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

TL;DR

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

AI Summary

AMICUS THERAPEUTICS, INC. (FOLD) filed a Annual Report (10-K) with the SEC on February 28, 2024. Amicus Therapeutics, Inc. filed its 2023 Form 10-K on February 28, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 3675 Market Street, Philadelphia, PA 19104. Amicus Therapeutics, Inc. is in the Pharmaceutical Preparations industry (SIC code 2834). The company's fiscal year ends on December 31st annually.

Why It Matters

For investors and stakeholders tracking AMICUS THERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Amicus Therapeutics' financial health, operational strategies, and risk factors for the past fiscal year, which is crucial for investors to assess the company's performance and future prospects. As a publicly traded company, Amicus Therapeutics is required to disclose detailed financial information and business operations annually, ensuring transparency for shareholders and the market.

Risk Assessment

Risk Level: medium — AMICUS THERAPEUTICS, INC. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy drug development cycles, and intense competition, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Amicus Therapeutics' current financial standing and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-02-28 — Filing Date (FILED AS OF DATE)
• 2834 — SIC Code (STANDARD INDUSTRIAL CLASSIFICATION)
• DE — State of Incorporation (STATE OF INCORPORATION)

Key Players & Entities

• AMICUS THERAPEUTICS, INC. (company) — FILER
• 2023 (date) — CONFORMED PERIOD OF REPORT
• 2024-02-28 (date) — FILED AS OF DATE
• 3675 MARKET STREET (address) — BUSINESS ADDRESS
• PHILADELPHIA (location) — BUSINESS ADDRESS CITY
• PA (location) — BUSINESS ADDRESS STATE
• 19104 (postal_code) — BUSINESS ADDRESS ZIP
• 2834 (industry_code) — STANDARD INDUSTRIAL CLASSIFICATION

FAQ

Industry Context

Amicus Therapeutics operates within the pharmaceutical preparations industry, focusing on the development and commercialization of treatments for rare metabolic diseases.

Regulatory Implications

As a pharmaceutical company, Amicus Therapeutics is subject to stringent regulations from bodies like the FDA regarding drug development, approval, and marketing.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Compare the 2023 financial results with previous years to identify trends and performance changes.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-28: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This filing is the 2023 annual report (10-K), providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.01 — ich registered Common Stock, par value $0.01 per share FOLD NASDAQ Global Market S
• $387.8 million — December 31, 2023, Galafold revenue was $387.8 million of consolidated revenue, which represen
• $58.7 million — venue, which represented an increase of $58.7 million compared to the prior year. We continue
• $11.6 million — 1, 2023 Pombiliti + Opfolda revenue was $11.6 million of consolidated revenue. Pombiliti + Op
• $286.2 million — securities as of December 31, 2023 was $286.2 million. Our Commercial Products and Product C

Filing Documents

• fold-20231231.htm (10-K) — 2063KB
• exhibit104-secondrestatedg.htm (EX-10.4) — 412KB
• exhibit21_2023.htm (EX-21) — 9KB
• exhibit231_2023.htm (EX-23.1) — 11KB
• exhibit311_2023.htm (EX-31.1) — 8KB
• exhibit312_2023.htm (EX-31.2) — 8KB
• exhibit321_2023.htm (EX-32.1) — 3KB
• exhibit322_2023.htm (EX-32.2) — 3KB
• exhibit-97clawbackpolicy.htm (EX-97) — 43KB
• fold-20231231_g1.jpg (GRAPHIC) — 101KB
• 0001178879-24-000003.txt (&nbsp;) — 9830KB
• fold-20231231.xsd (EX-101.SCH) — 54KB
• fold-20231231_cal.xml (EX-101.CAL) — 103KB
• fold-20231231_def.xml (EX-101.DEF) — 208KB
• fold-20231231_lab.xml (EX-101.LAB) — 818KB
• fold-20231231_pre.xml (EX-101.PRE) — 512KB
• fold-20231231_htm.xml (XML) — 1208KB

BUSINESS

BUSINESS 5 Item 1A.

RISK FACTORS

RISK FACTORS 26 Item 1B. UNRESOLVED STAFF COMMENTS 68 Item 1C . CYBERSECURITY 68 Item 2.

PROPERTIES

PROPERTIES 69 Item 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 69 Item 4. MINE SAFETY DISCLOSURES 70 PART II Item 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 71 Item 6. [RESERVED] 72 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 72 Item 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 79 Item 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 80 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 112 Item 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 112 Item 9B. OTHER INFORMATION 113 Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 113 PART III Item 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 114 Item 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 114 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 114 Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 114 Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 114 PART IV Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 115 Item 16 . FORM 10-K SUMMARY 119

SIGNATURES

SIGNATURES 120 We have filed applications to register certain trademarks in the United States and abroad, including AMICUS THERAPEUTICS and design, AMICUS ASSIST and design, CHART and design, AT THE FOREFRONT OF THERAPIES FOR RARE AND ORPHAN DISEASES, HEALING BEYOND DISEASE, OUR GOOD STUFF, Galafold and design, Pombiliti and design, Opfolda and design. Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements that involve risks, uncertainties, and assumptions. Forward-looking statements are all statements, other than statements of historical facts, that discuss our current expectation and projections relating to our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objectives of management. These statements may be preceded by, followed by or include the words "aim," "anticipate," "believe," "can," "could," "estimate," "expect," "forecast," "intend," "likely," "may," "might," "outlook," "plan," "potential," "predict," "project," "seek," "should," "will," "would," the negatives or plurals thereof, and other words and terms of similar meaning, although not all forward-looking statements contain these identifying words. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct. You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements: the scope, progress, results and costs of clinical trials for our drug candidates; the cost of manufacturing drug supply for our commercial, clinical and preclinical studies, incl

BUSINESS

Item 1. BUSINESS Overview We are a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases. We seek to deliver the highest quality therapies that have the potential to obsolete current treatments, provide significant benefits to patients, and be first- or best-in-class. Our two marketed therapies are Galafold , the first oral monotherapy for people living with Fabry disease who have amenable genetic variants, and Pombiliti + Opfolda , a novel treatment designed to improve uptake of active enzyme into key disease relevant tissues for adults living with late-onset Pompe disease. Galafold (also referred to as "migalastat") is approved in over 40 countries around the world, including the United States ("U.S."), European Union ("E.U."), United Kingdom ("U.K."), and Japan. Additionally, Galafold has been granted orphan drug designation in the U.S., E.U., U.K., Japan, and several other countries. Pombiliti + Opfolda (also referred to as "cipaglucosidase alfa-atga/miglustat") was approved in 2023 in the three largest Pompe markets: the U.S., the E.U., and the U.K. Multiple regulatory submissions and reimbursement processes with global health authorities are currently underway. Additionally, Pombiliti + Opfolda has been granted orphan drug designation in the U.S., E.U., U.K., Japan and several other countries. Our Strategy Our strategy is to create, manufacture, test, and deliver the highest quality medicines for people living with rare diseases through internally developed, jointly developed, acquired, or in-licensed products and product candidates. We are leveraging our global capabilities to develop and broaden our franchises in Fabry and Pompe disease, with focused discovery work on next-generation therapies and novel technologies. Highlights of our progress include: Commercial and regulatory success in Fabry disease . For the year ended December 31, 2023, Galafold revenue was $387.8 mil

View Full Filing

View this 10-K filing on SEC EDGAR