BioMarin Pharmaceutical Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>BioMarin Pharmaceutical Inc. has submitted its 2023 annual report (10-K), detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

BIOMARIN PHARMACEUTICAL INC (BMRN) filed a Annual Report (10-K) with the SEC on February 26, 2024. BioMarin Pharmaceutical Inc. filed its 2023 Form 10-K on February 26, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 105 Digital Drive, Novato, CA 94949. BioMarin Pharmaceutical Inc. is classified under Pharmaceutical Preparations (SIC 2834). The filing includes financial data for the fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking BIOMARIN PHARMACEUTICAL INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of BioMarin's financial health, operational results, and strategic positioning for the past fiscal year, which is crucial for investors to assess the company's performance and future prospects. As a key regulatory filing, this document offers insights into the company's compliance, risk factors, and executive compensation, enabling stakeholders to make informed investment decisions.

Risk Assessment

Risk Level: medium — BIOMARIN PHARMACEUTICAL INC 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 detailed in its risk factors section.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand BioMarin's performance and potential challenges in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-26 — Filing Date (Date of submission)
• 119 — Document Count (Number of documents in the filing)

Key Players & Entities

• BIOMARIN PHARMACEUTICAL INC (company) — Filer name
• BMRN (company) — Ticker symbol
• 2024-02-26 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• 105 Digital Drive, Novato, CA 94949 (address) — Business address
• 2834 (industry) — Standard Industrial Classification
• Erin Burkhart (person) — Executive compensation plan member

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: BioMarin faces intense competition from other pharmaceutical and biotechnology companies, which could affect market share and pricing.
• Financial Risks [medium — financial]: The company's financial performance is dependent on the success of its products and the ability to secure future funding.
• Operational Risks [medium — operational]: Risks associated with manufacturing, supply chain disruptions, and the potential for product recalls can impact operations.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-26: Filing Date — Date BioMarin Pharmaceutical Inc. submitted its 10-K filing.

Key Financial Figures

• $0 — 5,622 shares of common stock, par value $0.001, outstanding. Documents Incorporat
• $2.4 billion — cent Developments In 2023, we achieved $2.4 billion in total revenues, including a signific

Filing Documents

• bmrn-20231231.htm (10-K) — 2458KB
• bmrn-2023xexx211.htm (EX-21.1) — 5KB
• bmrn-20231231xexx231.htm (EX-23.1) — 2KB
• bmrn-exx311x2023.htm (EX-31.1) — 9KB
• bmrn-exx312x2023.htm (EX-31.2) — 9KB
• bmrn-exx321x2023.htm (EX-32.1) — 5KB
• bmrn-exx971xrecoupmentpoli.htm (EX-97.1) — 35KB
• bmrn-20231231_g1.jpg (GRAPHIC) — 58KB
• 0001048477-24-000016.txt (&nbsp;) — 12864KB
• bmrn-20231231.xsd (EX-101.SCH) — 88KB
• bmrn-20231231_cal.xml (EX-101.CAL) — 143KB
• bmrn-20231231_def.xml (EX-101.DEF) — 425KB
• bmrn-20231231_lab.xml (EX-101.LAB) — 1128KB
• bmrn-20231231_pre.xml (EX-101.PRE) — 748KB
• bmrn-20231231_htm.xml (XML) — 2041KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 24 Item 1B. Unresolved Staff Comments 53 I tem 1C. C ybersecurity 53 Item 2.

Properties

Properties 54 Item 3.

Legal Proceedings

Legal Proceedings 54 Item 4. Mine Safety Disclosures 55 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 56 Item 6. [Reserved] 57 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 58 Item 7A. Quantitative and Qualitative Disclosure About Market Risk 70 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 71 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 71 Item 9A.

Controls and Procedures

Controls and Procedures 71 Item 9B. Other Information 72 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 73 Part III Item 10. Directors, Executive Officers and Corporate Governance 74 Item 11.

Executive Compensation

Executive Compensation 74 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 74 Item 13. Certain Relationships and Related Transactions and Director Independence 74 Item 14. Principal Accounting Fees and Services 74 Part IV Item 15. Exhibits, Financial Statement Schedules 75 Item 16. Form 10-K Summary 79

SIGNATURES

SIGNATURES 80 2 Unless the context suggests otherwise, references in this Annual Report on Form 10-K to "BioMarin," the "Company," "we," "us," and "our" refer to BioMarin Pharmaceutical Inc. and, where appropriate, its wholly owned subsidiaries. BioMarin , BRINEURA , KUVAN , NAGLAZYME , PALYNZIQ , VIMIZIM and VOXZOGO are our registered trademarks. ROCTAVIAN is our registered trademark in the European Union. ROCTAVIAN TM is our trademark in the United States (U.S.). ALDURAZYME is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this report are the property of their respective owners.

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K contains "forward-looking statements" as defined under securities laws. Many of these statements can be identified by the use of terminology such as "believes," "expects," "intends," "anticipates," "plans," "may," "will," "could," "would," "projects," "continues," "estimates," "potential," "opportunity" or the negative versions of these terms and other similar expressions. You should not place undue reliance on these types of forward-looking statements, which speak only as of the date that they were made. These forward-looking statements are based on the beliefs and assumptions of our management based on information currently available to management and should be considered in connection with any written or oral forward-looking statements that we may issue in the future as well as other cautionary statements we have made and may make. Our actual results or experience could differ significantly from the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the section titled "Risk Factors" in Part I, Item 1A of this Annual Report on Form 10-K as well as information provided elsewhere in this Annual Report on Form 10-K. You should carefully consider that information before you make an investment decision. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Annual Report on Form 10-K may not occur and actual results could differ materially and adversely from those anticipated or impl

Business

Item 1. Business Overview Founded in 1997, BioMarin Pharmaceutical Inc. (BioMarin, we, us or our) is a global biotechnology company dedicated to transforming lives through genetic discovery. We develop and commercialize targeted therapies that address the root cause of genetic conditions. Our robust research and development capabilities have resulted in multiple innovative commercial therapies for patients with rare genetic disorders. Our distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. Recent Developments In 2023, we achieved $2.4 billion in total revenues, including a significant contribution from our ongoing expansion of VOXZOGO, and we continued making important advancements in our product development pipeline. Our key business developments in 2023 include U.S. Food and Drug Administration (FDA) approval of VOXZOGO for children with achondroplasia of all ages with open growth plates in the United States, European Commission (EC) approval to expand the indication for VOXZOGO to treat children with achondroplasia aged four months and older with open growth plates in the European Union (EU), and FDA approval of ROCTAVIAN in the U.S . Please see the disclosures below in this Annual Report on Form 10-K for further discussion of these recent developments. Commercial Products Commercial Products Indication 2023 Net Product Revenues (in millions of U.S. Dollars) Enzyme Products: VIMIZIM (elosulfase alpha) Mucopolysaccharidosis (MPS) IVA $ 701.0 NAGLAZYME (galsulfase) MPS VI $ 420.3 PALYNZIQ (pegvaliase-pqpz) Phenylketonuria (PKU) $ 303.9 BRINEURA (cerliponase alfa) Neuronal ceroid lipofuscinosis type 2 (CLN2) $ 161.9 ALDURAZYME (laronidase) MPS I $ 131.2 Other Products: VOXZOGO (vosoritide)

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View this 10-K filing on SEC EDGAR