Jazz Pharmaceuticals (JAZZ) 1 May 242024 Q1 Earnings call transcript

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

I would now like to turn the conference over to Andrea Flynn, Vice President, Head of Investor Relations. your begin may you conference. Andrea,

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

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

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

encourage slide deck the We our in risks may uncertainties and identify factors release the our that statements today's described press certain you cause contained filings, and and which in review SEC to from events, made duty actual company's update or differ in those undertake materially and statements results the to forward-looking the statements. on contained We to forward-looking webcast. our today's performance no obligation

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

call the over turn I'll Bruce. now to

Rylaze excited quarter welcoming I quarter, first are to to I'm have made drivers, thank as X, XXXX for key financial Phil our the forward progress our who and revenue Jazz also growth from Phil team want in along double-digit meaningful delivering Chief our in we We're review important you executive on our report on during to afternoon, our including Good us advances shareholders. Beginning Andrea. very patients Epidiolex look year-over-year that by Officer. Thanks, today affirming Financial Slide contributions for with and our growth and joined his to and March we Johnson, to to begin combined everyone, value guidance. results. pleased Xywav, first joining pipeline.

the be commercial On blockbuster and generated growing $XXX Epidiolex potential. medicines. and revenues diversified Xywav its its our durability. and than strong, front, revenues in portfolio confident of we year-over-year in XX% in million demand more increased our remains continue to across confidence trajectory we reinforcing total

with surpassed area oncology delivered growth. billion strong last first Our time. year established continues another momentum $X when quarter therapeutic This revenue oncology we for the annual XX% the in year-over-year revenue we

in for We Moving multiple Jazz catalysts significant the March opportunities. XXXX completion with important of the to we would for a pipeline rolling year for BLA specifically of first for approved, late-stage be is targeting our market for U.S. with HERX-positive and treatment milestone achieved substantial R&D or an XXXX and the efforts. HERX-targeted submission therapies in BTC If earlier. tract or our Zanidatamab commercial expect BTC, launch cancer Zanidatamab biliary in treatment, the

Zepzelca We suvecaltamide lung for Zanidatamab Epidiolex future tremor, in in data also clinical cell essential Japan, in gastroesophageal the expect cancer. important in readouts and cancer, first-line near in small

maintaining are On disciplined focus we our front, operational the on capital allocation.

the healthy portfolio to development including execute commercial of invest to in growth and flow, positioning strength, operating continued Our enables opportunities. on pipeline us also while our financial corporate us cash

leader. along oncology to and advancing core our We focused to as enhance X. global in realize portfolio, decisions with growing disorders value remain XXXX. to our sleep tenets of expand therapies investing capabilities on Slide ambition Turning the biopharma includes R&D advancing to epilepsy This and Vision we X leading disciplined shareholders and a allocation to making pipeline in capital high-growth be a

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

the excited period Thanks, strong revenue We drivers, progress across our from I'm combined delivered to continued compared Bruce. report our portfolio. XXXX. to XX% key Rylaze on and growing quarter the commercial growth Epidiolex Xywav, revenue first same by in

first seasonal of impacted reauthorizations headwinds is year, the As of was by and inventory from the typical payer revenue quarter drawdown.

In to sodium discuss entrance expect competitive the XXXX, with or our AG details generics $XXX which Xywav through in saw franchise. sleep well from Xywav the the Xywav market high revenue XXXX, quarter view quarter. sodium XXXX, to X sodium was We this into million. I'll on oxybate and Xywav growth of several first from to were first deliver pleased Let's remain period the and of high Total market overall revenue $XXX in includes of the first few of note minutes from choice, get to narcolepsy. year-over-year the oxybate grew high to plus treatment branded items AGs, the net Xywav. a durability royalties and growth the our million oxybate take the the as of fixed and as sleep, oxybate. #X commercial including quarter revenue XX% starting dose of for confident Xyrem authorized Slide the and with availability remain we of both we as sales oxybate In continue to

their I want the on chose treatment to was from multiple with based oxybate downstream physicians dynamics of of initiate to Xywav. As XXXX, Many expected, of formularies transition. start of the excluded of this commercial products, recognize and patients including benefits sodium Xywav. several call out Xyrem certain newer the low availability at these and

the a we significant XXXX. compared Xywav to quarter patients fourth narcolepsy saw of of active quarter at First, the first in the increase of from number the end benefiting XXXX of

sleep insurance transition for saw limited a from to Xyrem ensure we quarter the to patient to support navigated patients have as coverage. utilization first therapy provide programs the patients increase they obtain their an Second, helping Xywav duration, in our uninterrupted access programs These with Xywav product of in as providers.

benefit IH have of coverage both in commercial approximately indications achieved we a As lives. and narcolepsy for XX% reminder,

may While that event. over be other onetime these time. the we 'XX plans first number view from the spread we as exclude the from that of forward, expect Xyrem concentrated We less quarter large out will of changes formulary 'XX anticipate occurred to quarter of going fourth transitions a and patient

Finally, all branded this dynamics resulted for were I'll in note our guidance. that significant Xyrem in of decrease transition in revenue revenues. XXXX neuroscience these accounted a

of quarter, metrics, X,XXX quarter. approximately patient patients were quarterly patients exiting an taking the prior XXX from our increase at narcolepsy Xywav there the Looking first

of newly support with Given do long-term patient going durability as patient believe the use these the patient revenues providers. the product of quarter additions. are We being increased this of for and to and fully best more forward reflect insurance that revert numbers indicator programs, their not numbers aligned revenues transitioned expect be value the patient by patients will fully covered

for The to patients associated market. the with IH impact not coverage transition Turning did narcolepsy IH. dynamics

of the We continue X,XXX for patients as IH opportunity quarter. to there an exiting view Xywav prior IH on active the from quarter, the XXX increase growth Xywav approximately were strongest and

additional our investments are deployed. on the focused build expanded and now increasing field breadth prescribers. of prioritizing the personnel is and We These depth field market are to IH further fully force

and revenue, recognized both in AG rate. increased transitions which business, was branded the $XX oxybate Outside million driven by patient approximately royalty royalty our we of

are results sleep positioned and our billion into and Given market the well in believe of entry in quarter we we vision high for since of revenue. to goal confident visibility increased that remain Xywav dynamics $X oxybate oxybate, the durability sodium our XXXX achieve the of

to Moving Slide X.

pleased to in net million the the of X% same quarter continued are XXXX. product the first with compared of Epidiolex representing in growth quarter, We increase a with approximately sales $XXX

reminder, half a build second see inventory with half which the in Epidiolex, of the first primarily of the year, in burns a As year, following throughout we in quarter. first the then off the typically

expect We be remain Epidiolex. in blockbuster growth potential demand geographic driven future of and the by confident expansion and underlying to

diagnosis, by continued the additional geographic and include focused data increased showing reimbursement such increased by currently that providing supported XX for without LGS with demand and with see as patient in setting, and executive synergies benefits the Clobazam. beyond social expected than Key Epidiolex more penetration in cognition, is adulthood the market to support and We're growth language launches the HCPs the Epidiolex to communication, adult response with also beyond clear optimal Epidiolex in generation part emotional plus in U.S. seizure which as many data drivers diagnostic tools specific countries well as patients included and of adult from control, a data may expansion for is reach approved opportunities of education XXXX. where continuing patients. Further function dosing, on and to positive function treatment

delivered revenue was Shifting led the of U.S. Rylaze of XXXX. sales our million, the driven from regimen. Monday, including protocols net and strong Total Rylaze to representing the continues approximately oncology several $XXX near universal Slide of for pediatric dosing adoption demand and to Strong Zepzelca. Wednesday, product on quarter XX. its business by increase quarter oncology Rylaze quarter $XXX the be factors, another million, in with XX% first oncology asparaginase-based Friday a by for and adoption

seeing also the profile based current first Rylaze short-acting setting of first-line in of relative to usage are therapies. We asparaginase benefits a the on line

adolescents growth the adults, continued and on of the in or market. focused remain we addition, In of Rylaze AYA young treatment

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

on as We small administration for practices. care feedback lung providers ease to well and care cell hear health cancer the its and from #X of have their patients, second-line as Zepzelca benefit use patients clinical as positive and established continue for treatment the health we

of there drive lives ongoing lung addition from in cancer importantly, the growth remains and III biggest most small to opportunity patient cell In further opportunity outcomes. would setting, trial cancer therapy. provide Phase second-line in data patients small need to We to the first-line unmet believe cell earlier and a an improve for lung lines is the significant positive

We in expect trial XXXX data XXXX. late early or that from

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

pipeline. Thank anticipate time and multiple you, Renee. oncology neuroscience. catalysts for meaningful XXXX exciting represents our we an across And

the we oncology diversified milestones provided in key and And I'll Zanidatamab. with reach pipeline. of Starting in XX, programs an Slide On several term. near our overview the expect we to clinical highlight

for accelerated U.S. or potential BLA have We tract approval. in completed submission for the second-line our cancer with biliary BTC,

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

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

neuroscience. to Turning

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

engaged We also trial ET tremor. expected believe for reads manual X exposures provide XXX, in an or update indicating have trial ongoing therapeutic predicted ECGs. in XXXX. receptor we data on regulatory with external line of index If paused positive, are of automated observing a for [ pivotal Phase or That I trials findings essential to in both ET be to XXX the as tremor there recently to efficacious stage JZP also half trial we report the With ECD work and be first perform top package. the ] type of signal may on serve Parkinson's from prolongation after November JZP interval disease patients. part late experts recordings. clinical agonist. the a that Since to this QTC was We completed I'd the narcolepsy initial our HERX JZP-XXX trial time, could suvecaltamide like last

with this our provide I make XQ call. partner, and and Pharma our expect a We to update are will alliance next an if Jazz a steps, information to then decision on in earnings on any. position Sumitomo reviewing be

XX detail to on Slide our Returning Zanidatamab, plan. provides development more

in multiple across we excited indications, cancers. Jazz. since multiple on Zanidatamab data development transform HERX-expressing bringing across And it standard current have to emerging to the strong indications the potential We Zanidatamab meaningfully care progressed based of of about remain

anticipate and end As earlier, usual FDA second-line line. would we priority window. XX-day establish acceptance, response completed the time BLA our Upon the a March our at FDA was from and review submission, the of also within BTC of noted PDUFA

present I'll note, more including also to ongoing planning at ASCO survive. we BTC mature from data are this trial the overall year,

half we types Phase in including in in of recently GEA several cancer. III announced multiple tumor plan believe that of have combination to with to to Our development this in lands which trial the evaluate HERX. indication and that progression an HERX, a will therapy in represents would on the initiate where support molecule we HERX-targeted year, patients the chemotherapy POWER post ongoing in robust We've in second breast trials trial cancer in Zanidatamab this first safety investigation demonstrate opportunity efficacy after registration be the breast

strategy need Zanidatamab patients near the a to deliver term of opportunity us more believe billion. In program to the that initial development we indications. summary, BTC in we in generate second-line our commercial in will to In and significant executing enable than the bring regulatory total, a with we're other for opportunity market an indication and rapidly advance $X and believe can

agents, external Zanidatamab would be the website improve which webcast hosted quality detailed of from treatment overview our to go would HERX from the data on and care demonstrating Day HERX-expressing thought fit a prospectus how access included of patients the Zanidatamab landscape listeners HERX-targeted I to with R&D tumors. Zanidatamab to potential March, differentiation leaders on to in in and encourage other of IR for

XX. Slide to Turning

development XX treatment ET and suvecaltamide, With tremor selective of new quarter T-type second the calcium approved highlight clinical state-dependent the with is tremor. unmet from than the the in a trial need in Parkinson's more for no high disease channels medicines There of treatment top of for years. in I'd ET modulator like this highly anticipated data a readout year, and which essential is line to

of dressing, highly with a drinking, significant quality be functioning. living, and on as effects physical can eating, substantial can in lead writing activities patient's impairment of ET debilitating daily and life such negative shaving and to

experienced prevalence million diagnosed social XX the phobia, deficits million X approximately patients. are and estimated depression with also markets, In there patients key cognitive U.S. Some sleep and European anxiety, disturbance. approximately patients at the

I to want Moving suvecaltamide's differentiated on Slide touch XX. to action. of mechanism

of pathophysiology acting there the prompt channels evidence T-type underlying of activation these the to leads as such exact makes of was enter rhythmic balance ET help in The some gatekeeper tremor. calcium in of treatment selectivity T-type the increased a calcium states regulate ions, which clear, II and calcium to for cell is TCOM demonstrated not channels of the leave pathological role high membrane. a While In support channels. both excessive candidate ET, T-type is the of ET, the strong for calcium that channels to suvecaltamide it signals promising Phase trial. as

targets it Importantly, suvecaltamide is state differentiated that from other T-type calcium the channel blockers neuronal of dependent, the in development it normal is important for sparing hyperexcitability, signaling. as conditions channel, of under channels while meaning form

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

Rob. Thanks,

of patients success of to like transform because First, the am I I'd And have lives of we value. came integrity to lives the quality, is we to enthusiasm patients join Jazz. how enhance and because company on express I to his history impact innovating impressive, us the our excited to opportunities and which of since their of families. the Jazz and serve people, the accomplished shareholder has of great create of significant founding, to its its ahead and

first our XX quarter to now XXXX the performance. summarizes financial Turning highlights. Slide

revenues, in a representing reminder, and We As increase our million a quarter XXXX. growth with same first continued $XXX is financial of on in over information results available press the our top the in more total saw XXXX release line in X% period XX-Q.

the QX. have leads As build of Renee the including inventory burn latter the which prior affected inventory patient noted, of year, by programs factors, which our and use to in historically drive support part several first reauthorizations, quarter revenues been in

year combined our results we in are $X.X with growth billion. and revenue and and QX Rylaze of Epidiolex to Xywav, our guidance area. from affirming expectation full billion growth therapeutic growth our expectations our including in double-digit $X.X for oncology our line are Our drivers, double-digit key

support the to AYA. is Slide Rylaze initiatives, commercial Epidiolex efforts reflected educational in expansion Xywav of dedicated SG&A and non-GAAP XX. sensitive, including U.S. Epidiolex where market growth IH A promotionally key adjusted for the drivers, U.S. the commercial Moving and geographic the our outside investments to for

by for of the critical expense R&D which was enhancing we quarter as in future adjusted the late-stage multiple Non-GAAP to value view driven pipeline. investment programs, our

respectively. On and business for in linear at Investments a spend our Phase well plan our XXXX for programs suvecaltamide patient into trials robust of on with drivers development trials in are in executing growth Epidiolex disease support are as XXXX. as to first and II and we and best quarter commercial extended to that tumor our strategic across note the types X new Zanidatamab of expenses our margin products the areas incur and Zepzelca We pipeline. potential key for for ramped support multiple the different populations, and expand those commercial that time initiatives fourth up have and geographies operating not business the to quarter into

We 'XX progresses. expect year higher the in these the as trial. Patent investments expense primarily and to Avadel to also costs, litigation a related bad positively impact debt included infringement SG&A revenue expenses XQ

activity up expect at Our R&D clinical remain levels throughout these expenses, along ramped consistent XXXX, and to XXXX. with trial we expenses relatively in

Therefore, we tax expired recorded guidance. stock full are SG&A options. related R&D our that point affirming we also discrete and out to a I'd expense XXXX year

increased XXXX the expect we tax for our the year tax While quarter, non-GAAP in non-GAAP effective of full rate this to range significantly rate XX% effective to XX%. our remain

and of first the our our We cash of continue driven hand. to We on million ended and generate operations approximately from $X.X quarter diversity cash portfolio. in business, recorded significant the million in the by with cash strength $XXX.X from quarter

in late-stage Epidiolex, income development corporate strong multiple top including provide $X.XX all growth our significant Our invest potential drivers programs programs, significant and which key generate EPS pipeline of of line and commercial by non-GAAP clinical flexibility priority Zepzelca, the net cash flow as and $XXX million investment in opportunities. R&D with position value. growth, were Non-GAAP to to suvecaltamide and driven as our operating along of adjusted financial long-term adjusted well Zanidatamab, have and

Based development, strategic $X.XX non-GAAP spent to greatly for and a I adjusted net overpay with will the contributing on shared. and investors we capital to on our perspective income I've of they our $XXX focus and Since corporate these continued time and goal and speaking considerable Jazz, million input $X.XXX our results allocation, disciplined are heard analysts conversations, affirming appreciate concern joining billion. Jazz quarter to of that guidance meet from billion acquisition In an XXXX revenue. the

thinking we're how Here's about this.

licensing is outside walls achieve acquiring or the transforming First, lives and their our innovation from purpose we'll our to central families. how of of patients

we value allocate capital internal for can create as sustainable development, the making we corporate revenues to on projects focused and investments are that and Second, deliver shareholders.

up remain meet to just have speed, our disciplined and company this opportunities and both of make and investors. will to to the close acquisition goal. not value Vision future incredibly the about on deliver will excited patients while that XXXX price I'm noting an to still I'll getting I'm by we We

I'll turn that, the for to closing Bruce remarks. call With back

We've Conclude XX. important today. Slide XXXX our towards guidance to our and guidance be our on delivering made are on affirming progress prepared remarks pleased objectives and

data Epidiolex front, in commercial Zanidatamab, our growth On long-term see and Zepzelca. We our to advance near suvecaltamide, we catalysts term, XXXX. multiple invest on That the R&D readouts products side, in of we concludes remarks. the key our And to prepared the including for in and pipeline growth. expect continue continued

to call open turn to the would to the I the operator for like Q&A. line over now

Instructions] We Fye comes begin of line session. the now question question-and-answer [Operator from Jessica with will JPMorgan. the First

the narcolepsy quarter. oxybate on question in dynamics X-part

second, an losing how you and Xyrem from to the Xywav? many support the First, you do to in have of XQ use not generic of increase patients transition patient understanding as the or nightly coverage can to to And patients transition once Xyrem Xyrem programs quantify headwind Xywav?

question. the and I'll Renee, for both Jess let take you of that. maybe Thanks, parts

Sure.

patients Xyrem of to share. made part have how able access that those that the first. we patients terms came of to of to AG with not would So those their HCPs to because being I the did many not over. that low take we there patients say patient adopt see patients in along able to ensure Jess, Xywav disclosing to breakdown portion uninterrupted those second for data in respect data the our to be and good decision a I'll quantify to directly go establish from But We're support was Xywav. is -- a and with question sodiums programs

revenue from in those come sales see and future we'll see a representation patients of better you quarters what net the So is should Xywav. the in that

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

is essential about tremor Phase IIb My study. your question

wondering expeditious confirmatory data? X.X second randomized successful, this you're trial, how something some goal run start which abbreviated about yourself this get Would if to a you I'm could of is more the could withdrawal manner? trial. line roughly from there to thinking took So it trial years look study in subsequent that like to be sort more Or

to in want you Rob, jump on that?

Yes, happy to.

And So It dose remember, to to Phase the Jason, choose when all move one we III would confirmatory those expect first necessarily a levels we IIb regulatory And or bring X levels have level. ideally, of would it we would trial, we call pivotal package. then contribute forward. the this But call believe, dose included let's Phase we IIb Phase a, count, wouldn't we suvecaltamide. trial. we to of all, because the is

a So streamlined more design. creates that

at and to we trial in all that. data, And we'll to with be fastest we your support for data authorities, we possible approval looking engage point, and certainly, regulatory designs have look when to path compelling hand the

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

discussion and of of become at believe to wants you want Bruce the that's with an oncology out months over there. and be to discussions what Jazz and perception lot picture the a company, the had past from whole investors it's transitioning lot just what and investors big about to least X a

because be talk X become X to talk X, Just just and obviously in or what be in was about you and since it's to maybe what that going all years Jazz to are that it is X expect Jazz curious, years, you X how today XX just the you're reflected ago? looking years, about what just Jazz can evolved years making you're investments years, X for

Thanks, Yes. Marc.

front in a the we're Epidiolex coming and double-digit portfolio, where XXX promise but were business Zanidatamab, we 'XX from with position just or about. submission including with, talking Zanidatamab So with of on pipeline side growth an Xywav what's neuroscience us side on us, opportunities pipeline, front of in data also earlier. in current of upcoming, Rylaze, the program, of earlier growing our We're but the and expansion also by in having complete going looking we with assets a like led we've excited launch also already oncology believe, of got the to beyond. the nice our and programs including about on, opportunities Zepzelca business forward particular stage in

those excited we're about franchises. both So

turn not While there like say and trying company on of I been certainly is we're would franchises. lot right into we'd has company. Zanidatamab, to to pipeline largest focus an have oncology our in our a now R&D both of program the oncology the single in strength

doing more corporate of also and impact history that to our those it world. to by balance The cash investments sheet can transactions our our and broaden continue a will over investments then making, continue provide think diseases, patients we from the continue the some both medium investments -- long add and nicely commercial generate that that great but of in allow are in opportunities, the fueled to to more designed and territories in described comments term and short that development portfolio to our both pipeline R&D us to growth and more the commercial we're term help around flow term, his particularly portfolio. think near Phil growth strong I the and

So having to to of I to term shareholders. create as and company the smart we're both given the to the make strength fuel short a about financial it the long do for decisions, position our think which value investment in

you better that we're execution the think important, investment So give decisions should are sense but a important, where I term in for always headed. short

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

I Zani can data, a guess, how for new how Zani cancer think as is, on profiles nonfatal KEYNOTE or ] these just say, they should disrupt indications, sit think OS had in that for this more how conditions. rapidly and in [ And opportunity in of as, be GEA about today would we I superior where drugs in better guess, of light on Zani. launch all mainstay first I into X-part the in guess Zani I going the the challenging KEYTRUDA. are paradigm. ramps secondly, Separately, standard should efficacy words, other rapid about we other to we with care? think as about announced these

So some wanted get characterization there. to I just

on people first expecting of had Yes, some GEA, most Annabel, question, thanks been the had. And for we results positive the question. think OS at Zanidatamab, I point out that trial,

Rob where changes into comment Zani landscape. fit that think don't landscape, the let could I'll on the but I GEA So

launch. second to patients traction can results things to sometimes of something in of a benefit, new you oncology space, and And move to you regulatory opportunity mechanism how approval, terms really fast I if been have about rapid benefit allows from then better the relative make can particularly therapies strong with there's other it's think we can fairly of for the determine and and bring up where that presented ahead NCCN option. And data get even in a guidelines that's when question, all action the uniqueness that's reimbursement, on your in of progress picked

GEA? landscape the talk to Rob, you about want in

Yes.

safety its the antagonist mechanism sizable, because differentiated we the over the of think of differentiated which of action is adenocarcinoma, HERX there PD-LX we profile. is no So has positive agents. PD-X choice efficacy approved and Zanidatamab population, in expressed the the HERX context gastroesophageal because Certainly think in of potential negative be to

PD-X positive agents backbone PD-X Zanidatamab, the HERX comparator antagonist. essentially to are in chemotherapy. combination show differentiated again, a have opportunity a the And we has antagonist with so interchangeable, think combination benefit we PD-LX there even in chemotherapy of the population, But the with is and where Herceptin in Tislelizumab

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

the Horizon study, interpret really going we Just trial. JACOB how should on the GA

no that benefit -- of Traschemo, Phase we early top tremor, accelerometer that you in on do and of Phase JZP hold on up Do upcoming large a Here, didn't confident may maybe an show will XXX how base you a in then OS administered about large-scale this endpoint the the [indiscernible] you confident provide addition like ability [ in Perjeta II your study And -- is saw skewed III confidence gives results feel how effectively team and your to on ZWXX's the do this was on feel something its setting? in signal ] showed essential like how any data. that were kits feel just with data in measurement GA trial. what there your benefit have those

for Akash, add Rob the the start questions. Yes, maybe your I'll thanks on then anything and comment the let he'd like tremor zani ongoing on on then trial And essential question. and

tremor. remember to drink endpoints later-stage out very to actually did pleased is we the able their life And the daily which activities to for of essential the to believe that be be on a important need to focus they to to Just nice that, able of that's a that demonstrate more to want than live to for be clothes, things do button pivotal of became the TCOM the measurement benefit to do in more a care cup, trials. to able to a do we they unbutton TETRAS patients living, things the What were is quantity makeup to able apply XX prior tremor study about. of and measure patients be of

going do I understands really to to provide what's you a patients. to too want benefit FDA think

to Zani. about ongoing and trial then Rob, a our to you talk little pivot want bit

to. happy Yes,

Bruce, XX-milligram confidence so endpoints and because And would new formulation, that I would we patients, XX, that that have we to in most that the not to higher primary, that prioritize meaningful And TCOM in agree, Phase the current trial TCOM on that, as we've the the And a just to by from doses endorsed with IIb endpoints, trial. FDA. to the but push dose able would exposures add I those itself trial. trial be only than XX we in have once-daily been

based we we're that, success. positioned for So think on

point combination question is differentiated And the like really that even then on and believe of key I'd is GEA, Herceptin PERJETA. to and from the to coming make the we zanidatamab JACOB back

we X have at function, were epitopes Day, R&D presented important immune more our differentiated. internalization clustering in for effective and to some Zanidatamab stepped published necessarily With example, through we As Nature Communications, data how fixation. receptors, causing complement demonstrated and showing distinct receptor that better buying

very over better Perjeta great and experiments compares that And PERJETA. so duration are the where greater head-to-head months, of that XX out clinical the and going Herceptin than the data data prior into of if response preclinical without rates and data, BTC and to XX% look in favorably detail, bear that combination than paper the at Herceptin you with and response

part Herceptin we of in activity have cancer even of therapy breast And CLIA a failed and as of patients regimen. showing PERJETA have course, with data frontline patch zanidatamab after

referred be combination but very, only very very Zani, with III that successful. at trial in then chemo Tislelizumab shown responses. will promising cohort response you us chemo, our not what That's rates, durable and that separately, the So gives Phase Zani, that data confidence to,

next Your Company. of from with line comes Fadia Needham question & Amy the

meet development. what Perhaps in shares? a of use buyback from but some to of comments you would capital And could I also get on? that's Jazz about question well. development, also, question a of R&D, talk talk with you the kind metrics executing bar be -- terms just investors potential you often really we that use for And Can that of terms perhaps had to in interested evaluate would about as regards his the Phil, of around really across capital can deals what business of in business

Thanks, Phil, ahead jump Ami. right in. go and

for on around Great, Ami. My even one my the I've to question. these. earnings and for call all Jazz miles to been listen Thank first you

for thanks present. So Mother's giving her Day early

area efficient a are an of criteria these evaluation, corporate nonfinancial that really the there commercial meaningfully there unmet there we Is would and impact Primarily, foremost, of our are number medicine need we're with medicines at. that with call things at look terms is like our acquiring In patients. looking significant success we've an out for and development the us commercialize to expertise have focused to to that do built set out, coming soon. been a leverage continue for relatively We we're the first commercial want sure up that got business make we're in-house, Will footprint point. build to in. allow the Japan assets we've with bringing and example,

oncology, rare limited we capabilities these given space things looked we we largely have and in well past, as up in well with types but the populations. the the at built that stay we'll products neuroscience orphan kinds of of selling And patient as talked as focused as

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and I unusual we figure one a nothing for first proposition just foremost, in Jazz find and value that asset patients. of significant think financial can terms out there. have be we where is to the But So there a need evaluation

Zanidatamab, benefit the we monies on get those significant I'd capital the We terms medicines. driving the as possible with development that the those once look behind Obviously, we've excess given business to then to the deal to and we post to at rapidly looking we exhausted significant data for looking progress cash making future. are return prospects that from priorities, and pipeline focused to in-market possibilities, the products opportunities existing Bruce, the of for augment first and very that then heard generated In can from the are then consistent have patients were we to team growth you've in shareholders. we're investments foremost, have. as say, licensing past what many those our that Renee further dedicating commercial

that a going at you So gives I prioritizing how we're sense for capital looking hope forward.

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

clarification for on TETRAS of clinical what bar the internal your because you one What upcoming I earlier is for forward. the think, one the Or meaningfulness one as III in questions, is Phase response tremor of program bar, confirmatory essential endpoint? the trial. to on essential Maybe of the And taking guess then think tremor point for sort just readout. of was referred kind a to I the

potentially for actually to IIb used you and that would was not just make study? approval I be Phase that that then and So the want dose a Phase confirmatory could confirming III sure do

we Phase out did want dose, Yes. in FDA Thanks just for based a I package space, the get study you on will the earlier when to Phase study. to it giving because likely mean me with, and did which that clarify. imply more we're streamlined IIb IIb be independent I the a question that to only that to typically studies I use part with move efficacy could looking for design of do be to would the opportunity approval point to had X didn't go to you we would than be the second will quickly confirm think that efficacy.

propranolol difference performance or for would They highlight ever, We approval on haven't minimal used. enough though really specifically, things or scale or that for the would disease of efficacy. I level what the have almost therapies even ADS been and in hasn't that really just this there any particular meaningful patients. be are like primidone But said, for

unmet a there's substantial need. So

based secondary And the primary overall matter to titration those the be that that And suvecaltamide meaningful endpoints what good as think will say, really we that and TCOM well saw to given did study, as the we on its -- patients. the provability, it overall, I given we based that on that a be make from the extended terms on which has think we in the will endpoints an tolerability, of difference just in would release effect size and the once-daily trial. of opportunity

line of comes question next from with UBS. Your the Verma Ash

believe oxybate patients trying switch you percentage think to Xywav in sleep ultimately to the to wanted extend or that to choice. just leadership of develop like what to narcolepsy. get I will I long view, sense [indiscernible]. once-nightly generic Xyrem? understand may your in But the committed another potentially pursuing then a internally term a are your or do Orexin remain your you in as from for that like try you And arena, you're an perspective

Yes.

work program. then, a gave can we Rob And an conferring maybe in part Ash, before maybe with I'll take little of the you you bit next second doing XXX question announce narcolepsy there side. more of on on steps. a hop update the Renee, and partner first. your We're little the our

lot proof We behind terms orexin as have in promise, though a to it that we the have mechanism benefit we're already development this concept, interested an We remains in action, area, other find definitely can of said with of backup previously has early that and programs patients. Renee? space. of the bring well. certainly But a interesting of in new

Bruce. Thanks, Yes.

fixed do a respect treatment growth. respect patients a for not is sodium some Xywav try net expect dose want hearing patients seeing with with are say therapy. that that branded oxybate regimen. the year-over-year, that only Xywav, low with XX% high we night's to on terms growth What being coverage. experience and sales to respect sales get to with we a that certain that some and we So seeing HCPs market expect I We we say #X reflects of to therapy, to full And and patients also would get oxybate, dose was people the a would clearly, as said and we fixed will the patients I strong growth believe are net saw we've do both patient narcolepsy. trying in sodium differentiated anecdotically

that comes and HCPs the low on investing sleep. seeing the comes from have HCPs, on to being sodium a the therapy benefits with perspective prioritize are And full these night low high patients on gives we importantly, ultimately are the us that will their sodium, We durability when But to evidence of it front. market, both flexibility in to message this impact oxybate the expected and negative cardiovascular in continued conditions, twice-nightly to believe long-term health educating they respect is That in when than with publishing resonating seen the sodium the we that generation have there only as confidence chronic benefit that a oxybate patients that able a is to have of more and -- believe Xywav. that start terms coverage faster long-term we therapy, data of continue oxybate and showing and with growth dosing.

Securities. Truist with Lee Joon from comes question Next

range. growth lot Epidiolex. efficacy of prevalent do And of the of a the mid-XX% features expanded And You the presentations in had on the at the an a is [indiscernible] in these of particular access one interest program. showed a study seizure median There's focal context on Epidiolex and reduction [indiscernible] AN in lot off-label of and opportunities investor days. use what have How sort in think there? you of you focal was

want that? you take to do Renee,

where well-characterized terms and and see particular, in treatment, that Epidiolex multiple a lends to it safety a in being physicians to that is has we which focus use we by promotional area being Sure. is profile when in efficacy of approved, of Well, that favorable an through a activities with benefits clearly, do type. TSC, with LGS, spectrum see continue we to those seizures. our area, our combined ] broad patients use polypharmacy the respect novel promotional growth differentiated overall for product The will we activities, other [ characterized that respect Dravet an other continued refractory indications continued are However, with on having about refractory working based are that do in on the that think we means being therapies, epilepsies, you reality, well Epidiolex. assume itself And provide see seizure to for and highly MOA and

we data around the investment And getting that even that generating as starting and study underpins we're based on they're to such EpiCoM beyond also seizures top generate further the present of on in to data benefits that, our appreciate continue really more additional underway. the and

will again, to do a is continue believe at U.S. also both epilepsies, that with which, in opportunities. long-lived additional a do indications product growth continue for refractory So Epidiolex, durable our to approved the we'll in This not asset and growth with we outside look as we other see global us growth for. we promote

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

benefits the provided appreciate certainly when Philip and top capital to the portfolios, well to comes the color when Jazz just the to know diversification from when you synergies, of us for just the it oncology even important speak the can all we and as you strategic especially to as you on sleep line as it umbrella. the to thinking keeping think as talk the cross allocation, well both internal it and aside comes that is Bruce, And neuroscience comes under investments. portfolios

Well, an whether these to across benefit past we're offers there being There that's times the over as find therapeutic Greg, believe across an look and both but categories And stages that's And commercial R&D. area also a side nice likely if heats often development, the can seen few valuations we've and corporate also growth get to more on fortunate all investing or that worth able think places are to strategic when you I decades. are profile. have X of opportunity more therapeutic development in is on sides, fit, both look areas broadly you're high. I up a across return opportunities

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

that quick you cap structure. talk balance potential to Just you have have. long-term sheet the a and question on the any Can targets leverage

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that? you to take do Phil, want

Yes, happy to.

the ATW by that communication down [ David, a XXXX. as when mentioned, we and rapidly was about interest X.X would there So the acquisition, really end turns we strong delever had to you ]

You beat that saw net us leverage. currently with actually months. about X.Xx sit X by about We

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the have to the near in term, upcoming As financing additional ways opportunities. the with alternatives at build below the how maturity where increase back CorpDev get in that business to to convert, development, a active probably flexibility strong we in got you'd significant think do that of would we or business opportunity. we I we've might expect, through currently an I aware, XXXX say to GW, looking our plan were or particular have as did to for kind to like engage you're quickly. that planning or into opportunity repayment at we we continue some we're business reduce of levels debt we look got approach if development we have

get at be will any front as move as to and not external. like looking forward, kind we'd specified internal well actively of have currently investment below and To the of us, discussed where a in through opportunities target date, to but specific we sitting we as work we're where both this

to additionally? you want if Bruce, comment

think I Phil, covered you well. No, it

to I recent that Phil general when financial rapidly said, from transactions shareholders. We've the tried of rating the positive company. used delever the to we've we agencies always thought in think for some about as do best we've profile thing But that. commentary the after seen leverage was

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

staying with understanding was And naive revenue be Xywav, talk in also patients, is IH in to younger dynamics LUMRYZ, if a in on impact lower I quarters about crowded, the strictly for the that since off-label more the oxybate could the then the on maybe coming are it's I support guess, with there revenue particular? are key lot that that factor NIH, Is of use the factor going you competitive patients lot in So XQ. forward a that a is And years. getting still Xywav hearing program space to Or patient in And some coming guess, going physicians can narcolepsy? label? consider? get

Yes. Thanks right hop in for question. there. the I'll

for differentiation It support more in overlap broadly of a product. benefits narcolepsy looking them to in be of the being to the speaks and at of we're on of speaks leader low high our and IH sleep, and services continuing to front patient to to and when to physicians we new So naive starting based narcolepsy to on respect oxybate any on oxybate I new oxybate available into the we patients full don't while would that our numbers, do narcolepsy, with capture continue we Xywav have patients And therapy. of being say more visibility estimates, other to of educate patient those host the the sodium. believe able

being see -- the don't on a test and much any a to we week really for for IH, to respect these to tend IH, we're use order seeing required not see with LUMRYZ, narcolepsy or -- payer products restrictions that With tend to if either need validated we given receive off-label in prescription. we for the

hypersomnia. And for unusual the see it able a prescription or be to pretty idiopathic so to for AG LUMRYZ for would be

that to narcolepsy, as therapy respect the rather we continue complementary while on seen being continue dynamic large into on came of a with a for on idiopathic in like that with up end benefit had probably see expect we've wake-promoting think mind, dynamics wake-promoting in idiopathic of to and competitive would to much a addition Very agent percentage hypersomnia. I study similar Xywav we'll in meaningful to wake-promoting Xywav to agents wake-promoting their hypersomnia then studied we very patients being hypersomnia. And our baseline. agents part see in Keep agents idiopathic

largely little no IH. respect the example, saw same to on market with impact coming with would same and For our dynamic the for oxybate the to We to franchise Wakix to expect narcolepsy.

the Cantor Fitzgerald. of Your Charles next line question from with Duncan comes

of Congrats tremor and know BLA wondering is said, going -- would what REIT seems Phase a at being the to supportive be bit composites, is submission to forward? with to it essential so -- of next analysis. a That looking the tried, you? strategy, static like And on but with neuro X if more IIb you of but I'm sizes data I actually others granularity. I'm little see Zani. the Is certain definitely X to like for important really effect important, are registrational suvecaltamide the of have which ask move and out it's you will completed the responder

Yes. start that with dangerously then want adds really he that a patients wants the jump of Charles, if What general a approval value, payers would in really regulatory providing is a as that let see aside provide Rob I'll prescribers generate something will package and to all to and specifics. patients that we from is comments more benefit. something meaningful value and

that that nothing said, for really we need prospective available trials And in backdrop, trials of that's -- benefit. But certainly, against go the endpoints establishing benefit we really things currently designed profile hit. patients that's that to of measure lots key of with these providing are as our that Rob to kind

want do anything talk to Rob, specific. you about

endpoint want many important that primary think would with there. get is don't is the the But our when we is TCOM Well, you really the be again, to well how data, that matters. all trial. an optimize to look there we We've it dose, what of And measure in say specify honing to we for some I sure optimized holistic an in effect accurate I effect think bode that changes picture the we trial the agreement was would meaningful because I more FDA, at thought respects made measurements. necessarily size

the We suvecaltamide in other T-type development. have reference is differentiated calcium is think inhibitors certainly of other couple a in respects. I think channel point you

a gives we've TCOM. and that which really that, therapeutic able inhibitor, the with are we tremor state-dependent doses pathologic in achieved higher means we than hyperactive exposures have that push essential to dose potentially the is a are And It's it channels to the even why targets it would think in us better been iron which condition. index,

that the FDA. we've again, of the will So around and it's included acceptable secondary and to patients data primary we that know the meaningful totality be endpoints to

Your from Barclays. next Balaji with question Prasad comes

indications diseases and outgrow to the that see opportunity I can comment the it, patients a were Epidiolex, data Just at curious approved because on tend couple thought most, to that On when you me. childhood is for or adult asking data expecting? the I'm this quantify primary do additional either also you primarily you're and qualify it what expect

the provided understand could if XXXX X can further. combined guide, for be double-digit helpful since are this stage Xywav, all on growth Secondly, you Epidiolex dissect help Rylaze the categories, that us it per you you would in different and

the just part year, we the the provide and we growth I'm year on refer do wants our say we That's let from to Xywav, combined often these basis. Balaji, and if the your this emphasizing as there on of let there's Epidiolex Renee any childhood also that's because first Yes. seizure second they're for part your you question drivers, we don't They into But not disorders out, to. in substantial think hit why Rylaze childhood that know, other to of not product jump onset she disorders. guidance of to that year. question, it opportunity we only and going single were point do adulthood, key persist me and double-digit growth different on

Obviously, for those of reporting each each products. we're quarter, actual results

opportunity want you Renee, on Epidiolex? add anything for to adult

long-term adult care we'll we see at drivers, the broader look do sure growth here, population, quantify say the would just as one not underserved. I Yes. if it is Balaji, that the currently that I'm environment we but

is Epidiolex Epidiolex. to weight-based respect dosing. With

Clobazam population. remarks, comes on say, that you in up end of would have an -- do it perhaps would pediatric placed my when you a you into But the centers the at move getting heard is, with getting to care on what ensure diagnosis impact level I to there going or respect results of dosing the has, from whether Epidiolex, the adult care and are focus prepared So right indication when times, have optimize attention higher all actual to it's those environment long-term care the where less or forward. and you of with right see diagnostic we the that long-term ensuring we continuing dosing educating combined on to tools of can that right better opportunities

session. closing Ladies I and gentlemen, that remarks. concludes our And over question-and-answer to call will Close the Bruce now turn for

Thanks, operator.

confidence always, of efforts colleagues close today's their support. all and and you by behalf today. our their families recognizing Thank and continued joining thank us shareholders for Jazz on for and As to for our I'd partners like call patients their

for now and you Thank participation, This may conference your concludes you call. disconnect. today's