JAZZ - Earnings call transcript Q2 2018 | Jazz Pharmaceuticals plc

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Operator

Hello and welcome to the Jazz Pharmaceuticals second 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, Andrew, and thanks to each of you for joining our investor call. Today, we reported our second quarter 2018 financial results and updated 2018 financial guidance. the Investors accompanying section and available call release the in of press slide this presentation are The our website.

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

Bruce C. Cozadd

key second recommending CHMP across long-term a we've adjusted an last from for to and pediatric Xyrem Add-on we New CMS for [NTAP] options regarding made at year productive grant or a Kathee. apnea in objectives Thanks, corporate We sleep Cancer patients results collaboration Technology you execution Center Xyrem for with quarter, our Xyrem our and everyone, evaluate the growth XXXX additional treatment for with afternoon, of Good had with excited joining our potential few this the We're for the toward strategy. hematological and with to leaving about highly and solriamfetol strong agreement business. Prialt; execution advancing malignancies, us. presentation thank an growth A significant efficacy progress date; settlement sNDA XX of with for authorization with bottom XXXX narcolepsy focus market MD of on two positive line narcolepsy. long-term highlights October to one Anderson and include: sell patent since Vyxeos; PDUFA an adult announcement related ANDA obstructive Xyrem rights Payment with and filers, by safety of Vyxeos; a SLEEP and a reported pediatric Review our litigation; filer our on patients Vyxeos; top patients an basis; of ANDA remaining initial Priority of acceptance double-digit only narcolepsy opinion for the meeting of

centers volume, In growth of transferring grow the multi-pronged in in the R&D profile of represent to saw Now to hospital community backbone demand efforts quarter, to due updates this our our can academic led in value you provide of to centers patients continue relative there majority continue with the believe We unprecedented mutation has key oncologists Matt commercial, quarters, and product regulatory, as on and AML globally the environment, although opportunity launch some AML. it status, of treatment and generation to we and therapy, multiple Academic our we for the AML. significant I'll some U.S., of and Vyxeos setting. the in to second to to a expand of complex multiple part for and courses reinforce update with our agents have Vyxeos the is believe stages the soft. strategy new therapeutic previous call therapy. then quarter establish turn consolidation community we to early and as relatively Vyxeos's offer is chemotherapy introduction treatment decisions data based on differentiated activities, advance options patients over phase was more patient We confidence upside to on financials. the

and opportunity, treatment have to We not have the overall clinical changes can patients behaviors impacted of the that Vyxeos time. agents understanding physicians, incorporate confusion. and into care complexity AML for recognize directly some take how decades-long they these near-term some changing new market and added practices While management

Comprehensive overall consistent we NCCN physicians an importantly, including increased data can bring our amplify in with for that published expanding patients' and Clinical Phase value the in not promotional treating survival. field messages some tools the Journal the Additionally, X Vyxeos protocol, important manner as the emphasize these research design, team July. recent XX% a in Phase dedicated Cancer are product the to the key be opportunity of market materials outreach, will improving recently X label, this The X conveying we indicates AML our that and and study To Phase penetration study and by to in outcomes, see market. Network] Oncology our [National the Vyxeos

On on-label the reimbursement support. strong side, we see continue to and formulary commercial use uptake strong for payer

and Importantly, will substantial as week. application to by technologies. our Technology clinical Vyxeos beneficiaries' Payment a last improvement validates access over support approved Add-on Vyxeos CMS New for This Vyxeos was existing Medicare

and early support sales Our is team of potential are Hiring EU training September. and essentially launch complete. our European Commission Vyxeos approval teams by to of preparing the for medical

making available reimbursement of will such to secure the with to UK, across individual EU and patients launch the pricing in We're in although markets. we forward select Vyxeos France, Netherlands, rolling EU, Our Germany, Vyxeos looking Nordics. take markets begin as to the AML recognize and the it time the will

have the accelerate with and variety NICE announced final our We use collaboration a in the us groups of believe in appraisal to over for the of the data the submitted in generation fourth technology quarter. we and dossier that key Vyxeos. to Vyxeos to decision by Vyxeos settings, [National our patients and the excited Health key anticipate We We're for Institute our of to with a MD working leaders UK of Excellence] and that study development value offers as and leaders oncology NICE will assessment Care ability for Anderson, confident opinion and such key recently expand leukemia, Vyxeos in allow remain time. enthusiasm

We've earlier approvals of efforts are to VOD-related for Defitelio, educational transplant greater have the we're support global as our patient ensuring team remains that oncology of and efforts benefits to Defitelio black-box are these vigilance progress created in believe resonating well the with and and adult our strong recent pleased VOD U.S., physician to improved as awareness recognition, diagnosis, medications Turning outcomes. We physicians. the of with warnings VOD. understood treatment treatment made committed well

the our for of On VOD prevention side, X enrollment X the is Phase ongoing. both graft-versus-host Phase in development for prevention acute study and of study disease the patient our

protocol regulatory pivotal with are We development TA-TMA. the upcoming for optimal for treatment on our authorities collaborating of actively study

challenges, do [Porton manufacturer, For Erwinase, future to can improve to we while actively unfortunately with have to supply. we PBL supply that the are of we Biopharma], everything reliability continue working

Xyrem second number same period XX,XXX year. quarter the to on area, our JZP-XXX, to growth second sleep bottle to of performance the X% in compared Xyrem in increased period our last therapeutic average same to with low-sodium patients the of starting and XXXX, volume quarter, year. compared oxybate Now The active of strong the with program. was up Xyrem X% last

During rates. we observed approval high and payer the second consistent quarter, reimbursement

and patients, has opportunity diagnosis XXXX, pleased that we will to is our increased there diagnosis disease which that throughout are new program, for awareness of narcolepsy We education already led expect future growth. an unbranded run

for is October NDA pediatric for date Xyrem for Priority XX. narcolepsy accepted goal Review, Our our was PDUFA supplemental and

launch We a first in the to implementation [Risk and and indication the REMS FDA Mitigation of the approval expect to information Strategy] specific of populations. and half to XXXX Evaluation pediatric in this include modification caregiver following

excessive our enrollment patients in safety planned cataplexy On plan submission adult efficacy year to sleepiness enrollment JZP-XXX positive the study and with in Phase narcolepsy complete X and development a data. year NDA front, withdrawal of is with next patient We randomized near end, assuming ongoing.

excessive living, X X randomized approximately and narcolepsy We're spring results to also JZP-XXX enroll to the will share double-blind, We our XXX of this Phase Phase in sleep in plan endpoints line inertia, preparing XXXX. Primary idiopathic with evaluate study patients daily withdrawal evaluating study. patients JZP-XXX hypersomnia. to expect initiate top from activities the study of in We sleepiness, placebo-controlled safety.

fall. begin to patient expect We enrollment this

rebound multiple Now a at treatment, withdrawal and of solriamfetol placebo-controlled X, TONES meeting or lack of after had TONES with on with during TONES in randomized of withdrawal-related and efficacy the from demonstrated SLEEP X profile of after maintenance the the At X. consistent least year after treatment. X, discontinuation presentations solriamfetol. TONES we our six study data importantly, sleepiness abrupt studies, to one X of safety phase Phase June, prior a the of studies, months important effects

the and both the X TONES studies of wakefulness test improvement and demonstrated Additionally, presented. OSA X wakefulness And at hour in sustained narcolepsy. across post-dosing nine solriamfetol all maintenance TONES results hours efficacious were in to from doses, one day

research, conducting well activities strategy. unbranded our prelaunch the completing hiring sales team, work, our force health and programs, marketing are economics U.S. and access including market developing sizing launching Our developing awareness of underway,

physicians will of our strategy some narcolepsy universe, and a strong part focus launch currently both manage initially whom are call of Xyrem establishing foothold on Our with patients. current who OSA

As develops, additional by DEA The providers OSA plan we FDA patient scheduling targeting with into XX, first date is PDUFA initiatives. and quarter. healthcare anticipated market December to late expand access launching by

launch a scheduling the following for U.S. planning DEA decision. are We

our expect We sales to quarter in place the year. take next expansion force first

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

On solriamfetol Parkinson's our side, Phase we in completed the study X development disease. sleepiness proof-of-concept in enrollment excessive evaluating for

this year. We share results early inform from future expect for to decisions next The top help our will study development programs. line data

We globally. needs of identifying, critical and products are we've made year developing, this proud toward of the to meaningful and new innovative the commercializing address progress patients

We a Phase for of of for solriamfetol in EU; for year Vyxeos idiopathic are pivotal TA-TMA. the half pediatric of activation of in heading solriamfetol hypersomnia; sight, the and approval into study in of X and launch of of narcolepsy with study milestones of OSA EU; U.S.; the including: treatment in excessive for in the excessive rolling JZP-XXX Defitelio sleepiness for in near-term approval Phase Xyrem with multiple sleepiness initiation MAA approval an with second the the the study patients and narcolepsy; of of submission patients for the the FDA sites X

through to focused the remain corporate and portfolio studies new Matt, on and turn diversifying you. commencement growing further now also call our over I'll development We opportunities. the of development

Matthew P. Young

so good our We everyone. to while year. strong of and commercial strong bottom line and the continuing delivered business. growth significant investments encouraged results and far financial growth on top an by highly Bruce, make We're Thanks, our drive basis future performance adjusted this afternoon, to

second $XXX another quarter strong Xyrem, sales with growth million million net to of the to to We year. last quarter XX% in are report of $XXX for compared pleased

$X.XX are to for guidance $X.XX sales of XXXX growth XX% billion $X.XX result, our to range a expected from billion $X.XX increasing net of we range representing to a of are billion bottle billion, a to As the we Xyrem previous XXXX X% second digits XXXX. XX% from period quarter, year, same to improved and In volume Xyrem digits. volume guidance the single last mid over to mid-single growth increasing our over high

$XX Turning net to XXXX. were second $XX Erwinase, second compared the quarter quarter sales million million to of in

time for will these temporary occur and time from anticipate During of remainder both periods, the experienced supply we continue disruptions global to to XXXX.

the net the net We of to to our of million. of increased million guidance in $XXX for period $XX million to the quarter in $XXX maintaining sales $XX for XX% in million sales Defitelio are same Erwinase compared XXXX range XXXX second XXXX.

encouraged by in in period with of year. last the the the nearly double We net are quarter, U.S., sales performance $XX strong same the million

We reflects XXXX to the of are XX%. for net sales year-over-year our in in sales approximately maintaining guidance guidance $XX million the Defitelio Vyxeos The of to increased $XXX $XXX XXXX. million for compared second quarter net our million midpoint $XX of X% of million. growth in the quarter to first range

We long-term significant growth a are there confident is opportunity.

more guidance. and that However, these provider to we in healthcare are than efforts taking education understand critical earlier our is time anticipated

our to U.S. Technology publication, in use NCCN million field of $XXX We $XXX efforts lowering the MD result, we range and look forward second Vyxeos expanded closing XXXX into TerSera entered In $XXX $XXX XXXX. related third reflected with XX% building are million. increase representing recent of Payment, quarter initiatives. are and we awareness to through $XXX quarter Anderson the a in quarter to XXXX, transaction we compared of New for team, the a second the promotional for million to and working of Prialt. the through momentum our as an quarter. sales the collaboration an As second close our to range materials, from of our million sell Vyxeos the Revenues generating in previous our million, totaled agreement guidance to Add-on to of our well to agreement, subject recently a other to with conditions Closing data the remains as JCO rights

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

This increase well launch U.S., U.S. the of compared Vyxeos expenses SG&A periods. revenues $XXX prelaunch XXXX million our in Xyrem in Turning second quarter Vyxeos adjusted reflects for in quarter activities XXXX, XX% our solriamfetol the for total EU, operating expenses, the investments the million in were patients of ongoing and of both in the of U.S. to to for in our $XXX pediatric in second or as as

spend For to the than second half XXXX, of first SG&A higher we be XXXX. of expect half the

programs guidance quarter continued revenues, of partner R&D Our compared XX% the total expenses submission. same XXXX in regulatory of were of EU as year expenses million, in $XXX in range XXXX. the $XXX planned million. $XX investment Adjusted solriamfetol The in well increase the the our $XX programs period adjusted for the of second or R&D revenues, for to in remains support of quarter million R&D progress as reflects X% in and of to our million, or the total

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

for XXXX. the $XXX million, share diluted or increased million, Second per quarter to quarter $X.XX XXXX second net diluted XX% income or $XXX per compared $X.XX share, adjusted of

second million. $XX.XX generated for to our XX the diluted million note cash $XXX of to the adjusted a $XXX from range and outstanding our EPS million shares of a weighted and we of Priority XX for Please maintaining estimate from non-GAAP to shares. share. Review repurchase operations used are of $XX voucher $XX.XX In purchase million quarter, has guidance guidance million per increased XXXX average We previous

$XXX These $X.X $X.XX principal and cash refinanced million billion. revolver debt and on balance will corporate revolver. our had undrawn senior attractive billion to we to cash equivalents, XX capacity June combined billion $X.X agreement we credit provide June development of and in long-term and and our In support credit $X.X from extending was with the us July our quickly billion investments, June increasing outstanding As ability from profile facilities, to the move opportunities changes our borrowing in our available XXXX. to XXXX our maturity cash, of through

on to of as and we organization $XX to the across quarter, momentum net our the $XX adjusted to performance our range the we progresses. summarize, first second are interest expect million strong to pleased in continue continue year We expect expense the half in to build be with million. To XXXX

advance are our reflects and the strategy. well for on positioned Kathee. investments our I'll strategic that growth and targeted for to now joining turn Thank you the call guidance pursue We priorities, to our flexibility support our XXXX financial us today, call to over sustainable

Katherine A. Littrell

Thanks, Matt. opportunity a an that everyone With we company, to you over during call this ask one to limit question. XX our request analysts question so covering highly that has yourself

We gladly can address With operator, said, questions. for queue. additional please call or will reenter after any that questions the the open the line you

Operator

line first of question BMO the Nachman Markets. Capital our comes Gary from And with

Your line open. now is

Gary Nachman

good Hi, afternoon.

broader the look Phase indication, just for hypersomnia, in data X at look indication narcolepsy just to if maybe see that currently in and to data file to do think how the the all? would file is or you Thanks. then off-label indication that X Xyrem generally, you a used being opportunity for JZP-XXX, would waiting is, Phase you are For idiopathic for and hypersomnia positive, consider for idiopathic And JZP-XXX? big first

Bruce C. Cozadd

Gary, from program the with IH well. let's our JZP-XXX, where data we're see and look the question, Good at see as timing,

look things it, may don't use in file Our want an see later at payers for the to therefore use product think obviously, of expanded current their any there we base probably off-label we be and significant and for IH, occasional play don't is been in IH. we use, for it, IH. how On assumption prescriptions but question out. there about cover narcolepsy expect But we'd indication has then your

Katherine A. Littrell

on we'll please. next the to call, Operator, move

Operator

next with Umer the question from comes our of Certainly, Raffat Evercore. line

open. now is Your line

Umer Raffat

on peak anticipated, Bruce, still number you same to what on academic question, the but expect have say, taking since for to one only ask to question. somewhat as the and the first to few versus adoption Vyxeos the driving Vyxeos the Maybe ask months could do much currently? you a ADCs, I ago? think you one. And I'll sales is so thanks speak get let's practices. Hi, wanted do you slower I community

Bruce C. Cozadd

number the yes, we So, market for limiting absolutely expectations. what the to use in Umer, a question We market have on generate fairly first that on The centers. can broad-based all, and agents, of you that us. we're including other data we're seeing we're answer a take on to where you your bit what will Maybe a If the see anything, Mike short question. in detail thank same give with of is of more and excited everyone. opportunity Vyxeos to forward Vyxeos is to ask appreciate effort from in moving new and think combination I community settings, we from in academic little

Michael P. Miller

we Sure, Bruce. some we driven from offset outpatient consolidation, by saw accounts, continue in and slowing that was quarter, and which In probably to in academic the hear community largely growth was accounts, our customers. that by

is will would with can short which drug highly and time addressed high our further to remains say a through ago. I and JCO reinforced education. (XX:XX) factors, be got think Vyxeos I we this, testament a and value, that can and with clinical probably publication, just differentiated a it the two NTAP both there's be

may I and point a And ingrained. X+X see Vyxeos to out switch years bone have chemo, a of of when learning think can example effect, use a not to the if they I little to would marrow. longer longer And bit. waited and is done early they be biopsy we the X+X. CR too is and seen half-life may old remember curve fact Vyxeos lasts First not habits, have is sometimes patient they a important can has bit that it that a XX could the thing challenge in you a know that a different at around in and a all be And being

rate no see The as but six in other takes that can difference the you'll about It is infection count take that. In of longer. recovery. result of a days there JCO our pub, longer was it

And pub. need on think physicians very That a not to that very I our is, fact, learn education. again, different It critical much is drug. will behind we JCO in are be the X+X. this So

speaker We on a into big going have push the programs fall.

shakeup. aspect think was the I AML was other The to that earlier market it alluded

been care are I I entries to sequence out, As years, think really of about I you to for exactly trying think cautious standard patients. all type and then X+X the sure how and they had in five heme/oncs, and said, being patient market And and this had XX making institutions the all understand sort new nurses, identify months. XX are that pharmacists,

Our NCCN positive. standing remains very

coupled teaching NCCN NTAP, we tools feel the have coupled with very June. that. just available We and And in recently going with the into again, JCO, our institutions good

Umer Raffat

Thank you.

Operator

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

Your line is now open.

Jason M. Gerberry

you for elaborate using up Can little Vyxeos a using maintenance physicians as mutation a the FLTX thanks If a Is can was just have patients front who and that it apps would taking status? little bigger comment maybe Thanks. the that provide is or Vyxeos clarity evening, bit just that, that that, Good more on expected? are maybe and after just my mutational that on right that patients' helpful. be questions. bit using you not treatment status, than and is

Bruce C. Cozadd

have Thanks question, I'll Jason. one. this take for the Allen

Allen Yang

in physician's mutational and new us of these we perspective off and by or we interested and it from for Vyxeos the me why were expanding targeted some was let so treatments explaining Jason, strategically. important thought start and Vyxeos therapies

unique As daunorubicin more is Vyxeos our cytarabine doses takes AML vision what's Bruce lower and said, and And them of is about backbone efficacious. Vyxeos actually therapy. make the it to of makes

terms those the We the or AML. of therapy called in in indication secondary we a related population traditionally. a a And physician, as AML-MRC term or changes don't indication, myelodysplasia-related Now practice initial to AML. use high-risk is use

have for learn mutation, physician mutation, say or IDHX a fairly I (XX:XX), to the a (XX:XX) have or easy FLTX I it's mutation, whereas an mutation therefore let's So IDHX therapy. this this

curve that a identifying steeper For is little the us With those in be equating learning patients. said, terms and to terms of going bit of AML-MRC it's our what in label, that physicians little landscape lot of think be they're different. very bit going treat the will in environment for that a quickly leukemia, learn a the academic to space or I that

trials therapies in and are centers the As clinical come more more initiated, clinical trials. other will out competition be academic

However, really it's familiar what is FLTX which curve in to trials, there to this the AML-MRC, a knee-jerk of that lingo I FLTX will targeted report that the and therapy. and community be more less learning with if that, setting, AML, I'm learning mutational as learning there's where saying equating clinical secondary opposed use a mutation, getting

you alluded Now, to data. also combination

were think I talking you about Vyxeos and data. FLT X combination

be been looked let's the there well There's clear reported with yeah, that's the JCO, data in When So, here, exciting. in-vitro hasn't in Vyxeos. published been that XXX was population patients. FLTX data that did very very at recently we the study

So therapies, the with us on and as FLTX safety well the very in still combination as data to team and is generate inhibitors efficacy the Vyxeos to moving of targeted do other onus is that. quickly

Jason M. Gerberry

Thank Okay. you.

Operator

Stifel. And Samimy with question Annabel line from next you. the Thank of comes our

now is line open. Your

Annabel Eva Samimy

some very to taking Hi. tacks going question. volume my growth. very, clearly I'm had Thanks a for solid switch Xyrem little.

Now high because to pediatric single continue What's Thank growth can it? diagnosis? what you're do population sustainable up is to to in that? you volume digits. How driving those you maintain raised And of guidance it. high think Is the the do it you. Clearly, numbers? mid

Bruce C. Cozadd

Yeah.

field time in a a in and period tailwind government XXXX over what this Xyrem, secular coming Mike will I'm of said out increased point pediatric long trend really we We're in we diagnosis, half numbers, higher think then patient I bit. seeing with the to first we're might we Xyrem we to me because are bit let half year, at of see a increased Annabel, ask have will comment in than be some little opportunity the to of start, of the of the what a for due of recovery So, seeing were going they that we're very growth and XXXX. that first strong performance in of into because levels on growth patients our and the teams. strong pleased the little by pay

year. I an won't this that's year effect we think next but we'll see see

So but should Mike, We growth the perhaps you one-time that's piece years, of two-part for little bit? with a Xyrem. to Xyrem decrement we want ongoing growth of the some into a XXXX. like talk of ongoing to think that about related pediatric future answer, do persist

Michael P. Miller

Sure.

So that the this are of some is in these pediatric the pediatric pediatric X,XXX are on, And Most managed implication are them by call are there this force. aware about we not to sales is our the we patients to any that is current And our going category, that being of important a any but to patients. fulfilling currently going U.S. if physicians call patients. really call need we're opportunity add Xyrem believe in so others we not to for we very on, audience.

Bruce C. Cozadd

did trial moment help patients. these And that of the physicians importance maybe treat I'll pediatric our just and new will about a take we in say data this generate opportunity. Jed, to if you the wanted how

Jed Black

a Xyrem information. in the and narcolepsy interested narcolepsy in is in for adults, pediatric so to children prescribers in that haven't have long Yes, but been had using time highly similar population

that been and has a provides the profile on executed ever is information controlled trial is the of profile safety And the and wealth and narcolepsy in in efficacy profile, to to which pediatric adults. efficacy so this prescriber the biggest study safety highly the similar

Annabel Eva Samimy

Thank you.

Operator

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

line open. is now Your

Gregg Gilbert

in it now? capital corporate current of at you more have look Bruce way the planned the then structure cash Thanks. let your the build launches and pipeline are with ponder a of you that the a biz-dev development taking is couple team, to should And than international you continue given you'll possibilities, your assume Thanks. opportunities we past? internationally, as products

Bruce C. Cozadd

let Gregg, have me Matt this one. Yeah, take

Matthew P. Young

expanding to and the generation choice, to with flow our regional on our also we global we're year we're cash at cash launches extent footprint directly but the to remain think looking Obviously, in you and progress. I'll first as the remind outside in the the strong at we U.S. I quarters continue U.S. franchises thanks. interested globally, Gregg, what indirectly. deploying will capital, a the (XX:XX) basis not and Relative we ex-U.S., our certainly given what build as transacting are Hey, looking

for pursue that. So to on-strategy would it's say I continue definitely us to

Bruce C. Cozadd

add And answer. Matt's I'll just to

refinancing or moment. is on recently us hang the particularly having us we expands think I firepower our at borrow cash completed the without because helpful to to to additional it

So fit positioning us. way aggressive be are opportunities that particularly a efficient us on good to a of for

Gregg Gilbert

So for now. are another saying share way of hold on buybacks

Bruce C. Cozadd

stock a No, recent We've been repurchase more that an way that in program, were little the program. at repurchase we still aggressive less share of aggressive have part active $XXX prices, we We million share through. prices. at about stock lower ongoing but are we're buying

Gregg Gilbert

Thanks.

Operator

you. And Amsellem Piper our Jaffray. of from next the question Thank with line comes David

is now line Your open.

David A. Amsellem

Thanks.

given you some vein in about in a the hypersomnia program. with extent So generics at used off-label that talk And opportunity this underlying the future. view talk specifically would have I in which you're is the and setting going market question that what and and the just the given Can to usage you off-label point about JZP-XXX success? how Xyrem that had on degree idiopathic to in of

some usage So that IH? light existing you in and on about think how would maybe shed

Bruce C. Cozadd

multipart a weaving job, in there. Yes, so nice question David,

David A. Amsellem

There you go.

Bruce C. Cozadd

But all related.

JZP-XXX. what us to think there's the of just population trial opposed by Xyrem start patient reiterating marketplace, in with But payer coverage this part decisions me today launch in use don't as confidently interest. led to is use related significant mostly Let we in this to off-label physician past

past maybe idiopathic we of in Jed, about talk patients. could what hypersomnia little you use oxybate so, a about know bit And

Jed Black

Yes.

sleepiness the clinical has in experience been So in use excessive impact been with that narcolepsy historically, similar hypersomnia. has we to there what The respect in population. saw to idiopathic on

by on become in occurring. Arnulf use have ago there's might was couple publication more their I focused that in that Isabelle to experience the use over idiopathic headed with point by And paper And years the you nice time the very up when consistent had that mentioned, a narcolepsy. some experience a years payers that information is recent Bruce as decreased As has we characterized France provides ago off-label that versus clinical group hypersomnia. narcolepsy

Bruce C. Cozadd

is state there's molecule. know XX% generic remind think the in trial David, patients And about And are oxybate think if going you, reduced be version part last you we that chronic doing to I'll on a important medication. your do available. who that treatment sodium of then aspect of this how really with future of very a that for we was we're some question, and

And that be Xyrem, so may know patients for sodium sodium. before maximum generic daily the of of by north intake full of while dietary a that we in the version salt there Heart you recommended factor Association American load salt is

anticipating aren't for generic a we long for time. So competition JZP-XXX

David A. Amsellem

thanks. Okay,

Operator

Sachs. Goldman line our Thank question you. from with Flanders next Dana And comes the of

line now Your open. is

Dana Flanders

you're for does you're that Mine how there? into And you Thank the just in force thank play reps Europe you. think U.S. how and what are you and you you I Where I question. back mentioned is in the guess needed Vyxeos, expanded it launch just planning on Hi, the to now? sales the July. learning number in of

Bruce C. Cozadd

and we've then in done me have the bit let the Dana, Europe. of talk for U.S., little that a what our terms in about Dan plans have Mike take of part first

Michael P. Miller

Vyxeos. Sure, include expanded on That X, that. to that We the created Defitelio team we dedicated that saw dedicated made reps. to focus in managers we sales also MSLs and with management the XX and think not the I success our importantly U.S. moves important. had when about is does force by And extremely sales the us are of a that We or XX% July we top Bruce. reimbursement team,

Daniel N. Swisher, Jr.

the from one Europe to and has organization. to that cetera, goes, about European Europe the with so the task. et messages, positive here learn of learnings been staffed up U.S. taking importance their as closely learn is team far has also the very As team working rollout,

as and field liaisons, to that force includes as sales increased science XX personnel, from gone well reps, medical, which XX. we've So

been has ready now expecting force that we're of Commission, that from the European from All hired be September launch and And we'll point forward. a trained. approval rolling for and a

Dana Flanders

Thanks.

Operator

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

Your line is now open.

Randall S. Stanicky

or credible JZP-XXX, of case Thanks. there for you what the label? could you either sight help think then language now with the do your X argument safety Phase of pursue, Bruce, would a in studies need for line some you thanks. include have to FDA Great, into could that? sort differentiated bolster later, in the that that And are data X to data to see for Phase

Bruce C. Cozadd

let so that have one. me Yes, Jed take

Jed Black

And what's sodium sensitive of this population Bruce as over highlight CDC so disease. I the and risk by Yes, is and substantial to JZP-XXX. that individuals. research substantial XX that mentioned, the sodium cardiovascular and current sodium there's intake for is including all is based for in organizations, publication identified recent think important XX% average intake, of of at daily That load less than reduction half is the in on recommended the of the a intake health a has current the is AMA,

There's to and on down the evidence adds conducted dose. ranges. and CDC So reducing Xyrem thousands been – gram-by-gram identify studies value also half substantial have depending a AMA the across by gram individuals, – significant the and recommended statistically to intake the that recommended significant a sodium impact in to on basis, another the to of gram of

reducing are with are magnitude we evaluations done the the data There are be with So exploring value value for information is of But to exist. to JZP-XXX. indeed exists, the in that the we're favor already already could overwhelmingly that think some the sodium that complement we that already those well-established that data those. and other

Bruce C. Cozadd

level. does exist Xyrem. different in And very a you, high load at I'll not remind label current new would obviously the product the That sodium a reference sodium in

that we'll label, As to leave for the discussions. I think implications other future for

Randall S. Stanicky

Great, thank you.

Operator

Thank Ronny from And the Bernstein. our of line Gal with next question, you.

Your line is now open.

Aharon Gal

Vyxeos versus does for for us you you DRG added take cost today, they're can this once thank of was is, payment to guys code using additional my And to through I and wondering sodium that change how by the their for equation them? come second. question. that treating substrate the hospitals; in, afternoon them? (XX:XX) taking I the the economics much a will if if this good Hi, want in Vyxeos code how back comes

Bruce C. Cozadd

want take Mike, that? to do you

Michael P. Miller

Sure.

so historical based a DRGs So now, it's are information, look-back. on right

AML current the So And or DRGs NTAP, New do pursued the Vyxeos. that's not we include the Add-on with the why Payment. Technology treatment

of creates through payment and consolidation a half that above what the induction of the be therapy. the about is to full cost would cost Vyxeos what institution and beyond DRG So for to up a

the So DRG. the it's of the adding on of on for a use payment drug top

Aharon Gal

make that situation? hospitals for to versus it current – the the the profitable Does physicians use for Vyxeos

Michael P. Miller

think makes are certainly I group milestone important the with think much These largely that for AML. an it Medicare it more patients cost-effective. very This is age in product. I

this important an lot for So and a these of these win Vyxeos. is seeing institutions are patients,

Bruce C. Cozadd

Ronny, of you I of different in terms treatment, in Vyxeos use out appreciate, of reminder, fundamentally know already a as just getting setting hospitalization. And continuous particularly as the patients from X+X be can phase, of consolidation

for are implications system are spend that a there terms model drug I think economic healthcare So the institutions helpful. in for the as of than other whole and

Michael P. Miller

And point, the just outpatient is use is ASP. the one inpatient only other and Ronny, this for

Aharon Gal

Okay, thank you.

Operator

question and line you Fye Thank next our with from of JPMorgan. comes the Jessica

open. Your line is now

Jessica M. Fye

this, of any Hey high-level some for settlements? settlements, offer. sure recent the I'm there, Xyrem volume the but most if I those on provisions, what and/or thanks my missed are not question. taking terms sorry dates color if there's and any, can of you But if

Bruce C. Cozadd

an of of recent Jess, sharing sharing, think, the and They've we Jazz. with an if settlements, economic the them Hikma authorized all we volume the economic with and XXXX the date December generic, of couple look number period economics add I with substantial entry beginning rights Jazz. other first-filer them couple, again, got most with generic a you've most to settlements have a And to at time, with of got limited years. mid-XXXX, of XX, rights XXXX. starting to authorized Of that for a for are entry settlements, for a

Jessica M. Fye

you. Thank

Operator

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

open. now is line Your

Ken Cacciatore

Erwinase – give And to supply is Thank the the more manufacturing, us fairly corrected, the you Hi. maybe corrected, low could market correct if bit a the guys. it? few could Thanks, I able what a of years update. product manufacturing sense you were an but can expectations if can last it know this around be little over up if for you've what or fully you. to set

Bruce C. Cozadd

question, easy get little actually to Ken, answer. it's to more a the like sounds it but an complicated

at course periods those While get to for product of and we've we of have ship who significant of time, had to conclusion supply patients out need been treatment. some the to all generally outages outages, it try able

to impact we all of sufficient promotional meet not of have to to time So demand, not has efforts periods product. of the minimize that. level while around availability there terms at our our shipping, patient been supply have certainly Knowing been reduce intent we're in we've had chosen product

populations, can't want don't particularly we we and create go patient So in to then new demand, out satisfy. that

pediatric where positive answering for would possibility part question clinical those regimen of doing to haven't out see young we more in were been some experiment your education patients. part we on adult we asparaginase the the do, patients the I think run So to treated the containing actively focus the and if adolescent about be with like which inspired trials tricky kind outcomes have in that we'd know to is to

that community thought greatly be story company with to out efforts of leader getting like a Honestly, to we'd be (XX:XX). this whose So responsible relationships more. some to we our we've had curtail dealing

Ken Cacciatore

you. Thank

Operator

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

now is line Your open.

Douglas D. Tsao

questions. for good taking Hi, afternoon. the Thanks

you're on to you potential and Vyxeos the that to slower, is of ramp Bruce, track back get little on a So, coming sales sort initiatives number it the of see. a obviously pursuing peak

guidance, I even which help NCCN guidance, us sales given us think through curve going the how XXXX. of the not right us think to be obviously about into that, XXXX a maybe do launch little and give to now? of cetera, guideposts you of when some starting some impact see of Just initiatives, that an should not think but on terms year, just bit this the expansion, in remainder understand but you're guidelines, understand and you've et we timing, these help only the force as have shape it we of

Bruce C. Cozadd

important we to we it's opportunity. that only at And great to launch and two. learning Doug. think to is the to We're learning we the couple opportunity It's get do need the a quarters this what into and question, between point, question about really differentiate I what the are size are of about those a what

learning we're thing what about doing size confirms we're enthusiasm, our get of right to there. the I think the and I think the opportunity

won't doing has tool, educating new said of field this oriented tools, former we'll AML, to think that the a cooperative the year. of alluding I for X+X. current JCO To right need in and But involves Some the about got yes, management obviously out an team that. guidance the Mike reflect make best was the treatment monitor think as making year treaters things focus, when the Mike to need I to well, we've and have, trial medical and treatment as backbone, I like seeing team changed getting chemo as we importantly, they now starting when education advance effect go product, force, half benefit think how populations our the continue can this the And within learn longer-term clinical them, the education. to, pace is this continue group you information. we're I adoption, think they've I by about while to good a And always, the some we the the of then efforts available in used and we've second outside the an got need for And impact, alluded soon. later I significant the to efforts do that fact where bring in obviously AML indication physicians understand a it which of an important then disease. We the And the highlighted I process, NCCN-related the education, not including But that we've tools, launch right fast patients. work, NTAP to we'll promotional We've that model think to new government relative might to as make think of the correctly we that, call of I treatment they're How things. to, that's on publication, our and I already. to start you way couple the we'll of represents sure Mike use it's an change to and how expansion to right our to studying new but thinking this and do the to a make for product yet that adjust message use. think we're sure the in now expanding this was use talked MDS, impact think during

Douglas D. Tsao

very Great, Bruce. thank you much,

Operator

you. question line our And next Thank comes with the from Davis Seaport. Corey of

now Your open. line is

Corey George Davis

much. very Thanks

broad a its you do individual or Regarding each et that cetera, Parkinson's, OSA, disease could going are sleepiness get associated narcolepsy to excessive think sleepiness? solriamfetol, associated ES and as ever you claim getting to supposed be with relegated to

Bruce C. Cozadd

Corey, in trial a excessive brink populations, up a sleepiness have great in hope know Parkinson's. in already and we of really on question. the we and you an Obviously, approval two running narcolepsy OSA,

with in we've going we're about route additional studies But a that And non-disease sleepiness In said the clinical enrollment completed fact, of getting indication. potential your population-specific excessive let Jed to address question do me we've solriamfetol. have trial.

Jed Black

be that call likely deliver we on. Yes, about as symptom-based question drug think lot able the to to seems here. would to like make of something it's indications, that this we a sense a course it, And

regulators. definitely There And to are more I in is need understand little a topic a it so Parkinson's that indication. for That It's precedent bringing in we think symptom-based we with disease. why bit interest populations. insomnia looking in at a have other up we is

something we the thinking that drug now populations. need but in I little this we'll for think so understand be to about, is more other a And about

Corey George Davis

you. Thank

Bruce C. Cozadd

to or say we various in think trials about of clinical addition expense said, its trials, and patient length clinical a this patients need existing terms what's be is better go, the know of accomplish, be included molecule also size we of it is more agents we would in in could Jazz the hands patients for whether those then disease in just want many populations. the broadly, to trials, what strategy those population-specific, because Jed trials, best which something to in difference would leave what which which trials, of of to to Corey, like, of route shareholders to of these I we and that's and of get value to just optimize our everything a would look and start making desired directions

Corey George Davis

you. thank Yes,

Operator

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

now is line open. Your

Irina R. Koffler

disruption I Thanks changes to existing going if the there's for in to help operations? it are happen was to the how Can any current roll plan what Hi. could visualize Thanks. you REMS to implement REMS, have and wondering you out, risk if of taking you Xyrem the us going you're for pediatric question. to revisit that XXXX.

Bruce C. Cozadd

Yeah.

are future our of couple obvious REMS terms of I versus think changes there a existing the in REMS.

little they adult anyone adult REMS sign drug having making assumes might in administering sure treating bit drug you're that be patient that understand position for that Our use existing everything an treating need and that to of shipping the drug. a and different, of In to kids, product. you're understands that's who safe pediatric patient, patient appropriate about

change, So talking narcolepsy. reenroll treatment there patients about a job asking everyone like we're that population from with we safe sure that's both they're hands in the I responsible as doing opportunity of pretty our of way. asking patients, feel significant impact. an in percentage final physicians, these different REMS when a and a be certainly were a in the several making we're saw extent think out doing that to the patients intuitive, but want for there what to we years ago, Could with to people To of this where pediatric I some we saw change REMS, pediatric small are pieces make we of Anytime are rolled good a you're disruption? we and getting

those So taking change, I'm learnings slightly a that But and how team we've the some prepare to historically got different you're important to through think concerned this great the at Scripts, will provide right. Jazz, we making from anytime it's to this of who Express about for that. us, our less and relevant experiences to impact a And that. REMS services think modification, get audiences nature all of at and we had have these

Irina R. Koffler

you. Thank Okay.

Operator

question Liav of next Abraham line our the And from you. with Thank comes Citi.

now is open. line Your

Liav Abraham

afternoon. Good

would in timelines Is something mentioned I develop you I this considering past whether think, was patient are any the still European if Bruce, you. to that solriamfetol wondering regard. if in what so, And this Thank be? you you're in that population. you've considering? the have update

Bruce C. Cozadd

mentioned So U.S. Dan MAA by outside bit how to a thinking Europe I planned that maybe proceeding the year solriamfetol I we ask submission in on But the we're could little with a expand for end. opportunity are about

Daniel N. Swisher, Jr.

Yeah. Thanks, Bruce.

solriamfetol. across different best-in-class a such it's centers, different So we for studied there clear across countries. wake-promoting And need that Europe significant as agent is a well as

committed very that, market outside the are people And to been moving we hematology-focused look we're of business. filing. to with opportunity hiring and we're what's few forward assessing a as a the So specific doing

the up reimbursement dig And scrutiny. about that so from the which think European we important data we into holds really far the actually of an as factor, and eyes the authorities, it is to think data

of decisions program on what sort further we'll Jazz and support So to year. and investment market make encouraged do we're continuing work, to the will specifically launch and next the development of give

Liav Abraham

you. Thank

Operator

our Thank from the Tanner line Bill with next comes you. And question of Fitzgerald. Cantor

Your now line open. is

William Tanner

that expect lack then in an comment the going priced Xyrem at to than that question. because should that Xyrem. is you JZP-XXX indication, seems or reimburse that's might Thanks former, we – Thanks. or a level the taking Bruce, be And lower it's wondering a if of data like made to if it of price don't mentioned a for you for the payers that a I'm issue IH. extent

Bruce C. Cozadd

No, not to that patients issue data FDA taken specifically it's it IH an issue that an on-label. trials in of have data. get we It's and run clinical to

used patient generate with forward some said, trial, Jed we've it's historical which go experience move has As important and this ahead and us to with positive treatment encouraged for is response that but Xyrem being data. seen population, there to this in certainly us

is we generate need to But data. even doing the go opportunity. it the wouldn't Bill, concerned market We think we're which Now we're and I out with say, better an just about product. JZP-XXX,

William Tanner

Yes, Thanks. okay.

Operator

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

Your now line is open.

David George Buck

about whether on progression? predictable, this taking additional maybe And whether VOD for the then you a this lumpy X terms can for a in graft-versus-host that's talk see little of Maybe of talk disease, Defitelio, prevention Phase see the in a you about, of for and quarterly size Defitelio? staying bit a is bit be talk little rather those could something you're bit X Bruce, and about bit little getting you or also little market more indications how and to thanks going for Yes, dynamics since Phase still question. market you Thanks.

Bruce C. Cozadd

I results. seen might have Yeah. I'll asking a question. about very it's the I take in the But because for is of first thank you these talk importance have bit drug variability part of and condition, first in This the think that other of a we important little studying question to quarterly Allen people. that the remind rare indications. part

product. in and where Defitelio. we people forward. think We we bit you particularly a quarter, see expect they're and of to a do it well. of the the to strong fact we trials is the can particularly running go. why but I sight weak our for about encouraged It's results We that want we'll the Allen, expect have we're message about we're quarter growth resonating, that important? overall very want would talk a or Occasionally, lose But continue don't the going variability performing to like little

Allen Yang

Yeah.

the you trials. mentioned the think two study VOD. HARMONY specific I or One prevention of So is

published pediatric where XXXX, patients, XXX And believe, in in looked Lancet I he by Oncology so on randomized based a this patients. Selim data study approximately Corbacioglu, at was in

adult that population patients. replicating of a broader we're in So

at that I define patients think how you the in is the challenge VOD. are transplant risk for space

that population puts on much population transplant, put will benefit terms or agents for be in or versus VOD. regimens gemtuzumab you will those larger or preventive so if high agents will use at for may of to depending specific And the going VOD. the very has of it like the you inotuzumab conditioning look with But from to use to the that risk Things at some that of treatment disease defibrotide of eligible are clearly vary. prior the or And used risk, the transplant. of criteria do you at be the prevention

still for could and the curative prevention expect original based treatment be large. get the fairly malignancies, heme In larger. program the was of still and we it graft-versus-host maybe again, picture to a fairly the regimen a with potential this to benefits. disease, of I by determine that need in we'll graft-versus-host that better that, early. would patients of once disease exactly Transplant, lot in But is could early, terms on But be especially unrelated be Corbacioglu observations it and or graft-versus-host we so effect so who in much again, donors, relapsed disease, have is there And a of study disease. acute that understand is think we matched

in both with the I So changing be on it's that to populations, the transplant. data size but and said, landscape in dependent those think larger the going both magnitude is and

David George Buck

Okay.

Operator

with comes Fadia the Leerink. line from question next our And Ami of you. Thank

Your line is open. now

Ami Fadia

solriamfetol give on current Maybe mix could X narcolepsy? you the Type of launch pitolisant, entry maybe landscape the do question. Type competing what's products evolving? treatment you like And the excessive use sleepiness X us also the or taking the for and you Xyrem, Thank Thank with a you. of potential X from and see sense a of how Type narcolepsy between landscape

Bruce C. Cozadd

questions. good Ami,

that don't super-accurate every have accurate the we and that in particularly we that. say let don't on a changes are also data. mix belief believe wake-promoting we On do don't Jed too. treated to a our comment ask that just on how minute most from today use patient, why, who the agent. is or But data what reminder, let on as Xyrem have answer the use, patients future, of Mike Xyrem me comment stimulant so some excessive I'll treatment I in landscape get On sleepiness I'll but a

years I data what there's narcolepsy place seen We on to it advantages think of wake-promoting real excited to to research product head. clinical but and this available on a agent our place get we've our X now agent on and other and over that we know seen that's go launch some and the the solriamfetol our understanding the the that to us program. important rights be the side, product to in treatment really in trials, agent. offers patients in interest those patients, Phase also drove the an data clinical bringing precipice not head based to first large and are sparked We're start for so dissatisfied of fraction with certainly trial we've the based relative our what they're on But like the think options

Jed, very the we solriamfetol, data confident think in I That's our in minimize to confident come. think and pieces little will product. X feel pitolisant. going We agents a and to not those sleepiness around or bit the data about around Mike versus treatment of years you talk be narcolepsy? Type to about excessive feel both want Type for I'm Xyrem, do X comments very critical

Jed Black

Sure.

patient that do X highly sleepiness sleepiness in that Type Xyrem Type ago from X of highly our types. we Type folks the as The cataplexy. is similar. data see and is impact express those excessive narcolepsy X patients So across identifies not And two years similar on know,

for similar we don't solriamfetol exactly majority of back such of as as X, unmet Bruce in place, sleepiness patients which need agents. sleepy are and Xyrem – a we Xyrem. population with or percent patients know Xyrem flowing currently so solriamfetol, on efficacy solriamfetol in expect additional what we prescribed profile respect X for that tolerability seen other with to Type patients will versus for the Xyrem. they its helps as Bruce need the the other that as as well And as that wake-promoting stimulants efficacy are but sleep highly the sleepiness, great and as have With we've being populations tremendously Type sleepiness help profile is with to with have fill apnea. the And such populations obstructive data mentioned, but we mentioned, on

Ami Fadia

you. Thank

Operator

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

is Your now line open.

David Maris

you've look price for think not any that year? tougher just but you if interaction doing companies rest on healthcare had specifically, you. the environment know on at just could, of I year, this the you administration how and give administration this the year? thoughts taking increases pricing the the ahead. overall the took And Good of think price afternoon. have lot you year, comments do ideas blueprint discussions, you the environment next maybe type increases on increases if precludes a it Do us think with we're different Bruce, some next more price said getting of is is your do with price you the that and moving the your same taking Thank

Bruce C. Cozadd

moderating couple years for a a things. now. David, increases We've been price number our of

general So (X:XX:XX) been the increases, taking we clear. increases, haven't price be to same same in price

really In the individual a lot continue costs medications the is blueprint our need, they to terms of and around focused their pricing on how what primarily We to it be can of focus get on pharmaceutical access think comes a we impacting thoughts frustration often the are. out-of-pocket patients that, patients. to with drug on down

determined. spending I of patients healthcare overall for not out-of-pocket the complexity would as system on think to drug how as those some are on the data costs the due the alarming impact be quite

to get had for sure So that, a remains including support of make assistance drug we'll medicines our patients. doing everything programs good sure can make those through who patients We get to patients medicines. access drugs. focus patients, patient to are medicines track to our great record we've think can't available access do otherwise to appropriate can And to continue free available for we make our

David Maris

Thank right. All very you much.

Operator

our with of you. Thank David line Risinger next the Stanley. And Morgan from comes question

now line open. Your is

David R. Risinger

some appears if what to you for just attractive Great, thanks face in Bruce, outlook M&A oncology. Thank provide be curious, assets color Jazz, was in can environment particularly the just of much. competitive you. I very the on very for a

Bruce C. Cozadd

new for and are funding to maybe being interesting but and I'll The has clinical capabilities. innovative generating be of investigated, both data. take oncology, a are say a a those at And shot Matt tremendous. particular would with supply new our interesting fit across good new a diseases, of been the of opportunities approaches are think I really is lot many could and variety I environment this. research important David, of

of to it focus. very and to rapidly we products, important proving represent that of additional pick tends lot of the partner up in the I and those therapies bring for continue to to company each think and make which smaller and sure developing we Celator a through in companies We're successfully good additional deal Gentium through deal, can a also terms develop we geographies. it an a of in focus us is a and receives indications on that patients asset number

we'd these opportunities. with a us we so a may of partner have that for things I for be lot good a to going as the of as again collaborator, those case think acquirer be partner, opportunities, somebody suggest And licensor,

the been true I But to That's of confident in we're growth through get sure positioned on went have significant, after. to felt think would execute we've So think a that in we where true with we places of different you remain people will other who place. put of the we're terms we for We continue well in absolutely Maybe, at set look the is similarly. well look could some those opportunities and model Matt, there's how is historically. that opportunities, on it comment also the sustainable true I we It our I'm opportunities. opportunity on number and positioned broad-based we for dimensions. every play efforts opportunities, look be never we that future. competition feel

Matthew P. Young

Sure.

for that we can something be clinical differentiated for where areas therapeutic patients. product to focused as said, different think and really see I we we've often importantly, an significant specific tend on indications within do opportunities opportunity

dialogue growth evolve and that start And looking (X:XX:XX). value We assets focused domains. or period terms of are to and we assets is long tend at drivers adding pipeline presence out we identify opportunity, those with need equation through those think partners operational of areas appropriate broader but be as that, are and the for Bruce risk in or that result, change to to top-down companies the able company as and focused on needs or to a that ultimately to do all the at not and said, in a pace that our secure to so on with time a often commercial in stay a to have ways and companies interested time. both us in otherwise, And and ability and building what sustain building, just every company's need capital structure, execute, to we hearing win over be the relationship

David R. Risinger

you. thank Great,

Katherine A. Littrell

will this our operator, last be question. And,

Operator

Certainly.

Our comes question John the final line from Boris with of SunTrust.

Your line is open. now

John T. Boris

prescribe. when you Thanks at Vyxeos, physicians quite off results. to the commercial, certain for product the and that When your and uncover clinical question Defitelio on needs two are taking for launches, frequently last things to look hands you congratulations the a

other physicians not leads that participated to risk in prescribing. may for that each in by get trial, or a academic way learning have quite So a experiences may frequently publication experiential putting Phase physicians that Phase ameliorating asset increased respectively of to Xb but healthy program to community doesn't have words, have, leads clinical that the X someone together

funding do, base AML? learning really the are has and potentially So just question in those to that studies physician experiential from get adequately to the both VOD you

Bruce C. Cozadd

back pre-clinical developing cases some question. as goes that earlier on, assets some our has some very strategy really, And data. on, from relied cases in cases, the in to and really things great as John, are early acquiring remind you, I'll to close in that market, and

that assets of generating to from goal I our think have are be also financial payers are and as think we I and developed, largely the along that gotten back would assets will change to generate anything, make we're value optimize to faster, we what the generating a already useful Defitelio additional data of that's in cognizant assets the question occasionally what of data feel only the and But doing was really data generate true about go develop not we're that to we can way. early do sure to be I it's of and but that and time. stages, to treaters going and is more importance that very regulators than question. to to over a I If to Vyxeos do we additional those time data. question with resourcing great acquire

describing. great was of our and team dollars very We heme/onc to the on in that go ready We've side are on put development that advantage molecules, in, to or we that rewind to remain have to the excited team you're continued the go whether broadly do work not and to of with sleep full molecules, about. go take go isn't move comment our really quickly the we place side It's if to which and needed we and existing but a a I bringing of early-stage as molecules. existing ready that. just important additional Again, think molecules ready hit I molecules with an the this weren't R&D faster these those on potential late-stage organization. couple is on comment a years, It's saying a

many company. north It spend million $XX seen been we've with wasn't R&D come than be that R&D will our And has remarkable was Our years really productivity. ago total excellent that less year. R&D of this growth transformation this spend that $XXX well at It million.

regulatory regulatory that in clinical U.S. outside approvals, to our ability markets our the submissions, data, our enrollments, trial So our initiations, do completions,

to got important that. through for we growth been execute do want and I an to each have years, do has want the think the thought strategy well it's that we've improving. remarkable over really company, And think team in molecule that the we sustainable and a timely efficient to past I a we few we as a way, that and but keep strategy

John T. Boris

Thanks.

Katherine A. Littrell

Okay.

Operator

And that our concludes question-and-answer portion.

with turn over So the to call for remarks closing to back I'll Littrell like Kathee Ms. that,

Katherine A. Littrell

Thanks, Andrew. again today. you joining for Thank us all

This be Healthcare We of Stanley participating conferences and hope will Biotech, now Morgan call. next Fargo, and our Wells see in ends the to many month Citi you.

Operator

gentlemen, and day. does disconnect. you Ladies may thank you for in Everyone, all participating conclude the have This wonderful today's a conference. and program

Jazz Pharmaceuticals (JAZZ) 8 Aug 182018 Q2 Earnings call transcript