Peregrine Pharmaceuticals, Inc. (PPHM) reported a net loss of 5 cents per share in the first quarter of fiscal 2014 (ended Jul 31, 2013), in line with the Zacks Consensus Estimate. The first quarter loss was however narrower than the year-ago loss of 7 cents. The narrower year-over-year loss was primarily due to higher revenues.
First quarter fiscal 2014 revenues at Peregrine Pharma increased 10.3% to $4.7 million, edging past the Zacks Consensus Estimate of $4 million. The top-line growth was mainly due to the rise in contract manufacturing revenue.
Avid Bioservices, a Peregrine Pharma subsidiary, posted contract manufacturing revenues of $4.6 million during the quarter, up 10.8%. For fiscal 2014, Peregrine expects contract manufacturing revenue in the range of $18−$22 million.
Peregrine Pharma’s total costs and expenses increased 3.2% during the first quarter of fiscal 2014 to $12.3 million. Although research and development expenses decreased 24% to $5.3 million, selling, general and administrative expenses were up 48.6% to $4.3 million.
Peregrine Pharma’s lead pipeline candidate, bavituximab, is being developed for multiple oncology indications including the treatment of second-line non-small cell lung cancer (:NSCLC). Peregrine is on-track to initiate a phase III study, SUNRISE on the candidate for this indication by the end of calendar year 2013. In May 2013, the U.S. Food and Drug Administration agreed on the design of the phase III registration trial on bavituximab for the treatment of second-line NSCLC.
The randomized, double-blind, placebo-controlled, phase III trial (n=600) will be conducted across the world among stage IIIB/IV non-squamous NSCLC patients, whose disease progressed after standard front-line treatment, with the primary endpoint being overall survival. The study will compare bavituximab in combination with Sanofi’s (SNY) Taxotere (docetaxel) to Taxotere and placebo.
We expect investor focus to remain on updates pertaining to bavituximab. The successful development and commercialization of bavituximab would be a major positive for Peregrine Pharma, which currently has no approved drug.
Peregrine currently carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Biogen Idec Inc. (BIIB) with a Zacks Rank #1 (Strong Buy).
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