10-QPeriod: Q2 FY2017

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2017

Filed August 9, 2017For Securities:ALNY

Summary

This 10-Q filing for Alnylam Pharmaceuticals, Inc. for the period ending June 30, 2017, highlights the company's continued progress in advancing its RNA interference (RNAi) therapeutic pipeline, particularly its Alnylam 2020 strategy. The company is focused on developing novel therapeutics for rare genetic diseases, cardio-metabolic diseases, and hepatic infectious diseases. Significant milestones include the advancement of patisiran towards a potential New Drug Application (NDA) submission by year-end 2017, initiation of the ATLAS Phase 3 program for fitusiran, and progress with givosiran, which received Breakthrough Therapy designation from the FDA. Financially, Alnylam reported an increase in net revenues from collaborators, primarily driven by its collaboration with Sanofi Genzyme. However, the company continues to incur significant operating losses due to substantial investments in research and development. Alnylam successfully raised $355.2 million in net proceeds from a public stock offering in May 2017, enhancing its liquidity and providing resources to support its ongoing development and transition towards a commercial-stage company. The company believes its current cash reserves and expected collaboration revenues will be sufficient for its strategic goals in the coming years.

Financial Highlights

40 data points
Beta

Revenue

$15.93M

Net Income

-$118.42M

-743.3% Net Margin

EPS (Diluted)

$-1.34

Total Assets

$1.43B

Cash & Equivalents

$408.67M

Free Cash Flow

-$102.70M

Financial Statements
Beta
Revenue$15.93M
R&D Expenses$90.63M
Operating Expenses$136.41M
Operating Income-$120.47M
Net Income-$118.42M
EPS (Basic)$-1.34
Shares Outstanding (Basic)88.10M

Key Highlights

  • 1Alnylam is progressing its RNAi therapeutic pipeline with patisiran nearing potential NDA submission by end of 2017, fitusiran entering Phase 3, and givosiran receiving FDA Breakthrough Therapy designation.
  • 2Net revenues from collaborators increased significantly, driven primarily by the Sanofi Genzyme collaboration.
  • 3The company successfully raised approximately $355.2 million in net proceeds from a public stock offering in May 2017, strengthening its financial position.
  • 4Research and development expenses remain substantial, reflecting continued investment in pipeline advancement and platform development.
  • 5General and administrative expenses increased, driven by efforts to build commercial and medical affairs capabilities in anticipation of potential product launches.
  • 6The company holds a robust intellectual property portfolio with over 3,400 active cases and over 1,400 granted patents, reinforcing its leadership in RNAi therapeutics.
  • 7Alnylam's cash and cash equivalents position has strengthened, ending the period at $408.7 million, supported by the recent equity financing.

Frequently Asked Questions

The company's most advanced candidate, patisiran, is expected to report top-line data from its APOLLO Phase 3 study in mid-2017, with a potential NDA submission by year-end 2017. Fitusiran has initiated its ATLAS Phase 3 program, and givosiran, for acute hepatic porphyrias, received FDA Breakthrough Therapy designation and is expected to enter Phase 3 in late 2017. Inclisiran, partnered with MDCO, also has a Phase 3 study planned for late 2017.

Alnylam relies on revenues from strategic alliances with companies like Sanofi Genzyme and The Medicines Company (MDCO), as well as proceeds from equity financings. In May 2017, the company raised $355.2 million in net proceeds from a public stock offering, which is intended for general corporate purposes, including clinical trials and R&D expenses.

For the three months ended June 30, 2017, Alnylam reported net revenues from collaborators of $15.9 million, an increase from $8.7 million in the prior year period. Despite revenue growth, the company incurred an operating loss of $120.5 million and a net loss of $118.4 million for the quarter, reflecting significant ongoing investment in research and development. The company expects continued operating losses for the foreseeable future.

Key risks include the inherent uncertainties of developing RNAi therapeutics, as the technology is still relatively new and unproven in terms of broad market approval. The company has a history of significant losses and may not achieve profitability. Dependence on strategic alliances, the need for substantial future financing, potential clinical trial failures, regulatory hurdles, and competition from other companies developing similar technologies or alternative treatments are also significant concerns.