DBV TECHNOLOGIES S.A. (Exact Name of Registrant As Specified in Its Charter and Translation of Registrant’S Name Into English)
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission File Number 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant as specified in its charter and translation of registrant’s name into English) France (Jurisdiction of incorporation or organization) 177-181 avenue Pierre Brossolette 92120 Montrouge France (Address of principal executive offices) Mr. Daniel Tassé Chief Executive Officer and Director DBV Technologies S.A. 177-181 avenue Pierre Brossolette 92120 Montrouge France Tel: +33 1 55 42 78 78 Fax: +33 1 43 26 10 83 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act. Title of each class Name of each exchange on which registered American Depositary Shares, each representing one-half of one The Nasdaq Stock Market LLC ordinary share, nominal value €0.10 per share Ordinary shares, nominal value €0.10 per share* The Nasdaq Stock Market LLC* * Not for trading, but only in connection with the registration of the American Depositary Shares. Securities registered or to be registered pursuant to Section 12(g) of the Act. None Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report. Ordinary shares, nominal value €0.10 per share: 30,157,777 as of December 31, 2018 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☒ Non-accelerated filer ☐ Emerging growth company ☐ If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13 (a) of the Exchange Act. ☐ † The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: U.S. GAAP ☐ International Financial Reporting Standards as issued Other ☐ by the International Accounting Standards Board ☒ If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No TABLE OF CONTENTS PAGE INTRODUCTION 1 PART I 4 Item 1. Identity of Directors, Senior Management and Advisers 4 Item 2. Offer Statistics and Expected Timetable 4 Item 3. Key Information 4 A. Selected Financial Data 4 B. Capitalization and Indebtedness 5 C. Reasons for the Offer and Use of Proceeds 5 D. Risk Factors 5 Item 4. Information on the Company 45 A. History and Development of the Company 45 B. Business Overview 46 C. Organizational Structure 91 D. Property, Plants and Equipment 91 Item 4A. Unresolved Staff Comments 91 Item 5. Operating and Financial Review and Prospects 91 A. Operating Results 98 B. Liquidity and Capital Resources 103 C. Research and Development, Patents and Licenses 107 D. Trend Information 107 E. Off-Balance Sheet Arrangements 107 F. Tabular Disclosure of Contractual Obligations 107 G. Safe Harbor 108 Item 6. Directors, Senior Management and Employees 108 A. Directors and Senior Management 108 B. Compensation 112 C. Board Practices 129 D. Employees 134 E. Share Ownership 134 Item 7. Major Shareholders and Related Party Transactions 134 A. Major Shareholders 134 B. Related Party Transactions 136 C. Interests of Experts and Counsel 141 Item 8. Financial Information 141 A. Consolidated Statements and Other Financial Information 141 B. Significant Changes 141 Item 9. The Offer and Listing 142 A. Offer and Listing Details 142 B. Plan of Distribution 142 C. Markets 142 D. Selling Shareholders 142 E. Dilution 142 F. Expenses of the Issue 142 Item 10. Additional Information 142 A. Share Capital 142 B. Memorandum and Articles of Association 142 C. Material Contracts 142 D. Exchange Controls 143 E. Taxation 143 F. Dividends and Paying Agents 149 G. Statement by Experts 149 H. Documents on Display 149 I. Subsidiary Information 150 Item 11. Quantitative and Qualitative Disclosures About Market Risk 150 Item 12. Description of Securities Other than Equity Securities 151 A. Debt Securities 151 B. Warrants and Rights 151 C. Other Securities 151 D. American Depositary Shares 151 PART II Item 13. Defaults, Dividend Arrearages and Delinquencies 153 Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds 153 Item 15. Controls and Procedures 153 Item 16A. Audit Committee Financial Expert 154 Item 16B. Code of Ethics 154 Item 16C. Principal Accountant Fees and Services 154 Item 16D. Exemptions from the Listing Standards for Audit Committees 154 Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers 155 Item 16F. Change in Registrant’s Certifying Accountant 155 Item 16G. Corporate Governance 155 Item 16H. Mine Safety Disclosure 155 PART III Item 17. Financial Statements 156 Item 18. Financial Statements 156 Item 19. Exhibits 156 INTRODUCTION Unless otherwise indicated, “DBV,” “the company,” “our company,” “we,” “us” and “our” refer to DBV Technologies S.A. and its consolidated subsidiary. We own various trademark registrations and applications, and unregistered trademarks and servicemarks, including,” “Viaskin®,” “EPIT®,” “DBV Technologies®”, “Abyldis®” and our corporate logo. All other trademarks or trade names referred to in this Annual Report on Form 20-F are the property of their respective owners. Trade names, trademarks and service marks of other companies appearing in this Annual Report on Form 20-F are the property of their respective holders. Solely for convenience, the trademarks and trade names in this Annual Report on Form 20-F may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Our audited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements are presented in euros. All references in this Annual Report on Form 20-F to “$,” “US$,” “U.S.$,” “U.S. dollars,” “dollars” and “USD” mean U.S. dollars and all references to “€” and “euros” mean euros, unless otherwise noted. Throughout this Annual Report on Form 20-F, references to ADSs mean ADSs or ordinary shares represented by ADSs, as the case may be. 1 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 20-F contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this Annual Report on Form 20-F, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this Annual Report on Form 20-F, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements.