10-KPeriod: FY2017

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2017

Filed February 15, 2018For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc.'s 2017 10-K highlights a pivotal year marked by significant progress in its RNA interference (RNAi) therapeutic pipeline, particularly with patisiran. The company reached a major milestone by filing its first New Drug Application (NDA) with the FDA and a Marketing Authorisation Application (MAA) with the EMA for patisiran, targeting hereditary transthyretin-mediated (hATTR) amyloidosis. Regulatory reviews are underway with anticipated action dates in 2018, positioning Alnylam for potential product launch and revenue generation within the year. Financially, Alnylam strengthened its position by completing two public offerings that raised substantial net proceeds, ending the year with a robust cash balance. The company continues to invest heavily in research and development to advance its Alnylam 2020 strategy, aiming to have three marketed products and ten clinical-stage programs by the end of 2020. Key collaborations, notably with Sanofi Genzyme and The Medicines Company, remain central to its development and commercialization efforts, with recent amendments to the Sanofi Genzyme agreement significantly reshaping global rights for key pipeline assets.

Financial Highlights

46 data points
Beta

Revenue

$89.91M

100.0% Gross Margin

Net Income

-$490.87M

-545.9% Net Margin

EPS (Diluted)

$-5.42

Total Assets

$1.99B

Cash & Equivalents

$645.36M

Free Cash Flow

-$487.00M

Financial Statements
Beta
Revenue$89.91M
Cost of Revenue$0
Gross Profit$89.91M
R&D Expenses$390.63M
SG&A Expenses$199.37M
Operating Expenses$590.00M
Operating Income-$500.09M
Net Income-$490.87M
EPS (Basic)$-5.42
Shares Outstanding (Basic)90.55M

Key Highlights

  • 1Filed first NDA and MAA for patisiran (hATTR amyloidosis) with the FDA and EMA, respectively, with anticipated regulatory action in 2018.
  • 2Successfully raised approximately $1.14 billion in net proceeds through two public equity offerings, significantly bolstering cash reserves.
  • 3Ended 2017 with $1.7 billion in cash, cash equivalents, and marketable securities, providing strong financial footing.
  • 4Advanced multiple pipeline programs into late-stage clinical development, including givosiran (Acute Hepatic Porphyrias) and fitusiran (Hemophilia A and B), with significant clinical trial updates.
  • 5Restructured global rights for patisiran, ALN-TTRsc02, and fitusiran with Sanofi Genzyme, consolidating patisiran rights with Alnylam and global rights for fitusiran with Sanofi Genzyme.
  • 6Continued to invest heavily in R&D, with expenses reaching $390.6 million in 2017, underscoring commitment to pipeline advancement.
  • 7Established commercial readiness by expanding organizational capabilities in anticipation of patisiran's potential launch.

Frequently Asked Questions

The most significant regulatory milestone for Alnylam in 2017 was the filing of its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for patisiran, a treatment for hereditary transthyretin-mediated (hATTR) amyloidosis. This marked a critical step towards potentially bringing their first product to market.

Alnylam significantly strengthened its financial position in 2017 by raising approximately $1.14 billion in net proceeds through two public equity offerings. This increased their cash, cash equivalents, and marketable securities to $1.7 billion by year-end. Their strategy to fund ongoing operations and pipeline advancement relies on these cash reserves, existing and future strategic alliances, and potential milestone and royalty payments.

Alnylam made significant strategic adjustments to its collaboration with Sanofi Genzyme in early 2018. The key changes include Alnylam gaining exclusive global rights for the development and commercialization of patisiran and ALN-TTRsc02, while Sanofi Genzyme obtained exclusive global rights for fitusiran. This restructuring aims to streamline development and commercialization efforts for these important pipeline assets.

Alnylam is focused on executing its 'Alnylam 2020' strategy, which aims to establish the company as a multi-product commercial-stage biopharmaceutical firm with three marketed products and ten clinical-stage RNAi therapeutic programs by the end of 2020. The company is heavily investing in R&D and building its commercial infrastructure in preparation for the potential launch of patisiran in 2018, while continuing to advance its broader pipeline.