Alnylam Pharmaceuticals Inc (ALNY) Reports 35% YoY Growth in Q3 2023 Net Product Revenues

In this article:
  • Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) reported Q3 2023 global net product revenues of $313 million, marking a 35% YoY growth.

  • Despite a setback with the FDA's response to the supplemental new drug application for Patisiran, the company remains on track with its HELIOS-B Phase 3 study.

  • Alnylam also reported positive topline results from the KARDIA-1 Phase 2 study of Zilebesiran.

  • The company updated its 2023 guidance for revenues from collaborations and royalties to $575 million to $625 million.

On November 2, 2023, Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) released its Q3 2023 financial results, highlighting a 35% YoY growth in global net product revenues, which reached $313 million. Despite a setback with the FDA's response to the supplemental new drug application for Patisiran, the company remains on track with its HELIOS-B Phase 3 study. Alnylam also reported positive topline results from the KARDIA-1 Phase 2 study of Zilebesiran.

Financial Performance

Alnylam's Q3 2023 financial results showed a significant increase in net product revenues, which rose by 35% YoY to reach $313 million. This growth was primarily driven by the successful launch of AMVUTTRA and increased patients on GIVLAARI and OXLUMO therapies. However, the demand for ONPATTRO decreased due to patients switching to AMVUTTRA.

Net revenues from collaborations also saw a substantial increase, primarily due to revenue related to collaborations with Roche and Regeneron. During the quarter, Alnylam recognized $310 million of revenue from the upfront payment received from Roche and $65 million in connection with the Regeneron Collaboration.

Operating Expenses and Other Financial Highlights

Alnylam's operating expenses for Q3 2023 included cost of goods sold, research and development (R&D) expenses, and selling, general & administrative (SG&A) expenses. The cost of goods sold as a percent of net product revenues increased during the third quarter 2023, primarily due to recording an impairment of ONPATTRO inventory that had been manufactured for future demand associated with the ATTR cardiomyopathy indication for patisiran for which the company did not receive regulatory approval.

As of September 30, 2023, Alnylam's cash, cash equivalents, and marketable securities were $2.41 billion, compared to $2.19 billion as of December 31, 2022. The increase was primarily related to the $310 million upfront payment received from Roche in connection with the partnership to co-develop and co-commercialize zilebesiran, offset by the company's operating loss year-to-date.

2023 Financial Guidance

Alnylam updated its full-year 2023 financial guidance, with net revenues from collaborations and royalties now expected to be between $575 million and $625 million. The guidance for combined net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO remains unchanged at $1,200 million to $1,285 million.

Explore the complete 8-K earnings release (here) from Alnylam Pharmaceuticals Inc for further details.

This article first appeared on GuruFocus.

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