10-QPeriod: Q1 FY2023

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2023

Filed May 4, 2023For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported significant top-line growth in the first quarter of 2023, with total revenues increasing by 50% year-over-year to $319.3 million. This growth was driven by a substantial 48% increase in net product revenues, primarily due to the successful launch and uptake of AMVUTTRA in the U.S., alongside continued growth for GIVLAARI and OXLUMO. Collaboration revenues also saw a healthy increase of 41%, largely attributed to enhanced activity with Regeneron Pharmaceuticals. Despite the strong revenue performance, the company continued to operate at a net loss of $174.1 million, though this represents a 28% improvement compared to the same period last year, indicating progress in managing operational costs relative to revenue growth. Operationally, Alnylam is advancing its pipeline with ONPATTRO receiving FDA acceptance for an sNDA for ATTR amyloidosis cardiomyopathy, and AMVUTTRA continuing its global rollout. The company maintains a solid liquidity position with $2.07 billion in cash, cash equivalents, and marketable securities as of March 31, 2023, which it believes is sufficient for at least the next 12 months. While the company continues to invest heavily in R&D, the strong revenue growth suggests a positive trajectory towards its Alnylam P5x25 strategy.

Financial Highlights

47 data points
Beta

Revenue

$319.29M

87.0% Gross Margin

Net Income

-$174.10M

-54.5% Net Margin

EPS (Diluted)

$-1.40

Total Assets

$3.39B

Cash & Equivalents

$672.25M

Free Cash Flow

-$180.37M

Financial Statements
Beta
Revenue$319.29M
Cost of Revenue$41.43M
Gross Profit$277.86M
R&D Expenses$230.57M
SG&A Expenses$183.66M
Operating Expenses$469.10M
Operating Income-$149.81M
Interest Expense$28.95M
Net Income-$174.10M
EPS (Basic)$-1.40
EPS (Diluted)$-1.40
Shares Outstanding (Basic)124.11M
Shares Outstanding (Diluted)124.11M

Key Highlights

  • 1Total revenues surged by 50% year-over-year to $319.3 million for Q1 2023.
  • 2Net product revenues increased by 48% to $276.3 million, driven by AMVUTTRA's U.S. launch and growth in GIVLAARI and OXLUMO.
  • 3Collaboration revenues grew by 41% to $36.5 million, primarily due to increased activity with Regeneron.
  • 4Net loss improved by 28% to $174.1 million, indicating better cost management relative to revenue growth.
  • 5ONPATTRO's sNDA for ATTR amyloidosis cardiomyopathy accepted by the FDA, with an action date in October 2023.
  • 6Company maintains a strong liquidity position with $2.07 billion in cash, cash equivalents, and marketable securities as of March 31, 2023.
  • 7Research and Development expenses increased by 36% to $230.6 million, reflecting continued investment in the pipeline.

Frequently Asked Questions

Alnylam reported total revenues of $319.3 million, a 50% increase year-over-year. Net product revenues were $276.3 million, up 48%, and net revenues from collaborations and royalty revenue totaled $42.9 million, up 55%. The company incurred a net loss of $174.1 million, an improvement from $240.3 million in Q1 2022.

The significant increase in net product revenues is primarily driven by the U.S. launch of AMVUTTRA in the third quarter of 2022. Growth was also supported by increased patient uptake for GIVLAARI and OXLUMO, although ONPATTRO revenue saw a decrease, partly due to patients switching to AMVUTTRA.

While research and development expenses increased by 36% to $230.6 million and selling, general, and administrative expenses rose by 19% to $183.7 million, the overall increase in operating costs and expenses (30%) was less than the revenue growth (50%). This indicates improved operational efficiency relative to revenue generation, leading to a reduced net loss compared to the prior year.

Alnylam believes its cash, cash equivalents, and marketable securities totaling $2.07 billion as of March 31, 2023, along with expected product sales and alliance revenues, are sufficient to fund its operations for at least the next 12 months. The company continues to invest in its pipeline, with R&D expenses increasing, but expects to achieve a self-sustainable financial profile by the end of 2025.