Alnylam Pharmaceuticals ALNY reported fourth-quarter 2024 adjusted earnings of 6 cents per share, in contrast with the Zacks Consensus Estimate of a loss of 21 cents. The company had incurred a loss of 77 cents per share in the year-ago quarter. The adjusted figure excluded items like stock-based compensation expenses and realized and unrealized loss on marketable equity securities.
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Alnylam recorded total revenues of $593.2 million in the quarter, which surpassed the Zacks Consensus Estimate of $570 million. In the year-ago quarter, total revenues were $439.7 million. The top line rose 35% year over year, mainly driven by increased product sales.
Net product revenues were $450.8 million, up 30% year over year on a reported basis and 29% at a constant exchange rate, driven by strong growth in patient demand for the newly approved drug, Amvuttra (vutrisiran), as well as for Givlaari (givosiran) and Oxlumo (lumasiran).
Net revenues from collaborators were $106.9 million, up 40% from the year-ago quarter, primarily driven by revenues recognized under Alnylam’s ongoing collaborations with Regeneron REGN and Novartis NVS. The company also recognizes collaboration revenues from Roche RHHBY.
In the past three months, shares of Alnylam have gained 12.5% compared with the industry’s growth of 7.7%.
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Alnylam, in collaboration with REGN, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases. The agreement regarding cemdisiran underwent a modification. 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.
Alnylam 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 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 earlier use in high-risk patients alongside diet and statins. As of January 2025, Leqvio is approved in over 100 countries, with ongoing late-stage studies for further label expansion.
Alnylam, in collaboration with Roche, is developing zilebesiran in a mid-stage study to treat hypertension.
ALNY’s Q4 Results in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $56.1 million in the reported quarter, down 29% on a reported basis. Onpattro sales beat the Zacks Consensus Estimate of $47.7 million as well as our model estimate of $55.5 million.
In 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, 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. Amvuttra generated sales worth $286.5 million in the fourth quarter, up 63% 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. Amvuttra sales beat the Zacks Consensus Estimate of $280 million and matched our model estimate.
Givlaari, approved for the treatment of acute hepatic porphyria, recorded sales of $64.6 million, reflecting a year-over-year increase of 9% on a reported basis. Givlaari sales missed the Zacks Consensus Estimate of $69 million but matched our model estimate. Oxlumo recorded global net product revenues of $43.6 million in the reported quarter, reflecting a year-over-year increase of 33% on a reported basis. However, Oxlumo sales missed the Zacks Consensus Estimate of $44.8 million as well as our estimate of $44 million.
Adjusted research and development (R&D) expenses increased 3% year over year to $259.5 million, primarily driven by a rise in expenses associated with the KARDIA-3 clinical study evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk, in partnership with Roche. Increased pre-clinical activities and expenses associated with mivelsiran cAPPRicorn-1 clinical studies also hiked R&D costs. Adjusted selling, general and administrative (SG&A) expenses increased 39% year over year to $244.3 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally, along with preparations for the potential launch of Amvuttra for ATTR amyloidosis with cardiomyopathy, subject to successful label expansion.
Cash, cash equivalents and marketable securities as of Dec. 31, 2024, amounted to $$2.69 billion compared with $2.78 billion recorded as of Sept. 30, 2024.
ALNY’s Full-Year 2024 Results
For 2024, Alnylam generated total revenues of $2.25 billion compared with $1.83 billion recorded in 2023. The figure beat the Zacks Consensus Estimate of $2.23 billion.
For the full-year 2024, the company reported a loss of 2 cents per share, narrower than a loss of $1.61 reported in 2023 due to higher revenues. The reported figure was also narrower than the Zacks Consensus Estimate of a loss of 39 cents per share.
ALNY’s 2025 Financial Guidance
Alnylam expects net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.05-$2.25 billion for 2025.
Net revenues from collaborations and royalties are expected in the range of $650-$750 million. Adjusted R&D and SG&A expenses are anticipated in the band of $2.1-$2.2 billion.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
ALNY’s Key Pipeline Updates
Alnylam has submitted regulatory applications in both the United States (using a Priority Review Voucher) and EU, seeking the label expansion of Amvuttra to treat ATTR amyloidosis with cardiomyopathy. Additional filings in other major geographies across the globe have also been completed. A final decision from the FDA is expected on March 23, 2025.
ALNY’s Zacks Rank
Alnylam currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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