ALNY Announces Preliminary 2024 Results, 2025 View & Pipeline Goals

Financial Performance - Preliminary net product revenues for Givlaari and Oxlumo were $65 million and$44 million, respectively, for Q4 2024 [1] - Full-year 2024 preliminary net product revenues for Givlaari and Oxlumo were $256 million and$167 million, respectively [1] - Preliminary net product revenues for Onpattro and Amvuttra were $56 million and$287 million, respectively, for Q4 2024 [13] - Full-year 2024 preliminary net product revenues for Onpattro and Amvuttra were $253 million and$970 million, respectively [13] - Combined net product revenues for Onpattro, Amvuttra, Givlaari, and Oxlumo are expected to be $2.05-$2.25 billion in 2025, implying 31% growth at the mid-point [11] - Total Onpattro and Amvuttra net product revenues are expected to be $1.60-$1.72 billion in 2025, reflecting 36% growth at the mid-point [11] - Total Givlaari and Oxlumo net product revenues are expected to be $450-$525 million in 2025, indicating 15% growth at the mid-point [12] Pipeline and Product Updates - FDA accepted Alnylam's sNDA for Amvuttra label expansion to treat ATTR amyloidosis with cardiomyopathy, with a decision expected on March 23, 2025 [2] - If approved, Amvuttra will be the first therapeutic in the US to treat both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis [3] - Interim data from part B of the phase I study on mivelsiran for Alzheimer's disease is expected in H2 2025 [4] - Phase II study on mivelsiran for Alzheimer's disease is expected to initiate in H2 2025 [4] - Data from the phase II KARDIA-3 study on zilebesiran for hypertension is expected in H2 2025 [6] - Phase III cardiovascular outcomes study on zilebesiran is planned to initiate in H2 2025 [6] Market and Industry Trends - Amvuttra, Givlaari, and Oxlumo have seen strong patient demand, while Onpattro sales are declining due to patient switching to Amvuttra [10] - Alnylam's shares have rallied 23.1% in the past year, against the industry's decline of 16% [10] Collaborations and Rights - Alnylam regained full global development and commercialization rights to mivelsiran after Regeneron opted out of further co-development [5] - Regeneron will be eligible to receive low double-digit royalties on mivelsiran sales if approved [5] - Alnylam is collaborating with Roche on the development of zilebesiran [6]