SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the quarter ended March 31, 2009. For the first quarter of 2009, the Company reported a net loss of $19.7 million, or $0.51 per share compared with a net loss of $21.1 million, or $0.55 per share, for the same period in 2008.
Revenues for the first quarter of 2009 were $0.7 million compared with $1.8 million for the same period last year. The decrease in revenues is primarily due to revenues recognized in 2008 under our collaboration agreement with GlaxoSmithKline (GSK). During the first quarter of 2008, the Company recognized $1.0 million in milestone revenue from GSK for clinical advancements relating to the Company's CRF program.
Research and development expenses decreased to $10.8 million during the first quarter of 2009 compared with $14.2 million for the same period in 2008. The decrease in research and development expenses is primarily due to expense management efforts and lower external clinical development expenses related to the elagolix program.
General and administrative expenses were $4.2 million for the first quarter of 2009 and $8.3 million during the same period last year. The decrease in general and administrative expenses is primarily due to severance costs incurred in the first quarter of 2008 and expense management efforts in the first quarter of 2009.
The Company incurred $4.8 million in cease-use expense during the first quarter of 2009 due to a change in assumptions on timing of tenant occupancy for the front building of its campus.
The Company's balance sheet on March 31, 2009 reflected total assets of $101.0 million, including cash, cash equivalents, and investments of $86.0 million compared with balances at December 31, 2008 of $118.2 million and $101.5 million, respectively.
'We continue to move our GnRH program forward with the most recent twelve month data from our 603 study showing that elagolix had no deleterious impact on bone mineral density. To date we have successfully treated approximately 700 subjects with elagolix, and continue to build value in this franchise through our ongoing development efforts,' said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences.
Pipeline Highlights
GnRH Antagonists in Phase II Clinical Trials for Endometriosis
Elagolix for Endometriosis
Petal Study (NBI-56418-0603)
The Company has recently completed the entire twelve months of the Petal study, which included the post-treatment reviews to determine the impact, if any, of elagolix on bone mineral density (BMD) six months after stopping treatment. The dual energy X-ray absorptiometry (DXA) data were consistent with the six-month end of treatment results showing a negligible change from baseline in the elagolix treatment arms. In particular, the elagolix 150 mg once daily mean percent change in BMD at twelve months in the spine was 0.19% and in the femur was -0.28%. Analysis of the pain data, collected utilizing the Visual Analog Scale (VAS) and the Composite Pelvic Sign and Symptoms Scale (CPSSS), revealed that the subjects report a sustained improvement of endometriosis symptoms while off medication. While there is a modest increase in scores during the six months after discontinuation of treatment, the mean scores did not return to baseline severity. This would be consistent with a disease modification effect but such a conclusion requires additional clinical study for confirmation.
Lilac Petal Study (NBI-56418-0702)
The Company recently reported the top-line study results from the three-month, double-blind placebo controlled portion of the Lilac Petal Study. These data confirmed the efficacy and safety of elagolix at 150 mg and 250 mg once daily. All subjects have completed the six months of treatment and final study results are expected during the summer. The Company found that for two exploratory scales, daily assessment of non-menstrual pelvic pain was associated with a statistical 'floor effect' given the overall mild nature of this symptom in many subjects as assessed utilizing these scales. Analysis of these scores for the sub-set of subjects with moderate or severe non-menstrual pelvic pain at baseline revealed statistically significant separation of elagolix from placebo.
