ENDP - Earnings call transcript Q2 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Second Quarter 2019 Endo International LTC Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session, and instructions will be given at that time. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to introduce your host for today's call, Laure Park, Senior Vice President, Investor Relations and Corporate Affairs. ahead. go Please

Laure Park

morning discuss Good you joining for Thank second and quarter to our XXXX us you. thank financial results.

today's Blaise President Branded Business. Joining CEO and Chief Barry, on call of Campanelli, President Paul me our Officer President Executive of Vice Endo; CFO; Coleman, and Vice Commercial Executive and Pat are and

endo.com. online We a to presentation presentation, slide have Investors in that materials the as well other accompany as section at prepared are today's posted webcast. And

any forward-looking Litigation I made to filings. XXXX U.S. would the you that and described the laws, Securities like are changes, management Private and securities uncertainties our under and to in Reform statements Canadian covered are Canadian remind by of subject yesterday’s securities and risks in the press U.S. applicable Act release,

this the the with that in States prepared call, by may during Endo's are report measures for in refer accordance on earnings today's financial measures furnished may financial different in current addition, the course review accepted to those United that generally financial yesterday X-K SEC we measures non-GAAP non-GAAP In from not presentation. other to be and encouraged used accounting principles in non-GAAP the our with for Form Endo's including reasons release are Investors companies. of

yesterday The GAAP unless issued the our otherwise reconciliation financial therein. to press of comparable earnings noted non-GAAP most measure release directly financial measures in is contained

Paul. I would now turn like to to over call the

Paul Campanelli

you and yesterday. company's Good issued you've Laurie. you, earnings us the thank a morning joining review had call. for to Thank hope for today's chance I release

here's presentation. a earnings quarter call. X attention brief slide Let's to today's turn our second on XXXX the agenda for Beginning

for our momentum. reflecting execution continued to pleased of both their growth solid Pharmaceuticals the quarter to portfolio double-digit our revenues the Products VASOSTRICT Led Branded adjusted Injectable segment of operating plan. X. the of results, Sterile Moving strategic ADRENALIN, XIAFLEX, and segment by another Specialty and slide report continued multiyear Endo's

of revenues EBITDA XXXX which total in $XXX We million, both second $XXX enterprise were of expectations. adjusted million reported quarter our and with line

provided adjusted XXXX previously later our our Blaise reaffirming and financial full are will adjusted EBITDA presentation. revenue, our guidance. year in We walk you performance through EPS

slide to Moving X.

consolidated will our the You for and quarter. second our of snapshot EBITDA segment adjusted revenues see a

to slide X. moving Now

While by with Pharmaceuticals portfolio Products XX%. segment of Specialty segment of revenue second portfolio was Branded our year-over-year year-over-year the continued across the growth our quarter overall driven Branded X% advance declined all Specialty our in This within Products products strong to execution by performance Pharmaceuticals

growth. XIAFLEX Starting with of another quarter our franchise. outstanding We had

and quarter, quarter grew to in investment quarterly continued second Our reflects year-on-year the efforts and growth Peyronie's This Dupuytren's second the XIAFLEX franchise indications and of disease the due to the compared first to the Contracture driven growth promotional of behind by sequential both demand XX% XXXX XIAFLEX. X% and quarter strong compared XXXX.

in segment. the we are quarter volume. and primarily and with Aveed performance generic Branded NASCOBAL the established second grew to year, pleased the XX% is Products. Offsetting of competition LA, XX%, portfolio ongoing driven growth respectively our Additionally in the SUPPRELIN prior X%, the by other by of the Pharmaceuticals products compared Specialty

capabilities opportunities. launch action our unbranded proud as execution as framework am that built. we've for are branded with campaigns their that and media provide of tactics well our today growth other and teams. capabilities sales and digital encouraging them coupled for for to Across PR physicians patients specialty and take includes capabilities exceptional exceptional targeted consumer populations innovative by access are as This These strong provide business, field of engaging and reimbursement cellulite the the I commercial as well driving that a expected CCH channel

of lives pleased feedback physicians improving from with of that the their campaigns we proud are especially I'm our quality Additionally, patients. I'm and for

in XXXX growth low Specialty revenue full underlying year year the are our range. percentage our guidance to in XXXX double-digit guidance portfolio, on the and our continued we XIAFLEX the revenue range Products teens percentage strong full of growth reaffirming Based in high mid growth

CCH to treatment of our the development for program cellulite. assessing Moving

We commercial for and half on targeted prepare the regulatory with the BLA track to subject both front. continue remain XXXX to market on half second XXXX second FDA We launch the for submission a approval. of

we leaderships marketing our build to later front, sales commercial this out the On year. add and are plan to team continuing

to XXX Aesthetics XX approximately We As part July. and of aesthetics congresses attended meetings HCPs hundreds the introduce plan of we've had to opportunity through KOL our medical the engage meetings. community, with including Endo physician to

Topics III Aesthetic the the for Plastic the including presented data our Dr. Surgery physicians investigator clinical Phase multiple was session during is Vegas Lawrence which premier recently at by multi-specialty investigator and American Dr. meeting Cosmetic the Gold Society Hot Additionally, by at Premier Aesthetics. within Surgery Michael Global Medical clinical meeting, Bass meeting

Turning to slide X.

sales versus XXXX. INVANZ, second of net XXXX in $XX up million. ertapenem growth of with segment by the the second of injection, performance Sterile driven Generic to net with was Authorized sales the launched quarter in XXXX the Our XX% quarter quarter was continues for Injectables which of This deliver third

the with of Also period driven sales sales mix the with quarter, by business and contributing in sales million up and volume. were price XX% to driven by to ADRENALIN $XX net -- VASOSTRICT and net the increase growth of in last $XXX year revenue a versus price compared million, same X% with XXXX

competition was offset within of Sterile products The Injectable performance Sterile impact key our partially the Injectables portfolio. products by our on other of

the result quarter. primarily the first quarter As in anticipated, XXXX, quarter stocking as benefit Sterile the second XXXX second expected the declined Injectable non-recurrence sales destocking and first net a of of a versus quarter

by facilities. compounding outsourcing to Transitioning

clinical Act. District no Court need is the granting upheld the extremely by under the supporting that outsourcing for for facilities. decision used the bulk of Court Securities FDA's are judgment, for the be In that U.S. pleased recent cannot We vasopressin with Columbia's court District decision summary determination compounding such Quality the compounding FDA's Drug there specifically

compounding appeal to unless required or filed for and stay along cease facility its an motion. We That and ruling selling motion until a its a injunction is said, granted. outsourcing Athenex, Athenex' stay oppose vasopressin a a the with it product compounded of an is plan FDA or injunction court's has will announced while to

of by we percentage XXXX Injectables reaffirm single VASOSTRICT our in forward, revenues percentage. double-digit low Looking growth with revenue guidance range grow double-digit low Sterile the expected high to to a

slide the offset of tablets, during benefit settlement. period The including of decrease Authorized IV This primarily certain Generic to pressures second reflects competitive segment in Pharmaceuticals revenue generic this the the same a Turning launches products. for on Paragraph last our on Colchicine X. of versus product the quarter the anticipated impact segment decrease by Generic was partially year, Colcrys,

related in increase Now over several weeks, the have to experienced market. generic the we past an questions

by before, of a we've dynamic driven As decline competition, generics we to for primarily With are high we year noted mid- in market landscape, environment range. guidance that seeing normalization a percentage the high full reflecting in while to our are said, revenue level the entrants. active and remains new XXXX the reaffirming teens

Moving to slide X.

ex-U.S. competition of International business. things generic Canadian Pharmaceutical the segment impact ongoing expected, As reflects amongst including businesses our our performance on other our

full International Pharmaceutical's For XXXX, our guidance to year declines revenue XXXX. XX% year compared the full reaffirm of approximately of we

our X. We Turning to pipeline. shift to focus slide diverse

in half track pre-commercialization we for XXXX. activities referenced second for and remain earlier, commercial on launch planned As regulatory CCH, to for our the our continued and progress cellulite of through

generation part durability. as dosing, studies rollover in As on have in several studies as of our target responses development populations real-world on technique we plan, well data focused and CCH injection patient

products CCH in with Sterile optionality to have to indications. and remain launched Pharmaceuticals to continue Generic segments across we XXXX and have We our track on Also, XX develop year-to-date. approximately Injectables products new Pharmaceuticals new six International launch

such Nevakar differentiated strategic which XXX(b)(X) care-based will is Sterile with and products. relationships supplemented Our hospital potentially five as Injectables third-parties critical pipeline by provide

XXXX. to We continue launch Nevakar to our agreement from first product the late expect in

and part where of will our actively portfolio the and success. choose of we we normal As investment. we the to have those review are no provide profitability, believe guarantees highest are return The durability, appropriate course, on commercialize an projects there manage

anticipated focusing portfolio on XX In projects attention our FDA that XX products are approximately approximately high-value opportunities. that on called and in as development with file context, we the our endurable

related is pipeline core shows and growth is of CCH. focused future Slide opportunities. strategy. our these and our our of the now first-to-market table or The X with reflective some R&D disclosed actions, along increasingly Branded key more After heavily Specialty Our on bottom sterile portfolio of products on first-to-file

year Now, let the performance the me Blaise? turn guidance. further to financial company's to XXXX quarter Blaise discuss second full and call financial over

Blaise Coleman

you, Paul everyone. and Thank good morning,

second First revenues a Paul earlier, see and not on review snapshot again. quarter the so that will I GAAP non-GAAP XX, slide of segment company results. you'll financial covered the and

quarter the XXXX share $XX compared in second share XXXX. income operating a the of had $X.XX we basis, $XX GAAP $X.XX operations period GAAP XXXX. of diluted the a of was a from of GAAP in per in during continuing quarter income to second same loss million in per loss the quarter operating million On versus

$XXX per an lower in a our XXXX. Adjusted due quarter compared than to diluted to the in by operations segment adjusted was quarter second was quarter On an net continuing product operations unfavorable revenue $X.XX mix. of primarily from margin million second income year, continuing adjusted driven lower basis, Generic previous adjusted gross Pharmaceuticals share change XXXX and the in income in second in decline $X.XX from

full summary financial year a XXXX Slide XX provides guidance. of Endo's

and year financial assumptions reaffirming XX. guidance are the We the at assumptions are for are bottom presented These financial our the of Slide unchanged. guidance

is the segment guidance slide previously summary Moving XX. This to discussed. of product-specific a and

XX priorities. our June revolving for and billion financial the proceeds allocation under slide and $XXX credit our stated expect previously with to $X we capital consistent wrapping borrowing In this discussion. from the use borrowed to purposes Advancing million up XXXX, facility

XXXX, of the flow with cash to payment debt leverage $XXX and we approximately X.X approximately six adjusted $X.X EBITDA quarter of unrestricted the unrestricted we million ratio second to cash billion For debt and of net ended a of first times. months of had prior XXXX

XXXX of payment to our of to guidance $XXX debt million in million This are June payment compared cash debt XXXX. impact approximately range revolver unrestricted the expected to of cash in $XXX the for million $XXX be updating reflects million change unrestricted previously. of to executed We $XXX we flow to use to expected drawdown prior prior the

turn Paul? Now, Paul. to over it back let me

Paul Campanelli

Thank you, Blaise.

today's XX to slide Moving presentation. and concluding

to teams on focus our to-date taken to our We are objectives. many and will We've the of very steadfast longer-term needed levels. proud we to all actions take execute the achievements the achieve of continue and

our team our their that enhancing members hard I including profile for for us work. Medical and portfolio well Sterile our strengthening am our the future. capabilities Specialty Products in all of grateful and portfolio and on Endo our commitment generics to position believe We Injectables focus their Branded Aesthetics

turn our back question-and-answer Let me Laure? to call now manage the to Laure period. over

Laure Park

could you as it. allow your if Thank time get possible, in would first initial we questions to limit have as to the you, we the may many Paul. In interest of us question? appreciate Operator,

Operator

question from [Operator comes Gilbert you. First SunTrust. Thank Greg Instructions] from

Your open. is line

Gregg Gilbert

Thank good you. morning, And team.

Paul, to seems that puts you if two-parter, issue MDL to like the the actions leading so, lack agree on imminent wanted I if Just most that? one what's anytime importance it us let the know on that and a agree know soon of with up and or speak to And opioid can you the bed been to ruling is unlikely trial. going the settlement Oklahoma with

strategy. and from to Thanks. injectables standpoint? maybe on second internal about standpoint injectable on the and this you And your Can strategy touch both is capability portfolio us that an update could your debt you your expand question

Paul Campanelli

Sure. Thanks, Gregg.

But was I will we're think the be take frame are knows which and everybody terms or consider anything has on The off for of we course. said table. opioids that appropriate been is So it? time of teams going MDL but global absent we something focus need don't if be always potential always not, hard settlement. we're a October. would we never to trial, to know something Of we've the focused as material, If a working in in as

Oklahoma. So there's really no material or really MDL to update the with respect

can here to is have business internal J&J, respect The a we decision this Injectables what I about At what with really can't focus and or on Sterile that's the do we're respect speculate from to way of opioid situation another. strategy. respect the end day, at to obviously our and the focus one standpoint external we attorneys our Endo. execution an to high with have and doing With

We're launch incredible of facility proud real we've portfolio. Michigan hoping expand actually We're that We're decisions speak. We've also in a We've our as timeframe. that of to looking injectable expand to products XXXX-XXXX Rochester, opportunities have to the capabilities of. proud got got made construction some on in we to in going indoor. we're the

will move forward. Endo a Scarsdale So of we as be that big part in

that say hands but RT and focused on lot of this we've to going The critical that focus injectables. focus on is people polypeptides it's hard-to-make care I to proven of really a be a and something the our strategy caregivers I think is ready-to-use into know a get from formulations standpoint. capabilities strong really it that

we're that's a So where sterile as headed company.

Gregg Gilbert

Thanks.

Operator

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

open. is line Your

Randall Stanicky

Great. that in latter spend two much the Thanks. to avenues not shift to there hearing diversify seems I'm that you the correctly And if seem diversify to retail to away be are and delever try business to be generics Paul, if two, you we've strategy. pursuing one, Endo's over -- in strategically development number be seems from look sector; companies or seen number consolidate although of that; bigger-picture time.

is to that that process? correct? number one. then way expedite a That's is And So there

two the June on that rationale And the million talk needed from then balance intended just sheet given you cash the you $XXX number like about seem existing? the Can drawdown the use it there didn't for you cash had behind given revolver Blaise.

Paul Campanelli

Randall Yes, Paul. is this so

away And is an put But side. not think -- is we of we're on to need be generics of walking we correct. very smart to just want first retail we're it. doing sterile emphasis from I instinct about your we're our more what all,

build we're see I you're think to products complex so an injectable skill starting to shift area set with is respect that to Endo. that going a

to being price the we we're respect to mindful that where with bring announcement an market. made We've very

to of generics more size a place of In not gets product portfolio be have in products the think your that. for as to it portfolio. If lot going a than of there's quality we really want we're down important believe is the retail now, to within I we right could that a avoid competition.

a side. products going even mind, approach in mindful focus start that more you're see to we With to that to the retail on

and on to heightened as into of sterile as portion a be XIAFLEX our respect our focus SUPPRELIN-LA NASCOBAL products focus our our heightened going to well and there's specialty So CCH. and business product with on moving like a

portfolio. So of specialty a sterile and view, of our from you see our strengthening point Endo's should

Blaise Coleman

Sure.

of of XX-month trailing So decreasing our our $XXX just with for Randall, your question based on provided borrowing likely on financial be drawdown throughout Consistent regarding the XXXX, will million. we've that secured the rest XXXX guidance EBITDA. the projected capacity covenant

the decision of context really by that XXXX. revolver draw the $XXX be in through the improve made through And to secured portion would really credit to use with of we financial of million the a capacity that our flexibility rest otherwise the liquidity increasing time decreasing our

for to us So capital stated and flexibilities really deploy was this that that providing additional forward previously we financial the moving really priorities up allocation about set ourselves. against

Randall Stanicky

drawdown? specific intended Makes just there's no sense. use But of an was it opportunistic more

Blaise Coleman

Yes.

to Just increase flexibility our correct. financial that's

Randall Stanicky

Thanks, guys. Great.

Operator

from Schott from JPMorgan. comes Chris question Next

Your is line open.

Ekaterina Knyazkova

question this a in is bit accelerating Good elaborate prepared my first citing little morning. companies is remarks, Ekaterina seen the but could my environment that taking you we've say touched generic Thank you've your for And others by is competition questions. you stabilizing are Chris. consortium maybe This more pressure. for some on upon

So seeing the what you on are ground?

approved fourth-quarter three-quarter these that can four a as you're of – second the Are Are topic just are half? date kind heavy? we generics, these certain, progression quarterly these pending of quarter terms we quarters or approvals a the Thank or these heavy ago are better on And of expecting in well? on or there the additional the you. place some were launches – or ago? some more the color provide in then And you in year than two

Paul Campanelli

Ekaterina. you thank Yeah, Okay.

the are part just portfolio, just There respect course, I just products are to that's the are mean, which one part on of unable disclose I with agreements, just first. presentation. settlement take normal it. some back I'll of to I of That's – would negotiations. exactly enormous our to the think amount settlement we an go place date. launch of these that Unfortunately, – can't color I we

at Products disadvantage to so ask settlements of competitive be we you patient. that to frankly, we'd ourselves are either, not put a want don't part just

at make. will products release challenging molecules hard thing we hope we difficult The that you the that trial extended technically we have look There durability. important requirements, when anticipate disclose that to either are portfolio, things and is clinical are

With at particular own respect is been to based are of mean, words the generic there's market, of look words These with portfolio. I I needs to a stable, use in normalization, lot company time. what upon every a point their think

off not need And comparing we you if think to of to that So, are, right? we where get to pre-XXXX that's mindset. I start want

a hypercompetitive by right? driven that's it's new end the market in are it. we're the way the looking We day and consortiums At the with at environment entrants, of

or really environment, you way So react are the But be you it hear we're that on their able the and navigate ones mean a looking understand to process to the going to through are that mindful to today's when companies may that it. normalization, at how navigate, thoughtful in going this need portfolios. are to that's take

particular So that to case, five, strategy we going very, have products seven our is taking to we very choose disciplined right? where products bring market a that we're approach our to in to don't we In and want areas, we're six, players, to play develop.

the at thing. looking generic I'm way, the that's So market

Ekaterina Knyazkova

Great. Thank you.

Operator

Our from comes from next Ami question Fadia Leerink. SVB

open. is line Your

Ami Fadia

Paul, capital more to morning. market? bring launch? specialty commercial to CCH Hi, doors the sort open on or focus Thanks to towards prioritize I you side, you on specialty in support your the trade-off you would additional injectables to that for the in a on building how assets bringing the for between organization of Does using more about out wanted think about a question. ask good taking to you side

Paul Campanelli

Yeah.

We be think – to – want going right? to now we're agnostic, starting point. right thank you. that's the be So I

back Now us area clear that pretty don't retail we're in to people. I'll to see take to one think side, be that not trying I've all on myself further looking is made Maybe step I the all regard. things and an I expand

something So very unlikely. – I is that that's don't

point However, our I The or right? don't injectables, go into is there's think we a execute we to building to necessarily to us deeper want on between out starting plan, should specialty. we have BLA say need trade-off for

the for about talked this filings preparing success. in We've half year, back of we're

through allow either advance not or of process the us. time. we too time would opportunities to priority deeper more little I go a that's come, it's for be That'll but as teams company But a think the we regulatory business filtering clearly into that process development prove in bit over product need deep our to on a success.

the capabilities On we Sterile side, standpoint. have development Injectable a from

is So up maybe Absolutely. we giving But small excited what would like opportunity of and there very about magnitude. developing development, profits company don't acquisition M&A a exploiting where partnership, product even was which where collaborations we're some I we're we after don't internal feel consider? aggressive deals, on an we're go If much. we

we're sterile business the and active normal to and side are focused course, on that's development And Aesthetic very that. So teams continuing side. do our the Medical

up team not for – real not And right? These is health a from So casting a lastly, the not looking same we're in-licensing of giving it's standpoint net. this on products. side, a the wide men's of either that are

to is execute on. for think and something exciting I us this manageable is that

Ami Fadia

Thank you.

Operator

Piper David Amsellem from question comes Jaffray. from next Our

Your line open. is

David Amsellem

Thanks.

dovetail market talked your with settle? retail specifically about Paul the retail margins think more know You've complex your peers' where are philosophically about on focusing you ultimately – products, I commoditization. just but on comments to on going So, do and

you the robust over that's So number can the retail think generics markets? one. long-term do margins be in So U.S.

and I well expanding with working -- get secondly on on since taken your your to on companies is even and your then company's work potentially And thoughts that point XXX(b)(X)s, your there. wanted more focus your XXX(b)(X)-based Nevakar focus on and products. pipeline with or XXX(b)(X)s just on cultivating other internally more with working potentially

within sense that to a is I of how context want the get business? Thanks. So Sterile a big of of the priority

Paul Campanelli

Dave. Sure

What us. have property file something The for is intellectual formulation, something have one is obviously So start very is major property. like can and I'll for we potential market to is the we a something attractive bring about a differentiates that with If novel that add priority we XXX(b)(X)s that. XXX(b)(X)s us. yourself the to number patient the that intellectual needs very, and

got real bodes It a right sales XX into Specifically fits on force the Sterile strategy. reps. about This of side, well. our we've

specialty side, to mean well here XXX(b)(X)s the doing I On our what team. Obviously, respect we've sales we're got with Pat's right? those with as force

XXX(b)(X)s standpoint a very intellectual formulation standpoint. exciting property So, and are from then

should expect move us see regard. you that aggressively to in So,

first on still planned looking retail margins, I and smaller on to our strategy be it these question are pursue that's acceptable to And on mean -- of into question we're are for APIs offshore backward-integrated company-specific issues company's They and your to and strategy. it. part-generic margins our hand A me Endo that's There part-generic company it's first Regarding kind version focused depends on to can typically like really on -- my companies companies. and is they'd a market. particular absorption operate offset file put strategy. their or volume hard that for a are subsidiary,

see, higher more you nature frankly to risk to going dollars and doing, going but quite and been what to success, investing you're file strategy successful you're you and IV, the and Ultimately, margins, Upon higher you're the litigate, been to time. greater cost something you're that sheer benefit it's higher that Paragraph of our going going and to what get realize hopefully see of reward. expenses a we've over can that's you're that's

of strategy. you would more a it's Endo, a that different would tell I So anticipate for because little I a question. margins being it's robust type bit tough

David Amsellem

Thanks.

Operator

comes question from Our from Samimy Stifel. next Annabel

open. is line Your

open line Your ma’am. is

Annabel Samimy

the Thanks Hi. taking for Hello. question.

to give the treatment. you're in the if number studies these filing? of them for acquired the which just are as I seeing of can trials. for and of of experience the whether, some CCH just real-world know establish was as cellulite to merge goals additional BLA a doing extent you any I So, be And well in any a endpoints us data wondering of sense of we'd

infrastructure. Medical here And build a then have some with to Aesthetics, follow-on you clearly new a in different presence

I think leverage. can what have you've And past, build? that, any to place in portfolio plans procedures platform? with you the you leverage the Can in certain still articulate can Thanks. you to leverage, add additional existing that systems your you products have you exactly mentioned entire and to what

Paul Campanelli

Sure.

So and Annabel, I'm to to it Pat. start going hand I'll then over

In terms with CCH. and I of I've basically I answered adding be products, going BLA question. to additional that's And think that into think, success over time our assuming launching

building team already building a clearly, area business that's development companies consideration. to portfolio in or products But future. we the of a Pat. out excited on a I'll it's when the Our that going talk pass trials. expand we're He We to bit for can is the little be about. plan bit an call either appropriate. over But about want more to and

Pat Barry

Thanks Sure. Yes. Paul.

largest the Phase the the trial have and of IIb both a the obviously trial submission, well. data rollover which trial very ever III with as being of robustness and got terms Phase In very, submission. a cellulite of strong designs We've BLA conducted,

Paul position the review to said, that BLA would submit as for us. in excited clock we're So, a trigger to and be that

us KOLs in been what having of it understanding mindful an terms to our of and Aesthetics at in data successful will generation launch. available that Medical also towards We've are telling with be take ear what

we're real-world submission in which of successful data also robustness the track So having setting. and having at timing a the launch commercial a on really about is

I couple a things say. of would And so,

the III of the As want that durability designs, that'll durability the an and which injectors for understanding have I and that about us think because an IIb to mentioned, be Phase insight so data product. important provide Phase KOLs of I will will and rollover know type is

unveiled also for and and just We and at as we insights being buttock the which thigh. into data And also for launch. was -- We anticipate as these XXX we'll we study commercial studies be you presenting is most get presentation this But our an closer technique and publication of injection launch. next the year right we and timing a as again, completed did new up can publishing XXX validated get what get some of dosing technique. to

news for for thigh, it's with good is The us used modalities. how injection thought leaders technique other have consistent

outcomes So able and strong meaningful to to that. are be patient so presenting and be those drive insights publishing we'll

which thighs. in more will mild, upon trial, in be also trial Also, We evaluating active not for embarking are clinic, obese, aesthetically an severe moderate closely even these mirroring in patients physician see patients patient, a open-label is cellulite what experienced. the a likely potentially and probably XXX CCH would younger

we're data about that may excited show. So what

buttocks is And day and the be open-label study and an real-world investigator as satisfaction an then score follow to XXX continue Global as finally, we'll patient XX. thigh trial all in using these we'll efficacy assessing well Improvement And Aesthetic at patients.

form complimenting So strong real-world very we've the plans. generation science takeaway that we're the and data science in of is that, got really strong with regulatory

patient have to lots launch. we going of to focused get outcomes data we're So ready great on when

think question, distribution very I on side. strong we've built Branded sales question. And capability on and the the Specialty yes Again, it's the -- a other marketing fair and capabilities

to distribution injectable master that. of channel, a is Aesthetics would ability model able have be buy-and-bill I is, direct again, Medical a and what our we to So mastery say so

We've also absolutely built very, very application. will which direct-to-consumer a strong capability, have

And so, and we support also marketing how know to infrastructure. sales

So function in strong a place. sales operations backroom we have support

hire the hires we on and to out for what launch. made continue as teams of allow to force we'll build So the marketing side us and out those is we've prepare strategic the sales do will that already

Annabel Samimy

much. you Thank Okay. so

Operator

from question comes Liav Citi. Abraham next from Our

Your line is open.

Liav Abraham

preliminary second Thank the be that on any relatively and more would then, whether liability get potential Do this where there, could Paul, pulls unencumbered comments your EBITDA on I And be and you. access you helpful. could given year XXXX, and year what are respect? development are to is hoping the a little aggressive will need on to morning. given provide strategy. clarity was Good flows that on development, be -- you in business bit with pushes in this That XXXX? opioid there and the business more cash question, we your trough the color situation more

Paul Campanelli

into going forward situation on opioids, business So, we've at do at deals apologize, had appropriate to future the on here impeding Liav, we're strategy over before BD deep they didn't as the our the deals. not to the some the probably looking With not opioid development and we're EBITDA. past announced day, table get I reasons. end of too the in the year respect I go the ability that to mean, we've BD yes, for

is are we we comes where and of well if if we'll would deal, nature deal, continue we and think are And by a lower bolt-on, things I right are to Those course, right they risk. now us. size right us think, I excites the do consider the that through, small can works the Nevakar it. for at while deal

the Medical if at for consider out I injectable looking opportunity now an consider company that's time side, showing came And there on And team's right would we an Aesthetics said, urology. appropriate But appropriate size, an sure for right would BD the the that. more success as that. we

our that believe impedes don't situation opioid on to the our BD strategy, no. ability I no, So, execute

Liav Abraham

Thanks, Paul. Great.

Operator

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

open. is Your line

Gary Nachman

Thank Injectables? rate relative products? experienced timing stocking Sterile the meaningful been FDA now key you the pipeline VASOSTRICT new at run in is have Hi. when how delays to normalized you. you any of characterize especially Have Good challenges approvals XQ? products after there benefit a morning. Paul, your and for secondly, would launching additional And expectations,

Paul Campanelli

So to on I'll rate to latter I'm the run over Blaise. -- going VASOSTRICT the question pass

Blaise Coleman

Yes.

in QX of back now had VASOSTRICT we run indicated, be to in So, we normal QX see destocking as did rate. Gary, we through. we see expect which come would VASOSTRICT the terms And to would

Paul Campanelli

tough first Gary, FDA of terms time XX-months of Paragraph IVs, a a mean, story, stay product the I it's delays, is we're So things typically in a lines, mean, has inherent question. a appeal, right? dealing one and portfolio of in And that our in with. then I every much are the and nature right? Regarding

a or into type delays with take standpoint. from of we're that So Paragraph salivoral to with IV injectable out standpoint, you cadence, see to from that portfolio when respect of FDA that always coming have dealing our the our so dosage consideration don't I

you're on you watching from Those you I things Things closely API mind, to inspection need that would I quality I are at are tell only appoint, that this tell that can that create strength you company. a our and is your delays, people I quality good an right the our as and here be sources your think as of you the would but mean, now standpoint. Endo systems

delay that us point it's something at it's for we but issue standpoint, So I wouldn't this a in that a manage through, problematic time. say from

to we're plan products XX launch I six executing we seven on our we kind going as would thought So indicated, and we're exactly of when or about I we're say year-to-date. mean, where around be. think we're we've hitting we

think on here Endo. a that's focused execution, success we're proving and I at operational So

Gary Nachman

Okay. given that challenges And launch any seeing just additional you just the when you about you product, competitive are earlier? dynamics a talked

Paul Campanelli

So competition, in referring heavy terms of that to? is what you're

Gary Nachman

Exactly. Yeah.

Paul Campanelli

every different. product Again, it's -- is

competition time. if over product, launching little example, to as ertapenem no high-barrier a So we're an with launched we

of make a here an That more Authorized little to we be multiple with got runway, realize would example we a where product it's Generic. didn't a competition. So difficult

a no competition, product players model. it's our that's elect going heavy doesn't product, we're have barrier, have a four, to longer patent to to six manufacture changing, to that to you look that's at we're not and have not yeah, but you're difficult coming that going the launch If going market to

you're forward, move to are us, we see going away we that. moving from As

what So, we to exactly avoid. that's want

Gary Nachman

Okay, great. Thank you.

Operator

comes question Our from Koffler from next Mizuho. Irina

is line open. Your

Irina Koffler

my for Hi. Thanks taking question.

development through products and -- you're cosmetics a and any development, to to As that's business build are about pay there segment of products this internal how segment performance you cash and this going as there build thinking medical plan of out segment? is or disclose medically the you pure your this And segment, that separately? or within financials or reimbursed out other be dermatology business could Thanks.

Paul Campanelli

to So first I'll take pass Pat. it the of part and it I'll over

this So a I is very we're on early preface focusing by got saying, CCH. very,

success, BLA In to in assuming assuming the area. we that future, the the with like be clearly, terms area of a building success cash play in CCH, is going out

any limit have to to but I'll in it no, Now you you Pat, that we and we focused want only pass so if clearly, pay I'm on. much never in be in myself can terms Aesthetics, over And highly other Medical say -- of to areas going cash more… do

Pat Barry

thanks No, Paul. Yeah.

Medical would sales would be of terms this a In the sales type that be injectable on-boarding force Aesthetic we force. of

a sales rep -- and who is that So medical of type for that that is sales model space, derm. a reimbursed those know remarkably different capability than

injectable-like So cash businesses synergistic that we cash an injectables we innovation for cellulite, look would for build be would or with out obviously that to would businesses, from cellulite. complementary complement to and other team CCH with CCH portfolio that would products and be that perspective successful

strategy, our an where be down So field our of now. products would part we totally have were would different as but that's right to line that would we be that strategy medical specialty If that a not pursuing derm co-travel. force, wouldn't likely extension the thinking an BD opportunity

Irina Koffler

more, shoulder, any Okay. XIAFLEX used And other moving time? -- I haven't there if you but talked be we in are pipeline one indications? in I know could on it forward frozen some is just sneak about to

Paul Campanelli

Yeah.

to think – we about a have fibromatosis, access also certainly, capsulites, we talked we So about I plantar is other Irina, indications use the laxity possibility. talked

right think focused now one the CCH, number for priority. we're execution that's I on

budgets up considering start roll we As our indications. we'll other year, next for

-- the where but But when I be the follow This most have to importantly, area are. appropriate. we rights want that's we indications we think that on to in. is we

Irina Koffler

Great. Thank you.

Operator

from question Raymond James. Elliot Wilbur next from Our comes

is line Your open.

Elliot Wilbur

been the competition terms miscalculating generic in generics on in you been Paul volatility established burned leading couple key And the materially new of competition. toward your variable of of sort by peers of mentioned have impact impact a the the of guess, driving Thanks. incremental Good sort that of has space. I morning.

new forcing might have think established seeing interest a so structure in you're much just of couple like seen you wondering in much networks, current Just to is respect impact in share that about wrestling aggressive a your with share be consortium of changes negative trying coming colchicines, to more perspective, whether market the that into seeing from more you're from companies the behavior if terms products you to ago? or fact, of as years take market the

Paul Campanelli

Yeah And the on at is behavior have you mature -- have so both I there aggressive market Elliot, saturation see behavior where I of going again, you the the aggressive even the day to generic both exclusivities of right? price. and products you're mean it's end that clearly think a so in right?

So there is still that degree that you're seeing.

when years couple The big A the obvious, years cobble market and these exist we ago couple and here a normalization doesn't as going on today stability, well the together when between right? -- back XX right? we customers change I and had we is of of ago That of words the used change keep could anymore share.

massive, right? in when about you all change at that XX% swings a you're know the consortium a creates supply seeing environment. what talking you're That's challenges. chain have So we that level This market of in massive the

doesn't formularies all I creates change your what everything backwards chain. kind and on supply happening, company a that pressure which a right? also if with right? consortiums XX% clearly because to of And a of -- bit you mean split a that consortium, And think market we of but environment get falls a lands going the of know one the within that they're necessarily lot there's a the the products That's within is

first on manufacturers. intertwined. So what sources That's into we So API we've talked that I a existence We today our pressure pressure of years about there's culling I portfolio. little starting on were with. think -- you're dealt all see obviously, putting pressures the to right? the of consortiums in came movers, a believe believe here couple it's Those we Today bit ago. are I said XXXX. kind

We smart that to we're first bring just the division. market, we movers be we a generics really with segment so think can again. products want about I to have durable

So that's what you're seeing.

that in today. challenges the I have environment think generic we that's some of the

Laure Park

the there -- questions there's I no more if in queue? are think any more

Operator

no No call ma'am. want further to time. I this questions CEO over remarks. Campanelli, Paul for to the and I'm closing President showing at turn

Paul Campanelli

you Okay. Well to And as your of look we to say, support again thank continued appreciate a thank forward. you we and everybody. interest We I have providing our move just great company. you updates forward morning. want and with

Endo International (ENDPQ) 6 Aug 192019 Q2 Earnings call transcript