Alnylam Pharmaceuticals ALNY reported third-quarter 2024 adjusted loss of 50 cents per share, which matched the Zacks Consensus Estimate. The company had recorded earnings of $1.74 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.
Alnylam recorded total revenues of $500.9 million in the quarter, which missed the Zacks Consensus Estimate of $529 million. In the year-ago quarter, total revenues were $750.5 million. The top line declined 33% year over year due to significantly lesser collaboration revenues earned in the reported quarter. Alnylam shares lost 5.3% on Thursday after the company reported its third-quarter results.
Net product revenues were $420.1 million, up 34% year over year on a reported basis and 35% 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 $57.4 million, down 87% from the year-ago quarter figure due to less revenues recognized under Alnylam’s ongoing collaborations with Roche RHHBY and Regeneron REGN.
Year to date, shares of Alnylam have soared 39.3% against the industry’s decline of 4.3%.
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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 recently underwent a modification. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy for complement-mediated indications.
Alnylam had earlier regained full global development and commercialization rights to mivelsiran in all indications, 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 to treat hypertension.
ALNY also earns revenues under its ongoing collaboration agreementwith Novartis NVS. Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for treating hypercholesterolemia and other human diseases, including Leqvio (inclisiran). Novartis has also received FDA approval to expand Leqvio’s label to include earlier use in patients with elevated LDL-C who have an increased risk of heart disease as an adjunct to diet and statin therapy.
During the third quarter of 2024, the company recorded royalty revenues of $23.4 million, driven by higher Leqvio sales as Novartis continues to grow demand for the drug worldwide. In the year-ago quarter, the company recorded royalty revenues of $9.9 million.
ALNY’s Q3 Results in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $50.3 million in the reported quarter, down 38% on a reported basis. Onpattro sales missed the Zacks Consensus Estimate of $65.3 million as well as our model estimate of $63.1 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 $258.6 million in the third quarter, up 74% 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 $240.2 million as well as our model estimate of $240.6 million.
Givlaari, approved for the treatment of acute hepatic porphyria, recorded sales of $71 million, reflecting a year-over-year increase of 31% on a reported basis. Givlaari sales also surpassed the Zacks Consensus Estimate as well as our estimate of $65.5 million and $65 million, respectively. Oxlumo recorded global net product revenues of $40.2 million in the reported quarter, reflecting a year-over-year increase of 40% on a reported basis. However, Oxlumo sales missed the Zacks Consensus Estimate of $42.3 million as well as our estimate of $43.9 million.
Adjusted research and development (R&D) expenses increased 12% year over year to $251.1 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. Adjusted selling, general and administrative (SG&A) expenses increased 19% year over year to $195 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 Sept. 30, 2024, amounted to $2.78 billion compared with $2.62 billion recorded as of June 30, 2024. The uptick can be attributed to improved operating performance and increased net proceeds from the issuance of common stock in connection with stock option exercises.
ALNY Maintains 2024 Financial Guidance
Alnylam expects combined net product revenues from Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1.575-$1.650 billion.
The company continues to anticipate net revenues from collaborations and royalties to be in the $575-$650 million range in 2024.
Alnylam expects adjusted R&D and SG&A expenses to be in the range of $1.775-$1.875 billion for the current year.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
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ALNY’s Key Pipeline Updates
During the reported quarter, Alnylam submitted regulatory applications in both the United States (using a Priority Review Voucher) and the EU, seeking the label expansion of Amvuttra to treat ATTR amyloidosis with cardiomyopathy. Additional filings in other geographies across the globe are also currently underway.
ALNY’s Zacks Rank
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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