JAZZ - Earnings call transcript Q3 2020 | Jazz Pharmaceuticals plc

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Operator

Welcome to the Jazz Pharmaceuticals plc Third Quarter 2020 Earnings Conference Call.

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

Kathy Littrell

Thank you, Eugene [ph], and thanks to those of you joining our investor call. Today we reported our third quarter 2020 financial results and updated our financial guidance for 2020. the Investors accompanying section and available call release the in of press slide this presentation are The our website.

today President; Executive call CFO; the are CEO; Cozadd, On Renée Dan Swisher, President, and Vice Iannone, Rob R&D. Bruce Galá,

statements our undertake forward-looking of our identify Europe today's that to and financial Global you Reconciliations or remind Kim Senior Lead, We measures such this in call to available I'd presentation Therapeutic GAAP Joining I'll turn company's you Executive and results actual that call, statements. we our results, website. We now measures. in financial from press review General Neuroscience. Senior that differ Head; call related which Bruce. forward to Strategy uncertainties obligation doc, discuss the duty contained disclosure cause results Phil Neuroscience discussed Sam statements, Vice materially America; Vice and over operating and the those release certain release future Borgman, to Ann could non-GAAP President, those Sablich, non-GAAP cause are SEC this slide Therapeutic and and for the On projected. materially. Pearce, of Larry to no may on North encourage to forward-looking session included – update Head; factors press of to today's on our and latest actual Development differ and Carter, risks performance Hematology like President, Mindus, Q&A which financial and Jockelson, our President International; today's are Shawn Manager to and Finance; call Vice as involve to includes Oncology events,

Bruce Cozadd

build quarter, positioning goals the ongoing our despite key thank Jazz first team the impacts to the set us. significant strategy midyear you worked of diligently Since XXXX. product on half our the to growth. long-term operational afternoon, milestones five we advance and beginning significant has year. that results year, in for the XXXX us launches third our on key We joining Good for from and strong objectives we including progress value and during financial COVID-XX, everyone, we with made and delivered deliver the the align In and of at executed and

sleep of on focus more commercial we ensure to across Our and today has cataplexy optimize R&D benefit. reducing and with strongly achieve of to is patients. and in lifelong Xywav our that and new EDS business We're oxybate We another our this of milestone than hard exciting patients transforming with XX through franchise regulatory, execution in continued and our neuroscience U.S. existing that narcolepsy. fully engagement on patients the based and intake understand launch working oxybate for burden believe physician our education an patient specialists advance years high important sodium for initiatives operations

We look quarter Additionally, next IH compelling data last the submitting to no whom the first approved month, lives in quarter forward patients closer in bringing sNDA hypersomnia to another for there in JZP-XXX XXXX therapy. the launch improving step we and IH, announced or and idiopathic our topline year. of us is fourth targeting for of our positive

franchise. toward in the Our coupled confidence launching narcolepsy of launch our year, us durability give today, with continue of Xywav progress oxybate AH in to an next our

therapy giving in disease. of a the the important advance cancer over management to a in setting launch of in launch U.S. both the in Another demonstrated successful milestone deal commercialization Zepzelca represents announcement this with from capabilities, this is for years, relapsed launch XX in new approved major patients and an our agility and quarter of was matter progressing a cell Zepzelca This lung physicians important small tool months. the first our strong second-line

execute and exceptionally Our XXXX, flexibility, Through XXXX for remain launches important that pipeline advancements underway with innovation track and three team commitment, launches and next pleased through to already planned and across and is have we our well embraced two on benefits enthusiastically executing profile. and on physicians I'm objectives Zepzelca’s product year.

to leveraging call and bring I'll To patients are platform, and about medicines our end, value. I'm continued and is of innovation, positioned we to priority the commercial commitment our and new ranks a most deliver overarching develop productive will of commercial provide Jazz's turn our of year lives for on global strong in financial R&D this performance. patients excited Our changing high of our With update. future. And and to the productive tremendous our unmet areas pipeline overview Renée life one franchises, an in robust need. then investing history. Rob in to across Dan that the programs. progress over now the shareholder give more will well update to a change an as

Renée Galá

our led for substantial goal results performance year, towards growth which $XXX million, we increase quarter, double-digit in reflects from the an from bottomline operational our as of With financial strong a this the third same contribution share our and progress top Thanks, revenues of of portfolio. meaningful recent our make our are continue growth poised launch over for products strong diversification launched year, including XXXX. Bruce. delivering last growth revenue of to since to by and Total financial this I'm representing oncology we Zepzelca. pleased our quarter period half nearly XXXX and XX% revenues were

increased robust sales net significantly where last in net cell Erwinaze quarter, COVID-XX. constraints, of the of by by launch Xyrem. been grew continued net of quarter market X% a million generated in Neuroscience as resumes Defitelio to and sales had in by on revenues the the first have $XX sales compared Excluding increase net its Oncology a that to sales stem strong Zepzelca impacted delayed due led sales physicians increased quarter driven XX% in $XX transplants performance million that supply been XX%, total year. third

expense our XXXX, increased Turning of to the support to operating million our compared launches. quarter third commercial by $XX SG&A by multiple driven to investments targeted expenses, adjusted

expense acquired to collaboration recorded IPR&D quarter Redx $XX the expanded a related During Pharma. we million our also with

approach Our allocation, revenue our in EPS in in enabling capital share. while adjusted X% adjusted a investments growth the to same non-GAAP delivering is our topline business, significant non-GAAP over make to last EPS resulting of growth combined our still with $X.XX disciplined of year, period us

the Turning XXXX to approach taking guidance. year guidance, the the we're full as to our of update end we financial year, opportunity

represents On of of guidance $X.XX raising the the from increase to total guidance billion, million topline, at revenue midpoint. prior range are to $X.XX our we which our an a billion $XX

guidance $X.X guidance at of $XXX million, to of $XXX In guidance. range to net the launch and $X.XX from to billion continued a are the a million performance of and midpoint robust to for our Zepzelca million our neuroscience, increasing strong raising we're trends we to sales guidance increase Vyxeos. oncology, sales end this $XX performance range updated represents the improve a This Defitelio reflect reflecting prior lower net billion For of of business.

year, seamless access to Also As we we a programs, the obtain revenue that reminder, continue both The by in enable coupled our in in designed patient our a commercial of while and quarter. investment potential growth Xywav impacted IH for Xywav of will next our contributor expect payer bottle key expect the product, to oxybate to JZP-XXX access reinforce narcolepsy are broad which the we launch of revenue coverage. be to net gross many throughout launch minimal to confidence with years. launch, Xywav be in sales today, fourth

increased given commercial our our to expense impacts our to and $XXX to reflect to strong guidance, range $XXX SG&A turning our adjusted million to ability guidance the navigate Now we operational behind launches. COVID-XX, a investment have of performance further million of

unchanged. Our guidance remains R&D adjusted

in as raising pipeline, increase our $XX a end million in SpringWorks upfront the $XX to $XX.XX while quarter. adjusted EPS acquired a expense, continuing guidance share, million $XX lower per are IPR&D in the which the upfront million to Redx, well share payment includes $XX the of reflected to the as fourth diversification of our as payment in We non-GAAP per range of to for to invest

As we of adjusted nature longer our this subtract a no income. net reminder, payments from

potential. we and with to quarter robust $XXX balance and Driving in assets. with very of of ended the billion. have we a $X.X flow capable from program and pipeline and our of Redx sustainable cash our we operations profitability innovative The partners with Year-to-date, is market deal from cash investments is have great our neuroscience how sheet. research and the generated commercial in cash Turning healthy inhibitor strategically million corporate of balance set to brings priority interest. externalize FAAH rights sheet example the portfolio oncology pursue opportunities. expanded and recent broad And SpringWorks, pathways acquisition specific development give assets a X to transaction pursue ready a SpringWorks to with and aligned such remains our capacity as liquidity that transactions us has global and a large with With Redx the collaboration promising Phase of the

we capabilities look I'll growing turn drive and transaction strengths our call with this long-term balance continue and deliver regulatory on to to into sheet a With beginning that rapidly at sheet company. us leveraging to we in productive enabled commercial, Dan. corporate year, generating value which meaningful the development with now revenue our balance PharmaMar, Finally, diversification expect a of closed combined convert forward development, for across company. cash to growth for to assets the the substantial over and to our the

Dan Swisher

to results U.S. Thank last therapeutic increased multiple being of catalyst an Xyrem of and our X% reflects the Sunosi objectives is year strong of the agility past physicians, many engagements strong the volume you, the and in same the our pleased as rich been of Xyrem commercial products. launch of COVID-XX strong regulators period as launch key launch the FDA persistence including product of year, a of our challenges The of With commitment three and our increase narcolepsy. reflecting teams, well pandemic. performance and period XX,XXX, the the last and rolling same innovative patient across achieved operational July approvals in despite Xyrem Renée. and European of compared compliance. us from number quarter, the for for average I'm XXXX In organizations, U.S. year. Xywav of delivered has in launches, our value with active we've virtual, patients third and today's X% of quarter May, the payers Xywav this Zepzelca regulatory Zepzelca treatment and

COVID-XX and and we be continue to patient negatively quarter continue New pandemic. the the impact diagnoses during the impacted to enrollments by expect during

centers we in prioritized. enrollments as trend were sleep However, the during encouraged patients symptoms an as more and severe reopened with were more by quarter upward new patient

related a in observed demand increase meaningful there was programs, government this in mix the in we assistance meaningful quarter Although, payer slight mix. patient in shift no no COVID-XX for or

for narcolepsy implementation narcolepsy of and following the available only commercially Xywav, EDS first of treatment a now to patients the sodium patients. Turning Xywav significant is the represents which oxybate is lower cataplexy our in advance REMS. for rapid for approved and or

Our sodium narcolepsy and physicians are focused through their unlocking potential launch and burden understanding efforts lifelong of of in for the the ensure patients to programs on awareness narcolepsy high intake.

emphasizing on preferred the Express health. healthcare provider our patients day Additionally, commercial our on pleased Xywav for today first is Scripts the I'm national total formulary importance coverage of that commercial launch lives. of education has

is reduce commercial While yet for commercial payer treatment, who launch. robust to patients not those have programs we which Xywav help important we to coverage continue have in initiating at barriers secure additional to patient coverage, may place assistance particularly

by majority of XXXX. the to patients oxybate Our Xywav have on goal is

As finish about supply may We know in each before will cabinet the their their expectation that their script. over new we time. Xywav a adopt don't have doctor patients will is curve, month medicine many see patients still Xyrem Xyrem think and they launch our and seeking that

of and including concerns Xywav on previously to We expect narcolepsy newly based choice patients, of oxybate all patients were prescribed treatment patients. not diagnosed become Xyrem current Xyrem the who patients, sodium

the positive JZP-XXX X topline to recently idiopathic forward next with we Additionally, results to population hypersomnia, announced bringing year. Phase the look in patient IH

Sunosi. now Turning to

who growth pleased are we on with the and managing starts, the progress quarter, continued in front-line with patient patients. in despite pulmonologists, challenges COVID-XX engaging were the continued new Sunosi’s During

$X quarter increase increase during Our prescriptions XXXX quarter second physicians face-to-face the the month XXXX, nine the in $XX of in Sunosi with force U.S. XX% variability approximately to for third were and interactions refills. interactions were included strong X% and person. to able of inter-quarter in quarter in We and sales period Net compared third a was patient sales the of million gross-to-nets. including million observed

dedicated have the to and partnered expect with audience, gross-to-nets reach the years deploy To continue We representatives to over larger with with year sales promotional last trained efforts additional These experience with Sunosi. and full prescribers. reaching XX other the sales consistent month customers XXXX OSA expand hired in organization Sunosi representatives additional in sales and XX% will field prescriber XX% of a OSA we they're were starting to analogues. engage range, XX These contract each representatives exclusively today. to X,XXX

forward HCPs more looking option and to are make expanding We reach this available to OSA treatment patients. narcolepsy ensuring important our and their

bringing making the Sunosi month the look world. countries We to continuing patients to launched launch rolling Denmark in we progress European in Additionally, around we're and forward months. over more to the other next XX last

to very of which to Zepzelca, available the small became commercially lung launch of pleased an early give treatment metastatic now oncology update I'm the on for portfolio. Turning cell July in cancer. you our

Third net quarter million. were sales $XX

treatment reflecting and unmet new Zepzelca’s in profile small in and are the physicians, setting. prescribers this top the cell strong on from lung in focused particular been have product efforts favorable interest for we significant seeing options need launch cancer Our

XXX XX% of the first and third quarter, in month centers data expectations. second-line and observed and placed third-line we and the During more in with launch, There from a our reordered. beyond split both Based accounts on between usage was Zepzelca claims academic early XX/XX than settings. line orders approximately community

forward Zepzelca these would to there July the are three be began and was we rolling we materials decreases anticipate in NCCN and guidelines the audiences. promotional usage last pent-up We third-line as included expect setting treated some received in going and demand healthcare initial out our Zepzelca. that NCCN with patients second-line month in more this plus

extremely are pleased launch Zepzelca’s with robust We performance. initial

into well. Canadian rights to as entered forward PharmaMar license Lastly, we and Zepzelca to recently agreement we a in with for look bringing Canada patients

quarter. U.S. continued Erwinaze to and in manufacturer owner issues quality the was Erwinaze. day one the the market available of to in only product for Now at third and turning manufacturing Due PVL, sole

global the We to of continue disruptions supply expect the year for significant COVID-XX. to remainder unrelated

expires year. PVL with at the this end of agreement Our

We have Erwinaze the post-termination. right inventory to sell certain

expect supply to distribute during XXXX. the available We Erwinaze half first of

durable recombinant across focused extremely for progress Given market our and our asparaginase, launches. quality we third turn on need indications an urgent multiple new to as the a the to look programs. deliver continuing diversified summary, In year-to-date programs portfolio forward quickly and we possible. now We will high the new long-term high-value from as we've portfolio, to expanding I'm significant call I that as and to market. near- bring product pleased execution quarter and an reliable bringing Rob of over with made and JZP-XXX update to revenue development medicines for with on are including our

Rob Iannone

In start of and program inhibitor an this October, as pathway. pan-RAF SpringWorks In cancer of for we changing to response current targets the preclinical two idiopathic plan the Thank includes conditions the progress you, across topline which our including completion of announced the as the of significant well pipeline therapies the significant stress treatment in and that kinase tirelessly post-traumatic Redx therapies. important third inhibitor and two additions people pathway. to JZP-XXX broadens volunteer with which Therapeutics our complements program data PF-XXXXXXXX, of areas we JZP-XXX program, strategy abbreviate in since X improve our irreversible our this from into that quarter, the unmet disorder, mid-stage This of initially September, interest mitigate in the and interesting re-initiation strong FAAH in targeted portfolio, entered focus JZP-XXX approach In potential the impact early- for need. pleased delivery FAAH made acquisition we in Ras/Raf/MAP I'll in we have by on PF-'XXX, the recent affected JZP-XXX. R&D made work inhibitor inadequate collaboration COVID-XX development the our lacking, to with on Phase is are healthy for hypersomnia, to enrollment a as and life patients focus of Dan. agreement medicines discovery third studies continued I'm study, and PTSD, to which our and of to our reading. for Consistent with quarter, we

a two agents for front-line PTSD and global in been expect chronic We initiate treatments development two a nearly a is public following to health which Current have for other no there disorder late protocol with and interactions. and concern regulatory that symptoms. XXXX Phase approved are significant approved include new try psychotherapy, off-label decades. pharmacotherapies multiple to treatment SSRIs used to Xstudy control

not patients are However, symptoms. over have residual of XX% and well-controlled

extinction, enhancing undergoing by inhibitor sleep PTSD, million. extinction, a withdrawal, and of X of population strong is as rate really with results to the experimental be under with treatment lung and fear the disorder from treatment PTSD. patients the our rates there target patients U.S. sleep other as significant and the inadequate of Symptoms support cannabis approximately diagnosed of PTSD on Based a in With adding particularly number PTSD, excited positive responses, patients of anxiety improving quality with compared of action approach extinction, to represents an volunteer fear mood clinical model to to patient's effects on well that patients disrupted ability disease of effects mechanism is pipeline. innovative the address expanding this has core the rationale evaluation novel of treating life. to fear PTSD We're anxiety neuroscience multiple the sleep. negative healthy their acute significant and a stage disturbances to have potential in reducing and cannabis clinical observed function symptoms molecule use FAAH with of therefore PF-'XXX on

adult in patients share Last positive pleased meaningful significant X JZP-XXX highly from results statistically were to hypersomnia. with we Turning topline month, clinically study to and JZP-XXX. Phase the our idiopathic

the study. magnitude improvement observed the by of results are the and in We excited compelling

in We the on pleased were treatment the end, fully of we supplemental as important this granted of FDA FDA the focused NDA Fast idiopathic fourth JZP-XXX that targeted to hypersomnia. therapy of designation to in bring XXXX. to intend to quarter soon with now first a XXXX. Track September, patients as are this the for possible, launch submitting We To quarter in

modulator September, calcium study progress proud Turning of in tremor, PK an to patients of restart that XXXX. made our channels T-type essential volunteers, treatment track to and on I'm JZP-XXX, a COVID-XX, a of highly improved quickly due protecting Phase study the us study formulation. a selective of in the our after important we pause of of for completing complete able half first to Xb this efficiently the keeping trial, the team while was and for initiation safety with

our tumor partner of development program Zepzelca. and to Now in small interest Zepzelca development both with combination well X/X cancer with one the with with external We're investigators. lung our collaboration cell PharmaMar robust of for cell relapsed data cancer Areas small as in the are starting In in types. -- evaluating Zepzelca oncology first-line with program and and post-flattening other other in supporting atezolizumab. pembrolizumab Zepzelca underway, working and setting another the as studies settings, in immunotherapy, small lung combination with cancer cell initiated in Phase with in actively include investigator generation on collaboration two exploration setting therapies combination

Phase study to We X receive results this quarter. of expect the Atlantis

of enroll in of third for JZP-XXX, JZP-XXX our among -- quarter, a In with the in unmet pivotal Pediatric patients recombinant patients need ALL. further ALL, with Now FDA September, the endorsement Rare moving Disease treatment were granted to the designation that pediatric study. clear pediatric pleased asparaginase. We patients continue Phase X/X ALL a we Erwinia to

remain demonstrated modest in continues completed of studies pronounced prevention Defitelio in with disease following quickly and benefit to profile in trend possible clinical submission the of of We on receiving safety support early year JZP-XXX with the a the study X study safety Phase of patients U.S. subgroup with as was profile launch to track consistent our which outcome and patients end. globulin. proof-of-concept toward defibrotide. a for bringing to graft-versus-host favorable are and goal acute as as previously The The mid-XXXX, BLA focused Defitelio, a was reported on as more is anti-thymocyte

any of an data, further of the Following for made decision full GvHD. will acute a about research prevention the evaluation be

For I'll Phase Vyxeos, Hematology clinical from upcoming been clinical at including study a Society the virtual for presentation data December Vyxeos University of or of XXXX, myeloid closing preliminary remarks. X call submitted de to now MD Anderson data over combination Bruce by the the relapsed/refractory meeting for have being conducted American in in turn evaluating novo with back Texas Center in Cancer venetoclax acute leukemia.

Bruce Cozadd

transformative you, XXXX. objectives innovation year. thank despite incredible on we set track teams, to out and Thank deliver I'm all employees for I key want our impact flexibility, around that really and are the proud We our Rob. on for an of our commitment range globe of to efforts XXXX the of the this their through objectives, ambitious pandemic. the

track foundation development is liquidity advantage strong and our to thoughtful on a durable take our resources, performance with for this executing of significant number positions financial in gives And and XXXX, well transactions launched to corporate and us opportunities management arise. well will already IH in us end they year, two our as strategic of is additional the allow JZP-XXX mid-XXXX us Together and improvements value completed shareholders. in the growth year. we you are Thank as launch call serve, deliver for We've through the for us to fourth three advances and next and JZP-XXX continue of in significant also five made products for this We to targeted way on the of to well on lives R&D patients launches disciplined Kathy? joining have quarter. launch a today. pipeline of the to and as

Kathy Littrell

yourself request this you one that so limit an during opportunity question everyone call, question. that to ask kindly has to a We

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

Operator

Folkes Cantor a Okay. from from Fitzgerald. question have [Operator Instructions] We Brandon do

You live. are now

Brandon Folkes

near-term? on the year of here that what can we filing track is clinical see path my data from the submit Maybe terms just on taking congratulations the you just end? in by on a question and JZP-XXX, to talk Thank you. remaining in you about for will remain Thanks interim And Hi. confident quarter. if

Bruce Cozadd

point people that could have ask release along that maybe Thanks, I we that'll you comment Yeah. just the is, looking to at we to analysis What little forward path data we way Brandon, will Rob, have our data. bit and ahead. interim a we'll with said inform necessarily for I'll what publicly said on question. out FDA. be not lies

Rob Iannone

Yeah.

So where we the on FDA data said year. for submissions with and and as we work transcript BLA BLA to target in continue to the continue this the the package appropriate I timing submission the as with early potential midyear as launch

Brandon Folkes

you Thank much. Great. very

Operator

Next Evercore. Raffat is one on Umer the queue from

You are now alive.

Umer Raffat

so Thanks for my taking much Hi. question.

First, the indication? perhaps, Bruce, you much. sorry, also, speak and remind post-XXXX? to structure if the hypersomnia on real many for current hypersomnia how settlement congrats you size Bruce you the And us, my you note risk remind Thank tell on are – that Xyrem could believe study, market, patients very have us on of us was, you on arm if of are question also could you the to any there's could

Bruce Cozadd

with thanks second question there's Maybe patients. current I'll overlap I'll the that hypersomnia on we're at Those and Dan don't agreements settlement the a Xyrem come So, entered to more for We of agreements say and this confident. number treated to whether have part and of question are anything take good first. opportunity point. idiopathic Umer.

Dan Swisher

But teleconference. XX,XXX U.S. is on there's which think Thanks, is diagnosed under information IH an the And diagnosis, probably claims Yeah. some Xywav of in gave based we the the on patients. we Bruce. last data, this also week

that We generated sleep a XX% to also diagnosis the writers, with Xyrem physicians. Xywa, know doctors of by that strong with similar overlap really majority is XXX

on patients the or We many on with currently exposure. treated IH and number question a very had the only Xyrem? basis. we single-digit In know what previous study in few patients we think clinic And based how about so Xyrem had even terms being of are anecdotes where XXX

an So need up this for overlap open new very us, we unmet is also do it will where will opportunity we payer which are access. really think with close a obviously for and got unlock

Bruce Cozadd

Operator?

Operator

Yeah.

the Next Nachman from BMO one on Capital queue Gary is Markets.

now live. are You

Gary Nachman

Hi, the guys. The was number in impressive quarter. Zepzelca very third

detail on more from product. early is some And been what initially helped patients? with are is been so provide feedback it pricing Thank using on How on just Zepzelca? they physicians guidelines getting far much reimbursement the you. receptivity and How their from NCCN on uptake? how the has So in with payers the

Bruce Cozadd

over to Kim question. Gary. to take this Yeah. Thanks it turn Maybe I'll

Kim Sablich

Yes. Thank you. Sure.

very to We launch, and the pleased most of of and at performance in important response orders Zepzelca and the having and accounts nice placed excited and beyond of some customer numbers XX% a the with of positive very a are also of XXX there the setting, indicator of setting, in launch community portion And having that the the is highlights of the that expect decline some -- forward. nice them and of first of we based Dan anticipate a of having – to that observing reorder both do going them and which us second-line early and that early and that using are initial a claims value having healthy see third-line on across the prescribers patients data treatment mix business looked accounts month Early there third-line and we the academic. from in we the Zepzelca see second-line for product in this setting. moving is beyond group We would patients pent-up in that demand would usage regimen. terms be

coverage reimbursement very standpoint. on reimbursement, embraced strong a Zepzelca and from issues no have we're and really We're in Payers front terms In a that there's situation. of very pleased.

Gary Nachman

you. Thank Okay.

Operator

queue Next Leerink. one the SVB on from Ami Fadia is

You are live. now

Ami Fadia

question for on Xyrem/Xywav is Thank franchise. question. you sales. the on the Congratulations Zepzelca on the quarter the nice My

gain that if about or expense coverage you you – months Thank you. the the You you having And this from product of impact volumes talked price talk next you or market? that expecting some is impact about well? that to will realized as expect going net as some on on also expand we have Xywav. should any can context, Vyxeos in that if think to anticipate over couple the be impact Is for alone that

Bruce Cozadd

come the Renée, Kim I'll maybe what's on standpoint. see talk what level you first at from comment about to Maybe financial going and just could Yeah. patient then people on a will to

Kim Sablich

what on question specific at patient part level, the clarify the the to is of Just front that question?

Ami Fadia

Oh! going you net on The or impact question is realized that, price are patient the anticipate would well? number alone total to an we impact on or volume an as see

Kim Sablich

I'm the – the I'm understanding So, of not part sorry, patient question.

Bruce Cozadd

Yeah. have the patients ask can all working on the very as financials. transition Xywav take sure Renée, you can piece call in who access maybe jump in I on product. mean, to script, to we Kim. want I'll and I hard to to said we're the make Xywav

Renée Galá

Yeah. Sure.

access do payer Xywav, program, impact that we different revenue access to have through And to bottle So expect are impact as patient offered. put see the of sorry, an we as programs will growth, adopting place you well patients we've both in that an the as that's that the programs gross-to-net. the because

So will other through the couponing subprograms come bridge and programs in of bottles. through will gross-to-net as such free come form

will make you're the do provide Xyrem growth, Xywav that to So, what bottle since revenue in bottle not since access patient in may completely terms of programs connect report revenue versus you transitions. sense? seeing in Does that be able we revenue smooth bottles growth

Ami Fadia

Thank That's very you. helpful.

Dan Swisher

the really a and to just Ami. their the been on had recent question about including presented, just been and to and out time some Yeah, published market maybe data your label Vyxeos of weigh already there. cataplexy reanalysis then change has And for on was that Vyxeos, supplemental is now

diagnosis profile the see of a impact don't seen come both eventually still for patients we only additional be a very benefit having market rate those oxybate the with given cataplexy. addressing is haven't relatively first will and much who anything, an treatment low It's of that to if sodium we we EDS market, And believe now – to got unique there grow Xywav the have competitors our and in and can low if be So, oxybate. choice oxybate the patients. for we

Ami Fadia

Thanks, Dan.

Operator

Amsellem of Piper Next comes Sandler. from from question line the David

now are You live.

David Amsellem

Thanks.

on franchise? that the I investment sales trajectory guess of your given direction me strategic that, sales and made more I appropriate would In us positions. that focus. Sunosi. may a So Maybe narcolepsy my going and specifically, comments comfortable what you question disease help the significant is guess thinking are the you're And understand and question Thanks. contract marketing is focusing rare about I'm I surrounding more other how investment, the with or the given in is organization sense? understand noted OSA, focus exclusively the here product? product of is, overall words, targeting at help And have the getting in that forward? about

Bruce Cozadd

you ask weigh I'll Kim, on Maybe, Yeah. to in this.

Kim Sablich

from very the and the remain utilized future about Sunosi. had feedback strong very optimistic patients the We it. prescribers favorable and have We that Sure.

we and product believe to do investment going warranted. is that this incremental in So, be pay off

important trained are experienced an that were haven’t and As they're will this Dan we us adding hired our They force, X,XXX to just today sales additional additional last we reach with and enable each believe an prescribers very that experience. over able OSA be we're representative. now sales for do representatives These reach sales and current investment years starting with mentioned, right been to And XX month. of us. going to

medication our important continuing to to reach this narcolepsy patient. and bring looking we're and both to So, OSA forward expanding

Operator

is Next queue on from one Bernstein. the Ronny Gal

now live. are You

Ronny Gal

ESI, Hi. on need people Xywav get the given and for transition Xyrem? the Good for your something spec not be congratulations call on other least said you since up you can -- we my Xywav, quarter, but by directional at driven pharmacies. to so you dynamics going be of Should on want the a if thinking this, from for and just give not the us access some can careful kind still open can deals importantly, that know think taking even pharmacies of year ears, multiple say, Xywav have My a orders kind which give you've I kind was despite about elaborate is north coverage you does just but we give contracts of per second, be could done you if you dispense partner And Thank large reasonable what question decline, wondering here, of Monday you it most by especially or to coverage to as away call more. non-trivial beat through the net I any be we a to said XXXB on not on question of to is And just franchise this my just directional just to be you made here on was got already to you from the the Xyrem. some payer you us Xyrem was on of but the X%, able to amount, those discounts give some other point to lower you payers, XX% transition wondering afternoon. is X% expectations? Xyrem? you from the your mean this so or bottle your products. you've that on but this and something price are I will expect now

Bruce Cozadd

the maybe Ronny, first. that take Yeah. part of second I'll

from and reasons. So Xywav that's pharmacy a like Xyrem is exclusively still related shipped single for REMS

back let So come access question. maybe broader the I'll Kim to

Kim Sablich

Sure. Yeah.

mentioned we've growth and we level of at priced the objective and as I have the parity Xywav on move to other negotiations at course, we at as have think the right two calls, be approximately for by same is contracting really net parity as going on the our subject into well, that at Xyrem payer to products we level now.

Ronny Gal

about we net so is as such step down the Should I anticipate I we a your and think the beyond. for step in kind question So XXXX, question franchise? the you guess don't -- or price in guess down of pricing versus XXXX

Bruce Cozadd

that? comment Renée, on you to want

Renée Galá

for from expect XXXX is guidance XXXX, newer what do products our XXXX, in been that grow would coming Well, have grow given said XXXX we have we XXXX for launched and our forward. Ronny. of to have by in topline that and sorry, we XXXX, that expect specific to them revenues our from But XXXX we sales or haven't XX% we nearly

So Xywav right while guidance now. giving specific we're for not

we're XXXX, topline a of our of diversified the still meaningful to and at we really expecting to We is as you looking for revenues. launching forward. this oxybate products that know percentage And contribute and large makes up XXXX portfolio are the are to franchise growth going our revenue

Ronny Gal

you. it. Appreciate Thank

Operator

Gerberry the Next of Bank Jason is America. from queue on one

are live. You now

Jason Gerberry

comment taking the maybe and Hey. the what's with just Good situation this going Question are Erwinaze, million it evening. of from Bruce, supply a you product looks bit lowest Thank questions. XX seen on my for like value with you for a that can I've with think year of unwind competitive year. think dynamics sensitive I launching JZP-XXX ended dislocation the in into and But important with it's realize to could about investors position PBL? for that the the you're kind a next of contract I the be ever

color on on provide going incremental supply with what's So situation? any perhaps can the you

Bruce Cozadd

Yeah. much who your supply Jason is the is to everything erratic to that for patients Erwinia thing in can demand It's when to lots of available, And still as quickly make we be they the important we're been demand. product. asparaginase as and we provide here when in dispersed need supply market good they separate have are just of distributed absolute are mind, terms the There question. doing sure just we help and possible. can to and

manufactured said all would it's U.S. both we we year over more then of meet So, have patients than two sufficient the that the capacity, product high will needs have think or even and markets. in that moderately quality, reliable, a we ago a more important reliably in time

we doing everything can. So, we're

limited you availability of to on product add You're availability Dan, very of just want unpredictable seeing that? anything and product.

Dan Swisher

are quality to Just but website But see to the some we U.S. do time new coming our have products in going continue FDA supply available recently with We November work the to keep takes each sporadic batch we it's the guy’s we informed anticipating in some it as we customers particular the updated through and Xth that do the soon. Xth. as system can possibly to quite be

Jason Gerberry

you. Thank Great.

Operator

from one is Annabel from Samimy Stifel. Next

are You live. now

Annabel Samimy

Thanks great. taking what into a initial the going congratulations if you you be pent-up patients, is does channels if Hi. just a was demand of a was sense stocking bit give price represents all mean Can of average on launches demand the or could my quarter? granularity that specifically just that for there of demand? next cycle decline question underlying That And and of Thanks. there to in maybe for us if a any us looks? Zepzelca. that was it cycle give patient little per how terms the And

Bruce Cozadd

this? So, Dan, on do you want to jump in

Dan Swisher

Yeah.

standard-of-care third-line since those patients. into benefit for and the to carefully and we're news relapsed what it's growth. and was script second-line If a you fourth-line patients that's for of the what still plenty is, and penetrating is saying was some listen getting room it was bullish really expected for good the we be we're But Zepzelca there there

But and the so, shouldn't anticipate quarter-over-quarter third-line will a off fall second-line cetera And as that more et patients more have decline. exposure. in you

Annabel Samimy

patients And any granularity or price on or per cycle? the average cycles

Dan Swisher

to the right Not it's data. little I it takes time data not now. mean claims bit so of based much like collect prescription a

uptake some and got window are duration you of well patients hearing as chance therapy, prognosis we anecdotally more longer we've but as good and in platinum better sensitive and on, we'll and July for where goes better is on each So have both platinum-resistant month platinum expect as sensitive response.

Annabel Samimy

Okay.

heard correctly, So it's bullish inventory. all necessarily I and if not

Dan Swisher

Correct.

Bruce Cozadd

Correct.

Annabel Samimy

you. Thank Okay.

Operator

Prasad queue on one Balaji from the Next Barclays.

now are You live.

Balaji Prasad

questions. my taking for Thanks Hi.

cadence on Zepzelca as efforts now how up commercial wanted more understand about think following converted about to accounts So couple your should itself, and we next being we the quarters. think of the of just right about

go when at currently would So Thanks. XXX reach? accounts, a broader around you for

Bruce Cozadd

Kim?

Kim Sablich

Yeah. Really subset. all and with we on the we're we starting are a providers calling accounts valuable, not think that are

along the So we've by for is driven really I that of have awareness believe the to that patients accounts created. the demand begin Zepzelca what we're with terms seeing ready already in

really expand to accounts try and So, and generate but reach educate to not those to continue that, awareness. to looking

Operator

All right.

Next one Wolfe on Research. the is Tewari queue from Akash

are now live. You

Akash Tewari

much. so Thanks

implying XX% Xyrem about estimates a I Xywav are next XXXX, year. switch on and $XXX of, Xywav from for think, that's So and kind million to

$X.X where X, implied and for what in that Phase some over, those think will Thanks. JZP-XXX, make Phase sodium cadence wait billion quickly into And you do stand whether late readout slide when new now You of XX%? switch switching a on mentioned on taking script percent up we program your just we still trials? before for data then know today and would and patients about X enrollment you're of very adopters of mentioned what right that oxybate do sales about that and

Bruce Cozadd

Yeah. XXX today. Akash no on update

we give. So information don't have additional to

the not given plan yet. in have estimates February on obviously, out late that there The from for I do us. to On for XXXX guidance Xyrem, are dynamic call. we XXXX, that year-end come Xywav will didn't our

time. happen heard today's and patients to over to comments the you about Xywav. Xywav to think educate of to we think benefits this about the I physicians important adoption We call both in expect it's

to other of or financial next perspective, on Zepzelca Sunosi patients as Xyrem big hypersomnia is results Xywav from growth have assets. in idiopathic not a or driver XXXX financial launch our a relative course our we the or as in year example XXX whether Of the launch in or for

So it time. will out play over

XXXX. for not We of on given goal the Xywav have majority all longer oxybate patients have set yet XXXX, getting term a to a but we specific of in target

Akash Tewari

Thank you. Very helpful.

Operator

from Gregg Securities. Next queue one is the on Truist Gilbert

You are live. now

Gregg Gilbert

of and product in looking geographies begin terms how that XXX you you. And you or product. the you are on to Thank meet development like are aspects just additional some Rob of also can quickly it and I can for I would could to making Thanks. make indications? to demand and offense all for think, and Back trial to Dan confirm already degree. to when track it's you at XXX, play probably

Rob Iannone

I answer me…. for mean short

Bruce Cozadd

Rob.

Rob Iannone

me, yes. I track. mean consider answer from We short on is program the

Bruce Cozadd

talk And supplier? Dan, to do the about you want

Dan Swisher

of Sure. part part was have have tens of been of package. would commercial recombinant we're key the for modern we've at be the were we working will sure actually process a quality and a scale and Yes. launch in vials to and available got and is That thousands of that that – regulatory already generated make be commercial factor system

Gregg Gilbert

approved? as it's you Does could as that all mean meet demand soon

Dan Swisher

but Within Yeah. yes. reason,

Gregg Gilbert

Okay. Thank you.

Operator

Jessica is JPMorgan. line from the Fye on one Next

live. now are You

Jessica Fye

Thanks. Good taking afternoon. question. Thanks for my

and release in you the are now? study you you modified JZP-XXX, Can molecule confident in on For tolerability the the of concluded there, volunteer of safety particular, the this results healthy formulation. and elaborate

Bruce Cozadd

Phil, that? want or you Rob take to Yeah. do

Phil Jockelson

Yes. Yeah. that. you, Thank Great. I Bruce. can take

a of formulation in But study to the we point a study we that of better Actually tolerated this once time. that at and have the and don't but completed results we've not that conduct. results the hope day modified we product yet. taken was these be be could So have do the have goal

Operator

Okay.

Next the one Morgan David from Stanley. queue on is Risinger

Your line open. is now

David Risinger

much and very performance. on Thanks the Yes. congrats

unexpected for So, a And how shares basically is a Bruce, at I the PE just high picture Jazz wanted to XXXX to XXXX timeframe? trading paint see you concerns generics due you about see the be performance faces a feared would Thank you. Xyrem frame in years? think And evolution you you for helpful Xyrem to how it I ask cliff. financial reason are the as single-digit to that EPS a of it few the company's

Bruce Cozadd

us goal future a launched goal come years to of half newly XXXX. our about And Xywav year Yeah. all from have including to performing the we focused designed next doing and couple of well patients this well products to Thanks, position by revenues our things we're in majority have is in of lot our of intention a time. beyond a business We're have oxybate total of XXXX every good question. diversify really and on to what David, over really and year, while

the talked So creation, grow about market you can do the we've first think potential about of that year. NIH how oxybate we of to franchise next value well with the Xywav do which as is launch piece and as continuing with

they on and years, our things be a launched generating value development. of months, that what are do broadening products to forth, XXX call. capital as put we we But well I with while piece programs do some could bringing those opportunity be that and how few from in things don't pipeline. as clinical key clinical want will we and did new which rest earlier the people is mid-stage our, like including other of market where help terms and that miss piece And we portfolio, continuing our then our deal Zepzelca too, growing not second with portfolio featured to in do third to work do within in that set might the is Sunosi both people the opportunities Zepzelca today's The in to in a and data that

in So our and I those really growth like of each now of those sustainable in over the to well contribute performing strategy a term. feel buckets were all mind longer right

David Risinger

you. Thank

Operator

Next question Suvannavejh Graig Goldman line comes Sachs. from the from of

You live. are now

Graig Suvannavejh

national Great. of Thank BD just Jazz could as maybe congrats a great you. pipeline, How early perspective, quarter. do some the the from Thanks on mid, my off for taking my from interesting of on my if you I synergies on just think seen stage got desire And a first for a deals. earlier just as I've a we've and was that's perspective added or question? two one questions of Zepzelca such about BD don't different what the looking focus have across you is terms there that. which increments new should we PTSD our commercialization so having think SpringWorks PTSD, developmental fill and perhaps about wondering, How is stages selling be in second so and near-term revenue. more about stage I products to asset? grow to capability know, question, whether be the you to thinking would I'm And and more

that think about on thoughts perspective? you how will any just be Thanks. the So

Renée Galá

Hey, I'll take this is that. That’s question. -- Renée. Great

provide the strategy meaningful clinical can assets hasn't at to continuing changed corporate we're that differentiated to highly respect sense patients. that for with our durable development, really So in look benefit

different then of of are the stage pipeline, focused about think the we parts As the we pipeline. on

But to deals out continue to to an transactions asset well transformative we balance a bring SpringWorks mid-stage in asset Phase acquire mid-stage some also a sheet, the FAAH cash specifically ready infrastructure our do asset. in us nice to looking we're some II to at and strategic on-market with able see us where flow continue early leverage portfolio. deals our fill for leverage as as that being balance sheet probably could say I'd will You inhibitor for

those as fewer deal We at you in M&A are opportunities are nature. looking as well. larger know But just

leverage more base the also we able order much how us Bruce what be we're terms trying sheet our enhance appropriately be to most of that we're how So in take for something that we to on most described revenue do can also to calculated establish. the about would respect strategically durability with and diversified in balance that advantageous long-term to think

near- With and on-market then So I infrastructure we augmentation fairly, we looking globally opportunities where that continue we're would commercial to to also have say able could for pipeline both leverage and to more and that we be broadly unmet a Rob the at we profitable look financial PTSD, do piece, make effective respect as to it perspective. think is that need this had when commercial from described, area. high

indication something an a internally then that some this get and we study, meaningful We a through to need PTSD activities we on while also the over our where expand of because commercial we've have if such portfolio can market large order unmet time, that build positive, is and is a around this II you there need opportunity. Phase in at this interest. to look focused support capabilities we future, in been of would as And

Kathy Littrell

the in last this queue our And question be will next Operator, question.

Operator

Okay.

the have for So do from David last we question Steinberg Jefferies.

are You live. now

David Steinberg

an I on Thanks. I components for Zepzelca, to reported some of want on drill the million you down QX. additional of $XX have the question

If pent-up and strong the of the Specifically not, rough demand don't the you you you us could gave breakdown approximation initial that split others. for in second-line versus some were I actual give that and fact us sales Thanks. the or that reasons an that quarterly highlighted one recall fourth-line there? really third- so

Bruce Cozadd

and used that recent us from don't just data the Bruce. product say, we back we Yeah. understand first month would David, come more was help launch have this data. like and I'll is the of where have

you So, give quarter we was really percentage. can't the the for here

said, the ordering. second-line growth Kim are good use number in seeing As of we accounts and in

this take a of feel field. good we about message are where we launch as to continue product So the in the we to out

And our So launch. performing doing would with commercial how pleased really overall up program. new saying wrap and portfolio is my with I on by we're progress into R&D making just company the just rapid comments to months few how across really happy a a the

We've were on of side. us launching IH a the think ahead pleased update submissions and got today I XXX to Xywav near-term coming with some we the in lot and today. So give just

a So year, work a quarter. still ahead we lot us of finish the really of before third great but

Operator

there are now I the further will no on Littrell. back And call Okay. turn to questions queue. Kathy the

Kathy Littrell

today. us again for Well, thank joining you you, Eugene. Thank

and Virtual now We many will London Conference call. hope be the participating with this Healthcare month Jefferies to in you. of speak This our later ends

Operator

concludes Ladies call. today's gentlemen, this and conference

You may now disconnect.

Jazz Pharmaceuticals (JAZZ) 2 Nov 202020 Q3 Earnings call transcript