Alnylam Pharmaceuticals, Inc. ALNY incurred adjusted loss of $1.82 per share, wider than the year-ago loss of $1.20 but narrower than the Zacks Consensus Estimate of a loss of $1.97.
In the past six months, Alnylam’s share price has lost 12.3% compared with 13.8% decline for the industry.
Revenues declined 44.5% year over year to $21 million but beat the Zacks Consensus Estimate of $12.53 million. The top line in the quarter included net product revenues of $12.1 million from sales of Onpattro (patisiran), which was approved by the FDA in August 2018. The decline in sales was due to a significant drop in collaboration revenues, which came in at $9 million compared with $37.9 million in the year-ago period.
Quarter in Detail
The company launched its sole commercial drug, Onpattro as a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults in the United States and Europe, and made efforts to make it accessible to a larger patient population. The company is currently working on pricing & reimbursement agreement in both the territories and has signed several of them. It is also looking to expand in Asian and Latin American countries.
Adjusted research and development (R&D) expenses increased 14.8% from the year-ago period to $118.1 million. Adjusted selling, general and administrative (SG&A) expenses increased 69.7% from the year-ago quarter to $93.7 million.
Alnylam ended the year with $1.13 billion in cash, cash equivalents and marketable debt securities and restricted investments (excluding equity securities). In January 2019, the company sold its common stock through a public offering adding additional $382 million to its coffers.
Full Year Results
The company reported total revenues of $74.9 million in 2018, down 16.7% year-over-year, and adjusted loss was $6.21 per share compared to $4.40 per share in 2017.
Alnylam provided its guidance for adjusted operating expenses in 2019. The company expects adjusted SG&A expense to be in the range of $390 to $420 million while adjusted R&D expense is expected to be $520-$560 million. The company also expects its current liquid resources to fund its operations approximately for the next two years at the current pace of cash burn.
During the quarter, the company obtained regulatory alignment with the FDA on the design of its phase III study, which will evaluate Onpattro in hereditary and wild-type ATTR amyloidosis patients with cardiomyopathy. The study is expected to start in mid-2019. The drug is also under review in Japan, Canada and Switzerland.
During the quarter, the company initiated the HELIOS-A study on vutrisiran (ALN-TTRsc02), a subcutaneously administered investigational RNAi therapeutic as a treatment for hATTR amyloidosis with polyneuropathy. Alnylam also plans to initiate another phase III study, HELIOS-B on the candidate in hereditary and wild-type ATTR amyloidosis cardiomyopathy in late 2019.
The company initiated a rolling submission of a new drug application (“NDA”) for givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs) based on interim results from phase III ENVISION study. It plans to pursue full approval based on complete results – now expected in March 2019 – from the ENVISION phase III study. The full clinical sections are expected to be submitted in mid-2019, assuming positive results.
Alnylam initiated 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 late 2019, and, if positive, will submit filings for global regulatory approvals starting in early 2020.
In October 2018, Alnylam’s partner, The Medicines Company MDCO announced that the Independent Data Monitoring Committee for the ongoing inclisiran phase III clinical trials (ORION 9, 10, and 11) conducted its fourth planned review of safety and efficacy data from the studies and recommended that the studies continue without modification. The company’s another partner, Sanofi SNY is currently enrolling patients in phase III ATLAS program evaluating fitusiran for treating hemophilia A or B.
Alnylam beat earnings and revenue estimates in the fourth quarter of 2018 presumably due to addition of Onpattro sales. With the launch of Onpattro in progress and several pipeline related events lined up, we expect investors’ focus to remain on the related updates.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Alnylam is a Zacks Rank #3 (Hold) stock.
A better-ranked stock from the same space is Bristol-Myers Squibb Company BMY, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.08 to $4.16 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with the average beat being 14.26%.
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