Axsome Therapeutics, Inc.
For the period ended Mar 31, 2026. Filed May 4, 2026.
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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.
Mar 31, 2026 · Filed May 4, 2026
AXSM$132.37+2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-03.
0001193125-25-262664
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-04.
0001193125-26-204274
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 106 previous paragraphs and 116 current paragraphs.
56 unchanged; 45 reworded; 15 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (15)
Current report
Our commercial products represent our primary sources of revenue and are expected to be key contributors to future revenue growth.
Current report
AUVELITY®
Current report
AUVELITY (dextromethorphan and bupropion) was developed by Axsome and approved by the FDA for the treatment of MDD (as defined below) in adults in August 2022. 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, AUVELITY was approved for the treatment of agitation associated with dementia due to Alzheimer’s disease. AUVELITY utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components.
Current report
SUNOSI®
Current report
SYMBRAVO®
Current report
We continue to advance 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.
Current report
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.
Current report
AXS-20 is a novel, oral, investigational phosphodiesterase 10A (PDE10A) inhibitor that we acquired from Takeda in April 2026. We plan to initially evaluate AXS-20 as a potential treatment for schizophrenia and Tourette syndrome. 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.
Current report
Intangible asset amortization
Current report
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.
Current report
Fair value in contingent consideration
Current report
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 during such period a 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.
Current report
Asset Acquisitions
Current report
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.
Current report
Shelf Registration Statement
Removed paragraphs (5)
Previous report
Auvelity®. Auvelity (dextromethorphan-bupropion) is a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor. Auvelity was developed by the Company and approved by the FDA for the treatment of major depressive disorder (MDD) in adults in August 2022. We initiated the commercial launch of Auvelity in the United States in October 2022. We refer to the proprietary dextromethorphan-bupropion formulation contained in Auvelity as AXS-05. As used in this report, “Auvelity” refers to AXS-05 approved by the FDA for the treatment of MDD in adults, and “AXS-05” refers to, where applicable, Auvelity as well as AXS-05 for the treatment of indications beyond MDD in adults.
Previous report
We are advancing a diversified, late-stage pipeline of novel product candidates for serious neurological and psychiatric conditions.
Previous report
Reserves for Variable Consideration
Previous report
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. We estimate 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.
Previous report
In June 2023, we completed an underwritten public offering of our common stock and sold 3.0 million shares of our common stock at a public offering price of $75.00 per share. Net proceeds were $211.3 million, net of underwriting discounts and commissions of $13.5 million and other offering costs of $0.2 million. Additionally, in connection with this public offering, in July 2023, the underwriters fully exercised their option to purchase 450,000 additional shares of our common stock, at a public offering price of $75.00 per share. The net proceeds were $31.7 million, net of underwriting discounts and commissions of $2.0 million and other minimal offering costs.
Reworded paragraphs (45)
Previous wording
The following discussion and analysis contains 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.
Current wording
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.
Previous wording
We are a biopharmaceutical company dedicated to the development and commercialization of innovative medicines for people living central nervous system (“CNS”) conditions.
Current wording
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.
Previous wording
Sunosi®. Sunosi (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT 1A agonist. Sunosi was approved for the treatment of EDS in adult patients with narcolepsy or obstructive sleep apnea (OSA) by the FDA in 2019 and by the European Commission in 2020. 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. As used in this report, “Sunosi” refers to solriamfetol approved for the treatment of EDS in patients with narcolepsy or OSA, and “solriamfetol” refers to, where applicable, Sunosi as well as solriamfetol for the treatment of indications beyond EDS in patients with narcolepsy or OSA.
Current wording
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.
Previous wording
Symbravo®. Symbravo (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT 1B/1D agonist. Symbravo was developed by the Company and approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. We initiated the commercial launch of Symbravo in the United States in June 2025.
Current wording
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.
Previous wording
AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease agitation, or AD agitation, and 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. We have submitted a supplemental NDA (sNDA) to the FDA for AXS-05 in AD agitation supported by four completed Phase 3, placebo-controlled efficacy trials and a long-term safety trial. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.
Current wording
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.
Previous wording
Solriamfetol is a novel, oral, investigational DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (“ADHD”), major depressive disorder (MDD) with EDS, binge eating disorder (“BED”) and excessive sleepiness associated with shift work disorder (“SWD”). In March 2025, we announced topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults, and in April 2025, we announced topline results from the PARADIGM Phase 3 trial of solriamfetol in MDD. Enrollment for the ENGAGE and SUSTAIN Phase 3 trials of solriamfetol in BED and SWD, respectively, are ongoing.
Current wording
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 topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults. We plan to conduct two pediatric Phase 3 trials of solriamfetol in ADHD, one in children and one in adolescents. In April 2025, we announced topline results from the PARADIGM Phase 3 trial of solriamfetol in MDD. We are conducting 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.
Previous wording
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 successfully completed three Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. AXS-12 has been granted FDA Orphan Drug Designation for narcolepsy.
Current wording
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 successfully completed three Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. In December 2025, we received formal pre-NDA meeting minutes from the FDA supporting an NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy. AXS-12 was previously granted FDA Orphan Drug Designation for narcolepsy.
Previous wording
AXS-14 (esreboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. In May 2025, we announced that we submitted an NDA to the FDA for AXS-14 for the management of fibromyalgia. In June 2025, we received a Refusal to File letter from the FDA for the NDA. To address the FDA’s feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA.
Current wording
AXS-14 (esreboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. In May 2025, we submitted an NDA to the FDA for AXS-14 for the management of fibromyalgia based on the previously completed efficacy and safety trials. Following a preliminary review, the FDA determined that the NDA was not sufficiently complete to permit a substantive review, indicating that one of the two placebo-controlled trials included in the submission was not adequate and well-controlled due to its 8-week primary endpoint and flexible-dose design, while confirming that the other trial, which utilized a 12-week primary endpoint and a fixed-dose paradigm, was adequate and well-controlled. The FDA did not raise any concerns regarding the positive results of either trial, both of which met their primary endpoints. We are conducting the FORWARD Phase 3 trial to address the FDA’s feedback.
Previous wording
Our ability to become profitable depends on our ability to generate revenue. We have begun commercial sales of Auvelity, Sunosi, and Symbravo, but we have limited experience with commercializing these, or any, products.
Current wording
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.
Previous wording
We have incurred significant operating and net losses since inception. We incurred net losses of $154.6 million and $212.3 million for the nine months ended September 30, 2025 and 2024, respectively. Our accumulated deficit as of September 30, 2025 was $1,277.4 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.
Current wording
We have incurred significant operating and net losses since inception. We incurred net losses of $64.5 million and $59.4 million for the three months ended March 31, 2026 and 2025, respectively. Our accumulated deficit as of March 31, 2026 was $1,370.5 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.
Previous wording
We generated total revenues of $171.0 million and $104.8 million in the three months ended September 30, 2025 and 2024, respectively, and $442.5 million and $266.9 million in the nine months ended September 30, 2025 and 2024, respectively.
Current wording
We generated total revenues of $191.2 million and $121.5 million in the three months ended March 31, 2026 and 2025, respectively.
Previous wording
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 $1.2 million and $1.0 million for the three months ended September 30, 2025 and 2024, respectively, and $3.4 million and $2.6 million for the nine months ended September 30, 2025 and 2024, respectively, related to Pharmanovia’s sales of Sunosi.
Current wording
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 $1.3 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively, related to Pharmanovia’s sales of SUNOSI.
Previous wording
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.
Current wording
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.
Previous wording
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, 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.
Current wording
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.
Previous wording
Except for the Medicare Part D Program Redesign, as discussed above, there have been no material changes to the critical accounting policies disclosed in our 2024 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.
Current wording
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.
Previous wording
Product sales, net. Auvelity U.S. net sales were $136.1 million and $352.0 million for the three and nine months ended September 30, 2025, respectively, as compared to $80.4 million and $198.8 million for the same periods in 2024. Sunosi net sales were $31.6 million and $84.6 million for the three and nine months ended September 30, 2025, respectively, as compared to $23.4 million and $65.6 million for the same periods in 2024. We began commercial sales of Symbravo in June 2025 and had U.S. net sales of $2.1 million and $2.5 million for the three and nine months ended September 30, 2025. There were no Symbravo sales recorded in 2024, which reflects the timing of the Symbravo approval and launch. The increases in both comparable periods were primarily due to the increase in unit sales volume for both Auvelity and Sunosi, and commercial launch of Symbravo in June 2025.
Current wording
Product sales, net. AUVELITY U.S. net sales were $152.7 million and $96.2 million for the three months ended March 31, 2026 and 2025, respectively. SUNOSI net sales were $32.6 million and $24.1 million for the three months ended March 31, 2026 and 2025, respectively. We began commercial sales of SYMBRAVO in June 2025 and had U.S. net sales of $4.1 million for the three months ended March 31, 2026. There were no SYMBRAVO sales recorded during the same period in 2025, which reflects the timing of the SYMBRAVO approval and launch. The increases in product sales were primarily due to the increase in unit sales volume for both AUVELITY and SUNOSI, and the commercial launch of SYMBRAVO.
Previous wording
The following table summarizes the activity of our sales allowance and reserves as of and for the nine months ended September 30, 2025 (in thousands):
Current wording
The following table summarizes the activity of our sales allowance and reserves as of and for the three months ended March 31, 2026 (in thousands):
Previous wording
Royalty revenue. In connection with the February 2023 Pharmanovia License Agreement to commercialize Sunosi in certain ex-U.S. markets, we recognized royalty revenue of $1.2 million and $3.4 million for the three and nine months ended September 30, 2025, respectively, as compared to $1.0 million and $2.6 million for the same periods in 2024 attributable to Pharmanovia sales of Sunosi in the out-licensed markets. The increases in both comparable periods were in line with the increase in unit sales volume of Sunosi in certain ex-U.S. markets.
Current wording
Royalty revenue and milestone revenue. Royalty revenue was $1.3 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively, 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, in the first quarter of 2026, we recognized milestone revenue of $0.5 million related to an achievement of a regulatory milestone for AUVELITY.
Previous wording
Cost of revenue. Cost of revenue was $11.9 million and $35.1 million for the three and nine months ended September 30, 2025, respectively, as compared to $8.4 million and $22.8 million for the same periods in 2024. The increase was in line with the increase in sales of Auvelity and Sunosi, and commercial launch of Symbravo in June 2025.
Current wording
Cost of revenue. Cost of revenue was $14.7 million for the three months ended March 31, 2026, as compared to $9.8 million for the same period in 2025. The increase was in line with the increase in sales of AUVELITY and SUNOSI, and the commercial launch of SYMBRAVO in June 2025.
Previous wording
Research and development. The following table summarizes our research and development expenses for our primary products for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Current wording
Research and development. The following table summarizes our research and development expenses for our primary products for the three months ended March 31, 2026 and 2025 (in thousands):
Previous wording
(*) Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs.
Current wording
(*) 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.
Previous wording
Research and development expenses decreased by $5.2 million and increased by $2.4 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024. The decrease in the three months ended comparable period was due to the completion of trials for solriamfetol in ADHD and MDD and a refund of a regulatory filing fee related to AXS-14, partially offset by ongoing supplier validation costs for AXS-07. The increase in the nine months ended comparable period was due to the ongoing supplier validation costs for AXS-07, partially offset by lower spending due to completion of trials for MDD and ADHD for solriamfetol. We expect research and development costs to moderately increase through the end of 2025 and into 2026 as new development programs commence while certain development programs near completion.
Current wording
Research and development expenses increased by $7.9 million for the three months ended March 31, 2026, as compared to the same periods in 2025. The increase was primarily related to asset acquisition costs related to AXS-20. We expect research and development costs to moderately increase through the end of 2026 as new development programs commence.
Previous wording
Selling, general and administrative. Selling, general and administrative expenses were $150.2 million and $401.3 million for the three and nine months ended September 30, 2025, respectively, as compared to $95.6 million and $298.1 million for the same periods in 2024. The increases in both comparable periods were related to higher commercial activities for Auvelity, including a sales force expansion and a national direct-to-consumer advertising campaign, commercial launch of Symbravo, and higher personnel costs related to organizational growth, including non-cash stock-based compensation. We anticipate modest growth in SG&A expenses through 2025 and into 2026 as we increase marketing and promotional spending for Auvelity.
Current wording
Selling, general and administrative. Selling, general and administrative expenses were $185.0 million for the three months ended March 31, 2026, as compared to $120.8 million for the same period in 2025. The increase was primarily related to pre-launch activities for Auvelity for the Alzheimer’s Disease Agitation indication, 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 to increase marketing and promotional spending for AUVELITY and continue commercial activities for SYMBRAVO.
Previous wording
Loss in Fair Value of Contingent Consideration. The $13.2 million and $6.6 million changes for the three and nine months ended September 30, 2025, respectively, as compared to $16.4 million and $17.1 million changes for the same periods in 2024, were primarily related to changes in significant unobservable inputs, including discount rates.
Current wording
Loss in Fair Value of Contingent Consideration. The $0.6 million change for the three months ended March 31, 2026, as compared to $1.5 million change for the same period in 2025, was primarily related to changes in significant assumptions, including future sales estimates, and significant unobservable inputs, including discount rates.
Previous wording
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 September 30, 2025 and 2024 and $4.8 million for both the nine months ended September 30, 2025 and 2024.
Current wording
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 March 31, 2026 and 2025.
Previous wording
Interest expense, net. Interest expense, net was $1.1 million and $5.4 million for the three and nine months ended September 30, 2025, respectively, as compared to $2.0 million and $4.4 million for the same periods in 2024. The decrease in the three months ended comparable period was due to the lower interest expense from the Blackstone Loan Agreement, which was partially offset by less interest income on lower cash balances. The increase in the nine months ended comparable period was mainly due to less interest income on lower cash balances.
Current wording
Interest expense, net. Interest expense, net was $1.2 million for the three months ended March 31, 2026, as compared to $2.4 million for the same period 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.
Previous wording
Income tax expense. We did not record an income tax expense or benefit for the three months ended September 30, 2025. We recorded a tax benefit of $1.0 million for the nine months ended September 30, 2025 due to favorable return-to-provision adjustments attributable to certain foreign tax returns filed during July 2025 that were recorded as a discrete tax benefit in the second quarter of 2025. We did not record an income tax benefit or expense for the same periods in 2024.
Current wording
Income tax expense. We did not record an income tax expense or benefit for the three months ended March 31, 2026. We did not record an income tax benefit or expense for the same period in 2025.
Previous wording
Net loss. Net loss was $47.2 million and $154.6 million for the three and nine months ended September 30, 2025, respectively, as compared to $64.6 million and $212.3 million for the same periods in 2024. The decreases in both comparable periods were primarily due to higher sales which was partially offset by higher research and development spend from ongoing clinical trial expenses, higher selling, general and administrative expenses from commercial activities related to Auvelity and Symbravo, including sales force and marketing spend, and higher personnel costs due to organizational growth, including non-cash stock compensation expense.
Current wording
Net loss. Net loss was $64.5 million for the three months ended March 31, 2026, as compared to $59.4 million for the same period 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, as well as an increase in research and development expenses primarily related to asset acquisition costs. This was partially offset by higher net product revenues from AUVELITY, SUNOSI, and SYMBRAVO.
Previous wording
In March 2022, we entered into a sales agreement, 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 prior at-the-market offering program.
Current wording
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.
Previous wording
Under the March 2022 Sales Agreement, for the nine months ended September 30, 2025, we received approximately $47.2 million in gross proceeds through the sale of 411,482 shares, of which net proceeds were approximately $46.3 million.
Current wording
Under the March 2022 Sales Agreement, for the three months ended March 31, 2026, we received approximately $6.3 million in gross proceeds through the sale of 35,802 shares, of which net proceeds were approximately $6.2 million.
Previous wording
On February 21, 2023, we entered into a Sublease with Advance Magazine Publishers d/b/a Conde Nast for the entirety of the twenty-second floor of One Word Trade Center in New York, NY, or the Initial Sublease.
Current wording
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.
Previous wording
On January 17, 2025, we entered into an Amendment to our Sublease, or 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 Initial 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. The Company is 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 Initial Sublease and First Amendment, we received certain rent and work concessions from the sublandlord.
Current wording
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.
Previous wording
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. See Note 9. Commitments and Contingencies for further information on future contractual obligations.
Current wording
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.
Previous wording
As described below in the “Loan Agreement with Blackstone” section, on May 8, 2025, we 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 our party thereto as guarantors, Wilmington Trust, National Association, as agent, 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.
Current wording
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.
Previous wording
Operating Activities. Cash used in operating activities for the nine months ended September 30, 2025 was $74.8 million, as compared to $102.2 million for the same period in 2024. The decrease of $27.4 million was primarily due to higher net product revenues from Auvelity and Sunosi in 2025, which was partially offset by an increase in cash used in commercial and clinical related activities.
Current wording
Operating Activities. Cash used in operating activities for the three months ended March 31, 2026 was $20.7 million, as compared to $43.4 million for the same period in 2025. The decrease of $22.7 million was primarily due to higher net product revenues from AUVELITY and SUNOSI, and favorable working capital changes, including higher accounts payable and accrued expenses and other current liabilities, partially offset by increased cash used for commercial and clinical-related activities.
Previous wording
Investing Activities. Cash used in investing activities for the nine months ended September 30, 2025 was $409 thousand, as compared to $240 thousand for the same period in 2024. The increase was attributable to additional equipment purchases in 2025 to support our expanded office space and workforce.
Current wording
Investing Activities. Cash used in investing activities for the three months ended March 31, 2026 was $121 thousand, as compared to $338 thousand for the same period in 2025. The decrease was due to higher purchases of fixed assets in the first quarter of 2025 related to the new corporate office space lease.
Previous wording
Financing Activities. Cash provided by financing activities was $85.1 million for the nine months ended September 30, 2025, which included net proceeds of $256.4 million from draw-downs related to the Blackstone Loans and net proceeds of $61.1 million from issuance of common stock for financing purposes as well as proceeds of $44.2 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 and revolving loan commitments under the Blackstone Loan Agreement, for a total of $262.0 million, and payments of contingent consideration and tax withholdings on stock awards, for a total of $13.1 million. Cash provided by financing activities was $43.6 million for the nine months ended September 30, 2024, which included net proceeds of $23.9 million from issuance of common stock for financing purposes as well as proceeds of $29.5 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $9.2 million.
Current wording
Financing Activities. Cash provided by financing activities was $3.0 million for the three months ended March 31, 2026, which primarily included net proceeds of $6.2 million from issuance of common stock for financing purposes as well as proceeds of $10.0 million from the issuance of common stock upon the exercise of employee stock options, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $12.6 million. Financing activities also include $70.0 million in gross proceeds from the Blackstone revolving credit facilities and $70.0 million in repayments for the Blackstone revolving credit facilities. Cash provided by financing activities was $29.3 million for the three months ended March 31, 2025, which included net proceeds of $19.3 million from issuance of common stock from the at-the-market offering program as well as proceeds of $17.0 million from the issuance of common stock upon the exercise of employee stock options, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $6.6 million.
Previous wording
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 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.
Current wording
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.
Previous wording
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 esreboxetine. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14.
Current wording
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.
Previous wording
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 and Blackstone.
Current wording
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.
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