Loading...
Docoh

Teva- Pharmaceutical Industries (TEVA)

Participants
Kevin Mannix SVP, IR
Kare Schultz President, CEO & Director
Eli Kalif EVP & CFO
Brendan O'Grady EVP, North America Commercial
Gregory Gilbert Truist Securities
Umer Raffat Evercore ISI
Aaron Gal Sanford C. Bernstein & Co.
Lucas Lee Raymond James & Associates
Akash Tewari Wolfe Research
David Amsellem Piper Sandler & Co.
Randall Stanicky RBC Capital Markets
Call transcript
Due to licensing restrictions, you must log in to view earnings call transcripts.
Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Teva Pharmaceutical Third Quarter 2020 Earnings Call. [Operator Instructions]. And I would now like to hand the conference over to your first speaker, Kevin Mannix, Senior Vice President, Investor Relations. Please go ahead, sir.

Kevin Mannix

Thank you, Valerie, and thank you, everyone, for joining us today to discuss Teva's third quarter 2020 financial results.

me Chief Schultz, O'Grady, Financial of America with Officer; Chief Teva's call North Kalif, Eli Officer; Commercial. the are Teva's Kare Executive Head On and Brendan press opportunity morning. review an earlier had you've was issued hope our We earnings release, which this to the website well as of Teva well through at slides www.tevapharm.com of a be can Investor as this our on as presented call release Relations found copy copy the A being on app. our as certain the non-GAAP SEC. that Please discussion by call includes as on the measures note today's defined evaluate Management the uses to both disclosed non-GAAP GAAP business. manage financial measures financial and measures the internally and its and operations company's better understand to company's the and of operations financial meaningful inclusion believes financial non-GAAP and supplementary trends. management facilitates measures investors information by provides the performance, Further, analysis results of evaluating in of GAAP presentation. our measures in is non-GAAP and release to available earnings A in today's reconciliation Eli call, and third events, performance, today's recent Kare begin To provide forward. and the of an quarter going outlook overview financial will priorities a followed will session. question-and-answer This be by Today's run for is and hour, call, which live will being recorded. webcast X

to Kare, able please. as I'll the on CEO, well today later Relations as Teva be call to Schultz. would, call Investor transcript the over And turn Kare the with replay now if website. that, you view You'll Teva's the

Kare Schultz

below look quarter. saw billion, Thanks, line saw is this going as you, at for to to EBITDA then slightly your third both billion, COVID-XX patients expectations. Kevin. had and therapy. script at overall actually revenues Welcome with for which and and to $X.X the of all EBITDA, lower hospitals joining Europe in expectation. and We in non-GAAP of slightly call, and was in consequent the came U.S. We that's completely our volume When we solid a of our reason doctors a less thanks thanks that for total interest Teva. $X The in we

$X.XX, a was which of we share GAAP And revenues had line flow compensated EPS a in $X.X at billion. also billion had goodwill completely We The expectations. expectations impairment. cost by of line our loss with in $X.XX, and lower So was that slightly per we savings. non-GAAP $X.X with cash free for includes a the

reduction happy debt the and to as of see of end We debt at a quarter the now continued are in the our very net $XX.X billion. stands third

the terms In in we news, interesting happening third of several things business had quarter.

caregiver. of their since one the is and physical in And penetration We're Japan the Digihaler feedback digital and full of sort which you successful treating from and the our of looking inhalers, a actually AirDuo Digihaler, to which portfolio asthma to in authorities quarter. the we first day Digihalers, was sales fact happened did a strong communicates for end Atripla advanced now basically direct means in partner, to a launched our by therapeutic of and that also the treat Truvada quarter, asthma get new the device continue direct that way of the the and booked here very with last I to your we're smartphone, been TRUXIMA. day opportunity mentioned the device the U.S. we we HIV at July. launch inhalers medications, very it in of with very U.S. where it where also people to we all your offer in launch the that your very our but of see forward Otsuka, the now And move, ArmonAir of has interesting the approved have getting asthma complement actually now very space. also quarter, happy the have sent we In the about the we the quarter, very of versions The of the The very generic are fourth the that last happy development in third on are AJOVY

which expectations So whole in our COVID-XX, patients a very XXX is we through course, we fact serve this forward. operations, on high were world organization, least, that I'd are our to briefly essential countries able, daily have the serve to like which having going the and, affecting all medicines. and the our operational not capacity for roughly despite on Last with resilience remain of affects full just basis we million of the everywhere touch but we

$XX Next of, things, I've And key I one I have slide, this coming X years. $XX CEO. the I'm billion the as reduction actually seeing celebrate here. that from Today, more to debt doing as to X please. reduced In proud down you is than on it's which we our the company the since so this years of billion, joined, reduction. ambition been debt years billion know, the in keep And $XX.X you're with passed that

years, following Actavis financials not the reduction debt. X a will sure we the company reached because that level, the a overall of term. debt I'm next significant the had healthy that's, of see the long important So in for course, acquisition in And also was which

debt So here are Xx and really improvement to we good EBITDA. it's now a down that nice net below

please. Let's slide, to move the next

patent revenue you years, reduction flattened. of and in reached actually U.S. could revenue we've as in consequence now COPAXONE development, of the where say, X a terms of level we seen we've sort last a in in expiry the Europe. a the significant And have Now of

the there kind patient stabilized XXXX, There's of we in of of while. of always which happened first the revenue, generics, fourth shot, we a that at and the are you products, was arrival one quarter made we our one about, nature see, XXXX, quarter where we a going here a that We and year. have was patrolled the second And have That's of knew -- business. quarter products, we this looking of in increases why have that can couple forward the just launch. marginal we -- COVID-XX in now Europe, [indiscernible] the of all kinds that's jump as quarters forward. to revenues all One the a boosted, of once where generic that that in the in the where, first lockdowns. saw North Then American was of holding sales, jump European then And see a level the quarter. you reverse in before launch sales

down $X now $X.X more the you in of would to in European the quarter a And So first go you see from And second billion the quarter. I normalization. sales billion see in share not would they our the market lost rate share. market carry. European quarter, run here that the and X% any are below We've sales U.S. the third say probably normal around

do really is market And the launch the quarter, hope, we will fourth So in course, volume that get by will total the will of a normalization see market affected we very course, America. North size. back coming somewhat of negatively so in we Atripla that it's the do we in quarters, Truvada COVID-XX. in of that We of normal see the then, the benefit and successful far to -- still so

there next move a QX. in America please. the slide, bump in North So Can to we little up

up, have key products. and So are And that our drive drivers revenue that main drive X our will as know, drivers the element. we X revenue stable one then X very up, you we have will they

The get AUSTEDO launch record one random That's strongly. had ups has there or up The It's downs is are now, And of that we But some suffering years, the just really quarter is at thing the the its still everybody patients in quarter. which mentioned There is but since is more are therapy. above roughly dyskinesia And main it the and Also and we XX% and sure good to I'm that moves and the right value dyskinesia know potential Huntington's XXXX, tardive X is dyskinesia. huge. end before, per same looking of growing so we're first I've AUSTEDO. chain. can see patients keeps we'll really U.S. actually years in is a not than I speak, therapy in track in disease are tardive now XXX,XXX patients. the this versus will now. important course, it U.S. to at patients exactly combination the And ago. one XX,XXX a of you the ago, all here realize keeps for have year see here, tardive the XX,XXX it pipeline, in from a increasing. following in

If continued move we So growth next I'm slide, quarters. that to we'll in very the see the please. optimistic coming AUSTEDO of a strong

Now drive And here AJOVY. our the have development. an element to growth that quite worldwide interesting we is actually second needs

the that's beginning due of million, lost that basically have like we the as nBRx partly traction this the and the a the that a not we had negative piece. The to little in let's and them X the piece our higher. see low year, an fact competing did And all, due fact to were lost auto-injector now both products, with share of sales TRx is an to auto-injector. would we market bit we in $XX is First start because that negative

that launched what seen, once have in and a device. is successful pharmaceuticals. in by I I've now we few a before doubled my relaunch, of being Now what capture months think, And see this auto-injector the you rate driven you to has in It's count. close case, only to through TRx And that the years May, see really in XX here back see something sort carry being nearly starts to to XX%. a is it that the can you now than XX% from in more

expect market the will grow Europe, year, also continue big as also very it's share in tell So development of to see this percent. XX-some will both and nice where U.S. see Europe. same, the not grow optimistic on to throughout nicely. we this in next see constantly can in But market AJOVY slide. continue to also growing launched I'm sort such very And market, Germany, level same that And a that a I I in we the we of auto-injector, we share you,

really, growth that number the and indicators year, next not revenue both Europe. show here have but really to see, in will would So strong AJOVY high good U.S. we liked some

slide, please. Next

more share, have year. with the what that is can new of launched important that we And really our And to And we we those biosimilars from in criteria know, time that actually the would biosimilars. element is for market if are products are a It's market right of strategy who a we commercial I it's biosimilars. right launching is you you because than and XX followed satisfied is prove beginning XX% biosimilars. old know TRUXIMA be in And traditional a is that here And also this the where been very, it make we is, forward. just business some good market. believe And a ago And And company market to U.S. around the a have U.S. see think launch. saying And increasing But looking more will our year strategy. it's promised which we good share quarters. refer the before in for just Another forward we pipeline good. very is U.S. many of because, supplement I here, America, course, really with disclosed double-digit you our get the which ago to validating on is a And that now. a going a setup, wanted I that have keep shares I've to that generics. open North as this coming you now the there's to this success to get we business a I we nice the have for market penetrate commercial the nicely. in that good possible biosimilar model launch situation needed within TRUXIMA. it's R&D double-digit important

its of it's RA really One on part think we reasons biosimilar is has why TRUXIMA indication the of label. the rituximab growing will as that keep only that that -- biosimilar

Next please. slide,

optimization consequence growing. a a I with our are are looking the in keeps the course, into, combined growth these the of declining of than COPAXONE less coming periods the that we that's growing hopefully, elements which drivers sort revenue So into business. declining, goes just but of only described. keeps not But And as thing, of these marginally fact X

we upper business model. the We through gross improvement through XXXX, you will working improving out see margin that the are margin, hard Eli on total guidance. go XX.X% the how where both our end here, earnings very on band in the we a bottomed later and narrow the also guidance of through in that operating little And how the

of XX%. can our somewhere between Teva. XXXX. driving the a long-term we and towards how which just X margin target And is set this also a Here, for now committed are than ago, in is is to. years doable. optimization is of more financial XX.X% see target you firmly the you band we that our after see business operating is all target XX% And And I achieving very joined very, this target, the And this

X numbers, the will from we unchanged, which years a you be it the let's X slide. for the here, stay you've of which that's times, through next I realize end Now years. And is will of now. the have where get to slide, and a until couple And the hopefully, been actually I this many as basically take seen the unchanged for is same at next think years slide point we XXXX,

are First income of operating all, XX% margin. the we committed to

been to the course, cash XX%, way do and I this we the and getting management Xx. actually down equity. on below team to plan is my last has the pay do cash we little to reflect with net earnings together to committed so utilizing any operationally with to a a are debt, to Teva, because slide, are our X years would flows the not on And debt-to-EBITDA employees. bit journey above all and committed We And phenomenal raise like of to it

job of company, down our around company, has all to is a organization and with according margin debt. ago. U.S. would the company. are you on it legal when whole then securing who gets a which cash to than in company doing that good control listening and I loss before flow see that operational situations your plan what basis, actually course, before you way great a yearly plan, is, like job restructuring despite the getting paying billion that executed you net shareholders think years revenue joined related done optimizing your everybody $X frustrating X keeping the on situations, are of completely litigation the healthy on to have in joined you that a a situations fantastic Litigation the share the saw events I you worse the

it and to it the maybe if held I complex overhang is we or to value -- solve that love we And especially at look than the these Now price years is the with think I I the course, is would that and decreased litigations. the share something X fixing from share market actually, has developed a everybody more say, foreseen price by X, the both that of And the fact litigations. down the be opioids opioids company, then ago. of would was

on we positive AGs constructive And We state with are trial with fixing. a the to opioids. still in DOJ you on as know, dialogue the the going are price

the do good down situations. course, of cap So market frustration now, right But eventually we we that cases, a see situations. will held these being the of legal a settlement believe that by both these we see in is, it

will Now Kalif. Eli on that hand note, over I to

Eli Kalif

to Thank and you, good Kare, afternoon morning everyone. and

from discuss of quarter. by which majority a local from $X.XX, we third X% which restructuring of to review compared $X.XX The posted all on segment the for result we XXXX, I $X.X unit for GAAP As approximately the and in a billion, regions goodwill see committed in U.S. always, The COPAXONE time quarter billion resolution litigation. the to that management capitalization, year-over-year of to impairment, of per $X.X XXXX billion start the AUSTEDO significant to the of adjustments, influenced a COVID-XX the were has for in XX. products revenue was in slide. market well was America the frame on GAAP third AJOVY. The due of due on pandemic, exposure North quarter litigation its approximately projected of third to $X generics, can other in for quarter Slide cash with company reduced lower and as the loss GAAP changed. North a impairment, basis partially the current the the decline and this currency impairment of dollar of Revenue impact $X of booked On XXXX. the Slide goodwill share billion next a and from the mainly a decrease quarterly was will with loss XX, billion, terms on both non-GAAP amount performance mainly revenue certain totaled Teva revenue by QVAR from uncertainty BENDEKA/TREANDA a reporting connection certain of is and lower flow our offset and higher target regarding a as view not and demand OTC resulting America

resolution developments time indicate longer However, than take recent frame significantly will the expected. for previously

purposes, accounting management the that $XXX North unit, per guided the an to in with for year. reporting million its we into Amortization third $X.X impairment quarter was factors resulting range valuation for million the quarter, of such, million charge billion. As of has of to America $XXX as beginning these the the incorporated $XXX of aligned

we in on to XX. performance modest operating year-over-year Now remarks. decline quarterly turning I revenue, addressed our Again, non-GAAP my in Slide which see

period the to in margin QX with XX.X% coupled sales network, operating P&L, our XX.X% for was improvements in XXXX in The due to gross is gross increased was the XXXX. gross business legacy our in XX.X% high the as the year well margin AUSTEDO in Year-to-date, by specialty margin, offset full gross XXXX. generics as versus with margin partially U.S. down XX.X% the Moving compared of higher our same mainly in a decline brands

ongoing on the most optimal long-term the margin gross with in manufacturing plan target. to mentioned, a operate improvement our financial efficient to The structure. we our track and reach reflection of overhead cost is year-to-date development Kare remain As

our Operating quarter year-to-date at our was Still, in months level $XXX our expenses first by XX.X% for margin of ahead, QX to quarter XX.X%. the XX.X% same we the margin the QX margin last same Looking same operating reach for than and were XXXX XXXX. year In year. income the the XXXX, year, line less operating full of XX.X% period full declined compared the the operating gross in expect of X of XXXX. while XXXX, with period to was million, X% the versus in

long-term financial expenses our of view earning part as with disciplined overall provide to up As begin the the incremental expense structure leverage structure a operating that fundamentally to manage reposition again. continues and targets, and company revenues cost grow stabilize can

to Looking at the level the operating the QX non-GAAP bringing in notified $X.XX margin earlier. as $X.XX, year, were be in and year we year-to-date first our year. of XX% line with period last per same at earnings share to the XX.X% per to last $X.XX quarter full stable share versus expect earnings Kare our Non-GAAP and

to briefly base. quarterly our like year job Turning I the spend due to touch line, the good on COVID-XX base. have managing to Slide fluctuation pandemic, overall this would a done spend XX. our the in we Despite top

our spend quality reflection spend our transformation $X million in the versus base the network, the $XXX X in through and optimization add compared if of management The efforts the period and cost see active to year. in together progress same the Overall, restructuring, integration network expansion Our earlier under can key first introduced levers reduction end-to-end X chain the in organization. XXXX the margin decrease this gross which the both margin was expenses just outlined base agile we operational the operating in and of supply of XXXX, is at operating we of excellence, model XXXX. ongoing operating gross improve year: our the the we a and main excellence, year and of to a of the both procurement start billion, we the months and of

$X.X generation from compared came the in months We first are for the our billion, brings X of in Slide result year, our the of for $XXX for flow Based $X.X outlook first XX. total mainly decline the free at to XXXX, than million guidance flow benefiting cash to remainder more was This of QX of the cash X $XXX the to which our free our stronger-than-an-usual The inventory. million Turning an for XXXX billion. start we billion to increase in on the is year. quarters quarter sequential from $X.X and XXXX. XXXX see maintaining

debt our development to XX. on turning Now Slide

In $X.X As was you debt-to-EBITDA July, to a billion. differences, situational in total $X.X all repaid our company be debt saw transaction to total bringing modest the maturities, debt reduction. current X.XX ratio, long-term slight we decline focus and repaid continues billion net to year in this know, on uptick our in net due and debt turns. which Unfortunately, only our the a

expect turns to continue ratio We year, turns reaching forward each to decline year-end remain under X XXXX. and going this X by under

with refinance we the noted As have to XXXX, and cash flow liquidity and throughout for the before year, looking the repayments bond XXXX the year XXXX to cover maturity.

has highly the still very to volatile with turning presenting This the world and to XX. year the a to we global all the it of regions line. unique operation pandemic environment. most have to on proven dynamic made challenges focus accurately operating remember outlook that indeed top that Slide year in for in financial the need a XXXX X be are our So We with difficult

every the health day local We through locations are worldwide, worldwide. perfectly employees our and while ensure of changing well-being managing working our at to conditions

stronger-than-expected current of effect seen on continued is offset unexpected decline products was customer information experienced businesses. the Throughout year, large and we by our QX. effect In and impact a and Our stocking. QX, our and in reflect on revenue is, pandemic-related This any a we in QX, of purchasing customers pattern financial significant have visibility and ahead therefore, today our does outlook based COVID-XX available on not overall that utilization the patients. global we saw of

full billion. we're The to full range the $XX.X adjustments range sales based $XX the for original the includes on This billion $XX.X billion billion of of adjusting global revenue and first X and range our our by to the for range $XX.X result year new AJOVY. of to As million. months, expectation lowers of COPAXONE midpoint this, today, a performance from year new $XXX of of range to guidance the our

$X.X For COPAXONE, approximately by our we to billion. raising are guidance $XXX million

lowering million million we -- by the Kare to our are guidance $XXX described. for $XX AJOVY, For reasons mentioned

will For share our remained other financial EBITDA range we a bringing utilization guidance, for financial each our earnings well concludes recovery targets overall the patients, for the up as of and be quarter reduction within XXXX per spend pattern the income, mix guidance. base our rate been has the business And end my already impacted XXXX, range tightening cash pandemic product and in end the one, in the purchasing mentioned, were as operating flow reflecting mainly the lower as of year. by outlined by unchanged. rest the which review and few by in results each minutes third Free these ongoing of I for that Where I by of just up generic determined ago. this

questions answers. for would open We please open call you will for Operator, the the now questions? call and

Operator

And Instructions]. Truist from line Gilbert [Operator the question of first your Gregg of comes Securities.

Gregory Gilbert

equity your out have against in held and is out targets pointed laid team back to you prepared you your that the that liabilities remarks, executing as be that by company the Kare, you well continues inherited. the

have financials could recently those it what On their J&J like on liabilities? I opioids, So distributors reflect to or updated a update looks the be you hoping near-term was very comment settlement. us and could

you previously penalty. in mindedness with sailed, your great. whether you perhaps comments could is other our even Has that, the not own? or reasonable would into going with settling given view, price and your linked on ship and offer expressed, in open a Any on a DOJ, So about Teva on color on And trial? or fixing, that to weigh then DPA could you be that

Kevin Mannix

Kare, button, just check please? your mute

Kare Schultz

that, very good question. for a thanks So

we course, on So the opioids, hopefully still AGs, group that's firm that the settlement AGs. framework are settlement it is dialogue the see of And positive same that a in so foreseeable of very did with with. the the we'll And future. within we a

before of claimant lot problem parties because also there's the of to for involved done settlement states, actual this, the one lawyers triggering a lot is and of said alluded the Now signs where and points fact in I've I've so that of that a getting the a everybody on. lot the

a triggering for that there getting postponed, the it yet. that guess, is New January, postponed. all about points And parties optimistic, trial one West trial settlements was year very then ago then going an even this hasn't done then the I actual got that York trial January, like is when I was scheduled from that for got And March, then happened pressure origin was So there the are the a of to. Virginia

to between progressed beginning, between of all number deal. It's all mention would that the with could important the seems a, that would negotiate the were say, the negotiating maybe fact So reached it been them, so more that in company with from to were the combined framework. we speak, it's started deals, individual in had the they with, the But that at we It's other that AGs, [indiscernible] AGs deal say the AGs having that companies the postponed. they X been the And lawyers. are out like. each have sign than and trials negotiations participating same and a trigger but you time ongoing there's X terms that us enough people they quite obvious on I that the companies are dotted financial X didn't of line

be settlement able will be seeing a that a because that help doing off solution to whole I'm thing the misuse chance really of we is where best of we where all will see that of to win So come to have we And Suboxone opioids. very people supplying solution U.S. still the the optimistic we so, a in will to

So opioids. reasonable. settlement, a is that's on open settlement a always what's the it's situation fixing, if On that I'm price to

I with. is a reasonable course, DPA sign, did, live that live company my do. the reasonable assessment, a can acts not to can't in admit that So criminal to best of something, with with having that I

towards So really a moving it's that's why trial.

Sometimes, which long we we in saw this not ago. last with acquisition settled so on these cases, it programs,

we you goes does I'm once your date, to not negotiation. for sense people sometimes evidence a and believe to that I'm go of get involved, is new whole, just So question. us clarifies trial. really it And of there's that get it the saying the sometimes so that you close actually against say, I to makes a to could that settling. weak you that but trial, trial it's body hope it new settled, have lot

Operator

next Umer from comes of of Raffat your And Evercore. the line question

Umer Raffat

where for Teva? to from do lay you put Do the months, assuming you get real I to I are over see the next perhaps huge XX what litigations opportunity know get real your out where and base AJOVY would other line the and about I settlements and innovation you the if next a offer an path definitely American a focus plan we Well a There's one going? I investors to you is to -- be and make scale on. business, this on the line settlements. perspective of CFO And unusually XX excited these the plans -- beyond question, and -- products, evolution the to about business for vision, do it as base quite thing feel if of direction we investments willing and from may, aren't But like AUSTEDO wonder which Kare, there's the I large hearing think aware And Corporation. laid are just a multiple top a as And top on like think there's a if is new people it's well. clear we real the sustained new an gain should next within quick likes? growth,

Kare Schultz

our North to Thanks have those we a a therapeutic in these questions, several extra the a course, -- I future any And America America Yes. then years, I'll one launch business terms growing business. have of much. Europe, in we of, some terms stable and business make in and not several a the sales, is a the of you when low probably of next in we quarter, Europe, the see environment it's file, in of keeps you the categories. comprised chain chain. the I then quite single-digit coming and there, and And course, in most situation start we buckets bit some the North so America very focus if from a and would supply volume a say, of European-centric North to And for generics answer give million and really of stable or about And as of long have quarter. chain business $XXX little underlying and we leaps with OTC is first because two Europe at say, we know, And pricing make you some business Umer. first growth. and you in have in customers supply in reliability we the then supply renewed underlying, look generic and on stable U.S. supplier. the could in on, it the that But

stability total biosimilars, in Not on business. rest years, world our went see lot optimistic, as but I'm basis. biosimilar growth, a I through, just growth generics. coming and America the the the really in of North in on we that in the Then the some that's will So of growth

competitors. that several due stable XX relatively product, be be are there fact but in the competition it's sustainable traditional hurdle a to think each more means of And higher will that in for generics. most I to get form prices competitors they be there there's which likely will the there than will in less investment be there, won't

then, think there course, And contribute saw. drivers growth that will just biosimilars X that you to growth. of also the I So

saw you $XXX million we in is that if growing fast. and So here in AJOVY, the and total, quarter, third we this like something probably did AUSTEDO combine

they do the So $X combined, next year, and math, if keep will be growing. they you will billion, on

on I would positive in quarter. fasinumab in, foreseeable have fasinumab, has that There's one think, we drag it, of readout of then, what getting So future. efficacy call And Phase go they the growth, in the the lot shape and of the a the surprise of on actually first III its are long-term possible will trials. safety because finished the -- sort you you course, will that

a I modality an development indication they X have good FDA, whether their with of AdCom X are will medication. tanezumab, just gotten for we're pain by Lilly, -- And that of for approved. And actually getting get basically action companies ahead product with we think the We it's chance Pfizer and two March. scheduled in has means March, products a this that or no, companies, but their of ones in us,

difference at from similar look compare know mechanism it view. any you of of look or to And safety, that at an overall really our to Now there's you you the that. it significant look product. trial if just point But is in from efficacy if action trial, I can't it, doesn't

get situation of it they And negative get positive talked to huge likelihood high of there's and a eventually if fasinumab opinion have then medications, and a if all FDA, the pain So opioid positive unmet the one approval just for a the medical by fasinumab does, that in be same. those. the we regulatory there's nonaddictive the can elements a course, of could U.S. It need side about

based the end not talk the range, the we so X, more I about three other broad just don't than So exciting many to said will, U.S. had we years, XX our makes also but the preferred but driving in and that, Add then line. have biosimilars specialty if the the our as of we the antipsychotic new products. action And and the of action new know, be, a you of of preferred longer III really which a creating on a the modality the made version as is for long-acting we've from it risperidone, profile. far, basically schizophrenia, by program long prolonged view, here, long-acting sort that is means product. should patient solution point and next products for things which before, pipeline we subcutaneous, formulation actually, much, And for it, then Phase a in main fasinumab top for have --

Now readout we III Phase the trial of don't yet. have that

have And follow. that will first We to quarter. are olanzapine are lurasidone the follow, two there in to sometime

that the different growth we So lot in coming drive of years. things can have do a

So it anything. growth course, revenue dramatic optimistic but means see that really else answer, And over being these the that I'm everything revenue years, basically was quite not of promise that single-digit we can't a long in you growth, I coming equal. will but COVID times,

You'll see that's other for ones. on the we need American of a questions. where it's having we the American cash about key until Right growth the in we based quarterly that year, Well. the if outlook, Well, question are And to have next major year are in sort your the they the Then February. about wait how me a don't coming flagging that any But sort ask I drivers, guidance shareholding you holdings for sort longer-term a correct have we give of situation of predictions in now, -- in pop-up that our Thanks accounts. my for value. minor is would

Operator

your question Gal the of of line from Ronny comes next And Bernstein.

Aaron Gal

have how around let's That you share those you is from us sourcing you here? guess if with because Could Celltrion share kind you before many bit the little this of other finish of with is only the pipeline. one. biosimilars partners? And I the Kare, margins XXXX? a this I in of or I'd XX, really start growth then may XX like products like drivers. to just products name yours -- you how are any are XX of products, the out I specifically on And many with think like talk biosimilars. the your Humira versus what's interesting

with I haven't Specifically a around settlement the AbbVie. for biosimilars, seen you Humira

you trial. no seems to So about I it good when in. interchangeability are have idea going And you're come doing its

us And the marketplace? positions comment it do think you you you how expect tell on those when in that, If you can results?

Kare Schultz

Yes.

So first have that have development it's or development and say, the biosimilars, of we in-sourced. approval for things are roughly in of where all, and waiting internal U.S., let's we in the, out XX-plus XX-XX we launch between

we the saw You recently. announced just Alvotech which deal,

have them, difficult from we to and So roughly that any from competitive It's reasons, disappoint sense. own not internal most on have to the And we I our comment because basically half decided then because specifics. makes some have of you half I'm coming that deal XX development. guess far going sure, we coming the for so that basically to not are biggest for

reasons. actual of you but them, actually So we've timing the guess actual and really competitive comment on can products, and decided I'm that's sure most the not to for

that. about sorry I'm So

Operator

line question the And of Wilbur Raymond Elliot from comes of your next James.

Lucas Lee

for Lucas Elliot. is Lee on This

$XXX AJOVY other lower million, line with by is million and a by top $XX $XXX the million outlook areas. in COPAXONE increased So by outlook million $XXX implying reduction down

function Or by line? there us Rx heightened leading the So measured a factors expected And dynamics has product-specific sneak were AJOVY help pressure? you question, what understand growth I trends. that? sales there? rebate than top to absolute for are sequential could given Could the the primary and factors been if Is flattish this a accounting of other in as lighter relative onetime

Kare Schultz

Thank you.

those we the we that in from of same on to in course, and different because and lot and are pharmacies tune that our significant the the are saw average, have increase lines that lockdowns So it's million getting any $XXX on why in both in lockdowns I saw change you those saying basically across -- across $XXX market the an to the the in there's, XX%. the And that your talk the is older of different seen as United volumes in quarter, it's second third in none and to reduction top we open. in we none here now, specialty downs lockdowns know States, in script maybe related in related you products to We Europe million U.S. pharmacies. a are something so right total we've average on. of seeing And decrease on script the the lot our, ups marketplace. open, our And doctors first could is a shares are doctors, people was, like that's more we lower hope a of, But sort Europe the generics, X% quarter business this total products, predict, probably not the of include volume And in on and to Europe. of so TRx absolutely reduction and course, of or now but of including used thing math then saw that in a volume I'm of say, Europe, and on difficult to know. U.S. volumes include in first we right the generics we let's correct. line in of total say, about Europe hope basically volume reduction is quarter, What

see back continue normal in states, we hope also know, trying the could there's say, doctors in the quarter. we so and to fourth see to the approach a, pharmacies you And U.S., as get also to to you we'll with that and there's volume, that and quite So asymtotic most a normal. on open situation in

course, that lower up than The in around quarter. So that's be we the climbing affected catching we slightly the NBRx reason of If buy versus TRx fact at support the will, seeing then these it we for scripts commented fact of to out phase. sales really The getting here also that. the had you on And they have factor new-to-brand get then really initial only of fourth TRx some buy net TRx increase And down nicely a are NBRx the course, now stable of XX%. volume, due with already back is means we're are look in you AJOVY, less now, that high-volume that I that other has to up expected. coupons. in do get that a a your if which down that the

in any seen the changes not have environment. contracting We

So the given answers under question. I contracts. that any seen we've hope in rebates increases your various the not

Operator

Research. comes Wolfe question from of the next Your of Tewari Akash line

Akash Tewari

on Can guys And you it to talk to brings you getting on product admitting then civil about on is fair that? on liabilities you what civil when pretty And your there would it to regarding to uncertainty for goodwill resolution the more have What generic price strongly had and is deals Does side, market? long-term And an a liabilities? charge on in with business. So the impairment with there liability is DOJ say have the fixing? significant litigation certain civil for there North time price a DOJ. settlement is legal fixing Revlimid? ongoing resolution is wasn't regards do American ramifications frame the a comment of generic the the of that the anything then any resolution considered

Kare Schultz

give Brendan, Okay. now. price first Thank to you. fixing the I'll question I'll the and then just take

exactly that, which hassle the or we did whether are to side broad-based can criminal if how the to our correct. you're situation legal have with they DPA That's AG that, know reasons whether it's admit often And act the if typically, So point from it's trial. a is looks defense And or and your course, would it Brendan also with absolutely which the side, and with AGs. to state on would DOJ And with were criminal DOJ with us first meet And And able the something own conduct, to then we, it's raising. that? will DOJ you on which be you with that were There's, pricing unfounded, And civil in course, the of going trial the not a to as have that conducted. financial can of price potentially on DOJ. force answer criminal correct, a away you DOJ that's more a But have that a circumstances side of AGs is of civil we settle take commit, the accusation the that's with civil one, on to of go with then a to a given a not view did view, to that uncertain to a solution sort because price accept, Eli more one fixing. then reach company, on fixing, whether we right. a of the trial not the you along would why is, we want financial I don't cost. higher

Brendan O'Grady

it. have was and So Kare, it? him a loud you repeat me you little I'm repeat but it be question happy address to I'd the clear, -- muffled. or for Could just I hearing

Akash Tewari

No problem. Yes.

hear So timing. America given goodwill me, impairment leading it just uncertainty can North if on does to of on And legal that that [indiscernible] product And big onto the with is get billion could certain the you impairment? to when generic kind have do down the Revlimid? $X.X charge, goodwill ready settlement? market, regarding What step on anything

Kare Schultz

Yes.

just to Brendan, first So could answer maybe revenue, give it. I'll talk the brief but of you part about a the

the your the capitalization. our is that assets you if for is, adjustment, fact we're say, and before -- the And accounts the net main technical, between market would there reason showing that that the So reason a adjustment in accounting, you have then the for for a closer it discrepancy write-down cap this the this assets good to year, the than to your and market or look then at look practice case, it's adjust to good whether cap. bring should closer at the -- actual accounting, to more a net take in rather you market bring goodwill your the

on we comment of that, as very to goodwill. go share in on could that litigation. write-down The fixing with continue, an decided of the a They will say for are nothing the maybe do fixing believe can't that on factors you And But consequence will We to prolonged. probably removed COVID-XX, consequence could can has on that, price it there the we that overall to go the a price make could the the as on. is assessment Brendan, And price be soon. be Revlimid. overall litigation, litigation market just overhang such due the a So these Revlimid. years. do that as It

Brendan O'Grady

Yes.

comment we reasons dates the Kare, comment typically So don't And make typically for Revlimid settlements and I'll particular don't on on We launches. just piece. comment a on obvious the confidentiality. of

and with answer. Kare's just I'll leave that at leave So it Revlimid

Operator

Piper the Your of next from comes line question Sandler. David of Amsellem

David Amsellem

couple. Just a

get trajectory wanted I of your to on AUSTEDO's. So thoughts the longer-term

manner number move that, know, think term? they extent of AUSTEDO all number something have do the landscape year. Huntington's expansion have running over bear business, that competitive have that extent extent impact fruit to sort something think That's which year, the think should a of the two, particularly we we How that in launches biosimilars? study To As a you that those you next that of more get that's if have to for you And that mean, you that the next Neurocrine should one. to a and the an generics label some about chorea, stun of NuvaRing. considering trajectory a the timely generics of to growth read mean, I long year, the is don't then a pass? to high-value paucity could the could I comes out is Forteo, next valbenazine you on

Kare Schultz

lot. a Thanks

disease. approved first are for and development, like tardive So AUSTEDO in I I this products good the product are AUSTEDO, the a competitive when X terms approved for dyskinesia. on in where said, very of actually is comment There only position they products the

potential. the in due reflected could quite think around XX,XXX Ingrezza on it little patients. and And ahead drug, bit get is I the They a similar for have just dyskinesia, is, on that around us. ever a we means the of around maybe active and half have big will therapy, there's say, tardive patients just XXX,XXX patient patient pool, and of you but only the launched to competitiveness XX,XXX that accounts fact

So companies. think X the similar growth a the ahead, little between I in is pretty bit but patients

potential would their a that Huntington's in in dynamics. major market see don't I So change make the approval

to get and you we 'XX, the more quarter We and of and have 'XX. continue very in we're fourth we I likely, have and of regard say, -- one in I'm years. most need, can showed AUSTEDO these EpiPen growing the will to always gives many launches, leap. that the high-value optimistic due key, high-value little next a so see year, complex, the Truvada on. going you positive just of that So drugs still huge [indiscernible] course, With Atripla here to approved. medical And We it to unmet the for every

going know, if to earnings what terms to I don't But difference of major Brendan, play we next you I see year. it's a of these a want launches? So maybe high-value give some to think don't and revenue comment specific to in

Brendan O'Grady

I'd be to. happy Kare. Sure,

And potential ones we X that next see, approved change ones always in takes the the We'll regulatory the way So risk certainly and There's you're don't. consideration. we possible those and as we can that or are all have numerous process, X high-value launches get time through move those for right, approval get account which launch, and we market into by year. adjust our them. but of which the that P&L

next So plays is add it we'll that the I'm We'll competitor. optimistic see several only on And available way out. Kare treated year, have market number but I our that of X% and -- us of patients out generally launches. market other said, high-value that's how the would between as goes, significant there AUSTEDO is there, thing that a is about the

we certainly the is see but and represents the the And disease Huntington's tardive dyskinesia So growth value. tardive is do dyskinesia potential the significant important, dyskinesia. tardive market. bigger of upside majority with

there. just leave I'll So it -- I'll

Operator

Your from Randall the next RBC of comes Stanicky line Capital. of question

Randall Stanicky

on EBITDA net target that by Xx close you're in implied take leverage. debt of billion year get and net like can a looks it $X under your of you -- couple on billion XXXX a reaffirming to down Kare, the assumption debt

to XX% mid- growth growth your of So that on high-single revenue X% X% seems imply EBITDA to digits. margin to

think generic additional back base XXX(b)(X) digital sorry, business, So can digital in the opportunity a metrics? secondly, right first talk outlook the to brand is, do as see you way on either And question opportunities opportunity is digital that and the or on biosimilar? there about Are And then of those AirDuo you you health ArmonAir? broader therapeutics about think about of therapeutics? the -- the

Kare Schultz

Thanks.

of So on the are, you course, first spot there. question, overall,

And billion-plus We have probably allocate we'll to cash $X flow the flow debt cash billion, will per $X a reduction. year.

reason what that pretty then, the operating sort years, EBITDA you be EBITDA next to based we is And Umer the contributing that's math the we to get can to is that can the with rates need on to be low think revenues do billion all the end And of growth we we a believe our we to why $X be add question growth combination margin single-digit you order that in it course, growth. of calculate, some And explained debt. do. way to of to the plus straightforward already we can going various as I we'll when his you that stability you is believe in of rightly of the then, that's going to period. also what means in did, what said the in get $X on course, And XX% because should there. that explained of you around revenue. will quite take a because we've up, straightforward the And to elements out So you And and in and billion. single-digit get

of I'll and pharmaceuticals. question, on So that's really possibilities comment the the Digihalers, I'll the our within plan. then second comment your With digitalization further then actual to regard on first

extremely there I perfectly think, on the product if a needs. have patient here, we unmet Because So therapy, are Digihaler, fits it's, at you least on asthma the exciting because then things with medication are hospitalization avoid your is your take that monitor attacks. you somebody One correctly. is And crucial. that X helps severe and are two so you monitor you or else you disease, asthma that

of patients. both any parents, being to inhalation. access, your cloud can could bad ones, to super believe with, short-term way. doctor, but you on the want patterns, to good your aware following Amazon anybody more who inhaler, inhalation people of be slightly that your artificial predictability of share inhaler, the on the be and what's giving smartphone sorry by And Services. in-built the run do and avoid for in asthma That's important caregiver registers your answer, meter whether value it you quality through be could long that's attacks course, is give flow smartphone your a but inside platform, to or Digihaler flow a that consists nurse, really able Now them. Cloud major to and from for a we from And and, could for that that -- your cloud a be the intelligence, the the compliance. of automated major life your communication systems There's improve be driver you will we could therapy hospital loved by your that it the and longer-term And in a data of that by going for normal

So world first system. we're We the launch system. we the such a have We're great in this. very a about happy think to

whatever, all but efficient, You on systems add right you inhaler. your super is these into the have other nicely to something inhaler where this and built

that seeing are this. look a lot uptake. are give on much we more and steady also We we launched, nice, have And because, medical course, we sharing already, we and seeing insights. us of data to very forward And just usage will collect of

Now that's said, the and keep Europe. Digihaler, in based on the will the I on U.S. we franchise respiratory in And on have. now we both as building respiratory franchise

all of, other products things? digitalized the but adherence then therapy of how patients of to the the this our and patient do you inspiration ideas, ideas improve communication tracking caregivers and we And sort help clinical won't Of say, give we to put I improve to will that, do between share question might and just sort compliance also does. able outcomes. course, into that On kind be through it have of this with today long-term does for more

a very it's So exciting area.

Operator

line comes from Balaji last of the And Barclays. of question your Prasad

Unidentified Analyst

This the August? the prevention Maybe on what view Balaji. AJOVY. coming to then you more I color market on the X And next you over provide has about provided changed from is for Steven how just little migraine if you for could could more in the into bit a do the outlook additional outlook talk guess, competition X exactly years?

Kare Schultz

much. Yes. Thank very you

total growth changed exactly what been market that for. has as really So the been has hoped we not

a getting as So are TRx therefore, we number, higher you saw.

NBRx a higher are We getting share.

most new held to the people share grow we higher to the good, back to for And to fact is less and that's simply but a getting key that for are hope its go continued we market slower of due be driver. therapies growth plan total and doctor. what market, when has the COVID which likely the So the compared in

element that could and and ramp-up to probably in compared has we're ended other The has is say, you where were we the could where more, we of a slower, we up cards a that per downs, using -- co-pay scripts seeing pay what for. to revenue been you say, new factor planning come script that led were

course, that to buy as more Now the rate. down. regular follow-on growth expect And NBRx be people get next we the on in initial net the that going get from script see continuous revenue of therapy, and means per a they up. same year, as a And don't TRx that, the rate will

are quite initial the performance that number strong the see optimistic year, the we So sales nice in increasing development by also a of very next we're of European we'll AJOVY seeing launches helped there.

thank So much very you question. for that

Kevin Mannix

again you Thank to That and come. today. our speaking for weeks you, participating. for tomorrow the concludes look call to today, We you to Thank everybody. forward

Operator

call Thank for you. X conclude be today. available time. in A of Ladies replay and gentlemen, hours' will that this your conference event does

You participating, may can listen to for now all conference you thank XXXXXXX. by you dialing this disconnect. and at any +XX-XXXX-XXX-XXX, time by We ID,