10-KPeriod: FY2020

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2020

Filed February 11, 2021For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial and operational highlights for the fiscal year ending December 31, 2020. The company, a leader in RNAi therapeutics, continues to advance its commercial-stage pipeline with four approved products: ONPATTRO®, GIVLAARI®, OXLUMO™, and Leqvio® (partnered with Novartis). Despite a net loss of $858.3 million for the year, the company demonstrated significant revenue growth, with total revenues reaching $492.9 million, a 124% increase year-over-year, driven by strong performance of ONPATTRO and GIVLAARI and the initial launch of OXLUMO. Key strategic advancements include progress on the APOLLO-B and HELIOS-B Phase 3 studies for ATTR amyloidosis with cardiomyopathy, positive topline results from the HELIOS-A Phase 3 study for vutrisiran, and the ongoing development of multiple early-stage pipeline candidates. Alnylam also secured a significant financing collaboration with Blackstone, providing up to $2 billion to support its growth initiatives, including the ambitious "Alnylam P5x25" strategy aimed at becoming a top five biotech company by market capitalization by the end of 2025. The company ended the year with a strong cash position of $1.87 billion, providing a solid foundation for future investments in research, development, and commercialization.

Financial Highlights

52 data points
Beta

Revenue

$492.85M

84.9% Gross Margin

Net Income

-$858.28M

-174.1% Net Margin

EPS (Diluted)

$-7.46

Total Assets

$3.41B

Cash & Equivalents

$496.58M

Free Cash Flow

-$685.32M

Financial Statements
Beta
Revenue$492.85M
Cost of Revenue$74.19M
Gross Profit$418.67M
R&D Expenses$654.82M
SG&A Expenses$588.42M
Operating Expenses$1.32B
Operating Income-$828.44M
Interest Expense$84.50M
Net Income-$858.28M
EPS (Basic)$-7.46
EPS (Diluted)$-7.46
Shares Outstanding (Basic)114.99M
Shares Outstanding (Diluted)114.99M

Key Highlights

  • 1Alnylam reported total revenues of $492.9 million for 2020, a 124% increase from $219.8 million in 2019, primarily driven by product sales and collaboration revenues.
  • 2The company's net loss for 2020 was $858.3 million, an improvement from a net loss of $886.1 million in 2019.
  • 3Alnylam has four approved RNAi therapeutics: ONPATTRO, GIVLAARI, OXLUMO, and Leqvio (in collaboration with Novartis).
  • 4Significant progress was made in clinical development, including positive topline results from the HELIOS-A Phase 3 study for vutrisiran, with plans for an FDA submission in early 2021.
  • 5The company ended 2020 with $1.87 billion in cash, cash equivalents, and marketable securities, enhancing its financial flexibility.
  • 6Alnylam launched its "Alnylam P5x25" strategy, aiming for significant growth and market capitalization by 2025.
  • 7A strategic financing collaboration with Blackstone provided up to $2 billion to accelerate development and commercialization efforts.

Frequently Asked Questions

Alnylam has four approved RNAi therapeutics: ONPATTRO (patisiran) for hATTR amyloidosis with polyneuropathy, GIVLAARI (givosiran) for acute hepatic porphyria, OXLUMO (lumasiran) for primary hyperoxaluria type 1, and Leqvio (inclisiran) for hypercholesterolemia, which is partnered with Novartis. ONPATTRO generated $306.1 million in global net revenue in 2020, while GIVLAARI generated $55.1 million. OXLUMO began generating initial net product revenues in Q4 2020. Leqvio received EU marketing authorization, but its U.S. FDA approval was delayed due to facility inspection issues, with a resubmission anticipated in Q2-Q3 2021.

Alnylam ended 2020 with $1.87 billion in cash, cash equivalents, and marketable securities, providing strong liquidity. The company aims to achieve sustainable non-GAAP profitability by the end of 2025 through its 'Alnylam P5x25' strategy, which targets becoming a top five biotech company by market capitalization. This strategy includes launching six or more products in rare and prevalent diseases and advancing over 20 clinical programs.

Key risks include the ongoing impact of the COVID-19 pandemic on operations, clinical trials, and commercialization; the inherent risks of drug development with potential for trial failures or delays; competition from other pharmaceutical companies; the dependence on third-party collaborators for development and commercialization; and the potential for unfavorable regulatory actions or pricing and reimbursement challenges. The company also notes risks related to its intellectual property portfolio and the potential volatility of its stock price.

Alnylam is actively developing its pipeline, with a focus on ATTR amyloidosis. ONPATTRO is approved for hATTR amyloidosis with polyneuropathy. Patisiran is being investigated for ATTR amyloidosis with cardiomyopathy in the APOLLO-B Phase 3 study. Vutrisiran, a subcutaneously administered RNAi therapeutic for ATTR amyloidosis, reported positive topline results from the HELIOS-A Phase 3 study and is planned for an NDA submission in early 2021. The HELIOS-B Phase 3 study is also ongoing for vutrisiran in ATTR amyloidosis patients with cardiomyopathy.