JAZZ - Earnings call transcript Q2 2024 | Jazz Pharmaceuticals plc

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Operator

Thank you for standing by. My name is Mandeep, and I'll be your operator today. At this time, I'd like to welcome everyone to the Jazz Pharmaceuticals 2024 Second Quarter Earnings Call. [Operator Instructions] I would now like to turn the call over to Andrea Flynn, Vice President and Head of Investor Relations.

You may begin.

Andrea Flynn

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

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

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

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

the turn call I'll over to Bruce. now

Bruce Cozadd

view brief and you and everyone, for update with I'll us on of to an second then quarter the afternoon, business our forward. the open of moving joining Good Andrea. overview today. move thank Thanks, a

X. the with results Slide the on quarter for Beginning second

diversified portfolio performance than total across of more and generated $X revenue medicines. quarter our revenues Our our strong in billion growing commercial largest ever with

Looking Xywav XX% choice, durability remains therapeutic quarter compared area. by and oxybate in XXXX. a neuroscience product increase same its sales the underscored in the at our net of is to

and first this we #X hepatic the to approved patient remains Xywav therapy and remains hypersomnia, narcolepsy, see and XD only IH, build or In we are Xywav for strong treatment. market. condition the continuing demand the

in more million Closing pleased its in sixth Epidiolex U.S. reinforcing with Renee market approximately continues with being we're our our by multiple reaching the on which belief $XXX is year detail, quarter, grow, and blockbuster its outside availability, the commercial of in Patient initiatives, cover progress in sales on demand driven will U.S. potential. to expansion

young area proceeding a adolescent therapeutic particularly highlight perform market see the oncology With population high Rylaze utilization while I'll slowly continue anticipated. pediatric a adoption had well, Zepzelca in Our that bit more we and to the quarter. strong to in is than continues adult

Moving efforts. to our R&D and pipeline

potentially data quarters, cell cancer We from small expecting Each next point. a in Zepzelca meaningful which of programs GEA, Zanidatamab and late-stage or derisked the Epidiolex Japan value readouts first-line cancer. first-line gastroesophageal including and inflection lung are in for represents in within several

line of a was is generate which operational the and on result capital and an call, overview maintaining we Phil On our front, in of This guidance, clear updated also proposition outlined today's in release. focus will value ongoing top provide that Later return a investing to and investment. disciplined the we on opportunities have growth press quarter. financial flow believe in continue operational second the strength cash during our strong allocation and

brighter in progress oxybate forward. we've we we'll made future business, future our growth concerns to we looming expressed saw about could 'XX, as Epidiolex we expect handle X. out? I investors as franchise to we both Turning want Why narcolepsy our going blockbuster XXXX, how we the early saw and comment communicate a XXXX to Xyrem. by driven to to Vision potential drive oxybate given IH, rolled XXXX while it branded our product. on competition in significant Slide In that generics from entry of Vision where In become that well of introduced XXXX. Xywav business and substantial grow competition. away The We diversifying a through the for

opportunities margins growth pipeline to our We We business. business prospects, as and to scale. we our our increase in development oncology augment expected and future corporate operating would growth use substantial saw

Turning from is those -- revenue revenue guidance, have to billion Comparing billion to XXXX to revenue slide XXXX our delivered $X we against how in $X.X in to grow $X.X projected X, overall our priorities. our to XXXX XXXX.

billion our grown than over $X.X is $XXX approximately XXXX, past revenue the with higher to having oxybate grown have which $X.XX quarters, total was from approximately it Xywav to billion. million in X We

quarters, from in achieving status, revenue last quarter, in already X was approximately approximately we're and has nearly up confident in roughly billion Epidiolex business XXXX. oncology And status. last achieved in $XXX the In million blockbuster for of including the the our year the second $X.X $XXX $XXX blockbuster year, generating million, million revenue full

of Xyrem, including AG down In quarter, royalties, revenue, total this represented XX% XXXX. from of in our diversification, approximately terms XX%

rolled not was Jazz's On XXXX. of development part pipeline Vision we the out corporate front, Zanidatamab when

XXXX. contribute won't to million in it $XXX While revenue

provide durability. done corporate much long other revenue we and than believe term, and more we less peak deals offered more but has that revenue potential development near-term value could revenue the to Over the it have

where of product operating with they we the our vary terms cycle are In life in across will portfolio. margins,

continue use for Jazz, allocate scale we should when as revenues promising late-stage clinical drive You experienced to should of investing uptake, value assets, and be move higher as just patients mid- framework margins to to expect benefit investments to expect in maximize we're We'll margins. for XXXX. long-term early lower them not you to to when and launch and capital post a commercial we we're near-term to maximize making in ensure development

externally a X. Continuing XXXX Vision and map slide to useful road provided internally.

the manage our achieve investors, longer is business too with no whether in year focus it creating for we'll However, not long-term in including our case one future, become or it's near-term value to much our or on and single clear that metrics. is conversations

we providing XXXX. XXXX and are how no longer our Vision Vision about revert will guidance to the pre with manage communicated we metrics So and you

XXXX We our will provide which 'XX business. developments guidance fourth and our across quarter expectations our key on our on earnings reflect call, advancements will

trade-offs reaching commercial to value smart and sustainable and for commercial specifically Our priorities investments R&D, for invest patients diversified being pipeline, excellence best in creating through making excellence our development business to capital disciplined shareholders more unchanged, long-term value. by development corporate including growing our remain and and operational corporate drive revenues, and achieving across growth making allocators,

company these that are and success make We believe focused to in the to on priorities Jazz. executing for investments drive will and we continuing on changes our

more also bringing committed is to We innovative that medicines organization shareholder focused great and to value. being place remain work a on high-performance delivering a to cultivating patients and

a In I'm we've confident terms been, capabilities, assets future. very in of and as and our people, company financial as are we ever strong resources,

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

Renée Galá

and commercial approximately $XXX in Thanks, during on sodium Bruce. from compared million provide an was Xyrem from quarter sales second oxybate XXXX. Starting same AG second during our authorized quarter. excited update high the the royalties Slide to on net progress I'm to or includes generics of fleet, revenue Total approximately plus XX. XXXX the $XXX Xywav which million during period

and approximately year-over-year net quarter, growth choice. oxybate sales second Xywav to it XX% expect to the product of $XXX of continue grew confident Xywav be the in durability to In We remain million. the and

this of initiated as Xywav. seasonal experienced to from Xywav second being the normalized headwinds patients payer quarter. levels the of Xywav during quarter of a those also that narcolepsy programs formularies. returned utilizing a large support initially from first Following and result Xyrem number in the transition bridging historical churn certain renewed therapy and pattern, the we I'll percentage they year as note during inventory to of first meaningful With a patients the quarter reauthorizations the

a coverage quarter, the benefits these as the review the we've in process. In use authorization and in the of many normalization who following second initiated first usual seen commercial resumed those patients programs of quarter

or care treatment. the therapy time to oxybate health program and enables have when of support their to they quarterly that begin an just program we optimizing highlight are an and patients taking approximately additional were during patients therapy. person Xywav There interact quarter, professionals trained promising are of questions in patient quarter. metrics. patients receiving narcolepsy we prior This exiting increase the our feedback second this I'll approximately nurse the are earlier to from educator X,XXX XX titrating as field oxybate likely Turning year. early continued new patients layer from with most the Xywav launched Providing

IH. to Moving

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

active field which been prescribers, full Our demand. a of continues force expanded in breadth now on focus drive the depth increasing the a particular quarter market has with IH for and to

$XXX oxybate our and is in narcolepsy, narcolepsy active oxybate initiation to experience less especially treatment. to the community, the Similar important nurse field helping IH with This high has second we is AG of patients compared which million navigate royalty educator of program approximately the community. in business branded will confident remain exceed Outside AG $XX million in sodium XXXX. that in revenue recognized revenue oxybate the royalty We quarter.

quarter product $XXX representing the increase Moving same the to remained strong, slide with in compared second of XX. million approximately a sales XXXX. XX% in Epidiolex growth quarter to net

affecting growth slightly product approximately of quarters where same of last inventory And X year. period the to patterns XXXX. compared XXXX half first it's burn helpful XXXX, build think Epidiolex at Given look the increased and sales XX% different first net and the over to I

emotional quarter We communications, increased potential which confident U.S. diagnosis and initiatives, growth well plus by of HCPs from growth function included the ex providing continuing as long-term the supported and showing ]. also is tools beyond Overall cognition, increased Epidiolex prospects function penetration blockbuster geographic for in Epidiolex positive patients. clear with our adulthood synergies diagnostic and second benefits Epidiolex. response patient data language part by LGS a We're Key the as Clobazam demand expansion. as of the as specific to in drivers many on adult without in U.S. by the as treatment such seizure in reach was adult of driven in well and executive setting, [ U.S. commercial to the may that with data control patients remain social and see

virtual It's to focused topics dosing, where optimal Further patients but generation expansion the early, currently positive. such support response launched than been launches and as data navigator nurse program exceptionally year. for education growth still initial approved XX their include program quarter, discuss continued dosing. during with to more Epidiolex families a has later also the a resource countries providing this reimbursement We medication-related the Epidiolex optimized and and opportunities market is additional geographic to beyond expected with this

was of oncology demand our asperaginase-based pediatric sales product to to net Rylaze Moving the the several XXXX. and near adoption Total XX from of be in and approximately X% factors, quarter by represent driven including Rylaze's the Friday for dosing U.S. oncology continues oncology approximately a slide protocols Monday, increase its $XXX regimen. million. Wednesday, in revenue of universal adoption second million the business. quarter $XXX

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

overall XX evidence saw #X profile increasing cancer small population. $XX significant XX% cell to net lung quarter patients, year-over-year and Zepzelca sales benefit/risk We for real-world million. with data positive survival product to this the difficult-to-treat slide this treatment the underscore second-line the remains growth and and for Turning Zepzelca.

We their valuable physicians chemotheric Zepzelca influenced shortage also platinum during that decisions. with experience believe the has that gain treatment

deliver to administration their benefit well the positive ease health clinical of product's continue on patients as providers for and care use feedback care and Health as practices.

outcomes. Zepzelca in need have cancer clear lung first-line ongoing and Beyond patients Phase we If Zepzelca trial lung treatment, unmet is an a significant first-line small believe growth opportunity in we small there treatment. cell cell drive for patient improve second-line is importantly, and positive, most of cancer III in to lives use our

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

Robert Iannone

of and clinical provides XX overview our Slide key Renee. diversified the Thanks, programs pipeline. an

oncology neuroscience the program. We Including data priority late-stage have and begin in across with anticipated programs. oncology from our near catalysts highest readouts derisked Zanidatamab, future. I'll and pipeline

report, quarterly we regulatory last our toward significant advancing made have Since strategy. progress our

biliary FDA unresectable, the second previously date cancer treated, the BLA. not tract November Advisory advanced locally Drug our HERX-positive an we date, to the review the action of do quarter, on During with or in and granted Committee, or an metastatic the expect XX, meeting FDA Based accepted priority second-line BLA Oncology connection agency ODAC, review hold our XXXX. setting for or with treatment of to of for BTC, communication

EMA In addition, has early potential of as our with Zanidatamab as XXXX. validated approval the marketing the authorization second application quarter

are III gastroesophageal remains We GEA, first-line progressing also our Enrollment on track. or adenocarcinoma, Phase trial.

a to the survival just an PFS reminder, Zanidatamab trend timing by event-based updated If line of is and available data analysis, supported estimate not trial, on relative XXXX. the be PFS the registration. speak plan expected positive protocol exact. initial support more the in development on Based based of assessment this the we we is As would readout moment. in a will blinded progression or second quarter top and events is overall to interim trial assumptions, our a in progression-free survival an I'll

with We're pleased Zepzelca progress ongoing small cancer the cell the trial. also first-line of lung

data with lung top small Tecentriq with cell longer cancer more new of would potentially therapy cell with to Zepzelca. Zepzelca approved, We in cancer If patients expect enable indication in duration first-line line PFS from extensive-stage benefit this lung XXXX. in for combination late small

data Turning not that tremor were trial top Epidiolex. Suvacaltamide from half second Phase disappointed to the essential was of IIb in line for We the Phase trial XXXX. of III in We positive. Japan anticipate our

larger-than-expected the the in restarts. we Pending Parkinson's to is quarter II disease do not program effect data and from we further XXXX, anticipate steps in characterize are better annual. for program, the next the in expected substantial first the tremor, Phase placebo treatment investment will ongoing results continuing to While determine are which trial analyze of ET the we

of to FDA, stage planning also trial further and the our JZPXXX Ib patients. based I'd data I pending of like a in JZPXXX from the orexin-X an we receptor review Phase provide update agonist Phase to clinical initiate feedback on NTX small are on

inform We from providing expect understanding of could and agonism, development key this efforts. future further trial orexin-X our data that JZPXXX learnings

turning Now provides our Slide detail back more to development on Zanidatamab. XX plan.

HERX potential current into meaningfully indications bringing other about cancers, in Zanidatamab have and including cases of multiple across development care the of remain And in to excited the therapies. to progressed HERX-expressing we Jazz. We multiple standard Zanidatamab it transform prior resistant

support GA that ongoing in investigation molecule, in trials we of indication that including and development represents plan robust Our a breast this cancer. several an trial in would believe registration

progression to trial, we evaluate are post therapy III breast to patients and targeted first we to initiated We demonstrate pleased have the combination HERX announce opportunity Phase in have chemotherapy the cancer Zanidatamab POWER to where HERX, safety after which efficacy HERX. in is the with in on be designed

cancer. ] from treated At we XX, June, XX to and maturing Slide tract continue BTC ASCO Zanidatamab presented trial, overall evaluating in we biliary in be with by BTC. follow-up impressed survival longer-term data On previously the HERX-positive patients [ data in HORIZON the

primary and immunohistochemistry median the additional response, trial's X-plus centrally objective a with Meeting rate confirmed And one end patient approximately results ASCO were achieved to Zanidatamab in in also of the XX.X initial survival by XX.X trial's demonstrated at the presented response with complete at median all a duration increased months maintained XX.X% Annual confirmed was secondary XX.X BTC. endpoint, one response patients patients and overall For XXXX. X points in a The findings key months months demonstrated of HERX-positive of months. tumors. that

also treatment the differentiation from with HERX In results other continued meaningful sustained these its our benefits clinically with of Zanidatamab view, supporting agents. highlight responses

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

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

Philip Johnson

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

$X Epidiolex revenues. Rylaze and achieved by of was as reminder, XXXX. in growth billion press neuroscience more of of key a full the we and available growth our oncology, in both of and This including than second are our As second Xywav, total driven combined the our XX% XXXX, results quarter to quarter products In in financial compared release XX-Q.

and allocation an excellence, the represents in adjusted XXXX. million, net focus cash on $XXX increase same disciplined period operational which drove to of XX% Our of compared income

We from in business, continue operations from to cash approximately of our the million generate quarter. significant recording cash $XXX second

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

XX. to Turning Slide

reflect visibility greater our two lower. expect the oncology foresee do revenue Rather, around reflect X that not belt, which for do modestly exceptions, expectations with we where substantially lower they likely and revenue, count, we have we updates fact guidance months our under With variability into year. actual Our substantially of estimates. results the to the our be our changed share

is half for we in revenue. This growth The the and of initial outlook have see revised is build we to to noted, full take adult that in expectations primary support of performance to half time On for year of continue offset as year, opportunities market market. adolescent our oncology AYA, our continued Rylaze driver revenue as uptake in first previously being partially needed the young strong second by Rylaze the it for not but seen Zepzelca. will the

variability revenue, expectations us to sides performance we're our on and confidence both well tracking gives For to estimate. year-to-date neuroscience our of less points

is that $X.X a billion So of $X to And narrowing of $X.X for to these our we're narrow billion range revenue a accordingly. total to $X changes of billion. expectations range effect the range from to billion

unchanged end so largely of achieve as of think the income narrowed we'll the the unlikely the Gross is expenses guidance initial for it's lower range, we've accordingly. percent XX%. do at ranges our guidance and rest we well, slide Moving unchanged next statement. are on margin to operating the Expectations but

the discussed investment items part quarter call making incremental like litigation the first of in making targeted expenses investments initial end range on the And guidance unlikely. we higher contribute funded launch, Epidiolex up the in sales Zanidatamab bad other reduced and for to low we're debt prepare write-off For by and drive SG&A to our areas. to

R&D, is greater year as us full that R&D spend. visibility On note progressing into expected, program expected I would our Zanidatamab development giving

notes XX of we've points. equates under current the At current to $XX basis repay anticipated to we the savings year cash. our made in narrowed savings shares on the whether unchanged per I we and principal effective annual XX%. XX% Loan repay remains to election approximately our of roughly the the by guidance the guidance interest $X.XX to reflect outstanding, tax billion refinance loan, amount rate made cash would quarter available driven XXXX our repay election convertible the expected the note term by share last the EPS or million. rate we've range repurchases. Earlier that and range convertible GAAP in to we're evaluating updated addition, to mature our In lower of lesser mid-August, the is guidance Adjusted Term been billion, our share note B, interest has $X this outstanding And income reducing the to to net principal of repricing $X.XXX reflected increased a guidance. notes second non-GAAP our year convertible of with XXXX at XXXX by to in while to cash election and XXXX we our them the XXXX extent, in finalized similar month, to notes. this for notes The a

shares share effectively just As quarter, authorization million no outlined earnings a with we prior in repurchasing our new our in in authorization release, To Board share million $XXX repurchase $XXX expiration approved date. future the in repurchases, enable our over June. press has second exhausted

opportunities and cash this balance I development primarily allocated quickly forward, provides act at and believe quarters, sufficient of note balance. about free think to approximately in investment We stood corporate arise. you capital to investment increased moving $X positions cash our us our creating And value to cash as XX, June If flows fund recent cash operations billion. balance

growth we Going prudent level, drive forward, on. share portion of make some for combination cash flow balance in our so business, to to paydown, after likely expect significant go $X we of investment investments repurchase cash billion our or a free modest this a there growth is future the debt above

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

Bruce Cozadd

XX. global we value can high-growth pipeline I'll remain prepared on balance creation. on that We conclude Slide diverse our with for a biopharma healthy focused leverage and creating sheet remarks company. a

front, catalysts, of are shareholder On well near-term future the value. Jazz to And growth side, key of data we and excited in positioned Zepzelca. R&D drivers growth continued readouts we're we seeing forward commercial growth about for We're believe XXXX. our and on the Epidiolex Zanidatamab, and including deliver look the to several

to I'd for to concludes now turn call That the over prepared remarks. line open like the our to operator the Q&A.

Operator

you. Thank

question-and-answer Instructions] session. [Operator first will the We of from America. Jason now the of with line Our question begin Bank Gerberry comes

Jason Gerberry

I you is mine to decided why that. So the XXXX get Vision on follow-up And a just update. of remove kind

meaningful Just of agree the business of head growth then the premises if that your with a stable thinking into which of thing XXXX? some as to would curious product about general reasonable drivers. and nonoxybate basically is from revenue some other growth kind Is be we still on you side, oxybate still

Bruce Cozadd

question, Yes. be Short would Thanks for answer the Jason. yes.

the XXXX. specific removed numerical for we've While targets

way oxybate to our the with the of We very growth particularly business developing, Xywav. is be pleased continue

You're business. the oncology seeing really Epidiolex nice and growth in

second highlighting same. the trends for our the So in general remain that the and XXXX forward guidance we're moving for quarter

Operator

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

Marc Goodman

and about bit. we the quite Can Xywav number gone of a [ little bit just has a talk ] Barco patients, up

just look IH, versus And XQ out just year. it flattish. like yet are revenues you seems you If strip year if last the at this XQ

just And just us seems you behind So and to missing. there. help is what can we're something pricing It on with scenes gross or maybe nets. going the

in you the why if revenue the because in revenues the But had programs. where quarter, you thought higher? patients, didn't XQ, went in I book have you but been wouldn't away programs first of it the the explained went up

Bruce Cozadd

the Xywav business? bit to jump want Renee, in on a little you

Renée Galá

Sure.

So Marc. for question, thanks the

see with number formulary did Xyrem patients a up QX causing higher choose Xywav. we a changes, ended of which to of influx in certainly, patients So

important difference idiopathic and hypersomnia. Now it's also the remember between narcolepsy to

Our patients the coming do they through first narcolepsy they're our quarter. we shift, access programs, generally did is they when And highly transition, when dose. that on they at relatively which same support the in it on a likely similar see come

payer we for And first reauthorizations in of and -- also both narcolepsy quarter. authorization see course, IH the

And those so that did of normalize the programs, have largely an second those leveraging use impact. did programs The quarter. across

So higher of not just but did transitions, more normalization. also we that despite reauthorizations, see a volume from

When it comes to IH when those patients patients. begin, they are typically not prior oxybate

through And we With meaningful so where not time. to are you market, have impacts that. take as But they competition the coming net, does into respect there do of go titration, gross to see our which to impacts of any a with seen terms product to area greater have gross full net. in

what largely, net in terms So on of a change we is basis. positive a Recall see quarterly that you patient patient -- adds. change do give adds

front then seasonal we near have pricing XX% coverage, anything second that future good you're we're on quarters the seeing strong and idiopathic to continue that's than some is And quarter. the what with hypersomnia seeing other between the growth the universal also commercial this not but impacts for really on So revenue. in confidence

Operator

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

Jessica Fye

about right What's to from narcolepsy, narcolepsy Xywav way with Sticking you're for modestly. think Xywav that in net still in patients, adds outlook the Great. here? growing the albeit

Bruce Cozadd

Renee?

Renée Galá

Yes. Great question.

I hypersomnia. think a growing that idiopathic the in not market So is narcolepsy, that say about that broadly way respect with to would would is same I

and add a just larger would that going few did say keeping would moments the quarter that's have with to compared bit net a number So adds QX more as as mentioned in patient we that I and the there, in forward at what ago, first expect little look we QX. we I of

and I think is performance see of having narcolepsy, in equates strong remarkable low treatment strong health very a benefits is Xywav immensely, to sodium. as adds we market to the of the long-term the not continue Xywav of choice growing business about narcolepsy valuing and that that patients physicians what's valuing underlying that despite

we continue as of growth continue field say the and are that programs stronger nurse, in where for invest idiopathic support programs services. Xywav starting and then hypersomnia, therapy I both different through both And turn we support to would patient patients to to educator more we area brand as see a that other an driver and increase diagnosis to

I'll quarter quarter reminder, did see to second then And before, of question as we Marc's to going in of year-over-year last second the for of year year back just this Xywav. just growth the note, a XX%

So we expectations. overall very nice the with line are some brand in growth seeing much our in

Operator

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

Annabel Samimy

So as When [ core investments ]. XXXX. attain guess, and core from as revenue driving could in prospects to margin wanted still portfolio you Inzai to growth a Vision had And other organic support it you margins well to back I the idea that. you a of I after about go that, made your just certain number a I the said and your perspective, you guess portfolio for

made revenue should possibly additional I Xywav with to And made initially bridge or out guess, core a you of investments stretch is other the of our given the that's that goal? since you we the So corporate been of for the or think than set some but idea these of investments, out it more development anticipated thinking. Epidiolex that that drive of could you whether even just question that related, international take removed, it's growth, gap sort this you

Bruce Cozadd

we than did in Annabel, we contribute your not opportunity. XXXX, to more a now see vision, we Thanks, our have question. $XXX the notably respect yes, comments said first Zanidatamab. that's in product the portfolio And million for while we as part of question, going revenue earlier, when set we to Yes. sizable very as in the that our With in

profile over see investing so for have Zanidatamab example, we brought time, as opposed that a near-term for but might revenues, the return less dev deal that growth better And corp to, asset. a behind

So respect the we the the to in products that's on have with pipeline? currently currently have market and

elaborate a think part our out? short CorpDev And a is little how to you to no, maybe Phil bit the strategy. answer of part your as we maybe question, take corporate development continue on but core The of about let then should second I'll

Philip Johnson

happy Annabel. keep an neuroscience. see to million screen. focused in Yes, as Bruce. as We driving revenue aren't both oncology on would thanks, where This year the calendar is CorpDev we well XXXX. area And to, opportunities in in on I definitely radar get in simply build $XXX to to the our business, continue

moving I of call on on think improve care the durable for revenue forward, been global footprint looking last create part can CorpDev expanding point. of our that strategy to focused remain medicines of couple the significantly a a Can commercial we've of does pretty our and vital a stream for clear for would have leverage quarters continuing and efficient that company. standard U.S. be a

that to like It's disease when at We play more times on looking opportunities have we'll the to not are rare whack in opportunities at. we've versus and simply infrastructure either more at kinds to only in difficult ability build are the on TAs. and built make nice better of able of one And expertise, opportunistic orphan populations. other we're in it when get prices or multiple the kinds do other that oncology value. There areas could to cross and out looking be neuroscience that but be of looking also

Operator

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

Gregory Renza

the Appreciate time.

Just in theme. Vision keeping with XXXX the

But investors rationale comes be when sounds investments. about we time the mentioned looking of is on out, judging that believe like do for right Jazz you certainly is how to should be business if to trade-offs had you horizon [ horizon helpful. But Bruce, you the just reflect certainly it to spelled the the do it in you make and a where you've order in at time the [indiscernible]. which Just should which investors what bit time ]? think Certainly, aspect

Bruce Cozadd

Well, launch Xywav in of add Zanidatamab a right led revenues. We we're data got growth our drivers excited think commercial coming growth a this where just I fortunate and we're at key we've position make some would growth Rylaze a products. by I seeing and current now is strong, mean our and or right? performance in can record reported Places about. later as potential double-digit certainly company us year. we looking We're readouts near-term near-commercial to Epidiolex that from

the to beyond. corporate we're development, through us decade also of the are whether But our in making, through the potential the have those or power investments and pipeline, end

we're wanting that for have healthy decisions things but year, flow capital right and return it's the to throwing over nearly allocate that a we the of ensure X a first in produce so that off $XXX continuing that to to capital months of And business our those million allocation to shareholders. are going make balance operating cash the

strong a having able of invest position fortunate now but that in to future. the business we're also for So

success, of So I short-term It's number give but you a over can't horizon, about not time to positioning it's that's longer years, a company Greg, a success continued the right? particular your having exactly horizon. time right for question, the

Operator

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

Joseph Thome

on one Maybe Suvecaltamide.

bit differences any study secondarily, is Now different particularly in the you you is you the hand, guess, the disease study? the later. you That be a endpoints population in in have you in little the looking note I secondary to PD some that the design? And activity maybe related PD signs successful know I of specific that see about then or trial would is confidence gives ET anything that, in there trial? ET might data the any Parkinson's maybe did tremor of

Bruce Cozadd

do to in this? you on jump want Rob,

Robert Iannone

to. happy Yes,

addressing tremor. So just disease Parkinson's

thing, So the tremor is it's a different disease it for some same measuring we setting. And while different setting. of one a attributes, are disease

is for trial results. make versus Cramer if wait difference, up arms those ] levels. to ultimately. will It's to [ There have know only design X a that are Hard essential has dose just trial. a which trial, straight a different. the X we different The bit proof-of-concept So little

some haven't of regard placebo with in we gone into to haven't secondary on additional to disclose say additional I would the Yes, that we might we little And digging of understand why saw endpoints, seen endpoints. gone the bit are that have a or that detail. we effect into detail but we level

Operator

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

Akash Tewari

is product, is So With kind which Jazz consider profile that you'll spinning [ product Exoaxis low. is stock parts right the XX-year even would off portfolio shareholder value close to you in the that that oncology trading a core $X given Bruce, mind, where with a of up there you currently if ends have to Zanidatamab oncology now. ], your would comparable any versus business are a ever portfolio an would billion consider of being unlock financial to noncore? be And

Bruce Cozadd

Yes. Good question, Akash.

whole First a assets, licensed, individual out we been We've seller a We've of companies, bought of all, assets. we businesses. assets. we history, we've bought spun been over Jazz's a couple of of decade buyer

believe, active the of us forward business So we in the we an look The at makes one sense. always oncology and investing $X.X now, is Zanidatamab and was and look double to still quarters for business billion I revenue, in. horizon strength X continuing over digits, past will what growing on certainly our

of are of got and us we investments durability well terms most business products, still in growing our in just growth believe assets and accordingly, individual as revenue. believe place our lot our of cycle, in of We've the We're has those a are that different got their There course, good business epilepsy capital what a oncology. about mentioned what things front we of parts that core. life have most putting of In as of We've are in sleep I the product growth that smaller those certainly potential. vary we behind right? a business

though then flow assets we for you cash higher there's So be those can producing opportunities. core we're may great in great mean still reinvest investing by less, us, on for They're products core, patients. depending what where which less profile

Operator

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

Ami Fadia

decision of on continue can inform development on if that forward? some from details of type shed can the you drove light type there? half could what see what -- whether give expect the the you in going what evaluating second JZPXXX, And some we future of data to to Perhaps could on And it year.

Bruce Cozadd

Rob?

Robert Iannone

to happy take that Yes, Ami. one,

be orexin-X dose It's able sleep only lower. characteristics the exposure in of field we've quite result that the a agents healthy biology the healthy developed. in dose other know, response meaningful studied JZPXXX field, might volunteer from in the bit assess in we've the to you volunteers, of been as and and from patients from So a could NTX effects deprivation and model. being know We

to understand evaluate that And therapeutic relationship to potential so index. wanted we the characterize patients and in better NTX in patients

a that before. XXX the as We to move a can mentioned think very be we program we've that, that obviously know in think if and about be forward, XX we that discrete what characterized have would backup well. and that ultimately patient a even field valuable trial we learn doesn't backup support for on endeavor based we felt program can

Operator

Goldman comes next Our from question the Tan Sachs. Andrea line of with

Andrea Tan

to you your interpret here. GEA you expectations? for we of you separation should understand a if trial? the one maybe see the your PFS speak the evolution to the you're of be the the prior thinking about frontline that How Rob, for confidence to able data could of pushout help Maybe will profile And us level meaningful how relative arms? between

Robert Iannone

Sure.

previously just It based more on really entirely giving event-driven is are a guidance that assumptions. The bit little context. as protocol been So have we an trial.

PFS accumulate top results events would we that inform as the -- we when will come ultimately out. line So

and into blinded a And so re-projection making we're seen data, XQ. some now we've

this data published thing ] expected in some is We, overall. that The initially plus outside presented just coming necessarily data this the are were more trial. that blinded highlight data trials first I of to for is those data that well slowly clinical published were And at ASCO have the you that been would point have and to titles not in [ as in chemo gives bad of think [ would Danny few a are will of that ] from you the course, predicted. events and might well to believe that I reason Zanidatamab the very GI upcoming very, probably last other across trials updated the data and months a XXXX and [indiscernible], out will the be XXXX, ESMO, you've performing as seen data us chemo positively. indications where Zanidatamab read that we than

Operator

from comes next with Hung Morgan Stanley. Our question Jeff the of line

Lee Hung

or the For it can to you implement levers differed you the Rylaze, your expectations? uptake market. Are you slower specific for AYA time initiatives reasons take what that pull? that build will there And can of indicated kind from

Bruce Cozadd

Renee?

Renée Galá

Yes. the Thanks for question.

as with we takes with not We believe opportunity addressable. adult be AYA asparaginase and growth that believe So the do is to with that time protocols education the Rylaze. do a driving market. is education treaters This largely that this about familiarity a market drive familiar is that there's within contain it and may

reliable part that remains seeing pediatric of business a underlying of being to also would is say strong business therapy quite switching therapy. base available the reaction. first a that What the respect I the we're with and sign only in that Rylaze with at our hypersensitivity business,

positive and has getting on the Wednesday, We're really to Monday, lot helpful also us. back for best getting So practice, that been Friday of a feedback regimen.

a and that something we the So in a respect terms continued with more of it growth confidence element And really AYA education population. this of us. is have in, to time is for driver

Operator

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

David Amsellem

IH. on question A

their III Phase in idiopathic Your competitor dosing started for hypersomnia.

for landscape the getting So growth product and in see of with payer that patient do the for another with labeled how in IH, evolving mind a potential Xywav oxybate and even you terms landscape.

Bruce Cozadd

to take want that? you Renee,

Renée Galá

that mind keep once label, we're either differentiators are we nightly to building to respect to There of know a to. going with market Xywav. lot that there's even flexibility Sure. in we for twice once-nightly first are hypersomnia for an idiopathic with happy dosing all, aside, hypersomnia. sodium, in that for competitor dosing. have But or I'm don't a have play some approval what's idiopathic important Xywav putting out Well, beyond in the confidence low with we of actual in do the

time up support we helps the and field nurse prescription cares and then to time the right the process then that prescription they support educator a between a services helps actually in program, they help patients the in physicians. through patients of have the which dose position also facilitate in communication and to mail to some a terms this receive suite titrating get educate the the that call go initial of benefits, full what patient of nurse talked beyond from also from financial wraparound about until the on that We patient but of

in that help to disease think inertia. HCPs on focusing we're IH awareness increasing patients I identify the specifically investments better making sleep

that choice on help a in hypersomnia beyond to stronger well provides. Xywav with because things idiopathic hypersomnia respect think both of the that treatment services Jazz therapy general as of are these to as the also of All within currently number patient a but in market we patients it and it's build brand idiopathic build the

Operator

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

Gary Nachman

pipeline all, if given commentary for looking much at assets CorpDev, of on more have changed the you're may curious there? to stage some looking there And is and beef your oncology CNS I'm the know recent up urgency earlier So maybe closer of you're but philosophy on there, now to versus some misses neuro, at given both commercial your more I how types stage?

Bruce Cozadd

Phil, this? want do jump on to in you

Philip Johnson

for Yes. thanks question, to, Gary. Happy the

in look So the we still the from terms all across by stage, market and assets CorpDev early interest collaborations. way spectrum of preclinical to

transact. just assets In of available, and number to of opportunities are terms that

in we that next specifically and at moved tend itself. in focus across trying look that paradigm, as full more to earlier but you revenue for of priority a year have think to opportunities trying find of I to aren't do on those you Is we development spectrum. that

a standard terms characteristics that we depend we fit that had, up. the it it can be front doesn't on we it's But dictated I anything of opportunities of it that with earlier improve really mentioned that CNS has will add? That's the that's want would we those what just in materially to And Jazz that does Bruce, find I first upon look and urgency, at. then will set the us, of come lens patients. while you science had that It care the the and really in could the depend change if that for opportunity our and of capabilities. access. some we say, point, by readouts for And something really

Bruce Cozadd

as answer, of to want rate. to We Gary, to not to across said, find need again, be opportunities And at business And value looking Phil. both oncology. best that's other to I No, a one a create added business. across side advantages the question, neuroscience particular really good it's the Phil that to we the your the and are think or there

Operator

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

Mohit Bansal

taking for franchise. and much I my to little more bit oxybate longer-term just very you the underscore a questions want transparency for for thanks here. dynamics Thank on

-- And should think you how and first in the about point go think because [indiscernible]. the well. announced one if but the beyond, XXXX also the -- franchise, generic about oxybate we patient of from then of view your dosing was our authorized today to one IH also, So only agreements nicely trial competitor as

IH in at? you do that help? growing be a with do term could franchise So you Or longer think how this think about

Bruce Cozadd

of little Yes. the a There's question. complexity Thanks this. bit to for

So it. the end or I'll AG at The of take a to technically second beginning tenser 'XX. doesn't end 'XX the of

their also for generic, to authorized authorized if longer. launch the continue that's Hikma generic, [ ] their the generic they to can't own elects but Although sell option

quarter remember as you our in and to that are for royalties this thing XX% important lower we chronic physicians sodium understanding of and benefit product down Xyrem we high latest patients the that part market, sodium The we therapy and in mentioned AG the that only the believe have on is if a business, to of high-risk the the sodium in revenues sales together. is of call, combine population. That low

in both idiopathic of part obviously narcolepsy it's smaller in The Xywav, becoming is in part our business. a So we invest to continue hypersomnia. growing and

competition is is. whether our or on focus high not More generics sodium where it's branded the side,

we've that better squarely be product patients whittled XX%. risk, at high where focus safety in by sodium that these down on are known who Our cardiovascular to is

Operator

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

Balaji Prasad

extension one, XXXX. while But can management Kind of understand longer-term of a I XXXX growth, the why from installing go. on previous vision an did signaling debate to 'XX team perspective maybe -- and Vision

for the year possible on runs exclusivity, focused means Epidiolex. the XXXX Asking a this, a in generic word inflection also especially the desire it as and longer-term end for of investors a of points after additional key and one, what years are after, couple in wave Xywav including IP of

Bruce Cozadd

past we've the goals I and trying what and commercial Jazz. described And back We've both the the many our for and R&D side we're side and the talk business into corporate approached always Yes. question. how how to Thanks go had can development. on accomplish, ongoing long-term about years at we've strategic

are that specific once. a new we looming different That's uncertainty multiyear. time don't think I is oxybate a did only there little out putting are now competition. where from particular it We've was that change from where targets we that. financial that a So And done about in

question, to got since the cases, exclusivities parts but durability or in on well. I will about are strong I understand patent response XXXX business referred we're as you are with your Epidiolex Epidiolex specific to confident long-term to IP that protection of multiple that the out the of going in say some a we've very certain XXXX. families going there away, more

durability. we growth that continue so in lot to of front is believe great an a it, also of And with asset but

And to I'm going here. note

got we've think time Operator? I for one more question.

Operator

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

Joon Lee

All right.

agonists window alluded models? Going words, is in the dose multi-volunteers. better other back Did have the correctly? hear In orexin is than program, developing narcolepsy require that And a therapeutic compared patients. something Orexin you shown to that I lower that or to to so, preclinical if that observed others narcoleptics maybe something a that also possibly patients having you

Robert Iannone

you rationale loss receptors. a upregulation of Bruce. that biological see of Yes. Thanks, with neurons for orexin There is may

peptide you when sensitivity be an the may essentially replace replace agonist. there to so And with attempt

theoretically, So it's possible.

that's by several lower programs, a You healthy than in the of dose was a maximal in see that fold. volunteers of do to a effect kind required other have selection was development dose

it's worth And so testing. that's why we think

Bruce Cozadd

right. All

support. And to Conference all call families. behalf and shareholders September. their in in our partners of Healthcare you I'd you patients their concludes confidence today's think seeing many Healthcare Boston colleagues today. on thank of Global Wells for for at look their of questions. always, close and I efforts for by America recognizing person in forward Conference Bank and Thank our continued as our that the like us the to We in do Jazz and Fargo London joining And

Operator

call. today's concludes This

now may disconnect. You

Jazz Pharmaceuticals (JAZZ) 31 Jul 242024 Q2 Earnings call transcript