10-QPeriod: Q3 FY2023

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2023

Filed November 2, 2023For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the third quarter and first nine months of 2023, driven by strong growth in net product revenues and substantial collaboration revenues, particularly from the new Roche agreement and an early clinical milestone from Regeneron. Net product revenues saw a notable increase of 35% year-over-year in Q3, primarily due to the launch and uptake of AMVUTTRA, offsetting a decline in ONPATTRO sales as patients switched to the newer therapy. The company also reported positive momentum across its other key products, GIVLAARI and OXLUMO. Operationally, the company's focus remains on advancing its pipeline, with significant R&D expenses supporting various clinical programs. Despite an increase in Cost of Goods Sold, largely due to an inventory impairment related to ONPATTRO's ATTR cardiomyopathy indication, the company achieved a net income of $147.8 million in Q3 2023, a significant turnaround from a net loss in the prior year's quarter. This improved profitability reflects the substantial collaboration revenue and disciplined expense management. The company maintains sufficient liquidity and believes its current cash and cash equivalents will support operations for at least the next 12 months.

Financial Statements
Beta
Revenue$750.53M
Cost of Revenue$79.47M
Gross Profit$671.06M
R&D Expenses$253.18M
SG&A Expenses$199.18M
Operating Expenses$536.66M
Operating Income$213.87M
Interest Expense$30.89M
Net Income$147.75M
EPS (Basic)$1.18
EPS (Diluted)$1.15
Shares Outstanding (Basic)125.22M
Shares Outstanding (Diluted)131.34M

Key Highlights

  • 1Total revenues surged by 184% year-over-year to $750.5 million in Q3 2023, primarily driven by a substantial $311.3 million upfront payment from the Roche collaboration for zilebesiran.
  • 2Net product revenues increased by 35% to $313.2 million in Q3 2023, with AMVUTTRA showing strong growth (489% increase), offsetting a decline in ONPATTRO sales.
  • 3The company reported a net income of $147.8 million for Q3 2023, a significant improvement from a net loss of $405.9 million in Q3 2022, reflecting the impact of increased revenues and effective cost management.
  • 4Research and development expenses increased by 3% to $253.2 million in Q3 2023, primarily due to increased clinical trial activities, particularly for zilebesiran and ALN-TTRsc04.
  • 5Selling, general and administrative expenses decreased by 16% to $199.2 million in Q3 2023, mainly due to lower stock-based compensation expenses.
  • 6The company ended the quarter with strong liquidity, holding $1.03 billion in cash and cash equivalents and $1.36 billion in marketable debt securities, providing ample resources for ongoing operations and development.

Frequently Asked Questions

The substantial increase in total revenues, up 184% year-over-year to $750.5 million, was primarily driven by the recognition of $311.3 million in collaboration revenue from the upfront payment received from Roche for the zilebesiran collaboration, as well as a $100 million milestone earned from Regeneron for the ALN-APP CNS program, and continued growth in net product revenues.

Net product revenues increased by 35% to $313.2 million in Q3 2023 compared to the prior year. This growth was largely attributable to the successful launch and market adoption of AMVUTTRA, which saw a significant 489% increase in revenue. This growth partially offset a decline in ONPATTRO revenue, as patients are switching to AMVUTTRA. GIVLAARI and OXLUMO also contributed to revenue growth.

Alnylam Pharmaceuticals maintained a strong liquidity position as of September 30, 2023, with $1.03 billion in cash and cash equivalents and an additional $1.36 billion in marketable debt securities. The company's operating activities generated positive cash flow of $134 million for the first nine months of 2023, and management believes its current resources are sufficient to support operations for at least the next 12 months.

The collaboration with Roche, signed in July 2023, significantly boosted revenue in Q3 2023 with an upfront payment of $311.3 million. The ongoing collaboration with Regeneron also contributed positively, with the company recognizing a $65 million cumulative catch-up adjustment related to an early clinical milestone for the ALN-APP program. These collaborations are crucial for funding pipeline development and generating substantial revenue.