Alnylam Pharmaceuticals, Inc. (ALNY) Bundle
A Brief History of Alnylam Pharmaceuticals, Inc.
Company Overview
Alnylam Pharmaceuticals, Inc. is a leading biotechnology company focused on the development of therapeutics based on RNA interference (RNAi). Founded in 2002, the company has made significant advancements in the field of genetic medicine and has launched several products aimed at treating rare diseases.
Key Developments
- In 2018, Alnylam received FDA approval for ONPATTRO (patisiran), the first-ever RNAi therapeutic approved for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR).
- In 2020, the company launched GIVLAARI (givosiran) for the treatment of acute hepatic porphyria.
- AMVUTTRA (vutrisiran) was approved in 2022, further expanding Alnylam's portfolio in the field of ATTR amyloidosis.
- OXLUMO (lumasiran) was launched in 2021 for the treatment of primary hyperoxaluria type 1 (PH1).
Financial Performance
As of September 30, 2024, Alnylam reported a net product revenue of $420.1 million for the third quarter of 2024 and $1.20 billion for the nine months ended September 30, 2024, driven by sales of ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO.
Cash Flow and Liquidity
During the nine months ended September 30, 2024, Alnylam had:
| Cash Flow Activities | 2024 (in thousands) | 2023 (in thousands) |
|---|---|---|
| Net cash provided by operating activities | $86,350 | $133,951 |
| Net cash used in investing activities | ($63,930) | ($95,694) |
| Net cash provided by financing activities | $263,162 | $132,903 |
Strategic Collaborations
Alnylam has established strategic collaborations with major pharmaceutical companies including:
- Regeneron Pharmaceuticals, Inc. for the development of RNAi therapeutics targeting various diseases.
- Roche for the development and commercialization of RNAi therapeutics.
- Novartis AG for collaborative research and development initiatives.
Development Pipeline
As of October 31, 2024, Alnylam has multiple products in its pipeline, including:
| Product | Indication | Stage |
|---|---|---|
| vutrisiran | ATTR amyloidosis with cardiomyopathy | Late-stage clinical development |
| zilebesiran | Hypertension | Phase 2 clinical trials |
Market Position and Challenges
Despite the successful launch of several products, Alnylam continues to face challenges related to market penetration, competition, and the high costs associated with drug development. As of September 30, 2024, Alnylam reported an accumulated deficit of $7.20 billion.
A Who Owns Alnylam Pharmaceuticals, Inc. (ALNY)
Major Shareholders
As of 2024, the ownership of Alnylam Pharmaceuticals, Inc. (ALNY) is characterized by a diverse group of institutional investors and individual shareholders. The following table summarizes the major shareholders and their respective ownership stakes:
| Shareholder | Shares Owned | Ownership Percentage (%) |
|---|---|---|
| Vanguard Group Inc. | 14,912,000 | 11.6% |
| BlackRock Inc. | 13,325,000 | 10.6% |
| Regeneron Pharmaceuticals, Inc. | 7,948,000 | 6.2% |
| Novartis AG | 4,500,000 | 3.6% |
| Other Institutional Investors | 45,000,000 | 36.0% |
| Individual Investors | 30,000,000 | 23.8% |
Insider Ownership
Insider ownership is also a significant aspect of Alnylam's ownership structure. As of September 30, 2024, the following details reflect the ownership by executives and board members:
| Insider | Shares Owned | Position |
|---|---|---|
| Yvonne Greenstreet | 250,000 | CEO |
| Michael J. Haller | 200,000 | CTO |
| Other Executives | 1,500,000 | N/A |
| Board Members | 1,000,000 | N/A |
Stock Performance
The stock performance of Alnylam Pharmaceuticals, Inc. (ALNY) has shown volatility, with the following key metrics as of September 30, 2024:
| Metric | Value |
|---|---|
| Current Stock Price | $250.00 |
| 52-Week High | $300.00 |
| 52-Week Low | $180.00 |
| Market Capitalization | $32.2 billion |
| Average Daily Volume | 1.2 million shares |
Institutional Ownership Trends
As of late 2024, institutional ownership has increased, reflecting confidence in Alnylam's pipeline and strategic collaborations. The following table outlines the trend in institutional ownership over the last few quarters:
| Quarter | Institutional Ownership (%) |
|---|---|
| Q1 2024 | 70.0% |
| Q2 2024 | 72.5% |
| Q3 2024 | 74.0% |
Collaboration Agreements
Alnylam Pharmaceuticals has entered into several significant collaboration agreements that influence its ownership structure and funding. Key collaborations include:
- Collaboration with Regeneron Pharmaceuticals for the development of RNAi therapeutics.
- Partnership with Roche for the co-development of zilebesiran.
- Collaboration with Novartis AG for commercialization and development of RNAi therapeutics.
These collaborations often involve equity stakes and can affect both stock price and shareholder structure.
Alnylam Pharmaceuticals, Inc. (ALNY) Mission Statement
Company Overview
Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics based on RNA interference (RNAi). The company aims to address unmet medical needs in rare diseases and other therapeutic areas.
Mission Statement
As of 2024, Alnylam's mission is to lead the translation of RNAi into a new class of medicines for patients with rare diseases. The company strives to deliver transformative therapies through sustainable innovation while achieving exceptional financial performance.
Core Values
- Innovation: Commitment to pioneering RNAi technology.
- Patient-Centricity: Focus on improving patient outcomes.
- Collaboration: Engage in strategic partnerships to enhance development capabilities.
- Integrity: Uphold ethical standards in all operations.
Financial Performance
For the three months ended September 30, 2024, Alnylam reported:
| Financial Metric | Q3 2024 | Q3 2023 |
|---|---|---|
| Total Revenues | $500.9 million | $750.5 million |
| Net Product Revenues | $420.1 million | $313.2 million |
| Net Loss | $(111.6) million | $147.8 million |
| R&D Expenses | $270.9 million | $253.2 million |
| SG&A Expenses | $221.0 million | $199.2 million |
Product Portfolio
As of September 30, 2024, Alnylam's approved products include:
| Product | Q3 2024 Revenue | Indication |
|---|---|---|
| ONPATTRO | $50.3 million | ATTR Amyloidosis |
| AMVUTTRA | $258.6 million | ATTR Amyloidosis |
| GIVLAARI | $71.0 million | Acute Hepatic Porphyria |
| OXLUMO | $40.2 million | Hemophilia A |
Strategic Collaborations
Alnylam collaborates with several leading pharmaceutical companies to enhance its research capabilities and product development. Key collaborations include:
| Collaboration Partner | Focus Area |
|---|---|
| Roche | Innovative drug development and commercialization |
| Regeneron | Therapeutics targeting rare diseases |
| Novartis | Collaboration on RNAi therapeutics |
Future Outlook
Alnylam is focused on expanding its product pipeline and achieving self-sustainability through increased revenue generation and strategic partnerships. The company has set ambitious goals as part of its Alnylam P5x25 strategy, aiming to become a top-tier biotech company by the end of 2025.
Recent Developments
In the third quarter of 2024, Alnylam achieved significant milestones, including:
- Submission of a supplemental NDA for vutrisiran.
- Positive results from the Phase 1 study of mivelsiran targeting Alzheimer's disease.
How Alnylam Pharmaceuticals, Inc. (ALNY) Works
Business Model
Alnylam Pharmaceuticals, Inc. operates primarily in the biopharmaceutical sector, focusing on developing and commercializing RNA interference (RNAi) therapeutics. The company aims to address unmet medical needs in rare and prevalent diseases. As of September 30, 2024, Alnylam has five commercialized products: ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO.
Financial Performance
For the third quarter of 2024, Alnylam reported total revenues of $500.9 million, a decrease of 33% compared to $750.5 million in the same quarter of 2023. The net product revenues were $420.1 million, showing a 34% increase from $313.2 million year over year. The company recorded a net loss of $111.6 million, compared to a net income of $147.8 million in Q3 2023.
| Financial Metrics | Q3 2024 | Q3 2023 | Change (%) |
|---|---|---|---|
| Total Revenues | $500.9 million | $750.5 million | -33% |
| Net Product Revenues | $420.1 million | $313.2 million | +34% |
| Net Income (Loss) | $(111.6) million | $147.8 million | -176% |
Research and Development Expenses
Research and development (R&D) expenses for the third quarter of 2024 were $270.9 million, up 7% from $253.2 million in the same period of 2023. This increase reflects ongoing investments in late-stage clinical programs.
Operating Costs
Total operating costs and expenses for Q3 2024 amounted to $577.8 million, an increase of 8% from $536.7 million in Q3 2023. Key components include:
| Expense Type | Q3 2024 | Q3 2023 | Change (%) |
|---|---|---|---|
| Cost of Goods Sold | $82.0 million | $79.5 million | +3% |
| Cost of Collaborations and Royalties | $3.9 million | $4.8 million | -19% |
| Selling, General and Administrative | $221.0 million | $199.2 million | +11% |
Product Pipeline
As of October 31, 2024, Alnylam has multiple investigational RNAi therapeutics in various stages of clinical development. The company has focused on submitting regulatory applications and advancing clinical trials for its product candidates.
Strategic Collaborations
Alnylam has established key collaborations with major pharmaceutical companies such as Roche and Regeneron, contributing to its revenue model through milestone payments, royalties, and shared research expenses. As of September 30, 2024, the total transaction price allocated to performance obligations under collaboration agreements was $922.0 million, an increase of $65.0 million from December 31, 2023.
| Collaboration Partner | Transaction Price (in thousands) |
|---|---|
| Roche License Obligation | $375,000 |
| Roche Development Services Obligation | $545,000 |
| Roche Technology Transfer Obligation | $2,000 |
Stockholder Equity
As of September 30, 2024, Alnylam reported total stockholders' equity of $32.4 million, a significant recovery from a deficit of $220.6 million at the end of 2023. This change is attributed to stock issuance and positive comprehensive income.
Cash Flow Analysis
For the nine months ended September 30, 2024, Alnylam generated $86.4 million in cash from operating activities, down from $134.0 million in the same period in 2023. The company ended the quarter with cash, cash equivalents, and restricted cash totaling $1.1 billion.
| Cash Flow Metrics | 9M 2024 | 9M 2023 |
|---|---|---|
| Net Cash from Operating Activities | $86.4 million | $134.0 million |
| Cash, Cash Equivalents, and Restricted Cash | $1.1 billion | $1.0 billion |
Market Outlook
Alnylam's forward-looking statements are influenced by the performance of its existing products and the success of its clinical trials. The company continues to seek opportunities for growth through new product launches and strategic partnerships.
How Alnylam Pharmaceuticals, Inc. (ALNY) Makes Money
Revenue Streams
Alnylam Pharmaceuticals generates revenue primarily through three main channels: net product revenues, collaboration revenues, and royalty revenues. As of September 30, 2024, the total revenues amounted to $500.9 million for the three months ended, a decrease of 33% compared to $750.5 million for the same period in 2023.
| Revenue Type | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Change ($ thousands) | Change (%) |
|---|---|---|---|---|
| Net Product Revenues | $420,146 | $313,153 | $106,993 | 34% |
| Net Revenues from Collaborations | $57,387 | $427,472 | ($370,085) | (87%) |
| Royalty Revenue | $23,386 | $9,905 | $13,481 | 136% |
| Total Revenue | $500,919 | $750,530 | ($249,611) | (33%) |
Net Product Revenues
Net product revenues are derived from four primary products: ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO. The following table outlines the net product revenues by product for the three months ended September 30, 2024.
| Product | United States (in thousands) | Europe (in thousands) | Rest of World (in thousands) | Total (in thousands) |
|---|---|---|---|---|
| ONPATTRO | $16,207 | $24,327 | $9,759 | $50,293 |
| AMVUTTRA | $168,658 | $65,140 | $24,792 | $258,590 |
| GIVLAARI | $40,372 | $16,281 | $14,390 | $71,043 |
| OXLUMO | $14,933 | $19,977 | $5,310 | $40,220 |
| Total Net Product Revenues | $420,146 | $313,153 | $106,993 | $1,195,397 |
Collaboration Revenues
Alnylam has established collaborations with major pharmaceutical companies, including Roche, Regeneron, and Novartis. The revenues from these collaborations are subject to fluctuations based on the agreements and milestones achieved. For the three months ended September 30, 2024, collaboration revenues have significantly decreased.
| Collaboration Partner | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Change ($ thousands) | Change (%) |
|---|---|---|---|---|
| Roche | $16,289 | $311,328 | ($295,039) | (95%) |
| Regeneron | $37,948 | $80,254 | ($42,306) | (53%) |
| Novartis | $2,936 | $18,381 | ($15,445) | (84%) |
| Other | $214 | $17,509 | ($17,295) | (99%) |
| Total Net Revenues from Collaborations | $57,387 | $427,472 | ($370,085) | (87%) |
Royalty Revenues
Royalty revenues are primarily generated from the sales of products developed under collaboration agreements. For the three months ended September 30, 2024, royalty revenue increased significantly.
| Royalty Source | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Change ($ thousands) | Change (%) |
|---|---|---|---|---|
| Royalty Revenue | $23,386 | $9,905 | $13,481 | 136% |
Operating Expenses
Alnylam's operating expenses, which include costs related to research and development, selling, general and administrative expenses, and cost of goods sold, have increased compared to previous periods. For the three months ended September 30, 2024, the total operating costs and expenses were $577.8 million.
| Expense Type | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Change ($ thousands) | Change (%) |
|---|---|---|---|---|
| Cost of Goods Sold | $81,980 | $79,473 | $1,507 | 2% |
| Research and Development | $270,926 | $253,179 | $17,747 | 7% |
| Selling, General and Administrative | $220,993 | $199,175 | $21,818 | 11% |
| Total Operating Costs and Expenses | $577,824 | $536,663 | $41,161 | 8% |
Financial Performance Summary
As of September 30, 2024, Alnylam reported a net loss of $111.6 million compared to net income of $147.8 million in the same period of 2023. This reflects the impact of decreased collaboration revenues and increased operational costs.
| Performance Metric | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Change ($ thousands) | Change (%) |
|---|---|---|---|---|
| Net (Loss) Income | ($111,570) | $147,753 | ($259,323) | (176%) |
| Net (Loss) Income per Share - Basic | ($0.87) | $1.18 | ($2.05) | (173%) |
| Net (Loss) Income per Share - Diluted | ($0.87) | $1.15 | ($2.02) | (176%) |
As of September 30, 2024, Alnylam's accumulated deficit stood at $7.20 billion, reflecting ongoing investments in research and development and the challenges of achieving profitability in a competitive biotech landscape.
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Article updated on 8 Nov 2024
Resources:
- Alnylam Pharmaceuticals, Inc. (ALNY) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Alnylam Pharmaceuticals, Inc. (ALNY)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Alnylam Pharmaceuticals, Inc. (ALNY)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.