10-QPeriod: Q1 FY2024

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2024

Filed May 2, 2024For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported a substantial increase in total revenues for the first quarter of 2024, driven by strong performance in both net product revenues and collaboration revenues. Net product revenues saw a 32% increase year-over-year, primarily fueled by the robust growth of AMVUTTRA, alongside continued strength from GIVLAARI and OXLUMO. Collaboration revenues more than doubled, largely due to revenue recognized from the Roche collaboration, including a significant milestone payment related to the zilebesiran program, and increased activity with Regeneron. Despite the revenue growth, the company reported a net loss of $65.9 million, an improvement from the previous year's loss of $174.1 million, indicating progress in narrowing the operational loss. Research and development expenses increased by 13%, reflecting continued investment in pipeline advancement, particularly for zilebesiran and the HELIOS-B study. Selling, general, and administrative expenses also rose, driven by marketing investments and headcount growth. The company's liquidity remains strong, with cash, cash equivalents, and marketable securities sufficient for at least the next 12 months, according to management.

Financial Highlights

48 data points
Beta

Revenue

$494.33M

89.0% Gross Margin

Net Income

-$65.94M

-13.3% Net Margin

EPS (Diluted)

$-0.52

Total Assets

$3.82B

Cash & Equivalents

$681.88M

Free Cash Flow

-$94.49M

Financial Statements
Beta
Revenue$494.33M
Cost of Revenue$54.61M
Gross Profit$439.72M
R&D Expenses$261.00M
SG&A Expenses$210.80M
Operating Expenses$537.77M
Operating Income-$43.44M
Interest Expense$35.25M
Net Income-$65.94M
EPS (Basic)$-0.52
EPS (Diluted)$-0.52
Shares Outstanding (Basic)126.14M
Shares Outstanding (Diluted)126.14M

Key Highlights

  • 1Total revenues surged by 55% to $494.3 million in Q1 2024 compared to Q1 2023, driven by strong product sales and significant collaboration revenue.
  • 2Net product revenues grew by 32% to $365.2 million, with AMVUTTRA showing 92% year-over-year growth, while ONPATTRO saw a decline.
  • 3Net revenues from collaborations increased by 225% to $118.5 million, primarily due to a $65 million milestone payment from Roche for the zilebesiran program and increased activity with Regeneron.
  • 4Royalty revenue also increased by 63% to $10.6 million, primarily from Leqvio sales.
  • 5The net loss improved to $65.9 million ($0.52 per share) in Q1 2024, a significant reduction from $174.1 million ($1.40 per share) in Q1 2023.
  • 6Research and Development (R&D) expenses increased by 13% to $261 million, reflecting ongoing investment in clinical studies like zilebesiran and HELIOS-B.
  • 7Selling, General, and Administrative (SG&A) expenses increased by 15% to $210.8 million, driven by marketing investments and increased headcount.

Frequently Asked Questions

Alnylam Pharmaceuticals experienced a significant 55% increase in total revenues, reaching $494.3 million in the first quarter of 2024, up from $319.3 million in the same period of 2023. This growth was driven by a 32% rise in net product revenues, largely from AMVUTTRA, and a substantial 225% increase in net revenues from collaborations, notably from the Roche milestone payment and increased Regeneron activity.

Alnylam reported an improved net loss of $65.9 million in Q1 2024, compared to $174.1 million in Q1 2023, demonstrating progress in narrowing its losses. The company maintains a strong liquidity position, with cash, cash equivalents, and marketable securities totaling $2.37 billion as of March 31, 2024, which management believes is sufficient to cover operating needs for at least the next 12 months.

The 13% increase in R&D expenses was primarily driven by continued investment in clinical studies, particularly for zilebesiran (KARDIA-2 and KARDIA-3) and the HELIOS-B study, as well as increased preclinical activities and higher compensation costs due to increased headcount. The 15% rise in SG&A expenses was due to increased marketing investments for TTR therapies and expansion of the global infrastructure, including headcount growth.

The collaboration with Roche significantly boosted Alnylam's revenue in Q1 2024, contributing $74.7 million, which included a $65 million milestone payment related to the KARDIA-3 study for zilebesiran. The Regeneron collaboration also saw increased revenue recognition, up 34% year-over-year, due to higher activity levels in research services and licensed programs.