Axsome Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Axsome Therapeutics filed its 2023 10-K, detailing financial activities and corporate structure.</b>

AI Summary

Axsome Therapeutics, Inc. (AXSM) filed a Annual Report (10-K) with the SEC on February 23, 2024. Axsome Therapeutics, Inc. filed its 2023 Form 10-K on February 23, 2024. The filing covers the fiscal year ending December 31, 2023. Key financial instruments mentioned include warrants and term loans. The company's business address is One World Trade Center, 22nd Floor, New York, NY 10007. Axsome Therapeutics is in the Pharmaceutical Preparations industry (SIC 2834).

Why It Matters

For investors and stakeholders tracking Axsome Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Axsome's financial performance and strategic positioning for the fiscal year 2023, crucial for investors assessing the company's health and future prospects. The detailed financial disclosures, including information on debt, equity, and various financial instruments, are essential for understanding the company's capital structure and risk management strategies.

Risk Assessment

Risk Level: medium — Axsome Therapeutics, Inc. shows moderate risk based on this filing. The company's financial health and operational success are subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, market competition, and R&D outcomes, as detailed in its 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Axsome's growth potential and associated risks.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of report)
• 2024-02-23 — Filing Date (Date the 10-K was filed)
• 2022-01-01 — Reporting Period Start (Example reporting period for expenses and licenses)
• 2023-01-09 — Loan Event Date (Date related to Term Loan 2020 and Tranche One)

Key Players & Entities

• Axsome Therapeutics, Inc. (company) — Filer name
• Hercules Capital Inc. (company) — Mentioned in relation to loan and security agreement
• Jazz Pharmaceuticals Plc (company) — Mentioned in context of Sunosi
• Pfizer Inc. (company) — Mentioned in relation to license agreement terms
• Leerink (company) — Mentioned in context of sales agreement
• One World Trade Center (location) — Business and mail address
• New York (location) — Business and mail address
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive regulation by governmental authorities, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors to develop superior products or offer lower prices.
• Financing Risks [medium — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance that such financing will be available on favorable terms.
• Dependence on Key Personnel [medium — operational]: The success of the company may depend on the continued service of key scientific and management personnel.
• Intellectual Property Risks [medium — legal]: The company's ability to protect its intellectual property and avoid infringing on the intellectual property rights of others is critical.

Key Financial Figures

• $0.0001 — f each class: Common Stock, Par Value $0.0001 Per Share (Title of Class) Trading

Filing Documents

• axsm-20231231.htm (10-K) — 2885KB
• axsm-ex10_2.htm (EX-10.2) — 143KB
• axsm-ex19_1.htm (EX-19.1) — 98KB
• axsm-ex21_1.htm (EX-21.1) — 8KB
• axsm-ex23_1.htm (EX-23.1) — 4KB
• axsm-ex23_2.htm (EX-23.2) — 12KB
• axsm-ex31_1.htm (EX-31.1) — 17KB
• axsm-ex31_2.htm (EX-31.2) — 16KB
• axsm-ex32_1.htm (EX-32.1) — 6KB
• axsm-ex32_2.htm (EX-32.2) — 6KB
• axsm-ex97_1.htm (EX-97.1) — 24KB
• img240245562_0.jpg (GRAPHIC) — 109KB
• img240245562_1.jpg (GRAPHIC) — 283KB
• 0000950170-24-019118.txt (&nbsp;) — 12954KB
• axsm-20231231.xsd (EX-101.SCH) — 1811KB
• axsm-20231231_htm.xml (XML) — 1919KB

Business

Business 4 ITEM 1A

Risk Factors

Risk Factors 42 ITEM 1B Unresolved Staff Comments 100 ITEM 1C Cybersecurity 100 ITEM 2

Properties

Properties 101 ITEM 3

Legal Proceedings

Legal Proceedings 101 ITEM 4 Mine Safety Disclosures 103 PART II ITEM 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 104 ITEM 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 106 ITEM 7A Quantitative and Qualitative Disclosure About Market Risk 121 ITEM 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 121 ITEM 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 122 ITEM 9A

Controls and Procedures

Controls and Procedures 122 ITEM 9B Other Information 123 ITEM 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 123 PART III ITEM 10 Directors, Executive Officers and Corporate Governance 124 ITEM 11

Executive Compensation

Executive Compensation 124 ITEM 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 124 ITEM 13 Certain Relationships and Related Transactions and Director Independence 124 ITEM 14 Principal Accountant Fees and Services 124 PART IV ITEM 15 Exhibits and Financial Statement Schedules 125 ITEM 16 Form 10-K Summary 131

Signatures

Signatures 132 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARDLOOKING STATEMENTS Certain matters discussed in this report, including matters discussed under the caption "Management's Discussion and Analysis of Financial Condition and Results of Operations," may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words "anticipate," "believe," "estimate," "may," "expect" and similar expressions are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under the captions "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this report, as well as other factors which may be identified from time to time in our other filings with the U.S. Securities and Exchange Commission, or the SEC, or in the documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements. Such forward-looking statements include, but are not limited to, statements about: our expectations for increases or decreases in expenses; our expectations for the clinical and preclinical development, manufacturing and regulatory approval of our product candidates, and commercialization of our pharmaceutical products or any other products that we may acquire or in-license; our estimates of the sufficiency of o

BU SINESS

ITEM 1. BU SINESS. OVERVIEW We are a commercial-stage biopharmaceutical company developing and delivering novel therapies for central nervous system, or CNS, conditions that have limited treatment options. By focusing on this therapeutic area, we are addressing significant and growing markets where current treatment options are limited or inadequate. Our portfolio primarily consists of two commercial products and the development programs described below. Commercial Products 1. 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 U.S. Food and Drug Administration, or the FDA, for the treatment of MDD in August 2022. We commenced the commercial sale of Auvelity in the United States in October 2022. 2. 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 with Atnahs Pharma UK Limited (Pharmanovia) to market Sunosi in in Europe and certain countries in the Middle East / North Africa. Development Programs When used in programs for further development, we refer to the proprietary d

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View this 10-K filing on SEC EDGAR