JAZZ - Earnings call transcript Q2 2019 | Jazz Pharmaceuticals plc

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Operator

Welcome to the Jazz Pharmaceuticals Plc Second Quarter 2019 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 Littrell

Thank you, Valerie, and thanks to those of you who are joining our investor call today. We reported our second quarter 2019 financial results and updated our financial guidance for 2019. the Investors accompanying section and available call release the on of press slide this presentation are The our website.

today President Senior Clinical CMO. EVP Miller, Executive call Iannone, Vice Dan Swisher, for President the are President-U.S. COO; CEO; session Cozadd, On Mike and and the Executive Q&A Vice Acting CFO, Commercial; R&D, Development and Young, Vice and President Matt and joining Bruce Rob Allen Yang,

challenges, on this like facts statements make I’d and of efforts. results, operating activities growth strategy, remind we and sales those events and development future regulatory and other some financial you and include to and related and corporate Examples historical relate the growth supply of launches, call performance, activities, to that clinical future forward-looking. product forward-looking XXXX goals, than ongoing financial development future trials, guidance and product statements our to future volumes, including will and rather are

statements. ended that June shortly. duty XX-Q events, in our XXXX XX, the our quarter the to update will for involve presentation are in XX-Q obligation release, risks press These or update differ results risk factors today’s under identified ended and cause quarter and They forward-looking performance We to the XX, could and for accompanying our we March which no XXXX, forward-looking Form materially. to file Form and undertake described statements uncertainties – in actual slide or

website. included measures. financial be call are discussed measures on non-GAAP the performance to considered potential helpful to our understanding financial in On meant release financial presentation a and isolation We GAAP are for or are press measures of They as Reconciliations results. our today’s slide this measures. on in comparable and call, GAAP we available believe discuss this substitute these future past reported not in non-GAAP

now Bruce. turn to I’ll over the call

Bruce Cozadd

significant had year, global portfolio, of and aspects our for diversification thank execution, achievements business, joining our of us. financial through Good continued including product we've Kathy. you pipeline afternoon, everyone, our and and strong expansion. internal across programs development Thanks, This all of R&D acquired expansion

our patients the daytime was with achievements excessive and sleepiness Sunosi for narcolepsy significant U.S. of the recent launch with in or associated of One most OSA. approval

remainder year-end. the year, be approval of on planning for an R&D EU will and JZP-XXX, the package preparing advancing For for of focus our the early solriamfetol programs as potential as the in NDA our

lead the on Rob Patel, pleased some who's our of We're you Nina to on to new our development on legal organization; regulatory department. to activities, an our After details provide call I'll commercial to leading Rob then Matt the will and providing and leadership who executive update and our will programs Iannone, company including update R& financials. turn global D welcome our over

on to with third delighted the in market quarter. and be reporting We're the in Sunosi U.S. sales the we'll begin

of As available to pharmacies was contacting sales care sleep providers. expanded began retail force and our July health X, Sunosi

program. we've first over care and of Sunosi providers utilization with the of sample health X,XXX weeks good launch, our three Over had interactions

implemented this as goal the service progressing robust expenses obtaining patient $X out-of-pocket for little patient of reduce to Sunosi, to optimal have are new with and We month programs access aim payers with a therapy. to discussions as which important

Sunosi's as patients and how and as and the few are in of health strong experience clinical weeks Sunosi with management OSA medications the their patients best switch interest in with pleased to narcolepsy other providers launch, such knowledge they increase to of we their incorporate Sunosi to their Sunosi how a Just from profile. into understanding from care

will underway. and other a scheduling complete the regarding health OSA launching training emerging is pharmacotherapy. the the the pathophysiology peer-to-peer EDS on is future, publications science the programs of near number for Jazz efforts and working of educate in and is and Sunosi be on to care physicians also role team medical of Our providers

the Additionally people campaign the over with million this visited in to consumer half more we and a year, different are of first million kind reached www.adifferentkindoftired.com pleased learn Jazz's of nearly seven visitors about effort their response the disease one to OSA. unique tired. have In awareness EDS

closely metrics to the monitoring progress. We're launch Sunosi's and evaluate leading

received feedback and our by encouraged next are quarter. progress forward We and date the to to positive interest reporting we've look

and regulatory an of marketing we end front, as solriamfetol decision authorization as EMA the are On an submitted for MAA expecting the this November we in early year.

a team initiating We rolling have as launch EU added our EU to prepare major next we sleep in for year. countries key leadership

for to continuing currently with are a debilitating for solriamfetol disorder. discussing We with major associated evaluate to conditions agencies solriamfetol evaluate regulatory We're in opportunities other development program in EDS depressive program EDS.

performance year. X% last in quarter same compared The last the period year. strong to to up to the Xyrem was of bottle X% period with growth Xyrem active of second increased patients again same the XX,XXX volume compared number average

sales Xyrem both Our fully trained and sales for last in new began month. efforts and expanded promotional sleep Sunosi territories on force their is products

promotional from to contribution have from of while minimizing year half of that term with Xyrem changing occur the from short-term can any media goal We look this. a first increased efforts the the positive We our potential territories. disruption forward momentum maintaining longer the

therapies. our approved reimbursement Italy. from area. on therapeutic progress in the on qualify made benefited sales not second similar reimbursement and central for hospital launch. obtaining pricing Vyxeos will In funded Vyxeos, be from the France Vyxeos Now We EU national did reimbursement our ongoing but other budgets In to by quarter, AML HemOnc recently front to

negotiations in Our EU pricing Germany team and Spain. continues

education upward as outreach AML strong efficacy profile intensive accounts In where overall our community particularly trended the of U.S. initiatives, in and for continued therapy Vyxeos the secondary emphasizing we've demand first-line the patients.

that research S. are U. our recent secondary indicates use educational Vyxeos. most Our to X+X efforts shifting AML market from and

and these We them XX to to of by in the In order begin expanding Vyxeos share dedicated AML fourth quarter. voice promoting and in quarter we representatives. to plan train are increase our sales the this reps Vyxeos our expect hire force setting, new

of of for Defitelio commercial performance is Japan's who the Shinyaku to VOD was by the June, in and vials shipping Nippon treatment strong responsible in continued its Defitelio and Japan. quarter. global commercialization Health began Ministry Welfare for In second Labor we the of Defitelio approved

our to We global plans Defitelio for progress make are requested Australia continuing Switzerland. with expansion and in and authorization recently marketing

sites underway of defibrotide and advance. this we global development Our activate neurotoxicity Phase X program to and CAR-T continues Startup are activities study to our for expect quarter. prevention exploratory associated

sites study for are preparing to We late year. our also this X for activate TA-TMA Phase of treatment the

our to complete our of interim of is year. enrollment prevention ongoing X of in X study the Enrollment study been end our an analysis. Phase at Patient recruitment has is Phase strong. and includes the the The study prevention acute in GvHD goal VOD

to expect interim the on of have year. We the later analysis update timing an this

we Erwinaze, ongoing For PBL year. to issues sole we and quarter an due the experienced extended in to further the at this supply manufacturer out-of-stock disruptions expect continue second

remain available patients. component supply patients our taking Erwinaze ALL. supply has treatment Erwinaze of been available is the committed with We ensure cornerstone to working for XXXX to with remain of a the reliability our that within and all steps to to since improve critical and hem/onc control of made and franchise PBL

expanding to ongoing We I'll remain R&D track our planned wrap-up achievements. multiple our our and proud efforts, billion our by and $X first saying global launches. we're advancing in more business half than deliver executing year, successfully on of revenues capabilities, significant and while this commercial

I'll to call turn the Rob, now over you.

Rob Iannone

XXXX, pipeline patients. I'm have of In the collaboration. advancing addition Bruce. life-changing Jazz of you, progress R& program further we for therapeutics our development incapable the that excited Thank with team medicines committed R&D made the diversifying in D we inhibitor and growing to joined Pan-RAF have focusing our exosome on have

JZP-XXX. starting I'll therapeutic begin the in sleep development activities our area with

progress novel We than patients. oxybate resulting less to JZP-XXX JZP-XXX with sodium bringing XX% toward to formulation unique a make composition narcolepsy in of continuing are the Xyrem. cations is

between sodium exceed receive ideal for and per daily in Xyrem a not X,XXX To milligrams intake to context, Heart medication taking X,XXX X,XXX American sodium with the patients Association of milligrams. night X,XXX recommends that limit of milligrams put alone. the an Most

indicated cardiovascular therapy chronic Narcolepsy be comorbid may and an hypertension of clinically researchers disease. risk is have in lifelong increased conditions including narcolepsy associated and a disease with which

of have disease. importance lower organizations, hypertension cardiovascular advocacy health of and public to and the the Many risk societies organizations medical patient professional reduction sodium highlighted

oxidative sodium per of excessive therapies. intake. that We reduction believe prime meaningful sodium risk a case, believe substantial a milligrams to this the In inherent milligrams a upon benefit patients. sodium innovating of with available of represents of for to range patients JZP-XXX of by intake We night XXX improve approximately JZP-XXX a associated to example narcolepsy reducing for is XX

on Wednesday, accepted Data cataplexy Sleep with and XX, X study presentation the narcolepsy in during of Congress World for JZP-XXX the from our in patients adult EDS the been evaluating for oral Phase has afternoon. September treatment

discuss year-end. The the goal we to FDA York. X as to expect with meet is idiopathic of and recently enrolling the also our with NDA in in We hypersomnia quarter study to early submitting activated package, JZP-XXX well New as fourth sites patients of with study Phase

Drug received recently JZP-XXX hypersomnia Designation for FDA Orphan from Additionally, idiopathic the indication.

of in HemOnc development evaluated per determining dose. AML. and administered X on Phase XXX of Primary was continued start during Diseases with cycle Group, efficacy a X objectives COG young Vyxeos meter and combination one X children positive was I'll with Turning June, known also and daunorubicin presented and the focused At Vyxeos in fludarabine ASCO as activities, to our cytarabine units data and the safety relapsed/refractory Oncology recommended Phase then Vyxeos. Children's at with patients and were adults including squared. FLAG.

and XX.X% cycle with Vyxeos. The consistent CRP patients with with AML overall response on based was regiments. best was intensive XX% CRI one response Toxicity CR, of rate after achieving

achieved response cycle cytometry. who after of The XX% XX% flow patients, For overall. MRD and an XX% percent by residual negative objective one no status patients have disease who achieved was

the to broad to benefit a finding transplantation. we monotherapy with study Hematopoietic in that commitments. patients our curative robust successfully who potentially of reach understanding in to Stem development and and pediatric plan is with investigation may generate of program European data additional also the of make both authorities. Vyxeos, our the treatment Medicines Another expect in post-marketing continuing as part and physician's Cell with to from progress to Agency, bridged We're facilitate data important was to XX.X% the Vyxeos patients the these satisfy of study regulatory discuss This also value combination,

dose Cancer higher initiated Anderson MD X Center in of quarter, second risk MDS attenuated a study patients. the Phase binding During Vyxeos

with the Xb study we low patients. therapy quarter, patient expect to first enroll Phase combination onset This intensity Vyxeos the in first-line in venetoclax in evaluating

currently Additionally, study Overall, are active XX two cooperative sites have studies. key there activated group in studies.

development I'll turn Now the program. to recombinant crisantaspase

candidates and processes a quality supplier We of compelling to and reliable recombinant and profile. are new manufacturing, the with goals product target efforts develop continuing crisantaspase our consistent

of Xstudy in JZP-XXX novel Pseudomonas study in a expression and that is healthy and of sheer U.S. uses based a Phase volunteers platform. recombinant safety levels. the asparaginase measurement We met efficacy a JCP-XXX crisantaspase parameters fluorescens on completed activity the

with and support FDA X/X to required and Phase results path Recently information a BLA. for we on agreed forward expectation these met to study of discuss design a

to to plans will X/Xstudy pivotal COG We the working initiate with and this with a finalize year. single-arm be protocol FDA later Phase

need closely other with FDA, for goal coli-based who the soon option therapy health as bring this our Given to and continue patients for as patients is COG to hypersensitivity and possible. E. experts asparaginase, work critical to global authorities reliable to treatment develop to

precision high-value on in an key development early-stage Jazz's therapeutic building multiple areas this effort fuel focused pipeline a to are we In portfolio with R&D completed to across oncology two broad year. transactions expand we growth. of of potential our future assets stages In

its first potential in the Codiak was Exosome innovative technology malignancies of treatment and tumors. hematologic for The solid

acquired there since recently progress made program Pharma’s has RedX of Pan-RAF has equal generate potential early inhibition. RAF inhibitors from treatment a RedX while matured the best-in-class prior Pan-RAF development Pan-RAF the in RAF differentiates of program advancement Pan-RAF More believe RAS potential development, inhibitor and to tumors. published RedX's for is candidates and work significant with other mutant inhibitor. for and inhibitors we the This we

to as cancer transform early-stage opportunity treatment. these programs future about excited provide they an are We

call Matt. I'll the Now turn over to

Matthew Young

top X% we million, quarter were increased second to good Revenues and Rob with quarter XXXX. In of million in growth. the $XXX our to afternoon, and pleased $XXX everyone. second bottom Thanks, compared line the

a $X.XX range billion We previous are increasing to to to $X.XX our for $X.XX of billion billion total revenue XXXX range of billion. $X.XX from guidance

our of Xyrem year. up the sales net about million performance delivered strong key talk of quarter XX% another products. $XXX with $XXX from last million we'll Now

and in are $X.XX range range growth. our the of the the performance billion increasing As $X.XX a XXXX result, Xyrem the mid-single-digit strong billion net half year of maintaining for first to billion Xyrem of billion guidance sales previous volume to of are our $X.XX $X.XX we from the expectation

the in XXXX. for compared to was the Product million Turning same to in significantly Erwinaze. Net quarter million availability $XX reduced. in $XX period with sales quarter the second

disruptions We create quarterly will to supply remainder expect further which the continue of XXXX, for variability.

are Even million. our XXXX range sales guidance maintaining so in net for the of we Erwinaze $XXX

same quarter Nippon increases Defitelio to as were to Shinyaku, million, Defitelio. the sales included XXXX, sales in demand. commercial of period net Reported they launch to Second in partner shipment of Japan XX% compared primarily $XX due our vials prepare also to up a

to contribution We of are to sequentially from X% second quarter maintaining $XXX Defitelio increasing and year $XX increase guidance first of million range EUs. the increase $XXX quarter in this for net over were the sales for quarter sales due of net million from of second an million. an XX% our Vyxeos XXXX primarily the

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

for our Sunosi a we July. early net the sales which from total As includes reminder, launched revenue U.S. contribution XXXX in minimal in guidance

Sunosi gradual net insurance after current XXXX. more $XXX as indications sales We coverage of expect to than ramp sales net XXXX and up in in achieve could its U.S. believe much Sunosi million we expands

$XXX second Turning revenues to operating million XX% the SG&A XXXX. for revenues total compared million quarter $XXX adjusted second or XX% total quarter of of to of to in expenses, increased XX% or the

the these ongoing in second in to SG&A quarter we to of due Adjusted half our and product expenses launches increase and primarily year. increased the the planned expenses expect

$XXX of million to XX% SG&A guidance. our XXXX of in to or $XXX range expenses For million adjusted revenue for XX% total remain the guidance

$XX Adjusted for expenses compared XXXX. in revenues was in to R&D of of expenses or of XX% XX% our second reflected CombiPlex million JZP-XXX $XX the solriamfetol, Adjusted were and second of XXXX the quarter revenue R&D quarter of development quarter or as the partner programs preparation IND-enabling support million with NDA total and the growing platform. package, JZP-XXX, of the investments the of in work defibrotide, Vyxeos,

R&D increasing advance expenses and half We as our expand expect in continue to second R&D programs. we the

guidance of range XXXX, For to the to $XXX in R&D XX% adjusted approximately revenue total for of remains or guidance. million million our XX% expenses $XXX

XX%. effective our to million the rate maintaining asset property included range -- of quarter. XXXX in transfer XX% adjusted On are the the intellectual tax GAAP of rate $XXX resulting guidance We tax in second a tax a an benefit effective one-time basis, from

XXXX of to to to for $XXX X% Adjusted the second the income adjusted net net increased income second to and quarter diluted in million in $XXX second increased million per of quarter quarter $X.XX compared XXXX. share XX% $X.XX compared the

are outstanding guidance EPS a As the $XX our late our our average in adjusted and that XXXX is XXXX XXXX. we guidance half significant Please reminder, possibly EPS of million. non-GAAP to of approximately impacted by XX range diluted and made adjusted first maintaining $XX.XX for XXXX note weighted shares repurchases for share of

during to quarter of we operations. million repurchase of second million remaining from as $XXX shares had $XX $XXX repurchase million used June. under In share the quarter XXXX, program the our in We generated cash and

payments quarter, totaling Sunosi. the the FDA's of to million milestone During made related $XX we approval

of $XXX had and investments and debt. $X.X equivalents, $X.X under XX, billion billion borrowing capacity cash, in in As outstanding balance revolver our June principal million we on cash long-term our of

potentially novel We're addition resulted launches development pleased this pipeline. corporate have companywide expanding and technologies in the with underway rapidly candidates that best-in-class of year strong and a execution efforts to product with multiple our product

fuel second As we we positive multiple XXXX, head half catalysts into the expect of our momentum. to

at forward --. presentations to JZP-XXX data several solriamfetol including data look We and

of preparing to also are Phase year-end. and On forward looking early solriamfetol the initiating JZP-XXX We're as expecting the JZP-XXX. the regulatory on X/X front, as NDA an decision study for we EMA

business focused and our we on of are and to shareholder on our for R&D part internal to and access prioritizing successful product strategy preparing patients launches drive medicines. our portfolios driving delivering diversify to value, and and efforts As importantly their commercial differentiated external

over the to Thank now on call you turn back the us for call today. I'll And Kathy. joining

Katherine Littrell

Thanks, during two everyone their to so you today questions to Matt. limit request this that that call, has We opportunity question. one an yourself to kindly ask

queue. the call reenter We can will address the after you or questions additional any gladly

With that open said, for operator line questions. the please

Operator

first you. [Operator Instructions] Fadia comes Ami SVB of Thank from Our question Leerink.

open. is line Your

Ami Fadia

provide to acquisition Good FDA Perhaps, discussions additional you're Maybe with could like of if of would evening. us give you the the Hi. that details duration Thanks of cost questions. relatively current of around us run. the cost sense how asparaginase the Thanks. for study the manufacturing the – for around endpoints the asparaginase? the product some And your going study. look some cost also this structure the of to

Bruce Cozadd

Ami, Bruce. So, is this

release we're but that be that JZP-XXX although On now to and size X/X I modern and in on – the this and your to part a question, answer designing about right jump question production we not Rob pivotal can have going methodology the of in endpoints we're second phase – Phase trial.

Rob Iannone

Bruce. to Happy

patients. what we So that that discussion activity. clarity With that on with design having came anticipate U.S. and arrived collaborative the around was the that, from so have we would at productive we the meeting approval We endpoint a starters away really for single-arm XXX very is primary FDA support a I feel the asparaginase enrolling where design ultimately study

However, an earlier an interim BLA after could there patients. analysis That opportunity for submission. support is XX an

Operator

you. Thank

comes from Wolfe Our Research. Akash next question of Tewari

line Your is open.

Akash Tewari

Thanks so much.

on content? get Thanks the XXX's a including XXX study on high warning didn't kind some meaningful Vyxeos, us you much. dynamics? other a get see sodium So you of you it it the not do of Will new sense back Xyrem's change and so give market they changing half you run of of narcolepsy oral label How year. looks options that the And any a considering space approvals way? readouts like we'll current versus could these in this in then can on language treatment head-to-head what in outside

Bruce Cozadd

Yes.

On new of treatment the as with patients the and well about as course. course, we're options, first expanding Xyrem patients of We've already for now happy. year, patients this EDS number treatment pediatric narcolepsy options the question OSA and of starting narcolepsy patients to narcolepsy for launching introduced Sunosi label

Xyrem As those reminded And at patients from take we we're under-diagnosed number know undertreated you treated. is that not it, take is small of look a drug the an the number for expansion effective and of think the either remains diagnosed are for narcolepsy, number disease, while but that the that disease. narcolepsy potential patients patients the treatments to particularly suffer of number yet narcolepsy of appropriately who that drug patients the that diagnosed broader of relative are we and

so is And to think treatment. additional and want narcolepsy additional community. for narcolepsy that of treatment conversation of on be options, a the thing our with treatment we focus diagnosis really continue important part we patients to correct the And

question can JZP-XXX, Maybe on little on let Dan your that about I bit. talk a

Daniel Swisher

Bruce. Thanks,

so XXX remind that data the presentation – to the Just September. on Conference Sleep that just upcoming top-line will too World people Phase X in given the the oral of have readouts milestones presentation we've at data

We and in label. the initial premature with quarter in FDA clinical a to do will that the relevant study albeit pretty but FDA, endpoints content this label. to looking now, not clearly be sodium with that sodium reflected the the obviously having with and about streamlined we'll level talk label FDA that fourth with got meeting package Xyrem around NDA the It's a in be approval get the that little meeting a in we've to was have to discussion scheduled pre-NDA put together that

to how supplement. what in publications. to we're think in real-world data both both might on we at and do continue about market generate how label in want also the studies What's terms also but of data additional I that looking think that to increasingly really that

Operator

Thank you.

Jessica question JPMorgan. next Fye of comes Our from

Your line is open.

Jessica Fye

Do approval is support pivotal questions. might any see potential for it could Great. trial? taking would help of driving second focus of about you. recruit pivotal XXX, us you take how think light Europe? subsequent global growth. that part take to company's single supply early Thank afternoon. Or Thanks that that On X/Xparticularly was can issues? in on this in Good a part the you are my And the long Phase

Bruce Cozadd

part I projection process. a get that going time need trial. line protocol, to sites up We will So, and don't open CEO, start enrollment is remind Jess trial expect do COG believe strong go an provide on to We that I of there's think the certainly the condition. on finalize and this we're this specific and of will membership you that orphan for getting well. interest XXX running we

While do over global limited be there's cancer, I'll it's of trial going for But the number everything like to growth common Maybe we this who patients can we're childhood right eligible move most this. the to question Dan. to still would a turn along.

Daniel Swisher

Thanks Jess. Yes.

as yes, side, FDA. to the just global regulators effort provide additional the market differentiated new are possible, and think both looking with safe our focused similar market we where treatment other potentially interactions same to-date in our clinicians options growth streamline as get for But On and to regulatory that the are really need, products. we to market quickly reliable, conditions countries

actively input, we're FDA the we got we'll at and now that other update planning the approach calls. future So regulators how we've

Operator

you. Thank

Our next Stanley. Risinger from question of David Morgan comes

line Your open. is

Zhu Shen

David there. Reisinger. Zhu for Hi, Shen I have two It's questions.

second XXX is to investors the data efficacy question is one replacement should any released the Xyrem? first is, the associated profile XXX risks September formulation? how components the Thank And are assess there of when its with The you. relative in

Bruce Cozadd

particular sodium, David the way in had not we new reformulate So to concerns do risk Obviously, collecting the innovative regard. introduce mixture used provides cation that we safety we certainly in that this lower we benefit on are we've don't have all a in to in work, this that additional our data product in of any think product. but mind that would

endpoint already the either to this with about in we talked or or when Xyrem on naïve with design There's primary data remind trial. treatment. also in line people on just little we're the we of addition efficacy, released that, that to about On a entering arms trial bit a data top treatment how that anticataplectic naïve Xyrem trial to think from Remember secondary pre-specified patients was collecting the for lot treatment the endpoint.

trial we're these they the patients taper or as watching really either off anticataplectic. come and ramp-up JZP-XXX their as on they on so And down enter as different they of groups Xyrem

watching and about in Xyrem at lot this efficacy groups of those on how thinking we trial or relative compares the of to So patients then each to that to and both data in tolerability naïve looking past had us a treatment gives the and period over would expect see prior run-in we've what information.

at In where period the happened trial end at the to two-week the primary randomize endpoint a we on based our the primary end how period. randomization where cataplexy a for endpoint came and of and them on or and the regulatory looked kept people to the one sense back results that placebo strategy we attacks in out you either was XXX, gave supports we what the over the

both So World at we've forward more data look as already information told to you and forward. Congress that a we part was the presenting of sleep but the little move we strong,

Operator

of from comes Gary Markets. BMO question Capital next Our Nachman

line Your is open.

Gary Nachman

those are do narcolepsy? OSA about? going the some what focusing And How came and Hi, to actually markets quickly you the is then with pretty Gary you happen potentially coverage on early reasonable. prices could think WAC the Nachman. a reading that you think Do you team you or bit Thanks. payers out? starting progress guys more from are more shake your out make to talked on What with two beachhead

Bruce Cozadd

coverage last OSA. side, and have glad, do I'll payers and your speed on Maybe Gary know Mike for respond that. name the Thanks we then now. So Howard

Mike Miller

Hey Gary, Mike. this Yes. is

well have the not data. think It payer I nicely. already giving differently have about progress So responded At I the it. payers we is this than any -- are point, discussions the what think guidance have to we

your to importantly patients EDS. are all think think point when you narcolepsy treated almost with OSA, narcolepsy and I And about have being

is natural as plans. launch beachhead So said that in you our a

the with the that exists gone discussions opportunity OSA pulmonologist the well. and the opens really, though for real have up Importantly market brand. Those really

of and I the X-hour activities indications, the efficacy been lack received the differentiated think in particularly MOA, has robust interaction well. both drug the

Gary Nachman

you. Thank Okay.

Operator

Our from question next Raffat of Evercore. comes Umer

Your line is open.

Umer Raffat

two the questions. sizable Bruce, is, today much beyond expanding in understand the valuation year-end? reliance so the a urgency of Xyrem? M&A, especially Thanks how ranges of taking Are L guys we in one Vyxeos so has should on for expecting Xyrem the doing? in a franchise for what's the perhaps first have before level my on you're the I looking organization Specifically instance, of around I'm in and concern the you lot the reliance you at? of transaction be competitive backdrop the been sure investor P&

norm And the we pace noticed I July there's the that increases of but last to X% secondly this to towards a the year, again? moderation of XX% was you Xyrem the back increase for in the move price year Should be going with sort now a forward expect range. Thank very much.

Bruce Cozadd

many increases. on the years on take Umer your question commented forward not now price second for We have the I'll first. of -- on Yes, part thinking

ongoing our the important moment R&D that of when at it's narcolepsy look responsible patients. particular and we think I in arrive level situation time to at supports do to a help to something commitment

It's this what this do just So trend. happened to at new setting we think I of of terms period. a wouldn't in

terms nothing diversifying On help try patients continued expand pleased Xyrem's tremendously strong question we top of by ahead to pediatric our with more continue your and we're narcolepsy as product. years as in see second more we'd population into performance in line, that than the this continue the like we to to

better we've ways and includes Jazz, patients course the remind even that in of product years is where you under of will number about economics authorized a in and off talking there an future to been our come. a still including while components settlement to introducing competition agreements that there generic be generics efforts for Also the narcolepsy are some

into that business. we to growth said love build additional But our would drivers overall

broadening advancing in to look by and by R&D products continue our that R&D pipeline. our existing We at products by growing pipeline

market our we're We remain bit products dev market little there about in type on bringing maybe ask and Matt for of and today interested how near or corp those comment marketed assets. in products about we efforts into to a as think I'll well, efforts

Matt Young

Yes.

mean, I are about funding. and leveraged very cash around finance strong. enthusiastic we're before remain $X.X relatively build again, to those evaluating currently And markets continue firepower, and So any external at what we billion

continue We to both to build assets or pipeline our broad evaluate opportunities. bring product the of we to the believe in have acquire of look really opportunities range spectrum across and a and capacity

and early pipeline-building So well larger stage on while done in clearly focused ways existing very upon build later opportunities of franchises and we've looking our both we're to even. a couple as transactions

Operator

Thank you.

Next question comes Fargo. Wells from of David Maris

open. is line Your

David Maris

proposal Grassley afternoon. calls ASP The of coupons widening Medicare for Thank exclude for the Part manufacturers you. value Good the calculation B. for to

So bit can that's your related exposure? you I about to any exposure, a little use B color mostly couponing? the imagine And on would Part Xyrem. Medicare Medicare of maybe overall talk

of just So year this, of flat And or first coupons year to it if looks conservatism? for separately, maybe the don't first you then Xyrem? are for you. addressed patients the half of to Or assumes second know Thank but half that the Xyrem year. things – reason to any I what project use percentage the there that? second Is the is guidance

Bruce Cozadd

Yes. Thanks, David.

like think don't action how to pricing question a we or to your outcomes of going have land. it's government and has the otherwise. part host don't first that feel through landed of direction, I are the there yet We may possible approaches legislative where pharmaceutical On but know we

on sort Part mix company average any as feel our a of a generally one a commercial have I'll D up line don't discussion, products So pay. we like lot particularly just say rather Part or toward B, product-by-product than of piece I coupon and of otherwise. skewed through going

extreme an at measure. on we're think don't I any

other watching like companies So are what is happening. we

look on the would the of as Xyrem outsized question we then have months give can we'll move are think And types impact overly Matt clarity more and think over general, few the you we talked your next you better potential the toward end the But On an have sense I'll as that. we of our maybe that things address into year. a maybe company. in the we at have don't product lot sense portfolio the and fall current result. about I others of a better being

Matt Young

David. Thanks, Yes.

say the focused sleep we first I'd this two on is field force remember had our franchise have in quickly, products. time Just our

for we portends expected scenarios – want what as question, think your range nuances reflects we're there's to just to take uncertainties I want year some guiding nothing to regard. we progresses in that materialize our those a could that while account. And believe that the and specific into make of So of count guidance

David Maris

Great. Thank very much. you

Operator

Thank you.

Gerberry Our from of America. Bank Jason next comes question from

Your line is open.

Jason Gerberry

Thanks good questions. Hey taking evening. for my

outside how if Can Erwinaze end to pivotal on trials NDA pivotal XXX also you confirm Just Erwinaze? from does trial implications to process have the PBL XXXX supply implications get you were JZP-XXX. concluded? agreement? update And clarify that is able accelerated and then this this that as Does as And indicate or have the are of has their your bidding on the the of relationship? does differentiate stage on before might any

Bruce Cozadd

question. Jason to take Yes, Dan maybe this I'll ask

Daniel Swisher

Thanks Jason questions. for those

that programs we've we're a and a we've of approaches healthy from, on just to been one happy volunteers moving other that's crisantaspase now, years Phase got good X/X. into now For number focused experience recombinant at looking

to PBL. We've be long-term. partner countries, market. continue continue We've longer-term built the for short-term short-term were got most a and involved filings the we got We've to and for both and We that so natural KOL regulatory with believe PBL relationships. in

it the underway in that. their In still still and process, terms comment can't that engaged are we of is actual process. on That's we process. But

et in other reliability terms times differentiation little much premature modern cycle And now cetera. quality, process, manufacturing it's of than, obviously, more a and high faster

EU supply confident the got like ability to geographies approval launch. we So into we've we feel into would grow where not and to but have the the really very been Japan able market about segments the have

to a product. lot second a opportunity of So have there's

Jason Gerberry

Thanks. Okay.

Operator

you. Thank

Randall question Capital from Markets. comes next RBC of Stanicky Our

is line open. Your

Randall Stanicky

Thanks, Great. Bruce.

think about for as you looking Or we one this First upcoming about be should we we think anything XXX, thinking else foreign for the is is, there Should REMS? we for? largely FDA are meeting about? what

the little understand midpoint. Matt, run first half Should up infrastructure think a new half more the over of forward? appropriate been lot I couple there's first SG&A about flat years a half. rate this And then spend it’s Last going commercial into secondly this. of a we second for as half back going half stepping -- XX% SG&A at over the infrastructure in about back

Bruce Cozadd

focus to focused But patients, we making we first We across synced the just sure of at and submit get sure we don't that the make making pre-NDA optimizes and the handle On to to board. product this SG&A? advance much think to meeting particular as I ultimate your that's going regulators. of broadly that product on so just a Matt, sure know, approval a be we're in regulatory question, the meeting meet including will on has part of it our we that that's think this interaction way REMS. want package significant high-quality up want we review the but

Matt Young

a in ongoing even investments sure. Yes, and launch July of dollar hiring sales the before of just making expenses expense given it then medical early Sunosi recall marketing for picking Certainly while the last then we're year, basis on acceleration been with Randall. be launch. the the certainly And and will force investments through field the formal the that and for some of that up had U.S. accelerates but part of

doing also result theater or in anticipation year our of early are of the next. activities and some the later Europe in We this European market in hiring in building

we or commercially And investment. big additional in investment – well mentioned of an as a that's making an so this Vyxeos this year. reps, as And half behind back with – XX the we

on commercial basis an in would again layered ongoing significant in a I uptick again, support So costs, those performance. to be should expect that are

Randall Stanicky

Thanks. Great.

Operator

Piper Amsellem Our Jaffray. of comes next question from David

Your open. line is

David Amsellem

Thanks.

cataplexy narcolepsy, that competition term? going and can also regarding potentially long subsidize to planning Is how through that would much complementary what could Sunosi extent to you thought you aggressively to the on secondly given XXXX? Thanks. sample Xyrem to? remind exposure over out-of-pocket you're that So and be us think long aggressively? And is and you've pitolisant just then to you're And long of something how is planning persist

Bruce Cozadd

Yes.

sampling think this We of get our to benefited of a with product. of with significantly to experience the treated good underlying and HCPs lot trial give that's patients on and Sunosi on We'd the clinical gain to David efforts. saw We opportunity goals gate certainly the and are our So access early out our patients time. patient Sunosi it's an over experience like product. excellent

to continue our to over gain and of In to to how time that payer our over time, Mike have how efforts terms plays will I impact out certainly but described access the degree on an programs do think we'll that which need work. we'll watch that out

how we use for have I'll this comment use more maybe maybe often see we'll Xyrem my before potential address Rob on pitolisant But in ultimate comments that, in with with other wait generally. on Rob Xyrem the make an can remind combination of approval for patients I'll On that. pitolisant agents. you informed label to could

Rob Iannone

Sure.

we know who are treatments. using are Just often to also reiterate on Xyrem that daytime patients

with need overnight So that's that an for the may That's certainly will obvious be the pitolisant. the for case Sunosi well. Xyrem with and a possibility we think as benefits

David Amsellem

Thanks.

Operator

you. Thank

comes Our Oppenheimer. next question of from Esther Rajavelu

Your is please. sure One isn't moment mute. line make open. phone on Please your

next question Our comes of SunTrust. Gregg Gilbert from

open. is line Your

Gregg Gilbert

to Phoenix commercial given arrangement put with on there my larger in here. products longer question full speak kids and of the in we're Back data is your about the other bit I talking And scenario young opportunity? supply that extended context you. the Vyxeos. strong you other around about plus half-life a and Thanks. adults think assume Can and when XXX are as your Based about whether file, a how that part could you any very is in? are you to talk market on half-life or Thank of version little AML intention interested can you relapsed/refractory or

Bruce Cozadd

longer in the look one have product first earlier deck we an into dosing that. But slide that is not on make fact that the clear at fact less is we taking in will We It's be question, in Greg to half-life regard. see So another advantage. frequent website, in for more our product, the about product. similar attempt which your available of on talking our do to the a JZP-XXX not to be Erwinaze pivotal as potential we're trial you'll

it's market question. talked I about In here. great much opportunity terms And of a on the the Dan market how the is larger for products multiple think

that's meet to able foot gas been terms of to and haven't in off market adolescent promote the need caused to expanded adult use existing young in take market. for We continuing certainly asparaginase us of our

and Dan with broader I the beyond Japan even potentially specifically use. new geographic but to approval to do clinical product open of think do that applications, in no up its additional ability mentioned investigation expansion launch ability limited could And product. the

could significantly potential. there's use for So JZP-XXX unlock asparaginases that think and overall, we a expanded think we of that market help

And deals just that with On Phoenix, what much before publicly maybe the bit. potential, Phoenix a terms talk Vyxeos more than I broader in we're talking here. little we have think say I'll what said we've other ask that to a than Allen to don't about are that little got of in we've commercial about

Allen Yang

think is Yes, than population so ALL. pediatric Bruce the population pediatric AML to rare I clarify. in In

right So population. that an in is small represents data the it But think a what drug ASCO opportunity is that pediatrics. I is effective

different AML is still relapsed/refractory AML, profile is active. the with therapy-related drug This highly disease, So a the not population the or AML-MRC. younger genetic high-risk it's and

the indication. drug so this wider fits it And implications our outside hypothesis has current that of

Gregg Gilbert

Thanks.

Operator

Thank you.

Annabel Samimy from from comes question next Stifel. Our

Your is open. line

Annabel Samimy

my questions. taking for thanks Hi,

of off piggyback the for questions Xyrem. to narcolepsy Just some of

a you're in You market any pressures if mean, with new competitive options viewing might you been new the how want mentioned there's narcolepsy kind market and Could to I you how always you evolution landscape? maybe playing know a this on sense you've us rebate available? Xyrem entrants. for affect just give of if on the payer expect

the have, you the do new have you Vyxeos, of Thanks. any the earlier with MDS really design? cities been populations kind study in on some that additional And on high-risk Vyxeos treatment? move there their of touched and outside has city I updates comfort you guess of this, And populations but any to on then

Bruce Cozadd

terms treatment important On Xyrem this as again patients. of in the an view option we for payer landscape,

from say anything number We're to don't whom a think think on patients of in what that on in doing want a your AML Xyrem been payers. secondary it's On that question of frontline AML I'm I beyond a to your understand treatment not Rob think have It's have many important terms frontline We on of for well quite that. I that. Vyxeos a the high-risk We could on to in on, maybe we treated But to number MDS, we're particular Vyxeos, maintain question. pressure are I is committed I access. the of jump patients. years. treatment. medication for who sure, ask

Rob Iannone

Yes.

the any So Anderson in on that, study mentioned MD you MDS. studies? Allen the other have collaboration we've do as comments, in we are through activating prepared And

Allen Yang

Yes.

I think we've cooperative of one publically Europe study groups. disclose randomized in that a the by conducted be will

as a is transplant So in is that population fit eligible there well. just MDS remember

to less population. So which patients of I older be your with in then And a tend have usually fit. disease and that you current with is as could we dosing alluded regimen those the Rob think patients MDS, to go our is collaboration MDS

add, Walters and And but you so risk Jorge of on in building for doses of you're generated we'll what lower talking exploring I think sort we patients. meant a by Cortes. the just activities about younger think earlier have standard by Roland I to those are number fit less patients data therapy, frontline And

single to Children's back as think a already cytarabine the the This this Group, relapse/refractory about data to so exposed excited is population. it, was daunorubicin. were alluding a Oncology agent the of I and in that difficult-to-treat They things one ASCO from used we're patients And patients. again,

a You very high had CR rate.

as confidence gave that's as as a well. be very I MRD see a high in to populations that common agent I pediatric study. well. test And a moving to Children's you'll And the in Group other think You think had going Oncology that and to rate frontline this frontline theme large

Annabel Samimy

That's Yes. Thank meant. what you. I

Allen Yang

you. Thank

Operator

Thank you.

of question Citi. Liav next comes Our Abraham from

open. is line Your

Liav Abraham

afternoon. Good

is various the take consider review Regarding have possible important Thank you voucher drug? how to you for And of this market into get JZP-XXX, XXX soon you. to the considerations FDA you your drug? for using review and given to some as account it of Bruce the as commercializing would

Bruce Cozadd

Okay. Liav, question. – great great

We other we of as are haven't think might We we as patients have that for we it quickly to the that for patients respect – can. to announced own forward represents advance an looking we uses well. are with what there number a XXX ways to PRV getting our intentions as important are and and PRV. do said, to That

So are I about we this commenting perspective think a avoid from more rapid that we've on where good to made timeline particularly point. But at that do going we feel progress. we're

presentation I our are now. XXX back think, looking Got And already the forward data month you look enrolled that we positive next preparing trial if We're NDA. well. results. underway an

to forward we're good So look feel the it in making bringing that we progress program about to and market.

Liav Abraham

Thank you.

Katherine Littrell

Operator, question. this will be last our

Operator

back to Thank Since over I'd further questions, call for the no like you. closing to turn there Kathee is remarks.

Katherine Littrell

I think there's…

Bruce Cozadd

line back Do Esther is see to the go if you and want to unmuted?

Esther Rajavelu

thank so question. Apology for taking Hey you much for my earlier.

Defitelio. was expect for in a What longer? Or last remainder of to Just on the just And the quick the XXXX? should question quarter segment benefit the that variability quarter? did

Bruce Cozadd

going Matt, characterize to the… we are

Matthew Young

U.S. and Yes, the we in both from saw on mean growth volume basis that. Europe still I apart

growth so And we're the board. importantly seeing across think I

even consider that just to timing environment. will within describe inter-quarter the that as And that occurrence we results. relatively and availability transplant the way given wouldn't this it being be I true to it rare of material product transplants a quarterly VOD relates with So

based So will just that we effect of still I think presentation. some patient see on

Bruce Cozadd

us Vyxeos of working to super Erwinaze late. are our launch on really But yet. Vyxeos the done Xyrem I U.S. corp including will where challenges, busy trend, of a feeling going how we've start market of That say we progress about of leaves in the pipeline, really lot to good accomplish not We're year. half staying back the the We've side. rapid R&D the dev Sunosi address good got a and the in strong we're half in hard team positive growing of to very the coupled first the seen with with Europe, Defitelio happy year, particularly performance reestablishing a strong in

forward year progress don't for year. start I want can want coast to sound the I through looking our half great our a So the the to to come. reporting the think to months like in we're I employees to thank second of But we and make it

Esther Rajavelu

Thank you.

Operator

questions at further Kathy no back call showing I'm to over for the any turn you. remarks. Thank this time. closing I'll

Katherine Littrell

you for thank again Valerie you, and today. us Thank joining

Fargo Congress Care Conferences now be we of Wells see an also will investor update in and World our This and participating Stanley Morgan the we'll the there. We will many around call. upcoming you end Sleep Health to host and hope

Operator

does Ladies and a today's and gentlemen, Thank for have participation you you. Thank your wonderful conclude day. this conference.

may You all disconnect.

Jazz Pharmaceuticals (JAZZ) 6 Aug 192019 Q2 Earnings call transcript