SEC Filings

Form 6-K
MESOBLAST LTD filed this Form 6-K on 11/16/2018
Document Outline
Entire Document (3755.1 KB)
Subdocument 1 - 6-K - Q1.FY19-30SEP2018
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - QUARTERLY REPORT ON FORM 6-K
Page 4 - N/A
Page 5 - The above consolidated income statement should be read in conjunction with the accompanying Notes.
Page 6 - The above consolidated statement of comprehensive income should be read in conjunction with the acco
Page 7 - The above consolidated statement of changes in equity should be read in conjunction with the accompa
Page 8 - The above consolidated balance sheet should be read in conjunction with the accompanying Notes.
Page 9 - The above consolidated statement of cash flows should be read in conjunction with the accompanying N
Page 10 - 1. Basis of preparation
Page 11 - Revenue from Contracts with Customers
Page 12 - Tasly arrangement
Page 13 - Financial Instruments
Page 14 - 2. Significant changes in the current reporting period
Page 15 - 3. Loss before income tax
Page 16 - 4. Income tax benefit/(expense)
Page 17 - 5. Financial assets and liabilities
Page 18 - N/A
Page 19 - N/A
Page 20 - Hercules Capital, Inc.
Page 21 - N/A
Page 22 - Level 1
Page 23 - N/A
Page 24 - N/A
Page 25 - N/A
Page 26 - 6. Non-financial assets and liabilities
Page 27 - 7. Cash flow information
Page 28 - 8. Issued capital
Page 29 - N/A
Page 30 - N/A
Page 31 - N/A
Page 32 - 10. Losses per share
Page 33 - 12. Segment information
Page 34 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 35 - N/A
Page 36 - Mergers and Acquisitions
Page 37 - Commercialization and Milestone Revenue.
Page 38 - Manufacturing Commercialization.
Page 39 - Results of Operations
Page 40 - Research and development
Page 41 - Manufacturing commercialization
Page 42 - Fair value remeasurement of contingent consideration
Page 43 - Finance costs
Page 44 - Liquidity and Capital Resources
Page 45 - Net cash outflows in investing activities
Page 46 - Contractual Obligations and Commitments
Page 47 - Quantitative and Qualitative Disclosure About Market Risk
Page 48 - Revenue Recognition
Page 49 - Sales-based or usage-based royalties
Page 50 - Government grant income
Page 51 - In-process research and development
Page 52 - Investments and other financial assets
Page 53 - Borrowings
Page 54 - Hercules arrangement
Page 55 - Events subsequent to balance date
Page 56 - RISK FACTORS
Page 57 - We require substantial additional financing to achieve our goals, and our failure to obtain this nec
Page 58 - The terms of our loan facilities with Hercules Capital, Inc. ( Hercules ) and NovaQuest Capital Mana
Page 59 - We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies
Page 60 - We may find it difficult to enroll patients in our clinical trials, which could delay or prevent dev
Page 61 - We may conduct multinational clinical trials, which present additional and unique risks.
Page 62 - Several of our product candidates are being evaluated for the treatment of patients who are extremel
Page 63 - Our drug candidates may not benefit from an expedited approval path for cellular medicines designate
Page 64 - Ethical and other concerns surrounding the use of embryonic stem cell-based therapy may negatively a
Page 65 - Orphan drug designation may not ensure that we will enjoy market exclusivity in a particular market,
Page 66 - We may face competition from biosimilars due to changes in the regulatory environment.
Page 67 - Our existing product development and/or commercialization arrangements, and any that we may enter in
Page 68 - Risks Related to Our Manufacturing and Supply Chain
Page 69 - We may not be able to manufacture or commercialize our product candidates in a profitable manner.
Page 70 - We and our collaborators and Lonza are subject to significant regulation with respect to manufacturi
Page 71 - We will rely on third parties to perform many necessary services for the commercialization of our pr
Page 72 - If, in the future, we are unable to establish our own sales, marketing and distribution capabilities
Page 73 - Healthcare legislative reform measures may have a material adverse effect on our business and result
Page 74 - Due to the novel nature of our stem cell therapy and the potential for our product candidates to off
Page 75 - Use of animal-derived materials could harm our product development and commercialization efforts.
Page 76 - If product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 77 - The patent positions of biopharmaceutical products are complex and uncertain.
Page 78 - Intellectual property disputes could cause us to spend substantial resources and distract our person
Page 79 - If third parties claim that intellectual property used by us infringes upon their intellectual prope
Page 80 - We may acquire other companies or assets which could divert our management s attention, result in ad
Page 81 - We work with outside scientists and their institutions in developing product candidates. These scien
Page 82 - Taxing authorities could reallocate our taxable income within our subsidiaries, which could increase
Page 83 - A failure to adequately protect private health information could result in severe harm to our reputa
Page 84 - We may lose our foreign private issuer status, which would then require us to comply with the Exchan
Page 85 - Australian takeover laws may discourage takeover offers being made for us or may discourage the acqu
Page 86 - The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of
Page 87 - Securities Exchange Act of 1934
Page 88 - Changes in foreign currency exchange rates could impact amounts you receive as a result of any divid
Page 89 - Our Constitution and Australian laws and regulations applicable to us may adversely affect our abili
Page 90 - Signatures

Share Price ASX: MSB  AUD 1.14 as of Dec 14, 2018