SEC Filings

Form 424B4
ERYTECH PHARMA S.A. filed this Form 424B4 on 11/13/2017
Document Outline
Entire Document (3117.3 KB)
Subdocument 1 - 424B4 - 424B4
Page 1 - PROSPECTUS
Page 2 - TABLE OF CONTENTS
Page 3 - EXCHANGE RATE INFORMATION
Page 4 - MARKET, INDUSTRY AND OTHER DATA
Page 5 - PROSPECTUS SUMMARY
Page 6 - Eryaspase Our Lead Cancer Metabolism Targeting Product Candidate
Page 7 - Our Product Development Pipeline
Page 8 - E. coli
Page 9 - Our Additional ERYCAPS Product Candidates
Page 10 - Summary Risk Factors
Page 11 - Implications of Being an Emerging Growth Company
Page 12 - Corporate Information
Page 13 - THE GLOBAL OFFERING
Page 14 - N/A
Page 15 - N/A
Page 16 - SUMMARY CONSOLIDATED FINANCIAL DATA
Page 17 - N/A
Page 18 - RISK FACTORS
Page 19 - We may not be successful in our efforts to use and expand our ERYCAPS platform to develop marketable
Page 20 - Risks Related to our Financial Position and Capital Needs
Page 21 - We may need to raise additional funding, which may not be available on acceptable terms, or at all,
Page 22 - Our product candidates will need to undergo clinical trials that are time-consuming and expensive, t
Page 23 - Delays, suspensions and terminations in our clinical trials could result in increased costs to us an
Page 24 - Changes in regulatory requirements, guidance from regulatory authorities or unanticipated events dur
Page 25 - In the European Union, GRASPA contains a known active substance, which would undermine its data and
Page 26 - We have entered, and may in the future enter into, collaboration agreements with third parties for t
Page 27 - Risks Related to the Commercialization of Our Product Candidates
Page 28 - Even if we successfully complete clinical trials of our product candidates, those candidates may not
Page 29 - Even though we have obtained orphan drug designation from the EMA for eryaspase for the treatment of
Page 30 - Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-contain
Page 31 - Any of our product candidates for which we obtain marketing approval could be subject to post-market
Page 32 - The EMA, FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the
Page 33 - Adverse market and economic conditions may exacerbate certain risks associated with commercializing
Page 34 - Our manufacturing facilities are subject to significant government regulations and approvals. If we
Page 35 - Risks Related to Our Operations
Page 36 - Our business may be exposed to foreign exchange risks.
Page 37 - Our internal computer systems, or those of our third-party contractors or consultants, may fail or s
Page 38 - Our employees may engage in misconduct or other improper activities, including violating applicable
Page 39 - Risks Related to Intellectual Property
Page 40 - Issued patents covering our product candidates could be found invalid or unenforceable if challenged
Page 41 - If we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation fo
Page 42 - Third parties may assert ownership or commercial rights to inventions we develop.
Page 43 - Third parties may assert that our employees or consultants have wrongfully used or disclosed confide
Page 44 - Risks Related to the Global Offering, Ownership of our Ordinary Shares and ADSs and Our Status as a
Page 45 - After the completion of the global offering, we may be at an increased risk of securities class acti
Page 46 - We do not currently intend to pay dividends on our securities and, consequently, your ability to ach
Page 47 - The rights of shareholders in companies subject to French corporate law differ in material respects
Page 48 - You may not be able to exercise your right to vote the ordinary shares underlying your ADSs.
Page 49 - Purchasers of ADSs in the U.S. offering may not be directly holding our ordinary shares.
Page 50 - As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and
Page 51 - We may lose our foreign private issuer status in the future, which could result in significant addit
Page 52 - We must maintain effective internal control over financial reporting, and if we are unable to do so,
Page 53 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 54 - MARKET INFORMATION
Page 55 - USE OF PROCEEDS
Page 56 - DIVIDEND POLICY
Page 57 - CAPITALIZATION
Page 58 - DILUTION
Page 59 - N/A
Page 60 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 61 - N/A
Page 62 - MANAGEMENT S DISCUSSION AND ANALYSIS
Page 63 - Eryaspase - Our Lead Cancer Metabolism-Targeting Product Candidate
Page 64 - Interim Financial Reporting
Page 65 - Financial Operations Overview
Page 66 - Reimbursements from Orphan Europe
Page 67 - Agreement with Orphan Europe
Page 68 - Results of Operations
Page 69 - General and Administrative Expenses
Page 70 - Financial Income (Loss)
Page 71 - Research and Development Expenses
Page 72 - General and Administrative Expenses
Page 73 - Critical Accounting Policies and Estimates
Page 74 - Share-based payment
Page 75 - Liquidity and Capital Resources
Page 76 - Non-refundable Subsidies and Conditional Advances from BPI France
Page 77 - Contractual Obligations
Page 78 - Capital Expenditures
Page 79 - Foreign Currency Exchange Risk
Page 80 - N/A
Page 81 - BUSINESS
Page 82 - Acute Lymphoblastic Leukemia
Page 83 - Our Additional ERYCAPS Product Candidates
Page 84 - Corporate Information
Page 85 - Our ERYCAPS Platform Technology
Page 86 - Our Product Development Pipeline
Page 87 - N/A
Page 88 - Clinical Development of Eryaspase
Page 89 - Background and Potential for L-asparaginase as a Treatment for Pancreatic Cancer
Page 90 - Trial Design
Page 91 - Completed Phase 1 Clinical Trial of Eryaspase for the Treatment of Pancreatic Cancer
Page 92 - Background and Market for ALL
Page 93 - Limitations of Free-Form L-asparaginase Administration
Page 94 - Trial Design
Page 95 - Safety Results
Page 96 - Ongoing Phase 2 Clinical Trial in the Nordic Countries of Europe for Treatment of Patients Allergic
Page 97 - Eryaspase for the Treatment of Acute Myeloid Leukemia (AML)
Page 98 - Other ERYCAPS Development Programs
Page 99 - N/A
Page 100 - Commercialization
Page 101 - Agreement with Teva
Page 102 - Patent License from U.S. Public Health Service
Page 103 - Erwinaze
Page 104 - Government Regulation
Page 105 - N/A
Page 106 - BLA and FDA Review Process
Page 107 - Other U.S. Regulatory Matters
Page 108 - U.S. Patent Term Restoration and Marketing Exclusivity
Page 109 - European Union Drug Development
Page 110 - Orphan Drugs
Page 111 - Commission Nationale de l Informatique et des Libert s
Page 112 - Protection of Clinical Trial Subjects
Page 113 - Reimbursement
Page 114 - Other Healthcare Laws and Compliance Requirements
Page 115 - N/A
Page 116 - Employees
Page 117 - MANAGEMENT
Page 118 - Iman El-Hariry, M.D., Ph.D.
Page 119 - Luc Dochez
Page 120 - Director Independence
Page 121 - Corporate Governance Practices
Page 122 - Remuneration and Appointments Committee
Page 123 - Code of Business Conduct and Ethics
Page 124 - Executive Compensation Arrangements and Change of Control and Severance Benefits
Page 125 - Founder s Share Warrants (BSPCE)
Page 126 - Share Warrants (BSA)
Page 127 - Free Shares (AGA)
Page 128 - Stock Options (SO)
Page 129 - N/A
Page 130 - CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS
Page 131 - Profit-Sharing Agreement
Page 132 - Other Arrangements
Page 133 - N/A
Page 134 - PRINCIPAL SHAREHOLDERS
Page 135 - N/A
Page 136 - DESCRIPTION OF SHARE CAPITAL
Page 137 - Key Provisions of Our Bylaws and French Law Affecting Our Ordinary Shares
Page 138 - Directors Voting Powers on Proposal, Arrangement or Contract in which any Director is Materially Int
Page 139 - Timing of Payment.
Page 140 - Sinking Fund Provisions.
Page 141 - Notice of Annual Shareholders Meetings.
Page 142 - Extraordinary Shareholders Meeting.
Page 143 - Declaration of Crossing of Ownership Thresholds (Article 9 of the Bylaws)
Page 144 - Reduction in Share Capital.
Page 145 - Holding of Shares.
Page 146 - N/A
Page 147 - N/A
Page 148 - N/A
Page 149 - N/A
Page 150 - N/A
Page 151 - N/A
Page 152 - N/A
Page 153 - N/A
Page 154 - Listing
Page 155 - LIMITATIONS AFFECTING SHAREHOLDERS OF A FRENCH COMPANY
Page 156 - DESCRIPTION OF AMERICAN DEPOSITARY SHARES
Page 157 - If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currenc
Page 158 - How can ADS holders interchange between certificated ADSs and uncertificated ADSs?
Page 159 - N/A
Page 160 - Payment of Taxes
Page 161 - pro rata
Page 162 - Your Right to Receive the Ordinary Shares Underlying Your ADSs
Page 163 - Shareholder Communications; Inspection of Register of Holders of ADSs; ADS Holder Information
Page 164 - SHARES AND ADSs ELIGIBLE FOR FUTURE SALE
Page 165 - Lock-up Agreements
Page 166 - MATERIAL UNITED STATES FEDERAL INCOME AND FRENCH TAX CONSIDERATIONS
Page 167 - Material French Tax Considerations
Page 168 - Tax on Sale or Other Disposition
Page 169 - Wealth Tax
Page 170 - Distributions.
Page 171 - Sale, Exchange or Other Taxable Disposition of the ADSs.
Page 172 - The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urge
Page 173 - of an investment in a PFIC, any elections available with respect to the ADSs and the IRS information
Page 174 - ENFORCEMENT OF CIVIL LIABILITIES
Page 175 - UNDERWRITING
Page 176 - Commission and Expenses
Page 177 - No Sales of Similar Securities
Page 178 - Electronic Distribution
Page 179 - NOTICE TO INVESTORS
Page 180 - Taxation and Eligibility for Investment
Page 181 - Code mon taire et financier
Page 182 - Singapore
Page 183 - N/A
Page 184 - EXPENSES RELATING TO THE GLOBAL OFFERING
Page 185 - LEGAL MATTERS
Page 186 - WHERE YOU CAN FIND MORE INFORMATION
Page 187 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 188 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 189 - CONSOLIDATED STATEMENTS OF INCOME (LOSS)
Page 190 - CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Page 191 - CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 192 - CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
Page 193 - CONSOLIDATED STATEMENTS OF CASH FLOWS
Page 194 - NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page 195 - 3. STATEMENT OF COMPLIANCE
Page 196 - 4. SIGNIFICANT ACCOUNTING POLICIES
Page 197 - 4.5 Use of estimates and judgments
Page 198 - 4.8 Impairment tests
Page 199 - Financial liabilities at the amortized cost
Page 200 - Provisions for risks
Page 201 - Accounting for Government Grants and Disclosure of Government Assistance
Page 202 - Partnership with Orphan Europe
Page 203 - 4.19 Earnings per share
Page 204 - 5. NOTES RELATED TO THE CONSOLIDATED STATEMENT OF INCOME (LOSS)
Page 205 - 5.3 Personnel expenses
Page 206 - Allocation of 3,585 BSA on August 31, 2015.
Page 207 - 2016 Plan
Page 208 - Allocation of 111,261 free shares (AGA2016) on October 3, 2016
Page 209 - Allocation of 45,000 share subscription warrants (BSA2016) on October 3, 2016
Page 210 - 5.6 Income tax
Page 211 - 6.2 Property, plant and equipment
Page 212 - 6.4 Inventories
Page 213 - 6.8 Shareholders equity
Page 214 - 6.9 Provisions
Page 215 - 6.10 Financial liabilities
Page 216 - BPI France / Pancreas
Page 217 - BPI France / GR-SIL
Page 218 - 6.11 Other current liabilities
Page 219 - 6.13 Financial instruments recognized in the consolidated statement of financial position and effect
Page 220 - Liquidity risk
Page 221 - Interest rate risk
Page 222 - Agreement with the Teva Group
Page 223 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
Page 224 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Page 225 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 226 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS EQUITY
Page 227 - UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Page 228 - NOTES TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Page 229 - 2. BASIS OF PREPARATION AND STATEMENT OF COMPLIANCE
Page 230 - Use of judgments and estimates
Page 231 - 5.2 Operating expenses by nature
Page 232 - Share-based payments (IFRS 2)
Page 233 - Allocation of 55,000 share subscription warrants (BSA2017) on June 27, 2017
Page 234 - 6 NOTES RELATED TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Page 235 - Other non-current financial assets
Page 236 - Research Tax Credit
Page 237 - 6.7 Financial liabilities
Page 238 - 6.8 Other current liabilities
Page 239 - 7 OFF-BALANCE SHEET COMMITMENTS
Page 240 - ERYTECH Pharma S.A.
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