10-KPeriod: FY2023

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2023

Filed February 15, 2024For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported its 2023 financial and operational results, showcasing significant revenue growth driven by its expanding portfolio of RNAi therapeutics. The company's net product revenues reached $1.24 billion, up 39% year-over-year, primarily due to the strong performance of AMVUTTRA and continued growth in GIVLAARI and OXLUMO, partially offset by a decline in ONPATTRO sales as patients transitioned to AMVUTTRA. Collaboration revenues also saw a substantial increase, largely from the new agreement with Roche for zilebesiran and increased royalties from Novartis on Leqvio. Alnylam continues to invest heavily in research and development, with expenses increasing by 14% to $1.0 billion, reflecting progress in its pipeline, including the development of zilebesiran for hypertension and ALN-APP for Alzheimer's disease. The company ended the year with $2.44 billion in cash, cash equivalents, and marketable securities, providing a solid liquidity position. Despite a net loss of $440 million, Alnylam is progressing towards its P5x25 strategic goals, aiming for profitability and a leading biotech profile by the end of 2025.

Financial Statements
Beta
Revenue$1.83B
Cost of Revenue$268.22M
Gross Profit$1.56B
R&D Expenses$1.00B
SG&A Expenses$795.65M
Operating Expenses$2.11B
Operating Income-$282.18M
Interest Expense$121.22M
Net Income-$440.24M
EPS (Basic)$-3.52
EPS (Diluted)$-3.52
Shares Outstanding (Basic)124.91M
Shares Outstanding (Diluted)124.91M

Key Highlights

  • 1Total revenues increased by 76% to $1.83 billion in 2023, driven by a 39% rise in net product revenues to $1.24 billion and a significant increase in collaboration revenues to $546 million.
  • 2AMVUTTRA sales grew substantially to $558 million, while ONPATTRO sales declined to $355 million, indicating a product franchise shift.
  • 3GIVLAARI and OXLUMO demonstrated solid growth, with revenues reaching $219 million and $110 million, respectively.
  • 4Research and development expenses increased by 14% to $1.0 billion, reflecting continued investment in pipeline advancement, particularly for zilebesiran and ALN-APP.
  • 5The company ended 2023 with $2.44 billion in cash, cash equivalents, and marketable securities, providing a strong liquidity foundation.
  • 6Alnylam advanced its key pipeline programs, including reporting positive topline results for zilebesiran's KARDIA-1 Phase 2 study and positive interim results for ALN-APP's Phase 1 study.
  • 7The FDA issued a Complete Response Letter (CRL) for ONPATTRO's sNDA for ATTR amyloidosis with cardiomyopathy, indicating that clinical meaningfulness was not established for this indication.

Frequently Asked Questions

Alnylam's net product revenues increased by 39% to $1.24 billion in 2023. This growth was primarily driven by the launch and strong performance of AMVUTTRA ($558 million in sales), which benefited from patient transitions from ONPATTRO. GIVLAARI ($219 million) and OXLUMO ($110 million) also contributed with solid growth. ONPATTRO sales decreased to $355 million, largely due to the shift to AMVUTTRA.

Alnylam's collaboration revenues increased significantly to $546 million in 2023, primarily due to a $338 million revenue recognition from the new collaboration with Roche for zilebesiran and increased milestone and royalty payments from Novartis for Leqvio. Other key collaborations include those with Regeneron and Sanofi.

Alnylam's HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy is expected to report topline results in late June or early July 2024. Regarding zilebesiran, the company reported positive topline results from the KARDIA-1 Phase 2 study and completed enrollment in the KARDIA-2 study. Furthermore, the FDA issued a Complete Response Letter (CRL) for ONPATTRO's sNDA for ATTR amyloidosis with cardiomyopathy, stating that clinical meaningfulness was not established for this indication.

Alnylam ended 2023 with a strong liquidity position, reporting $2.44 billion in cash, cash equivalents, and marketable securities. Despite this, the company reported a net loss of $440 million for the year, continuing its trend of losses as it invests heavily in R&D and commercial infrastructure. Alnylam is working towards achieving financial self-sustainability by the end of 2025 as part of its P5x25 strategy.