Neurocrine Biosciences, Inc. · NASDAQ:NBIX
Neurocrine Biosciences — Investor Presentation (March 2010)
23 slides from Neurocrine Biosciences's investor presentation, March 2010
Slide 1: Neurocrine Biosciences Corporate Presentation
1 Website based on 03-10-10 Conf
Slide 2: Safe Harbor Statement
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, compet
Slide 3: Transformed and Focused
Transformed and Focused • Advanced Pipeline • Proven Pro en Discovery Disco er Platform • Fiscal Discipline 3 Website based on 03-10-10 Conf
Slide 4: Poised to Deliver Significant Shareholder Value Near Term
Poised to Deliver Significant Shareholder Value Near Term Elagolix g • Transformative First‐ First‐In In‐‐Class Women’s Health Product • Multiple potential milestones in next 9 months • 901 Studyy results • End of Phase II Meeting and Special Protocol Assessment • Phase III Ready • Worldwide Partner
Slide 5: Poised to Deliver Significant Shareholder Value Long Term
Poised to Deliver Significant Shareholder Value Long Term Multiple Product Opportunities in Significant Markets • Elagolix – Women’s and Men’s Health • VMAT2 – Movement Disorders • CRF – Major Depressive Disorder • Urocortin 2 – Heart Failure • Indiplon – Sleep Strong Research Platform with Proven T
Slide 6: Clinical Pipeline Discovered at Neurocrine
Clinical Pipeline Discovered at Neurocrine GSK‐561679 GSK‐ NBI‐98854 NBI‐ Major Depression Movement Disorders Elagolix g Phase II Phase I GSK‐586529 GSK‐ Endometriosis Anxiety & Depression Phase II Phase I Convergent Chemical Synthesis SiNERG Profile : Suite of Automated Purification, Proprietary In
Slide 7: A Pipeline of Innovation
A Pipeline of Innovation Program and Indication Preclinical Phase 1 Phase 2 Phase 3 Women’s and Men’s Health Endometriosis Pain Elagolix Uterine Fibroids Elagolix Endometriosis Oncology Endometriosis, Oncolog GnRH Antagonists Central Nervous System Anxiety and Depression 561679 Anxietyy and Depressi
Slide 8: Endometriosis is Pain
Endometriosis is Pain “It’s disabling. I’ll do everything I have to do but I don’t d ’ feel f l like l k I am BLEEDING reaching my full potential… it’s honestly a huge disadvantage.” PAIN “I live my life based on this (endometriosis). I have to INFERTILITY rearrange my whole life based on when this
Slide 9: 100 MM Endometriosis Sufferers Worldwide
100 MM Endometriosis Sufferers Worldwide 7.5 MM Women in US 15% of contraceptives Rx used “off‐label” to ~90% 90% of the high treat endometriosis prescribing physicians are OBGYNs implying a cost‐effective t ff ti commercial effort Equates q to a >100 MM TRx significant market contraceptives opportu
Slide 10: Endometriosis Treatment Options
Endometriosis Treatment Options Option Issues I ffi i t pain Insufficient i relief, li f weight i ht gain i deep d vein i Oral contraceptives thrombosis Opioids Abuse, Abuse addiction, addiction tolerance, tolerance constipation Irregular bleeding, bone loss, weight gain, Depo‐Provera injection site
Slide 11: Competitive Landscape – Endometriosis (US)
Competitive Landscape – Endometriosis (US) Elagolix is First‐in‐class GnRH Antagonist Research → Preclinical Phase 1 Phase 2 Kissei TAK‐385 elagolix Nonpeptide GnRH Antagonist Nonpeptide GnRH Antagonist Astellas (Takeda) (Neurocrine Biosciences) Takeda PGL2001 Steriod Sulphatase Inh Aeterna Zentaris
Slide 12: Elagolix Expected Advantages
Elagolix Expected Advantages vs. Approved Agents Against Against Attribute Lupron Depot Depo‐‐Provera Depo Dosing/ Convenience SUPERIOR SUPERIOR Pain Reduction Comparable Comparable Onset of Pain Reduction SUPERIOR Comparable Quality of Life Improvements SUPERIOR SUPERIOR Hot flashes SUPERIOR Compar
Slide 13: First to Prove Efficacy
First to Prove Efficacy Elagolix Phase II Program Early Phase II Studies Late Phase II Studies Primary Measure 501 504, 501, 504 603 702 703 702, CPSSS (Monthly) + Not measured VAS (Monthly) + Not measured EHP5 (Monthly) + + Dyspareunia (Monthly) + + Dysmenorrhea (Daily) Not measured + Nonmenstrual
Slide 14: Daily Non-Menstrual Pelvic Pain Endpoints
Daily Non‐Menstrual Pelvic Pain Endpoints 702 Trial 901 Trial 100% 100% 75% 75% 0.8 mean score 1.4 mean score 50% 50% 25% 25% 0% 0% 0 1 2 3 0 1 2 3 901 data due end of May 14
Slide 15: First to Prove Bone Neutrality
First to Prove Bone Neutrality Confirmation of Bone Safety: Week 24 and Week 48 (603) LS Mean and 95% Confidence Interval for Elagolix 150 mg qd Density No Effect Level e in Bone D Change FDA Mandated Lower Limit 15
Slide 16: First to Prove a Favorable Safety Profile
First to Prove a Favorable Safety Profile Combined Data From Phase 2 Trials Discontinuation due to an AE while receiving elagolix 75-250 mg per day was 7.4% in these trials (19% with Depo-Provera and 2% with placebo) Placebo Elagolix Treatment Emergent 75‐‐250 mg/day 75 (n=100) (n=405) (n=405) Adver
Slide 17: A First-in-Class Opportunity
A First‐in‐Class Opportunity Elagolix Product Attributes Improved tolerability Rapid No flare recovery effect time Bone Fast Onset neutral Oral No Dosing Elagolix tolerance 17 Website based on 03-10-10 Conf
Slide 18: A Pipeline Within a Program
A Pipeline Within a Program Follow‐‐On Follow Elagolix NBI 98341 NBI 97934 Primary Indications Primary Indications Oncology Endometriosis Uterine Fibroids Men’s Health Prostate Breast Additional Indications Menorrhagia PCOS Adenomyosis Primary PMDD ART Dysmenorrhea 18
Slide 19: Elagolix Intellectual Property
Elagolix Intellectual Property Market Exclusivity Provides Market Expansion Opportunities 5 Issued U.S. Patents covering: • Elagolix El li composition iti off matter tt • Pharmaceutical composition • Methods of using elagolix Composition of matter patent expires 2024 (not including patent term e
Slide 20: VMAT-2 Inhibitor – Potential Phase II in 2010
VMAT‐2 Inhibitor – Potential Phase II in 2010 Tardive Dyskinesia (Movement Disorders), Schizophrenia Modulation of Dopaminergic Transmission for Hyperkinetic Movement Disorders 20
Slide 21: Hyperkinetic Movement Disorders (US)
Hyperkinetic Movement Disorders (US) VMAT2 Inhibition Has Established Efficacy in Multiple Conditions Tardive Prevalence: 150‐250k d ki i dyskinesia Currently C l approvedd therapies: h i None N Prevalence: 2 2.5 5 MM Schizophrenia Currently approved therapies: Dopamine Receptor Antagonists,
Slide 22: Best-in-Class VMAT2 Inhibitor
Best‐in‐Class VMAT2 Inhibitor • Highly selective for VMAT2 • Good bioavailability, low variability, predictable metabolism • Dose titration not required • Long t1/2 = Once daily dosing • Developed by Neurocrine Research 22 Website based on 03-10-10 Conf
Slide 23: Financial Highlights
Financial Highlights Year Ended Year Ended December 31, 2008 December 31 , 2009 Revenues and other Income $ 2.7 million $ 5.6 million Operating and other Expenses $ 91.3 million $ 56.6 million Net Loss $ (88.6) (88 6) million $ (51.0) (51 0) million Cash and Investments $ 101.5 million $ 59.9 millio
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