10-QPeriod: Q2 FY2023

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2023

Filed August 3, 2023For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the second quarter of 2023, reaching $318.8 million, a 42% increase year-over-year, primarily driven by strong net product revenues. Net product revenues surged by 43% to $305.7 million, largely due to the successful launch and uptake of AMVUTTRA, alongside continued growth from GIVLAARI and OXLUMO. ONPATTRO revenue saw a decline, attributed to patient switches to AMVUTTRA. Collaboration revenues experienced a decrease, mainly due to revised assumptions for the Regeneron collaboration, while royalty revenue from Leqvio significantly increased. Despite revenue growth, the company reported a net loss of $276.0 million for the quarter, reflecting ongoing substantial investments in research and development and selling, general, and administrative expenses. The company's cash position remains robust, providing at least 12 months of operating runway.

Financial Highlights

47 data points
Beta

Revenue

$318.75M

76.4% Gross Margin

Net Income

-$276.02M

-86.6% Net Margin

EPS (Diluted)

$-2.21

Total Assets

$3.40B

Cash & Equivalents

$657.80M

Free Cash Flow

-$74.91M

Financial Statements
Beta
Revenue$318.75M
Cost of Revenue$75.34M
Gross Profit$243.42M
R&D Expenses$248.53M
SG&A Expenses$214.69M
Operating Expenses$548.59M
Operating Income-$229.83M
Interest Expense$30.04M
Net Income-$276.02M
EPS (Basic)$-2.21
EPS (Diluted)$-2.21
Shares Outstanding (Basic)124.66M
Shares Outstanding (Diluted)124.66M

Key Highlights

  • 1Total revenues increased by 42% to $318.8 million in Q2 2023 compared to Q2 2022.
  • 2Net product revenues grew by 43% to $305.7 million, driven by AMVUTTRA's launch and contributions from GIVLAARI and OXLUMO.
  • 3ONPATTRO net product revenues decreased by 40% due to patient shifts to AMVUTTRA.
  • 4Royalty revenue from Leqvio significantly increased, contributing to overall revenue growth.
  • 5Research and development expenses rose by 21% to $248.5 million, indicating continued investment in pipeline advancement.
  • 6Selling, general, and administrative expenses increased by 26% to $214.7 million, reflecting investments in commercialization and infrastructure.
  • 7The company reported a net loss of $276.0 million for the quarter, while maintaining a strong liquidity position with $657.8 million in cash and cash equivalents.

Frequently Asked Questions

The primary driver for the 43% increase in net product revenues to $305.7 million was the successful launch and commercial uptake of AMVUTTRA, which began contributing significantly in Q2 2023. GIVLAARI and OXLUMO also showed growth. This growth was partially offset by a decline in ONPATTRO revenue, as patients switched to AMVUTTRA.

Net revenues from collaborations decreased by 35% to $5.8 million in Q2 2023 compared to Q2 2022. This decline was mainly attributed to revised assumptions in the Regeneron collaboration, leading to a revenue reversal. However, royalty revenue, primarily from Leqvio sales through Novartis, saw a substantial increase of 216% year-over-year, indicating positive performance in that partnership.

Alnylam Pharmaceuticals reported a net loss of $276.0 million for the quarter, which is consistent with its strategy of investing heavily in research and development. Despite the net loss, the company maintains a strong liquidity position with $657.8 million in cash and cash equivalents as of June 30, 2023. Management believes its current cash reserves, coupled with expected product sales and alliance revenue, are sufficient to support operations for at least the next 12 months.

The company disclosed that on August 1, 2023, the U.S. Attorney's Office informed them that it planned to close its investigation into the marketing and promotion of ONPATTRO. The company is also involved in ongoing patent infringement lawsuits against Pfizer and Moderna related to its mRNA COVID-19 vaccine technology.