- Earnings call transcript Q3 2022

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Operator

Good morning. My name is Rob and I will be your conference operator today. At this time I would like to welcome everyone to the Avadel Pharmaceuticals' Third Quarter 2022 Earnings Call. [Operator Instructions] Thank you. Austin Morton [ph] from Avadel Investor Relations.

conference. your begin may You

Unidentified Company Representative

Good morning, conference us our for thank to discuss you call earnings. joining third on and quarter XXXX

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

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

Financial and Chief the Affairs, McHugh, Richard Greg. Divis, are Jennifer Commercial the At Chief Medical and call Greg President I'll call turn Tom and Clinical to today Gudeman, Kim, On Executive this Officer; Vice over Dr. Officer; time, Chief Officer.

Gregory Divis

formal with for quarter for therapy narcolepsy. importantly, FDA's Avadel's QX people for to tentative was everyone, granted in bring of our adults results Good in us important Austin. by you third narcolepsy the or was for this developments granting Most Avadel. XXXX with pursuit oxybate and very in three discuss morning, to to you, quarter our July. Thank Avadel approval LUMRYZ results. once-at-bedtime LUMRYZ, the treatment The FDA decision tentative daytime joining another approval cataplexy important thank sleepiness excessive of investigational morning and

First, has for is safety this as We and major it event derisking efficacy clinical LUMRYZ therapy. a that view as once-at-bedtime such, validates regulatory approvable Avadel. profile as LUMRYZ's and a confirmed

us the enables the end activities are in program manufacture launch-related of and complete key these launch and year. activities, have made in before it including work the track build-out Second, significant on on the both completed REMS to commercial to supply. We of progress QX of the

is potential no opportunity. market expiry XX, now. what it X date which after that will a we is we patent, should XXXX be launch later that then final Lastly, QX billion-plus occur than is REMS the expected of on a the followed will final approval of approval believe months confirms $X latest receive June A into by from decision a approximately XXXX,

significant $X the with data real-world prefer research our the segments, our interest will analytics market Richard capture The see belief the to and where from take share more the We recent confirm projected of will and in our we and Very in supported provide actions seeking comprehensive coming switch approval, options. of continue continues are twice-nightly by dosing which all bring to new the people well to confirms once-at-bedtime is to across further data to to shortly, patient necessary importantly, with treatment is desperately RESTORE RESTORE, the of a study, research of final data LUMRYZ of who that narcolepsy combination market highlight all that LUMRYZ XX% physician what real-world extensive market. billion-plus LUMRYZ. LUMRYZ oxybate meaningful patients to positioned access of once-at-bedtime along

Book we at to We data the XX that, has turn motion launch delist XX the efforts to sooner. request approval our continue REMS to next Delaware accelerate Jennifer LUMRYZ. case potentially patent opportunity has details over the Orange of Eastern call week lead Court of XXXX, subsequent specifically, a decision following is our More and base to in to expiration to provide receive final presentations. approval that on and on from forward Jennifer? I'll Delaware to Tuesday, for final to a REMS on look assumption a hearing to decision our timeline recent renewed the the the November Time. and granted pursue Court's the expedited for decision approval potentially the our a.m. a With could final June Although patent scheduled

Jennifer Gudeman

good and Greg, morning. Thanks,

important As Greg Avadel. was this an for said, quarter progress of

continue add the support extensive of robust FDA final will and positive the supporting to body launch, data These evidence We to potential approval. following LUMRYZ.

Let's start we Test RESTORE. weeks from few the Congress updated three a presented with ago, held posters where our had data study open-label with

least further dose. one long-term of tolerability provided who we participants First, XXX LUMRYZ confirmation safety among and with at received the

been dosing After not will These immediate consider of for LUMRYZ, perspective prefer. three equivalent patients oxybate, titrated to clinicians months previous to within total oxybate. have are data patients, patient the one of be may release when experience critical and commercially. Second, their Understanding regimen The asked once-nightly at to is intake an instructive dose of to efficiently taking dose stable for nightly switch on real-world we LUMRYZ previously which more launch most Avadel. remain month. switch therapy patients majority a they of

overwhelming will preferred for they that As offer, we there regimen XX% with preference consistently, only is over stating twice dosing nightly. once-nightly an dosing LUMRYZ the have seen

twice-nightly understanding the Let's look with some oxybate. the of at preference reasons that for by challenges

either For which of dose, key several those about second from revealed the baseline with points. the their at experience asked we twice-nightly oxybate, switching

the participants the as align worse feeling them, frequently the day. accidently dose negative hear thirds next past directly their dose with from three XX% Of data missed we reported of a in patients First, months. these, a about what next had second impact two These having worse day. missing and feeling to

Of that they more confirmed reported than Next, patients. their experienced after first second dose. grogginess. day XX% with what next align anecdotally - the data also XX% taking dose These these, hear from hours we four

wake reported need someone for the them participants to else dose. Lastly, approximately second the of XX% for

towards the of were Mayo an data Mayo with turning findings. were cohort. the ANA psychiatric recognized generated that three more patients the without the comorbidities to at number narcolepsy conditions. conditions, increased, the considerable in Among of be were XX with additional Clinic X,XXX XX years. What matched were interest Both equivalent sleep in are pleased Now narcolepsy We to identify examined seen people XX past very in increased were increased the patients top to in to with partnership cohort than debut narcolepsy. top three comorbidities compared These narcolepsy well a two meeting.

First, disorders cohort. five increased narcolepsy the significantly were gain-related in

hypertension include the types infarction as disease, XX or or Second, other comorbidities myocardial top stroke. such did of cardiac not

and over impact and further with can our will available I focused is will details We that most Richard? narcolepsy XXXX and specifically have data on collaboration commercial additional excited that with for LUMRYZ opportunity LUMRYZ the transformational real-world about the turn provide when medical to is now submitting narcolepsy. evidence the Richard advancing preparations real-world has from we of to congresses launch. be to the treated call be we community been are Mayo validate people What for cohort oxybate. for generated the the the Clinic on with sodium

Richard Kim

were narcolepsy specialists asked people growing But [ph] and These provide people And lot and I'll overall good told morning, demonstrate our reminder we us, our meetings readiness. I'd commitment with are updates with a community. launch to for and product do. with times market we Avadel's like of conference, several when of our Jennifer. unsolicited, today, have seat to they narcolepsy to of team do insights on are waiting aware approved will made be This each a fall, continue Thanks, the why our we what everyone. well start and it. to At LUMRYZ available. attended

want step told in share a.m. he couple the to at patient that one single has really every to us father up story so a call college Now family take that me. he A X stuck to son wakes does up a.m. his have weeks son ago, dose his for taking I he oxybate attend for that and where the with X night, of the can't of to day of in miss wake night the middle not don't son that both next day. wait his classes and further, the the to at second just he

and as we caregivers. overlook bringing narcolepsy and their people we much in sometimes This is remind narcolepsy, cannot hear families. the relent our why to many As on of us, of to continues family focus and on people with that LUMRYZ with pursuit often once-at-bedtime the we members one personal stories we just impact

planning. of narcolepsy of understanding focus XXX which validated Let our advancing market, and some once research treaters me launch assumptions continued inform about again offered quantitative deep from conducted to now project insights on market continues non-oxybate transition that our market narcolepsy a new current new to important the prescribers. our We our key over

takeaway even and prescribers. oxybate While current LUMRYZ questions, non-oxybate several we one prescribers that use available will oxybate increase is is across ask once key

market Here are a research. points key few from this

can eligible for patients identify therapy. prescribers oxybate all First, who are

treated patients about However, using XX% of narcolepsy of narcolepsy low-volume High-volume an in with additional being all By with oxybate. treated oxybate using with their oxybate treated. another an comparison, eligible, many under oxybate eligible but state in an stay XX% with being not prescribers patients are not XX% oxybate. but oxybate eligible, not prescribers still XX% patients

Second, XX%. by oxybate when as at shown share the by profile, will current utilization measured market prescribers predict grow market oxybate product LUMRYZ that least

are despite use the not in state Third, not prescribers patients formulations. for who currently one narcolepsy narcolepsy that eligible oxybates, HCPs oxybate do prescribing four their twice-nightly of these

that, their not top twice-nightly other the to comply challenges with prescribers the In similar are are and oxybates inability reimbursement for dosing. concerned the with of Now with using reasons patients groups.

the oxybate the treat. and they eligible in that these LUMRYZ identify LUMRYZ almost patients would profile, can they future current shown when product would non-prescribing half HCPs already of use they However, stated,

high increasing these prescribing all We LUMRYZ oxybate into intend LUMRYZ segments, to also the LUMRYZ a when in oxybate and What scripts last greatest Avadel, market. with prescribers. growing give all awareness once-nightly sodium is of awareness increase this in compared across HCPs available about highest that the see future to translates is share oxybate year, oxybate

oxybate a three market, analytics suggest that the LUMRYZ current total estimated the Now oxybate the with [ph] the segments. perspective, XX,XXX more patient of from of our Recall, key potential claims that twice-nightly double position potential market market eligible when roughly be than could patients. consists we patient look for at

twice-nightly actively First, approximately patients. XX,XXX treated

And robust patients also XX% we yearly per have Second, in roughly growth previously of year segment, potential this are years. XX,XXX patient that an XX,XXX HCPs, preference an high three patient who expressed oxybate different estimated oxybate therapy X within and LUMRYZ in is important third, dosing for in X,XXX treated most to formulations. LUMRYZ levels All Thus, bedtime and expect with in the the the have starts, XX% twice-nightly care. to last demonstrating the attribute the current comparing with interest standard oxybate of aligned new belief segments over our discontinued when of future. along an for therapy once-at-

the our QX the launch patient to and made from launch full for all of us specialty mainly pharmacy The significant contracts a we finalization of approval, of busy team. quarter commercial LUMRYZ our progress for decision ongoing our LUMRYZ prescription services time the our support the detailed final turning will efforts. have to the enable shorten building a progress supply REMS, approval Now the build-out readiness for and made June We in a fulfillment of development, was the XXXX. of launch enable after quarter in to our third will network. that programs

strong and attending of the we and at mentioned, at CHEST live a some showing meetings as ANA congresses, Jennifer well patient a couple As organization of as the presenting in first years. had

manage payer our and with insured at the several XX% commercially the the makers key GPOs that of had the over team lives. On meetings decision front, PBMs

are just update to now updates update the build-out We final portion our LUMRYZ, invest paired and build the I knowing decision. at look future launch a continue conversations company's be began from with about call financials. to how team, This forward We feedback out One contracts Tom continuing away while X more to for when and our months latest only of an to advance readiness. coverage that, first that on positive. with we will providing key to launch need continues them to are plan resources. the approval remains, thoughtful around more what We over the balances to on we and calls. turn our about our Tom? With now be for launched-ready, on be

Tom McHugh

quarter. September the notes, also the in reported at XXXX. October And of few marketable a September million Richard. had $XXX.X we provide February market repurchase cash note you, highlights $X.X we press also release with company Thank the XX, The of of $XXX.X XXXX. that of as in in I'll cash, results $XXX.X of and notes start maturing XX, balance sheet a Subsequent financial which million available of XX-Q. discount I'll are million and million where open for full securities equivalents million mature completed the par $XX.X to that convertible to XXXX. includes of an the

As a reduced was amount February $XX.X that the result, matures in million. to

And operating Greg excluding inventory taken primarily period were The $XX operating compensation related factors, September $X.XX in quarter million. consulting fees. call million resulted total costs cost quarter in the quarterly and in XX, to XX, costs. number the in million remarks. target the cost $X.X in diluted $X.X are third same for diluted $XX.X is to million manufacturer per million ended $X.X September of of in decrease company. $XX million LUMRYZ XXXX, share XX, ended XXXX. including lower XXXX, compensation, a from million of and approximately in $XX.X to will the current period charges, or for closing the expenses per expenses in or track net our quarter affairs $X.XX quarter actions September lower million to $XX same for compared expenses, $XX.X was loss loss of lower the The is XXXX million compared expenses $XX.X to quarter XXXX The by on Net million Excluding compared optimization XX, a decrease quarter the cash $XX the to now of in medical to operating restructuring period $XX.X compared to the same turn million R&D were same due XXXX. in the result XXXX, the marketing, of June were XXXX. decrease to share back purchases range approximately period XXXX. I we in for in the reduce million the to expenses ended ended and SG&A

Gregory Divis

a share stakeholder once-at-bedtime demonstrate our and command for value approval meaningful of the market. for launch $X executing on wrap important is derisking our to for insights a time element up, opportunities are supported and date from and LUMRYZ to Thank approval offer thereafter, and X a to approval approximately a we both, final backstop opportunity and which you, launch. as Receiving months To that Tom. further being accelerate which is receive to the expect feedback, between to which by mission a on billion continue our potential away LUMRYZ company, we all tentative of LUMRYZ the overall the plus priorities shortly a most approval final focused customer us significant decision decision the significant the proposition shorten oxybate

of and our future for relentless look for including will fully patients, and thank call you support, for Operator? efforts progress. we investors. stakeholders, on the We our will value all We updates questions. realize open we to the prescribers LUMRYZ With to forward in providing remain that, your

Operator

[Operator your the question Francois line Instructions] Brisebois from And from Oppenheimer. first of comes

Your line open. is

Francois Brisebois

Congrats Thanks on All for the right. the progress question. here. taking

quick couple of a ones just here. So

you when what more us can be REMS, Why you might of Just building around understand the just it might little color In REMS? can straightforward, challenges it a be? come that. out not why up terms maybe out help build

Gregory Divis

a work it Greg. ensure to infrastructure a two do an describe and this staffing you of it's then and launch. from infrastructure, a fully approval And the as staffing programming safe that final designed there is you it which whatnot. technology execute is in to to REMS program necessary an and Frank, Thanks. There's component IT becomes second the it - toward a subsequent piece head actually use, I really that, and as required Yeah, would get steps.

a great experience who controlled partnered experienced very again, substances. with REMS we provider leading has So with

is the we And be advance. you date, track. from is standpoint execution head the to end our the before year, of to so well up the this of We'll on an again, from be completed that which underlying, calendar to expected begin as to staff build-out standpoint, components will clearly, operationalize approval, will, toward in necessary But of it, final if a done it. resources operational

Francois Brisebois

useful it. reimbursement? Okay. guys in important Great. the data payer's good - of perspective terms data on And is some of Is showing the that then in terms - payers you RESTORE data, for keep or there from

Gregory Divis

Well, maybe let on comment that. I'll Richard

Richard Kim

is, question. for clinical from Yeah. bank a thing that team of really RESTORE from her range from we're Thanks Frank. produced data the full Jennifer RESTORE. have with the great and and posters The of both, Hey, now blessed actually

with say, once-nightly the been in-depth get being XX% everything think, payers. prefer we So a formulation, patients, conversations to I And would conversations, very I twice previously be with the has useful of fact nightly well. bodes as the on when on into that more

short, the payer leverage absolutely the in forward well. as Frank, yes, So going appropriate that we'll answer in settings is

Francois Brisebois

happen not, on timelines? mean in Just the in get that made, made better what on is what if expect a Okay. just The of about feel the can to Great. through And last of if for is you terms does hard of next say, week. here, you do Delaware the although, in but decision so Can terms I then the be the just potential, walk us here? have to in I a bench? the ask I outcomes hearing here. question. to potential of decision it's terms XXth feel steps it just the And on Or kind next it to like - sorry, - timeline? favor, maybe your

Gregory Divis

Yeah.

situation view well, a were I we we our on we large expedited hearing how the an for pleased is that think, hearing specifics to speak going - describe after kind what the the to and the we to of sides That Delaware the it be, request decided at of what we're which just briefings that motion obviously noted, Court litigation, not construction standpoint, what part to not not as is that process grant major from to But the it's for this do. listed all of a matter will argued all Tuesday. that delist, of August. end were the be should by documentation, by specific parties, of completed will be And next purposes, in hearing. this on reference both Book? both this be as from Orange And patent the will claim work

been briefed fully quite it's for some time. So

Book be chance Tuesday, us, would path to request with a court their issue path respectively. one So go agrees both patent outcome decision. our final expect to transition will patent If the of to of certainly tentative sides either then will listable if or because that us. that, to on the he we expect with the for - delisted, be to of a the not agree that, of work The Orange us down have down that a nature we agrees of begin things. won't to with approval of argue would from that court we and go approval it agree - their two the with is The sides, would immediately us, patent

will the delisting be two this be final will there [Technical subsequent to steps. FDA's that be decision. required It approval will in and Difficulty] So a then case,

that the We insight We're has So pleased of or expedited perspective. in and judge he not? meeting. Tuesday's from that the just no granted to that for look bench hearing the when how occur, request timing terms from rule our will and and have forward will

Francois Brisebois

much. Thank very Perfect. you

Operator

of Fadia next comes Your Needham. the line Ami from from question

open. line Your is

Ami Fadia

Thanks morning, questions. for Good Hi. taking everyone. my

payers. to coverage to about patients about Thanks. payers wanted as some as the questions us entry you're thinking Firstly, of dynamic to in of XYWAY give thinking you of what have XYREM you're potential how in thinking I color the And how more the or of about I understand payers Can of from regards have how context are you FTXXX FTXXX there? sort multi XYREM from contracting then year, generic the around some later. future? next early with received possible with And or on Thanks. switching feedback well

Gregory Divis

want Richard, to do take that? you

Richard Kim

Yeah, great Thank sure. you. No, questions.

sort X.X% brand. is, generic that will authorized the priced really least from that Most other again, brand XYWAY well. generic in meetings. meetings. they're great just conversations in mind really of the been as time the for our the team strategy, several it's be parity be so general a the coverage are range foremost, parity. think we we've more our in the stated and compared to generic is - more fall, market once we also And a potentially it been discount payers. feedback treating again, and times, we compared front and payers First, we've the assumed that basic XX% to at extension. the about predicting AMCP of people with this the than Also, has strategy, about to first always XYREM authorized keep be by authorized the hear expensive seek Well, to out the to currently the PCMA And payers really Overall, is similar price generics will really is as branded oxybate when about launch. And But overall more in one-on-one of our priced

which when think directly So is we sort of going we're of what foremost, others through launch. philosophy, contracting be GPOs haven't, first contracting about X with we sort and to our the going before

oxybates had our of across for have years. XX well no what under major is, the competition say had has think They've conversations really sort feedback positive. the sort I of been we're X So way really can our I - GPOs. And with

of, leverage one conveying done our the not that I'll as I they the another to I branded it's really job the well. to clinical board naive. thing value we're has conversation. fact proposition mean, know think enjoyed compound But across We also team have really the payers conversations. an the excellent marketplace, coming want there's say So the in us that their

progress the be payers And we've the like really with we're is feel where GPOs. the PBMs far the the we place around we now. coverage downstream we're need with So decisions in And the that later. so impressed of right right with made to also, sort

spot So now be we really the think sort in where we with right right should today. with sweet we're right payers of the

Ami Fadia

Great. Thanks. And purpose, Let's my to you that set us question will assume be but second help after can how about for think ramp year? is, it some expectations time of just the next for sort June.

So in to really seek early familiarized that wait the coming the where context, sort two it XYWAY Would understand start up processes. with long would to and things new physicians I to of you the have rents better. are XYREM? get running, from? wanted And sign or up How be Thanks. that until to to adopters and given it get to take approval

Richard Kim

Yeah.

final We our to certainly I you and we we timeline post on, So can will an was them, prior one going to of a REMS done condensed a physicians limiter question approve. significantly question first be What rate approval register to be regarding for decision. launch. until post be previously second engage that final our to that impacting with sorry, had relative of an the don't on we've X be timing rate with sure. on approval a and physicians' significant actual continue work months, you point that's as forth after approval. at We view And will the and could date so in to I'm that upwards question, just given down, actively Ami, your But from think, on the limiter a don't restate? approval, view REMS a to so out done to terms been engaging to REMS the certainly build

Ami Fadia

how physicians on sort new was, to filled or needs whether processes The it coming the patient had familiarize form part around, themselves second or patient The early a the of that take you you with from, other be to hub? to from just be to REMS think see for send long do where do XYREM sort adopters was it question your would XYWAY? would of support I

Ami Fadia

that Yeah. Richard, you to do take want question?

Richard Kim

Yeah.

the use really far and certification our right maybe really laborious and in critical products. sure that process. board. make sort it's PI familiarize training Obviously, really timing of of physicians. is So as the on we themselves a some But the People as to REMS first, component appropriate for not essence, have the a to

take done So long. in very label. past, dissimilar been but not to And clearly, own our has it's it shouldn't what the have unique we

more about as we've there's XYREM from a Clearly, we a see interested that long prescribers. business process, learning sources current of all as that prescribers and LUMRYZ of well. familiarity in see sort don't types both, XYWAV pretty as patients lot market just well. And much this of From as our as from. a tapering the a we are of very more And with coming far patients. we've So answer of oxybate high do in marketplace seen also uptake But bit done we where and the latest see candid sort research the is, really of our Ami. research XYWAV wave, segments that

opportunities our great we've - more be see as tend research. And as very motivated for for earlier - we done is even from patients value clear doctors the more as for market well. to probably them our So proposition XYWAY XYREM seen is patients,

on use support to all narcolepsy of want us see becomes them as we volume, There great the current to market in sort this the the interesting opportunities what efforts prescribers really marketplace, is, research research continues would to low of focusing for wave said, really ones. was end high they prescribe will day, to our show are within latest have at But of users half LUMRYZ current is, almost when going of it volume oxybate, what for we're And our be sort oxybate well. who within users. prescribers. the clearly of initial the So the high available don't

clearly we'll value the So to all that we're across to sort out first really to. speak see segments stages of over very of launch. But those delighted LUMRYZ proposition time the trying of our we're that just of to sort comes

Gregory Divis

only Richard's that these I highly thing we've described within business, XX,XXX to is The all make same X,XXX that that add these physicians in within the of Ami, that really would standpoint. predominantly XX% volume. to segments, that that concentrated that they three fall from comment, up It's XX,XXX group Yeah. of patients source

users, referenced a of So for the opportunity as the opportunity it is exists. kind where lion's of high us our concentrated oxybate Richard very share is

So thank you.

Ami Fadia

Thank it. you. Got

Operator

Howerton comes from question from Chris Jefferies. line of the next your And

Your line is open.

Chris Howerton

And little all respect two Thank for me what durability guess of sense of give specifically the us team. launch how LUMRYZ that persistency then good translate on a the more give questions. Could us to a with Hey, team to hiring ongoing like? respect discussion market? a and timing the on for you patients morning. of to be I the And the of you more you. your in commercial you look readiness. maybe I bit and Thank the study, commercial distribution expect kind appreciate understanding to terms about little so just would you seeing with might for that you're of taking RESTORE much that could

Gregory Divis

on start Thanks, do want RESTORE? to Chris. Yeah. Jen, you

Jennifer Gudeman

for Good question. absolutely. morning, the Yeah, thank Chris, you

put had of participants the March in out XXXX, with set, discontinue we've October this is XX% So study. study just coinciding level the we to in of What when pandemic RESTORE started. obviously, this that began about

once fact discontinuation. participants of a not the is trial point the that clinical surprised to their month travel until X it to site and medication Schedule a pick approval, to the label rate are of these open that by because having are up we being So

travel higher a basis. could fact, those understood to with on were In I if requirement sites have to it monthly the

that very low of about it's reactions. be participants to adverse to had about adverse one noted we we're presentations, X% discontinued oxybate And taking with due can I In think know October is biggest we formulation. a discontinuation have tolerability most due any who that the what there's of challenges pleased of that events. rate

Gregory Divis

Thanks, Jen.

Chris Howerton

That's helpful. Thank really you.

Gregory Divis

up we'll of can toward? frame Richard, just building maybe team of kind you be kind commercial the

Richard Kim

Yes, Chris. the super. question, for No, thanks

here. readiness for our we've of going that key first, skill to as somewhere what previously, of launch could representatives goals some mentioned sales Overall, retained stated we have So out around sets obviously keep we've our we XX our is there. sort momentum so our

had Greg volume. there's XX% up of As prescribers, X,XXX make X,XXX mentioned, the

know cover with team. sales we those all that prescribers we of can that So

field also out we field team have as will reimbursement there such key as We that well. will members have other our

as into as approval some is - have of well. outcomes begun trying we to sort as obviously, folks that where backwards June well. remain back be hearing building have depending We we're from date. of backstop But become here flexible, hiring on some just mentioned, the And the what mix of that we'll

buildup we're a next begun So year. the has make going June ready sure approval a to in way, that very latest we're to targeted but the of at peak for

Chris Howerton

one I you do mind And in if sneak maybe Greg, Awesome. more follow-up?

Gregory Divis

Chris. ahead, Go

Chris Howerton

want you of Okay. additional any Great. to due notes the the still the to I strategy that plan see that comments And that some there? kind you be Tom, that I'm opportunistic were Is guess. outstanding? for make purchased really Or potentially those happy to in February, around are of still notes

Tom McHugh

opportunistic a it No, some at discount. to we is buy nature, Chris, Yeah. a good and dose had opportunity back in

last that be in that the need of is come cash assumption due with cash in is settled the months February in to our runway regards commentary anyway. Our couple notes that to

So some along way. we a bit just the little accelerate purchase to able and were the money save

Chris Howerton

And taking nice Okay. Well, thanks that's for the awesome, question. to like see. I said,

Gregory Divis

Chris. Thanks,

Operator

from question Evertts comes of from next Adam LifeSci Capital. line Your the

Your line is open.

Adam Evertts

of Thank Great. sort One for you. me. clarification

from Richard surveys? XXXX? details a prior format or at new you On call, expect on medical I in data those the is do present other guess, that meeting to survey survey data either mentioned additional And by a this or way,

Gregory Divis

Yeah. understanding the new our and We're of refreshing It - research. market. it's a updating is constantly new

a don't future from some study a events certainly and recent these provide learnings at to in is And of referenced. these Richard insights kind commercial very, very data that that both continue of this if we'll quant data I large of prelaunch we as congress. scientific go present in some know a and So we'll then But potentially day. specific forward, sorts

Adam Evertts

you. Great, awesome. Thank

Operator

next Your the from SVB. line comes Goodman of question from Marc

open. is line Your

Marc Goodman

waiting legal we're anything the Court are could other Delaware Greg, it, you there then is If next trying there gives any a that should right, first, remember negative just to left? be stuff. week do? patent issues if I'm until the the is Or that listed, on outcome, June? you

Gregory Divis

Yeah.

the after case assumption decision week us happens that's will June. give primary little next toward whatever expiry And we're timing. a of bring either next whenever occurs otherwise, Tuesday, the Richard described, that that. think operating the XX up an depending next opportunity - I to the earlier, approval - Otherwise, potentially an as base case ruling upon June depending base it and is on post

Marc Goodman

the that hearing. out, the I'm thrown the process Right. like result saying this administrative just Markman is of got

this just scenario nothing is to else So if mean, goes going We'll okay. right? I fine, do you're it that where right? negative, it's like There's to June, legally. basically, it, go that

Gregory Divis

legal other no sooner, pending could There's something if you react result in matters, or will, that Yes. correct.

Marc Goodman

Right.

just of if Good. unclear there a the to judge long And it's be How be you - to going we month. this then if it figure what view takes is and week outcome, It Okay. then It think? it's couple a do a right weeks. positive clear, you on or take? out next think if could take do could positive

Gregory Divis

hearing later for It's really grant be would pleased I the request predict, on to X he after that inappropriate expedited hearing. only say. it It to claim We're that too was us October standpoint. that would decided days difficult construction our XX, from this

are away accordingly believe we've days the hearing expressed we than the and the understands X quite the is and matter now. from less urgency again, So well that court glad

Marc Goodman

Got it.

on at have all? Tom, the managing the you with finances, ability? that tapped Okay. Thanks. you just Don't through one, ATM I And guess, then, number have

Tom McHugh

Marc. - third And over our ATM. it's no that's we a the - during what a that's we is million sales little quarter in - XX-Q, from we raised But that Yeah, $XX off the right, if about right.

Marc Goodman

Right.

And $XXX.X? that so is in included the

Tom McHugh

It yes. is,

Marc Goodman

I convert? then date. I did the you catch for million And When in market Okay. buy the didn't the I'm the $X sorry, open just

Tom McHugh

It quarter. was the course of over third the

was purchase. no there So single

Gregory Divis

purchase? was a recent convert The Tom.

Tom McHugh

notes ago. this No, week month a the apologies, we repurchased It Marc. actually. The note. just was My in earlier the open about market just

Marc Goodman

see. I

pretty convert with up rates general? Okay. And darn holders mean quickly. in really how have would I - have I backed I discussions been guess the

So discussions been like? the what's

Tom McHugh

I I think Listen, as constructive. them characterize would

with formal haven't engagement the holders. convertible note any done We

deliberate this out think characterize I decisions next hearing like they, the would legal our making next before our approach. I us, for constructive. how generally discussions on in want week, But proceeding being see as what plays are We to to do.

Marc Goodman

everything hinging And been as well? of to week deal? waiting you, royalty And type anything discussions next forward? on moves started management doing kind as have team, in of Have a with potentially some discussions those is before also

Tom McHugh

Yeah, question, to And communications months, played we and that these do how Marc. been fair out. in several consistent want over things really the legal - thinking last our we've the our see

timeline how X at Delaware execute base and next a the pursue. played we week. not noted a course, puts our in puts an to up better decision. the legal favorable outcome, earlier, Of the to but as say do June us, to item looking the I approval year how form and in position. options. it us want out is know and necessarily - see a of favor a course, time decision next We're may of have coming just towards we that's out, of DC wouldn't a because case And planning of that to finance Greg we And a we us It's gating all proceeding turns

Gregory Divis

Yes.

every add, add, very financing consideration prescriptive sheet as -- just capital balance upon - One, and the the we've notion bit I the would approval thinking in of a and about I the valuable say on upon launch, of the And with launch. just the would cash as We've cash in The today. $XXX company million the committed Marc, - for Marc. I and of and been comes a our that of been form thing us couple quite that other over things. would hand, is this

So think advancement number parties that potentially committed to in - final who of we've had the a with upon future could sort the of discussions in approval. be NDA capital of of extensive a progress who do the sources

on we're position or and little if put whenever to to converge timelines that in ourselves again, for, ruling bit of next waiting to don't become So just have a favor the out lot Like the goes a I message we've to the to want or themselves. our work decision a between is compressed after in coming of begin after an and recognizing it have that hearing. done year, execute next in next that send June week week, approval of begun

interest at fund in through shareholders of how lens company we of, So the for we're solving best in launch the involved the our actively and what's sure.

Marc Goodman

Thanks.

Operator

from line Kaplan Thalmann. the question Matt from your next Ladenburg comes And of

Your line is open.

Matt Kaplan

sense launch? And oxybate sodium in in attending on in PBMs? on and guess, secondly, just expand kind you're the after meetings Hi, patients. recently cataplexy XX,XXX What's good the of product sodium oxybate to the mentioned going I market terms of I you terms [ph] market zero these seeing the and low X full in salt able of wanted in there of of payers, and twice-nightly morning. the impact And narcolepsy, sense your hearing the of approval out the dynamics what's that kind to out components with What's discussions your after with marketplace? the being

Gregory Divis

that? to you take Thanks, Matt. do Richard, want

Richard Kim

Yeah, sure. Thanks, Matt.

we've to have are been thinking are I of they that the mention more thing on the we far going with patients when XX,XXX add than been concerned, of how of payers one as that is, exposed them. top what's of already So an oxybate. treated, really at sort first, to marketplace. of very can about as been vast sort on great that as are benefits had marketplace conversations I Maybe in look before, before I to switches, payers And that mentioned have didn't of coming have the sort AGs, majority the this one

well they've even very that payers already light anything that AG us which experienced of in to the oxybate coming before, bodes we're very for acknowledge marketplace. or will confident So an an

we payers So probably think market far are and receiving what be concerned, a the very overall, users, greatest from is, the that to we've learned positioned. think And not well low eligible few quite recently currently oxybate, where this oxybate non we're within research market as we oxybate who will that there's expand, are we users oxybate as are most did about viewed patients clearly. as still

the lower longer latest see who the is in again, and What users they've mix largest is percentage patients proposition the that a marketplace least to the to this here growth introduction in grow with opportunities term should LUMRYZ research probably identified well. coming we of opportunity just with our oxybate struggled novo at for past. by there from as to the of XX% we the in round into twice-nightly is of once market with really see So the have including from de patients the from prescribe more sort them already get -

lower opportunities So well. the but within maybe clearly news into growth even the mix see of the high is, good opportunity higher growth as some from we still and a getting oxybate users percentage non-prescribers

Matt Kaplan

Okay. Thanks color. That's added helpful. the for

Operator

[Operator the from next Instructions] Knickerbocker Craig question Hallum. Your line comes of Chase from

open. Your is line

Chase Knickerbocker

the Around commercial key on I [ph] some morning, Is of MSL everyone. put mentioned what guess, the personnel it in some Richard, added first the around personnel to your you on what reps specifically able tranche really call, some questions the to on the field I hiring? a And think do Good the has hiring, point them this side. trained sales of just Chris want get capabilities? capabilities, finer you how I ramp be to assuming of of of want in asked. management ramp case most timeframe up Thanks. the base launch? on approval, guess, sales June should of of we preparation about kind board of for been

Gregory Divis

Thanks, want you Chase. start? Richard, to do

Richard Kim

Chase. Hey, Yeah, sure.

GPOs get the we resources on new selectively so the we our well. PBMs that framework in hired and a focused we've as the wave added are also couple areas for have the with our yes, force we the as head can sales, So going. more well of we payer some just And sales conversations that is, have in of a we with - of initial where

from So now the And goal the we'll financial balancing because June, But June, well, potential to approval to final to to that think our our if places, with need to XQ a of to we the territory, be sort force field as and of customers our situation as that a - well. bring time their are make is compressed once in lot launch, want of sure with the to sort at on familiar time. and right a sort our with timeline goal few you of is they the selectively decision that with approval adding grow. we've clearly fact peak a before backwards everything really

Tom need. as the We're balance of also mentioned, of may sort legal up proceedings sort that able to to continue in some both, from Greg and off. have But we be we still of and the So wind sort of the where with position as pull a financial to balancing raises well.

been The wanting is really I in right interest we're to spot. lot a now, Avadel. come great news of So a in join people there's good feel,

our retained really we've folks for right plans be and June that kept ready sort here, to the and time building with to the peak backstop at goal date. of So again, once out is that around our

Gregory Divis

Yeah.

sooner, in that toward to that build would we've and a a pull how that, if I have And how launch and of then a think, plan event of there's right, you comes decision we - and thereafter. that Chase, I detailed any got the June up really news disciplined add just you that approach from standpoint. a decision kind then good do

So kind days, of that the longer noted on out. and got poles where the again, -- are those require board. that that bring it's of into work in that things roles I leading are kind all we'll more Richard those that up tent We know think mapped

the appreciate I So question.

Chase Knickerbocker

approval of matters mean, is then the your X outcome could. thinking in that color. Around November. now kind if November sitting potential due at your we're it what - needs that potential of And make kind and to approval In thoughts, what regulatory accelerate patent less deal now. we're Thanks. its I happen. Helpful a Yes. positive if that getting for extra just assumption, it Thanks. last accelerate I with in being to me, on those we does

Gregory Divis

to process. Yeah. that two Again, I steps there think, is

results approval we The from working then decision and a court first making the that in want is delisting the final be as have obviously But than the that we're X would that in to moves then getting a from done and positive of soon to that decision as months standpoint, us earlier direction upside that possible that away. our standpoint. just sort is any from June that - create momentum only FDA recognizing

a have important slipped standpoint we're noted little but taking that as bit we've have this pleased hearing that that place in bit, week from think little Delaware standpoint. next timelines certainly that that converged the is I from cases So a the

- kind if as is decision the ultimately, approval of and think function to launch is simply a any really we earlier, I put a difference June QX, said And that, come if in it better, if sooner. standpoint. we go between before quite launching, of and from frankly, launching we've that

Chase Knickerbocker

Thanks for sense. Makes the understood. guys. Yeah, question,

Operator

comes question next from Matteis from Your the line of Paul Stifel.

is open. Your line

Unidentified Analyst

activities Thanks And that needs This can there? one for is would there to that latest gating James clarifying us occur? of prelaunch a approval? of question. full scheduling. there just happen you to kind taking need guess, be remind post that anything on to quick the And Thanks for other our so DEA on any much. kind I Maybe Paul. is

Gregory Divis

what Yeah. oxybate has oxybate Thanks. Schedule a congress sodium There's the product scheduling of - is or determined is first already III. of all, requirement

we'll any standpoint. we isn't to not - it had certainly that whether It's after all that limiter QX, us - DEA our sorts a be therefore an contemplated it's relative June from launch market happen in administratively that we be So to expectation ready from of would If contemplates rate those or to anything XX be matters. consideration an timing. and in has of in approval whatnot, QX, related of to coming that launch

Unidentified Analyst

Got it. Thanks. That's helpful.

Gregory Divis

James. Thanks,

Operator

no may this participation, now at further questions time. conference conclude This your you there and does thank for disconnect. today's We you And are call.

Avadel Pharmaceuticals (AVDL) 9 Nov 222022 Q3 Earnings call transcript