JAZZ - Earnings call transcript Q4 2024 | Jazz Pharmaceuticals plc

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Operator

Thank you for standing by. My name is Jeannie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals Fourth Quarter 2024 Webcast. [Operator Instructions]

Thank you. to Investor call Relations. like Macdonald, to now Director, Executive would turn over the Jeff I

You begin. may

Jeff Macdonald

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

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

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

review to and on annual with statements. may differ duty today's that to factors forward-looking XX-Q for and and encourage and subsequent these the the actual XX-K the deck cause XX, made quarterly on on for slide the contained obligation statements Form to today's Form under the results on identifies those quarter in undertake our our in September the contained the our filings ended annual SEC risk performance Factors webcast. caption the year Form certain XXXX, fiscal December report We our no the events, XXXX, XX, XXXX, in you report Risk including statements forward-looking ended XX-K report press materially or for risks fiscal XX, described uncertainties year release, which our in ended company's We from update December

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

turn I'll over to now Bruce. call the

Bruce Cozadd

today afternoon, year I'll to Good Jeff. us full fourth for start Jazz's joining X. results. discuss Thanks, on Slide quarter everyone. and Thank you XXXX

XXXX I'm year was another very report to Jazz. pleased for that record

commercial strong quarter nearly our $X.X revenue of total more annual highest execution than Our resulted fourth $X revenue ever. in billion, and billion in

Importantly, from therapies we of who helped areas patients These reflect no the highly the limited benefit tenacity differentiated therapeutic more or our in around our talented achievements dedication world. and employees with options.

several of U.S. by or approval important On XXXX, achieved second-line regulatory treatment headlined November. accelerated development milestones the biliary for the the tract HERX-positive R&D the in Ziihera front, in in cancer we and of BTC,

population. in further results patient cell focus strategic addition, corporate expansion development, into plan key In broader Phase maintenance treatment, Zepzelca Jazz. lung we potentially an the and of remains portfolios diversify small benefiting believe which for clinical III a cancer trial commercial our will first-line the line positive support a from earlier to pipeline for We through

other diseases. evaluating part our and we're As ongoing neuroscience rare assets, search, oncology while contemplating also orphan and of

to R&D assess capabilities shareholder of call part our durability corporate alignment we are commercial as addition, efficiency our expanded In and maximize revenue, through of points development. opportunities of considerations with value long-term

Phil end income guidance on XXXX I'm XXXX in detail results the net our non-GAAP financial adjusted range will later the confirm and at Turning in achieved in our to of top billion line Slide guidance, delivering XXXX discuss $X.XX growth call. pleased to we and upper a X. basis. more our

dose, FDA-approved narcolepsy over branded each the the XXXX. idiopathic narcolepsy execution and competition team navigated as fourth based authorized sodium IH in epilepsy or an and $X annualizing across On based entry has our branded pleased with and oncology only on sales. oxybate, our fixed Xyway billion at revenue generic the the quarter hypersomnia front, introduction #X are IH. product commercial or to for portfolios treat since net of our We've remains AG SLEEP, been their therapy on high treatment

the Epidiolex XXXX, X% is it net status temporarily to to Oncology Rylaze's XXXX in in XX% blockbuster X% year. with billion revenues reach discuss even a implementing. Renee to second we grew our XXXX, pediatric in XXXX which Overall, commercial commercial grew reflecting impacted of the product our XXXX. revenue half changes and than are this execution in poised compared compared XXXX revenue performance grew record to detail. revenues stronXXnhjg our total will to of of $X.X strategies protocols, more greater

forward opportunities in advance to Phase HERIZON-GEA-XX zanidatamab adenocarcinoma, look GEA. evaluating or trial, data We readout our We gastroesophageal the in pipeline. promising to continue III from the first-line

an previously will of trial we a share on survival now the of color expect this mature had bit data additional Rob top this progression-free line year on quarter date, our second this events for provided we more in of call. While estimate of based readout, the accrued later projections half year. the in second and to readout

first-line The breast are Phase trial progressing PanTumour Phase II well. all trial, trial cancer confirmatory BTC III and

a approach growth strategic addition, as first-line cell lung small in or first disciplined new to We of extensive-stage XXXX. in capital half cancer submit application focused on to while therapy we supplemental drug maintenance and allocation. In plan maintaining remain the driving Zepzelca sNDA, a for

our opportunities. commercial strength development cash corporate flow and and portfolio, us invest future pipeline financial in Our to enable

Before from been has diversification is the transformed significant on, integrated previously lead move It's this and through business to we my Jazz the CEO a company I'll into fully year. privilege that it growth shared, today. role as retiring the as biopharma be

Chairman CEO a by After will development, a reaching appointed, to delivering continue for will next corporate employees, as the committed Board continue making transition the is partners strategic and providing leadership shareholders. I'm remain successor patients, confident continue leader of I'll we Directors, guidance. serving during that and period. focus investments through Jazz's strategic patients of more Importantly, ongoing

overview XXXX will guidance, Rob which R&D cover and commercial Phil turn after I'll we'll Renee to open our financial now our the then Q&A. Renee? for will performance, pipeline. over to review a and the provide call call our discuss then

Renée Galá

Thanks, Bruce.

tremendous for of achieving their in across revenues the annual highest Before I'd I our which products, their to ever products each year, team efforts cover commercial commercial like promoted XXXX. in individual the Jazz resulted thank

benefit narcolepsy higher low cardiovascular the sodium one failure at comorbidities heart X educate with and on Xywavs portfolio, Beginning and oxybate to high We including as general patients the living our of Slide such physicians Xx sodium of continue as to on in Xywav, benefits population. market. efforts people could risk patient the intake reducing focused SLEEP our than from stroke X view are a to and as who every importance meaningfully sodiums of the resonate

approximately study of In a patients RHYTHM exiting conditions clinical addition, from comorbid IH XXXX. patients conditions. approximately the experienced across cardiovascular multiple results representing XXXX, with X,XXX Xywav There the of patient were demonstrated higher including end adds net to taking XX,XXX categories, compared likelihood

there expansion, the Xyrem approximately educator our the the including sodium sales oxybate In both field coupled of Xywav's quarter fourth of XXXX and services comprised and the includes and. AG JazzCares XXX represents FDA-approved narcolepsy are net and end plus opportunity contributed throughout fourth most demand and revenue, to for across therapy were with million nurse and meaningful of increase in we IH was growth is portfolio. product building field full net year-over-year SLEEP market patients. digital royalties $XXX patient $XXX patient the XXXX, approximately at IH Total XXX persistency XX% billion was quarter, and first patient from of XXXX We million XXXX. to Xywav force in sweep campaigns patients narcolepsy The fourth net the a and treat a product initiatives high segment which the only media believe sales, billion and adds XXX of and we with our program durable quarter implemented in $X.X the to for IH $X.X and grew the year. exceeded

sales million breadth Our symptoms of $XXX quarter Slide HCP's fourth field depth expand a IH the product net by XX% of IH same to the Xywav. needs of to with to Epidiolex turn patient the for treating and significant of benefits prescribing Xyway XXXX. representing compared with multiple in X, highlighting team the the unmet in On continues increase quarter, we and

Epidiolex primarily million, seizure continued broad demand positive in of demand. by Epidiolex response full and driven adult included along underlying U.S. the to reaching data Key beyond with of the long-term $XXX revenue growth year-over-year, XXXX, approximately facilities, was XX% control, year the patients quality benefits up drivers For on access. care

Epidiolex in patients' In December, the frequency an abilities reported nurse emotional facilities long-term in was survey and cognition to showed treatment such that with associated overall in as seizure improvements presented communication, functioning. and we reduction care become responses

setting patient care care showing patients clear health data generation professionals and to is adult setting drive by continued without LGS penetration part LGS Growth demand. patient in this and adulthood long-term diagnosis the adult expect tools many in a in providing adult identify diagnostic by We the patients. facilities will specific supported LGS reach with data and increase

granted under long-lived a filers. ANDA settlement I'm the Epidiolex Under recently -- we the a its believe status Further, current those and pleased of with to filers or and XXXX. very sell expect of beginning and momentum blockbuster Epidiolex We're earlier pleased and own it version XXXXs in certain market growth XX share manufacture, settled asset, ANDA each the all to is of we agreements, license late with reach in generic Epidiolex durable, we to circumstances.

the of acute timing administration demand lymphoblastic approximately doses, Slide $XXX an Rylaze. changes and expected anticipate oncology compared representing to It's Group for Revenues to X% still XX. In to Moving underlying by change not important Rylaze net increase million treatment of note impact to year-over-year are Children's million the update for early the approximately normalize protocol asparaginase update and reported full we This Rylaze this pediatric earnings, negative use were we the a fourth asparaginase the recommended third year the product XXXX. Oncology $XXX for total year. our leukemia impact revenue XXXX to don't sales of ALL. an pushing due quarter to for temporary or number a do weeks. impacts on full year, quarter Rylaze's to XX to back protocols

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

the on fourth discuss I'll $XX approximately $XXX lung and their ease we million. the the to product XX% XX, positive full quarter, product Zepzelca X% small of choice year treatment second-line year-over-year. sales up sales In in administration Slide On remains physicians cancer, to were use patients year-over-year XXXX approximately care hear net Zepzelca feedback Net health for increased and practices. million, for Zepzelca cell from and for its benefit clinical continue of

progression. disease lung therapy cell submit treatment their of an Expansion extensive for indication reaching We small in to an to cancer opportunity this for stage year. the plan earlier into Zepzelca this first-line of sNDA patients first duration the represents extend maintenance in while in half

the Moving Slide had XX fourth with Ziihera. to to exciting We cover FDA of approval an Ziihera. quarter

dual HERX The first BTC targeted bispecific and for antibody U.S. only the HERX-positive approved in second-line

and uptake team initial our reception first and our the infrastructure oncology the We that HERX-positive to [ capabilities share overlap universe, $X to Ziihera HCPs of from Ziihera swiftly currently us ] has Ziihera leverage sales been call of BTC HERX-positive experienced and approximately in diagnosing with have significantly accelerate positive, Zepzelca successful with and patient Our the following net current I'm we BTC and in help to launch recognized patients Ziihera XQ BTC. launch pleased December. treating footprint BTC. to commercial product for million in deliver second-line treated right a positioning initiated Physicians of second-line existing The launch of the approval was 'XX.

to and for care Ziihera the to current has and better standard providing to benefit. potential outcomes tolerability BTC of deliver patient outcomes safety compared greater the maximize while efficacy

professionals represents to Although them help patient establish meaningful it. with get initial care with and health experience launch this BTC population, small will Ziihera allow a

that, it Rob? Rob upcoming to I'll update and With our for on turn milestones. over pipeline an

Robert Iannone

initiation of Thanks, begin the in and of along an FDA Renee. confirmatory BTC with important company zanidatamab on I'll our our patients approval with first-line in Slide trial. BTC XXXX milestone second-line for achieved XX. the We

including Beyond advanced III our we ongoing GEA first-line breast EmpowHER zanidatamab the BTC, trial development, of trial. the and cancer and initiation pan-tumor Phase significantly Phase trial II

this expecting expect chemotherapy of with trial now of and PFS PD-X are a we our the from earlier, for care second complete agent addition zanidatamab III mentioned Bruce in of we frontline XXXX. within GEA evaluating half track, line readout Phase top with next on without the standard trial to few enrollment the weeks. the As is Recruitment and

to more updated a is As events on trial, reminder, the of is a relative based progression event-driven and initial protocol this mature an our projection estimate assumptions.

If duration While results demonstrated data increased the expect PFS, the have response that rates. of remain registration. from sponsor confirmed will we we, trial blinded response objective median and trial this the GEA to support as PFS of [indiscernible] the positive,

programs. other significant when reported III in administered in from to highly and atezolizumab endpoints alone first-line with potential which medical survival. guidelines and is Moving step combination to results ] we in IMforte at and [ In trial inclusion Phase small overall combination look the toward of results clinically the as cancer. progression-free presenting extensive-stage to October statistically meeting atezolizumab cell of therapy lung survival the and data forward compendia to year, primary this improvements maintenance demonstrated in be listings. The important encouraging Zepzelca meaningful an potential the XXXX, practice-changing The NCCN have compared a we

an half in NDA in XXXX safety included Epidiolex secondary analyses. to FDA as data, with mid-XXXX. we to to the Zepzelca maintenance. and PMDA As endpoints, ongoing to design of Numeric and trial which include expect for the The was submit XX- Renee were long-term in Japan by first-line trial substantive expand we and primary we collect discussions several label first mentioned, the remains in XX-week plan the have observed to improvements

the tumor causes level to demonstrated [indiscernible] XX. Slide binding interfere with action, highly to of also Ziihera I'll which cell why HERX activity mechanisms death. zanidatamab we in the believe HERX CDC. a profile We signaling further shown growth. is also cancers. and heterodimerization tumor Zanidatamab through Its inducing HERX-expressing ADCP think that immune resulting has in unique and inhibiting complement-dependent of Turning for in become ADCC, in and to and choice. review disrupts cytotoxicity of biparatopic potential results clinical the signaling, has has cell that clustering HERX, and been it differentiated all receptor Zanidatamab agent HERX-targeted multiple at induces multiple the of internalization, category. zanidatamab destruction

Zanidatamab's profile zanidatamab including it has believe includes and of established potential, administration, therapies, best-in-class targeted other combines chemotherapy, safety and solid HERX-positive HERX therapy multiple activity We tumors. without for tolerability, well with single-agent the ease chemotherapy. the

as highlighting was approval added ESMO advance tract cancer the for after Ziihera part and biliary review, for an BTC meaningful patients. guidelines to Importantly, Ziihera the of HERX-positive NCCN represents off-cycle

the highlights beyond. for and zanidatamab XX Slide potential in BTC

as validated authorization zanidatamab are we the for application BTC the approval approval European in early discussed In second-line the we addition GEA. XQ potential to Medicines already BTC, FDA and Agency await XXXX. for marketing in opportunity We've XXXX, as pursuing in

Additionally, evaluate with we is patients to III EmpowHER breast progressed the to in Phase which have initiated intolerant combination HERX. are or in in chemotherapy designed on zanidatamab cancer trial, who

in be efficacy this demonstrate and trial, have first in Phase With safety HERX. HERX-targeted the cancer the III opportunity to therapy to patients post ongoing breast we

And tumor in Zanidatamab Anderson Phase range early-stage also across through the We Overall, data incredibly tumors. program. trials a ongoing additional tumors. we with multiple breast MD pan-tumor with zanidatamab are I-SPY patients have collaboration opportunity types. a shown a the trial of including activity promising for initiated Center monotherapy represents cancer, our across excited HERX and has of expressing HERX-expressing variety II about solid we generate that Cancer to

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

Philip Johnson

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

nearly morning. of tomorrow growth results of our be expect top As oncology press and billion by representing year revenues. growth, XX-K, We driven a this our our growth. $X.X in consecutive consecutive billion line total which line we pleased we in seen reminder, deliver full Epidiolex today's in X% XXXX, our XXXX, are total be In release filed in And and This which quarter XXth fourth as for was top XXXX. financial to were over $X.X full will available increased to year our marks guidance, in the you've XXXX And revenues, we of revenues. approximately Xyway year. recorded XXst achieved

Turning to Slide XX.

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

XXXX to cash of of a million January, for diversity $X with strength of year our recorded the communications, generate repayment to voluntary operations ended portfolio. the approximately the with Consistent and significant principal our loan term and cash billion $XXX in demonstrating full our of our We billion in made amount year We B. from we from hand. the prior reduce business, continue $X.X cash on

we to XXXX, approximately utilize continue shares. and repurchasing During repurchase spent our share authorization $XXX million

if toward flow future not portion forward, repurchases of to paydown, investments thereof. Going prospects, some for or development used significant cash our corporate we expect share go to debt a enhance free combination growth

and corporate our well robust commercial significant Finally, as promising provides financial programs and flows invest position opportunities. flexibility as value-driving R&D to operating cash in overall development in

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

by XXXX oncology. by Our XXXX billion underpinned $X.XX royalty of blockbuster billion midpoint, SLEEP, continue represents that status year. portfolio, will at line sodium to total Epidiolex Top range Xywav, driven and revenue for continued AG top assumption in the diversified reaching X% commercial high our the revenue growth growth is oxybate $X.X expectation growth of the our guidance spanning year-over-year of and full line epilepsy

As if revenue of and our remaining away reminder, royalty enter Xyrem rapid we with generics, could will a revenue. AG Hikma true others erosion market go and have the

with of other continued of payers not number on oxybate, and uncertain While it's low revenue rated all and true by well the on Xywav, the Xywav the the we high we'll a such believe depend to of recognition be impact value given patients generic including HCPs, factors, sodium will sodium. is positioned Xyrem as of generics,

Ziihera key launch experience from to in BTC given continued population, anticipate of Ziihera successful ahead launch GEA. a include revenue Rylaze's modest with HCPs We although is valuable with a potential normalization this patient early of providing of year a BTC the the throughout revenue dynamics Xyrem revenues Other and we anticipate decline year. small

provide been while do quarter in first latter Finally, compared which to we guidance, want to the part quarters. historically first note can lower reauthorizations including inventory and revenues revenues affected have the prior by don't quarterly other in build our I year, the factors, several contribute quarter to of

billion. further attention draw to in to We drive your from guidance With continued adjusted to SG&A excellence $X.XX in products. expenses, like non-GAAP reflects initiatives lead continued several to I'd Slide last diversified our non-GAAP range commercial operational and Now increase our the growth SG&A remain our portfolio. on of on year focused items execution of $X.XX operating is investment billion adjusted XX. to regard The commercial

many Our guidance million an X% program R&D non-GAAP clinical $XXX impact investments programs, The significant priority continuing decrease that the million has $XXX outside JZP-XXX adjusted and studies continued focus to to primarily range of costs in decrease by the to patients zanidatamab XXXX. service represents positively value. and development portfolio from prioritization. a to potential broad shareholder on We're relating reduction XXXX is deliver including from driven and

net billion On plan. portfolio the in continuing remarks. I'll $X.X disciplined we strong line, expense commercial now in management to to This back closing XXXX billion. highly of commercial continued while our to bottom reflects income and expect for [indiscernible] performance be invest $X.X differentiated expectation adjusted to in the our call Bruce turn

Bruce Cozadd

in $X longer Ziihera in for with Xywav branded submitting and extend plus Epidiolex IH. billion prepared We #X sNDA to continued the XX. remarks remains reach to was sales to significant a look an deliver and with the our for help status we treatment for survival. duration blockbuster XXXX. peak potential. promoted commercial products, to record with conclude year XXXX growth we potential narcolepsy I'll forward and opportunity represents a our in to XXXX estimated a patients expect remain in execution the more Zepzelca strong poised on expect continued Slide growth

continued to line to excellence execution strength development in our and top corporate XXXX, as for concludes development I'm That corporate the open Q&A. pipeline proven pursue is operational XXst III our I'd the growth. by GEA Phase value over deliver of and prepared to turn long-term in positioned are and strategic Our strategic now consecutive like sustainable and focus with call operator data remarks. supported meaningful allocation. trial the drive confident opportunities Jazz capital on such shareholder commercial well our deliver line year to growth the to readouts

Operator

with of [Operator your Instructions] question Goodman Marc comes first the from line Leerink. And

Marc Goodman

reason doing talk comment your figured Can you is Rob, the kind to about what then do? would so make? Any settlement you you're us wanted actually can you on type kg? comments out be you Is you can helpful. XXX? the just date? with Epidiolex, Have Any low of margin? safety there being any the orexin, give And dose of the there

Bruce Cozadd

question specific. late to Bruce. We Epidiolex is what settlements filers this limit actually agreements think with which pretty on XXXXs the can Maybe say. jump confidentiality Marc, provisions, out remind your in I'll XX you being first. saying ANDA second is very our else So we go all those have I'll

we're all to have at for you it over very kick that's late So to moment say to Rob, the XXXXs. going update. is I'll XXX a

Robert Iannone

Bruce. Thanks,

number don't that therapeutic on initiating. NTX us XX% patients we small we we index. Mark, on or a So XXX do a define the that we about will that number even a we an so small think trial no patients, But with said thought This help trial so. far, But that. in of updates better are have is in update

this at updates time. no So

Operator

of Fye Jessica question the line next from JPMorgan. with Your comes

Jessica Fye

said few weeks. I you complete For you'll think trial, the the HERIZON-GEA enrollment next in

patient you made to the success? Can confirm, I for upsized do I enrollment that Rob, than remind guess you And seems or negative event you target XXX trial, XXX of probability when that just planned the you then this on originally is the enrollment. rate to us when while completed take of as here, positive, maturing as differently projected see it initially So for be patients? neutral

Bruce Cozadd

Rob. ahead, Go

Robert Iannone

Yes. Okay.

the are the completing be enrollment weeks. say in when we referring coming we we'll So XXX to

was said haven't XXX the when We enrolled.

of trial. blinded the As the to are you know, results we

it control the a that are pushing of so driving that's thing we coming don't having the the significant And out. certainly arms. But good effect could can't be see the or and what's Generally accrual a speaking, experimental from data. that whether say slower we arms events, arm experimental

don't sure. we know So for

arm trials. control could the that say would certainly be behaving differently than I prior

those. III been However, the control we've setting, consistent pretty and trials X this in across seen Phase arm has

So I big a on blinded are we to expect the don't arm. information. But that control surprise again,

as half depending tracking gives of events periodic year, have is how an roll come updates. and external in certainly we've events we're us in on this said, We vendor confident continue the second who in, the that could XQ. But to

Operator

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

Jason Gerberry

Mine just on M&A.

guys to for dominant that again swung GW. year. the big it's I while a of And a bat a guess part seem way this been like You be now, flagging really the discussion haven't Jazz investor you since in but

settlement just plus And place franchise then is, maybe so that. well into decade. not kind with a can why of on you patent if billion on curious having runway a reflect and $X next this that Epidiolex And ultimately, in

guys Just assets how think longevity M&A about how does that having you alter of that now?

Bruce Cozadd

give So more you jump I Jason, view. historical have this forward-looking is little in and Bruce. Phil maybe a can then I'll perspective, a with

XXXX transactions a completed as down to quickly and pursuing not and of that back as we had needless period, some after up bringing we that, larger spend time considerably. the levered were Just some that to say, we and reminder, in forecast. leverage acquisition GW May do during And to degree

creation had for potential we anything, which haven't focus company, zanidatamab major that think, and the excited the I we upfront To it about certainly while a has say we done of been smaller value transaction, forget it. for remain did in us a terms would

to take we're could Phil? question refers of part you that what expecting the going the maybe Phil, forward.

Philip Johnson

bad a Sorry, I connection have here.

to was not to second. handheld I me get trying on to So a a speaker use the on

time So GW Jason, deal. we've Bruce as the mentioned, substantially the of delevered from

at we point net at X.Xx that think effectively time. about I leverage closed in

of end XXXX As of to down was the X.Xx. that

be significant We have have and as certainly various by each build that financial we to efforts licensing growth activities looking our in the to bolstered our resources generate active at we verticals continues I do has cash flow continue for the strong story of to sizes. So would Epidiolex engage the been well in M&A long in us attractive even investing for to epilepsies where very runway making prospects be the and well with point, a area as those strong in. that overall include as to think, for more Jazz it

we do out certainly, opportunities build So that look to franchise. at

areas remarks, cases, Bruce in where we've more orphan as do to characteristics in newer to indications the the adjacencies that past. our areas be years. at share just and his either use that Further, and honed mentioned more been addition that successful we and would call those to, in services focused prepared significant the look we've some in points, ability add over with value we built product leverage Often, capabilities with

lack those would active the as certainly certainly, continued or and So I seen interest of quarters. things a in announcing not deal looking. very the no take we've expectation in lack large doing activities slowing of as past, of move coming activity commented down we into the

and being at a I opportunities in don't of there's looking. valuations this areas if value time patients to looking. be impediment and transacting active significant Jazz see do to we're the where We're tuned. stay feel So in point

color. hope you I gives that some So

Operator

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

Annabel Samimy

we of the saw The it approval quickly bit. and -- listing I sNDA? entity Just this you're expected XXXX, specific what compressing be year, but trend guideline little we year? until this there is just on the from strange at know could not can to then was indication? a compendia if And filing seeing expect for expect we some end Zepzelca, the any curious Zepzelca

Renée Galá

Thanks the Yes. question. for is Renee. This

QX QX QX, distributor strong We we I XXXX. do where terms in seen compared QX. from in had typically have say less there of to have in to we a with are performance. Zepzelca, for see continued dynamic to would dynamic what So our a similar we've buying days

impact. some have did that So

though, the Endeltra [ entrant to competitive note, was ]. will with with $XXX and XX% highest XXXX. ever I the that the is in increased that market on Zepzelca million call, our we a year as in mentioned for That sales

not we We at we first we our data, in peer-reviewed approval. working would hope the will which promoting, first-line first we As and guidelines we're to as of stage for half on. look and course, on soon plan file we extensive have our we year first-line as in be mentioned to out the data with available journal, this extensive-stage treatment that a XXXX, in the of line until have get diligently

And then to in first course, be first-line duration the say the longer there's in stage. of patients are I also line larger in of XX% earlier group of access line. patients overall first-line in to line is patients also and would a the to believe treatment their reach treatment second extensive able XX,XXX the about in of XX,XXX those versus journey. There's We benefit, do that first

So line in won't expect but approval. we we have until do actual an be in see first growth we the to promoting again, Zepzelca,

I second to if I'd see to see competitive line, Zepzelca. think entrant Zepzelca's [indiscernible] as then and of step positive on expect And positioning new also some a receive line, while gain about to lot the second we the in continue would from feedback physicians back just a say in we

[indiscernible]. terms its clinical extended of an from use, of different inpatient require which monitoring of In is, course, benefit, ease or stay, does the it not

in to So we we strength continue to some expect having and ability do to first forward look the see to Zepzelca, line. promote in the

Operator

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

Andrea Newkirk

that an you provide And fit to then update context if CEO is ongoing was are this the might be the I wondering of and Bruce, Board for? background search the just in transition. on willing the looking

the about BD occur we strategy potential timing should the to that or how earlier, question this for As a to year? transaction a and M&A follow-up think

Bruce Cozadd

for Thanks question. the Yes.

company is is will excited it. about XXXX. we getting today to strong off positive for today, the is say, a We we're and in position marketplace, than and starting are very detailed to one and our prospects coming not by want a our want was not we're choice We're obviously where update out I'm XXXX take it take time CEO this the announced get choice going is selection to in as the in right. dictated other a true right terms the right the reach an I back the the say when that was on to in feedback attractive give hurry. make going and and So December, we're where company of to to process we're just where position

operating we're positioned On right strong well We've side, the M&A got now. results. BD really

are executing our Our commercial board. teams, R&D well across the teams

we on and hand, balance sheet, as and mentioned, from additional it's advantage opportunities growth our cash perspective, we continue very well take to positioned from to flow, it a our leverage to And products. take to perspective, operational again, cash our an whether infrastructure, our programs So business. feel feel on Phil add of ready our more really financial

Operator

with Your the of comes TD Troy from line Cowen. Langford next question

Troy Langford

this on Congrats the results quarter.

Phase breast the breast About really or you total Ziihera would progression Just Should and could into trial? succeed that quick cancer bucket opportunity one many Ziihera a the on intolerance address? and [indiscernible] think III patients for in fall do how cancer. potentially that HERX

Bruce Cozadd

see in if treatment I bit comment a landscape. don't Renee, know to we little about fitting breast breast the So you the want And cancer opportunity more maybe for how an overarching could we zanidatamab, then Rob, about see make including into cancer. talk you this

Renée Galá

Thanks, Sure. Bruce.

we BTC, opportunity, cancer as $X-plus market billion well broader includes the overall a GEA, at look opportunity right That indications PanTumour. focused when this and on at back as breast step as look do see we we're the now. we as So

But across Now for said very modest we're into progress larger BTC, we that Europe patients to revenues GEA, XX,XXX BTC. as be population. as small indications, geographies. into get at looking across those we same compared patients And XXX,XXX and U.S., look as breast than then XX,XXX expect more the cancer, Japan patient the given the we quite such consistently we've we at there as to

broken So go that feel a to up after is do there. much that there Rob? haven't quite while opportunity we elements, confident we broader the different into

Robert Iannone

tend Currently, [indiscernible] an would therapy. I HERX. in the there's HERX-positive cancer that's There multiple care of regimen will metastatic standard optimism followed get frontline. become lines just is ultimately of HERX ongoing in in to by add and that setting in Yes. the breast patients that that, trial frontline

become be lines plus, of these to to have high the that it positive patients able Ziihera progressed to would that on choice of plus HERX. line we So proportion subsequent that whether from second after given or go results of think line have with treatment be therapy. on captures patients third think we ongoing And the we patients that trial tend

Operator

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

Amy Li

if depending estimates? whether for the how should is How on or remained Akash. sales strategy peak zani outcome This on HERIZON-GEA, consistent, arms of triplet the we would think for pricing pricing about Amy impact the in hits these doublet your arm

Renée Galá

Yes, I'm happy to jump in there.

with cycle Ziihera have XX-day for $XX,XXX. priced approximately we a BTC So WAC cost of

Now priced of thereafter. for it coming when shortly we thinking about BTC, also there was view a GEA

when BTC given dosing the BTC. and is different But a for We be with We're cycle an XX-day weight, of would around XX-day days we dosing. you what GEA. GEA, looking the a more at specificity haven't a XX to looking there the threshold the we're weight-based above respect then of a with is certain for average and going say give versus cycle certain patient below median is slightly at cycle weight I'll price.

the we're We're the a GEA. guidance specific ensuring not really as able meaningful breast And much is respect we're pricing Rob a triplet peak. also with arm and the looking opportunity larger and specifically opportunity with doublet at with or focused that then What capture cancer. had giving to on mentioned, to

Operator

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

Mohit Bansal

It that not it enough. it Congrats on again, over arm the be understand trial you little if seems Rob, -- the commercial a like show a in [ seems of help the me important benefit bit just we That GEA ] of the benefit context Herceptin. is given like any high this are of so is to majority patients. at over could arm patients pretty aspect, looking believe you may progress. But detail. that in power RMC are

you like at would context, out should help context understand of look So how and opportunity? us look the in [indiscernible] you investors that when at us in market [indiscernible] how data come the like could

Robert Iannone

Yes.

represents that enriched the we proportion true that PD-LX is PD-LX when epidemiology. for testing positive PD-LX Herceptin for trial starters, we conducted. was was think high. during trial, that, say trial whom positive, would I So chemo, likely quite KEYNOTE-XXX The care ubiquitous of the for of don't standard the patients It's think that remains patients given the

Or bit. around a be it how a really if cutoff We PD-X a all of also would higher, drive patients positive. down there's that that truly X who indiscernible] it's does define benefiting? optimal to Are higher? PD-LX higher, are with And patients think from quite truly question benefit proportion

be in in B that, the combination said agent the has that to think to PD-LX of Having ARM combined we the [ chemotherapy additionally Arm opportunity HERX Ziihera with will has C ] and with Ziihera demonstrate opportunity of choice that status. tisielizumab. regardless demonstrate

power a to to Ziihera and specific mean combo And think the from the it tisielizumab C A. be necessarily chemo be with a to to to both comparison we than versus B, and being as and spoken has alone ARM regimen haven't giving Ziihera benefit/risk than of We certainly of perspective, of I for better it that don't has C required. ARM be, better also approved, with broad chemotherapy. ARM

of And all opportunity of PD-LX so of part as regardless will be an the trial. data have to HERX look we'll And of status think we choice. at those Ziihera this again, of

Operator

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

David Amsellem

terms there's to turn you feel your of your forward orexin in how then be moves is, the do your franchise Just the runway how that So pan get that you're number other that you one. your expansion speak? better to here about badly trying I particularly program to how need to a guess that's first-line? And so my are to an focus isn't other continue the do other M&A secondly, In there Zepzelca's game, label then thinking pipeline? doesn't extent with would out, thinking about in to extent Or opportunity So question in of orexin sleep and own exclusivity orexin you like in [indiscernible] orexin? on? would you you the words, sense pursue areas

Bruce Cozadd

want start Zepzelca question? do Renee, the on you to

Renée Galá

that. Sure, happy to do

to So that to of And today, that XXXX. respect that extends extend offer with have matter protection further. applications any we then don't comments tuned. have IP additional a we December beyond we stay composition patent think I have but exclusivity, could patent that to

Bruce Cozadd

orexin oxybate do And that at available the been specific daytime fact, benefits we therapy, of the an disorders, a then in agent whether have certainly absolutely we sleep. currently with terms continue different nighttime as to are produce from and are, what whether potential less there now, space, sleep clear of is daytime role of benefits, watch consolidate ongoing the these that there the emerging We question serious as nighttime agents concerns orexin your right it sleep or what a new particularly a on exciting data with believe benefits additional across on seen for with all in action of mechanism little would certainly benefit, seeing as we're night or daytime other positive helps are to do studied. use agents

be SLEEP about, oncology, rare a to got where do other we've space, of the a We're in neuroscience, disease across In leader. talked terms we where of relevant that we need as interested we're, in course, capabilities. space we've are in potential interested areas also

but we that I opportunities meeting growth we're and diversify and and an down to side, durability would good capabilities [ fit, be of the longer So want narrow think term. looking produce for with only need efficient commercial good fit area, to on broadly over our areas sustainable point, to one don't good us these call a across opportunity each ] the

Operator

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

Ami Fadia

to revenues, Can you're then the ability switch Perhaps have the seeing about impact you how any or the market dynamics seeing the you overall as either business some facts? Xyrem also talk to the oxybate AGs from of or Are narcolepsy Xywav And your expect the or shoring gears franchise. rise should market? and switch in impact just switches generics and how additional that about generics think the of their how Xyrem dynamics them sort -- to the own we and or to at once sort the type might of end you launch Xyway switching payer maybe Xywav? to market of up of year, what come

Bruce Cozadd

in positioned. Renee, that what question But continued could a space the has we're just mean, how sure. about I was for Yes. we maybe talk oxybate multipart particular, think seeing and Xywav in to you be

Renée Galá

through that. absolutely. Yes, step to Happy

That's with we're had, that results we full seeing just really with the includes, We fourth both and that in that's at are high XXX adds narcolepsy So our look sodium IH. record with new from year fourth and had across what quarter, coming at XX% oxybates. adds, pleased as when and And oxybate, oxybate revenues I'd the course, patient from results switching say to high of narcolepsy. the well patients from sodium where as all Xywav. in you quarter we're year-over-year. looking coming our patients

AG. about think we how of terms In

REMS. our we in generics decide royalty XXXX generics you respect decide the from at XXXX, case, the will because look our don't were AGs to of the we need REMS market launch about know early, So right any would XXXX. revenues or into they course, And authorized include in Phil guidance, when that we're generics, generics own that launch would other be we are that to distributed that to before market if receiving invite for earlier if the if authorized and Hikma early, way, heard So to would to now, will with throughout XXXX, assumptions specifically full thinking say that that be have through our early their fact

to health. our we generics not then is that of situation exist. revenues drive to Xyrem, continued where to promoted erosion further on long-term do on with the which is cease launched the and the dependent the would looks Xywav like we of And royalty to full since continue a would differentiation at actively actively ability In have expect if XXXX, since revenues XXXX, look as and of appreciation So low of that also we what we Xywav. importance market see we then promote not sodium

one the generating low the and the the doesn't including We sodium, that comes high as of that this with with data continue important -- on oxybate and only oxybate only Xywav. sodium area, a benefit that carry physicians dosing high to to therefore, reducing related sodium that Xywav long-term clearly educate being in sodium choosing can as intake are well flexible we see warning patients health benefits

Maintaining strong course, throughout this. payer is coverage, important of

great today. We commercial patients that covered. with than are of majority XX% had our coverage And vast have commercial of lives the we more

both sodium continue bond will to already and data continue CB the reducing generate narcolepsy that compared failure including to both benefits and from that and findings there's of heart the and an came so Those have CB prevalence educate hypersomnia, we shared And it general increased we comorbidities, to clear stroke cardiovascular of studies. Rhythm makes And population. idiopathic with on data.

hypersomnia, focus we'll and generics. So believe be to look stepping as of And relative We for growth. customers the idiopathic we and for hypersomnia. idiopathic that on definitely see we do not still well XXXX. continuing differentiation narcolepsy to market, room and with positioned but build we're to payers. market we're back, early, Xywav very rated strengthening most the at with additional is continuing the for with low physicians, opportunity We're AB growth currently penetration Xywav

Bruce Cozadd

And high probably over has I'll AG to for the just and now time Xyrem sodium business, old XX% maybe time. the dipping sales jump quarter, in first the the revenues from decline our coming to branded remind in below continued royalties that of percentage latest people

Operator

line question the from Raymond James. Gary with comes of Nachman next Your

Gary Nachman

On specifically down the guidance, break time. didn't the XXXX this components revenue you

of of as the pipeline? that you of as the then spend of relative year? a forward to said talk can growth back So the going sense you R&D scaling you're revenue? in what's us reprioritization R&D, And and last X% of just of give trend year, to the more to expenses And revenue the how overall down relative more the about X%, right for level this just percentage franchises a oncology you expect neuro

Bruce Cozadd

want [indiscernible] to on you that? Phil,

Philip Johnson

Gary, Yes. to. happy I'm

pulls for the on sort So and year step the products the various first, as and with start you ones that pushes way what working about through larger of revenue, helpful the we think down. might be

fourth So XXX full fourth mentioned, quarter, XX% XX% strong Xywav, quarter. as in last the strong momentum, adds really net year, growing year had the in really patient Renee the in

with XXXX. full blockbuster positioned So well positioned in pleased longevity again, fourth quarter, XX% really the Epidiolex, we're XX% I'm growth of franchise reach forward. to Similarly, the strong for continued moving the that and well status long for there. very in growth year, momentum,

number half fourth reflecting expect continue for setting. for negative protocol include the that approved of growth that about we again, we early year, that did this the Rylaze, sales mentioned. we the share in line for mentioned treatment We the to the the down maintenance XX% second by when coming may we gained shipping, label full year, good relatively growth of Renee And X% the where normalize in fourth guidelines the X% for Zepzelca revenue to in full first as for Zepzelca, weakness COG Zepzelca about and that in we indication change to dip flat second had days quarter get see that plus part from year. impact feel really FDA. when prospects get in it [indiscernible] some in the quarter, line the in into as XXXX [indiscernible],

growth, second Defitelio the the the half in really year in strong of U.S. particularly

saw increased As relates we procedures of you we're really their the to incidence product use mentioned for understand monitoring of situation that of of how much uptick VOD. providing patients in second and [indiscernible] new be that to past, lead how half in an to the much for this the that to may is sustainable, a can that transitory base prepare

we'll quarters So coming if that's see again, in durable.

as accordingly largely in that XXXX. about XXXX in That revenue with than due significant XX%. then well mentioned, With growth in increase rate volume AG on tripled the now as in increase finally, the that was what rate think royalty was royalty less nearly it revenue, coming royalty in coming XXXX oxybate to then as fully compared revenue Renee through sodium half XXXX that revenue And And was should XXXX. additional channel you XXXX. that XXXX, in royalty down in Xyrem, annualized moderate the from the late front, to

drag buy, So last was you than a [indiscernible] has from a to mathematically, XXXX, if growth less the will, year this Xyrem drag of on revenue it moderate lower in year.

gives us some color across the that portfolio. So

when we've opportunities, investment will of of think got at of question, We your invest as in many that sense way. have moderate the where of we spend, given some we're make very extent, those [ answer we context readouts end the of you on ] down of or to have. mentioning terms on outcomes. we Gary, percent of year, very some R&D it in percent of revenue, of zanidatamab the depending In thinking the lot up of mentioned not the no the really sort behind that necessarily funding revenue prior fund a are great will as cause reflects to the how questions level on opportunities last And that opportunities, those to and good of those XXX XXX that the certain behind. particularly a some with those programs prioritization R&D, investing a are to longer had well, we do And

drive lead in We additional invest so additional asset in the promising development that to But invest how assets certainly come the additional for be activities pushes and we and to to forward value the most will of there. can that and we the would we'll do And site. expect to data our add corporate zanidatamab, and the more fully for active portfolio to talked program that the on about could in see uptick. to most as that then of patient be with behind, bring that Jazz readouts investments will of pulls impact sort those full some go

Operator

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

Unknown Analyst

[ It's on Anish Greg. ] for

GA thinking remove Epidiolex, or can III top overall and about should for the second the hangups time second line segments? And treatment third for quickly guided look analyses, what interim half, at survival uptake enhance subsequent levers including how Phase As now the Ziihera's to on we analysis? you be lines across be pulled

Bruce Cozadd

then can you Rob, Epidiolex. start don't the Renee, And on zanidatamab why you comment readout on timing?

Robert Iannone

Yes.

provided So readout of at that first progression the on the the PFS analysis have And time based survival. we just interim overall analysis, would we events. projected is that for

that you course, So and for line as greater survival. maturity of see that allows pushed get -- overall you've as also seen time out,

overall we'd we're survival the first events. or if we So not specifically Again, of more maturity expect interim referring might readout pace had than to that the sooner. of have

or no X in final. second implications projection are So the survival for total. new There analysis this has the

Renée Galá

And question. jump then on Epidiolex I'll the in

quite transaction, do durability where we're were quite point pleased looks seeing. bit what So I the live have would we're we GW a greater of and about. say of really growth a have that confident in now pleased In this with that the long now excited clarity to nature and that closing We runway can the we really we're like. asset, at be on we're

lean both we now into. at for and So seizure we'll increased what data growth look and as physicians highly supported that caregivers. the and by continue that to right non-seizure we've differentiated, as really resonates with data what Epidiolex the that's benefits and with driving is as generated well

programs through early to this added the where as momentum We additional and benefit seeing navigator ads new even in have a we're adult some area access position. of persistency and we're consumer having also and see account the continues targeted long-term impact great of within seeing our impact highly making nurse that's we has improve, that's area and success, setting, a to positive piloting also hallmark brand, we're -- been in breadth always care and great things manager and investments persistency we're like an virtual we've quality pull-through and programs, this

we're an with So we to really area seeing. where this learn, and that is we're the continue results thrilled

Operator

of question from Truist with Lee next line the Your Joon Securities. comes

Unknown Analyst

This is Lee. Joon [indiscernible] for

on us pending And earlier question haven't exclusivity XXXX? patents dose completely from could December how David's amount off just what you beyond couple longer program. in But are reduction? extend updated XXX a for us. Just much Zepzelca of of thinking the going I you terms around know the the

Bruce Cozadd

we're don't patients we've I than of but the either Obviously, dose in I hate last question, to to additional those. on this information the normals a go ability on XXX. in to lower about do provide think healthy to you going to on talked

additional So the And things of what on number Zepzelca, for this at longer of don't exploring, we even patients. in terms could exclusivity that of information agent have a then that's one point. on small in specific mean that we're

Operator

turn Chief the will over I concludes Chairman Cozadd, for and That session. back Officer, Q&A our conference now closing Executive to Bruce remarks.

Bruce Cozadd

and and we get I to. our hopefully, sell-siders Thank to get couple close apologize shareholders partners were shot everything. operator, of continued call our didn't you best evening. talk later support, and just to today's on we'll thank Yes. recognizing you given their to through And We to all and this for you, colleagues for the and Jazz I'd joining like their thank by us efforts today. our confidence for

Operator

call. conference today's concludes This

disconnect. now may You

Jazz Pharmaceuticals (JAZZ) 25 Feb 252024 Q4 Earnings call transcript