10-KPeriod: FY2011

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2011

Filed February 13, 2012For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics based on RNA interference (RNAi). In 2011, the company continued to advance its pipeline, with key programs like ALN-TTR for transthyretin-mediated amyloidosis (ATTR) and ALN-APC for hemophilia showing progress. The company reported preliminary Phase I data for ALN-TTR01 demonstrating dose-dependent reduction in serum TTR levels and for ALN-PCS showing significant silencing of PCSK9 protein levels and reductions in LDL-c. Financially, Alnylam continued to operate at a net loss, with significant investments in research and development. The company ended 2011 with a solid cash position of $260.8 million, supported by collaboration revenues primarily from Roche/Arrowhead and Takeda. However, total revenues decreased compared to the prior year, and the company implemented a strategic restructuring in early 2012, reducing its workforce by approximately 33% to focus resources on its highest-value opportunities. Significant legal proceedings related to intellectual property with Tekmira and other parties were ongoing, posing a potential risk to the company's operations and financial performance.

Financial Highlights

41 data points
Beta

Net Income

-$57.65M

EPS (Diluted)

$-1.36

Total Assets

$281.92M

Cash & Equivalents

$70.23M

Free Cash Flow

-$88.36M

Financial Statements
Beta
R&D Expenses$99.30M
Operating Expenses$137.57M
Operating Income-$54.82M
Net Income-$57.65M
EPS (Basic)$-1.36
Shares Outstanding (Basic)42.41M

Key Highlights

  • 1Alnylam is focused on developing RNAi-based therapeutics, with ALN-TTR (for ATTR) and ALN-APC (for hemophilia) as lead programs.
  • 2Preliminary Phase I data for ALN-TTR01 showed significant TTR reduction, and for ALN-PCS demonstrated dose-dependent reduction in PCSK9 and LDL-c.
  • 3The company ended 2011 with $260.8 million in cash, cash equivalents, and marketable securities.
  • 4Revenues from research collaborations decreased in 2011 compared to 2010, primarily due to the completion of research programs with Novartis and a reduction in government contract activities.
  • 5A strategic corporate restructuring was implemented in January 2012, reducing the workforce by approximately 33% to focus on key programs.
  • 6Significant legal proceedings were ongoing related to intellectual property disputes with Tekmira and others.

Frequently Asked Questions

Alnylam's core strategy, known as "Alnylam 5x15," focuses on developing novel RNAi therapeutics for genetically defined diseases with high unmet medical needs. The goal is to have five RNAi therapeutic programs in clinical development by the end of 2015, with candidates that have a genetically defined target, address significant unmet needs, leverage the company's delivery platform, allow for early biomarker monitoring, and have clear clinical endpoints for regulatory filings.

As of the filing date (February 13, 2012), Alnylam's most advanced core product development program was ALN-TTR, targeting transthyretin-mediated amyloidosis (ATTR), which had preliminary Phase I clinical trial data. ALN-APC for hemophilia was also a core program. Partner-based programs in clinical or pre-clinical development included ALN-RSV01 for RSV infection and ALN-VSP for liver cancers.

For the year ended December 31, 2011, Alnylam reported net revenues from research collaborators of $82.8 million, a decrease from $100.0 million in 2010. Operating expenses were $137.6 million, a decrease from $144.1 million in 2010. The company reported a net loss of $57.6 million for 2011, compared to a net loss of $43.5 million in 2010. The company maintained a strong liquidity position with $260.8 million in cash, cash equivalents, and marketable securities at year-end.

In January 2012, Alnylam implemented a strategic corporate restructuring that reduced its workforce by approximately 33% to around 115 employees. This was done to align resources with its highest-value opportunities, specifically focusing on ALN-TTR and ALN-APC as lead programs, while advancing other pipeline programs through alliances. The company anticipated significant savings in operating expenses for 2012 as a result of this restructuring.