Jazz Pharmaceuticals (JAZZ) 10 May 232023 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Q1 2023 Jazz Pharmaceuticals Earnings Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Andrea Flynn, Vice President and Head of Investor Relations. ahead. go Please

of and today, its operator, presentation everyone. Jazz our release Investors Today, this refer may Thank the website. is to quarter good also XXXX reported press section the on first is issued slide website. financial Pharmaceuticals Investors webcast also earlier you, we available afternoon, our which results. accompanying to The posted

Officer; Executive Dan call Head are Executive President Executive and Bruce Officer; Chief Renee join Manager General today and President Iannone, Gala, President United the Vice Operating On Chief of Chief States, the Chairman Financial Swisher, and Rob Sablich, Officer; will Vice Executive for Cozadd, team and of R&D; and Kim Global President, Q&A.

remind statements, actual could includes to goals, our statements. milestones differ forward-looking materially today's On which potential from related results, to commercialization risks I'd you such that and financial those anticipated and Slide contained forward-looking cause these and operating results in and and those to events, involve future performance growth like webcast as and that development X, uncertainties

to urge deck We latest on to in the webcast. to cause may disclosure today's our made today's contained actual factors materially statements. performance update the obligation differ SEC those forward-looking We certain which that and documents, identify our these from statements our forward-looking in company's you press release, results undertake in in events, review slide statements and no contained

release to presentation the are of included website. non-GAAP turn Turning non-GAAP measures GAAP measures today's I'll of discuss over section financial Bruce. press and to call Slide non-GAAP measures. Descriptions to On financial Investors and of available these this the X. our we'll slide webcast, financial now on the in reconciliation

record and again operational today. continued our on pipeline XXXX, to advance once I'll Thanks, you our Andrea. X. joining first the of afternoon, thank Slide we built strong start quarter commercial delivered In everyone, us excellence. for on and Good results,

Our our core durability growth and our results the of products commercial quarter capabilities. and R&D underscore enhanced

our sales, on continues these front, choose Xywav. AG, generic, sodium the commercial patients product We're execution a the strong drive entered key and as the to authorized even physicians high by to On continued that focus or market. oxybate Xywav, performance of especially low-sodium headlined

We high in both and sodium continue fixed that expect to availability grow the the oxybate. sodium Xywav of dose and remain AG of even will oxybate oxybate with XXXX, choice high branded

idiopathic remain the Xywav-active the educate our patients quarter. hypersomnia, effective and Xywav And is grew to in the are benefits both XXXX. product billion in efforts of as annualizing we anticipate resonating and now about in revenue patients product and narcolepsy net generate first Xywav in making IH, or prescribers outlined at $X our than will And billion more our sales, in in largest Vision by net market. franchise $X XXXX, in oxybate sales.

sales saw significant Epidiolex. We year-over-year growth in for product

our the ongoing term, meaningful to have first-line several lung growth. Zepzelca patient including now of open all small choice we European this potential new effort may strong populations, outside in longer for remains U.S. in cell opportunities European later remains approval Zepzelca lung cell cancer second-line up explore with Importantly, markets. X Demand U.S., Rylaze key year. treatment for the the launched in And cancer. in small

R&D. to Moving

by We stress in at the have in first-line Zanidatamab suvecaltamide continue JZPXXX in adenocarcinoma, gastroesophageal X tremor and post-traumatic of expect therapies least to GEA. advance to including multiple in and or pipeline disorder, 'XX, our investigational essential end readouts late-stage

significant strong prior top our execution line in first drove side, the and the bottom growth year. the quarter compared On operational to

for to allocation, benefit our line will business neuroscience, with candidates shareholders, we with meaningful in cannabinoids. more generate and robust novel disciplined our the including a business XX continue across most we a believe that drive oncology have value and cash than of We to invest In capital that pipeline areas continues for flow. patients

guidance, will our more are which detail. Renee XXXX discuss reaffirming in We

to growth and Vision value. Turning Slide North enhanced Star, believe sustainable X. deliver XXXX strategic which will we remains our

all to meaningful Vision areas critical we believe in to XXXX have important We of high-growth into are are each these a well achieve X our biopharma which transformation and global made progress of milestones, leader. positioned

our then the progress. turn which our to now I'll will Renee Q&A. call over financial commercial Dan? an will share to and Dan call update provide to R&D we'll the Rob open after on review a performance, overview,

largest treatment of of a fourth our at of became Thanks, in franchise. product across and with oxybate adoption as neuroscience share choice. the oxybate Bruce. durability commercial than low annualizing have X net remain begin narcolepsy I'm IH. as our Slide continued sales franchise the progress to of established sodium on $X confident and both the Xywav quarter is We excited as our and by result our continued of product portfolio. more XXXX of oxybate I'll and billion the Xywav

sodium first this the reducing of patients and and In royalties active quarter, on by is average sodium narcolepsy, continue educating we representing the growth resonating. to oxybate from focus approximately grew X% AG X% prior. prescribers intake, including year approximately on In revenues, to oxybate high the benefits to increased XX,XXX patients of message and approximately oxybate total Jazz compared

by and X,XXX exiting treat prescribers. is there only Xywav of approximately the XX-hour and of we condition fourth FDA approximately in 'XX the X,XXX IH, with were exited patients a taking an taking quarter, And new the In to the patients very of IH. sleep XXX disorder, with see quarter first IH increase continued growth performance Xywav, were quarter Xywav. XXXX. full of from treatment-approved first XQ approximately IH We is pleased patients and first the

symptoms been of IH. the Importantly, multiple it studied has across

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than Narcolepsy patients cardiovascular of an a narcolepsy who reduction sodium is condition, sodium has burden to X,XXX high milligrams on comorbidities. oxybate. chronic sodium X,XXX and risk XX% milligrams The sodium with sodium only compared of Xywav have of has recommends day the less of a focused of a lifelong Association approved day, maximum to the is intake education live and of oxybate Heart milligrams, oxybates. for high we debilitating Xywav per to around American sodium sodium low XXX XXX X,XXX per high increased

days health. and we This that of has significant potential had onset sodium of to of at control year's cardiovascular higher oxybate improved a with initiation To sodium group to the literature starting narcolepsy patients American of Academy new meeting data medication therapy high oxybate. a health diagnosis, narcolepsy antihypertensive not compared lower patients blood this sodium treated treated when pressure impact, high showed Neurology mass add within risk including presented being benefits, on with XXX hypertension

sodium in takeaways the In fact, months. quarter. competition dose high the that share branded anticipate few our first group. of With the based and control oxybate those key approximately January, on the I'll oxybate now the high AG competition, coming to With was risk and high taking in marketplace, experience regard of oxybate was our fixed AG competition in a launched in sodium additional we oxybate twice sodium

remains patients, to First, on oxybate of Xywav. the the only to sodium we the low available the be for expect It successful launch and future. it oxybate IH only build we indicated for continue to foreseeable

of the beginning choice Second, availability XXXX, narcolepsy in oxybate. oxybate will the the high both Xywav the sodium highlight high of therapy that patients that oxybate of we expect even first in large Xywav chose grow over with quarter I'll remain oxybates. and sodium majority

from to And and sodium to expect see both high AG Xywav. patients oxybate we continue Xyrem to transition

has years believe in we providers care for in XXXX of when LUMRYZ that high continues prioritize of such be in health all to FDA oxybate FDA majority also to oxybate, and recognize Xywav that sodium the meaningful likely Third, and all difference orphan sodium with between evaluating exclusivity clinically drug patients. Xywav the narcolepsy a continue therapy. to will Xywav recognized July is long-term narcolepsy. dose patients in in safer and than health patients fixed Lumeris, X content

I'll high is that sodium and does only related branded fixed to Xywav not AG. the therapy the high-sodium and carry a oxybate high also has intake. And as oxybate content sodium same oxybate sodium Xyrem approved the precaution dose note that warning

All of continue a will these Xywav is that be to driver give for us factors growth we that confidence durable believe core Jazz. a product

Moving to Slide XX.

net 'XX sales product growth million. $XXX pleased quarter XX% growing year-over-year first with in the are Epidiolex of We to with continued by

underlying treatment Epidiolex and the was in outside are earlier Growth seeing markets demand U.S., the we by the new to expansion algorithm. driven increasing of use and in U.S.

year combination first not a over see of second in more seasonality and resets the ordering in of payers continue historically half quarter, with to the to in seen insurance gradual the patterns impacting with U.S. the with we've plan oxybate. what build inventory a dissimilar We

to Turning XX. Slide

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complemented Epidiolex of are combination year These in the presented new by Clobazam. data use for compelling initiatives with last

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first schedule indicated switching quarter, on line clinical Rylaze, providers Moving allows the preferred and best is signs increase have sales year-over-year. to product for returning XX% to they Rylaze Wednesday, the were with in more Slide of the for first health are practice approval XX. therapy clinical for Friday a dosing care a of The availability Monday, at Net dosing practice. hypersensitivity. that of Based

Rylaze been momentum protocols in and strong oncology adopted has has setting. almost in pediatric maintained this universally

which Outside in we is to use increased to XXXX. there the encouraged European We also and adults is see that of adolescent U.S., application young of the the in or treatment Agency market, a us submitted in area of are May Rylaze Medicine emphasis of increasing XXXX. marketing the AYA for an an authorization

cell discuss first evaluate are to product have that Slide patient will also treatment the period which for sales quarter established Rob continuing second-line our increased net same in trials rapidly growth other Zepzelca the XX% small lung cell We highlights development in patient future XXXX. choice to tumor in types, cancer. 'XX opportunity lung to million in Zepzelca small new of we needs and includes other Zepzelca, for compared in also $XX geographies. meaningful in XX populations. as cancer plans first-line providing the

turn pipeline Rob milestones. Rob? update Now call an the upcoming for over on and our to I'll

in detailed programs Starting pipeline. Dan. key Thanks, our on XX, clinical Slide we've

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we're To breast cancer this the was excited year. high that Zani end, platform spine to added that

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Top of ET the half XXXX. in line data for readout trial the first is anticipated

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represent keys; scale, of X with such which composed hygiene study TETRAS includes understand XX We The post-hoc on handwriting performance composite feeding placebo-controlled and the a Slide which depicted as with drawing spiral, living, of T-CALM, X-week was on Archimedes' which XX. was from from a scales. measures daily items spoon, and X composite activity items the and and to double-blind, measure treatment endpoint. effect the conducted analyses TETRAS which from items TETRAS better randomized, using X is the

believe been safety the that have adequately exploring levels. population, duration trial Phase We patient and JZPXXX that across endpoint has of to affects IIa Slide IIb aspects of we've dose to primary psychiatric XX, several use study highlighted treatment selected an and designed been the disorder our the Phase evaluate for ongoing appropriate and X optimally suvecaltamide program learnings efficacy of people. PTSD, millions On key of a our that

Patients therapy frequently and in with lifetime behavior There mortality. have to the SNRIs adults uncontrolled function. living activities and to standard first-line includes treatment SSRIs Current treatments. X% been during of and X up associated is pharmacotherapy and of PTSD PTSD morbidity approved decades. medicines haven't significant cognitive used symptoms with that any perform impact new effects their as of their for ability daily of social care over

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is or Tecentriq expect an by in end and first-line Roche setting year. bottom the slide, the Zepzelca portion the of collaboration evaluate design being run with have on the to atezolizumab. the We we The with complete enrollment plus trial outlined to of ongoing trial chemotherapy in

will turn for Now to financial call the Renee? update. I Renee a over

'XX. Thanks, I'll start results Rob. top our with line bottom and on

As release revenue in by a and Xywav, Rylaze. key quarter was our year-over-year driven This revenues. XXXX, In products our both including of full XX-Q. reminder, double-digit the total and in our first impressive Epidiolex of are recorded of XX%, oncology, achieving of available financial growth year-over-year neuroscience results growth million $XXX press we in and

focus to $XXX Our adjusted compared revenues in income broadly period drove growing million, excellence net XXXX. allocation our on line with disciplined of and in same capital the operational

business, XXXX, recording cash of compared the of quarter continue first our XX% operations increase of an We to of to million $XXX the significant generate more than cash first in from XXXX. from quarter

cash important sheet, balance a healthy in With invest and development growth flows opportunities. business strong and drivers and meaningful is actively building we within corporate that contribute our to to innovation sustainable Vision well as component development have a an for patients deliver we we flexibility provides returns are opportunities Corporate that as strategic business shareholders. will of XXXX, current assessing believe to

Turning XX. Slide to

we We are XXXX the March. reiterating provided revenue guidance in

The the key expectations anticipated of We and growth with around quarter, our are products. and across in the our first oxybate expectations are our our strong reflects line meeting our performance executing in durability franchise confident guidance in those targets.

Our total growth. revenue guidance year-over-year total $X.XXX is for to billion, range revenue for billion us XXXX $X.XXX positioning

as guidance of oxybates. billion high sodium and in adoption both for XXXX incorporates $X.XXX of growth competitive Xywav to as Xyrem Our billion robust Xywav due and well $X.XXX to expected for neuroscience continued the introduction decline the Epidiolex

under net which neuroscience includes reminder, AG sales. oxybate neuroscience recognized under royalties, high product not also are sodium guidance a total within As royalties, revenues our

Due royalty expect half. we our within relative to to half AG in the higher significantly first XXXX of royalties be agreement second the to with structure the Hikma, our

is sold all a volume to ranging, XX% rights maintains in reminder, units oxybate distribute percentage the oxybate on to the and as a while tiered high going sodium and the wide based to and of royalty the high XX% the of AG, at half Xywav, paid total referring Xyrem AG. units, oxybate rate with starting way AG total XXXX, of Hikma sodium As Jazz first exclusive to

the Jazz Hikma AG to and where During economics of rate a half have at we of volumes. regardless XXXX, royalty substantial the becomes second both rate fixed the

$XXX double-digit in midpoint billion. growth guidance reflects a a million of for with expectations continued franchise resulting to revenue oncology billion, range this $X.XX $X of of Our

our quarter is a expected. we on the Continuing for first are Slide XX, through XXXX compared SG&A as guidance tracking XXXX, and reduction to

of the we reflecting last R&D represents Rob and midpoint our noted call. noted update, As as million our in in pipline, XXXX, enhanced of $XXX at guidance earlier the our over investment the quarterly growth maturation

bottom range deliver adjusted an our On expect adjusted We'll to financial of to strong shareholder development cash corporate billion midpoint line growth most we the The value, of the continue to returns. continue will with XX% line, commercial, operating in net that $X.XX the the $X.XX for margin XX% our and imply billion. prioritize at R&D our midpoint guidance to of efforts income deliver leveraging invest a guidance approximately we improve year. to our generation believe and strong deliver business, bottom and

shareholders. our diversification, and investments, call With positioned to patients enhanced like well further XXXX. the expanding value to strategic to on progress excellence, Vision operational focus achieve and And are Bruce. deliver back product turn to now we R&D sustainable portfolio, growth we believe I'd to and

I'll of Renee. prepared first our remarks report we've We continued momentum, started strong that Slide to on with pleased XXXX. and making the XXXX progress I'm quarter in XX. Thanks, conclude significant

the several strong now demonstrating past successfully front, commercial which On launched products and are the years, over multiple we've performance. durable

our company's to ever pipeline that at the we through it's than business. least have X data Our more And XXXX diversify in been history. have and robust anticipated late-stage transform to readouts is the continue potential

like allocation. sustainable development to to on operator have focused line the to turn for and corporate remarks. open concludes cash remain to call and investments make to our we our strong also We significant drive over the sheet flexibility I'd growth enhanced commercial, flow, across strategic now the margins, value. capital and Q&A. With That balance prepared the pipeline

from first with And the Fye our line [Operator comes of JPMorgan. Instructions]. Jessica question

kind in are? to color is what for Can this And us some is you business current environment? of interesting what [indiscernible] playing is Xyrem on This second, out AG give the of you how expectations Jessica the most your development Fye. then on versus introduction

say about authorized played All start with development. far. thing an let's can thought corporate our is way AG the it question out to that the quarter you jump Well, And handle thus then much Renee, maybe on about to with we important first most very right. generic. the market it's in the would The

entrant are category a only high growing in as when in new the and it we low-sodium obviously sodium in have an We without narcolepsy approved Xywav AG the hypersomnia, the remains both idiopathic where generic. only product product,

to grow hypersomnia ability year narcolepsy and Renee, you with guidance to, in idiopathic you and in I us The our both had experience. the [indiscernible]? is the think, for take guided on saw face corporate we to reaffirm want of generic, quarter consistent AG that overall based first what

Sure. Thanks, Bruce.

continues So important remarks. mentioned corporate in as prepared for I us, development be priority an our to

are not and goal, it assets to squarely certainly near in, commercial that of terms contribute think can cover the interested revenue Zanidatamab on are part of that commercial but We we our will assets we fully In as XXXX focused Vision it. goals.

assets. We also pipeline are at looking

that to do assets, we're to across in areas. not those clear, pipeline us rather With think can nor complement a we're right opportunities pipeline. continue are look bringing we now good We to believe that assets this need have near that in overpay We think that commercial we of assets, for do to or to And at for commercial environment. to both we respect be some robust we can there transact pushing going forward.

just have expertise, our multiple terms focus get then us commercial assets, busy here an for there's our revenue specific areas great footprint quite And a where a create the are global impact to for team. types really we of unmet point think we're there So need where within in, durable that that and opportunities tend leverage of in enables call meaningful interested can sitting bit we the addressable a we're then on patients, of company. to really to and today, more stream we

given vast developed disease on We're of we already. largely we that therapeutic applicable those the products commercial outside we're areas rare areas X neurosynology majority so currently certainly, and or of there's focused our there. serving orphan areas, expertise have also are exploring orphan operate certainly currently But where rare population, current

positioned We excited. lot from So well to a be to able we're think We're opportunity. also there's financial of transact. perspective a

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

last us number can you from on color, quarter, give you quarter in to some color anecdotal what's a of Could that the We but help IH the market? behind you happening understand more just with information. little on the us scenes. patients this Anything going know moved what's

Marc, that question over me let Yes, turn [indiscernible]

Yes.

growth they're going quarter. And sleep of look So we patients prescribers to increase we're see is the which to of on indicating active that and base, specialists, X we in a they're with first when to that, larger the continuing see prescriber prescribers experience see of is idiopathic great. Dan board compelling IH is the months. prescribing their get hypersomnia that bring And as what survey quite over new underneath X,XXX exiting you are we with the that Xywav product, next as mentioned for XX% continuing a in creating

only their idiopathic future. multiple But good only mind across So hypersomnia, remains do in for date in the that both indicators is a treatment well rare the and treatment with IH. to as multiple the studied the adults Xywav they're symptoms keep experience of disorder that FDA-approved as of symptom attentions having which the sleep options

and across this on Xywav. kind emphasis importance platforms. patients both channels really And that for just diagnosis identifying nonexisting patients providers building as is executing as And a are our of and the multiple well solid And campaign education result, prescribers as comprehensive and care health we're for on of disease the educating we're still market. proper really a a appropriate

really they've symptom actually daytime the them so been since a is condition just years the number Xywav approved the excessive condition. that sleepiness that they been on And of XX-hour focused reminding about core important have off-label that of hypersomnia well, some the daytime treating really fact of at And is as agents. idiopathic weight-promoting not treat full for a idiopathic of excessive hypersomnia, daytime that sleepiness to with the is

can the hypersomnia. Xywav of address And idiopathic multiple symptoms

gaining occasional with path Jazz been So quite an customized Patients the to reporting they're far support so the we're effort have access. during pleased important that they're comprehensive receiving from and and there, traction. that

feeling very confident this market. really in good, really to potential overall, we're So Xywav of remaining in maximize our ability underserved the

line comes of question Jason America. Gerberry of the next Bank with Your from

off is on in their up volumes second the in the rate it in big step Hikma the half. step-up, half? step-up sales? driven assumption will is a in up Or spikes the in Just the royalty Is a Or the with royalty convention AG have that and then way meaningful Hikma sort pay the that question you're that more second just of just that And to you it to AG revenue the once-nightly expect [indiscernible] the which for the convenience? just to captured? is it would stepped not reluctance an payers for be on through align just accounting period perfectly of generics, may also oxybate, realizing where

Yes.

of the of in trying they more has not over at really timing been patients of part to is the rate the the meaningfully the adding we're patients to accounting at half Hikma probably Jason, be the It's On have expected a really put than end or second the of beginning higher is year. the first period period. emphasis pretty thing. it's royalty straightforward. the The time, question, there that so

and that come to might contribute, oxybate maybe is Kim, handle the side will in space sort royalty I'll rate So the payer different. you. of they on that, high And how too. But meaningfully

Sure.

payers than been we and formulary the we patients of time commercial of So some anticipate importance experience coverage year do reducing educating the that coverage, for sodium, believe payer for And started are having greater and importance we understanding about reduction. Xywav. continue. patients, We've that generally to XX% payers that of we the out now can

the fact patients And the fact oxybate oxybate over oxybate -- grow position with leader is the sodium Xywav half they're more to this that of than we've leading the oxybate. continued Xywav seeing market all high and that on

that oxybate, Xywav that high commercial AG expect added high we other formularies coverage. including oxybates, So anticipate maintain are the broad sodium sodium as we to to

Cowen. Thome your next Joseph with question And

change of data support this in neuropsych Maybe since for think And this or pipeline the pretty -- historically in cat one and see program? are investment meaningful placebo what they do clinically be year. Maybe indications. scale in on additional rates the you is going sort would to JZPXXX those respense variable can we're PTSD

placebo II So Phase of there in anything context that try is do and the response? the you minimize to can

happy Sure. take I'd that. be to

Yes. over to you that one. on Rob,

Thanks, question. happy to Yes. the take Bruce,

it's So on with well-controlled levels we with the we've exactly first with meaningful, dose feel part, well study we your point, what placebo. design is that had will haven't discussions key we but FDA And we that said certainly And experts. powered the and be a think included the X to clinically

in recruiting population think entry. certainly see well-established severity pretty any patients study in upon might us particular of effect that differentiate level placebo allow in the we're that the from We you will the severe that endpoint to is

the Cantor line comes question Folkes Fitzgerald. of next from Your with Brandon

Maybe just.

the IH a on Following sleep-promoting agent on a from Can an market. the about earlier of bit the it the prescribers you patients, question especially try little there you're willingness seeing IH seeing you some less for with those Just education prescribers. maybe use you color elaborate to inertia? called heavy field on Are in inertia? just patients that morning prescribers intense with for patients initially sleep any with sleep

Kim?

Sure.

and are IH. to out highlights educate if in to there a agent that to XX-hour nighttime I the that So we are is marketplace. of a as education there prescribers Where, sleep-promoting daytime think can working that the we use IH that and that mentioned multiple address earlier, physicians I actually condition symptoms do just hesitant need both this

And are of sense. or nighttime we makes symptoms, that sleep call Xywav with result at once the quality the mentioned night they they treating understand nonrestorative at sleep, port what inertia understand why including daytime that sleep you

there, their we're progress to -- key making is and education and changing understanding their beliefs. it's So

your the And next Fadia line & question comes from with Company. of Ami Needham

I have question one follow-up. one and

suvecaltamide, PS what were looks that on basically it scores with for earlier the Just study studying reported the is Praxis the of [indiscernible]. same studied some the year, they where the you're endpoint that as performance like this

was curious you going continue see your point And so expect I study from that and you you [indiscernible] just to forward? its evaluate thought what to might

really to And is that Xyrem? really and really as in down generic, switches market, it that to who boils choice? it in influencing to the to oxybate generic physician just follow-up there say fair the taking a case, So dynamic the aren't the is

So Rob, let's suvecaltamide. on come to you first

Yes.

we remote from of question. aspects through endpoints, a that a that not number learned to lot the noticed measure in study, a respects, the can So as IIa only the We though including feel the challenging be T-CALM assess certainly server. thanks was study, for TETRAS Phase to performance it the how of but And endpoints. we

that. in not trial, doing So we're our

the around and of And differences and But with would agreed study, you're I confidence overall, do activities endpoints think the also having living lines potentially, scale, performance have in I evaluate we highlighting able in our something drive. our is with upon but and differences TETRAS certainly in trial FDA highlight to is combined to were T-CALM drugs. we daily

push calcium state-dependent into Our that's on given channels. potentially ion activity and ranges [indiscernible], higher you because it normal the agent is resting a to dose the pathologic efficacious state critical allows versus differential channels

think we have those doses that's by asset. a We design a evaluate differentiated X to So the our think in II we're we able and prior data. dose Phase supported push

And want a make to the comment uptake, AG that? Kim, you on on

I'll in really is happen even payer, say in think AG. can happen that the Yes, happen can we on Bruce we're a the that. so They the nice is the data see dynamics can mean, continuing said, a I in have or now. sure. to don't which face of as exact Xywav can we're They seeing don't I of actually uptake, HCP What Switching number case they places. happen of the right at pharmacy. with

Xywav or in about talked is therapeutically rated. have particular, equivalent We AB not that

the pharmacy a switching where that we AG. happen to at don't Xyrem can with is the for Xywav, switching but from certainly So place anticipate

comes question next Balaji Your from the line with Barclays. of Prasad

Just from ones two quick me.

the should upside delisting the scope Firstly, you secondly, of that the -- post the physicians comment neurologists question, perspective? a minor the court? regard thoughts could your to rest from the And to your direction received on you an the access with litigation from and that we year on Epidiolex? have anticipate any or Avadel further commercial for access with around you And on updates

about of second not worldwide? Epidiolex why we're I'll going and that But comment question take talk just Dan, to the litigation. the say first, Dan, don't of access sort on part ongoing you

Yes.

market. broadly brand. wins we more got coming face-to-face in about strong Epidiolex, we've the and growth as got remain great thinking great, access engagement. of engagement, into we sort is the that near both had year-over-year blockbuster In XX% some Just We've confident HCP status U.S. that we're markets,

had And of the now quality we've so always but we've of it's quantity access, -- got access. the

both the that In countries to, Europe, get last France continuing as indication. to markets, well to drive of the in was access for reimbursement reimbursement major the X as smaller and TSC we're

well rationale, So interactions, of the the with of the not to talk some that thanks caregivers cognition outcome. data and had I think face-to-face combination is also seizure shared, HCPs ability to which but only the stage in this set BECOME the to Clobazam from behavioral benefit the the about also clinical was

And to of COVID. an physicians as remarks et presentation And the care plus double on as by adults. Adults see there's that had areas about down then we prepared areas focus impacted with the the cetera. also been growth well in further to enhanced long-term area getting those mentioned additional as or were I dosing, optimal that with

the going for think we're XXXX. set, the stage with I pleased year-over-year growth well is the So and is brand and where

with question Goldman Sachs. from next comes the Kumar And Madhu

shifts sense commercial wanting if get point, certain that kind front, assets like you commercial you about near moves Maybe be meaningfully how towards commercial Is really on each commercial forward it versus the kind boundary assets corporate really or and think as a between near do XXXX? to commercial contribute Vision to to a to to there of from XXXX. quarter the business development of

is would gaining really and commercial targeting of Thanks our business looking whether And shareholders. patients, that the benefit assets right question. to underlying It meaningful benefit where can therefore, expertise say our near on on With meaningful we're commercial, continue we're or it's have that on I an to depends a the primary that really a and can of to for business focus ensuring M&A think Yes. the that our nature or that asset. respect we of at a that significant impact. going footprint. into our you're for type something depends access essentially the you're drop we amount lift it opportunity,

on opportunities hitting it focused not but we're do fits that We're value. is ensure we're growth just and the longer-term value how and essentially overall asset, to the sustainability Vision broader long-term So our And into generation, goal, XXXX our that focus the durability are on focused portfolio. enhanced there our of we myopically goal. think

Markets. comes with Renza next question Your from of Capital Gregory RBC the line

perhaps And sodium by progress. you Xywav and of team, the respect just just traction spinning as acknowledge as just others back that messaging, to you Bruce, to Xywav? point are that would curious that message I'm investors messaging, you the think and is with with go Bruce which congrats we the to rather maybe and simplicity on gain market to and what with intuitive. pull-through underappreciated low barriers to

let one? I this you don't why take Kim,

Sure.

good onboard, of Xyrem their and most hear many from they patients, switch because messaging that or started -- barrier have to with that our and common patients evidenced one, portion think, as most as this transitioned that a resonating my either has I've low providers feel lives. X their brought want of we been them we the patient to well, said, the amount is as at that changed care to by do patients So subscribers prescriber: many with being a it of sodium That have offered we Xywav. hear barriers health we've point, and on switched I really don't

mode of patients terms switching just any chance tell much how underestimate their no same product them want take matter you the to never and about active should don't in Xyrem love being what products. We the

of patient time. patients educating over Xywav So side things we're on work and and nice progress that continuing to about making

means health most don't we smaller they that the to reason have just patients. hear they the that other in The care feel do is the the transitioning of practices,

larger the So for staff. see of to does with transition don't patients reduction. offices Xywav, feel offices they have plenty it and on to starting But they we do in problem over. sodium No patients believe manpower smaller do take these some that. just the work some they But these of offices, that in

Your with Tewari next Akash the line question comes of from Jefferies.

for is This on [indiscernible] Akash.

what I franchise same guess here? the the what IH the X,XXX add, ask end continues the guidance, of XXX I [indiscernible] guess current over dollar patients rate and year, fiscal XXX last you trend and [indiscernible] in of continues for for guess narcolepsy assume year with to rest you as guidance, your QX patients are the So do trend this we add growth if year, to missing [indiscernible] Xywav year-over-year had patients think I for lower

then just orexin. on a quick And one

dose. [indiscernible] for patients So type-X they different X guess dosage at And and for narcolepsy [indiscernible] what you be targeting said type right will drug and patients doses on use [indiscernible]. your [indiscernible] are range this X I And [indiscernible]? also comment? now what's doses for for will view several

first a was say ago the our and the guidance take part to months we're into Rob oncology, progressed. neuroscience level, and we're we first all that with as with saying and our coming just of I'll and was pleased quarter think And in line product the come achieve get way today, Yes, overall to right at very the we into level. then expectations guidance. year the we're franchise couple didn't And

that. on the Rob, specific more of part the get you to going take not orexin we're question? could maybe So

the was, across heard I question populations. we to be the patient different do dose And Yes. expect

me say might there factors and possibility different itself drug, any depends if hear I across is cetera. that availability as needed didn't would and But I doses So cetera, on et the et drug different correct course, that. such dose, of populations. given high potency, the certainly be within the

of interested or relative well. certainly NT-X differ NT-X we're may other as other because populations brain sleepy between level the that in populations in know and We orexin

And we you patients to most know, populations. we're appropriate transition have data dosing healthy As those in understand XXX, would patient use best learning different to but the and ultimately program an to where effects volunteers. be ongoing evaluating in for

from with Your Fraser of comes the Securities. Greg next line Truist question

prescribers? for increase on Xywav curious the hear the Xywav additional include current learnings survey predictions? physicians your growing, would IH, what helpful. Xywav color prescribing on the diagnosis their were reasons the as about the yet I'm awareness survey some patient any growing, of up of that behind haven't following as those key thoughts to for rates prescribed Did to And Just Xywav well survey. plan that be

Sure. Happy do was of general. to the in survey do believe that. Yes, I specialists

have that yet it those So would it. increase who mean both tried and try to who've those

going were with better to it's are clinical III continue use you In whether based main they the -- line reasons in I they than why, anticipated. what but Phase have don't tell terms reason that qualitative actually of to of we my the more fingertips from it we've on performing that physicians survey, ask expected I is the had the health -- can in feedback provider trial, more which from that care that community

it's on in from results, They the to the were those positive. very of happy performing feedback patients. getting patient see coverage payers has that that getting experience all the And with they're been that has those there been with along very and and the from very line their results, and product, positive excited they're and about

want they many and they've be still these patients with patients, them lots had with to In very and really are stimulants weight-promoting agents not the to be and treat off-label line years, of where have those those to of clinically. little with, able than they than over other taking them

that's marketplace. we're in So there simple the the hearing out story that

Mortgage next with the Jeff of Stanley. Hung Your comes from line question

XX% think this will And accomplish proportion this? U.S. a initiatives further that you to of do take drive kind providers? of using What you earlier have what greater in providers it do treatment of Epidiolex algorithm. in are mentioned to help You the

you to start want one? that do on Kim,

still very this can under Yes. along this the coming and quite been to I and with after year interact quarter, of U.S. new past And being being to Jazz. pleased rewarding year-over-year not are has quite that's is years how Epidiolex community with speak just again, from the COVID we able growth XX% not but

of high-level access and for with really And centers to was terms number absent physicians' have engagement in continuing so years very to that there a key to that offices. a treatment of is our customers

clinical seeing that board. the great Clobazam is data, discussions that data great encouraging really moving in we've about some in with terms quite of for driving have with year got really out light very in some you and off bulb there Epidiolex. the coming that's But been now combining of can a we've go them a the prescribers and having great more growth showing impact few forward, on We're of and with terms

It's care-driver traction with year, treatment and the then about that, not that earlier it of using seizure And marketplace. XX% we as go a really talk to this getting shows. BECOME. in or on in they're really this HCPs algorithm the more lot out We're called getting to -- started just reconsider survey why using than control there of layer of through top earlier more that

showing quantitatively behavior and they've of cognition launch for. they're HCPs And that caregivers the since caring improvements the been what that and actually Epidiolex, hearing sees from in the patients is in that caregiver

open adult I'd So particularly care were setting, up slower that, post-COVID. the was in the the long-term say setting to combined as institutions many with, U.S.

achieving HCPs optimal care this in is recently not patients. They're the And setting. and the for still in So more to product. there, long-term get excited in are optimal able penetrating underdosing which we've achieving market, about is fully the outcome the thing not that we're the particularly last say more U.S., adult dosing, then been I'll

them some moving it continuing an optimally experience dosing positive putting what Epidiolex to out we're even programs So educate forward. with can deliver so on more they new like, to have and looks there really

then ex-U.S. obviously, of a So that's we've expected launches within number the U.S. And year. this

And is Kim, Dan. this

we drivers are Vision peak the appreciate real assisting going setting a to beyond. with add multi their in performance core to into of as see our habits of into it pleased that as world pharmacy Epidiolex. and profile one physicians growth and Just XXXX and We're really change Epidiolex

doing trying from and to addition are great generation. is leverage ability the Sam all Pearce to in full in team So evidence in her work the we're our and an Kim that Europe, U.S. doing also

indications, as new such of types. terms EMA additional in with have going exploring with be that's of we Some seizure to

it be observational going to is of studies. Some

optimal leveraging you going now of it's records be medical some better to of some to an and that higher more And those can with efficacy get to number sooner. of show increasing dosing, trends

beyond example, survey, in in seizure saw benefit caregiver that And data. the then we of what exploring for and additional clinical the seeing

excited product. the long-term generation support all of for evidence growth super this So in got regions should we've the that

next Simons the comes of from Your Annabelle Stifel. line question with

Annabelle, we're not you. hearing

UBS. from Your with Verma Ash question next

I have two.

price particularly X/X you can a Avadel's second can at getting least like any that with that to our that dose. their IH to of they're patients taking KOL hear I elaborate feedback, know data patients IH Xywav dose, on struggle skip up point? on discount? have based with can if don't comes And LUMRYZ towards we be used As a LUMRYZ, I to do mean second, So understand, if view, then nacolepsy could respect you off also in like in your for can a think payers push using once-nightly with patients Avadel label IH? product significant

want in you on do jump this? Kim, Yes. to

Sure. general. I'd little to. be a happy while talked And payers in ago we about

that, understanding patients today. believe not Again, are time importance really, that benefits to do low strategy greater of So for payers are understand we and XX there our some talking and sodium changing. we've that than of the that been are is choosing the And HCPs payers they increasingly Xywav on Xywav. Xywav about

on rebates today. nice enjoying they're Xywav And

the to as So believe going broad do commercial to Xywav continue is I and high a they're to oxybate formularies other market come that that added sodium maintain on ultimately coverage. really to

And market hypersomnia. the it's affect idiopathic approved hypersomnia. idiopathic IH expect don't the about not approval we asked You of as FTXXX will for

for the this you as in adult And to once-nightly either twice administered for That's allows. Xywav I what FDA-approved only the Xywav the nightly IH good can is think or remind still that patients. therapy it's be label condition. regimen

And your last question comes with from Piper Amsellem Sandler. David

WAKIX Xywav your of product wanted the secondly on thoughts gets And get that on extent approved? So to potential that, on to eventually or impact then the the pitolisant Orexin.

it before, asked you're here? it. a seems reign wanted you I at take counterintuitive. to I little dosing but on Any thoughts this It think night why on I've

doing wondering was if mechanistically a PK perspective reason or there's from you're I that any So so?

I that that to If one that want first? orexin. was do Rob, about question, take understood you

-- just sorry, is I follow at would orexin Yes. night, fully Bruce. didn't it understand The it. question you I didn't either, dosing be I I'm why

so -- That's you your there others, [indiscernible] all are adjusting why I drug, it at -- mean right. the I believe night?

like volunteers the good people We're and the are model turns leveraging high, our healthy propensity narcolepsy. have in Phase of be disorders a wakefulness daytime That when a for model sleep-deprived where you Oh, for out I. healthies intervention a sleepiness in measure pretty high to sleep. of then --

And so us the when an gives drug who doses to opportunity the more drug the then select receive about learn into just day. patients, and will we it ultimately get during

Yes. Maybe on... start I'll

Bruce. pitolisant then And ahead, on -- go

Yes. Go ahead, Dan.

and to just across it's some full will you during sleepers a But was to condition the pitolisant, is efficacy pitolisant be -- wake-promoting to multiple challenge depend day, agents oral resulting a take the whereas Xywav day, data, I nighttime always got dose. going a we I long the bit and be wait the say used powerful on mean endpoints benefit the to going going all be it's of treat to through course. to having have very significant on the the has in for a because of to the similar therapy

commercial education don't displacement. would options benefit threat be But a treatment So a again, more us. as noise patients, significant we or for more and these around IH a for it see

at turn this Bruce call now to will And no further over back we the time. questions I Cozadd. have

All Thanks, right. operator.

So the wrap, thanks just wide-ranging for to questions.

news questions the we we covered much I'll of release, really and Zepzelca. think pretty we're hit many I script. that oncology the just got reiterate, by we our franchise key our topics growth Rylaze oncology. in in for our led don't on excited all I think

IIb Zanidatamab, featured to to forward be questions in an clinical Zani going on Most Remember that news Phase looking upcoming program data focused first XXXX. And data many at lots additional rapidly. get to time but ASCO Vision oncology are BTC got we're upcoming the That's with a progress of we're important, didn't that And be at on major findings conference. during Zanidatamab continuing presentations. we've there June. oral session

multiple after the or review webcast a at Medicine findings. Shubham may we're is immediately sleep, this ASCO we data of who presenting presentation, there. also see data And Meeting Dr. at will year's presenting Academy at [indiscernible] where Annual the ASCO American sets Pant, We're Sleep hosting you

the Also XX. note, we're participating in RBC Investor on May Conference upcoming

options work to patients. today's our partners and support. for confidence me close Thank to I And to you thank want Jazz new deliver joining colleagues therapeutic call today. their us recognizing shareholders Let for continued all by our for and their

call. for conference today's concludes participation. Thank your This you

now You disconnect. may