Neurocrine Biosciences, Inc. · NASDAQ:NBIX
Neurocrine Biosciences — Q3 2019 Earnings Presentation
34 slides from Neurocrine Biosciences's earnings presentation, Nov 4, 2019
Slide 1: Advancing Life-Changing Discoveries in Neuroscience
Advancing Life-Changing Discoveries in Neuroscience Q3 2019 Corporate Presentation November 4, 2019 neurocrine.com NASDAQ: NBIX
Slide 2: Safe Harbor Statement
Safe Harbor Statement In addition to historical facts, this presentation 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 can
Slide 3: Neurocrine 2019 Q3 Highlights & Q4 Key Activities
Neurocrine 2019 Q3 Highlights & Q4 Key Activities Q3 2019 Highlights Q4 2019 Key Activities ▪ INGREZZA® (valbenazine) Net Product Sales: ▪ Continued Focus on INGREZZA Commercial – $198MM with 34,800 TRx in Q3 2019 Execution and “Talk About TD” Disease State – $515MM with 90,700 TRx YTD Awareness Cam
Slide 4: 2019: A Defining Year of Significant Milestones
2019: A Defining Year of Significant Milestones 2 NDA Submissions: Parkinson’s Disease & Uterine Fibroids Opicapone (Parkinson’s Disease) COMPLETED Elagolix (Uterine Fibroids) submitted by AbbVie COMPLETED Advancing Congenital Adrenal Hyperplasia Program Positive interim results from Phase II Study
Slide 5: 2020: Potential for Approved Treatments in 4 Indications
2020: Potential for 3 Approved Treatments in 4 Indications 2018 2019 2020 2 APPROVED TREATMENTS 2 INDICATIONS 2 NEW DRUG APPLICATIONS IN Opicapone Parkinson’s Disease 3 Approved treatments in Tardive Dyskinesia Endometriosis Elagolix Uterine Fibroids 4 indications ▪ Valbenazine (Chorea Associated wi
Slide 6: Our Medicines, Our Patients
w/ NeuUrocrine BIOSCIENCES Our Medicines Our Patients
Slide 7: 1st FDA-approved Treatment for Adults with Tardive Dyskinesia
1st FDA-approved Treatment for Adults with Tardive Dyskinesia (TD); Launched in 2017 Most-Prescribed and Most-Preferred TD Therapy ▪ Rapid Improvement in Involuntary Movements ▪ Generally Well Tolerated ▪ Ease of Use: One Capsule, Once-daily Q3 2019 Earnings Presentation 7
Slide 8: Tardive Dyskinesia Overview: Symptoms
Tardive Dyskinesia Overview: Symptoms Oral and Facial Dyskinesia • Abnormal tongue and lip movements • Retractions of the corners of the mouth • Abnormal eyelid closure or eyebrow Torso Dyskinesia movements • Shoulder shrugging • Bulging of the cheeks • Chewing movement Axial Dyskinesia • Twisting o
Slide 9: INGREZZA: Most Prescribed Tardive Dyskinesia Therapy
INGREZZA® Most Prescribed Tardive Dyskinesia (TD) Therapy z Tardive Dyskinesia Efficacy: Label: Use: affects approximately Rapid and No Boxed Convenient Dosing 500,000 patients Robust Warning in the U.S. ▪ Involuntary Movement Disorder ▪ ~30% Reduction in TD ▪ No Boxed Warning ▪ Convenient One Capsu
Slide 10: Two Years Post-Launch, Expectations Exceeded
Two Years Post-Launch, Expectations Exceeded INGREZZA® Net Sales and ~TRx 40,000 $200 $198 $181 35,000 34,800 16,700 31,600 30,000 Approximate TRx Net Product Sales $150 $136 ($ in Millions) $130 25,000 24,200 $111 22,900 $97 19,400 20,000 $100 16,700 $64 $71 15,000 12,500 $46 10,000 $50 9,100 5,100
Slide 11: KINECT 3: INGREZZA Reduction in Abnormal Involuntary Movement Scores
KINECT 3: INGREZZA® Reduction in Abnormal Involuntary Movement Scores at Each Study Visit Through Week Six AIMS Change from Baseline by Study Visit (ITT Population) 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
Slide 12: 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 (ITT Population) 1 0 Placebo -1 INGREZZA 40 mg Improvement -2 Once Daily -3 INGREZZA 80 mg Once Daily -4 Placebo to -5 INGREZZA 40 mg -6 Placebo to INGREZZA 80 mg -7 PBO Control
Slide 13: 1st FDA-approved Oral Treatment for Endometriosis Pain
Neurocrine Biosciences discovered and developed through Phase II; AbbVie received FDA approval and is responsible for commercialization 1st FDA-approved Oral Treatment for Women with Moderate to Severe Endometriosis Pain in Over a Decade; Launched in 2018 ▪ Rapid, Sustained Pain Relief Addresses thr
Slide 14: ORILISSA (elagolix) Overview
ORILISSA® (elagolix) Overview Largest Ever Endometriosis Program Conducted to Date z 3,000,000 patients Efficacy: Label: AbbVie are affected by moderate to Rapid and No Boxed Warnings or Collaboration severe endometriosis in the Robust Required Monitoring U.S. ▪ Chronic and Painful Disease ▪ Efficac
Slide 15: Elagolix For Women's Health (Partnered with AbbVie)
Elagolix For Women’s Health (Partnered with AbbVie) ORILISSA® Approved for Endometriosis; Uterine Fibroids NDA Submitted with PDUFA in Q2 2020 ENDOMETRIOSIS Most common UTERINE FIBROIDS pelvic growth Impacts affecting 10% ≥20% 9 million 7.5 million women with symptomatic uterine fibroids of of all w
Slide 16: Our Investigational Therapies
Our Investigational Therapies
Slide 17: Diversified Portfolio with Multi-Stage Pipeline
Diversified Portfolio with Multi-Stage Pipeline Program/Therapy Disorder Stage of Development Partner 1 2 3 NDA Commercial Tardive Dyskinesia (Asia) Endometriosis (Worldwide) opicapone Parkinson’s Disease (NBIX Rights: U.S. & Canada) elagolix Uterine Fibroids (Worldwide) Chorea in valbenazine Huntin
Slide 18: Opicapone: NDA Accepted by FDA for Parkinson's Disease
Opicapone: New Drug Application (NDA) Accepted by FDA for Parkinson’s Disease Target PDUFA Date of April 26, 2020; In-Licensed from BIAL in 2017 The Need: Parkinson’s Disease (PD) The Opportunity: Opicapone* 1 million people impacted in the U.S. ▪ Novel COMT inhibitor as adjunctive therapy to levodo
Slide 19: Opicapone: Reducing OFF Time For Patients with Parkinson's Disease
Opicapone: Reducing “OFF Time” For Patients with Parkinson’s Disease COMT Inhibition Reduces “OFF time” and Increases ▪ Parkinson’s Disease (PD): Lifelong, “ON time” Without Troublesome Dyskinesia Incurable, Progressive ▪ 2nd Most Common Neurodegenerative Disease Following Alzheimer’s Disease ▪ Appr
Slide 20: Phase III BIPARK-1: Opicapone Maintenance of Effect at One Year
Phase III, BIPARK-1: Once Daily Opicapone Shows Maintenance of Effect at One Year* Mean Change in Absolute OFF time Double-blind Period Open-label Extension Period 12 Weeks 1-year 0 Placebo → OPC 50mg Switch to Opicapone Open-label LS MEAN (±SE) Change in OFF time 200mg ENT From DB Baseline (min) -6
Slide 21: Valbenazine: Chorea Associated with Huntington's Disease
Valbenazine: Chorea Associated with Huntington’s Disease Initiation of Phase III Trial to Treat Chorea in Adult Patients with Huntington’s Disease The Need: Treatment of Chorea in Patients The Opportunity: Valbenazine* with Huntington’s Disease (HD) Chorea associated with HD is an ▪ Targeted symptom
Slide 22: NBI-74788: Classic Congenital Adrenal Hyperplasia
NBI-74788: Classic Congenital Adrenal Hyperplasia Positive Interim Phase II Results in Adults; Phase II Adaptive Pediatric Trial Initiated in Q3 The Need: Congenital Adrenal Hyperplasia The Opportunity: NBI-74788* (CAH) Rare genetic disorder caused by enzyme ▪ Potent, selective, orally-active, non-p
Slide 23: NBI-74788: Interim Phase II Data in Adults & CAH Next Steps
NBI-74788: Interim Phase II Data in Adults & CAH Program Next Steps Positive Interim Results from Phase II Study in Adults ▪ Reduction of at least 50% from baseline in 17-hydroxyprogesterone and adrenocorticotropic (ACTH) hormone levels in more than 50% of CAH patients treated for 14 days ▪ Meaningf
Slide 24: Elagolix: NDA Accepted for Uterine Fibroids
Elagolix: NDA Accepted for Uterine Fibroids (Q3 2019) Discovered & Developed by Neurocrine Biosciences to Phase II; Further Development by AbbVie The Need: Uterine Fibroids (UF) The Opportunity: Elagolix* ▪ Target PDUFA date in Q2 2020 3 million women diagnosed with symptomatic uterine fibroids ▪ Si
Slide 25: Elagolix: Polycystic Ovary Syndrome (PCOS)
Elagolix: Polycystic Ovary Syndrome (PCOS) AbbVie Initiated Phase II Study in Q3 2019 The Need: Polycystic Ovary The Opportunity: Elagolix* Sndrome (PCOS) ▪ PCOS is one of the most common hormonal 3.5 million women of reproductive disorders in women of reproductive age, yet few age with no approved
Slide 26: Voyager Therapeutics Collaboration
Voyager Therapeutics Collaboration
Slide 27: Voyager Gene Therapy Collaboration to Address Key Neuroscience Programs
Voyager Gene Therapy Collaboration to Address Key Neuroscience Programs Collaboration leverages strengths and efforts of both companies towards developing and commercializing life-changing treatments for severe neurological diseases Programs: Neurocrine Biosciences gains development and commercializ
Slide 28: VY-AADC: Gene Therapy for Parkinson's Disease
VY-AADC: Gene Therapy for Parkinson’s Disease Developed by Voyager Therapeutics; Finalize Registration Plan with FDA in Q4 2019 The Need: Moderate to Advanced PD The Opportunity: VY-AADC* One million patients with PD in the U.S., ▪ One-time treatment restores AADC enzyme activity with moderate to ad
Slide 29: VY-AADC: Durable Improvements in Good ON Time
VY-AADC (Study PD-1101): Durable, Clinically Meaningful Improvements in Good “ON Time” 2.8 Hour Improvement at 1-Year in Cohort 2/3 Combined and Phase II Eligible Group 4.0 (N=7) 3.0 2.8 2.6 2.5 2.3 1.9 2.4 2.0 2.1 1.7 1.6 Hours 1.0 0.0 -0.3 Dosage (vg) Cohort 1 (n=5) -1.0 Cohort 1: 7.5 x 1011 Cohor
Slide 30: VY-FXN01: Gene Therapy for Friedreich's Ataxia
VY-FXN01: Gene Therapy for Friedreich’s Ataxia Discovered by Voyager Therapeutics The Need: Friedreich’s Ataxia (FA) The Opportunity: VY-FXN01 ~6,400 patients impacted in the U.S. ▪ One-time treatment to deliver the functional FXN gene and restore frataxin levels to at least 50% of normal FA is an a
Slide 31: Our Vision for the Future
Our Vision fomihe Future _ * = *
Slide 32: 2019: A Defining Year of Significant Milestones
2019: A Defining Year of Significant Milestones 2 NDA Submissions: Parkinson’s Disease & Uterine Fibroids Opicapone (Parkinson’s Disease) COMPLETED Elagolix (Uterine Fibroids) submitted by AbbVie COMPLETED Advancing Congenital Adrenal Hyperplasia Program Positive interim results from Phase II Study
Slide 33: Neurocrine Biosciences: Well-Positioned for Sustained Growth
Neurocrine Biosciences: Well-Positioned for Sustained Growth Strong Proven R&D Strategic Solid Financial Commercial with Strong Partnerships Position to Capabilities Multi-stage Invest Pipeline INGREZZA Blockbuster 3 Approved Potential; Medicines in ~$875MM Cash Experienced, 4 Indications in and Inv
Slide 34: Advancing Life-Changing Discoveries in Neuroscience
Advancing Life-Changing Discoveries in Neuroscience Q3 2019 Corporate Presentation November 4, 2019 neurocrine.com NASDAQ: NBIX
Neurocrine Biosciences — Q3 2019 Earnings Presentation on 6ix