AVDL - Earnings call transcript Q2 2021 | Avadel Pharmaceuticals plc

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Operator

Greetings and welcome to Avadel Pharmaceuticals Second Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Courtney Turiano. you. Thank

begin. may You

Courtney Turiano

ended thank morning, joining release we and our the corporate and can The conference accessed be providing on call. update on quarter for results This issued www.avadel.com. financial XX, you morning XXXX. us release for website our a June Good our press

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

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

Q&A At additionally Executive Richard I’ll Medical Greg are of Jennifer for turn to Chief Kim, Affairs our Dr. call today Officer; Officer. Officer; Clinical McHugh, Commercial Gudeman, over me with and Greg. us the Divis, following call this the will Chief Chief Tom call. On Financial time, and the join VP

Gregory Divis

begin on the our and update managing we the our thank the providing Good move you will progress treatment call by significant once highlighting call. planning morning Richard our an we an launch continue FTXXX, October turn the will and I everyone our to commercialization bedtime us symptoms over PDUFA on towards potential then to Thank I commercialization you, quarter of to approval XX provide of on date. update business XXXX for at Courtney. closer as our narcolepsy. conference will second joining for and make who

Lastly, only results Tom will review we a enter will final the look of the date assigned first joined the review and sleepiness with stages bedtime Jennifer. from we suffering and This will particularly option session Avadel, conclude important or October for excessive managing progress be and has our will toward once an PDUFA for approved quarter where been If of and financial NDA narcolepsy. at FTXXX by we of Q&A for be XX. cataplexy quarter the as EDS daytime

and the our advance organizational our commercialization and future NDA course regulatory XX, of to capabilities potential of to from just and expansion, legal continue readiness and priorities, aspects progress, preparation that We October are only away report months all we of excited on I'm remain two incredibly pleased our track to business all across and planning launch FTXXX. we are support and execution, of

market. to living shareholders, and filing vision two at our starts excited delivered be would related we of beyond Avadel, for patients for as days and ensure advance course FTXXX to narcolepsy, FTXXX today. our store of in the with we bedtime with XX exactly a where are and plus regulatory are bringing and our continue to months our This plus once have XX against what for have plus team, date for strategy. NDA a last the business months, consistently PDUFA As the for we we key and company we objectives our until next

date. regulatory to matter Book Paragraph and report. I'm agency on we have stated As submission, news we have pleased effectively by generated clear, how stated and related issues is with regulatory this have the in Orange of anticipation this to to basis approval, filing no forward commercialization such filing been good our to to strategy. FTXXX our be and executed not have with preparing and to review a nothing against Based advance the To exchanges certify the to the barriers bring we market filing as are we and with to FDA IV there to and with confident based or date strategy on In and strategically before, FTXXX has to filing. data on the FDA and NDA the To deployed remain asked XXX(b)(X) we potential developed on have news diligently have navigate certification. our listed differently, any we regulatory is our request previously we and a patents launch plans. potential we we progress believe any share in Said regulatory indeed track to we date specifically, we such continue remain this, have don’t gone parallel, new are any pleased

to by importance narcolepsy. as of gathering living and potential FTXXX people be feedback energized the a continue the treatment option with on We are insights for we

for if approved market. opportunity narcolepsy As share meaningful research upon based to extensive market we confident treatment a for remain in and such, potential the FTXXX command the our of the FTXXX

from On pivotal at the announced FTXXX new the evaluated. support clinical benefit X to XXXX, which the QX of at during continues data all doses clinical we of REST-ON SLEEP front, all Phase trial

and FTXXX. endpoints FTXXX, efficacy of they a generally well as at the demonstrated statistically top positive were of II a Phase met regardless all by As doses not. effect participants positive bolstered hoc as three points a co-primary secondary or these of whether benefit FTXXX Showing narcolepsy was consistent compared evaluated, week-three delivered co-primary or stable if of or pivotal of early as and benefit SLEEP we I from significant The trial data unequivocal receiving post dose of are analysis clinical results which overwhelmingly type all shared previously treatment. REST-ON stimulants meaningful positive the for had to strength additional well placebo three further tolerated as presented reminder, line clinically have the X XXXX. type

Additionally, dosed compared greater to in to decrease mass FTXXX patients from strengthened a that the These body with and option. a baseline FTXXX has placebo. potential of be data additional to treatment study transformative if weight index end approved significantly experienced body evidence the

with XXXX be journal expect and XXXX additional scientific through we at in FTXXX presented to pivotal the Phase meetings we seek data to once practitioners establish a as clinical of we the choice our review for progress healthcare As patients at for in have X made bedtime of FTXXX XXXX. and proceed To future we investigational sum and to leading up, I'm published as a peer extremely be proud data of narcolepsy. living remainder treating tremendous our expect treatment

and the approval plans on pursuit and our commercial forward With revelatory Our days strategy our and XX launch. filing we over date turn PDUFA to toward call look will including that, tract, date Richard? of as XX to plus Richard. we head next our potential FDA remain to the the October I

Richard Kim

Thank you, Greg.

option what hear customers some about launch continue at we overall our are I for the few our to made look have on that extremely people from in back meaningful with for narcolepsy. execution. track look full accomplished that tremendous to FTXXX continued I progress on at we for I we engaging pleased with Avadel, the now As we And be are to months. opportunity the significant have When launch preparations, provide treatment last a we

FTXXX. a First, the to of potential support launch build we team continue top-tier to

our with caliber impressed and of now in so heads to to of deliver ultimately sales, are We access, say are the who candidates pleased recent of our marketing, the I place market the commercial our team entire launch. people am joining with leadership distribution more. us and additions is

quarter out of as commercial regional we strong building first also even at and to more our company our experienced objective This what are of Collectively, milestone core really attracting the leaders, we the facing of patient do. are team customer talent key to putting the a furthering wave we team. directors, we success highly direct who build a also begin hired sales of

Second, our full milestones we of pharmacy customer REMS for the and deliver support will across specialty hub, all work, and XXXX. ensure ready achieving launch of our service in our target front is on walls our distribution network focused to patient are

we both with Third, team are and internal launch building full the to capabilities. needed support our external infrastructure

data We through data in customer efforts more supporting decisions analytic virtual enable are addition our or augment that platform relationship as and connected to leverage continue go our building our CRM management make as our highly to timely better and will in we to tools customer us customer building launch. face-to-face are interactions, tools we to enhancement

payers the and is nothing is, [indiscernible] are launch our as engaging physicians, more time than we important with important As patients.

our done boards of and advisory meetings. have We virtual share

are. our customers We to pressed have they really meet where

of the date. first corporate therapy across we the patient the have community. Jennifer's the mind, also out fully With narcolepsy sites now physicians, country, new had leading how since is just just been Avadel, their dreams to several World working our in of weeks a a which SLEEP including we active MSL XX, to has face-to-face and make team, Congress many in For reality. our that activate at that nights in meetings them narcolepsy really to PDUFA showing to a as advocacy few of we reminder, working narcolepsy is in in better a the before are groups, From narcolepsy to what met key days market, June. to only have Day the perspective, leaders from bring weeks, but we recent a Also, rolled have Narcolepsy with important some understand at campaign September not

market to market. largest FTXXX, address another having GPOs our need up interactions, payers. to cannot. to activity Avadel, payer the prepare consistent very research; discussions do here core PBMs an at been interest narcolepsy in bedtime with of engaging continue unmet Turning have and our come some significantly if to have options, have has groups high simply that we us and as once expressed customer we're our What shows with the the across The insightful, more we in at about as treatment FTXXX, customer group, country potential learn to with is with the that we approved approved, that currently to stepped

expand the our a oxybate the have as meaningful well really am potential Additionally, the bedtime utilization our I preparations. with of pleased of market, in that summarize, launch sodium current treatment as at narcolepsy with gain to prescribers. introduction the share oxybate of our To progress once data a shows

data of financial that connecting approval do of forward a to once-at-bedtime potential Tom customers to living with appreciate plan I track treatment now the be simplicity We I the and are provide I on updates progress with all further Throughout and launch our the our call our core provide our back conversations providing on have to commercial so that following and could on overview We more results over I throughout people of turn detail what our continue transformative approved, of FTXXX quarter. look narcolepsy. of are ever. readiness at, for an the if to looked than now for more plans year. to will for to

Tom McHugh

Thank a ended a in balance and sheet February of quarter equivalents we provide the with full you, results XXXX. matures million I'll securities that in reminder cash, as highlights and $XXX.X a million the press position cash in cash for release convertible have perspective, available we strong and quarter the debt marketable From few are the of and $XXX.X of a Richard. financial XX-Q.

ended revenue statement, XX income June intangible of any our also quarter compared any if as cost primarily quarter is not products, number in marketing, The a expanding SG&A resulted record medical activities, the in compensation consideration, ended The $XX.X and XXXX, in on did result XX, Turning $X.X change approved, the in injectable for affairs June portfolio on of the XX, pre-NDA a of and in FTXXX compared we costs XXXX.These $X.X contingent to operating asset changes expense XXXX to did quarter were respect in the we year-over-year year-over-year increase XX, a from activities, of a sterile the the same with of year-over-year include our as fair R&D our for preparing result research, not record period raw approval same value in year. million period related materials. June its as million well our expenses million and factors purchase and for to divesting expenses to the $X.X of expenses increase million XXXX. for XXXX the higher of to costs market basis, launch of ended associated organization. amortization, approval products With last in of XXXX. were June

little second June continue of in to team and share the diluted a XXXX. launch, tax income XX of the preparations have loss compared the $XX.X benefit second XXXX diluted or the the last XX for ago. have We primarily As sterile share the and to prior sale quarter In $XX.X our gain of to in XX year, and diluted sterile gain from Income XXXX product expanded year $X.XX was to million sale period $X.X people reported was as year. income recognized our same portfolio. share, we versus we the the net per of prior on million for of million $X.XX $X.X tax products. income compared due $XX.X or we million per to Net approval close injectable we per of net injectable over the quarter year the income the primarily recorded million in expense in expense of due

and execution approval, position Finally, progress with of of hand strategic little With our we fund believe incredibly overall the financial strong $XXX investments we're as over we a prepare to until remarked, our are a FTXXX. the we in over to remaining plan. Greg both for with on cash launch Richard pleased the million XX potential need financial against days and

for closing his the Q&A. going open line provides Greg remarks, Before to we're Operator?

Operator

Thank [Operator instructions] comes first from question Matteis with you. Stifel. Our Paul

open. is line Your

Paul Matteis

what or scheduling the you time was things how are REMS so Great, holds, kind thinking detail if that any one at interaction you might there's assuming would of guess much. there's but second, on give drug is around our a thanks when launch resolved, the And Thanks NDA commence more discussions more our on administrative, in you you the look guys which kind XX on then any that still one is so can two actually your there like. obviously much. this so I just variables through drug-drug note that, is is about would launch timing, I minds, been launch? if ongoing formally lawsuits on other approved I of wondering like with FDA haven't months are stay so risk? guess and

Gregory Divis

Yes, thanks, Paul. Thanks for your questions.

those, gearing very the at to how the progress although and mean I confident any fronts overall relates in one we've approval. we as it and to We process specifically the made REMS, it remain DDI As NDA on specifics into those two up won't around remain that regulatory full we go and a on confident that any strategy ties to relates to quite good the we the days looked of we're date received recognizing, pleased review progress to we XX now down about. how which date, our questions every both the obviously and topics with we've aspect of feel on them to really We NDA to appreciate number had the of of the engagement we're certainly and kind going to about content context of and a very NDA the forward the date. last FDA

couple to drug things the referenced a references relative there's upon completion relates and things to that related. of to the approval, that data building related of that and from do think to beginning. launch, that it takes and to lot the the we're you to timing, certain to I a be A ready time some we analog and to of label, or that think that approval whether final good DEA it the something our work, from extent I to obviously out be, the complete the the there's of build launch be dependent have that's whether of launch, REMS are As

and feel are that. the stage where this progress to we the assembled, great we relative we've team again at about So, made they've really

won't considerations, here is specifically to -- not as full or or to if relates otherwise, launch. intend we the telling is we will it judge about As we we resolved, that say what the legal litigation sit patent matter although speak upon final should absent even a approval, we strategy whatnot, us the today a it

Paul Matteis

Got thanks so much. it,

Operator

you. Thank

next Amsellem Dave with Sandler. Our comes from Piper question

is open. Your line

David Amsellem

thanks. Hey

is So, authorized gained for enter that, one that earlier space the than Xywav market XXXX. as Xyrem it is generics wildcard share possible in the oxybate could

understand payer think there about thought launching So legacy cetera, us or into XX contracting just does a but [ph], in at no help dynamics, market AGs timely where able space months over product on change a entry view are be how you'll in assuming the cetera, manner, how to do and launch of et all, with assuming scenario? that also your AGs all that there's an we're aggressive there's process if how your at that early et you Thanks. stay

Gregory Divis

it. appreciate perhaps, add start I any commentary? to want that do David. I'll thanks Richard and Yes, you on

Richard Kim

Sure, no thanks Dave. problem but here,

a an market. it's exactly comment won't great AG when question. could great, yes, So, the on we on be Obviously

we've what up, And that at this proposition, pay we're a we've the will the see data making with thus clinical with comes guess preparations strength the they've time there that payers However, good oxybate. stepping really, we marketplace. or of in is there that not and launch an been Xyrem one really the bringing our the clearly think being that AG be I it the going than had even payers by the and they're be convenience absolutely not either the we is, constrained We've assumption value is still we're and been are overall to far by Xywave marketplace, will definitely engagement both there be And and clear clearly with when it one I can the say the very all. to table. clear received if only also twice to

still doesn't dynamics. sort treatment the change potentially we generic best, a of in the landscape cost and like at and overall really well very AG go see as being high marketplace, conversations most our being So the

it it ready or if we with it and the comes with in have it our exception maybe a if you insights of few for doesn't, we add? know don’t won't Greg, to meaningfully really for there's marketplace, that change anything what So, if I we're do the payers,

Gregory Divis

part it Richard contemplated with think the that sure we're or not our But Yes, considering all obviously not we've you we think engage know. how as David information predicated event when that the going the our as noted affects is. large of what category. would product. That's pricing trigger is twice will be is net strategy, when we saw in stakeholders, done what earlier before We're I or on occur. the in and all that on to about we We work AG price net or cost be to that oxybate that increase a pricing us contracting the comes that that to of Xyrem going plan if of this nightly an X.X% year relative

And be drug there's that between AG that differential price sounds of and certainly we to now come so to it a there's appreciate know references, on we the distributor. holder exists, AG left their is margin whatever and like going sharing a that have the

I marketplace. going current from typical payers in is XX% will to the AG that an price be to that be assumption which to is where talking get a more into and may of off our brand perspective, is establish pricing think So point likely the XX% to

David Amsellem

Xywav? been there you yet where to think switched in how focus can a oxybate have on the us to intend you to terms who patients grab on, switched Help And just commercial understand or Okay. if may take sneak not with Do experience? patients been think patient continuing that second from do is about to in had potential you you share, of Xywav landscape patients over. I question pull

Gregory Divis

want again? do Richard to David. start Thanks you

Richard Kim

treatments of a narcolepsy, they're in think what they really to generally people their Sure, get yes, generally getting they I overall, level therapy. we with until with from that Once certain satisfaction see adjusting again, results are interested with so their

is Xyrem surprise the a fundamentals considered to those doesn't that for know if have from see David, still not see oxybate we still Overall, be has that to they're treatment. as to if the here of patients opportunity twice there nightly The at it's their all So us to some been Xywav. a change reality FTXXX is really you receiving approved. absolutely and shifts

target switch Anyone fact be absolutely approved. there despite see patients opportunities have for consider Xywav, So already some been treatment a and not. that the twice who with also switches made to who's once considered have has we within on definitely to a the for night we'd FTXXX a patients oxybate who key

Gregory Divis

this recently recent I I very from, would on oxybate, both really the think to where obviously really projects source about or come who of those naive to around Yes, have business novo we terms the only feel of twice talking topic. thing that sodium in also we continue add the nightly to patients assess physicians is, marketplace explicitly of And to can of good hundreds research but patients come de product. off and large a

again, I the think landscape how changed relative to has recently. So,

obviously well at commercial of So FTXXX to a creation fair market for shareholders. opportunity meaningful and the for narcolepsy I bodes to take our all patients bedtime the think of our that value for again large share and once at to contributor be

David Amsellem

guys. thanks Great,

Gregory Divis

David. Thanks

Operator

Out next Oppenheimer. question Francois from with Brisebois comes

is line Your open.

Francois Brisebois

guys. that out from Thanks anything the my taking showing side, come bringing week a is obviously are comparisons SLEEP it's And wondering, couple all was three? for down then why conferences, as of fact, something that that's important so specialists questions, the instance, just is about? I as Conference early results but just these the cross are here. it talking BMI difficult, for Hi BMI, the on

Gregory Divis

weigh you to want do in? Jennifer, Franc. Thanks,

Jennifer Gudeman

Franc. absolutely. Sure, Good morning,

and with trials. oxybate, So to once FTXXX just the that this given is by are forced is week-three, the living of fact FTXXX. fact reported with associated degree far nightly than sodium randomized positive many controlled why that we're we significant has a narcolepsy earliest nightly. have been reduction a could a obesity, reason as the at as as BMI Then have earlier of reason patients with without who don't that weight certainly and that is effect but is, shown a with And demonstrated possible twice very been the results clinicians viewed pleased do interruption a onset with why certainly patients high co-morbid has in definitive occurs be as that loss, in the for weight

Francois Brisebois

Okay, talked you can conferences out expect conferences there, about XXXX, out what other second there, I maybe there just in quick that can If there some much. can are there's we expect data, which thank some something? where very ones we a one sneaked in you still are that

Jennifer Gudeman

happy It's to begins we meeting present, Orlando. past that start couple Association Absolutely, our we've the to a which XX. virtual begins accepted share of also accepted the a to at Congress October PDUFA. been of that so a Neurological have mix present in the And CHEST October and American then and days ANA, live both been also XX, meeting

Francois Brisebois

Okay great, to trial, from the from like RESTORE what see we trial? that would and

Jennifer Gudeman

is patients already it preference share nightly allowing closer into important and most efficacy. nightly, safety, who transition FTXXX. tolerability tolerability, results were importantly, to continue patient and addition It to and efficacy the are expect once RESTORE, the far which information And pleased in with to oxybate in what with dosing safety, we we're nightly so with accumulating to we're for twice about related once on very very is to launch. allows accumulating and regimen, to the for we're regarding original information the who participants pivotal So long-term the on trial also the

Francois Brisebois

Great, That's from it me. much. thank you very

Gregory Divis

Franc. Thanks

Operator

Out next question Livnat with comes from Wainwright. Oren HC

is line open. Your

Oren Livnat

if lot you, are what might in for recent anything. orphan Obviously, a of exclusivity Xywav couple. of a mean interested Thanks, granting people I had the

to related guess would to get that be else's get is is was to question, you originally is bit have I that to or question is, major contribution did just wondering thanks. the hurdle What I you about with your orphan separate care? own And the with hurdle talk regards what to same FDA think what exclusivity? little probably conversations So in likely orphan and if you I that have, patient get most around a safety to criteria do you exclusivity, could a the to And someone market? to the is NDA your

Gregory Divis

Yes, thanks Oren.

for and that the superior of I granted that think, mixed product that support FDA we the was here Our clinically of was sodium our night. hypothesis FDA for under narcolepsy Drug NDA narcolepsy Drug twice on oxybate exclusivity Orphan the not approved as in first granted nightly as the FTXXX plausible may our our as a it we the data So believe, actual foremost Designation obtaining already of wake does today the symptoms be support not we've should middle to that treatment in XXX despite the having noted, and approval. reminder prevent formulation that Orphan based full provided our submission us is and impact orphan a designation, to in up Right? XXXX from efforts generated to standpoint. clearly exclusivity from salt that the to we you for secure Designation Right? those full sit own review drug to

certainly shared sit that review gone date. we what speak we the with that to as with how won't we In certainly here specifics. to we pleased gone how than interaction has Other have been terms and FDA, has of explicitly the today,

Oren Livnat

that officially on approved existing in original that not guess after of sodium I though I same is NDA? guess Xywav your addressing had when I correct, there we filed and orphan information already you assume been guess NDA, or questioning, should low your Okay, exclusivity line hadn't you yet, received

Gregory Divis

incorporated mixed it given our where since Yes, submission be the where assume could and it product again, you into appropriate it's bedtime, at had was. versus it was twice-nightly that a been once certainly should salt still approved

Oren Livnat

Xywav switch an which as Okay product point profile to I'll reflection understanding you just there on to move or well your Xyrem in and patient you we're as patients, they as and because looking also for represents just guess you large commercial. of unserved do improved those for you then on curious, data are patients that in unsatisfied willing just population market, encouraging warehouse Xywav seeing my a on just think Obviously, and fast that do and/or there's the new? think think I'm Do maybe something will that's a or view an it -- have switches, of patients really the Xywav, go either faster inappropriate market? general this it I were based simply that therapy, represent obviously does

Gregory Divis

Richard, do take want to that? you

Richard Kim

question. Sure. great Yes,

So of little we their people more bit narcolepsy think about seeking generally as ways improve with Clearly are treatment. I overall a everything. to it's talked

potentially So a something is even something mixed version salt small different. new maybe as as, as

know are it far on concerned. in co-pay lower new think are We therapies the as seeking just assistance patients there's commercial that I also a bodes that But people well differential as marketplace. relatively

are mixed probably patients a are lower version benefiting few therapy. salt who who a from the there from out there, So salt are

overall, speaks that I narcolepsy. patients to bodes this once to bedtime relief well think us a I the are their can your more and marketplace. the we for it And once seeking really However, think point, have to therapy from generally get at fact that

Oren Livnat

Got I it. appreciate luck. it. Good Thanks,

Gregory Divis

Thank you, Oren.

Operator

-Hallum. Our next question with Craig from Robin comes Garner

open. line Your is

Robin Garner

morning thank you questions. and Good for my taking

had You've a on few to shift comments the Xywav.

specifically guess, this for been mentioned, net sales you if in at I have could Xyrem curious that and point. comment on the total Just product Xywav

Gregory Divis

have do you any Richard, comments?

Richard Kim

are to from still the we Yes, XX,XXX is others see see I therapies. currently marketplace, overall there's that who still on about mean, on I think that patients oxybate what reporting XX,XXX overall Robin, we

oxybate last transition here probably well. that's been year that's from, to it the as the sodium there's mixed because almost are patients the But obviously, from an off about of our for as who offered we relatively twice-nightly of build not oxybate as bit We salt a are version it So know research, to base actually stable taking plus. know, the a going of but taking the challenges of today oxybate. we half from good

to opportunity marketplace, but patients in stability addressed oxybates the the clearly our concerned, the good as see sort where of of far prospects patients overall are we for we haven't see also really growth both, the twice-nightly as needs today. So

Gregory Divis

you're the Yes, really Richards, we again, that, And relatively and had opportunities. its which example. the seen that once I untapped I'd just what same other continues of to hasn't commercial really you FTXXX, for pitolisant one an indications introduction robust which as effect, at with market, on when with our But products having agree add couple impact relative bedtime. oxybate that again comment be no excited the the the on the is whether franchise, performance. about patient remain we've oxybate bullish potential historical despite looking with to is to

Robin Garner

the you more your Okay, oxybates out to franchise. question, provide building can is program? distribution any Last on us other about and for REMS the that sodium efforts there your thank comment the challengers you of detail to

Gregory Divis

you ahead, want if to Go Richard, start?

Richard Kim

market of that approved. Robin, really get with all we what doing to bedtime ensure the once can we're FTXXX pleased we're aspects at once if to so Yes,

our we're developing our our excellent across get out services on now. had patients. We've is to milestones To network our not discussions goal there, and our right hub a for a world with approximate partners class support update our build scheduled it and so get are clearly deliver we So to our and strong track easy. to SPs offices of is will can that therapy across fully the REMS, [ph] patient ensure we that all

that the circle. with believe do all really we focus customer really the throughout Support, and Patient the outstanding provide to service can we on However,

to are upon So track commercial full deliver our launch. on we fully

Robin Garner

Okay, the thank you and luck to team. good

Gregory Divis

Robin Thanks,

Operator

[Operator Thalmann. comes with from Thank Matt Kaplan you. Ladenburg Instructions] next Our question

line open. Your is

Matthew Kaplan

night just questions. done my study terms doctor preference a dovetailing the and I'm switching the hearing wanting product? for taking patient you're research kind what to guess, and preference that are I for that twice-nightly And seeing patient out to thanks oxybate of there? see in in once-nightly you terms sodium there from of far of on in RESTORE open once so what with you've label Hi, preference

Gregory Divis

you part and Maybe Yes, second Matt. the take part? can first Jen the thanks, Richard,

Richard Kim

absolutely. Yes,

It's been So to pretty We've relatively work we've darn what's is of extensive. hundreds our far simple proposition hundreds it's clear, we to great the research been and physicians know, that spoken market the to and in, Matt, understand. inside as patients. pretty from do really see as is that you

actually they marketplace. us really to leading overall clearly, tend the the given is It's of First the and and proposition physicians within oxybate for people understand foremost, patients an not supported data and by And bedtime once what give a is, we therapy. of there'll see hard what outstanding thing comprehend. to at are when second, clinical of and opportunity a share be a option, course the

very to receive can done So we've at value next are the like that mean research of the strong market insights patients. reports Jen, multiple the the part would you a bedtime both consistent we take physicians FTXXX to once and that of around and proposition to question?

Jennifer Gudeman

Absolutely. because can't We're regimen specifics coincide with I we're are fall the for share submit thus those very right bedtime in congresses, at night. our with to seeing pleased patients prefer, a once consideration at or oxybate we would what of now, launch. planning far springtime in terms which dosing a the twice which

ask to unequivocally can more with what but tuned stay for very, details, stay pleased seeing. we're you very that I'll So -- we I are say

Matthew Kaplan

I a great. Greg. guess Fair FTXXX pricing PDUFA? thoughts question for going the on October current into Great, And then enough.

Gregory Divis

thanks. Again, that decisions no we Matt, been that there's although -- that Yes, think would I say have I made. final

variables the is lot assume this as price to certainly at we of no at at of safe to managed it's across looked different it think work, front, we've a given a a and and have payer number different category I how doesn't intention there factors premium. ranging certainly price

I priced. of treatments the of be kind are the would where as would I area oxybate So describe currently it current think zone in

Matthew Kaplan

Thanks detail. Okay. the for

Operator

Thank you.

Our from next comes Jason America. Gerberry Bank with question of

open. is line Your

Jason Gerberry

think good FDA about one, ODE know, ask than This at the clinical Jazz like the more confident Thanks step the and superiority on Do the of approval time something concurrent with for Jazz's And approval. mechanics taking ODE once-nightly the is, ruling initial guys, FTXXX the reason you dosing to you curious six of only issue Hey, a question. got know ODE like my I reach of and approval. ODE? you're approval, months just I needs after morning. thus precise sequencing

approval? this if a is that instance, approval, the So to decision at in wondering, with thus just ultimate rendered be needs drug Thanks. your more time is ODE and of intertwined

Gregory Divis

we we our to Xywav impact expectation of that full Again, doesn't believe perspective the ODE I potentially being FDA answer Jason. your said, obtaining That us FTXXX. where of our approval question, today, from specifically those our is we sit submission thanks think the around Yes, from designation the same XX FTXXX in with on and specifically be other -- for we decided period. or month our delay that and approval time saw would provided that that's be an view. product, current you that Orphan and the It decisions both prevent arbitrary wouldn't shouldn't

Jason Gerberry

thanks. Okay,

Gregory Divis

Jason. Thanks,

Operator

And closing session. to would you. for this like Divis call back now Thank turn Greg the question-and-answer over remarks. to concludes I

Gregory Divis

And of support thanks continued your operator. for joining Avadel. and you, everyone Thank

by for. I our again October the really at this just XX ourselves you a strong some date we're a two from many long of Date, PDUFA know which find of views, just time me up have Let where wrap that months restating is in particularly we position time, our waited away

our So at our And patients excited as for track, subsequent this XX we that date we shareholders, really approval FDA about in once the of has what plus bedtime commercial to filing we all are stated head on plans our for for and FTXXX. are prior, next includes Avadel, and strategy. launch store regulatory days potential toward as

wish great joining and all Thank be you you. for a us everyone, call. you today healthy all have thank the So day. stay best on the and and to safe We

Operator

Thank participating. call. This all for concludes today's conference you

may You disconnect. now

Avadel Pharmaceuticals (AVDL) 9 Aug 212021 Q2 Earnings call transcript