10-QPeriod: Q3 FY2013

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2013

Filed November 7, 2013For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported its financial results for the quarterly period ended September 30, 2013. The company continues to operate at a net loss, with a loss of $29.7 million for the third quarter and $56.9 million for the first nine months of the year. This reflects significant ongoing investment in research and development, which increased by 56% and 25% year-over-year for the respective periods. Despite the losses, Alnylam bolstered its financial position by raising approximately $173.6 million in net proceeds from a public offering in January 2013, contributing to a total cash and marketable securities balance of $367.1 million as of September 30, 2013. Operationally, the company is advancing its 'Alnylam 5x15' strategy, focusing on five RNAi therapeutic programs in clinical development by the end of 2015. Key updates include positive interim results from the Phase II trial of patisiran (ALN-TTR02) for transthyretin-mediated amyloidosis (ATTR) and promising early data for ALN-TTRsc, demonstrating human translation of its GalNAc-siRNA conjugate platform. The company also filed an application to initiate a Phase I clinical trial for ALN-AT3 and identified a development candidate for ALN-AS1. Revenue from research collaborators decreased compared to the prior year, primarily due to the completion of the Roche/Arrowhead alliance, though this was partially offset by recognition of deferred revenue from the Cubist agreement termination and new revenues from Monsanto and The Medicines Company.

Financial Highlights

38 data points
Beta

Net Income

-$29.69M

EPS (Diluted)

$-0.48

Total Assets

$447.50M

Cash & Equivalents

$11.84M

Free Cash Flow

-$22.66M

Financial Statements
Beta
R&D Expenses$34.46M
Operating Expenses$41.23M
Operating Income-$32.23M
Net Income-$29.69M
EPS (Basic)$-0.48
Shares Outstanding (Basic)62.42M

Key Highlights

  • 1Net loss for the third quarter of 2013 was $29.7 million, and $56.9 million for the first nine months.
  • 2Research and development expenses increased significantly, by 56% for the three months and 25% for the nine months ended September 30, 2013, reflecting continued investment in pipeline advancement.
  • 3The company raised approximately $173.6 million in net proceeds from a public offering in January 2013, significantly strengthening its cash position.
  • 4Total cash, cash equivalents, and marketable securities stood at $367.1 million as of September 30, 2013.
  • 5Positive interim clinical results were reported for patisiran (ALN-TTR02) and early promising data for ALN-TTRsc, validating the GalNAc-siRNA conjugate delivery platform.
  • 6The company advanced its ALN-AT3 program by filing a clinical trial application and identified ALN-AS1 as a development candidate.
  • 7Net revenues from research collaborators decreased year-over-year, impacted by the completion of the Roche/Arrowhead alliance, but new collaborations with Monsanto and The Medicines Company are contributing revenue.

Frequently Asked Questions

As of September 30, 2013, Alnylam Pharmaceuticals had $367.1 million in cash, cash equivalents, and fixed income marketable securities. This was significantly bolstered by a public offering in January 2013 that generated approximately $173.6 million in net proceeds. Despite ongoing net losses, the company believes its current cash position is sufficient to fund operations through at least the end of 2016.

Alnylam reported positive interim Phase II results for patisiran (ALN-TTR02) in patients with transthyretin-mediated amyloidosis (ATTR), showing dose-dependent knockdown of serum TTR levels. Additionally, early data for ALN-TTRsc demonstrated successful human translation of their GalNAc-siRNA conjugate delivery platform. The company also filed to initiate a Phase I trial for ALN-AT3 and identified a development candidate for ALN-AS1.

Total net revenues from research collaborators decreased in the nine months ended September 30, 2013, compared to the prior year, mainly due to the completion of the Roche/Arrowhead alliance. However, revenues from new alliances with Monsanto and The Medicines Company are starting to contribute. A significant portion of future revenue is expected to come from existing and new strategic alliances, with $125.3 million in deferred revenue recorded as of September 30, 2013.

Alnylam continues to invest heavily in research and development, which increased significantly in the reported periods. The company anticipates continued operating losses in the foreseeable future due to these investments. Profitability will depend on the successful development and commercialization of its RNAi therapeutics, which is a lengthy and uncertain process. Management believes its current cash reserves will fund operations through at least late 2016, but significant additional funding may be required earlier.