SEC Filings

Form 10-K
NEUROCRINE BIOSCIENCES INC filed this Form 10-K on 02/08/2019
Document Outline
Entire Document (9643.1 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - PART I
Page 4 - Our Product Pipeline
Page 5 - Valbenazine as a Treatment for Tourette Syndrome.
Page 6 - Uterine Fibroids.
Page 7 - NBI-74788 Corticotropin-Releasing Factor Receptor1 Antagonist
Page 8 - New VMAT2 Inhibitor
Page 9 - Selectively Establishing Corporate Collaborations with Global Pharmaceutical Companies to Assist in
Page 10 - Intellectual Property
Page 11 - INGREZZA Manufacturers
Page 12 - Development and Marketing Approval for Products
Page 13 - Orphan Drug Designation
Page 14 - Special FDA Expedited Review and Approval Programs
Page 15 - Reimbursement
Page 16 - Healthcare Reform
Page 17 - Competition
Page 18 - N/A
Page 19 - Employees
Page 20 - We currently depend on single source suppliers. The loss of these suppliers, or delays or problems i
Page 21 - We are subject to ongoing obligations and continued regulatory review for INGREZZA, which may result
Page 22 - Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, which
Page 23 - We depend on our current collaborators for the development and commercialization of our products and
Page 24 - We do not and will not have access to all information regarding the products and product candidates
Page 25 - The independent clinical investigators and contract research organizations that we rely upon to cond
Page 26 - The conditional conversion feature of the 2024 Notes, if triggered, may adversely affect our financi
Page 27 - We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade
Page 28 - U.S. federal income tax reform could adversely affect our business and financial condition.
Page 29 - If we cannot raise additional funding, we may be unable to complete development of our product candi
Page 30 - Compliance with changing regulation of corporate governance and public disclosure may result in addi
Page 31 - N/A
Page 32 - We face intense competition, and if we are unable to compete effectively, the demand for our product
Page 33 - If we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of
Page 34 - Our employees, independent contractors, principal investigators, consultants, commercial partners an
Page 35 - We face potential product liability exposure far in excess of our limited insurance coverage.
Page 36 - Compliance with global privacy and data security requirements could result in additional costs and l
Page 37 - PART II
Page 38 - SELECTED FINANCIAL DATA
Page 39 - RESULTS OF OPERATIONS
Page 40 - Results of Operations
Page 41 - Sales, General and Administrative
Page 42 - Liquidity and Capital Resources
Page 43 - Trade Discounts and Allowances:
Page 44 - N/A
Page 45 - Contractual Obligations
Page 46 - Operating Leases.
Page 47 - NEUROCRINE BIOSCIENCES, INC.
Page 48 - Report of Independent Registered Public Accounting Firm
Page 49 - NEUROCRINE BIOSCIENCES, INC.
Page 50 - NEUROCRINE BIOSCIENCES, INC.
Page 51 - NEUROCRINE BIOSCIENCES, INC.
Page 52 - NEUROCRINE BIOSCIENCES, INC.
Page 53 - NEUROCRINE BIOSCIENCES, INC.
Page 54 - Property and Equipment.
Page 55 - Collaborative and Other Revenue.
Page 56 - Cost of Sales.
Page 57 - Recently Issued Accounting Pronouncements
Page 58 - NOTE 2. SIGNIFICANT COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
Page 59 - BIAL Portela Ca, S.A.
Page 60 - NOTE 3. INVESTMENTS
Page 61 - NOTE 4. FAIR VALUE MEASUREMENTS
Page 62 - NOTE 5. CONVERTIBLE SENIOR NOTES
Page 63 - N/A
Page 64 - NOTE 6. OTHER BALANCE SHEET DETAILS
Page 65 - NOTE 7. NET INCOME (LOSS) PER SHARE
Page 66 - NOTE 8. SHARE-BASED COMPENSATION
Page 67 - Restricted Stock Units.
Page 68 - Employee Stock Purchase Plan.
Page 69 - N/A
Page 70 - NOTE 10. LEASES
Page 71 - NOTE 11. RETIREMENT PLAN
Page 72 - NOTE 14. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
Page 73 - N/A
Page 74 - Management s Report on Internal Control Over Financial Reporting
Page 75 - Report of Independent Registered Public Accounting Firm
Page 76 - N/A
Page 77 - PART III
Page 78 - PART IV
Page 79 - N/A
Page 80 - N/A
Page 81 - SIGNATURES
Subdocument 2 - EX-10.5 - EX-10.5
Page 1 - Exhibit 10.5
Page 2 - TABLE OF CONTENTS
Page 3 - N/A
Page 4 - N/A
Page 5 - AgreementExecution DateVoyagerNeurocrinePartyParties
Page 6 - AADC Program Development PlanExisting Pivotal Trial
Page 7 - Calendar Quarter
Page 8 - Commercialization
Page 9 - DevelopDevelopment
Page 10 - Existing In-License AgreementSchedule 1.37
Page 11 - FTE Costs
Page 12 - HSR Act
Page 13 - Law
Page 14 - Combination ProductSupplemental Ingredient(s)
Page 15 - Neurocrine IP
Page 16 - ...***...] Agreement
Page 17 - Program
Page 18 - Target
Page 19 - Vectorization IP
Page 20 - Voyager Licensed Patent RightsReGenX Agreement
Page 21 - VY-AADC
Page 22 - N/A
Page 23 - ARTICLE 2
Page 24 - Conduct of Programs
Page 25 - Voyager Development Breach
Page 26 - Development Candidates
Page 27 - Records of Activities
Page 28 - ARTICLE 3
Page 29 - N/A
Page 30 - Formation and Dissolution of Subcommittee(s)
Page 31 - Groupprovidedthat
Page 32 - providedthat
Page 33 - Escalation to the Executive Officers
Page 34 - Discovery Programs
Page 35 - Co-Co AgreementCo-Co TerritoryCo-Co ProductCo-Co ProgramCo-Co Trigger Date
Page 36 - N/A
Page 37 - Co-Co RateCo-Co RateRate-Shifting Fee
Page 38 - providedthat
Page 39 - Neurocrine PlanNeurocrine Plan
Page 40 - Transition Activities
Page 41 - ARTICLE 5
Page 42 - Schedule 5.2.4(a)
Page 43 - Alternative Method
Page 44 - N/A
Page 45 - Genzyme Agreement
Page 46 - No Other Rights
Page 47 - ARTICLE 6
Page 48 - Ownership and Assignment of Regulatory Filings
Page 49 - Records and Audits
Page 50 - Milestone Payment
Page 51 - Development Milestone Payments for Collaboration Products under FA Program
Page 52 - Development Milestone Payments for Collaboration Products under Discovery Programs
Page 53 - Commercial Milestones for Collaboration Products
Page 54 - Royalties
Page 55 - Royalties on Collaboration Products under FA Program
Page 56 - Royalties on Collaboration Products under Discovery Programs
Page 57 - Calculation of Royalties
Page 58 - Biosimilar Reduction
Page 59 - Compliance with In-License Agreements
Page 60 - Currency Conversion
Page 61 - Withholding Tax Action
Page 62 - Exception for Basic Research
Page 63 - ARTICLE 10
Page 64 - Patent Prosecution and Maintenance
Page 65 - mutatis mutandis
Page 66 - Neurocrine Patent Rights
Page 67 - mutatis mutandis
Page 68 - Enforcement and Defense
Page 69 - provided that
Page 70 - Defense
Page 71 - TrademarksNeurocrine Product Marks
Page 72 - Existing Confidentiality Agreement
Page 73 - Press Release; Disclosure of Agreement
Page 74 - Publications
Page 75 - ARTICLE 12
Page 76 - N/A
Page 77 - Schedule 1.37
Page 78 - N/A
Page 79 - Mutual Covenants
Page 80 - Disclaimer
Page 81 - ...***... Indemnitees
Page 82 - Insurance
Page 83 - ARTICLE 14
Page 84 - Termination for Failure to Make Equity Purchase
Page 85 - N/A
Page 86 - N/A
Page 87 - Effects of Termination by Neurocrine for Voyager Breach
Page 88 - Accrued Rights; Surviving Provisions of the Agreement
Page 89 - Costsprovidedhowever
Page 90 - Consolidation
Page 91 - Notices
Page 92 - providedthat
Page 93 - Independent Contractors
Page 94 - Further Actions
Page 95 - Voyager Therapeutics, Inc.
Page 96 - Schedule 1.37
Page 97 - Schedule 1.68
Page 98 - Schedule 5.2.1
Page 99 - N/A
Page 100 - Schedule 5.2.4(a)
Page 101 - Schedule 8.1
Page 102 - Exhibit A
Page 103 - EXECUTION VERSION
Page 104 - TABLE OF CONTENTS
Page 105 - N/A
Page 106 - N/A
Page 107 - STOCK PURCHASE AGREEMENT
Page 108 - Aggregate Purchase Price
Page 109 - HSR Filing
Page 110 - Sales Agreement
Page 111 - Purchase and Sale of Common Stock
Page 112 - Representations and Warranties of the Company
Page 113 - Subsidiaries
Page 114 - Enforceability Exceptions
Page 115 - Valid Issuance of Shares
Page 116 - N/A
Page 117 - Absence of Certain Changes
Page 118 - Offering
Page 119 - Office of Foreign Assets Control
Page 120 - Intellectual Property Assets
Page 121 - Labor and Employment
Page 122 - Environmental Laws
Page 123 - Representations and Warranties of the Investor
Page 124 - No Governmental Authority or Third Party Consents
Page 125 - Legends
Page 126 - Representations and Warranties in the Collaboration Agreementprovidedhowever
Page 127 - Collaboration Agreement
Page 128 - Effect of Terminationprovidedhowever
Page 129 - Assistance and Cooperation
Page 130 - Conduct of Business
Page 131 - NoticesExhibit Aprovided
Page 132 - Parties in Interest
Page 133 - NEUROCRINE BIOSCIENCES, INC.
Page 134 - SCHEDULE 1
Page 135 - EXHIBIT A
Page 136 - Exhibit B
Page 137 - Exhibit B
Page 138 - *Status Key
Page 139 - *Status Key
Page 140 - *Status Key
Page 141 - *Status Key
Page 142 - *Status Key
Page 143 - *Status Key
Page 144 - *Status Key
Page 145 - *Status Key
Page 146 - *Status Key
Page 147 - *Status Key
Page 148 - Exhibit C
Subdocument 3 - EX-10.6 - EX-10.6
Page 1 - Exhibit 10.6
Page 2 - TABLE OF CONTENTS
Page 3 - N/A
Page 4 - N/A
Page 5 - STOCK PURCHASE AGREEMENT
Page 6 - Aggregate Purchase Price
Page 7 - Investor Agreement
Page 8 - Termination Date
Page 9 - Closing Date; Deliveries
Page 10 - Representations and Warranties of the Company
Page 11 - Subsidiaries
Page 12 - No Conflicts
Page 13 - Licenses and Other Rights; Compliance with Laws
Page 14 - N/A
Page 15 - Absence of Certain Changes
Page 16 - Investment Company
Page 17 - FDA
Page 18 - Real and Personal Property
Page 19 - ERISACode
Page 20 - Taxes
Page 21 - Authorization
Page 22 - Disclosure of Information
Page 23 - Financial Assurances
Page 24 - Covenants
Page 25 - Absence of Litigation
Page 26 - Effect of Terminationprovidedhowever
Page 27 - Assistance and Cooperation
Page 28 - Conduct of Business
Page 29 - provided
Page 30 - Parties in Interest
Page 31 - N/A
Page 32 - SCHEDULE 1
Page 33 - EXHIBIT A
Subdocument 4 - EX-10.7 - EX-10.7
Page 1 - Exhibit 10.7
Page 2 - TABLEOFCONTENTS
Page 3 - INVESTORAGREEMENT
Page 4 - Beneficialownerbeneficiallyownsbeneficialownership
Page 5 - Company
Page 6 - Law
Page 7 - SharesofThen-OutstandingCommonStock
Page 8 - Restrictions on Dispositions
Page 9 - Certain Tender Offers
Page 10 - IrrevocableProxyPermittedTransfereeIrrevocableProxy
Page 11 - ExtraordinaryMatter
Page 12 - Termination of Voting Agreement Term
Page 13 - Waiver
Page 14 - Assignment
Page 15 - Use of Proceeds
Page 16 - Signature Page to Investor Agreement
Page 17 - EXHIBITA
Page 18 - EXHIBITB
Subdocument 5 - EX-10.10 - EX-10.10
Page 1 - Exhibit 10.10
Page 2 - EXHIBITS AND SCHEDULES TO AGREEMENT
Page 3 - COMMERCIAL SUPPLY AGREEMENT
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - Sale and Purchase of API
Page 9 - N/A
Page 10 - Prices for APIs; Shipment; Payments
Page 11 - Manufacture of Product
Page 12 - N/A
Page 13 - Testing and Quality Assurance
Page 14 - Independent Testing
Page 15 - N/A
Page 16 - Regulatory Matters
Page 17 - FIS Rights
Page 18 - Representations, Warranties, and Covenants
Page 19 - No Other License Required
Page 20 - 10.2FIS Indemnity
Page 21 - Insurance
Page 22 - N/A
Page 23 - Force Majeure Event
Page 24 - Term; Termination; Remedies
Page 25 - Miscellaneous
Page 26 - Alternative Dispute Resolution
Page 27 - N/A
Page 28 - N/A
Page 29 - Schedule 1.1
Page 30 - Schedule 1.2
Page 31 - Exhibit 2.1
Page 32 - Schedule 2.3
Page 33 - Schedule 3.1
Page 34 - Exhibit 5.1
Subdocument 6 - EX-21.1 - EX-21.1
Page 1 - N/A
Subdocument 7 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 8 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 9 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 10 - EX-32 - EX-32
Page 1 - N/A
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