10-QPeriod: Q1 FY2016

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2016

Filed May 4, 2016For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial results for the quarter ended March 31, 2016. The company continued to experience significant operating losses, with a net loss of $102.97 million for the quarter. Revenue from collaborators decreased to $7.345 million from $18.537 million in the prior year period, primarily due to the completion of performance obligations under certain agreements. Despite the net loss, Alnylam maintains a strong cash position with $231.278 million in cash and cash equivalents and $977.012 million in marketable securities. The company is actively investing in research and development, with R&D expenses increasing to $96.273 million from $58.035 million year-over-year, reflecting advancements in its pipeline, particularly in Genetic Medicines. Significant upcoming events include expected data from the APOLLO Phase 3 trial for patisiran in mid-2017 and the initiation of two Phase 3 trials for fitusiran in mid-to-late 2016.

Financial Highlights

38 data points
Beta

Net Income

-$102.97M

EPS (Diluted)

$-1.21

Total Assets

$1.32B

Cash & Equivalents

$231.28M

Free Cash Flow

-$86.38M

Financial Statements
Beta
R&D Expenses$96.27M
Operating Expenses$117.37M
Operating Income-$110.03M
Net Income-$102.97M
EPS (Basic)$-1.21
Shares Outstanding (Basic)85.28M

Key Highlights

  • 1Net loss for the quarter was $102.97 million, compared to $50.78 million in the same period last year, an increase driven by higher operating expenses.
  • 2Total operating expenses increased significantly to $117.37 million from $70.76 million, with Research & Development expenses rising 66% to $96.27 million.
  • 3Collaboration revenue decreased to $7.35 million from $18.54 million, mainly due to the completion of obligations under agreements with Monsanto and Takeda.
  • 4The company ended the quarter with $231.28 million in cash and cash equivalents and $748.42 million in short-term marketable securities, indicating substantial liquidity.
  • 5Alnylam is advancing its Genetic Medicine pipeline, with the APOLLO Phase 3 trial for patisiran having completed enrollment and expecting mid-2017 data.
  • 6Two Phase 3 trials for fitusiran are expected to initiate in mid-to-late 2016, targeting hemophilia A and B patients.
  • 7The company entered into new credit agreements totaling $150 million to support the build-out of a new drug substance manufacturing facility.

Frequently Asked Questions

As of March 31, 2016, Alnylam had $231.28 million in cash and cash equivalents and $748.42 million in short-term marketable securities, totaling over $979 million in liquid assets. The company stated that its existing cash and marketable securities, along with expected cash from current alliances, are believed to be sufficient to achieve its 'Alnylam 2020' guidance, which aims for three marketed products and ten clinical programs by the end of 2020.

The decrease in collaboration revenue from $18.54 million in Q1 2015 to $7.35 million in Q1 2016 was primarily due to the completion of performance obligations under agreements with Monsanto (completed February 2015) and the amortization of revenue under the Takeda agreement (completed May 2015). This was partially offset by increased services performed under the Sanofi Genzyme agreement.

For patisiran (ALN-TTR02), the APOLLO Phase 3 trial for hereditary ATTR amyloidosis (hATTR-PN) has completed enrollment, with data expected in mid-2017. For fitusiran (ALN-AT3), two Phase 3 trials for hemophilia A and B are on track to initiate in mid-2016 and late 2016. The company also reported preliminary evidence of clinical activity for ALN-CC5 in paroxysmal nocturnal hemoglobinuria (PNH) and plans for a new Phase 2 study by the end of 2016. Additionally, ALN-HBV is set to begin a Phase 1 study in mid-2016.

Alnylam is investing in its manufacturing infrastructure. In February 2016, the company entered into an agreement to purchase land in Norton, Massachusetts, for the construction of a drug substance manufacturing facility, with an expected capital investment of approximately $100 million in 2016. Furthermore, in April 2016, the company secured credit agreements totaling $150 million to support the build-out of this facility.