0000000000-20-008893.txt : 20210223 0000000000-20-008893.hdr.sgml : 20210223 20200922171405 ACCESSION NUMBER: 0000000000-20-008893 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200922 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$1&3"Q\<'QA6_?__&K *98K_? 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M[_UI6"ZM_)BWD\<4)T_D(ED=_VU1E%5OV+U5O3LC._")OQWD5.(H55.*LSM4 M.7:6+Y-MA_R7^-8XI1CH+&,!4Q#*3""_LKJ\G1D/-(F=GNW/)#A/;Q>'(98M*-[4DU;>BA(@ODT1D M6 ,ZDY#T9*:@VE,@YUSI(K6778"G"%;BL=HGR7LOXS^\/"G])Y 6COV(6.N& MW2"W36'NF_O7;U/:2IM:;+29&J-4=6M_E6^7+5:G]K3[<]$CFD+E#?B5^ M=.5VL4_D_PZ7]W\#B"^)>PIE;F1S=')E86T*96YD;V)J"C$S(# @;V)J"CP\ M+U1Y<&4O6%)E9B]76S$@,B R72]2;V]T(#$Q(# @4B]);F1E>%LP(#$T72]) M1"!;/#5C,V8X-&$Q.#@Y83$S,C@X-&(U8S@Q-S-A,V1F9C0Y/CPU8S-F.#1A M,3@X.6$Q,S(X.#1B-6,X,3 TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo September 21, 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 August 26, 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 August 12, 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. Pursuant to ASC 205-20-45-1B, the sale of the sterile injectable drugs portfolio business appears to represent a strategic shift that has had a major effect on your operations and financial results and correspondingly it would appear that this business, which also represents a component of an entity, should be reported as discontinued operations. In this regard, we note that this business appears to be a different product line than your current lead drug candidate, FT218, which you note is management s primary focus. In addition, the pro forma financial information provided Thomas McHugh AVADEL PHARMACEUTICALS PLC September 21, 2020 Page 2 indicates that the strategic shift had a major effect on your operations and financial results in terms of revenues, net income/loss and net income/loss per share amounts. Please also refer to Example 1 of the Implementation Guidance in ASC 205-20-55-82 through 55- 101. Please revise your financial statements to reflect the sterile drugs portfolio business as discontinued operations. 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 September 21, 2020 Page 2 Office of Life Sciences FirstName LastName