0000000000-19-012936.txt : 20191011 0000000000-19-012936.hdr.sgml : 20191011 20190828171243 ACCESSION NUMBER: 0000000000-19-012936 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20190828 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: AVADEL PHARMACEUTICALS PLC CENTRAL INDEX KEY: 0001012477 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: BLOCK 10-1 BLANCHARDSTOWN CORPORATE PARK STREET 2: BALLYCOOLIN CITY: DUBLIN STATE: L2 ZIP: 15 BUSINESS PHONE: 636-449-1830 MAIL ADDRESS: STREET 1: 16640 CHESTERFIELD GROVE ROAD STREET 2: SUITE 200 CITY: CHESTERFIELD STATE: MO ZIP: 63005 FORMER COMPANY: FORMER CONFORMED NAME: FLAMEL TECHNOLOGIES SA DATE OF NAME CHANGE: 19960422 PUBLIC REFERENCE ACCESSION NUMBER: 0001012477-19-000002 LETTER 1 filename1.pdf begin 644 filename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Kanan Senior Vice President and Chief Financial Officer Avadel Pharmaceuticals plc Block 10-1 Blanchardstown Corporate Park Ballycoolin Dublin 15, Ireland Re: Avadel Pharmaceuticals plc Form 10-K For the Fiscal Year Ended December 31, 2018 Filed March 15, 2019 File No. 001-37977 Dear Mr. Kanan: We have reviewed your filing and have the following comment. In our comment, we ask you to provide us with information so we may better understand your disclosure. Please respond to this comment within 10 business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this comment, we may have additional comments. Form 10-K for the Fiscal Year Ended December 31, 2018 Business Unapproved Marketed Drug ("UMD") Products, page 6 1. In a risk factor on page 20 and in Note 21 to the Notes to the Consolidated Financial Statements on page 95 you disclose the customer concentration related to your product sales. Please address the following: Tell us the names of each customer identified as Customer A, B, C and D in the table on page 95. Tell us why sales to Customer D dropped from 30.8% of all revenues in 2017 to 9.3% in 2018 and your consideration for disclosing the cause in your filing. Represent to us that you will disclose the names of all customers accounting for at least 10% of consolidated revenues in future Forms 10-K as required by Item 101(c)(1)(vii) of Regulation S-K. Michael F. Kanan Avadel Pharmaceuticals plc August 28, 2019 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. You may contact Mark Brunhofer at (202) 551-3638 or Sharon Blume at (202) 551- 3474 if you have any questions. FirstName LastNameMichael F. Kanan Sincerely, Comapany NameAvadel Pharmaceuticals plc Division of Corporation Finance August 28, 2019 Page 2 Office of Healthcare & Insurance FirstName LastName