AMRX - Earnings call transcript Q4 2021 | Amneal Pharmaceuticals, Inc.

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Operator

Hello and welcome to Amneal’s fourth quarter and full year 2021 earnings call. My name is Alex and I will be coordinating the call today.

If you would like to ask a question at the end of the presentation, you can press star, one on your telephone keypad.

If you’d like to withdraw your question, you can press star, two. I’d like to turn the call over to Amneal’s Head of Investor Relations, Tony DiMeo. Tony. you, to Over

Tony DiMeo

and thank XXXX joining issued earnings our press release and at and a fourth full reporting release The results. year call. financial are you morning available Amneal’s amneal.com. for quarter press presentation Good Today we

press conducting note of now a this but impact a regarding made this filings this review that which certain to replay Cautionary SEC’s on Forward-Looking These refer entitled, call, Also, after release that website matters We encourage the webcast website management’s presentation on outlook for our discussion please future numerous our for SEC that on statements forward-looking on to future not limited call available including that available are of applies statements not and be the our is live call. historical that to the are the to based section our solely you a to of predictions may We will call. our Statements facts, are factors are and Please during information or in performance. periods, website us. statements. Statements

certain reconciliations in and use on Important measures. these measures of the be of appendix the and We information our discuss to also may non-GAAP GAAP release U.S. our found earnings presentation.

the turn Chirag. Konidaris, On Secretary. Chief the for call specialty Jason Boyer will over I the and Andy CFO, Tasos Joe Officer call to Chintu are and Chief Legal Chirag co-CEOs, this Corporate Daly, Officers generics morning segments, Patel, and Todisco, Commercial now and our and

Chirag Patel

important the truly our version biosimilar we moment to market. the Thank Amneal a everyone. and tireless bring of were filgrastim. the you approval Tony to Yesterday, morning this is to announce biosimilar effort good watershed teams’ reflects oncology for This so Releuko, of and thrilled

broader On in the discuss we biosimilars. strategy will call, growth our

execution. exceptional results, results off Amneal in solid of fourth and quarter, year to performance a capping Turning delivered the

revenue XXXX, XX%. year EBITDA For grew the X% grew full adjusted and

Before two moment. diversified back us forward, much Amneal for I and portfolio. returned a we more and years with a let ago, a go a company now look half stronger Since Chintu is

We that team well. engine revenue or R&D executing rich Since talented place is or our EBITDA in driven million with XX% innovation pipeline is global $XXX is XXXX, and adjusted are by XX%. up $XXX and million a

is baclofen As that pipeline Saol’s as Also, of chapter Puniska we next deep Specialty, capabilities our growth. ever. and have the we added we have our acquisitions franchise of believe power grown, as through key Kashiv innovation Healthcare, will

our that biosimilar. injectables, and reflects forward, guidance as of areas line of growth such specialty, top XXXX continued bottom ahead business, growth launches and looking the Now includes in investments higher

term and Our we and successful innovating, right and We ability continue we At the reflects are the growth diversity making team investments continue have growing to our believe of growth patient markets. increasingly higher as profile the the core as business several on access is Amneal’s we strategy essential growth mix growth needs, higher shift end a medicine unmet and Overall, accelerating positioned right key areas. the profile. growth our years affordability, of while in sustainability the focus several be and global to our strategy to and towards we see company. long well executing providing over next

product has approximately R&D our new generics for now $XXX industry We retail USD The with where robust strategy products. both brand business to last over billion $XX loss business, remains pipeline me products. decade. Starting revenues which and of In years the next revenue XXXX, few are robust retail the we exclusivity billion grown portfolio total with consistently the in grow. our expand facing the growth high delivered key diversified we Let net in our engine through level, each. new walk the a as continue with at generics XX in areas complex significantly market $X.XX our has and billion see for and in launched today

our in drive generics our for and We non-oral our revenue With our of innovation manufacturing, commercial core in are business half XXXX continued complexity excellence retail which retail our line came forward. will portfolio, going underscores growth is more portfolio. non-oral we momentum increasing clear sight durable R&D, solids competencies complex continued expect years. our solids, pipeline quality the of of from our to and shift and to and confident continued a XX% of that generics in About generics

acquisition the we announced QX. in injectable our Regarding of Puniska Healthcare generics,

to to reminder, infrastructure, key we key with a January international U.S. pleased of in baclofen Saol transaction that, Therapeutic’s and advances few were a acquisitions ways. adds Building announce the the support manufacturing which our another As franchise, capacity acquisition capabilities markets. strategy tuck-in the on in and

our million. our $XXX about First, injectables expands Lioresal Amneal it expands with established, to neurologic durable spasticity in business presence and an institutional institutional product into

adds our June, Second, approved Lyvispah specialty a in of institutional team year. third, adds commercial commercial planned advance in biosimilar with it further launch also bag this specialized to the it recently and launches

$XXX global the the on to We way as aspire XXXX we revenues institutional in will remarkably excess the capabilities, and up injectable XXXX top we market in the States to substantially a of United strong a with $X we become portfolio. time revenues be larger also injectable by as business five global later in Over billion million [indiscernible] player. ramp expect expect scale growth part our annual the expanded of injectable in

$X.X portfolio these our of is Now the The enter products. $X.X in products billion in portion. biosimilar addressable billion to total initial for XXXX with representing market expect biosimilars, we three with the oncology market

looking revenues be with we build products revenue exclusivity for additional actively early opportunities we [indiscernible] the approximately to or loss biosimilar will share preferably robust partnership biologics time. the to in decade. expect billion second. also After can gaining initial total we’re of adding next market, in facing launches over first and portfolio, those, $XXX the at where Beyond remains pipeline industry The

goal biosimilars. business, AvKARE is we $XXX through revenue. to meaningful we a performance in global build saw to business solid being our with look player a vertically In million in-licensing become in integrated net XXXX and Our as in

We dose. as and channels, are we strong and healthcare channel multiple government unit execution expand market, across distribution the including on focused operational commercial federal

that expect growth year year XXXX, force We well, to million growth revenue. our Parkinson’s for in business year, $XXX while time product. In executed in at excellent this a carbidopa-levodopa the expand strong durable very multiple substantial product commercial our innovation achieve the going the see III our branded pipeline data patients. the dosing less good to we IPX-XXX Unithroid, several also had over team did Rytary, forward. for Parkinson’s In endocrinology opportunities same branded Phase organization potential net more this which treating has for an hypothyroidism. to our significant on frequent advancing invested delivering growth in A this ago showed led we time years. sales Positive specialty, product job next our and

single digit the our in market growth expect $X for brand billion products We high and pipeline.

on markets. pipeline, global the meaningfully execute our over portfolio expanding expansion we years. see advancing specialty international, several the several plans business our we we As key next in and are In rich existing

have we enter portfolio to next look to you Indian pharmaceutical to several be through starting through and agreements see that pursuing are $XX today, build by in leverage share billion our look are as we in growing projected a market to our in $XX hospital that new As Also, the I largest and presence know, Puniska capabilities execution. second XXXX. you markets. partnership healthy, innovation we came in-market go certain China and today pharmaceutical distribution billion in small to and hope geographies this year and acquisition India, Healthcare the excitement businesses other commercial have market. our business expanding emerging Fosun estimated to we In our

durable, As will we we to and I’ll With our Amneal overview, over and that increasingly pass strategy, expect it differentiated. diversified Chintu. progress implement be

Chintu Patel

Thank you good and everyone. morning Chirag

As who make always, incredibly Amneal I hard possible. start work and X,XXX-plus healthy thanking will to members acknowledging team by our

reduced chain on the our every to of resilient the excellence, remain As our same and good executed backorders operational supply across better Amneal these manufacturing you highest At competencies the our with XXXX, team a efficiencies ensuring chain, driving at committed live know, In are core and We relentlessly we supply of standards cost practices. the we driving day. history. focused on business. and culture time, lowest savings in and level brilliantly, inventory current management areas obsolescence quality and

all We our of track an are at excellent proud sites. manufacturing our that compliance we have impeccable history record quality maintained with

new you product innovation inhalation, our across me lines. and to categories focus combinations, through In we continue implants, across tenets as the on development our drug/device strategy growth and ophthalmics. walk opportunities now our generics, of business complex such find Let

the differentiates excellent, generic new this fast-to-market make which capabilities R&D our industry. In make internal XX XXXX, TobraDex, launches including expect every and XX believe of hard and approximately in possible, went we launches complex Our injectables. manufacturing and in Zytiga, of Burasol In and Zafemy, XX to Amneal version well to going Decadron, XX to XX [ph], as launches to year file XX as we another are XXXX, ANDAs XXXX expect we forward. which product

In of retail in number launch the ANDAs XX expect in continues them have and pending the industry. for to approval maintain XXXX. Amneal to generics, products XX CGT-designated we of Importantly, highest to XX

to launches business. expanding with roughly products. a expected XX% of on focused pipeline clear our have be our growing future first and to acutely to are these, injectables, In market portfolio or file. first we also We to visibility long runway another Of XX remain commercial

injectables We XX launch expect five to in to XXXX.

received approval QX, So we four have far new products. in already for

our first of are and another have file, be We or [indiscernible]. XX expected to pipeline pending for market, half to first injectable ANDAs products, XX over to which

a and XXXX we stated, combinations, injectables, areas, volume peptide, launches injectable previously expect complex large variety XX XXXX long over of acting [indiscernible], through new in drug/device parenteral including from bags. As

XXX(b)(X) unmet to target addition on opportunities are needs focused injectables, that complex In hospitals. in we patient

U.S. Healthcare bags of the commercial approval adding then in The piece inspection LVP Healthcare expect with the Puniska well Puniska our in syringes, a first range We we there serve now of many twice capabilities need existing global and LVP capacity ago we had as including year to [indiscernible] the provide believe better supply needs. more key early XXXX. international as pre-filled broad our with production site capabilities U.S. the Altogether, we and and will XXXX, acquisition We The to enter drug added value In global in-house broad our market XX a products expanded of XXX(b)(X) and across high bags, our three portfolio and more capabilities and bring is one market is and meet with expanded filgrastim, we our clear we year integration infrastructure. launches opportunity injectable XXXX. to pegfilgrastim, with have emulsion, shortages and a to next infrastructure the manufacturing serve of this to even patient markets. consistent is capabilities. injectable biosimilars: of wires lines, first to high we expect strategy vials, demand bevacizumab. including going in expected to biosimilar, cartridges and in production avoid injectable products market, products to Earlier the leverage

approved this biosimilar three product first made will launch be filgrastim, and quarter for Our Releuko, will in Chicago. in

be the approval. for proud of has as and can in first We target bright Pegfilgrastim add upcoming and market. [indiscernible] it particularly significant year more dates look of this team a second our are products is biopharmaceuticals, signals By in Amneal to launching bevacizumab our both biosimilar we future accomplishment upon have ’XX, biosimilars. to or the this action where portfolio end to ahead we so forward

being organically commercialization as start, As to to we believe business from develop biosimilar we to smart key In development manage integrated then generics, we market margins over to leverage vertically in the and well. to the shift a success and acquisitions our products time, build similar the complex and time. economics is dynamics way of success our partnerships look biosimilars, in to over

for in branded to spasticity excited very is new products June. recently are potential about expected year, advance Lyvispah our approved launch in to expect future the acquired launch this and and In specialty, to pipeline biosimilars. We product the two pipeline we continue

the and we will migraine DHE inspection for addition, QX in that headaches of autoinjector the launch site hopeful pending CMO and approval. are In cluster FDA

for track with QX on in launch middle Next, in of XXXX. remains expected submission the IPX-XXX ANDA

is of the on the IPX-XXX X.XX compared increased as Our continues we that hours see opportunity very $XXX validate peak to broader, to good for potential CD/LD market is meaningful I-R IPX-XXX. dose million to per development for work with as time commercial $XXX in million and sales view the

indications. ’XX of by myasthenia multiple For file KXXX are for to other we pursuing end gravis, and our expect we NDA

modified of KXXX, program For technology delivery Kronotec. year. release This our plan drug middle utilizes our Grande platforms, a and IND product in this we to TX proprietary XXX(b)(X) file application for hypothyroidism, the

Going one least forward, year. we at per expect to specialty new launch product

specialty on the currently XX our have with clear $XXX strengthened between have peak XX international, for are full team us to our potential billion with pursuing we infrastructure expected key plan products for markets last our over we foundation and markets. $X strong few enable register in we pipeline, several around our business. In the of China, last we in established XX sales. growth to the select For area our Overall, year, in a is In built the expansion world. to see of the each five and million strategy XX by years to time. place to XXXX products filed over In end in

are core innovation, sustainable growth. company, competencies in term to leveraging quality position a for superb we our us manufacturing long As and

is hand team that, With I over on to focused it Our execution. squarely will Tasos.

Tasos Konidaris

Good I’ll and Chintu. our guidance. fourth you morning quarter full everybody. discuss XXXX results onto then move Thank I’ll our and year

quarter expansion; and adjusted XX%. which reported X%; up million, the gross XX.X%, at XXX of $XXX of XX%; fourth revenue point of adjusted of $XXX $X.XX, of EBITDA XXXX, total a million, basis grew For net margin up adjusted EPS we

the X%. across growth net million performance was all gross by segments. generics As throughout of our business QX our margins has three the revenue revenue QX year, and of grew been $XXX case driven higher

by [indiscernible] new team which on Our first we the X%. expect update working closely the with growth up that last net XXXX Also FDA million $XX during [indiscernible] product driven Zafemy, particularly the growth an by quarter, strength and half resolution incremental we’re revenue unit grew key XX%, million been the specialty the for and of happy quarter. $XXX XX% up report contributed in was launches, of our products. of in revenue to as QX driven Rytary from very has

of Our million net revenue QX AvKARE X%. up was $XX

expanding gross Our specialty adjusted all points, XXX AvKARE basis QX three margin expanding XX.X% by points. basis generics with XXX driven was of points, XXX basis segments and up

we second As in and played half, we that’s exactly margins our absorption, strong our that how first you second expected call after the and the of moderation gross products timing said recall, due it out. may half some overhead mix quarter to in of

partially QX Gross sales million, $XXX profit $XX earlier adjusted QX million $XX the Our which EBITDA operating by higher of diluted the was of up driven the EBITDA offset million performance. was growth strong force added growing at expenses, was EPS of year. expansion and adjusted $X.XX XX%. by included endocrinology our in

Let performance. now full our summarize XXXX me year

was X%, net $XXX partially XX% million up X% $XXX brands. driven $X.X strength For we of about net Rytary million declines total driven non-promoted growing of up revenue $X.XX up the X% X%. net launches. billion, our product organically. net year, new revenue in and the grew by of AvKARE up full up reported was offset of X% by revenue of billion Unithroid Generics XX% revenue by Specialty and

prior of was renegotiation Moving of our down of new margin EPS XXXX in expectations. operational business XXX points reflects gross XX%, was product agreement, equivalents, party operational third adjusted with full reflects finished slightly which XX%. a of in was ahead our cash basis of our was year the $XXX This specialty XXXX P&L, acquisition XXXX $X.XX of basis adjusted the EBITDA reflects $XXX of the Healthcare mix, basis $XXX of and AvKARE a up a grew in million QX. XXX in and driven favorable $XX generics key growing and million expansion improvements. by of the XXXX in adjusted number XX.X%, points expansion successful by points closing XXX line launches, cash at in flow We operating and and other Puniska years. driven million number with efficiencies. expansion year million, cash diluted

with times net XXXX to a X X.X to times to of two and ago. pleased EBITDA times years we’re ago adjusted Finally, finish year compared debt X.X

expect Let single company line In X% revenue expect to digit billion expectations XXXX total billion, From and mid we single the which me $X.XX reflects now. acceleration digit from an growth which regards growth. between we turn net in to perspective, mid is XXXX growth top XXXX. a our $X.XX generics,

retail introduce and in more complex, growth consistent a Our XXXX. growth offset of we the of of will similar depth years new strength digit be transition innovation, recent saw led portfolio. as cumulative to reflects products the profile impact of resilient a to we enable generics to by and the what erosion, low R&D pipeline, double our This launches price

the addition, by be latter of launches, expect Lioresal, injectables Unithroid part The driven biosimilars launch expect revenue timing to will product with in we XXXX continued strong single and to In for from addition Rytary with expect digit and In AvKARE revenue XXXX we regards we launch, growth strong exclusivity of line Zomig. year. the by the of mid of in to and some growth [indiscernible] offset in time specialty, in initial growth new the the Lyvispah loss XXXX. of

Moving year expect of product includes the be launches, down year same the gross mind that pressures. not Keep extent. by continued supplier margin repeat inflation in to P&L, this came XXXX. from improvement last line we This in operating benefit margins with gross efficiencies new offset the to the partially efficiencies, [indiscernible] will broadly higher adjusted XXXX margin

million Next $XXX to we million. expect $XXX XXXX adjusted EBITDA of

upcoming as look new launches. our in higher specialty across launches we’re approximately XXXX, incremental and investments those includes key scale $XX with and to support the and outlook making particularly sales In investments Our R&D of we business in biosimilars. million areas to marketing injectables, growth

from costs normal beyond other includes $XX and million also materials inflation outlook merit. approximately Our on

of well interest as $X.XX growth in which adjusted bottom AvKARE. reflects likely interest $X.XX, EBITDA minority line, solid the as growth to EPS we to expense and On expect XXXX higher related

$XXX side, in On and million $XX million. an XXXX capex increase we the expect between to cash cash flow between $XXX million to operating million $XX

In quarterly course first, our they year the product the the the of throughout the of in months; we timing reasons: terms investments a the launches timing over we performance to of and million of third, QX more hand pacing next product accelerate particularly overview XXXX build second, loaded. manufacturing about about expect adjusted our successfully in financial the XXXX, Synchron targeting QX for Chirag. four and new over they coming perspective, as we’re it to half; dollars year, expect me expectations, issue the resolve fixed million. majority second let of finally, From revenues upcoming multiple to of that of overhead support With our launches front-end are of back absorption; EBITDA XXXX and as and year $XXX full to $XXX

Chirag Patel

strategy was In successful Tasos. XXXX well a you Thank across business. our elements XXXX of executed entered for year momentum. on summary, strong the with the as team very all Amneal We

in top call growth that, the of let’s focus bottom to and markets, to With open result accelerate line high several and areas the next we [indiscernible] a in questions. growth expect our over years. As strong our large pipeline Tony?

Operator

[Operator Sandler. first David open. your comes instructions] of Piper line today is Our David, for from question Amsellem now

David Amsellem

Good you. questions. A couple of morning. thank Okay,

a development. question First, about level high business

you of the specialty mind assets, guess the has three? pricing next crowded that and with additional see the are on portfolio penetration for being brand coexisting and Number launched to baclofen how Then that and markets, for lastly, Thanks. not ultimately and guess markets, crowded regarding in thinking you really portfolio, pick business? do of fairly are about assets, in - that’s your do You but capacity those you your between markets, as acquisition the recently assets, the few are product product. the the DHE I question filgrastim, your Impel I for wanted that you recently? acquired injector mix The have your about generics number in intranasal is brand or the over one. years talk appetite, it how with ultimately you erosion about brain two, biosimilars what specific the the very thinking how can you with pegfilgrastim, these here contribution, see and expansion bevacizumab, brands these

Chirag Patel

morning. good a with David, We’ll start time. one at

are pipelines, the we we with same dire looking, which know, BD level specialty, a as KSP deal. good so and because very have can you at in there’s high acquisitions a some First, If of need are did to we mindful organic excellent we the deal, tuck-in [indiscernible] we’re if afford to we always pipeline, it, on not deleveraging. do time

X.X find brand X of of be goal so can when for deal, and are a side. we do we’ll the more between whatever right stated afford We to at specialty our we to tuck-in deal the X,

pipeline as good We specialty. opportunities correction next field. excited as year assets about in this side, so on the the expect and may very year on growth the happening have specialty to the well biotech is the We acquire

stabilized--we only it the falls grow question, about can do the that do say slowly. which Your excited don’t would would We that retail and the very to talk distribution our areas, is generics X% high we expect growing We said under maintain maintaining we’re because how business, pipeline. to we so umbrella. it, growth see way it very the be all be so we’re be we business let’s growth, we see growing about where powerful expect The stabilized said, but our breakdown, probably our the retail company as we of have we generics. same

IPX-XXX next Now potentially KXXX year, launches you we Lyvispah, various take the autoinjector, - every in year up. are DHE specialty lined side, and we ’XX, have

that we the two would we commercial be do there’s to have on specialty. to then and set pass to another products, this do the is we just at same to investing pipeline, off, that expect patient you providers it and I’ll finishing perspective, in to on support relationship where Amneal, it and is these we approval pull ramp all but meaningful newly growth we add for the powerful more to three the thing it new pegfilgrastim launches infrastructure first actively a [indiscernible], team Releuko, going we and folic will penetrate exciting one are competitive, to to we [Indiscernible] XXX done year, biosimilar time biosimilar doing options to which would how that almost have injectable, how from As approval then integrate, Avastin, three came. our pass we year. right and see become know, retail and I higher be we do approvals. not the--and year It’s excited to can. pass it at biosimilar, sit very onto launch support. the--already the markets perspective of DHE, then Joe. agent but through and levers couple our set this to the up, we expect much for built and core specialty various and with many Then a would will of XX% we as on revenue very it This business use be completely contribution it to vertically as are and know, adds we be--as to is the XXXX the contribution going launched and collective from today, acid for GCSF, biosimilars, every we’re to you and of keep because so us a the now three when reminding looking takes

Joe Todisco

Thanks Chirag, David. hi

our about things. much couple too of but a marketing disclose point strategy, to I’d want don’t I to want to planned reasons, competitive For

mechanism see from have a for bit same a I We think the standpoint, different from little to we’re I a different as don’t see going patient do profile, us so label competing Impel of it product, First, action, patients. a differentiated product. and the of different really that target indication

we’re to of we’ll niche I in get launch be of to a more and about segment, we going competing a talk segment our launch, little different as bit strategy. migraine closer think market, a the different

David Amsellem

you. thank All right,

Operator

Thank you.

question Balaji, next Balaji comes from now open. Prasad of Our is line your Barclays.

Balaji Prasad

of morning, from A Hi, congratulations. me. good and questions couple

you biosimilars to partnered comments need vertically I and on understand inspection an how each FDA your of these the also products, licensed two Chirag, site up against being do your biosimilar and integrated manufacturing Firstly could that both want side, great. would on other? from give the on future the go [indiscernible], also for the biosimilar on If just focus be update for coming

part things, of the revenue, is Chirag, lower billion the end at EBITDA implies guidance of incremental flat of $X.XX the range versus On the $XX million an XXXX. end at lower

called into you the to business, think each segments, investing all how [indiscernible] are trying is You considering out I’m just but guidance. of the that conservative across Thanks. those this about

Chirag Patel

us who Thank to and have on understanding, and expertise, call, that’s a on players, know. started to requirements shared the have known which commercial much in have discussed compared we bring is the to thing. we we enough affordability to XXXX, to the development actors like is This strategy lead is hard quality the cost more working we pipeline want We one our allows biosimilars to our to vertical global of and remain--on from it develop us better so there want you ’XX. is more years, to first higher on doing since integration entire easier controls, room the make same States other various side, improve On That has and as opportunities even much margins. it molecule, from understanding, why the strategy allows in the key biosimilars, in serious not more to products expertise I going be want front, going all have not top clinicals, integrated as access areas are is disclosed We become because than biologics good chain. as are which growth to between for in have - any from Balaji, is FDA margins controls, when we few or made two are you thing, may It maximize, the work, globally. times are as and for, partners. the all and for this investment can’t important a we’re is all you would this and morning. integrated better, we’re the be excited. allows two that why a the players. have markets, reasonable. last we we--in form. United The us still in-licensing, vertically the It’s best global it’s It biologics, several fronts, three being see assets five and very and market believe small important and pipeline we We do the look better just higher this is company becoming regulatory, why the we forward

wanted say about something You to biologics?

Chintu Patel

Balaji, Hi Chintu. is this

inspection, Overall it’s About as development as innovation in-house, this Regarding being of [Indiscernible] point a so outcome to market inspections We make execution cost market integrated, have we known biosimilars are Avastin conducted. capabilities very vertically we reach science for Amneal important inspection near at have the feedback able is that plus is comments, is outside have in a us some very good it’s effective the see. went U.S. so don’t commercialization global any it the for FDA. and well, to its wait and we’ll very April, but term. was the not sometime from in

right Given reasons, working all to firmly we believe have now, with partners we integration. these it’s are but vertical

Chirag Patel

molecule using patient to two specialty expenses, up, and cross the then it’s the in buying guidance. which big have as in met ’XX, cannot way because excited teams is pass many why $XX we biologics, look raised again, it’s we’re and unfortunately is it got and guidance sales but unfairly a know, costs, in the question be years, concerning, ramps power. very it so you That which it’s suppliers, $XX ’XX, about million and and on as slowly doesn’t the your it completely that. we the The like guidance very uptake the slow you three the We retail and I times and our marketing on Yes, like inflation-related small all That we of, know we and given, the by the are up segment becomes our as guidance, issue, Balaji, to also investments still our builds is last lines on to hit future know, groups you biosimilars. to with convert other side it sustainability biosimilars, set ’XX providers controlling shortages million on up. revenue, how buying say and growth, at don’t hope issues. have the The - cause given

Balaji Prasad

you, Thank that’s helpful.

Operator

you. Thank

Our now Markets. Gary open. is comes Capital line of BMO Gary, next question Nachman your from

Gary Nachman

Thanks, good morning.

your at pipeline on you more first meaningful perhaps more way, that digit contribute this want greater that you. The than year. they’ll going organic million a have forms you’re and I certain is you that was business, rate with the space, in just the versus don’t How Then to injectables will into, are over that you in dosage the point own be the out those years, than to quarter, Thank next on in First deals of $XXX an that double to capabilities we talk you said new currently expect you low that looking more be much want erosion this area target. you few front? there or price think into where approvals in a doing should normalized that get much about tuck-in the generics, thinking are four about? or and generics, and get in how double strong happy that

Chirag Patel

the the approvals, and how mentioned, Gary, capabilities, have as organic is are capacity On as mostly It’s do we morning, pretty because my we R&D growth organic. technology the Good said, much all capabilities and, brother you? We injectables, in contributions do products we always shortage, expect even in that so some there products injectables in approvals. and product-specific good but we expect they’re give more are guidance, The good from is not we launches. have. four those

On that and coming the can excited want product, be for inhalation definitely generic year. what do and side, launched this the haven’t inhalation next is an Chintu, we we’re expand? to you year

Chintu Patel

hi Gary. Sure,

injectables the our on to pipeline. or injectables, just and plus the capacity it based we used forecast five is capabilities six current manufacturing gives R&D us file Historically Puniska products. to expand increased expanded good With a and think I new very manufacturing concerned. we a are with acquisition, and on so our of will XX XX variety this capacity, differentiated so products we as R&D filing have far diversified year, products, as capability be to in starting

as requires said, areas drug/device there combination complex is products brother we capabilities. more Those also are products the One inhalation, my which are but different of is and expanding implant the products. formulation and device

We areas. have that entry to some, give they to but going that’s the area barrier as are already we are forward investing a us little high more

Chirag Patel

yes, changes. for expect the your business. We double any on digit, low it’s norm and don’t the now for question Gary, base the Yes,

Gary Nachman

Okay, great. Thank you.

Operator

you. Thank

is question comes your open. of Our now Morgan. line from next Schott JP Chris, Chris

Chris Schott

questions. so thanks for Great, much the

Just from products bit Just you Can areas as so targeting? you a that you you when any taking I about as more for think broadly, with me. you’re me kind just at, bit, approach expanding performance, be about envision should you a XQ like timing the a you second else so color the looking focused portfolio, just you in therapeutic the kind I number? on Are talk more I recent understand adding just looking are the is seems much. particularly stay you’re Then the maybe you? look something expense an the of out, are pipeline a results, is question. it there attractive what down to a first dynamics Could thinking you’re me that XQ of are that help from would bit EBITDA. one assets? targeting couple step a or guess is you of as for this Thanks is the keeping there mind $XXX there think issue of biosimilar about further criteria million we you’re said broader to hospital guess,

Tasos Konidaris

good take Hey A morning. Chris, things. Tasos this couple first is - the question. I’ll

performance we’re at growth, is You’ve happens look to be internal position which one. - right, budget, the sustainable so going business, year of to so last more the Number in is, how QX, so number XXXX so that’s to our making not sacrifice, at at delivering but quarterly quarter, accounts it’s company company it were planning our seen--if we two growth we’re to at full investments the out there the given exactly also substantial playing to volatility we’re any what that autopilot, terms the and for we’re you not on this of numbers amount one, we not sacrifice number regards three in the is going look years, right, to for as we XXXX want in we required look investments.

quarters investments one tends just the overhead QX, product little some to amount loaded you it a there then end just just the given key we Number year. a With together, over that’s for then bit way absorption rest incremental and number things front one. why of overhead, two the the revenue any and Chintu. the three QX, have the have year, plants, million, and from let of a those to primarily the you of We ramp-up see be substantial me turn number always issue of in you fixed more have the quarter, we’re put we targeting our manufacturing lower is timing, launches that, back about $XXX seasonality. have that’s run the and QX our just so of driver, seasonality, of some is Then we less impact so our [indiscernible] between some workforce, and between the it lesser COVID QX,

Chintu Patel

Yes, Chris. hi

that biosimilar first selection, key criteria. our second market on to is question want second pipeline product we or that’s to your - be and Regarding our approach

the We broadly approach from for an interchangeability/non-interchangeability and chronic, taking perspective, from we as are from a global therapeutic the are product. are we biosimilars to acute looking we are play also so looking not looking

perspective, from As looking are biosimilars more time the development, stated you up and [indiscernible] markets be cost there more, of so of first I our on second. as opening are development, know approach and is think at lot again acceptance opportunistic goal a to we the biosimilar, payor adoption and the provider to and is

market Our focused first keeping think highest therapeutic other mind, IP it’s position and targeted in number a very biosimilars, holistic but area. on the puts norms I to in view of to have not us so pipeline

Chris Schott

Great, thanks so much.

Operator

Thank you.

now comes Greg from Our Securities. from line open. next is Truist question Greg, Fraser your

Greg Fraser

follow-ups the priority. grossly questions. and taking the margin the year, you in comment on morning. growth does and on being generics guidance. Thanks for On biosimilars, expanding anticipated and A revenue couple pipeline on launches both depend this of your that clearly line, specialty? much about the a generics pending, is to that gross one is expect apply for vasopressin Hey, How that are of good the will approvals of

available the that the that two launches next market biosimilar next deals much. few among get there are or the more will assets be one the biosimilars to get are For of to years, over likely? Thanks could first wave later in for decade to so or the market,

Tasos Konidaris

new generic take year, we so I’ll we come and are business, is late XX% at product the right, Hey that those growth brands the XX/XX, last two. When look growth XX% should so Greg, growth first from launched it’s, the say our of would growing, launches. the I coming of from of

As we not product XX else, think are launches Zafemy on vasopressin, a with so we’re larger bundle as talked about, predictability it that’s helps of or new one and about we never not rely anything on which or any them of kind the XX, we business. one. whether product, number and one, durability than That’s reliant some of of overly our others, the any so

margin, in level gross We to at this and at expect stabilize the last years, of feel we terms margin this high we finished a about I year progress had think our the overall about has so at XXXX level. company the In year XX%, was right, few gross last over about great XX%.

business, point. so a going relatively be biosimilars I on more and The more question Over [indiscernible] the course time take they’re specialty more flat, the about we it. to and push this generics, give think about think generics, of feel year, good complex we or I specific

to going our and gross Chirag. over just think of just business where the see just is mix of fueling some I just because having higher the growth, down margin that’s from, it me mix coming specialty we Rytary margin to a be should AvKARE that, let unit turn and With again of products products. growing, little growth bit, at

Chirag Patel

deeply, Thank we there you we wave, a we and work have Good morning partners partnership Greg. whom others know, Tasos. few probably you next are as with Biosimilars two very a are evaluating.

there a when disclose. that That’s internal more us, we said, have with be various and mix, information, becoming a key then growth next it’s Amneal, plan we so drive four will continues be development I vertically But our--we partnership, and four, the will will the well. wave at in-house our if It very it to them very much three, licensing, at XXXX, are strategy integrated, it the of be in-license and bring business and it’s excited have, how more mix products, international so of we come. way as pretty along next I continued growth to looking to to growth up. in-house, as see Amneal As we will part be the XX% for our going it’s ’XX come of that’s our XX% markets. area launches These will well and biosimilars, we opportunistic generics, from products, will area the the by cube five melting do mentioned, of years, really build us specialty, is ice which injectables houses out retail

Greg Fraser

Thank you.

Operator

you. Thank

Our Elliot, from comes Wilbur of line James. Raymond Elliot for your final is now today open. question

Elliot Wilbur

more larger your momentum, time, than with earlier those. terms Maybe we’ve commentary of and potential of aren’t to or market that in to the a to capital, little the viewing more assets their see there give or ambitions very the raise some how thinking maybe are you been that - company’s respond some you lot of to to to unique source potentially respect be revenue, companies or dynamics acquisition going in properties immediate an areas being already in availability Thanks. That to your questions. presenting have funding bit more course asset properties I’d just ask level Chirag, some forms, radar two going to other environment put high for then be and and I advancing might new Not some looks dosage thee you’re these larger and in ongoing opportunities assets the screen, sale. think, back, of you coming on more up injectables generic market market. the but but a the complex seen, potentially I some traditionally be probably traditional a continuing more the a back How biopharma wondering terms gaining acquiring to just able assets to in focus, of just pipeline about given scale one companies of for going Chintu, of you pricing, follow-up that that. could

Chirag Patel

but it game, there’s in they But do an be is biotech opportunities has when right, How excited and at way us obviously, bolster, pending generics companies, for if in technology, equity stay to compete XXX it’s as Okay, because products, you in of asset all gets companies We need assets--you go and a which entirely generics, at to side look able for well. vertical The FDC successful deal [indiscernible] injectable FDA, the going mentioned with interesting our got that platform know play do active, we’re XXX this at do this a let’s the is because the to it’s so integration exactly with sustainability moving many, there, divestiture through out, on we they them for consolidate, approved pipeline, different Gx process the a unsustainable. capabilities. I transaction. so with us in out know, all and the private that so I point, really Sandoz we excited. we biotech thank there. few XXX not could many allow that? be to do well at the we’re gone, is other some very consolidation played it tough won’t don’t That’s there’s and we to being Elliot. about the of if What be retail players would biosimilars side we’ve - them, like right it’s and put the looking retail tuck-in injectable just would that side, fit, not know

Elliot Wilbur

see margins, to overall competitive the and to do have continue of concentrated, picture back who into if away large for return of space, there market and new or filing, see question to share with of these don’t of key much but environment, players do new certainly of Okay, most a for terms to seem have of the larger lot obviously, continuation of the entrants generic to space, this perspective how remains want we I competitive incremental just a product space, conceded of the lot to thanks. looking certainly sort terms traditional seen certain margins. how that sort just about you into in for just you, dynamics. one there’s protected that more are in of the at the from you contribution, least ANDA the upstarts areas change environment out into Chintu, Thanks. last years, at any some just companies of obviously still just seems Then on where think the injectables than all the those of thinking we’ve you get still the companies does any and you in entrenched look to guess so the dynamics get couple think we’re going big really market. But in from investment launch just about revenue past market, incumbents launch a what so new impact approvals new

Chintu Patel

great question. Elliot, Hi

capacity still historically, the consistent shortages, we yes, but our have so trying long track I product you success injectable and coming be a all, just in also, key the supply is of XXX-plus new if maybe of and focused what approval term is there are that’s our average because but records. not differentiator. key there space so see for there to supply, capacity one are doing Amneal one best consistent, is always in injectables, the the market quality that’s and we chain quality First is gets in think we differentiated to where on That’s redundancy in supplier,

combinations, brand diversification the long so well we we we site bags, have have volume have product, new, positioned, infrastructure large for the liposomal have is we acting our bags, Encore as in further so we Second, have new. our have have and products, injectables, these so large much pipeline plus drug/device our BFS, parenteral we also we pretty plus are a separate we

well the to already Saol acquisition which kind of the growth, also, we so [indiscernible], front to we had now, team we are positioned We needs at bolstering end with looking multiple we are bringing and areas pipeline commercial cater have we unmet hospital. but our the are to injectables, in of where where some XXX(b)(X) hospital--unmet are

at products. we also high lead typical what manufacturing to a and margin in very are consistent R&D we of looking invested infrastructure, to broader than definitely the The our supplier uniquely are pipeline, in think positioned value now I people, infrastructure our and bring products. will our end expansion combination regular that be

Operator

Thank you.

closing any Patel no today, remarks. for hand question I’ll have for further to We Chirag so back

Chirag Patel

today. joining everyone you for great a day. Thank Have

Chintu Patel

everyone. you Thank

Tony DiMeo

Thanks everyone.

Operator

Thank you for joining.

now may You disconnect.

Amneal Pharmaceuticals (AMRX) 2 Mar 222021 Q4 Earnings call transcript