Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred loss of $1.92 per share in the third quarter of 2019, narrower than the year-ago quarter’s loss of $2.43 and the Zacks Consensus Estimate of a loss of $2.17. Adjusted loss, which excluded stock-based compensation expenses, was $1.50 per share compared with adjusted loss of $1.56 per share in the year-ago quarter.
The company’s share price has increased 19.9% year to date against the industry’s decline of 0.9%.
The company recorded revenues of $70.1 million, which beat the Zacks Consensus Estimate of $61.38 million. In the year-ago quarter, revenues were $2.1 million. The top line in the quarter included net product revenues of $46.1 million from sales of Onpattro (patisiran), which was approved by the FDA in August 2018. Net revenues from collaborators were $24 million, including $15.3 million from the recently inked collaboration with Regeneron Pharmaceuticals, Inc. (REGN - Free Report) compared with $1.6 million in the year-ago quarter.
Quarter in Detail
Alnylam received marketing authorization approvals for Onpattro in Switzerland and launched the drug in Japan and Canada. These approvals, launches and multiple reimbursement approvals enabling commercial sales in more than several countries across the Canada, Europe, Middle East and Africa (CEMEA) region expanded the company’s global footprint.
Adjusted research and development (R&D) expenses increased 46.6% from the year-ago period to $138.1 million. Adjusted selling, general and administrative (SG&A) expenses rose 30.5% from the year-ago quarter to $97.1 million.
Alnylam maintained its guidance for adjusted operating expenses in 2019. The company expects adjusted SG&A expenses to be $390-$400 million and adjusted R&D expenses in the range of $550-$575 million. The company also expects its current liquid resources to fund its operations for multiple years at the current pace of cash burn.
The company initiated the APOLLO-B phase III study for Onpattro in ATTR amyloidosis patients with cardiomyopathy during the third quarter.
During the quarter, Alnylam continued enrollment in the HELIOS-A phase III study on vutrisiran (ALN-TTRsc02), a subcutaneously-administered, investigational RNAi therapeutic, for the treatment of hATTR amyloidosis with polyneuropathy. The company expects to start another phase III study, HELIOS-B, on the candidate in hereditary and wild-type ATTR amyloidosis cardiomyopathy by the end of 2019.
Alnylam announced that the FDA has granted priority review to the new drug application (“NDA”), seeking approval for RNAi therapeutic candidate, givosiran, for the treatment of acute hepatic porphyrias (AHPs). The regulatory authority has set an action date of Feb 4, 2020 for the NDA. The company has also submitted a regulatory application for givosiran in Europe. The company is planning to initiate launch activities for givosiran, assuming potential approvals.
Alnylam continued enrollment in the 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 by the end of 2019. The company also continued enrollment in ILLUMINATE-B, a phase III pediatric study of lumasiran in PH1 patients under six years of age. It expects to initiate the ILLUMINATE-C phase III study of the drug in PH1 patients with severe renal impairment in late 2019.
Alnylam’s partner, The Medicines Company (MDCO - Free Report) , reported successful completion of three pivotal studies evaluating inclisiran for the treatment of hypercholesterolemia. The company intends to file regulatory applications in the United States and Europe seeking approval for inclisiran by the end of 2019 and early 2020.
The company is also developing another candidate, fitusiran, in partnership with Sanofi (SNY - Free Report) for the treatment of hemophilia.
Alnylam incurred narrower-than-expected loss and beat revenue estimates in the third quarter of 2019. We expect investors to focus on label expansions and continued global launch of Onpattro and regulatory updates related to givosiran.
Alnylam is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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