Alnylam Pharmaceuticals (ALNY) Q3 2024 earnings summary

Executive summary

• Achieved $420.1 million in Q3 2024 global net product revenues, up 34% year-over-year, driven by strong TTR and rare franchise performance, especially AMVUTTRA, GIVLAARI, and OXLUMO, partially offset by ONPATTRO declines.

• Submitted regulatory applications in the U.S. and EU for vutrisiran (AMVUTTRA) for ATTR amyloidosis with cardiomyopathy, targeting a potential U.S. launch in early 2025.

• Advanced pipeline with positive Phase 1 results for mivelsiran in Alzheimer's disease and initiation of Phase 1 for ALN-HTT02 in Huntington's disease.

• Net loss of $111.6 million for Q3 2024 compared to net income of $147.8 million in Q3 2023, reflecting lower collaboration revenue and higher R&D and SG&A expenses.

• On track to achieve P5x25 goals by year-end 2025, aiming for top-tier biotech status with a high-yielding pipeline.

Financial highlights

• Q3 2024 net product revenues reached $420.1 million, up 34% year-over-year, led by AMVUTTRA (+74%), GIVLAARI (+31%), and OXLUMO (+40%), while ONPATTRO declined 38%.

• Total revenues were $500.9 million, down 33% year-over-year due to lower collaboration revenue; nine-month revenues rose 19% to $1.66 billion.

• Gross margin on product sales improved to 80% (cost of goods sold as a percentage of net product revenues decreased to 19.5% from 25.4% in Q3 2023).

• Ended the quarter with $2.78 billion in cash, cash equivalents, and marketable securities.

• Net loss per share was $(0.87) basic and diluted for Q3 2024; non-GAAP net loss was $64.2 million, or $(0.50) per share.

Outlook and guidance

• Reiterated 2024 guidance: combined net product revenues expected between $1.575–$1.65 billion, representing 27–33% growth at reported FX rates.

• Collaboration and royalty revenue guidance: $575 million–$650 million.

• Combined non-GAAP R&D and SG&A expenses guidance: $1.775–$1.875 billion; GAAP at $2.0–$2.15 billion.

• Preparing for a potential ATTR cardiomyopathy launch in 2025, with additional clinical milestones expected late 2024 and early 2025.

• Cash and marketable securities expected to cover operating needs for at least the next 12 months.