Axonics Modulation Technologies, Inc. (Exact Name of Registrant As Specified in Its Charter) ______
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________________________ FORM 10-K/A (Amendment No. 1) _________________________________________________________________ (Mark One) ý 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 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38721 _________________________________________________________________ Axonics Modulation Technologies, Inc. (Exact name of registrant as specified in its charter) _________________________________________________________________ Delaware 45-4744083 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 26 Technology Drive Irvine, California 92618 (Address of principal executive offices) (Zip Code) (949) 396-6322 (Registrant’s telephone number, including area code) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No ý Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No ý 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 ý No o 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 ý No o Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10- K. ý Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer o Accelerated filer o Non-accelerated filer ý Smaller reporting company ý Emerging growth company ý If an emerging growth company, 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. ý Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý The registrant was not a public company as of the last business day of its most recently completed second fiscal quarter, and therefore cannot calculate the aggregate market value of its voting and non-voting common equity held by non-affiliates as of such date. As of April 29, 2019, 28,224,605 shares of the registrant’s common stock, par value $0.0001 per share, were outstanding. EXPLANATORY NOTE This Amendment No. 1 on Form 10-K/A (“Amendment”) amends the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 of Axonics Modulation Technologies, Inc. (“Company,” “Axonics,” “we,” “our,” and “us”), originally filed with the Securities and Exchange Commission (“SEC”) on March 5, 2019 (“Original Filing”). At the time that we filed the Original Filing, we intended to file a definitive proxy statement for our 2019 Annual Meeting of Stockholders within 120 days after the end of our fiscal year pursuant to Regulation 14A promulgated under the Securities Exchange Act of 1934, as amended (“Exchange Act”), and to incorporate by reference the Part III information omitted from the Original Filing to such definitive proxy statement. We are filing this Amendment to amend Part III of the Original Filing to include the information required by and not included in Part III of the Original Filing because we now expect to file a definitive proxy statement for our 2019 Annual Meeting of Stockholders after such 120-day period. Part IV of the Original Filing is being amended solely to add as exhibits certain new certifications in accordance with Rule 13a-14 promulgated by the SEC under the Exchange Act. Except as described above, no other changes have been made to the Original Filing. The Original Filing continues to speak as of the date of the Original Filing, and we have not updated the disclosures contained therein to reflect any events which occurred at a date subsequent to the filing of the Original Filing other than as expressly indicated in this Amendment. Accordingly, this Amendment should be read in conjunction with the Original Filing and our other filings made with the SEC subsequent to March 5, 2019. TABLE OF CONTENTS Page PART III Item 10. Directors, Executive Officers and Corporate Governance 1 Item 11. Executive Compensation 5 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 11 Item 13. Certain Relationships and Related Transactions, and Director Independence 13 Item 14. Principal Accounting Fees and Services 17 PART IV Item 15. Exhibits and Financial Statement Schedules 18 Signatures 19 Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance. Executive Officers and Directors The following table sets forth certain information regarding our current executive officers and directors: Name Age Position(s) Executive Officers and Director Raymond W. Cohen 60 Chief Executive Officer, Director Danny L. Dearen 56 President, Chief Financial Officer Rinda K. Sama 40 Chief Operating Officer Karen Noblett, M.D. 56 Chief Medical Officer Prabodh Mathur 59 Chief Product Development Officer Guangqiang (Jay) Jiang, Ph.D. 46 Chief Technology Officer Alfred Ford 48 Chief Commercial Officer John Woock, Ph.D. 36 Chief Marketing Officer Michael V. Williamson 48 Senior Vice President, General Counsel Non-Employee Directors Raphaël Wisniewski 48 Chair of the Board of Directors Erik Amble, Ph.D. 66 Director Juliet Tammenoms Bakker 56 Director Robert E. McNamara 61 Director Michael H. Carrel 47 Director Jane E. Kiernan 58 Director Nancy Snyderman, M.D., FACS 67 Director Executive Officers and Director Raymond W. Cohen has served as our Chief Executive Officer and as a member of our board of directors since October 2013. Mr. Cohen has extensive international medical device experience, holding several Chair and Chief Executive Officer positions on the boards of both publicly listed and private life sciences companies in the United States and Europe. Since June 2013, Mr. Cohen has served as a member of the board of directors, Chair of the compensation committee, member of the audit committee and member of the nominating and corporate governance committee of Spectrum Pharmaceuticals, Inc., a developer and marketer of oncology and hematology drugs. From April 2016 to June 2017, Mr. Cohen served as a member of the board of directors and a member of the compensation and audit committees of Zurich-based LifeWatch AG, a manufacturer and marketer of ambulatory electrocardiogram services, which was acquired by Biotelemetry Inc. in July 2017. From June 2013 to December 2017, Mr. Cohen served as Chair of the board of directors of Lombard Medical, Inc., a manufacturer and marketer of abdominal aortic aneurysm stent graphs. Since May 2006, Mr. Cohen has served as a member of the board of directors, Chair of the audit committee, compensation committee and nominating committee, and since November 2013 as Chair of the board of directors, of BioLife Solutions, Inc., a developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. From August 2010 to November 2012, Mr. Cohen served as Chief Executive Officer and as a member of the board of directors of Vessix Vascular, Inc. a developer of a novel renal denervation system used to treat uncontrolled hypertension, which was acquired by Boston Scientific Corporation. From 1997 to 2006, Mr. Cohen served as Chair and Chief Executive Officer of Cardiac Science, Inc., a manufacturer of external automatic defibrillators. From 1982 to 1997, Mr. Cohen served in various sales and marketing positions for a number of medical device companies. In 2008, Mr. Cohen was named by AeA as the Private Company Life Science Chief Executive Officer of the Year. Mr. Cohen was named Entrepreneur of the Year in 2002 by the Orange County Business Journal and was a finalist for Ernst & Young’s Entrepreneur of the Year in the medical company category in 2004. Mr. Cohen holds a B.S. in Business Management from the State University of New York at Binghamton. We believe Mr. Cohen’s extensive experience in the medical device industry qualifies him to serve on our board of directors. Danny L. Dearen has served as our President since August 2018 and our Chief Financial Officer since October 2013. From October 2013 to August 2018, Mr. Dearen served as our Chief Operating Officer. From July 2009 to October 2013, Mr. Dearen served as Chief Operating Officer and Chief Financial Officer of Vessix Vascular, Inc., a developer of a novel renal 1 Table of Contents denervation system used to treat uncontrolled hypertension, which was acquired by Boston Scientific Corporation. Mr. Dearen holds a B.A.