Alnylam Pharmaceuticals Files 2024 10-K

Ticker: ALNY · Form: 10-K · Filed: Feb 13, 2025 · CIK: 1178670

Sentiment: neutral

Topics: 10-K, annual-report, pharmaceuticals

TL;DR

ALNY 10-K is IN. Full 2024 financials out now.

AI Summary

Alnylam Pharmaceuticals, Inc. filed its 2024 10-K on February 13, 2025, reporting on its fiscal year ending December 31, 2024. The company, based in Cambridge, MA, operates in the pharmaceutical preparations sector. Key financial data and operational details for the fiscal year are presented in this comprehensive filing.

Why It Matters

This filing provides investors and analysts with a detailed overview of Alnylam's financial performance, strategic initiatives, and risk factors for the fiscal year 2024, crucial for understanding the company's current standing and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Alnylam faces inherent risks related to drug development, regulatory approvals, market competition, and intellectual property.

Key Numbers

Key Players & Entities

FAQ

What is Alnylam Pharmaceuticals' primary business sector?

Alnylam Pharmaceuticals, Inc. operates in the Pharmaceutical Preparations sector, as indicated by its Standard Industrial Classification code 2834.

When was the 10-K filing submitted to the SEC?

The 10-K filing for Alnylam Pharmaceuticals, Inc. was submitted to the SEC on February 13, 2025.

What is the fiscal year end date for this report?

The fiscal year end date for this 10-K report is December 31, 2024.

Where is Alnylam Pharmaceuticals, Inc. headquartered?

Alnylam Pharmaceuticals, Inc. is headquartered in Cambridge, MA, with its business and mail address listed as 675 West Kendall Street.

What is the SEC file number for Alnylam Pharmaceuticals?

The SEC file number for Alnylam Pharmaceuticals, Inc. is 001-36407.

Filing Stats: 4,419 words · 18 min read · ~15 pages · Grade level 17.7 · Accepted 2025-02-13 08:31:57

Key Financial Figures

Filing Documents

BUSINESS

BUSINESS 5 ITEM 1A.

RISK FACTORS

RISK FACTORS 38 ITEM 1B. UNRESOLVED STAFF COMMENTS 73

C

ITEM 1 C . CYBERSECURITY 74 ITEM 2.

PROPERTIES

PROPERTIES 76 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 76 ITEM 4. MINE SAFETY DISCLOSURES 76 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 77 ITEM 6. RESERVED 78 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 78 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 86 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 87 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 127 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 127 ITEM 9B. OTHER INFORMATION 127 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 128 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 129 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 129 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 129 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 129 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 129 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 130 ITEM 16. FORM 10-K SUMMARY 136

SIGNATURES

SIGNATURES 137 "Alnylam," ONPATTRO , AMVUTTRA , GIVLAARI , OXLUMO , Alnylam Act and IKARIA are trademarks and registered trademarks of Alnylam Pharmaceuticals, Inc. Our logo, trademarks and service marks are property of Alnylam. All other trademarks or service marks appearing in this Annual Report on Form 10-K are the property of their respective holders. 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of complying with those safe harbor provisions. All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: our views with respect to the potential for our approved and investigational RNAi therapeutics and those of our collaborators, including ONPATTRO, AMVUTTRA, GIVLAARI, OXLUMO, Leqvio (inclisiran), fitusiran, zilebesiran, mivelsiran and nucresiran; our plans for additional global regulatory filings and the continuing product launches of ONPATTRO, AMVUTTRA, GIVLAARI, OXLUMO and our collaborators' plans with respect to Leqvio and fitusiran; our ability to obtain regulatory approval of AMVUTTRA (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyo

BUSINESS

ITEM 1. BUSINESS Overview Alnylam Pharmaceuticals, Inc. (also referred to as Alnylam, the Company, we, our or us) is a global commercial-stage biopharmaceutical company developing novel therapeutics based on ribonucleic acid interference, or RNAi. RNAi is a naturally occurring biological pathway within cells for sequence-specific silencing and regulation of gene expression. By harnessing the RNAi pathway, we have developed a new class of innovative medicines, known as RNAi therapeutics. RNAi therapeutics are comprised of small interfering RNA, or siRNA, that function upstream of conventional medicines by potently silencing messenger RNA, or mRNA, that encode for proteins implicated in the cause or pathway of disease, thus preventing them from being made. We believe this is a revolutionary approach with the potential to transform the care of patients across a broad range of disease areas and indications. To date, our efforts to advance this revolutionary approach have yielded the approval of five first-in-class RNAi-based medicines, ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), OXLUMO (lumasiran) and Leqvio (inclisiran). Our research and development strategy is to target genetically validated genes that have been implicated in the cause or pathway of human disease. We utilize a N-acetylgalactosamine (GalNAc) conjugate approach or lipid nanoparticle (LNP) to enable hepatic delivery of siRNAs. For delivery to the central nervous system, or CNS, and the eye (ocular delivery), we are utilizing an alternative conjugate approach based on a hexadecyl (C16) moiety as a lipophilic ligand. We are also advancing approaches for heart, skeletal muscle and adipose tissue delivery of siRNAs. Our focus is on clinical indications where there is a high unmet need, a genetically validated target, early biomarkers for the assessment of clinical activity in Phase 1 clinical trials, and a definable path for drug development, regulatory approval, patient access and

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