10-QPeriod: Q3 FY2024

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2024

Filed October 31, 2024For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported a net loss of $111.6 million for the third quarter of 2024, compared to a net income of $147.8 million in the same period last year. This shift is largely due to a significant decrease in collaboration revenues, primarily from the Roche collaboration, which included a substantial upfront payment recognized in Q3 2023. Despite the net loss, product revenues saw robust growth, increasing by 34% year-over-year to $420.1 million, driven by strong performance from AMVUTTRA and growth in GIVLAARI and OXLUMO, partially offset by a decline in ONPATTRO sales. For the nine months ended September 30, 2024, Alnylam reported a net loss of $194.4 million, an improvement from the $302.4 million net loss in the prior year period. Total revenues increased by 19% to $1.66 billion, with net product revenues up 34% to $1.20 billion. However, the company's operating costs and expenses also rose by 11% to $1.73 billion. The company ended the quarter with a strong cash position of $1.10 billion, providing ample liquidity for at least the next 12 months. Management remains focused on advancing its pipeline, with key submissions for AMVUTTRA in cardiomyopathy and positive interim results for mivelsiran in Alzheimer's disease.

Financial Statements
Beta

Key Highlights

  • 1Net loss for Q3 2024 was $111.6 million, a significant shift from a net income of $147.8 million in Q3 2023.
  • 2Net product revenues increased 34% year-over-year to $420.1 million in Q3 2024, driven by AMVUTTRA's strong performance.
  • 3Total revenues for Q3 2024 decreased 33% to $500.9 million, primarily due to a substantial drop in collaboration revenues from the prior year's milestone payments.
  • 4Nine-month net loss improved to $194.4 million from $302.4 million in the same period last year.
  • 5Nine-month net product revenues grew 34% to $1.20 billion.
  • 6Operating costs and expenses increased 11% for the nine months ended September 30, 2024, to $1.73 billion.
  • 7Cash, cash equivalents, and restricted cash totaled $1.10 billion as of September 30, 2024, indicating sufficient liquidity.
  • 8Positive interim results announced for mivelsiran in Alzheimer's disease.
  • 9Submitted sNDA to the FDA and Type II Variation to the EMA for AMVUTTRA for the treatment of ATTR amyloidosis with cardiomyopathy.

Frequently Asked Questions

The substantial decrease in collaboration revenues in Q3 2024 compared to Q3 2023 is primarily due to the recognition of a $310.0 million upfront payment from the Roche collaboration in the prior year's quarter. This year, collaboration revenues were mainly driven by milestone payments and ongoing development activities.

AMVUTTRA is performing very strongly, with net product revenues of $258.6 million in Q3 2024, a significant increase of 74% compared to $148.7 million in Q3 2023. It was the leading contributor to the company's net product revenues in the quarter.

Alnylam ended the quarter with $1.10 billion in cash, cash equivalents, and restricted cash. Based on their current operating plan, the company believes this liquidity is sufficient to meet its working capital and operating needs for at least the next 12 months.

Key near-term developments include the regulatory review of AMVUTTRA for the treatment of ATTR amyloidosis with cardiomyopathy (with sNDA submitted to FDA and Type II Variation to EMA) and the ongoing clinical development of mivelsiran, for which positive interim results were announced.