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Alnylam (ALNY) Reports Wider-than-Expected Loss in Q1

Alnylam Pharmaceuticals, Inc. ALNY reported a loss of $1.21 per share in the first quarter of 2016, wider than both the Zacks Consensus Estimate of a loss of $1.08 and the year-ago loss of 62 cents.

Quarterly revenues came in at $7.3 million, down 60.5% year over year due to the completion of obligations related to the Feb 2015 Monsanto agreement and the completion of revenue amortization under the May 2015 agreement with Takeda Pharmaceutical Company Limited TKPYY. Nevertheless, revenues were above the Zacks Consensus Estimate of $6.6 million.

The Quarter in Detail

Revenues included $4.4 million from the company's alliance with Sanofi's SNY subsidiary, Genzyme.

For the rest of 2016, the company expects collaboration revenues to increase due to an expected increase in expense reimbursement and milestone payment, under the agreement with Genzyme.

Research and development (R&D) expenses shot up 66% from the year-ago period to $96.3 million primarily due to additional expenses related to the advancement of pipeline. Likewise, general and administrative (G&A) expenses escalated 66.1% to $21.1 million.

In 2016, on a quarterly basis, R&D expenses are expected to increase compared with the first quarter, while G&A expenses are expected to remain sequentially flat.

Pipeline Update

Alnylam has been making considerable progress on the development of its candidates. Currently, the company is evaluating two candidates in phase III studies – patisiran (in the APOLLO study) for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis) with familial amyloidotic polyneuropathy, and revusiran (in the ENDEAVOUR study) for ATTR amyloidosis patients with familial amyloidotic cardiomyopathy. In the reported quarter, the company completed enrolment in the APOLLO study. Enrolment in the ENDEAVOUR study is expected to complete in late 2016.

Data from the APOLLO study are expected in mid 2017, while data from the ENDEAVOUR study are expected in mid 2018. The company plans to file regulatory applications for patisiran in both the U.S. and the EU in late 2017.

The company is also evaluating fitusiran (phase I) for the treatment of hemophilia and rare bleeding disorders. Data from the study are expected in July. Meanwhile, Alnylam expects to initiate two phase III studies on fitusiran in hemophilia A and B patients with inhibitors (in mid 2016); and in moderate or severe hemophilia A and B patients without inhibitors (in late 2016).

Our Take

Alnylam’s first-quarter results were disappointing with the company reporting a wider-than-expected loss. We are, however, encouraged by the company’s progress on its pipeline. With several pipeline-related events lined up for the upcoming quarters, we expect investor focus to remain on further updates by the company.

Alnylam holds a Zacks Rank #2 (Buy). Gilead Sciences Inc. GILD is another favorably-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).

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