We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Alnylam's (ALNY) Q2 Earnings Miss Estimates, 2021 Guidance Up
Read MoreHide Full Article
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.61 per share in the second quarter of 2021, wider than the Zacks Consensus Estimate of a loss of $1.57. The loss includes stock-based compensation expenses and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.30 per share, narrower than the adjusted loss of $1.67 reported in the year-ago quarter.
The company recorded total revenues of $220.6 million, which beat the Zacks Consensus Estimate of $200 million. In the year-ago quarter, total revenues were $103.9 million. Net product revenues were $160.8 million, significantly up 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 $59.4 million, up from $26.4 million in the year-ago quarter, primarily due to an increase in revenues recognized in connection with the collaboration agreement with Regeneron (REGN - Free Report) . During the second quarter, Alnylam also recorded royalty revenues of $0.3 million, owing to the global sales of Leqvio from its partner, Novartis (NVS - Free Report) .
Shares of Alnylam have rallied 37.6% so far this year against the industry’s decrease of 1.1%.
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 $113.8 million in the second quarter, up 71.1% year over year, driven by new patient demand. Per the company, as of Jun 30, 2021, more than 1,725 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 second quarter of 2021, it recorded sales of $30.6 million, reflecting an increase of 23.9% 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 $16.3 million in the second quarter of 2021, reflecting an increase of 79.1% sequentially.
Adjusted research and development expenses (R&D) increased to $169.5 million from $139.2 million reported in the year-ago quarter. The increase was due to higher investment in late-stage pipeline programs.
Adjusted selling, general and administrative expenses (SG&A) rose to $126.3 million from $109.6 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 revised its product revenue guidance for 2021 upward owing to strong business performance of the three commercialized products.
The company now expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $640-$665 million compared with the previous range of $610-$660 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. All unchanged from the previous guidance.
Pipeline Updates
Alnylam is developing Leqvio (inclisiran) for hypercholesterolemia in partnership with Novartis. The European Commission granted marketing authorization to Leqvio in December 2020.
Along with earnings release, Novartis announced that it has resubmitted the new drug application (“NDA”) for inclisiran to the FDA for the treatment hypercholesterolemia. A decision from the regulatory body is expected on Jan 1, 2022. A potential approval of the same will boost sales for the company.
We remind investors that Alnylam’s partner, Novartis, received a Complete Response Letter for inclisiran from the FDA in December 2020, due to unresolved facility-inspection-related conditions at a third-party manufacturing facility in Europe.
In June 2021, the FDA accepted Alnylam’s NDA for its investigational RNAi therapeutic, vutrisiran, being developed for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
A decision from the regulatory body is expected on Apr 14, 2022. If approved, vutrisiran might become a new treatment option for the given patient population.
Also, in June 2021, Alnylam initiated the phase II KARDIA-1 study, which is the efficacy and safety study of its investigational subcutaneous RNAi therapeutic, zilebesiran, for the treatment of hypertension.
Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Image: Bigstock
Alnylam's (ALNY) Q2 Earnings Miss Estimates, 2021 Guidance Up
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.61 per share in the second quarter of 2021, wider than the Zacks Consensus Estimate of a loss of $1.57. The loss includes stock-based compensation expenses and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.30 per share, narrower than the adjusted loss of $1.67 reported in the year-ago quarter.
The company recorded total revenues of $220.6 million, which beat the Zacks Consensus Estimate of $200 million. In the year-ago quarter, total revenues were $103.9 million. Net product revenues were $160.8 million, significantly up 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 $59.4 million, up from $26.4 million in the year-ago quarter, primarily due to an increase in revenues recognized in connection with the collaboration agreement with Regeneron (REGN - Free Report) . During the second quarter, Alnylam also recorded royalty revenues of $0.3 million, owing to the global sales of Leqvio from its partner, Novartis (NVS - Free Report) .
Shares of Alnylam have rallied 37.6% so far this year against the industry’s decrease of 1.1%.
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 $113.8 million in the second quarter, up 71.1% year over year, driven by new patient demand. Per the company, as of Jun 30, 2021, more than 1,725 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 second quarter of 2021, it recorded sales of $30.6 million, reflecting an increase of 23.9% 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 $16.3 million in the second quarter of 2021, reflecting an increase of 79.1% sequentially.
Adjusted research and development expenses (R&D) increased to $169.5 million from $139.2 million reported in the year-ago quarter. The increase was due to higher investment in late-stage pipeline programs.
Adjusted selling, general and administrative expenses (SG&A) rose to $126.3 million from $109.6 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 revised its product revenue guidance for 2021 upward owing to strong business performance of the three commercialized products.
The company now expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $640-$665 million compared with the previous range of $610-$660 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. All unchanged from the previous guidance.
Pipeline Updates
Alnylam is developing Leqvio (inclisiran) for hypercholesterolemia in partnership with Novartis. The European Commission granted marketing authorization to Leqvio in December 2020.
Along with earnings release, Novartis announced that it has resubmitted the new drug application (“NDA”) for inclisiran to the FDA for the treatment hypercholesterolemia. A decision from the regulatory body is expected on Jan 1, 2022. A potential approval of the same will boost sales for the company.
We remind investors that Alnylam’s partner, Novartis, received a Complete Response Letter for inclisiran from the FDA in December 2020, due to unresolved facility-inspection-related conditions at a third-party manufacturing facility in Europe.
In June 2021, the FDA accepted Alnylam’s NDA for its investigational RNAi therapeutic, vutrisiran, being developed for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
A decision from the regulatory body is expected on Apr 14, 2022. If approved, vutrisiran might become a new treatment option for the given patient population.
Also, in June 2021, Alnylam initiated the phase II KARDIA-1 study, which is the efficacy and safety study of its investigational subcutaneous RNAi therapeutic, zilebesiran, for the treatment of hypertension.
Alnylam is developing fitusiran in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors.
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.