0000000000-20-010258.txt : 20210223 0000000000-20-010258.hdr.sgml : 20210223 20201029172618 ACCESSION NUMBER: 0000000000-20-010258 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20201029 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 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]4>7!E+UA/8FIE8W0O0V]L;W)3 M<&%C92]$979I8V5',Z%$;3 BU,"VEA6J % M6J %6J %6J %6J %6O ]*WOEK(,D*\X#9H:[]P]6<&19EAU+^GP>RR(B(B(B M(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B+_-A\?'^_O[V]O;Z^OKR\' MGI^?GP[$AY="%(AB43AV^=.M%A$1$1$1$9$?2,H4S\_/CX^/]_?WOP[<'=E- MR6+L]?OW[ZCAZ>GI]?5504-$1$1$1$1$+N;M[>WIZ>GAX6&_WS<"Q:]?O^[O M[^.KQW.(\K]__VZJBLJ1,EY>7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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filename2.txt United States securities and exchange commission logo October 29, 2020 Thomas McHugh Senior Vice President and Chief Financial Officer AVADEL PHARMACEUTICALS PLC 10 Earlsfort Terrace Dublin 2, Ireland D02 T380 Re: AVADEL PHARMACEUTICALS PLC Form 10-K for the Year Ended December 31, 2019 Filed March 16, 2020 Form 10-Q for the Period Ended June 30, 2020 Filed August 10, 2020 File No. 001-37977 Dear Mr. McHugh: We have reviewed your October 14, 2020 response to our comment letter and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our September 21, 2020 letter. Form 10-Q for the Period Ended June 30, 2020 Note 4. Disposition of the Hospital Business, page 13 1. We note your response to comment 1. You state that the sterile injectable drugs (the Products ) do not represent a product line, and therefore are not a distinguishable component of the company. Please tell us if you believe that the Products meet the definition of a component of an entity as defined in ASC 205-20. If not, please explain. In your response, please address your presentation of the unaudited pro forma financial information you presented in exhibit 99.2 of Form 8-K dated July 2, 2020, which gives effect to the sale of the Products. Based on this presentation, it appears that, at a Thomas McHugh AVADEL PHARMACEUTICALS PLC October 29, 2020 Page 2 minimum, the operations of the Products can be clearly distinguished, operationally and for financial reporting purposes, from the rest of the entity. 2. We note from your response to comment 1 that you do not believe the sale of the sterile injectable drugs represented a strategic shift as contemplated by ASC 205-20-45. We continue to believe that the disposal may have represented a strategic shift. Please help us better understand your conclusion. In your response, please address the statements made in the press release announcing the sale of the Products on July 1, 2020. We note that in that press release, the company articulated that the sale of the sterile injectable drug portfolio was a significant milestone for the company, as it further reflected your commitment to strategically focus on advancing FT218 through the regulatory review process and, if approved, bringing your formulation of sodium oxybate to patients. We also note the statement made by Mr. Greg Divis, your Chief Executive Officer, in which he stated, By divesting our portfolio of sterile injectable drugs, we are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for FT218. Please also tell us how you considered the fact that the Products sold and FT218 are based on different technologies. You may contact Nudrat Salik at (202) 551-3692 or Ameen Hamady at (202) 551-3891 if you have any questions. FirstName LastNameThomas McHugh Sincerely, Comapany NameAVADEL PHARMACEUTICALS PLC Division of Corporation Finance October 29, 2020 Page 2 Office of Life Sciences FirstName LastName