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Alnylam's (ALNY) Q3 Loss Narrower Than Expected, Sales Miss
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.56 per share (excluding stock-based compensation expenses), wider than the year-ago loss of $1.06 but narrower than the Zacks Consensus Estimate of a loss of $1.73.
Share price of Alnylam fell by about 12% following the news release. Year to date, Alnylam’s share price has lost 40.1% compared with 14% decline for the industry.
Quarterly revenues declined 87.9% to $2.1 million and missed the Zacks Consensus Estimate of $19 million. The top line in the quarter included net product revenues of $0.5 million from sales of Onpattro which was approved by the FDA in August. The sales recorded by this newly launched drug in the seven weeks of its launch, probably failed to meet investor expectations which led to the share price decline.
Revenues also included $1.6 million earned under the company's collaboration agreement. The company has collaboration agreements with with Sanofi’s (SNY - Free Report) subsidiary, Genzyme and the Medicine Company .
Quarter in Detail
Adjusted research and development (R&D) expenses increased 17.5% from the year-ago period to $94.2 million. Adjusted general and administrative (G&A) expenses increased 102.2% from the year-ago quarter to $74.4 million.
2018 Guidance
Alnylam reaffirmed its 2018 guidance. The company is on track to end the year with approximately $1 billion in cash, cash equivalents and marketable debt securities, restricted cash, and restricted investments, excluding equity securities. Adjusted R&D expenses guidance was reiterated to be $420-$460 million. The company reiterated its outlook for adjusted selling, general and administrative expenses to be $280-$320 million.
Pipeline Updates
During the quarter, the company received FDA approval for the first-ever regulatory approval of an RNAi therapeutic, Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The candidate also received approval in the EU for the treatment of hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy. The company also submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency for Onpattro, and received a priority review designation in Canada for the same.
The company is on track to start the HELIOS-A study in late 2018 on ALN-TTRsc02, a subcutaneously administered investigational RNAi therapeutic. Alnylam also plans to initiate additional phase III studies on the candidate in hereditary and wild-type ATTR amyloidosis cardiomyopathy in 2019.
The company announced positive top-line results from the interim analysis of the ENVISION phase III study on givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs). The company plans to initiate a rolling submission of an NDA and pursue full approval based on complete results – now expected in early 2019 – from the ENVISION phase III study. The rolling NDA submission is expected to be initiated in 2018, with full clinical sections submitted in mid-2019, assuming positive results.
Alnylam initiated ILLUMINATE-A, a global phase III study of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1). The company expects to report top-line results from the study in late 2019, and if positive, will submit filings for global regulatory approvals starting in early 2020.
In October 2018, Alnylam’s partner, The Medicines Company announced that the Independent Data Monitoring Committee for the ongoing inclisiran phase III clinical trials (ORION 9, 10, and 11) conducted its fourth planned review of safety and efficacy data from the studies and recommended that the studies continue without modification.
Our Take
Alnylam posted wider-than-expected loss and missed revenue estimates in the third quarter of 2018. With several pipeline related events lined up, we expect investors’ focus to remain on the related updates.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.81 for 2018 and from $3.83 to $4.03 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 11.99%.
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Alnylam's (ALNY) Q3 Loss Narrower Than Expected, Sales Miss
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.56 per share (excluding stock-based compensation expenses), wider than the year-ago loss of $1.06 but narrower than the Zacks Consensus Estimate of a loss of $1.73.
Share price of Alnylam fell by about 12% following the news release. Year to date, Alnylam’s share price has lost 40.1% compared with 14% decline for the industry.
Quarterly revenues declined 87.9% to $2.1 million and missed the Zacks Consensus Estimate of $19 million. The top line in the quarter included net product revenues of $0.5 million from sales of Onpattro which was approved by the FDA in August. The sales recorded by this newly launched drug in the seven weeks of its launch, probably failed to meet investor expectations which led to the share price decline.
Revenues also included $1.6 million earned under the company's collaboration agreement. The company has collaboration agreements with with Sanofi’s (SNY - Free Report) subsidiary, Genzyme and the Medicine Company .
Quarter in Detail
Adjusted research and development (R&D) expenses increased 17.5% from the year-ago period to $94.2 million. Adjusted general and administrative (G&A) expenses increased 102.2% from the year-ago quarter to $74.4 million.
2018 Guidance
Alnylam reaffirmed its 2018 guidance. The company is on track to end the year with approximately $1 billion in cash, cash equivalents and marketable debt securities, restricted cash, and restricted investments, excluding equity securities. Adjusted R&D expenses guidance was reiterated to be $420-$460 million. The company reiterated its outlook for adjusted selling, general and administrative expenses to be $280-$320 million.
Pipeline Updates
During the quarter, the company received FDA approval for the first-ever regulatory approval of an RNAi therapeutic, Onpattro for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The candidate also received approval in the EU for the treatment of hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy. The company also submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency for Onpattro, and received a priority review designation in Canada for the same.
The company is on track to start the HELIOS-A study in late 2018 on ALN-TTRsc02, a subcutaneously administered investigational RNAi therapeutic. Alnylam also plans to initiate additional phase III studies on the candidate in hereditary and wild-type ATTR amyloidosis cardiomyopathy in 2019.
The company announced positive top-line results from the interim analysis of the ENVISION phase III study on givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs). The company plans to initiate a rolling submission of an NDA and pursue full approval based on complete results – now expected in early 2019 – from the ENVISION phase III study. The rolling NDA submission is expected to be initiated in 2018, with full clinical sections submitted in mid-2019, assuming positive results.
Alnylam initiated ILLUMINATE-A, a global phase III study of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1). The company expects to report top-line results from the study in late 2019, and if positive, will submit filings for global regulatory approvals starting in early 2020.
In October 2018, Alnylam’s partner, The Medicines Company announced that the Independent Data Monitoring Committee for the ongoing inclisiran phase III clinical trials (ORION 9, 10, and 11) conducted its fourth planned review of safety and efficacy data from the studies and recommended that the studies continue without modification.
Our Take
Alnylam posted wider-than-expected loss and missed revenue estimates in the third quarter of 2018. With several pipeline related events lined up, we expect investors’ focus to remain on the related updates.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Alnylam is a Zacks Rank #3 (Hold) stock.
A better-ranked stock worth considering is Bristol-Myers Squibb Company (BMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.81 for 2018 and from $3.83 to $4.03 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 11.99%.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>