JAZZ - Earnings call transcript Q3 2024 | Jazz Pharmaceuticals plc

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Operator

Ladies and gentlemen, thank you for standing by. My name is Abby, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals Third Quarter 2024 Earnings Call. [Operator Instructions].

And I would now like to turn the conference over to Andrea Flynn, Vice President and Head of Investor Relations.

begin. may You

Andrea Flynn

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

Iannone, Executive Executive call are President, Chief Operating Bruce Officer; Chief Renee today and Chief Johnson, Gala, the of On Officer; Head Chairman Rob Vice Global Phil R&D; and President Cozadd, and Officer. Financial

I'd to to in results operating statements and in factors that to forward-looking review described actual statements. filings, webcast. update to in materially certain identify that statements from We risks to involve our which contained obligation risks to X, our Slide and results development undertake in growth that could On cause related or in those today's forward-looking these our those press the uncertainties duty and statements, goals, the and contained the which events, may company's and the cause and financial anticipated made like differ milestones results, today's forward-looking deck on webcast commercialization uncertainties includes SEC performance slide future those you differ and today's performance We contained potential release, you no forward-looking our events, as statements. from actual such materially and remind and encourage

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

Bruce Cozadd

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

across clinical with our to development we was by our our advancing commercial quarter third maintenance from stage cell cancer. growth zanidatamab pleased an data delivering evaluating trial of small portfolio progress program. III our milestone report important headlined in positive are XXXX, Zepzelca which strong extensive and We on lung first-line Phase for Recently, in the achieved

with bit quarter. the for more The neuroscience detail, and durability our Diving execution both Epidiolex quarterly I'll was therapeutic underscored begin year-over-year into posting growth. our sales of commercial a double-digit third Xywav and record by area

our oncology Zepzelca. addition, growth including reported strong In business revenue quarter X% year-over-year, a for

feedback on positive to narcolepsy, we the market, or area, we provide patients the as indication drive therapy continue strong therapeutic Xywav neuroscience our as Xywav approved branded of narcolepsy for #X this patient and treatment brand. the for In And growth benefits we see idiopathic oxybate IH. the hypersomnia, for expect only IH, the In physicians demand. in choice and the and build to to of remains continue

market Epidiolex progress growth is remains multiple ex in ongoing nears by U.S. strong our steady Patient made in it commercial U.S. the being and as we've blockbuster initiatives, expansion. demand status. driven

move from positive and Moving trial on next to Zepzelca first-line the treatment an the we based to Imforte will second-line Rob and have continues to results well, our steps the now in area. opportunity to of the oncology trial. therapy maintenance call. later review perform therapeutic results

administration. recent adolescent for seeing Group protocols treatment Oncology market. are to programs we Rylaze, of roll adoption asparaginase A the continuing drive For adult and has update impacted out and high to the Children's young to in pediatric the population utilization timing are ALL in pediatric

next to have new protocols normalize a temporary quarter fourth negative third these will by expect after impact and year. early we which on expect quarter revenue, demand We Rylaze's

pipeline efforts. and our to Turning R&D

this month coming advancing zanidatamab second-line is up launch cancer in end are for we positioned or We date biliary PDUFA our tract and are of program. well BTC, focused rapidly zanidatamab following on at for The approval. the

Our Zani of patients pipeline a our across deliver in therapy. this lines development number with of treatment therapy of purpose in moving a HERX-positive HERX-positive in to options. who forward urgency tumors derisked and effective to ongoing with multiple asset are most sense trials new and order is of and includes program we are tumors need

response start broader I is and therapy of extending that population, At earlier have survival. the where delaying patient there their readout duration disease mentioned the will our to the We're data to recent increase Zepzelca. this in potentially patients treatment excited in call, of a on progression potential access

quarter. Our commercial this strong execution have financial focus and on position a operational kept again in us excellence

continue growth investing on believe significant pipeline from operations. we development programs that have opportunities sustainable the and deliver We We to generate potential enhance top corporate in the products, focused flow deliver highest and cash value. growth to line remain and

call updated I'll As guidance. net and adjusted call cover guidance in our certain of an now Renee will elements to Renee? commercial later progress. share detail affirming and will more revenue a call on Phil income we R&D which on provide will overview, call, are financial have we'll our after in Q&A. to turn then Rob the the performance, the our Phil review our second over other our 'XX total to quarter update and provided open

Renée Galá

our approximately royalties X. sales generics quarter. or authorized the high quarter, to Slide and Xywav plus $XXX year-over-year million. we both approximately net the Thanks, this revenue, Xywav Bruce. narcolepsy and sales was and expect XX% from with of I'll includes to business choice be $XXX Xywav to oxybate sodium million, pleased Total of third begin sleep in We're In IH. which AG, continue oxybate the net grew product Xyrem on performance

benefit exiting many low focused XXX saw the increase as from approximately patients quarter Xywav as the and an net to on of to enabling possible quarter. patients sodium are We compared third second

new and compared And benefits to narcolepsy narcolepsy, prior I'm to focus ongoing dosing prescribers patients intake seeing and In individualized patient report, sodium demand continues we to growth. XXX quarter. adds drive both transition approximately of the and Further, are about pleased net patients. from we on strong educating our the reducing recorded

Moving on of third patients quarters. recent Xywav X,XXX to with potential in There of approximately We is an line the to XXX in the about increase this the remain were indication. the compared patients active seen we've Xywav growth exiting IH. which IH excited growth in quarter, prior approximately quarter,

force Our focus continuing is breadth the primary expanded on driver demand. increasing which field a to prescribers, is depth IH and of of

related therapy titrating Xywav and have therapy impact care professionals IH their oxybate person interact are are providing seeing as education optimizing from they are to and field which with their treatment. to enables the and program, in supports oxybate trained likely when patients to narcolepsy health positive We This also nurse educator questions patients begin time our indications. during most new program both

in the from patient of non-seizure U.S. executive demonstrated September and we Moving that evidence, to that XXXX. Key experiences, drivers beyond function synergies emotional body positive on we in data approximately to function such and the plus at of than and with Slide from X,XXX Epidiolex Building in in language in combination with Epidiolex, of improvements quarter includes and now Epidiolex increase communication, $XXX X cognition, social of response control, another million as European outcomes third an net the in treatment Clobazam. patients demand compared to data more quarter Clobazam. seizure as and which as XX% with product seizure increased presented strong sales included representing data Epidiolex quarter on Congress the receiving in achieved Epilepsy benefits same the well the

well. improved as to understanding Epidiolex Importantly, their caregivers not benefits outcomes our patients, to of families real-world and but the of only extends

that continuing also supported tools providing health see adult data reach patients. showing to We're the adulthood is penetration patient adult may clear setting, for in LGS care with specific without and a many which patients part professionals diagnosis, by in diagnostic by

navigator launched and which discuss with such provides Epidiolex as earlier topics Our the program, optimized resource nurse we virtual year, medication-related their families to this patients dosing.

opportunities positive seeing focused are growth currently the with include we geographic momentum where and for countries Further early, approved. XX still is it's more beyond this generation expansion than data Epidiolex program. While

same Slide product oncology X quarter period Total XXXX. representing a to business. for were X% was quarter Rylaze X% the year. the last approximately our million, $XXX sales representing $XX from third oncology and growth million, decrease revenue approximately Moving from of the

summer, that administration. noted impact timing asparaginase earlier, the the ALL updated of Oncology Group As the protocols pediatric Children's for over Bruce

of demand for overall and protocols to change impact updated recommended not the so by to be the the normalize year. quarter to revenue this We shift of the do year asparaginase, of of we impact number anticipate doses to early primarily total third Importantly, Rylaze. fourth expect an not timing and next limited this do

benefits in see to continue educate AYA of most therapy. these are We patients opportunity adolescent and about who treat oncologists young the the for the continuing we or to growth market asparaginase adult and

and continue adoption to This market build initiated several programs see quarter, new time. drive over to AYA's we opportunity to that

deliver we another the pleased million. regimen. in Zepzelca health from care Zepzelca month, were increasing positive XX maintenance product IMforte use. to announce for very strong on $XX delivered with patients quarter remains the feedback treatment cancer evaluating of lung ease XX% and providers Turning choice clinical of small Last to cell the and Slide Zepzelca. net continue product's and approximately year-over-year benefit second-line We to a sales data positive to trial first-line

be small would to is number to eligible upcoming Zepzelca for approved, maintenance an pipeline cancer I enable in on practice treatment. for an update If that, and first-line Zepzelca patients include sNDA preparing this change lung Our cell Rob? it larger submit will Rob to maintenance team to first-line over the of label. milestones. to therapy With to our turn a

Robert Iannone

pipeline. with oncology an overview our our Thanks, XX the pipeline programs Renee. provides priority start key and I'll in clinical Slide zanidatamab, of program. highest

review action quarter, November previously granted locally of HERX-positive priority advanced BTC BLA unresectable, second second-line accepted setting XXXX. metastatic FDA or the an our and During XX, treated date for

III survival interim and PFS the top PFS to quarter or be trend and for adenocarcinoma, support it second survival Phase of If first-line analysis, supported in in data XXXX. on we or is positive would the remains on our GEA, line based trial we registration Enrollment a the trial overall track, expect progression-free available by gastroesophageal filings. estimate

in recently in development moment. pan-tumor solid We study a initiated of I'll tumors. II the zanidatamab more our have basket also plan speak zanidatamab broad HERX-positive Phase a a to trial, just

maintenance Given induction commonly cell from therapy help Phase Zepzelca a inhibitor Atezolizumab treatment maintenance were care in III following for the and improvement used with in of results combination we atezolizumab combination are atezolizumab with evaluated and the the trial PD-LX demonstrated in first-line opportunity The stage Zepzelca to trial, primary the etoposide overall first-line standard most significant meaningful atezolizumab statistically progression-free the is alone. and clinically of of survival therapy with in and carboplatin, IMforte endpoints pleased compared agent announced lung The month. PD-LX of or survival immunotherapy. last positive the small patients, cancer extensive to very Tecentriq. which more

demonstrated These disease regimen patients results delay the and disease. this of extend progression for survival with to potential this aggressive

paradigm, a Importantly, have duration survival. the increase to patients potential response upon patient and population access who Zepzelca delaying broader to in disease extending where approval, there's progression of treatment in earlier

plan include to half label Zepzelca We a the expand in to the submit maintenance. FDA of NDA first to supplemental XXXX to first-line

appropriate are present data, is We in forms possible toward which and step inclusion the to at also looking listings. NCCN important guidelines peer-reviewed an compendia

we top August, in our In Phase data Epidiolex. announced Japan. to III trial from line Turning

in to in in the not frequency clinical Japan a endpoints. application. new secondary were in efficacy endpoint Japanese change data in observed and remain the with overall improvements drug profile and Epidiolex, during trial pediatric indication period regulatory patients, primary engage the While we of authorities treatment the primary associated plan in did We regarding collect continuing seizure meet the are patients. potential We confident to of

a following patients Phase we with for half first note the FDA, of receptor the to JZPXXX, in stage Ib discussions [indiscernible] initiate of are type now X also agonist XXXX. our I'll trial narcolepsy clinical in planning

to data touch at were months XX.X back from recent of a with response Phase and from in duration confirmed Slide the of response from zanidatamab choice chemotherapy zanidatamab GEA presented first-line clinical XX combination II physician's demonstrated want on to objective in XX. patients Turning ESMO trial rate that the zanidatamab an updated Data zanidatamab treated ongoing highlighting of I in with durability on treatment. September. of conference XX%

ESMO the yet mature zanidatamab body We XX.X of of not overall Kaplan-Meier survival XX%, estimated median and promising PFS XX%. to of XX-month survival XX.X HERX-positive II in also zanidatamab presented which was overall a while plus GEA, in growing was tizolizumab. at also reported months. was adds the a first-line of And chemotherapy evidence Phase includes XX-month This months, after from for combination data XXXX follow-up with study survival overall the

in readout confidence treatment trial next The we year. give cohorts data III Horizon arms both from expected these of separate us results approach Phase GAXX as the the

excited strategy cases zanidatamab. for first multiple current and with XX, represents including the We potential HERX-expressing to of of November Moving potential action prior approval about resistant standard overview PDUFA to BTC cancers, therapies. Slide HERX-targeted for to zanidatamab in XX. remain the its our transform an care development in set our date for

Our HERX-positive III DTC tumors we in enrolling, for are Phase indications trial is pursuing multiple confirmatory first-line beyond BTC. and

Phase is As in our GEA noted, trial III I ongoing.

III also have We designed first EMPOWER to and to safety breast T-DXd combination therapy the opportunity zanidatamab with to cancer the HERX-targeted initiated patients after the in efficacy where progression which in be Phase trial, chemotherapy evaluate is T-DXd. we have on post demonstrate

opportunity expressing types. of cohort Phase efficiently treatment a variety of X an including this II a trial. recently with tumors trial shown X were Zanidatamab additional HERX a tumors. is naive as generate previously pan-tumor HERX across data tumor The HERX-positive we range pan-tumor activity Additionally, monotherapy who patients to solid trial are has promising a as treated cohorts cohorts: well across of enrolling with And patients T-DXd. who is initiated

is enrolling cohorts HERX-positive the patients. and breast these is cancer of HERX-positive patients enrolling One GEA other

we're the multiple plan patients development about conviction zanidatamab prospect improve to delivering zanidatamab of on to robust in for with based that patients the potential care our on term, tumors. executing excited we're and Overall, significant HERX-expressing BTC has a near

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

Philip Johnson

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

filed are press issued our release results available be morning. XX-Q, in and our in a As our today will earlier full tomorrow financial which reminder,

quarter During the increase generated more XXXX. X% of $X.XX of than third we quarter in third revenue, to total XXXX, a billion the compared

was line performance key XX% and Our by combined our grew the Rylaze, strong Epidiolex growth products, top which driven of year-over-year. Xywav,

of of third income for our ] increase quarter net represents of XX% adjusted the to compared addition, $XXX last In million an the quarter [ year.

from million of from and the quarters significant cash quarter We our business the $XXX operations continue recording the through approximately third billion X $X to generate in in year. cash roughly first

strong overall and development billion cash have Our cash in programs to financial corporate significant in opportunities. including and R&D priority equivalents, and flexibility invest position, $X.X commercial [indiscernible]

make most I in would a on balance, payment XXXX that B Loan repricing. investment cash of prepayment our premium On place the to substantial after X% following our highlight mid-January we intend our recent expiration Term the

and to Turning XX Slide guidance.

XXXX $X.X of revenue billion. We midpoint. a X% guidance revenue are affirming full year total $X This the at represents billion in increase to

a are the the to lowering at updates affirming earlier, that are Renee revenue billion. billion protocol $X.XX from Rylaze's million $X.XXX neuroscience Bruce We from resulting X% to treatment by $XX also also to revenue of temporary guidance $X.XX guidance we increase revenue billion Based to on $X.XXX spoke billion, and oncology to midpoint. impact which our is revenue XXXX

by Rylaze We continue growth for and to double-digit expect total XXXX driven Epidiolex to Xywav, growth revenue combined. be of percentage

Moving slide on guidance. non-GAAP to the adjusted next and

$XX million ongoing is R&D SG&A million reduction The are driven by prioritization, data spend strategic response in guidance ]. clinical in maintaining expected to including to primarily million lowering to $XXX guidance [ by readouts. R&D prior and our pipeline We $XXX

highest programs We potential continue the with to to impact. direct investments for

of for line cash guidance. operating than operating Our notes was approximately with our with to effective to the XX%, XX% remains our issuance convertible impact settle net on full XX%, election year our that guidance XX%. share notes. in convertible a bringing amount we tax XXXX a range rate while also income our $X.XX year-to-date EPS to the highlight share remains XXXX our range margin in our billion as I to quarter of unchanged reflect are principal of as at count conjunction at increasing $X.XXX of guidance the billion to the in Adjusted repurchase well margin

website, useful EPS interest outstanding meaningful it greater our turn our to these for ask that disclosures non-GAAP and breakdown your additional in our you others investors. opportunities our joining I remarks. analysts we'll Before the and results, look are and on back information to calculations. On find workbook back We requests. hope revenue, express for to to remarks, historical for arrive website. in posted closing some to analyzing GAAP continue investors geographic I the for in greater call find wanted conversations for an In responsive investors to of call information shares some at that how contains Excel I'll our our on gaining over Bruce we since with into Bruce information you'll to for With that, clarity Jazz, enhance closing visibility and the attention ways this turn

Bruce Cozadd

XX. our conclude on prepared I'll remarks Slide

the in compared from of Our benefiting record increasing addition franchise. oncology to XXX the resulted exiting revenue the growth Epidiolex of quarterly approximately commercial of execution our quarter and and net third the quarter the second patients patients with driving . number Xywav in quarter

sheet, R&D advancing for program operational and continues that critical business balance Zepzelca development of line like strategic productive, strong investments enable value. and to believe about to to open focus excited continue I on our need. Jazz may reach and be which would shareholder turn are and engine excellence, the well That in our We're to deliver us to And the the for future Our our remarks. future the patients growth. to growth we more disciplined our zanidatamab generating retaining prepared to Q&A. operator and in over call enables now data concludes we positioned

Operator

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

Jessica Fye

on the a big narcolepsy XXX what was from net quarter. saw of last patient in It's can as Xywav, we uptick the adds I think future? in wondering we reproducible

with the field of treatment So might thinking in nurse the And educator about you're how that. I'm this . early helping program the impact persistence be curious phase? if

Renée Galá

really I question. Jess. appreciate the Thanks, Yes.

the services wraparound benefit an that's we We our think program to and on. both Xywav. field are spend something important in educator lot to that So of to greater addition that And physicians seeing definitely, of persistency nurse we we provide from that's patients. and focus a differentiator

narcolepsy, With have seen we some respect variability. to

I a new from It [indiscernible]. high continues Xywav demand physicians sodium patient starts. mind, factor in is warning the the driving that's demand. think only what's the the It's reversions coming of on related focus source sodium carry of most the what that ongoing biggest Probably including to appreciation from therapy is from of important by the low is to and oxybate, high Keep coming transitions doesn't patients. also oxybate to patient the benefits is sodium intake. be

look that we with the as business, add. So really holistically pleased at we're net XXX patient

For the predisposed quarter, seeing from definitely are we to real as appreciation program persistency patient the population of in low and mentioned, importance, that's appreciation, improved conditions. the I've sodium messaging nurse this particular field cardiovascular in educator continued

And worth is seeing by a what by really it's then all is that execution. noting focus also, this teams, field strong underpinned on which we're our

Operator

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

Jason Gerberry

past. Phase haven't but does the guess, frontline data indication? confirmatory? own Is Lagoon to can Zepzelca, you ] unique, of about there result clinically the opportunity. submission -- Or and [ study wondering any alone? III it's Phase you thinking stand if being this its I just own, this On said frame it us on kind mean, just you help implications I given meaningful. kind III detailed I'm its Is commercial data, the the be reg presumably, of on And would

a adding PFS. months So few it's of

and think a adding just right of about we to the sort therapy. about Is X,XXX couple be relative as should cycles about of expanding that market this the of patients here? way impact So thinking the

Robert Iannone

Thanks the Rob. -- happy for I'm this question, Jason. Yes. is

care And in for said in meaningful expansion said, clinically would the as And frontline which that possible half indication. So approval only an we data this to those therapy. an is trial, in think into and the year. planned think we a PFS interim alone support statistically first submission which working We as survival, frontline, the benefit III change analysis. was we're quickly a label in of get we said, as standard stand on and frontline submission but Phase will we resulted significant, next overall of not ultimate

this would your to that line. our the may timing think relative of the confirmatory could to submission was, existing Part also second of certainly data when frontline activity that in. line. be second has on or approval we in demonstrate it's and think effects of benefits Zepzelca overall question it these in can, the We depend accelerated [indiscernible] ultimately in data that whether in come of for used But knock-on frontline, the

new small patients in XX,XXX of said treated. fraction the cancer those extensive a stage every cell year, those we've XX,XXX are As of past, maybe are there's lung and about

it's to likely well. think larger a of of a as do we number patients have So longer that duration that therapy

Operator

line next of question Marc Partners. Leerink Goodman your comes with And the from

Marc Goodman

how your thinking about the recent from data that us working of data on comment you XXX, the you share Can it? on you product on this the can any you any And adverse before. class, give latest orexin from your you're events thoughts what -- stopped on that about the competition, releases can commentary

Just you us well? product tell anything your can more as about

Bruce Cozadd

you jump don't on orexins. Yes. Rob, why in

Robert Iannone

Yes, happy to. I'm

over field Marc, we'll these regard insomnia half-life. compare advancing, relatively couple potential space. on would best-in-class certainly for And X is compounds the to is would how time, based safe hepatic especially toxicity, in yet for So tolerated. with I potential even things or visual But know in a see disturbances what one Certainly, still -- of it's don't the One profile well what NTX we early that that the longer the respects. and polyuria, be. like other say to a possibly is

that of has sleepiness. this depending the of asset the benefit NTX, profile and beyond class potentially NTX, even IH or daytime the other think on conditions also We

next but could will to index only think a we've we year whether that potentially would our seen. also of the evaluate some programs. that in forward toxicities those that not indications, evaluate XXX backup in therapeutic would potentially a -- XXX we And study of inform have go any inform dose patients we NTX we plan As with a we mentioned, have Ib at where

Operator

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

Ami Fadia

X the the the patients the done topic what negative Maybe trial. -- study, Horizon conducting I [indiscernible]. could In versus difference you Can results the about GEA, of on across just you're positive II us color some other saw thinking sense PD-LX any in in zani on some if if give Phase that types. [indiscernible] for you work of and believe Just percent the And X efficacy had before some you you [indiscernible] how guys just trial. give subsets. cancer on took in of

trial basket be broader and this kind how to exploring? in likely be So of what might areas it

Bruce Cozadd

Rob?

Robert Iannone

that happy to Yes, take Bruce.

the So any we on also PD-LX yet, is Overall, the the half of think data the we about positive frontline first in we because define be the of define [indiscernible] important at that suggests a in in published that maybe would on patients looked it PD-LX terms how but at that we've epidemiology think defined from we that setting. one, PD-LX think effective and what that, in whether should are you be would terms GEA, haven't benefit or that has use cutoff status, depending the of that bearing it is don't agent. or certainly of you on predict don't how least PD-X

who you're run cohorts to been agents from variety and In find its on And we are Phase a have that experience study we mechanism just we've what action, patients compares overexpressing And differentiated HERX, We from patients wherever absolutely in pan-tumor tested have a across right. HERX. favorably different do we that that tumor zanidatamab. think terms strong the started, of broad are is activity of of types. overexpressing other see based we with I

So tumors are a rare experience, in of what the us to do that study HERX naive therapies. especially extend pan-tumor who allows variety is to

support depending ultimately could that ultimately label. an results, expanded could So the on

also with are that us other who gastric pan-tumor allows HERX as could well. cancer support in and agents, data patients overall a in monotherapy breast It get as indication additional some cancer such to experienced with

Operator

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

Unknown Analyst

opportunity how cancer. Greg. on like you share to thinking the assumption respect Could current in just us look the the perhaps to [indiscernible] [indiscernible] like assumption continuing peak on curious on ramp for with zani, second-line how [indiscernible] your cancer? that look with in and peak And

Renée Galá

Yes.

with to just with think the how a represents But patient ramp, important about very So are quite you to revenue guidance. is about this would X,XXX remind line I product-specific first think don't we're the after, in And a provide expectations low. we BTC, we about remember, small first, to going patients think respect first and mind, I this rare that line. in indication that When therefore, population. keep second BTC it's the cancer, U.S. the in

metastatic survival in also a it's devastating rates with X-year less cancer X% However, than the setting.

And so the as reason, quickly opportunity this possible, forward largest as strongly for is we the patients very therapy set. for feel in this bringing but not

out coming in we then, and cancer breast course, said, of also next that quarter second much pan-tumor being read see on X with underway. to in Now the study of do opportunity, a year those metastatic target opportunities the larger from billion and GEA broader being $X-plus now peak with

Operator

with Joseph And line the Thome your from next TD of comes question Cowen.

Unknown Analyst

path Do the study I RMB it X will to as GEA endpoint. there Joe. be RPC doublet, guess any forward you [indiscernible]? you different hit could the important primary think walk and of on scenarios study through benefit the This is Payton on that with for for in triplet is you see how us both in zanidatamab, the sticking maybe this the And a subsets? for

Robert Iannone

for Yes. question. Thanks the

and is there's There's is trend goal. supported we think arm, there's chemo plus on direction. approval, a the X would So then data you're the zani, be The absolutely right. basis which is in addition control a long so then on as for that right as zani progression-free PD-X which of with have the of the in chemo, And up set shots trial going inhibitor. we certainly, overall survival survival [indiscernible],

benefit either arm the includes of that incrementally show we has so over so-called that PD-X the approval, arm of zani contribution for agent, and arm control components. need be For to than the chemo, to better

gives But think demonstrate we to shots so need X we'll certainly, that. it goal. us And on

data regardless the PD-X the the as that are X the us that PD-LX PD-LX for cohorts well status, on who do opportunity mentioned We chemo can in of incrementally have patients that positive have that been because first zani PD-Xs improve addition another will of gives very benefit. it's patient's plus the before, and of truly line based confidence published I clear

Operator

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

Unknown Analyst

Deja Dennis for on is Akash. This

opportunity have like study maybe you details design, to us that III just some that, timing, resistance if breast HERX+ might So a confident mechanisms the in you GEA. HERX HERX, [indiscernible]? how you're plan, relative setting. planning [indiscernible] like look Could any cancer in And that additional development you more you patient mentioned earlier and studies maybe Phase are what give on the

Robert Iannone

Yes.

you for preclinical cancer We thanks data different find in the the which on it. of not feel Nature HERX patients. Communications. different only and very But that's question, cohorts best-in-class tumor agent. the based of data, several I'll last of of across includes and that breast highly data, published that differentiated, steady on in zanidatamab encouraging stream with can And really as So a the part start action combinations. types And different mechanism

or in data either Phase the progressed with generate ongoing patients those on see is we intolerant opportunity III to The T-DXd. trial who to are now

as the have growing a in progress has and differentiated, on in who trastuzumab patients that's use with activity patients foothold As We a -- progressed setting, treat supports what PERJETA, patients of after PD-LX gap, T-DXd. up main potentially line T-DXd. into as moves it's well, PD-X that think the who body and as second they we data frontline, see and data taken T-DXd that after well once in we progressed to zanidatamab that of

generate need, that's first to hope the data unmet is here and And that the that be be first those it's to going into to be and in significant the a we concept we'd space. space, so basic

The be basic would patients already and that design receive randomized these plus is be a would fairly of standard had patients the backbone otherwise trastuzumab. they or would on progressed top care [indiscernible] the in where of physician chemotherapy then on is choose unclear. that And for line to space, trastuzumab third who

winning in space. think So we supportive data are very that of our

Operator

Annabel with of Samimy comes Stifel. question next your line And the from

Unknown Analyst

calling This it's [indiscernible] And to Annabel. for is Zepzelca. in related

better then the setting, the be how guys do it. the a will will physicians receive maintenance for data? that take away now you does what And from line on opportunity peak quick to flip in the showed And second the You of they setting? think be have you could side, adopt do idea product? And the efficacy first-line

Renée Galá

I'm Yes, jump on happy that. in to

really all, the look it full to practice mentioned first will first-line think So about the do set the the in we trial, excited as be earlier. changing, future. forward had results we're data Rob We and of sharing in

[ second NCCN being tarlatamab course. guidelines, we'll that we by adopted the first-line we that said, indication, use there, line we with are the even to important we market. expect of we today, expect promoting but out until continuing of to on with I on strong In actively line. we're it's Zepzelca as use until where get note look of data first won't would would are ] a the we at we Now meantime, in once the in approval, ton not the have the use be get see

get setting being the inpatient standard require doesn't lot and getting benefit, outpatient of monitoring. have have years of of with and the lot care in physicians it's of regarding line, a We given ease response its positive experience the Zepzelca, use, several we of recall, clinical we second a in

XX,XXX think bode had is about those the And majority and first very line, so will well stage. vast once there's available patients the extensive first of mentioned for we adoption the as data in Rob this in line being earlier, the

overall an expect opportunity, as patient population larger to longer as duration. as treatment you well? jump be get into a that to line, we do the in want looking once Rob, we we'll did increase well given first at revenue So

Robert Iannone

Yes, I said love we to. I practice are data mean, do as think we before, changing. these

but the PFS only planned We themselves, differences haven't at a survival, said on that data was but meaningful of and interim clinically overall static, remember time survival both analysis. overall shared not we've the

compelling as going compelling as think And we uptake be the and we're to possible, physicians that move we there significant will there. will given quickly as it's find case. a data well, So think,

As it do a we disease expect remission a be line. and that are second after currently standard it's patient that complete we so of does I can mentioned the can therapy. that longer and not larger essentially get residual progress. waiting current We to mean in their duration a patients population address, induction, before, and typically Remember, under have do active chemotherapy to they

longer them And so this opportunity has for period think that, clinical data I progression a an preemptively waiting treats that the now for show those patients line. time. rather to benefit of than that in second just gives And

do more longer of for time. think a we it's So period patients

frontline. has until patient Zepzelca induction get in patients unlike traditional will a If received And chemotherapy, progression. Zepzelca remember,

get think So for will go patients to have they case, Zepzelca But Zepzelca, duration. on point longer then that access use is preemptively we that second the we again a which more line. in do wouldn't

Operator

next question with from David Amsellem Piper your of comes the line Sandler. And

David Amsellem

to also your products. Zepzelca. my So I wanted on for the the is question get runway on specifically, And exclusivity thoughts

So then [ you've in in 'XX. orphan have And patent a you of got expiration the book, orange expiring December in 'XX. exclusivity ]

on first-line to think data, may change get the exclusivity or Sage how we first extensive you line? expect with ODE your With may data? [indiscernible] an should the How first-line about runway not do

Renée Galá

Yes.

thrilled just to right we've terms in runway, of I a that in to updates. thinking speculate particular exclusivity on here think we're jump the the recently any position in now We're with don't data generated. So about

time update over really the would understanding getting drive said, it the time changes say be updates of I be but the look we that a any able into first as sharing at result further that of the we of line, further might to relevant. be As that in to out this IP we Zepzelca forward use on and market something would to would

Operator

Newkirk the Goldman from comes question line next of Your Sachs. Andrea with

Unknown Analyst

you if oncology? in for whether portfolio just does be provide the your wondering of then that pipeline we And that BD about prioritization how changes, was I versus neuro mentioned? the now. these impact could the color transactions, given it potential here on appetite more you And should think how makeup

Bruce Cozadd

first take Maybe part to the [indiscernible] the of Yes. in I'll on happy have of jump that piece and you Phil, it. then

molecule we of have given prioritized trying settings. after data done In and those always our assets We we calls, any excitement but have invest we are don't think first some particularly terms the on pipeline in most work, to progressing. existing among we've in clearly programs our broad or map of about programs do that talk some see we derisking potential, that multiple potential earlier have the these that prioritization, you'll applicability proof-of-concept about much portfolio are as

do programs. more website. And if that some get of in, phase we're on in R&D in were milestone partner in always our can spend on You we see trials then some on depending variation what information exactly quarter-to-quarter clinical payments cases,

I So that much too wouldn't particular into on CorpDev. comment, Phil, read

Philip Johnson

our put I'd allocation. Andrea, it overall in capital Yes. of context the

growth great are on seeing we're currently products clearly, the our number So that of a among market.

So where, are bolster then zanidatamab that through to maximize [indiscernible]. the as key well the to those and patients Jazz, looking we investment we're revenue house you and then prosecuting near-term to pipeline, to right of prospects ensuring putting the really behind currently we that the heard pipeline benefit we're on our growth in the as as that the to continue medium-term to future sort is have call, and

whether actively that have corp definitely but dev. of have probably movement the I anytime only variety in things BD oncology, opportunities things. are readouts advancing, need well the we cash some that the think for earlier in that you accessibility desire and not do of say markets sheet and could balance We rare the readouts looking Obviously, we that's also to call those increases obviate innovative may on the to very internal strong cash or the deploy We positive opportunities corp as neuroscience creates rapidly benefit the would to our a select some and at negative have are do of debt flow, efforts. through bring capabilities, back dev I as as we patients market. therapies to where footprint or in on mentioned to capital,

Operator

And Morgan your the next line Stanley. question Jeffrey of with Hung comes from

Michael Riad

Hung. Riad This the program. to on is discussion Jeff for Michael Circling on the Orexin back

leeway dose Ib, be the like level to enough any accommodate do for you [indiscernible] could for provide go color types on or you'd you IH? there additional For QX? to Phase expanding reduction narcolepsy have of of in other potentially would the And with

Robert Iannone

we're going see of observed versus in we really disclosed we relative observed yet NTX. we described, effect. we in understand part there they've goal evaluate Yes, kind volunteers we QX. at think and programs where what need [indiscernible] but healthy very will we've that to haven't a watched doses is to had the we dose Obviously, robust doses we'll that relative multiple study to the of What's the we in look of because dose the other the in that what

NTX dictate where a have And you're so see in where we a of think we other whether path or safety we we need have will need doses. margin, where forward indications higher land to and to we enough that in ultimately likely

study the characterize So aspects the better the you to some goal it's of highlight. of really

Operator

question And Truist. Joon of line from next Lee comes your the with

Joon Lee

like expansion geographic [indiscernible] is former, growth? X epilepsy within or gives line see use -- segment greater in And what the penetration? how hear our nice versus years that's it in growth you is latter, for approval EBITDA the for since Japan. of driving a It's of questions. particular to much there And the of launch, confidence the

Renée Galá

Yes. ask start Japan. to on question. the forward a happening Thanks what's bit business out in I'll to with the in Rob currently then talk jump the for path comments with and about

with we're I million more year-over-year. So really Epidiolex, highest saw, with net our we would date $XXX sales than growth It's that with sales. say pleased quarter the XX% of to

see franchise. $X our we are a billion So well to way on having can you

differentiated just what's of product. the driving we data. a to terms Epidiolex with as That highly continue the In seen starts have growth,

as robust the caregivers seizure First and social physicians on and have with body non-seizure really benefits data of cognition that that resonates emotional, foremost, benefit we behavior, such and both non-seizure evidence function. a those and supports benefits

that having in the an is impact differentiator So market. a Epidiolex for and very strong

had the Also good strong team care here from key seeing the setting. of on growth. drivers in our adult execution focused and long-term really momentum We've

the Within earlier. screening there tools we've provided about U.S., new some we that talked

positive some in nurse and targeted organized program. in teams a terms impact multiple we we're added the programs talked virtual we're that highly also operating, We've even of structural some our improve. navigator few in our reimbursement outside to collaborate, the that's positions. a but the Also some changes having consumer where how early seeing how new account both some piloting and out U.S., how virtual some about new also decisions positive we're field our the of campaigns, success We have manager and rolled quality That's in U.S. we're continuing breadth ads made is access to we've and effectiveness, U.S.,

impact. more to doing And can then greater drive working, really pilots cover having see invest can you these you about and what's understanding by an would like growth Japan? what's them Rob, the good is, behind you thing

Robert Iannone

Yes.

next we XX with what at Just interaction do to efficacy steps. didn't remind to could the prespecified interim folks We we safety to We do hit an analysis reported that by additional XX registration support think and Japan. the the Japan, continue PMDA we to trial next collect the was -- planning to have XX mark, support registration previously data data while year, at in midyear interim that weeks had are on its think weeks. on and the needs clarify know to in an order based in

Operator

question And from your next line of with the Mohit comes Bansal Wells Fargo.

Unknown Analyst

the that the on on Or ask lowered if guidance. political all to expected market, in pediatric factor? and [indiscernible] Mohit. for the study? than wanted that's a is to slower due update adult change is adolescent Rylaze This I And oncology in and also

Bruce Cozadd

that impact we're Rylaze. to due That's entirely It's the on temporary change. seeing drove what

Operator

question Nachman with the your line from And James. of Raymond comes final Gary

Gary Nachman

oncology. on up following Just

peak quarter. was Rylaze, third [indiscernible] opportunity? anything for has with And you And then noticeably also, AYA. expand where see the about to that in the potential your specifically So more and in talk initiatives changed higher just

So forward? anything going just if highlighting durable that's worth there

Renée Galá

for Thanks the Yes. question.

]. So maybe I'll with just [ start Defitelio

historically timing respect saw well as quarter, in I both would quarter-to-quarter that related given the U.S., we did that given an has Of course, a variability treat it has this U.S. as that increase ultra-rare ex what much very variability. used U.S. to an as you to the With in know, ex to and current quarterly say is condition. is we product see

[ pediatric would this patients use Within to because dosing, the increase increased U.S., seen ]. increase then we've saw coming see patients prep both revenue and is adult This weight-based you we across something is inotuzumab typically is uptick also patients, of and from in separately an that our an used I we'll for because is risk stem typical would VOD. continue this be going cell if also as it's But variability factor Defitelio for early greater a a to transplants. durable. could that about it's think It be driving use tell for the too that of to to time monitor. it little being, adults

the overall protocol do number of this emphasizes reason, treatment of Rylaze, great that doses in news importance temporary to also asparaginase by protocol. which asparaginase Rylaze With adopting of of for really it talk the this the update, new we And impact by survival respect because data meaningful showed protocol. this way, for pediatric that adopted. the confidence from given be same driven have rates by widely the as will was And about protocol protocol is improvements and this underpins did to we the patients ALL treatment, ultimately, this rapidly part change

on we've the With is to slowly respect that We're anticipated. build happening little continued in to to here. are a probably field but to most piloting we have having educate what population. the Epidiolex treating similar originally underway, needle of the continuing I I of AYA, that franchise teams impact AYA respect focusing have can With more to through benefits to had in initiatives in than that the the described all the we is see [indiscernible], the on where moving our some go work impact. doing won't an also of what into what importance those,

Bruce Cozadd

All our right. question. that looks like was last It

partners for and and joining for Thank colleagues wrap their by families continued today. me and behalf confidence for and you of their us let So our patients recognizing all their Jazz shareholders our support. efforts on thank

Operator

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

now may You disconnect.

Jazz Pharmaceuticals (JAZZ) 6 Nov 242024 Q3 Earnings call transcript