10-QPeriod: Q1 FY2022

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2022

Filed April 28, 2022For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. reported total revenues of $213.3 million for the first quarter of 2022, a 20% increase compared to the same period in the previous year. This growth was primarily driven by a significant 38% increase in net product revenues, reaching $186.9 million, with ONPATTRO, GIVLAARI, and OXLUMO all showing strong year-over-year performance. The company experienced a net loss of $240.3 million for the quarter, widening from $200.3 million in Q1 2021, largely due to increased operating expenses, particularly in selling, general, and administrative categories, as well as higher interest expenses. Despite the increased net loss, Alnylam's cash position remains robust, with cash, cash equivalents, and marketable securities totaling $2.24 billion as of March 31, 2022, providing adequate runway for at least the next 12 months. The company continues to advance its pipeline, with notable progress in the vutrisiran New Drug Application (NDA) review by the FDA, which has an extended PDUFA goal date of July 14, 2022. OXLUMO also received FDA acceptance for a supplemental NDA for advanced PH1, with an action date in October 2022. These developments, coupled with strong commercial performance of its existing products, position Alnylam for continued growth, although strategic investments in R&D and SG&A are expected to impact near-term profitability.

Financial Statements
Beta

Key Highlights

  • 1Total revenues increased by 20% year-over-year to $213.3 million in Q1 2022.
  • 2Net product revenues grew by 38% to $186.9 million, driven by strong performance across ONPATTRO, GIVLAARI, and OXLUMO.
  • 3Net loss widened to $240.3 million from $200.3 million in the prior year's quarter, primarily due to increased operating expenses.
  • 4Selling, general, and administrative expenses increased by 5% to $154.5 million.
  • 5Research and development expenses decreased by 9% to $169.9 million, mainly due to lower stock-based compensation and clinical manufacturing activities.
  • 6Cash, cash equivalents, and marketable securities stood at $2.24 billion as of March 31, 2022, providing ample liquidity.
  • 7FDA extended the PDUFA date for vutrisiran NDA to July 14, 2022; supplemental NDA for OXLUMO for advanced PH1 accepted by FDA with October 6, 2022 PDUFA date.

Frequently Asked Questions

Alnylam reported total revenues of $213.3 million for the first quarter of 2022, a 20% increase compared to $177.6 million in the first quarter of 2021. This growth was primarily driven by a 38% increase in net product revenues, reaching $186.9 million, with ONPATTRO, GIVLAARI, and OXLUMO all contributing to the rise. Collaboration revenues decreased by 38% to $25.9 million.

Alnylam reported a net loss of $240.3 million for the first quarter of 2022, compared to a net loss of $200.3 million in the same period of 2021. This widening loss was primarily due to higher selling, general, and administrative expenses, as well as increased interest expense. The company has a history of losses and expects to continue incurring operating losses as it invests in research and development.

As of March 31, 2022, Alnylam had $534.1 million in cash and cash equivalents and $1.72 billion in marketable securities, totaling $2.25 billion in cash, cash equivalents, and marketable securities. The company believes this liquidity is sufficient to support its operations for at least the next 12 months, according to its current operating plan.

Alnylam made progress in its late-stage pipeline. The FDA extended the review timeline for the vutrisiran NDA to July 14, 2022. Additionally, the FDA accepted Alnylam's supplemental NDA for OXLUMO for advanced PH1, with an action date set for October 6, 2022. The company continues to advance its other therapeutic programs and commercialize its approved products.