SEC Filings

Form 20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
Document Outline
Entire Document (29932.3 KB)
Subdocument 1 - 20-F - 20-F
Page 1 - UNITED STATES
Page 2 - None
Page 3 - Table of Contents
Page 4 - SIGNATURES
Page 5 - INTRODUCTION AND USE OF CERTAIN TERMS
Page 6 - N/A
Page 7 - PART I
Page 8 - Exchange Rate
Page 9 - Risks Related to Our Financial Position and Capital Requirements
Page 10 - We require substantial additional financing to achieve our goals, and our failure to obtain this nec
Page 11 - The terms of our loan facilities with Hercules Capital, Inc. ( Hercules ) and NovaQuest Capital Mana
Page 12 - Risks Related to Clinical Development and Regulatory Review and Approval of Our Product Candidates
Page 13 - We may find it difficult to enroll patients in our clinical trials, which could delay or prevent dev
Page 14 - We may conduct multinational clinical trials, which present additional and unique risks.
Page 15 - Several of our product candidates are being evaluated for the treatment of patients who are extremel
Page 16 - Our drug candidates may not benefit from an expedited approval path for cellular medicines designate
Page 17 - Even if we obtain regulatory approval for a product candidate, our products will be subject to ongoi
Page 18 - Fast track designation by the FDA may not lead to a faster development or regulatory review or appro
Page 19 - We may be required to participate in FDA Advisory Committee proceedings for some or all of our produ
Page 20 - Our existing product development and/or commercialization arrangements, and any that we may enter in
Page 21 - Risks Related to Our Manufacturing and Supply Chain
Page 22 - We may not be able to manufacture or commercialize our product candidates in a profitable manner.
Page 23 - We and our collaborators and Lonza are subject to significant regulation with respect to manufacturi
Page 24 - Product recalls or inventory losses caused by unforeseen events may adversely affect our operating r
Page 25 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 26 - If we or our collaborators fail to obtain and sustain an adequate level of reimbursement for our pro
Page 27 - Due to the novel nature of our stem cell therapy and the potential for our product candidates to off
Page 28 - Use of animal-derived materials could harm our product development and commercialization efforts.
Page 29 - If product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 30 - The patent positions of biopharmaceutical products are complex and uncertain.
Page 31 - Intellectual property disputes could cause us to spend substantial resources and distract our person
Page 32 - If third parties claim that intellectual property used by us infringes upon their intellectual prope
Page 33 - We may acquire other companies or assets which could divert our management s attention, result in ad
Page 34 - We work with outside scientists and their institutions in developing product candidates. These scien
Page 35 - Taxing authorities could reallocate our taxable income within our subsidiaries, which could increase
Page 36 - A failure to adequately protect private health information could result in severe harm to our reputa
Page 37 - If we fail to maintain proper internal controls, our ability to produce accurate financial statement
Page 38 - Risks Related to Our Trading Markets
Page 39 - If securities or industry analysts do not publish research reports about our business, or if they is
Page 40 - ADS holders may be subject to additional risks related to holding ADSs rather than ordinary shares.
Page 41 - Changes in foreign currency exchange rates could impact amounts you receive as a result of any divid
Page 42 - Mesoblast Limited
Page 43 - Fiscal year 2017
Page 44 - Stem Cell Research Therapy
Page 45 - Disruptive Technology Platform
Page 46 - Allogeneic, Off-the-Shelf, Commercially Scalable Products
Page 47 - Tier 1 Programs
Page 48 - Current Status and Anticipated Milestones
Page 49 - Completed Phase 2 Trial in NYHA Class II/III CHF Patients
Page 50 - Program for Class II/III CHF patients
Page 51 - Current Status and Anticipated Milestones
Page 52 - Manufacturing and Supply Chain
Page 53 - Intellectual Property
Page 54 - License and Collaboration Agreements
Page 55 - Singapore Economic Development Board (EDB) Singapore Operations
Page 56 - Tasly Pharmaceutical Group Cardiovascular Alliance for China
Page 57 - Competition
Page 58 - Product Development Process
Page 59 - U.S. Review and Approval Processes
Page 60 - N/A
Page 61 - Post-Approval Requirements
Page 62 - U.S. Patent Term Restoration and Marketing Exclusivity
Page 63 - EU Exclusivity Periods
Page 64 - Pharmaceutical Coverage, Pricing and Reimbursement
Page 65 - N/A
Page 66 - Other Healthcare Laws and Compliance Requirements
Page 67 - Australian Disclosure Requirements
Page 68 - Dividends
Page 69 - Commercialization and Milestone Revenue.
Page 70 - Manufacturing Commercialization.
Page 71 - Income Tax Benefit/Expense.
Page 72 - Results of Operations
Page 73 - Research and development
Page 74 - Manufacturing commercialization
Page 75 - Fair value remeasurement of contingent consideration
Page 76 - Finance costs
Page 77 - Comparison of Our Results for the Year ended June 30, 2017 with the Year ended June 30, 2016
Page 78 - Research and development
Page 79 - Manufacturing commercialization
Page 80 - Fair value remeasurement of contingent consideration
Page 81 - Other operating income and expenses
Page 82 - Certain Differences Between IFRS and U.S. GAAP
Page 83 - Critical Accounting Policies and Estimates
Page 84 - JCR arrangement
Page 85 - In-process research and development
Page 86 - Investments and other financial assets
Page 87 - N/A
Page 88 - Borrowings
Page 89 - Australian Disclosure Requirements
Page 90 - Cash flows
Page 91 - Comparison of cash flows for the Year ended June 30, 2017 with the Year ended June 30, 2016
Page 92 - Borrowings
Page 93 - Borrowing commitments:
Page 94 - Contingent liabilities
Page 95 - N/A
Page 96 - Details of Directors and Senior Management
Page 97 - Other current directorships of listed public companies
Page 98 - Ben-Zion Weiner, BSc, MSc, PhD
Page 99 - Former directorships of listed public companies within the last 3 years
Page 100 - Josh Muntner, BFA, MBA
Page 101 - Geraldine Storton, BSc, MMS, MBA
Page 102 - Meeting of Directors
Page 103 - Overview of FY18 performance and remuneration outcomes
Page 104 - Remuneration outcomes for FY18
Page 105 - N/A
Page 106 - Executive KMP remuneration received in FY18
Page 107 - Remuneration Framework Summary
Page 108 - A pay mix for performance
Page 109 - Long-Term Incentives (LTIs) Program
Page 110 - N/A
Page 111 - Non-Executive Director ( NED ) Remuneration
Page 112 - Remuneration Details - NEDs
Page 113 - Remuneration Governance
Page 114 - Additional remuneration disclosures
Page 115 - Remuneration Values
Page 116 - Reconciliation of Options held by KMP
Page 117 - Shares provided on exercise of remuneration options:
Page 118 - Employee Profile
Page 119 - Non-Executive Director Profile
Page 120 - Australian Disclosure Requirements
Page 121 - Indemnification of Officers
Page 122 - N/A
Page 123 - Committees
Page 124 - N/A
Page 125 - N/A
Page 126 - N/A
Page 127 - Legal Proceedings
Page 128 - The NASDAQ Global Select Market
Page 129 - The Australian Securities Exchange
Page 130 - Directors
Page 131 - Share Qualifications
Page 132 - Right to Share in Our Profits
Page 133 - General Meetings of Shareholders
Page 134 - Ownership Threshold
Page 135 - Loan Agreement with NovaQuest
Page 136 - Regulation of acquisition by foreign entities
Page 137 - Australia s Foreign Investment Policy
Page 138 - You are urged to consult your own tax advisor with respect to the U.S. federal, as well as state, lo
Page 139 - Distributions
Page 140 - Sale, Exchange or Other Disposition of Ordinary Shares or ADSs
Page 141 - Mark-to-Market Election
Page 142 - Reporting
Page 143 - Australian Income Tax
Page 144 - Dual Residency
Page 145 - N/A
Page 146 - Fees Payable by ADR Holders
Page 147 - PART II
Page 148 - Pre-Approval of Audit and Non-Audit Services
Page 149 - PART III
Page 150 - Report of Independent Registered Public Accounting Firm
Page 151 - Definition and Limitations of Internal Control over Financial Reporting
Page 152 - Index to Financial Statements
Page 153 - The above consolidated income statement should be read in conjunction with the accompanying Notes.
Page 154 - The above consolidated statement of comprehensive income should be read in conjunction with the acco
Page 155 - The above consolidated statement of changes in equity should be read in conjunction with the accompa
Page 156 - The above consolidated balance sheet should be read in conjunction with the accompanying Notes.
Page 157 - The above consolidated statement of cash flows should be read in conjunction with the accompanying N
Page 158 - N/A
Page 159 - N/A
Page 160 - N/A
Page 161 - 2. Significant changes in the current reporting period
Page 162 - 3. Loss before income tax
Page 163 - 4. Income tax benefit/(expense)
Page 164 - N/A
Page 165 - 5. Financial assets and liabilities
Page 166 - N/A
Page 167 - N/A
Page 168 - Bank guarantee
Page 169 - f.
Page 170 - g.Recognized fair value measurements
Page 171 - Level 1:
Page 172 - N/A
Page 173 - N/A
Page 174 - 6. Non-financial assets and liabilities
Page 175 - N/A
Page 176 - N/A
Page 177 - Contingent consideration
Page 178 - 7. Equity
Page 179 - N/A
Page 180 - Share-based payment reserve
Page 181 - 8. Cash flow information
Page 182 - 10. Financial risk management
Page 183 - N/A
Page 184 - N/A
Page 185 - N/A
Page 186 - i
Page 187 - 11. Capital management
Page 188 - 15. Events occurring after the reporting period
Page 189 - 16. Related party transactions
Page 190 - N/A
Page 191 - N/A
Page 192 - N/A
Page 193 - N/A
Page 194 - General terms and conditions attached to share based payments
Page 195 - Modifications to share-based payment arrangements
Page 196 - Model inputs
Page 197 - 18. Remuneration of auditors
Page 198 - 19. Losses per share
Page 199 - 20. Parent entity financial information
Page 200 - N/A
Page 201 - TiGenix arrangement
Page 202 - JCR arrangement
Page 203 - N/A
Page 204 - N/A
Page 205 - N/A
Page 206 - Assets carried at amortized cost
Page 207 - N/A
Page 208 - N/A
Page 209 - Hercules
Page 210 - N/A
Page 211 - N/A
Page 212 - Australian Disclosure Requirements
Page 213 - N/A
Page 214 - N/A
Page 215 - N/A
Page 216 - N/A
Page 217 - N/A
Page 218 - N/A
Page 219 - N/A
Page 220 - N/A
Page 221 - N/A
Page 222 - SIGNATURES
Subdocument 2 - EX-4.21 - EX-4.21
Page 1 - Exhibit 4.21
Page 2 - Accounting Standards
Page 3 - Euro
Page 4 - Portfolio Offering
Page 5 - Patent
Page 6 - Takeda
Page 7 - Interpretation
Page 8 - Sublicenses
Page 9 - Payment Method
Page 10 - Enforcement
Page 11 - Patent Marking
Page 12 - Authority
Page 13 - Fees
Page 14 - Indemnified PartyIndemnifying Party
Page 15 - Authorized Use and Disclosure
Page 16 - Publicity
Page 17 - ProductPre-Issued MSB PatentNegotiation RequestDenial Notice8(b) Expiration Date
Page 18 - Challenge Notice
Page 19 - Termination for Failure under Section 4(h)
Page 20 - Dispute
Page 21 - Notices
Page 22 - Relationship of Parties
Page 23 - Compliance with Applicable Law; Anti-Corruption
Page 24 - N/A
Page 25 - EXHIBIT A
Page 26 - EXHIBIT B
Page 27 - EXHIBIT C
Page 28 - N/A
Page 29 - EXHIBIT D
Page 30 - EXHIBIT E
Page 31 - PRESS RELEASE
Page 32 - About TiGenix
Page 33 - Mesoblast forward looking information
Page 34 - EXHIBIT F
Page 35 - N/A
Page 36 - N/A
Subdocument 3 - EX-4.22 - EX-4.22
Page 1 - Exhibit 4.22
Page 2 - Kassenobligation
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - N/A
Page 10 - Merkblatt "Verrechnungssteuer auf Zinsen von Bankguthaben, deren Gl ubiger Banken sind (Interbankgut
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - N/A
Page 17 - provided
Page 18 - N/A
Page 19 - Bundesgesetz ber die Banken und Sparkassen
Page 20 - N/A
Page 21 - Bundesgesetz ber die Verrechnungssteuer
Page 22 - N/A
Page 23 - N/A
Page 24 - N/A
Page 25 - SECTION 2. THE LOAN
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Page 29 - N/A
Page 30 - N/A
Page 31 - N/A
Page 32 - N/A
Page 33 - N/A
Page 34 - SECTION 3. SECURITY INTEREST
Page 35 - SECTION 4. CONDITIONS PRECEDENT TO LOAN
Page 36 - N/A
Page 37 - satisfactory
Page 38 - SECTION 5. REPRESENTATIONS AND WARRANTIES OF THE LOAN PARTIES
Page 39 - N/A
Page 40 - N/A
Page 41 - N/A
Page 42 - N/A
Page 43 - N/A
Page 44 - SECTION 6. INSURANCE; INDEMNIFICATION
Page 45 - SECTION 7. COVENANTS OF BORROWER
Page 46 - N/A
Page 47 - nolo contendere
Page 48 - providedprovided
Page 49 - N/A
Page 50 - N/A
Page 51 - N/A
Page 52 - N/A
Page 53 - N/A
Page 54 - SECTION 8. RIGHT TO invest
Page 55 - SECTION 9. EVENTS OF DEFAULT
Page 56 - SECTION 10. REMEDIES
Page 57 - N/A
Page 58 - SECTION 11. MISCELLANEOUS
Page 59 - N/A
Page 60 - N/A
Page 61 - N/A
Page 62 - N/A
Page 63 - N/A
Page 64 - N/A
Page 65 - N/A
Page 66 - N/A
Page 67 - N/A
Page 68 - N/A
Page 69 - N/A
Page 70 - Einlager ckgew hr/Kapitalr ckzahlunggesetzlich gesch tzte ReservenGewinnaussch ttung
Page 71 - N/A
Page 72 - nicht betriebsnotwendig
Page 73 - SECTION 12. GUARANTY.
Page 74 - N/A
Page 75 - N/A
Page 76 - Guarantor Payment
Page 77 - N/A
Page 78 - Exhibit 4.22
Page 79 - N/A
Page 80 - N/A
Page 81 - TABLE OF EXHIBITS AND SCHEDULES
Page 82 - EXHIBIT A
Page 83 - N/A
Page 84 - ATTACHMENT TO ADVANCE REQUEST
Page 85 - EXHIBIT B
Page 86 - EXHIBIT F
Page 87 - multiplied by
Page 88 - N/A
Page 89 - EXHIBIT G
Page 90 - N/A
Page 91 - N/A
Page 92 - EXHIBIT H
Page 93 - EXHIBIT I-1
Page 94 - EXHIBIT I-2
Page 95 - EXHIBIT I-3
Page 96 - EXHIBIT I-4
Page 97 - SCHEDULE 1.1
Subdocument 4 - EX-4.23 - EX-4.23
Page 1 - Exhibit 4.23
Page 2 - Additional Royalty Payments
Page 3 - Approved Subsidiary
Page 4 - Australian Tax Sharing Agreement
Page 5 - Change in Law
Page 6 - Designated Senior IndebtednessDesignated Senior Credit Agreement
Page 7 - Excluded Assets
Page 8 - FATCA
Page 9 - N/A
Page 10 - Insolvency Proceeding
Page 11 - Liensecurity interestsecurity interest
Page 12 - Net Sales
Page 13 - Other Taxes
Page 14 - Permitted Indebtedness****
Page 15 - Section 7.13
Page 16 - Permitted Transfers********
Page 17 - Prepayment Amount
Page 18 - Product Know-How
Page 19 - Secured Obligations
Page 20 - Third Party
Page 21 - Conventions
Page 22 - Limit
Page 23 - Amortization Payment AmountAnnual Amortization Cap********Additional Amortization Royalty Payment
Page 24 - Recordkeeping Period
Page 25 - Reserved
Page 26 - Indemnification by the Loan Parties
Page 27 - Foreign Lender
Page 28 - Treatment of Certain Refunds
Page 29 - U.S. Tax Reporting.
Page 30 - Section 3.
Page 31 - Section 4.
Page 32 - warning noticerestrictions notice
Page 33 - Section 4.3
Page 34 - Actions Before Governmental Authorities
Page 35 - Information Correct and Current
Page 36 - Intellectual Property
Page 37 - Capitalization and Subsidiaries
Page 38 - CertificatesSection 6.1Section 6.2
Page 39 - Section 7.
Page 40 - Sections 7.1(a)(b)(c)
Page 41 - all assets or all personal property
Page 42 - Investments
Page 43 - Corporate Changes; Location of Collateral
Page 44 - Compliance with Laws
Page 45 - COMI
Page 46 - Section 8.
Page 47 - Pensions
Page 48 - No Waiver
Page 49 - [email protected]
Page 50 - Entire Agreement; Amendments.
Page 51 - No Strict Construction
Page 52 - Governing Law
Page 53 - Confidential Information
Page 54 - Revival of Secured Obligations
Page 55 - Exculpatory Provisions
Page 56 - Publicity Materials
Page 57 - Consents
Page 58 - Independent Liability
Page 59 - N/A
Page 60 - nicht betriebsnotwendig
Page 61 - Section 12.
Page 62 - Subordination of Subrogation, Etc. Section 12.7Section 12Section 12.4
Page 63 - Section 12Section 12.7
Page 64 - Section 12.7
Page 65 - N/A
Page 66 - GUARANTOR:
Page 67 - N/A
Page 68 - TABLE OF EXHIBITS AND SCHEDULES
Page 69 - EXHIBIT A
Page 70 - Company:
Page 71 - ATTACHMENT TO ADVANCE REQUEST
Page 72 - EXHIBIT B
Page 73 - EXHIBIT F
Page 74 - EXHIBIT G
Page 75 - AGENT:
Page 76 - EXHIBIT H-1
Page 77 - EXHIBIT H-2
Page 78 - EXHIBIT H-3
Page 79 - EXHIBIT H-4
Page 80 - EXHIBIT I
Page 81 - SCHEDULE 1.1
Subdocument 5 - EX-4.24 - EX-4.24
Page 1 - Exhibit 4.24
Page 2 - Table of Contents
Page 3 - N/A
Page 4 - N/A
Page 5 - CONFIDENTIAL
Page 6 - ARTICLE 1
Page 7 - Applicable Law
Page 8 - Competing Product
Page 9 - Data
Page 10 - Field
Page 11 - ManufactureManufacturingManufactured
Page 12 - BundledProduct
Page 13 - Person
Page 14 - Product Technology
Page 15 - TaxTaxes
Page 16 - Additional Definitions
Page 17 - Interpretation
Page 18 - PRC Filing
Page 19 - Working Group
Page 20 - MWG
Page 21 - provided
Page 22 - Guiding Principles
Page 23 - Use of Affiliates and Third Parties
Page 24 - License to Collaborator Improvements
Page 25 - Subject PartySubject TransactionSubject Affiliate
Page 26 - ARTICLE 4
Page 27 - Updates
Page 28 - Development Data, Regulatory Materials and Other Reporting Obligations
Page 29 - Commercialization Plan
Page 30 - Trademarks
Page 31 - ARTICLE 6
Page 32 - Manufacturing Plan
Page 33 - ARTICLE 7
Page 34 - Involvement of MSB
Page 35 - Third Parties
Page 36 - ARTICLE 8
Page 37 - Taxes
Page 38 - N/A
Page 39 - Currency ConversionThe Wall Street Journal
Page 40 - Patent Prosecution
Page 41 - providedhowever
Page 42 - Other Enforcement Actions
Page 43 - provided, however,
Page 44 - Authorized Use and Disclosure
Page 45 - provided
Page 46 - Exhibit 10.5.1
Page 47 - ARTICLE 11
Page 48 - MSB s Warranties
Page 49 - N/A
Page 50 - Disclaimer of Warranties
Page 51 - provided, howeverprovided
Page 52 - ARTICLE 12
Page 53 - Termination for No Occurrence of the Condition Precedent
Page 54 - Additional Effects of Certain Terminations
Page 55 - Regulatory Materials Transfer Request****
Page 56 - Trademarks / Internet Presence
Page 57 - Costs and Expenses
Page 58 - ARTICLE 13
Page 59 - N/A
Page 60 - provided
Page 61 - English Language
Page 62 - No Third Party Beneficiaries
Page 63 - Compliance with Applicable Law; Anti-Corruption.
Page 64 - IN WITNESS WHEREOF
Page 65 - List of Exhibits:
Page 66 - EXHIBIT 1
Page 67 - EXHIBIT 5.5.2
Page 68 - EXHIBIT 8.4.1
Page 69 - EXHIBIT 10.5.1
Subdocument 6 - EX-8.1 - EX-8.1
Page 1 - N/A
Subdocument 7 - EX-10 - EX-10
Page 1 - N/A
Subdocument 8 - EX-12.1 - EX-12.1
Page 1 - N/A
Subdocument 9 - EX-12.2 - EX-12.2
Page 1 - N/A
Subdocument 10 - EX-13.1 - EX-13.1
Page 1 - N/A
Subdocument 11 - EX-13.2 - EX-13.2
Page 1 - N/A
Subdocument 12 - EX-99.1 - EX-99.1
Page 1 - Exhibit 99.1
Page 2 - N/A
Page 3 - N/A
Subdocument 13 - EX-99.2 - EX-99.2
Page 1 - N/A
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