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Alnylam Pharmaceuticals, Inc. ALNY reported second-quarter 2025 earnings of 32 cents per share, in contrast to the Zacks Consensus Estimate of a loss of 3 cents. The improvement was due to higher revenues from the sale of its lead drug, Amvuttra (vutrisiran). The company reported adjusted earnings of 56 cents in the year-ago quarter.
Alnylam recorded total revenues of $773.7 million in the quarter, which easily surpassed the Zacks Consensus Estimate of $673 million. In the year-ago quarter, total revenues were $659.8. The top line rose 17% year over year on a reported basis and 16% at a constant exchange rate (CER), mainly driven by increased product sales.
Net product revenues were $672.2 million, up 64% year over year on a reported basis and 62% at CER, driven by strong growth in patient demand for Amvuttra, as well as for Givlaari (givosiran) and Oxlumo (lumasiran). ALNY shares jumped 15.4% on Thursday as investors responded positively to the strong financial performance of its marketed drug portfolio.
Net revenues from collaborators were $61.5 million, down 73% from the year-ago quarter, primarily due to a $185 million milestone payment received from Regeneron REGN in the year-ago quarter upon granting REGN an exclusive license to develop, manufacture and commercialize cemdisiran as a monotherapy. Furthermore, Alnylam did not recognize any revenues from Novartis NVS in the reported quarter. ALNY recognizes revenues under its ongoing collaborations with Roche RHHBY.
Alnylam also recognized royalty revenues of $40 million in the reported quarter, up 78% year over year.
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $52.5 million in the reported quarter, down 32% on a reported basis. Onpattro sales beat the Zacks Consensus Estimate of $45.9 million as well as our model estimate of $46 million.
Amvuttra is FDA-approved for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission also approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy. Recently, label expansion for the drug has also been approved in the United States and the EU for treating cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.
Amvuttra generated sales worth $492 million in the second quarter, up 114% on a reported basis. The uptake for the product has been encouraging, with new patients starting treatment as well as several patients switching from Onpattro. The expanded label is also boosting sales. Amvuttra sales easily beat the Zacks Consensus Estimate of $365.4 million as well as our model estimate of $330.7 million.
Givlaari, approved for the treatment of acute hepatic porphyria, recorded sales of $80.8 million, reflecting a year-over-year increase of 30% on a reported basis. Givlaari sales beat the Zacks Consensus Estimate of $72.6 million and our model estimate of $73.1 million. Oxlumo recorded global net product revenues of $46.9 million in the reported quarter, up 15% year over year on a reported basis. Oxlumo sales marginally beat the Zacks Consensus Estimate of $46.6 million as well as our estimate of $43.5 million.
Year to date, ALNY stock has soared 66.7% compared with the industry’s 1.5% rise.
Adjusted research and development (R&D) expenses gained 11% year over year to $274.1 million. R&D expenses accounted for costs associated with the startup activities for a phase III cardiovascular outcomes study, which will evaluate zilebesiran to treat patients with hypertension at high cardiovascular risk, in partnership with Roche. Expenses associated with the recently initiated phase III TRITON-CM study, evaluating nucresiran in patients with ATTR-CM, also contributed to higher R&D costs.
Adjusted selling, general and administrative (SG&A) expenses increased 26% year over year to $261.2 million, primarily due to higher employee compensation costs and increased marketing investment associated with the Amvuttra launch for ATTR-CM.
Cash, cash equivalents and marketable securities as of June 30, 2025, amounted to $2.86 billion compared with $2.63 billion recorded as of March 31, 2025, with the increase primarily driven by net cash inflows from operating activities and proceeds from the exercise of employee stock options.
Alnylam now expects its net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.65-$2.8 billion for 2025, up from the previously guided range of $2.05-$2.25 billion.
The guidance for net revenues from collaborations and royalties is maintained in the range of $650-$750 million. Adjusted R&D and SG&A expenses are expected to remain in the band of $2.1-$2.2 billion.
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
Alnylam, in collaboration with Regeneron, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases. The agreement regarding cemdisiran underwent a modification last year. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy and in combination with anti-C5 antibodies for complement-mediated indications.
ALNY regained full global development and commercialization rights to mivelsiran in all indications in 2024, after Regeneron opted out of further co-development and co-commercialization of mivelsiran in development for cerebral amyloid angiopathy and Alzheimer's disease. However, Regeneron will be eligible to receive low double-digit royalties on sales of mivelsiran, if approved.
Alnylam, in collaboration with Roche, is developing zilebesiran in a mid-stage study (KARDIA-3) to treat hypertension. ALNY and RHHBY also plan to initiate a phase III cardiovascular outcomes study for the candidate by the end of 2025 for the same indication.
Alnylam has granted Novartis exclusive global rights to manufacture and commercialize RNAi therapeutics targeting PCSK9, including Leqvio (inclisiran), for hypercholesterolemia and other diseases. The FDA has approved Leqvio for several heart disease indications alongside diet and statins. As of June 2025, Leqvio is approved in more than 106 countries, with ongoing late-stage studies for further label expansion.
Alnylam reported better-than-expected results in the second quarter of 2025, beating earnings and revenue estimates. The year-over-year increase in revenues has been mainly fueled by growing Amvuttra sales as a result of increased patient demand. The recent label expansion of the drug for the ATTR-CM indication in the United States and the EU has further expanded the eligible patient population for the drug, which is boosting sales and is expected to continue to do so in the quarters ahead. Sales of other products, Givlaari and Oxlumo, are also contributing to the top line.
Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).
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