JAZZ - Earnings call transcript Q4 2017 | Jazz Pharmaceuticals plc

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Operator

Welcome to the Jazz Pharmaceuticals Plc fourth quarter and full-year 2017 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 A. Littrell

Thank you, Taquia. Thank you for joining us today on our investor call. fourth guidance full-year for our and financial reported financial provided XXXX. we quarter XXXX and results Today The press our release call are and the slide on Investors presentation the section of website. available accompanying this

rates. challenges; guidance intellectual results, financial efforts; volumes; growth and and operating sales tax reform; events; strategy; XXXX Risk of which like file property-related Factors ended events litigation adjusted measures for and for Officer include net Bruce of On our SG&A Form the Vice from; clinical the On to the CFO; forward-looking. we inventory Swisher, launches; remind trials; than future expense; ongoing and and we considered December financial including: of slide President and and and adjusted to and future XX, the goals; Vice cause Form of year R&D and Q&A GAAP a to President regulatory timing development performance events, in product Karen could some income the today's effective presentation financial supply activities. this Reconciliations of expected call Chairman future benefits XX-K non-GAAP product today's growth Executive isolation shortly. the Medical We this not and U.S. the website. corporate update and measures comparable be future substitute CEO; statements forward-looking Mike expenses financial undertake our to U.S. the XX, those XXXX or make GAAP and and and uncertainty September XX-Q Matt R&D understanding call discuss that Dan Miller, measures tax accompanying Cozadd, will in results presentation COO. potential forward-looking turn our on will President financial future non-GAAP events call XXXX, and to and non-GAAP differ materially. slide and identified including: historical now Young, development I'd to are Bruce. discussed financial duty to will of these net and for product results. found section performance, included derived adjusted described and as press and release future under per-share our measures. call, risk and this and this call on statements session. forward-looking We to are They meant Smith, Investors I'll join these our and call measures, measures; Examples of are are: will for related you activities rather related facts over are today These Commercial; actual in and in several relate that and helpful we They are the statements in other our or Chief the and past involve quarter Executive performance and and statements. believe press interest ended in our reported there obligation no adjusted release our

Bruce C. Cozadd

our two MAA and completed NDA and the you fully a Vyxeos received everyone, U.S. many Jazz of significant advancements integrated evolution biopharmaceutical XXXX was in regulatory with EU. year our afternoon, on solriamfetol for the thank continuing in in key We pivotal approvals, Good Canada, the Kathy. marketing Thanks, a Defitelio and and as joining for in company, U.S. Vyxeos the for in us. fronts. including submissions,

in Phase of solriamfetol X narcolepsy or sleep and the or the the obstructive make clinical to for multiple continued population. in narcolepsy sleep hematology/oncology, apnea treatment study excessive positive and both OSA, substantial Phase studies Xyrem of in in results We programs announced ES, progress and and pediatric sleepiness, late-stage of in three X/X

We provide also significant our three and to Defitelio with move transactions, our quickly debt on antibody Shinyaku drug to collaboration programs We and and structure including expand opportunities enhanced market to our on capacity Nippon corporate business. to multiple ImmunoGen announced innovative conjugate develop Vyxeos development with in Japan.

our are opportunities We forward products, evaluating clinical into momentum XXXX, portfolio. multiple commercialization moving excited our submissions, of advancing corporate expand to investing with carry in the activities, development and pre-clinical regulatory further and development our to

events increase Tax on our XXXX We the results and detailed financial legal, are year-end, benefits Matt turn the allow us expected of the providing should new to patients. expected regulatory, with to therapeutic over updates more key Act, I'll options After commercial, innovative Cuts review for investment activities guidance. key call before highlighting U.S. financial also provide and pleased in development Jobs and to and

our earlier Dan leadership JPMorgan had growth. of year. Swisher, at our continued want team also on, drive effective to I is that wish strong brought I all years, and organization welcome an the Dan moving Officer, the global who Cox take to positioned support our time conference the the this Chief to Before Russ U.S. Russ for We the Chief he with is many to working recently President Operating want you meet as to for thank Officer. strong our best. most leading organization chance that Commercial of Jazz initially to to efficient leadership and Operating members and the other seven

So area. our in $XXX global advances let approximately with and million of should therapeutic our XXXX for be a great with pipeline. our business, expected heme/onc start revenues me heme/onc year

higher as adoption in with academic start accelerate in well see hospitals. in Vyxeos. were demand as to the pleased by community driven early select me Let expected quarter, key fourth growth than We institutions continued

XX to adding by transplant AML for solely months continued the key centers our a product. dedicated academic positioning XX of force highest focus Defitelio. accounts of community ensure Vyxeos half ordered the accounts fourth the are of academic ordering quarter, we During four of sales expand Through and the by high-potential number reach initial To all type we the as launch, highest team volume well the while orders. represented coverage to of as top on accounts, our a accounts

the P&T outcomes reviews, formulary. of now were NCCN our continue supportive in in a and induction the formulary Guideline top treatment phases. observe the We on majority label and We of to with accounts for evidence committee are On recommendation the Vyxeos very Vyxeos Guidelines decile level of the provide have the of AML. of strong pleased front, positive and believe we our for use consolidation

a consolidation treatment our age patients Level a AML or indication. beyond For AML recommendation labeled patients therapy-related include Category use MRC, for newly years groups with and of for of Guidelines or of NCCN XX diagnosed the X Vyxeos induction, now and Xa for greater

these in believe importance provide the benefits of the under accelerated pathway. Vyxeos these The Given was submitted and our further data Guidelines, MAA an November Vyxeos. we recommendations validation of of

our working enable EU approval, the begin us half mid-year during are countries to and a and which the maintain year. of rolling We select our to our regulators this in accelerated with anticipate in second pricing reimbursement the would we launch And timing. successful, EU EU if efforts

AML with in therapy. efforts R&D multiple new targeted populations. and on trials the both of alone in a Our combination plan group AML focused and cooperative Vyxeos are oncology investigator-sponsored positioning to patient therapies in We evaluate variety XXXX studies as backbone support to Vyxeos of

we with the second planned year. cooperative half example, study initiation support patients, to one of intend high-risk a X in in group in the Phase As MDS

Now I'll Defitelio. turn to

commercialization high. additional in the efforts, accounts awareness of to is pediatric We our continue progress with ordering make new and U.S., In use Defitelio. centers

However, we are underpenetrated in centers. adult

disease, of life-threatening healthcare Our veno-occlusive knowledge experiencing stem to on education cell or disease treat VOD, urgency adults, of to this are complication expand global efforts and transplant. providers' patients, focused awareness recognition the medical and and including

to As a mentioned transplant dedicated U.S. expand earlier, specialized for Defitelio. team with we modestly our hematology/oncology force plan sales and

of us to opportunity awareness beginning second of at of introduction marketing important Defitelio. hepatotoxic leukemia to and importance the We place in globally. has In available expect approval Brazil. of be VOD, the remains became for the quarter. an submitted of agents in reinforce we and an increased this in for us for Defitelio The the treatment XXXX, new opportunity Canada, Defitelio providing growth team value

in further of multi-organ regions adult building scientific severity patients presence, based post-HSCT we supporting and defibrotide, data final medical treatment recognition dysfunction, a cut for reinforcing the continues for treat At in from team and IND upon BMT pediatric well last the the as six to diagnosis. identify had initiatives on defibrotide-related patients outcomes evidence on Tandem to presentations as and of education XXXX the data global providers' Our week, expansion. including to meetings our with knowledge geographic important Salt urgency VOD, City healthcare on Lake poster expand the strong

defibrotide endothelial may on the development identifying rare life-threatening side, damage are programs conditions cell focused benefit. have where our related to On

of We earlier month. well. X for activated study our in study acute and proof-of-concept prevention the the the X for this enrolled continues Phase VOD graft-versus-host January patient of first enroll to prevention disease for Phase sites Our

We also significant result with the announced have as disease cell another very a high evaluate which endothelial rare following to associated cell These rate morbidity defibrotide is mortality treatment can of damage transplant. transplant-associated of our patients thrombotic plans for stem and have microangiopathy, renal a damage.

beginning the the We study and sites mid-year fourth to are study finalizing activate protocol toward working during anticipate by quarter. clinical

fourth Now supply global including Erwinaze. continued for on to quarter, Erwinaze. in we the Throughout XXXX, experience challenges to

for We may disruptions and markets, disruptions temporary in are the numerous of experiencing there year. supply temporary further currently be balance the

timeliness the increasing of manufacturer patients of to releases, need Erwinaze with work to Erwinaze. of and and product continue in with the consistent of capacity goal predictability increase ensuring the supply for ultimate We

treated will accounts is both young healthcare and an progressing with for are appropriately continue product crisantaspase hypersensitivity added we Because the the part of importance XXXX, recognizing pediatric and in accounts adult new of clinical we on sales a reactions into In these to at to patients. candidate acute During in the populations. to or identifying global all XX regimen Erwinaze switching our lymphoblastic adolescent development. asparaginase our patients new and leukemia, XXXX, U.S., R&D treatment programs educate asparaginase force but providers advance aimed also of Erwinaze or and one improved adult important

and partner, in companies working Phase neoplasms. supply. patients of in hematologic is ImmunoGen, in are AML malignancies, IMGNXXX multiple AML and blastic cell patients with IMGNXXX dendritic plasmacytoid currently study X space, in XXX-positive CD Also goal study target reliability improving of began the enrollment enrolling heme/onc Phase a the recently and We our the with of a toward of profile including X

XXXX to full-year of XXXX. on quarter. therapeutic compared Volume sales the Xyrem; in of in quarter periods operational and half patients the compared X% central issue and issue the than XXXX throughout our the to the the automated quarter to of delayed growth fourth XXXX bottle caused to the pharmacy Xyrem the loss Now same system quarter less in in a X% implementation was government-pay XXXX. growth compared grew was fourth that during Xyrem flat in starting year growth some area, prescription by with delivered last resolved sleep volume with fourth of by phone new central operational fulfillment. XXXX was in the fourth pharmacy year impacted some an second The and

expect volume and up the X% for number in volume fourth Xyrem year. bottle quarter XXXX, will growth to compared to active increased low in that the XXXX. in to of expect same XXXX, XX,XXX mid-single-digit average We normalize The growth patients period the of

and helping the period. During levels. newly the by patients efforts payer reimbursement rates diagnosed unbranded are narcolepsy consistent during awareness evidenced We we narcolepsy stable in our disease as believe quarter, that high patient fourth increase enrollment the experienced investment patients, approval

confidence XXXX unbranded XXXX will patient enrollments year. and program continue the diagnosed observed in our new disease in awareness volume of we positive of trend success is during growth. the newly a number underway that increase for XXXX full the and program, patients narcolepsy positive the The we us planned generate to give Following

Finally, approval our targeted to field trends prior reimbursement the positively authorizations accounts impact across team rates for the continues country. and and

limited update Par annual a the Pharmaceutical, authorized the the January year granted Xyrem beginning U.S. brief with of will give volume Par an X, Xyrem. proceedings entered property entry AG Inc. right version with volume meaningful sales on In sell XXXX resolving me to an intellectual to net was during against connection litigation in term low infringement our patent we equal December by AG, settlement XXXX, preceding Let of into on volume we a amount In Par ANDA be legal the or for percentage be to a XXXX. receive a XX, Par's single-digit and a Xyrem royalties the generic, filer, July AG a fifth settlement, AG date, related and to sales ending of the period. and entitled will sales limited over and

that to license accelerated XX, could patent Patent granted be entry ANDAs under four its as of a Watson, Xyrem. Par Amneal, for nine against a the These and filers, are circumstances. have ongoing certain remaining companies also the We consolidated December product launch of case. Three in version of the remaining generic non-exclusive a litigation is sodium generic filed of dates oxybate Lupin, XXXX.

date been trial in as case, set could be no has year. this scheduled for third of the early as Although trial that quarter

progress a programs. report I'll on oxybate-related Next, you development brief give our

submit narcolepsy on patients Xyrem sNDA We FDA's daytime mid-XXXX, track our pediatric the are planned and sleepiness pediatric to with for cataplexy response in in written requests. excessive including to

JZP-XXX patient JZP-XXX, candidates reduce-sodium safety. our that and could both believe advance improvements to in oxybate and continue potential product We provide

is a stroke, the an and to recently patients highly independently of hypertension our provide dietary product improved the published is to stress XXXX cardiovascular risk excessive reduced-sodium other sodium well-accepted with The disease, associated for of consumption that and addition In for relationship between of part and development guidelines blood commitment increased high with oxybate narcolepsy sodium therapeutic this a debilitating adverse priority disease. of outcomes. options new us, pressure,

candidate, lead JZP-XXX, sodium XX% than has less Xyrem. Our

We of as in bioequivalence, can has an study and JZP-XXX than Xyrem efficacy X expect assuming positive of safety we submission anticipate in be midyear. our XXXX, demonstrating and ready while quarter NDA Phase fourth JZP-XXX submit sodium early an to enrollment to data. less NDA as XX% and complete the

with of development to identifying best and these continuing reduce-sodium for look option are of patients We the forward candidates product both narcolepsy.

with to develop continue. once-nightly also product oxybate efforts an dosing Our

Phase of JZP-XXX half the is study hypersomnia an a XXXX. second area idiopathic initiate medical approved X unmet therapies. of in to Idiopathic plan significant in no we hypersomnia Finally, with of need

protocol. provide We will study the we more details as finalize

sleepiness to with XXXX solriamfetol, of referred JZP-XXX, was excessive significant as OSA. and an in treatment by during of the submission narcolepsy Our for progress NDA our highlighted previously December

occurs and to after to the months preparation U.S. which ready for anticipate approval. In have product, FDA as be a continue late XXXX We begun approval for activities. launch typically soon schedules expect DEA in as we launch, few pre-commercialization

to enthusiastic offer since rights therapeutic in to excessive year. narcolepsy potential submission patients other in medication solriamfetol certain worldwide for solriamfetol an and We in are the have treatment OSA late the about we regulatory new new U.S. an as for option We the potential and sleepiness this than Asian of preparing EU the jurisdictions, first remain XXXX. of important

proof-of-concept in solriamfetol pipeline, disease, end. promising we multiple advancing is product bringing to XXXX, our and and patients the action, portfolio. evaluating a where study invest unique solriamfetol expansion and Because our of Parkinson's and excessive R&D commercial a to In mechanism debilitating is significant large enroll organization, need. disease. candidate objective our sleepiness products, in innovation excessive medical to evolution R&D performance OSA, diseases continue We complete for of and opportunity in driving unmet a continuing of highly our are Phase by is aggressively other to plan is our X sleepiness, we our in of strong enrollment solriamfetol in narcolepsy, there in year there global key opportunities We with additional differentiated market Parkinson's believe

a the same our At years. at low-sodium targeted Xyrem oxybate leverage, portfolio cash will aimed pursue and significant products development generation for Our with our enable products to the differentiated strong medically $X.X activities, over position, candidates, the our to business significant and long-lived, our the a we oxybate anticipated continued next approximately current time, low cash and contributor a believe many through to on broaden remain near-term product three that billion of us years focus corporate opportunities prescriber including base. from portfolio,

last long-term significant patients driving progress over new call made to look we we move and let innovative me forward into toward turn Matt, to bringing you. products sustainable to growth. continuing As year this XXXX, now the

Matthew P. Young

of in Net Net revenues $X.XX Thanks, XXXX XXXX, of and XXXX Defitelio Xyrem Bruce, XXXX. of from billion by billion, driven sales compared launch as total in for in the Xyrem good from up were fourth the of changes by the Xyrem year. afternoon, second X% half growth government-pay XXXX well pharmacy year. million for Vyxeos million, of were XXXX higher loss to the and operational U.S. the volume compared quarter impacted the $XXX were the X% net $X.XX some Xyrem to of sales patients through XXXX everyone. at X% $XXX up of quarter and as and last sales increased primarily during the sales

mid-single-digit in Excluding range these would factors, the in have volume been growth XXXX.

the XX% range $X.XX This $X.XX that to growth low guidance in for and took price increase XXXX. XX% mid-single-digit sales XXXX billion of of volume reflects to for Our in is billion, guidance XXXX. we to early expected the Xyrem representing expectation January over of growth X% our net

For quarter occur for specialty have products net Xyrem adjustments XXXX, period. higher I'll payer our historically during remind you as across been that well impacted as sales churn industry first gross-to-net typically by this that

duration reported disruption. by sales net compared that higher quarter net net worldwide Erwinaze, And, decrease in quarter fourth extended the following usual a ordering were an in million, to a $XXX in net fourth as to mind patterns Fourth our million quarter of can sales reflected negatively of Turning $XX Fourth XXXX. upon of sales quarter variability to sales. increased supply Keep of XXXX XX% sales million disruption. of were re-availability XXXX. for worldwide $XXX in net net impacted sales supply increase $XX XXXX a net interruptions the reminder, than million XXXX timing the ordering were in and sales supply of compared

sales X%. net million million, XXXX volumes XXXX. approximately sales in This the million sales of $XX guidance in net increase disruptions a of XXXX. an to supply Erwinaze million Fourth The reflect growth were from year volumes XXXX reflects temporary million net Defitelio XXXX. $XXX an increased from $XXX of to $XXX our sales XX% full expectation of XX% U.S. outside for million. in U.S. for in range our guidance increase period is same of launch an Defitelio in of midpoint due XXXX year, April $XX sales $XXX mainly of and the last the after of in increase to quarter sales year-over-year Our guidance in reflects

We treatment priority. Defitelio and Recognition, variability in dysfunction inter-quarter diagnosis, the in an expect early continue multi-organ remain educational net U.S. of with VOD sales. to

the of be XXXX range guidance. $XXX the contribution Our Defitelio net this approximately guidance net were of XX% $XX we our sales to of reflects million The the following $XX to midpoint million year-over-year growth in U.S. million in guidance $XXX is of Vyxeos million, expect for quarter and of XX%. approximately U.S. XXXX. in XXXX sales in launch fourth August and the

Our sales the the Vyxeos to start European for includes guidance range million were of half million million second net this anticipated million. $XXX were of sales sales rolling $XX in in net Prialt XXXX to This XXXX the quarter XXXX minimal XXXX. in in million. of following guidance net sales is in net $X $XXX launch compared Fourth year. both XXXX $XX the and

we total estimated XXXX. growth, revenues of $X.XX with billion in billion, the range to For expect up XX% XXXX, from top line strong $X.XX XX% to

XX% period the to same of $XXX SG&A SG&A compared $XXX total operating expenses fourth $XXX to million the XX% of $XXX million revenues XXXX. of million of adjusted quarter compared or revenues to XXXX. of or XX% were for expenses revenues XX% million of Adjusted revenues expenses, total were total or XXXX total in for Turning XXXX or for

the the Vyxeos XXXX, increase count U.S. the our and including due higher of head of primarily SG&A the in For in business, expansion was adjusted launch to

a to guidance. churn. the XXXX, are increase of periods. of $XXX due compared the adjusted were our were also for narcolepsy or our historically $XXX in defibrotide million an we the would first million, sleep-related R&D activities, XXXX million in in XXXX, in Xyrem be of million of years. activities. costs Adjusted head revenue R&D to that or note U.S. to range in related these percentage same SG&A label of partially well in commercial and increase EU, compared SG&A expenses return the for in these asparaginase Vyxeos, expenses to XX% study, Phase planned for XXXX and in expansion I'll XX% expenses on Vyxeos initiatives Adjusted and increase Adjusted XX% growth as million included XXXX to revenue studies expense activities, completion to payer spending higher R&D prelaunch in in the Vyxeos of to both due in related expenses activities XXXX to $XX of is of was or prevention to of revenue fourth impacts are to million million, the XXXX programs, The the coming in in in these of SG&A of XX% revenue adjusted periods. total incremental expect has in expected the VOD X increased $XX support primarily regulatory to of investments R&D launch pediatric and $XX to expected The spend XXXX period both adjusted continued the pattern $XX quarter count expenses XXXX solriamfetol in and the XXXX, solriamfetol, required of as Xyrem R&D compared $XXX the as XXXX. the to by million launch offset For U.S. revenue Adjusted expenses range a in quarter solriamfetol $XXX patients. investments typical

margin move programs to this We're key and make utilizing revenue XXXX, lead opportunities that top by and the our launches. beyond to For line be to XXXX and XX% CombiPlex range growth are of in to XXXX, guidance regulatory excited investments and plan programs, as advancing the Vyxeos to important expenses adjusted $XXX our ImmunoGen includes million time including we over the late-stage of leverage expenses continued the in our XX% our or expected development R&D defibrotide, and related submissions, support This revenue asparaginase million, EU of programs, product and advancement will JZP-XXX, believe platform. of Vyxeos, approximately to early programs, guidance. and expansion $XXX we P&L solriamfetol

a million, from on in For year diluted and deferred the GAAP per XXXX, income taxes been quarter excluded our the Cuts of subsidiaries, and basis fourth on full and taxation the and of $X.XX net benefit liabilities This of fourth foreign remeasurement and one-time year Act. U.S. $XXX full adjusted assets a of or the included accordance related from earnings approximately XXXX. tax of previously share, negative impact income per-share the measures Tax net has for of with Jobs unrepatriated quarter resulting benefit the and

on which end $XX growth EPS million shares. of in repurchase range $XX.XX to we for payments expect rate XX% front, cash approximately of lowered XXXX the Lastly, to at to $XXX XX% repurchases. XXXX million XXXX. our be was as the on our business of the represents tax income the be and a adjusted share range will estimate tax Adjusted main year. $XX XX% adjusted that our the result of will non-GAAP diluted quarter for a we In repurchase fourth for net of remaining included our XXXX. XXXX compared or our based per $XX.XX under for million this million, diluted new $XXX adjusted the legislation, effective or to We milestone per profile. the share, XXXX, share, In net diluted program $XX.XX $X.XX diluted had $XXX $XXX compared per in upfront million, $XXX spent share XXXX. diluted quarter to or million $XX.XX of million, and XXXX share, of compared share the of was quarter, million, per Fourth fourth or income uses $X.XX $XXX per We to in current XX% share to

$X.X in cash $X.XX undrawn our of outstanding December XX, revolver. and we our under and debt had and of As million equivalents, investments, $XXX balance the principal cash, billion, billion was approximately long-term

expect of business $XX adjusted several to in interest development events years led deployed the corporate In deep regulatory, and expertise a capital and Vyxeos, solriamfetol. milestones. net as investments our $X hematology/oncology-related We build million. allowed approximately will Defitelio, in diseases. billion we key deal we Erwinaze, portfolio or expanded and therapeutic of to and our have significantly model met addition Between our range XXXX. of our have last and transactions XXXX over multiple general, development, sales-related illustrated XXXX, achievement and be In the expectations our in the These diversified with by XXXX milestone exceeded sleep expense $XX to in us closing, to-date, key

to efforts for to along and drive other time. an identifying I'll development global, investments further to Corporate value and these CombiPlex the additional and collaboration with further expect portfolio, R&D capabilities infrastructure, expansion expand growing commercial, as over meaningful up delivering such for of growth us over turn executing attractive and commercial the our on ImmunoGen current We our exciting and the joining our look future. initiatives, set forward shareholders. call We our options for patients on to us you assets, sustainable and call therapeutic to Kathy. Thank now today, and

Katherine A. Littrell

up then questions to open questions. further to have With the time, operator free request to for I'll queue limit said, two We at Matt. reenter and you the your turn feel a the to that questions. Thanks, if line your call back you that the

Operator

you. Thank

of Our question from Partners. Ami Leerink the with comes Fadia first line

open. now Your is line

Ami Fadia

Thanks the two evening. for Good questions. Hi. question,

you Erwinaze, starting would order to has Par own little their need all, just to of on a its solution is with that? and what the XXXX launch continued near-term And REMS your disruptions recent what launch settlement for ability independent supply? elaborate program the separately, you. Thank to longer-term they have could in in on about the and just Par, whether First end own bit generic of

Bruce C. Cozadd

right. All

believe launch were question, you generic. first is asking Par its the free when On own to I

right of of the one our product need yes. doing But supply not the is you to answer have also that the a of quality capacity just result side, they remedy improve can great REMS XX, existing some And efforts you near-term would REMS that the I long-term. ANDAs. paper As unable remains be our disruptions, situation patients, December the only say our XXXX, both On answer contract remind supplier working that on the can to I'll of exists fully been it will on to-date. of We is they we're own their everything team separate through many of but that assume REMS. tell that are the on the we And as in REMS? availability a need waiver early I'll of Erwinaze, And ways to product. Erwinaze side, continuing disappointments yes, approvals would for limited we now

to future. supply product availability to the while look continue that ways also patients improve for We potential for upon improving in

you, year. quickly which a have good is we throughout you supply don't I But everything can. disruptions problem we as this answer I can for to that solve can doing we short-term we're So of as think some predicting tell why are

Ami Fadia

Thank I the follow-up your on way you. about settlement terms comment in any may Par. impact Hikma? ask Does And if the with that a with settlement

Bruce C. Cozadd

I'll XX, your had about for just same asked thing say the REMS you entry settlements a separate for with those. about the would XXXX, and have the been previous need question exact answer No, to Same respect December if reached we as goes date.

Ami Fadia

you. Thank it. Got

Operator

Thank you.

from with Stanley. Our next comes Morgan question David Risinger

is open. now line Your

David R. Risinger

hear Can me? hi. you Yes,

Bruce C. Cozadd

can. We

David R. Risinger

Great.

relative year you how in December just of you the plans little should JZP-XXX, be you Thank of be that much. on timing So I color then more action to, date bit the to a to that we and to first FDA of the of start launch think was will able about think guess, that launch hoping might product. I provide specifically XXXX, your very

Bruce C. Cozadd

things launch. to we said, We need an of FDA need On we approval. timing launch, two as

DEA need also We scheduling.

of in quarter to at would which estimate of early days want is a to XXXX know best FDA us of this what within launch. launch brings happen about XX approval, point you don't Mike, I say terms solriamfetol. that how think to planned first Our

Michael P. Miller

begin built of There efficiencies this our sales the would at lot year maybe some expansion. We force extent to expand members. specialists. we would are so be what pulmonology Yes, current since call look call a audience, of the would already on audience into of to we

doing – excessive the the working very think narcolepsy. prop. and about would excited be we're with very, creating product on and the We'll I But right launch. value we sleepiness we're in around working now awareness be OSA

David R. Risinger

you commercial potential for opportunity that be longer-term how know potential And excuse talked helpful. discuss it, the but quantified – And just long I the sales product? could very if term, you've see as don't us you you if could remind the would you've me, about

Bruce C. Cozadd

discussed it in also extensive. that will, U.S., sales of population you many a And remarkable. have this important the it's as associated the Sure, narcolepsy those It's action it a excessive patients with think, suffering it's worldwide of role very for unique a we basis, them perform in you OSA look we think molecule daytime med of at have – But at believe well OSA. we quite have not serves patients forecasts. mechanism on ES very OSA And look as patients. We the that I the opportunity with sleepiness well. When when X million about pretty from

David R. Risinger

thank Great, you.

Bruce C. Cozadd

may we that we're hinted We've beyond think drug a we associated of one of sleepiness. already that have initial in as other of then And course sleepiness would number excessive be beyond launch, in sleepiness. excessive conditions Parkinson's, go studying significant the which excessive that

agents submitting at in other might arenas. strong been where EU. product. and an drug We look we studied, think in has then MAA the mentioned efficacy another have awake-promoting the we of and course, of year this use And here you have other If there's the that potential late stimulants geographic have

you the excessive And of the potential if sense beyond to about OSA, broadly desired starting of So in other initial from to the for point, to a moving and term. sleepiness global that's molecule longer sleepiness U.S. moving think market you a label indications. excessive that perhaps the gives the narcolepsy

David R. Risinger

since Great, data? What's Parkinson's and just one timing it. for the mentioned the you more, Bruce,

Bruce C. Cozadd

this want enrollment we said year. to We complete

David R. Risinger

Okay, thanks again.

Bruce C. Cozadd

Yes.

Operator

you. Thank

Our Fye JPMorgan. next with comes from question Jessica

Your line now open. is

Jessica M. Fye

taking questions. I Thanks two. guys. have my for Hey,

your if you whether the confidence about the in can proportion JZP-XXX to second they're the in this is guide just predictable assume a $XXX you for in Thank the you homogeneous for when population of labeled is group $XXX can sleepiness and trial absence patient treatment. And million evidence you of to idiopathic treated then curious with I'm you. the curious is working hypersomnia? give was that color year? clinical one degree million on if patients, of just in there Vyxeos I'd any talk also these First any a of Xyrem be

Bruce C. Cozadd

Okay.

then talk Mike, bit the me maybe, comment about idiopathic have And let little on you Karen for hypersomnia. JZP-XXX So potential in question. a Vyxeos can the

Karen L. Smith

this there's about population, are actually Karen in look overlap therapy what could of this area it's approved hypersomnia, idiopathic things see we definitely area, to and but at an there's definitely idiopathic this about there the an you any patients, terms need, option. potential that narcolepsy, couple patient debilitating generally apply is in population. When you treatment So you One it's think here. are The and treatment think disease, physicians When very which approved the no think you a new why have if that use could that hi, compound to is are Jess. looking in about. unmet this patient for therapies. a patterns It's significant hypersomnia this that can current similar a of of in present at doesn't

signal patients. product in that it also patients. a profile, opposed have be anecdotal the So as single actually with which could think seen, be that the evidence clinical seeing instead own we've in with that these we're overlay and believe clinical that at hypersomnia then our has safety trials diagnosed cases, that series when these you also narcolepsy, to you of for add that just that candidate patients and with an JZP-XXX, along we then improved And experience literature the good idiopathic the I with would a recent together looking and case we

Bruce C. Cozadd

the say terms it your variety Jess, sure in would to different completely we'd symptoms question a say homogenous about is a of narcolepsy a And, severity I'm I at the response idiopathic something, population. you to want just that Vyxeos, probably Karen? you narcolepsy do well-characterized to the treatment. less take want in say of general a Mike, to did And would hypersomnia add homogenous of group. of shot group group is population or I a a just and not to little harder the little answer is it's than

Karen L. Smith

going just go be it sleep a you to just overlap fairly look And narcolepsy. add, I are idiopathic to with would of of there these much a these with that of in clinical chronic was well-defined said with terms what Bruce that be types an diagnose is the hypersomnia, adding disorder, diagnosing overlap. When them to degree diagnosing and that neurological and you'd docs definitely has just these patients would at there of parameters remembering is these patients. is

And perhaps of months. of excessive is thing things it's three as MSLT, is patient, is note and actually an seeing seen sleepiness idiopathic the why to they're patient. is relooks know are persist tired. has who and overlap. at, there diagnosed So idiopathic classic of than this one and physician excessive that back need of the too sorts MWT, for that's that been the is in patients have to and hypersomnia. to we patients through more looking other feeling hypersomnia have sleepiness, or This the this what narcolepsy have a what some is these clinical treated past the beyond hallmarks the sleep, coming they're And goes perhaps the these uncontrollable When we the trials more at

it around there we versus signals parameters diagnostic this population have clear identifying this could and effective. clear patient are be that narcolepsy, are there for that molecule So Mike?

Michael P. Miller

which the include Guidelines, of Hi, date very and cost the It's that do label to A has support forward. the been to but I P&T reason our Vyxeos say used lot also that. some that think to and populations, And the according other monitor of we that that oversight difference would go think I NCCN would Jess. has Vyxeos I much strongly have X+X label. I we between being Mike. as to say with

use the what we monitor done continue We'll the output. be. NCCN Guideline not have We chart to pleased with are know but will that, spontaneous studies. We don't

Jessica M. Fye

you. thank Great,

Operator

Thank you.

Our with next from Evercore. question Umer Raffat comes

Your line is open. now

Umer Raffat

my so questions. how of have back many the for I since foundation on And secondly very XXXX guidance patients is are what than had Vyxeos, is because patients taking my you them Bruce, much trying guess any already at X, years patients XXXX rolled younger commercial much. or on thanks you Thank January become age? of of I'm Xyrem, for patients And this one? patients? from free being Hi, to is, number in XX how Xyrem not, there foundation in to seeing question get in in many and/or actually MDS issues? utilization included contribution

Bruce C. Cozadd

come which tracked don't respect They're question. to respond first our up But we question, the are not throughout we asking know the to the patient mix continued we're particularly necessarily from. the that year, is way seeing So seeing change bit little in first it patients with quarter, where on end in year. program Umer, drug what a in starting free in patients, although last trends government-pay saw, first in better the the to the we quarter you're

than did patients in government-pay this more actually seeing we're So time we in at XXXX XXXX.

it So I essentially that direction did year. how last from is the trend think going opposite

way we're quarter. the through Now, part only

give is so out. I playing. sense year, you best the full that's guidance see Mike, the on for things how how question? Our MDS can let's the play right that's But now for

Michael P. Miller

Sure.

we label. believe the done I around date Vyxeos our to but our not yet, chart – been use very have of I has said, of a most I've much As think most study of

Umer Raffat

you Thank very much.

Operator

you. Thank

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

now Your line is open.

Randall S. Stanicky

thanks. when Matt, spend, picture even big year. this the Bruce question, is is just the maybe look a or we clearly but obviously at line Great, investment bigger top growing, a

business So quick basis follow-up about think question multiyear a been do operating has is leverage operating just we Bruce. a And how the on then from in mid-XX% for what margins? the the

dosing low-sodium oxybate, is once-nightly that Thanks. formulation? a the On

Bruce C. Cozadd

question, the and margins, Matt is question yes. just which I'll the So I'll second quickly take answer on let

oxybate. does low-sodium incorporate program So once-nightly the version of a

Matthew P. Young

specifically Bruce. in prelaunch-related of SG&A spend we products. in as it to to various elucidate and to time, launch for very over $XX million year, margin Thanks, trend increased in relates Randall, geographies numbers tied as the to tried $XX is activities million this various

clearly is down. going mature to our revenue were you of the percentage if as see start inside portfolio, across to emerge. of a actually think curve I a of more The point sales to fast-forward leverage G&A you'd significant embedded P&L the in SG&A

going and to sales much making marketing-related other is significant the which G&A. base seeing your The spending are that there. in – SG&A line we're and we some is some activities medical, in investments the and So direction, related are medical

over we products, set hope of to launch not to assume would drivers that course secure static a again, and portfolio, more of in which product a So time. diversified so continuing bring

while XXXX. other of period existing have course solriamfetol emerge also leverage funding we the across in expect portfolio, launches, which pretty would we'll heavy would certainly get as be So to a P&L we may include launches past we of

you'd the to SG&A on leverage think see that So I emerge start post-XXXX side. more of really

Randall S. Stanicky

Okay, great. Thanks.

Operator

you. Thank

next Maris comes Wells David question from Our Fargo. with

open. now line is Your

David Maris

of for some metrics. Are for with traditional you're that by while more bit what tell so you, that And any deals. Hi. Bruce, folks Thanks. recent little or just seeing pickup or us M&A not of about completing financial as you had heard the deals as that defy this could a the are a or far you're pharma deal whether in and more happy on confident has some the it about difficult demanding maybe flow still likelihood impact larger the prices you the been? you year make are we've Does have seeing? you

Bruce C. Cozadd

as that return while we nice think to have would the achieving That would provide earn in we the while of for I seeing a years occasional doesn't our for portfolio our returns are wouldn't in fact a been our strategic this prices lots that a aren't at opportunities say the true past, many at deal year, to priced level seen shareholders. diversify of really where David, math that has broaden objectives we our us of mean actionable business. and number work

really I is deal good. flow think the

we've flow and existing $X detailed strength. years encourages about expectations be in that to balance a think paid. of been argue to It past a the as got about also over high of at I our sheet done number Matt I've transactions the can course can lot helpful. couple about what cash addition prices transacting, next people billion been increase You historically? optimistic people's over which I may more the am. transactions the itself they've in couple we've I talked years, as Am upcoming

things Europe commercial R&D So I global got to we've organizationally of variety think in a capacity to do believe ways think the U.S. returns we've direction got we all broadening that think our that do transactions of in and Financially, the across of deals, I shareholders. putting products, work earn capital licensing, programs, business collaborations, deals, I for the go our capacity. a good deals, range

David Maris

very you much. Okay, thank

Operator

you. Thank

Our David with next question Jaffray. from Piper Amsellem comes

Your line is now open.

David A. Amsellem

Thanks, solriamfetol. just a couple on

commercialization in And your the IV and First, any D thoughts a designation will a be shake particular. payers? III color on on get out? it heavily the I controlled or where you you expect wanted think And to questions, substance do whether will remind Schedule Part some with maybe just then, how between us Schedule you to mix Medicare Thanks. commercial. contract think

Bruce C. Cozadd

We see submitting we'll question Schedule that first we're and wait But our support part believe out. data not on scheduling, on of the IV. a where So your decision. would turns the

sure terms share all that, let contracting, turn exact over Mike's Mike. ready to me details so to I'm In of it of our

Michael P. Miller

respond to. value an that I right efficacy well the we're the We the proposition think significant. I think And product's medical payers quite commercial sparkles unmet will is ES we that need product, building believe think Look, now which for important frankly. is

I think the So when together, year. we'll I going very we into feel that put think good

Bruce C. Cozadd

Mike? payer And mix, then

Michael P. Miller

is predominantly mix commercial. Payer

David A. Amsellem

Okay, thank you.

Operator

Thank you.

question Our next with comes Citi. from Liav Abraham

is now line open. Your

Liav Abraham

a just quick afternoon, ones. Good couple of

of to Bruce, I your as ago. we to some about a at a allocation comments trends expense level your year. on R&D of minutes get the beyond to on just up, strategy color There's uptick sense modeling? capital think some give you this can follow on is whether Matt, few then Firstly, just expected beyond XXXX. continue want same this And an XXXX

this you're Thank focus SG&A a the to in capital still the curious your as to so-called upcoming therapeutic in current or given this interested Just whether your case, adding perspective allocation especially a on Is areas? third R&D you. your investments from still company, leg and is year.

Matthew P. Young

long-term to for R&D, that of indicated But past, we've the to With we'll sure I as been earn respect a our and in capacity would investments over guidance try just make has line return. give to We increasing last metric. want not say, operational we financial percentage we measuring believe sure Liav. sales that few Thanks, an balance item attractive can making with R&D as make the that years. we

and across areas. So we're we're terms our excited the phase grow investments across see pipeline of portfolio in of spectrum therapeutic growing and the to making our

as the will with So the bring to our company, I ImmunoGen molecules we most collaboration. have as our would other well molecules expect we continue existing as make of into

R&D certainly expect says a Whether spent right to XX% review see going innovation grow operational even to externally. we're percentage up and our capability will Obviously, But company. year very we come to persist on idea continue what that. down our we than time what continue given of will certainly going we'll XX%. this dollars a revenues molecules up, faster as we're as and and to up I important to revenue open portfolio the for capital internally it's to our So going guided diversify are growing now would that believe means the thing that identifying deploying business over that through is

Bruce C. Cozadd

fit portfolio capabilities, other good we opportunities a see we us therapeutic add area to If the see on a almost our of with to strategy do a into an area growth good to a question to do product on I therapeutic where over I certainly bring found a going our opportunity say will horizon with area you Hard sustainable strategy in at third say. then in a that area. that, new we commercial point. we the see about second be interest have terms to and over the therapeutic where can three-year, that lead that, think we not our we it think, area, now, know a certainly entering commercial portfolio we must-do we're But all a period, R&D five-year, in Will act another your so to XXXX. true longer-term We enter part some see it's It's behind objectives. time XXXX? it, to right and a in And if growth it's meet must-do would that. an XX-year of would if the do to

Liav Abraham

Thank right. you. All

Operator

Thank you.

Sachs. comes Flanders with from Dana question next Goldman Our

open. Your now line is

Dana Flanders

very you for Thank Hi. much question. the

strategy So quick on on launch then Thank XXXX? Vyxeos will just to mean the there one that plan think that here follow my I build-out do opportunity. into and any to and how the should ex-U.S. you. needed U.S., ex-U.S. what what's you've you are maybe Europe, key in that will here, up just or we commercial And in OpEx mirror just employed differences? specifically about to

Bruce C. Cozadd

probably which I would early Dana, put into for this would launch need a little as And say the from but gearing launch to for solri question. that with We point. the talking in probably activities be U.S. the be in to a differences of some it I ex-U.S. us up as to now as solri in too trying XXXX. particular talking to in starting that. early address U.S. learnings European pre-commercial about that comment we'll a the submitting We're year think a that plans. Remember our commercial Europe on lagged leverage market would behind full want for late to we're U.S. well a in European take about year, early be account

Operator

Thank you.

UBS. comes next Marc Goodman with Our from question

is now Your line open.

Marc Goodman

looks something $XX million point the on of the we Hi. give curious Could up guiding the put from million sales more Defitelio? $XX like growing you're product for penetration that It here. very not if and what quarter, much, just or $XX and reached growth million U.S., you seems little quarter? $XX million in this expect or you U.S. in high I'm mean is slow XXXX. us color something $XX and should a whether in were a hit million you'd we've I It like U.S. to

can could talk U.S. you about and about you maybe So then the talk specifically Thanks. separately. Europe

Bruce C. Cozadd

market experiencing would U.S. expecting the have ex-U.S. market. the say we in both and growth I Marc, been and we are in

a of of in which we've recognition of but launch, we've XX seen incidence traction VOD in back had slower in the although treat U.S. intervene adult the pretty something on our and real Europe some time. severe we've in that and have pediatric penetration. to in saw or early similar the I we But think We to little some and in what took really started need market rapid growth Europe, quarters I to year seen took the in some three market fairly the again in XXXX, we years get succeeded U.S. we pediatric educational gaining being It completely of momentum and over first terms European the is uptake, accounts, which change in the minds there, good until efforts. rapid days. made think And quickly to resolution progress. some saw of

think side. it's go on the a I adult tougher

our team that in our Defitelio side will have comments the the benefits a efforts of that same I think Defitelio it heard in You adult a to today with separation dedicated transplant-focused sales on way Vyxeos. benefit

in but it I on give ourselves think also Vyxeos well. as it So us we're more doing the academic part help bandwidth will core beyond on to Defitelio centers,

talked as other of much well describe do how clinical about there really continue Again, part your solri, time geographic like take how you into it expansion. about Japan we're investigating remain molecule. We make is do We new exploring of and explore label. the in work optimistic can Defitelio existing more may over Part for you Obviously, through progress to indications. be talked to heard and indications with future. opportunity defibrotide, this we with we're with markets. about me So you it three what trying our new do is coming we

about growth within long new and indications, with for good then time. as appropriately, geographically. look Defitelio explore expand potential existing at the for your indications, those our feel So promising all molecules, optimize a I

Marc Goodman

U.S. quarter? in were sales What the

Matthew P. Young

$XX million.

Marc Goodman

you. Thank

Operator

you. Thank

next question Samimy Stifel. with Annabel Our comes from

line now Your is open.

Annabel Eva Samimy

Guidelines, a for the that's to guess Is can at at you payment? Vyxeos tool to talking you help all? understand? little longer staying bit Vyxeos Thanks patients facilitate that NCCN looking us On DRG that the use control question. And I the hospital be the are your that the Hi. tail help may you seeing with end? in taking P&T in that Is committees a can how to Thanks. and something changes on my new

Bruce C. Cozadd

do little discouraged low Annabel, little We've intra-quarter expect I'm get It's a question get out experienced they're pop seen we bit too also of excited sales. a go want to just that forward. experience And once for around. a we answer that an an would add going before quarter. Defitelio will and So, point It that year, to and when ultra-rare on. continued I when at least up, last bit too Marc's which but back over have move say to happened time I to don't cheat and they don't going bounce way and condition. expect variability

was they'll Right part looking that now, where doesn't impact available. be no at looking now, that Remember because are the at DRG back help data. rates. at when Vyxeos periods us DRG we're Vyxeos actual directly years looking of on was periods back there available. A couple from question, back On years effectively don't the NCCN your set rates first or Guidelines, Annabel, those a a couple

reset to And do time. tend over so DRG rates

applied even We we'll Of that's which get that is course, that, that know bridge there to is without possibility. We've it. that, realize it, mechanism a a don't But NTAP. but for spending over payers from and want periods. rates prior a treatment bit do Mike, time, do in to DRG Vyxeos that? on reflect you you're actual time talk little about hearing what

Michael P. Miller

community is seeing and P&T before only NCCN And The good quite as were event, interactions the expect that we recent the early We the positive. about Vyxeos, it very but those, had been well for actually consolidation have now. even it that, we P&T in we're was but setting setting. expected very more Guidelines. a the gone feel NCCN have didn't and outpatient committees we're what and as seeing so Sure, very Guidelines

event patients and patient a is also does system ones to not loved that this the money, for be go some their in It and treatment home can So center. infusion the consolidation need saves the in after patient hospital. great an the

a the of really benefit product. great it's So

Operator

Thank you.

B. with Buck David from FBR. comes question Riley next Our

open. Your line is now

David George Buck

for you your the Xyrem settlements to you're solriamfetol reduced-sodium at direct-to-consumer that looking follow-on remind advertising for launch you generic taking the orals things little thanks in bit can separately, are that a and of us to how XXXX, of be? impacting going Bruce, just talk products like And can that? the opposed be the timing of timing might about with category, in question. Yes, as and the what how

Bruce C. Cozadd

Sure, so and concepts. think about on terms launch the you're is in do of of first talk question, I ready version One of results that course, David, from what oxybate, reduced-sodium bringing a expect quite together a not to a couple we're yet. of we

choice clearly, But has long-term know of that benefit but We a a benefit And who avoiding levels. haven't high this health considerable. narcolepsy intake high therapy submitted that very yet. could very, the we patients is have think currently no with we be salt to sodium

are that forward to looking opportunity the oxybate a therapy sodium product be patients today receive there it who to and would number think patients So to us prescribe tell they because of both for alone. don't better patients whom but we're for for but doctors potentially expand current great a reason offer load that therapy the to that know we

they're existing our that fall that happens date. settlements other for impact generics pretty sales significant our You're can have of could generic protects in is the on provision for else existing market launch the provision then where which to settlements. if the precipitously tied findings, is competitors' sidelines that anything way product sales decline market that settlements, I there's There existing sooner. they mechanism anything about talking to I sales. against that for a what market a impact think bring be any that but the specifically what sitting future on typical changes in that's to is products. a erosion a our safety waiting don't may enter could know up treatments, low-sodium in product, not That new That in And

So two link I the wouldn't directly.

that along lot on Xyrem We and come. a market come is the have to think continue in to franchise are helping patients. for many a successful even of We'd we expand patients product that for products years to like out that better with

Katherine A. Littrell

a the minute next let we operator, for me to before go And, person. speak

Bruce C. Cozadd

was question a of world, part second into genericized solri the too, the thinking which Mike. take launching Let's about

Michael P. Miller

a So would launching well that visual have in envision market those in a retail done a solri largely X setting. Tier and products, as visual we new generic, step-at-it core into pharmacy as branded process, a probably both a would

I big one disease awareness, and would. would clear, think at. branded a the can would an be in of are as not at done DTC a it costs around is DTC. in DTC first year we to of unbranded awareness be something And believers around launch, But component the think fraction important disease I You an look question branded had be the we ES and

Katherine A. Littrell

we a And of people have line number the still. on

be want we give so a get a to able to in And to chance question. everybody

you to if limiting all you. us that. there's We'd one. one, second would, Thank unless appreciate please absolutely an help urgent So by

Operator

And you. Nachman Thank next our question from comes Gary Capital Markets. BMO with

open. Your line is now

Gary Nachman

AML how some just mostly thanks. year? that that with something therapies some that long physicians label. of heard potentially it combination might Hi, on that of year? know about. lead excited before Vyxeos, use? I we It's Could we've data Will But On for it's now get right be on the targeted next to this come

about curious Thanks. that. I'm So

Michael P. Miller

is Karen. This I'm Mike, at and looking

I excitement you can Karen, agree you to speak and it there interest. think there's with maybe around that. And, I is

Karen L. Smith

the potential the I the certainly in about we've think had IST. therapy. equally interest Vyxeos are excited backbone we of there, utilize inbound a to of And of as lot form

So at utilizing like in we Vyxeos or the those, running FLIP-X a that combis currently are some look XX do ISTs moment, at have a other regimen. that X+X with combination things over of (X:XX:XX) are

there. we the think excited by I So that potential equally are

Gary Nachman

this something until it it is probably next see And year, be year... wouldn't we can Okay. or

Karen L. Smith

It's to difficult say...

Gary Nachman

of ...in data? terms

Karen L. Smith

of an IST. the timing don't we control ...because

Gary Nachman

Thank you. right. all Okay,

Bruce C. Cozadd

And different types of data to of take different time amounts get.

types various data come there and to over some safety how long-term time. happen to survival this year, reviews get out get data start but to not You It's data. as of respond trial are patients can initially will a that going

Gary Nachman

you. Okay, thank

Operator

Thank you.

question next with Greg Our from Bank. Deutsche comes Fraser

Your line now open. is

Gregory D. Fraser

the the the the You are you last patients wondering Fraser for average population diagnosed of north on Great, in Gilbert. proportion are taking for patients is. with that was U.S., you Xyrem penetrated I'm narcolepsy Gregg of that the diagnosed thanks what question. on would It's do Xyrem? On year. XX,XXX-plus say for of number know just how think XX,XXX current candidates Xyrem,

Bruce C. Cozadd

sodium has warning Xyrem, against, oxybate. excessive things, excessive drug and Xyrem box and alcohol the with about limitations is among black for narcolepsy in So use a theoretically concomitant that narcolepsy the other risks, all black box sleepiness combination as cataplexy a have and That just which candidate depressant, dangerous know used warns that including be sleepiness, treat a also given warning. therapy. of would is and given of potential patients every We patient which indication to

can to eliminate controlled give to not history for use you daytime alcohol, So abuse agents. other know including unwilling be or cause awake-promoting patients are them up are stimulants that or docs other and therapies with patients drug candidates a this more try of of We who to substance. would unable certainly first, likely things good

of can't the I be whereas over That time be think say upon get to of a to a to population? grow XX% the once I there's product than to, has to XX% used grown up so. time continue and in No, So treated fraction suddenly we've market while tends XX% we to XX% volume said, closer And we to that as faster patients. that do patient to used fraction grow to and you patients patients. smaller anything? patients, is maybe think fraction of don't you to that of close But a get going growth. huge to add couldn't the can diagnosed Mike, to think volume want we jump practically,

Michael P. Miller

the and of would just claims say encouraged campaign we diagnosis response the it. disease around to again, that, Yeah. the very remain I awareness

So we're do that to XXXX. year in full going

Bruce C. Cozadd

Yes.

Michael P. Miller

while continue diagnosed population. also grow diagnosed grow the population, our So in we to look penetration we to the

Gregory D. Fraser

Got it.

Bruce C. Cozadd

XXX,XXX-plus for patients [Greg], get who of narcolepsy Xyrem yet there should Gary become part future might candidates diagnosis of equation out they the is diagnosis about who haven't the what the So, (sic) received an other therapy. that accurate

Gregory D. Fraser

Great, thanks for the color.

Operator

you. Thank

Fitzgerald. Bill with from Tanner Our Cantor next question comes

Your now line open. is

William Tanner

taking Thanks the for question.

sense Phase you'd so quickly, data, the inclined about you solriamfetol move on Just the PD Obviously, know make physician X a Phase asset. going might in if and to and with where into Bruce, knowing data, depend whether with maybe to to call and new compound X another would about to Thanks. POC on it's wondering. I'm create bulk point sleepiness, then that PD, up you what get be straight it

Bruce C. Cozadd

Good questions, Bill.

of unmet the POC data into study. We the we clearly an trial. see here, believe place think need medical is out very and we the went significant interesting Let's this because it's to disease

second success, But with potential see we or opportunities potentially audience, about action we part registration into bring to with in there is Solriamfetol, let's commercial question, that that mechanism along On that of other call selling right a products given be we and your move? move point different a wait this other might and development the bring things PD drug, your to the would moving products potentially know a we the Absolutely. patients and that slightly data. and have into know different of some of trial. so would about certainly of

William Tanner

Okay, much. thanks very

Operator

you. Thank

with Our Douglas comes next from question Tsao Barclays.

open. now line is Your

Douglas Tsao

Erwinaze. of Hi, good quick afternoon. supply-constrained a maybe some Obviously, on been Thanks for the question just now. time you've for amount question,

But be than others product? in more I unfettered be opportunity that had a certainly how additional portfolio. you Erwinaze? growing you much If Thank mature you Bruce, know or supply, to think would able unlimited the your it's product you do is you. think this there do with –

Bruce C. Cozadd

for to create could over answer think, asparaginases that, in would, in to we of issue. there's said grow use the see want And trying including the now question, generating it the investing is core not time, of Doug, product. better supply, even we've imagine broadening and near-term now, emphatic we treatment right We're patients. those reliable can't customers we We great less we I address time, growing for willingness behind think resources on adolescent this appreciation real while the and fair yes. and young our you invest ALL and a outcome fill. for Erwinaze, patients. we to use in young we potentially the limited hypersensitivity be population, beyond But our It's with good some there's as we of the And adolescent and But demand supply be don't there. an the unlimited absolutely pediatric sure adult population, appreciation could asparaginases, adult got think market. for That's to because opportunity in to right

Douglas Tsao

very Thank great. much. you Okay,

Operator

closing this I'm remarks. you. further in time. at the like for over to would I questions to back turn Thank no showing Littrell queue Kathy conference

Katherine A. Littrell

Cowen you again we at We today. you really conference joining the Healthcare call. end us Thank participating our as of conferences. to in for upcoming will and well be This conferences it, the hope see appreciate many as Barclays and will now those

Operator

gentlemen, participation your you for today's conference. and program. thank in concludes Ladies today's This

now may Everyone great You disconnect. have a day.

Jazz Pharmaceuticals (JAZZ) 27 Feb 182017 Q4 Earnings call transcript