JAZZ - Earnings call transcript Q1 2021 | Jazz Pharmaceuticals plc

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Operator

Welcome to the Jazz Pharmaceuticals plc First Quarter 2021 Earnings Conference Call.

Following an introduction from the company, we will open the call to questions. I will now turn the call over to Andrea Flynn, Head of Investor Relations at Jazz Pharmaceuticals. Thank you. Please go ahead.

Andrea Flynn

you. Thank everyone. afternoon, good And we reported financial quarter our first XXXX results. Today, presentation release section webcast and press accompanying of the website. Investors The the slide this on are our available

Executive are Chief Chief and Officer; Medical R&D Rob Dan Chief Chairman call Iannone, Vice and Financial Bruce President Officer. Officer; the Galá, Executive today and On and Chief Operating Officer; Swisher, Executive Renée President President, Cozadd, and Vice

risks in Therapeutic includes America; Head; release Sablich, to performance, you operating Executive Anne duty differ factors to Vice those General contained the obligation forward-looking results Phil Joining that Jochelson, the Oncology actual Q&A statements GW certain North the We undertake company's projected. differ today's may Neuroscience identify our this I'd review transaction and call of results like related to latest over and discuss included to Bruce. measures such the slides materially are disclosure webcast, statements. involve could those acquire financial Kim measures. which press Hematology to non-GAAP release Reconciliations press or to cause today's documents, that encourage results uncertainties in actual SEC to no on update forward-looking cause the on this our I'll presentation. GAAP turn On now remind our On X and and financial future X, and non-GAAP materially. are from to we'll discussed call that Manager and Borgman, President, slide Head. you of events, Therapeutic webcast today's and as financial We to and which statements, Pharmaceuticals, and

Bruce Cozadd

X. you everyone. And for on I'll us Thanks, start joining Andrea. Good today. thank afternoon, slide

of and XXXX, we remainder organizations, into continued milestones R&D year. across Following positioning commercial our XXXX with an during momentum to the us sustained the multiple operational excellence achieve incredibly this productive have

our we combined we Renée an with lives financing the and team building are The way. in planned even Pharmaceuticals, We our for which GW continue also on customers and and patients, will acquisition Jazz shareholders. high with later the executing together close a impact industry support transformation is global biopharma to Our positions Jazz around acquisition pipeline diversifies commercial GW drive well existing and the our done GW to February, fantastic This for on complementary debt further more forward to neuroscience to with company of operational a patients. innovating GW company structure. excited commercial a growth and have In around an month. is that provide the colleagues, look that, to track announced to plans greater as its business. therapies an to in and very innovative this secured the of common stronger updated She'll early are a guidance culture as to job call. the GW well our portfolio mission, share her addition in same about transform provide and built our as of acquisition favorable footprint. leader enterprise color Jazz

completion quarter. As in delivered transaction, in of we progress the on the key toward we the milestones first parallel, have GW

sodium view patients more exiting the were Xywav oxybate will that benefits our be approximately view strong indication positive physicians We multiple oxybate will our XXXX. This a It approved the sodium choice we approval of available. appreciate oxybate very indications potential there actives specifically that Xywav. first a adoption I of out all product want as option. the commercial majority once of call lower that therapy for and only expect oxybate and the are see lower sodium discuss commercial but this because preparing quarter. Xywav across is patients in FDA higher patients in to we continue of a And that I We highlight as Dan indications all on excited continue efforts shortly, to X,XXX detail of to are with new this will option in products be to or later IH, this an IH. is bring therapies. launch area we're for And people hypersomnia, high treatment of opportunity no to unmet idiopathic a Xywav Xywav year. FDA need, approved with

Turning to Zepzelca.

cancer, of of lung the growth with resistant Zepzelca is Zepzelca in to continued line second the move care expect important option patients we course sensitive for relapsed cell our an platinum in becoming patients seeing continued platinum see the the of year. providing and small are toward as both standard setting and we in setting. over We target therapeutic growth

significant As and targets, a contribution Xywav diversification in to of the product already Zepzelca recently we coming with quarters, exit our launched from revenue the XX% quarter making products. are sales first

which to the IH robust for completion JZPXXX being maturing demonstrating our we These a option development I'll commercialization enable in for taking inactivation narcolepsy, several team's and and a will commercial the with mid-XXXX initiated close Renée have financial are addition patients following Q&A. additional to to on Xywav asparaginase. capabilities. across Rob important from an call an believe with for time update upon to derived hypersensitivity GW clinical remarks launch is capabilities progress readiness, E. which our JZPXXX will a the then coli after call will who to under Dan? our supply important the our to our We a and development and to R&D therapeutic preparing Another transaction. us therapy lymphoma, We also in acute review open for provide regulatory across R&D JZPXXX advanced of high portfolio FDA with wave real are include commercial overview approval. have developed FDA programs. performance, Dan to JZPXXX stage leveraged pipeline, the provide prepared in is successfully oncology oncology now concept quality lymphoblastic to Xywav that we'll of silent December. lymphoblastic our in turn or overview submission in leukemia over patients reliable programs note through will It these

Daniel Swisher

I'm across Bruce. over increased In than including share to period combined X% and of over net same sales million. Xywav higher our neuroscience same and to in approximately a on the average $XX oxybate product last active increase including progress with slide excited portfolio. first million, I Xywav. oxybate XXXX, year a XX,XXX, oxybate to X our Net discuss quarter. product begin and increase quarter, period sales franchise, X% the the the prior for the patients the first franchise want Xyrem X X% and commercial $XXX Thanks, were

strong to we see adoption of quarter, This Xywav. continued

key enables X. Xywav detail the high to up we with of on initiatives as X,XXX of to is a as use As message X, modifiable from pleased the matters intake ended stay resonating approximately We're X,XXX end sodium the patients. educate Bruce at on I'm Xywav how noted, with on to so is we've them both slide actives physicians what year. slide launch going burden well well quarter patients intake A This risk of why factor. approximately this audiences. and but of address further included about sodium lifelong our component is the reference, the is that for

many research Xywav new patients comfortable existing field strong existing and highlight oxybate the from offices to that adoption transitioning Specific with the physician seeing patients. our and reports to seamlessly oxybate to among over are we're market Importantly, patients, Xywav.

patients, Xyrem with products the from information pharmacy. about they're their Xywav existing along receiving For shipments availability specialty

made adoption, within HCPs We we Coupled payer of multiple our increase with launch. excellent of agreements goal progress meeting place broad months our coverage PBMs. seen six payers, target have also with We recently. to an have in-person major in three strong now payers, engagement with field with including obtain

lives our to XX% continue team is currently of expand covered is overall working to payers and coverage commercial Our at coverage. with

for for and So are with ahead, fourth planned in we no approved Xywav improve idiopathic There looking we the of disorder. treatment are sleep debilitating FDA for treatments to preparing quarter launch have people the IH this opportunity hypersomnia.

April Phase discussion IH IH review at III to IH, webcast the and American in year's commentary Meeting presented where Xywav Annual more refer opportunity. we around data I opportunity of of investors would a Neurology For the of Academy detailed provided our this XX the

sales quarter the year We're progress in expanded by to $X Sunosi. in ongoing million increase in and same new first began force $XX early million the the rolling patients therapy. the promotion to period year are US consumer quarter increase Moving product Sunosi and compared We're the to in dedicated including of ongoing to of including $X first US. our XXXX. pleased to encouraged in increased of were invest direct and growth quarter, fourth European prior XX% in first which launches Prescriptions we also with Sunosi, to the million in this compared last quarter and Sunosi, the trends an sales recent in net continuing the and the time of campaign, and our TV an demand prescribers

So, turning to X. on oncology slide our now portfolio

second compared Vyxeos, net period we $XX XXXX. Notably, million, strong quarter. across been the settings, uptake We sales are academic to growth first strong product There increase same of growth both continued both in sensitive and first resistant see patient the platinum has Zepzelca with for and $XX line continue share. platinum X% In product million the to net in of seeing an patients. quarter, the were in sales and and demand significant community in market

support international continue Vyxeos to commercial expansion growth as markets. activities new the of and We as development ongoing with into well

$XX net the we year. same of product X% period of saw million, Defitelio, last sales over increase For an

period product sales same Erwinaze quarter net $XX First XXXX. million, above in X% the were

of was of first the PBL other in supply to end Erwinaze with at agreement year. half we markets our have the and this select through For of expect terminated the US XXXX,

and as asparaginase, on JZPXXX reliable for quality as to recombinant possible. remain need focused bringing market quickly urgent the Given high we

product led which remain a team preparing continued launch our In for is anticipating we operating commercial including summary, US the start FDA to performance focused We our are on XXXX. teams, has approval, Our currently strong to upon Xywav progress across for to call mid-year. execution for over our of turn upcoming Rob Rob? planned continued an development going our our in the I'm and IH. update for launches programs. recent the launches to and now successful of execution the of JZPXXX

Robert Iannone

the to make significant efforts. progress Thank slide on we In continued quarter, our XX. across Dan. you, first start R&D I'll

announced we the JZPXXX. April, in review in action year Our two Xywav are and a priority hypersomnia of near-term and for XX granted areas set of FDA August date that of Xywav IH. focus this In PDUFA idiopathic

to NDA clinically disorder debilitating stress provide Meeting, of socially significant impact option IH. at clinical with that condition needed meaningful moment clinical striking, The Xywav American about for measures Dan Patients statistically highly sleep has Annual approved supplemental the a is sleep. to the Neurology consequences severe by presented the poor professionally, Academy III take We're Phase brain As want which our also are compelling were often and overall of to people therapies. submission. therapeutic and and endpoints sleep episodes and exhibit outcomes. I trial of memory, IH and patient a pre-specified consumed mentioned, inertia, excited potential results, the of to are foundational we of living all results The no trial reported FDA lives. much to daily fog, patients' in micro with a of

Now programs our XX, Zepzelca. I'll start oncology to turning with slide on development

immunotherapy work with as to small cancer first trial in cell patients support as line data lung well alone types. our a in cell small other in to collaboration PharmaMar, after cancer in as use the This with maintenance continue We program evaluated extensive combination generation chemotherapy. therapy in immunotherapy partner, on development induction combination therapies in lung with stage compared includes with III tumor to other robust Phase

initiated launch US. to the on BLA we review. under FDA a the to the mid-XXXX to for Moving complete working December, the submission a In track and oncology We're FDA real BLA submission with time JZPXXX. closely remain in

a there trial. to are two reminder, this parts As

first The evaluated enrollment, has of which intramuscular JZPXXX. part, completed administration

currently in on part, The strategy Europe well in and opened Canada, of in JZPXXX. approach our working February, second as and also our participants, is administration is enrolling which Japan. as regulatory We're evaluating program development and we Canada our current the later seek our Europe JZPXXX and efforts from plans these will support data regulators be in approval confirming in the with for that anticipate will We year. to intravenous

results the the again determine meeting We of we the As to met PharmaMar quarter FDA with results. this noted, we to trial package. share confirmatory line trial, and ATLANTIS with top FDA appropriate anticipate the later previously

pediatric include Vyxeos, year label FDA For approved patients to recently revised the AML the and one aged for above.

to an later European We also a submitted regulatory potential in authorities for this with application Europe year. approval

the more to there pediatric patients overlooked relatively that, setting high need While Rene. I'll of approval the a in often the groups proportion turn and need. for With the critical a call unmet AML over our with demonstrates represent effective to small cases, therapies is commitment

Renée Galá

strong to share a highlight Full quarter. XXXX, which several particular, from I'm adoption call, for driven release by key Rob. recently and financial results Xywav first top revenue QX are the In Zepzelca line very growth, XX-Q. performance including I'll products. results demonstrate from Thanks, our of pleased today's quarter was available in financial On the our growth. and launched our items contribution continued our meaningful press

from Zepzelca Xywav coming with IH of XX% to quarter we of generated ended As product shown substantial in quarter the quarter in our and focused to the our maintaining We the GW on newly of financial revenues Cash launches an Xywav, cash, to efforts XXXX. first further Xywav note, commercial business. XX, in the In revenue XX% to strengthening $X.X the billion launches in the see increase upcoming of in increased strong the continuing our adoption significant sales in transaction. of represented million total same We operations being on key remain with plan of JZPXXX. were as A the close while in also pleased $XXX from quarter and products. first the compared Sunosi position portfolio. to $XXX million invest to cash with by generation, prepare period and and point quarter, XXXX, of diversify first are launched to the XXXX we slide growth net compared of realized, oncology

neuroscience to XX, impact growth high some like and adds multiple around clinical GW of transaction slide and portfolio, and product status our stage the also expand the GW to commentary Turning to the on programs, current provide substantial I'd guidance. importantly, overall a value commercial strategy the cannabinoid team. our allocation research to for accelerate This revenue and our growth with capital shareholders. our development, manufacturing our and transaction expertise commercialization is drives portfolio, diversify and consistent GW of business expand and

transaction acquisition, meet demand $X.XX were we're weighted terms track in of total for the of to on notes, pleased and hearing We billion. debt that The of term target the X.X in than are billion acquisition approve pending We financing. the is the post of a we total market rapid this times end close of a favorable the and on to plan XX. the Court decision, positive of May. expect Wales meet secured successfully senior leverage And scheduled GW sanction the High X%. of to tomorrow, of strong the voted to a secured net $X.X in average of close XXXX. loan early now we less To at approximately with shareholders We by with acquisition financing Inclusive non-dilutive billion debt, target this be April cost X our May support of $X.XX to pleased X. new for our Justice acquisition of to England less date deleveraging times expect the of than

we in to growth, continue accelerate be expected The line to business. EPS will year combined full will the first accretive revenue to investments grow is we XXXX, thereafter. also GW aggressive make in the the accretive calendar transaction double-digit substantially our and deleveraging, operations of While top

talents teams, progressed excitement deliver patients. Jazz As opportunity and and colleagues that develop increased. we real integration combined GW Leveraging the transaction our to and the new this has launch at our GW, the work only differentiated about our we've to value of with therapies global expertise have

Jazz guidance line track business and Jazz underlying remains standalone performing expectations are for the we previously in XXXX. with financial reiterating our guidance, communicated is and to on our Turning

$X.XX date the billion total $X.X adjusted of non-GAAP range GW plan reminder, We to financial be of XXXX billion organization are and from on $XXX a is in $XX.XX, close income net and guidance I'll $XX.XX ranges of revenue to to and of close the the the million EPS in for provide combined million eight the $XXX the As respectively. guidance year-end, will to we to Jazz guidance following approximately addition GW which include XX. through expect months. the close slide This of transaction.

We are to XXXX on deliver goals. our track

an commercial Zepzelca. and team has recent job the of launches Our on done outstanding Xywav

for We will the to globally R&D portfolio launches review preparing late programs organization contribute both and and are seeing are begin novel two strong clinical clinical this to slated pipeline. FDA momentum advance and for by this two stage our trials The The therapies, acquisition with growth commercial continues Sunosi GW under to year. three and mid additional stage year. later

of the XX% or XXXX. well have goal positioned launched that acquired products our we to Following acquisition, revenues generating been reach XXXX will our from of since be

continuing an and first significant company biopharma growth high of a are number innovative, quarter milestones We achieved that to contribute transformation that our to the goal. in

potential like to direction to and and deliver for operator our our We therapies patients are shareholders. the the to Q&A. over to turn important now up prepared new concludes to line about excited open the company of the the value I'd call remarks. to meaningful That

Operator

[Operator Instructions].

question first Our Ken the Cacciatore of comes from and line Cowen Company. from

Ken Cacciatore

on your congratulations I'll Really one and question the big respect team, fantastic performance. to Hey just picture. all go results.

Just the by delever about the you looks you're a generation months quickly, like do combined in looking company another could ability XX be the my to math, at $X cash billion in position just the in talk timelines and it to type really billion out? fairly of into in BD transaction of $X appetite your laid of just to about equity. near any I the Can around for without or term the going combined business you terms just talking either

Bruce Cozadd

take one. that Renée have me Let

Renée Galá

in, Ken. to jump happy I'm

below that's growth, of So, acceleration a on And the the confidence this we of by as currently. we the cash did, then next year X.X see getting yes, to gives and continuing us our lot combined times execute to a business end and that profile, thereafter. cash as in well that target what generates rapidly deleverage of of confidence of clearly, the financing basis,

pipeline able realize and value with do how Epidiolex certainly, that the rapid It we integrate say, would transformative able is transactions profile certainly company, this about acquisition transaction gives deleveraging, cash momentum from full to the continue additional for excited want we what full have are us think with also transformation to a I how this ensure perspective. integrate the to we're of to the the emphasize So, I just optionality. and at is that just to us be to that us providing and that ability time. particular

Operator

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

Jason Gerberry

IH just as penetration from going the you another will a something pertains rates? the pretty to My is look potential over you or contracting? Xywav IH how perspective, population access severe I'm or to are through which potential And Should do to Thanks. I will Xywav meaningfully potentially narcolepsy could it about XX% about we access rates six elucidated launch curious, Or could treatment versus know Xywav the narcolepsy penetration reimbursement another? oxybate in about the to question you similar? if one guys get TAM, that more patients? guys into moderate opportunity. roughly different you And much in the process has that share this be step these nine just be level talked be rates think think Xywav when for as way that larger time, you they that at set you curious month have you to but for

Bruce Cozadd

on one. jump this to Dan in ask me Let

Daniel Swisher

diagnosis chart terms feel free did XX,XXX we and diagnosed But, well a this looking been market. We as have add yeah, to on planning. across of at the we in came patients. review Kim, launch

approved we start under there an that much once really an no representation see start get can Given how a to that's probably once we understatement chance promotion, promotion. exactly can we'll is we better believe treatments, of

narcolepsy. there in centers, have of certain heard, offices, the to We an could number some be equal bigger IH sleep patients of

meaningful at into are clinically I going we as adopt and think the AAN from be the there benefit severe similar across pattern, meeting, Xywav all presented we there is meaningful. very but the moderate But their to is patients know going going therapy, an meaningful endpoints, that to clinical results to well oxybate be adopt lifestyle. as statistically more it's

about we're for excited So preparation? to track want and say launch. anything on the you launch further Kim,

Kim Sablich

say the around narcolepsy address commercial well specific we've discussions into that to about very us I'll setting idiopathic payer is What position question of go achieved coverage the I the payers space. with really strong and is, up hypersomnia. terms in in can Xywav

more patients. Given to down this rapidly what rates those discussions in in coverage, did expect we management going with for these in what we type have that place contracts probably is around going to very similar achieve put to in is payers coverage narcolepsy, Really given place. we IH be come and of utilization is than

I'll side more started the a So, the in going handle for with – that's mention condition. different narcolepsy really it's prep really bit It's of and educating a providers the HCPs medical depression. I'll well, on little this already – what as from condition we're and really to indication. on and as terms such focused is helping understand launch healthcare on reinforcing our conditions say around better about gotten critical we've patients to little other access IH how Yeah, be

with same launched. campaign So, education recently our that gotten started we've through MSLs, we've with patients we're recent doing on the disease

important of of aspect the doing actual going advance that's really a to launch in the product be launch. So, branded

Operator

the comes from Morgan. question from of J.P. Fye next line Our Jessica

Jessica Fye

slowing the switch. can A here? that initial a Xywav to that of adding per X,XXX Is should low this you represent question Or and quarter? of adopters from there think we a could that see about any sign take continue, Xywav on as fruit patients reason hanging momentum

Bruce Cozadd

at higher or been but reminding past. newly or narcolepsy new the This diagnosed tried getting past, start point I'll before, were the whether diagnosed just also patients by and who Xyrem is both Xywav, we're immediately to oxybate that on you the we're in patients, haven't some on they've Xyrem Bruce. with getting sodium before to they're in

adoption sorts a patients. just not of It's So, switch. all it's by

hanging fruit, to maybe Kim it sustainability of about your For comment. I'll and low momentum ask was question

Kim Sablich

the not five low hanging really in With transitioned X,XXX matter first slowdown really don't believe see of in fruit. already that. we it's patients any months, We a

the hear Qualitatively, strong. just not number using Xywav. subset subset is – not a the that customers quantitatively, product they that them are a it's talk about patients just customers, we of are to of So, adopting don't when just and thinking it's we

do momentum really is that we a believe continue. this healthy so, in very to And place

Operator

Our comes the line next from Capital. question BMO from Nachman Gary of

Gary Nachman

access Regarding for in we've few history from preventative physicians the narcolepsy, in Xywav measure heard patient to it to rather some payer could CV get challenging happening. if Xywav a a a be documented of as cases that prevent hypertension doesn't issues the than have from a

where you order sort So, is physicians it you on It to patients potential how of have get are this getting something for get in hurdle, you? sounds very about hurdle the around that point, is a but at like that to the feel good if Thanks. the is around access it?

Bruce Cozadd

a provides efficacy but of a high that Xywav majority for that known We – delivers to to access to that access the is cardiovascular patients, the chronically vast We're active of population generalizable in This sodium risk. that a have is that moiety is gram-and-a-half patient the night a to occur not heard in patients, trend. finding a to at that most product every additional gram and tracks Xyrem. without treated that same condition

heard general, in not, add that? have we anything you're describing. Kim, to you what to want So,

Kim Sablich

Yeah, no.

by can differ it I to out rule, think certainly there geography. are and exceptions there the

part, that a pleased has most to opposite the you've transition up how got the not somebody this for heard patients that the Xywav. we've to So, exceptions, geographies but where were are easy with that it's perhaps been We've in to with been barrier. very customers talked coming

Operator

David the question Sandler. from from line of next comes Amsellem Our Piper

David Amsellem

you're ask is are about going to on wanted payer have have won't to that? guess exposure? have how to or question only landscape. you're to that your the that and thinking and utilization is, about stimulants have step I Xyrem expectation the contract is The Provigil patients a will specifically have that's management And worry or view be to these way think your and about, to say, do about I hypersomnia, idiopathic you in through? such where that How going it you a it

Bruce Cozadd

I patients into and you maybe, Well, let's expectations that? pieces. added And take in could with IH ask our who for how an approved comment what Phil, just the on side before Xywav without are we go might this therapy two currently payer dealing are to be to

Philip Jochelson

with symptoms. XX I on agent, the many and agent these range scores. that actually narcolepsy agents would we are patients showed say these of wake-promoting similar may that the a a still in hypersomnia still First, agent, coming the from are of already actually I further be or on in to pathological of despite the the getting only sleepiness clinical benefit in not was very they idiopathic providing already trial, of wake-promoting that patients the the Epworth wake-promoting sleepiness in population need think improvement about but And wake-promoting benefit with in XX, from not other where, many Epworth of their score a baseline about, say,

a showed, many including multiple for perspective, presented, the all benefits I've not that most people my think scale, we IHSS symptomatology on both I in IH. on symptoms from the So, And as said, part satisfactory we nighttime the of daytime going had get to which sleep data symptoms inertia. symptoms wake-promoting and measures and be will in agent. I'm benefits the still

Bruce Cozadd

And, part Phil. take Kim, David's of question. maybe could you Thanks, the second

Kim Sablich

are and authorizations of mentioned have will management be a as negotiating patients with already to edits payers tried step utilization much the we Phil we're going required. prior how I Provigil that said, thing as the moment will Nuvigil. is, such really, As main majority And or be ago, see that

it's to the other product. if in will hand, will be nor even indicated be, any not So, go that through. on a step other oxybate And Xyrem not there, burdensome

we through is but value it's And required. of that to payers low sodium the So are recognizing not going are hearing. already that probably believe significance We impossible, a step unlikely be clinical oxybate. the the and

positive I where up, terms where about feel But ultimately negotiations in end we'll see quite our again, probably but that's think of headed. So, unlikely. we're we

Operator

next Risinger from of the comes Stanley. Our question Morgan David from line

David Risinger

I you the sales very its detail, some discuss of Zepzelca So, sequentially please? think marginally quarter in launch. quarter effectively in the were its Could only in third fourth being product -- despite up the versus full

outlook you. you then growth. so, forward just sequential if about that sequentially? talk And And Thank for could looking the performance

Bruce Cozadd

of Kim we're ask the on I'll comment the for our quarter first that growth. to basis seeing confidence in continued forms what

we for the think want we've comment move We but to provided guidance quarter? the we Zepzelca, XXXX. you first on significant growth revenue expect haven't of product-specific year, said, as I do through Kim,

Kim Sablich

actually that the quarter the underlying we first our demand performance increase very We're maintain we quarter. based strong see. very is really that with on quarter saw the that in over patterns projections on the full-year pleased And have. demand We and optimism

very demand feel is at encouraged that we the patient very strong types. particularly So, look when and confident underlying

growth and patients. really platinum-sensitive new patients among see to continue We the nice we both see share second in and platinum-resistant that in line the market

So, reason demand to good feeling very and flattening. have no believe is that

Operator

comes of Our line next from Prasad from Balaji Barclays. question the

Balaji Prasad

be material any was that your Since one it deal the cannabis infringement I Canopy restrictions So, Growth on last GW the Pharma? closure, on insights on December. extraction legal pattern potential raw Bruce. for wanted based it against think has seem question, quite to GW close sticking and to a to filed I landscape lawsuit

Bruce Cozadd

make legal action. Balaji, to any that on disclosure going I'm not additional

from really launch, excited the this which more out continue excellent describing. years its go of continue under on Epidiolex continue don't market the first what early feel and grow really any coming where in to We're on couple momentum leadership product see in ability our full confident about can the and is of GW's recently European to We barriers to you're phases. the to

Operator

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

Marc Goodman

decline us talk and year-on-year the give bit on X% growth bottle give bottle Thanks. in you're you color context higher growth us Could for a how thinking of the quarter-to-quarter? in whole more about for of franchise? patients about oxybate the then sense year the the And a maybe

Bruce Cozadd

Xyrem Xywav continued growth patients see in the toward moving Xywav. It's and the important share to across oxybate on and increasingly

underlying patients, trend. temporal but on revenue think as don't some occurs have said that an be impact, for there'll We we impact it's bottles, transition some

to to therapy see patients new directly Xyrem. to often continue Xywav are who We to going and oxybate more

Marc Goodman

The bottles. what talking less this is taking basically [indiscernible] dynamic patients So, about. that is bottles It's is not not dynamic. you're

Bruce Cozadd

bottles, Revenue correct. Correct.

Marc Goodman

Revenue Got thanks. Yeah. models. it,

Operator

from of comes next question Gregg Our line from Security. Gilbert the Truist

Gregg Gilbert

versus situation? you on more former the ability interactions the have are an the US unique partner's product you. circumstances with your compete situation XXX, to or FDA around actions approval world? it, of in the typical the you supply Thank a older let's call thoughts updated on in with, given On any confidence do providing And

Bruce Cozadd

me let that For part the question, the answer Rob first on regulatory side, that. have of

Robert Iannone

granting would just everything the great. invested process oncology this past. real-time quickly in would parties so collaboration and that far, all see are FDA Oncology I as throughout this the I Children's the with has can as is possible. review, development, the in of having from on say Group you And on just go as we've say track And based review that really been given guidance really

Daniel Swisher

file COG likely I that's the very on get and need with international their BLA. your And supply plans the product think to going little in filing a forward internationally Greg, get of I what in recombinant land, what then a the to going UK reference are, just a certain question the markets. to it's bit a for to easier a US. quality is FDA and approval make to and about think as well. into little less with them high They It's former their be difference marketplace path are And their again, and the partner supportive

a timing I the be to US less and market. in their So, little where is exactly think strategy certain going

Bruce Cozadd

where, think penetration for more of be young benefit been could then adolescent expansion to from able patients just on able again, into treatment promoting not number international and answer We've saying and this the who back pediatric patients for our supply supply have effective regimen constraints. market, hypersensitivity or years, to had limited by reaction get tag really really ALL continue Dan's a an to but I'll containing be silent those to where years. we that activities a only effective excited to to by promotional adult curtail asparaginase given expand the we're our marketplace for continue Gregg, And a of we've in number inactivation.

Operator

comes next from of Sachs. Graig Goldman line question Your from Suvannavejh the

Graig Suvannavejh

Xywav. Xyrem. would question discontinuation you Maybe of but quarter. early, sticky give about you real this are on any get around on or be my to I'm a think know color? will business any Congrats who Could rates? compliance on be now trying of the patients the kind experience it's I world still relative to how color just sense

Bruce Cozadd

your on to Kim, over parts. patients we'll about you're talk tolerability. saw what that I'd Phil? clinical patients moving terms take we our And on perspective can trials two seeing just Xywav. in started Phil, Xywav in on on then, who've with love what we Well, on of the maybe

Philip Jochelson

the Xywav, broad study brought portion a turned clinical discontinuation in treatment-naive the population a of without who versus switch Xyrem, be agent. those on a with we of Xywav for that the they were on or transition trial previously protocol including sticking who range were patients as in with with gram of of with with the and the with were the trial XXXX gram previously which those a patient that majority clinical our was previously Xyrem and on substantial that And subjects, In wake-promoting having narcolepsy, [ph] participants, seamless were of dose part out a patients vast same had minimal rates. to very with transition we Xyrem

and a experience And that Xyrem part switch. overall, seemed is with population. continue trial. very of good So, we're And into optimization more coming dose already who There very with think seemed has Xyrem clinical I clinical obviously, well on with for the to Xyrem persist may a as little for trial. patients gram do that a patient and and to be the bit who really gram stayed

Bruce Cozadd

with launch do thus Kim, we're the jump what want with to seeing you in far?

Kim Sablich

I of majority don't have experienced patients say patients what are Xyrem. Xywav quantitative I starting are with hard that data. can the But that large

it's that no differ and really There reason see on and we're persistence patients terms some Xywav. believe customers, with took launch point getting Xywav previously is In of who positive. would we the do feedback coming with actually of the been oxybate discontinued from to back largely therapy Xyrem from Xyrem at this

Operator

of Your from comes Rajavelu line the Esther next UBS. from question

Esther Rajavelu

the you markets any have On the for on administrations different versus the us that O-US markets? two considerations and might remind the can whether implications US XXX, for

Bruce Cozadd

do Anne, Rob start want about of how you thinking or route we're just on to administration on XXX?

Anne Borgman

intramuscular, This we of The of or IV States. initiated focus an after JZPXXX. the follow the the the so that said, through RTOR is route and trial process pursuing on focusing United swiftly portion current study very the our shortly administration the nicely on IM, intravenous being have will approval study. That has for progressed on efforts in IM

Bruce Cozadd

a do US? Dan, not little talk globally, thinking we're how you want the And the just about to opportunity about in bit

Daniel Swisher

will the very to the of clinical importantly, get It's to something exploring first working and terms dosing us In well. and how pivot and that's both we've relationship the which will able so. may get Europe, part really the label file profile In include important to IV packet for accrual likely in be the be results, will for of to but rate the and approval, optimizing just we're data and as the IV, of together IM FDA. the IM best do the that given be IM. the study full But to quickly, with we'll current we close US, been to the

Operator

from from Stifel. Our Samimy the next of Annabel question line comes

Annabel Samimy

earlier the touched maybe Can level is a I really if this to of just pattern change then underlying assistance can been Zepzelca, patient big have second Zepzelca? a [indiscernible] in this Just touch the factor uptake us know doesn't you you or of think classification line about? a The should patterns with back had demand just if for immuno-oncology this that on quarter. understand that if seems ordering of help down maybe of the jive that you in on is you factor strong setting, slightly deductibles, talking have sales that because this you're Thanks. And before. also impact on

Bruce Cozadd

focused want you're I you with little Rob, the growth we're point later impact but Zepzelca, demand reported the a IO trends out that Other sales on things Zepzelca. seeing which underlie with changes Annabel, term, for think of our continued and do main the comment can some is on short in mean Zepzelca? moving will confidence growth. to of the therapy we're what see the right bit seeing the of lines of

Robert Iannone

the was if to I so going that's clarification, ask for question. that

line have small think been it first on in extensive happened has space little patients. and of the stage approvals majority IO I impact. for What's great that's the there that cell the is

which IO good. data or second that's becoming And line my getting second is therapies to of to line, third so, and effectively, chemotherapy after care based is standard relevant are plus of IO upfront failure other like Zepzelca upfront, like patients particularly really on later practice. a not line relative topotecan, and not are the clinical

Operator

comes Your the from Jefferies. next from question line Steinberg David of

David Steinberg

you market, the it evolving the I wanted down question competitively see and an to road. about XXX ask particularly asparaginase additional how

and are market And three-way do they're I your share II are behind you. players, you see over obviously seeking that – as a some time? as So, data They're you're competitor, ERYTECH, see good market their Phase them understand, supply how see you a evolving How meaningful of had FDA sort time? more are recently you pathway. third negatives guidance approval the there breaking Do over do out positives competitor? roughly The constrained? on

Bruce Cozadd

could Rob, market just on on Rob then, the side. give want Dan, And can to perspective? you jump Maybe in little of sort But, do start you medical back scientific side. a the

Robert Iannone

are limited, and very The aware cell red I therapy based I'm data would on at adults-only. least deliver of asparaginase. relatively far that's say to so different using transfusions

point. XXX strong this in So, pretty at I think positioning is the

Daniel Swisher

silent and looking to into broadening of addition for add, have supply think inactivation quality AYA product really just time and in as for to with with this and going recombinant it high broadly good to the to promotion asparaginase reestablish use looking regrow awareness market moving the into geographies. Just the some I hypersensitivity, market of we're

of plenty growth. there's So,

the the control can in offering, near think label wait really I time. to term all we promotional of We'll and the rest market our over evolves product see efforts. is how

Bruce Cozadd

we questions? shall up? Or more any wrap Operator,

Operator

Bruce I'll for turn call time. back at remarks. the questions to closing no this There are Cozadd Mr.

Bruce Cozadd

another you year thank us great much. today. so in Okay, excited everyone XXXX. for really thanks We're about And joining

launch the launches Zepzelca. talked As about with and development got concept and on portfolio are all I JZPXXX asked of as excited with ability to is pleased XXX going. of really look think how about And GW speaks the should at about about advance of through ahead the launches And with transaction. Xywav we've IH programs this well and growth capabilities. Great great be that transformative we the and our We're you couldn't we hypersomnia from progress to way we're questions readiness, more way call, commercial the upcoming examples us. talk which Xywav And today, Sunosi. remember seeing people to idiopathic our

Bank We America, for will our this just at I'd look their creativity, forward by of our close new month. fuel to close We continued that, RBC we at colleagues conferences to continues the support. strong with to like look And thank and speaking sense our of we'll you success. call. the and and UBS partners Jazz And to of urgency thanking and later shareholders our colleagues welcoming many confidence with patients, commitment that their forward GW for and here

Operator

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

disconnect. You may now

Jazz Pharmaceuticals (JAZZ) 5 May 212021 Q1 Earnings call transcript