Alnylam Pharmaceuticals, Inc. ALNY incurred adjusted loss of $1.83 per share in the second quarter of 2019, wider than the year-ago quarter’s loss of $1.61 and the Zacks Consensus Estimate of a loss of $1.81.
The company’s share price has increased 2% year to date against the industry’s decline of 2.5%.
Revenues increased 49.5% year over year to $44.7 million but missed the Zacks Consensus Estimate of $47 million. The top line in the quarter included net product revenues of $38.2 million from sales of Onpattro (patisiran), which was approved by the FDA in August 2018. Net revenues from collaborators were $6.5 million in the second quarter compared with $29.9 million in the year-ago quarter.
Quarter in Detail
Alnylam received marketing authorization approvals for Onpattro in Japan and Canada. With these approvals and multiple pricing or reimbursement approvals enabling commercial sales in more than 10 countries across the Canada, Europe, Middle East and Africa (CEMEA) region, the company expanded its global footprint.
Adjusted research and development (R&D) expenses increased 17.9% from the year-ago period to $148.6 million. Adjusted selling, general and administrative (SG&A) expenses rose 31.4% from the year-ago quarter to $97.4 million.
Alnylam lowered its guidance for adjusted operating expenses in 2019. The company expects adjusted SG&A expenses to be $390-$400 million compared with the previous guidance of $390-$410 million. Adjusted R&D expenses are expected to be $550-$575 million compared with the prior guidance of $550-$590 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 expects to initiate the APOLLO-B phase III study for Onpattro in ATTR amyloidosis patients with cardiomyopathy in mid-2019.
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 also obtained regulatory alignment from the FDA on the design of another phase III study, HELIOS-B, on the candidate in hereditary and wild-type ATTR amyloidosis cardiomyopathy, and expects to start the study in late 2019.
The company presented positive results from the ENVISION phase III study for givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs). Alnylam completed the submission of a new drug application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency for the candidate. Both agencies have accepted the applications. The FDA has already granted the NDA a Priority Review status and set an action date of Feb 4, 2020. The FDA is not planning to hold an advisory committee meeting to discuss this application.
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 in the second half of 2019. The company initiated 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 the second half of 2019.
Alnylam’s partner, The Medicines Company MDCO, reported new results for inclisiran, an investigational RNAi therapeutic in development for the treatment of hypercholesterolemia. The company intends to report initial top-line results from the ORION-9, 10 and 11 phase III studies of inclisiran, and file an NDA in the second half of 2019, assuming positive results.
Another partner of Alnylam, Sanofi SNY, reported new results from the phase II OLE study evaluating fitusiran for the treatment of hemophilia.
The company inked a broad collaboration with Regeneron Pharmaceuticals, Inc. REGN to discover, develop and commercialize RNAi therapeutics focused on ocular and CNS diseases.
Alnylam incurred wider-than-expected loss and missed revenue estimates in the second quarter of 2019. We expect investors to focus on the launch of Onpattro and several upcoming pipeline-related events.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
Alnylam is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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