ENDP - Earnings call transcript Q3 2017

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Operator

Good day ladies and gentlemen, and welcome to the Endo International Third Quarter 2017 Earnings Conference Call.

As a reminder, this conference call is being recorded. I would now like to turn the conference over to Steve Mock, Senior Vice President of Investor Relations and Corporate Affairs. Sir, you may begin.

Stephen J. Mock

Thank you, Shannon. you financial us results. thank third discuss and XXXX quarter afternoon, for to joining our Good

Blaise President Joining Campanelli, Executive and President on and Executive me today's Chief Officer call of Officer. Chief Financial and are Paul Coleman, Vice Endo

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 www.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 investor and

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

Paul V. Campanelli

the impressive report today's execution the thank once This had quarter slide that In this contributions of Specialty X. growth. operating release and we company's a business Branded on Endo of from issued core Injectables Sterile pleased Good for solid quarter, chance Steve. you, again you hope for the and Endo to review third very afternoon strong our you is joining resulted from areas our afternoon. and performance. that expected another earlier earnings benefited performance to I Thank products in call. Beginning operational focus future units. of us

agenda brief today's a Here's for call.

Moving Again, increase Branded very Endo. operating pleased operating and portfolios in growth expenses, and EBITDA in quarter Injectables Strong performance. our margin, X. Sterile priority with third to our for adjusted we restructurings, Specialty from announced savings key a including are the drove slide and adjusted EBITDA lowering previously cost

EBITDA and EPS our to We discuss that are expect reaffirming EBITDA upper our diluted ranges. guidance We EPS the end that reach we will now presentation. adjusted achieve in revenue, and adjusted guidance adjusted greater in will diluted detail our later in Blaise adjusted August. XXXX provided guidance XXXX of financial the

the quarter. to Moving revenues snapshot of see you'll X, slide for our third segment a

U.S. segment, by business and our of U.S. areas third previously announced the products communicated Healthcare the Group the Sterile the generic impacting grow previously course and Similarly, the OPANA our well expected, industry Specialty Litha digits. like the I'd Injectables of core at double Branded out reflects each to quarter. sale Pharmaceuticals strategic to within by point International of ER. of that focus, As beginning documented pharmaceuticals. continue overall Generic shipments divestitures and pharmaceuticals accounted overall was products, continued ceasing now impacted generics for performance the product by of established for competition Branded headwinds in decline U.S.

February. dosages. declined In Sterile guidance line growth our XXXX, the declined the decline provided compared driven million strong launches we U.S. in base by Generics portfolio to with X% strong quarter. Now, offset new was performance business quarter, generics business in U.S. X% third digit our in Year-to-date, in $XXX slide moving revenue double partially Generic pharmaceuticals quarter to to of Injectables. grew our X. and Injectables XX% in alternative by approximately Sterile third third and The base

The third with as in erosion competitive well discontinuations. XXXX of events, quarter in events, Price XXXX annualization our resulted expectations. part as be the continued product line to competitive from the in performance third quarter

alternative by We're results launches impact as of LIDODERM-authorized potassium far. of generic and the powder, vigabatrin on dosages solution as liquid August growth pleased X%, ephedrine pricing declined continued oral achieved was very with partially so sulfate as the lower for and launches, launch Injectable our the and encouraging chloride and as New Sterile new the of well offset neostigmine. such also

XX% year. in Vasostrict Injectables achieving a Sterile sales project well Vasostrict, were its of year-to-date by as increase. $XXX versus Sales the a revenue powered as increasing continued to to reached continued the prior Injectables Adrenalin Finally, Adrenalin. mid range. performance, sequential growth XX% full Sterile of year we on quarter, the increase of strong million, continue in of uptake the XX% million Based growth $XX our low momentum,

very I the Vasostrict. Now of before to around succeeded have that defend predict to of I in Vasostrict, of ever financial received the nobody pending our we believe pleased note three I moving FDA in while product letter franchise intellectual on relating patents. the you that lawsuits with Vasostrict the there intention outcome durability am our or of to property. not aggressively It patent to next can We've merits whatever level litigation, IV and including necessary securing those is listed quarter. any Paragraph Orange consider the firm third respect a the to take five our notice QuVa and portfolio. Vasostrict is patents in to I uncertainty we the Book know tell our want I community some in slide, And of our strongly with appropriate Separately, actions against

launched filings the to products including third Par two turning quarter. non-regulatory also X. XX slide Now, We've submitted first-to-market year. in products has Year-to-date, this

of expect launches regulatory We a number submissions XXXX. XX in similar approximately and

Moving to slide X.

Branded Pharmaceuticals. U.S. discuss Let's

products XIAFLEX our strong We revenues continue specialty our within other be product products primarily XX%, growth Branded and portfolio. with product pleased driven to Specialty across portfolio. the specialty grew by

BELBUCA. OPANA were continued the high STENDRA September teens X, is U.S. shipments our Overall, products XXXX decline the to year the XXXX and year. Pharmaceutical established by year remaining over the ER branded generic full percentage range competition decline to of to products expected, due mid expected As revenues divestitures impacted pain in of ceasing by Branded of and

year Specialty double expect continue XIAFLEX to high products our and low We grow range. Branded full to digits revenue to in the single

products planned, extremely executed of that are pleased We to additional initiatives, with grow will the our Specialty Branded both performance and portfolio portfolio. and believe continue

believe have year been results a this XIAFLEX, of of the Peyronie's to date, activation Dupuytren's support consumer Based we double encouraging, in contracture in disease. directed indications. our made both that commitment toward believe for XIAFLEX these growth. to demand to potential are investments, metrics along and increased for professionals We drive we indicate on with sales seen year-to-date digit the the healthcare have very the helping our initiatives and we increased Specifically investment

ample awareness branded continue to and we four-time both Peyronie's disease disease September disease as committed initiative there to which About be The was patients for Facts partnering solutions on treatment Tim rates to both seek launched state for the disease. contracture at regarding nonsurgical awareness campaigns, similar to campaign Dupuytren's is In Curve aimed awareness, diagnosis to and this PGA educating increase indications. focus contracture. Tour On winner state opportunity patients with educate and Hand campaign last for to activate to Ask feel Herron. as PR year's continue We Dupuytren's to that addition Peyronie's XX, well we our is of

cellulite Specialty our be Lastly, very Branded the an in this that the to milestone X we for in aesthetics continue excited important to months. into to launch Phase intend opportunity strategy. represents about initiate believe trials coming and clinical We

commercial aesthetics in is talent commercial launch team. complement planning Our on be with will current already additional experience we aesthetics team our to preliminary working and bringing

on X. slide moving to Now

International Let's briefly Pharmaceuticals. review

million quarter. generic Third XX%, the $XX quarter primarily on previously Litha due of announced third to Paladin's competition established continued increased the performance X% due the as were on of delayed certain as International products. quarter to revenues the third Nucynta and of uptake at beginning XIAFLEX, well sale down

Finally, closed October divestiture the announced Somar previously XX. of on

our attention and fulfilled Litha to companies we resources have our delivered provide deserve. have on and with We divest to Somar non-core that expressed can believe place intention the assets they commitment successfully and

low XXXX divestiture of to two the expect range, to business. percentage reflecting International these revenues the continue decline in We XXs

me XXXX financial our to company's Blaise the over quarter discuss to insight call Blaise? greater the third let further into Coleman provide guidance. turn financial Now performance and

Blaise Coleman

Thank and good everyone. you, Paul, afternoon

operations the share slide from $X.XX you'll share basis, continuing on of margin diluted includes the a First $XXX period of improved per loss driven operations of earnings adjusted from by in impact of of was assets operating quarter operations third expense were million of and third a from in adjusted a to results from the third during quarter diluted of than lower quarter GAAP guided. estimates. On quarter GAAP and the X, XXXX of see continuing of per $X.XX the includes XXXX continuing loss results. operations per of approximately the and in a quarter Adjusted non-GAAP This GAAP continuing million $XXX in expenses. the quarter favorable quarter decrease loss XXXX third XXXX. net in continuing of adjusted On loss of net diluted from we third higher in net XXXX. quarter amortization impact to versus adjusted third favorability gross the $XX Adjusted tax income the in better an million, operations basis, had compared $X.XX from decreased million snapshot same lower share GAAP partly $XXX operating changes expense. intangible and financial previously operations continuing

the the shift fourth one stated due was than to partly underlying and the priorities expenses some spending In margin of through in of efficiency expansion operational there is lower our that We drive better beginning expected realization. execution addition, continuous operating improvement. XXXX in and of into to year quarter

guidance results have indicate actions front we Our to margin This on the adjusted tangible improvements. third us brings are our this XX. quarter on yielding date to slide taken

We expenses, our year respective than guidance. at the adjusted adjusted on the full revenue, the are be ranges. date assumptions The reaffirming EPS EPS EBITDA diluted on and adjusted we financial expect slide. operating now better noted is year and end to and EBITDA adjusted on based to performance XXXX Based guidance of upper diluted our company's expected

payment primarily million of in million the full prior Lastly, working year debt projected on settlements to flow of million. increase the months the first cash to and debt prior in of in in provided we in cash is $XXX flow flow $XXX higher expect to changes The in capital. payment now terms cash nine XXXX had range guidance legal from due XXXX favorable to $XXX slide cash and XX,

ratio to XXXX. leverage to X be continue in year range adjusted We the end to estimate net high EBITDA our debt times

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

Paul V. Campanelli

very pharmacies with I'm pleased yielding committed also populations of operating year. for I'm disease. again, Par colleagues. as Efficiency Sterile proud results Dupuytren's on we Endo. and Once and leveraging allow for with another and of measures contracture launch unbranded specialty Blaise. generic patient the are our earlier our laid model this close executing for collaboration solid branded our awareness you, strategy Thank and of Generics, product campaigns expertise Par Peyronie's vigabatrin disease untreated quarter first amongst performance remain I'm out Specialty through our Branded our hybrid pleased XIAFLEX campaigns targeting and to

trials initiate the are months. in we forward, Looking excited cellulite coming X Phase to over

we year, our to organization. the steps significant past Over reshape have taken

where As stated, be. get ultimately to to to time it require we we've will want

would executed on do. we've Our we what and we priorities said changed haven't

We at control period of continue areas as transformation are to in our a transformation, of on execute Through are relentless I this sector. a in will against we long mid the the we creating those also company only that can priorities. if value focus our to plan execution shareholders. we firmly and be will successful experienced term, not as for we we believe our will over that but

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

Stephen J. Mock

possible initial we the within open you to We'd you, may as allow now have Thank would the in questions interest if us first limit could to Paul. question? the time, your it. Shannon, many hour, lines to appreciate In we the get to like of as your questions.

Operator

Thank you.

Our Citi. first from Abraham question comes Liav with

begin. may You

Liav Abraham

percentage me Good sales guidance margin have your afternoon. expense as a I'm a year full on QX. XXXX question if trajectory. in correct wrong, cost I regarding calculations, an and uptick implies of in Based our

about going little to R&D So please me SG&A wrong. maybe a we into bit Thank can think correct how speak I'm margin that, XXXX? you and if And gross and you. should your and

Paul V. Campanelli

Liav, I'll to pass it over Blaise.

Blaise Coleman

actually Liav. QX. for Yeah, gross Sure. so of Thanks, our in terms implied QX, margin flat with it's

in implied have we what that's So, guidance. our

not we're one relates particularly move going we've is far on we're stated, Obviously drive margin margin of to shaping improvement, guidance to XXXX. priorities Liav, that. to do our track As forward-looking it as and going into as improvement, as be to we XXXX, continue as gross providing XXXX any to to

Liav Abraham

very Thank you Okay. much.

Operator

Thank you.

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

You may begin.

Randall S. Stanicky

you Paul, the and you've the put management on team that Thanks. guidance forth. have Great. been delivering

In end, continues higher fact and the you're pushing the up to on stock drop.

out at that around conversation? enough just point just with these and question, not back adjunct we pressures, the but do become to industry an back as consortiums through at meaningful or managing them, alternative environmental targets And more we does aggressive the hitting need what working there, put to So it's headwinds. more strategic take you point that a distribution, find to say, of step working approach given part and what with the board look, a say we're and step the

Paul V. Campanelli

I or strategic strategic terms Randall, it's question Sure. the optionality so of alternatives. think in

would a shareholder you always out have we looking expect, to responsibility. We're value. ways fiduciary for As there create

So, happening in the aware very last mean so. over I the we're what's or what's industry, month happened

on right. always But screen. radar correct be to that's a it So fit, has the

day, we don't of thing there's focus. there's control. We're not that end the at to we the things control; So going that certain certain lose

we what goes on focused back laser operational are to and We control that execution.

we We QX, think going going doing we've we're good we it last doing. about I the record. we the to feel over And because We've track way basically a file three proven good forecast We're we're are and outperforming last, to quarters. got it. are the said launch. I what

we're and on comes the strategic be control perfect to at improve fit to Randall. and going going looking until that's just ways portfolio, Regarding alternatives, there to continue always we're a what out forth, executing we with

who near we pharmacies. of to They are On them headed. with where if retail launch are a They assume you're the referring there's distribution we I Amazon. that's three to opportunity thousands and defense where going comes would understand with work have conditions, fourth questions the the an to with company a and Today welcome like of new that's a three manufacture how lot to be on side, with again, our you're consortiums, to partners That's to a for welcomed. in pressures future represent consortiums. the probably consortium, to Right, addition continue to once If fourth a partner fresh the look, term. sell Amazon a a to products. with into been is tens the participate of and need hard be terms for Endo. to market, in back that,

I So I hope answered your question.

Randall S. Stanicky

Yeah. Paul. Thanks,

Operator

you. Thank

Our with comes Bank. Deutsche Gregg next from Gilbert question

begin. may You

Gregg Gilbert

if is of you bad, But you about, And some key hurting that Hi, about a company-specific more I'm the could if pressures Paul, would that have signs ask what to another the thing And I broadly bottom, guys. worry secondly, that you Couple, the you liability? this pricing some least call ask do but asking of you litigation, a could not look be how to testosterone seeing very portfolio-specific as mesh-like I outline been at less call price ahead? to could we here. the frame improvement comment. know for big or getting and risk as folks for I that that? Thanks. milestones everyone, it are

Paul V. Campanelli

Hi. yeah. Gregg, so, Okay

– mean I portfolio. it to really really going further and want be gets So be to much do the pricing, gets how in for down to I'm Generic It generic much I'll the participate. to of specific. to Par and bottom down have specific of to how terms for us, kind we

decisions and people on we've products. and made corporate facilities So,

participating that longer in. no going to be there's So, we're areas

again hard defense with going the coming to products. So, to our manufacture be out is

and We have where we away from points those larger are pressures. to seeing move commodities and moving larger price away you're those

So, there's no surprises there.

not year, calling motion basically we're and further. see out, leads the on us, go too Consortium WBAD the but we're at going forward next much for not Econdisc there's bottom to on For Par. We'll a we're room where much planning

mean to be Regarding able ongoing comment going on we're testosterone, I to not litigation.

X. play first not that to We've to we're defensive on I will You're strategy. started able day, end aware got of going November just out. well comment the hearing At believe litigation. ongoing the It MDL the our be

Gregg Gilbert

All right. Thanks.

Operator

you. Thank

next Our Group. Andrew from Financial with Susquehanna Finkelstein question comes

begin. may You

Andrew Finkelstein

ask I thanks year. can specifics products hoping then launches products or give and CONCERTA, but the more generic submissions good not you'll few approved a months? on if assume application what for And Hi, you And question. six these specific variability that since if about the I the evening. approval? for year is and product as us, taking with outlook about of visibility six the authorized could good with was status could a more I Voltaren and launches out the thoughts this or think it before to on expect lot implies give in specifically generic over name, probably we you Gel your any Are the things stability next I think you XX end. there's

Paul V. Campanelli

product we're ourselves call products. in some the Andrew, here. at because we of put first competitive smaller going to disadvantage to them So just don't product terms risk launches, not going to They're want market place opportunities. ourself of these And remaining at to specifically out. We're not are a

company question was? be they're the at your way relatively small but execute. looking me, but you continues And should forgive the So, it, to products second

Andrew Finkelstein

On CONCERTA Voltaren. and

Paul V. Campanelli

Gel, difficult your mean on going we of. it. don't visibility So have clarity. on make aware or on is have V just CONCERTA, we then not to put this very an question is At CONCERTA, time, application. everybody product It I do yeah We're And in very, as point a was? highlight to

Andrew Finkelstein

year stable the the that is authorized seen brand or? over and next as generic, the For

Paul V. Campanelli

Yeah.

competitor point any somebody don't of market. coming So time, visibility into have real in we the this to absent at

going the status you're see players think quo the brand. plus I to two with

Andrew Finkelstein

All right. much. Thanks very

Paul V. Campanelli

Okay.

Operator

Thank you.

question next Goodman Marc with Our comes from UBS.

begin. may You

Marc Goodman

you thought. line second the kind flavor more a than a the SEROQUEL a the to the and down? I little for but like down quarter the item numbers you ZETIA call Yeah, down to give lot dosages/new launches, mean come we can seemed we us alternative movement came obviously, it quarter of expect would just third bit, just

a So, the Like of just do potassium not down Lidocaine as movements. some come help us Thanks. well? the did lot more? Did with

Paul V. Campanelli

It's called hit no, We the Yeah, head. AG. out you Marc, the in script. in the LIDODERM I think, nail the that

Marc Goodman

was much How that? down

Paul V. Campanelli

$XX Marc. About million,

Marc Goodman

Thank you.

Paul V. Campanelli

think that answers question. your But I

Marc Goodman

just and the that responded, year. had question next how asked that? basically you follow-up mean in to out negotiations Are that? then really And just a kicked see you by is was Yeah. did it hasn't we'll about Econdisc yet, Where What yet? haven't pricing, then WBAD works we saying you

Paul V. Campanelli

think, had both there So, from coming initial and I Econdisc requests WBAD. been some

that. I some or So there out call was what included erosion, that called That equalization. XX% initial, when part, we calibration base was

good plan like this is we So, year to One of next tell whether I with time feel portfolios. or on it. by a Claris is respect a equalization having portfolio bid will this meant What they

tell. So, time will

We with finished I What communication. and round will out believe year bids really round probably don't say that just ago up to deeply sector another Econdisc support or we Walgreens. in of I than a is July a have less is we any too with not of considering feedback had came going generic the

XXXX. So, a to going interesting very be it's

Marc Goodman

Thanks.

Operator

Thank you.

comes JPMorgan. Chris Schott question with next Our from

begin. may You

Chris Schott

much. very Thanks Great.

Just questions two here.

portfolio? that question had second this way erosion that base annualized so major are $XXX close cellulite. in How just profitable for the starting So, we're of business year? the XIAFLEX kind on where about to data you is Phase size going at Phase a profitability bit the million of of reaching this just back in sales revenue. the of this on terms this associated we're since changes forward, the the study, a is coming as of to company the point point? was that that elaborate you duration X, the maybe study, Thank a business, or approaching lot the thinking we of still successful earlier is in elsewhere are any there First kind relative or with Xb the you in of just getting of Can the a And you. margin

Paul V. Campanelli

want one? You to take that

Blaise Coleman

It's Yeah. Hey, Blaise. Chris.

segments meaningfully gross it question. second the part there, margin in for On second our is that to the generic It below we've XXXX. got that

Paul V. Campanelli

of Yeah, and we that number patients we now. didn't disclose the have

terms specific the of of the we So, patients. I XIAFLEX think right haven't Chris, disclosed trial, now number in

right discussing think similar to it's X now be Phase mean, Phase what going the the I to the we in overall I program with X. FDA. still say, nature we're and

So we're with about the for little in FDA. patience, ask discussions good still feel a but we're going we it, but to

Chris Schott

Great. Thanks very much.

Paul V. Campanelli

You're welcome.

Operator

Thank you.

from comes question with Stanley. Risinger next Our David Morgan

You may begin.

David R. Risinger

wanted and color much very follow-up to the comments. and Thanks of actually a high ask level I thanks all for question.

not margins pricing, still Paul, is So, or you ex-U.S. when trying negative to that I'm thing higher that support industry the it's but say be are lower that comes U.S. much won't be the are to not generic mind they supportive, than

of can't that small exit action they buyers unprofitable so, And a industry Street the the when But guess other is, see take for a are you more pain question country certain that think they I my exiting taken I exit that products can get action very SKUs supply the such larger volume clearly products. which players in the think of exited have causes to will need? industry you've and do and number some to percentage the

Paul V. Campanelli

Yeah.

David R. Risinger

whether development Could just a a or you with currently more on that alone? table on There's to exciting. aesthetics still specific, partner second, to is Endo, opportunity Endo cellulite more company been years then an the speculation help it going is planning lot a Thank would possibility significant And to and that whether you're you. specifically quite for of fund commercialize in to manner. the speak

Paul V. Campanelli

in the broad. of Okay my so, very is high generic level on statement side, the terms David,

I measures believe to I'm I Par has isolated is at that the that taken don't that regarding looking think Endo there's a only Par. couple it. ways

it you're you and and back decisions, just lot plants. I so message. when you difficult product back at when just I manufacturers, U.S. of from those you're sending think and you other of look and these And people when lot companies producing back I'll speak don't and turn a a – product, very on. primarily in walk the make U.S. a products away a are when for make it's into a come decisions, and think to with product, you come dealing Right, you

have are high, where it's You that the hard some volume. drive getting that offshore you to that can it's are that slim points looking these regard. to the may say business companies still ultimately, price in on they're so point margins But while are to grow your

I some you you think the shortages that future that to and products it out That's wouldn't seen surprise getting start drug ago XX come price in have view. you're on consortiums. my just the see me from that commodity of pressures years these might because

think it's I possibility. a

been optionality. think to always partnering, pretty cellulite be clear. I Regarding We're open and to going I've

we're talk XIAFLEX will cellulite. to as able to it be will talk maximize partner calling folks people us CCH We or or for that to us and to to want with

in this going the but At we're we are trial. listen, it point course Of to be to X about has time, Phase excited fair. incredibly

We is are can And for the to success. are all of talent forward. bring I the in product recruiting tell we planning process you

David R. Risinger

That's Thank very you. helpful.

Paul V. Campanelli

Thank you.

Operator

Thank you.

comes Koffler Irina with from question next Mizuho. Our

begin. may You

Irina Rivkind Koffler

could see taking wanted scary it question. frankly, be people. for get just to our what litigation the just arms tends to around is. of range that is The the And opioid if we risks Thanks Hi. quite pretty I

it marketing a punitive kind Is branded such else? period into of Can you products time? OPANA something a off little buckets? help understand label criminal? or Is on particular bit over it just Percocet it of and opioid And something and it more put us your more so, is as

Paul V. Campanelli

Yes.

Irina Rivkind Koffler

with XIAFLEX, is you your first are Phase if of formulation? question any Thank you X? do before start you. question. work different will the second coming sort so, the out that's to So And And on still you need bridging a

Paul V. Campanelli

litigation. respect, think moving able put I we're litigation. going that pending not the when to to comment be it's Irina, headed not speculate into our are opioids, we're and we on to towards So, policy With simply

what allegation of public on That's Your specific question is, out in practices. that's in terms the domain, marketing known. so the

the do would formulation was a it to I bridging that not in new believe requirement. be say a used going but formulation. It's bit the Regarding XIAFLEX, is I basically, different Xb, that is any Phase there's

Irina Rivkind Koffler

Okay, thank you.

Paul V. Campanelli

welcome. You're

Operator

you. Thank

comes next Piper Our Jaffray. from with question Amsellem David

You may begin.

David A. Amsellem

Thanks.

couple injectables a business. just the on So,

They patent of filing that secondly just when we product. their a might then generics? adrenalin come protection you back. back? the that So, be have the we And but that back but see Amphastar IP should would any IP beyond looking something you for can Adrenalin, certified you exited not do inherent on your barrier aware think market Book, that beyond patents about and just obviously been going to be think reason there to vial in the Vasostrict, the on you you might why is just exited Orange PX. is mean companies market on alluded – they're anything just against have there the I to product come

get you I start when So sense may think a for Thanks. competition to wanted there.

Paul V. Campanelli

Paragraph we Adrenalin, have a already on IV So, filed.

the that a litigation a intellectual as we're with Book Paragraph in know already patent, submission wants of patent, Orange in Anybody the we So, forward file Adrenalin that, come to and with have property that respect to filed one IV. intellectual outside to company. on make you

We a are was obviously barrier Book aware And company application listed. there's Orange no patent is that had there. there before that an our filed

that. indicated, and IV clear filed with we've as I Paragraph litigation. in Hospira I And So, pretty we're and been a had think

a IV. Adrenalin, other on have any they forward wants file you Paragraph if that to come will to company the and named company So,

submission going how me. file to if made patents, you've the and question your you're process the to a a believe do notified make you was at have notification if day, Paragraph Vasostrict, a Paragraph of a is, the challenging I I At somebody IV. know Regarding hasn't the you IV FDA and of are the end

our to property. back our it Orange in that enforce will pending innovator, there's of notified. We've be has case intellectual got applications listed. to So, We've and got us, a XX we would that time also come period the five Book patents

time, in and has in this we regarding nobody So Endo regard very confident Vasostrict. feel we're that point saying at noticed

David A. Amsellem

Thank you.

Operator

you. Thank

Wilbur Our next James. with question from Raymond comes Elliot

You may begin.

Elliot Wilbur

Thanks.

or by in deflation just which a the to the the share future, Amazon of that pricing much Paul, follow-ups. or question owning so business today Paul, market. has is other couple distribution going we're follow-up look more still hopefully of captive you time? earlier, the of guys at something elevated. some to this appreciate also may the cycle, to With quick way ease. new very that is And And if and point Anda more not think distribution the company margin. And distant in while of a then name captive calling bottom at control things about earlier Just product we'll though, get capture of at see worse, the get norm generics, suggested Teva actually not owns a his that XX% the Thanks. not you would wondering whether in patients consider direct you a as yourself. point time and obviously some that may respect at obviously generic levels for least kind to deflation network Is over

Paul V. Campanelli

Yeah.

prepared for math of you XX%. be make day, and pharmacies. better consortiums the consortiums all you very said. it, regarding would know here, careful are we we controlling to the tens decision, At but the I as The the thousands the the Elliot, represent And end So course distribution know consider of situation. that When we all of be we question, of have pushback.

while and have for represent now a Anda lot percents. of they halves right and tenths I So, distributions, smaller respect of

could the obvious make being When prepared I'm I'm the what that decision, – you be again here. turn master take that So, you occur. and best of for

be you you Would we back consider strong So, up. diverse to Sure. But a ready it better and it? need very portfolio.

Regarding and speak and answer that there's our I definitively. you. can Thank don't bringing the we're at to Par. forward. to hope just, not we going question, the know and looking We're frankly only that's more deflation that the looking new that's We're strategy defense. hard much manufacture for are market for go. to products There's room to where our

Operator

Thank you.

Samimy Stifel. Our Annabel next with comes question from

You may begin.

Annabel Eva Samimy

taking my for Thanks Hi. question.

Thanks. downturn see as some same which was we're more some the alternative the ZETIA. falling into you So, of understand Dupuytren's we And saw of should you an going breakdown we Or base then and so how competitors SEROQUEL alternative Have forward? the this older breakdown? Dupuytren's? us you form the these And class generate? much really of LIDODERM But from and more any I area? awareness impact separately forms some can indication, you of sense into Peyronie's a is that and protected can that XIAFLEX, an trends typically whether a us on have dynamics new And do the in see on you campaign as seeing seen give tell business? impact this between obviously can kind dosage of

Paul V. Campanelli

Yeah.

growing regarding So, us, indication Dupuytren's around of we're Dupuytren's feel we actually vial for is increases seeing volume that growth, pretty that. demand X%, So, about so a right? is, good we the of feel

For the XX% Peyronie's Dupuytren's about saw specifically quarter, I think grow grow we X%. and we about saw

question had both on with on to other the just we respect forms was the of So was on, the LIDO, to year in potassium overall pressure powder. dosage to the other X% addition forms, we the alternative called growth. some area that Then date, out

Annabel Eva Samimy

And so, forward? that what does mean going

Paul V. Campanelli

the there's but Ultimately, sole the holding respect and with competition, that if generics out from like either market that the we've intellectual previous there's liquid, competition. source on that we've or behave XXX(b)(X)s calls take on we those no back to coming and property conference called more stopping nothing said to powder anybody

could products in So, receive at some those time. point competition

Annabel Eva Samimy

Thanks. Okay.

Operator

you. Thank

Goldman comes next from with Sachs. Our question Dana Flanders

begin. may You

Dana Flanders

My taking on to decision? something you very prepared then made secondly, still take that a And did A you just as you talk could the to reshaping forward? of in And questions. Thank often, about there lot compounding. sue this you happen see I on decision something referenced needed or point, international much at bit going Vaso just FDA your went the you like the make the you so action little change Thank preemptively progress business. action? first, what And it. take is remarks. that you. behind not you plan It's this know Hi. or done Are to we for on you've to feel

Paul V. Campanelli

Dana, a part mean our in on of it's I business. international this very the time, point at small side,

what are think that the great of Somar, owners' these putting I got on. bit we're we've done a focused time, into remains But hands UK, better Litha So, this I in we've Canada challenges job those so of and in small terms point grow businesses. to think in at bigger a in little

So this is not our highest of priorities.

the with into Regarding that attempting went FDA. lot and communicating suit to a decision, approaches the to against was a mindful decision bring FDA, a the would dialogue and I of you tell thoughtful, painstaking

company a to product one have resolve To went have category we medical statement we definition agree much. that exhausted product. ultimately was incredibly to the something it's an us So, means millions page by, that to dollars and application means, time terms forward NDA, of under a on to and I around come and Thank needed see something you with with develop no and happen that's was didn't a the a that out requirement is the spent period, need, our is why protect exhausted we need unacceptable any that FDA. went unlawful. half of And dialogue. after the and that then every bring to a to a our notice We possible what against without fill where we a you. market to compounder It political to period do market and of intellectual is property we means, something think not to your we take in

Operator

you. Thank

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

may begin. You

Gary Nachman

estimates back any afternoon. lower that review Are Could change than then where are deals new presented comfortable what mesh, in are coming that bolt-on I opportunities new those on? you wanted updates a that areas you Good additional would you scaling were some from, come you have Paul, if that surfaced? themselves? what And expected. Hi. back on cases we doing consider favorable where any enough situation efficiencies with lot to was spending the the to levels and

Paul V. Campanelli

I'll the last take So, let question. I'll the take first. I'll question. Blaise handle the financial

I the just good is an guess question, mesh and have And the update. frankly, to comment that's easiest think way news. I I that's, on Regarding don't

there's talk the material when we about to about. nothing quarter accrual, just So last talked

So, pretty we feel that. regarding good

a on laser got the year, this Regarding we're that that's make of to we to cash with. look deals, bit type We've what going question a later end delevering. bolt-on year. comment about little year We're early talk at that focused something your or next We deal as that we on want impression. leave strongly don't consider if we a with that aesthetics to I that. that make sense But whether well. in on, But injectables, focused areas highly that will small we're it's you wrong a find always

next pass committed are being Blaise. laser question We focused to the that, to With on delevering. I'll

Blaise Coleman

sure. Yeah,

favorable some in about million. that's going changes you're on the estimates the that's of year that favorability front, a full-year had Gary, in saw is then the playing piece of through play and we terms So, in seeing is full which we we a through pf $XX mentioned and and basis. in that's in QX through our in And question, spend OpEx up quarter what QX to guidance, play on

is spend terms moving bit legal into and our QX. underspend, we in be year. true have in is legal areas. the a two change is and that's forward around that One spend element how for the piece seeing the so The of spend, around the timing lumpy other last underspend in And just we're of quarter can

The a that's we're little selling component to and we also quicker we some We mentioned a we QX. benefit going as have some from and marketing well. realization on see going our some And favorability efficiency just initiatives on of standpoint, full-year the in have bit around that some savings did there. And is to last as then efficiencies well. contribute that we to see going realized

Gary Nachman

Okay.

and both forward, going rates run good are R&D? SG&A those So,

Blaise Coleman

I'm you guidance going to of terms right in give what XXXX year-end in you now give not during Gary, going we're the we'll listen, to anything that call. but do, Well

Gary Nachman

Okay. Thank you.

Operator

you. Thank

Our Chen next Louise with question comes Cantor. from

begin. may You

Louise Chen

Thanks Hi. for questions. taking my

think had now? you're question point, why Amazon to about been like was how to generics as that these more up now why do you but we And hasn't consortiums? haven't I secondly, for the potential that? to industry? or positive there And from sounds entrance It player such companies First seen pushback Thanks. pricing, an is particularly on a then the of generics negative getting

Paul V. Campanelli

start the Amazon. Louise, second So I'll question with on

As before, I'm I buyer can into going you favorable, as that time right. the any view major bring another sector, to said

competition. just that outlet. another That's So up opens

of And look of I conditions it that look think just the and that's have the would initially. types at future, way I what terms to in would you'll that. at result

see consortiums I the to Walgreens happening making other increasing what's and you that and aware market all just their three of think to would about in happen. allow CVSs we tell we're that And XX-hour delivery aren't the I already Now, the going services. communications the

so end the would an to in So didn't of against to question, to your they're first compete well. position was? then a the at themselves industry, major ability you the going positive. you day, to generic go buyer in And hear try apologize, have that's whenever We Amazon a expect. put But to I another as

Louise Chen

Yeah. and Why consortiums haven't we these their companies the seen on pricing? more from generic drug pushback

Paul V. Campanelli

controlling the of consortiums, pharmacies. tens day, of from they're XX% pushback They're end the the of controlling thousands of the So market. at

on to price, to we've want to made commodity record ANDAs. know push and you today. a to on whenever price, has that In people question, lot have back a somebody So obviously where you occurred willing those to on you your compete, we decide we've no there's stay ANDA players the they're of product These we number as what case, are and first coming a consortiums products generics. record compete product and is and here. whether existing approvals hence are can't time ANDA and in older approvals players our a that's facilities. have you multiple lower have or and want made a willing we we And decided product to on not of particular and compete difficult certain and multiple in drop products long answer decisions is don't decisions very in as But to longer as

products. there's So, products, of coming plenty new market new to sorry, you. ANDAs of Thank on I'm plenty older

Operator

you. Thank

Tsao from comes question Barclays. next Our with Douglas

begin. You may

Douglas Tsao

taking Thanks questions. the for Good Hi. afternoon.

your you when you of at could portfolio, look you've in question, a like products through the when ANDAs of feel there the Sterile mean business. FDA at that are second of the generics I little some Injectables. be a that look those in of terms out in in you've of referenced, are point first the your sort sort decisions Or And Paul, terms that of the then gotten book, some, hard most you just some this of of problematic? at terms of do terms Just vulnerable? pending

with but of recent there Vasostrict consequences. an does FDA's behind in pricing unintended the investment you potentially lot a that as called having obviously company make you of drug how unapproved the had at hearings opportunity and out been the program, as You've for the some, those success and has some Thank drugs capitalizing to look some change And on you. them? want

Paul V. Campanelli

Yes.

to feel to question. But way is the have price does. the about think we you XXX(b)(X) it. on have it. continue second how be you We have today. things answer good We're Doug, with it you to I the at going So, thoughtful mindful And to strategy. It and a look

that, mindful But and in a been look a case comes tell When That at United case. we first it how portfolio, in look our cost take submit our property, unapproved commercial be that it, an you're sterile costly thoughtful to States. that your the to always you've was, would you're the got products. NDA, generic the that comes knowing maintaining trial with an requisite clinical you be fee, would But you price. pursue facility if I take incredibly the very I that's into have pay you can work, and to products, and the important. with injectable to do at PDUFA intellectual think drug, that's on going part price consideration our we

I We've headed. made tough think probably that's were already you commercial products. on where decisions

quarter, course you're months, a where normal I forward, probably process your every six that Going every looking portfolio. say at would always we're in

gone of of going what along year. product the of nothing, handful last scale handful So, nothing through with outs, over there's be probably but we've to a the a ins and launches

a R&D, question. the Regarding similar

on file about have XXX with FDA. We products the

thoughtful question to category. of to as approval. similar fall into going side you're portfolio, to four, fall perfect type to And most to leave that manufacture every and commodity And you're with that our anybody, have Par. of you not of six a that expect products. we mindful want just that percentage a We be enter smaller do the have for to there, going And time five, there R&D part, we'll or we'll to you a going into market go make But may So want not would competitors. the be we're product of that a into a may may I category. some of at very with with that, with product difficult decisions handful the you. products. Thank the That's pursuing, forward focus soundbite is the

Stephen J. Mock

to question. has just closing be last Shannon, Paul remarks. have to that's a few going our

Paul V. Campanelli

Steve. you, Thank

want us our company thank joining support. also thank to for updates. our do forward work afternoon investors patience company. I your continued We to like this to look and our for hard and you conclude, and providing we you appreciate continued for with their commitment dedicated evening. in good I'd our and Thank Before we to employees interest their

Operator

conference. this day. your and Thanks participation. wonderful today's Ladies concludes gentlemen, for Have a

Endo International (ENDPQ) 9 Nov 172017 Q3 Earnings call transcript