Neurocrine Biosciences, Inc. · NASDAQ:NBIX
Neurocrine Biosciences — Investor Presentation (September 2017)
18 slides from Neurocrine Biosciences's investor presentation, September 2017
Slide 1: Neurocrine Biosciences Corporate Presentation September 2017
Neurocrine Biosciences, Inc. CORPORATE PRESENTATION SEPTEMBER 2017
Slide 2: Safe Harbor Statement
Safe Harbor Statement In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from Neurocrine's products and product ca
Slide 3: Our Mission: To Relieve Patient Suffering and Enhance Lives
Our Mission: To Relieve Patient Suffering and Enhance Lives Tardive Dyskinesia Tourette Syndrome Parkinson’s Disease Endometriosis Uterine Fibroids Essential Tremor Congenital Adrenal Hyperplasia 3
Slide 4: Tardive Dyskinesia Overview
Tardive Dyskinesia Overview TD IS CAUSED BY EXPOSURE TO DOPAMINE RECEPTOR BLOCKING MEDICATIONS • Antipsychotics for schizophrenia, bipolar disorder, depression • Results in dysregulation of basal ganglia pathways responsible for movement control TD EFFECTS APPROXIMATELY 500,000 PATIENTS IN THE US •
Slide 5: Tardive Dyskinesia Symptoms
Tardive Dyskinesia Symptoms Oral and Facial Dyskinesia • Abnormal tongue and lip movements • Retractions of the corners of the mouth • Abnormal eyeline closure or eyebrow Trunk Dyskinesia movements • Shoulder shrugging • Bulging of the cheeks • Chewing movement Axial Dystonia • Twisting of the trunk
Slide 6: INGREZZA (valbenazine) Mechanism of Action
INGREZZA® (valbenazine) Mechanism of Action Selective VMAT2 Inhibition INGREZZA®’s exact mechanism of action in the treatment of TD is unknown but is thought to be mediated through the reversible inhibition of VMAT21 1. Margolese HC, et al. Can J Psychiatry. 2005;50:541-547. 2. INGREZZA® [package in
Slide 7: INGREZZA: First Approved Tardive Dyskinesia Treatment
INGREZZA®: First Approved Tardive Dyskinesia Treatment INDICATIONS AND USAGE INGREZZA® is a vesicular No Boxed Warning monoamine transporter 2 (VMAT2) inhibitor indicated for No Contraindications the treatment of adults with tardive dyskinesia No Complex Titration Initial dose is 40 mg once da
Slide 8: KINECT 3: Reduction in Abnormal Involuntary Movement Scores
KINECT 3: INGREZZA® Reduction in Abnormal Involuntary Movement Scores at Each Study Visit Through Week 6 AIMS Change From Baseline by Study Visit WEEK 0: Baseline WEEK 2 WEEK 4 WEEK 6 n=76 n=70 n=79 n=76 n=70 n=77 n=73 n=64 n=73 n=69 n=63 n=70 LS Mean Change From Baseline (SEM) 0 -0.1 -0.1 -0.3 -1 P
Slide 9: KINECT 3: AIMS Change From Baseline Long-Term Extension
KINECT 3: AIMS Change From Baseline for INGREZZA® Groups Long-Term Extension Period AIMS Mean Change (SEM) From Baseline 1 Placebo 0 -1 INGREZZA® 40 mg Once Daily -2 Improvement INGREZZA® 80 mg -3 Once Daily -4 Placebo to INGREZZA® 40 mg -5 Placebo to -6 INGREZZA® 80 mg -7 PBO Controlled INGREZZA® B
Slide 10: INGREZZA Safety Profile
INGREZZA® Safety Profile Adverse Reactions Reported INGREZZA® Once Daily Placebo at ≥2% and >Placebo n=262 (%) n=183 (%) General Disorders Somnolence, fatigue and sedation 10.9 4.2 Nervous System Disorders Anticholinergic effects 5.4 4.9 Balance disorders/falls 4.1 2.2 Headache 3.4 2.7 Akathisia 2.7
Slide 11: INGREZZA Launch Commenced May 1st, 2017
INGREZZA® Launch Commenced May 1st, 2017 Specialty sales team of ~140 Account Specialists • Calling on approximately 10,000 providers (¾ psychiatrists, ¼ neurologists) • Additionally covering ~2,000 community mental health centers Current reimbursement generally by formulary exception process wi
Slide 12: Clinical Pipeline
Clinical Pipeline Stage of Development Disease Program Partner 1 2 3 NDA Submitted Commercial Neurology Tardive Dyskinesia INGREZZA® Tourette Syndrome valbenazine Asia Parkinson’s Disease opicapone NBI Rights: US & Canada Essential Tremor NBI-640756 Endocrinology Endometriosis elagolix Worldwide Ute
Slide 13: Tourette Syndrome: Program Update
Tourette Syndrome: Program Update Phase 2 T-Force GREEN study results announced in May 2017 • Study did not meet its primary endpoint • Doses used in the study were determined to be too low • From Phase 1 to Phase 2 studies, a clear exposure/response relationship was determined • Going forward dos
Slide 14: Opicapone: Overview
Opicapone: Overview Approved in Europe and marketed by our partner BIAL Reversible and peripherally selective COMT inhibitor that increases levodopa plasma levels when co-administered with levodopa and a peripheral dopa decarboxylase inhibitor (DDCI) High binding affinity (Kd sub-picomolar) re
Slide 15: Opicapone: Clinical Experience
Opicapone: Clinical Experience 28 Phase 1 studies completed >900 subjects exposed to opicapone Two phase 2 studies in Parkinson’s Disease patients completed >40 patients exposed to opicapone Two pivotal phase 3 studies in fluctuating Parkinson’s Disease patients BIPARK I and II: Double-b
Slide 16: BIPARK-I and II – Absolute OFF-time reduction – Primary Endpoint
BIPARK-I and II – Absolute OFF-time reduction – Primary Endpoint Phase 3 Program 16
Slide 17: 2H2017 Key Milestones
2H2017 Key Milestones Timeline Event 2nd Half Begin valbenazine Phase 2b in Tourette Syndrome 2nd Half Begin Phase 2 PoC in CAH and Essential Tremor 4th Quarter Opicapone path forward 4th Quarter Advance new candidate to IND filing 4th Quarter or Elagolix Topline Phase 3 Data for Uterine Fibroids 1s
Slide 18: Financial Highlights
Financial Highlights Year Ended Quarter Ended ($ in millions) December 31, 2016 June 30, 2017 Revenues and other Income $ 21.3 $ 6.3 Operating Expenses $ 162.4 $ 57.3 Net Loss $ (141.1) $ (60.0) Cash, Investments, Receivables $ 352.1 $ 739.6 18
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