Alnylam Pharmaceuticals, Inc. Files 10-Q for Period Ending March 31, 2024

TL;DR

<b>Alnylam Pharmaceuticals filed its Q1 2024 10-Q, detailing product revenues and financial position.</b>

AI Summary

ALNYLAM PHARMACEUTICALS, INC. (ALNY) filed a Quarterly Report (10-Q) with the SEC on May 2, 2024. Alnylam Pharmaceuticals reported financial results for the quarter ended March 31, 2024. The filing details revenue from product sales and collaborations for the specified periods. Key financial statement components like common stock, additional paid-in capital, and retained earnings are presented for Q1 2024 and prior periods. Specific product revenue data for ONPATTRO and Amvuttra across different regions (US, Europe, Non-US/Europe) is provided. The filing includes data on the company's financial position as of March 31, 2024, and December 31, 2023.

Why It Matters

For investors and stakeholders tracking ALNYLAM PHARMACEUTICALS, INC., this filing contains several important signals. This 10-Q provides investors with the latest quarterly financial performance and operational data for Alnylam Pharmaceuticals. Understanding the revenue breakdown by product and region is crucial for assessing the company's growth trajectory and market penetration.

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, which could impact financial performance.

Analyst Insight

Monitor Alnylam's product revenue growth, particularly for ONPATTRO and Amvuttra, and analyze any new pipeline developments or regulatory updates in subsequent filings.

Revenue Breakdown

Key Numbers

• 2024-03-31 — Reporting Period End Date (Conformed period of report)
• 2024-05-02 — Filing Date (Filed as of date)
• 2834 — Standard Industrial Classification (Pharmaceutical Preparations)

Key Players & Entities

• ALNYLAM PHARMACEUTICALS, INC. (company) — Filer name
• ALNY (company) — Ticker symbol
• 2024-03-31 (date) — Conformed period of report
• 2024-05-02 (date) — Filed as of date
• 675 WEST KENDALL STREET (address) — Business address street 1
• CAMBRIDGE (location) — Business address city
• MA (location) — Business address state
• 02142 (postal_code) — Business address zip

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, approval, manufacturing, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors to develop superior products or pricing strategies.
• Research and Development Costs [medium — financial]: Significant investment in R&D is required, with no guarantee of successful product development or commercialization, impacting financial performance.
• Manufacturing and Supply Chain [medium — operational]: Reliance on complex manufacturing processes and supply chains carries risks of disruption, quality control issues, or inability to meet demand.

Key Financial Figures

• $0.01 — ange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Sto

Filing Documents

• alny-20240331.htm (10-Q) — 1556KB
• alny2024q110-qex101.htm (EX-10.1) — 18KB
• alny2024q110-qex311.htm (EX-31.1) — 9KB
• alny2024q110-qex312.htm (EX-31.2) — 9KB
• alny2024q110-qex321.htm (EX-32.1) — 4KB
• alny2024q110-qex322.htm (EX-32.2) — 4KB
• alny-20240331_g1.jpg (GRAPHIC) — 894KB
• 0001178670-24-000023.txt (&nbsp;) — 9077KB
• alny-20240331.xsd (EX-101.SCH) — 55KB
• alny-20240331_cal.xml (EX-101.CAL) — 62KB
• alny-20240331_def.xml (EX-101.DEF) — 247KB
• alny-20240331_lab.xml (EX-101.LAB) — 567KB
• alny-20240331_pre.xml (EX-101.PRE) — 417KB
• alny-20240331_htm.xml (XML) — 1051KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

FINANCIAL STATEMENTS (Unaudited)

ITEM 1. FINANCIAL STATEMENTS (Unaudited) CONDENSED CONSOLIDATED BALANCE SHEETS AS OF MARCH 31 , 202 4 AND DECEMBER 31, 202 3 5 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 3 1 , 202 4 AND 202 3 6 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT FOR THE THREE MONTHS ENDED MARCH 3 1 , 202 4 AND 202 3 7 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 3 1 , 202 4 AND 202 3 8 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS 9

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 26

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 37

CONTROLS AND PROCEDURES

ITEM 4. CONTROLS AND PROCEDURES 37

OTHER INFORMATION

PART II. OTHER INFORMATION

LEGAL PROCEEDINGS

ITEM 1. LEGAL PROCEEDINGS 38

RISK FACTORS

ITEM 1A. RISK FACTORS 38

OTHER INFORMATION

ITEM 5. OTHER INFORMATION 73

EXHIBITS

ITEM 6. EXHIBITS 74

SIGNATURES

SIGNATURES 75 "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 Quarterly Report on Form 10-Q are the property of their respective holders. 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q 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 Quarterly Report on Form 10-Q 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) fo

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

FINANCIAL STATEMENTS (Unaudited)

ITEM 1. FINANCIAL STATEMENTS (Unaudited) ALNYLAM PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) March 31, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 681,879 $ 812,688 Marketable debt securities 1,678,147 1,615,516 Marketable equity securities 11,256 11,178 Accounts receivable, net 321,377 327,787 Inventory 93,988 89,146 Prepaid expenses and other current assets 201,960 126,382 Total current assets 2,988,607 2,982,697 Property, plant and equipment, net 523,460 526,057 Operating lease right-of-use assets 195,468 199,732 Restricted investments 49,390 49,391 Other assets 67,461 72,003 Total assets $ 3,824,386 $ 3,829,880 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 78,148 $ 55,519 Accrued expenses 698,865 713,013 Operating lease liability 41,672 41,510 Deferred revenue 76,850 102,753 Liability related to the sale of future royalties 46,174 54,991 Total current liabilities 941,709 967,786 Operating lease liability, net of current portion 237,829 243,101 Deferred revenue, net of current portion 185,506 188,175 Convertible debt 1,021,732 1,020,776 Liability related to the sale of future royalties, net of current portion 1,336,892 1,322,248 Other liabilities 319,990 308,438 Total liabilities 4,043,658 4,050,524 Commitments and contingencies (Note 13) Stockholders' deficit: Preferred stock, $ 0.01 par value per share, 5,000 shares authorized and no shares issued and outstanding as of March 31, 2024 and December 31, 2023 — — Common stock, $ 0.01 par value per share, 250,000 shares authorized; 126,463 shares issued and outstanding as of March 31, 2024; 125,794 shares issued and outstanding as of December 31, 2023 1,265 1,259 Additional paid-in capital 6,881,977 6,811,063 Accumulated other comprehensive loss ( 26,988 ) ( 23,375 ) Accumulated deficit ( 7,075,526 ) ( 7,009,591 ) Total stockholders' defici

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View this 10-Q filing on SEC EDGAR