10-KPeriod: FY2021

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2021

Filed February 10, 2022For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) presented its 2021 performance, highlighting continued growth in its approved RNAi therapeutics portfolio with ONPATTRO, GIVLAARI, and OXLUMO. The company is advancing its "Alnylam P5x25" strategy, aiming to become a top five biotech company by 2025, with ambitious goals for patient reach, product launches, pipeline expansion, revenue growth, and profitability. Key developments include the FDA approval of Leqvio (inclisiran) for heterozygous familial hypercholesterolemia (HeFH) and clinical data for vutrisiran in ATTR amyloidosis, positioning it for potential regulatory approval. Financially, Alnylam ended 2021 with substantial cash reserves, but also reported an operating loss, reflecting ongoing investment in its pipeline and commercialization efforts. The company's strategic financing collaboration with Blackstone provided significant capital. Alnylam continues to navigate a competitive landscape and manages various risks, including those related to regulatory approvals, clinical trial outcomes, intellectual property, and market access.

Financial Highlights

52 data points
Beta

Revenue

$844.29M

86.4% Gross Margin

Net Income

-$852.82M

-101.0% Net Margin

EPS (Diluted)

$-7.20

Total Assets

$3.64B

Cash & Equivalents

$819.98M

Free Cash Flow

-$718.07M

Financial Statements
Beta
Revenue$844.29M
Cost of Revenue$115.00M
Gross Profit$729.28M
R&D Expenses$792.16M
SG&A Expenses$620.64M
Operating Expenses$1.55B
Operating Income-$708.65M
Interest Expense$143.02M
Net Income-$852.82M
EPS (Basic)$-7.20
EPS (Diluted)$-7.20
Shares Outstanding (Basic)118.45M
Shares Outstanding (Diluted)118.45M

Key Highlights

  • 1Alnylam Pharmaceuticals reported strong revenue growth in 2021, driven by its approved RNAi therapeutics ONPATTRO, GIVLAARI, and OXLUMO, with global net revenues reaching $662.1 million.
  • 2The company achieved significant progress with its key pipeline assets, including positive data for vutrisiran in ATTR amyloidosis, leading to regulatory submissions.
  • 3Leqvio (inclisiran), partnered with Novartis, received FDA approval in December 2021 for treating adults with HeFH or clinical atherosclerotic cardiovascular disease (ASCVD).
  • 4Alnylam ended 2021 with $2.44 billion in cash, cash equivalents, and marketable securities, providing financial flexibility for ongoing operations and development.
  • 5The company is executing its "Alnylam P5x25" strategy, targeting a transition to a top five biotech company by 2025 with goals for revenue CAGR, patient numbers, and pipeline advancement.
  • 6Operating costs and expenses increased year-over-year, primarily due to higher research and development and selling, general, and administrative expenses to support pipeline advancement and commercialization.

Frequently Asked Questions

In 2021, Alnylam reported total revenues of $844.3 million, an increase of 71% year-over-year, primarily driven by net product revenues of $662.1 million and net revenues from collaborations of $181.0 million. The company maintained a strong cash position, ending the year with $2.44 billion in cash, cash equivalents, and marketable securities. However, Alnylam continued to incur operating losses, with a loss from operations of $708.7 million in 2021.

Alnylam highlighted progress across its RNAi therapeutic portfolio. ONPATTRO (patisiran) continued to drive revenue growth. GIVLAARI (givosiran) and OXLUMO (lumasiran) also showed strong uptake. Crucially, Leqvio (inclisiran), partnered with Novartis, received FDA approval in late 2021. Furthermore, vutrisiran showed positive clinical data in ATTR amyloidosis, with regulatory submissions underway. The company also advanced early-stage programs in hypertension, gout, and CNS diseases.

Alnylam is focused on its "Alnylam P5x25" strategy, aiming to become a top five biotech company by market capitalization by the end of 2025. This strategy includes goals of having six or more marketed products, over 20 clinical programs (with 10+ in late-stage), achieving at least 40% revenue CAGR through 2025, and reaching sustainable non-GAAP profitability within the period.

Alnylam faces several risks, including the potential for product candidates to fail in development or be delayed, challenges in obtaining regulatory approvals, competition from other companies, reliance on third-party manufacturers and collaborators, the need for substantial funding for continued R&D and commercialization, and the potential impact of litigation and regulatory investigations, such as the ongoing subpoena regarding ONPATTRO's marketing and promotion.