Alkermes plc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Alkermes plc. has submitted its comprehensive 2023 annual report on Form 10-K, detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

Alkermes plc. (ALKS) filed a Annual Report (10-K) with the SEC on February 21, 2024. Alkermes plc. filed its annual report on Form 10-K for the fiscal year ending December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal executive offices are located in Dublin, Ireland. Alkermes plc. is classified under the SIC code 2834 for Pharmaceutical Preparations. The filing was made on February 21, 2024.

Why It Matters

For investors and stakeholders tracking Alkermes plc., this filing contains several important signals. This 10-K filing provides investors and stakeholders with a detailed overview of Alkermes' financial health, strategic initiatives, and risk factors for the past fiscal year. The report is crucial for understanding the company's performance in the pharmaceutical preparations sector and its outlook for the upcoming year.

Risk Assessment

Risk Level: medium — Alkermes plc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as evidenced by the numerous disclosures typical in a 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to assess Alkermes' performance and potential future challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period for the 10-K)
• 2024-02-21 — Filing Date (Date the 10-K was submitted)
• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations)

Key Players & Entities

• Alkermes plc. (company) — Filer of the 10-K
• McKesson Corporation (company) — Customer concentration risk related to Revenues Net
• Cardinal Health (company) — Credit concentration risk related to Accounts Receivable
• Rodin Therapeutics (company) — Incorporation context
• Baudax Bio Inc (company) — Related entity context

FAQ

Industry Context

Alkermes plc. operates within the pharmaceutical preparations industry, focusing on the development and commercialization of medicines for central nervous system disorders.

Regulatory Implications

As a pharmaceutical company, Alkermes is subject to extensive regulation by health authorities like the FDA in the US and EMA in Europe, impacting drug approval, manufacturing, and marketing.

What Investors Should Do

1. Analyze Alkermes' revenue streams and product performance for the fiscal year 2023.
2. Examine the company's disclosed risk factors, particularly those related to regulatory changes and market competition.
3. Review management's discussion and analysis of financial condition and results of operations.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K
• 2024-02-21: Filing Date — Date the 10-K was officially submitted to the SEC

Year-Over-Year Comparison

This filing represents the company's annual update for the fiscal year 2023, following previous filings which would have detailed prior periods.

Key Financial Figures

• $0.01 — on which registered Ordinary shares, $0.01 par value ALKS Nasdaq Global Select

Filing Documents

• alks-20231231.htm (10-K) — 4363KB
• alks-ex2_1.htm (EX-2.1) — 1262KB
• alks-ex3_1.htm (EX-3.1) — 473KB
• alks-ex4_1.htm (EX-4.1) — 97KB
• alks-ex10_5.htm (EX-10.5) — 322KB
• alks-ex10_16.htm (EX-10.16) — 799KB
• alks-ex10_13a.htm (EX-10.13A) — 32KB
• alks-ex10_25m.htm (EX-10.25M) — 37KB
• alks-ex10_25n.htm (EX-10.25N) — 33KB
• alks-ex10_5a.htm (EX-10.5A) — 151KB
• alks-ex21_1.htm (EX-21.1) — 14KB
• alks-ex23_1.htm (EX-23.1) — 3KB
• alks-ex31_1.htm (EX-31.1) — 16KB
• alks-ex31_2.htm (EX-31.2) — 16KB
• alks-ex32_1.htm (EX-32.1) — 19KB
• alks-ex97.htm (EX-97) — 45KB
• img76622712_0.jpg (GRAPHIC) — 88KB
• img76622712_1.jpg (GRAPHIC) — 132KB
• img76622712_2.jpg (GRAPHIC) — 42KB
• img76622712_3.jpg (GRAPHIC) — 21KB
• img76622712_4.jpg (GRAPHIC) — 97KB
• 0000950170-24-017883.txt (&nbsp;) — 22430KB
• alks-20231231.xsd (EX-101.SCH) — 2328KB
• alks-20231231_htm.xml (XML) — 3694KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 51 Item 1C. Cybersecurity 51 Item 2.

Properties

Properties 52 Item 3.

Legal Proceedings

Legal Proceedings 52 Item 4. Mine Safety Disclosures 52 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 53 Item 6. [Reserved] 55 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 56 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 68 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures 70 Item 9A.

Controls and Procedures

Controls and Procedures 70 Item 9B. Other Information 70 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 71 PART III Item 10. Directors, Executive Officers and Corporate Governance 72 Item 11.

Executive Compensation

Executive Compensation 72 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 72 Item 13. Certain Relationships and Related Transactions, and Director Independence 72 Item 14. Principal Accounting Fees and Services 72 PART IV Item 15. Exhibits and Financial Statement Schedules 73 Item 16. Form 10-K Summary 80

SIGNATURES

SIGNATURES 81 2 CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS This document contains and incorporates by reference "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). In some cases, these statements can be identified by the use of forward-looking terminology such as "may," "will," "could," "should," "would," "expect," "anticipate," "continue," "believe," "plan," "estimate," "intend," or other similar words. These statements discuss future expectations and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward-looking statements in this Annual Report on Form 10-K (this "Annual Report") may include, without limitation, statements regarding: our expectations regarding our financial performance, including revenues, expenses, liquidity, capital expenditures, income taxes and potential profitability; our expectations regarding our products, including expectations related to product development, regulatory filings, approvals and timelines; therapeutic and commercial value, scope and potential; and the costs and expenses related to such activities and expectations; our expectations regarding the initiation, timing and results of clinical trials of our products; our expectations regarding the competitive, payer, legislative, regulatory and policy landscape, and changes therein, related to our products, including competition from generic forms of our products or competitive products and development programs; barriers to access or coverage of our products and potential changes in reimbursement of our products; and legislation, regulations, executive orders, guidance or other measures that may impact pricing and reimbursement of, and access to, our products; our expectations regarding the

Business

Item 1. Business The following discussion contains forward-looking statements. Actual results may differ significantly from those expressed or implied in the forward-looking statements. See "Cautionary Note Concerning Forward-Looking Statements" on page 3 of this Annual Report. Factors that might cause future results to differ materially from those expressed or implied in the forward-looking statements include, but are not limited to, those discussed in "Item 1A—Risk Factors" and elsewhere in this Annual Report. Overview Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. Marketed Products The key marketed products discussed below have generated, or are expected to generate, significant revenues for us. See "Patents and Proprietary Rights" in "Item 1—Business" in this Annual Report for information with respect to the IP protection for these marketed products. The following provides summary information regarding our proprietary products that we commercialize: Proprietary Products Product Indication(s) Territory Initiation or re-initiation of ARISTADA for the treatment of Schizophrenia U.S. Schizophrenia U.S. 6 Schizophrenia; Bipolar I disorder U.S. Alcohol dependence; Opioid dependence U.S. 7 The following provides summary information regarding our key licensed product, and certain key third-party products using our proprietary technologies under license, that are commercialized by our lice