10-QPeriod: Q3 FY2017

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2017

Filed November 7, 2017For Securities:ALNY

Summary

This filing from Alnylam Pharmaceuticals, Inc. for the quarter ended September 30, 2017, highlights significant progress in their RNA interference (RNAi) therapeutic development. The company reported positive Phase 3 results for patisiran, its lead candidate for hereditary TTR-mediated amyloidosis (hATTR), with plans to submit regulatory applications by year-end 2017. Despite this positive news, the company also disclosed a temporary suspension of dosing for its fitusiran program due to a serious adverse event, which is undergoing regulatory review. Alnylam continues to advance its pipeline across three strategic therapeutic areas, aiming for three marketed products and ten clinical programs by 2020. Financially, Alnylam reported an increase in net revenues from collaborators, primarily driven by their partnership with Sanofi Genzyme. However, the company continues to incur substantial operating losses, as expected for a clinical-stage biopharmaceutical company, with a significant accumulated deficit. To support ongoing research and development and operational growth, Alnylam successfully raised substantial capital through a public offering in May 2017. The company believes its current cash position, along with anticipated collaboration revenues, will be sufficient to fund its operations for the next few years.

Financial Highlights

41 data points
Beta

Revenue

$17.10M

Net Income

-$122.94M

-719.1% Net Margin

EPS (Diluted)

$-1.34

Total Assets

$1.36B

Cash & Equivalents

$202.04M

Free Cash Flow

-$124.04M

Financial Statements
Beta
Revenue$17.10M
R&D Expenses$95.25M
SG&A Expenses$47.64M
Operating Expenses$142.90M
Operating Income-$125.80M
Net Income-$122.94M
EPS (Basic)$-1.34
Shares Outstanding (Basic)91.83M

Key Highlights

  • 1Positive complete results from the APOLLO Phase 3 study for patisiran, with plans for NDA submission by the end of 2017.
  • 2Temporary suspension of dosing in the fitusiran program due to a fatal thrombotic serious adverse event; regulatory discussions are ongoing to resume dosing.
  • 3Net revenues from collaborators increased in both the three and nine-month periods, driven primarily by higher service performance for Sanofi Genzyme.
  • 4Significant increase in General and Administrative (G&A) expenses, mainly due to increased headcount for commercial and medical affairs to support future product launches.
  • 5Successfully raised $355.2 million in net proceeds from a public offering of common stock in May 2017.
  • 6The company continues to operate at a loss, with an accumulated deficit of $2.01 billion as of September 30, 2017, reflecting substantial investments in research and development.
  • 7Initiation of the ENVISION Phase 3 study for givosiran for acute hepatic porphyrias.

Frequently Asked Questions

Alnylam reported positive complete results from the APOLLO Phase 3 study for patisiran in early November 2017. The study met its primary and all secondary endpoints. Based on these results, the company plans to submit a New Drug Application (NDA) in the U.S. by the end of 2017 and a Marketing Authorization Application (MAA) in Europe shortly thereafter.

Dosing in all ongoing fitusiran studies was temporarily suspended in September 2017 following a fatal thrombotic serious adverse event (SAE) in a patient. Alnylam has aligned on a risk management plan with study investigators and is conferring with global regulators to resume dosing as soon as possible, potentially by the end of 2017.

Alnylam primarily funds its operations through strategic alliances and collaborations, which generate revenue from license fees, research funding, and milestone payments. In May 2017, the company also successfully raised approximately $355.2 million in net proceeds from a public offering of its common stock. The company believes its existing cash reserves and anticipated collaboration revenues will be sufficient to fund its operations for at least the next few years.

For the three months ended September 30, 2017, Alnylam reported net revenues from collaborators of $17.1 million, an increase from $13.7 million in the prior year period. However, operating expenses were $142.9 million, leading to a loss from operations of $125.8 million and a net loss of $122.9 million. The company has a substantial accumulated deficit of $2.01 billion as of September 30, 2017, reflecting its ongoing investment in research and development for its RNAi therapeutics.