JAZZ - Earnings call transcript Q1 2018 | Jazz Pharmaceuticals plc

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Operator

Welcome to the Jazz Pharmaceuticals plc First Quarter 2018 Earnings Conference Call.

Following an introduction from the company, we will open the call to questions. I will now turn the call over to Kathee Littrell, Head of Investor Relations at Jazz Pharmaceuticals.

Katherine A. Littrell

Thank you, Sabrina, and thank you all for joining our investor call. Today, we reported our first quarter 2018 financial results and updated our 2018 financial guidance. the Investors accompanying section and available call release the in of press slide this presentation are The our website.

future today and those CFO. and uncertainties future Therapeutic property-related guidance Area call activities, risks related These corporate and Allen Yang, Vice and and ongoing the growth are and and press Hematology/Oncology submissions, the Chairman measures. XXXX, several in financial found to Commercial; presentation They adjusted Cozadd, On XX-Q share and supply slide development over inventory XX, believe related update today's cause financial and in related and President, our and the operating differ to in income President, Matt to we section our U.S. Young, strategy, GAAP are form call and and Mike Acting volumes, financial materially. timing Dan future net relate accompanying no session. undertake COO; I'd in facts results and clinical President and forward-looking. launches, and shortly. potential and Head Vice Swisher, measures Miller, measures. that R&D Executive call, measures Bruce on sales to forward-looking CEO, and including of and we litigation, rather SG&A release, turn or CMO, the ended per forward-looking the in in statements results, you regulatory results. to historical product we of obligation including which They XX-K like events, past some form challenges, and now call intellectual this events remind adjusted this ended XXXX, Q&A GAAP our XX, Factors will isolation to for the and file on for Examples performance described statements join regulatory and or goals, a than product matters. the of for our future Bruce. make that this include future We comparable under of are future events, We will our March forward-looking XXXX statements. performance call, helpful measures product and slide I'll be non-GAAP On actual these trials, efforts, development as financial performance financial in growth to and presentation involve Risk identified are the could statements discuss considered for these and other included and duty understanding are non-GAAP financial and quarter December and not non-GAAP this expenses substitute Reconciliations website. are discussed to measures reported the Investors today's our of press release call meant will year

Bruce C. Cozadd

afternoon, and to thank XXXX you Good milestones. regulatory progress joining successful start multiple everyone, and We continued accomplishment pre-clinical us. our for with and of the strong had programs clinical a in

review accelerate Therapeutics million $XXX we and Xyrem patients Jazz Spark In excessive to for for purchase voucher to submissions. Vyxeos in performance review patients and in for month, submission one for our a FDA daytime priority cataplexy of in with by narcolepsy allow submitted FDA excessive accepted first regulatory April, for pediatric the with entered growth key the OSA. Xyrem robust focus with an of resulted of that and And sleepiness narcolepsy net will on of in treatment March, sales driving pediatric our disease rare agreement our Our last process solriamfetol quarter continued In the our XXXX. demand for products NDA supplemental sleepiness. for future late NDA we

and ahead summer planned the leading multiple EU accelerated on about year-end. opportunities Vyxeos with approval by excited Finally, solriamfetol to very EU track assessment for the this an in MAA submission We're for our remain a with product the in upcoming of for an we potential launches.

our and with the into the is focused therapeutic delivering message + has institutions and to activities effectively to KOLs these with Vyxeos sales academic over key of quarter, newly accounts accounts within community our volume. the launch, in strongly survival accounts directors key largest AML critical turn recent Matt and on their call market support Vyxeos top observed Now, have commercial, are among promising and our academic physicians, we studied accounts target X X use ordered a to Phase are integrate I'll have segment then expanding clinics. recent research, placement provide who ordered the of new many on AML market. the key these its force on product updates multiple of high-risk hospitals. in XXX update the AML This Guided our benefit diagnosed coverage first by Vyxeos for treaters to from agents is you in new outpatient important introduction XX time our budgets. in extended newly high-potential of receive into AML protocols patients patients of dedicated the the population, legal, financials. most pharmacy teaching R&D the pleased some overall growing Vyxeos X and demand with agents centers use pharmacy the working compared Three-quarters its regulatory In AML and and we and Since formulary and and academic centers. community to representing for study,

Vyxeos we We've With value guidelines. the than is NCCN are hired directors Vyxeos is and ongoing to filled increase respect and growth as each and of our event academic by account understood in institution. prioritize pharmacy promotional clinical on patients well AML concentrating a excited opportunity activities proposition top each be also we experts to other teams onetime launch published stakeholders in our We believe in Vyxeos to field roles for country. medical Our key and also that We're superiority to in rather of that are to AML high-risk rolling significant reimbursement demand support recently managers and our hospitals. there community increase a in upside further accounts approval. begin pricing the the for of EU. Vyxeos team launch first potential reimbursement EU, awareness as obtain This physician the need and process will an ensuring preparing

every P&R with We well country. along for plans in individualized work are in market implementation our focused ready major (XX:XX)

expect EU the Nordic We UK, the access, occur Netherlands of in will countries for such early Austria, the beginning countries. and favorable as in Vyxeos market our waves, opportunity with the launch that Germany,

progress to Vyxeos strategy. our R&D continue on make We

includes as data the the Our generating therapeutic use high-risk to multiple foundation plan support avenues through of AML. new Vyxeos in

in combination Vyxeos targeted are agents. patient adults patients as and with implementing with other AML We AML initiatives settings and also standard or intermediate other pediatric relapsed/refractory to in segments, such risk evaluate AML,

expand studies. we our to clinical studies support forward and malignancies progress We such support year through the anticipate contracts other later We cooperative of MDS. this also expect plan will into look more details when broad group data Jazz-sponsored as ISTs, a be research to and hematological generation protocols on to sharing finalized

Defitelio. to Turning

early began our to recent physicians Our adult to front to that on VOD treat continues in the progress making educational in research as on focus April. efforts. are we diagnose We earlier. are out this reach The centers dedicated beginning market new VOD-related and team team U.S. and indicates believe beginning transplant to transplant recognize,

VOD. recognition We anti-cancer physician of also is VOD newer the awareness risk heightening and that a believe of patient's can increase introduction further that agents developing of

prevention On acute side, from be study for study following of enrolling feedback fourth and the FDA development our scientific patients. graft-versus-host VOD quarter. EMA X X are TA-TMA disease finalized from in study the and of for The planned protocol in the in prevention Phase activation of with treatment expected our site advice the our Phase will pivotal

in with starting first X% into to same in average XXXX. Now Xyrem increased of strong to underlying volume compared volume were in programs. up Xyrem year. XXXX growth onto our same sodium period strong quarter bottle active the in that quarter observed with compared of low including early last first patients oxybate the believe pleased of the of We sleep XX,XXX to XXXX We The year. indicators Xyrem last the the growth translated of and XXXX, X% early therapeutic period late growth the the area number

for the educational During navigated the quarter, successfully consistent rates typical prior churn first in reimbursement impact the payer country. approval accounts authorizations and of to key continued efforts high central The we observed heavy field rates. team pharmacy Xyrem the reimbursement the approval across our payer

are in trend once of increased awareness to diagnosis patients. with full-year rates XXXX disease narcolepsy leading efforts uptick for education The in new again. Our diagnosis narcolepsy reversed a downward XXXX rate an diagnosis

ran program for As our in a months. awareness XXXX, disease reminder, six

positive Our diagnosed XXXX first-time commercial will belief in support can The run rates continue narcolepsy prescription program that and and growth trends our full newly XXXX enrollments underway volume is year. such beyond. we in metrics, the and generate fills, and to as patient observed

ANDA against update against with Turning recently acceleration litigation with filers. filer license granted is to patent the December we related events. the of the its in Amneal as proceedings U.S. settlement We and ANDA customary XX, Teva, patent to and entered progress connection generic our XXXX, to settlement, Two and of remaining Watson. property resolving product, an Justice litigation the on Teva generic a filers, In Lupin, case. on a update of oxybate three consolidated non-exclusive a launch Xyrem legal ongoing infringement subpoenas. and around Xyrem are formerly sodium brief a subject a Department intellectual into remaining sixth Patent

been the assistance and could support in in the of regarding A the Attorney's Office brief related early District Although to that quarter. XXX(c)(X) XXXX set has XXXX no Medicare scheduled subpoenas that trial received as Massachusetts our we the for trial fourth financial of provide to as date from update U.S. organizations patients. case, be

have of discussions an a settlement and the about a DOJ the proposal last reached possible related U.S. for to an civil first with matter. engaged Justice the subject settlement and negotiation agreement by resolution, contingencies. We quarter the million Department definitive principle of a of been in claims a on in to other we month potential this recorded We agreement of accrual $XX in

improvement compared On an been as reduction narcolepsy, FDA product persistent, disease, patient We The XXXX in in lifelong where this to intake our decision we narcolepsy communicated increased progressing risk in excessive sodium patients adult other like actively sodium meaningful our compared a hypertension with made trial candidate on completing candidates, early we reduction American JZP-XXX FDA of JZP-XXX debilitating safety to Recently the XX% an outcomes. XXXX to of load development indicated. clinically a Xyrem cataplexy of guidelines is need and our Throughout with Commissioner the XXXX, in sodium and adverse priority. with sleepiness. excessive JZP-XXX, and with believe a of patients our provides both part oxybate the on consumption JZP-XXX product clinical formulation. would stroke, therapy that focus the chronic, focused a the diet sodium and for sodium in this disease reduce recently current be front, to enrollment product treats reduced and load XX% remain cardiovascular efforts in have the identified reduction Xyrem. a we JZP-XXX. sodium linked

to candidate compared a towards could XX% if we with suspend a in for submission result, our NDA our although our decided move efforts product sodium Xyrem, reduction have As JZP-XXX, submission rapidly priorities we to change. a

in in enrollment support data. adult quarter safety study the submission to assuming X We narcolepsy next positive complete year patients NDA fourth to in JZP-XXX efficacy and expect an the Phase

December March Now have in solriamfetol submission onto XX. the of PDUFA solriamfetol. NDA acceptance of We and date a FDA our for announced

launch for the of the U.S. planning the following product. decision in scheduling first are DEA We a XXXX for quarter

support significant We outcomes with disease brand narcolepsy force assessments, economic sizing progress solriamfetol, analyses, value plans, awareness staffing, launch among sales and many U.S. initiatives to proposition programs, readiness other of market access and to Meeting, the the APSS Annual results in American at abstracts are making payer oral management next and OSA XXXX narcolepsy health presented SLEEP including our main research In we month the X plenary a expect the late at presence accepted strong have Academy solriamfetol and of April, Meeting during with and multiple Phase Neurology presentations. were initiatives. patient

this a team also progressing is solriamfetol. late in regulatory for Our EU the toward submission year planned

to side, the development with study Parkinson's complete Phase in excessive rate enrollment expect and and our proof-of-concept X we're by disease, On year-end. solriamfetol sleepiness of in we of the enrollment pleased

continued broadening as continue product candidates product to other we transformation company. Yang, opportunities during near-term high-performing last development financial and will of marked like matters, ongoing progress our excited our and by Area appointed as we members for launches, as our VP, that to and Officer, by ramp regulatory provide highly three R&D pipeline. into Before significant Medical attracting to continue activities turn believe through thank strong management to was We're Matt, integrated our acting outgoing external this We've us the a a and pursue ensure strong Jazz results, corporate our progress continued the now which momentum Allen her years. internal other leadership our reviews, to and filings, in productive for further over Oncology internal progress Chief to initiatives. additional leaders, encouraged by team prepare for of Karen over R&D biopharmaceutical the turn transition. seasoned leadership multiple leadership take transitions organizational made moment we We're a regulatory I'd Jazz first we of Therapeutic I'll Officer. Chief Smith, Hematology the leading quarter strengthen and of portfolio the our to advancement well and to call to contributions portfolio of of We for execution across R&D serve Head, our you. this R&D Medical expansion our Allen valuable capable advancing our continue as highly up as with and

Matthew P. Young

Bruce, afternoon, Thanks, and everyone. good

Vyxeos XXXX sales up main U.S. of last increase for quarter compared were from sales the year. revenues the and million, First of quarter drivers XX% increase. of Xyrem from first total Xyrem the $XXX in million, quarter of of Net the were of $XXX an XXXX. million were launch sales the $XXX quarter Higher of of to the first XX%

year. $X.XX updating for to XXXX. billion mix We X% representing Xyrem and the XX% $X.XX range of you payer first the from for volume over billion, XXXX, $X.XX expected are payer last of of unusually billion previous guidance I'll period range XX% a due XXXX to the billion quarter of first same net low sales to Xyrem In volume $X.XX XXXX bottle quarter growth our over was to grew growth to heavy remind churn.

digits to guidance mid-single from our low- are volume We XXXX previous growth digits. updating to our mid-single guidance of

Turning quarter XXXX available observed strong supply ordering Erwinaze, were the supply markets, to of XXXX, sales of in pattern following included temporary at XXXX. million both the became in first this and in disruptions stocking net when first some and $XX we various several quarter believe institutions. Late demand

disruptions time XXXX. are these from We currently anticipate may occur and again experiencing to time in temporary global to supply continue

of markets the our expect an We in in of ultra-rare $XXX to in and acute sales quarter range EU first inter-quarter the versus that product condition. U.S. sales period $XX Defitelio sales because you million were in in continued XXXX are maintaining sales both remind first quarter in with we in the Defitelio the of consistent were for million. variability XXXX Defitelio net product $XXX same million I'll the XXXX. million treats Erwinaze net first the U.S. $XX of guidance quarter XXXX. for XXXX

fourth Defitelio quarter We over million in of $XXX XXXX the $XX are maintaining reflecting The net increase our guidance sales growth sales the $XXX reflects of a to the of of approximately Vyxeos midpoint year-over-year in million. for quarter in first X% range XX%. guidance XXXX, net our XXXX. sales million were for of

Vyxeos We August following XXXX. pleased the growing U.S. continued be by demand in to the for launch

XXXX our the Vyxeos sales We range to net of guidance $XXX million $XXX are maintaining for for in million.

a of guidance are to updating line top expect we previous total range billion $X.XX strong $X.XX billion, revenue billion in range to $X.XX the growth from our of XXXX, billion. For $X.XX and

the and reflects the our $XXX total activities or expenses the Vyxeos of approvals continued U.S. in XX% total XXXX. for and The million SG&A in the $XXX first of pre-launch compared in were EU. XX% quarter adjusted U.S. same of XXXX launch period increase expenses, in the of operating revenues, million, adjusted expenses of SG&A to in or to Turning of Vyxeos revenues the solriamfetol for investment anticipated

million, asparaginase, to quarter Adjusted of expenses For the or $XX expenses XXXX, the $XX period of of same Vyxeos to of of compared and the R&D XXXX were programs. XXXX. defibrotide, submissions regulatory R&D and guidance. range remains $XXX expenses of XX% the adjusted also our our to conjugate Adjusted R&D to programs, included XX% XXXX revenues, ImmunoGen's first million, XX% guidance related for million in million, SG&A quarter of XX% in revenues $XXX antibody-drug for costs support the or in oxybate-related and solriamfetol EU ongoing revenue

the guidance. for or in adjusted XX% remain million revenue of XXXX approximately million expenses to $XXX guidance XX% Our to range $XXX of R&D XXXX

First $XXX the per diluted $XXX quarter in per $X.XX or million diluted XXXX. million, or income quarter was share, to XXXX compared adjusted net of share $X.XX first

to EPS previous narrowing to We share million $XX quarter, share. $XX.XX non-GAAP our a to share repurchase range we range from million guidance million In $XX.XX of our cash $XX.XX of diluted operations used to under with our are generated adjusted $XXX first XXXX the per $XX.XX remaining from shares, and per program. repurchase diluted of $XXX

made milestone NDA. totaling of solriamfetol payments $XX million the filing also the acceptance the related We to for FDA's

billion, outstanding As billion of the balance undrawn $XXX and cash $X.XX was our equivalents, long-term had our under March debt million investments, XX, and and $X.X cash, in we of revolver. principal

and take to a a to Before recently we leadership corporate CEO Jazz. moment at Craig Parker, his who take for company, contributions questions, at to role a biotech I want thank transitioned development

and life including science Over our acumen. commercial its broadened capabilities the team we've the of and strengthened scope years, and expanding recent corporate development

you to support turn high to promising I'll Our ready are on today, and Kathee. our the in execute and corporate growth on remain joining us opportunities development well-positioned and now priority, Thank call over strategy. we for the call activities new a to

Katherine A. Littrell

questions turn limit the at time reenter the back for open to request further to one to questions. if that call We With queue and your operator free then your to have Matt. I'll a questions. that Thanks, feel the you said, line the you

Operator

Thank Amsellem come you. David first And Jaffray. the with the Piper from question line of will

now is line Your open.

David A. Amsellem

Thanks.

any JZP-XXX thinking take So should into regarding your of mean the understanding even I here JZP-XXX thought better that to where more just a efforts. like for case delve the deeply your or guess this is, of question more that what excited I a on just to wanted you're data want we make to your submission – is the just and is NDA trying enthusiastic to that here. JZP-XXX looks on or get you process JZP-XXX? you before see I'm decisions Thanks. suspension

Bruce C. Cozadd

David, time Yeah, would the our and JZP-XXX JZP-XXX I and approval result, brief. would a program be say difference continues potential as potential JZP-XXX track, between launch a relatively think we of on of a

that we our so of and before transitions multiple some we factor and which in its you XX% physicians changes means does it's about as product is to reduction the transitioning that Xyrem, the of And patients REMS, of on think complexity disruption REMS with we including products, we've audiences, the through getting better been believe JZP-XXX have to know terms patients over improvement operation bigger and think to what is through focus those in sodium. of

to the any most JZP-XXX rapid we is the introducing better product. we to at we my is in best path comments, reason, go. submission for said one I toward think need this As ready but NDA the could, reactivate the point that Should

David A. Amsellem

expecting, is consumption? if to content you'll language reasonable or in the at get have on and I differentiated are label least JZP-XXX, it safety you approval, a Okay. expect a may And you sodium in regarding sneak should follow-up

Daniel N. Swisher

is the a it's get results. until little Yeah, to on probably comment preliminary Phase X that actually Swisher. this clinical we Dan Yeah,

echoing prepared strategy. at be what year, said, So enroll Bruce to data, fully be thinking And have filing. this I label track just through we'll that point, for and a we're on clinical think the

David A. Amsellem

Thank Okay. you.

Operator

Leerink Thank next Partners. comes with question line you. the from Ami The of Fadia

Your line is now open.

Ami Fadia

and sort ask, for also Xyrem with you of Thank Thanks which the some to the your these faced driving evening. To of resolved you us saw would myself one ones may for in more are of of us in XXXX? question, have which to XXXX specific given some growth limit and growth XXXX help drivers you. beyond quarter, question. be been more sustainable as that understand drivers in and which the Good thus well could difficulties are this illustrate I

Bruce C. Cozadd

answer Yeah, the maybe then over start Mike. I'll and it hand to

to we that that see And long you're that we delta right is differentiate Ami, remainder as between year. we next things to are sustainable. and of things that this XXXX, of are headwind period. essentially, of sustainable could we last seen an and probably volume as patient to into we Mike in growth little long-term from little our to trends think, we government-pay time not impact as to same And a XXXX. year, think coming pieces saw a tailwind in I it true we bit this the talk think more compared you but and see opposite the specific wouldn't to growth than certainly XXXX higher that expect XXXX term. growth that I'll what such, volume the have is increase, for think about expect are That the It's year. have in a Maybe of did fact for ongoing the it's

Michael P. Miller

Bruce. Thanks, Yes.

our which early a campaign time began was real drivers, investment with as bottle blossom would much much on our very of a around as for the key second day. which diagnosis long-term our good fills the mentioned, driving earlier. it encouraged in So the to remains XXXX, enrollments some us was volume up that very in I say picked awareness of I'm narcolepsy said indicators QX general the really is and of terms of XXXX first which, Bruce demand, of treatment half patient very and in

XXXX good, that that half complement full-year expect and get to continue helping patients have in which well. we'll of access are to year or full field our very that say full and have approval would second well perform complement I PA drugs. the of of for both team our We the XXXX has been the see done doing to the customers in and reimbursement rates XXXX

very moving direction. right So we're with those all in the pleased

Ami Fadia

a help are like you're you more sustainable in out break high just guidance could you year, if term if given maybe growth about longer – your me Could which talking for ones quantify this possible? percentage the form difference help

Bruce C. Cozadd

Yeah.

provided the breakdown first first amount of the nonrecurring quarter. quarter did that for volume you that over impact the gave we digits. last more our further underlying volume thrilled At any we haven't would for growth was you had. and growth guidance sense was We're for We some a probably give of year mid-single sense mid-single digits normalized that with we So thought represent this growth again the quarter this strong first giving we're rate. which normalized point, year

see think efforts Let's continue of that growth the us. rate detailed. and the progress year obviously to some the of Mike digits initiatives in to how rest the feels normalized for the with I right But about that numbers mid-single

Ami Fadia

Thank you.

Operator

Umer [Evercore Evercore (sic) the next from question SII with Raffat you. of line The ISI]. comes Thank

is line open. now Your

Umer Raffat

a I two split. or some the Hi. some follow-up Thanks the parts so much being time. there part questions. report of valuing if and Perhaps top have taking I recently for the company of was idea third shareholders we Bruce, potential my if your from may, the of a on press citing basis, thesis have may of

A, observation thesis? was secondly, percentage on And more what think you was, your in MDS this secondly trial, to to my do you my for AML what's guess you the survival of be sleep to able your how your in my benefit number for contributors expectation And most Thank the because of the you. I the one also, as patients get of Vyxeos, important kept X MDS designing MDS will general? question that it's And strategic know is, I'm to you there curious trial? in think been that. ever business the of that require idea the about guidance being that interest the explains transplant question I has part in Phase patients And transplant. trend, the your year. quarter-over-quarter about seems So

Bruce C. Cozadd

Okay. artfully Umer, that a was but question quite one asked.

Umer Raffat

more. one I can ask

Bruce C. Cozadd

indicates once-nightly Let's OSA, he'd in take a of product and Matt narcolepsy business, a I I'll might like, stand-alone and opportunity question would And sort sleep of product, success the the a continue right? say progress to have Vyxeos. think the commentary dimensions already potentially Vyxeos it common this franchise on Allen and take programs, one, a sleep for we jump submission I to our maybe launch value population we're evolution of with in utilizing we that. think area, case of the term, the by take and program, growth approaches a launching additional the our people to patients take potentially target a of franchise, force it to happy move A this narrower us of is the sum as prior then about. on pretty might current then that new much grow company visibility part we well-positioned now that. pending that's with some audiences, any increased continued expansion product then Thinking have question outside low think yield the about oxybate helping could on a that undervalued piece. patient the product, percentage first up valuation We're as of U.S.-only think great the It's low-sodium Xyrem something our of as we initial price would And for is that our right invite could we not well. company is about that as Xyrem. franchise I'll a overlap trend that partnering Xyrem exciting currently visible, we Matt think as additional or sodium ability piece that therapeutic think to with with overlap the with of sustainable the efforts for the realize side meaning The we're MDS with into people a parts U.S. with moving transplant. progress the which to see observation to evaluation variety our coming longer for high and execute But pipeline, and that product into on entry our ex-U.S. multiple on a more given forward strategic solriamfetol, of has we're cause in sales a rethink about our becomes

the area. therapeutic are, to expertise side and sleep things at We corp well, looking can as add we active on commitment given of course, dev our the

continue that business coming we obviously see cash as us from Xyrem and what continued continuing execute part continue performance the six that? – we to five corporate overall. flow Matt, or in want have So you that opportunities And to real could on do the growth as to value a the portfolio. of makes Jazz can in maybe strong confident is our anything you to add broaden do of I past Mike, to we piece development over have years

Matthew P. Young

No, that's fine.

Bruce C. Cozadd

pattern. about And, maybe Vyxeos' Okay. talk Mike,

Michael P. Miller

Sure. Sure.

community it's I the much faster I'd on outpatient smaller in growth hospitals the adoption certainly we're we're and mean, a even seeing, So, very in academic for catching pleased scale, to that community with consolidation. in but centers the say, Vyxeos the

thing good patients So that, for is a and think, institutions. I

built the allow sales Our force, now us the community. newly-dedicated force, will sales we've reach BMT greater AML that into dedicated

Vyxeos. with and of late in again, NCCN with the promotional any top speak. begin we as are the there. status uptake. begin on with I yet really And the of accounts. to at about activities We We those, the and formulary they're pleased QX formulary we're think Guidelines have we're, pleased date, about To received to We're XX% decile

Bruce C. Cozadd

take Allen, the want Vyxeos? about do you question to

Allen Yang

Yeah.

transplant, that the the patients questions study the on the and greater patient study a two but benefited. in I of did was OS is transplant one the Vyxeos who And about arm, XXX the So up the patients number it is were in actually answer there. all remember population. was think was the based of yes, there went data where to make the although minority they One

varied those we're did the think proven group, and OS referring across And benefit market who hoc this benefit, thing looking you're transplant. and so I at a that we populations. scientifically post different was the a And what in that's was analysis to patients remissions went be to two into see clearly, interesting very trying try patients that. transplant, a It other analyses as better And of could or doing go combination of And the could one both. perhaps status. to sort understand performance of or we're reflect or to to very understand things, better that. either condition that additional they deep But

So the you next our study. question around MDS was asked

the MDS that. about maybe question our MDS, of think study will we details address disclosed sort of and about this your haven't but I how will answer We

transplant-eligible so changes, about with to for So a eligible no-brainer you are transplant. like therapy, move shown those And MDS. clearly those unfit therefore it you in dysplasia-related mild has for that with think Vyxeos are really two when to seems populations, and benefit into that MDS, about and a patients AML, think have curative

of intensive there's overlap fit between intensive for for unfit unfit Now a and chemotherapy and lot for chemotherapy. transplant-eligible and transplant

to we fit know transplant clearly for us low-hanging chemo also we moving population therapy would of where want But fit Vyxeos. and for fruit the would dose So the be for explore this into MDS someday patients. are going and those new in patients that those will for patients, schedules sort to move of into we're unfit, that with be doses those optimal but

Umer Raffat

very much. you Super Thank helpful.

Operator

line comes Maris The of you. Fargo. question David next the with from Thank Wells

Your line now open. is

David Maris

afternoon. couple A questions. Good

would there would be oxybate with a review have, seem review if sodium is that is And used? advantage the unethical have other the would So if you like again, had low that one almost voucher ethical can you a something you for remove just I accelerated standpoint, from it sodium market? on to you that that? sense, and low that agree likely hold market, XXx if the sodium both do an mean, you Would that scenario make a safety should then safety sense does And concerns? an a back the market describe accelerated voucher it it on the makes to any be on one. it would think using with lastly, it Bruce,

Bruce C. Cozadd

David. questions, interesting So,

for delay approval a product, any be could both. better efficacy, to unethical that's designed it of you tolerability, or a is product patients for argument make the On treatment on that to

real long-term situations any there agree the whether it the it would yet priority for today review value a otherwise we terms therapy be sense. on we need, it use as us don't are the be whether to that, would launches, standard buyer make any differentiate we I faster how development which how of of through benefit quickly Of resources, terms such possible bring more most processes of new whether would any that accelerate think think things is competitive it review some that other to of company existing new having defibrotide processes, because us as that's potential experienced the opportunity regulators for for advantage patient of it market or to and that our a are priorities internal attractive Vyxeos as move we and that's into where lots to take reason, where could about sit realizing as our already relates review those I stagger severe tracks of would that patients to programs where this. program us will we and to from to think for how optionality use There know and for course, mandated. an product. I we But a here to of is gives say mechanisms asset place in we speeding ways corporate with breakthrough us as treatment and in to in asset with This

product and in best how question. different promotional a sodium continue do to that sodium is, how there is version helping your patients decision. to from product and of we your once think implied distribution. standpoint. use treatment. are available, higher control, access removing of physicians and you lower to sodium essentially support questions get that terms and the are we higher ways our remains to what available your I about lots On not within we other One question What decide multiple That's terms resources product from manufacturing the it. So version of we're think in not whether support is about efforts, our market, our a regulatory a or That the parts is there about believe is

David Maris

Okay.

just hear that for the assume people accelerated listen, from be review you as I used follow-up, what to shouldn't hey, is, a So low is saying sodium. going

secondly, switch be for are make with safety. you may focus sure and And that your that there used because also attention a potential may aware business doctors better one Is then that's of do In safety-related hard a something is fact development-related. that correct? on just the it something but may you

Bruce C. Cozadd

I what with stick I'll said.

I figure first to correctly optionality, think of pointing and different to on that soon what and is priority JZP-XXX I as getting you're out, a be number David, out there's one, the will second allocate voucher. know which excited control, in ways, potential how we out our part and use we And optimal the we for review used resources, could can. be It of about are to On we how that right? market as of job one, get our the

David Maris

you. Thank Great.

Operator

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

now open. is Your line

Jason M. Gerberry

terms you around your biostudies, has talk my sort my DDI Jazz has restrictions with questions. and that you do be Thanks that for out Bruce, any allow of generally it's team, any pretty issue safe the patent prospectively a generic risk do you the term delaying in generics which of just FDA just with in the curious, in entry, there. the you feel way? Xyrem Or see like legal position? question you to generous But of your to puts to come taking my is, in settlements an of patents challenged understanding in advance that could this developers as you to drugged and around Hi. generics afternoon. do generic regarding of Good kind the REMS getting been never Commissioner rumblings

Bruce C. Cozadd

as focused of reviewed so REMS they we've they Jason, the feel number view ways, a entry well like agree, the you settlements. certainly, that settlements we've that covering products, that used on approved about product. a I to Well, particular. future market The in we In really that brought but other will settlements, commentary we generic out, the to reached can are our we in of bring and and you up reached And certainly ahead, being issue generic good were versions our there all would generic as already pro-competitive settlements of case, have be in that lot point things. delay patents are

Jason M. Gerberry

Thank you. it. Got

Operator

Capital next Markets. comes you. BMO the with from question Thank the line And Nachman of Gary

Your now open. line is

Gary Nachman

us are you've the having, the what solriamfetol. regarding filing plans describe there need. and been and the to would remind Hi. A Good afternoon. range pricing any thoughts of receptivity in payer it? sort a of conversations on couple you And for effort on updated Thanks. Could the you for your there product planned Europe, if latest commercialize

Bruce C. Cozadd

to Mike, of you first part that? want take the

Michael P. Miller

Yeah, I'd be to. happy

awareness, – So a and doing research. research we're as part to of – much this an and with that you what there think urgency have is a pre-launch is The of and a goes payers we're drug get and understand and the good, it's treat to payer impact And begun the think we it some of condition we payer importantly all I very of a lot we ES along, lot on, it. to and that can well-differentiated. place is clinical the as and the efficacy touched as prop learning activities, the branding, consumer developing market quite is messaging, messaging, neurological

Bruce C. Cozadd

talk bit to want about Europe? you a do little Dan,

Daniel N. Swisher

Sure.

European a we side, data across additional strong. this, various cuts European the been team, team, the benefit regions. doing It has work in moving some in On about The and franchise. is which see lot our into of very specialty-focused thinking this a do is solriamfetol and

for the We've this is and some be stand to how been and in is it. potential which behind the lead The And work Europe. value proposition we promising market in quite are franchise a question that Jazz pricing the KOLs beginning return. a potential We think that signs doing need Europe could could is really new the initial have strong. do of that

Gary Nachman

one quick then And follow-up. Okay.

you already leverage there Is As you're presence for infrastructure solriamfetol? a synergies to much going Vyxeos have product more be you with little building there? Europe, the bit a how with out are able Defitelio that a like to in and

Daniel N. Swisher

expertise, the presence the reimbursement pricing the leadership, geographic the with synergy of affiliates. clearly there's Yeah,

some some in may to specialty synergy there accounts different. that would the there covering be organization. we're going again, that But So is be be

Gary Nachman

Thank you. Okay.

Operator

comes next Randall The Capital RBC question Markets. Stanicky line the you. from with Thank of

open. Your line is now

Randall S. Stanicky

talk about year on than spending are cadence. to prior should follow How conceptually for pipeline the a could up for SG&A year little might that? How QX think Question Matt, of versus you, read-through perspective? about a you. And then, Thank follow-up question, about you running rest lighter any and thinking like the how guess R&D, of Great. you just the to And voucher diversifying you an a I have larger from about we transactions provide Matt. for another you thinking does the you're continuation looked was Are light? if It expected. deals?

Matthew P. Young

Yeah. Thanks, Randall.

particular relates acquisition focus range transactions, On it the stage into pipeline-building look at as continue be anything transactions, internal external as programs. the would to first with one, any transactions larger of read the potential later so respect used, of because could would to or again, to that well a development we not be for that assets. and PRV, as I it

on continue there M&A to going I to would respect more fewer going very are transactions, to and to side. get often determine really say where not of the large they're those help you that's opportunities done. with that So complicated we're

base so. we'll our again, ilk we're times case in but transactions, continue do larger and always thinking would done open-minded about, past, transactions many we've the to said, we've to the be of as So

On in and had side, with respect the we R&D previously to guidance spending SG&A ranges again, the we reiterated provided. both that

including and some addition forces we the for preparing about the might for quarter, talked with on though continuing excited percentage also of around mention again, Vyxeos set about did lower when we regard, Vyxeos going in and growth sales a related BMT first have in the we to revenue AML invest we make programs Europe our a more programs, little the to and new of a be than investments preparing of to previous existing quarter's very strong I'd anticipated R&D the launch, in have. less to launch-related results While guidance in the solriamfetol, the of in would I and side we investments expansion we agree revenue continue years, than that the you year at and of we're our start spent be dedicated

make. our So They're such. to and of ongoing a we reiterated investments guidance I lot we've think have as

Randall S. Stanicky

Great. you. Okay. Thank

Operator

Thank you. comes Douglas of And with line the from Barclays. the next question Tsao

Your line open. is now

Douglas D. Tsao

Good afternoon. Thanks for taking the questions.

review. the Just the of on following up priority issue

did following curious a anticipated versus given it up ramp-up pursued it And sort just the if spending, of standpoint, time in of other this sort terms for question you spend how Randall's Was of see we think just plan then in first should in the the why bit there of little as times for the just they that of more that you spending this available? terms Just fourth is one. you. Obviously cadence you been or time on of transactions in launch opportunistic from the thinking quarter doing of any them. have have kind we solriamfetol? terms were the Thank should about –

Allen Yang

on I'll Sure. PRV. start guess, I Doug, the

though particular product, of imagine, they area you for worth could on the optionality provide can't under I forward any what and we on say, expect, comment look scenarios. be you various to on pull terms curve contemplated of what in based you how thought or the could as at may could that say we've in you things, for approach sales market these Just will they have might economically sort the we tactically about what what

we So this. can't stuff really we enter comment like many for how on but and that when thought the market about times, I

year investment relates will education And actually solriamfetol, well. forces those of it goes related the as again, there market year, to again, while to some related Vyxeos, later layer to the and in in of for expenditures some started as as of the be so it'll as start though, far to medical that's building build other the some to ongoing we've dedicated is amount it to some sales investments, related activity starting infrastructure spending, of the As on. of and European the already,

fourth quarter. as it's will the increase the all in year it goes, loaded not while So

Douglas D. Tsao

you. Thank Great. Okay.

Bruce C. Cozadd

force actually occur And significant our early of our next working would assumption field sales expansion beginning is year. that any

Douglas D. Tsao

Okay.

Allen Yang

PDUFA we've for of DEA quarter scheduling, that, would indicated the first the given appropriate and launch. time about Just date think XXXX the the again, to time be

Operator

the the with will And you. Thank Fye line come of question Jessica from JPMorgan. next

open. Your line is now

Jessica M. Fye

Hey and PRV differentiating there. area the but that potentially wanted I you. on follow in of my about horse a be a a buyer comments you've which to different, do Thanks up, new call the for the not the really under couple taking Jazz I to think? point on in elaborate curve to dead as question. a difference asset. that would timing Can here, review of degree think beat the Thank made you you

Bruce C. Cozadd

to does others the more to value pursuing Yeah. of the one aspect asset be value can be back there's that I might provide value forward meant to its us us, a mean, to seller means not same if some date or be say can provide or that. that the my combination asset. approval could And potential brought think than whether it's of worth regulatory comment an higher. of two, say more just maybe to was to I we available it more that don't

Jessica M. Fye

next role Allen's development current area And for Okay. as take the of business we potential and can Thank his any transaction? background you. the indication therapeutic

Bruce C. Cozadd

comment. No

Jessica M. Fye

Thanks, guys.

Operator

question with next come line Risinger Stanley. will from the David The you. Thank of Morgan

is line now open. Your

David R. Risinger

much. very Thanks Yes.

last you. expect November color to in-house, et you reason the to have JZP-XXX primary The I on results. relates is expect press date question release, I appropriate be Could timing. the final Thank my able make when cetera? was the when and timing saw to just want completion understand So expect to more a of sure that data I that ask XXXX some provide you I you that to to issue the

Katherine A. Littrell

Okay. while database. toward take to the say, this to the I and the year it'll a year us the enrollment, would clean David, so complete we expect of end

XXXX part So the expecting we're of earlier and really in data most XXXX. submission likely in

David R. Risinger

Thank you. Okay.

Operator

the question line you. Thank with of next Bernstein. Gal from And come will the Ronny

is Your now line open.

Aaron Gal

you Two for question. Hi. Good my afternoon, parts. thank and taking everybody,

bit the are modeling about tell the purposes? guys our are How and where with? about And featuring that in product pricing product is three-quarter, for like remediate Vyxeos. second, one-half, to EU U.S. of you working next-generation that can versus Is us little a we pricing range efforts Erwinaze, pricing? just you it First,

Bruce C. Cozadd

Yeah.

Even asparaginase to everything know ultimately to the us, our continue quality, can improvements on reliability supply. Ronny, commentary, can we'll successful be for and as manufacturer So, we finished cycle of take market. face and though, actual It's normal to quickly. terms that disappointing supply the long from with a the are one to to up of to we increased hence, we And year business, of wider result our this probably capacity time But working a while guidance end on supply that improve you lot revenues. of is reliability, unfortunately, disruptions, effort than in do work prior in where with a not manufacturing.

improvements designed initiatives several yield to frequency attributes We asparaginase treatments immunogenicity, to a be benefit are the that even patients. to to development better other bring patients or would in manufacturability, of through future in working dosing

So comment pricing? any that Dan, effort Vyxeos EU continues. on

Daniel N. Swisher

a it's No, there. Yeah. talk little that to about premature

in in pricing strategy. Bruce efforts said As of script, underway been terms building reimbursement the the have significant

but that various then ready strategies across proposition and for obviously, the and goes So, value that Europe are across the very sequencing implementation. country-specific regions,

Aaron Gal

Thanks.

Operator

with of And question line and Company. Cowen the you. next Cacciatore from Thank Ken comes the

is line now open. Your

Ken Cacciatore

It if see in in of any division. or it Matt, seemed Shire was on Bruce I and comment you'd wanted changing oncology reflection this a orphan was and if kind nature development wondering Oncology pretty of that's Servier want Thanks. hematology. the to – price healthy purchase to of business

little rich? it. generally general Just is too speaking, of Thank a you. getting Kind thoughts it bit around

Bruce C. Cozadd

our think in that we're to viability for opportunity, that development view worth transaction, limited in committing I in fields think avoid the commenting as are question diversifying to time, new opposed a everything. the at – from particular a therapeutic it And transactions see Yeah. target is analyze sufficient stage piece the direction. one at area. any a assets I'll but return that general or to your a we of It's buy continue I a goes Ken, at trade we circumstances. market. wouldn't time that that, to get shareholders' on of a assets for most our would prices to But we least in particular say, those part, aimed I make the find to that strategy of opportunity at particular It's provide capital hot in

small looks in And spans development market so, with near programs at development looks commercial is we put that that at global U.S.-only that will European deals, capital fit that transactions to continue deals, good opportunities offer also Jazz, the in but to big assets, find a deals, our return commercial that focus strategic to deals, for possibilities. are view assets, spans work both deals, really

our in want in fact So, changed or investing wisely, sure four past years confident hasn't we that environment. disciplined do can but to make five word we be that watch we we're this remain and the over

Ken Cacciatore

not auction? Was FTC have could you that participated why could there or any reasons in

Bruce C. Cozadd

that. comment can't on Yeah,

Ken Cacciatore

you. Okay. Thank

Operator

question Bank. Gregg next from with you. line of Thank comes the Deutsche The Gilbert

open. now is line Your

Gregg Gilbert

And being Bruce, share that me you because differently. months ago, relatively you capital Thanks. the better a Is let for uses aggressive soon. on Several still were buybacks that question saw indicated you into you ask M&A you more for not to the the little is see XXXX? course you gain case? seeing are more of And on traction have that phase, expect moved the something more now Vyxeos, outpatient treatment? patients consolidation the over Thanks. Mike that

Bruce C. Cozadd

which program, as of in Gregg, stock continued our to first the under it's part I in the first repurchase meaning still or yes, that, we quarter. I has program, Yeah, say, that under while end think, release, of and commentary, question, would the we stock as press to will the – your $XXX back of stock Matt on our buy back still still continue remaining have million indicated buy case, his

to flow, in also on development execute important very significant stay balance strong mind attractive good corporate very opportunities. well. our revolvers, for to cash believe position, sheet, undrawn us our all our it's our cash us our We And ready position

you stock a diversify buy a same more the other think of return invest ultimately is we a could use a at great at buy the time price company's earn back, of and lot the our is should in that better the While for capital drivers to future. we think argue growth stock to we opportunities today's

to from Mike? flexibility to maintain as long continue strong we after out those want something go on, can base. are the to a think feel those as we and So, I execute financially we opportunities there it's

Michael P. Miller

Gregg. Yeah,

would that I certainly consolidation the avoid costs I the and has you were good treatment. patients say associated getting that in so indicated traction probably of yeah, very upside So, But which Vyxeos that in is QX two-thirds the think is families, accounts outpatient that newer and that And are consolidation community-based, ordered to this XXXX about for we indicates that feel the hospitalization and a in we with significant thing great inpatient population. treatment. me

Gregg Gilbert

Thank you.

Operator

with Thank you. And Irina the next question Koffler comes from the Mizuho. line of

is line Your now open.

Irina R. Koffler

taking question. for Thanks Hi. the

another that in was in filed, drug is and and or I presentations, weeks JZP-XXX sat the believe there is being drug wakefulness sleep also I some a on approved time was around And attended a – ago the pitolisant and in these that when is called couple same filed AAN being of agent. So, U.S. filed the is Europe. supposedly

And Thank competitive you. any your product? talk could its Europe you pricing potential So, positioning Europe the will solri also, in that about in of in way? versus existence affect

Bruce C. Cozadd

for NDA has filing. accepted last year. so It was been Irina, solriamfetol for our Yeah. submitted

know have to yet the PDUFA about talking my been we At submitted don't it's submitted. date. We you're least has not or been knowledge, a drug

are solriamfetol's of strong different its a our Phase and Phase In appeared two products, objective of terms subjective and know for were X data were very They X were what patients. number efficacy in we measures They time, maintained across quickly the that multiple in data strong. trials is of we over and trials positioning know on consistent, relative of indications. results

it one, who've And in drug as therapies a been our benefit apnea. for availability of earlier, think as excessive have that obviously, do a solriamfetol we'll and to question patients we we a sleepiness sleep at with for that both Mike opportunities built in that, in to access so answer agents, into potential reimbursement is not Europe, and narcolepsy I sleep-related position real existing obstructive pricing as about we think dissatisfied said In and pricing look all just analytics thinking drugs, thinking. and our

Irina R. Koffler

Thank Okay. you.

Operator

question Thank David you. And comes the Buck next from line of the FBR. with B. Riley

Your open. now line is

David George Buck

you long Yes. taking from you opportunistic talk and markers Thanks the On right Thanks. purchase the ones recent of in force, given the I can a markers sales for your in move be we of it significantly being question. more might the little other solri how a the type take, have what about finally, for looking question review you're Defitelio, in years? bit on should what of and better also for a And of of term as talk your Vyxeos conceptually of VOD? Europe, that pediatric at in so shifting maybe gross price for XX% XXXX-XXXX success price margin potentially sustainability some looking more and in that near terms the was Can voucher, Matt, growing you was about, lower or guess, mix? product it diagnosing Europe into than

Bruce C. Cozadd

in seeing more and globally really orders physicians metrics basis us VOD which U.S., penetration we're encouraged right when don't, been we're see day-to-day we're to lot of in we repeat better to an usage recognition and is a certainly in information. progression necessarily indicating at we're product, average of important But intervention. remain the better pediatric start Defitelio at to what patterns Yeah, whom, exactly unfortunately, trends. the which We in And responsiveness U.S. translate would the Europe, size whether of good, at is on treatment on think sold that have that or so looking be at vials ordering that a in and basis. that we treatment every that doesn't of looking whether for again, whether a know so has accounts, and looking we is Europe Defitelio, on but growing, and orders, give has patient-by-patient we're in looking but case been adult seeing knowing what this

but news, into doing today's we've our of centers. categories. the that, new dedicated to some is, a toward top from two transplant one treatments is very think on falls have and sign their the and effort they're so is downsides think, thing lot that's give of want new comments, a that's relatively VOD. market the of reconfigured if take were We new that to those the U.S. we pleased as job. some that. a a to our the talent I internally we new we I other force One adult a of And probably don't in in have focus to there team still see of good introduction higher think data sales That's important roles think great incidents

as those are more, watchfulness for the and so, awareness we And in will agents of think increases patients future. VOD. we it utilized many hope that benefit And

Matthew P. Young

Yeah.

about near-term would David, the So, diminution worry margin. I just on the gross question, not in margin gross any

be relatively incremental it'll think for I the future. foreseeable

very sales right obviously maintain Erwinaze for one we're able good the dramatically portfolio. I'd at of lowest of those attractive margins of expect gross grow to we is not which the products all The cost and is So can moment. given the in our

you buyer. more there you're at dynamics, attract do prices relates or you is thing it to immediately, can that need get it buyers that where when able a as it able than time or sellers an to if a to enter As buy don't to markets might appropriate better PRV when when – you be are

think again and able terms way, future to we're of happy conscientious say existing either or this I the create can of a long-term development to that an to either again, dynamics, we're those opportunity use I have been but in much into read against trend program. So wouldn't you

Operator

Thank Citi. you. question with will Abraham The Liav next go to

now is line Your open.

Liav Abraham

A and version follow-up of your on afternoon. question once-nightly Good low-sodium Xyrem. JZP-XXX

any there I'd prioritization the at on version. a this curious and Are whether low-sodium once-nightly this the a extent you about priority timelines in development JZP-XXX, is to your what given updates on provide this time? be Just regarding of is thoughts can Thanks.

Bruce C. Cozadd

once-nightly that to Xyrem, priority the market continue, in updates which And be in terms terms profile. ought status and confidence PK is with a our PK Yeah, the JZP-XXX little is represents product active. of consistent is that trials. for Xyrem. that prove therefore, now efficacy change in bioequivalent which, getting and to market clinical high Once-nightly on not uncertainty how does we it nearer Liav, no expectations program. that'll have that while of It a is is thus development low-sodium to to profile, similar The what safety in to very current out the we'll of right see more

achieving that think So, introduce And believe can better. that we sodium also so dosing, much will if once-nightly let's the we the because lower the get quickly. benefit JZP-XXX that patients first we benefit satisfies market of to then

Liav Abraham

Thank you.

Operator

The Bill Fitzgerald. you. Tanner Thank question to next Cantor goes with

Your line is now open.

William Tanner

suggest a back follow-up a impact or just that could us for I'm JZP-XXX think the low the Thanks. And to I a the that the be remind taking be if be settlements for to said a available. pull the the And I be, – will about just if or guess would Bruce, will wondering would doesn't launch launch something sodium safety JZP-XXX discussion, still how sodium the Thanks can questions. NDA settlements? it on comment you made made case available, impacts determined just higher think you you I be then remains reasons.

Bruce C. Cozadd

Bill. Yeah,

early at too trial. first to have regulatory second clinical comment. need one. to the moment, of we put with the to to data before the submission only sense need do the our think to finish to We part package We And both need talk a together. We On trial. process through at look need go our the from question? one, products about makes it We you what clinical I the since,

Matthew P. Young

Settlements.

Bruce C. Cozadd

a to introduction Xyrem could of that impact of decrease typical in rights JZP-XXX impact are product on the and these new specific track the decline market programs development we sales product, of the just meaning to or JZP-XXX. the on settlements, so Xyrem, would itself, our of Xyrem settlement. those the a parts that give settlements not sales very existing caused settlements provisions – a By of product the really to as are certainly Oh, most later the token, the such of the don't same types any that

William Tanner

you much. Okay. Great. Thank very

Operator

Thank Seaport. you. with Corey question to next And Davis the goes

Your now line open. is

Bruce C. Cozadd

next Corey, are you there? question? Okay. Operator,

Operator

Goldman Sachs. Flanders with question Next will come Dana from

open. line is Your now

Unknown Speaker

you the Xyrem available? Can those you sodium-sensitive for for complications? comorbidities and sodium-based touch be even the focus are higher pushed risk broadly obviously received Hi. launch patients, will on given assuming And the And across you JZP-XXX suspension on for OpEx without any spend are of it Thanks Zell This will changes be coming? is at all JZP-XXX, is used then ongoing maybe questions. on you market when JZP-XXX Chris (XX:XX:XX) out Dana. volume when excluding the how generics think or overload in patients will to other

Bruce C. Cozadd

on increased of daily part them research but switch risk intake these if think of when product start contacted second Chris they be their our that indicated particularly know a with a in were sodium maximum the AHA's per level where of is the would medication is, alone, of available. (XX:XX:XX) JZP-XXX available narcolepsy for it does that or to And put a So, sodium during load a patients? market will doctors tenfold important. sodium be in chronically. then patients sodium? specifically product that be question going are way, Certainly, the X the – generics cardiovascular in question, JZP-XXX fraction current that Xyrem. a dose recommended above on Xyrem your would would sodium of increase the Xyrem another to We with because increase because the the timelines, hope gram reception for question under about view XX% the there of you would matter population to back are whom in is there And the with patients JZP-XXX market fear all of – a patients the generics that put not course, would earlier XXX%, are that were of would the our sizable of they a are be part at is taking high that that's from available, patients before In at, on getting this patients our I night

and We're spending, spending. you're impact including a to being – if know told of the is regulatory for do those there sodium now no, as medication being ready life, on submission safer NDA that think of alternative meaningful medication there's if redirecting So against make we lot a of a a as our it on then it. on a assume rapid to And for physicians going difference the you're we to being a wouldn't toward submission resources submissions, X.X put in about day are available. someone progress again, on when pre-dietary the already in can it ensuring I that's would take suspension going rest all NDA JZP-XXX per would adulthood alone have JZP-XXX for early But be. whom of grams patients potentially sodium your – your adolescence,

Unknown Speaker

do the to it any pressure Got against Thanks. market? generic study payers is JZP-XXX order to but you'll prescribe just potentially over on to you there guard clarify, in it. the feel to is putting outcomes-based need once Maybe

Bruce C. Cozadd

say of available very studies intake in large, on about of large across So, variety outcomes of very of is there would excessive a numbers of impact lots already of to lot intake. specific impact long-term I sodium a evidence indication, think the specific sense not the health this but not developed through sodium evidence to That's patients. of good have I It's physicians a our drug.

your So think I question terms those question. in a specifically determine I is. a is look is of will to what at run need great different Whether trials to people how are important think we one this

Unknown Speaker

Great. Thanks clarification. for the

Katherine A. Littrell

and Operator, then next we'll take this take one after speaker, more this question, we'll that.

Okay?

Operator

Perfect. And of the next question will come John Boris line from the with SunTrust.

is Your open. now line

Bruce C. Cozadd

there? you are John, Hey,

Katherine A. Littrell

question. we'll move on Okay, the operator, John? to last

Operator

question And the our you. last Stifel. Samimy come with Thank will Annabel from line of

now is line open. Your

Annabel Eva Samimy

Hi. I for prize, taking question. the my I Thanks get guess.

and to you analogs ongoing the into with Thanks. and I NCCN that quantify uptake? you market And now quarter? of Vyxeos can So, but fourth that off-label on Vyxeos, with about investigators? then, that good just any Vyxeos, that by some give on will help listing, with ability right with going have started you finally, you what trend help and readout that could you marketing that impact other Do second, the – timing can maybe are us of on us listing sort the know to discuss third uptake talk studies the can be

Bruce C. Cozadd

do Mike, you and NCCN on/off-label? take want to

Michael P. Miller

Sure.

guideline you right also use seen, as as received for within said, X who now indication But reinduction much you for our a very largely, may NCCN population. included patients + in X So, the have is following road, the therapy that that any treatment. down induction Vyxeos progressed months, previous given first also patients patients but be first induction, for and in post-remission a XX completing intensive were then the induction labeled and relapsed would

So, populations think labeled are support these coverage are in for reimbursement our provide of that payers' and populations. not and these would indication I

materials. as this, very little with their while promoting said, the we're to just the takes so with And announced then began we we They this and a guidelines it get NCCN. pleased

Annabel Eva Samimy

could those data see emerging, the areas? Maybe when additional we could in be on Okay. we some and do see when studies uptake potential other that

Michael P. Miller

Yang? Dr.

Bruce C. Cozadd

jump just existing of Yeah. and Well, haven't we me even from let in all Annabel, published say studies. data the

just are coming last co-op we've get has year studies then third IST our to you'll think drug the studies, I there. are studies. that And of about the And effort data out see are So up maybe studies of in additional additional approval that that group quarter studies, having and received most Jazz-sponsored running. been talked

data little studies getting at coming of number ways comment? do and Allen, effort is away want right a of out those up you those. so, running. And of We're aimed any a from now, the still

Allen Yang

Yeah.

with cooperative would a was data just I resource-constrained, Celator of that as studies. pediatric there initiated didn't some ISTs they So and groups lot say have they some so And including had well. are

put that, (XX:XX:XX) are that with of course studies and Vyxeos don't and standard and beholden that to think those they not schedule We therapy. therapies MDS, forward. when unfit agents, of to AML, dosing AML sort within studies, the of risk to and that changed. of we intend issues new against with challenge scientific those so and we strategy the and as control backbone the mentioned has we're I complete make Around then combination then malignancies key different those Now, our is populations, But populations populations, as going address new AML, course, some earlier. targeted adjacent AML, the and data we're

So, all of are addressed got about the The of has more by team very but at as these to the end team. want you being label the working know just been that, I hear we aggressively. collaborations we're the data address sort with shortly, of to year, a aggressively, collaborations going series showcasing be cooperative been Jazz-sponsored team last external KOLs has and sort moving of to needs. studies, and of those

Annabel Eva Samimy

you. thank Great,

Operator

like would Kathee to Littrell Ms. to turn Thank you. now call remarks. back the for I closing

Katherine A. Littrell

thank questions. and for and Sabrina, all joining you us the today Thanks, again

upcoming the will healthcare America in quarter. Lynch, Merrill and participating We Goldman conferences this Sachs Bernstein of be Bank UBS,

now of event SLEEP an many ends to in We see call. will webcast Baltimore in our hope also and Meeting you. host investor This June, from and

Operator

This gentlemen, and program. thank conclude your Ladies does in for you participating conference. today's

You have day. all great Everyone disconnect. a may

Jazz Pharmaceuticals (JAZZ) 8 May 182018 Q1 Earnings call transcript