AMRX - Earnings call transcript Q1 2021 | Amneal Pharmaceuticals, Inc.

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Operator

Hello, and welcome to the Amneal First Quarter 2021 Conference Call. [Operator Instructions]. I would now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Anthony DiMeo

Good morning, and thank you for joining us for Amneal's First Quarter 2021 Earnings Call. Earlier this morning, we issued a press release reporting our financial results. well call slides website are as presented will at release this on available press as that the be amneal.com. The on our

call, that a to copyrighted solely this also the consent. or conducting of available for Please to applies that website release rebroadcast statements note are during a Statements you without call webcast company's outlook made remind stating Amneal conclusion. These this We forward-looking call. I Cautionary is predictions this and entitled encourage now today's on future press management's a be live and statements. to after statements its written which forward-looking of would available be presentation, statements is call, will section you our review that to We on which material periods on like our expressed are us. are of the based information replay cannot in

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

also certain We non-GAAP measures. discuss

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

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

Chirag Patel

Good welcome Thank to you, thank morning. this Amneal. for joining morning, us and and all, Tony, you

the challenged has access India. over But situation India many public to challenging the acknowledge standards in ways. health to year, COVID-XX want is crisis even the I very by last limited. world is First, set in care the in medical the and

with care to are equipment. other utilize and and We to critical resources secure our Indian charitable diligently foundations medications expertise, pharmaceutical Government officials, working leaders

hearts colleagues well to who world. fight in our are Our all with those as around as India COVID-XX continue the

to essential As protecting are the proud an our business, and the make well-being health continue of we investments we employees. of in

of customers addition, In States. supply medicines also the and in the we are patients United ensuring continuous for

the and global is robust of manufacturing Our procurement, our and truly heroic. efforts chain teams quality supply have the -- been operating well

this products more the reminder Finally, pharmaceutical latest generics the of in America. critically of important for America to manufacturing. COVID industry believe outbreak a on We is foreign dependency remains it U.S. make

enabled with U.S. quality solutions. look domestic Fortunately, domicile Amneal's superb the federal and policymakers manufacturing forward significant legislators to updates state record sharing work closely we provide make and meaningful We as progress. to public and base, us to

confident our bottom pipeline strong commercialized our that and the our financial of performance, execution quarter full year remain shaping up. how will year line top results. another and assets, consistent and am is the Turning our first with our now pleased guidance. extremely to of with solid results deliver and We I operating momentum, strength

provide update now initiatives me across business. key Let you our with an on

organizations. our to specialty. portfolio, industry a to and generics our replenish development in invest believe Innovation well-oiled strong continue we product growth, only product generics, in we in are R&D companies drive we First, increasingly complex development as and engine and have launches. is as In their established both

experiencing growth delivered secular capabilities reason innovation major strong in pressure. are a industry Our have we an

In earlier longer is Pharmaceuticals we and year. competition, value to chain specialty, and greater acquired products the with acutely high that we Specialty shortly. faces base our have profits. are our on IPXXXX R&D programs entry for in executing moving the plans this barrier development of innovation up will business constantly Kashiv on Chintu team detail While us focused revenues tails touch

excited continue increase are came excess manufacturing to public our see quarter. global to one operations, When optimize our we in supply every chain and and margins generics improve was of improve cost, goals, our we back, Second, and overhead first reduce it ultimately, our profitability.

grew executing as well goals the XX%. quarter towards in these first to We generics' margin gross are

time. Going forward, to additional margins we pursuing improve are efficiencies over

execution creative us the transactions know help and we growth. can of Third, accretive accelerate our strategic,

molecule quarter, small Just Kashiv, organic development Amneal our will talent, of first value With our long-term which formulation end Pharmaceuticals. Specialty Kashiv we substantial across after completed portfolio. and the gained expect we of best-in-class, acquisition drive

that We programs endocrinology we as to across not as expect stopping NDA also near-term XXXX. launch to gained But and begin there. we're neurology early several

are to infrastructure value and our Given We neurology as and well further over uniquely drive clinical to existing late-stage complementary strengthen provide sheet commercial we as near-term are pursuing assets all we commercial our in synergistic endocrinology, substantial revenue positioned streams. to stage balance stakeholders believe time. programs

saw Finally, and where distribution AvKARE solid we we to profitability grow performance line continue this top business our quarter.

including past, long-term branded opportunity going As us generics we continued by is every business represents we a channel. have stream buoyed This government for of favorable as discussed the federal strategic AvKARE the in focus pharmaceuticals tailwinds, year. the on

could to expect direction. business towards of call and our and as look operational about we continued and I'll turn Chintu XXXX financial is in that, performance all more cylinders, confident Amneal beyond, on move Today, firing forward. I we and With Chintu. be the truly excited our over rest the strong not As and we strategic now

Chintu Patel

Chirag. you, Thank everyone. morning, Good

our every team's patients As trying I our employees, success with healthy making recognizing drives and delivering medicines for contributed. for whose even gratitude have all and in service and we is are your our for customers always, remarkable. truly and To thank times day these Chirag relentless begin you you in possible. inspires our by tremendous I to The continued dedication like employees commitment would to filled

them amazing light actively care the in Our we need get they have to employees demonstrated in outbreak. COVID recent India the courage, most ensure supporting of they are and

of Our led we India chain beginning even team is has have which those the building focused From strong has supply our resilient on and we pray family inventory pandemic, products flow the for uninterrupted. members strong to and ensure the locations. lost the world. who and are continued across terrible levels in times, more an to supply These of all global remains across to unprecedented chain, India this virus

Now key provide business a let updates. me few

we key that share to will company improve happy the cost I'm efficiencies, save advancing initiatives across margins. to are and expand which First,

sustainable our manufacturing we compliance manufacture initiatives of chain. in-house, have very continue From and levels, generics the margins is our most prioritized which always, our improve as example, are and and products beginning, partners highest transferring reduce to it cost of aspect way. supply facilities, of manufacturing standards will these help will we to For types quality culture. in in practices the we several Many good improve of gross from integrity while external across and we And our at a uphold our business. of truly every all part DNA Amneal's of

designation, XX, complex pipeline X.X far, are combinations. and engine we grants Zafemy future with As invest We strategy which And in manufacturing, it competition Chirag believe that start industry-wide, Amneal drug-device at for industry. the we limited exciting action. an I is is complexity launched a in pipeline. for our we example in highest our in to of which continue even as generics. launched time R&D will number the said, and and our benefits generics believe products development increasing industry, March CGT our is a growth drug-device received approved XX% that the XX see it other of towards Zafemy, programs. an we is our has days nonoral, transition to the share and CGT hormonal Over is dosage its perfect of exclusivity. begin designation XXX of generics the patch, high-value activities our will exclusivity. of and the development Of we solid post combinations of have with Amneal of complex by given forms,

will we pipeline. refreshing continue forward, Looking our

least basis. on to expect high-value We X at deliver an annual to products X

to looking generic via partners. high-value expand international into select our In complex are addition, portfolio we external actively markets

Our by collaborations. file expect sustainable products Fosun this vector of filed the for with and first year, we proceeding existing already China as see global nicely. long-term X of Overall, growth. the to Together, we multiple international partnership end and just have is the another is another X in expansion

Next, biosimilar pipeline will of our component an increasingly be meaningful going forward.

over in couple we expect generics extremely our filed well biosimilar As like the Currently, the this we the biosimilars manufacturing, years. will products, core We quality in innovation we us believe think high market have position to shared X commercial we of have and which execution more past, strength over next behave launch space. will time. strong in complex

biosimilar market. the X opportunity opportunities via additional or evaluating we key will be we that, strategic a be next to XX models are believe first over second us can Beyond actively partnership years. where We to for

Turning specialty in IPXXXX XXXX. to pipeline our trials is advanced III pipeline. the is of currently launch X Phase in most and an programs with specialty estimated our clinical

product IPXXXX next-generation reminder, our a As is disease. Parkinson's for

form Immediate first-line offer a people, the reduced off on over improvement which roughly is function periods of for of Rytary dopamine. expect drastically the existing motor help therapy In levels therapies. XXX,XXX material to or some United manage a carbidopa-levodopa due therapy time, Parkinson's. XX% We product will of are low are patients, PD and levodopa to of States, release

can is an extended release and patient periods life on-time product of provide release. in for generic severe this hour quality or designed painful. In Rytary, Our better on X of time immediate patients carbidopa-levodopa current large product, be moderate an to compared leading improvement as to and can off additional stressful a be population,

more demonstrate IPXXXX profile a dosing superior immediate expect boast much regimen. will versus release will convenient efficacy We a and clinically

of we help IPXXXX larger a be drive result, Rytary product a market us the leadership has in disease. As the than Parkinson's much and management that potential believe further to

well. year. line to Specialty the both and second excited The Kashiv This of are specialty product significantly integration We sticking Pharmaceuticals half our see proceeding of endocrinology has this neurology. in pipeline data is expanded top deal in

KXXX, modified a modified hypothyroidism. treatment treatment TX and We the of myasthenia product for KXXX gravis; sialorrhea; have for the a trihexyphenidyl KXXX, for of

With this build are To well. delivery all specialty drug and for to medicines our the technology we for products of The company launch believe for a the positioned at patients various wellspring create these is to new of come. platforms least year to acquired X programs, value addition we also company and we will essential years per stakeholders. affordable, deliver we in starting well provide XXXX, summarize, executing branded product

Our people elevating now over call technologies, journey to commitment Amneal Chirag I importantly, are to ahead. quality in to confidence turn share excitement Tasos. and our new the and the our and heights. will our most pipeline, I

Anastasios Konidaris

Chintu. Thank you,

and launches first focus Our our and reflects product quarter the product diversification and of successful relevancy portfolio, financial efficiencies. of momentum on our execution new driving

a $X.XX. diluted revenue result, of the year, adjusted in quarter reported this EPS EBITDA of we $XXX and first of As net million, $XXX of adjusted million

In we and million operating cash reduced flow further $XXX our generated net of leverage. addition,

as which as events, well digits. for the Let purchases various pro XXXX. low adversely compared grew to flu and $XXX XX% generics, down cold as not me now season, results, revenues generic basis, mid-single where and a onset to non-existent we impacted forma an starting of the our with move to year pandemic. decline discrete primarily $XX Tamiflu million driven net last was was COVID-XX almost revenue or at products net of generic On million surprising like segment QX adjust This the was by higher

the pleased contributors very a products the as We year were product performance product deflation as be well net last levothyroxine million price azathioprine, launched offsetting the epinephrine, launches, continue and revenue the our over in to pandemic. January quarter. negative where $XX lingering of delivered current since growth with of strong From new impact perspective, in of sucralfate

we In well. quarter. the of so launched X you is performing current there very only as in March addition, month And of this year, remember, Zafemy may in is it it

purchases the Adjusted margin last product expect nature strong a us. flu the reflects of higher basis and points chain as team gross Looking revenue the fact the XXX in increase on seasonal manufacturing complex for well execution, XXX materials. more commercial new continued generics year to QX XXXX in are behind execution as supply full and than due and efficiencies ahead, XX.X%, the growth, pandemic points growth to step-change of ahead that due we and pricing was high generic basis strategy efforts This generics certain transitioning XXXX. our to favorable of solid our drive and year net to

million our QX up Let $X net now segment revenue or me expectations XXXX. $XX million, with of to turn in specialty with from X% line our

endocrinology And to as $XX neurology it. QX XXXX. aggregate, around Both Zomig in they centers loss segment versus grow. than million, well up due due basis points away XXXX This XX.X%, its of ahead getting mostly gross our specialty with in our gross promoted reminder, a to improvements was favorable As in XX% basis net XXXX, delivered specialty continue right Adjusted upcoming to our for offset to brands declines full mix. brands as to QX of points margin and XXX product exclusivity. higher a to XXX year growth

which Let now me $XX.X reported or $XX.X XX%. million, to move revenue million AvKARE, net up of

As acquisition XXXX. XX, a January was reminder, the closed on

X XXX As months in quarter sales last gross basis of months for a XXXX higher X full AvKARE with result, year. was margin XX.X% points than reflects for versus the current year quarter QX and line XXXX. Adjusted the

of pandemic, our lower slightly by as of a leveraging well expectations $X business ahead was expectations efficiencies. reflecting X more the While Total million profitable it due the as expense overcome adjusted $XXX to the to company EBITDA lingering product dynamics. XXXX, below million of effects our line operating slightly QX mix was top able was than and

First, and efficiencies mix product operating gross profit, a due year. favorable higher to primarily this

of flat marketing $X.XX higher remaining EBITDA substantial our Second, R&D Adjusted our was as XXXX, QX $X.XX the than of lower we offset million X to and making million expense performance last of than last and flow third, high cash substantially ahead million perspective, the And $XXX the EPS year. quarter to of very $XX expectations much comps. a higher adjusted comparison quarters in our drive of generated the prior XXXX. EPS From long-term growth. operating XXXX, EBITDA X sales tough QX our the the $XXX average remaining of $XXX and of Again, ahead XXXX. year's year million where first average we're in cash QX in of interest was and well for diluted was adjusted $X.XX was of the in investments the of quarters

Nevertheless, was this have some DSO to performance, the strong favorable inherently timing. driven that mindful be variable. line lower We metric is by top and performance

remains our equivalent result and million pleased we're EBITDA March full strong the our in over of let debt levels Chirag. me net XXXX our and balance that, improved our As we year. remainder confident to cash and balance sheet of financial in strengthened cash top compared the profitability, with our With and we to million the Cash higher summary, operating improved to line March the Consequently, performance, $XXX to financial in quarter, generation a our adjusted to turn ratio was in In flexibility. sheet. performance our XXXX. unchanged, year call for XXXX XXXX, compared financials and in remain of $XXX and December X.Xx X.Xx guidance

Chirag Patel

Thank you, Tasos.

would continue to positive growth. the call as like I now your momentum execute to start operator we sustainable strategic are vision with take to turn XXXX of the questions. We our over pleased continued our through against Amneal X.X of long-term the to

Operator

the from Gilbert And Instructions]. Greg question comes Truist. [Operator with first

Gregory Gilbert

few. are generic upfront. the your of Tasos, that little how strength have yours, the companies, I other you is interesting there? question. how with side. customer I on the Chintu, Chirag, on AvKARE maybe that to what on? high-level a for chain hasn't have work brands. a drivers and I But to comment the underway? a move independent would lastly, industry up given and durable lumpy a me in of want something desire I strategic questions that's challenging in could your perhaps we've seen and and ask NEXPLANON what to you've understand also, wonder start like stand-alone sort think that to of project had projects curious some other is I for more, Do the value certainly -- is Let be understand the U.S. you and cards generic including more consolidated products right the And why the that. bit the to you team want And strategy? compared

Chirag Patel

the holy fresh guess. Greg, Consolidation you're that's I grail, generics, in this so morning.

it a go many With requires And reason went know, you the products we Impax tough we to tough. had And with As and value products forth divesting of back up plants the moving through. it is plants, FTC Amneal, between. and we from away. agency divest of to the to a lot ended Impax is lot also their lost is revenue merger, the in

hard. So it very becomes

there so do Of and the lots overlaps back we should say, course, of look we You synergies that? are "Okay, can why up." many. pick are But

needed. must. hope target and comes new find we overlaps, it is The what in. I really -- good. a form just if if consolidation a So it without is And It's emerge, divesting without they small for are and need overlaps, players which that. industry, of was Perrigo's the consolidate if good. they do couple can a companies, Good. together? Good generic There we And

have Indian As time companies doing know, very you anything. a hard

go of little consolidate. they you. AvKARE Chintu... and they hope for answered on slope. bit so do their go, years I a to a So question on uphill families for It's not many then Tasos legacy to I that

Anastasios Konidaris

let me if works. this try So that

So is AvKARE overall growing nicely.

top year, last million. digits. This about that We did for will deal, so knew is year, profitability feel mid-double around when almost the we So about it growth. grow high we double did the digits, line Profitability. business good the $XXX

last So at QX, was it year, And we're XX%. seeing XX%.

improved with So of profitability. that we're level pleased

we many contracts. million we government contracts this things business, $XXX business. growing One long-term what the XX% of year about about the are is than more this, like And of double-digit the the like of that about

it the growth a So we team stable over grow our and the rate government us that that can overnight, reason, it us with turn platform And time. has a But of expertise. right? we embeds lot customers nice, cannot gives for

business grow profitable products, products, only third-party we're a that leveraging much also segment, time, by like other there. single businesses number where with low more but growing you we're that's looking the can of over been time. more distribution for And looking efficiencies growth business. The imagine, provide rest of to which, more as not So nice, over operating Amneal a nicely, and is margin that's

business, to overall, is digits. this think I going think I mid-double year So grow the again,

Greg, it the margin. XX% $XX $XX of will for will and profitability low few quarters, be XX% terms next low think in million Hopefully, to that helps. in million I be of quarterly revenues that to gross

Chirag Patel

a to own add to of our products branch launching site. dose the XX just X New liquid out And our also by bit, business we're growing unit at Jersey

for that uptick a So year. should nice be AvKARE next Chintu?

Chintu Patel

so on question NEXPLANON. Greg, good

So that you on continue and with knowledge chain. into to develop implant been get the not And Kashiv's Amneal, that perspective most the into to move and as space, implant product investing the has drug-device products will NEXPLANON, FDA. which the also complex how sits and some these -- value the of up I know, the how like a but years conduct complexity from acquired from particular products. development X acquisitions, combination to to the a long of the top is generic we work on and we Amneal, talent X is the good have we With required. device product,

the the the understand good to are PK but moving group drug-device have working aggressively And regulatory to and we part excited. knowledge, have is other absolutely, the the requirements. very that our formulation and market. is are Amneal and up, drug-device But something we bring the the category organization. studies implant entire portfolio, very we other We challenges particular product and it's not and combination of the We within

Operator

Daniel from with the Markets. question And comes RBC Busby Capital next

Daniel Busby

with theme. Maybe the picture big sticking

in versus about weighted like I is still and to term, heavily what we now? year? right As this what generics But step-change when generic of about U.S. generic play are new you U.S. we how And you the mix view, look those specialty, you're that additional more increase the also, Clearly, revenue business mentioned? the cadence revenue longer your for think the OUS? development the ideal generics. that? guess, towards now, the second, years and of And we launches important think business at from remainder business would X see in between ideally anticipated And into over should does how how

Chirag Patel

Thank you, Daniel.

the X.X? see Amneal do So right? got We've said say, Amneal business generics of we complex dosage generics, all big So picture, the complex the genetics is forms. kind driver growing, within a you of how

we biosimilars, products, as the products, mentioned, Chintu And in we that complex said As a it inhalation year the generics. products. injectable device have put ago them

billion that in to give to scientific because there from growth but for somewhere level So us X this. a made all the now, and to We're over you is we years. going of segment enough at investment produce exact billion, $X.X years higher capabilities number going not these $X.X have

growth own it The specialty, pipeline. segment be in the have will excellent So of one our that we business.

got moving haven't We job. And that And get we is KXXX. very serious in, does IPXXXX to got and platform, Amneal one we the forecast given technology. we finish really we on, the well so are the pipeline. once do nicely is it, we we've is thing

mix view for years. great at a it's So business -- And be don't long-term the we the to have to the will the revenue. by EBITDA exactly, strategic than a say We've build on more got it because want We'll M&A specialty generics And the strength. tremendous on trajectory. contribution it complex a us, accretive cash X, be the a I on growth we level specialty. XX we've got complemented but is also, complementing flow,

we can. there's Same thing TX and on So consolidate our to how then it's more many come. Parkinson's disease as as products endocrinology, we our side, like comes to

and excited to X targeted very on those this? you take areas. very Do So want

Anastasios Konidaris

Yes.

number next have, new fueling and Number step the products into be launches in, product year. terms Based will are to. step really lead product of QX any spoke product new additional change to But products we of launches those currently overall, portfolio new we I relying on the us, critical confident one. in come mostly that right? as that to change, to not on growth are we're two, very towards new Just

Operator

David with the Piper And Amsellem from question comes Sandler. next

David Amsellem

couple. a just So

lastly, relative When are partnership be you to is how identified, about other can there you overall And So a opportunity but economics, the do about X about to -- these your that talked going other position or identify to this what programs, better on similar Generic biosimilar just anything So other and net add number to number a should in that's know those two your that one. this margins those talk on to economics you've economics? opportunities have expect that of biosimilars, the fruit you how programs. to you this given Avastin then G-CSFs? other is economics have And you margins, the and part still expect Then bear I Copaxone that you've they'll can later is, generic? is shared of And kind model, your we the year? expectation think opportunities? opportunities

Chirag Patel

Thank you, David.

biologics or then, and see as we only just business. could as you will biosimilars how it follow-on to in develops strategy, wanted is We end adoption biobetters partnership into now it brought over to a -- may we nicely biosimilar which million, to the the how not and not over which so out, -- the branded the And market. $XXX because XXX(b)(X), $XXX waited, -- biosimilars, playing see all biosimilars thicket we because effective very we molecule years, or it's biologic. like be XX in our pointed plus next biosimilars, small us. is per the for dance, So earlier model of did spend patents, a patent begin see invest of to which now great cost million with, want And want up

like we've a very just put is couple the is So favor, become -- like partner. to how will for are understand manufacturing And biosimilars. doing will to manufacturing. we in the gives Margins, expect do our high-end EBITDA will we last XX% on us go we If to on almost And been We manufacturing than key. great establish be our model, do them of a product. whenever sooner identify split generics with we later. I our of XX-plus value would it a XX% complex diligently on in-house, to continue start up then to in we to we the We partners. capabilities it that very percent. champion manufacturing R&D, working per consistent XX% XX% years strategies XX% obviously, it, around probably and which working over

know So This that's And will year. you partnership? for the plan next when we David, announce now. the

Chintu Patel

And David, your question can we later launch on Yes, or and the XXXX. last year Copaxone. working, quarter this have first are early product

Operator

And the from Raymond with next question Elliot James. Wilbur comes

Lucas Lee

This Zomig? what is is, during a impact margin I gross quarter? how follow-up, a your have expectations on competition are trends? drove generic does And on gross that for question prior Lee, The upside Elliot. Lucas this margin the as the how you And Is sustainable? around thinking about potential generic

Anastasios Konidaris

performance. the to was, the We incredibly on focused very margins some we XXs, sustainable. finished And that the XX%. and we improving I on you we is in year the Listen, saw, to had margins, XXs, we're as were But every this we're XXXX. low increase believe something XX% are we're Generics pleased right, which on margin know, going business to think side about is the Lucas, moderation, last feel some with you the gross quarter low finish a likely most which, year it is going XX% as versus moderation. delivered the is great which a gut see substantial profitability. generic those My expanded Tasos.

had are years. of XX%. can terms the you of last executing over couple going over we So what We in we see, as margins said see generic

that year. pleased this our bridge be in So expectations. cross terms I That's to think we'll of

same X On generic the thing much Zomig, mean is overall. it's not And sustainable. So parts pretty of business. the other the I this across remaining

the have what is about things created. are One we of proud we

much so business, We X a have than ago. more very created diversified years

big that's the part So grown. of a have business. has AvKARE, Specialty we

portfolio have generic of We XXX products. a products, over

So insight. bit we're give of Zomig, a over kind that to me not on dependent on any to turn single more us Joe product. little let it With

Joseph Todisco

this on assume authorized got inventory someone both competition come preemptively coming May. we of nasal of could Sure. regardless X Thanks, competitors an of at sufficient we've be Zomig market. publicly spray, the that always value but known, generic Tasos. already of to launched number market do generic and year. With that else product filers generic are to steps the We labels, to had that specific the end we're aware respect of We've of earlier maximize taken the to

Operator

next And from comes with Flanders question Dana the Guggenheim.

Dana Flanders

you pricing My is, had if could I wondering trends. was just business first on generic base two. I comment just

some the manufacturers supply competition. comments that independent hearing kind they're from more of are seeing a year, pressure bit chain We of this little other and

wondering COVID. to if positioned? as or second market just India on I And you're with start And seeing and are you was going question, comment unfortunate the see Amneal's sad if in to wondering situation up, overall just my and expecting kind you then of that could supply So if pop seeing on chain relatively just impacting U.S. is how wondering shortages just the well?

Anastasios Konidaris

we to I'll But as point first just on out, We're level. And other from you're hearing seeing pricing. I also some behavior, the Dana, year. this want seeing Tasos. we're high is question is exactly a what manufacturers. planned take this the this consistent of

our guidance, in reminder, a single-digit assumed deflation. we mid-to-high as So

profitability areas, you our it's our efficiencies ultimately, But the and team of own in mentioned, share commercial product our get areas. launches is and worse that, that. is chain that seeing new actually our right, ahead And little Certain coming market new we by a sustainable it's way. our in the drive ability a to operating certain offsetting expectations. As coming to is growth of than ability, are supply increasing

forth. this much with and so very the company we're dealing So is how pretty happy

As let Chirag. turn to terms in over it to India, me

perspective he think has I that. on a good

Chirag Patel

Thank you, Tasos.

grim. very levels is pharmaceuticals is are inventory secured being local month, have it's it industry, But Amneal you And lockdowns. to situation is X plus and There operate. allowed come good we to the months. inventory, if almost X -- overall So essential The APIs. for very are X

for now, as next preplanning as is shortages based where done. expect, or they it face product. don't and may fine. be how much any on we our So month should But from are X have Amneal they Others far located concerned,

help after everything or on license situation hopefully, market anything the Indian and can remdesivir steroid Amneal concentrators never We FDA-approved plant U.S. or our And India, in to to doing sell. month. we're working products. sold with we government from donating oxygen expect We X to We improve, local supplying situation with got India. the to

So help. is of everybody countries know, -- lots you and have, assisting. Many offered as

-- enough to vials, Gilead, they be with I this million there's produce call will a seem -- XX was in enough remdesivir. month. they So

available thing AstraZeneca. besides they're to more help. Same be with So and trying hopefully, just will vaccines all Pfizer,

grim very improves it's and there, hope it So soon. we

Chintu Patel

proactive And Amneal add, we in one just just employees. many point, vaccinating very to were India of our

strong. with to good are diligently So sure large base working we has provide been But still everyone and situation everything attendance very chain But very a employee our is And our vaccinated. led that support. has very, supply population in of do supply make this to strong to chain. health we current and

Operator

with Goldman Rich next question from comes Nathan Sachs. And the

Nathan Rich

the to Maybe Tasos understood make cadence generic you. that sure starting just I wanted segment. the for with revenue I

your looks the You season. been it It and related year. but like like the that kind balance over that, introduction. million kind traction revenue that the so, fair back of called I'm cold pricing of a did the trends the mild headwind if of Is doesn't mention out flu the assuming to business And product underlying better. come with of new got sounds consistent, view have assumption? you $XX

opportunity remainder generic the then the of increase thinking maybe should we So how the follow-up, segment what as of average. just the a think is implied year? we be is margins relative over the about to those about that outlook margin for generics, And driving complex kind in as

that mentioned had north biosimilar kind EBITDA for relative be you I if XX%, that margins -- maybe of you of think right. average being like caught margin margins complex of would the to number kind segment? I Where generic feel

Anastasios Konidaris

Yes.

I yes, to not QX flu think going right, that et in $XX to season, million, low So come cetera, related back. that's

that increased the overall low nevertheless the margins, But ahead for rest profitability the or I expectations. versus our number the extremely, the the that's and projections, new extremely in rest on. sustainability so side, on So just think the think slightly see generic doing with for unchanged -- you're product primarily And introductions that Zafemy of well spot our really year of initial well, of own but year and bodes XXs launch one. reflects I remains generics we the initial

X, overall, exclusivity. of we the where in In is terms than and complex the have right? XXs, generic new generics, So you margins the more first, during months, so the product, the primarily an X that's call low can assume it, substantially that,

So bodes Biosimilars, gross it's about we early think that of as year the stages. about year that and after improving of margins well I think the next kind generics.

first we at earlier Chirag internal more about there. because we up that is much it's our X have biosimilars I time, Over just good those the it, expertise, there XX%, because the partnered, as the think I I going time more think place, manufacturing and and this in think I talked think EBITDA we point just see call number. in our that's on, enhance from a competition capabilities

Chirag Patel

is Yes. Nathan, this Chirag.

have filed. it higher as or XX% XX%. between the second biosimilars. we generics, the X be these see a But with It competitive, as be EBITDA may start much to complex come biosimilar, first are what margins, stay complex XX%. because And out of will may The durability be for products margins, and second the So out just let's or highly north like generics we XX% generics biosimilars would shorter, be longer. complex and first than we will the is

Operator

Capital comes question [Operator next Instructions]. with Markets. And from Nachman Gary the BMO

Gary Nachman

especially when seeing you biosimilars? competitive partners Or being deals like you assets, are what how at have advantages most some with Chintu, for where BD of And segments you technologies the Do discussions sellers do different the these I'm most you or reasonable? portfolio, expanding curious on? sort or feel point? about is So of focused having this are you're environment in getting done? opportunities are and parties Chirag your what

Chirag Patel

biosimilars, go establishing But also are assets. you. we XX, or few we'll a on with more have just long-term we generics. oncology well we'll a side we did the oncology eye so The for the biologics go assets, like Thank as XX complex follow-on portfolio platform, on biosimilar years, to because on autoimmune

the navigate ones. to pretty we where are -- And to stuck BD we on Those focused same So branded we'll in how States company. and we can up complex much companies with how we got second using those, brands in those market, the the looking XX a on portfolio, platform. you invested they of patent, they're or years, of build biosimilar can the even because are patent situation be and where the R&D. come biosimilars then the small the more the be side, first actually, available. are assets the know goes mostly, last generics Because at with the playbook thinking, same United all it

time So launch the unlike really biosimilars it to takes Europe.

in there manufacturing especially there, So and in out is and excess South sitting China. capacity Korea Europe

are reasons, United we many as existing have climate So to to changes and on expand probably and including pandemics those. in we more three tapping well with And keen States two we're do partners, or would for to and and partnership, very great manufacturing we X emergencies. the bringing manage

manufacturing, footing, it a export a a are fast in than helping. biologics our our vaccinated well. war other put up people to countries, got expanded in United States now as We that. manufacturing position We and We vaccine and the have we we is in --

Parkinson's deals is a believe it commercial where leading on advantageous. already, I asset. category here So very we're looking making at other And would we asset our have be very,

second up, have results consolidate year. like their of the space. coming this We is And IPXXXX, top we line to half which

the that side. So now right from are main those BD expanding -- the on the focus portfolio

Gary Nachman

could X other. Okay. if in I just And actually, squeeze

manufacturing? be over the internal talk getting about margin help gross to the you Just how where of back to efficiencies efficiencies time? gross you're many from just in manufacturing? the that And to faced margin, And are external most products shifting how will

Chirag Patel

sorry. Yes,

So pretty work is since our much we came done back.

in the Stevens, partnered we quality products and EpiPen products over And trusted continue and levothyroxine of levothyroxine, Pfizer such We reliable, excellent our Long have Jerome the partners. of great years as that is one in the comes very brought our market. our relationship. expand partner, best Island most Philips, in-house. to partner, The Then the from

from besides those, we now So to various CMOs, have those allowed margins. much brought everything -- which us more XX-or-so pretty more and products like produce in-house

So highly very, efficient very already.

Anastasios Konidaris

Yes.

kind So spot $XXX areas, think -- the other purchasing million material. that's I of spent we raw on more than close right?

within kind think area that's strategic sourcing opportunity right? pushing our on I down for own the The the footprint, goes So global customers opportunity The of manufacturing right? of our that supply our an gives same our organization. well us a nice that as are price efficiencies way for efficiencies So as chain, plant.

we And are foreseeable continue -- So it's for Chintu we to produce focused team us on cannot future. that. this very not won't And and his income that for the see we done -- yet.

Chirag Patel

Yes.

an you example, Just our was back $XX order $X plus year it's million. to week give a ago, Last million.

York, operations, and soon. So coming now New is we Ireland India all gained across up tremendous Jersey in have efficiencies New

So Thank it's fantastic. you.

Operator

itself. call Thank as presentation. Thank concludes as question-and-answer so attending the session the well That today's you. both you for much

your now lines. disconnect You may

Amneal Pharmaceuticals (AMRX) 7 May 212021 Q1 Earnings call transcript