Neurocrine Biosciences, Inc. · NASDAQ:NBIX

Neurocrine Biosciences — Q2 2024 Earnings Presentation

43 slides from Neurocrine Biosciences's earnings presentation, Aug 1, 2024

  1. Slide 1: Advancing Life-Changing Discoveries in Neuroscience

    Advancing Life-Changing Discoveries in Neuroscience Q2 2024 Corporate Presentation August 1, 2024 Nasdaq: NBIX

  2. 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

  3. Slide 3: Well-Positioned for Sustained & Long-term Growth

    Well-Positioned for Sustained & Long-term Growth Commercial R&D Focus Strong Financial Position * Neurology ~$1.7B TARDIVE DYSKINESIA AND CHOREA Neuroendocrinology Cash and Investments ASSOCIATED WITH HUNTINGTON’S DISEASE as of 6/30/2024 2024 Annual Neuropsychiatry $2.25 - $2.30 Net Sales Guidance R

  4. Slide 4: Where Are We Today?

    Where Are We Today? • Discovered and Developed Three Novel FDA-Approved Programs • Deep Expertise in Neuroscience Drug Development • Fully-Integrated Organization with Both R&D and Commercial Capabilities • Growing Blockbuster Commercial Product in INGREZZA with Strong IP Protection • Future Blockbu

  5. Slide 5: Q2 2024 Highlights and 2024 Key Milestones and Activities

    Q2 2024 Highlights and 2024 Key Milestones and Activities Q2 2024 / Recent Highlights 2024 Key Milestones and Activities ▪ INGREZZA® (valbenazine) Net Product Sales of $580M ▪ NBI-’845 End of Phase 2 Meeting with FDA in 2H 2024; − Represents YoY Sales Growth of 32% vs. Q2 2023 Engaging with Agency o

  6. Slide 6: Building and Maximizing the Pipeline

    Building and Maximizing the Pipeline Phase 1 # of Programs by Stage Phase 2 Phase 3 NDA 5 8 2 2 Phase 1 Phase 2 Phase 3 NDA Milestone Neurology valbenazine* Dyskinetic Cerebral Palsy VMAT2 Inhibitor Phase 3 Ongoing NBI-8271042 EE-CSWS Cav 3.1, 3.2, 3.3 Phase 2 Ongoing NBI-9213523 SCN8A-DEE Nav1.6 Ph

  7. Slide 7: Q2 2024 Financial Summary

    Q2 2024 Financial Summary $ Millions, Except Non-GAAP Earnings Per Share Item Q2 2024 Q2 2023 Highlights / Comments Revenue $590 $453 INGREZZA Sales of $580M Represents YoY Growth of 32% - Product Sales, Net $584 $446 Driven by Strong Underlying Patient Demand and Improvement in Gross-to-Net Dynamic

  8. Slide 8: YTD 2024 Financial Summary

    YTD 2024 Financial Summary $ Millions, Except Non-GAAP Earnings Per Share Item 1H 2024 1H 2023 Highlights / Comments Revenue $1,106 $873 INGREZZA Sales of ~$1.1B Represents YoY Growth of 28% - Product Sales, Net $1,093 $862 vs. 1H 2023 - Collaboration Revenue $13 $12 Increase Driven by Expanded / Ad

  9. Slide 9: Raised 2024 INGREZZA Net Sales Guidance and Updated Expense Guidance

    Raised 2024 INGREZZA Net Sales Guidance and Updated Expense Guidance 2023 2024 Previous 2024 Current Item ($ Millions) Comments Actuals Guidance Range Guidance Range Raised Sales INGREZZA Net Product Sales1 $1,836 $2,100 - $2,200 $2,250 - $2,300 Guidance Raised GAAP R&D Expense2 $565 $665 - $695 $66

  10. Slide 10: Corporate Sustainability: A Rated at MSCI

    Corporate Sustainability: “A” Rated at MSCI and Rank in 11th Percentile for Biotech at Sustainalytics Our Purpose: Relieve Suffering for People with Great Needs, but Few Options Adhere to the highest Invest in our people Minimize our impact product quality and and communities on the environment safe

  11. Slide 11: Our Medicines, Our Patients

    © NEYROCRINE Our Medicines, Our Patients

  12. Slide 12: Multiple Commercial Products

    Multiple Commercial Products In the U.S. In the U.S. and Europe † * ENDOMETRIOSIS ADRENAL INSUFFICIENCY In Europe TARDIVE DYSKINESIA † CHOREA ASSOCIATED WITH HD UTERINE FIBROIDS CONGENITAL ADRENAL HYPERPLASIA HD = Huntington’s Disease *Mitsubishi Tanabe Pharma Corporation (MTPC) has commercializatio

  13. Slide 13: INGREZZA

    INGREZZA (valbenazine) capsules NEUROCRINE BIOSCIENCES

  14. Slide 14: INGREZZA Quarterly Net Sales Performance

    INGREZZA Quarterly Net Sales Performance ($MM) Q2 2024 Sales of $580M Represents $600 32% Year-Over-Year Growth vs. Q2 2023 $580 $550 $506 $500 $500 $486 $450 $440 $410 $399 $400 $376 $350 Q3 '22 Q4 '22 Q1 '23 Q2 '23 Q3 '23 Q4 '23 Q1 '24 Q2 '24 14

  15. Slide 15: Substantial Impact on TD Patients and Care Partners

    Substantial Impact on TD Patients and Care Partners Movement disorder caused by prolonged use of antipsychotics and anti-nausea medications Uncontrollable, abnormal and repetitive movements >50% of patients experience meaningful emotional, social and psychological impact* Job Performance Low Self-Wo

  16. Slide 16: Nascent Tardive Dyskinesia Market Presents Significant Opportunity

    Nascent Tardive Dyskinesia Market Presents Significant Opportunity Approximately 65% of TD E S T I M AT E D T O A F F E C T Patients Remain Undiagnosed ~600,000 ✓ Only half of diagnosed patients receive treatment with a VMAT2 inhibitor like INGREZZA people in the U.S. ~35% ~18% TD Diagnosed Increasi

  17. Slide 17: INGREZZA Approved by the FDA for Chorea Associated with Huntington's Disease

    INGREZZA® Approved by the FDA for the Treatment of Chorea Associated with Huntington’s Disease INGREZZA Simple once-a-day treatment targeted for symptom control of chorea movements Safety profile consistent with and supported by extensive safety data in tardive dyskinesia In randomized, double-blind

  18. Slide 18: Driving Long-Term Growth for INGREZZA

    Driving Long-Term Growth for INGREZZA Launched INGREZZA® SPRINKLE (valbenazine) oral granules formulation IP Protection to 2038 Additional indication to treat chorea associated with Huntington’s disease Salesforce and distribution expansion (Including Psychiatry and LTC Salesforce Expansion in 2H 20

  19. Slide 19: Neuropsychiatry Pipeline

    (5) NEUROCRINE BIOSCIENCES

  20. Slide 20: NBI-1065845 (AMPA Potentiator): Positive Phase 2 Results in MDD

    NBI-1065845* (AMPA Potentiator): Reported Positive Phase 2 Top- Line Study Results in Adults with Major Depressive Disorder Inadequate Response to Treatment NBI-1065845 (or NBI-’845) in Major Depressive Disorder (MDD) Potent first-in-class AMPA potentiator ~1/3 of the 16 million+ people in the • Ora

  21. Slide 21: NBI-1065845: SAVITRI Phase 2 Study Summary Results

    NBI-1065845* (AMPA Potentiator): TM SAVITRI Phase 2 Study Summary Results EFFICACY SAFETY AND TOLERABILITY • The study met its primary and key secondary endpoints • NBI-1065845 was generally well-tolerated • Once-daily, oral administration of NBI-’845 produced a • Most common adverse event was heada

  22. Slide 22: Muscarinic Platform Includes Multiple Clinical Programs

    Muscarinic Platform Includes Multiple Clinical Programs From M1 to M4 Selective Orthosteric Agonists M1 M1/M4 M4 “Cognition” DUAL “Psychosis” PREFERRING PREFERRING ▪ Phase 1 ▪ Phase 1 ▪ Phase 1 NBI-1117570 SELECTIVE NBI-1117567 NBI-1117569 SELECTIVE ▪ Phase 2: Schizophrenia Preclinical NBI-1117568 C

  23. Slide 23: Developing Novel Muscarinic System Portfolio

    Developing Novel Muscarinic System Portfolio Neurocrine Biosciences Advancing Muscarinic Portfolio (Largest in Industry) ➢ Phase 2 placebo-controlled study of NBI-1117568*, a selective M4 agonist, as a potential treatment for schizophrenia with top-line data on track in Q3 2024 ✓ NBI-1117568 offers

  24. Slide 24: Luvadaxistat: DAAO Inhibitor in Phase 2 Study

    Luvadaxistat*: D-Amino Acid Oxidase (DAAO) Inhibitor in Phase 2 Study with Top-Line Data On Track in Q3 2024 Cognitive Impairment Associated with Luvadaxistat Schizophrenia (CIAS) Affects approximately 80% of the 3.5 Potent first-in-class DAAO inhibitor • Once daily million people in the U.S. diagno

  25. Slide 25: Valbenazine: ATS Study Will Inform Next-Generation VMAT2 Inhibitors

    Valbenazine*: ATS Study Will Inform Development of Our Next-Generation VMAT2 Inhibitors Including NBI-1065890 (Currently in Phase 1) Adjunctive Treatment of Schizophrenia (ATS) Schizophrenia is one of the leading causes of disability worldwide, affecting up to 3.5M people in the U.S. alone. A seriou

  26. Slide 26: Neuroendocrinology Pipeline

    Neuroendocrinology Pipeline

  27. Slide 27: Classic Congenital Adrenal Hyperplasia (CAH)

    Classic Congenital Adrenal Hyperplasia (CAH) Rare Genetic Disorder Enzyme deficiency & reduced cortisol levels and excess androgen levels U.S. ~30,000* Europe ~50,000* Complex and Treatment Options Highly Stagnant for 70 Years Variable • Hormone replacement Symptoms • Do not address underlying issue

  28. Slide 28: Classic CAH Due to 21-Hydroxylase Deficiency (21OHD CAH)

    Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency (21OHD CAH) High ACTH and Androgen Excess TARTs Cortisol Excess From Supraphysiologic GC Dosing Hirsutism, Infertility amenorrhea Psychological 21OHD CAH Results in: Diabetes, Abnormal and/or early effects insulin resistance Sho

  29. Slide 29: Classic CAH Due to 21-Hydroxylase Deficiency (21OHD CAH)

    Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency (21OHD CAH) Cortisol Excess From Supraphysiologic GC Dosing Obesity Cardiovascular striae Diabetes, Psychological High ACTH and Androgen Excess insulin resistance 21OHD CAH Results in: risk Short stature Fractures, effects Hirsu

  30. Slide 30: Classic CAH Due to 21-Hydroxylase Deficiency (21OHD CAH)

    Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency (21OHD CAH) 21OHD CAH Results in: Reduced GC Dosing crinecerfont Androgen Control • Impaired Synthesis of Cortisol and (Often) Aldosterone • Excess Adrenal Androgen Production Treatment Must Balance Consequences of: • Supraphysi

  31. Slide 31: CAHtalyst Adult and Pediatric Study Androgen Reduction

    CAHtalystTM Adult and Pediatric Study Androgen Reduction Percent Change* in Androstenedione at Week 4 (Following Glucocorticoid Stable Period) Adult Study Pediatric Study Study Characteristic Key Takeaways (N = 182) (N = 103) Substantial and Meaningful Reduction in Patients Receiving Crinecerfont -4

  32. Slide 32: CAHtalyst Glucocorticoid Dose Reduction While Maintaining Androgen Control

    CAHtalystTM Adult and Pediatric Study Glucocorticoid Dose Reduction While Maintaining Androgen Control Percent of Subjects Achieving a Glucocorticoid Daily Dose ≤ 11 mg/m2/day While Maintaining Androgen Control Adult Study @ Pediatric Study @ CAHtalystTM Trial Participants Key Takeaways Week 24 Week

  33. Slide 33: CAHtalyst Adult and Pediatric Study Safety and Tolerability

    CAHtalystTM Adult and Pediatric Study Safety and Tolerability • Crinecerfont Treatment was Overall Well-Tolerated with Few Serious Adverse Events (SAEs), None Were Assessed as Related to Crinecerfont • Most Common Adverse Events During the Double-Blind, Placebo-Controlled Period of the Adult Study w

  34. Slide 34: Neurocrine Next Steps Regarding Crinecerfont

    Neurocrine Next Steps Regarding Crinecerfont • New Drug Applications (NDAs) Have Been Accepted by the FDA • FDA Granted Priority Review For Crinecerfont for Adult and Pediatric Patients with CAH • Prescription Drug User Fee (PDUFA) Target Action Dates Set for December 29 for the Capsule Formulation

  35. Slide 35: Neurology Pipeline

    © NEVROCRINE Neurology Pipeline

  36. Slide 36: Valbenazine: Registrational Program in Dyskinetic Cerebral Palsy

    Valbenazine*: Registrational Program in Dyskinetic Cerebral Palsy Dyskinetic Cerebral Palsy (DCP) A form of cerebral palsy (CP) that affects ~15% of the approximately 500,000 to 1M people in the U.S. diagnosed with the disease. Can result in a range of developmental delays, physical difficulties and

  37. Slide 37: Well-Positioned for Sustained & Long-term Growth

    Well-Positioned for Sustained & Long-term Growth Commercial R&D Focus Strong Financial Position * Neurology ~$1.7B TARDIVE DYSKINESIA AND CHOREA Neuroendocrinology Cash and Investments ASSOCIATED WITH HUNTINGTON’S DISEASE as of 6/30/2024 2024 Annual Neuropsychiatry $2.25 - $2.30 Net Sales Guidance R

  38. Slide 38: GAAP to Non-GAAP Reconciliations

    GAAP to Non-GAAP Reconciliations neurocrine.com

  39. Slide 39: Condensed Consolidated Statements of Income

    NEUROCRINE BIOSCIENCES NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in millions, except per share data) Revenues: Net product sales Collaboration revenue Total revenues Operating expenses: Cost of revenues Research and development Acquired in-process research and develop

  40. Slide 40: Condensed Consolidated Balance Sheets

    NEUROCRINE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) June 30, December 31, (in millions) 2024 2023 Cash. cash equivalents and marketable securities $ 1,038.9 $ 1,031.6 Other current assets 630.9 575.4 Total current assets 1,669.8 1,607.0 Deferred tax assets 419.5 362.6 Debt

  41. Slide 41: Reconciliation of GAAP to Non-GAAP Financial Results

    NEUROCRINE BIOSCIENCES NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (unaudited) Three Months Ended ‘Six Months Ended June 30, June 30, (in millions, except per share data) 2024 2023 2024 2023 GAAP net income ! $ 65.0 $ 95.5 $ 108.4 $ 18.9 Adjustments: Stock-based

  42. Slide 42: Reconciliation of GAAP to Non-GAAP Expenses

    NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES, (unaudited) ‘Tluee Months Ended Six Months Ended 130, Tune 30, (in mittions) 7024 2023 204 Tos GAAP cost of revermes $s 92 3 ms § 167 S$ 20.0 Adjustments: Non-cash amortization related to acquired intangible assets 09 09 18 18

  43. Slide 43: Advancing Life-Changing Discoveries in Neuroscience

    Advancing Life-Changing Discoveries in Neuroscience Q2 2024 Corporate Presentation August 1, 2024 Nasdaq: NBIX

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