Neurocrine Biosciences, Inc. · NASDAQ:NBIX
Neurocrine Biosciences — Q2 2021 Earnings Presentation
36 slides from Neurocrine Biosciences's earnings presentation, Aug 3, 2021
Slide 1: Advancing Life-Changing Discoveries in Neuroscience
Advancing Life-Changing Discoveries in Neuroscience Q2 2021 Corporate Presentation August 3, 2021 neurocrine.com Nasdaq: NBIX
Slide 2: Safe Harbor Statement and Non-GAAP Financial Measures
Safe Harbor Statement and Non-GAAP Financial Measures 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 our
Slide 3: Neuroscience Company Well-Positioned for Sustained and Long-Term Growth
Neuroscience Company Well-Positioned for Sustained and Long-Term Growth Strong Commercial 4 Approved Products* Capabilities INGREZZA® Blockbuster Status Experienced Sales Team ‡ ONGENTYS® Launched Q3 2020 Robust Pipeline R&D Focus on Neurological, 12 Mid-to-Late-Stage Programs Endocrine, and Psychia
Slide 4: Neurocrine Q2 2021 Highlights & 2H 2021 Key Activities
Neurocrine Q2 2021 Highlights & 2H 2021 Key Activities Q2 and 1H 2021 Highlights 2021 Key Milestones and Activities ▪ INGREZZA® (Valbenazine) Net Product Sales ▪ Continued Focus on INGREZZA Commercial Execution − $269MM Inventory-Adjusted Net Product Sales ▪ Grow Awareness and Adoption of ONGENTYS v
Slide 5: Strong Pipeline Momentum Through 2021
Strong Pipeline Momentum Through 2021 PROGRAM INDICATION PHASE 1 PHASE 2 PHASE 3 PARTNER 2021 UPCOMING MILESTONES MTPC Submitted Marketing Authorization valbenazine* Tardive Dyskinesia (Japan) Filed Marketing Authorization with Ministry of Health & Welfare in Japan valbenazine* Chorea in Huntington
Slide 6: 2021 Scorecard
2021 Scorecard Expanding Potential Indications and Advancing Clinical Programs ✓ ✓ Phase 3 Global Registrational Study of Crinecerfont for CAH (Adults) Ongoing 5 ✓ Phase 3 Global Registrational Study of Crinecerfont for CAH (Pediatric) Ongoing Phase 3 Study of Valbenazine* for Chorea in Huntington D
Slide 7: Q2 2021 Financial Summary
Q2 2021 Financial Summary $ Millions, Except Non-GAAP Earnings Per Share Item Q2 ’21 Q2 ’20 Q2 ‘21 Financial Highlights / Comments Revenue $289 $302 INGREZZA Sales of $265MM; Collaboration - Product Sales, Net 267 268 Revenue Includes $15M Milestone Payment from - Collaboration Revenue 22 35 MTPC Ch
Slide 8: 2021 GAAP and Non-GAAP Expense Guidance Reaffirmed
2021 GAAP and Non-GAAP Expense Guidance Reaffirmed $ Millions 2020 2021 Expense Combined R&D and SG&A Expenses Actuals Guidance Range GAAP Basis $873 $855 - $905 Non-GAAP Basis $588 $720 - $770 ▪ Guidance Range Reflects Increased Investment in R&D, Including Planned Initiation of 9 Mid-to-Late-Stage
Slide 9: Our Medicines, Our Patients
Our Medicines Our Patients Q2 2021 Earnings Presentation
Slide 10: INGREZZA Quarterly Sales and TRx Performance
INGREZZA Quarterly Sales and TRx Performance INGREZZA Net Sales and ~Total Prescriptions (TRx) $300 60 Approximate TRx (in Thousands) $268 Net Product Sales ($ in Millions) $265 $254 $250 $238 $231 $240 $230 50 48.9 $198 46.4 45.1 $200 42.1 42.7 43.3 40 41.5 $150 34.8 30 $100 20 $50 10 $0 0 Q3 '19 Q
Slide 11: Substantial Impact on TD Patients and Caregivers
Substantial Impact on TD Patients and Caregivers Movement disorder caused by prolonged use of antipsychotics and anti-nausea medications Uncontrollable, abnormal of patients experience meaningful and repetitive movements >50% emotional, social and psychological impact* Job Performance Low Self-Worth
Slide 12: Nascent TD Market Presents Significant Opportunity
Nascent TD Market Presents Significant Opportunity ~20% E S T I M AT E D T O A F F E C T ~600,000 people in the U.S. patients with TD diagnosed Increasing Antipsychotic Prescriptions (U.S.) ~80 % 18.0 3.3% Compound Annual Growth Rate from 2017 - 2020 TRx (Millions) 17.0 market is not 16.0 yet diagno
Slide 13: Driving Long-Term Growth for INGREZZA
Driving Long-Term Growth for INGREZZA INGREZZA and ONGENTYS offering greater access to neurology practices Investing in telemedicine capabilities Recommends patients with TD associated with antipsychotic therapy be treated with a VMAT2 inhibitor Patient outreach programs including “TD Spotlight” dir
Slide 14: Pursuing New Indications: Chorea in Huntington Disease
Pursuing New Indications: Chorea in Huntington Disease Registrational Study Fully-Enrolled with Top-Line Data Expected End of 2021 Supplemental New Drug Application (sNDA) Planned in 2022 Valbenazine* Simple once a day treatment targeted for symptom control of chorea movements Promising safety profi
Slide 15: Valbenazine: Initiating Registrational Programs in ATS and DCP in 2H 2021
Valbenazine*: Initiating Registrational Programs in ATS and DCP in Second Half of 2021 Psychiatric Indication: Neurologic Indication: Adjunctive Treatment of Schizophrenia (ATS) Dyskinesia Due to Cerebral Palsy (DCP) Schizophrenia is one of the leading causes of A form of cerebral palsy (CP) that af
Slide 16: ONGENTYS Is the 1st and Only FDA-Approved Once-Daily COMT Inhibitor
ONGENTYS Is the 1st and Only FDA-Approved Once-Daily COMT Inhibitor for Parkinson’s Disease ‡ Provides Significant Reduction of Daily “Off” Time; Increase in Good “On” Time – Add-on treatment to levodopa/carbidopa prolongs clinical effects – One capsule, once a day treatment – Helps patients achieve
Slide 17: Advancements in Women's Health
Advancements in Women’s Health Neurocrine Biosciences discovered and developed through Phase 2; AbbVie received FDA approval and responsible for commercialization 1st FDA-Approved Oral Treatment in 1st FDA-Approved Oral Medication to Manage 10+ Years for Women with Moderate- Heavy Menstrual Bleeding
Slide 18: Classic Congenital Adrenal Hyperplasia (CAH)
Classic Congenital Adrenal Hyperplasia (CAH) Rare Genetic Disorder ▪ Enzyme deficiency ▪ Reduced adrenal U.S. E.U. steroids & excess androgen levels ~30,000 ~50,000 Complex Treatment Options and Highly Stagnant for 60 Variable Years Symptoms ▪ Hormone replacement ▪ Do not address underlying issue Q2
Slide 19: Congenital Adrenal Hyperplasia Disease Mechanism
Congenital Adrenal Hyperplasia Disease Mechanism Normal Homeostasis CAH Patients Q2 2021 Earnings Presentation 19
Slide 20: Crinecerfont Potentially Meets the Challenges of the Standard of Care
Crinecerfont Potentially Meets the Challenges of the Standard of Care Overtreatment Hypercortisolism Overtreatment Insulin Resistance Undertreatment Hypercortisolism Central Obesity Hyperandrogenism Osteoporosis Insulin Resistance Impaired Glucose Tolerance CRINECERFONT Undertreatment Potentially Fa
Slide 21: Potential Paradigm Shift in the Treatment of CAH
Potential Paradigm Shift in the Treatment of CAH crinecerfont* Phase 3 Global Registrational Study in Adults Ongoing Phase 3 Pediatric Registrational Study Ongoing Potent Orally Active Selective Well-Tolerated * Crinecerfont is investigational and not approved in any country Q2 2021 Earnings Present
Slide 22: Potential First-in-Class Psychiatry Programs
Potential First-in-Class Psychiatry Programs Early-to-Mid-Stage Compounds Takeda* Collaborations Clinical Programs Cognitive Impairment Associated with Initiating Phase 2 Study Luvadaxistat in Second Half of 2021 Schizophrenia (CIAS) Inadequate Response to Treatment in Initiate Phase 2 Study NBI-106
Slide 23: Luvadaxistat: D-Amino Acid Oxidase (DAAO) Inhibitor
Luvadaxistat*: D-Amino Acid Oxidase (DAAO) Inhibitor Cognitive Impairment Associated with Luvadaxistat Schizophrenia (CIAS) Affects approximately 60% - 80% of ▪ Potent first-in-class DAAO inhibitor the 3.5 million people in the U.S. ‒ Once daily diagnosed with schizophrenia ‒ No titration requiremen
Slide 24: Potential First-in-Class Precision Medicine Programs
Potential First-in-Class Precision Medicine Programs Early-to-Mid-Stage Compounds in Neurology Collaborations with Idorsia and Xenon Clinical Programs Rare Pediatric Epilepsy: CSWS Enrolling Phase 2 Study NBI-827104* Essential Tremor Enrolling Phase 2 Study Initiating Phase 2 Study Rare Pediatric Ep
Slide 25: NBI-827104: Selective CaV Inhibitor
NBI-827104*: Selective CaV Inhibitor NBI-827104† • Potentially the first potent, selective inhibitor and 1x/day dosing to precisely target calcium channels 3.1, 3.2 and 3.3 • Program has potential to address other central nervous system diseases CSWS Program Essential Tremor Program Phase 2 study en
Slide 26: NBI-827104: Enrolling Patients in Phase 2 Studies
NBI-827104*: Enrolling Patients in Phase 2 Studies CSWS Background Essential Tremor Background Essential tremor is one of the most common Rare childhood epilepsy characterized by onset movement disorders, with an estimated seizures between 2 and 12 years Ashley 10 million people living with essentia
Slide 27: NBI-921352: Selective NaV1.6 Inhibitor
NBI-921352*: Selective NaV1.6 Inhibitor NBI-921352* • First potent and selective inhibitor to precisely target the sodium channel affected by the genetic mutation of SCN8A – NaV1.6 • Program has potential to address other central nervous system diseases SCN8A-DEE Program Adult Focal-Onset Seizures P
Slide 28: NBI-921352: Initiating Phase 2 Studies
NBI-921352*: Initiating Phase 2 Studies SCN8A-DEE Background Adult Focal-Onset Seizures Background Rare form of early-onset epilepsy with Also referred to as partial-onset seizures, occurrence of seizures beginning in the first 18 these are the most common form of seizures months of life and a high
Slide 29: Our Vision for the Future
Our Vision for the Future Q2 2021 Earnings Presentation
Slide 30: Well-Positioned for Sustained and Long-term Growth
Well-Positioned for Sustained and Long-term Growth Achieved ~$1B in Significant Annual Sales in Opportunity for ‡ 3.5 Years GROWTH R&D Focus ➢ Neurology Robust 12 Total Mid-to-Late- ➢ Endocrinology Pipeline Stage Programs ➢ Psychiatry Strong Financial Position >$1.2B Cash and Investments (as of 6/30
Slide 31: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations neurocrine.com
Slide 32: Q2 2021 Earnings Presentation
Q2 2021 Earnings Presentation 32
Slide 33: Q2 2021 Earnings Presentation
Q2 2021 Earnings Presentation 35
Slide 34: Q2 2021 Earnings Presentation
Q2 2021 Earnings Presentation 36
Slide 35: Q2 2021 Earnings Presentation
Q2 2021 Earnings Presentation 37
Slide 36: Advancing Life-Changing Discoveries in Neuroscience
Advancing Life-Changing Discoveries in Neuroscience Q2 2021 Corporate Presentation August 3, 2021 neurocrine.com Nasdaq: NBIX
Neurocrine Biosciences — Q2 2021 Earnings Presentation on 6ix