Axsome Therapeutics Inc

Previous wording

Auvelity®. Auvelity (dextromethorphan-bupropion) is a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity indicated to the treatment of major depressive disorder, also known as MDD. Auvelity was developed by the Company and approved by the FDA for the treatment of MDD in August 2022. We commenced the commercial sale of Auvelity in the United States in October 2022.

Current wording

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 wording

Sunosi®. Sunosi (solriamfetol) is a novel, oral medication indicated to the treatment of excessive daytime sleepiness, also known as EDS, in patients with narcolepsy or obstructive sleep apnea. Sunosi was approved for the treatment of EDS in the United States in 2019 and by the European Commission in 2022. We acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals plc, or Jazz, in May 2022 and worldwide 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 announced a licensing transaction, or the Pharmanovia License Agreement, with Atnahs Pharma UK Limited, or Pharmanovia, to market Sunosi in Europe and certain countries in the Middle East and North Africa, or the Territory.

Current 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.

Previous wording

When used in programs for further development, we refer to the proprietary dextromethorphan-bupropion formulation contained in Auvelity as “AXS-05.” AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity under development 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 completed a Phase 2/3 trial of AXS-05 in AD agitation, which we refer to as the ADVANCE-1 trial. AXS-05 achieved the primary endpoint in the ADVANCE-1 trial. We have also completed the ACCORD-1 trial, a Phase 3, double blind, placebo-controlled, randomized withdrawal trial in patients with AD agitation, and we are conducting an open-label long-term safety study in AD agitation. We are currently conducting the ADVANCE-2 trial, another Phase 3, double blind, placebo-controlled, trial in patients with AD agitation. We are also conducting the ACCORD-2 study, a Phase 3, double-blind, placebo-controlled, randomized withdrawal trial in patients with AD agitation. A positive Phase 2 trial for the use of AXS-05 in smoking cessation has been completed under a research collaboration with Duke University.

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 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 successfully completed the Phase 3 clinical program of AXS-05 in AD agitation consisting of four Phase 3, placebo-controlled efficacy trials and a long-term safety trial. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.

Previous wording

AXS-14, esreboxetine, is a novel, oral, investigational medicine in development for the treatment of fibromyalgia. AXS-14 is a highly selective and potent norepinephrine reuptake inhibitor. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. We have in-licensed data from Pfizer Inc., or Pfizer, which includes a completed Phase 2 trial and Phase 3 trial in fibromyalgia, both of which were positive.

Current 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. We have submitted an NDA to the FDA for AXS-14 for the management of fibromyalgia.

Previous wording

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 and Sunosi. 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.

Current wording

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, the commercial launches of Auvelity and Sunosi, and preparatory activities for the launch of 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.

Previous wording

Our ability to become profitable depends on our ability to generate revenue. We have begun commercial sales of Auvelity and Sunosi, 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. We have begun commercial sales of Auvelity and Sunosi, and plan to commercially launch Symbravo, but we have limited experience with commercializing these, or any, products.

Previous wording

We have incurred significant operating and net losses since inception. We incurred net losses of $212.3 million and $140.6 million for the nine months ended September 30, 2024 and 2023, respectively. Our accumulated deficit as of September 30, 2024 was $1,047.9 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 currently marketed 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 $59.4 million and $68.4 million for the three months ended March 31, 2025 and 2024, respectively. Our accumulated deficit as of March 31, 2025 was $1,182.2 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 expect that Auvelity and Sunosi 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.

Current wording

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.

Previous wording

We received an upfront payment of €62.0 million ($65.7 million) during the first quarter of 2023 and 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 $1.0 million and $0.7 million for the three months ended September 30, 2024 and 2023, respectively, and $2.6 million and $1.6 million for the nine months ended September 30, 2024 and 2023, 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 $1.1 million and $0.9 million for the three months ended March 31, 2025 and 2024, respectively, related to Pharmanovia’s sales of Sunosi.

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 a new drug application, or 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 and Sunosi 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, 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

Selling, general and administrative expenses primarily 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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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 U.S. 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.

Current wording

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.

Previous wording

There have been no material changes to the critical accounting policies disclosed in our 2023 Annual Report on Form 10-K, except for revenue recognition related to license agreements. 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

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.

Previous wording

The following table summarizes our results of operations for the periods indicated (in thousands):

Current wording

The following table summarizes our results of operations for the periods indicated (in thousands, except share and per share amounts):

Previous wording

Product sales, net. Auvelity U.S. net sales were $80.4 million and $198.8 million for the three and nine months ended September 30, 2024, respectively, as compared to $37.7 million and $81.0 million for the same periods in 2023. Sunosi net sales were $23.4 million and $65.6 million for the three and nine months ended September 30, 2024, respectively, as compared to $19.4 million and $50.7 million for the same periods in 2023. The increases in both comparable periods were primarily due to the increase in unit sales volume for both Auvelity and Sunosi.

Current wording

Product sales, net. Auvelity U.S. net sales were $96.2 million and $53.4 million for the three months ended March 31, 2025 and 2024, respectively. Sunosi net sales were $24.1 million and $20.7 million for the three months ended March 31, 2025 and 2024, respectively. The increases in product sales were primarily due to the increase in unit sales volume for both Auvelity and Sunosi.

Previous wording

The following table summarizes the activity of our sales allowance and reserves as of and for the nine months ended September 30, 2024 (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, 2025 (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 $1.0 million and $2.6 million for the three and nine months ended September 30, 2024, respectively, as compared to $0.7 million and $1.6 million for the same periods in 2023 attributable to Pharmanovia sales of Sunosi in the out-licensed markets.

Current 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 $1.1 million and $0.9 million for the three months ended March 31, 2025 and 2024, 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.

Previous wording

Cost of revenue. Cost of revenue was $8.4 million and $22.8 million for the three and nine months ended September 30, 2024, respectively, as compared to $6.5 million and $18.7 million for the same periods in 2023. The increases in both comparable periods were in line with the increase in sales of Auvelity and Sunosi. Cost of revenue for the nine months ended September 30, 2023 includes $5.0 million in-license revenue sharing expense related to the Pharmanovia License Agreement.

Current wording

Cost of revenue. Cost of revenue was $9.8 million for the three months ended March 31, 2025, as compared to $6.3 million for the same period in 2024. The increase was in line with the increase in sales of Auvelity and Sunosi.

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, 2024 and 2023 (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, 2025 and 2024 (in thousands):

Previous wording

(*) Other research and development expenses primarily consist of costs related to other product candidates, facilities and overhead costs

Current 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.

Previous wording

Research and development expenses increased by $16.6 million and $65.0 million for the three and nine months ended September 30, 2024, respectively, as compared to the same periods in 2023. The increases in both comparable periods were primarily related to the Phase 3 trials for additional indications, including studies in ADHD, MDD, BED, and SWD, for solriamfetol, the advancement of ongoing Phase 3 trials of AXS-05 and AXS-12, higher manufacturing costs for AXS-07 and AXS-14, and higher personnel costs due to organizational growth. We expect research and development costs to stabilize at current levels as existing trials near completion while new trials are initiated.

Current wording

Research and development expenses increased by $8.0 million for the three months ended March 31, 2025, as compared to the same period in 2024. The increase was primarily related to the ongoing Phase 3 trials for solriamfetol and AXS-12, higher pre-FDA approval activity costs for AXS-07, and higher personnel costs due to organizational growth. We expect research and development costs to increase moderately from current levels as we continue to further develop our current and future product candidates.

Previous wording

Selling, general and administrative. Selling, general and administrative expenses were $95.6 million and $298.1 million for the three and nine months ended September 30, 2024, respectively, as compared to $83.2 million and $236.3 million for the same periods in 2023. The increases in both comparable periods were primarily related to greater commercial activities for Auvelity and Sunosi, and higher personnel costs related to organizational growth, including non-cash stock-based compensation. We expect selling, general and administrative expenses to increase as we expand marketing, promotional, and advertising costs for Auvelity, Sunosi, and potential future product launches.

Current wording

Selling, general and administrative. Selling, general and administrative expenses were $120.8 million for the three months ended March 31, 2025, as compared to $99.0 million for the same period in 2024. The increase was primarily related to higher commercial activities for Auvelity, launch readiness activities for Symbravo, and higher personnel costs related to organizational growth, including non-cash stock-based compensation. We expect selling, general and administrative expenses to increase as we expand marketing, promotional, and advertising costs for Auvelity, and prepare for the launch of Symbravo and other potential product launches.

Previous wording

Loss in Fair Value of Contingent Consideration. The loss positions of $16.4 million and $17.1 million for the three and nine months ended September 30, 2024, respectively, as compared to a gain position of $0.2 million and a loss position of $5.7 million for the same periods in 2023, respectively, are related to changes in significant unobservable inputs, including discount rates, and significant assumptions, including future sales estimates.

Current wording

Loss (Gain) in Fair Value of Contingent Consideration. The $1.5 million change for the three months ended March 31, 2025, as compared to a $1.4 million change for the same period in 2024, was primarily related to changes in 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, 2024 and 2023, and $4.8 million for both the nine months ended September 30, 2024 and 2023.

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, 2025 and 2024.

Previous wording

Interest expense, net. Interest expense, net, was $2.0 million and $4.4 million for the three and nine months ended September 30, 2024, respectively, as compared to $0.8 million and $5.8 million for the same periods in 2023. The increase in the three months ended comparable period was mainly due to less interest income on lower cash balances. The decrease in the nine months ended comparable period was mainly due to greater interest income on higher cash balances, which partially offset the interest expense, issuance costs, and fees related to the Loan Agreement.

Current wording

Interest expense, net. Interest expense, net was $2.4 million for the three months ended March 31, 2025, as compared to $1.1 million for the same period in 2024. The increase was mainly due to less interest income on lower cash balances.

Previous wording

Income tax expense. We did not record an income tax expense for the three and nine months ended September 30, 2024 due to losses incurred in all jurisdictions during the quarter from which we do not benefit due to the full valuation allowance position against our deferred tax assets. We recorded a tax benefit of $0.7 million for the three months ended September 30, 2023 and tax expense of $1.3 million for the nine months ended September 30, 2023 due to income earned in Malta in relation to the license revenue recognized from the Pharmanovia License Agreement.

Current wording

Income tax expense. We did not record an income tax expense for both the three months ended March 31, 2025 and 2024 due to losses incurred in all jurisdictions during the quarter from which we do not benefit due to the full valuation allowance position against our deferred tax assets.

Previous wording

Net loss. Net loss was $64.6 million and $212.3 million for the three and nine months ended September 30, 2024, respectively, as compared to $62.2 million and $140.6 million for the same periods in 2023. The increases in both comparable periods are primarily due to higher research and development spend from pre-clinical and ongoing clinical trial expenses, higher selling, general and administrative expenses from commercial activities related to Auvelity and Sunosi, including sales force and marketing spend, and higher personnel costs due to organizational growth, including non-cash stock compensation expense. Additionally, the increase in net loss for the nine months ended September 30, 2024, in comparison to the same period in 2023, was impacted by the upfront payment of $65.7 million received from Pharmanovia in the first quarter of 2023.

Current wording

Net loss. Net loss was $59.4 million for the three months ended March 31, 2025, as compared to $68.4 million for the same period in 2024. The decrease was 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, Sunosi, and Symbravo, including sales force and marketing spend, and higher personnel costs due to organizational growth, including non-cash stock compensation expense.

Previous wording

Under the March 2022 Sales Agreement, for the nine months ended September 30, 2024, we received approximately $24.4 million in gross proceeds through the sale of 297,135 shares, of which net proceeds were approximately $23.9 million. We did not utilize the March 2022 Sales Agreement with Leerink during the three months ended March 31, 2024. We also did not utilize the March 2022 Sales Agreement with Leerink during the year ended December 31, 2023.

Current wording

Under the March 2022 Sales Agreement, for the three months ended March 31, 2025, we received approximately $19.7 million in gross proceeds through the sale of 156,484 shares, of which net proceeds were approximately $19.3 million. We did not utilize the March 2022 Sales Agreement with Leerink during the three months ended March 31, 2024.

Previous wording

In January 2023, we entered into a Third Amendment to the Loan Agreement, or the Third Amendment, with Hercules. The Third Amendment increased the size of the Term Loan Advance (as defined in the Loan Agreement) to $350.0 million, reduces the interest rate, and extends the maturity and interest-only period of the Loan Agreement. In September 2024, we entered into a Fifth Amendment to the Loan Agreement, or the Fifth Amendment, with Hercules. The Fifth Amendment amended the terms of the Loan Agreement to, among other things: (i) increase the size of the aggregate principal amount under tranche 3 of the 2020 Term Loan (as defined below) from $75.0 to $80.0 million; (ii) extend the availability periods of certain tranches of the 2020 Term Loan; (iii) alter the terms of the performance covenants contained in the Loan Agreement and also add a new performance covenant; (iv) conditionally waive the minimum cash requirement during such periods of time that Axsome’s market capitalization exceeds $1.5 billion; and (v) permit Axsome Malta Ltd., or the Malta Subsidiary, to request an advance from the Lenders (as defined in the Loan Agreement) up to a certain amount to the extent that Axsome may request an advance in such amount and to increase the amount of cash that the Malta Subsidiary may hold outside of the United States, as set forth in greater detail in the Fifth Amendment. The Company drew down upon tranche 1C of the 2020 Term Loan, and as of September 30, 2024, the Company had approximately $180 million outstanding and $150 million remaining under the 2020 Term Loan. See the “Contractual Obligations and Commitments – January 2023 Third Amendment to the Loan and Security Agreement – Hercules” and “Contractual Obligations and Commitments – September 2024 Fifth Amendment to the Loan and Security Agreement – Hercules” sections below for more information.

Current wording

In January 2023, we entered into a Third Amendment to the Loan Agreement, or the Third Amendment, with Hercules. The Third Amendment increased the size of the Term Loan Advance (as defined in the Loan Agreement) to $350.0 million, reduces the interest rate, and extends the maturity and interest-only period of the Loan Agreement. In September 2024, we entered into a Fifth Amendment to the Loan Agreement, or the Fifth Amendment, with Hercules. The Fifth Amendment amended the terms of the Loan Agreement to, among other things: (i) increase the size of the aggregate principal amount under tranche 3 of the 2020 Term Loan (as defined below) from $75.0 to $80.0 million; (ii) extend the availability periods of certain tranches of the 2020 Term Loan; (iii) alter the terms of the performance covenants contained in the Loan Agreement and also add a new performance covenant; (iv) conditionally waive the minimum cash requirement during such periods of time that Axsome’s market capitalization exceeds $1.5 billion; and (v) permit Axsome Malta Ltd., or the Malta Subsidiary, to request an advance from the Lenders (as defined in the Loan Agreement) up to a certain amount to the extent that Axsome may request an advance in such amount and to increase the amount of cash that the Malta Subsidiary may hold outside of the United States, as set forth in greater detail in the Fifth Amendment. We drew down upon tranche 1C of the 2020 Term Loan, and as of March 31, 2025, we had approximately $180 million outstanding and $150 million remaining under the 2020 Term Loan. See the “Contractual Obligations and Commitments – January 2023 Third Amendment to the Loan and Security Agreement – Hercules” and “Contractual Obligations and Commitments – September 2024 Fifth Amendment to the Loan and Security Agreement – Hercules” sections below, and Note 8. Loan and Security Agreement for more information.

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 Sublease. This space is utilized by the Company for its corporate and executive offices. The Sublease commenced on April 7, 2023 and will run for ten (10) years. The Company has a one-time option to terminate the Sublease on its fifth anniversary 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 Sublease, the Company received certain rent and work concessions from the sublandlord.

Current wording

On January 17, 2025, we entered into an Amendment to our Sublease, or First Amendment, pursuant to which we will relinquish our existing space in One World Trade Center and commence 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.

Previous wording

Operating Activities. Cash used in operating activities for the nine months ended September 30, 2024 was $102.2 million, as compared to $114.7 million for the nine months ended September 30, 2023. The decrease of $12.5 million was impacted by the upfront payment of $65.7 million received from Pharmanovia in the first quarter of 2023 and higher net product revenues from Auvelity and Sunosi in 2024, which were offset by an increase in cash used in commercial and clinical activities in 2024.

Current wording

Operating Activities. Cash used in operating activities for the three months ended March 31, 2025 was $43.4 million, as compared to $53.5 million for the three months ended March 31, 2024. The decrease of $10.1 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 activities.

Previous wording

Financing Activities. 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. Cash provided by financing activities was $331.0 million for the nine months ended September 30, 2023, which included net proceeds related to the June 2023 public offering of $211.3 million and additional net proceeds of $31.7 million as the underwriters fully exercised their option to purchase additional shares, net proceeds of $82.7 million related to drawing upon tranches of the Loan Agreement with Hercules, and proceeds of $11.2 million from the issuance of common stock upon the exercise of employee stock options, offset by payments of contingent consideration and tax withholdings on stock awards of a total of $6.0 million.

Current wording

Financing Activities. 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 for financing purposes 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. Cash used in financing activities was $1.2 million for the three months ended March 31, 2024, which included payments of contingent consideration and tax withholdings on stock awards for a total of $3.5 million, which was partially offset by proceeds of $2.5 million from the issuance of common stock upon the exercise of employee stock options.

Previous wording

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, and begin to commercialize any additional approved products while further investing in Auvelity and Sunosi. 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.

Current wording

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, and begin to commercially launch Symbravo while further investing in Auvelity and Sunosi. 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.

Previous wording

Under three exclusive license agreements with Antecip Bioventures II LLC, or 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.

Current wording

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.

Previous wording

At the initial closing, we assumed all of the commitments of Jazz to SK and Aerial Biopharma, LLC, or 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 $165.0 million based on revenue milestones and $1.0 million based on development milestones.

Current wording

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 $165.0 million based on revenue milestones and $1.0 million based on development milestones.

Previous wording

As of November 5, 2024, we had 607 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.

Current wording

As of April 28, 2025, we had 712 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.