10-KPeriod: FY2016

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2016

Filed February 15, 2017For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) presented its 2016 10-K, highlighting a significant focus on its RNA interference (RNAi) therapeutic platform. The company is advancing its "Alnylam 2020" strategy with the goal of becoming a multi-product commercial-stage biopharmaceutical company by the end of 2020, aiming for three marketed products and ten RNAi therapeutic clinical programs. The company's lead candidate, patisiran, for hereditary TTR-mediated amyloidosis (hATTR), is in Phase 3 development with top-line data expected mid-2017, and potential regulatory submissions planned for late 2017. Significant R&D investments continued in 2016, reflecting the advancement of a broad pipeline across three strategic therapeutic areas: Genetic Medicines, Cardio-Metabolic Diseases, and Hepatic Infectious Diseases. The company also detailed progress in its manufacturing capabilities and global expansion, including its operational manufacturing facility for patisiran and construction of a new drug substance facility. Despite a substantial net loss of $410.1 million for 2016, driven by significant R&D expenses, Alnylam maintained a strong cash position of $942.6 million in cash, cash equivalents, and marketable securities at year-end, supported by strategic collaborations with companies like Sanofi Genzyme and The Medicines Company.

Financial Highlights

41 data points
Beta

Revenue

$47.16M

Net Income

-$410.11M

-869.6% Net Margin

EPS (Diluted)

$-4.79

Total Assets

$1.26B

Cash & Equivalents

$193.62M

Free Cash Flow

-$372.26M

Financial Statements
Beta
Revenue$47.16M
R&D Expenses$382.39M
SG&A Expenses$89.35M
Operating Expenses$471.75M
Operating Income-$424.59M
Net Income-$410.11M
EPS (Basic)$-4.79
Shares Outstanding (Basic)85.60M

Key Highlights

  • 1Alnylam is strategically positioned to become a multi-product commercial-stage biopharmaceutical company by 2020, with its "Alnylam 2020" strategy.
  • 2Patisiran, the lead product candidate for hATTR amyloidosis, is in Phase 3 (APOLLO study) with top-line data anticipated mid-2017 and regulatory submissions planned for late 2017.
  • 3Significant investment in Research and Development ($382.4 million in 2016) continues to drive pipeline advancement across Genetic Medicines, Cardio-Metabolic Diseases, and Hepatic Infectious Diseases.
  • 4The company is expanding its manufacturing infrastructure, including a new drug substance manufacturing facility, to support future commercialization.
  • 5Alnylam ended 2016 with a strong liquidity position, holding $942.6 million in cash, cash equivalents, and marketable securities.
  • 6Key strategic alliances with Sanofi Genzyme and The Medicines Company provide crucial support for development and commercialization efforts.
  • 7The company experienced a net loss of $410.1 million for 2016, primarily due to substantial R&D expenditures necessary for pipeline development.

Frequently Asked Questions

Alnylam's primary focus is on developing novel therapeutics based on RNA interference (RNAi) technology. Its "Alnylam 2020" strategy aims to become a multi-product commercial-stage biopharmaceutical company by the end of 2020, with a pipeline of ten clinical programs, including at least four in late-stage development, and three marketed products.

Patisiran, targeted for hereditary TTR-mediated amyloidosis (hATTR), is in a Phase 3 clinical trial called APOLLO. Alnylam expected to report top-line data in mid-2017 and planned to submit its first New Drug Application (NDA) and Marketing Authorization Application (MAA) by the end of 2017.

Alnylam funds its operations through a combination of equity financings and strategic alliances. Significant collaborations with partners like Sanofi Genzyme and The Medicines Company provide upfront payments, research funding, and potential milestone payments, which are critical for advancing its pipeline.

For the year ended December 31, 2016, Alnylam reported a net loss of $410.1 million, driven by R&D expenses of $382.4 million. The company maintained a strong cash position, ending the year with $942.6 million in cash, cash equivalents, and marketable securities. Net revenues from collaborators were $47.2 million, primarily from its strategic alliances.