Neurocrine Biosciences, Inc. · NASDAQ:NBIX
Neurocrine Biosciences — Investor Presentation (August 2017)
19 slides from Neurocrine Biosciences's investor presentation, August 2017
Slide 1: Neurocrine Biosciences Corporate Presentation August 2017
Neurocrine Biosciences, Inc. CORPORATE PRESENTATION AUGUST 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 & Only FDA Approved Tardive Dyskinesia Treatment
INGREZZA®: First & Only FDA Approved Tardive Dyskinesia Treatment INDICATIONS AND USAGE INGREZZA® is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia Initial dose is 40 mg once daily After one week, increase the dose to the recommend
Slide 8: INGREZZA: First & Only FDA Approved Tardive Dyskinesia Treatment
INGREZZA®: First & Only FDA Approved Tardive Dyskinesia Treatment No Boxed Warning No Contraindications No Requirement for AIMS Simple Once-Daily Dosing 8
Slide 9: KINECT 3: INGREZZA 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 10: KINECT 3: AIMS Change From Baseline for INGREZZA Groups
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 11: 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 12: 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 13: Clinical Pipeline
Clinical Pipeline Stage of Development Disease Program Partner 1 2 3 Commercial Neurology Tardive Dyskinesia INGREZZA® Tourette Syndrome valbenazine Asia Parkinson’s Disease opicapone NBI Rights: US & Canada Essential Tremor NBI-640756 Endocrinology Endometriosis elagolix Complete Worldwide Uterine
Slide 14: 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 15: 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 16: Opicapone: Clinical Experience
Opicapone: Clinical Experience 28 Phase I 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 17: BIPARK-I and II – Absolute OFF-time reduction – Primary Endpoint
BIPARK-I and II – Absolute OFF-time reduction – Primary Endpoint Phase 3 Program 17
Slide 18: 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 3rd Quarter Elagolix NDA Filing for Endometriosis 4th Quarter Opicapone path forward 4th Quarter Advance new candidate to IND filing 4th Quarter or Ela
Slide 19: 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 19
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