Alnylam's (ALNY) Q1 Loss Wider Than Expected, Sales Miss

 | May 04, 2018 02:35AM ET

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) incurred a loss of $1.22 per share (excluding stock based compensation expense), wider than the year ago loss of $1.06 per share and wider than the Zacks Consensus Estimate of a loss of $1.18

Quarterly revenues improved 15.3% to $21.9 million, but missed the Zacks Consensus Estimate of $36 million. The top line in the quarter included $18.9 million earned under the company's collaboration agreement with Sanofi’s (NYSE:SNY) subsidiary, Genzyme as well as $1.3 million from the company’s alliance with The Medicines Company (NASDAQ:MDCO) and $1.7 million from other sources.

Quarter in Detail

Adjusted research and development (R&D) expenses increased 10.7% from the year-ago period to $86.7 million. Adjusted general and administrative (G&A) expenses doubled from the year ago quarter to $63 million.

2018 Guidance

Alnylam remains on track to end the year with approximately $1 billion in cash, cash equivalents and fixed income marketable. Adjusted R&D expenses are expected in the range of $420 to $460 million up from the prior guidance of $400 million to $440 million. The company reiterated its outlook for adjusted selling, general and administrative expenses and expects them to be in the range of $280 million to $320 million.

Pipeline Updates

Alnylam received acceptance from the FDA and the European Medicines Agency (EMA) of patisiran’s new drug application (NDA) and Marketing Authorisation Application (MAA), respectively. Patisiran is an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR (hATTR) amyloidosis with polyneuropathy.

The company expects to gain regulatory approval for patisiran from the FDA in mid-2018. The FDA has set an action date of Aug 11, 2018, and launch patisiran in the United States shortly after that.

Alnylam expects to report topline interim results from the ENVISION Phase III trial for givosiran by September 2018. The company also expects to initiate the lumasiran phase III study in mid-2018.

The company announced a strategic restructuring of the its rare disease alliance with Sanofi (PA:SASY), originally formed in 2014, with Alnylam obtaining global rights to its ATTR amyloidosis programs – patisiran and ALN-TTRsc02 – and Sanofi obtaining global rights to fitusiran. Alnylam and Sanofi expect to enroll patients in the ATLAS phase III program of fitusiran in patients with hemophilia A and B with or without inhibitors throughout the year.

Our Take

Alnylam posted wider than expected loss and missed revenue estimates in the first quarter of 2018. With several pipeline related events lined up and potential approval for patisiran, we expect investor focus to remain on the related updates.

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Shares of the company rose more than 1.4% in after-hours trading owing to the strong quarterly results. However, year to date, Alnylam’s shares price have lost 30.5%, compared with a 13% decline for the industry .