Alnylam Pharmaceuticals Q3 2024 Financial Results and Recent Highlights

Alnylam Pharmaceuticals, the leading RNAi therapeutics company, has released its consolidated financial results for the third quarter ending September 30, 2024. The company has demonstrated significant commercial and clinical progress, achieving a notable 34% year-over-year growth and generating $420 million in global net product revenues. This growth has been primarily driven by their transthyretin (TTR) business.

The company's CEO, Yvonne Greenstreet, highlighted the robust commercial and clinical performance in the third quarter. A key driver of revenue was the TTR business, which includes products such as ONPATTRO and AMVUTTRA. ONPATTRO generated $50 million, while AMVUTTRA brought in $259 million, together contributing to a 34% annual growth in TTR net product revenues. Additionally, the company has made significant strides towards the commercialization of vutrisiran, presenting detailed results from the HELIOS-B study at the European Society of Cardiology Congress and the Heart Failure Society of America Annual Scientific Meeting. Regulatory filings for vutrisiran have been submitted in both the U.S. and the EU, aiming for a potential U.S. launch in early 2025.

Alnylam has also advanced its research and development initiatives. The Phase 1 study of mivelsiran in Alzheimer’s disease patients showed promising results, with significant reductions in sAPPβ levels and no new safety concerns identified. The company has also initiated a Phase 1 study for ALN-HTT02 in adult patients with Huntington’s disease. This progress in clinical development aligns with Alnylam's goal of becoming a leading global biotech company under its "Alnylam P5x25" strategy.

In terms of commercial performance beyond the TTR business, Alnylam reported $71 million in global net product revenues for GIVLAARI and $40 million for OXLUMO, both showing a 34% annual growth compared to Q3 2023. These products target rare diseases and have contributed significantly to the company’s overall revenue growth.

Financially, Alnylam's consolidated revenues for the third quarter totaled approximately $500.9 million, which included $57.4 million from collaborations and $23.4 million in royalty revenue. The company's operating loss was reported at $76.9 million on a GAAP basis, while the non-GAAP operating loss was $31.1 million. The net loss for the quarter was $111.6 million on a GAAP basis and $64.2 million on a non-GAAP basis.

The financial results also indicate a decrease in the cost of goods sold as a percentage of net product revenues, which was mainly due to higher costs in the previous year associated with canceled manufacturing commitments and the impairment of ONPATTRO inventory. Research and development expenses increased, reflecting the company’s investment in its clinical pipeline and preclinical activities.

Alnylam's cash, cash equivalents, and marketable securities totaled $2.78 billion as of September 30, 2024, up from $2.44 billion at the end of 2023. This increase is attributed to improved operating performance and net proceeds from the issuance of common stock through stock option exercises.

Looking ahead, Alnylam has reiterated its full-year 2024 financial guidance. The company aims to achieve combined net product revenues of $1.575 billion to $1.650 billion, with a projected growth rate of 27% to 33% compared to 2023 at reported FX rates. Additionally, net revenues from collaborations and royalties are expected to range between $575 million and $650 million.

In conclusion, Alnylam Pharmaceuticals has demonstrated a strong performance in the third quarter of 2024, driven by its TTR business and significant advancements in its clinical pipeline. The company remains focused on achieving its strategic goals and delivering transformative RNAi therapeutics to patients globally.