AVDL - Earnings call transcript Q1 2019 | Avadel Pharmaceuticals plc

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Operator

Good morning, ladies and gentlemen, thank you for standing by. And welcome to the Avadel Pharmaceuticals’ First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. I will now turn the call over to Mr. Officer Financial Chief Kanan, of Avadel. Mike

now may begin. You

Mike Kanan

can joining Good issued conference our thank The our at our for morning, you us release release. call. news quarter financial on accessed www.avadel.com. XXXX on website and first results be This morning we

matters of XXXX. reminder, of the Litigation Act we of Private a before statements forward-looking a the following Securities constitute As includes within presentation begin, number that the meaning Reform

other Avadel's differ was at this XXXX. public the could Forward-looking undertakes Exchange December for objectives the from update law, in forward-looking not are in fully statements by risks risks and scientific ended be uncertainties to impact in actual forward-looking described XX, those materially no including are the stage the remarks, will revise regarding meet to acceptance reflect on XX-K events any Form to Avadel such or obligation and achieve otherwise. and uncertainties stringent statements the contemplated regulatory prepared cause and requirements, include results that risks we milestones or risks products contained of filed information, more Act, the the filings as subject products After statements. of may Q&A. for required or call under opening or new XXXX March to competitive future These market presentation that which development products These year Except pricing. XX,

turn of Divis. Chairman call Greg Chief Board Greg Directors. Greg? Officer Officer; Jordon new Dr. today our the Medical I this to On time, over Executive call Glass, Geoff Dubow, me Divis, will At our Chief are the Interim with and our of

Greg Divis

and and us Mike you call this Thank good joining everyone morning. you, for morning on our thank

past toward successful accomplish treatment majority financial by actions FTXXX, objective initiated preserve of have development but our this not include, resources Four, our five, financial strengthen cash the cash a sustainable our enhancing To Noctiva. on probability to dedicated clarity substantial novel our Avadel As actions of and declining major have that and for the timing this, the expertise of potential overall the of few of positioning to the the last sodium health increasing stopping our only of with more made aware burn program we focus a significant our directing company and the our the spend assessment Three, business. health, conducting hospital clinical comprehensive quarter deployed status a the profitability and internal the for the our company identify one, opportunities one-nightly FTXXX. formulation strengthening maximizing FTXXX. restructuring you ceasing on of strengthen strategy, are most and and these initiatives months. progress And of operational of growth series to value over each focus thus critical and pleased narcolepsy. of of taken to our and also creation. longer Two, we medical urgent and I'm to term independent providing FTXXX in with flow communicate success. progress to rapidly These and position our investors the transparency on of of the the market, development and by oxybate clinical

quarterly as progress well update REST-ON timing of committed on clinical study of enrollment. completion we've as provide the on will the trial, enrollment be to the our of guidance latest as First, we a providing

to trial enrollment XXXX. half rate, patients in we of XXX the or enrolled of now second enrolling has XX% during XX on enrollment. target patients Based that REST-ON X enrollment finish the needed the to May leaves expect patients of As complete the current

team, Chief with on our Medical of enhance FTXXX. to Second, among value and important clinical Officer. driving development the of an physicians maximizes announced Dr. and Last restructuring awareness our we our Dubow strategy medical the a plan assuring coming was as development focus objective week of and the out Jordon of FTXXX internal appointment

to in of on for We and regulatory development sleep. leading data a disorders, his are our patients regulatory best has have package how Jordan suffering on including their team. be join extensive FTXXX medical will to a in development from community He FTXXX to thrilled us our improvement drive clinical may position help the neurological the will FTXXX lives approval, awareness experience focus clinical greater program, create thorough in narcolepsy. and He and meaningful be preparing

Additionally, announce intended FTXXX received patent our to by pleased to formulation This strengthen estate. patent pack future, the a that is property is first further granted pattern in have FTXXX provide the of to mid-XXXX. long-term we PTO. value support I to am intellectual all expected through opportunity Furthermore, protection additional issuances expect the that we our U.S.

will appropriate. as We the update market

company these product. that was opportunity and it Noctiva. Chapter with now assets success remaining the for Specialty Avadel Pharmaceuticals, of not responsible personnel a are The LLC, halted marketing action via at distribution an a a of exited rapidly subsidiary the in Third, has sold. and have Noctiva The been cash was Noctiva-related burn sustainable, selling sales, assets we XX operationally or the sale functions of have company. There provided now no a that XXX new

we and business. maximizing continue on flow the hospital performance cash of the to focus products Finally

previously March from are As of the acceptance AVBXXX on stated the the XX, submission. waiting for we NDA our feedback filed and on FDA we

For business has This approved the April. through prior existing products, a remains profitable. trend strong had and quarter, continued surpassing the revenue positive guidance

given assumed downward previously increasing this on and new business pressure However, approved the business. anticipate this we and nature competitors, the of

and cash briefly Dubow, program. himself the introduce comment the over call our our that margin like development we to hand done position newly generate Dr. continue Officer the aggressively would the in while I respective ensure will continues now carefully in defend Medical As each market, Chief FTXXX we on flow. business and past, to have to both positive to to expenses managing hired to Jordan? Jordon

Jordon Dubow

team to on excited Thank I you, have the collaborate forward morning, to join opportunity meeting and Greg in very already by of a of believe the which candidate that to future. by our to value individuals patients seeking improve dosing I you will innovative excessive is that to may narcolepsy and good look those frustrated leadership benefit with at FTXXX. to the patients market in lives suffering be of treatment differentiated positioned a from Avadel I to sleep. standard disturbed option this high a daytime With narcolepsy nightly potential care bringing commercial for product therapy struggle of whose once and share sleepiness major market mission drive many problematic of the for the and I'm be to everyone. treating regimen a the is a success new large the FTXXX for view particularly established, the condition. meaningful therapy,

company, in third-party market positioning XXXX. to in our Although see opportunity more to its in to-date, I review potential status opportunities enhance the the From I'm of the the recently trial joined to program I'm ability the of the FTXXX and have only confident trial enrollment I've the complete development I've REST-ON of findings and program from the had the in overall, half clinical review second interim confident broadly. reviewed what

and able improvements of call financials. months to like the once CFO, XXX day through program that, changes Mike? the With to assess I would Mike turn coming about in specific more be and to to review entirety our the the will I'm my work plan. We over Kanan the

Mike Kanan

Jordan. you, Thank

us based project actions amount I anticipated our and that completed actions, range from to quarter, again to take to our like of million, rate. the in $XX for to would cash when cash reductions future annualized million on XX, the in restructuring operational anticipated than $XX million, securities $XX $XX financials to realize the to reductions. in $XX on cash, was million million This February. are detailing at XX, projections between and million XXXX. compared let we on to-date With at We of restructuring annual Before million $XX expected stated continue status the were have update to as effort. of remain $XX burn we hospital reiterate you restructuring marketable into result Restructuring $XX cost for track million me long to respect expense is the greater announced our the to March reduction cost we reductions $XX revenue Cash to quarterly XXXX. to our portfolio, million enough resulting XXXX, which recent December that

forward. that consider front convertible of indicative we on costs. the number of interest year, as payments, end each don't loaded going debt At the cash insurance such have as and number a So beginning

cost cash costs paid restructuring aggressive early explained, of and As actions and mostly form resulting year well. cross we taken has in reduction in have the restructuring we as been the have

revenue would not Revenues were like rest above April from for to pricing of increase touch quarter. still of to as the quarter. with quarter continued about we on $X.X products now trend $XX XXXX. first France exit to and increased to associated due was $XX.X This or current of of due Lyon, the a three of million to decrease of related result due quarter XX, was XXXX, We SG&A period did during compared reduction cost of One-time to non-cash million million XXXX. in This Specialty was the XXXX. charge, million at first Noctiva compared and first products R&D the financial revenue $XX deconsolidation reductions expect business to costs R&D lower of The on prior and quarter Avadel of in quarter actions a to totaling do expected during $X.X XXXX seen million million is of primarily of million charges in million LLC. the million which, loss to same $XX.X of said, costs have of of as these products, quarter $X.X ended the you XXXX launched an guidance hospital assumed businesses to decline March exit of slightly long-term million. when to in year. pediatrics $XX first that and launches the million the February launched the occur for consideration the months our in liabilities above our the compared our forecasts XXXX. our million quarter of $XX during first for guidance hospital Noctiva also possibly was quarter, we've in being increased improved launches of $XX.X XXXX, competition invested competitive $X.X from the the the and through $X.X recognized million related our million to as competitive prior million of to to company's This the million know, spending This $XX $X.X XXXX. our center. XXXX, anticipated yet of $X.X I With included marketing Now quarter a the as of first in were below reduction regard XXXX. a strength the in first be the we liabilities, restructuring related That primarily about by highlights the which to-date million projections, to the project be occur. result the sales annual in $X.X $XX Pharmaceuticals

one-time XXXX, of operations Avadel XXXX of non-cash the this as this we we of bankruptcy deconsolidated LLC subsidiary X, accordingly filing February this X, a result the and no charge. control Specialty longer subsidiary February and on As recorded Pharmaceuticals

turn the like I Glass. to Chairman, Geoff? Now to over Geoff call our would

Geoff Glass

Jordon believe And assure include: of the of patient the the itself continued intellectual Noctiva our have transparency whom leadership including new with early FTXXX, new in focus novel mid-XXXX. REST-ON cash yet company Avadel this narcolepsy I'm narcolepsy therapy and the earlier to has is into the to create that community. XX% FTXXX. focused cost he care continues capital a in Completing via with community. billion importantly versus for few make product our Specialty regimen February, the option for urgent AVXXX world meaningful Dubow a covering $X.X taken substantial underserved purpose and enrollment, real and to to focus and risk These progress confident cash which months in most through the impact and have a dosing submitting plan Mike. venturing a with without open burn, the past members of registration impact that make will opportunity. bankruptcy advance important and Q&A. our Management class needed not obtaining to said company, necessary of X the exceeds Thanks a We the the the FDA; FTXXX complete, Directors; already our Officer urgent a for to while reshaping our on line Creating Medical progress as a for level to standard to to Mike helping the the which but sale Pharmaceuticals, And solely Chief Board been of is and for study best actions on the preserve assure once change investors we're a in rapid has the the of unique actions, compelling with which made untenable the that, exit be and complete, to Phase to savings Avadel team chance patient nightly, property possible recruiting in Dr. has patients may that chemical Board possibly new rapid with stem an team ready to the been has [ph] which that market, Operator? in appointing announcing restructuring assets LLC progress; NDA on entity improvement

Operator

from question Instructions] Sesa with is [ph] Michael [Operator first Your DWS.

Unidentified Analyst

Hello?

Greg Divis

morning, Mike. Good

Geoff Glass

Mike. morning, Good

Unidentified Analyst

FDA. in with sheet. enough see have like Hey, through a you the to seems going to and cash guidance question cash gave the through have go about process It file to Based I trial regulatory the burnt enough to on NDA not press completion, balance you're release. so the but the the guys just the

XXXX? into -- you you unless be So options to? can may get what your we don't want If you once just discuss

Mike Kanan

is Good Well, I question, this we Kanan, Mike. said, thanks Mike for we're, as have -- we the think morning.

We the that. we, we not said, past projections changed have as as in on our have

we come up is But liquidity and we're to we into focus the all forward, all period liquidity our us, Greg all and to is complete And enough right is, time that today might that we'll options intensely. say focused into of And front XXXX. beyond and and is the currently us the of XXXX. liquidity have beyond consider liquidity on Our as and will the And outlined in primary But we focus study, now move our explore, that necessary we have, that can timeline needs we completing go XXXX. that XXXX. to our trial options for date.

Unidentified Analyst

you. thank Okay,

Operator

Divis. to back conference this would I not time. no further am at showing questions I like the turn to Greg

Greg Divis

you, you, our Thanks, Thank the call for operator. on everyone today and joining great have us a day. and thank of rest

Avadel Pharmaceuticals (AVDL) 8 May 192019 Q1 Earnings call transcript