10-QPeriod: Q2 FY2020

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2020

Filed August 6, 2020For Securities:ALNY

Summary

Alnylam Pharmaceuticals reported robust top-line growth driven by strong ONPATTRO and GIVLAARI sales, with total revenues increasing by 133% year-over-year for the quarter and 161% for the six months ended June 30, 2020. This growth was bolstered by significant increases in net product revenues, up 103% and 132% respectively, and a substantial surge in collaboration revenues, up 308% and 300% respectively, primarily from the Regeneron and Vir collaborations. The company also secured a significant strategic financing collaboration with Blackstone, providing up to $2.00 billion in financing to accelerate pipeline advancement. Despite increased operating costs, particularly in R&D and SG&A supporting long-term growth, Alnylam demonstrated a reduction in its net loss by 18% for the quarter and 10% for the six months, reflecting improved operational efficiency and commercial execution. The company maintains a strong liquidity position, with substantial cash reserves, and is focused on advancing its multi-product RNAi therapeutics pipeline, highlighted by the positive regulatory progress for lumasiran.

Financial Highlights

49 data points
Beta

Revenue

$103.96M

82.4% Gross Margin

Net Income

-$179.23M

-172.4% Net Margin

EPS (Diluted)

$-1.56

Total Assets

$3.37B

Cash & Equivalents

$580.83M

Free Cash Flow

-$151.99M

Financial Statements
Beta
Revenue$103.96M
Cost of Revenue$18.27M
Gross Profit$85.70M
R&D Expenses$155.00M
SG&A Expenses$127.90M
Operating Expenses$302.82M
Operating Income-$198.86M
Interest Expense$27.25M
Net Income-$179.23M
EPS (Basic)$-1.56
EPS (Diluted)$-1.56
Shares Outstanding (Basic)114.91M
Shares Outstanding (Diluted)114.91M

Key Highlights

  • 1Total revenues saw significant year-over-year increases of 133% for the quarter and 161% for the six months ended June 30, 2020.
  • 2Net product revenues for ONPATTRO and GIVLAARI grew substantially, up 103% and 132% for the respective periods.
  • 3Collaboration revenues experienced a dramatic increase, rising 308% for the quarter and 300% for the six months, primarily due to agreements with Regeneron and Vir.
  • 4A major strategic financing collaboration with Blackstone provided up to $2.00 billion, enhancing financial flexibility and funding pipeline development.
  • 5Net loss decreased by 18% for the quarter and 10% for the six months, indicating improved financial performance despite increased operating expenses.
  • 6Significant progress in late-stage clinical development and regulatory submissions, notably for lumasiran (PH1) with an FDA action date set for December 3, 2020.
  • 7The company continues to manage operational expenses, with R&D and SG&A increasing to support long-term growth and potential product launches.

Frequently Asked Questions

Alnylam's revenue growth was primarily driven by strong net product revenues from its marketed products, ONPATTRO and GIVLAARI, and a significant increase in collaboration revenues from strategic partnerships, particularly with Regeneron and Vir.

The strategic financing collaboration with Blackstone provided up to $2.00 billion, significantly bolstering Alnylam's liquidity and financial flexibility, enabling accelerated advancement of its RNAi therapeutics pipeline without the immediate need for further equity financing.

Alnylam has submitted a New Drug Application (NDA) to the FDA for lumasiran, which has been accepted and granted Priority Review with an action date of December 3, 2020. A Marketing Authorisation Application (MAA) has also been submitted to the European Medicines Agency (EMA) and validated.

While operating costs, particularly in research & development and selling, general & administrative expenses, have increased to support long-term growth and pipeline development, the company has achieved a reduction in its net loss, indicating improved cost management and operational efficiency relative to revenue growth.