← Back to AXSM filing summaryOriginal filing text · Part I
Item 2 — Management's Discussion and Analysis
Axsome Therapeutics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The following discussion and analysis contain forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in “Risk Factors.” See also the “Cautionary Note Regarding Forward-Looking Statements” set forth at the beginning of this report.
You should read the following discussion and analysis in conjunction with the unaudited interim consolidated financial statements, and the related footnotes thereto, appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 which was filed with the U.S. Securities and Exchange Commission, or SEC, on February 23, 2026.
Overview
We are a biopharmaceutical company focused on the development and commercialization of innovative medicines for people living with central nervous system (“CNS”) conditions. Our operations are primarily directed toward the commercialization of our marketed products, AUVELITY®, SUNOSI®, and SYMBRAVO®, as well as the advancement of our pipeline of novel product candidates.
Commercial Products
Our commercial products are our primary sources of revenue and are expected to be key contributors to future revenue growth.
AUVELITY®
AUVELITY (dextromethorphan and bupropion) was developed by Axsome and approved by the FDA in August 2022 for the treatment of MDD (as defined below) in adults. We launched AUVELITY in the U.S. in October 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist approved for MDD in adults and the only oral antidepressant with rapid-acting efficacy reflected in the FDA label. In April 2026, the FDA approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer’s disease (AADDAD). We initiated the commercial launch of AUVELITY for the treatment of AADDAD in June 2026. AUVELITY utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.
SUNOSI®
SUNOSI (solriamfetol) 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 EDS in adult patients with obstructive sleep apnea or narcolepsy. We acquired the U.S. rights to SUNOSI from Jazz Pharmaceuticals plc, or Jazz, in May 2022, and the ex-U.S. rights (excluding certain Asian markets) from Jazz in November 2022. We have been commercializing SUNOSI since we completed these acquisitions. SK Biopharmaceuticals Co. Ltd., or SK, is the originator of SUNOSI and retains rights in 12 Asian markets, including China, Korea, and Japan. We refer to the acquisition of SUNOSI herein as the Acquisition. In February 2023, we entered into a licensing agreement, or the Pharmanovia License Agreement, with Atnahs Pharma UK Limited, or Pharmanovia, that granted to Pharmanovia the exclusive right to market SUNOSI in Europe and certain countries in the Middle East and North Africa, referred to as the Licensed Territory. Approximately 22 million adults and 185,000 people in the U.S. are affected by OSA and narcolepsy, respectively.
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SYMBRAVO®
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 us and approved by the FDA in January 2025 for the acute treatment of migraine with or without aura in adults. We launched SYMBRAVO in the U.S. in June 2025.
Pipeline
We are advancing a diversified CNS pipeline of potentially transformative medicines for serious neurological and psychiatric conditions. As part of our ongoing research and development activities, we have and will continue to allocate significant resources to support the development of our product candidates.
AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor being developed for smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.
Solriamfetol is a novel, oral, investigational DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (“ADHD”), binge eating disorder (“BED”), major depressive disorder (“MDD”) with EDS symptoms, and excessive sleepiness associated with shift work disorder (“SWD”). In March 2025, we announced positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults. We recently announced the initiations of the FOCUS-2 and FOCUS-3 studies, Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol in children and adolescents with ADHD, respectively. In February 2026, we initiated the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial of solriamfetol in patients with MDD with EDS symptoms. Enrollment for the ENGAGE and SUSTAIN Phase 3 trials of solriamfetol in BED and SWD, respectively, are ongoing.
AXS-12 (reboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. We have completed three positive Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. In July 2026, the FDA accepted for filing the Company’s New Drug Application (NDA) for AXS-12 for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. AXS-12 was previously granted FDA Orphan Drug Designation for narcolepsy.
AXS-14 (esreboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. The efficacy and safety of AXS-14 have previously been demonstrated in completed, positive Phase 2 and Phase 3 clinical trials. In January 2026, we initiated the FORWARD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial of AXS-14 in patients with fibromyalgia.
AXS-17 is a novel, oral, investigational GABAA α2,3 receptor positive allosteric modulator that we acquired in November 2025. We plan to evaluate AXS-17 as a potential treatment for epilepsy.
AXS-20 is a novel, oral, investigational phosphodiesterase 10A (PDE10A) inhibitor that we acquired from Takeda in the first quarter of 2026. AXS-20 has completed a proof-of-concept Phase 2 trial in 164 patients with schizophrenia and has demonstrated a favorable safety and tolerability profile in clinical studies in over 360 individuals to date. We plan to evaluate AXS-20 as a potential treatment for schizophrenia and Tourette syndrome.
Since our incorporation in January 2012, our operations to date have included organizing and staffing our company, business planning, raising capital, developing our compounds, engaging in other discovery and preclinical activities, and the commercial launches of AUVELITY, SUNOSI, and SYMBRAVO. Subsequent to our IPO, we financed our operations primarily through proceeds from sales of our common stock to equity investors and debt borrowings. For a further discussion, see the section entitled “Liquidity and Capital Resources” below.
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Our ability to become profitable depends on our ability to generate revenue. The revenue we have generated, and anticipate to continue to generate, from the commercial sales of AUVELITY, SUNOSI, and SYMBRAVO, is expected to be an important contributor to our progress toward profitability.
We have incurred significant operating and net losses since inception. We incurred net losses of $115.9 million and $107.4 million for the six months ended June 30, 2026 and 2025, respectively. Our accumulated deficit as of June 30, 2026 was $1,421.8 million, and we expect to incur significant expenses and continuing operating losses. We expect our expenses to increase in connection with our ongoing activities, as we continue the commercialization of our on-market products and the development and clinical trials of, and seek regulatory approval for, our current product candidates and any other product candidates that we develop or in-license and advance to clinical development. Further, we have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we may need additional financing to support our continuing operations. We may seek to fund our operations through public or private equity, debt financings, or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.
Financial Overview
Revenue
We generated total revenues of $218.4 million and $150.0 million in the three months ended June 30, 2026 and 2025, respectively, and $409.6 million and $271.5 million in the six months ended June 30, 2026 and 2025, respectively.
Additionally, in the first quarter of 2026, we recorded a milestone revenue of $0.5 million related to an achievement of a regulatory milestone for AUVELITY and in the second quarter of 2026, we recorded a milestone revenue of $0.5 million related to a developmental milestone for SUNOSI.
We expect that AUVELITY, SUNOSI, and SYMBRAVO revenues are likely to fluctuate based on demand quarter to quarter. We will not generate revenue from other products unless and until we successfully develop, obtain regulatory approval of, and commercialize one of our current or future product candidates. We have incurred significant operating losses since inception. If we fail to complete the development of our product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenue from such product candidates, and our results of operations and financial position, would be materially and adversely affected. If we enter into licensing or collaboration arrangements, such agreements may or may not generate revenue in the future.
License Agreement with Pharmanovia
In February 2023, we entered into the Pharmanovia License Agreement with Pharmanovia to commercialize and further develop SUNOSI in the Territory. Pharmanovia is a UK-based global life cycle management healthcare company that focuses on four core therapeutic areas – Oncology, Endocrinology, Neurology and Cardiovascular.
We are eligible to receive sales-based and other milestone payments totaling up to €94.5 million. We will receive a royalty percentage in the mid-twenties on net sales of the Licensed Products (as defined in the Pharmanovia License Agreement) in the Territory. We 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.
Cost of revenue
Cost of revenue includes direct costs of formulating, manufacturing and packaging drug product, overhead costs consisting of labor, customs, stock-based compensation, shipping, outside inventory management, royalty expense, and other miscellaneous operating costs.
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Research and development expenses
Research and development expenses primarily include preclinical studies, clinical trials, manufacturing costs, employee-related expenses including salaries, benefits, travel, and stock‑based compensation expense, contract services, including external research and development expenses incurred under arrangements with third parties, such as contract research organizations, or CROs, facilities costs, overhead costs, depreciation, and other related costs. 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 and development activities are central to our business model. We have and will incur substantial costs beyond our present and planned clinical trials in order to file an NDA for any of our product candidates. It is difficult to determine with certainty the costs and duration of our current or future clinical trials and preclinical studies, or to what extent we will generate revenue from the commercialization and sale of AUVELITY, SUNOSI, and SYMBRAVO or our product candidates if we obtain regulatory approval. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including the uncertainties of future clinical trials and preclinical studies, uncertainties in clinical trial enrollment rate, and significant and changing government regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability, and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.
Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made.
Selling, general and administrative expenses
Selling, general and administrative expenses consist of salaries and related costs for personnel in executive, commercial, finance, and operational functions, including stock-based compensation and travel expenses. Also included in selling, general and administrative expenses are marketing costs, other commercial costs, pre-commercialization costs, facility-related costs, insurance expense, professional fees for legal and accounting services, and patent filing and prosecution costs. Selling, general and administrative expenses are expensed when incurred.
Interest expense, net
Interest expense, net primarily consists of cash interest and non-cash costs related to our term loans (see “Liquidity and Capital Resources” below for a further discussion). We amortize these costs over the term of our debt agreements as interest expense in our consolidated statement of operations. Interest expense, net also includes interest income earned on cash and cash equivalents.
Intangible asset amortization
The intangible asset is amortized using the straight-line method over its estimated period of benefit of ten years. We evaluate recoverability of the intangible asset periodically by considering events or changes in circumstances that may warrant revised estimates of useful life or that indicate the asset may be impaired.
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Fair value in 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 our U.S. net sales of SUNOSI in the current indication and a mid single-digit royalty on our 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 in the period the change is recognized. We estimate the fair value of the contingent consideration as of the acquisition date and reporting periods thereafter using the estimated future cash outflows based on future sales.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reported period. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to the critical accounting policies disclosed in our 2025 Annual Report on Form 10-K. Our critical accounting policies are described in the notes to the consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Results of Operations
The following table summarizes our results of operations for the periods indicated (in thousands, except share and per share amounts):
Three months ended June 30, Six months ended June 30,
2026 2025 2026 2025
Revenues:
Product sales, net $ 216,355 $ 148,959 $ 405,755 $ 269,317
Royalty revenue and milestone revenue 2,020 1,083 3,823 2,188
Total revenues 218,375 150,042 409,578 271,505
Operating expenses:
Cost of revenue (excluding amortization and depreciation) 13,564 13,448 28,289 23,237
Research and development 46,227 49,541 98,904 94,326
Selling, general and administrative 208,137 130,280 393,133 251,067
Gain in fair value of contingent consideration (1,496 ) (8,102 ) (906 ) (6,590 )
Intangible asset amortization 1,589 1,589 3,161 3,161
Total operating expenses 268,021 186,756 522,581 365,201
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 diluted 51,799,708 49,442,001 51,500,690 49,158,159
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Product sales, net. AUVELITY U.S. net sales were $180.3 million and $333.0 million for the three and six months ended June 30, 2026, respectively, as compared to $119.6 million and $215.9 million for the same periods in 2025. SUNOSI net sales were $33.8 million and $66.5 million for the three and six months ended June 30, 2026, respectively, as compared to $28.9 million and $53.0 million for the same periods in 2025. We began commercial sales of SYMBRAVO in June 2025 and had U.S. net sales of $2.3 million and $6.3 million for the three and six months ended June 30, 2026, respectively, as compared to $0.4 million for the three months ended June 30, 2025. There were no SYMBRAVO sales recorded during the three months ended March 31, 2025. The increases in product sales were primarily due to the increase in unit sales volume for both AUVELITY and SUNOSI.
The following table summarizes the activity of our sales allowance and reserves as of and for the six months ended June 30, 2026 (in thousands):
Commercial discounts and rebates, returns and other Cash discounts and chargebacks Medicaid and Medicare rebates Total
Balance at December 31, 2025 $ 105,003 $ 22,210 $ 45,242 $ 172,455
Provisions 256,803 93,406 69,964 420,173
Payments/credits (234,576 ) (87,077 ) (37,815 ) (359,468 )
Balance at June 30, 2026 $ 127,230 $ 28,539 $ 77,391 $ 233,160
Royalty revenue and milestone revenue. Royalty revenue was $1.5 million and $2.8 million for the three and six months ended June 30, 2026, respectively, as compared to $1.1 million and $2.2 million for the same periods in 2025, attributable to Pharmanovia sales of SUNOSI in the out-licensed markets. The increase was in line with the increase in unit sales volume of SUNOSI in certain ex-U.S. markets. Further, we recognized milestone revenue of $0.5 million related to a regulatory milestone for AUVELITY in the first quarter of 2026 and $0.5 million related to a developmental milestone for SUNOSI in the second quarter of 2026.
Cost of revenue. Cost of revenue was $13.6 million and $28.3 million for the three and six months ended June 30, 2026, respectively, as compared to $13.4 million and $23.2 million for the same periods in 2025. The increase was in line with the increase in sales of AUVELITY and SUNOSI, the commercial launch of AUVELITY for the treatment of AADDAD in June 2026, and the commercial launch of SYMBRAVO in June 2025.
Research and development. The following table summarizes our research and development expenses for our primary products for the three and six months ended June 30, 2026 and 2025 (in thousands):
Three months ended June 30, Six months ended June 30,
2026 2025 2026 2025
Solriamfetol $ 13,397 $ 10,770 $ 24,628 $ 22,576
AXS-05 11,491 14,564 22,395 29,041
AXS-07 4,584 6,075 10,054 10,554
AXS-12 2,399 1,737 3,887 4,146
AXS-14 3,544 6,225 6,240 7,411
Other research and development (*) 3,073 3,229 17,058 7,198
Stock-based compensation 7,739 6,941 14,642 13,400
Total research and development expenses $ 46,227 $ 49,541 $ 98,904 $ 94,326
(*) 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.
Research and development expenses decreased by $3.3 million and increased by $4.6 million for the three and six months ended June 30, 2026, respectively, as compared to the same periods in 2025. The decrease for the three months period was primarily due to lower spending on AXS-05, driven by the timing of clinical study activities, along with lower costs for AXS-14, reflecting regulatory costs incurred in the prior year period. This was partially offset by higher spending on solriamfetol. The increase for the six months period was primarily due to asset acquisition costs related to AXS-20, which were partially offset by lower spending on AXS-05, driven by the timing of clinical study activities. We expect research and development costs to moderately increase as our recently started clinical trials further enroll.
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Selling, general and administrative. Selling, general and administrative expenses were $208.1 million and $393.1 million for the three and six months ended June 30, 2026, respectively, as compared to $130.3 million and $251.1 million for the same periods in 2025. The increases in both comparable periods were primarily related to pre-launch activities for AUVELITY for the treatment of AADDAD, higher commercial activities for AUVELITY including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO which was launched in June 2025, and higher personnel costs related to organizational growth. We anticipate SG&A expenses to marginally increase through the end of 2026 as we continue commercial activities for AUVELITY and SYMBRAVO.
Gain in Fair Value of Contingent Consideration. The $1.5 million and $0.9 million changes for the three and six months ended June 30, 2026, respectively, as compared to $8.1 million and $6.6 million changes for the same periods in 2025, were primarily related to changes in significant assumptions, including future sales estimates, and significant unobservable inputs, including discount rates.
Intangible asset amortization. We amortize the intangible asset, which we recognized as part of the Acquisition, over its useful life of 10 years. Intangible asset amortization was $1.6 million for both the three months ended June 30, 2026 and 2025 and $3.2 million for both the six months ended June 30, 2026 and 2025.
Interest expense, net. Interest expense, net was $1.5 million and $2.7 million for the three and six months ended June 30, 2026, respectively, as compared to $1.8 million and $4.3 million for the same periods in 2025. The decrease was due to lower interest expense from the Blackstone Loan Agreement, which was partially offset by less interest income from lower interest rates.
Income tax expense. We recorded an income tax expense of $0.1 million for the three and six months ended June 30, 2026. We recorded an income tax benefit of $1.0 million for the same periods in 2025.
Net loss. Net loss was $51.3 million and $115.9 million for the three and six months ended June 30, 2026, respectively, as compared to $48.0 million and $107.4 million for the same periods in 2025. The increase was primarily due to higher selling, general and administrative expenses from commercial activities for AUVELITY, including a national direct-to-consumer advertising campaign and sales force expansion, commercial activities for SYMBRAVO, and higher personnel costs related to organizational growth. This was partially offset by higher net product sales from AUVELITY, SUNOSI, and SYMBRAVO.
Liquidity and Capital Resources
Since our inception through June 30, 2026, we have financed our operations primarily through proceeds from equity offerings, debt borrowings, and proceeds from product sales. See discussion below.
In March 2022, we entered into a sales agreement with Leerink, or the March 2022 Sales Agreement with Leerink, and filed a prospectus supplement. The March 2022 Sales Agreement supersedes the sales agreement, dated December 5, 2019, by and between us and Leerink. We exhausted sales of shares of our common stock under our sales agreement, dated December 5, 2019.
Under the March 2022 Sales Agreement, for the six months ended June 30, 2026, we received approximately $19.8 million in gross proceeds through the sale of 90,446 shares, of which net proceeds were approximately $19.5 million.
In the future, we may conduct additional offerings of one or more of the securities covered by the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our 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.
On February 21, 2023, we entered into a sublease agreement with Advance Magazine Publishers d/b/a Conde Nast for the entirety of the twenty-second floor of One World Trade Center in New York, NY, or the Sublease.
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On January 17, 2025, we entered into an Amendment to our Sublease, or the First Amendment, pursuant to which we relinquished our then existing space in One World Trade Center and commenced occupancy of different space within the building. This space is utilized as our corporate and executive offices. The First Amendment extends the Sublease expiration date to January 31, 2036. We now have a one-time option to terminate the Sublease effective March 30, 2031 upon the payment of a fee to the sublandlord. We are responsible for base rent under the Sublease and certain additional customary variable costs, such as an allocable portion of building taxes and operating expenses. In connection with the Sublease and First Amendment, we received certain rent and work concessions from the sublandlord.
We entered into a fleet lease program in 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. See Note 9. Commitments and Contingencies for further information on future contractual obligations.
As described below in the “Loan Agreement with Blackstone” section, on May 8, 2025, we entered into the Blackstone Loan Agreement with Blackstone, certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, and the Lenders. The Blackstone Loan Agreement provides for Loans in an aggregate principal amount of up to $570.0 million. Further, we 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 our 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.
On May 8, 2025, we repaid in full our obligations under the Hercules Loan Agreement using proceeds from the Blackstone Loan Agreement. As of June 30, 2026, there are no outstanding obligations under the Hercules Loan Agreement.
We believe that our current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Because the process of commercializing products and evaluating product candidates in clinical trials is costly and the timing of progress in these trials is uncertain, it is possible that the assumptions upon which we have based this estimate may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Cash Flows
The following table summarizes our primary sources and uses of cash for the periods indicated (in thousands):
Six months ended June 30,
2026 2025
Net cash (used in) provided by:
Operating activities $ (53,652 ) $ (75,798 )
Investing activities (571 ) (351 )
Financing activities 51,140 63,812
Net decrease in cash $ (3,083 ) $ (12,337 )
Operating Activities. Cash used in operating activities for the six months ended June 30, 2026 was $53.7 million, as compared to $75.8 million for the same period in 2025. The decrease of $22.1 million was primarily due to higher net product revenues from AUVELITY, SUNOSI, and SYMBRAVO, which was partially offset by increased cash used for commercial and clinical-related activities.
Investing Activities. Cash used in investing activities for the six months ended June 30, 2026 was $571 thousand, as compared to $351 thousand for the same period in 2025. The increase was due to higher purchases of equipment in the current year to support increased headcount.
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Financing Activities. Cash provided by financing activities was $51.1 million for the six months ended June 30, 2026, which primarily included proceeds of $51.9 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP as well as net proceeds of $19.5 million from issuance of common stock for financing purposes, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $18.4 million. Financing activities also include $140.0 million in gross proceeds from the Blackstone revolving credit facilities and $140.0 million in repayments for the Blackstone revolving credit facilities. Cash provided by financing activities was $63.8 million for the six months ended June 30, 2025, which included net proceeds of $186.4 million from draw-downs related to the Blackstone Loans and net proceeds of $51.4 million from issuance of common stock for financing purposes as well as proceeds of $28.7 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by the repayment of the Hercules Loan, for a total of $192.0 million, and payments of contingent consideration and tax withholdings on stock awards, for a total of $9.7 million.
Funding Requirements
We have not achieved profitability since our inception, and we expect to continue to have losses as we continue the development of, and seek regulatory approvals for, our product candidates, while further investing in AUVELITY, SUNOSI, and SYMBRAVO. We are subject to all of the risks pertinent to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may harm our business.
We may need to raise additional financing in the future to fund our operations. In the event that we need additional financing, we may incur additional debt, license certain intellectual property, and seek to sell additional equity or convertible securities that may result in dilution to our stockholders. If we raise additional funds through the issuance of equity or convertible securities, these securities could have rights or preferences senior to those of our common stock and could contain covenants that restrict our operations. There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all. Our future capital requirements will depend on many factors, including:
•the scope, rate of progress, results, and cost of our clinical studies and other related activities;
•our ability to enter into collaborative agreements for the development and commercialization of our product candidates;
•the number and development requirements of any other product candidates that we pursue;
•the costs, timing, and outcome of regulatory reviews of our product candidates;
•the costs and timing of our commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our products and product candidates for which we receive marketing approval;
•any product liability or other lawsuits related to our product candidates;
•the expenses needed to attract and retain skilled personnel;
•the general and administrative expenses related to being a public company;
•the revenue received from commercial sales of our products and product candidates for which we receive marketing approval; and
•the costs involved in preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending our intellectual property‑related claims.
Please see “Risk Factors” for additional risks associated with our substantial capital requirements.
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Contractual Obligations and Commitments
License agreement with Pfizer
In January 2020, we entered into a license agreement with Pfizer. Under the terms of our exclusive license agreement with Pfizer, Pfizer received 82,019 shares of our common stock having a stated value of $8.0 million, based on the average closing price of our common stock for the ten prior trading days of $97.54, in consideration for the license and rights. Pfizer also received an upfront cash payment of $3.0 million. We 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 our common stock on that date. As a result, the fair value of the stock issued was $7.2 million.
Pfizer can also receive up to $323 million upon the achievement of certain regulatory and sales milestones, and tiered mid-single to low double-digit royalties on future sales of any such approved clinical products containing compounds reboxetine and esreboxetine. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14.
License agreements with Antecip Bioventures
Under three exclusive license agreements with Antecip, an entity owned by our Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., we are obligated to make specified royalty payments ranging from 1.5% to 4.5%, subject to up to a 50% reduction depending on required payments to third parties, on net sales of our products containing the licensed technology of AXS-02, AXS-05, and AXS-04.
In connection with the Blackstone Loan Agreement (see below), Antecip consented to the collateral assignment of one of the license agreements, among other things, under a direct agreement among us, Antecip, a related party, and Blackstone. This new direct agreement superseded the prior direct agreement among us, 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.
Asset Acquisitions
In the first quarter of 2026, we 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.
Loan Agreement with Blackstone
On the Closing Date, we entered into the Blackstone Loan Agreement with Blackstone, certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, and the Lenders, providing 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 us on the Closing Date, (ii) a $180.0 million senior secured term loan which is available to us at our option, of which $90.0 million was available to us until May 31, 2026, and of which 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 our option (the “Revolver” and collectively with the Term Loans, the “Loans”). The Blackstone Loan Agreement also permits us, 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.
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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 our obligations under the Hercules Loan Agreement, which resulted in a recording of a loss on debt extinguishment of $10.4 million in the consolidated statement of operations. The Term Loans bear interest at a variable SOFR plus 4.75%. The Revolver bears interest at SOFR plus 4.0%. The maturity date of the Loans is May 8, 2030. The Blackstone Loan Agreement provides for additional drawdowns at our option, subject to certain conditions, and includes customary covenants and a minimum liquidity covenant of $30.0 million. The obligations under the Blackstone Loan Agreement are secured by a first lien on certain assets of ours and our subsidiaries. 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.
On May 8, 2025, we repaid in full our obligations under the Hercules Loan Agreement using proceeds from the Blackstone Loan Agreement. As of June 30, 2026, there are no outstanding obligations under the Hercules Loan Agreement.
Royalty Agreements
Pursuant to the Asset Purchase Agreement, dated as of March 25, 2022, or the Purchase Agreement, we 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 (in each case, as those terms are defined in the Purchase Agreement). There are no royalty payments due to Jazz for net sales outside of the U.S. Territory.
At the initial closing, we 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 our sales of SUNOSI, and we are committed to pay up to $162.5 million based on revenue milestones and $1.0 million based on development milestones.
Employees and Human Capital Management
As of August 3, 2026, we had 1,346 full‑time employees. None of our employees are represented by a collective bargaining agreement and we have never experienced any work stoppage. We believe that we maintain good relations with our employees. Our employees are highly skilled, and many hold advanced degrees. Many of our employees have experience with drug commercialization or development. Our future performance depends significantly upon the continued service of our key scientific, technical and senior management personnel and our continued ability to attract and retain highly skilled employees. We provide our employees with competitive salaries and bonuses, opportunities for equity ownership, development programs that enable continued learning and growth and a robust employment package that promotes well-being across all aspects of their lives. In addition to salaries, these programs include potential annual discretionary bonuses, stock awards, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and flexible work schedules, among other benefits. We may take further actions, in compliance with all appropriate government regulations, that we determine to be in the best interest of our employees.
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Shelf Registration Statement
On November 3, 2025, we filed an automatic shelf registration statement (File No. 333-291228), or the 2025 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units up to an unlimited amount, which we refer to as the 2025 Shelf Registration Statement. In the future, we may conduct additional offerings of one or more of these securities utilizing the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our 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.
In connection with the 2025 Shelf Registration Statement, we filed a new sales agreement prospectus to replace the prior prospectus supplement filed in December 2022, which would have expired in December 2025. The new sales agreement prospectus covered the issuance and sale by us of up to the same $250 million of our common stock that may be issued and sold from time to time through Leerink, as the sales agent, under the March 2022 Sales Agreement.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined by applicable SEC regulations.
Recent Accounting Pronouncements
Refer to Note 2. Summary of Significant Accounting Policies to our consolidated financial statements included in Part I, Financial Information, Item 1, Financial Statements, of this Quarterly Report on Form 10-Q for a discussion of recently issued accounting pronouncements.
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