JAZZ - Earnings call transcript Q2 2022 | Jazz Pharmaceuticals plc

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Operator

Ladies and gentlemen, and thank you for standing by. Welcome to the Second Quarter 2022 Jazz Pharmaceuticals Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to your host Andrea Flynn, Vice President and Head-Investor Relations.

begin. may You

Andrea Flynn

our good which second and accompanying Today, Pharmaceuticals website. we section Jazz webcast to also Thank press also the XXXX afternoon, posted financial its release of Investors the quarter available earlier presentation Investors results. reported may is refer today, you issued on everyone. website. is The this our slide to

team expectations Dan disclosure webcast. today’s obligation differ from on statements. those materially no SEC factors that the events, to results statements review update today’s and involve Officer; our for forward-looking Swisher, XXXX, events, materially today’s future XXXX may Bruce to undertake statements Sablich, Renée today remind General and the deck, our of risks guidance actual join identify forward-looking that cause the are made to Cozadd, latest Chief document, Chairman, to will could related results you and Financial in in Chief and Head slide and and our performance, our those certain and those call which milestones forward-looking Q&A. you North Manager, webcast encourage duty actual results, contained operating development Executive Officer; to which to We contained Executive Galá, and Executive Iannone, Executive related contained X, financial cause President; that Vice in the from Rob goals, and anticipated Global Vice statements. and press President Vision On and and including our these America Vice I’ll President, statements for release, performance, company’s President We forward-looking growth uncertainties commercialization Kim On includes such and potential in as or the R&D. in slide differ

over presentation GAAP available and Reconciliations Turning financial financial slide to Investors section of press in to on in I’ll today’s release we’ll now Bruce. on of this discuss included X, measures. the the our slide website. to are call non-GAAP webcast, non-GAAP the measures turn

Bruce Cozadd

Thank today. first notable slide you, through bottom first quarters. and We year, substantial second and and across has afternoon, half make to you our the thank on with and in entered start momentum, business while joining XXXX solid us Good the continued X. advances everyone, our of year-over-year line Andrea. for delivering the growth team I'll top

market the the confident productive reflects Our second progress results beginning commercial to entry the that the performing which are branded with competition. towards quarter our business, We're following with oxybate in remain full durability in year. year are oxybate Vision well, at confident and Xywav, therapy we which authorized we the and on of our and of of achieving in our choice half first meaningful we franchise sodium XXXX XXXX, higher our believe track is the be will Starting we pleased the introduced generics of the of guidance. year even potentially achieve

of launch about all a to underpinned the of growing strong pleased are engagement and reimbursement. which are level a in on narcolepsy Xywav in momentum and We high continued are of the receptivity in hypersomnia, and positive see therapy by There equally is adoption patients excited the IH. Xywav idiopathic market, or Xywav IH of number of

Epidiolex. to Turning

Epidiolex's real-world generating to across base further We data effect expand seizure types. continue evidence prescriber broad substantiate and our to and are

the additional in our experience the deliver portfolio robust launch, performance continued Zepzelca reaction aimed status a development of from therapy. for who and to to to pleased the our identifying Epidyolex. strong effort can overview only at excellent and Our across and team remains be achieve patient to are blockbuster remain patients provide of of ex-US, Dan has we able lung a may asparaginase. done choice is detailed in confident cancer, small treatment commercial E. the an we second-line coli-derived who in launching will its US populations benefit cell later therapy job product hypersensitivity we call. our Rylaze available the

remained in and of has team the R&D very Our half programs. clinical productive multiple first advancing XXXX

that In development. program the addition, enter FDA JZP-XXX, we to were IND pleased application clinical for cleared allowing this

patients Consistent objectives, opportunities. leverage time deleveraging are development, molecule The a alpha R&D pipeline last our a deliver to we've therapy, non-GAAP strong these to deals INDUKINE completed As balance early-stage pipeline be our in to the medicines with with and diversifying we we differentiated interferon for quarter, us the to in our advance ratio the that including earnings and its active thereby, in-licensing net conditionally quarter current selective highlighted on two programs agonist and expanding to the line, potential attractive associated to ahead macro orexin-X stated activated with and to minimize share that corporate also with molecules X.X. treatment two narcolepsy second flexibility JZPXXX, has new with options environment of I'm in achieved JZPXXX, identifying a our of finishing we to shareholders. revenue. transactions our other demonstrate is sheet potent, add highly second treating pleased to the value creating call, toxicity prioritizing These clinical additional our provides quarters expanding most cancer. disorders. likely our target potential the alpha the commitment sleep And interferon systemic and utility of our

in revenue through potential existing from in XXXX, includes to operational excellence. our Turning Vision value; road three business provides our we commercial, components Starting with we're pipeline to X. clear central to pipeline new $X through and in a to as slide a sustainable emerging billion and development. grow $X and billion us enhanced XXXX XXXX with over growth map driving therapies products, revenue positioned achieving commercial. well After corporate of as and as combination transform

of of And and on organization corporate and quarter was approvals Our decade an top R&D to share XXXX the plan patient of delivering to and bottom a the to call combination an turn overview, delivering line XXXX through on over of overview Q&A. to by Renée provide from will product then programs. line. that XXXX, for addressing Dan? to excellence, novel our the financial adjusted Rob more the XX%, open second Dan margin continues we our call which we programs, we'll the operational end improve points five I'll after significant of at development. least key advance R&D by And now progress our our existing in will commercial programs five a update performance, operating to the pipeline and anticipate needs percentage through oncology. neuroscience

Dan Swisher

oxybate gain narcolepsy. last opportunity Society. in IH. development XX their abstracts the and portfolio continuing narcolepsy well-attended Xywav launch data to commercial performance XXth slide same IH we SLEEP I'm breadth KOLs Bruce. partners with by the and was With our average X% Sleep period Thanks, to insights have and a oxybate and Professional of increase meaningfully second by we efforts recently Xywav, presence the debuted experience their compared In Meeting Xywav encouraged was quarter. lower for Xywav quarter, we neuroscience on in driving valuable customers have increased and second across encouraged momentum providing advanced our new made the nearly connect in in with in-person with patients the highlighted feedback. second across we in we IH, approximately to product. came very Associated narcolepsy the patient our strong the Starting quarter. narcolepsy, We progress the continue robust XXXX, into Xywav from year. the adoption away X, both and our see are to oxybate of franchise, active maintaining The by It of a XX,XXX, our at with in event, Annual to in an of sodium In care positive June

around and second X,XXX resonating, we of burden about with exited Xywav. efforts and patients lifelong educating quarter sodium taking Our the are physicians narcolepsy patients approximately intake high the

importantly, Xywav. existing to of large narcolepsy are Xyrem expect patients therapy we and oxybate ahead, of adoption to Xywav patients see their beginning majority additional with from the Looking new

momentum Xywav community. in patients there taking from Actually, feedback robust Xyway. we IH For X,XXX the positive approximately IH, by launch quarter, were and and IH remain the continued second the prescribers encouraged and

medical translated continue of safety both education awareness support profile We established therapy XX% quarter similar second than Xywav Stepping prescribers customized we to for the on coverage our confident active to patients the efforts in this of last and over this building more maximize approximately pleased and with quarter achieved commercial We're and IH We've oxybate of narcolepsy and And focus time. from educating patients about our have initiatives and market comprehensive Patients increase around prescribers recognized initiating patients will underserved our that efficacy approximately taking across find Xywav compelling of the XXX lives our in to and quarters, in growth indications. realize first the payers into Xywav's significant FDA-approved can therapy. per patients we and value Xywav only educational patients are four the covered. of with a that milestone have market. the that we goal active expect Xyrem. each obtaining for achieved valuable, potential in ability and IH, commercial back,

a across team Xywav call positioned for durable drivers. that to that drug extend both Book-listed supporting with one narcolepsy of for concentrated to among and sales and well and indications both believe as IH significant be we field integrated an that patents growth well as exclusivity core narcolepsy universe our XXXX Coupled have IH for is a Orange out XXXX, product and IH is overlap narcolepsy with orphan prescribers. We to XXXX extends

on forma to as prescribers. by compared the X period same XX% to continue add pro Epidiolex turning of in we sales product quarter Slide Now last Epidiolex. grew a second to year XXXX, Net the and basis

experience have cornerstone as for previously Epidiolex utility, patients. with that expect they gain Epidiolex see highlighted, adopt broadly prescribers as their more clinical and its we we treatment-resistant a will therapy As new

and committed across evidence also seizure a broad to of types. range clinical are utility Epidiolex support study to to further generate We treat to data of world continuing the difficult real

US. physician recent team continues that our and commercial five reimbursement will which field we're ex Epidyolex markets. encouraged in in and force Our continued experienced to all months. gain and be market, we increased access treatment growth year, promotionally in-person this is more And for centers to seeing We track engagement. reimbursed launched are France on remain sensitive European Epidyolex a This has and on in major adoption point, at offices sales focus to

opportunity year. anticipated coming and launches indication total for have a this also markets from additional of new XX growth We throughout

status blockbuster to global for Epidiolex and we action, are mechanism and efficacy epilepsies. other we treatment-resistant with achieve profile Epidiolex's safety therapies, of in unique Given care ability a a confident of as be standard can combined

Now moving on and starting to oncology Zepzelca with slide XX.

quarter product were million. sales $XX.X Second net

second-line highlighted, current additional studies. Bruce growth. in as we of patients has investing share in lung will lung cancer. this for support efforts have our for positive As in and in small benefit evidence treatment the benefit support providing of believe development data forward. Zepzelca rapidly Also, who from which observational depth cover small future potential To cancer to lung cell more therapy, could the opportunity other to real-world adoption the add cancer around populations Zepzelca's our and tumor further first-line the established identify second-line are to these body grow risk market plan, evidence We meaningful we indication, moving types, cell in robust choice of additional our patient treatment Rob small will increased including profile cell

slide to XX. Turning

of reaction coli demand among for therapy awareness asparaginase Rylaze's patients in increased reaction to recombinant Rylaze has switching to who feedback net derived Customer or position erwinia by asparaginase. quarter clinical million. market returning is that profile, services an be sales have observed. provide. indicated customers the product brand therapy, hypersensitivity to driven E. earlier the now support reflects a suite when in the coli have hypersensitivity only best prescribers of we and were and initial to the reliable been Rylaze, asparaginase there This US, Second the and product non-E. they positive, are supply as continues its practice available $XX to derived

the potential submission administration and for Looking in potential European with and XXXX. updates clinicians US also schedule the completed has patients. to the Application experience MAA improve We've the Marketing Medicines approval Monday, Authorization to or for Wednesday, in our dosing the ahead, label IV Rylaze Friday potential a Agency to

call Now, to will to provide I update. the turn an over Rob R&D Rob?

Rob Iannone

provides Dan. pipeline. R&D an of Thanks, our Slide XX overview

a initiate to fourth number a advancing are we Phase Epidiolex the type, first in also trial would atonic planning neuroscience, we potential X seizures Within This myoclonic with data provide Dravet, atonic pipeline, a TSC. for Phase in add fourth pivotal of on shortly. a the the indication to across programs. year would and epilepsy that X Looking to plan Japan LGS our We're clinical and label this seizures. for include seizure initiate trial Epidiolex myoclonic

continue assess Tone-X XX, of MSSX measured RELEASE have In the to With X of in the was to in nabiximols our with goal of as we and results trials trial Modified line early by June. Phase effect nabiximols addition, suvecaltamide Muscle III baseline in trial spasticity, program, Ashworth day top JZPXXX RELEASE ongoing. we between results. primary enrollment not Scale. at did and the trial Limb patients look from for our and respect Lower an MS the the MSS to is The endpoint meet change The in announced

of no the consistent previously with with attributable signals new profile events safety, reported terms to safety was adverse In nabiximol.

oncology. to Moving

urothelial cell cell four our our Dan first-line Meeting, other is multicenter a range This Roche, and extensive-stage to HRD year. efficacy data robust Annual and development cancer, in for have trial second-line with with of II a III Jazz carcinoma advancing and monotherapy supported we in We of designed small cancer. of lung advanced includes lung in initiation second-line are trial in assess neuroendocrine basket evaluating As post-marketing cell of small called PharmaMar, presented and cohorts of to a lung by partner, trial open-label carcinoma, mentioned, from effort also own in solid Phase and EMERGE-XXX our tumors confirmatory tumors ongoing Zepzelca tumors, Zepzelca cancer evaluate We're with three the lung observational large recently trial III the patients regimen. Phase of Zepzelca exploring solid settings. lung at ASCO our a Tecentriq progressed safety Zepzelca following presentations the by an cancer the run being cancer. combination This Zepzelca small for a treatment earlier in platinum-containing trial cell that this the poster cell small Phase partner, as lung

XX-hour the Annual using as XX Monday, Currently, recent treatment. is supplemental at Monday Monday, meter per clinical with Wednesday, per data followed In the meter more a schedule dosing of XX administration. would the of of milligrams we schedules dosing hours submission activity included maintain Rylaze. label our a Wednesday, weekend in duration and and and as the Wednesday schedule Meeting. to schedule, with the which quarter, completed serum IM update to dosing entire to through in dosing MAA Turning is ASCO second to asparaginase our BLA Monday, which Medicines The an Friday. squared Clinical presented well European squared. Agency, were the dosing patients a submission XX at to every current Wednesday, meaningful IV label clinically for Friday This Friday XX per to Friday Rylaze US patients avoid receiving milligrams on on meter practice line milligrams and squared level allow every

anticipation will real-time and RAS- are presented also in tumors data to under oncology IND preclinical the development. kinase IM for support dosing. JZPXXX, in antitumor schedule patients mutant inhibitor and the a through Monday, to sBLAs for solid our In enter to selectively being tumor demonstrating A, original JZPXXX both models. and allow activity AACR robust B FDA inhibits RAF MAP completed our RAF product the and potently we clinical meeting Wednesday, formulation process. dosing of We of on sBLA with INDs recently our Friday Similar of the that the C which the April, demonstrated annual that the pan-RAF application reviewed continue the At XXXX, separate line treatment IV with intravenous and BRAF-mutated also BLA, pathway, kinases in review cleared review multiple

the Renee off Now pass I update. our financial to will Renee? for call

Renée Galá

on Thanks, Rob. I'll Slide begin XX.

XXXX. strong Our included growth so the and XX% million, growth financial achieved demonstrate with quarter to $XXX net total results oncology product bottom revenues sales of of and net in same XX%, of quarter representing top impressive sales quarter million of respectively, representing neuroscience million, This progress and second of far XXXX. compared second quarter of product to in $XXX We XX% our second growth line compared $XXX the XXXX.

billion use disciplined come the meet of guidance OpEx of to track respect billion. to focus Importantly, guidance ranges. lower we With year full $X.X and our strategic, on total $X.X revenue to continue towards expect of on expenses, are XXXX operating in we capital to end to our

continued both same and period of XX% compared second million, the the quarter line income increase Our XXXX. Adjusted year. top adjusted last $X.XX the same increase in bottom EPS period the focus second to XX% was net a on to compared a drove $XXX in quarter,

projections Excluding XX% the convertible would half period from basis, XXXX. the for range to first non-GAAP towards year $X.XX adjusted the results the anticipate our performance the compared pleased billion. $X.XX our with debt year-to-date. on the change in have like-for-like been in remainder our end of to XXXX upper In guidance coming growth of billion of very on EPS and ANI we're summary, the a accounting of we for same the Based year,

guidance, and expense. dollar-denominated affirming on step-up guidance are updated and impact primarily our reflect We to inventory movements foreign exchange adjusted of non-US GAAP the have our non-GAAP currency amortization

on a and GW our am a committed that ahead achieved stated than of non-GAAP to leverage quarters report X.X of basis, goal pleased Turning two rapid to time of XX. Slide we line. net to have our We the following I less deleveraging transaction, ratio

to achievement initiatives. the will underpinned Corporate efforts approximately portfolio for our that, of strong both and of capital development patients unique to allocation value o achieve and and by was expanding on and line target, investments, Consistent on us deleveraging and flexibility capital leveraging the commercial positioned shareholders. strong allocation, and development operational has This our value our strategy cash shareholders ratio our is focusing deliver both excellence, managing through pipeline, corporate to and leveraging achieve Having and for enhancing been the remarks. continued with with XXXX. to product the diversifying insights development meaningful and in further achieved long-term I the sustainability pillar which be continue product With our to our important our leverage disciplined portfolio on efforts bottom is second well growth believe the X.X focus at to and provides focused our cash for corporate on net now our and a back our Vision top Vision deliver and focus strategic overall are flow, we will growth strengthening disciplined XXXX balance remain non-GAAP our sheet Bruce foundational of further quarter. as as end Our our generation. diversification, final call sustainable we infrastructure well business. patients turn enhanced

Bruce Cozadd

and potential execution of Epidiolex IH drive and development I'll over maximizing to cancer. in previous Zepzelca realizing lung Rylaze we period Slide portfolios, the adoption cell to and sector across quarters we of the Renee. In momentum building the markets our R&D including Thanks, global corporate blockbuster continuing despite in have on commercial small oncology commercial, and across in the created are Xywav pleased on We're the our be prepared and focused general. on our in remarks conclude a Xywav biotech neuroscience efforts, challenging and in narcolepsy launches, XX. strong

excellence for expect to concludes future is underscores and multiple adjusted the call and a operator the strategy In in like track area and to confidence through we while INDs submit XXXX Q&A. strategic key our XXXX. team to That summary, I'd our XXXX operating our on growth. and line the of maximizing remains Our line late-stage Operational also remarks. we our to guidance programs, bottom the making R&D several including for now to focus, mid- margin advancing and we open investments remain top over the of have turn execution the affirmation Vision business. across prepared achieve for

Operator

Fye Our Instructions] question from Jessica first comes JPMorgan. with [Operator

open. is line Your

Jessica Fye

taking guys. afternoon. for Hey, my Thanks Good question.

leverage that Now you've target development we should larger early, sooner of as your that unlocking exceeded business think than net transactions potentially XXXX?

Bruce Cozadd

through turn a continued question, for some paydown quickly of Really to profitability. growth over of also the I'll for Jess. Renée it pleased so achieved comments. to debt Thanks target have this of implications for both couple Maybe in but our this,

Renée Galá

Bruce, Yes. thanks question. Thanks, and the for

to does development. this yes, flexibility provide with agree, with greater us corporate respect So

we out look EBITDA. commercial today us greater development pillar to also Bruce down greater the us paying past targets. focus by And in just for both on getting mentioned, going on flexibility net the gives as As pipeline. forward, also we leverage us for future dollar but our capacity ratio corporate debt, the the increasing, forward, we're more on gives stated We've dollar, and expect on enhancing improving important not the also because that front that at going EBITDA and call the an of then be it

we're be well to execute on So that to continue front. to positioned excited

Operator

next Thank question. our One moment you. for

with Our next from question Marc comes Leerink. SVB Goodman

open. line is Your

Marc Goodman

they once do the with oxybate the patients patients -- these who being how a the are XX could patients have products? just didn't the sense naive that just night? dosed that. or give are they're XX. bit next what being used hi. talk study, little then update Just to you Yes, and time -- they Can other these on Thanks. twice they are night, nabiximols dosed And a doing? if about or a Are you of line Are us a Are they these you oxybate?

Bruce Cozadd

Yes, impact enter off people disease. primarily with segment stimulants, excited been to this very things we're We've on question. tried agents promoting treatment. way We historically, the have where there's small IH label your said daytime relatively know their FDA-approved Marc, let's start no despite

patient payer uncommon. to IH update bit on but wants chime We restrictions to on use a I'll then fairly historically, nabiximols going and is there from perspective. that any ask also your Maybe make was that And how answer dose, launch oxybate comments made the little a to to you Kim? some to Kim the in acquisition treat attempt she question. Rob know can

Kim Sablich

we for we're with only FDA-approved population. in the encouraged and Yes, so Xywav the Bruce. treatment the product, launch actually by their to be from IH, momentum continue who uptake feedback and Sure, especially really prescribers of hypersomnia first patient pleased idiopathic by we're very this robust that getting have utilized the really,

We're the today happy in disease not efficacy to remains we focus planned. breadth as as and Our in prescribers profile continuing understand itself about also shared on and had IH, at did to of addition to full to excessive and of sharing sleepiness. ensuring and focused we they the be Dan safety prior symptoms, We're just daytime educate a hypersomnia. Xywav idiopathic launch that particularly the also place patients

are are We we're idiopathic covered lives that XX% I've the us are And -- commercial this our both now is their and hypersomnia. product XX% services that idiopathic are we meeting of been lives now support offering. in needs, of terms for of the pleased customers are commercial plan, telling for covered with offering

Operator

[Operator Thanks. Instructions]

Rob Iannone

the follow-up timing the of study. nabiximols Marc, two There for the on was just a question ongoing

we're those challenges So we not working issues logistical were we Marc, I up through when running related and unexpected last trials on some those. know, as you say, this, pandemic, and in getting some, -- to sorry, the updated would ongoing experiencing

have mitigations trials line we're two don't firmer at place. We But putting those on we yet time some into a this that have time.

Operator

is from Our Ken Instructions] Cacciatore [Operator Cowen. question with next

Your open. line is

Ken Cacciatore

or performance. Can very bit this seeing And want this we've that Hey, not we're about the thoughts just on to forward? in team, force on kind consistent is demand? I the Is more Kim, degree have as asked Bruce I drill warehouse can sales versus forward? is And any Thanks pace on is -- marketing we you it's going which think And bolus aggressively, we still do IH what be seeing lastly, that? sales can down on a know focused much. narcolepsy that are lower you but often the or to the a at little launch. level retention? will great conversion? patients. the to patient than we talk of go view just talk indeed maybe or marketing early consistent where about we'll observing normal we are been days, or still any then force something early so degree We're

Bruce Cozadd

thanks questions. for Obviously, I'll and warehousing Kim of III don't strong was Yes, out to there launch in in. start seen or significant then Ken, that waiting clinical approval. for true there were any the bolus Phase have the It's our think that jump the were ask any KOLs some We certainly there saw way. patients data. the of product,

launch actual You by our are bit that REMS know post-state little approval completed a while we implementation.

that way as patients it. on we but of the in you're don't a So there for bolus the certainly was some think getting therapy, point starting suggesting

pace just a terms quarters you, I'd couple In of this into adding remind like launch. of patients, only to the of we're

for of a little lot super So early a probably too trending. accurate

patients, future comment comments in Xyrem, hypersomnia. the growth whether narcolepsy are we're really to efforts can the his from IH, be that's patients over whether oxybate or benefit newly patients coming just therapy, narcolepsy remarks said As for the Dan really in seeing or new pleased of the including to Xywav they're patients IH in diagnosed add patients getting seeing Kim any overall during how could script, whether our across and and Xywav on she'd retention franchise. that that strong she will idiopathic of change and on the narcolepsy and in like. treatment Maybe balancing growth We're the team

Kim Sablich

Sure, Bruce.

XX% a balancing base this very And your we're largely to the of is we're really, it's ACPs that same that, balancing act. I on a shared as to launch Ken, how are we IH. we've IH. out we've for and both. I think is starts efficient So can that of we've a narcolepsy that, very and strong But And between the both I customers. going question, the for teams patient and as overlap that before, those it that say us narcolepsy, and calling got of our say new narcolepsy keep know on full for as can from but the momentum there effort first well got supporting launch fully continued There's transitions foremost,

In terms the what of performance they instead patient HCPs gotten of terms and in feedback more pleased I them very we've that they retention, from I comment consistent studies. shared being the don't patients on with in just think but see is saw that product specific that with its we've would their qualitative when of the numbers, clinical

Operator

Thank you. question. One next our moment for

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

line open. Your is

Jason Gerberry

Hey, the wanted to on question. guys. in Thanks for just I taking drill Epidiolex.

If talk these marketing little the reported Thanks. us think US half-driven could help out contribution about you going is of more performance some marketing the perhaps and And lower you with on ex bit going the think now even as this was than seeing about if to as a just as benefit? are second second first-time sort figure of we like we growth we Just enhanced what U.S. what's Is half? be overall number? curious, the quarter, a this of efforts? meaningful can wondering about initiatives

Bruce Cozadd

including globally, in to I jump just the rollout ask in maybe Yes. recent on could you Epidiolex ex quarters. US Dan,

Dan Swisher

in past it the we're mean, much the the more of smaller growth We level I which experience -- prescriber we're our and and sensitive strong. that really face-to-face had engagement, this in increase great who epilepsy. is feedback move it from important, No, prescribers field see treatment-resistant the promotionally the and with to to Epidiolex product. offices into force said to experience a or broadly haven't for is especially very And increasing the their in is continue Yes. Sure. the hear remains base US persistence the pleased importantly,

especially Regarding growth driver indication couple number it plan, countries. we the brand. I gone which it break we a would already meaningful view that and as still always ex A reference them the the out we've of and Ireland, France, we've launches, Norway launches. but market franchise the big six have as indication the be and pending, has US, sales, don't to new a last of of got successful with countries -- a to XX overall did got global

about confident blockbuster epilepsy. cornerstone the very we're a as ultimately so achieving status of yes, treatment-resistant So

Operator

the Thank question. you. for One moment next

comes question Folkes Cantor. Brandon from next Our with

open. is Your line

Brandon Folkes

on thanks patient taking on your competitive the Can like. patients maybe new strong was from Hi, strong for you looks competitor a dynamics adds, patient question seeing was just quarter. you're saw start it good part We a narcolepsy. about my within report for congratulations new and quarter a talk adds. It to new

on post you. narcolepsy branded in the So Is two in this competitors market? we it Thank of interest thrown maybe -- or bit just durable maybe this year, headwinds normal earlier commentary with a given little you a just any sort getting of branded the agents? in promoting the had space, person. on can of front in more terms have And you a after just step-up XQ is bit a there Omnicon just physicians of in elaborate

Bruce Cozadd

say would we growth in I well over Brandon, Yes, as Xywav these quarters. as happy couldn't with narcolepsy IH continued more the past be in of

agents significant truly because this is think We due got of of So therapy just of the patient at we a we've that on the generally oxybate they this on but both true, -- is is low but a think patients, Often, exclusivity, orphan with very are referring at number daytime been treatment is but product intake population clinical a product I superiority Xyrem some adding that's something to basis agent FDAs taken of because differentiated large reduction in pitolisant taking. in that that where they're sodium there of is comorbidities. on potentially We've all a on are is cardiovascular It patients. very also that really -- better think new know disease are into our not safety the nightly the to risk falls in of sodium other patients. finding daytime other attracting chronic patients also patients generally And true along you're agents. cases, drug new former I come with that night, category gratifying. and

new to continued kind see make of experiment for the But oxybate again, So that growth and to we've with excellent combinations patients patients sense see, we've across really existing oxybate wanted patients. them.

Operator

our question. moment One you. Thank for next

comes question Amsellem with Sandler. next David Our Piper from

Your line is open.

David Amsellem

are wanted patients are who I these diagnoses patients of I these a terms this, I about missed And who to but thanks. already drill apologize more have or are IH, treatment, new down in that getting you then on now Can to with little IH. if Hey, diagnoses -- as do corollary general? that going that seeing agents a Xywav, in availability wakefulness question, more like think as modafinil? to you're the promoting of on And comment you're you Thanks. been well?

Bruce Cozadd

our diagnosis think agent go first-ever you'll that availability penetrating Broadly, well Kim there's reward remarks. when otherwise maybe and that It's not. where diagnosis often IH broad of to picture with more forward. it the doctors all see a I'll of option, we let a through do treatment option might space, for going make I'll reimbursement let current for approved in may strategy. more the But and case it maybe current -- FDA-approved our David, the move a start the Yes. unlocks diagnosis terms spur the Kim for unlocks in they a and few treatment a strategy IH way then

Kim Sablich

Yes, sure.

diagnosed a really initial market of nice our size launch. go got and we've patients So to focusing we're after,

as not we hypersomnia, health care. but formal also not existing also times, the health think a of actively call care said several see sleep we're only already diagnosis but adult who patients XX,XXX only in idiopathic can an system, on the universe, I on seeking we have

approach a So more really patients right the three-pronged HCPs And that's have get there we in our why to Xywav. started marketplace is really much strategy now. on appropriate focused on encouraging out

efficacy that the compelling our symptoms idiopathic continuing of given HCPs in the may for those helping in diagnosed they're They've are of many patient like their looks we're practice Xywav. case out And profile. getting oxybate figure experience we we're of be of disease broad patients narcolepsy hypersomnia, improve started and earlier, We're have ready in indication very also hypersomnia. a just mentioned particularly efforts identify that who to patient breadth safety who to educating that I this in what idiopathic on to understanding the already As relates the condition. had years general many,

really key that's in three the those diagnosed. So large we're focusing areas that population on are already

Operator

for our One you. question. Thank next moment

Our next your Hung, Sir, line open. comes question Jeff from is

Jeff Hung

for taking question. Thanks my

adding time? you're prescriptions Epidiolex. over do those the You've fairly new to Thanks. that talk multiple more tend new prescribers? have And they Can indicated US for rapidly? multiple about prescribers to dynamics much And changed you quarters for translate

Bruce Cozadd

Kim, to maybe terms who I'll to and of that in you that over means business. the hand our new are Epidiolex what prescribers

Kim Sablich

a experience as is with for we Yes, and And utility, now that see Clobazam yet in is to polypharmacy. their by able utilizes patients. the have as using Epidiolex we combination that's see see more have really of these is leveraging face-to-face, and to experience an syndrome is efficacy I'd that gains uncommon therapy them its there pretty impressed in these a with that And the from Dravet number the or than in key with are do data naturally have a to we they And number that in effect or with obviously the the -- the we're HCPs in outcome the found all sure. taking we've year, of is educating the that launch with because any have treatment-resistant already prescriber in first seizures they getting since clinical a I The synergistic data. we're that we is product Epidiolex Epidiolex fact recognize that just utilize getting moment who adopters LGS -- data highly start to by can of the newer an say on we robustly is HCPs patients. reduce once adopt very this more we say of their sharing a believe Epidiolex is hand cornerstone new approaches using the that is share slower underutilizing been the it on the with the What a and this to the at the board broadly data are that that one there beginning they've Epidiolex demonstrate much of majority marketplace. believe which ability don't you characteristic category vast until of practice, beginning prescribers, on as they number that what highlighting been clobazam. profile both and them product is XX%, product

move a we've our sensitive sales of access months, data. had it's is and got very the to just to in we're our has set going really continue that level of to those Epidiolex. adopters of a encouraged that promotionally treatment centers force increased trying and recent half in promotion We're strong increase to offices market. into slower second and So year, confident I had the

Operator

One next you. Thank question. for moment our

comes next question Our from with BMO. Gary Nachman

open. is line Your

Gary Nachman

afternoon. Thanks. Good

patients to XQ. Any demand? that So there in in unusual they Does Rylaze strong back have a was You in earlier if really are mentioned quarter? the all reaction that reflect asparaginase. stocking docs switching

Monday, Friday And So think from especially we could how get that you expand . on rate dosing? if run you should dynamic? Wednesday, about that here,

Bruce Cozadd

for question. are. Gary, thanks could not pleased be where with the We more Yes, we

we these for Just paradigm you think Rylaze. as Rylaze think for patients. there stocking answer let Kim, the a couple into ALL physicians treatment any and to about we I'll was quickly launch and have unusual possible run quarters how of rate the best this maybe moved to whether how

Kim Sablich

on don't quarter. anything this going think I unusual No, saw we

I think current outperforming. is utilization US in the

has think awareness only available hypersensitivity patients seeing right the with constraints numbers, patient reflects trend practices and and customers the such terms not peak at highlighted Erwinia, seeing desensitization increased position that its things for as the a that put familiarity If now experienced a rechallenge But that the that activities Rylaze we you this of utilize optimal we're the therapy with in and on to we asparaginase. look to the demand And have we ordering it starting had are impact place and see through who providing asparaginase reaction in the reinforcing had with care. coli-derived of point, sparing patterns market are really and they're stopping supply practices brand really they who at do the that lot think only us E. we're Dan instead. as we to in customers Rylaze telling now of those

that signals market to and is positive get to optimal about the ready back very practices. the all Rylaze excited So

Dan Swisher

rights with the that the optimizes But dynamics in on to our but quarter. on recombinant an updated administer Kim, levels to submission asparaginase we XX, through is and already easier do And think schedule patients. to in we second fully formulation the a is call, different did on, the complete are updated Dan. there. XX, it just We market. product. Market to EMA global and And we XX studied this into again, our Erwinia as dosing we little the add a importantly, also have

look marketplaces, Europe. we're assessing on the we then Japan. in in that being including XXXX other to And forward So market

Operator

Thank you. question. next our moment for One

with Our Sachs. next Kumar Goldman comes from Madhu question

Your open. line is

Madhu Kumar

risk we're questions. I do everyone. want to follow I of is for drug kind to see further of I expansion the what of the around some expansion Hi, indication it use taking growth expansion, geographic of Thanks like guess Epidiolex? up onboard lines around epilepsy? discussion extent in of kind the of curious our up are Is ultimately, you on think, of kind just Epidiolex. earlier And about prescribers the

Bruce Cozadd

the and global see for we future? want do going Epidiolex where that you to in opportunity Dan, take

Dan Swisher

XX pending real-world as move records. France, more broadly now types to you as just right indications than referenced. terms do of to plenty mean for XX we seizure then yes the year we just continued ex US, about at I as of we're well. more the have with from current I say there's opportunity much generation of the headroom I'd importantly, combination different think And as in medical data mean Clobazam this used sure. Asia well and evidence Epidiolex. clobazam. into in us everything across sharing countries launches. Yes, broadly And is

for cornerstone by of for unique antiseizure It's super long seen, activity, brand which combinable, enhanced with factor sort these can clobazam term. we've this we're what and example, mechanism, always do patients. So the excited critical is very

Operator

for question. moment next you. our One Thank

from comes question next Our with Fadia Ami Needham.

open. is line Your

Ami Fadia

evening. Good question. taking Thanks for my

the you are IH? give back terms give of Xyrem what existing so new? coming dynamics? for back you. give for especially are a from of there more on these been market if often they in Xywav patient could or Going patients patient these to prescribers the treatments hypersomnia, can patients available how Where treatment other be a also sense subscribers. you idiopathic And going given prescribed market, the for physician, And percent are something IH us us existing the color the who of fact some us or would that Thank Are haven't journey, for That your the narcolepsy? narcolepsy to prescribers in have around seeking color some helpful.

Bruce Cozadd

do you Kim, overlap and Yes. want their provide to additional of see any physicians? of information maybe when pattern on patients positions prescribing

Kim Sablich

know, hear patients Yes. are believe idiopathic I doctor main me doctor, Bruce. hypersomnia the let of of that year. have percentage reside for don't both receiving treatment, the what terms have in in don't the typically offices, but their where can twice somebody Maybe seeing is population of Really, if XX% and have in a I we in visit feel narcolepsy. share, this are potential of marketplace, there's physicians which how But the have IH statistics where and IH that we the overlap they frequently terms there data patients HCP otherwise. patients terms prescribed and the terms time about in at out that of data is what HCP to we we their that see

Operator

next for moment question. One you. Thank our

RBC. with Renza Our next question Gregory from comes

Your line is open.

Gregory Renza

developmental wanted taking Epidiolex. just for comment just just and Great. there on competitive context Epidiolex, back of developments maybe positive more Thanks, I'm congrats could bit one curious, have again longer Bruce of late. and just the my I'm a on the I to given if just touch therapies, landscape some and amongst to in been just quarter. landscape setbacks on with the question the you term, curious Bruce, team respect some

much. any but would You added certainly very evolved landscape commented on combination and even that Thank be cycling, great. thoughts you as

Bruce Cozadd

of have people the refractory very often they patients Epidiolex. epilepsies, Yes, with a we're Epidiolex I get treating remind would are severe tried conditions therapies number before just to and very treatment that

control child. try profile results tend and Epidiolex, therapy. of stay the additional rotate different I've personally that things try, physicians course, give better there if and just for that to good to off Epidiolex. these haven't with the for to seen better seen or even might benefit on their both reducing the strikes armamentarium to more put safety continued they Epidiolex as in heartened relief horizon patients, families seizure a us and Of we them we've to They might opportunity yet that developments agents their continue but offer so are anything overall patients, a seek that on as

much I bit may in touch Kim's think clobazam of see a treatment, combined heard little like about we comments earlier. on you benefits

that's in room is of seizure improvements that's like our and for continue results what just out elucidating we in or another with seizure disorders Epidiolex. current I better to that and Rob, see that benefit, seeing bring how on you are of from of maybe physician EMAS additional just and evidence generation whether trials lots whether patients trials So some type forward? these from treated patients could perspective ask in to onset jump a going you about treatment these at to

Rob Iannone

to, happy Sure, Bruce.

mentioned, observed of Epidiolex terms the safety reduction, you also with but been other measures so measures combining groups year's for frequency, there's for cornerstone other both allows that Last itself, for has of showed refractory in epilepsy becoming in and clear where example, outside it's epilepsy, but free of in highly And we a as very of of benefits days, seizure these AES, a around clearly well-being. So terms seizure therapy. survey caretaker just therapies. effective profile

practitioners set at to be the a about have pretty coming what's a refractory to And So it are highly terms into to of another of in about there more it. drugs new thinking combined of physicians, lot add-on extent to replace these enthusiasm moment, the continue that than conditions. probably spaces, rather in

Bruce Cozadd

think time have we for one probably Operator, more question. I

Operator

question from last UBS. comes Our Ashwani with Verma

Ashwani Verma

Sorry, anything Phase directional ask that I can benefit, III, like trial? understand you from this that did I MSSX you significant the share nabiximols, statistically on see to benefit? but going was you RELEASE see didn't

Bruce Cozadd

unblinded data top you do want jump from Rob, the line trial? recent on nabiximols Yes. in to

Rob Iannone

certainly are more we and detail we can might greater Nothing from how this rest data add understand in ultimately at does the that and all. through impact the time. that, learn to at on of if details further given to the this combing haven't program, what it We

Bruce Cozadd

ever first so forward. agent as chart nabiximols, is all And not ongoing Ash, with the that we're this trials remind the across you to none best looking Yes. with I'll the our as trials back course just trial well

Bruce Cozadd

track So and And really us. and all recognizing confidence support. joining about therapeutic our with shareholders XXXX. close commitment value. wrap the the maybe we'll all call, to we thank We Vision drive for by delivering I us achieving on We're continue colleagues to Jazz and I'd up excited remain that, for everyone new their focused our and thank call upcoming as partners for growth you today's for always, options. our across I'll as their shareholder opportunities of on continued to and love Thank joining today. business our

Operator

today's Ladies presentation. and gentlemen, conclude this does

day. wonderful a have and disconnect, now may You

Jazz Pharmaceuticals (JAZZ) 3 Aug 222022 Q2 Earnings call transcript