Form 20-F
MOTIF BIO PLC filed this Form 20-F on 04/15/2019
Document Outline
Entire Document (8278.7 KB)
Subdocument 1 - 20-F - 20-F
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - USE OF PROCEEDS
Page 4 - EXHIBIT
Page 5 - INTRODUCTION
Page 6 - N/A
Page 7 - PART I
Page 8 - Summary Statement of Financial Position:
Page 9 - We Are A Biopharmaceutical Company And Have A Limited Operating History On Which To Assess Our Busin
Page 10 - We Will Need Substantial Additional Funding Before We Can Expect To Complete The Development Of Our
Page 11 - The Commercial Success Of Iclaprim And Any Future Product Candidate Will Depend On The Degree Of Mar
Page 12 - We Have Never Generated Any Revenue From Product Sales And May Never Be Profitable.
Page 13 - The terms of our credit facility place restrictions on our operating and financial flexibility.
Page 14 - We May Not Be Successful In Executing Our Growth Strategy Or Our Growth Strategy May Not Deliver The
Page 15 - If We Acquire Other Businesses Or In-license Or Acquire Other Product Candidates And Are Unable To I
Page 16 - Our Business And Operations Would Suffer In The Event Of System Failures.
Page 17 - If We Are Successful In Commercializing Iclaprim, We May Be Subject To Claims From F. Hoffman-La Roc
Page 18 - The Successful Commercialization Of Our Product Candidates Will Depend In Part On The Extent To Whic
Page 19 - Bacteria Might Develop Resistance To Iclaprim, Which Would Decrease Its Efficacy And Commercial Viab
Page 20 - The Failure Of Our Suppliers To Supply Us With The Agreed Upon Drug Substance Or Drug Product Could
Page 21 - Our Reliance On Third-parties Requires Us To Share Our Trade Secrets And Other Proprietary Confident
Page 22 - Clinical Trials Are Very Expensive, Time Consuming And Difficult To Design And Implement And Involve
Page 23 - The Regulatory Approval Process Of The FDA, EMA Or Any Comparable Foreign Regulatory Agency May Be L
Page 24 - If Serious Adverse, Undesirable Or Unacceptable Side Effects Are Identified During The Development O
Page 25 - We May Become Exposed To Costly And Damaging Liability Claims, Either When Testing Our Future Produc
Page 26 - We May Not Have Sufficient Patent Terms To Effectively Protect Our Products And Business.
Page 27 - Third-party Claims Of Intellectual Property Infringement May Expose Us To Substantial Liability Or P
Page 28 - Although We Are Not Currently Involved In Any Litigation, We May Be Involved In Lawsuits To Protect
Page 29 - Failure To Secure Or Maintain Adequate Protection For Our Trademarks Could Adversely Affect Our Busi
Page 30 - Although We Are Not Currently Involved In Any Litigation, We May Be Involved In Lawsuits That May Re
Page 31 - Enacted And Future Legislation, as Well as Regulatory Policy Changes, May Increase The Difficulty An
Page 32 - N/A
Page 33 - Our Relationships With Customers, Consultants And Payors Will Be Subject To Applicable Fraud And Abu
Page 34 - N/A
Page 35 - We Are Subject To U.S. And Certain Foreign Export And Import Controls, Sanctions, Embargoes, Anti-Co
Page 36 - Risks Related To The Ownership Of The ADSs, The ADS Warrants And Our Ordinary Shares
Page 37 - Future Sales, Or The Possibility Of Future Sales, Of A Substantial Number Of The ADSs, The ADS Warra
Page 38 - The Dual Listing Of Our Ordinary Shares On AIM And The ADSs And ADS Warrants On The NASDAQ Capital M
Page 39 - We May Lose Our Foreign Private Issuer Status, Which Would Then Require Us To Comply With The Exchan
Page 40 - The ADS Holders Do Not Have The Same Rights To Receive Dividends Or Other Distributions As Our Share
Page 41 - You May Be Unable To Recover Any of Your Investment in the ADS Warrants.
Page 42 - The Effect Of Comprehensive U.S. Tax Reform Legislation On The Company, Whether Adverse Or Favorable
Page 43 - Item 4. Information on the Company.
Page 44 - B. Business Overview
Page 45 - Our Strategy
Page 46 - Our Product Development Pipeline
Page 47 - Market Research
Page 48 - Acute Bacterial Skin And Skin Structure Infections (ABSSSI)
Page 49 - Generating Antibiotics Incentives Now (GAIN) Act
Page 50 - Non-inferiority Testing
Page 51 - Clinical Development Plans and Results
Page 52 - REVIVE-1 and -2 Phase 3 Trial Design in ABSSSI; Approximately 600 patients per trial
Page 53 - REVIVE-2 topline efficacy results
Page 54 - Bacterial Pneumonia in Patients with Cystic Fibrosis (CF)
Page 55 - Efficacy Results.
Page 56 - Summary of Liver Function Tests of Pooled ASSIST-1 and -2: Number of Patients with Extreme Values
Page 57 - Phase 2 cSSSI trial versus vancomycin: 87 patients
Page 58 - Iclaprim
Page 59 - Comparison of the Activity (MIC50/90; g/mL) of Iclaprim and Other Anti-infectives against Clinical I
Page 60 - Microbiology
Page 61 - Mechanism Of Action
Page 62 - Pediatric and Other Indications
Page 63 - Competition
Page 64 - N/A
Page 65 - N/A
Page 66 - Post-Approval Requirements
Page 67 - Foreign Regulation
Page 68 - N/A
Page 69 - Pharmaceutical Coverage, Pricing And Reimbursement
Page 70 - Healthcare Reform
Page 71 - C. Organizational Structure.
Page 72 - Item 5. Operating and Financial Review and Prospects.
Page 73 - Acquisition Of Nuprim Assets
Page 74 - Revenues
Page 75 - Interest Income and Interest Expense
Page 76 - Comparison of the year ended December 31, 2018 and December 31, 2017
Page 77 - Net Foreign Exchange Gain (Loss)
Page 78 - B. Liquidity and Capital Resources
Page 79 - N/A
Page 80 - Cash Flows For
Page 81 - Critical Accounting Policies And Significant Judgments And Estimates
Page 82 - F. Tabular Disclosure of Contractual Obligations
Page 83 - Item 6. Directors, Senior Management and Employees.
Page 84 - Non-Employee Directors
Page 85 - Dr. Mary Lake Polan has served as a non-executive director of the Company since February 2004. Dr. P
Page 86 - Basic salary
Page 87 - Share Option Plan
Page 88 - Limitations On Liability And Indemnification Matters
Page 89 - N/A
Page 90 - Director Independence
Page 91 - Nomination Committee
Page 92 - N/A
Page 93 - B. Related Party Transactions.
Page 94 - Consultancy Agreement With Amphion Innovations US, Inc.
Page 95 - Consultancy Agreement for Robert Dickey IV
Page 96 - Transactions With Key Management Personnel
Page 97 - Item 8. Financial Information
Page 98 - Item 10. Additional Information.
Page 99 - POTENTIAL INVESTORS SHOULD SATISFY THEMSELVES PRIOR TO INVESTING AS TO THE OVERALL TAX CONSEQUENCES,
Page 100 - Taxation Of Capital Gains On Disposals Of ADSs, Ordinary Shares or Warrants
Page 101 - Depositary Receipt Systems And Clearance Services
Page 102 - Reporting Obligations
Page 103 - Treatment Of The Company As A Domestic Corporation For US Federal Income Tax Purposes
Page 104 - U.S. Holders
Page 105 - Net Investment Income Tax
Page 106 - Information Reporting And Backup Withholding
Page 107 - F. Dividends and Paying Agents.
Page 108 - Item 11. Quantitative and Qualitative Disclosures About Market Risk.
Page 109 - Item 12. Description of Securities Other than Equity Securities.
Page 110 - Payment Of Taxes
Page 111 - PART II
Page 112 - Management s Remediation Initiatives
Page 113 - Audit and Non-Audit Services Pre-Approval Policy
Page 114 - Item 16D. Exemptions from the Listing Standards for Audit Committees.
Page 115 - N/A
Page 116 - N/A
Page 117 - N/A
Page 118 - N/A
Page 119 - N/A
Page 120 - Other English Law Considerations
Page 121 - Sell-Out
Page 122 - Shareholder Rights
Page 123 - EXHIBIT INDEX
Page 124 - N/A
Page 125 - SIGNATURES
Page 126 - Motif Bio plc
Page 127 - Report of Independent Registered Public Accounting Firm
Page 128 - Motif Bio plc
Page 129 - Motif Bio plc
Page 130 - Motif Bio plc
Page 131 - Motif Bio plc
Page 132 - Motif Bio plc
Page 133 - N/A
Page 134 - Group reorganization and initial public offering
Page 135 - New standards and interpretations effective after 2018
Page 136 - d. Research and development costs
Page 137 - f. Impairment of non-financial assets
Page 138 - Trade payables and accrued liabilities
Page 139 - i. Offsetting financial instruments
Page 140 - n. Borrowings
Page 141 - Share based payments and fair value of warrants
Page 142 - c. Market risk
Page 143 - b. Breakdown of expenses by nature
Page 144 - 6. Directors remuneration
Page 145 - N/A
Page 146 - 7. Income tax expense
Page 147 - 9. Intangible assets
Page 148 - 10. Prepaid expenses and other receivables
Page 149 - 13. Interest bearing loans and borrowings
Page 150 - Liability classified warrants
Page 151 - Ordinary warrants
Page 152 - 15. Share based payments
Page 153 - 16. Share capital
Page 154 - 17. Financial assets and financial liabilities
Page 155 - 18. Subsidiaries
Page 156 - 20. Subsequent events
Subdocument 2 - EX-12.1 - EX-12.1
Page 1 - N/A
Subdocument 3 - EX-12.2 - EX-12.2
Page 1 - N/A
Subdocument 4 - EX-13.1 - EX-13.1
Page 1 - N/A
Subdocument 5 - EX-13.2 - EX-13.2
Page 1 - N/A
Subdocument 6 - EX-15.1 - EX-15.1
Page 1 - N/A
Subdocument 7 - EX-15.2 - EX-15.2
Page 1 - N/A
Subdocument 8 - EX-15.3 - EX-15.3
Page 1 - N/A
Subdocument 9 - EX-15.4 - EX-15.4
Page 1 - N/A
XBRL Item - EX-101.INS - XBRL INSTANCE DOCUMENT (What's this?)
XBRL Item - EX-101.SCH - XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT (What's this?)
XBRL Item - EX-101.CAL - XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT (What's this?)
XBRL Item - EX-101.DEF - XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT (What's this?)
XBRL Item - EX-101.LAB - XBRL TAXONOMY EXTENSION LABELS LINKBASE DOCUMENT (What's this?)
XBRL Item - EX-101.PRE - XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT (What's this?)
XBRL Viewer