Safe Harbor Statement
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2 Safe Harbor Statement These slides contain forward-looking statements based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Forward-looking statements involve risks and uncertainties, including, but not limited to, economic, competitive, governmental and technological factors outside of our control, that may cause our business, industry, strategy or actual results to differ materially from the forward-looking statements. These risks and uncertainties may include those discussed under the heading Risk Factors in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, and other factors which may not be known to us. Any forwardlooking statement speaks only as of its date. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Neurocrine Biosciences files Annual Reports, Quarterly Reports and other documents with the Securities and Exchange Commission. You should read the documents we have filed with the Securities and Exchange Commission for more complete information about Neurocrine Biosciences. You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission web site at or by visiting the Neurocrine Biosciences website at 2
3 Delivering Significant Shareholder Value in 2015 Elagolix Positive top-line data on first Phase III trial for endometriosis disclosed Jan 2015 Top-line data on second Phase III trial for endometriosis late 2015 Report on Phase IIb study for uterine fibroids in mid 2015 VMAT2 (NBI-98854) Wholly-owned; will commercialize in US Fast track and breakthrough designation in Tardive dyskinesia Top line Phase III data in Tardive dyskinesia second half 2015 Top line phase Ib data in Tourette Syndrome second half 2015 CRF Antagonist (NBI-77860) FDA Orphan Designation granted for Congenital Adrenal Hyperplasia (CAH) Phase Ib and IIa trials expected in second half 2015 New IND for neurological disorder expected to be filed in Q Phase I clinical data anticipated in
4 Elagolix A Pipeline Within a Program Elagolix Primary Targeted Disease States Endometriosis Phase III Uterine Fibroids Phase II Additional Disease States PCOS PMDD Adenomyosis ART Menorrhagia Primary Dysmenorrhea 4
5 Violet Petal Study Positive Primary Endpoint at Month 3» 150mg qd positive for both Dysmenorrhea and Non-menstrual pelvic pain p<0.001» 200mg bid positive for both Dysmenorrhea and Non-menstrual pelvic pain p<0.001 Duration of Effect at Month 6» 150mg qd positive for both Dysmenorrhea and Non-menstrual pelvic pain p<0.001» 200mg bid positive for both Dysmenorrhea and Non-menstrual pelvic pain p<0.001 Safety Profile Consistent with Phase 2 Program Bone Mineral Density (BMD) of 150mg dose consistent with 603 (Petal) Study Data has High Internal Integrity 5
6 Pipeline within a Program VMAT2 Inhibition: Potential for Multiple Conditions Tourette Syndrome Prevalence: 400k Currently approved therapies: Orap (pimozide), Haldol (haloperidol) both with black box warnings Tardive Dyskinesia* Schizophrenia Prevalence: 500k Currently approved therapies: None VMAT2 Inhibitor Pipeline Prevalence: 2.2MM Currently approved therapies: Dopamine Receptor Antagonists IMS Health, Kantar Health, Datamonitor *Fast Track Status Received Jan 2012 *Breakthrough Designation Received Oct
7 NBI Kinect 3 Phase III Study AIMS assessments at screening and every two weeks thereafter Placebo (n=80) Screening 40mg (n=80) Blinded 1-Year Safety Extension: Placebo randomized to 40mg or 80mg of NBI mg (n=80) Week 6 Primary Endpoint 1-Year Safety Study (n=150) 7
8 NBI Tourette Phase 1b Design Adolescents y.o. n=18 High Dose PK/PD Assessment Independent review of safety and PK data Mid Dose Low Dose Children 6 11 y.o. n=18 Mid Dose High Dose Low Dose Week
9 Classic Congenital Adrenal Hyperplasia (CAH) A group of autosomal recessive disorders characterized by impaired cortisol synthesis Worldwide incidence of 1 in 13,000 live births.» Approximately 30,000 in the USA Caused by a defect or mutation in 21 a-hydroxylase leading to a marked decrease in cortisol and a dramatic increased androgen production» The lack of cortisol feedback at the level of the pituitary causes increased ACTH release» The lack of cortisol feedback at the hypothalamus increases CRF release which compounds the increased ACTH released from the pituitary 9
10 Classic Congenital Adrenal Hyperplasia (CAH) Disease with Poor Treatment Alternatives Classic CAH is a lifelong disease that presents at birth with severe consequences Morbidity associated with CAH is related primarily to the effects of an absence of glucocorticoids and an excess of androgens» Salt wasting» Virilization of females including need for surgery, infertility, precocious puberty, menstrual irregularity, short stature, and hirsutism Current treatment is high doses hydrocortisone, prednisolone or dexamethasone» Bone loss and growth impairment» Cushing s syndrome» Metabolic Syndrome 10
11 Hypothalamic-Pituitary-Adrenal Axis (Normal) CRF ACTH Cortisol Androgens CORTISOL NEGATIVE FEEDBACK LOOPS CONTROL CRF, ACTH AND ANDROGEN LEVELS 11
12 Hypothalamic-Pituitary-Adrenal Axis (CAH) CRF ACTH Cortisol Androgens NO CORTISOL NEGATIVE FEEDBACK LOOPS UNCONTROLLED CRF, ACTH AND ANDROGEN LEVELS 12
13 Specific Enzyme Inefficiencies are Associated with types of Congenital Adrenal Hyperplasia Cholesterol ACTH CRF 95% of CAH Pregnenolone 17-OH Pregnenolone Progesterone 17-OH Progesterone 21-a-Hydroxylase Deoxycorticosterone Deoxycortisol 11-b-Hydroxylase Corticosterone Cortisol DHEA Androstenedione Testosterone Estrogens 13
14 Specific Enzyme Inefficiencies are Associated with types of Congenital Adrenal Hyperplasia Hypothalamus Cholesterol ACTH CRF 95% of CAH Pregnenolone 17-OH Pregnenolone Progesterone 17-OH Progesterone 21-a-Hydroxylase Deoxycorticosterone Deoxycortisol 11-b-Hydroxylase Corticosterone Cortisol DHEA Androstenedione Testosterone Estrogens 14
15 NBI for Classic Congenital Adrenal Hyperplasia Initial single dose pilot study of NBI CRF 1 antagonist in eight patients with CAH.» Demonstrated a robust decrease in ACTH and 17- OHP» Single site study of eight refractory adult females» three separate overnight visits consisting of bedtime dosing with placebo or one of two active doses of NBI
16 % Change from Predose Effect of a Single Dose NBI on Plasma ACTH and 17-hydroxy-Progesterone (17-OHP) % Change from Predose Pilot Single Dose Exploratory Study - % Change from Pre-dose ACTH : All Subjects (N=8) 17-OHP : All Subjects (N=8) Placebo 300 mg 600 mg Placebo 300 mg 600 mg Morning Window 6 10 AM Morning Window 6 10 AM 16
17 NBI for Classic Congenital Adrenal Hyperplasia Second study initiated (1401 study)» 15 patient open-label, sequential cohort, single ascending dose pharmacokinetic/pharmacodynamic study» assessing three doses of NBI at bedtime» adolescent females with classic CAH» three equal cohorts» Biomarker measurements include ACTH, 17-OHP, androgen, and cortisol levels collected the morning after dosing.» Results later in 2015 Third study to initiate shortly 17
18 Delivering Significant Shareholder Value in 2015 Elagolix Positive top-line data on first Phase III trial for endometriosis disclosed Jan 2015 Top-line data on second Phase III trial for endometriosis late 2015 Report on Phase IIb study for uterine fibroids in mid 2015 VMAT2 (NBI-98854) Wholly-owned; will commercialize in US Fast track and breakthrough designation in Tardive dyskinesia Top line Phase III data in Tardive dyskinesia second half 2015 Top line phase Ib data in Tourette Syndrome second half 2015 CRF Antagonist (NBI-77860) FDA Orphan Designation granted for Congenital Adrenal Hyperplasia (CAH) Phase 1b and 2a trials expected in second half 2015 New IND for neurological disorder expected to be filed in Q Phase I clinical data anticipated in
19 Financial Highlights Year Ended December 31, 2014 Year Ended December 31, 2013 Revenues and other Income $ 3.9 million $ 6.5 million Operating Expenses $ 64.4 million $ 52.6 million Net Loss $ (60.5 million) $ (46.1 million) Cash, Investments, Receivables $ million $ million Net Proceeds from February 2015 capital raise of approximately $270 million 19
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