BeiGene, Ltd. Files 2023 Annual Report on Form 10-K

TL;DR

<b>BeiGene, Ltd. has submitted its comprehensive 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

BeiGene, Ltd. (BEIGF) filed a Annual Report (10-K) with the SEC on February 26, 2024. BeiGene, Ltd. filed its annual report for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business is in Pharmaceutical Preparations (SIC 2834). The report was filed on February 26, 2024. The filing is a 10-K form, indicating a comprehensive annual financial disclosure.

Why It Matters

For investors and stakeholders tracking BeiGene, Ltd., this filing contains several important signals. This 10-K filing provides investors with a detailed overview of BeiGene's financial health, operational performance, and strategic direction for the fiscal year 2023. As a pharmaceutical company, the disclosures within this report are crucial for understanding its product development pipeline, market position, and regulatory compliance.

Risk Assessment

Risk Level: — BeiGene, Ltd. 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, which are inherent to its business model.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess BeiGene's growth prospects and potential challenges in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period)
• 2024-02-26 — Filing Date (The date the 10-K was submitted to the SEC)
• 10-K — Form Type (Type of SEC filing)

Key Players & Entities

• BeiGene, Ltd. (company) — Filer of the 10-K report
• 2023-12-31 (date) — Fiscal year end
• 2024-02-26 (date) — Filing date
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation and oversight, which can impact its ability to develop, manufacture, and market its products.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with many companies developing similar products, which could affect BeiGene's market share and profitability.
• Drug Development and Clinical Trials [high — operational]: The success of BeiGene's business depends on its ability to successfully develop and obtain regulatory approval for new drugs, which is a lengthy and uncertain process.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-26: 10-K Filing Date — Official submission date of the annual report to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (Provides investors with detailed financial and operational information about BeiGene for the fiscal year 2023.)

SIC Code 2834

Standard Industrial Classification code for Pharmaceutical Preparations. (Categorizes BeiGene's primary business activity, indicating its industry focus.)

Key Financial Figures

• $0.0001 — resenting 13 Ordinary Shares, par value $0.0001 per share BGNE The NASDAQ Global Select
• $2.5 billion — nerated global revenue of approximately $2.5 billion in 2023, which increased by approximate
• $1.0 b — 2023, which increased by approximately $1.0 billion, while reducing our net loss by a
• $1.1 billion — reducing our net loss by approximately $1.1 billion in comparison to 2022. We currently ha
• $1.5 billion — a, and collaborations that have secured $1.5 billion in collaboration payments to the compan
• $3.2 billion — ly. We had cash and cash equivalents of $3.2 billion as of December 31, 2023. We already hav
• $2.2 billion — ady have substantial product revenue of $2.2 billion including from our cornerstone assets,

Filing Documents

• bgne-20231231.htm (10-K) — 3396KB
• exhibit46-descriptionofsec.htm (EX-4.6) — 174KB
• exhibit1016-consultingagre.htm (EX-10.16) — 96KB
• exhibit1021bmssettlementag.htm (EX-10.21) — 34KB
• exhibit191-insidertradingp.htm (EX-19.1) — 43KB
• exhibit192-specialtradingp.htm (EX-19.2) — 109KB
• exhibit21-2023q4beigeneltd.htm (EX-21) — 65KB
• exhibit231-2023q4.htm (EX-23.1) — 8KB
• exhibit232-2023q4.htm (EX-23.2) — 8KB
• exhibit311-2023q4.htm (EX-31.1) — 10KB
• exhibit312-2023q4.htm (EX-31.2) — 9KB
• exhibit321-2023q4.htm (EX-32.1) — 6KB
• exhibit97-compensationreco.htm (EX-97) — 35KB
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• 0001651308-24-000014.txt (&nbsp;) — 20767KB
• bgne-20231231.xsd (EX-101.SCH) — 111KB
• bgne-20231231_cal.xml (EX-101.CAL) — 132KB
• bgne-20231231_def.xml (EX-101.DEF) — 601KB
• bgne-20231231_lab.xml (EX-101.LAB) — 1209KB
• bgne-20231231_pre.xml (EX-101.PRE) — 919KB
• bgne-20231231_htm.xml (XML) — 2368KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 59 Item 1B. Unresolved Staff Comments 113 Item 1C . Cybersecurity 113 Item 2.

Properties

Properties 114 Item 3.

Legal Proceedings

Legal Proceedings 114 Item 4. Mine Safety Disclosures 115 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 116 Item 6. Reserved 120 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 121 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 134 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 135 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 136 Item 9A.

Controls and Procedures

Controls and Procedures 136 Item 9B. Other Information 137 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 138 PART III Item 10. Directors, Executive Officers and Corporate Governance 139 Item 11.

Executive Compensation

Executive Compensation 139 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 139 Item 13. Certain Relationships and Related Transactions, and Director Independence 139 Item 14. Principal Account an t Fees and Services 139 PART IV Item 15. Exhibits and Financial Statement Schedules 140 Item 16. Form 10K Summary 140

SIGNATURES

SIGNATURES Table of Contents ForwardLooking Statements and Market Data This Annual Report on Form 10K (the "Annual Report") contains forwardlooking statements that involve substantial risks and uncertainties. These forward-looking statements are based on management's current expectations and projections about future events and trends that may affect the business, financial condition, and operating results. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected growth, are forwardlooking statements. Forward-looking statements often include words such as, but not limited to, "aim," "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "goal," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "seek," "should," "target," "will," "would" or the negative of these terms or similar expressions. These forwardlooking statements include, among other things, statements about: our ability to successfully commercialize our approved medicines and to obtain approvals in additional indications and territories for our medicines; our ability to successfully develop and commercialize our in-licensed medicines and drug candidates and any other medicines and drug candidates we may in-license ; our ability to further develop sales and marketing capabilities and launch and commercialize new medicines, if approved ; our ability to maintain and expand regulatory approvals for our medicines and drug candidates, if approved ; the pricing and reimbursement of our medicines and drug candidates, if approved; the initiation, timing, progress and results of our preclinical studies and clinical trials and our research and development programs; our ability to advance our drug candidates into, and successfully complete, clinical trials a

Business

Item 1. Business Overview We are a global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide. We generated global revenue of approximately $2.5 billion in 2023, which increased by approximately $1.0 billion, while reducing our net loss by approximately $1.1 billion in comparison to 2022. We currently have three approved medicines that were internally discovered and developed, including BRUKINSA (zanubrutinib), a small molecule inhibitor of Bruton's Tyrosine Kinase ("BTK") for the treatment of various blood cancers; TEVIMBRA (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and PARTRUVIX (pamiparib), a selective small molecule inhibitor of PARP1 and PARP2. We have obtained approvals to market BRUKINSA in the United States ("U.S."), the People's Republic of China ("China" or the "PRC"), the European Union ("EU"), the United Kingdom ("UK"), Canada, Australia, and additional international markets; TEVIMBRA (tislelizumab) in the EU and China; and PARTRUVIX in China. By leveraging our strong commercial capabilities, we have in-licensed the rights to distribute an additional 14 approved medicines for the China market. Supported by our global clinical development and commercial capabilities, we have entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc. ("Amgen") and Beijing Novartis Pharma Co., Ltd. ("Novartis") to develop and commercialize innovative medicines. We are committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. Recognizing the importance of clinical trial activities in our industry and the challenges associated with outsourcing to third-party contract research organizations ("CROs"), we have built our own 3,000+ person internal clinical team and a

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View this 10-K filing on SEC EDGAR