The Company's balance sheet at
"We have made significant progress over the past quarter with our VMAT2 program, including the initiation of the Kinect 3 Phase III study, receiving Breakthrough Therapy Designation from the
Research and development expenses were
Pipeline Highlights
VMAT2 Update
The Company recently initiated a Phase III study of NBI-98854, the Kinect 3 study. The Kinect 3 study, along with the previous efficacy studies of NBI-98854, is designed to complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The primary endpoint in the Kinect 3 study is the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The Company also intends to conduct a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.
Top-line efficacy data from the initial six weeks of placebo-controlled dosing is expected in the second half of 2015.
The Company also recently received Breakthrough Therapy Designation from the
The Company is also exploring NBI-98854 in an initial Tourette syndrome clinical trial, the T-Force study. This study is an open-label, multi-dose, two-week evaluation of 36 subjects with Tourette syndrome. Children and adolescents enrolled in the trial will receive once-daily dosing of NBI-98854 during a two-week treatment period to assess both the safety and tolerability of NBI-98854 in Tourette patients. Additionally, the Yale Global Tic Severity Scale and the Premonitory Urge for Tics Scale will be employed during the study to assess the impact of NBI-98854 on the patients' Tourette symptoms. Data readout from this study is expected in 2015.
Elagolix Update
Elagolix is also being evaluated in women with uterine fibroids. AbbVie is conducting a Phase IIb clinical trial evaluating the change in menstrual blood loss of 520 women, age 18-51, with heavy menstrual bleeding associated with uterine fibroids.
Conference Call and Webcast Today at
Neurocrine will hold a live conference call and webcast today at
If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's R&D pipeline as well as its business overall. Specifically, the risks and uncertainties the Company faces with respect to elagolix, include the risk that the elagolix endometriosis Phase III clinical trials will fail to demonstrate that elagolix is safe and effective; the risk that elagolix Phase III clinical trials will be delayed for regulatory or other reasons; the risk that the elagolix uterine fibroids clinical program will not proceed to later stage clinical trials; and the risks associated with the Company's dependence on
NEUROCRINE BIOSCIENCES, INC. |
||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||
(in thousands, except per share data) |
||||
(unaudited) |
||||
Three Months Ended |
Nine Months Ended |
|||
2014 |
2013 |
2014 |
2013 |
|
Revenues: |
||||
License fees |
$ - |
$ 729 |
$ - |
$ 2,189 |
Total revenues |
- |
729 |
- |
2,189 |
Operating expenses: |
||||
Research and development |
12,194 |
9,490 |
30,927 |
30,330 |
General and administrative |
4,663 |
3,245 |
13,016 |
10,007 |
Total operating expenses |
16,857 |
12,735 |
43,943 |
40,337 |
Loss from operations |
(16,857) |
(12,006) |
(43,943) |
(38,148) |
Other income: |
||||
Gain (loss) on sale/disposal of assets |
1 |
6 |
(4) |
38 |
Deferred gain on real estate |
805 |
781 |
2,414 |
2,344 |
Investment income, net |
176 |
93 |
432 |
317 |
Other income (loss), net |
- |
(5) |
3 |
1 |
Total other income |
982 |
875 |
2,845 |
2,700 |
Net loss |
$ (15,875) |
$ (11,131) |
$ (41,098) |
$ (35,448) |
Net loss per common share: |
||||
Basic and diluted |
$ (0.21) |
$ (0.17) |
$ (0.56) |
$ (0.53) |
Shares used in the calculation of net loss per common share: |
||||
Basic and diluted |
75,948 |
67,199 |
74,050 |
66,868 |
NEUROCRINE BIOSCIENCES, INC. |
||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||
(in thousands) |
||
(unaudited) |
||
September 30, 2014 |
December 31, |
|
Cash, cash equivalents and short-term investments, available for sale |
$ 179,674 |
$ 145,739 |
Other current assets |
4,194 |
2,723 |
Total current assets |
183,868 |
148,462 |
Property and equipment, net |
2,292 |
1,771 |
Long-term investments, available for sale |
67,148 |
- |
Restricted cash |
4,443 |
4,443 |
Total assets |
$ 257,751 |
$ 154,676 |
Current liabilities |
$ 14,045 |
$ 11,699 |
Long-term liabilities |
19,669 |
22,567 |
Stockholders' equity |
224,037 |
120,410 |
Total liabilities and stockholders' equity |
$ 257,751 |
$ 154,676 |
SOURCE
Neurocrine Biosciences, Investor Relations, (858) 617-7600