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Alnylam (ALNY) Q4 Earnings Top, Product Sales Boost Revenues

Alnylam Pharmaceuticals, Inc. ALNY incurred a loss of $1.68 per share in the fourth quarter of 2022, narrower than the Zacks Consensus Estimate of a loss of $2.13 and our estimate of a loss of $2.28 per share.

The fourth-quarter loss included stock-based compensation expenses, unrealized gain on equity securities and loss on extinguishment of debt. Excluding these items, the adjusted loss was $1.39 per share, narrower than the adjusted loss of $1.74 per share reported in the year-ago quarter. The adjusted loss was also lower than our estimate of $1.95 per share.

Alnylam recorded total revenues of $335 million in the quarter, which beat the Zacks Consensus Estimate of $306 million. In the year-ago quarter, total revenues were $259 million. Net product revenues were $261.7 million, up 32% year over year on a reported basis and 41% at constant exchange rate (CER), driven by increased patient numbers for Onpattro (patisiran), Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran). Total revenues beat our estimate of $295.5 million in the reported quarter as well.

Net revenues from collaborators were $70.6 million, up 18% from $59.6 million from the year-ago quarter, primarily driven by an increase in revenues recognized in connection with increased manufacturing activities with Regeneron REGN.

Alnylam, in collaboration with REGN, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases.

Alnylam, in partnership with Regeneron, is also developing ALN-APP for treating early-onset Alzheimer’s disease.

During the fourth quarter, Alnylam recorded royalty revenues of $2.7 million, owing to global sales of Leqvio from its partner, Novartis NVS. In the year-ago quarter, Alnylam recorded royalty revenues of $0.4 million from NVS.

Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam.

Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from NVS.

Shares of Alnylam have rallied 26.6% in the past year against the industry’s decline of 10.1%.

Zacks Investment Research
Zacks Investment Research


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Full-Year 2022 Results

For 2022, Alnylam generated total revenues of $1.04 billion compared with $844.3 million recorded in 2021, beating the Zacks consensus estimate of $1.01 billion and our estimate of $0.99 billion. Total recorded revenues also fell within the guided range provided by the company earlier.

For the full-year 2022, the company reported a loss of $9.30 per share compared with a net loss of $7.20 per share in 2021. The adjusted net loss for 2022 was $6.50 per share compared with the adjusted net loss of $6.27 per share in 2021.

Quarter in Detail

Onpattro (patisiran) is approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $122.2 million in the fourth quarter, down 11.8% on a reported basis. Onpattro sales fell short of the Zacks Consensus Estimate of $150 million but just beat our estimate of $122.1 million.

In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in September.

Amvuttra generated sales worth $68.6 million in the fourth quarter. The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.

Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the fourth quarter of 2022, Givlaari recorded sales of $47.1 million, reflecting a year-over-year increase of 16% on a reported basis and 22% at CER. Givlaari sales fell short of the Zacks Consensus Estimate of $51 million and just lower than our estimate of $47.2 million.

Oxlumo (lumasiran) 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 $23.8 million in the fourth quarter of 2022, reflecting a year-over-year increase of 24% on a reported basis and 33% at CER. Oxlumo sales also fell short of the Zacks Consensus Estimate of $28.5 million and missed our estimate of $24.1 million.

Adjusted research and development expenses (R&D) increased 16.4% year over year to $245.1 million driven by higher expenses incurred in development and study activities.

Adjusted selling, general and administrative expenses (SG&A) rose 15.1% year over year to $184.5 million because of higher headcount expenses and supporting the launch activities for Amvuttra.

2023 Financial Guidance

Alnylam expects net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1,200-$1,285 million for 2023. Our estimate for net product revenues is pegged at $1,143.2 for 2023.

Net revenues from collaborations and royalties are expected in the range of $100-$175 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,575-$1,650 million.

The Zacks Consensus Estimate and our estimate for the total revenues in 2023 stand at $1.5 billion and $1.32 billion, respectively.

Alnylam Pharmaceuticals, Inc. Price and EPS Surprise

Alnylam Pharmaceuticals, Inc. price-eps-surprise | Alnylam Pharmaceuticals, Inc. Quote

Zacks Rank & Stock to Consider

Alnylam currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same industry is ADMA Biologics, Inc. ADMA, carrying a Zacks Ranks #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 90 days, the consensus estimate for ADMA Biologics’ 2022 loss per share has remained stable at a loss of 33 cents. But, during the same period, the loss estimate per share for 2023 has narrowed from 20 cents to 19 cents. Shares of ADMA Biologics have increased by 118.7%.

ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%.

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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report

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ADMA Biologics Inc (ADMA) : Free Stock Analysis Report

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