10-QPeriod: Q1 FY2018

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2018

Filed May 4, 2018For Securities:ALNY

Summary

This 10-Q filing for Alnylam Pharmaceuticals, Inc. (ALNY) for the period ending March 31, 2018, highlights significant progress in advancing its RNA interference (RNAi) therapeutic pipeline, particularly with the regulatory submissions for patisiran. Patisiran is nearing potential approval, with an action date from the FDA set for August 11, 2018. If approved, this would mark Alnylam's first commercial product, potentially generating significant revenue in 2018. The company continues to strengthen its strategic alliances, notably with Sanofi Genzyme and The Medicines Company, which provide crucial funding and development support. However, Alnylam continues to incur substantial operating losses, a typical characteristic of a clinical-stage biopharmaceutical company, and expects these losses to persist as it invests heavily in research and development.

Financial Highlights

41 data points
Beta

Revenue

$21.90M

Net Income

-$141.21M

-644.8% Net Margin

EPS (Diluted)

$-1.41

Total Assets

$1.92B

Cash & Equivalents

$396.15M

Free Cash Flow

-$176.92M

Financial Statements
Beta
Revenue$21.90M
R&D Expenses$96.86M
SG&A Expenses$72.45M
Operating Expenses$169.30M
Operating Income-$147.41M
Net Income-$141.21M
EPS (Basic)$-1.41
Shares Outstanding (Basic)99.98M

Key Highlights

  • 1Patisiran NDA accepted by FDA with priority review, action date of August 11, 2018; MAA accepted by EMA for review.
  • 2Significant increase in R&D expenses, driven by compensation and external services, supporting pipeline advancement.
  • 3General and administrative expenses rose significantly, reflecting preparations for potential commercial launch of patisiran and expansion of commercial capabilities.
  • 4Net revenues from collaborators increased due to a $50 million milestone payment from Sanofi Genzyme related to the fitusiran program.
  • 5The company's cash, cash equivalents, and marketable securities remain substantial ($1.57 billion), providing a runway for at least the next few years.
  • 6Alnylam continues to advance multiple other product candidates in its pipeline across Genetic Medicines, Cardio-Metabolic Diseases, and Hepatic Infectious Diseases strategic therapeutic areas.
  • 7Agreements were updated with Sanofi Genzyme in January 2018, clarifying global development and commercialization rights for TTR products (including patisiran) and fitusiran.

Frequently Asked Questions

Patisiran has made significant progress. Its New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) with priority review, setting an action date of August 11, 2018. Similarly, its Marketing Authorisation Application (MAA) has been accepted by the European Medicines Agency (EMA) for review. These are critical steps towards potential commercial launch and revenue generation.

Alnylam is primarily funded through strategic alliances and existing cash reserves. As of March 31, 2018, the company held approximately $1.57 billion in cash, cash equivalents, and marketable securities. Revenues are generated through collaborations, notably with Sanofi Genzyme and The Medicines Company, which provide funding through milestone payments and research and development reimbursements. The company anticipates these sources will be sufficient to fund its operations for at least the next few years.

The company reported an increase in net revenues from collaborators, largely due to a $50 million milestone payment from Sanofi Genzyme. However, operating expenses also rose significantly, with research and development (R&D) expenses increasing by $9.9 million, driven by compensation and external services supporting pipeline advancement. General and administrative (G&A) expenses saw a substantial increase of $34 million, reflecting preparations for patisiran's potential launch and the build-out of commercial capabilities. Despite the increased spending, the company maintains a strong cash position.

Alnylam's overarching strategy is guided by its 'Alnylam 2020' plan, aiming to establish a profile with three marketed products and ten RNAi therapeutic clinical programs by the end of 2020. The company is focused on developing novel RNAi therapeutics for genetically validated, liver-expressed genes across its three strategic therapeutic areas: Genetic Medicines, Cardio-Metabolic Diseases, and Hepatic Infectious Diseases. The potential approval and launch of patisiran represent a pivotal moment in transitioning towards a commercial-stage biopharmaceutical company.