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Alnylam Pharmaceuticals (ALNY - Free Report) announced preliminary net product revenues for the fourth quarter and full-year 2024 for its approved products Onpattro (patisiran), Amvuttra (vutrisiran), Givlaari (givosiran) and Oxlumo (lumasiran).
The company also issued its net product revenue guidance for 2025 and outlined several key products and pipeline updates for the year.
Both Onpattro and Amvuttra are approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
Givlaari is approved for the treatment of acute hepatic porphyria. Oxlumo is approved for treating primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Amvuttra, Givlaari and Oxlumo have witnessed strong patient demand so far, while Onpattro sales are declining as more patients are switching to treatment with Amvuttra.
In the past year, shares of Alnylam have rallied 23.1% against the industry’s decline of 16%.
Image Source: Zacks Investment Research
ALNY's 2025 Financial Guidance
Alnylam expects combined net product revenues from Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.05-$2.25 billion in 2025, implying a combined full-year growth of 31% at the mid-point of the guidance range compared with 2024.
Total Onpattro and Amvuttra net product revenues are expected to be in the range of $1.60-$1.72 billion, reflecting a combined full-year growth of 36% at the mid-point of the guidance range against 2024.
Total Givlaari and Oxlumo net product revenues are expected to be in the range of $450-$525 million, indicating combined full-year growth of 15% at the mid-point of the guidance range versus 2024.
Per management, if the company is successful in meeting this product revenue guidance, then it expects to achieve adjusted operating income profitability in 2025.
ALNY's Preliminary Results for 2024
Preliminary net product revenues for Onpattro and Amvuttra were around $56 million and $287 million, respectively for the fourth quarter of 2024. For full-year 2024, preliminary net product revenues for Onpattro and Amvuttra were around $253 million and $970 million, respectively.
Preliminary net product revenues for Givlaari and Oxlumo were around $65 million and $44 million, respectively, for the fourth quarter of 2024. For full-year 2024, preliminary net product revenues for Givlaari and Oxlumo were around $256 million and $167 million, respectively.
ALNY's 2025 Pipeline Goals
In November 2025, the FDA accepted Alnylam’s supplemental new drug application (sNDA) seeking the label expansion of Amvuttra for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on March 23, 2025. The FDA does not plan to hold an advisory committee meeting to review the application.
If approved, Amvuttra will become the first therapeutic approved in the United States to treat both the polyneuropathy manifestations of hATTR and cardiomyopathy manifestations of ATTR amyloidosis. This should expand the eligible patient population for the drug and can significantly boost the drug’s sales in 2025 and beyond.
ALNY is developing investigational RNAi therapeutic, mivelsiran, for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy. The company expects to report interim data from part B of the phase I study in Alzheimer’s disease in the second half of 2025. It also expects to initiate a phase II study on mivelsiran in Alzheimer’s disease in the second half of 2025.
Alnylam had earlier regained full global development and commercialization rights to mivelsiran in all indications after Regeneron (REGN - Free Report) opted out of further co-development and co-commercialization of mivelsiran.
However, REGN will be eligible to receive low double-digit royalties on sales of mivelsiran, if approved.
Alnylam, in collaboration with Roche (RHHBY - Free Report) , is developing zilebesiran in a mid-stage study to treat hypertension. Data from the phase II KARDIA-3 study on zilebesiran is expected in the second half of 2025.
ALNY and RHHBY plan to initiate a phase III cardiovascular outcomes study on zilebesiran in the second half of 2025.
In the past 60 days, estimates for Puma Biotechnology’s 2025 earnings per share have increased from 52 cents to 55 cents. In the past year, shares of PBYI have declined 33.1%.
PBYI’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.78%.
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ALNY Announces Preliminary 2024 Results, 2025 View & Pipeline Goals
Alnylam Pharmaceuticals (ALNY - Free Report) announced preliminary net product revenues for the fourth quarter and full-year 2024 for its approved products Onpattro (patisiran), Amvuttra (vutrisiran), Givlaari (givosiran) and Oxlumo (lumasiran).
The company also issued its net product revenue guidance for 2025 and outlined several key products and pipeline updates for the year.
Both Onpattro and Amvuttra are approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
Givlaari is approved for the treatment of acute hepatic porphyria. Oxlumo is approved for treating primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Amvuttra, Givlaari and Oxlumo have witnessed strong patient demand so far, while Onpattro sales are declining as more patients are switching to treatment with Amvuttra.
In the past year, shares of Alnylam have rallied 23.1% against the industry’s decline of 16%.
Image Source: Zacks Investment Research
ALNY's 2025 Financial Guidance
Alnylam expects combined net product revenues from Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.05-$2.25 billion in 2025, implying a combined full-year growth of 31% at the mid-point of the guidance range compared with 2024.
Total Onpattro and Amvuttra net product revenues are expected to be in the range of $1.60-$1.72 billion, reflecting a combined full-year growth of 36% at the mid-point of the guidance range against 2024.
Total Givlaari and Oxlumo net product revenues are expected to be in the range of $450-$525 million, indicating combined full-year growth of 15% at the mid-point of the guidance range versus 2024.
Per management, if the company is successful in meeting this product revenue guidance, then it expects to achieve adjusted operating income profitability in 2025.
ALNY's Preliminary Results for 2024
Preliminary net product revenues for Onpattro and Amvuttra were around $56 million and $287 million, respectively for the fourth quarter of 2024. For full-year 2024, preliminary net product revenues for Onpattro and Amvuttra were around $253 million and $970 million, respectively.
Preliminary net product revenues for Givlaari and Oxlumo were around $65 million and $44 million, respectively, for the fourth quarter of 2024. For full-year 2024, preliminary net product revenues for Givlaari and Oxlumo were around $256 million and $167 million, respectively.
ALNY's 2025 Pipeline Goals
In November 2025, the FDA accepted Alnylam’s supplemental new drug application (sNDA) seeking the label expansion of Amvuttra for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on March 23, 2025. The FDA does not plan to hold an advisory committee meeting to review the application.
If approved, Amvuttra will become the first therapeutic approved in the United States to treat both the polyneuropathy manifestations of hATTR and cardiomyopathy manifestations of ATTR amyloidosis. This should expand the eligible patient population for the drug and can significantly boost the drug’s sales in 2025 and beyond.
ALNY is developing investigational RNAi therapeutic, mivelsiran, for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy. The company expects to report interim data from part B of the phase I study in Alzheimer’s disease in the second half of 2025. It also expects to initiate a phase II study on mivelsiran in Alzheimer’s disease in the second half of 2025.
Alnylam had earlier regained full global development and commercialization rights to mivelsiran in all indications after Regeneron (REGN - Free Report) opted out of further co-development and co-commercialization of mivelsiran.
However, REGN will be eligible to receive low double-digit royalties on sales of mivelsiran, if approved.
Alnylam, in collaboration with Roche (RHHBY - Free Report) , is developing zilebesiran in a mid-stage study to treat hypertension. Data from the phase II KARDIA-3 study on zilebesiran is expected in the second half of 2025.
ALNY and RHHBY plan to initiate a phase III cardiovascular outcomes study on zilebesiran in the second half of 2025.
ALNY's Zacks Rank & Stock to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2025 earnings per share have increased from 52 cents to 55 cents. In the past year, shares of PBYI have declined 33.1%.
PBYI’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.78%.