Oct. 28, 2009 (PR Newswire) --
SAN DIEGO, Oct. 28 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the quarter ended September 30, 2009. For the third quarter of 2009, the Company reported a net loss of $8.2 million, or $0.21 per share, compared with a net loss of $17.7 million, or $0.46 per share, for the same period in 2008. For the nine months ended September 30, 2009, the Company reported a net loss of $43.1 million, or $1.11 per share, as compared to $59.8 million, or $1.56 per share, for the same period last year.
Revenues for the third quarter of 2009 were $0.7 million, compared with $0.8 million for the same period last year. Revenues for the nine months ended September 30, 2009 were $2.2 million, compared with $3.2 million for the same period in 2008. The decrease in revenues is primarily due to milestones recognized in 2008 under our collaboration agreement with GlaxoSmithKline related to the clinical advancements of our CRF program. During both nine month periods ending September 30, 2009 and 2008, we recognized $2.2 million in revenue under our collaboration agreement for indiplon with Dainippon Sumitomo Pharma Co. Ltd. from amortization of up-front licensing fees.
Research and development expenses decreased to $7.4 million during the third quarter of 2009 compared with $13.0 million for the same period in 2008. For the nine months ended September 30, 2009, research and development expenses were $29.1 million, compared to $43.4 million for the same period last year. The decrease in research and development expenses is primarily due to cost savings from our recent restructuring and decreasing external clinical development expenses related to the elagolix program. Personnel costs decreased in the first nine months of 2009 by $3.0 million compared with the first nine months of 2008 and external development spending decreased by $8.3 million for the same period.
General and administrative expenses were $3.0 million for the third quarter of 2009 and $3.5 million during the same period last year. For the nine months ended September 30, 2009, general and administrative expenses were $12.0 million, compared to $16.4 million for the same period in 2008. Personnel expenses decreased by $3.0 million in the first nine months of 2009 compared to the first nine months of 2008 primarily as a result of our restructuring program in the second quarter of 2009. Additionally, other non-personnel cost reductions have resulted in savings of approximately $1.2 million in the nine month period ending September 30, 2009 compared with the same period in the prior year.
The Company's balance sheet on September 30, 2009 reflected total assets of $75.9 million, including cash and investments of $63.7 million compared with balances at December 31, 2008 of $118.2 million and $101.5 million, respectively.
"We have made tremendous progress in our lead programs this past quarter," said Kevin C. Gorman, President and Chief Executive Officer. "After a very productive Type C meeting with the FDA, we rapidly launched our Daisy Petal study which is enrolling well. In addition, we've moved our VMAT-2 program into the clinic to determine if the ideal pharmacokinetic profile we have seen in animal models is achieved in humans."
Pipeline Highlights
Elagolix Update
The Company held a Type C meeting with the Food and Drug Administration (FDA) in August to discuss the non-menstrual pelvic pain scale proposed by the FDA and used in the Lilac Petal Study (0702). Based on this meeting, the Company modified the wording of the non-menstrual pain daily scale and launched a new clinical trial, the Daisy Petal Study (0901). This double-blind placebo-controlled clinical trial is designed to provide an assessment of this modified scale over a two month treatment period of 150 mg elagolix, followed by twenty weeks of open-label treatment.
The blinded baseline data from the initial subjects screened for the Daisy Petal Study (0901) indicate that the modified daily non-menstrual pain scale reflects a wider dynamic range of pain scores which was lacking in the previous daily non-menstrual pelvic pain scale. This should allow for detection of treatment difference between elagolix and placebo for non-menstrual pain in the study population. The mean baseline score using the previous scale in the Lilac Petal Study (0702) was 0.83 (using the 0-3 scale on non-menstrual days), while preliminary Daisy Petal Study (0901) data with the new scale demonstrate a mean baseline score of approximately 1.5 (using the 0-3 scale on non-menstrual days), in the initial group of subjects recruited.
