Alnylam Pharmaceuticals, Inc. ALNY incurred a loss of $2.16 per share in the fourth quarter of 2021, wider than the Zacks Consensus Estimate of a loss of $1.47. The loss includes stock-based compensation expenses, payment on license and collaboration agreement, and unrealized gain on equity securities. Excluding these items, adjusted loss was $1.69 per share, wider than the adjusted loss of $1.60 reported in the year-ago quarter.
The company recorded total revenues of $258.5 million, which surpassed the Zacks Consensus Estimate of $239 million. In the year-ago quarter, total revenues were $163.5 million. Net product revenues were $198.5 million, up 76% year over year, driven by the global expansion of Onpattro (patisiran) and Givlaari (givosiran), as well as encouraging initial uptake for Oxlumo (lumasiran) following its launch in the first quarter of 2021.
Net revenues from collaborators were $59.6 million, up from $50.7 million in the year-ago quarter, primarily due to an increase in revenues recognized in connection with the collaboration agreements with Regeneron REGN and Novartis NVS. During the fourth quarter, Alnylam also recorded royalty revenues of $0.4 million owing to the global sales of Leqvio (inclisiran) from its partner Novartis.
Alnylam received a milestone payment of $25 million from Novartis owing to the FDA approval of Leqvio in December 2021.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam.
Shares of Alnylam have decreased 4.4% in the past year compared with the industry’s decrease of 38.4%.
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For 2021, Alnylam generated total revenues of $844.3 million compared with $492.8 million recorded in 2020.
For full-year 2021, the company reported a loss of $7.20 per share compared with net loss of $7.46 per share in 2020. Adjusted net loss for 2021 was $6.14 per share compared with adjusted net loss of $6.38 per share in 2020.
Quarter in Detail
Onpattro is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $139 million in the fourth quarter, up 53.4% year over year, driven by new patient demand. Per the company, as of Dec 31, 2021, more than 2,050 patients have received treatment with Onpattro worldwide.
Alnylam’s second product, Givlaari, was approved for the treatment of acute hepatic porphyria in the United States in November 2019 and in Europe in March 2020. In the fourth quarter of 2021, Givlaari recorded sales of $41 million, reflecting an increase of 28.1% sequentially.
Oxlumo injection for subcutaneous use was approved in November 2020 for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The injection recorded global net product revenues of about $19.2 million in the fourth quarter of 2021, reflecting an increase of 28% sequentially.
Adjusted research and development expenses (R&D) increased to $205.2 million from $153.5 million reported in the year-ago quarter. The increase was due to higher investments in late-stage pipeline programs.
Adjusted selling, general and administrative expenses (SG&A) rose to $160.3 million from $136.7 million incurred in the year-ago quarter. The increase was due to higher investments in commercial activities related to the three marketed products.
Alnylam expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $900-$1,000 million for 2022.
Net revenues from collaborations and royalties are expected in the range of $175-$225 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,400-$1,500 million.
In December 2021, Alnylam submitted a supplemental new drug application (sNDA) to the FDA and a Type II filing variation to the European Medicines Agency for lumasiran for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1.
In December 2021, the FDA approved Leqvio to reduce low-density lipoprotein cholesterol (LDL-C) with two doses a year. The drug is indicated in the United States as an adjunct to diet and maximally tolerated statin therapy for treating atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) in adult patients requiring additional lowering of LDL-C.
Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
Alnylam, in collaboration with Regeneron, is advancing cemdisiran, an investigational RNAi therapeutic, for the treatment of complement-mediated diseases.
Regeneron has initiated phase III studies of cemdisiran and pozelimab combination for treating myasthenia gravis and paroxysmal nocturnal hemoglobinuria.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Vertex Pharmaceuticals Incorporated VRTX, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex’s earnings estimates have been revised 7.6% upward for 2022 and 10.5% upward for 2023 over the past 60 days. The stock has rallied 12.1% in the past year.
Earnings of Vertex’s have surpassed estimates in each of the trailing four quarters.
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