Yahoo Finance Alnylam (ALNY) Posts Strong Preliminary Revenues for 4Q & FY22
Alnylam Pharmaceuticals, Inc. ALNY announced robust preliminary results for the fourth quarter and full year of 2022. The company reported preliminary net product revenues for its portfolio of marketed drugs – Onpattro (patisiran), Amvuttra (vutrisiran), Givlaari (givosiran) and Oxlumo (lumasiran).
Alnylam's lead drug, Onpattro is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for treating 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.
Worldwide preliminary net product revenues for Onpattro and Amvuttra were around $122 million and $69 million, respectively, for the fourth quarter of 2022, reflecting an increase of 12% in sequential growth. Preliminary revenues for Onpattro and the full year of 2022 were approximately $558 million and $94 million, respectively, reflecting an increase of 37% year over year.
More than 2,975 patients have received treatment with Onpattro or Amvuttra as of 2022-end across the world.
In December 2022, Alnylam submitted a supplemental New Drug Application with the FDA seeking approval to expand Onpattro’s label for treating cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis in adults.
Successful label expansion of Onpattro will help the drug treat a broader patient population, which is likely to boost sales in the days ahead.
The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.
Shares of Alnylam have rallied 49.8% in the past year against the industry’s decline of 17.7%.
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Alnylam’s second product, Givlaari, is approved for treating acute hepatic porphyria.
Preliminary global net product revenues of Givlaari for fourth-quarter and full-year 2022 were around $47 million and $173 million, respectively, reflecting sequential growth of 3% and a year-over-year increase of 35%, respectively.
As of 2022-end, more than 520 patients have received treatment with Givlaari worldwide.
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.
Preliminary global net product revenues of Oxlumo for fourth-quarter and full-year 2022 were around $24 million and $70 million, respectively, reflecting sequential growth of 45% and a year-over-year increase of 17%, respectively.
As of 2022-end, more than 280 patients have received treatment with Oxlumo worldwide.
In October 2022, the FDA approved Oxlumo for a new indication. The injection is now approved for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients.
This apart, Alnylam has a robust portfolio of pipeline candidates, which are being developed in various clinical studies for treating various indications.
Though Alnylam is making steady progress with its portfolio of marketed drugs, stiff competition in the target market remains a constant threat. Several other companies are also developing RNAi-based therapeutics. This can induce acute competition for Alnylam in the days ahead.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. SNDX, Celularity Inc. CELU and Repare Therapeutics Inc. RPTX, all sporting a Zacks Rank #1 (Strong Buy) at present.You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 7.2% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Celularity have narrowed 17.3% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.
Loss per share estimates for Repare Therapeutics have narrowed 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. RPTX witnessed an earnings surprise of 240.65% on average.
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