10-QPeriod: Q2 FY2018

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2018

Filed August 2, 2018For Securities:ALNY

Summary

This Q2 2018 report for Alnylam Pharmaceuticals highlights significant progress and key upcoming milestones, particularly concerning patisiran. The company received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for patisiran (ONPATTRO™) for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). A decision from the European Commission is expected in September 2018, and the US FDA has an action date of August 11, 2018. Successful approval and launch could lead to product revenues starting in 2018. Operationally, Alnylam reported increased net revenues from collaborators, primarily driven by a milestone payment for the fitusiran Phase 3 program and work with Vir Biotechnology. However, operating expenses, particularly in research and development and general and administrative functions, also saw significant increases, reflecting ongoing pipeline advancement and preparations for potential commercialization. The company continues to invest heavily in R&D, essential for its RNAi therapeutic platform, while maintaining a substantial cash position, indicating it has sufficient resources for its near-term strategic goals.

Financial Highlights

40 data points
Beta

Revenue

$29.91M

Net Income

-$163.56M

-546.9% Net Margin

EPS (Diluted)

$-1.63

Total Assets

$1.79B

Cash & Equivalents

$361.46M

Free Cash Flow

-$125.39M

Financial Statements
Beta
Revenue$29.91M
R&D Expenses$137.58M
SG&A Expenses$84.68M
Operating Expenses$222.26M
Operating Income-$192.35M
Net Income-$163.56M
EPS (Basic)$-1.63
Shares Outstanding (Basic)100.52M

Key Highlights

  • 1Patisiran (ONPATTRO™) received a positive CHMP opinion in Europe and has an upcoming FDA decision date of August 11, 2018, paving the way for potential commercial launch and revenue generation in late 2018.
  • 2Net revenues from collaborators increased by approximately $17.0 million for the six months ended June 30, 2018, compared to the same period in 2017, primarily due to a $50 million milestone payment for the fitusiran program.
  • 3Research and development expenses increased by approximately $56.8 million for the first six months of 2018, driven by manufacturing, compensation, and external services, reflecting pipeline advancement.
  • 4General and administrative expenses rose significantly by approximately $72.9 million for the first six months of 2018, due to increased headcount and services to support corporate growth and potential product launches.
  • 5The company recognized a $20.6 million gain on litigation settlement with Dicerna Therapeutics in the second quarter of 2018.
  • 6Alnylam maintains a strong liquidity position with $1.44 billion in cash, cash equivalents, and marketable debt securities as of June 30, 2018.
  • 7The company is advancing its 'Alnylam 2020' strategy, aiming for three marketed products and ten RNAi therapeutic clinical programs by the end of 2020.

Frequently Asked Questions

Alnylam announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for patisiran for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). A decision from the European Commission is expected in September 2018. In the United States, the FDA has an action date of August 11, 2018, for their review.

Net revenues from collaborators increased significantly, primarily driven by a $50 million milestone payment received in Q1 2018 related to the fitusiran Phase 3 program and increased work performed under the collaboration with Vir Biotechnology. However, the adoption of new revenue recognition standards led to a reduction in reported deferred revenue, impacting the timing of recognition compared to prior periods.

Alnylam reported a net loss of $163.6 million for the quarter ended June 30, 2018. Despite ongoing losses, the company has a substantial cash reserve of $1.44 billion, which, along with expected collaboration revenues, is believed to be sufficient to fund its 'Alnylam 2020' strategy for at least the next few years. Significant ongoing investments in research and development and general administrative expenses are expected to continue.

Alnylam expects to report topline results from the interim analysis of the givosiran ENVISION Phase 3 study by the end of September 2018, with potential for an NDA submission by year-end 2018 for accelerated approval. A Phase 3 pivotal trial for lumasiran is on track to initiate mid-2018 with results expected in late 2019. The company is also on track to start a Phase 3 study for ALN-TTRsc02 in late 2018.