10-QPeriod: Q1 FY2020

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2020

Filed May 6, 2020For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported significant year-over-year revenue growth in the first quarter of 2020, primarily driven by strong performance of its approved RNAi therapeutics, ONPATTRO and GIVLAARI. Total revenues surged by 199% to $99.5 million, with net product revenues increasing by 174% to $71.9 million, largely due to the global expansion of ONPATTRO and the initial launch of GIVLAARI. Despite revenue growth, the company continues to invest heavily in research and development, which increased by 31% to $169.6 million, contributing to an operating loss of $210.2 million. Alnylam also secured a significant strategic financing collaboration with Blackstone, providing up to $2.0 billion to advance its RNAi therapeutic pipeline. The company noted potential impacts of the COVID-19 pandemic on its operations and clinical trials, but remains focused on advancing its pipeline and achieving its Alnylam 2020 goals.

Financial Highlights

46 data points
Beta

Revenue

$99.48M

86.6% Gross Margin

Net Income

-$182.22M

-183.2% Net Margin

EPS (Diluted)

$-1.62

Total Assets

$2.28B

Cash & Equivalents

$467.78M

Free Cash Flow

-$265.78M

Financial Statements
Beta
Revenue$99.48M
Cost of Revenue$13.30M
Gross Profit$86.17M
R&D Expenses$169.57M
SG&A Expenses$126.76M
Operating Expenses$309.63M
Operating Income-$210.16M
Interest Expense$0
Net Income-$182.22M
EPS (Basic)$-1.62
Shares Outstanding (Basic)112.75M

Key Highlights

  • 1Total revenues increased by 199% year-over-year to $99.5 million for Q1 2020.
  • 2Net product revenues grew by 174% to $71.9 million, driven by ONPATTRO and GIVLAARI.
  • 3ONPATTRO generated $66.7 million in net product revenues, while GIVLAARI contributed $5.3 million.
  • 4Research and development expenses increased by 31% to $169.6 million, reflecting continued investment in the pipeline.
  • 5A strategic financing collaboration with Blackstone provides up to $2.0 billion in potential financing.
  • 6The company is advancing multiple late-stage investigational programs, including lumasiran for PH1, with regulatory submissions underway.
  • 7Alnylam is monitoring and mitigating the potential impacts of the COVID-19 pandemic on its business operations and clinical trials.

Frequently Asked Questions

The primary driver of revenue growth was the strong performance of Alnylam's marketed RNAi therapeutics, ONPATTRO and GIVLAARI. ONPATTRO experienced continued global expansion, and GIVLAARI, having recently received EU approval and commenced its initial launch, also contributed to the increase in net product revenues.

Alnylam is financing its R&D through a combination of product revenues, revenues from collaboration agreements, and a significant strategic financing collaboration with Blackstone. This collaboration provides up to $2.0 billion in financing, including committed payments for royalties and milestones from inclisiran, a term loan, and equity investment.

Alnylam is actively monitoring the COVID-19 pandemic and has implemented measures to mitigate adverse impacts. Potential effects include disruptions to clinical trials (e.g., enrollment delays), modifications to business practices (e.g., remote work), and potential impacts on commercial operations and sales. However, the company remains focused on maintaining strong balance sheet, liquidity, and financial flexibility.

Alnylam has several key late-stage investigational programs. These include givosiran for adolescent AHP, lumasiran for PH1 (with regulatory submissions underway), patisiran for ATTR amyloidosis with cardiomyopathy, and vutrisiran for ATTR amyloidosis. Additionally, inclisiran for hypercholesterolemia is being advanced by its partner Novartis, and fitusiran for hemophilia is being advanced by Sanofi Genzyme.