10-QPeriod: Q1 FY2021

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2021

Filed April 29, 2021For Securities:ALNY

Summary

Alnylam Pharmaceuticals reported a significant increase in total revenues for the first quarter of 2021, driven by strong growth in net product revenues from its marketed products ONPATTRO, GIVLAARI, and OXLUMO. Total revenues reached $177.6 million, a 79% increase year-over-year, primarily due to the expanding global reach of ONPATTRO and GIVLAARI, and the recent launch of OXLUMO. Collaboration revenues also saw a substantial boost, particularly from agreements with Regeneron and Novartis, indicating increased partnership activity and support for key products. Despite revenue growth, the company continued to report a net loss of $200.3 million for the quarter. This loss is attributed to significant investments in research and development ($185.9 million) and selling, general, and administrative expenses ($146.9 million), which increased to support its "Alnylam P5x25" strategy aimed at becoming a top five biotech company by market capitalization by 2025. The company's liquidity remains strong, with approximately $1.71 billion in cash, cash equivalents, and marketable securities as of March 31, 2021, which management believes is sufficient to support operations for at least the next 12 months.

Financial Highlights

48 data points
Beta

Revenue

$177.57M

87.0% Gross Margin

Net Income

-$200.29M

-112.8% Net Margin

EPS (Diluted)

$-1.71

Total Assets

$3.26B

Cash & Equivalents

$379.54M

Free Cash Flow

-$252.84M

Financial Statements
Beta
Revenue$177.57M
Cost of Revenue$23.02M
Gross Profit$154.54M
R&D Expenses$185.90M
SG&A Expenses$146.86M
Operating Expenses$363.82M
Operating Income-$186.25M
Interest Expense$32.52M
Net Income-$200.29M
EPS (Basic)$-1.71
EPS (Diluted)$-1.71
Shares Outstanding (Basic)117.08M
Shares Outstanding (Diluted)117.08M

Key Highlights

  • 1Total revenues increased by 79% to $177.6 million in Q1 2021 compared to Q1 2020.
  • 2Net product revenues grew by 89% to $135.8 million, driven by ONPATTRO, GIVLAARI, and OXLUMO.
  • 3Net revenues from collaborations increased by 52% to $41.8 million, primarily from Regeneron and Novartis.
  • 4Research and development expenses increased by 10% to $185.9 million, reflecting continued pipeline investment.
  • 5Selling, general, and administrative expenses rose by 16% to $146.9 million, supporting strategic growth initiatives.
  • 6The company maintained a strong cash position, with $1.71 billion in cash, cash equivalents, and marketable securities as of March 31, 2021.
  • 7Net loss for the quarter was $200.3 million.

Frequently Asked Questions

Alnylam Pharmaceuticals reported a strong increase in total revenues, up 79% to $177.6 million in the first quarter of 2021 compared to the same period in 2020. This growth was driven by an 89% increase in net product revenues to $135.8 million, primarily from ONPATTRO, GIVLAARI, and OXLUMO, and a 52% increase in collaboration revenues to $41.8 million, mainly from partnerships with Regeneron and Novartis.

Research and development (R&D) expenses increased by 10% to $185.9 million, reflecting continued investment in its pipeline. Selling, general, and administrative (SG&A) expenses also increased by 16% to $146.9 million, supporting the company's strategic growth initiatives, including its "Alnylam P5x25" plan.

Alnylam maintained a strong liquidity position, with $1.71 billion in cash, cash equivalents, and marketable securities as of March 31, 2021. Management believes this is sufficient to fund operations for at least the next 12 months. Despite the revenue growth, the company reported a net loss of $200.3 million for the quarter, consistent with its strategy of investing heavily in R&D and commercialization efforts.

Yes, the company reported positive topline results from the HELIOS-A Phase 3 study of vutrisiran and submitted an NDA for vutrisiran with the FDA. Novartis, Alnylam's partner for inclisiran (Leqvio), is expected to resubmit its NDA in Q2-Q3 2021. Additionally, the company continues to advance other late-stage programs such as patisiran for ATTR amyloidosis cardiomyopathy and lumasiran for PH.