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Alnylam's (ALNY) Q4 Loss Wider Than Expected, Revenues Beat
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Alnylam Pharmaceuticals,Inc. (ALNY - Free Report) incurred a loss of $2.09 per share in the fourth quarter of 2020, wider than the Zacks Consensus Estimate of a loss of $1.93. The loss includes stock-based compensation expenses, costs associated with the strategic financing collaboration, change in estimates of contingent liabilities and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.60 per share, narrower than the adjusted loss of $1.98 in the year-ago quarter.
The company recorded revenues of $163.6 million, which beat the Zacks Consensus Estimate of $142 million. In the year-ago quarter, revenues were $71.6 million. Net product revenues were $112.8 million, up 102% year over year, driven by the addition of new patients on therapy led by growth in established markets and the global expansion of Onpattro (patisiran) and Givlaari (givosiran)as well as initial net product revenues from Oxlumo following regulatory approval in the fourth quarter of 2020.
Net revenues from collaborators were $50.7 million, up from $15.7 million in the year-ago quarter, primarily due to the achievement of a $15-million milestone related to the Leqvio approval in Europe under the Novartis (NVS - Free Report) collaboration agreement, as well as an increase in revenues recognized in connection with the collaboration agreement with Regeneron (REGN - Free Report) .
The company’s share price has risen 23.4% in the past year compared with the industry’s growth of 14.2%.
Quarter in Detail
Onpattro was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $90 million in the fourth quarter, up 61.9% year over year, driven by new patient demand.
Givlaari (givosiran) is Alnylam’s second product and was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November 2019 and Europe in March 2020. In the fourth quarter, it recorded sales of $22 million.
For the period following the EMA and FDA approvals of Oxlumo in late November 2020, it recorded global net product revenues for the fourth quarter of about $0.3 million representing initial patient demand in Europe.
Adjusted research and development expenses (R&D) increased to $153.5 million from $166.5 million in the year-ago quarter. The decrease was primarily due to decreases in manufacturing activity for clinical drugs.
Adjusted selling, general and administrative expenses (SG&A) rose to $136.7 million from $124.9 million in the year-ago quarter. The increase was due to higher investments in commercial and medical affair activities to support the ongoing launches of Onpattro,Givlaari and Oxlumo.
Full-Year 2020 Results
The company reported revenues of $492.9 million, up 124.3% year over year. It surpassed the Zacks Consensus Estimate of $471.09 million.
Adjusted loss was $6.38 per share in 2020, narrower than $6.70 in 2019.
2021 Guidance
Alnylam expectsnet product revenues for Onpattro, Givlaari and Oxlumoin the range of $610-$660 million.
Net revenues from collaborations and royalties are expected in the range of $150-$200 million.
Pipeline & Collaboration Updates
The company is developing Leqvio (inclisiran) for hypercholesterolemia in partnership with Novartis.Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
Novartis received a complete response letter from the FDA in December 2020, due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. The company is working closely with the third-party manufacturer and the FDA to obtain approval as soon as possible and has guided for a resubmission of its new drug application (NDA) in the second or third quarter of 2021.
Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors. Sanofi resumed dosing and enrollment in the ATLAS phase III program.
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Alnylam's (ALNY) Q4 Loss Wider Than Expected, Revenues Beat
Alnylam Pharmaceuticals,Inc. (ALNY - Free Report) incurred a loss of $2.09 per share in the fourth quarter of 2020, wider than the Zacks Consensus Estimate of a loss of $1.93. The loss includes stock-based compensation expenses, costs associated with the strategic financing collaboration, change in estimates of contingent liabilities and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.60 per share, narrower than the adjusted loss of $1.98 in the year-ago quarter.
The company recorded revenues of $163.6 million, which beat the Zacks Consensus Estimate of $142 million. In the year-ago quarter, revenues were $71.6 million. Net product revenues were $112.8 million, up 102% year over year, driven by the addition of new patients on therapy led by growth in established markets and the global expansion of Onpattro (patisiran) and Givlaari (givosiran)as well as initial net product revenues from Oxlumo following regulatory approval in the fourth quarter of 2020.
Net revenues from collaborators were $50.7 million, up from $15.7 million in the year-ago quarter, primarily due to the achievement of a $15-million milestone related to the Leqvio approval in Europe under the Novartis (NVS - Free Report) collaboration agreement, as well as an increase in revenues recognized in connection with the collaboration agreement with Regeneron (REGN - Free Report) .
The company’s share price has risen 23.4% in the past year compared with the industry’s growth of 14.2%.
Quarter in Detail
Onpattro was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $90 million in the fourth quarter, up 61.9% year over year, driven by new patient demand.
Givlaari (givosiran) is Alnylam’s second product and was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November 2019 and Europe in March 2020. In the fourth quarter, it recorded sales of $22 million.
For the period following the EMA and FDA approvals of Oxlumo in late November 2020, it recorded global net product revenues for the fourth quarter of about $0.3 million representing initial patient demand in Europe.
Adjusted research and development expenses (R&D) increased to $153.5 million from $166.5 million in the year-ago quarter. The decrease was primarily due to decreases in manufacturing activity for clinical drugs.
Adjusted selling, general and administrative expenses (SG&A) rose to $136.7 million from $124.9 million in the year-ago quarter. The increase was due to higher investments in commercial and medical affair activities to support the ongoing launches of Onpattro,Givlaari and Oxlumo.
Full-Year 2020 Results
The company reported revenues of $492.9 million, up 124.3% year over year. It surpassed the Zacks Consensus Estimate of $471.09 million.
Adjusted loss was $6.38 per share in 2020, narrower than $6.70 in 2019.
2021 Guidance
Alnylam expectsnet product revenues for Onpattro, Givlaari and Oxlumoin the range of $610-$660 million.
Net revenues from collaborations and royalties are expected in the range of
$150-$200 million.
Pipeline & Collaboration Updates
The company is developing Leqvio (inclisiran) for hypercholesterolemia in partnership with Novartis.Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
Novartis received a complete response letter from the FDA in December 2020, due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. The company is working closely with the third-party manufacturer and the FDA to obtain approval as soon as possible and has guided for a resubmission of its new drug application (NDA) in the second or third quarter of 2021.
Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors. Sanofi resumed dosing and enrollment in the ATLAS phase III program.
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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