AMRX - Earnings call transcript Q3 2017 | Amneal Pharmaceuticals, Inc.

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Operator

Good morning. My name is Cecilia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Impax Laboratories' third quarter 2017 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. to call like to now would turn over the Mr. I and Head of Donohue, Communications. Investor Mark Relations Please go ahead, sir.

Mark J. Donohue

of will Good Impax's are Impax's earnings copy website third you. available quarter slides Thank morning, Relations and XXXX conference everyone. within the at call. section this impaxlabs.com, presented on be Welcome Investor to the call that of A difference those as are website. cause actual results and certain forward-looking part of statements, SEC could our the in that webcast. differ outlined The presented from filings discussion such our Factors a today may include on here. may and

to over to Boothe, are with President certain turn more measures to understand uses are of to call on non-GAAP of and internally of financial some slide Q&A And the management Further, Pharma investors in includes during by results quarter Bryan Executive Paul Doug evaluating and inclusion today Generics information supplementary discussion morning, measures presentation. its Officer, A Chief XXXX President SEC. measures results Specialty in meaningful going earnings today's non-GAAP Financial trends. our our the results Reasons, that, Division. Also the Division, facilitates disclosed detail. on defined the Paul. Bisaro, reconciliation measures President quarter of will financial review evaluate to our financial to in Management release and Michael analysis and the and and Our call the business. GAAP GAAP the and the and better I'm financial third and This a update. our the provide remarks third Chief Nestor, third available non-GAAP and the business non-GAAP will Officer, believes as performance, manage operations, measures are by quarter the financial company's both operations available company's in provides of

Paul M. Bisaro

continue this company. Thank ability quarter progress I evolving you, our and earnings, while that making report substantial pleased am to demonstrates to everyone. Mark, improve morning, Impax's in to streamlining and profitability and good

on total net revenues our As quarter. and for EPS the for $XX third can adjusted X, share million, the see adjusted results per you slide was were million, was $X.XX EBITDA $XXX third quarter,

versus by X% generic increased Compared second to consolidation competition, due as and declined quarter environment. continue year's percent. to revenues through generic third revenues lower year's quarter total revenue last the third quarter, couple in the buyer Our we net to navigate caused challenging this a additional

operational in cost adjusted in we a and to and double-digit a earnings led growth quarter year's second third result However, XX% quarter. This improvement improvement increase this program. compared the EPS of in XX% delivered profitability as in adjusted to increase our a and EBITDA

and the with revenues third slide Generic due approximately with were the was in was decline and factor, generic auto-injector XR. related pricing to epinephrine to The pricing driving to review XX%, the of pricing CVS. a two XX% compared year's last with X epinephrine decline down Turning primarily Total arrangement in products, of our Adderall one-half divisions. to Starting the net quarter. division. the third quarter generic Lower of

business on to gel and of buying quarter pricing and from primary authorized Unfortunately, receive the quickly X% we generic late higher were to sequential lower fenofibrate, FDA's seasonal three compared by budesonide, players of with In approval highly epinephrine it pleased roughly were the and quarter second OxyContin compared the this However, generic to sales offset turned multiple sales Renvela. quarter. offset consortiums. into some basis, we higher Generic with a XXXX. competitive our October, finally market, year's pursuing of the did were On price second third revenues volume. of sales Strong flat a decline of diclofenac

business. this to of our continue clear opportunities not additional one Concerta We pursue by our the would effort. late produced efforts time third-party require successful of additional October, were generic our increase that product, for it became AB-rated Also manufacturers share validation and in immediately to and

with the working impact to partner extent now manufacturing contract issue won't the the be and that Unfortunately, the quarter quickly the assess to this fourth of of of launch. in product believe we are on We our launch we able timing year. the

and and division, spend quarter priority, to from as Rytary maximizing higher up were and third evaluating the a Pharma we second period performance Specialty this result to we quarter ensure year's due programs to of the Pharma sales of Within continuing of were of our prior-year to are sales this up sales infrastructure compared Zomig. X% the time total Driving Rytary to is in Emverm. X% stronger franchise. Specialty are higher compared value a Albenza and revenues

X. for symptoms Turning the Parkinson's for a recently to completed slide We of Phase Xb the treatment study potential IPXXXX, disease.

Phase We with to last Xa study immediate reduction on data, are completed consistent X.X hours showed the to that diary the approximately patient on year. off results IPXXXX off a pleased significant were carbidopa-levodopa report release Based of with less patients compared study the time of time.

Rytary As advanced X.X in hours approximately off of PD time study carbidopa-levodopa. versus immediate-release its had a the perspective,

Phase with Our brand team have X we FDA, clinical an met agreement and development a the on plan.

the assessment reached a X on trial. special We also have Phase protocol

the this product. timing the for We are development evaluating of currently further

X. slide to Turning

our to and we on pleased good consolidation making progress are report are initiatives. We improvement cost that

in facility. packaging of are the accelerate we With the closing to installation of the by packaging FDA, Hayward Middlesex able the and the completed approved lines

Our expect this close year. original target this the we by this at the facility of end of of complete the quarter to end effort now first but was to XXXX,

exit. late towards number we are toured stage facility, efficient A we in with interested work buyer. parties the currently timely continue and potential to and an of Taiwan, Regarding a negotiations

the across accomplish we We savings schedule. would all sale by to XXXX. first savings cost are able optimistic initiatives that us of a approximately we ahead it quarter could achieve year complete run of full rate cost of transaction of If to the are this, end allow a one

was strong be us invest generic investment entry including to assets cash XX diversified new company to company, our the accelerate and will industry-leading, intention ability one improve strategic a with will in all will pipelines, the October broad with capabilities opportunities more its a of also The new The many further news, forms. across the into combined generate capabilities combination high-growth of biosimilars. will navigate announcement specialty to flow, Amneal most with will growth, allow new however, company's the the Our combination. X this and Slide R&D successfully new environment. Pharmaceuticals. financial growth. which and future an high-value These assets Amneal significant combine product dosage and of to benefits highlights few This provide of multiple significant drive

implementation. We are two actively companies, on focused the planning for day-one integration of

initial weeks. with Commission Hart-Scott-Rodino filed made forms. filings and have the our the next And we expect in couple We Trade S-X Federal to of the our file

first to in the of continue close target a We half XXXX.

to Now on turn it the more will I Bryan over for financials.

Bryan M. Reasons

Thanks, Offsetting second by second Paul. quarter performance quarter generic year-over-year adjusted on with OxyContin. fenofibrate, the lower with earnings third Good will the the primarily on XX. our quarter to revenues remarks these generic quarter. increases Starting we XXXX morning, therefore of $XXX division Adderall. basis; this increases sequential to my results our Notable budesonide, in over focus sales third Since Generic covered compared release, quarter performance flat Total seasonality; auto-injector, our sales XXXX XXXX. second of everyone. Solaraze; of included of slide million, morning's products authorized and on and compared were driven in the were epinephrine an generic

earlier this we received AG of supply quarter. third the year, which OxyContin, Our exhausted during was

and This was sales from the higher inventory In competition a gross quarter, of as lower-margin million a of impacted of third generic XX% Welchol a the partner. loss adjusted few gross XX% Teva Our metaxalone, few the pricing and sales partially as margin cost and products decline in note. product reserves, result of in third adjusted margin The sequential by XX%. charges on represented of diclofenac, an a items gross caused royalty and a sequentially few the excludes approximately declined Adderall, acquired margin. increase of decline of of margin products in adjusted lower the result to due Concerta, FDA quarter short-dated part also from was in a a charge mix to These generic his market lower gross related as additional recorded transaction. We by the our primarily generic the of and approximately short-dated remarks. approval batches noted in Paul of bad $XX delay as to of million, in inventory

built Welchol be year we wave last of this an generic inventory the may that you we'll still We're time approvals. of hopeful first recall, approval. in in As anticipation

sale cost manufacturing, facilities, or closure packaging, facility severance charges of $X as as savings a as related of the well of announced recorded the our and Taiwan also of the to programs. R&D part and Middlesex manufacturing We restructuring closure the million

Middlesex underabsorption as operating recorded second to million the a approximately gross charges $X Lastly, third R&D. of million Generics partially $XX spending the manufacturing of of across SG&A of facility. XXXX lower result offset to closure quarter to lower Adjusted declined million margins, income the in related quarter the division $X and for compared the by

an due XX%, results. Moving product flat. quarter the margin were in to and XXXX, short-dated and of the Albenza XXXX, Emverm third for in inventory R&D and the SG&A and Emverm $XX third and XXXX. while a second operating quarter second as revenue Specialty approximately in expense of of Total to sales X% the division gross reserve Pharma and the quarter controls. to Zomig increased quarter, result in expense revenues increased decline Rytary for increase mix. increase third division of Adjusted to a in of $XX compared to the gross second our the the million delivered compared income to an XX% sequential lower $XX million Specialty primarily million, XXXX, due ongoing over during to margins quarter growth quarter double-digit slide second XX compared essentially Individually, quarter, to were of Adjusted

slide to our results. and Turning XX consolidated

increased drive in for turn plan EBITDA second call adjusted and company our cost adjusted the only now to quarter earnings I'll the per share. a increase us XX% improvement this XX% quarter total revenues While in overall year's increase X%, a third Paul. helped back

Paul M. Bisaro

Thanks, Bryan.

based actuals and more that clarity Turning our narrowed first results. forecast nine-month the quarter fourth certain XXXX around slide our impact will to on We events XX.

of our adjusted it felt This generic our the on expectations. hoping direct of with adjusted approval to to of top-end generic XXXX approval generic were result Concerta and top-end launch modestly EPS gross we late currently delayed the EPS prudent the range we guidance, bring was no our combined and the a achieve Welchol, Renvela. down margin of of While reduce

that expect in to of of other The our initiatives result inventory product the and new royalty inability expect benefits product in a to generic Most fourth site in program timing income these the of the continued improvement good our some as will spending products importantly, cost as partner a of no of we accelerated quarter. the contribution see offset on is R&D resulted reduction improvement the program. news, however, Additionally, and consolidation acceleration with generic cost that the to generic events in the Aggrenox the of R&D that supply of full-year impact delayed in from we a well XXXX Hayward. from single generic launches, our to ongoing

on slide appears guidance updated XX. Our

As adjusted EPS The to $X.XX as strategy, stated creative transaction we enhance both Forward summary, to financially of Path our we share. outlined I this on strategically XXXX our of with our combination and XX. is and Amneal grow $X.XX as one slide a to our items pursue companies. result for per ways clearly the narrowed to for compelling of part objectives, as achieves continued In outlined, range business

aggressively employees hard its their to and our change for the continue company, to of organizational work focus will near-term our phase all objectives. driving growth in which and Again, prepare next thank I in helping and on We of long-term quarter will in success. focus achieve Impax our the us want for

the behalf yesterday we brought send perspective Mark Rick unique of Impax over and sincere a our our questions of board. now. leadership Mark? for board and condolences valued friends. was board who a to industry we Lastly, evening, announced family employees, was and distinguished Bierly. On executive of and the to member I'll turn Rick's Rick our passing the member it

Mark J. Donohue

you line Cecilia, please. now, Paul. questions open Thanks, can up for the

Operator

Certainly.

of with comes from the Susquehanna Group. Andrew Your line Financial Finkelstein first question

Andrew Finkelstein

Good thanks question. morning, taking the for and

Paul M. Bisaro

Andrew. morning, Good

Andrew Finkelstein

launches IPXXXX talk push could that in hoping if was about of of term. for an profile forma the outlook forward the Thanks. And and the talk these and want could about from on delays whether to that assumptions on and the you how I you some there impact aggressively Concerta. any made then, near product pro might that is to next in year, some with you these competition more first secondly, you the framework for

Paul M. Bisaro

process forecasting have information prepared of specifics What Again, from guidance Thanks, will Sure. the get we and to expect expect contribution for XXXX, to not be that along. we're I closer these these the help and budget for pass give do expect to completing XXXX contribute say of we'll our as support do that Andrew, to XXXX, XXXX, time products new launches in we able future will And growth. the which we we do in question. products to Well, is right in now. our XXXX.

of team full-year in a initiatives we've And Of expect a we obviously course, great negotiate the team pleased that we the that of as hope truly With by very we to program the pleased the effort entire of Phase X, here XXXX. cost clinical excited also impact program and as the improvement also continue a Specialty Xa. mentioned, to obviously a It's SPA. engaged an results were franchise for about – grow results to, effort. in, respect been well that I It at to We we're to almost able Xb the get very IPXXXX, Impax. our supported study. the were very as Phase with was study,

fund want are or we to that it us but So final begin final to find go, to we're that. and when around decisions ourselves working essentially out potential help whether and the timing ready want program partners we just do we to

this we a get we will that in imagine, sure study, on a can to need have row all started you fairly As is our expensive and make that. we ducks when of

for what that's would So XXX, at I say now. about least

Andrew Finkelstein

right. very Thanks much. All

Mark J. Donohue

Andrew. Thanks,

Operator

Tyler & next the of Van line Cowen Company. question Your with from Buren comes

Tyler Van Buren

for questions. guess the good comment operations in how going? the the Clearly, respect guys. are operations a on with are morning, Amneal Hey, Amneal. the taking second Thanks to acceleration operations, quarter with you to I able for guys expecting we're and half

Paul M. Bisaro

Tyler, Thanks, for the question.

me deal assumptions Let forward. is and the moving we're by for still thing, both companies important the intact, probably most model that are saying comfortable start and

it's So some fair there that results is no there. movement own to may say say I at lenders. to their reporting point would be Amneal their

the a details. may saw. respect information become we're can some their available, in say in ours, complete we and we to quarter pricing, So give with but of with that to was not position What what consistent is, pricing

So that's good news.

between And to now, of some November through public information is they've launched time XX of the they expect launch number products July products. and – a through additional

is steam, at as very and we're I'm are and they their So engine about excited sure full well. running that,

initial had pre-integration are done. meetings, teams how have kickoff of can work. now, with just think streams work to teams begun to right as pleased very we're get things have through the So the our the mentioned, the we set starting all that And do. going. we're I that We up We've work got work I and

be of day first the we to one and So XXXX want closure, at running we're to ground for the hit on ready half that possible earliest targeting time. mid,

ahead full deal are things Amneal. with all the steam So on

Tyler Van Buren

the you products Great. maybe a maybe pipeline. that to look Amneal clearly to of That's prior you back on be the out expectations in think combination, on Lialda Could As pipeline give potential us as there's appeared potential from next their mentioned of of all And and be opportunities Could good call more and I near-term the the some that XX any for an opportunities? some update follow-up very the hear. of help months just optimistic could meaningful? the understand you pipeline, generic for just notes you six could the launch Lialda pipeline on my to other that more list, opportunities. us one near-term

Paul M. Bisaro

can't I do Tyler, unfortunately Well, that.

So to able call. going on be I'm do this not to that

and the what we to time expectations would to and not optimistic, first and believe are were model we projections. on on just realistic, what is to deal the say record. do for the expectations what what we think model discussed on the I achieve necessary provided achieve, of So the all, that, in pipeline do And deal those track we is necessary they're at that is their of track deal

leave to that. going have I'm to So at it

Tyler Van Buren

so much. Great. Thanks

Operator

Your of comes Gilbert next DB. question with line Gregg from the

Gregg Gilbert

team. morning, good Hi,

Paul M. Bisaro

Good morning, Gregg.

Mark J. Donohue

Gregg. Hey,

Gregg Gilbert

generic us large? understand generally On at literally Welchol, and potential to lastly, could revenue or an approval, this any-day-now you help launch? of you've rationalization not Paul, kind be the can you and Secondly, event question. ready recently been this anticompetitive. point to I this they issues on are discussed, causing have small portfolio potentially about profit to at And you impact? Is with might or ask least noticed buying and involved an presented I'm consortia, I that's at the that the an sure of the power how FTC be FTC-related big-three and but you AAM FTC generic

So you're that, emerging? anything actually industry done advocating new that aware some model Are can is tangible short distribution steps of Thanks. there of next a be about the for?

Paul M. Bisaro

Sure. turn talk finish then to little me and that bit about Doug first, Well, FTC rationalization, portfolio I'll let but with with the question. deal it start. to I'll Welchol over me a let

we be if approval. yes, On to received the able we launch Welchol, would

not certain is it moved going of We to approval when quite come. the out that We quarter. are

true visibility to don't around the And I'll over expect portfolio for But perfect XXXX. to rationalization we would that we turn a question. I possible. that. event looks But remarks, As suppose we first much right or that quarter to do. it's I said like us likely in it was now, think to first our prepared Doug it prudent for half be anything's more have of everyone. But

Douglas S. Boothe

part you in investment. we're look have at to in increasing of it going Yeah, the begin certainly number active hey, in but projects way well cost-effective. an as portfolio the development, of our as a doing Certainly that's as expectation integration, of the the to good of morning, Gregg. course Yeah,

So until we go-forward of those the strengths some have filings, development breadth integration. we've of we as completed the uniqueness take for have as we Amneal closed that some we value of well based can't to perspective, and we from believe, can't well do the course basis. also as should we the of of potential the bring course, on identify strengths, most transaction. definitely company on will But accelerate that that a the portfolio which a specific as for their actions activity, And until the key

Paul M. Bisaro

And the about then matter of regarding question the around your the power FTC discussion groups. AAM's the three and buying

want considering you for product if have it. you're just mentioned point, is, the has rejoined AAM model member that their into people to their patients. kind to was as think there new is a you I that. very While probably distribution to matter. vocal way truth respect consolidation made companies three at manufacturers to It's sort that every Or players, to is I'm been you and to around have with missed finish products our or as of agree do on board almost I'm little for going this allow entirely I've about patients. get is – that it issue. for a not to. look Amazon that's industry, one in manufacturers I it's There think the will consider just to strong to area, to new sellers ways us on to certainly avenues that three new to is a product the not then a FTC. us and focused recently those there combine AAM. but new products the very supply model, difficult. by past, to the get But I the know And has on to my forced force to I the on is all the rest focused dispense believe be sell decision FTC AAM Impax, I've to of distribution particular take the This if a the that. point generic and the action And complicated because certainly bit, – With chain, overstating I been view, final sure in well, do of

look about talked start I we that see kind move we've of since to the I of next-day independent the delivery. the consortiums the was market. people, know think it at to I'm as next-day retailers talk to CVS this And I'm sure to to a bet there's chipping other look delivery. many delivery. of distributors next-day are considering and will locked new away model to fact sure would up move interesting all buying have that new three to number major companies way who a will

that in new help itself, be challenges our company that the and it think inevitable area most able was avoid more and the to models, And present new three Amneal, will and consortiums. company, the leader I and that distribution new directly in about a some of be would participate model aggressively we what new have has. finding this new major So the patients more our with combined I'm it to excited products get is

Mark J. Donohue

Gregg. Thanks,

Next question, please.

Operator

question Elliot comes line with Wilbur the next from James. Your Raymond of

Elliot Wilbur

Good morning. Thanks.

question or Doug. First Paul for

as rather well. we asset then And IPXXXX, if looking may just not thought I situation of switching and would don't study with the Rytary mistaken that competitive, may around from wondering at some Just was if to us Rytary, color some a certainly I happening data markets not maybe perfect just to a seems you lot at Certainly but I'm Welchol, into reduction more and time real dynamics. was around have guess, just X.X And insight off than looking I'm gears have you quickly, with the in that's hours. hoped commentary – on I similar be everything market obviously have Renvela be give expected.

just wanted follow-up that's Then confirm to a case fact to I if or And have similar very the in IPXXXX. So well. you, as I for not. Paul,

Paul M. Bisaro

the Doug IPXXXX. let take Okay. and Well, have Renvela, talk on Michael about me I'll let

Douglas S. Boothe

for think in first approvals. Yes, not that the of six got our weeks the were us after so first on the approval. disappointment we was I approval We wave certainly Renvela,

of on So the from activity, filers a there we Paragraph competition, other and there. expired, IV filers were were aware had based the IP multiple since out then

opportunity market market the certainly and a have available has affected would competitive suppliers, the late overall certainly we better an have getting perspective But really with several share. an placement. to we that greater work in from placement accounts, pricing we for colesevelam, continue the getting our product experienced product And mean challenge being to the have have get have initially. market, first So to see regarding I dynamics with wave, flow key number secured more and to will of to that we've others and ability we had approved. that

go. to ready are We

as be line We customers. to sooner, market, are could with the And, to later. aggressively, and are be to hopefully our finish it's activity, with an product Paul we the agency. but working We, active the working and it in believe said, in early-XXXX partnership discussions the getting on again, could really that agency

Michael J. Nestor

time, a Rytary to optimized immediate-release Rytary, trial, relative reduction in a versus and so this reduction showed Elliot, And IPXXXX advanced was off the showed in but in X.X-hour carbidopa-levodopa carbidopa-levodopa an one-hour Rytary. immediate-release because time, trial PD off

reduction in the in shown the was hours. carbidopa-levodopa. X.X about trial Rytary with What that to however, IPXXXX, X.X-hour is with carbidopa-levodopa immediate-release Xb improvement shows immediate-release off time IPXXXX So a we've and relative Phase difference

clarifies so hope Okay, that. I that

Elliot Wilbur

And big-picture time, Anda. and kind fit of despite there a I the acquisition Once of it and an name that Got that was with acquisition, thought hung time, never as of at a doing basically you of us some the that did you your you. Amazon to identified relative to establishing strategic catch that down the upon to some that it. fact throughout to Thank marketplace question didn't many this you, was I'm tenure captive seized within out Paul. on were that the upon an for Yeah. perhaps asset seems that is somehow captive is you what that to it that at by you the a point distribution And a network increase. is – revisit has maybe own road, have distribution the idea be what referring the are really, pressures similar particular idea solution But question going distribution that obviously it Anda. network, your there. channel The Teva company. could to really

Paul M. Bisaro

is it an the a about to that the series to of long-term that idea expect not channel good involved partnerships to some buying hospital have patient, both we're new Amneal. area. That whether smaller more with and a even as and directly else a looking of that ability and as some impact point went We Elliot, at that is a in in an and the about, believe, that need process our really, groups, I that's Actually, pharmacies, for strategy over in us we we potential like groups. to buying Yeah. channel. us need direct do acquisition somebody as or And well well as and that, with very We be discussion partners thinking idea. back is talking colleagues sitting for for and active waiting

something So Elliot, that's yeah, considering. we're

Mark J. Donohue

Thanks.

please. Next question,

Operator

of line with Chiang next Tim the from comes Your BTIG. question

Timothy Chiang

thanks. Hi,

Paul M. Bisaro

Good morning, Tim.

Timothy Chiang

Paul. morning, Concerta. question on had a I Good

of with You a product. experience this obviously lot have

market, market Given are the the product next or next the share and, B, seems that price just Teva the you going how still some are market share half wanted market? year? into like on sometime you first is A, can, XXXX, also you to the think It in important you your get in will points product there? get shares pricing think And has that How confident that meaningful the fall I really of get get do can this of to assuming the the be in the product sticky. you lion's for market where the thoughts on out year; do you

Paul M. Bisaro

Tim. Thanks, Okay.

be look, the we Concerta were good the can we and the do be that think depend unable every and that to when able additional to disappointment into as to with have. know into in Clearly, competitors important. XXXX. early to it. for market, to overall the in market early well reasonably XXXX. So, it to product a can And We have. major to market we contribution a are product product would hitting get whether obviously get was It will be is hopeful XXXX we value Concerta will or will product us there But it on we XXXX. get

And would able time. get from to to we things had value happen. challenging so originally the we it product launch we that been product, the these could thought on the Unfortunately, be get

we have schedules. have work third-party their to And have challenge an work additional with time have We to and manufacturer, a that that work on through. we we is and to them,

we'll for so push And that. to continue

early So to that for We've maybe us the been some the that right, years. seen little see it we comments it's pricing over it like future. what sticks. generally few I'll turn expect Concerta. it. to And product might would for a a for Doug But more that look over to you're in has predict But of a the on

Douglas S. Boothe

Yeah.

Just to at that note, some year-end. obviously this dynamics changing we we've been I have market. mean, actively are tracking

of think market, change may being situation the time changing J&J, off-price and in players two not BX other with who have if still as Teva again, as approved, sooner. in we We well although that products that light the have over ANDA the generic we are

rated. have AB ANDA that's We an

course filers. market; an coming to is and of to challenging we're not the this versus a the is product product certainly aware to again, market. exactly other who approved it BX get existing So to marketplace certain of bring advantage And And, a in players. we're challenging is of some

aggressively working get we our customers. to our So product still are available to

Mark J. Donohue

Thank you, Tim.

please. question, Next

Operator

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

David A. Amsellem

Thanks.

ones. quick So couple just a

that tamper-deterrent in point get the they way – product. extended-release it concern So at some well, to the opioid after on went Paul, – regarding your to products aggressive wanted with agency sense the of is properties. ER, relative after Opana same I mean, market and FDA abuse- could more the so getting transitioning go the product your Endo's certainly

and litigation are wanted and should So, legal can there? how Paragraph remind you, we secondly, ER IV be. just Rytary, a be on what product to important then, you of that And get of given where us Thanks. is filers regarding that oxymorphone should for much timelines sense you of with aware concern an your

Paul M. Bisaro

quicker. the trial's for with first trial Sure, That half That's XXXX. a for preparing of currently first. the is start Actavis/Teva. That trial. let against me little Rytary We're scheduled

protect So potentially filer been there we would and second Rytary, those our cases will a situations. of IP. aggressively whatever but our happens continue There's additional obviously one IP on to the and pursue follow first-filers with kinds

And defend, involved additionally abuse hope as we the help because not is would heroin there's in course, us it you problem. that do to to One, solve abuse as confused have and two looking product I sure that the of With programs. that time. solution, with just important necessarily what that to a in to But we of in an does that I responsible point way for be monitoring drug some are part we possible. it's early and an well, it that to take-back so product have are a done, participate about be But really it's all pain for problem, who make work can second had and well have because but of program the products is opioid make think abuse – suspicious know to probably a reduction, patients we we that, all, other to importantly, that what process. we we the that. some REMS We order is things. oxymorphone, participate We distribution. opioids out continue what's opioids just position and most and to program opioid opioid even in sort problem, analgesics controlled to XXXX. for be want aren't the most good respect understand sure able can the for well need you we be the at oxymorphone a determine more in news to what get give agency So want done, of the

some actively right? addiction of also a the not-for-profit necessarily to things problem best help not we what can And And We solve in we a with different responsibility participate want we're as been and opportunities support, to here. partner make recovery that state do with to at in can, product, to the of looking as to happens. is what's have the at some the addiction, want looking we that help So of problem and lot social we programs. involved deal efforts organizations ongoing, battling sure front-line to we're new

be with Now, this is works different be How it out. who on different hard oxycodone? product the how to is do a want of similar FDA and and will obviously in abused? And can product – the works the work We be in the best shouldn't it it we is it? we it to and patients just how to and help Is what to all to where protect – we getting kind will them help from we process. predict morphine? further try a participant participant process, it can and how But understand it's understand as people the will shake as

Mark J. Donohue

you. Thank

Next question, please.

Operator

next Goodman Marc comes UBS. from Your question with

Paul M. Bisaro

Good morning, Marc.

Marc Goodman

very us so Can sense WBAD-Econdisc. should give Hey. be from expecting, and Question one? the you what just that incremental a far about happened just specifically of impact about we what's

Paul M. Bisaro

Doug I'll turn it that. over to Sure. for

Douglas S. Boothe

their so we've And course harmonization coming mean, as Econdisc bids. been over I the that. and and the of certainly, initial also through with as process, been contracting activities, the of WBAD well Yeah, we've part then consolidation

completed we to exposed have we liked. were have actually have much would as as We less We unfortunately Econdisc. didn't business there –

that way. through pricing material impact, But So flow in it's not certainly a but results. been will see an less XXXX's we into of

Bryan M. Reasons

came No, out it where we about it's material to our not and forecasts, expected.

Paul M. Bisaro

Mark? Correct.

Marc Goodman

I -? Am still

Mark J. Donohue

Next question, please.

Operator

Cantor. Your line next Louise Chen comes question of with from the

Louise Chen

for taking questions. Thanks my Hi.

Paul M. Bisaro

Sure.

Louise Chen

the thinking somebody imply. respect you're that here question fully Amazon you I to your drug And I just that's auto-injector. what of channels, – that leverage had building is channels, is after this how on integrate are to types affect of question volume upon Specialty Amneal here, what types then was new if was epinephrine there business deal, these could didn't in trying second about on help new question last with pricing? to consortium? on you back the then And enough like and in My know first acquisition? potential And generic or then

think opportunity for some I in we you. about robust of headwinds should it's see the pricing? know light that in we opportunity how been of Just the a

for something So is hiccup, to think this Thank the just longer-term you. about? a or

Paul M. Bisaro

Sure.

distribution this a whether of we've new What model model, sure been the is it's or this With access is is, kinds improvement other an issue. pricing models Amazon not talking that about, process.

in it overall also to not a be of their Well, one I to as we to They from prices actually would other to just prices what the that, would to the that's down, we're this allows the not of yet and be But respect said about right? it of that, access, With of customer to start Amneal invest company, what expect them of one able flow a down. I'm the the And and we determined. to business question drive purchaser. But is of there. said, think growth Pharma announcement support assets, leverage say we expect drive sure. growth to company. prices is since is the to have over question but With respect of That's forward, help thinking course would to time. what the kind generic would slow not look those buy grow and pricing. overall the I consortiums, deal, values is through adjacencies volume and Specialty With whether deal, the we necessarily

that being of will potentially study important and While expand auto-injector, they that the positive but sure to were, beyond I'll we focus an not much with as Generics Specialty we pricing, is - continue we let on had franchise. obviously certainly, with to With other view Doug could But business. our results epinephrine the a areas look more I'm IPXXXX synergistic support Specialty the into business as CNS on the also of would area respect to

Douglas S. Boothe

big Epinephrine, that overall very CVS generics. shares the a look I now certainly and well as that script channel, collaboration volume. retail between time product, this as have in authorized is market brought to around mean, of we perform year-ago with XX% a our you Mylan their continue at we're very, data, year-over-year, the we change and out Comparing well with the as the

pricing get of by really that there. program with nominal the had So Mylan basically, seen Kaleo placement market, their back which than players forward to a a the some no product was activity share and unique other other a again, coming to has generics. lot authorized – -finding We've way distribution brought they're

participation. product to quite of no the seasonal supply period. our course, a way continued Our We weathered demand we capability with in supply issue investment, well and in – strongest expand had

go Now non-seasonal completed the the as going deductibles their offering year-end of scripts, company. of get we to significant for folks year. XXXX. we're some portion a trying role the product into certainly our back our as the and have value see just business. It's But we the into We're for

Bryan M. Reasons

pricing's business, And seen, since CVS Yeah. we obtained the have been the we stable.

roughly has over beginning the very since year grew pricing to course our the stable market. as been choice the go skewed, But in of a made it's from ton, we that year, X% year, compare so XX%. you volume the of to but if So as much

Mark J. Donohue

Louise. you, Thank

please. question, Next

Operator

Goldman Your line of next question the from with comes Sachs. Dana Flanders

Dana Flanders

that of savings you just I for some cost synergy know Hi, provided one questions. you you first selling closure Middlesex possibly morning the and XXXX. thank here, with year-end. the this on into numbers plant then accelerated the some had Taiwan heading My outlined by

how next Just what this to follow-up. that? news second mean does mean, I into just then year? is And this a heading quick additive

is this from And I fair state updated I Thank the is But were now? On complaint, to I it you you the assume had disclosed you mean, generic federal. is interestingly in named not price collusion case. very the know you separate behind one earlier. this know much. state subpoena a

Bryan M. Reasons

and I'll So turn synergy do over. then it the questions

of in year. kind we announcement, savings initial complete first the Middlesex in some our point XXXX that of had worth and late to versus projections a So the of about half half-year assumed at

certainly Now we by end had Taiwan, hope that completion year. of have the that to XXXX. of And we done in the modeled

So we XXXX. in no had savings Taiwan

sale savings would if we that to all incremental to XXXX. So were able of a be Taiwan, complete

all of aspects on timing-wise, exceeding kind So – executing this are program. of on we

in So programs. both it's significant these for of incremental savings XXXX

Paul M. Bisaro

the It's hard that with about not to know now. Dana, and We DOJ heard generic a Impax to two did pricing we the anything we've years means, receive haven't anything. ago responded subpoena, Yeah, what and respect issue, heard from since. that than to other subpoena

always and very early. state we as And named anything AG take place going There's complaint. to have, respect compliance nor the practice still of be in of that a we here. to the to a motion operate things lot in before that have Amneal With Again, with resolved lot Impax were neither continue it's to gets law. so other matter,

at I think it that. leave I'll just

Mark J. Donohue

Thank you, Dana.

please. question Next

Operator

comes question of with the [Canaccord]. line final Steadman Cantor (sic) from Dewey Your

Paul M. Bisaro

Dewey. Morning,

Dewey Steadman

the get been EpiPen, about also manufacturing in subject failures. us can for failures? is those you of may that this me Pfizer through product the Thanks. And Thanks to had CMO-ed. I Hi. product division EpiPen, now, different I a Good in. Amneal terms and know how business it's currently the of morning. impact through Impax guess CMOs, you running is has can processes on Mylan's mentioned How fitting of that at which change third-party much deal? then a Concerta with in than not differences comfortable CMO. But on CMOs that

Paul M. Bisaro

us Sure. by Impax for produced questions. The than the relationships They're our CMOs. at CMO Yes. of are significant. Thanks, for is – Dewey, greater XX% revenue

and to the at Amneal and division we as manufactured presented would Amneal it With consider we model. for And well. can EpiPen, achieve of we manufacturing portion deal one if the it a by some talked to so the significant Amneal – the others see is that's manufactured that's deal, is be something certainly able we're mentioned about bring fairly respect excited synergy we the in the very made the announced areas product. very of those and opportunity and the CMO being in capabilities to house. As and we bring it's Because many will with capture, Concerta its of the has capabilities, aggressively with, would volume different of in in of of about presented currently look outside us is major a benefits of be one when relationships that we different extensively Mylan that manufacturing

will with work – division very sure to comfortable chain, similarly and activities in that. involved CMO to suppliers one, it's the And the at some are we we because the supply if bringing are process. obviously Amneal all the We those do multiple, multiple not capabilities into manufacturing just in discussion, that look closely to and continue of that of who it's people in make can

bring of early our So volume both on. parties, to that of a for major transaction the strategic the our one will of really, efforts facilities, benefits the focus is to Amneal and be

Dewey Steadman

right, All thanks and thanks, the for update.

Bryan M. Reasons

Thanks.

Mark J. Donohue

us. of rest Enjoy Thank Thank day. next you, for We'll course, may joining Dewey. this rest have. for all of you. you week, questions answer weekend you Thank That today. concludes your and follow-up our available of all the be call the any of to

Operator

Impax gentlemen, earnings and the Ladies XXXX conference call. third quarter Laboratories' concludes this

disconnect. now may You

Amneal Pharmaceuticals (AMRX) 9 Nov 172017 Q3 Earnings call transcript