10-QPeriod: Q1 FY2019

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2019

Filed May 2, 2019For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the first quarter of 2019, reaching $33.3 million, a 52% rise compared to the same period last year. This growth is primarily driven by the successful commercialization of ONPATTRO®, their first RNAi therapeutic, which generated $26.3 million in net product revenues. While this marks a positive step, the company continues to operate at a loss, with an operating loss of $188.8 million and a net loss of $181.9 million for the quarter. This reflects substantial ongoing investment in research and development, crucial for advancing their broad pipeline of RNAi therapeutics across four strategic therapeutic areas. The company also bolstered its financial position through a $381.9 million public offering of common stock in January 2019 and entered into a significant global collaboration with Regeneron, which includes a $400 million upfront payment and potential future milestones, further strengthening their cash reserves.

Financial Highlights

44 data points
Beta

Revenue

$33.29M

89.9% Gross Margin

Net Income

-$181.91M

-546.4% Net Margin

EPS (Diluted)

$-1.73

Total Assets

$2.01B

Cash & Equivalents

$724.96M

Free Cash Flow

-$232.56M

Financial Statements
Beta
Revenue$33.29M
Cost of Revenue$3.35M
Gross Profit$29.95M
R&D Expenses$129.13M
SG&A Expenses$89.61M
Operating Expenses$222.08M
Operating Income-$188.79M
Net Income-$181.91M
EPS (Basic)$-1.73
Shares Outstanding (Basic)105.40M

Key Highlights

  • 1Total revenues increased by 52% to $33.3 million in Q1 2019, driven by ONPATTRO® product sales.
  • 2ONPATTRO® generated $26.3 million in net product revenues, signaling successful commercialization post-2018 approvals.
  • 3Significant investment in R&D continues, with expenses rising 33% to $129.1 million, reflecting pipeline advancement.
  • 4The company raised approximately $381.9 million in net proceeds from a public stock offering in January 2019.
  • 5A strategic collaboration with Regeneron was announced in April 2019, bringing a $400 million upfront payment and enhanced financial runway.
  • 6Despite revenue growth, the company reported an operating loss of $188.8 million and a net loss of $181.9 million, underscoring the early-stage, high-investment nature of the business.
  • 7Collaboration revenues decreased by 68% to $7.0 million, primarily due to lower reimbursable activities with Sanofi Genzyme.

Frequently Asked Questions

The primary driver of Alnylam's revenue growth in the first quarter of 2019 was the net product revenue generated from ONPATTRO®, their first commercialized RNAi therapeutic. ONPATTRO® achieved $26.3 million in sales during the quarter.

Alnylam is funding its operations and R&D through a combination of product sales (primarily ONPATTRO®), proceeds from equity offerings (such as the $381.9 million raised in January 2019), and strategic collaborations. The recent $400 million upfront payment from the Regeneron collaboration significantly enhances their financial resources.

Alnylam expects to continue incurring significant operating losses in the foreseeable future due to substantial investments in research and development. However, with the commercial launch of ONPATTRO® and new collaborations like the one with Regeneron, they anticipate increasing product revenues and believe their current cash position will support their 'Alnylam 2020' strategy for multiple years. Despite this, the company's financial results are expected to fluctuate period-to-period.

Besides ONPATTRO®, Alnylam has several other late-stage investigational programs. These include givosiran for acute hepatic porphyria (AHP), with an upcoming NDA/MAA submission planned; lumasiran for primary hyperoxaluria type 1 (PH1); and vutrisiran for ATTR amyloidosis. Additionally, they have partnered programs such as inclisiran with The Medicines Company and fitusiran with Sanofi Genzyme.