assets contemplated by the Purchase Agreement occurred on November 14, 2022, following the satisfaction or waiver of the closing conditions under the Purchase Agreement (the “Final Closing”). The Company accounted for the Initial Closing as a business combination using the acquisition method of accounting, and the Company accounted for the Final Closing as an asset acquisition.

Pursuant to the Purchase Agreement, the Company agreed to make non-refundable, non-creditable royalty payments to Jazz equal to a (A) high single-digit royalty for any current indication, or (B) mid single-digit royalty for any future indication of net sales in the U.S. Territory made during the applicable royalty term. There are no royalty payments due to Jazz for net sales outside of the U.S. Territory.

At the Initial Closing, the Company assumed all of the commitments of Jazz to SK and Aerial. SK is the originator of SUNOSI and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to SUNOSI excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company’s sales of SUNOSI, and additionally, the Company is committed to pay up to $162.5 million based on revenue milestones and $1.0 million based on development milestones. During thethree and six months ended June 30, 2026 and 2025, no milestone payments were made to SK or Aerial by the Company.

Note 17. Income Taxes

The table below presents the Company’s loss before income taxes and effective tax rates for all periods presented:

Three months ended June 30,Six months ended June 30,
2026202520262025
Loss before income taxes$(51,186)$(48,933)$(115,728)$(108,346)
Income tax benefit (expense)(128)960(128)960
Effective tax rate0.3%(2.0)%0.1%(0.9)%

The Company is subject to income taxes in the United States and foreign jurisdictions in which the Company does business. These foreign jurisdictions have statutory tax rates different from those in the United States. Accordingly, the Company’s effective tax rates will vary depending on the relative proportion of foreign to United States income, the utilization of net operating loss and tax credit carry forwards, changes in geographic mix of income and expense, and changes in management’s assessment of matters such as the ability to realize deferred tax assets and changes in tax laws. The Company regularly assesses the likelihood of adverse outcomes resulting from the examination of the Company’s tax returns by the Internal Revenue Service (the “IRS”) and other tax authorities to determine the adequacy of its income tax reserves and expense. Should actual events or results differ from the Company’s current expectations, charges or credits to its income tax expense may become necessary.

The Company recorded a tax expense of $0.1 million for the three and six months ended June 30, 2026. The tax expense is primarily related to unfavorable return-to-provision adjustments attributable to certain foreign tax returns filed during June 2026. For the three and six months ended June 30, 2025, the Company recorded a discrete income tax benefit of $1.0 million. The discrete tax benefit is related to favorable return-to-provision adjustments attributable to certain foreign tax returns filed during July 2025.

The Company didnot have any unrecognized tax benefits as of June 30, 2026 related to uncertain tax positions that would impact the effective income tax rate if recognized.

During the quarter ended March 31, 2026, the IRS completed its examination of the Company’s U.S. federal income tax returns for the 2021 tax year. The IRS made adjustments to the Company’s R&D and Orphan Drug tax credit carryforwards, however these adjustments did not have a material impact on the Company’s consolidated financial statements because the tax credits were fully offset by the valuation allowance. The Company is not currently under examination at the state level. The Company’s U.S. federal and state net operating losses have occurred since its inception in 2012 and, as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company is currently under examination by the Canada Revenue Agency for the Company’s 2024 and 2025 Canadian income tax returns.

Note 18. Related Party Transactions

From the Company’s inception, Herriot Tabuteau, M.D. has been the Company’s founder, Chief Executive Officer, Chairman of the Company’s Board, and the beneficial owner of more than 5% of the outstanding shares of the Company’s common stock. In connection with the formation of the Company, in January 2012, the Company issued to Antecip Bioventures II LLC, an entity controlled by Dr. Tabuteau, an aggregate of 7,344,500 shares of the Company’s common stock for nominal consideration. The Company recorded royalty expense due to Antecip of $5.3 million and $3.6 million for thethree months ended June 30, 2026 and 2025, respectively, and $9.9 million and $6.5 million for thesix months ended June 30, 2026 and 2025, respectively, which equal 3.0% of net sales of AUVELITY for those respective periods.

The Company is a party tothree 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.

Note 19. Segment Information

The Company views its operations and manages its business asone operating and reportable segment, which is the business of developing and delivering novel therapies for the management of CNS disorders. The Company’s focus centers around the CNS disorders market as its primary operating environment. Consistent with the operational structure, the Chief Executive Officer, as the chief operating decision maker (“CODM”), manages and allocates resources on a consolidated basis. This decision-making process reflects the way in which the financial information is regularly reviewed and used by the CODM to evaluate performance, set operational targets, forecast future financial results, and allocate resources.

The Company’s CODM assesses financial performance and allocates resources based on consolidated net loss that also is reported on the consolidated statements of operations. The measure of segment assets is reported on the balance sheet as total consolidated assets. The CODM utilizes consolidated net loss by comparing actual results against budgeted amounts on a quarterly basis. As part of this process, consolidated net loss is a critical performance measure used to evaluate the Company’s operating performance and guide strategic decisions and resource allocations, including additional investments in research and development and commercialization activities.

The following table provides information about the Company’s one reportable segment and includes the reconciliation to consolidated net loss.

Three months ended June 30,Six months ended June 30,
2026202520262025
Total revenues$218,375$150,042$409,578$271,505
Less:
Cost of revenue (excluding amortization and depreciation)13,56413,44828,28923,237
Research and development expense (excluding stock-based compensation expense):
Solriamfetol13,39710,77024,62822,576
AXS-0511,49114,56422,39529,041
AXS-074,5846,07510,05410,554
AXS-122,3991,7373,8874,146
AXS-143,5446,2256,2407,411
Other research and development(a)3,0733,22917,0587,198
General and administrative expense (excluding stock-based compensation expense)24,61513,23446,63924,884
Selling and marketing expense (excluding stock-based compensation expense)164,11399,376310,550191,664
Stock-based compensation expense27,14824,61150,58647,919
Gain in fair value of contingent consideration(1,496)(8,102)(906)(6,590)
Interest expense, net(b)1,5401,8342,7254,265
Other segment items(c)1,71711,0143,28912,586
Segment net loss(51,314)(47,973)$(115,856)$(107,386)
Reconciliation of net loss
Adjustments and reconciling items————
Consolidated net loss(51,314)(47,973)$(115,856)$(107,386)

(a)

Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, costs related to asset acquisitions, and other unallocated costs.

(b)

Interest expense, net of $1,540 for the three months ended June 30, 2026 comprises (i) consolidated interest expense of $3,200 and (ii) consolidated interest income of $1,660. Interest expense, net of $2,725 for the six months ended June 30, 2026 comprises (i) consolidated interest expense of $6,292 and (ii) consolidated interest income of $3,567. Interest expense, net of $1,834 for thethree months ended June 30, 2025 comprises (i) consolidated interest expense of $4,086 and (ii) consolidated interest income of $2,252. Interest expense, net of $4,265 for the six months ended June 30, 2025 comprises (i) consolidated interest expense of $9,344 and (ii) consolidated interest income of $5,079.

(c)

Other segment items included in Segment net loss include intangible asset amortization, loss on debt extinguishment, and other miscellaneous items.

See Note 2. Summary of Significant Accounting Policies for further details on the products from which the Company derives its revenues.

See Note 13. Revenues for details of revenue from external customers by geography.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.