Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) ) incurred a loss of $1.61 per share (excluding stock-based compensation expense), wider than the year ago loss of $1.07 per share and the Zacks Consensus Estimate of a loss of $1.54.
Quarterly revenues improved 87.7% to $29.9 million and exceeded the Zacks Consensus Estimate of $20 million. The top line in the quarter included $23.1 million earned under the company's collaboration agreement with Sanofi’s (SNY - Free Report) subsidiary, Genzyme, and $6.8 million from other sources.
Quarter in Detail
Adjusted research and development (R&D) expenses increased 62.8% from the year-ago period to $126 million. Adjusted general and administrative (G&A) expenses increased 111.7% from the year-ago quarter to $74.1 million.
Alnylam remains 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 in the range of $420 to $460 million. The company reiterated its outlook for adjusted selling, general and administrative expenses at the range of $280 million to $320 million.
Alnylam received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of patisiran, for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy. If approved by the European Commission (EC), the medicine will be commercialized under the brand name Onpattro. In the United States, the FDA has set a PDUFA date of Aug 11, 2018 for the same.
Alnylam expects to report top-line interim results from the ENVISION phase III trial for givosiran by September 2018. Assuming that the results will be positive, the company expects to submit a new drug application (NDA) around end 2018, seeking an accelerated approval.
The company also expects to initiate the lumasiran phase III study for the treatment of primary hyperoxaluria type 1 (PH1) in 2018 with results expected in late 2019 supporting a potential NDA filing in early 2020.
Alnylam’s partner, The Medicines Company (MDCO - Free Report) , announced in June that the Independent Data Monitoring Committee for the ongoing inclisiran phase III studies (ORION 9, 10, and 11) conducted its third, planned review of safety and efficacy data from the ORION trials and recommended that they continue without modification.
Alnylam posted wider-than-expected loss but surpassed revenue estimates in the second quarter of 2018. With several pipeline related events lined up and a potential approval for Onpattro, we expect investors’ focus to remain on the related updates.
However, year to date, Alnylam’s shares price has lost 29.0% compared with a 4.9% decline for the industry.
Zacks Rank & Stock to Consider
Alnylam is a Zacks Rank #4 (Sell) stock.
A better-ranked stock from the same space worth considering is Gilead Sciences Inc. (GILD - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 8.7% so far this year.
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