AMRX - Earnings call transcript Q4 2020 | Amneal Pharmaceuticals, Inc.

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Operator

Good morning and welcome to the Amneal Pharmaceuticals’ Fourth Quarter and Full Year 2020 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to, Tasos Konidaris, Executive Vice President and Chief Financial Officer. Please go ahead.

Tasos Konidaris

you year us XXXX thank quarter Amneal's and full and earnings morning for for joining fourth Good call. Earlier press this release a reporting our morning, financial results. we issued presented the The website our that press well www.amneal.com. call as release, will available as at be on on this are slides will its a conducting conclusion. which of available on a replay this We're be call, our webcast of live also website after call cannot expressed that today's is be written without note of and copyrighted Please Amneal company's rebroadcast the consent. material remind statements statements. future made to call you management's outlook for this like predictions stating periods would I that during or forward-looking are These information to available based statements us. are solely that is on now We encourage release entitled press and Statements you presentation, which on this section Cautionary Forward-looking applies Statements our review to in to the call.

to listed can which which due XX-Q Report on or on many Our and and the recent are Annual reports reports may numerous on X-K, on Form most on on future website are you sec.gov. XX-K and our at updated Form SEC's website also current on find revised differ of our quarterly factors, our performance Form

non-GAAP discuss certain measures. also We

find U.S. will earnings presentation. to in information You will you Included these the use GAAP today's of metrics find some release. non-U.S. of the presentation, GAAP in appendix our we our throughout reconciliations reference a U.S. on measures and correspond measures of financial important to our that non-GAAP

Boyer and now as over and Specialty our Counsel call are and the Steve I Patel, Todisco, morning Co-CEOs; Chirag Joe Chirag. this Secretary. will General the Andy Commercial Chintu Corporate Manzano, On well to our call Officers and Chief as segments, Generics turn of our

Chirag Patel

joining fourth and morning, XXXX full quarter of the Good review in and us Thank thank year results. you for you. Amneal’s

and XX% in prior XX% pleased the are $XXX fourth EPS up substantially versus and revenue net quarter of strong of $X.XX. million, up year adjusted $XXX up million, adjusted of $X.XX finish with EBITDA versus our We with

next It’s a and met financially pandemic. operational franchise, of solid the we over XXXX possible phase specialty momentum last execution. significant distribution to resiliency our guidance commitment and us a operationally the position course not consistent growth. strategically impact the and X.X. over been been could in business, like generics progress metrics and would execution the Amneal and performance to we ahead performance throughout have XXXX very started. opportunities year financial our channels Since and or Our reflects Chintu of COVID-XX health made exceeded as the our take I This We diversify year-and-a-half growth years returned and reinvigorate the the our drive to Amneal outline public since course the toward now term are of a dedication enabled of plan our over strategy. both the clear our patients to optimistic and Amneal global strengthen for our strong continued of about few has vision despite with without the evolution have enter longer to our X.X and crisis, just then, successful our minutes enhance of I whose and to team years recap of the meeting getting needs we with feel months our strategy

main for have portfolio generics XXXX. approximately months, In sustainable we billion the significantly start our strengthened ability growth our and $X.X in past me long-term delivered XX three in revenues generics to our drive are confident we net reasons. business, which Let with in

our market share. will XXX First, broad to continue our leverage portfolio we commercial presence commercial products and approximately to growing of increase

of excited noteworthy our to remain beyond to our and new These hydrochloride look increasingly extremely generic launches have are higher Lidoderm to performance and we in complex cetera [Indiscernible] due as Our forward versions base we success barriers and et both in about entry. Patch, [Indiscernible] which business product XXXX pipeline. EluRyng, include strong was our XXXX launches

manufacturing to commercial we our Second, over to engine has on inhalers. recently fruit an substantial already begun years many only this and next such slowing across focus bear injectables, Put year’s another the product R&D complex been growth it is innovation-driven developments have and have intention our as business made of effort investment the transition in steps way, portfolio. few have ophthalmics already we we R&D down. has and This and taken transition long generate and no will to

our dynamic talented team. boost momentarily. and expected and this touch India Chintu acquisition R&D the Specialty make employees Ireland will Kashiv on will U.S., of possible Pharma further Our throughout already this R&D

business Third actively our growing in working are U.S. on ex geographies. we

are As but in almost our pipeline States, exclusively portfolio sales ANDAs today the you know, a have fantastic and of that. we generated behind United approved significant

process market in and begun of example, opportunity Chinese partnerships, of have products the and plan acutely the these XXXX. we generics the a Through four more filed partnership leveraging is massive in our have file it are we to ten in We commercialize Pharma, to China, FDA for represents. internationally already assets Fosun aware to through up

China generics to over one the here We expect is commercial this to business new coming in outlicense our just of More in the and strategies quarters. our multiple be to come XXXX geographies.

delivered approximately million net turn XXXX. in – which business, revenue now $XXX specialty turn our over me in to Let

KXXX, pleased promoted brands track and long-term ensuring In continue potential. leveraging short-term, about our in with endocrinology. very are remain and prescription needs excited are these our We invest launch Pharma this we will with KXXX Specialty is the unmet projects and readout We specialty on and Kashiv brands new annual is we of provide programs And four top-line two and next the IPXXXX million. two quarter building At the which pending Unithroid. too peak CMS address of advancing of with same third doubles we for acquisition of the the well believe revenues substantial year clinic. and years, to potential sales us their to to programs $XXX growth additional programs, X KXXX. in of early for annual IPXXXX infrastructure is deep in while project Rytary year the key time, programs, a KXXX and pipeline commercial specialty strategically announced five our expertise on investing the R&D at neurology in in pipeline Phase least our threshold our focused in

improved Finally, we good our flexibility. very about feel financial

in to the comparison, to net that adjusted adjusted XXXX, a XX months. net we debt at I was finished X.X As reduction the a two pleased EBITDA to x end am company’s EBITDA, x. X.X XXXX at debt of report over turn

continue franchise. financial to accretive M&A to enables transactions, our flexibility to commercial look and our us specialty improve our profile for will which build us improved growth help leverage Our expertise,

monitoring and including to multiple part M&A. a We in both opportunities larger are and Amneal’s make segment business structures of the partnerships coming this actively are evaluating we years

distribution move Let which with now $XXX million our to revenue. me business, XXXX net in closed

year are We as revenue pleased how the independent headwinds as perform COVID-XX. an from first business despite its subsidiary

ahead primary VA and focus expanding our share to our XXXX, and Looking remains DoD expanding market our business. channels Unithroid within AVKARE’s

believe or market expect a well five in to the it. is and of products branded addressable AVKARE we years, next generics positioned we large Over

effort this our on country. to production support touch briefly me domestic Let pharmaceutical in

the COVID manufacturing of know, chain United preparedness supply the strengthening highlighted and medicines local States. and of the importance As in we essential

Chintu, be growing to domestic manufacturing me uniquely operational record around and that there position the part further to call assurance who strategy expertise when more provide Americans while medicines savings, turn of an expanded over strategy. drug their With will us Our they growth let need these essential color them. be quality providing that, our will

Chintu Patel

Chirag. you, business every and continuity deliver let employee dedicated they to eco and commitment strategies Thank everyone. To acknowledge our Together, working tirelessly are brother’s sentiment, talented and site a smart me wellness. health first morning, Good employees my and to across relentless function.

supply especially We are our Together, results customers creativity of patients. for and ensures determination teams quality team to and XXXX. whose our strong frontline our and progress ongoing medicines grateful in delivered an

and and continue our specialty business; our and and generics flow. improve commercial grow We revitalize to pipeline; our franchise R&D cash margins

in XXXXand return these our XXXX us continued to were the success Chirag company beyond. positioned As sat we has upon for the and growth and strategies in our late noted, execution

to remain commitment quality Our and unwavering. superb standards manufacturing

high gross operating which margins. are facilities a our capacity manufacturing Our is improving at

to continue and good integrity have also the highest hallmarks since manufacturing practices been company our uphold its standards years ago. of We which of XX founding

foundation solidifying R&D sustainable growth. the team for is global long-term Our

Our generic pipeline delivery platforms. drug includes nine now different

reliably in-house and bring uniquely more are helps forms more efficiently. We positioned to to and complex and commercialize dosage chain cost our supply faster, market complex products develop integrated us

a spend few R&D. progress me minutes our Let with generics on

Our XX In we high and at within top two our continues to years. complex generics value generics to across late least launch XXXX, business promised improve bottom-lines.

achieve XXXX to We and will August we not there. goal this are by stop track on

new XXXX XX in to seven to six forward. least at we a filings ANDA launch basis expect be and forms. ended dosage products of products to expect will XX going least at We yearly also XX% non-oral We solid high-value which, on with XXXX, file

patch, a and of Mylan can equivalent role other on you our is Ortho there generics of the market. Xulane, As in announced and momentum the only clear we Ortho Evra see, business morning the that the with our equivalent core this which is fantastic example of will and Evra compete

several on truvada. months, complex of evidence We In further will strong this strength of start have we is also and products. our for last to XXXX. three have two the this since CGT Zytiga And portfolio months generic product lower of transformation one six exclusivity is and just of it launches launched only

the sterile generics on growth XX months, retail meet better next We rapidly and XX demands are which institutional our complex meaningful products growing will of our in to generating the focused over business.

inhalation to not Peptides, Microspheres five next platform and our years, including the Over And , products XX Otics. but Ophthalmic continues strides. at Injectors, launch, Auto to to Liposomes, sterile we least great limited make expect

inhalation and currently targeting XXXX. in launches through with several We area we product approximately have this are filed under development three one

via commercializing we for for time. products to developing As be can partnership explore ex-U.S. Amneal believe this sure over we be growth meaningful and continue we these significant will On segment opportunities complex will of which very biosimilars, be a model. generics,

innings, over and quality like are biosimilar playing time While behave into generics we we still will more of the complex the manufacturing market execution. high the Amneal’s in early believe strength market nimble

actively and and strategies. commercialization that development utilize innovation a partnership are scientific lower cost-efficient We evaluating risk models

I R&D opportunity areas generics, wave growth the most remain represents. opportunities would biosimilars. second an specialized first also the deal to and other modified the center and market experienced to with release Starting as in like Bridgewater complex been therapeutic file by Specialty take being with our second to of boost pipeline XX in our us through KSP to now and partner, drug will first Kashiv walk categories on and in New The hot-melt Kashiv team across of forms. has R&D opportunities provide that the of operations Jersey. acquiring extrusions Pharma also We network potential one such adding will a of excellence combination, focused all or manufacturing a of scientists successful device deal

Specialty, we excited to technology Kashiv’s Moving a are drug delivery. about in proprietary

and for dosing once-daily for also These but drug. extended long-acting XX icebergs. the to that of Grande, suitable for Let’s The gastric absorbed application the is X are controlled hypothyroidism. release is PX has we KXXX. Gravis XX upper stomach which products safely significant this release Grande technology the disclosed is delivery technology last substantial. has is which promising. XX opportunities, similar Sialorrhea up with for potential the tip a just are compounds of release. with human to commercialized in allow behind subjects that KXXX sustained are to retentive expected of tested hours for technology, XX Through KXXX, start early-stage been all most drugs retention trihexyphenidyl these in far. the XXX incredibly Both hours Kashiv that to in KXXX have which to Pyridostigmine of commercial of set of for typically Myasthenia allows a candidate delivery Kashiv’s so to compared this GI of only products the provide technology is drug are expected hours KXXX track. are for and XX%

is timed, advanced delivery a engine customized to symptoms. pulsatile and an The For organic drug will timing sustainable of the create KRONOTEC instance, osmotic and addition Amneal’s disease capable their specialty. growth provides these match for of technology release that platform technologies oral

existing and R&D to perfectly measured increase both KXXX budget our areas product also our in in and therapeutic of branded endocrinology. internal and the way, KXXX a to expect We development directed a focus responsible align with share neurology

novel and molecule platform. require carry the naturally approval versus are lower program, with and cost to So commercialize cost risk development. be will lower synergistic so Also our development these lower they XXX(b)(X) naturally

Our one passion quality starting following is to results. our acquisition our will we life improve for technologies XXXX. products and pleased of to the expected least KSP at per of patient-centric we product existing with meaningfully and of specialty we performance have the growth patients company, potential these positioned Across and our believe launch in be are year XXXX improve

Our our growth call for collective healthy continued I will single have in to for make efforts by also over now XXXX remarkable possible. remain come. turn years Together, sparked momentum driven to motivated to the and we purpose Tasos. and

Tasos Konidaris

on compared Thank you, to $XXX million XXXX X%. was XXXX. fourth revenue business compared start and down products driven QX and up QX $XX to XX% offset while was second, promoted basis. grew compared specialty at finally million, launched let due discontinued to accounted and line of discuss of AVKARE XXXX. of flat a declines inventories; $XX quarter with the Generics’ Chintu, net was growth in $XX double-digit financials, XXXX XX% Levothyroxine of brands or our XX% $XXX up quarter $XX growth guidance. customer; for income million, walk well Generics Sucralfate, full fourth majority $XXX XX% large sequential me or product as as was to rise lower return first, year our in performance was EluRyng factors; growth for revenue our were Diclofenac. our three million or of while Net Adjusted million with of by then the revenue million and the consistent XXXX. of and solid and million in XXXX, finally, of combined $XX net the generics or The and This million gross of in Specialty rest reflects our portfolio essentially expectations. a margin QX XX%, single XX.X% COVID-XX. from a a non-recurring in

of Adjusted $X.XX by strong margin reflecting management. XX% up average performance. lower or EBITDA was XXXX XX% gross AVKARE $XX QX expense million reported was growth diluted tight in XX% Adjusted specialty generic $XXX for the adjusted mainly the interest XXXX, respectively, XXXX, consistent was EPS QX EBITDA While overall our of and with driven ahead to growth compared expense. the and and $X.XX adjusted of well million

Let COVID-XX was versus product up driven our XXXX This XXXX Specialty $XX XXXX the EPS million. XXXX. basis, and and launches million, related million Generics perspective, From XX%. plus both AVKARE flow standalone discussed margin non-promoted million. reflects XXX stable was our we we Sucralfate $XX year market XX.X%, million XXXX of up were to million, for cash AVKARE gross me share $XXX prior the almost XX.X% or the well of line of XXXX. the of was performance. net with year $X with in our $X.XXX billion, RMS XXXX a Adjusted rate diluted now revenue reflects XX.X%, points while $XX level Specialty XX% finally, On in in and in due expectations. at distributions ahead and million or Oxymorphone as lines. cash contributed $X.XX, Total for or offset double-digit of product Oxymorphone of for This a XX% EluRyng up added EBITDA reported X%. full $XXX XX.X% $XX offset COVID-XX generics XXXX Adjusted Unithroid AVKARE million, up declines for throughout $XXX summarize disruptions. $XXX million operating net generated growth headwinds Rytary expenses $X.XX growth average. net as to was XXXX revenue government in quarters. line basis million, full revenue brands, $XXX new was new segments. by offsetting and XXXX. the was Diclofenac million, and record compared broad a $XXX XXXX mainly or Levothyroxine well competition and gains Adjusted

and to $XXX key partly This $XXX $X Excluding we range million, by we of to million, the favorable guidance processing delivered of due customers. XXXX. of $XXX performance discussed to compared our of was million timing refund certain $XXX million in - expenses quarter, the collections second ahead million in tax

strong a today. position result of a Amneal in stronger much As is our performance, financial

$XXX As to as hand December to EBITDA was x to XXXX in a point XXXX we mentioned, debt of year $XXX finally, And X.X reference, Chirag x our improved generating million, earlier. in amount our cash. net on and cash of adjusted million compared X to compared a substantial are

growth. expect year our to we turn where of now me another Let XXXX guidance

First, specialty, the growth we us COVID-XX in issues from begins related $X.X leveraging product behind continue, legacy and for future COVID-XX offset expect billion. the X% long-term exclusivity to will the growth double-digits and in XXXX, $X.X grow product range should disruptions. revenues contracts are disruptions. billion by AVKARE new ready launches. is business Rytary new Unithroid of net as launches the accelerate to and loss In less as expected less to Generics itself

Second, EBITDA million. to we $XXX range $XXX of in expect adjusted the million

product full expectations benefits XXXX and Our actions. launches taken already and efficiency place, launches, are growth include expense of balanced year new operating

also guidance to general throughout expenses higher XXXX. high in economic long-term G&A risk and increase activity our drive R&D commercial to as picks neurology includes Our up in and in endocrinology investments value, footprint

we product as to Third, million to rates, current support the expect technologies adjusted in to of statutory our in $X.XX new complex tax in range of offerings. invest CapEx strategy expanding we at our reflecting continue to range EPS the federal $XX EBITDA expect of the $X.XX we strong growth. adjusted million Fourth, $XX new

Finally, range to timing million, in $XXX earlier. I we quarter XXXX expect $XXX which of fourth the benefits reflects million flow cash the operating discussed

will of can specific the a diverse gross shift provide expect in profiles that over business margin specialty With by in gross substantial margin the of segments AVKARE. noticed, led it As business have be we that, and you XXXX expect expansion Nevertheless, stability with me may significant we to not Chirag. guidance. also part such but let mix our have with did turn three we generic The and impact.

Chirag Patel

Thank you, Tasos.

confident. strong last We are pleased over the year delivered with and are the performance

beyond XXXX Thank your We are well to the I to in our positioned turn to and with the call over like X.X questions. to growth operator take drive Amneal now strategy. you. would

Operator

go The of Sandler. Instructions] comes Please question Piper Amsellem from first [Operator David ahead.

David Amsellem

thanks. Hey,

Just a couple.

contribution thinking So, patch. some the on talk you the you color are additional you particularly, today about the guidance get and on have wanted and to complex how first news approval generics? top-line about can Obviously, from

in what into have risk-adjusted and mean, is So, I you generic, But from and the there. in baked that’s a top-line do else this grew talked you COPAXONE the say, EBITDA? which contribution up. about past

what’s pegfilgrastim, we there. us the additional of So Bevacizumab, to are talk talk Thanks. filgrastim about prepared you are the the that about in? about then, just but in understand on might terms And additional products the see in opportunities? secondly just And what you three, I know help biosimilars, talk investing coming year and you in

Chirag Patel

Well, thank you, David.

for start turn first Let to and then it details. more Tasos me I’ll over

is your question NPOs. on first So,

do list competitive you reasons. know, them we As NPOs for out generics not

records best presentation. number speaks more itself. time this in our We did for X track the of Our slide to color give and X you

successful, if So gives we nine categories major those, pipelines the each where been categories. you trending very it you for at look now includes which have

have bottom achievement on Zafemy, So, you you got what’s was patches get vaginal the broadened much Slide And the approved five the the Patch and already. those the we go X, ring, pipeline. we end tells remarkable Actions insert introduced Lidocaine pretty all if in approved. implants to to a it you top ring,

New New our comes England, it right Jersey So facility. from

have $XXX area, the year is mentioned, that’s few, injectables Chintu big we would liquid last launch coming inejectables, have. we products subsector now manufacturing Jersey these the spray, multiple New year Topicals, Nasal infrastructures we only as well. The we so, have but and we’ll million. were products, pipelines. GX, growth we in still are in in filling are which And topical. This sites. as all oral So still in years did we of good say,

volume like growth we in products ophthalmics invested coming as coming well as the other parenteral in years and large We sterile well. products have huge potential just including

the And which Irish X. FDA standing value, We then products shows page few at X and you typically FDA, further paragraph launch our we exclusive approval, have broke a of first our we from down products. high expect what and single consider inhalation bunch plant. we the launch sourced, of OSC on And

a pipeline product year active launches architected six, value it’s XX% give products another more. of to products. mean So high nicely our next still are XX And – non-oral every expect very this XX% seven only are year. products, I six, and pipeline seven We year even

I So, enough the add question. you but hopefully, that color product biosimilar new can to gave I’ll your then Tasos launches. first a the did not products, our answers on you give specific question give I bit and more. answer

a it’s I’ll I and what repeatedly, broad our question know, is strategy. question this So, get and

we as company part ourselves have So, medicine of years, that. as we look over as built affordable an at biosimilars

they within So started in and Biosimilars, are like XXXX in XXXX, we all We in-house. generics nine the have products doing ones and we all a investing same. are GX, complex this categories.

We deal out players starting clinics. t and more have there have a you to We the it generics lot products. that. We model based to will buy of The would with the their go believe complex will hospital-based slow. on – with are bill market, deal of like behave it’s

complex two. it four, player you will generics, or much that So, it based all market than first will place, three, generics. eventually, lower third competition, it complex will if five, have a become which will six We more share are influence unlike on at sometimes you know the have, fourth sometimes have

it. three all after forward working way, these going the been I’ve it products. FDA products with should develop So, cost-efficient on the

years. and we generics, clinical built - complex it’s our biosimilars, to here next next we set and the for doesn’t bank. break in marketplace, strategies the of like which off are competitive Because, play all trials have of ten that’s commercial the So this and just

So, or year. at even one we look quarter don’t a

the coming years. we and in players We be the leading will this do will

how next it well as over looking good a second will next of Tasos, wave progress whole toXX the be are go the quality So, and eventually, as the market high manufacturer we matter first really manufacturing facility And States, know as biosimilars. on in years. our can XX are through And was that known focusing advantage at lot our United because biosimilars. on the is the we or we building ahead. key more you

Tasos Konidaris

Yes. No. Hey, David, good morning.

David Amsellem

Good morning.

Tasos Konidaris

A top-line, great those. about We couple our of number feel one.

I’ll because talk a bit little So, bit is all on right, the a which little riding treadmill, generics, us know about of a like continued price pressures.

However, team the leveraging strong months, gaining last I a leveraging great and over skills think commercial XX share, Andy’s market pipeline has built. job the have done their and we

and So, a to introductions, growth replenish product looking the is in base rely up resiliency, new last are on number as Number not the rate very well, just one. the it quarter, two, you saw QX, result, all high to business solely in going very XX%. was we simply So, do right? revenue generics

right. three, approvals. morning. new Xulane then, have in And this is and team introductions have a place continue half NDAs great definitely taken new of are it the and in not to those already second right. revenues, product big So now, into of top-line innovate, already the – place, of the XXX part of a stopped generating was and year his right, feeding taken we scientists getting number success last Chintu

but We jump bottom-line great at the COVID-XX implications. this growth on double-digit one. growing a which had That’s in continue to number accelerate lot rate EBITDA rates new in was high, the AVKARE we about X% growth two, the generics the launches of the Point on talked a why point So, from just to XXXX space, as number the drive is year. not top-line. growth which expect product will on generics is of

for double-digit expect growth And business. AVKARE specialty our So, in XXXX. we another finally,

patent, middle going is in field way share. the is historical that space time, in grew force also they business off of Rytary generic and terms in in grow we specialty as double-digits, So, same Xumane I our of XXXX mentioned. are to Unithroid same capturing transition, the At as footprint our a to investments making terms in right, the are we of of the in have majority a market the going expanding strategy commercial and

transition launches some XX% next and which such couple going folks of in to to ready But getting of the offset are finally, guidance. expect, to headwind. So grew but the in few the assumption? going ended team hey, And new at it over the not and some is do is KXXX, next thick things, as the grow it’s same the Listen, for as – I why, increasing is to grow time, that know top-line – product that’s going and grow business it’s in at going think right, XXXX, COVID-XX years. bottom-line of IPXXXX, how year, last then, about we you wondering, we up both also

though, impact. we grow Our At the way. time of an expectation expect this year margins in is less anticipating COVID-XX should not persist, same not but we our are

QX Chintu pipeline. building and last QX the have Chirag, sales, top-line of chain. spoke great encouraged you job in and million team If on about of alone, supply remember the stressing year, in $XX of in our his a done I orders

as quite XXXX. as expecting much So, not we headwinds are

So, address that questions. a lengthy, your but hopefully little

David Amsellem

guys. helpful. It’s Thanks

Operator

Nachman Capital The ahead. go next from BMO Gary question of comes Please Markets.

Gary Nachman

morning. Hi, good

are which highlighted, where aggressive to would would there a current to is you. with? good in Kashiv deals go in regions? that? the identified very ex-U.S., extending small you. be specialty, source pipeline of other First, that diversify do expansion? talk beyond aside in you in expand to terms neurology Thank you look of a going for the you of be As and would else just China, you And potentially from of Are How or geographically? just And area companies to going then, pace consider lot other about business endocrinology you’ve you of that the

Chirag Patel

Thank Gary. you,

to in excellent neurology is us has drug pipeline grow our Kashiv the allows platform, So, current endocrinology. which way and which in delivery

not years big the We all unmet years, we delivery by million vastly revenue become can to are thirty the big improve it somewhere and products, twenty pharma, the drug to would million. over $XXX products $XXX older where are because ignored needs technologies targeting molecules these where use our

So, business if are specialty assets. those would delivery it now, larger right forward. be a as as we could drug more portion launch opportunities as look find specialty as of to well. want we specialty, well assets, these And neurology make pipeline outlicensing specialty we and focused But products we add we globally the Amneal’s ex-U.S. on would And to We we going endocrinology. solely on the into products technologies. much commercial

has in a China. interest know China on significant Amneal. equity is attractive, The position Amneal second position, question and Fosun in vested very as they because you have

So in they identified in we have on China, came back since have a us am over we I pleased two the China. on China currently trusted in and now to pipeline gas which see whole worked great it and we a are three allows – to top years partner

in generics certain So, with States XXXX, molecules. looks it better than United

our We expect and have a and partnership in meaningful presence on portfolio. to building continue to China

The second market value will our products. be we technology-driven pipeline, high inhalation, products injectable mentioned certain products, Europe, and within right, for it just our

targeted, to looking ANDAs not of hundreds know, very international have out because as you in are we So, markets, crowded. it’s

to revenue Thank assets take to additional best U.S. our want it just you. we and via So, increase based revenues. our

Gary Nachman

of just lot are other that other Okay. Kashiv. There like one you’ve was that identified on potentially? deals There

Chirag Patel

on focused Right the more are now, we commercial.

actively look we into our good passion. are on pipeline will targets – that’s have So we and we and we commercial Then pursuing.

for quarters. both, now, right it’s few But commercial. R&D So, and commercial

Gary Nachman

you. Thank Got Okay. it.

Operator

from ahead. comes Please Wilbur question go Raymond next Elliot of James. The

Elliot Wilbur

still – room in improvement been am like market. to of I upward – business. think XXXX driver XX% follow-up optimistic wondering of Thanks, lot And number products case. am and right, over But longer And GX seeing approval that are at to make cautiously the is balance terms that COPAXONE you a metric? cadence the But in you movement incremental in potential XX% where that market It some and interestingly that of wondering we’ll there it is it for term? of of the just a how for quite seems gross been out there is ultimately a you’ve still we pronouncing clean also am for think gross not market a quite quick we aren’t mark And we even I in metrics. What about margin in are is constitution growing previously, of about can bit XX dynamics potential number second am you follow-up you the be of I dynamics can margin in you I that five curious I But question a said, at year. accelerate of then, market. yet. now actually morning. were then years? Zafemy? on in XX% think product that’s to business want I to can the think this am a point the Congratulations margin second your this half do sure business a in maybe or three going new on of you’ve the detail us that generic really in to that’s share? – of think in the kind towards working that something also, if just XX% of product. Thanks. generic forward, year-on-year. it’s Tasos product respiratory of capacity sure been launch as And better And thinking that And know what supply to if given sort you terms with and good I the there by if

Chirag Patel

you, Thank Elliot.

manufacturing First capabilities. question Ortho on Zafemy, Evra, our

been capacity. XXX% will competition not All expect CapEx you we in. As come say justify always complex out we we know, these not The as always manufacturing, that. do to

we case, XX% XX% at starting this going few in months. to around So, in are out

And always when So have there. grew. market good CapEx seen, our we it’s capacity launched allocated – that’s we Sucralfate we we how as and a have

grow in expect the to we So options available. generics market that are

Second gross on launched question your medical historically most and –because margin and enjoy of we products launches, point COPAXONE product question, remain third And want that’s our higher to be the I itself. just of XX% are this to and out by optimistic of we year that products efficiencies new plus the always both. and

profits in with not do we other So, share compartments.

the will give more But grow. gross expect to margins we So, Tasos you color.

Tasos Konidaris

good Elliot, morning. Hey, Yes.

this So, business a margin. the Listen, Generics of is I right. year, thoughts. think couple gross great

XX% XX.X% year. full gross for about last So the XX%, year, of year margin we have versus

And get excess you are not and the So the number there to a new trajectory sure, continue started plus improvement of gross which substantially substantially margin two, me And and XX%, was the of as right, confidence But excess XXX whether than Chirag in remind the the we but only for us to to year. go in after XXXX, Chintu we points one generic us gives in is product XX% number one. excess or terms quite know, almost XX%. definitely margin annual the the that positive, in of XX%. products introductions was gross scratching margin in us as legacy basis just of new surface we will not higher gives say

So, gross Number gross before, it’s time. new sorry, Number over average but of to there continue two to key they product good long-term, the the one, substantially efficiencies more cost am one than number XX% one margin mentioned XX% excess margin of introductions, a improvement after. is have chasing are than XX% probably an or is is, go is, number whether drivers not so, of that’s of more as I substantial - we two-fold. That’s amount essentially one. XX%, or also target I actually

For about the it’s cost line, goods $X billion, of right.

not for our baked by whether or are teams, we manufactured our So improve looking third-parties. our products it’s right, right, pushing actively it’s purchasing – or efficiencies not manufacturing purchasing in-house, power, whether to

as a for believe us room is to margins, good there opportunity I improvement plays gross I finally, I there. right, over you represent year new those AVKARE think looking the for think specialty, So for think know, And pipeline we time. still over for well. that then as are to And time, continues margins stability we I out, looking and expand are as then, next

Chirag Patel

for works that you And Elliott?

Elliot Wilbur

Thank you. Perfect. Yes.

Operator

next Ami Leerink. from SVB go of comes The ahead. Please Fadia question

Unidentified Analyst

if for on taking [Indiscernible] Ami. Thanks for can. Maybe I is our two this questions. Hi

thinking generic of new expect on you curious medicines you any updated this the been a do additional of entrants. I EluRyng, bigger year? And on to about there am just are And then, is durability this picture, we add how generic maybe Just product more then, U.S. domestic given there in around if of days of how and I am sort you. participate essential could President views curios in the has Thank initiatives this? manufacturing early administration, the for in guys just are discussions XXXX

Chirag Patel

Well, On you product. thank you as EluRyng, launched know, much. Terra very their

competition. have well. already get competitor, another We we So as may

we see The As the XX%. we a Good complex. pricing to durable. offsetting a XX%, market pressure now It’s share still and volume reminder, product. as was our is grew

So forward, always this good a year complex like. the going products will contribution is be great and as it contribution

and a on lower, United with We large already in a market remember in haven’t days make much here don’t say, medicine industry what review million focusing XXXX, XXX the XXXX, they heard administration, and XX contributor will less competitive the any it’s be competitors. reveal XXX on chain I dose plus in last would and America in States. billion If unit the solids everybody this make is probably don’t. in years year. And oral your XX facility. due as much will four But question days it we pressure supply I total make especially United has gave that we to some manufacturing specifically and still number pharmaceutical a what it to is than hundred manufacturing. And comes, more and the States in for the Biden essential and meaningful we that review

we So, well. that’s much Biologics, make example. one as don’t just here,

at universities capabilities supply to to needed. of any right by capacity I here capacity in our not is country? need in against have of whether going it’s pandemic, a why chain, And capabilities United make ourselves don’t have end and to what manufacturing XX% least global reviewing. have Congress is we supply and supporting capabilities it’s XX% that’s simple products, is well high not, this emergencies, both not and have up That whether states Biden it Also, are in administration am We States. but And utmost the making And – case is – and chain. happen. XX% the is happen as own why sides global XX% to the interested, as many a So we this to right, stepping so are generics, why the them the is which to biosimilars states, initiatives. and

Unidentified Analyst

Thank you.

Operator

Please comes of next Greg Gilbert question The ahead. go from Truist.

Greg Gilbert

there ways in participates and it AVKARE, that strategy on curious, if going NDA? on XXX? industry? make how not Hi, to the it a about lastly, talked Thank Chirag, it’s that but I Or question play does questions difficult good offer generics, that’s And it? or and file do an other update And Secondly, could as the a does the share of longer kind a Can when of thoughts us immunogenicity enrollment leverage you longer you your going. have to I maybe when an term approvability am if, and to assume to you your assets are might there? morning. for something in on along think term? growth technical soon. How hurdles play the chugs you. other strategy Should into a role you we bigger that approval about expect get I

Chirag Patel

Greg. you, Go Thank Joe. ahead

Joe Todisco

– Greg. on I’ll three, take just I’ll Sure or two

are the of a by middle be patient track results the in going We to have comment not quarter we we a that There year. safety on XXXX. to but to this on are NDA the is top-line follow-up of numbers position file specifically do by to fourth expect

Chirag Patel

anything? you do Chintu, to add want

Chintu Patel

in we No, expect file to a non-res oppressing. XXXX

further awaiting are FDA We comments.

We or areas biosimilars of expertise anything immunogenicity and roadblocks. on of haven’t peptides other we in-house. other other have any But the understanding heard in-depth and

the for CR this to broad we the FDA. be answer think are on So, science further capacity. is any on of in and But Chirag as first and – haul us from focus a and a evolve markets comes wave come to on or term it biosimilar next focused these response five company biosimilar, for market Greg play to swiftly years. out mentioned, that are ten biosimilar second will have. will to must equipped, We long long-term we I into and second And is you manufacturing

Chirag Patel

question for AVKARE. And Greg, your

VOD. business like seg One is VA them are is, – there we of up, VOD. segment So, part Amneal two because embark right, for of reasons. multiple and that that AVKARE, coming main products we as VA brought We

that is stages. business its those we need grow. which to second So, expect you is And at nascent

Branchburg, Jersey plus New eight from facility. launching in are liquid We unit our dose

dose. closer customers. grow one to the step we should to get on that a And So unit how is, one closer third do

about So customer. to which platform, we use talk may the always on ready we step to closer like, are looking are not it one but to looks we AVKARE get how

Greg Gilbert

Thank Okay. you.

Chirag Patel

Thanks, Greg.

Operator

question Balaji Barclays. Please next ahead. go Prasad from The comes of

Balaji Prasad

questions. A of everyone. good Hi, have lot them Thanks the for morning, been answered.

Evra. on Just Ortho

does thoughts in biosimilars, peers it future lot the terms But does your this Chirag. strategic side, the a be on again a being So, also, XXX helpful. assume other recently this I market past of what XXX one. the of seeing for signaled giving the there one That to designation you no future? biosimilars is exclusivity. is in Mylan on near saw space? into Thanks. and around you reversal that But investments competitor imply is Two, of for or that years, fair six will it days in CGT opportunities? color, a segment is that on influence alone That have you day How in anytime the the

Chirag Patel

you, Thank Balaji.

So, be very competition now this any we’ll it’s for if year. it And would that complicated complex Ortho product. limited extremely Evra, the

the million development – be strategy product. there. people $XX On the having to is million, $XXX it’s generics and for making. and returns It is the is where commercialization. be It’s cost-efficient are the to biosimilar some will biosimilars, invest the not competitor is – It the product. right. It cost-efficient we same you has a XXX What product, that our meaning XXX, do can’t

quality, integrated high well complex believe that manufacturing, it’s I science, – sharing affordable a manufacturing our ten, DNA the five, of like lot more company And will United not the will medicine the and It’s matter area portfolio here. make domestic in play nation in right broader the you leading have we States. our as case, your whole company in it’s in years margins, - play will twenty to And in a generics we invests manufacturing company believe in just big in coming as So, products. what a those do. it’s are fifteen, and and

Balaji Prasad

Thanks, Chirag.

Chirag Patel

you, And Balaji. that’s will it Thank play how out.

Balaji Prasad

maybe field, from the in are cost If three should on significantly say, years and or exploring let’s competition Just be you investments more more the entering now? two, follow-up, companies anticipate do lower, one lower, of or that.

Chirag Patel

it. I I think, peptides. not lot is similar and manufacturing than complex Balaji, The it’s mean, there more in to complex like these a It’s is a in task. Transdermals biologics it’s involved peptides, in all microsphere generics injectables easy and an is

will there yes, be to product. be So, high quality supply, competition, we but key going can consistently the is

Operator

questioner time due constraints, And Dana Guggenheim. will Flanders last ahead. the be to with Please go

Dana Flanders

that few for on revenue years two just better spend, you Should some from and are brands? diversification you. for that of time? And Thank a guess, value or spend just bias on over a and business, from R&D shift some Thank some it do generics a to to Or downside does guidance, upside the squeezing seems question ago. are And diversified quick much we I I me. know Maybe, think number? as just of just profit R&D on mean but you had at just you there focus positioned to the second then, perspective, first from lower what branded kind business, investment gross lower spend ones. Great. value shift wondering like, my than it – see total upside increase just you quick over you standpoint. generics least from I me, comment risks you base if could and how to always

Chirag Patel

from and to you, hear you. good Dana Thank

seven you right. concentrated the have keep were ago, is we The many year. is Few key complex highly we product launching and generic products highly are launched we on one every thing products since more now. diversified business, years first six, the are few complex It’s

specialty business base which offset we we XXX, R&Ds will for than more you or for be we we Transdermals, will have Topicals, capacity So generics. injectables, than more as pipeline stay base the dollars GX, on pressure know, to within lower more now. previous the business. refreshing R&D, continuous of to finding liquid is are On all so a years this and expanding XXX the also around subsectors allocating and But and is opportunities XXX(b)(X) as

As XXX(b)(X) will expenses. again, we any more. grow, we are they smartly so it’s in of invest kind But, not

answers questions. I hope So that your

Dana Flanders

Thank Great. you.

Chirag Patel

Thanks.

Operator

session attending quarter This you and Amneal Pharmaceuticals’ concludes Thank our year fourth XXXX full today's and question-and-answer the presentation. earnings call. for

may You now disconnect.

Amneal Pharmaceuticals (AMRX) 26 Feb 212020 Q4 Earnings call transcript