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Alnylam's (ALNY) Q3 Earnings & Revenues Fall Shy of Estimates
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.72 per share in the third quarter of 2021, wider than the Zacks Consensus Estimate of a loss of $1.51. The loss includes stock-based compensation expenses, payment on license and collaboration agreement and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.51 per share, narrower than the adjusted loss of $1.58 reported in the year-ago quarter.
The company recorded total revenues of $187.6 million, which lagged the Zacks Consensus Estimate of $221.4 million. In the year-ago quarter, total revenues were $125.8 million. Net product revenues were $167 million, up 68.3% 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 $20.1 million, down from $26.6 million in the year-ago quarter, primarily due to a decrease in revenues recognized in connection with the collaboration agreement with Vir Biotechnology. During the third quarter, Alnylam also recorded royalty revenues of $0.4 million, owing to the global sales of Leqvio from its partner Novartis (NVS - Free Report) .
Shares of Alnylam were down 15.2% on Thursday following the announcement of weaker-than-expected earnings results. The stock has rallied 24.8% so far this year against the industry’s decrease of 11.3%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $120.3 million in the third quarter, up 45.8% year over year, driven by new patient demand. Per the company, as of Sep 30, 2021, more than 1,875 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 third quarter of 2021, Givlaari recorded sales of $31.8 million, reflecting an increase of 3.9% 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 $15 million in the third quarter of 2021, reflecting a decrease of 9% sequentially.
Adjusted research and development expenses (R&D) increased to $172.1 million from $148.1 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 $121.1 million from $114.5 million incurred in the year-ago quarter. The increase was due to higher investments in commercial activities related to the three marketed products.
2021 Guidance
Alnylam reiterated the financial guidance it provided earlier this year.
The company expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $640-$665 million.
Net revenues from collaborations and royalties are expected in the range of $150-$200 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,175-$1,275 million.
Pipeline Updates
Alnylam is developing Leqvio (inclisiran) for the treatment of hypercholesterolemia in partnership with Novartis. The new drug application for inclisiran for the treatment of hypercholesterolemia is currently under review in the United States. A decision from the FDA is expected on Jan 1, 2022. A potential nod in the United States will boost sales for the company.
In September 2021, Alnylam submitted a marketing authorization application to the European Medicines Agency, seeking approval of its investigational RNAi therapeutic, vutrisiran, for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
We note that Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors. Alnylam, in collaboration with Regeneron (REGN - Free Report) , is advancing cemdisiran, an investigational RNAi therapeutic, for the treatment of complement-mediated diseases.
In a separate press release, Alnylam announced that its current CEO, Dr. John Maraganore, will be stepping down from his position by 2021-end. Dr. Yvonne Greenstreet will become the new CEO of the company following this transition.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Image: Bigstock
Alnylam's (ALNY) Q3 Earnings & Revenues Fall Shy of Estimates
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.72 per share in the third quarter of 2021, wider than the Zacks Consensus Estimate of a loss of $1.51. The loss includes stock-based compensation expenses, payment on license and collaboration agreement and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.51 per share, narrower than the adjusted loss of $1.58 reported in the year-ago quarter.
The company recorded total revenues of $187.6 million, which lagged the Zacks Consensus Estimate of $221.4 million. In the year-ago quarter, total revenues were $125.8 million. Net product revenues were $167 million, up 68.3% 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 $20.1 million, down from $26.6 million in the year-ago quarter, primarily due to a decrease in revenues recognized in connection with the collaboration agreement with Vir Biotechnology. During the third quarter, Alnylam also recorded royalty revenues of $0.4 million, owing to the global sales of Leqvio from its partner Novartis (NVS - Free Report) .
Shares of Alnylam were down 15.2% on Thursday following the announcement of weaker-than-expected earnings results. The stock has rallied 24.8% so far this year against the industry’s decrease of 11.3%.
Quarter in Detail
Onpattro is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $120.3 million in the third quarter, up 45.8% year over year, driven by new patient demand. Per the company, as of Sep 30, 2021, more than 1,875 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 third quarter of 2021, Givlaari recorded sales of $31.8 million, reflecting an increase of 3.9% 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 $15 million in the third quarter of 2021, reflecting a decrease of 9% sequentially.
Adjusted research and development expenses (R&D) increased to $172.1 million from $148.1 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 $121.1 million from $114.5 million incurred in the year-ago quarter. The increase was due to higher investments in commercial activities related to the three marketed products.
2021 Guidance
Alnylam reiterated the financial guidance it provided earlier this year.
The company expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $640-$665 million.
Net revenues from collaborations and royalties are expected in the range of $150-$200 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,175-$1,275 million.
Pipeline Updates
Alnylam is developing Leqvio (inclisiran) for the treatment of hypercholesterolemia in partnership with Novartis. The new drug application for inclisiran for the treatment of hypercholesterolemia is currently under review in the United States. A decision from the FDA is expected on Jan 1, 2022. A potential nod in the United States will boost sales for the company.
In September 2021, Alnylam submitted a marketing authorization application to the European Medicines Agency, seeking approval of its investigational RNAi therapeutic, vutrisiran, for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
We note that Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors. Alnylam, in collaboration with Regeneron (REGN - Free Report) , is advancing cemdisiran, an investigational RNAi therapeutic, for the treatment of complement-mediated diseases.
In a separate press release, Alnylam announced that its current CEO, Dr. John Maraganore, will be stepping down from his position by 2021-end. Dr. Yvonne Greenstreet will become the new CEO of the company following this transition.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank
Alnylam currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.