Jazz Pharmaceuticals (JAZZ) 26 Feb 202019 Q4 Earnings call transcript

Company Profile

Participants

Katherine Littrell	Vice President, Investor Relations
Bruce Cozadd	Chairman and Chief Executive Officer
Daniel Swisher, Jr.	President and Chief Operating Officer
Robert Iannone	Executive Vice President, Research and Development
Michael Miller	Executive Vice President, U.S. Commercial
Shawn Mindus	Senior Vice President, Financial Planning, Analysis and Strategy
Brandon Folkes	Cantor Fitzgerald
Umer Raffat	Evercore ISI
Gary Nachman	BMO Capital Markets
Gregg Gilbert	SunTrust Robinson Humphrey
David Amsellem	Piper Sandler & Co.
Jason Gerberry	Bank of America Securities
Ken Cacciatore	Cowen & Company
Esther Rajavelu	Oppenheimer & Co. Inc.
Akash Tewari	Wolfe Research, LLC
Aaron Gal	Sanford Bernstein
Annabel Samimy	Stifel Nicolaus
Randall Stanicky	RBC Capital Markets
Ami Fadia	SVB Leerink
David Risinger	Morgan Stanley
Balaji Prasad	Barclays
Jessica Fye	J.P. Morgan
Graig Suvannavejh	Goldman Sachs & Co. LLC

Call transcript

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Operator

Welcome to the Jazz Pharmaceuticals Plc Full-Year, Fourth Quarter 2019 Earnings Conference Call.

Following an introduction from the company, we will open the call to questions.

I will now turn the call over to Kathy Littrell, Head of Investor Relations at Jazz Pharmaceuticals.

Katherine Littrell

Thank you, Kevin, and thanks to those of you who are joining our investor call. Today, we reported our fourth quarter and full-year 2019 financial results and provided financial guidance for 2020.

the Investors accompanying section and available call release the on of press slide this presentation are The our website.

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

President, President, our Joining for are our Planning, and Jed Oncology session Financial our the Sleep Sleep Head; Senior and Senior President, Shawn Philip Head; Therapeutic U.S. Anne Hematology Strategy. Executive Vice Borgman, and Mike Black, Neuroscience; Commercial; Miller, Q&A Vice Vice Mindus, Jochelson, Neuroscience and Analysis Therapeutic and

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

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

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

Bruce. the over turn call now I'll to

Bruce Cozadd

you joining for thank everyone. afternoon, us. And Good

As executing the approximately strategy X,XXX employees, launches approvals XXXX, a successfully pleased objectives. with with progress two global key substantial made product we're as of growth in long-term and are well two as our we biopharmaceutical the achievement company R&D and including

new to into R&D stage Through four pipeline development, movement into multiple broadening transactions, late bolstered from and oncology area early we our our disorders. with neuroscience solid and our and medicines area therapeutic hematology announced therapeutic sleep tumors,

key multiple strong our growth. are a including we continued and position, revenue, product income $XXX critical for while well financial our net exceeding growing and With Supporting record million further of launches including priority. in strategic positioned objectives, remains on our expansion business, adjusted executing a XXXX, portfolio diversification

prescribers key unique demand on saw Now, provide X,XXX our for We fourth In had than and the year-end. rise. cumulative XX,XXX sleep more more an I'll scripts through than quarter, Sunosi neuroscience programs. update to continue we and

educate XXXX Scripts This for beyond to total XX% as of healthcare who manage establish expand encouraging Sunosi providers prescribers OSA OSA our scripts is launch. the the increase to to compared relationships of treatment excessive narcolepsy year-end and early were in daytime XX% focus outreach in and our at is patients. sleepiness with

access Therapeutics of Additionally, commercially the with Sunosi. are on CVS patients Express is to Scripts, strong pleased Sunosi. for formularies, for coverage and Sunosi Caremark than XX% we we more coverage have with obtained very Prime Cigna, tier the insured preferred having two

of the to adults European reduce or approved and Commission EU-approved therapies CDS EDS are with Sunosi for Currently, wakefulness treatment there the improve OSA. and no other narcolepsy January, OSA. In in

eligible in which X for that bringing forward million X We and patients to option this approximately are are Sunosi. Kingdom, million diagnosed patients with Spain treatment EDS important in potentially to OSA United treatment the look Germany, There France, Italy, experience this of region.

in launch reimbursement Germany rolling UK to in expect conclude. pricing in negotiations after by mid-year, and and our launches early followed We the XXXX France begin

Sales occur and medical in UK Germany, recruitment force We will activities in have of the education begun France. the first year. half

clinical an last voucher. redemption FDA priority to with And together successful quarter. as of the look third an we NDA development culminated as our of submission in month, Our JZP-XXX forward review program early decision

We broad reduction lifelong of blood and on JZP-XXX is the as developed pressure represents oxybate compared amount a consensus sodium otherwise half by gram per meaningful a and This receive option a for gram sodium sodium risk. reductions with cardiovascular disease patient would in reducing an Xyrem. and safer is reducing patients, a that treatment scientific dose. between depending this XX% and to a night by There that associated of consumption clinically

Based on to JZP-XXX patients and at immediately patients were Xyrem our transition Phase maintain dose, equivalent that able to an dose. III most studies,

meaningful is believe goal considerations. growth Xyrem bring JZP-XXX we is JZP-XXX a as quarter opportunity there prescribed to Additionally, and as implementation. cardiometabolic It fourth early patients in improvement is and patients high sodium to to clinically not REMS for market our the due priority for to currently this launch us following a

exceptional Xyrem year. to had an on Now Xyrem.

volume fourth X.X% same XXXX. in the for was For periods bottle And to Xyrem growth X%. compared XXXX, quarter was full-year XXXX,

at continue also to the prior number XX,XXX, up active average patients We on of an with Xyrem see therapy, of year. X.X% number increasing the patients over

the force, disease to to to focus on we efforts awareness expanded narcolepsy of market. this grow sales addition will Xyrem/Sunosi our In continue

hem-onc over and an on on our with call the turn update activities. an to up will performance. Dan Rob now I'll financial to our development provide update update you I'll operational Then wrap programs on key

Daniel Swisher

Thanks, Bruce.

XXXX versus collectively, hematology delivered oncology revenue So, our XX% products and of growth XXXX. in

for portfolio growth cell the current lung forward the in addition our lurbinectedin to looking in relapse, We continued United States. cancer of with small and XXXX, global both within are

of and over Rest to Also, for she general we're effective Celgene, in management Samantha president vice the served most senior international us multiple Pearce of comes markets. announce appointment years, Senior March Vice to last pleased Europe, from recently manager World as XX where, as the roles, X. global Sam President of

from as our Europe strong in So, starting making strong European sales with progress performance very quarter, teams and Vyxeos of increasing Vyxeos, awareness worldwide in the and efficacy benefited fourth its profile.

the to accounts. efforts we new adoption, States, United broaden community and reach physicians our among the continue particularly In

plans in promotion to community broader they Vyxeos have place that patient treated if accounts hospital ensure access or practice. distribution We regardless expand every of in and set at to local are to community of has a a outpatient to

to now on Defitelio. So,

We are Shinyaku. whole. is with in the physicians very pleased in performance positive Defitelio with the for a going XXXX of as from for Defitelio the recent Japan well, partner, quarter solid year launch global Nippon feedback and The our and fourth

educational reach new and to increase in to countries. additional to accounts, make VOD, the penetration to focused efforts Defitelio of Our on improve and and time are into XXXX and promotional initiatives physician diagnosis available awareness

Defitelio. Vyxeos for pursue global Our internal expansion to is expect to assess And multiple additional we geographic marketing XXXX, in continuing new authorization submissions team regions and countries. in

manufacturing outages PBL. broad significant disruptions experience guidance. XXXX supply reflected year, ongoing in which of XXXX and disruptions our sole For Erwinaze, manufacturer experience to we due at We range may a is throughout did supply issues the global continuous supply this

PBL We before effort and are an license engage of the this continuing Erwinaze agreement to year. current on end with PBL agreement new at the terminates with agreement to our in supply reach

this with NDA. the to PDUFA late-stage candidate FDA XX. And for earlier accelerated an to letter, in completed exclusive meeting a they lung last US August PharmaMar of December. date small cell advisory to lurbinectedin, month, submitted an relapsed license approval lurbinectedin NDA PharmaMar for FDA committee accepted currently on lurbinectedin, planning month, are acceptance priority a stated the review filing cancer. So, discuss with action product it agreement for with we the of was that an not In hold NDA

commenced we launch tumor we're market approval. are liaison to ready for including have upon medical activities, access pre-launch that out our commercial planning building and We ensure initiatives solid team science and

key we to lurbinectedin. Additionally, other launch the roles are of for recruiting vital

the in first and be hiring now sales are We additional representatives our sizing to Vyxeos will year analysis half force complement conducting right rigorous we of this team. the of sales current a initiating

X,XXX small force the cancer. cell academic of in sales treat oncologists in small allow both with the majority treatment medical lung receive who the settings community us vast A reach lung and X,XXX The thoracic the cancer to of majority cell the will and community patients to setting.

be in progresses. our outreach deciles launch as opportunity initially we'll the targeting the the be top initiatives prescribers expanding will and optimize to We

treatment prior to NCCN the the prescribers treatment May, heavily we're in setting, community to compelling in for into annual meeting are by Therefore, planning guidelines. scheduled to influenced So, its data submit guidelines approval. clinical inclusion timely upon lurbinectedin's

including leveraging we've ensuring the we're new relationships Vyxeos pursuing undertaking work will to we GPOs, purchasing and critical approval. in community options, believe practices distribution group that hospitals with across following lurbinectedin broader organizations, with Lastly, access be in been significant

with has PharmaMar to option meantime, the cancer, bringing program support available US outside treatment important the small So, new we're launched lung option access commercially, is treatment looking to before trials. cell relapsed this an to forward a patients clinical patients. in of lurbinectedin In expanded who need new

with turn call development programs. an I'll for update So, on Rob that, our over now to the

Robert Iannone

you, Thank Dan.

are partnerships as diversifying R&D opportunities, in our as portfolio capabilities and efforts progress with We external through pleased technologies, expanding of our innovative the organization our well internal and including collaboration.

medicines new therapeutic development, difficult-to-treat and through includes providing multiple late with our in and diseases. important We are patient which early options improved advancing goal R&D stage new pipeline, the strengthening of outcomes and

early indications, into data R&D continued pipeline, late-stage and candidates for portfolio. on of maximizing integrate and and opportunities evaluation acquire through our our products generation development XXXX, will to organization opportunities In our in-license commercial product of differentiated focus highly new diversification and expansion exploring our and

activities I'll therapeutic our neuroscience begin with development area. sleep and in

with idiopathic of we're second in reached which On study, in to III we enrollment the the XXXX this our hypersomnia half completing development quarter in forward are the JZP-XXX, XX% in looking year. pleased strong study front, this Phase enrollment enrollment and fourth

XX Sunosi a in with continues EDS of only therapy. EDS, about persistent receiving psychiatric of MDD XX% to development affecting MDD X% US. common depressive patients approximately major XX individuals Our million progress. with million also is to Approximately have patients disorder the for disorder, and

We have for study III expect finalized and the the initiate pivotal mid-year protocol Phase to this

selective tremor. T-type with highly treatment of for a patients central calcium of channels modulator the JZP-XXX, to Moving a

once-daily develop we of profile. with later JZP-XXX, a the plan Phase to in We are expect We study working I/IIb patients our this initiate use a tremor, to enhance to formulation clinical central formulation to year. which with administration this in modified-release

Turning activities, our begin I'll to with development Vyxeos. hematology-oncology

upfront, the program populations. for as intermediate Our forward, Vyxeos risk is broad development treatment fit Vyxeos borderline and evaluating moving

pleased therapies. are enrolled populations. evaluating in new important Vyxeos be safety these other particularly in These to activities and combination we in Vyxeos with patient the generation support efficacy We will other and Vyxeos, study, to data agents evaluate of in our the first with of the V-FAST combination have value patient as approved

pivotal forward year. the also some and data the data We combination from study potential this overall look survival for to the five-year early

enrollment completed and We defibrotide the prevention the global XXXX. study data in Our year program progress also initial in made good GvHD we of XXXX this second acute Phase in development the expect line II in of half top

Phase will determine study, efficacy year. reach analysis interim In the or patients the allow beyond patients the first to maximum of continue expect up of and to for design XXX of complete of we adaptive this XXX, VOD interim for continue to first early to prevention half XXX also predefined the This stop us a analysis to to XXX in or III of whether futility. our enrollment patients study the enrollment

and of Turning asparaginase. derived important manufacturing florescence and generating system process expression pseudomonas goal asparaginase supply non-E. to consistent novel recombinant with the platform. Erwinia expression a modern Erwinia a This medicine. a efficient is recombinant of a this our utilizes coli reliable JZP-XXX from

this In arm Phase early to the pivotal expect our in collaboration Children's II/III as Group. our BLA study conducted with we submit year. began as in we quarter And December, single fourth enrollment Oncology

call over update. will I the to financial back for turn now the Bruce

Bruce Cozadd

to FP&A, Thanks, finance, business our our relations and appointed Renée will years effective corporate strategy, development, technology across Renée lead March announce and of Rob. Officer I'm all brings corporate than Chief delighted investor corporate that strategy more in as Galá finance, and we've information areas experience Financial XX. XX development. new Renée groups. global industry

Renée's Biopharma. as insights instrumental recently served that, phase to will at be record, track proven of we maturity. CFO of as as most And GRAIL strategic before She the and next capabilities strong enter leadership Theravance CFO. Jazz

bottom adjusted million than was investments are income, exceptional line XXXX that and essential an for strong and in we our significant of to revenue sustainable growth $X.X XXXX. We more year to strategy. generated Jazz, compared while net supporting $XXX top making believe billion growth with

revenue following Sunosi and our diversifying JZP-XXX lurbinectedin, ongoing strategic and further to forward key including look on launches We European by launch upcoming approval. the as as executing US JZP-XXX the launch base well US priorities, of of

to billion billion, over For XXXX. is guidance X% to representing $X.X our total expected revenue $X.XX XXXX, of XX% growth

to sales increase products. growth, with of of net Now, $X.XX turning an to our strong XX% deliver compared XXXX billion, to key continued Xyrem XXXX.

initial think including JZP-XXX under As of net franchise. of about sales sales for we're XXXX, any we Xyrem heading sales and guidance oxybate the

The gross our to low digit mid-single expectations on reflect expanding our new nets, products. on we of guidance market volume strategy contracting patient focus and portfolio our high long-term the to for to ensure entrance, in sleep access growth, impact of quality as

oxybate. guidance sales XXXX $X.XX $X.XX revenue X% franchise for net is to representing to XXXX. billion X% of expected to The growth compared billion,

our this us later to Our guidance broad year year securing $XX early for coverage a million. we and as curve, is OSA XXXX with next base, expanding guidance for regarding provided sales TV position year. to of which launch or direct-to-consumer prescriber last consistent the payer expectations such campaign will Sunosi initiate factors is key million net assumes This which at launch the $XX the view

hematology-oncology For $XXX you global Vyxeos, presentation for million, product. growth including and our we our to and year-end portfolio, of to release midpoint. sales are on Defitelio representing to earnings the million website product investor by our specifics net $XXX Erwinaze, I'll refer slide XX% guiding at of

expenses. to launches, as to and year, product our corporate operating are continuing Now, prepare multiple business further invest for programs, in our clinical I'll key we This turn activities. development advancements in we

our thoughtfully our a on while R&D business. will year and future R&D be exciting developed and our as with portfolio value company, very diversify XXXX our commercial We pipeline. SG&A the prioritized have believe the We grow a for drivers further efficiencies and we've long-term in revenues leveraging focus we investments, base

SG&A adjusted of guidance of XXXX, XX% adjusted revenues R&D XX% total For is to to XX% and is guidance revenues. XX%

expiration incentive effective provision application non-GAAP reserves and the Our box of a for release of a upon and Italian rate XXXX statute patent the impacted the tax during of of the tax basis the by favorably on limitations were year.

ETR high XXXX these adjusted would have the Excluding been in our benefits, teens.

XX% Our XXXX is guidance adjusted XX%. to ETR

$XXX Let will an XXXX, payment in on me remind our $XXX income million XXXX for made which and diluted and after-tax Beginning January non-GAAP million we'll we I'll or you no milestone an to of EPS and will arriving and how update approximately per that share. we net upfront in of non-GAAP payments net at adjusted EPS. financial provide our measures. $X.XX our to an income have report adjust adjusted longer impact adjusted PharmaMar, upfront adjusted guidance

XXXX, is non-GAAP adjusted guidance $XX.XX. For $XX.XX to our EPS

global In base to investments our year closing, XXXX and biopharmaceutical will leveraging be growth. a drive presence of on and expertise as we broaden long-term business our focus

of balance liquidity commercial while portfolio, to to attractive financial we strong the broadly invest diversification corporate transactions. our position, development With the flexibility have business to the sheet and our R&D continuing support in pursue and robust

opportunities multiple advance ahead We to we are bring significant the multiple excited for launches, and about for patients. differentiated portfolio, as options treatment expand new Jazz prepare our and and

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

Katherine Littrell

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

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

Operator

Instructions]. [Operator

question first Cantor Fitzgerald. comes from Brandon with Our Folkes

Brandon Folkes

maybe guidelines the long And any would risk-weighted of guidance? Thank are inclusion Are lurbinectedin ramp post coverage? approved? Alright. guidelines it Thanks these revenue this and for we should approval can elaborate for about How in just it year. the and terms in take on any of on XXXX launch my you. question the for to the think the prerequisite congratulations there in is, for the assuming taking year, coverage? the My you NCCN change how progress then, question quarter gets lurbinectedin

Bruce Cozadd

I'll to in. and solid tumor the Mike really therapies add space, can way area in the in little But start and Sure. unmet be very second excited of need, line. new of

profile that favorable having we're company with interaction the really the date been So, to and happy the FDA. has with

you treatment can got them efficacy, we've safety Many what ramp, in we approved the said we've of and topotecan, advantages XX,XXX is out of option, with there's the which current are over line. dissatisfied and – think second launch that. terms is, In patients model administration one

that the data. clinical make do was, sure So, of awareness how there's key we the

data. And surprising Lung publishing from us was that there's And the some PharmaMar has of yet down Monica. done even just publication journal degree a Congress of nice a that. Many a back in Santa of World job there came awareness, that given of not on

the And guideline. think inclusion what to get community is practices, the we into about key, particularly moving into as is

So, into the in we're the which lean of be cell, small May. ahead of going their the data to meeting relevant this. will to annual NCCN We're going around part get to

data And get XX% near to the covering. reps from to a so, good market approval, get in after future, soon and them doctors we the hopefully the terms of label a potential and liaison potentially we're going with the in then, be sales in be we'll to science launch. front medical of prepared of inclusion then, And the would to close

We're But, excited as I not opportunity adult an really sales. us really field for do around for giving specific we think, expanded new force guidance, and that. oncology. on So, don't good anyway,

Michael Miller

it's bit And included revenues, to have question, in the to total our just as narrowly a lurbinectedin, company a really your whole. little not for significant but we

Brandon Folkes

you Great, very That was helpful. very much. thank

Operator

question next with from comes Raffat Our Evercore. Umer

Umer Raffat

the IM your the of one Erwinaze ongoing I on because, has for ask study, is rate a response Bruce, if Erwinaze your question this I of I Hi. Thanks interim this know response rate trial, XXX%. the summer. should we looking look label so study much be possible at And IM for? because for part what should IM taking on be my there And a is, be my question. could on bogey

be the us bogey for just right into should this. was I So, going sure what not

Bruce Cozadd

Yeah.

Rob, we'll JZP-XXX maybe, by could And study demonstrate we're for talking efficacy we just and need remind out, people what looking about start kind point the of end let be So, for of our to here. what the you pointing is product. this me

Robert Iannone

Yeah.

endpoint activity at the hours is asparaginase dose. after So, XX the

And proportion with that target precision who of the an so, hit the have around agreement patients on to need we FDA.

I for translate studies, into thing high is we'll transition, we based of hit dose healthy where that the confidence that guess selected have the we maybe other on is only volunteers degree would healthy trial as a from volunteer this target that add patients. I

Operator

you. Thank

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

Gary Nachman

and On benefits will afternoon. And Hi, you'll the directionally And two any handle the market. you'll on payers how and might you do how good thoughts product expand JZP-XXX, Xyrem? to if the over add products? you thoughts promoting the be any on aggressively reps also, you. try expect how be about thinking Thank pricing, any

Bruce Cozadd

Yeah.

So, maybe about bit I'll think let force. It's early a Dan pricing. we how to weigh too on little for us talk in sales about

of better And terms what the patients. be for we seeking payer be we for In lifelong believe better be benefit promotion a tied that. to we're product will product access, patients get And access certainly a candidate to excited to therapy will safer, broad all be developed We've to be for will for patients. our that. this of

Daniel Swisher

medically ensure have of with that as of behind share continue Yeah. who and field the yeah, franchise to a a cultivate the relationships been promotionally, we've the with to Thanks, proposition sure treaters. make we're brings force got good recently understanding And right as patients treaters. Bruce. expanding we we've value continue to very on narcoleptic therapy. those and longstanding right deep side, news got XXX force voice is Yeah, the well lifelong the both there's terms OSA into that good of in very as much And sales the we've going to XXX,

with high existing would patients, So, not opportunity otherwise new candidates with the good program. we patients who and sodium see for Xyrem the patients be with

initial terms to I have as that our do sure Bruce broadly And said, but most contracts pricing make In now franchise. we're pricing, payers we payer reference going goal sleep with is the not think that, obstacles. major of don't have we importantly, our of across

want and patients issues. access XXX, to over physicians blocked market convert as not the by it's to So,

Bruce Cozadd

ensuring when picking honestly, we on our sleep when activities, by And comment up wrap about I'll support think treatment. the the about go we It's it's launch we product, a to XXX. and, knowledge more promotional Sunosi encourage Dan's continue look we thinking our we seek It's physician and Sunosi, and expand just access successful expand say, understands up at across not to at about look base we of patients just we really eventually that franchise portfolio. as as

Gary Nachman

Okay, thank you.

Operator

Gregg from Our SunTrust. next comes Gilbert question with

Gregg Gilbert

Thank you.

can and future terms chosen about agent pipeline, maybe the that sense. study, on drawing why you could you make what's of combinations for past combination the talk about question perhaps ongoing in can On as was in doxorubicin potential that the lurbi, on the board talk

And to the issues? you some for decide provide we've may similarly, can potential revenue there Thanks. do the market historically to on pipeline beyond supply studies to well on XXX, expand what opportunities given seen get you color what

Robert Iannone

So, I the doxorubicin. take can take – this question is Rob with combination and the on I'll

So, those PharmaMar looked run obviously, And arm was mature. promising. data were the a very by program, and emerging single even before the doxorubicin combination were with had data they that

launched they pivotal a trial lurbinectedin. combination in with So, into

at mind patients their Bear continue combination upfront They is the lurbinectedin who gotten that for the dose those the dose. after portion of they've progressed full treatment doxorubicin. in of monotherapy on haven't full for that

other carefully We through opportunities there's think lurbinectedin. opportunity. with combinations, actually great of that something [Technical terms it's deal In Difficulty] We're are a we of now. thinking

therapy. are For immunotherapy such combinations, already. There lung initiation been with therapy. starters, agents cancer, may there small There's of think combination as potentially with within of be lines in rationale combining logical other subsequent lines those cell immunotherapy. into We getting will earlier well a and be of as for potentially some trials

basket small tumor some we and know, so be just data to forward other looking trial types we into as pursue giving to us signals able that included those tumor types cell, you and may potentially are beyond the As maturing well.

Bruce Cozadd

talk limited obviously to due comment can asparaginase clinical in use develop of if And, supply, to in asparaginase. on want potential Rob, We've but you we don't investigation limited been how we use I might XXX. asparaginase know about as you go where could with we broader

Robert Iannone

Thanks Yeah. that, for Bruce.

foremost, about thinking we'll be and the first US. So, JZP-XXX beyond

Japan around data ultimately So, conversation sets what to with Europe support approvals and other would we in need regions. and

asparaginase protocols age you the know, on groups. and differently is As depending the used

isn't think in as And certainly especially the and in adult of show to there's That so, much there that used XXX. it group, an younger young where in as benefits adolescent we be evaluate group that of would asparaginase the for interest it opportunity to setting.

the literature rich interestingly, would tumors, et combinations, solid in pretty say, is, tumor And I like data especially tests, AML, cetera. of leukemias asparaginase other around and other

so, supply, a will indications. truly And to, as us with in give alluded to other Bruce robust it opportunity JZP-XXX an explore really

Daniel Swisher

thing those constraints, one add supply I just with markets. would other the And constraints, geographic we move to XXX with into to expect, your able is supply be other and

other who got markets. And in of has and very in these despite quality, important unable some been we've So, a from it's to Japan both partner approval. launch I think supply

partners look so, those our to forward supporting we regions And in well. as

Operator

Thanks.

Piper Amsellem David next from Our question comes with Sandler.

David Amsellem

wanted to oxybate a ask I Thanks. question the franchise. about bigger picture

As down XXX, agents launch the you stare in wakefulness market. other you the also have of

there's have have product. pitolisant once-nightly you You Wakix, Sunosi, or then Avadel's

thinking at the to that regarding and your into think oxybate are some market, splinter say, that XXX? to does patient years all for more landscape longer-term for and Thank you So, the might the for start In you. that may the product? the mean market extent what as with other the play words, over, sodium of next picture you about to worried extent you four how how market three the varied capture look a low do at

Bruce Cozadd

question, David. Thank Yeah. for Good, you that. broad asking

opportunities. we at a As franchise, look number see growth our of we sleep

rights. daytime And to We're, treatment appropriate You've appropriate broadening to the has whom that of outside XXX been potential prior and that did seen run, treatment that opportunity I not Xyrem as be an with due choice. might now talked growth obviously, long potential a have We're for including, side diagnosis continued we the about, OSA. the excessive and in geographically narcolepsy narcolepsy. we think growth has commercial way on Xyrem broadening not sleepiness

the of market, in products. As its EDS data be wake-promoting both on oxybate efficacy good it's we we confident narcolepsy entrants very the and cataplexy the that product, true product really we That's terms more of and both that of think agent its standard well efficacy see long, we've and out true as as of on we're terms into Xyrem, and of side, in true Sunosi profile, the in potentially to have profile. our existing and sort OSA, XXX it's proven gold of put across going status, of the its side,

the on disease necessarily and to what market we're focused still a and options and the But on products as for is bad More The with we believe come. necessarily market treatment options Having isn't people patients understand here thing. to bad. doing other can treatment proper what sit we not under-diagnosed there are today out great undertreated really help out remains of we today. promotion diagnosis

Daniel Swisher

think of is, ideal one trial XXX significant need. also that add setting. thing in a would a pleased efficacy chronic pivotal hypersomnia, full for really pursuing be would the and Yeah, with year in the unmet on having and accrual we're this idiopathic I we first area that year which therapy last I ever got XX% look low forward soon. as again is And good to a and accrual profile We're track the sodium results

David Amsellem

you. thank All right,

Operator

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

Jason Gerberry

Bruce, Thanks a upcoming Avadel Good read-out. the there's my focus question. for amount fair on evening. investor of taking

remind you regarding – sort would PBL, to I there a have barrier and just XX-month intellectual any engaged should of that confidence PBL PBL us in clarify Thanks. being to different discussions just of read into property your of can with it, that comment is wanted So, pose that, something the your entry? and around And comment how with discussions tone evolved? lieu we shift on your

Bruce Cozadd

change question [Technical the be to take in there. before. was. it intended to Difficulty] I'll Hopefully, second intended was first. Jason, no was similar That said we There very what

people. On have be we'll that data the to will to shows. data, other We'll interested read-out, see what the see upcoming very as Avadel

IP could our the stay. we would in our But regulatory orange a and say, for – to appropriate, just we'll belief side, the provide do certify give pathway, our cover that, for using that patents, they're options litigation they evaluate intellectual at general, number listed to Xyrem a up least have On patents should the XX-month using that book if in which property. is enforcing opportunity, of

Jason Gerberry

Okay. Thanks.

Operator

Cacciatore Ken from comes question Cowen next and Company. Our with

Ken Cacciatore

Thanks. Bruce, strategic question. a just

You've keeps been and down. earlier doing stage just stock but the deals smaller these deals, going

the Does you you at or do thought a going all? Thank think private, strategic you. why think transactions, that. larger doing it wondering, just different what's pause a that's stock it your happening maybe telling path, taking sale make make on of Does just and So, you price you?

Bruce Cozadd

Ken, Yeah. good question.

we coming We had the from couple submitted. of of second end they're need excited Phase were variety a did believe approaches did have year, time, a what in fairly opportunities a those think II understand trial. pursuing. mid-stage signal also the a is that then, development where tremendous early we the done higher stage we're about. targets but that We At are really include worth market farther some trial at are to with the late, same risk, that we we deals NDA the off Phase proceed already II of been us gave we deal deal of Cavion the with And and

would of a that's haven't certainly on variety So, deals. or ruled larger market. out doing And be we things types already that of

capital to we across and appetite neuroscience, across sleep size. our way of potentially to at We into that, think across productively of hem-onc, is do that. of got an offer the other goal a our best right And work to returns shareholders. we've and continue geographies. do variety put types regardless our to to areas that even to therapeutic to opportunities continue to do And growing returns of want the a is will variety transactions the we And deals look

objectives we're focused on strategy. the or for but in XXXXs and oxybate XXXX, having deliver about that you move certainly, outlined very XXXX, vision. We're all growth And diversification, because we've through It's on I and at the not today. not an It's on inflection XXXX in interested you're we ability our as in XXXX think visibility to beyond necessarily franchise seeing the revenue very continued in sustainable franchise. what look progress growth in our revenues as that the oxybate if out

Operator

you. Thank

from comes Oppenheimer. Rajavelu from question next Our Esther

Esther Rajavelu

Defitelio. also Great, on just you opportunity you GvHD? maybe understand here VOD help my I us with question. thanks. the specifically indication acute and Thank have one for the that taking Can with

Bruce Cozadd

Yeah.

but of we that, is the and the of understand may GvHD, other people the CAR-T broader and in help US molecule. prevention So indication also clinical we really just maybe as potential at I'll around start indications Rob? today and world, potential a use. around molecule that of has of develop little work from picture, in for that prevention severe the is VOD, those, neurotoxicity associated VOD, is that on interesting as treatment Rob we we I'll And bit, ask not to look the potential data which have a but the potential think data the comment only Defitelio lot believe with coming big our it we a the which acute

Robert Iannone

Maybe add from clinical perspective. I'll Yeah. a just

to reads logical So, new especially positive. problem the treatment earlier that prevention progression and intensive a we're becomes of regimens out the bone and test as the hoping know VOD Defitelio agents, as outcomes, study the marrow major standard. better And continues that transplant, the notion intervention, giving more of in we VOD the be

remains GvHD, mortality cause morbidity significant bone acute it a for of and Likewise, transplantation. marrow in

more cases. as is significant in GvHD barriers, As BMT you know, more results in widely across which we're much transplants doing some HLA now available also

so, in we're treatment for had may that those GvHD, provides with acute Defitelio that activity another And the patients. hopeful option there suggesting we signal that be

Esther Rajavelu

Thank you.

Operator

next question Tewari Research. Akash with comes Our Wolfe

Akash Tewari

Hey, guys.

patients chemo-sensitive chance Do into chemo for fails? who see negatively, small the you is where in the re-challenge I patients lurbinectedin, the ATLANTIS sensitive? line chemo market where there drug who for in will fitting to second reads line share standard in Thanks. this similar because efficacy show it feel rates Like, you probably suggests taking given neutropenia the platinum-sensitive of a is lower kind see aren't trial home the trial if the or care? cell get lurbinectedin patients ATLANTIS out that do second maybe of So, like of

Robert Iannone

is take. if Rob mind, This Iannone. don't you So, I'll

strong that a with platinum than response to I is So, had six-month some patients lurbinectedin. observing certainly, more while in what a by who as as rate have that's no say in retreating doublet we're there interval, means when

I an in So, treated it's populations, all whether most lurbinectedin the for sensitive. advantage going there's across think the to be line second resistant or most

a infusions Secondly, Again, but at lung it low mentioned, open Dan we wide rate. very leaders. interest this as you talk conference give there's had big the opinion where I you poorly would presence is hear is only key say, because at tolerated, a as least difficult not to five is with initially, really consecutively, high the second to response also line topotecan Monica Santa and

really think going the in brisk. is uptake we be line to So, second

Having small there's therapy to opportunity comments from cell an lurbinectedin earlier, lung that, use cancer. in indications to to find within said where enhance my other

lurbinectedin, combinations therapy, upfront agents and are active several combined that it or is. through rationally example, even given So, may different rational for with be there how tolerable

Akash Tewari

Okay.

you're a it is maybe on than say as then Street trial follow-up, the fair to that maybe out would necessarily? reading Just the more bullish be ATLANTIS

Robert Iannone

response was… you to My

Daniel Swisher

that were I to path rationale combination one would the interesting they set thought. was best just as just submit that trial. thought profile much got it doesn't really signal sometimes they monotherapy got the trials than They data they monotherapy the into a based expand Rob. data to Hey, that support was actually add that and then Initially, to team. clinical to trial to because going positive the to were encouraged be and agent on what to they we know trial that a do without thought PharmaMar pre-clinical translate and was asked data. just have up the which did clinic They I and a they thing forward preclinical single stronger in

is most with monotherapy looks we'll us. tells other So, that agent really second to choice, I But the else second and we're likely like that want what that to combination the really do is being to banking therapy of frontline immunooncology. the our line but our the including a be explore analysis what therapy we and combinable going would it's standard where monotherapy areas, going Obviously, used. see say into get line now, it's expectation around

Akash Tewari

thank Got you. it,

Operator

comes Ronny Our next from with question Gal Bernstein.

Aaron Gal

my taking call. Hi. Thank you for

a bit more Just Xyrem. on little the

cumulative into X.X% count revenue growth. Can what share the, to us You're is guiding with embedded count assumption? just or that you your I volume guess, patient

And the now, your expect market? across oxybate market level rebate rest XXXX in should estimate we patient in in especially for Xyrem you then, in what's XXXX up of about if of step penetrated Just another the you rebating year. a you're fully feeling you are across or your providing this think as embedded the the capture right of

Bruce Cozadd

Yeah.

So, digit Ronny, perspective franchise. patient mid-single is in a the for volume growth what's to volume from oxybate built low

terms on Implies going guidance to this of total revenues, we rebating, which we In gave earlier year. of can than that into. we're you price took realize gross probably increase the half back less

to XXXX, there have volume be the growth early as although us price cover we net revenue commercial growth gave. most we does So, will the oxybate guidance franchise too put place contract as predict in lives. get well to Probably that

this too a XXXX imply to go probably to little call point. mean lot whole to there's a there, at don't I early So, but

Aaron Gal

are caps, contracts? But into there to incorporated so that are fair say to essentially those pricing caps growth rebate

Bruce Cozadd

in So, I'm done although our not certainly on going of we've specifics it a we've done how contracting, with the to mind. comment multiyear horizon

Aaron Gal

very much. Great. you Thank

Operator

Samimy with Stifel. comes from question next Annabel Our

Annabel Samimy

or question. And about is guess, pricing for gross I XXX might And of of I launch. just, when Thanks. as right you And or quarter these XXXX. us high any for pretty of just edits second the just proceed any and rolls contracting end I Hi. was agreements may if or what just sleep again, one to we so sense this Thanks without franchise? could your be of give kind the franchise, contracting Sunosi was that's year? priced, into authorizations wondering, NDC where how the you They nets think guess, that kind for hurdles prior the the my far, on I step first, taking the were blocks? a up benefits progression of just through from a that and wondering

Bruce Cozadd

Yeah, Annabel. questions. Thanks the for

yet. contracting Again, a to on early XXX but XXX with whole too long product. contracting, we of a our is sleep did over approved comment franchise yet not the time, as period an toward view On our a

expectations under as end nets, expectations. launch Sunosi reasonable talk sense to to in XXXX. the of we exact the On to call And honestly, most the that's certainly nets expect during now, yet I we but we to thought with where we Can't up. the quarter-to-quarter our good set about coming course of progression, contract lives might to a think gave a were think commercial over place gross us be gross

Mike, you want anything that? on add do to

Michael Miller

get we'll most thing, that the Yeah. suffer Bruce, seeing. I'd gross one be typically better. add what beginning the of And nets in that's the the to then launch in and

Annabel Samimy

Great, thank you.

Operator

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

Randall Stanicky

as about to of Thanks. take we as of oxybate the years. see you that place to franchise next well Great. the expect or next step over earlier over XXX? a you switch activity growing the several made business Do some a down years couple grow comment the versus the Bruce, taking move perhaps

SG&A year. has up follow Midpoint the up XX% then, up. And it XX% saw We last year. this

the be see products launched. to out? to When still model You've play expect in we the coming leverage start Jazz business to got Thanks. should several operating

Bruce Cozadd

but on probably I a So, we of answer, how early oxybate adoption from an of growth to that's entrants see comes to much to growth, of from patients there's Sunosi, how from of long going comes in own how think market call we do on including out said our impact opportunity. period business. of going patients the grow too opportunity other earlier think over continue play much XXX, continue, business time, I that into in to moving that as that Exactly new to XXX, this too Xyrem,

one important marketing is expenses. is would understand in and sales that to thing say really I On SG&A, an increase

of is that of portion flat G&A Our percentage a on revenues essentially basis.

right now of terms of think leverage, we increasing over period see because we'll long we're In for our when time. shareholders it'll operating a pay off investment

a we like product where oncology what XXX will see dynamic have launch product be that's by The you'll may different Sunosi, you already the retail an product. You'll look see from and with that which be would little see like to a different market operating launch an on you revenue what leverage from lurbinectedin. going different accelerate, see with as oxybate

all we'll and out into up terms that XXXX will of as XXXX, we in in more to add but rapid see do those we leverage start So, than revenues over expenses. time, get believe, growth

Randall Stanicky

thanks. Great,

Operator

next Fadia question Ami with from comes Leerink. Our SVB

Ami Fadia

How Avadel. got else And growth? as generics growth offset specifically need kind questions. competition Hi. are you Bruce, couple revenue of from it? frame? kind has anticipate Good a do continuous potentially next and you And then, of or think drive once-nightly your decline we the entry XXXX/XXXX of taking the can of some that more Thanks you other it what time and version we my portfolio think maybe anticipating time you've then from of of Street evening. years, in for most most do the in that would about to drivers as think frame, you your do of to the

Bruce Cozadd

Yeah.

So, franchise I of would think rest business. our then and about terms this the our oxybate in of

making those to independently. up wouldn't of is optimize for one I other. the think each goal Our about

after are course, that, of authorized side, oxybate we oxybate generic. through have significant we months authorized economics. an where generics that the six several anticipating, economics of in Remember, volume XXXX. in generic And again authorized we limited that significant. generic That's have On entry are then,

development many have generic, for So, once significant we've nightly lower we also A between continued case here Jazz in see to reminder into we once also revenue returns for and significant years got stream although think a XXX, opportunity share future. and a product, nightly, in Xyrem, shareholders. sodium our economic authorized the a that

adding intention our near in cash indication about or label upcoming stopping we corporate new the geographic expansion and drivers no our launches growth term our using to the launches, of of flow our number efforts. and a investment that, and expansion, development balance continue just talked term early of have we through longer Beyond sheet and business

Ami Fadia

you. Thank Okay.

Operator

Our Risinger Stanley. next Morgan David question with comes from

David Risinger

very much. Thanks Yes.

just of question. of at Could that you. follow-up I'll on low asked sodium Bruce. version timing And I'll of one update since you just I guess, you the comment, validation it your leave that us So, Xyrem Thank the mentioned? given just you once-nightly for just

Bruce Cozadd

at give David, update question In you be a much the just point. the which first, an haven't part, we said happy I'm to not We answer to second program. this with going you're have once-nightly because about to don't the internal going approval efforts JZP-XXX, our rather squarely now the more launch front there are less quality executing some at of on say because reasons than are to and that's right we us on but the think a high other is moment. for

to for back another question. So, you

David Risinger

very you much. Thank

– us candidate there proof-of-concept lot obviously, early key what could would frame it just for see readouts the you questions were be So, helpful you but a pipeline, as of about in and R&D stage the XXXX XXXX?

Bruce Cozadd

much not given about you to a I'm guidance bit talk sure we've directionally. Rob, specific little too that? want

Robert Iannone

Yeah.

the part how on far you far depending how look, earliest program. pan-RAF and the in to pipeline, want of we So, inhibitor the out have back

any updated encouraged on there. to timelines continue but we be haven't that, We

have collaboration area. to we in hem-malignancy especially on continue Codiak several work We targets, where the

that technology in the delivered context on We we ability a help have to to tumor progress candidate well. to work CombiFlex through the solid as other and continue drugs look at which

then, XXX, have to as accelerated you that a XXX products ongoing We as have that central mentioned well. mentioned than which trial Later Defitelio. central development, part and we the tremor. you if program, be trial, within tremor have have marketed go pivotal could acute later And you path in was think the earlier, IIb of a program bit hypersomnia GvHD which for could and approval a idiopathic about very for development pVOD

David Risinger

you. Thank

Operator

with Our comes Balaji question Prasad next from Barclays.

Balaji Prasad

and my call. evening for thanks Good taking Hi.

been So, have it of most answered.

levels? you to purchase of The accelerate capital years, of that you reconsider I average three last out share you. would it Thank that most Would thoughts When updated these capital last look a couple at allocation wanted currently you efficient you the on you be or that it? XXXX? stock updated repurchase years. accelerated. repurchase for are Just strategy at price And would get allocation. at share the the the What the your below over on could think of your price price have thoughts laid is programs have the

Bruce Cozadd

for Thanks the Yeah. question.

So, our existing billion authorization. we in $X.X still over available have

the do when stock average, our fully I business In continue And on think, maintain emphasize more we that higher. capital going flow fully predicting buyer Not back strength think lower priority give is us we've development because purchase part corporate than to a significant side. to continue liquidity but putting do being to been transactions. very next, that corp shares of and what our price right it's our stock that's being when balance but stock, bought want dev bigger our attractive to to our on buyer. we a flexibility is sheet a and and for and the intend cash necessarily intend to has we're been I and now work

So, expect dev. but a to maintain be biz corp us to flexibility to buyer, continue for and

Balaji Prasad

you. Thank

Operator

from comes question Jessica Morgan. next J.P. Our with Fye

Jessica Fye

guys. Hey, Good my questions. evening. Thanks for taking

ones. Just a couple of quick

will from relative what You're separately? to guiding that, you Xyrem the proportion plan to Xyrem do the coming report is And a sales of it XXX? and once to launches, volume basis quarterly oxybate franchise, you report but XXX XXX, related to for for on

Bruce Cozadd

and expect do I'm we sales not about made sure the all reporting we'll I we've not. products be will the Yeah. reporting of be what determinations individually.

do this year date. date, approval more group about uncertainty them Our with to guidance for had choice to launch

hard and how understand It's us that us trying guidance. closer are about to launch [Technical be more important about reasons. what talked what that you to we're for we get and a We will to important to granular There we like time. more performs for as should And of XXX But some understand give expectations over haven't investors for pricing give we it'll lots yet. Difficulty]. look

Jessica Fye

Okay.

anticipated Sorry, just not? why the if to it lurbi, confirm, does like to the upon it includes PharmaMar And approval? not reflect payment for sounds not, upfront the guidance

Bruce Cozadd

Thanks for the question, Jess.

So, does on would approval. include that payment, be but a guidance payment that our

the would of it the So, rather that life we over expensing capitalize that, product. than amortize and then

Shawn Mindus

The guidance payment is upfront $XXX million that's in PharmaMar. the the to

Bruce Cozadd

make that Did sense?

Jessica Fye

Yeah.

Katherine Littrell

will be this Operator, question. our last

Operator

with comes Suvannavejh from question Goldman Graig Sachs. Next

Graig Suvannavejh

several the guidance Any and the be longer-term about company a next I XXXX. should appreciated. But basis. on kind there you. how just earnings over question. realize ask to company a of you we position provided comments would I earnings to Great, thank in of wanted you that near-term the for about the think Thank you're years? power my provide perhaps a for growth not just taking

Bruce Cozadd

Yeah. then going Good growth bear, new tumor, revenue forward. drive continue neuroscience, our to to continue geographies wrap-up sleep to Again, unlocks across across I diversified solid we're to to question. trying portfolio earnings and think products bring that do products. growth existing hem-onc R&D significant across across that and growth And our and

even follow, the Obviously, very in lurbinectedin upfront years of we a out think that of the across very launch the expense make. excited announced to have results. about. the to But did we'll impact, million near-term of was We we're at aside the have did that we see another in revenue brought our to December XXXX, near-term our that adding that impact investment to as January, us putting more for that end line which products. closed great increasing deal expense, look really us think the But revenue of ahead benefit the we for $XXX

a February would question, And maybe is at wrap have to wasn't was since where as XXXX, about evaluated sit we long last And comment just you talking that that rate up business ago I'll you very it with that about change. our here that, just our differently. all it remind of of

NDA uptake III got September good an launch. hadn't gearing we've and and we quickly. launched. a submitted access achieved was we're and data initial And Phase until just good for Sunosi XXX, relatively up shown now we've

last and get labeled XXX, of to as the end before BLA August this now year. as in early of as in year, development pre-clinical we're trying a was

never year something a talked the we're this until launch. had was we Lurbinectedin beginning about and of for up product gearing

movement We've behind including talked that, we've and disorders. Coming the Defitelio We've progress idiopathic various we've talked clinical right upcoming. hypersomnia. got about in trials readouts good about now got

to pretty progress tremendous XXXX. for think our continuing same the been to management a near And of catalyst I rich tell proud can't company, management we've I you out Patil today's Remember, Galá And how Pearce then, our time, and added is Neena a term. in team. the I added sets Finbar the team. Rob At we've to build and executive it This up am us just committee. amount talent Renée today, Larkin the addition of including year the the to announcements. we of last Iannone we announced and And Sam

we So, our we're us company that's five to opportunities excited what on a new do demonstrate broadened this help to senior can managers execute team. of and really as joining portfolio

Kathy?

Katherine Littrell

to and all all us All thank you. of for thank right. today Thank today. you, We'd for joining you like help operator, your

participating We This there. the will healthcare be conferences Cowen our will you now in upcoming to we many Barclays call. and see and of hope end

Operator

Ladies and today's presentation. gentlemen, concludes that

a now may You and disconnect wonderful day. have

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