Neurocrine Biosciences fourth quarter net income increases to $9.5 million

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter and year ended December 31, 2012.

For the fourth quarter of 2012, the Company reported net income of $9.5 million, or $0.14 per fully diluted share, compared to net income of $1.3 million, or $0.02 per fully diluted share, for the same period in 2011. For the year ended December 31, 2012, the Company reported net income of $5.0 million, or $0.08 per fully diluted share, as compared to net income of $37.6 million, or $0.67 per fully diluted share, for 2011. One-time milestone payments of $30.0 million during 2011 were primarily responsible for the change in operating results year over year.

The Company's balance sheet at December 31, 2012 reflected total assets of $196.0 million, including cash, investments and receivables of $188.3 million compared with balances at December 31, 2011 of $138.4 million and $131.7 million, respectively.  During January 2012, the Company completed a public offering of approximately 10.9 million shares of common stock that resulted in net proceeds of approximately $83.0 million.

"During 2012 we continued to perform to financial plan and were successful in moving our VMAT2 tardive dyskinesia program forward, as well as AbbVie advancing the elagolix endometriosis and uterine fibroids programs," said Kevin C. Gorman, President and CEO of Neurocrine Biosciences. "Looking to 2013 we will have two Phase IIb readouts for our VMAT2 program, expect AbbVie to progress elagolix into Phase IIb in uterine fibroids, and we anticipate one additional program entering the clinic, resulting in a very productive year."

Revenues for the fourth quarter of 2012 were $21.9 million, compared to $11.1 million for the same period in 2011. The $10.8 million increase in revenue is primarily due to higher revenues under the Company's elagolix collaboration agreement. Revenues for the year ended December 31, 2012 were $53.1 million, compared with $77.4 million for 2011. The $24.3 million decrease in revenue is primarily due to $30 million in milestones achieved under the Company's elagolix collaboration agreement during the third quarter of 2011.

Research and development expenses increased to $9.1 million during the fourth quarter of 2012 compared with $8.0 million for the same period in 2011. For the year ended December 31, 2012, research and development expenses were $37.2 million, compared to $31.0 million for 2011. The increase in research and development expenses is primarily driven by Phase IIb development expenses for the VMAT2 program, coupled with increased compensation related costs, primarily due to equity based compensation.

General and administrative expenses increased to $3.3 million during the fourth quarter of 2012 compared with $2.7 million for the same period last year. For the year ended December 31, 2012, general and administrative expenses were $13.4 million, compared to $12.5 million for 2011. The increase in year-to-date general and administrative expenses is primarily related to higher equity based compensation costs.

2013 Financial Guidance

The Company expects to have a net cash burn from operations of approximately $50 to $55 million in 2013. Revenue is expected to approximate $3 million which consists solely of the amortization of up-front license fees. Expenses for 2013 should approximate $55 to $60 million. Net loss for 2013 is expected to be $50 to $55 million, or $0.75 to $0.83 loss per share based on 66.5 million basic shares outstanding. The Company expects to end 2013 with in excess of $130 million in cash, investments and receivables.

Pipeline Highlights

Elagolix Update

AbbVie is currently conducting the initial Phase III study of elagolix for endometriosis, the Violet Petal Study. The study is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate to severe endometriosis-associated pain. Approximately 160 sites in the United States, Puerto Rico and Canada are conducting this study.

AbbVie is also currently conducting a Phase II study of elagolix for uterine fibroids to assess blood loss in women with heavy uterine bleeding due to such fibroids. AbbVie expects a Phase IIb study in uterine fibroids to commence in 2013.

VMAT2 Update

The Company is currently conducting two Phase IIb studies of its VMAT2 inhibitor NBI-98854.

The Kinect Study is a 120 subject, placebo-controlled, double-blind, parallel design, multiple dose, 12-week study assessing six-week dosing of NBI-98854 against placebo, followed by six weeks of open-label treatment with NBI-98854. The primary endpoint is the Abnormal Involuntary Movement Scale (AIMS) at the end of the first six weeks of dosing. The study will also incorporate a capsule formulation of NBI-98854. Top-line data from the placebo-controlled portion of this study is expected in the second quarter of 2013.

The Kinect 2 Study is a 90 subject, placebo-controlled, double-blind, parallel design, multiple dose, six-week study assessing NBI-98854 against placebo. The primary endpoint is the AIMS at the end of the six weeks of dosing. Top-line data from this placebo-controlled study is expected in the third quarter of 2013.

Additionally, the Company is conducting appropriate preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette's syndrome.

The Company anticipates and end-of-phase-II meeting for NBI-98854 in tardive dyskinesia to be held with the FDA in the fourth quarter of 2013.