ENDP - Earnings call transcript Q1 2019

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Operator

Good day, ladies and gentlemen, and welcome to the First Quarter 2019 Endo International plc Earnings Conference Call.

As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Laure Park, Senior Vice President, Investor Relations and Corporate Affairs. Please begin.

Laure Park

Good morning and thank you for joining us to discuss our first quarter 2019 financial results.

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

Litigation changes, Securities slide materials you made our applicable We today's Private other I today's Act uncertainties webcast. well posted U.S. would at of and that endo.com. online the statements the under in like to and U.S. And have covered presentation management accompany remind presentation any that in and forward-looking Reform by Canadian filings. securities are XXXX are in described prepared as Canadian release, press section subject to risks laws, and securities a are to the as the Investors and

In may different announcement. directly in Endo's of the on financial unless principles companies. reconciliation measures that is Form noted the SEC earnings including call, current those call otherwise earnings are prior non-GAAP today of refer with to by with used contained may United prepared report comparable most the Investors non-GAAP course therein. States press generally measures are other review non-GAAP GAAP financial our we X-K be financial to today's accounting in to encouraged in in from that today's accordance Endo's the the non-GAAP reasons financial measures issued to not for furnished financial for The measures measures release accepted addition, during this and

on consolidated to the now to had This like I'd Endo reportable simplify or change, intended segment changed was Paul. turn first the Endo's XXXX, results. impact names segments. During names, over the the no segments' call its quarter which of to of

Paul Campanelli

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

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

performance Slide a X, same very year of attributable Branded of to I'm Injectables Products primarily our both growth growth. Sterile March, our Specialty Pharmaceuticals We presentation. debt performance will debt period proud segment. refinancing, consecutive on recorded our strong of increases second the revenue walk to on a our outstanding revenue portfolio strong and In operating operational full our which significantly in guidance. the quarter. financial the our flexibility performance maturity. executed in we year Blaise are financial to the was X% Moving quarter you later And amount versus meet segment near-term target last in and most we the our continued reduce through A

million revenues the which the Moving quarter portfolio segment to pressures of offset to delivered Pharmaceuticals by the EBITDA Generic quarter, see we Slide Products which the of first was first of the the and of quarter was growth We our Pharmaceuticals Specialty for will of strong a Branded the first International snapshot X, comparable the in you XXXX, reported competitive both segment $XXX Injectables XXXX. In segment. our the Products of Pharmaceuticals Branded portfolio Sterile continued segment, quarter. in Established first segment, and adjusted the partially in segment

our activation of the Contracture XIAFLEX first and first quarter which year-on-year consumer quarter compared Peyronie's growth in significant Branded largely continued the by grew demand was underlying in with Pharmaceuticals Dupuytren's to X% to segment Specialty to Pharmaceuticals the year-over-year for X, of our our portfolio XX% moving Products quarter expanded The of strong Slide of continued indications. Branded first This growth segment XX%. and Now, our This XXXX. reflects the due grew by both franchise advance awareness year-over-year. growth to driven

XXXX quarter first grew AVEED and volume. Products growth the prior year, our revenue Specialty to in Based growth affirming to XIAFLEX high-teens full our low-double-digit compared on in the are respectively XXXX we and in underlying continued guidance growth the portfolio, percentage our driven percentage guidance mid- NASCOBAL revenue in the range. Additionally, strong the of by primarily by year full range. year XX% And XX%

As of the Pharmaceuticals the first noted reflected our segment established of quarter ongoing products earlier, performance portfolio Branded competition. generic

of submission, target and our half to of regulatory launch to Moving XXXX, on on in market program second-half cellulite, approval. the the to track both the BLA assessing development commercial for for front, with CCH appear a continue and treatment a second subject FDA we XXXX

physician we to Endo in XX to between introduce and attend to XXXX. and As aesthetics XX congresses meetings community, part plan expect our the of medical

our data will recently Orleans This Aesthetic Society of the Hot Academy at X conference. Surgery was upcoming at data presented also Conference Bass. American American Dermatology for New at Phase Lawrence Additionally, by highlighted Plastic Topics in Dr. be the

with of XXXX. pleased are in in the peer-reviewed Phase first the quarter we Additionally, our X Surgery Dermatologic publication of data

deliver XX% versus of contributing X, authorized million. XXXX, driven in segment net sales net of with to in ertepenam year. to the Invanz, the XXXX generic sales the with Also Turning growth sales million same quarter in XXXX. of of ADRENALIN by $XX injection, Injectables XX% net performance to with Sterile sales $XXX This of of $XX up a the quarter, to for last were million, was our net continues compared XX% quarter VASOSTRICT first period the versus Slide of growth revenue with of increases growth in first the

Injectables benefit, sales net anticipated VASOSTRICT benefit timing result While Sterile shipments. the a fourth net the the of the included first sales we of quarter, drag by a XXXX the quarter driven stocking Injectables of unwinding a as actually Sterile on in quarter stocking

additional presentation. in related to second quarter. Blaise this in reverse commentary provide this will expect the We benefit our on later

decision remove Bulks While List. we are the pleased XXXB with the FDA's vasopressin to from

product is As meet is outsourcing vasopressin compound Currently, sell to only an a result, requirement. product. for unless unlawful the they using it those to vasopressin compounded products facilities now this products FDA-approved VASOSTRICT

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

products for to quarter the X. on pressures last competitive of segment Turning the the Pharmaceuticals competition the versus impact anticipated generic XXXX. reflects offset in had in this period first of during performance Colcrys. product generic revenue launches, of benefit authorized of the decrease primarily year, was same limited Generic certain partially first colchicine on the our Slide that This the by quarter including The tablets,

be affirm XXXX. guidance generics on our quarter year product in to be to in a a launches our call, XXXX number As key portfolio fourth year revenue margin of mid- we full percentage competition transitional high-teens to- we materializing contributors XXXX noted with larger expected for expect generics for our to earnings We decline in range. late on the

segment performance products. the generic X, to our ongoing in Moving impact of our shift International our sales as Slide business on competition of reflects timing Pharmaceuticals and Canada, certain on expected, in a

guidance full affirm our International declines approximately the we year revenue XXXX, For of to XXXX. compared for XX% Pharmaceuticals year full

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

our We And pre-commercialization second activities commercial regulatory to remain the of Cellulite. progress on and continue for CCH half for XXXX. through for launch track in

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

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

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

of or the late to continue bottom market The agreement file Nevakar opportunities. the Slide X key first our to first of first in launch to table XXXX. disclosed We expect on on shows some our future

Let financial me and the over to the first XXXX company's Blaise performance guidance. turn financial further Blaise? call to discuss quarter

Blaise Coleman

morning, Paul, you, Thank good and everyone.

snapshot Slide financial covered results. segment GAAP you'll a see Paul revenues the earlier. of first quarter and XX, First company and on non-GAAP

So I that review not again. will

of mix well on reflected quarter, reduction expense from lower continuing share On net we adjusted an by adjusted was in versus same in performance the gain asset driven slightly expenses. GAAP On loss March to and of first of by quarter basis, XXXX. earnings than operating was sales was authorized million refinancing in of generic effective a the the of tax $X.XX diluted interest margin the an primarily higher compared income a in the the a by charges income first XXXX of $X.XX, due per products rate, $XX loss basis, loss operating strong adjusted operating million quarter expenses. share our XXXX adjusted during in GAAP adjusted in to gross operations largest from reduction lower related adjusted higher a and to lower $XXX XXXX. The period year, overall operations operating quarter transactions, improvement $X.XX impairment debt diluted GAAP $XXX in share the the had million, driven quarter the previous per continuing of as offset first per as and the

Sterile the noted adjusted the quarter in quarter. Also As - Injectables quarter performance effective was to to rate the of of to income favorable net the in first levels driven $XX quarter volumes stocking price sales second by inventory not the fact, and we lower the by as our our higher-than-anticipated And million. XXXX estimated we by than to were first levels, mainly We in the in towards net year Sterile be in on was price. year-end Injectables year is benefit which as to the tax full with the customer above was quarter quarter revert well quarter an highest a in pre-tax as our projected channel the primarily lower Injectables better quarter first by in Sterile contributing quarter. quarterly to first And the of second estimated XXXX be end rate the driven XXXX stocking million non-recurrence the reflects well mix now the performance rate. sales anticipate expect VASOSTRICT de-stocking call, the due a and $XX our benefit This to the due adjusted de-stocking net did expected better-than-expected second net historical jurisdictional for occur. quarter. mix first estimated net quarter higher higher the there actually segment. On average sales

the second summary adjusted flat the with be higher included related compensation first expect Additionally, remain quarter XX non-stock Endo's due adjusted year expenses. total will a second guidance. a of full relatively to expenses in expense XXXX operating Slide XXXX. quarter quarter-on-quarter quarter adjusted portion EBITDA financial of while increased provides operating the A we

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

adjusted and and to weighted our XXXX the revenue, more tax be In second cadence. expect of anticipated adjusted launches. revenue, half of in slightly of new adjusted revenue operating earnings expected we per expense due second reflects adjusted EBITDA, enterprise XXXX split the timing half quarterly the effective to terms total share to XXXX rate higher The facing, expected product

prior ended approximately XX, the discussion, of debt this Advancing is cash up to XX, and payment. net quarter times. discussed. of of had specific Moving cash the product leverage billion first the previously million of to $XXX and unrestricted segment guidance and to We summary Slide a unrestricted we EBITDA financial XXXX to $X adjusted XXXX quarter wrapping X.X a Slide with debt use first ratio approximately a for

impact This XXXX unrestricted the we for million, million change to million $XXX cash from We payment cash the XXXX. $XX the March of to of approximately guidance our before. $XXX of expected in in of debt executed reflects are updating use debt use to refinancing $XXX - range of million prior

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

Paul Campanelli

you, Thank Blaise.

to to the achievements levels. and date on focus XX in execute many concluding of steadfast presentation, today's all we of Moving proud the very teams to Slide our are

capabilities Injectables taken be our have will Products the needed enhancing future. to aspire and Medical Branded our the on over and become the Sterile We us for we believe focus Specialty our well to We to portfolio, continue including long-term. actions take the company that positions Aesthetics, in

take highly will to maximize assets when of focused a portfolio. capital growth to prudent the drivers our We'll our to we comes our decisions. We continue invest allocation it value to optionality and how key in in and maintain our approach continue

path goal. the EBITDA in building our by lies grateful and commitment ultimate hard aligned work. with our allocation need The set grow However, of for to Endo our capital ability ourselves priorities their are investing success this in and we to the I'm to for future. adjusted we for colleagues all have portfolio

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

Laure Park

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

Operator

And Markets. our Capital Randall first question Stanicky with comes RBC from

You may proceed.

Ashley Ryu

about is Can more pressures my ramp? revenue you for with Randall. And little about more Hi, on a talk competitive for taking trial good XXXX would a you have December. transitional ADRENALIN? and expectation a around as your expectations little your as year? in XX-months in then I questions. and about overall you Thanks Can XXXX for new kind talk your expiring Obviously, bit stay Thanks. the a grower, you of Does a of imply believe, it's morning. bit bit little abate, launches nice also and product talk July, a This you in Ashley that just Ryu your that? the stability

Paul Campanelli

sure. Yeah,

little beyond XXXX. light I too going What not what would can a probably ADRENALIN. on maybe I we're So to go shed with - to respect deep anything

X have respect now, called a an to XmL the that market. presentation. Paragraph market Paragraph ampoule. XX% filer I to tell our IV milligram you IV is would the I Belcher. is presentation, that trial pursuing. is a on in with of is controls another a our believe intellectual on different we that that filer the a have X look which about on company has filer share than Right about control the There that vile that at we XX% we're property. company product respect mL, that, with embarking We When of the That the We already market that actually developed

we're $XX we to presentation X believe $XX focused. in where much million the mL million around pretty that's somewhere sales. that is net So - I

we're on launches. think in stick comment new of to really that's I in need later what the And terms dealing at to And as - ADRENALIN. more I we'll XXXX we're we'll XXXX. with how IV So at this Paragraph comments, said, time in regarding we'll on our just time looking point

Ashley Ryu

be can one sneak a period Sure, just visibility be what there of filing it that thanks. for typical what And you BLA be separate a get of will strategy? in CCH the that? could whether get BLA that just different think more, At of you it filing that you before if filing, kind Thanks. will accept within or clarity I will on more little said point, to at this the kind kind more point the around agency Will acceptance bit pricing.

Paul Campanelli

Yeah, sure.

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

we're as is I of indicated, half expectations a more that add latter And very prepared my our little we in As can continue. in we Pat, we BLA our indicated XXXX. in remarks, filing maybe confident that will color. you expectation the And, will a be

Patrick Barry

We agency, just had BLA Yeah. as productive and we've has appropriate the regulatory Paul pathway, to the Sure, very be again, believe Paul. said. - discussions with an

well. patient products, distinct two the of two regimen Regarding there treatment differences inherent the terms are the of as profile products safety indications, again, in and populations

we've as thus that second had far. the And on interactions based So for right we track, submission. those our confident Paul the reasons, for with call, on said confident the that we're very submission the in We're regulatory are on half. in agency

And file. get a then terms be obviously, we upon with again, in point. But filing, we to the So will with BLA submission protocol how at to agency. we incumbent position go discussions that agency would between obviously, those be agency the and we Once maintain submission all to once will the submit actually of agency. systems And our once it the and we'll keep communicate. it upon file we this incumbent better in be then want communicate, we file and the the discrete the

Ashley Ryu

much. so Great. Thank you

Operator

Thank with SunTrust. comes Gilbert And from Gregg next question our you.

may You proceed.

Gregg Gilbert

going any question on did this recent And you been there the part up Amphastar points see my else potentially and for or sides maybe you ADRENALIN Paul, brewing external know here see the on progress scenes you franchise, as questions. important you tied remaining in the good sue is Hi, discuss there have it months. to the I Thanks is how comment you. you that? opioid way. them. the Can on second their no and Is something therefore, big different of there? data fundamentally as on not light more not product the shed filed two more that morning. behind some of the sides But responsible or Thank the get could overhang. part in the about substitutable

Paul Campanelli

Thanks, sure. Gregg. Yeah,

respect - So, I our opioids opioid that aware, we there no I had mean, really with I'll think, new there remarks. just the update question take earnings prepared the last you're first. as since And to is call

know scheduled reports the is believe in what we I the what's in it's again, public on domain May, is and first XX. press the Oklahoma as trial May for So,

not part that of are We trial again.

is as this that's for Track of we I don't same that October you we in would time. understood. QX, in at well think response XX. point if I the said back tell part we scheduled X Track X And know are

We out have have way if there Track dialog with continue to and settle X. a is plaintiffs and to

to continue should X We that Absent Track we are we we settlement do October, that. for into prepared. the prepared trial, enter for are

I think today's accurate that's can with is facts. probably of get set we as

I not to mL, asserted on your the Paragraph previous have respect different you to us a on question our situation. think a intellectual we different we opinion a little file bit this fairly to property had folks goes Amphastar. intellectual Regarding first And X well. filing, the property with very ADRENALIN, so our IV we would bullish question rights, than the If did really know why with sue

Again, submission, this say also should reason little sue, submission strategy, us is we market on rather. stay allow a should XXX(b)(X) have longer. the to a I didn't ANDA regulatory complicated which we bit Regarding a the

resources to moving spent probably the of challenges the that. on there are with of as lot applicants. regulatory that I respect That's it. can we XXX(b)(X). a with enormous regarding an parts to is will work And there amount FDA ANDA We So go far

Gregg Gilbert

Okay, Paul. thanks,

Paul Campanelli

Okay.

Operator

from question with next Steadman comes our Dewey And Canaccord.

You may proceed.

Dewey Steadman

there guess, in there Hi, And then, going decision? question. litigation there the thanks update couple VASOSTRICT? you'd stocking the Bulks run appeal you. going the Thank million? for $XXX is is some million the in see between for on - of VASOSTRICT, on the to $XXX second I And $XXX adjustments VASO to FDA there at ability or to that million component could appropriate any is on use the quarter get rate we Sterile the is of that March quarter, taking and looking make terms for to compounders and forward an you're

Paul Campanelli

Sure. Yeah.

Dewey, take questions I'll with So in here first to Athenex. the respect compounding

Your is it already it's you that question of being tell in I litigated, right. appealed? terms would

in So it's already progress.

So we're a waiting decision. for

the about X think, or I to weeks weeks X decision be will so.

So that's Athenex on the situation stand where on compounding. we

the are is no, On situation, timing go is update no to are respect there we a scheduled right status, really IV there trial. to issue now, to Paragraph it's with

Just over a from year now.

will there'll appeal that be of way looking May prepared scheduled obviously will XXXX. series one we're will think, for come that's I decision think, And be So an we're that. of at a - of way weeks is That off another, we for last the and that it. I trial probably or

the has IV the material is is no regarding other in So VASOSTRICT. update the intellectual status Paragraph no submitted couple that, been there new certified of ANDAs Paragraph that against our and property. IV. materialization filers there have a Absent of There regarding of

Blaise Coleman

I as just about the a talked think, your in a VASOSTRICT call, and in did rate QX, stocking run we've see on from cadence And in we terms then question, benefit perspective. of specific question

well. as favorable We also mix some saw price

revert more rate normal below think would rate, we and from number So back to be a to expect and would run the QX see normalized that we should there. then about QX QX a run

Dewey Steadman

All right. you. Thank

Operator

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

proceed. You may

Gary Nachman

Hi, good morning.

stepping curious later new How high the speak First, Peyronie's on Thank new four over you quarter? much up executing efforts and And the will just the behind launches in how of seems traction you. generic expectations a be level on year. the product Dupuytren's, and Maybe the about then those getting still launches? contributed at you're just launches a year. environment first of this the for is course XIAFLEX, this new talking could like promotional there

Paul Campanelli

Yeah.

So XIAFLEX do going I'm Gary, pass to what start side. over this We'll I'm question is Pat. with branded to the going to

Patrick Barry

regarding Yeah. Thanks, Thank you XIAFLEX. question Paul. the the for

force. our excellent You out pointed in on see a and execution focus interactions base. focus expand the continuing from a customers. with on That's to our It's continue we to sales quality physician injector marketplace also our

And So then that's what them choice, a an mastery making we've had the that that easy of network, to treat. physician sure we when do for big a success that makes experience there of is can the treatment distributor well. part acquire so they as

not broadcast with through quality So our execution the And year but one the only also we across branded side investments activation on of we're board. to digitally, then television and increase made that around just the seeing unbranded to consumer this decisions enhance direct-to-consumer was continue, media.

by So talked that's been want about And what as result as driven and net which earnings to volume, highly the on saw exactly largely see. in we sales a QX, is Paul call, successful. growth XX% we

the was from driven. at contracture to then see perspective demand, X%. we underneath, that inspect what's indications of at So majority underlying Dupuytren's terms of and happening an And grew both grow. continue demand XX% in grew Peyronie's we when underlying volume

website, to And number course, click-through for the market, just there's are look those evaluate, having the good metrics marketplace. that So us. consumer terms of we're in activity, begin we're consumer what that we the rates sitting good the out qualitative in impressions and our at placing we of of signs in

So good really seeing signs. we're

growth is And we we so on hold potential guidance for the said, Paul firm put there. continue like XIAFLEX, to that for as out there the feel sustainable and we

Paul Campanelli

Pat. really launches, process. very market going Thanks. I go new at product what generic the regarding the at think, in terms in in deep time, not to early would tell We're I We're Thank question to contribution. it's formation. the point Yeah. And you, this of

going for to that we're standpoint, not opine too deeply. really So

the need our we new people to Maybe new out of share laid will terms in launches. in launches sound-bite there put of said XXXX. the is, for product be product as contribution we've I be what that one lion's would patient Now the

AG. albuterol. an a product very an We're is again, authorized as of with with series But relationship about formation. It's early we're to in could at a potentially product product, It's for excited We for which the them of an be it product. generic dental is need little more One Merck. substituted We're market process. this time pass. albuterol

Laure Park

just the in launches. a so for on And just that quick quarter, second One happened get want the late first in timing you. the and product quarter, the quarter, clarification early others mentioned second actually are they're right to but

Gary Nachman

Okay. Thanks for that.

Operator

And Koffler our question comes next from Mizuho. Irina with

You proceed. may

Irina Koffler

thanks question. the Hi, for taking

approval. And on, Thanks. be working definitely interested see they you also or we patients, So want so more to studies understand them get data you're very submit but or after whether the and that CCH of supplement on about going you're not data. the comment injection and the the timing appropriate in you will those to used technique can physicians to cosmetics, BLA

Paul Campanelli

Okay. Thank going I'm Pat, you, Irina. you respond. to let

Patrick Barry

the Yeah. excited. We're for Thanks very question.

already Of meet of about composite of - have podium the of be, course, course, But be ourselves impressive. excited that would data are endpoints we're putting manuscript given with and we I podium in and we But a data that is from aggressive the are program after stringent the a presentations. and available generation would course, this about stringent an have also this submission. data received. results. aim to mean, about to we're X been publications be best well part talked position our plan generation that have. two-point before been the for Phase able sure make endpoints very that And And have those excited that to

going multiple So programs on. we've got

Of give course, the positive Phase will marketplace with so think X make and data X I that will which in an durability rollover regarding impact design, our data. Phase important us durability,

which treatment pharmacokinetic know be multiple have important also work to treating want of aspect going some are We - the will work, Physicians safety work. area. safety some to

completed, was excited validates well. as Very technique, technique we data safety our that which have on our XXX dosing trial, An we'll optimized on injectable with were injection approaches has about modality. it consistent essentially and buttock interesting trial, key just the and that a So feedback. also another our which is enough opinion And validated they injection thigh based this it's trial, which technique. that techniques in outlined leader

that's exciting So for us. really

and real are embarking all focused what generating again data KOLs on that world this We really telling is will trial, be our us. XXX upon that's a

So be the patients, then, XXX that's we in XXX patient trial, and patients. buttocks be an or And on will the younger efficacy focused woman will world non-obese more open-label satisfaction thighs, walking real and today. real-world office experienced design, that into both like launching aesthetically real-world patients which be will in

begin have pivotal about So that X, when to we think the the profile you Phase the Phase Xs.

but type that approval. dialogue our real-world got believe they be the that KOLs remind putting profile we're disseminate investigators of that, Let able and ourselves to data of terms in our filings. to also me And We great had in with with that regulatory and the trial want. submit you physician would a regulatory publish we've that great that's And cellulite ever. for a largest we've our

a really to has works hats program. at hard got we've really R&D program, off the So great Endo, My excited team and who in here about we're it. this very

Irina Koffler

Great.

Paul Campanelli

Okay.

Next question?

Laure Park

Next question?

Operator

Instructions] with Piper [Operator you. from David And question next Thank comes our Jaffray. Amsellem

You may proceed.

David Amsellem

Thanks.

if I injectable on apologize missed VASOSTRICT, this. the on businesses and I So

the that you aggressive and the the the just of Just you Thanks. of of product? of that I putting you think of how generic pipeline a terms mean, over more of you focus business? capture adding market organic and acquisition be us of in some you part potentially years. is I over I'm question filings vasopressin to the then that more And for long-term? talk via the also pace can get guess, better as next injectables terms And about to on secondly, diversify which other Can approvals pace the can files extent, can sense couple in products runway the on growth look aside, get give a color of XXX(b)(X). you injectable trying volume injectable regarding filings - the of

Paul Campanelli

Thank David. Sure. you,

terms star million my So VASOSTRICT. you about tell trend. of X.X on historical in is I to would what that, X.X being market grow would of the in the understanding able to with That's vials. pretty much I million

we're growth only is this low-single-digit. be that going to the volume Now finding is in product what particular in the

So And from I this unapproved long been probably - we from XX volume think, here. months it's sources maximize the converted standpoint, has situation product back, that again ago.

just pretty maximized think, again seeing the situation, volume I much single-digit we've So small growth.

we what - about terms at other game, back is focused Regarding you new we And were approach looking taken years pace, a pipeline color how in we've many ago, on along volume we a are went if companies right. products. with have several of we're

XX Our file what has was environment changed. applications to seen that the and we've goal is XX,

your three question to our but is program frankly overlapping injectables, is specifically really R&D Now segments.

current Our not strategy, We're from really ratio we've this looking over the so. generic side. communicated dollars say or retail anything last our injectable the the it's current, R&D and to new the months XX side I at of

on XX target about are applications to We year. per file

just core we going Injectables, to see products through But last are going at in look see retail Now be and is to where I side. we of Sterile we communications then to And terms you going will towards so generic lion's how Sterile towards value on Injectables versus tell question acquisition. where Endo, maybe can and adding your we that's our for growth we lead the haven't share create moving quantified be how the how because many of majority Sterile Injectables.

our do So capabilities The provides Nevakar again, today. the to and we are not which reach of products we deal. in extended Nevakar have incredibly proud deal

trying So are them to into caregiver. into the different products this standard get we whereby to the really patient injectable presentations, is taking putting

an and critical room-type these in want So to are They continue Nevakar, as are previously we area and products. is targets. This we care At the to work we the that into emergency add process this well. to with communicated products time, category. particular same that are look

through our ourselves Mumbai, increasing We focused our injectable development research are capabilities program India. in at and Endo here

is we our and in up up So [AR&D] are that in and running India have many aware India. our R&D people - [ph] running

with Rochester respect timeframe, will XXXX India, program coming be own supplementing and to XXXX the in our R&D internal our coming applications our development see to which at current facility. out start of You'll

just M&A, with to us internal products help development a capabilities and vials, then acquisition, we And are prefilled syringes new have product presentations. coming going going you're program product out of that Endo. it's the clearly heightened So and I'd see say to

David Amsellem

All right. Thank you.

Operator

And our with Ami next question Fadia comes Leerink. from SVB

You may proceed.

Eason Lee

Thank good for Hi, Ami. taking questions. is Lee for you morning. on Eason This my

sort exclusivity that on the sort you're was of on key Just and mean is products for we decline range. should which certain expecting come year-over-year of Does of quarter, loss about haven't yet about stabilization sort of maybe generics, sort continuing do that sort that the of of this guidance expect XX%, this U.S. you to of just take to of you are see forward? sort generics, forth And the bigger going sort and picture, see maybe - how year? Thank U.S. later within then marketplace this in you.

Paul Campanelli

Sure.

So questions, this I'll and stabilization to Blaise. I'll take over then it pass

of portion how it. looking the at Regarding we're financial

how to in here frequency It's period how we were explanations terms and with kind I go am a I'm things have is, of retail in now. to first we on what to time. And that mini-bids, would words of want to when section, of pre-XXXX stabilization in That's We more really used be we've the normalization, what a respect we're careful a and generic you go pre-XXXX, of right versus choose words that nature. I our of a time cadence normalization So right. maybe right offers, of frame. that calling here saying things back saying of

So that XXXX seen and and these seeing XXXX had maybe swings shifts - we're to portfolio consortiums. late due we that not changes in we're large and large,

first it. as the communicate much right see Keeping the standpoint, said, the we and that mind consortiums we of portion my mini-bids. from That's challenge how that's of are normalization refusals the So today, in bigger. the

you generally launch plus. to the three you changes XX% win lose bids, you holding product, So about product bids, in whether swings how impact speaking whether a consortiums

to need about, You're be to we going right. That's swings. cautious material what

Blaise. or stability generics And much of segment. results cadence, to things normal the what material, normalization think, to to frequency So over we that that's see course I'll about were careful we're is what be pass in a the but second of maybe happened the that I more the need aspect the question and starting or

Blaise Coleman

for performance. the Thanks for QX question Yeah. Sure. on generics

expectations. in in consistent So the new late be the will our QX the about going Paul launches And generics That are run pressure that competitive XXXX. revenue with of be internal between rate call. we've But performance noted will guidance, by generics the as does product midpoint you to continue annualized of those spoke then to terms our year. significant guidance saw in pretty to earlier partially in that relationship of QX some see the the our with opposite sort very throughout offset full year imply

So that's you the playing really there. dynamic out see

Paul Campanelli

Next question?

Operator

Louise from Cantor Fitzgerald. comes question Chen next our And with

may proceed. You

Sudan Loganathan

in This Thanks Loganathan for Yes. is Sudan Louise. questions. my for taking

first And So to pricing be Therapeutics - if other Dupuytren's the development Peyronie's changed kind are secondly, can great? how and for any how you in as Peyronie's development how be that the than of any effect, plans business XXXX termination other will future formulation And or Thanks. or elaborate different the for well cellulite from of pipeline any be is, timing and then if treatment? XIAFLEX question advancements? the the the similar Dupuytren's for Somerset indications? the on would acquisition of, business on is and And

Paul Campanelli

of previously disappointed Somerset and terminating, products. CCH Somerset we a the the I the provides while formulation And ready-to-use mentioned us XIAFLEX on then would and on take I'll goal. here, deal as we I transaction Sudan, Pat. with So presentation to just pass I shots question, were have portfolio in multiple think, the say, and I'll always Nevakar over

to very grow and that's want again important area to untapped area an an that us, in. So we

the out acquisitions time are and/or business fit corporate Our team our to working small strategy. all for going products with potential is that development

when look business. our going going and agnostic be Sterile Specialty it's where value to that, our the we towards are lead We view across towards can that's area. focus in normal The to and always business our build value segments, we create

opportunities, so will got of full Mumbai strength we said our we we in allocation. and And BD is always have we execute maybe here may proud is at and just I'm earlier back program also has running of what R&D on and both where So capital at India, be as a and how portfolio look up our that I that aggressive very mindful in some we're in Rochester. today, evaluating,

and see shots over the start to two of goal So on think pass from in middle an being I'll to R&D Pat XXXX. I And for With formulation the starting applications that, question filed, fruitions of the XIAFLEX. CCH we'll standpoint.

Patrick Barry

for thanks Paul. the Yeah, sure, about cited as talking Essentially, the two different. Yeah, you question, formulations are products. you're different

proprietary. the is to want much keep it I is a treatment contain, they volume presentations, the at high formulations of obviously So some different excipients, different different. somewhat level, But contain because for they're this

so And implications, as right. there formulations with result clinical different is a

presentation And appropriate a this, different dose products, submission. So important correctly, to the is presentations of that's inherent BLA but patient indications. not to have the these that to is two for not be submissions the based populations different. Presentation or the but differences. wouldn't safety why to appropriate on much is two play are there so separate different, it's it out to those understand it's within only Again, important allowable obviously, separate a over-dose, under-dose transferable

our on. based on based that's regulatory what - strategy is So that's

the points different. able We operate to appropriately that markets. in that price understand to the to understand And are completely medical to markets the price we we be so, different. the And like are aesthetic feel be freedom going we have

doing of what's aesthetic got In point with I you're us. So reveal cellulite. CCH will market Obviously, the to of price price now right - honing for and surgeons dermatologist we've point. qualitative really the and some and medical both - and plastic as between our really time we physicians an launch. we're abundance on reveal the quantitative we price you the meantime, And in point research launch upon and other think

Our and a as an the an that we be for in communicated is sweet-spot FDA we injectable of we'll again, continue not cellulite, aim, there injectable is that treatment by for today. is the product approved there reminder consistently the to understand marketplace

would should so, a remarkable be approved it breakthrough. And CCH be the

consumers physicians. scale so, we want and that to And medical appropriately with from adoption understand wide both we for that, aesthetic would price

point so, And do for spot is to work to that to we're what find that sweet going that determine wide-scale adoption. price

to so, And get price price we too but what would it's closer really be launch, would about talk specifically to that point that soon reveal we point, as today.

Paul Campanelli

Next question.

Operator

Tirika] comes [ph] question Barclays. from next [Rifi with our And

You may proceed.

Unidentified Analyst

your business questions have secured your include and is Can questions, on asked. that under what couple you you're update an How does been today a just doing? revolver? give have Just of of you quick my as what of as most available us capacity

Blaise Coleman

Yeah, sure.

So $XXX around our at today, our looking capacity secured is covenant million. most restrictive

- would for And revolver that today we the that so amount. access could

Unidentified Analyst

And there behind out assume had Okay. the point you open then, that still going this case. safe of to favorable Pennsylvania are it you're rulings some are mesh mesh at through? that you Is or lawsuits trials

Paul Campanelli

we calls virtually So cases. all several mesh I known resolved said what probably we earnings ago, think had that

on say, probably our of lot So a seeing side. that's where left I it. not activity will We're we

that So virtually are known it's - us. all behind is we'll mesh previous virtually - mesh cases stay behind it's that - our comments

Unidentified Analyst

then, a trials? the on their update of to And know But is two with I on bench VASOSTRICT, regards you there Endo filers, last the going question have just any the starting May Great. next year. just trial other

Paul Campanelli

Again, they'll that think be right. case, I in enjoined probably particular

on So the and within my main the will understanding is mL XX in Sandoz enjoined the be that follow-on the - timeframe.

Unidentified Analyst

you. thank Okay,

Paul Campanelli

Okay.

Operator

question Citi. And from with our comes Abraham next Liav

You may proceed.

Liav Abraham

for a perhaps ex-U.S. Good for you bit And can bit launch. secondly, then, you the morning. approval Pat, currently opportunity how Thank you. CCH potential and investments cellulite. about little a thinking remind prepare launch as you're more about, behind just talk CCH of you're can the little and about making you

Paul Campanelli

So, then first pass question. it ex-U.S. regarding the Pat, maybe back and to take I'll over I'll the commercial Pat

ex-U.S., we're options. what simply evaluating our we're doing So

which commercial markets would we our and team ways development appropriate. business certain in if Our are looking that teams partner at

So market we've research. done, expect as would you

bumps half go to of after the to second submission we'll target could front into is. in the and to want situated U.S. material us. expected that pass focus Patrick. international don't then Obviously, to heightened we series we We'll BLA then more communicate where to We've just it over the about let, We're be appropriate U.S. need discussions how that the a focus focus exciting that, road the any the excited international on do. have at territories and of I've side. on on we'll the But I'll and is so year. forward international do get I move create really ourselves to look and We this for could on our be clear the that got is the That's raw can got market. work anything the With

Patrick Barry

Yeah, plethora We've to last we introduced Endo introduced had team he's a We got of started board a where on experience and of community, aesthetic with marketing hired really activity. Endo. Catlin of thanks, Yeah, medical a been Paul. sales of out Aesthetics. our Endo activity year, lot and talent. the building aesthetic lot Actually, we've medical head and his Rob credentialing

quant you We're at excited at is be support the to year, of We'll boards, begin which to sales aesthetic some be qual with our finalizing Aesthetics as one leaders rolling know physicians Paul leading approximately and we medical and this market. and footprint. materials into commercial territory hiring the call. Aesthetic official engaging several an out that branding So leaders ASDS, Endo XXXX, meetings. as premier plan. I XX significant the as we'll get We'll pricing the on research late we've and our that mentioned around out thought In build we mentioned Endo campaign meetings. and doing XX in as advisory already our about got

as regarding full come physicians of team get And cellulite begin we're science market Endo the the prevalence, will - the communicating with unbranded into launch, structural closer we properties in early and the XXXX. preparation. sales recruiting commercial around and XXXX, the course, force some on Aesthetic getting Of be as communications to great again will

campaign. then, late education spring in importance XXXX. and in understand an to begin of to to to unbranded influencers will and likely provide media consumer early education And the We unbranded in will begin we of fashion QX out - of summer or be begin And and reaching injection unbranded we XXXX. And likely - also training.

injectors at mass a and the medical towards driving aggressive And so, prepared great very appropriate that outcome. patients injection in to a create training critical program we've would targeting that can launch of be we on aesthetic focus got patient

you'll plan will look us to year. XXXX. So for to can congresses And in to that prominent continue the we build a you and - And we that medical at place. terrific this we'll medical meetings in - be presence the and continue got more of build momentum

infrastructure is launch sales investment associated with I it's that a support can complement with to with think that to important What obviously and CCH medical the on internal aesthetic have to our there that experience launch for lean marketing injectable understand we continue that. we also cellulite. to as successful commercial as necessary product an

Liav Abraham

Thank you.

Operator

conference. any turn Paul concludes over remarks. gentlemen, to for Campanelli Mr. of call may proceed. and I you now portion our Q&A Ladies this would to back closing you. now today's the Sir, Thank

Paul Campanelli

to excited move start us. want report out are new a interest Yeah, how we everyone's the us morning year I solid appreciate here just to forward QX, saying all. we and by I to of want great a on updates we that to for say close with for as very thank thank you you We forward providing the and this company. to look support continued you. joining

Operator

a have for you may wonderful thank gentlemen, and conference. Everyone, you This and today's attending Ladies does program the conclude disconnect. day.

Endo International (ENDPQ) 9 May 192019 Q1 Earnings call transcript