Alnylam Pharmaceuticals, Inc. Files 2023 Annual Report (10-K)
Ticker: ALNY · Form: 10-K · Filed: Feb 15, 2024 · CIK: 1178670
Sentiment: neutral
Topics: Alnylam Pharmaceuticals, 10-K, Annual Report, Financials, Pharmaceuticals
TL;DR
<b>Alnylam Pharmaceuticals, Inc. has filed its 2023 10-K annual report detailing its financial performance and business operations.</b>
AI Summary
ALNYLAM PHARMACEUTICALS, INC. (ALNY) filed a Annual Report (10-K) with the SEC on February 15, 2024. Alnylam Pharmaceuticals, Inc. filed its 2023 10-K report on February 15, 2024. The company's fiscal year ends on December 31st. The filing covers the fiscal year 2023. Alnylam Pharmaceuticals, Inc. is in the Pharmaceutical Preparations industry (SIC 2834). The company's principal executive offices are located at 675 West Kendall Street, Cambridge, MA 02142.
Why It Matters
For investors and stakeholders tracking ALNYLAM PHARMACEUTICALS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Alnylam's financial health, operational strategies, and risk factors for the fiscal year 2023, crucial for investors and stakeholders to assess the company's current standing and future prospects. Understanding the detailed financial statements, revenue breakdowns, and risk disclosures within this report is essential for making informed investment decisions regarding Alnylam Pharmaceuticals.
Risk Assessment
Risk Level: medium — ALNYLAM PHARMACEUTICALS, 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 assess Alnylam's growth potential and associated risks.
Key Numbers
- 2023-12-31 — Fiscal Year End (Conformed period of report)
- 2024-02-15 — Filing Date (Filed as of date)
- 0001178670-24-000008 — Accession Number (Unique identifier for the filing)
- 001-36407 — SEC File Number (SEC registration number)
Key Players & Entities
- ALNYLAM PHARMACEUTICALS, INC. (company) — Filer name
- ALNY (company) — Ticker symbol
- 2024-02-15 (date) — Filing date
- 2023-12-31 (date) — Fiscal year end
- 2834 (industry) — Standard Industrial Classification
- 675 WEST KENDALL STREET (address) — Business address
- CAMBRIDGE (location) — Business address city
- MA (location) — Business address state
FAQ
When did ALNYLAM PHARMACEUTICALS, INC. file this 10-K?
ALNYLAM PHARMACEUTICALS, INC. filed this Annual Report (10-K) with the SEC on February 15, 2024.
What is a 10-K filing?
A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by ALNYLAM PHARMACEUTICALS, INC. (ALNY).
Where can I read the original 10-K filing from ALNYLAM PHARMACEUTICALS, INC.?
You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by ALNYLAM PHARMACEUTICALS, INC..
What are the key takeaways from ALNYLAM PHARMACEUTICALS, INC.'s 10-K?
ALNYLAM PHARMACEUTICALS, INC. filed this 10-K on February 15, 2024. Key takeaways: Alnylam Pharmaceuticals, Inc. filed its 2023 10-K report on February 15, 2024.. The company's fiscal year ends on December 31st.. The filing covers the fiscal year 2023..
Is ALNYLAM PHARMACEUTICALS, INC. a risky investment based on this filing?
Based on this 10-K, ALNYLAM PHARMACEUTICALS, INC. presents a moderate-risk profile. 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.
What should investors do after reading ALNYLAM PHARMACEUTICALS, INC.'s 10-K?
Investors should review the detailed financial statements and risk factors in the 10-K to assess Alnylam's growth potential and associated risks. The overall sentiment from this filing is neutral.
Risk Factors
- Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, which can impact its ability to develop, manufacture, and market products.
- Market Competition [high — market]: Alnylam faces intense competition from other pharmaceutical and biotechnology companies, which could affect its market share and profitability.
- Product Development and Commercialization Risks [high — operational]: The success of Alnylam's product candidates depends on successful clinical trials and regulatory approvals, with no guarantee of commercial success.
- Dependence on Key Products [medium — financial]: The company's financial performance may be significantly impacted by the success or failure of a limited number of its key products.
Key Dates
- 2024-02-15: 10-K Filing — Annual report submission for fiscal year 2023.
- 2023-12-31: Fiscal Year End — End date of the reporting period.
Filing Stats: 4,414 words · 18 min read · ~15 pages · Grade level 17.1 · Accepted 2024-02-15 16:23:12
Key Financial Figures
- $0.01 — ange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Sto
- $1.04 billion — ior Notes In September 2022, we issued $1.04 billion aggregate principal amount of 1.00% Con
- $118.6 m — with the issuance of the Notes, we paid $118.6 million, including expenses, to enter int
- $424.00 — ped call transactions will initially be $424.00 per share, which represents a premium o
- $212.00 — orted sale price of our common stock of $212.00 per share on September 12, 2022, and is
Filing Documents
- alny-20231231.htm (10-K) — 2835KB
- alny2023q4exhibit211.htm (EX-21.1) — 23KB
- alny2023q4exhibit231.htm (EX-23.1) — 2KB
- alny2023q4exhibit311.htm (EX-31.1) — 9KB
- alny2023q4exhibit312.htm (EX-31.2) — 9KB
- alny2023q4exhibit321.htm (EX-32.1) — 4KB
- alny2023q4exhibit322.htm (EX-32.2) — 4KB
- alny2023q4exhibit97.htm (EX-97) — 30KB
- alny-20231231_g1.jpg (GRAPHIC) — 149KB
- alny-20231231_g2.jpg (GRAPHIC) — 347KB
- alny-20231231_g3.jpg (GRAPHIC) — 65KB
- 0001178670-24-000008.txt ( ) — 13639KB
- alny-20231231.xsd (EX-101.SCH) — 89KB
- alny-20231231_cal.xml (EX-101.CAL) — 106KB
- alny-20231231_def.xml (EX-101.DEF) — 399KB
- alny-20231231_lab.xml (EX-101.LAB) — 1004KB
- alny-20231231_pre.xml (EX-101.PRE) — 666KB
- alny-20231231_htm.xml (XML) — 1915KB
BUSINESS
BUSINESS 5 ITEM 1A.
RISK FACTORS
RISK FACTORS 43 ITEM 1B. UNRESOLVED STAFF COMMENTS 79
C
ITEM 1 C . C YBERSECURITY 79 ITEM 2.
PROPERTIES
PROPERTIES 81 ITEM 3.
LEGAL PROCEEDINGS
LEGAL PROCEEDINGS 81 ITEM 4. MINE SAFETY DISCLOSURES 81 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 82 ITEM 6. RESERVED 83 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 83 ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 91 ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 92 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 131 ITEM 9A.
CONTROLS AND PROCEDURES
CONTROLS AND PROCEDURES 131 ITEM 9B. OTHER INFORMATION 131 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 132 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 133 ITEM 11.
EXECUTIVE COMPENSATION
EXECUTIVE COMPENSATION 133 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 133 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 133 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 133 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 134 ITEM 16. FORM 10-K SUMMARY 139
SIGNATURES
SIGNATURES 140 "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 Con tents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws, 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 facts 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 approved and investigational RNAi therapeutics, including ONPATTRO, AMVUTTRA, GIVLAARI, OXLUMO, Leqvio (inclisiran), fitusiran and zilebesiran; our plans for additional global regulatory filings and the continuing product launches of ONPATTRO, AMVUTTRA, GIVLAARI, OXLUMO and our collaborator's plans with respect to Leqvio; the potential results of the HELIOS-B Phase 3 clinical trial of vutrisiran and our future ability to obtain regulatory approval of AMVUTTRA (vutrisiran) for the
BUSINESS
ITEM 1. BUSINESS Overview Alnylam Pharmaceuticals, Inc. (also referred to as Alnylam, 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 with rare and prevalent diseases. 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. During 2023, we continued to advance 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 studies, and a definable path for drug development, regulatory approval, patient access and commercialization