10-QPeriod: Q2 FY2021

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2021

Filed August 3, 2021For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported significant revenue growth in its second quarter of 2021, with total revenues nearly doubling year-over-year to $220.6 million. This increase was driven by strong performance in net product revenues, which more than doubled to $160.8 million, primarily from ONPATTRO and GIVLAARI, along with the new contribution from OXLUMO. Collaboration revenues also saw substantial growth, more than doubling to $59.4 million, largely due to increased activities with Regeneron Pharmaceuticals and Novartis AG. Despite the revenue growth, the company reported a net loss of $189.6 million for the quarter, a slight increase from the $179.2 million net loss in the prior year's second quarter. This was driven by higher operating costs and expenses, particularly in research and development, and increased interest expense related to its financing collaborations. The company's cash position remains strong, with $745.8 million in cash and cash equivalents, providing at least 12 months of operating runway according to management. Alnylam continues to advance its pipeline, with key updates on vutrisiran, including an NDA submission to the FDA and plans for an EU MAA based on positive Phase 3 data. The company's strategic therapeutic areas (STArs) and Alnylam P5x25 strategy remain on track, focusing on delivering transformative medicines and driving profitability.

Financial Highlights

49 data points
Beta

Revenue

$220.55M

86.3% Gross Margin

Net Income

-$189.56M

-85.9% Net Margin

EPS (Diluted)

$-1.61

Total Assets

$3.51B

Cash & Equivalents

$745.77M

Free Cash Flow

-$133.10M

Financial Statements
Beta
Revenue$220.55M
Cost of Revenue$30.26M
Gross Profit$190.30M
R&D Expenses$182.63M
SG&A Expenses$145.32M
Operating Expenses$366.71M
Operating Income-$146.16M
Interest Expense$33.42M
Net Income-$189.56M
EPS (Basic)$-1.61
EPS (Diluted)$-1.61
Shares Outstanding (Basic)117.77M
Shares Outstanding (Diluted)117.77M

Key Highlights

  • 1Total revenues increased by 112% to $220.6 million in Q2 2021 compared to $103.9 million in Q2 2020.
  • 2Net product revenues grew by 107% to $160.8 million, driven by ONPATTRO, GIVLAARI, and the launch of OXLUMO.
  • 3Net revenues from collaborations increased by 125% to $59.4 million, primarily due to Regeneron and Novartis collaborations.
  • 4Research and development expenses increased by 18% to $182.6 million, reflecting pipeline advancement.
  • 5Selling, general, and administrative expenses increased by 14% to $145.3 million, supporting commercial expansion.
  • 6Net loss for the quarter was $189.6 million, a slight increase from $179.2 million in the prior year.
  • 7Cash, cash equivalents, and marketable securities totaled $1.90 billion as of June 30, 2021, providing ample liquidity.

Frequently Asked Questions

Revenue growth was primarily driven by a strong increase in net product revenues, more than doubling to $160.8 million, due to the continued global expansion of ONPATTRO and GIVLAARI, and the initial sales contribution from OXLUMO. Net revenues from collaborations also saw substantial growth, increasing by 125% to $59.4 million, largely attributed to increased activity and milestone recognition under the agreements with Regeneron Pharmaceuticals and Novartis AG.

Alnylam reported a net loss of $189.6 million for the second quarter of 2021, a slight increase from the $179.2 million loss in the prior year's second quarter. This loss is primarily due to significant ongoing investments in research and development ($182.6 million) to advance its pipeline, as well as higher selling, general, and administrative expenses ($145.3 million) supporting commercialization efforts. Additionally, interest expense increased due to financing activities, contributing to the net loss.

Alnylam continues to advance its pipeline. Key updates include the submission of a New Drug Application (NDA) to the FDA for vutrisiran for the treatment of hATTR amyloidosis with polyneuropathy, with an expected FDA action date in April 2022. The company also plans to file a Marketing Authorisation Application (MAA) in the EU for vutrisiran. Progress is also being made on patisiran (APOLLO-B study) and lumasiran (ILLUMINATE-C study), with positive topline results reported for the latter. Collaborator-led advancements include Novartis's inclisiran (Leqvio) NDA resubmission to the FDA with an action date of January 1, 2022, and Sanofi Genzyme's fitusiran program showing substantial progress.

Alnylam maintains a strong liquidity position, with $745.8 million in cash, cash equivalents, and restricted cash as of June 30, 2021. Combined with marketable securities of $1.15 billion, the total cash, cash equivalents, and marketable securities stood at $1.90 billion. Management believes this level of liquidity, along with expected cash generated from product sales and alliances, is sufficient to advance its Alnylam P5x25 strategy for at least the next 12 months.