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Alnylam's (ALNY) Q3 Loss Wider Than Expected, Revenues Beat
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Alnylam Pharmaceuticals,Inc. (ALNY - Free Report) incurred a loss of $2.18 per share in the third quarter of 2020, wider than the Zacks Consensus Estimate of a loss of $1.75. The loss includes stock-based compensation expenses, costs associated with the strategic financing collaboration, change in estimates of contingent liabilities, unrealized gains on equity securities and lossfroma contractual settlement. Excluding these items, adjusted loss was $1.58 per share, wider than the adjusted loss of $1.50 in the year-ago quarter.
The company recorded revenues of $126 million, which beat the Zacks Consensus Estimate of $118 million. In the year-ago quarter, revenues were $70 million. Net product revenues were $99.2 million, up 115% year over year, driven by the addition of new patients on therapy and expansion into new markets of Onpattro (patisiran), and the U.S. commercial launch and initial European launch of Givlaari (givosiran). Net revenues from collaborators were $26.6 million, which includes new revenues recognized under the collaboration with Vir Biotechnology (VIR - Free Report) .
The company’s share price has risen 19.7% this year so far against the industry’s decline of 0.3%.
Quarter in Detail
Onpattro was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $82.5 million in the third quarter, up 79.1% year over year, driven by patient growth and expansion in new markets.
Givlaari (givosiran) is Alnylam’s second product and was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November last year and Europe in March 2020. In the third quarter, it recorded sales of $16.7 million.
Adjusted research and development expenses (R&D) increased to $148.1 million from $138.1 million in the year-ago quarter. The increase was primarily due to elevated expenses associated with clinical and preclinical activities, personnel, and facilities.
Adjusted selling, general and administrative expenses (SG&A) rose to $114.5 million from $97.1 million in the year-ago quarter. The increase was due to higher investments in commercial and medical affairs activities to support the ongoing launches of Onpattro and Givlaari and the initial launch preparation activities for lumasiran.
2020 Guidance
Alnylam tweaked the revenue guidance for Onpattro from $280-$315 million to $295-$310 million.
The company reiterated its expectations for net revenues from collaborations in the range of $100-$150 million.
Pipeline & Collaboration Updates
The company is developing inclisiran for hypercholesterolemia in partnership with Novartis (NVS - Free Report) . Inclisiran is undergoing regulatory review in the United States. and EU. The companies received a positive Committee for Medicinal Products for Human Use (CHMP) opinion from European Medicines Agency (EMA), recommending approval of the drug for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. If approved, inclisiran will be marketed under the brand name, Leqvio. The applications are under review.
The company is also evaluating several other candidates. In April, Alnylam completed a rolling submission of the NDA, seeking approval for lumasiran as a treatment for primary hyperoxaluria type 1 (PH1) in the United States. The company also filed a marketing authorization application (MAA) seeking approval for the candidate in Europe. Both applications are now accepted. The FDA also granted Priority Review tothe NDA and set an action date of Dec 3, 2020. The company received a positive CHMP opinion from the EMA recommending approval of lumasiran for the treatment of PH1 in patients of all ages. If approved, lumasiran will be marketed in Europe under the brand name, Oxlumo.
In collaboration with partner Regeneron (REGN - Free Report) , Alnylam Continued enrollment in a phase II study of cemdisiran monotherapy in patients with IgA nephropathy, with topline results expected in 2021.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Alnylam's (ALNY) Q3 Loss Wider Than Expected, Revenues Beat
Alnylam Pharmaceuticals,Inc. (ALNY - Free Report) incurred a loss of $2.18 per share in the third quarter of 2020, wider than the Zacks Consensus Estimate of a loss of $1.75. The loss includes stock-based compensation expenses, costs associated with the strategic financing collaboration, change in estimates of contingent liabilities, unrealized gains on equity securities and lossfroma contractual settlement. Excluding these items, adjusted loss was $1.58 per share, wider than the adjusted loss of $1.50 in the year-ago quarter.
The company recorded revenues of $126 million, which beat the Zacks Consensus Estimate of $118 million. In the year-ago quarter, revenues were $70 million. Net product revenues were $99.2 million, up 115% year over year, driven by the addition of new patients on therapy and expansion into new markets of Onpattro (patisiran), and the U.S. commercial launch and initial European launch of Givlaari (givosiran). Net revenues from collaborators were $26.6 million, which includes new revenues recognized under the collaboration with Vir Biotechnology (VIR - Free Report) .
The company’s share price has risen 19.7% this year so far against the industry’s decline of 0.3%.
Quarter in Detail
Onpattro was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $82.5 million in the third quarter, up 79.1% year over year, driven by patient growth and expansion in new markets.
Givlaari (givosiran) is Alnylam’s second product and was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November last year and Europe in March 2020. In the third quarter, it recorded sales of $16.7 million.
Adjusted research and development expenses (R&D) increased to $148.1 million from $138.1 million in the year-ago quarter. The increase was primarily due to elevated expenses associated with clinical and preclinical activities, personnel, and facilities.
Adjusted selling, general and administrative expenses (SG&A) rose to $114.5 million from $97.1 million in the year-ago quarter. The increase was due to higher investments in commercial and medical affairs activities to support the ongoing launches of Onpattro and Givlaari and the initial launch preparation activities for lumasiran.
2020 Guidance
Alnylam tweaked the revenue guidance for Onpattro from $280-$315 million to $295-$310 million.
The company reiterated its expectations for net revenues from collaborations in the range of $100-$150 million.
Pipeline & Collaboration Updates
The company is developing inclisiran for hypercholesterolemia in partnership with Novartis (NVS - Free Report) . Inclisiran is undergoing regulatory review in the United States. and EU. The companies received a positive Committee for Medicinal Products for Human Use (CHMP) opinion from European Medicines Agency (EMA), recommending approval of the drug for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. If approved, inclisiran will be marketed under the brand name, Leqvio. The applications are under review.
The company is also evaluating several other candidates. In April, Alnylam completed a rolling submission of the NDA, seeking approval for lumasiran as a treatment for primary hyperoxaluria type 1 (PH1) in the United States. The company also filed a marketing authorization application (MAA) seeking approval for the candidate in Europe. Both applications are now accepted. The FDA also granted Priority Review tothe NDA and set an action date of Dec 3, 2020. The company received a positive CHMP opinion from the EMA recommending approval of lumasiran for the treatment of PH1 in patients of all ages. If approved, lumasiran will be marketed in Europe under the brand name, Oxlumo.
In collaboration with partner Regeneron (REGN - Free Report) , Alnylam Continued enrollment in a phase II study of cemdisiran monotherapy in patients with IgA nephropathy, with topline results expected in 2021.
Zacks Rank
Alnylam is currently a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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