Shares of BioDelivery Sciences International, Inc. (BDSI) jumped 7.58% after the company reported its second-quarter 2014 results. However, shares have cooled off since then.
BioDelivery Sciences reported a second quarter loss of 5 cents per share, much narrower than the year-ago loss of 36 cents per share. The Zacks Consensus Estimate was 7 cents per share.
Total revenue for the reported quarter soared 402.3% year over year to $13.9 million. Revenues surpassed the Zacks Consensus Estimate of $12 million.
Quarter in Detail
Research & Development expenses decreased 37.4% to $8 million. This decrease was primarily due to the conclusion of a phase III study on BEMA buprenorphine in both opioid naïve and opioid experienced patients.
Selling, general & administrative expenses increased 133.1% to $7.2 million. This increase was essentially due to marketing and sales activity in anticipation of the launch of its pain drug Bunavail in the U.S.
Pipeline/Product Portfolio Update
BioDelivery Sciences provided updates on its pipeline while releasing second quarter results. The company announced the FDA approval of Bunavail for the maintenance of opioid dependence with launch expected towards the end of the third quarter of 2014.
In early July, the company along with its partner Endo International (ENDP) announced positive top-line results from a pivotal phase III efficacy study evaluating their pain candidate, BEMA buprenorphine, in opioid-experienced patients.
Earlier this year, BioDelivery Sciences and Endo had announced positive top-line results from a phase III study evaluating the use of BEMA buprenorphine in opioid-naïve patients.
Endo will file a New Drug Application (NDA) with the FDA by year end or early 2015. The submission is on track following a successful pre-NDA meeting with the FDA. Meanwhile, BioDelivery Sciences stands to receive a $10 million milestone payment from Endo due to the locking of the database for the opioid-experienced study.
The company also announced that enrolment for the phase III RHAPSODY study on clonidine topical gel for the treatment of painful diabetic neuropathy (PDN) will continue until the end of the year based on interim analysis. Top-line study results are expected by the end of the first quarter of 2015.
The RHAPSODY study is the first of two pivotal studies on the basis of which BioDelivery Sciences will file for an NDA for clonidine in the U.S. for the PDN indication. BioDelivery Sciences intends to start its second pivotal study in the first quarter of 2015 and file the NDA in 2016.
We expect investor focus to remain on pipeline updates.
BioDelivery Sciences has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering include Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).
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