Jazz Pharmaceuticals (JAZZ) 28 Feb 242023 Q4 Earnings call transcript

Company Profile

Participants

Andrea Flynn	executive
Bruce Cozadd	executive
Renée Galá	executive
Robert Iannone	executive
Jessica Fye	analyst
Marc Goodman	analyst
Jason Gerberry	analyst
Ami Fadia	analyst
Ashwani Verma	analyst
Joseph Thome	analyst
Gregory Renza	analyst
Annabel Samimy	analyst
David Amsellem	analyst
Joon Lee	analyst
Gary Nachman	analyst
Amy Li	analyst
Michael Riad	analyst
Joel Beatty	analyst

Call transcript

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Operator

Good afternoon, ladies and gentlemen. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions] Thank you. And I will now turn the conference over to Andrea Flynn, Head of Investor Relations. Ms. begin. may you Flynn,

Andrea Flynn

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

identify certain events, materially today's Chief and forward-looking our update X, materially those actual in statements. Renee webcast which and those Operating the and are today Cozadd, to factors and uncertainties Gala, growth our those cause Bruce Executive President Officer; results, differ undertake the results potential release, President, today's filings, to to statements that R&D. or includes and to that and contained actual in and and on these and webcast. that the you On obligation slide press anticipated to could to uncertainties forward-looking Head involve our risks encourage company's the deck We our the from cause contained commercialization today's as from which SEC events, call you Vice in goals, review made risks related future results We differ performance statements duty may no in Officer; development Chief Chairman described Iannone, forward-looking performance contained in statements. I'd Robert of Executive financial and operating remind Global statements, On forward-looking and like and such Slide milestones

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

Bruce Cozadd

than Slide our discuss innovation for today XXXX. these talented XXXX more X. programs. was assessing employees accelerating delivering top position full our you for advanced Jazz. success us billion and and we XXXX growth, the opportunities productive fourth multiple afternoon, catalysts to focus execution active creation. generated drive pipeline excitement more XXXX world, year in in key We for patients, everyone. on growth and helped on revenues on to development Andrea. and remaining the joining and results accomplishments Thank Good highly and start $X.X passion in of pipeline as quarter a we believe Thanks, about us commercial line to our and around Thanks I'll year corporate well value

from we Jazz highlight as led recently move several Jazz finance announcement to most I that March our Phil from Vice X. where Treasurer. President Eli almost is and and decades, Finance over the effective Phil functions Group on, Lilly, of our to course of comes Johnson Chief want joining was Officer, week Financial X last Before he

experience, to and executive excited As to into we Phil's are we leadership team. XXXX, strategic add approach our industry move

Turning to Slide X.

of Highlighting We the reinforcing from Xywav, drivers, revenue key transformed over and several our commercial $X.X durability. in past the our reflective increased a Epidiolex strong confidence is XXXX its execution area, Rylaze our growth years. in more XXXX, sleep in in performance Our XX% from revenue accomplishments year-over-year. billion our than that's combined few business drove therapeutic

and underlying on by to than on and $XXX team. grow, demand the blockbuster potential. million at deliver Epidiolex our is continues reflecting to commercial annualizing track now Epidiolex strong its more execution

the Our growth. with way with for oncology area year, therapeutic year-over-year revenue $X surpassed the billion leading in XX% Rylaze

efforts. our and R&D pipeline to Moving

significant near-term market multiple opportunities. catalysts have We late-stage targeting

peak asset, with potential. date Zanidatamab as $X strength billion our to we've indications, than multiple data the derisked across Given of most used a clinical more

disciplined operational financial growth cash to diversification and allocation in healthy the invest margins. the front, operating On while flow capital generating continued our and strength our provides

record track development focused strong corporate a have of and additional successful We remain transactions. on evaluating

Turning our performance XXXX XXXX. on to strong We progress made based in towards Slide Vision X.

side, narcolepsy growing and in successful commercial executed and launches with we've portfolio. leading the oncology On therapies a epilepsy

investments meaningful our and financial a continue of And Our put the depth capital most with making operational to our breadth to expanded the and and investments in pipeline. of us R&D have we mindful shareholder in on has value. disciplined impact be excellence, drive strong capabilities allocation position,

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

Renée Galá

a had on billion in Xywav, This or sales generics, double-digit across revenue We authorized XXXX, fourth was XXXX time. generating million for successful capped plus $X of the We of billion more which Bruce. quarter, $X exceeded high the Vision from and revenue. start Slide our net for year. billion quarter Xyrem first XXXX year-over-year a growth achieved Total and full products, sodium Xywav the we off goal we area. Rylaze. I'll positioned are includes well revenue in our which royalties achieve Epidiolex of sleep, AG, quarterly of sleep fourth with each Thanks, in therapeutic key $X.X believe $XXX sleep from oxybate our to and strong than X

XXXX year and Xywav full $XXX the of quarter represented billion which approximately growth fourth XXXX, for $X.X was for XX%. of revenue year-over-year million the annual

the We confident sodium remain and of oxybate dynamics and visibility XXXX. of since area in oxybate market AG our have We in sleep branded therapeutic the high durability in increasing entry into particular. Xywav

idiopathic Xywav therapy remain including the expect of oxybate choice, and approved we the oxybate to narcolepsy. #X sodium treatment for hypersomnia, only low only to treat the As IH, or the

there X,XXX patients Xywav. narcolepsy were approximately XXXX, taking Exiting

continue and the feedback educating from intake, will providers patients. on believe of sodium Our we high prioritize and health majority that focus burden positive evaluating narcolepsy of therapy. long-term sodium to for patients field around of health the is prescribers when Based reducing oxybate about benefits patients the care the on lifelong intake

approximately XXXX on revenue to annual continue IH from there Exiting X,XXX active from of doubled to Looking Xywav. sustained indication Xywav. we and for IH XXXX, patients at were growth view a source as XXXX, this IH,

our confidence represents in this indication building for growth we Xywav, invest opportunity are market. that further IH Given a continuing the to durable

have on expanded prescribers. primary force, IH, with sales We personnel the are IH field who to the and our of focused increase directive adding depth breadth

to to fourth another Turning product increase $XXX same quarter net million a drove of XX% We quarter, in in Epidiolex XX. Slide XXXX. approximately growth with compared of quarter the sales the representing

potential and is more now year in positive and demand XXXX. support beyond and well in expected growth benefits optimal and beyond drivers penetration seizure on million, this the more to reimbursement than control, such of market million up function, as geographic and executive cognition, the language revenue data in expansion. approved, Epidiolex, annualizing We $XXX.X where XX% Epidiolex underlying increased revenue. emotional driven include responses For social is generation Epidiolex adult the countries setting. of than as launches and as education confident for $XXX the Further with function and which full additional dosing, opportunities patient focused in of in expansion the the at communication, U.S. by to Epidiolex XXXX, growth prospects demand data blockbuster geographic remain was growth year-over-year, Key long-term continued include XX

first delivered billion which oncology. been A of to periods, and contributed product the of representing in the Rylaze in protocols business $XXX the Rylaze to respectively. has the strong Monday, approximately and full for increases continue Friday approximately $X sales number the year-over-year XX% million regimen. revenue of pediatric XX our demand $XXX Moving those in contributing adoption fourth performance are exceeding in total annual XX% we Wednesday, time. of highlights million Slide in new year, asparaginase-based dosing universally U.S., quarter strong of XXXX, almost for and net oncology the for Rylaze strong adopted see to continued for Rylaze. to oncology factors XXXX

increased are asparaginase in concerns first-line short-acting [ ALL to Rylaze including current from some of switches and therapies, first-line due usage also side ] seeing due to of a tolerability the patients therapies effects. relative to We benefits these profile of

with use market. continued an for of of have the in opportunity or adults, young Rylaze In AYA addition, and treatment the growth we adolescents increasing

quarter Turning to year-over-year the and to sales X% Slide product fourth XX million. Zepzelca. for $XX Net increased

year sales product $XXX.X were up million, year-over-year. For X% the net XXXX, full

be cell care and providers $XXX is practices. health Zepzelca #X generated ease administration We care Since for accretive the development revenue, established proving and from for highly treatment and and and and a its of benefit health its patients well-executed as patients, cancer has we feedback small their clinical lung second-line have to million Zepzelca on transactions. launch, hear positive in almost to use corporate continue

cell of turn patients to milestones. lives to I'll lung therapy. it setting, an there on remains second-line further unmet and as our the a drive in earlier first-line provides trial growth. outcomes small future to Rob? Phase addition for improve in well ongoing that, III update Rob With lines The pipeline need In as upcoming cancer patient and over opportunity for an

Robert Iannone

Renee. represents we've the I'll in oncology XX, we meaningful of And On the provided pipeline. programs to catalysts multiple diversified across neuroscience. our expect Thanks, anticipate time near highlight several overview we an term. the R&D us XXXX milestones And for exciting on key in Slide front. and reach an clinical

report this BTC, that Starting submission half completing in rolling in year. Zanidatamab with BTC of or second-line oncology trial. BLA biliary cancer, We we recently I'm approval first initiated anticipate excited first-line accelerated And for and of to Zanidatamab. our tract our the

trial Additionally, speak ongoing or plan expect If to this first-line to we this data top a are more registration. a would positive, our gastroesophageal moment. from I'll line Phase the GEA Zanidatamab just targeting support development trial. III year in report adenocarcinoma, we late

which expected with duration cell lung enable for the potentially XXXX combination year. also approved, Top extensive-stage of in of this in to pleased progression-free Zepzelca would the January benefit longer progress line more first-line indication with Tecentriq survival from small the early therapy enrollment cell If with patients cancer at completed data of Zepzelca. trial, in cancer lung this of is with XXXX. first-line Zepzelca or end We're small

to Turning neuroscience.

our second Epidiolex line Phase III top Japan half XXXX. the of data trial expect of in We from in

or ongoing suvecaltamide, regulatory trial essential we top Parkinson's XXXX. for half trial In package. ET from in JZP-XXX, with first serve pivotal the of and believe of positive, are We trial the If both part findings data trials expected could disease this also as tremor, line a tremor have late

for plan development our on Zanidatamab. detail more provides XX Slide

progressed for meaningfully have Zanidatamab in perspectives the GEA March across I'll are including focus differentiated Zanidatamab, note to therapy last confident on XX data, year. totality hosting the Jazz based it And we on R&D a molecule bringing since exclusively are KOLs. this cancers. on Day as cancer will and an highly indications that from HERX-expressing of we We development breast that

tumor multiple across tumors, broad in of this compelling a represents investigation types, a plan outlined activity shown on range as this development has of HERX-positive Zanidatamab slide. our and robust molecule

In to the highlights improve late-stage critical our see and meaningful opportunity Slide BTC GEA Zanidatamab X addition for breast programs, our most early factors cancer of contributing and we to for XX to around enthusiasm Zanidatamab. care patients.

Specifically, results HERX agents, other other the patients with as date activity monotherapy progression-free data. data to demonstrated has Zanidatamab durable and previously agents, overall in in survival combination with with treated encouraging generated and in responses survival

indications. Our currently development are there of HERX protocols. BTC, adoption starts area follow we believe prior may where where leverage We unmet treatment findings Zanidatamab and other potential an with strategy can a a for is we indication high BTC GEA to BTC into fast-to-market BLA to guidelines will believe next accelerate therapies. no market strategy enable in GEA approved coming the in patient and approval need and BTC, supplemental

the time approval, have endpoint. target. survival the overall the the we line increase GEA elected statistical on to target enrollment original not the enrollment for patient PFS potential for which power FDA, to discussions impact This improve is based Following still will to the with trial from

the We our the of and HERX-positive development transform in care has a multiple rapidly for committed molecule cancers. to current advancing standard remain to that expanding potential

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

Bruce Cozadd

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

release are and full press As results XX-K. financial a in available our our reminder,

recorded and for achieved We full billion quarter fourth And representing XXXX, over the total we were oncology, neuroscience in $X of growth of year growth total more double-digit X% oxybate AG our year drivers. of despite competition, growth and each X headwinds sodium both XXXX, in year revenues, than than in $X.X deliver with our billion driven we continued branded from the results full pleased In high more growth including both to growth by revenues. from XXXX. key full introduction

Turning to Slide XX.

adjusted XXXX year and full non-GAAP income adjusted approximately $XX.XX. non-GAAP was net of $X.X we Our billion, reported EPS

billion our year of ended and We $X.X demonstrating XXXX year billion approximately cash to of our the cash We continue in full $X.X significant recorded diversity generate cash on from business, hand. global for with the the and from portfolio. strength operations

we flexibility well development operating to position commercial flows financial priority invest have mean and overall in as as R&D cash strong corporate Our programs and significant opportunities.

to We our XXXX, Slide financial guidance share are beginning year for on XX. pleased full

Our range of growth line billion top XXXX year-over-year $X.X midpoint. total revenue $X X% represents guidance at to billion the

growth percentage growth combined We revenue drive expect total Rylaze of and Xywav, double-digit revenue this year. to Epidiolex

$X.X of offset in revenue of by the $XXX expect XXXX. Xywav is billion decline in exceed we Our note to Xyrem. I'll million and billion expected of guidance guidance reflects Epidiolex, growth XXXX to the neuroscience which inclusive IH expected in this AG royalties, $X.XX

therapeutic reflects continued Our $X.XX XXXX $X.XX of area. growth expectations oncology to billion revenue guidance billion for range of this double-digit

in expenses, for the U.S. to initiatives, where market SG&A promotionally a know continued growth educational in drivers, operating attention draw to in billion we SG&A efforts IH in Epidiolex and items several $X.XX Rylaze sensitive, commercial in result Xywav over your increase is for XXXX of expected is the to Epidiolex key investments including will our outside of like the billion. AYA. largely geographic XXXX U.S., on expansion I'd XX. support regard range guidance be $X.XX Slide The to our With

to million Our in X% at development R&D XXXX, represents SG&A midpoint range $XXX represent driven planned investment R&D midpoint the percentages program. our Both revenue Zanidatamab the same $XXX of continued robust guidance increase to total to million of the compared an and by at guidance XXXX. compared of

be with and commercial line This strategic with billion. allocation. and enabled by our to investments XXXX adjusted net reflects in of range $X.XX On in disciplined XXXX the growth drivers income $X.XXX expect billion guidance a in to we and line, bottom anticipated capital top pipeline line growth

I'll our on guidance. we on neuroscience, conclude revenue XX. oncology our prepared XXXX, and remarks total delivered Slide In

grow Xywav, XXXX and in double XXXX. our This multiple the combined On growth, long-term term. side, driven time Rylaze. growth in our we Epidiolex on combined expect is Jazz to of by commercial for a as pipeline double-digit products front R&D basis, very digits invest the we near in again advance the was a continue On to exciting expected by performance key and with catalysts these

with focused operational corporate an on remaining and growth additional remain we always, As diversification. allocation, development and opportunity excellence strategic capital for

to Vision with positioned excellence, patients in and focus over In our further value to Q&A. line XXXX to growth to top summary, and are diversification, sustainable product longer And poised our the well I for R&D deliver multiple are operator expanding enhanced catalysts remarks. to now we XXXX. deliver and prepared portfolio, to concludes achieve we line call and the like and shareholders. believe the growth progress would turn term, we open operational pipeline That on

Operator

JPMorgan. [Operator you. from our with We'll Thank Instructions] question take Jessica first Fye

Jessica Fye

expectations maybe that position what about for We're you now? clearly narcolepsy in [ talk for steering guidance in about Can sleep ] Xywav's looks narcolepsy setting? the set outlook right Xywav seeing what worries is And in despite think competitively of what like consensus. neuro you're ahead you

Bruce Cozadd

that for thanks turn Jess, you. question. maybe Renee, over one the Yes. to I'll

Renée Galá

happy to comment. Yes, Sure. Jess. Thanks,

as a only look at noted on So we level, expect the to and the where therapy do important as Xywav seeing call, of we be XXXX, to at is top new in year. the IH. for drug oxybate majority at high terms growth resonate will driver, We of the said, patients approved the #X starting of that we're the remain an a as some we as at it expect differentiated line do X believe market across course, oxybate, And looking choice. try to said, we low as then, growth Xywav on we on we QX, X the the to we're narcolepsy patients as see we it as look do continuing What treatment for We LUMRYZ. are only we've oxybate on do Xywav. of the seeing expect of sodium

patients expect on more now there. impact and we are naturally, there Xyrem, Given many some Xywav would

patients net number at patient quarter, our the as look year. we than in also a had that is more Keep fourth mind So ending X,XXX we exiting number. the narcolepsy

So it Also we quarter, we quarter, continue our from to adds reflects in fourth as discontinuations our an less support increase we any the in the had. [ bottles patient nonrevenue services refine the see that ] did program.

increase those an essentially programs. continue programs programs. seeing take seasonal, seek expect that how and are in of to We affordability we our refining increase don't was we're to given advantage This it

as titrate. we to within And the patients add narcolepsy, mind, in to IH need patients quarter then fourth finally, both in and continue those new keep

not starting that as commercial every for lower In patient therapy dose or coverage a will starting decreasing patients XXXX just discontinuing. growth is driver do that as branded may to we we that's course, be hypersomnia. say revenue additional Xyrem, a And is our in an royalty the growth more we either upon is sodium to to forward, expect significant authorized sodium of starting, from fixed patient importantly upon meaning idiopathic as generics, believe high Xywav, receive be Xywav high or we I'll patient potential we therapy narcolepsy, of a of look as to therapy patient. a that valuable for then therapy So that particular, shift on, which probably with coming which, see those

Operator

from question with next Marc Partners. our take will we And Goodman Leerink

Marc Goodman

Vyxeo mean Zepzelca sorry, say just [ can or a ] I products, than give can Yes, expected. Defitelio Defitelio just quarter? mean, you obviously the higher ] still oncology I Renees us give [ [ have I on Rylaze, [ portfolio? color on ], you ], I ] much I'm Any apologize. us the Bruce, little you Vyxeo and color that, [

quarter-to-quarter. X The products, flattish other

be helpful. So you provide anything would can

Bruce Cozadd

product of name. only years. This ] not for occasionally the see Defitelio for prior the refers has rare to significant true products, diseases. we of quarter-to-quarter our say in of you're I'll that some variability, particularly Marc, do a sort very one Yes, [ been

read Rylaze. side. wouldn't And much maybe on Rylaze. growth too We've on on in in with the to I'll I So performance our but comment particularly little over Vyxeo Zepzelca, [ ] bit on been turn Renee a more Defitelio, the focused it to strong

Renée Galá

I the into with certainly quarter did see here the seasonality in going we and Rylaze population echoing respect of holidays. relatively to the Bruce, market in we the that a This particular, end respect for would see small some use of the Marc. Thanks, Rylaze. terms rare question, variability the with at the thanks Yes. fourth to say, is in

Importantly, we as see driver a growth Rylaze XXXX. in do

contributor a we've the look then second-line cancer, and we respect study year late as a year. market reading strong future due the as the rolling really reminder, is growth the small in continuing Just about to were but that to out we And we for with Erwinaze, also to XXXX, constraints to late fourth expect That that never potential we lung we that we pleased Zepzelca, product, as a began either Europe in an in launch in to established able strong to cell growth opportunity area underway. And supply line with #X next for demand treatment able that see the but to Europe we early this quarter. this or understand we're get fully think first overall were not year. do see we're at see in

ease use, hear mentioned, as seeing we I of positive as quarter-to-quarter some additional to well. continue there. benefit, Bruce in clinical as But have variability from HCPs and use the feedback the area do, that We said, on

Operator

our take will America. from of question Jason with next Bank Gerberry we And

Jason Gerberry

PD-LX differentiating the with GEA aren't the PD-LX just of how foresee patients in My you subpopulation, question, status. the negative basis frontline you stratifying on if Zani,

can a result is that kind picture? long group, that produce Just versus should So here Merck discordant secured thought paint with broader ] KEYNOTE-XXX as of that subpopulation as the kind all-comer label of a wondering than [ regimen? that its how that the you doesn't facilitate

Bruce Cozadd

that? for Thanks, Jason, to want question. in the on Rob, you weigh

Robert Iannone

wouldn't have predictive Zanidatamab other biomarker PD-LX The any or for any therapies. value HERX

in the clearly we a subgroups. or So PD-LX can we negative define benefit positive think

one arms, PD-X an Of where atezolizumab where care of is Zani And course, Beijing. antagonist we combined with from have have chemo. we standard also we add to X arm experimental that

used. an negative PD-LX Herceptin both the opportunity group positive address so care group we And have of have segment, we benefit PD-LX there ] patients. shown to that a the standard the to [ We based the chemo, where anti-HERX think superior to continues we don't be and And where PD-Xs will that differential is which on in think drug. been be have PD-X

Operator

Ami will And our Company. with & from we Needham take question Fadia next

Ami Fadia

where you with you of particularly And you how market, And Going envision sales debt? additional about impacted talk How expanding oxybate? the guidance? market taking that entry to back to related on market in oxybate or dynamics can in elaborate focus that force the XXXX number on share? increased they Do in to maybe IH, the total that, you drive that just the the predominantly prescribing of can patients LUMRYZ? do your here, has on are evolving the will believe

Bruce Cozadd

for over Ami, one you. turn questions. Renee, those that Thanks, to I'll

Renée Galá

Sure. With patients seeing Yes. we Amy. Xywav. as in see on to thank majority today, the oxybate those we're you, I starting what of vast to narcolepsy, respect new mentioned, And

important a We exceed as said for we and $XXX to we expect Now look an driver. Xyrem. example, we But continued us. see XXXX, we as very I've expect Xywav expect versus of million, the see greater narcolepsy narcolepsy, on be royalties decline but to that in based to growth at will as AG business is growth IH to likely before, important mentioned

impact in are fixed growth As to on within opportunity natural terms are given related see would continue, market Xyrem we this on expansion. look versus forward happening We though, do we sodium narcolepsy that today think some starting narcolepsy, of patients some on to are what be about Xywav, LUMRYZ. expect patients that fewer as to from it there branded dose Xywav high some to for what's

patients market go at easier given are opportunity, be if much already little very we're right now. that looking of there's that a on it after oxybate. And to think you're just that experienced I would seeing

condition we market, to opportunity IH on to continue the IH, respect what's sleep of the benefit entire continue happening at improvement with an overall that to with of Now condition. as in restorative of the on educate look see we and that terms to

are where looking currently are we practice have both on are prescribing general, experienced as We on familiar IH doing prescribers, to of have not for prescribers who as lot at with a a but in of within less their patients oxybate number opportunities those broader but focus that opportunities oxybate well IH.

Operator

We will take our next question from Ash Verma with UBS.

Ashwani Verma

to on So you you latest reconsider to get just then the point? thinking $X second is it about for XXXX some of I at sales. wanted And question. in your vision to target there? thoughts XXXX need what development that bridging possible think you digital you're could metrics billion get Do And a

], Zepzelca well? on space lung front, [ is you might a think cancer -- cell drug you on small just competitive [ talletumab the if for Amgen how So there ], from can comment do

Bruce Cozadd

the Yes, for Ash, questions. thanks

excellent target still billion into outside $X nice showing on in Vision north particular, said U.S. billion had blockbuster as Epidiolex. year, in XXXX. specifically, $X.X a And expect for about with last remind we we as U.S. we million the the would with and I'll that from and We're to $X target. Epidiolex, On based $X came oxybate. Xywav, the currently had XXXX we of as growth we annualizing billion quarter coming that the towards additional XXXX XXXX. the we growth revenue. in revenue at continue had in over both over product move Last be progress identified $XXX And you in we billion

very business and $X.X of billion. billion believe we pleased, to contributing also So you that $X we solidly to on guidance as said XXXX, track business, billion and see oncology projected from north grow with nice together in in of Epidiolex can our our we And contribute we've growth oncology that. for XXXX. again we're see business $X our XXXX, for obviously, will were more oncology than And

revenues for announced on come after feel include organic done like in we $X.X Vision billion, corporate XXXX. did the development $XXX placeholder from for track of of piece, could Vision are the transactions XXXX we We, XXXX. So a million course, that

But we our launch additions that Zanidatamab, that active finish all in in we're with we submission flow BLA course, financial contribution are half or to be sooner. targets Of corporate and our for And cash our position could continue that would not suggesting first year. we a on strong of from revenue could we'll that would review XXXX. the said make We're come of in where interesting to up this that some in our XXXX development the projecting include business. $XXX cash to that million and side, make rolling

of I'll but point we if a XXXX. through out, use look not period, provides capital, a a a over it the do as driver to it's just we're our our not XXXX, XXXX do and adds going deal We're just do growth good to deal. going to furthers to sustainability deal strategy, an additional

question, one XXXX. So we're the that I'll turn long And Rob, you. short over on side, Zepzelca progress making answer maybe a but Vision excellent to towards to

Robert Iannone

Bruce. to, Happy

a support be [ or very -- cancer different are data line a of safety that BLA know, SeriousRS infusion given favorable for profile, that ], a neurological the profile as versus Zepzelca therapy lung the in add-on including Genentech [ safety the frontline treated. In cell supported weeks. in small cell for community small really different candidate And of really once challenge, as can especially setting. we Zepzelca partner well [ ] has contrast, will with tarolatimab ideal line. lung tarolatimab an many a And [ you even an practitioners The mechanism it very Zepzelca. may trial than you that action for profile that third high As in And with is easily frontline in effects. where makes be patients every is in have second And ], are cancer. quite significant CRS safety the know, a ] a risk and X running

of proportion year. as to We for end a PFS results time. patients of will longer as that the early this line greater expect a And therapy top receive allow

Renée Galá

that on build to And further.

appreciate, in quite the had second as the look generally of Rob cell in lung tolerability experience, second-line we coming have at Zepzelca also cancer patient the These use just first that with a health poor given the opportunity profile, prognosis. that line, mentioned, are line, we currently in small ease So as clinical activity. patients for

this relapsed So already they've point. at

to so a treatment the drug quite And easy having very decision. important in that's is use

Operator

take Thome with from We Cowen. TD next our will question Joseph

Joseph Thome

or program about start guess, cancer overall? sort on HERX-expressing should investment think in decision that X of either just to additional cancers? kind appetite studies other these works cancers. How you the opportunity we Is if we first the looking in Maybe at investment the the that? to cancer landscape GEA should the in competition? breast -- what's it know outlined in in it continued Zanidatamab, additional make the of in how are overall I BTC? more some to breast point it think expand other you Is approval or I of about

Bruce Cozadd

and can. in, you you to and start, certainly anything then I'll add Renee Rob, if Yes. want

Day BTC comparison our little you we'll at a reported a between growth well does Zanidatamab the apples-to-apples the guidance of guidance in we program, March specific year want revenues give our an our While XXXX me more full the a as activity in XXXX, for for total breast now. little as But saw in let plans. R&D same And by bit about having over as contributed have bit say percentage I guidance GEA. XXXX assume more more we if lot you With to R&D, we R&D R&D to say Rob, be don't and and XXXX. explaining certainly our represents know will of XXXX. about

Robert Iannone

of and setting, the both working combined published and of course, cancer we're in data GEA. that outside Only metastatic Yes. BTC areas in HERX early ER-positive already metastatic breast patients We've HERX-positive setting. the in

we now. So for And data. breast have Bruce in work mentioned, cancer planning additional already we as are even

Operator

from take RBC Gregory And next we Renza will with Capital our Markets. question

Gregory Renza

corporate on that just Congrats around adding Maybe, on $XXX and potentially provided progress. color through some that to 'XX the you Bruce, million Vision development. the of

looking I'm you're areas were attractiveness some for just the assets as maybe externally? based bit on if are XXXX comment where in which a just Jet curious where markets for Just you've Jazz ]? date [ Power you you see that position for XXXX, could Certainly, in noted, competition, how to put curious see strength. a you of on the of of valuations in

Bruce Cozadd

the for question. thanks Greg,

We disease have products, side, recent a some already bit active in years. oncology, all valuations development, set great we us. at a across and us I looking ability some as the at based there having well on-market on over opportunities dev Being spaces, things work a our of like there's number of on as experience lot done capabilities that transactions of find neuroscience build corp over the a those quite gives including and spaces out years that in-house would and rare these the activities have to of of near-market on think, late-stage in feel for

If earn Now look that's there at well. it areas as like looking maybe of little that's areas at time, true, where a return. pockets everyone's we be high good seems a to other same why valuations can the

So team, work of [indiscernible] we're to that with to longer financial a strong sustainable opportunities growth we'll with to position, continue confident and find period growth drive our time. our over

Operator

We next Stifel. question with our Annabel will from Samimy take

Annabel Samimy

And in impact, that might you're investment your preparing plans still can the of launch, could of Zani, but there, appropriately rolling make it potentially the terms how know you in you cancers? target On type BLA cancers about sales, to infrastructure need to say, GI versus what talk launch in Zepzelca? the that be process, you I lung for

I And X where points I of the be guess, on guess, related margin, sort supposed set XXXX. to guidance was XXXX, over back was in Vision operating then, the

XX, XX. still been would that you're think have at and I

operating have off that would backing number the of you that make given margin there, guidance, Or color just you great. that you of investments to little can be are give a So here? if

Bruce Cozadd

XX% first, Yes. us our essentially of Annabel, we That's increase we part to R&D moved and second then coming portfolio drivers great margin in we'll flexibility thinking. the XXXX. to margin in XXXX. commercial your to the I'll and that launch back take I'll the back key off side. target, come on of kinds behind that we make in as growth achieved given through commercial investments make we set it the Zanidatamab maybe question was out point When wanted

to glad making we're be today. So investments those

pointed that point given We not greater obviously out revenue and I out, or we've do spread haven't impact yet. over guidance expenses transaction development before, whether as margins. for specifically we a a our XXXX will our corporate base does

you to we want investments So return are for now, we built investments to Zanidatamab? talk Renee, high think that as about we're shareholders. that into will making our our for But thinking lead the well.

Renée Galá

Yes. Sure. question. for the Thanks

we're year. launch, BTC, our we effectively this So believe as ability likely be about as XXXX. how more respect early to with at BTC happen have thinking later looking to ready could cover certainly, than we're the but which really We'll we

we about end field So Zanidatamab. is early out important a have data is with should force. to our small with the BTC to the leverage experience targeting. is we're as able to launch Zepzelca current field enter to what do force that That's with key the be the field we're market right We thinking way our relatively in that help augment to the The this with as GEA of get HCPs year. now expect

at so a when well. thinking GEA, where more experience we course, with seamless for position by we're have you're faster as if getting GEA. a it's a being SBLA HCPs that's, Also, transition in about looking an Zani, process of And our bit

global the also at small footprint an So looking And brand, U.S. brand we us. global relatively we're the a it's for in as to important think Zani a expansion

looking unmet smaller, also high a U.S., of epidemiology cancer. Japan. it's Europe the need an So perspective the in opportunity And from as severity of we're at well the terms holistically is after the as BTC while

strategy, start XX,XXX a Japanese looking a say worldwide, we we so I GEA than then And build we're And XX,XXX. into as with much U.S., have when at larger and markets. the of into XXX,XXX patients. BTC, Europe expand [ build where population with around more at ] we're breast, And patients looking worldwide, mean I

we're opportunity. how broader at that's the looking So

Operator

And we will take our next question from David Amsellem with Piper Sandler.

David Amsellem

little Can should Is there you be we drove volume about more And Epidiolex stocking of? double-digit both you growth -- U.S. just aware was the and benefit that and what any are add ex-U.S.? performance? a seeing

Bruce Cozadd

question, for you. Renee, one to over that maybe David. Thanks I'll turn the

Renée Galá

to happy Yes, comment. Sure.

gradual we tend we as off the year, the half Epidiolex, year. in see works past, and that we've the look buildup So over over at then of as more of a the the said second to first half

fourth demand across understanding Europe. a we're continues very and of of we're XXXX. the both area the So continuing a that providers, in well seeing the in synergistic starting in of really patients in as said as seeing the well saw on. the more buildup. focus that We what seeing opportunity with the resonate U.S. small we are to adult an continued That's see quarter expect terms in We've growth, to is some seizure as But effect we in amount past, with be we're as beyond And to a bit segment. of of Clobazam. the that, growth driver physicians, benefits we

be with use demand the I and that of it to process understanding to then that is stating their seen well both norm this broadly, our which of is look itself seeing this it with as and very terms that means just the these to seizures creating they the area. of how beyond physicians viewed continue as polypharmacy And we intend -- the That's further market just continues at branded you're from tolerated in data Clobazam we Epidiolex treatment, as well-characterized described in the to patients. #X and drug, generate a lends effects polypharmacy. in data earlier as more And greater in

as We are mentioned. I seeing well, outside as U.S. growth the

launch So we're existing continuing add in geographies both and then new within to geographies. indications

nicely well. that is proceeding as so growth And

Operator

Securities. Lee take with will We our Joon next Truist question from

Joon Lee

top meeting for our you ], something you you the when update to that When report And a questions. orexin on you report outcome dependent is the Thanks events? have and to can suvecaltamide for And the consult latest a II able go/no-go and quickly, ascentitremor into ET? do advancement still and FDA before data is from have line? [ Parkinson's independent on line ] share the top on Phase of the just program. [ disease the decision on they comment with Or you the being are anything the decision? will Or taking that go/no-go

Bruce Cozadd

dependent line comment So part But general, the need I around would Whether our was we to we this been the a be know remains what top question the data time on share we say, of data. is that steps general, that -- precisely has And essential tremor. on in our practice basis. on remains to first remains timely in and seen to forward. program be view move

interaction. So a add involve barring want you surprise I'm not in ] to a on sure regulatory else that would Rob, ET different that the or on anything [ orexin? data,

Robert Iannone

the drug we program. part with positioned think poor. We approved and that. best-in-class high need. modulator. this a a have regard very trial. a ET, built action before certainly differentiated been the years, you have There pivotal in calcium to hasn't of of Certainly, I as with FDA on a pivotal guidance I was available given it, data, an is unmet agree just pretty XX is expecting would be and trial mechanism excited and there what's that channel say It not to that see about we're We're to to providing we'll some talk to

So I give think more data informative, be this don't tremor and quite think overall. is it in disease strong a we read essential Parkinson's the certainly would through, tremor do will and see direct confidence data. I us target but

And on there. characterized. findings we're previously examining finally, question of the There then that orexin. are We're pause we on no while the safety updates

Operator

Gary James. Raymond take next Nachman from will question our with We

Gary Nachman

parallel contribute be is And the data. of cancer? GEA to further year, you next trial, And Zani that just describe that into then size interim see line of it on OS with the and from just what BTC? hope not and increasing could GEA? doing the So that the you sales regarding Zani, to breast GEA in BTC what's just Will possible expanding time for

Bruce Cozadd

to over going Rob, to turn I'm you. this one

Robert Iannone

Yes.

So similar I the answer previously. to gave

on we early on we published We last cancer year, have ER-positive breast San stage been Antonio for in metastatic cancer working cancer already, HERX-positive disease. both recently setting published the at and breast in HERX-positive, then

in It's So data. those and have areas. other And any in development we dependent progressing readout. on not cancer on further publishing are working plans been we breast those

sample on time the line. power have survival something usual in based from ensure in impact final the those original the that typical first approval. made for health be at analysis, funky GEA at PFS overall an on to support out just the to the we regard changes health interactions the this expectation not overall OS detriment you're overall the a size you're to powered. And to there's authorities point. we that study. that plan is read that With know well no to that the on is -- albeit OS, not but interim so not would want time to on end looking somehow that to authority generally, setting, progression-free happening, seeing -- and to And It's Again, adequate the PFS. better sure interim changes do survival OS an early be We

we interim have it why the our which would with eat original course, And change. And on then the too we cake have which we this have time then we'd mature sort of OS occurring and is more data, trial, of it that the is analysis, power. believe second have on the around

Renée Galá

And then...

Robert Iannone

have BLA. we supplemental will seek even an faster in but while get we read compendia a didn't so where address Yes. we we BTC, we around scenario path for to market supplemental the the certainly is GEA, label, listing publish as in certainly out mean progressing are shared what that I revenue update question XXXX. are, are the I the in the data to for -- and the There U.S. a given also -- And terms a get we've of the to we on on BTC. as didn't

Operator

with will our from We Tewari Jefferies. next take question Akash

Amy Li

on This is for Amy Akash.

Just a quick Zani one and on GEA.

Zani, be to compared therapists' GEA III X Phase roughly [ perception is the given ] do which and the similarity similar enrolled arm, mechanism the failed? plus why Perjeta, given HERX, you [ HERX doesn't comparator arm Jacob It population ] So to between like trial chemo. related seem treatment Herceptin, expression Combo

in So your doing just is are only trial? you there anything

Bruce Cozadd

to want you do take Rob, that?

Robert Iannone

Yes, happy to, Bruce.

is the Perjeta bind, So positioned -- ] the on reason on Zanidatamab the same to first when what is they're same and of when Herceptin whether dimerization binding that different get immune correspond FAB that fragments enhances with do independently And for epitopes [ antibody the the HERX therefore, interference on or differentiated HERX marking the receptors. with it occur receptor destruction. through signaling of X epitopes interference is the be of you all, they while Zanidatamab that and antibody, causes internalization. is cells which signaling, clustering, of interference HERX And

with in head-to-head X data some just cytotoxicity, this which separately. and showing it comparing that experimental those occurs Nature of Communications published and also was data is antibodies this showing includes the clustering experimental that effect really antibody lot combining A biparatopic some antibodies nice to induces unique any complement-dependent and data amongst HERX

be more we will data, a that. think that the drug And way, we clinical by support than differentiated giving actually our the effective So have combination.

have have cancer. who ] we on [ breast of combination with patients activity progressed Perjeta the Herceptin in and So

we showing where data the seem in patients. So Perjeta results, our give in cancer when I preclinical results it mechanism also BTC, have or you better be are clinical think differentiated to the breast whether and data BTC show than better Herceptin, to

Operator

question And we will Cantor Charles Fitzgerald. our with take next Duncan from

Unknown Analyst

on ] Asiya [ is Charles. for This

have on We question a Epidiolex.

about talk And a U.S. you So additional to opportunity given half the you Japan second year. the can and this market compared also, did Phase addressable this of in the III mention the in readout opportunity market the launches bit in year, little

provide if this? bit a So on you wondering color more can I was

Bruce Cozadd

turn let me you. to that over Renee, one Yes,

Renée Galá

in Yes, I'm to jump Sure. happy there.

we're able is And to There's made indications Japan, to the quite market excited pharmaceutical XX,XXX have largest in X for progress the about obviously, think geography. opportunity. be an So different patients the we that we in that across important have provide second that world. Japan,

opportunity that meaningful be Epidiolex, with Zanidatamab the able not in opportunities now but have also have to market. We to only

half this top the do line expect of results year. second the in we So

updates countries. already more markets to reimbursements of already as launches XXXX. than the will outside go, as additional enable think to do we we're we to that Cannabis pleased XX we're made in think changes able the underway, about would the and Europe. we launch. terms of progress eventual there, we've see gradual U.S. We And And with reimbursed as be of approved have also different that X I in then progress are the which some the the we're in Control and And approved large through making Act in anticipated that end main

'XX if course the available course execute ensuring that have in million, the being our focused that We're we're very So what through product 'XX agreements not to on continuing we're of each than set now been countries. $XXX able where making in annualizing indication available much as on the of status. we we've going a over and partnership doing direct, the full place really the we're And we and of expect track to we're we'll XXXX. to at either see the over given to blockbuster partners be ensure more continue product for is

Operator

next take we Stanley. will And with from our Morgan question Jeff Hung

Michael Riad

on Jeff Riad for This Michael Hung. is

more need long-term think you On less benefits evidence towards drive that Or or treatment? and community and like the do support to the the generics, sodium? health with switch needed lifelong messaging the the majority high to sodium narcolepsy given is aligned of generation low patients are what the for the IH authorized

Bruce Cozadd

doesn't as by health XXX we meeting hypertension be last a the drug Xyrem either sodium incontrovertible. sodium. underlie evidence which the of diagnosis have oxybate is The therapy, say Certainly, as already, superior neurology mean saw of would that said to or determining starting days impact surrounding has that to original It I that exclusivity LUMRYZ, for on increased Xyrem. anti-hypertensive bring same data pretty Xywav level significantly have Yes. opportunities the of FDA of lower cardiovascular thing more clinically same orphan on year basis med. sodium our period with a within sodium of decision patients out they the including presentation was at aren't we could there beginning the

you that who begin see a aren't with. being to hypertensive original they patients which why is, Xywav even known diagnosed high if determination all risk in people, that again, narcolepsy on was be at short patients, already to So will safer period time, of are that be impact in a cardiovascular as product even

Operator

our Beatty Joel we And with take from next will Baird. question

Joel Beatty

the For when give to comes the Zanidatamab, potential And ] [ sense peak see how from a setting Anderson in [ projection $X much are from might data billion cancer? and that of in collaboration able we I-SPYX you of trials? breast MD sales ]

Bruce Cozadd

to I'll you. take the part it data first of and part and of Rob the that, then over

certainly provided not well, breakdown the say we a $X which beyond which BTC see certainly, billion. that breast on our and it made while indications opportunity have is have north potential cancer, and set believe Zanidatamab, And is GEA in commentary you the as has thus for extensive. we why slides, most We can far we of of those

We've else little to take it. Day. where we to our priorities quantified timing maybe I'll near-term fully looking information at data, R&D our you. got product over determine haven't the We how be Rob, one that big forward worked and to as on more a turn could sharing But out of

Robert Iannone

indicated were that They MD expect Yes, published, ongoing, That San aware Anderson exactly already would and for may at neoadjuvant study, the haven't some trial ] when is data I of updates. you some be has [ and On when Antonio. and will updates the that phase. published. on rate depends a which a results might enrollment little the that trial, I-SPY, started really little is graduate after the from bit bit be that late, December

the is don't ongoing, next particularly have where inform at point. specifics cancer. better But we're with we that early-stage that pleased positioned tolerated curative this Zani may well how see to are are think option so we provide trials that And steps any breast space, women excited to in and we for

Operator

this I And turn further the time. ladies closing Bruce to have for will and no back call gentlemen, remarks. at we Mr. Cozadd questions now

Bruce Cozadd

their by joining their operator. and all you, Thank call today's efforts like our continued and you thank partners for our us shareholders Thank I'd today. and colleagues support. for for Jazz confidence to recognizing close

Operator

for gentlemen, concludes today's and And your you this call, thank ladies and participation. we

You may disconnect. now

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