AMRX - Earnings call transcript Q3 2021 | Amneal Pharmaceuticals, Inc.

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Operator

Hello everyone and a warm welcome to Amneal's Third Quarter 2021 Earnings Conference Call. I would now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Tony DiMeo

Good morning and thank you for joining Amneal's third quarter 2021 earnings call. Today, we issued a press release reporting our financial results. The press release and a presentation are available on our website at amneal.com.

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

We of these our found discuss our in non-GAAP reconciliation today's on release may information use measures the and presentation. be also earnings of appendix measures. to certain Important and US GAAP

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

Chirag Patel

morning Amneal Thank $XXX and good and of adjusted of of quarter $XXX net everyone. you, million, EBITDA third achieved a EPS million, adjusted results Tony with $X.XX. solid revenue

have builds the performance yet is quarter we third Our believe best last strong seen momentum on two we these the and years to come.

in with Let updates competencies the and business manufacturing, Generics our start is excellence. me which few on I'll a core R&D, provide business. commercial built our across

increasingly Over products. engine significantly last has strengthened our the years complex portfolio with our several innovation robust

which market in-house us manufacturing most and these manufacture and accelerates products time extensive capabilities our allows to to Our operational improve margins. of

affordable customers to excellent these an done market products for bring have to these patients. and impactful provide teams job working to commercial with access medicines Our

a makes Generics increasingly profitability. a adjusted two new is and gross complex portfolio. result, business highlighted XXXX what different in are including quarter, Generics were Notably, and of sustained reiterate. of driving levels our the to year-to-date, strong There XX% which our increase XXXX. including Last remarkable from we pace in As margins performance points higher XX% is execution durable launches

the products launched First, comes of since revenue XXXX. Generics current third from our

Second, our solids, increasingly Aligned more strategy revenues revenues to profitability. is current to institutional manufacturer's more XX% X.X diversifying increasingly is our how in complex which complex demonstrating Healthcare, our with half and step in of and excited a non-oral perspective announce we pivotal our business is Today, acquisition products, growing. portfolio pipeline new with our products with of leading injectable around so over of expand growing durable our are is $X and a to market a from overall US billion business. the the Puniska size higher

is our for than and XXXX more to injectable us top that five. the of at acquisition strict aspiration our the Currently, more history $XXX accelerate this allows with to the is and is same international the to goal in shortages about need our strategy States be United This last supply double markets. market While Amneal a short quarter and capacity. revenue. time for in injectables million annual sterile for shared there's in by We

Specialty our business. to Moving

neurology We growing inorganic business the are strategy and continuing to expand advancing our We pipeline focused our and advance remained focused organically opportunities, portfolio. our in on endocrinology. pursuing and

quarter, First, largest over this we force execution, products, the of Rytary In Unithroid. two continued endocrinology commercial year. team is sales performance driving expanded our specialty strong leveraging strong and saw third the

broader Parkinson's Rytary. with a IPX-XXX frequent time III therapy be have with the this to prescribers. advance notably, IPX-XXX the good will we with a dosing. technology line data more positive as market patients treatment achieve But to view are of a potential and not Second, for we do Phase Most has distinct for the rather, pipeline. continue patients innovative help that Specialty believe We extension IPX-XXX on appeal our and of less we will pleased Parkinson's disease

advancing are our we are about work represents. and We opportunity excited pre-market the that IPX-XXX commercial

Specialty across in more will this and to Chintu portfolio continue detail. our the discuss We advance programs

growing commercial to Third, our infrastructure. to continued assets and business, distribution drive and continue market are our and leverage strong on the and profitability. government dose actively to stage healthcare expanding commercial large we we pursue to late-stage federal programs healthcare, in we quarter our focused complementary this In execution, Specialty federal sustainable operational growth clinical our market saw healthcare performance solid unit AvKARE presence existing offerings with

for import company highlights mission patients, stakeholders. medicines on on we initiatives insights efforts at social and provides important our governance and focused affordable business on inaugural to as sustainability essential our environmental, delighted our Amneal its in ongoing Finally, impact were driven release providing and a yesterday, report driving

terms example, were billion generics $XX year patients nearly United For in last in for of saving affordability, and alone. our access medicines responsible States the

implemented New our system clean Brookhaven, geothermal I'll a our In that, energy call facility Chintu. the impact stewardship With to addition, have we over to York environmental renewable at significantly. the turn on reduce environmental side,

Chintu Patel

and everyone. Chirag, good you, Thank morning

incredibly a manufacturing practices. we inception including pending quality maintain record the issues no compliance track with and have of continues inventory team in and nearly efficiencies we Since taller me gaining I'm as execution, with XX of whether quality The nearly our to our improvement current are we focused profitability. sites. possible. high sustained at make the operational proud maintained or better currently process have hard have Today, chain of reducing management, our we result team mindset, standards level of our supply to order the or impeccable open levels years healthy we thank its lowest improving and good of Amneal back FDA constantly our that team. obsolescence highest day the Since efficiencies continuous our let an with progress of that's tremendous on X,XXX return see as commitment been every of improvement, First, and work seen members, and excellence to all manufacturing history Amneal, Co-CEOs, history. who cost the

As the applicable assigned several you BX Services. performed raising Synchron concerns which FDA for impacted an issued by studies untitled are The manufacturers. around code aware, FDA the letter Research bioequivalence products,

bioanalytical CRO was restore independently For our to completed most handful CRO, Synchron. as timely to a impacted monitors manner. results. and responses studies we different all validated rating North We audit products, the as part by a statistical process data and Amneal our in these completed analysis of our FDA, AB the Also, and for want of normal

to injectable Turning the business.

enhanced our in of launches over injectables. planned. more This with injectable US the are rich expand highlighted, Chirag and Puniska pursuing R&D pipeline which commercial acquiring institutional R&D for expanding injectable with sterile opportunistic lines, more By be and we a accelerates the capabilities acquisition provide will more XX state-of-the-art supply, acquisition deep pipeline five capacity to products redundancy market in to As our production also as and the business. strategy and us facility advances XX we have our speed. meaningfully allow Today, approved adding

approval FDA injectable site expect is of our end this inspection global We the leading believe be in acquisition XXXX. the by the the and player a market. We of of plan to cornerstone

walk our progress. agenda now our on and an update Let innovation me provide company's through

and categories hard our to NuvaRing First, device is in are Definitely, from Amneal innovating such and innovate peers implants, complex these launch differentiated ophthalmics. in and to examples. our successfully in products across We injectables, product Generics, make combinations its as complex believe strategy areas. ability Sucralfate prioritizes drug inhalation, great

spending. XXX Our approximately drive XX% complex great products Currently, Overall, feel have our fast-to-market XXX solids. we in which internally is innovations. manufacturing over R&D pipeline and generic another developed capabilities non-oral we our and ANDA this with pipeline about products now

file expect to launch XX each to new year. XX XX ANDAs We to products and XX

COVID-XX. exclusivity. We has approval pleased of use week, engine sustain TobraDex. which such XXXX products for approval see dexamethasone in announced Amneal number we medical for of This represents CGT the respiratory associated another constantly the symptoms highest including turns very R&D Zafemy, with industry. launches a in of the long Abiraterone level treatment an product the high at important are and we a of our XXX-day innovation the and new of to profitability. short, number conditions Last drive and as CGT growth wheel designated steroid designated of runway In Amneal provides with

opportunities and about near in Second, partner products products leverage in markets we as in with look certain filing and our select China, in excited remain in XXXX. China we commercializing our to out-licensing sustain another Outside and our geographies more expansion and we as of global portfolio pursue as to share to term expansion, working XX Fosun, We focused we start for growth. vector global are see partners will we progress. we actively are

look to in market we enter the biosimilar XXXX. Third,

FDA. oncology three Neulasta review Neupogen, Avastin under We the an biosimilars all have filed with and

approvals We next expect to our year. initial receive

on IPX mid-XXXX. and patients times resulted in of in average IR baseline to the to Rytary, day, times its advance at good with compared as time Recent hours X.XX X compared per day. Amneal dosed to IPX-XXX one one where time we achieve to per demonstrating CD/LD. Good CD/LD time IPX-XXX in with from CD/LD We In partners market endpoint as this, Fourth, On Parkinson's to of ANDA are per specialty biggest a XXXX. expect our compared disease biosimilars. day has evaluating first three see continue represents starting dosed Starting we less with met a five CD/LD Phase appreciate only more which least primary specialty the analysis, opportunities additional on or hours in average dose year Beyond be the showed good look broader IR than we results for dosing to increased second to superior IPX-XXX. per and space post-hoc launch immediate in on when market to frequent on by help potential product believe we XXX we pipeline per new our IPX-XXX can release submit broader X%

to IPX-XXX, rest of to Specialty addition In our we pipeline. advance continue the

approval for DHE the launch with is cluster FDA in for ANDA our migraine headache mid-XXXX. expected pending and autoinjector First,

the Myasthenia of to Second, our second ANDA XXXX. expect in KXXX for half we for file Gravis

file GRANDE molecular relatively XXX(b)(X) middle to in our the new of pipeline lower. our entity drug platforms KRONOTEC. as we our near for the technology delivery than programs modified future KXXX level IND expand further are in for for the We application look additional share programs. next to proprietary product plan and we TX utilizing risk a programs which is all Third. These hypothyroidism year. release the

a We of expect these technologies new provide opportunities. wellspring will

turn Tasos. Now I over the call to will

Tasos Konidaris

Thank you, Chintu.

gross reported XX% third adjusted quarter we up XXX total adjusted EBITDA net of up all year-over-year. up $XXX million up adjusted million $X.XX of and For revenue EPS of X% margins of XX% $XXX XX.X% the points basis

report to by and of presence our From efficiencies both long-term to in R&D XXXX and substantial in operating Moody's. continued adjusted the rating balance Our debt decline primarily XXXX. perspective, product of times, net EBITDA I'm new our and X.X addition to launches, happy by growth. recent lower debt to specialty growth with reasons investments and driven drive is improved that includes and X also agency commercial it debt performance X.X to our gross The times levels debt net December for long-term for cited operational key as the upgrade were December compared times a

now me our with Let start Generics segment.

of launches net million For of complex and Growth million or our portfolio. driven product strength the revenue new increasingly up of $XXX of the diversity was $X year-over-year. increasingly X.X% -- by third the was quarter

this Generics and in XXXX to early for launches, a value to manufacturing up including by margin well net prior year our perspective a was basis and in driven product contributors the XX.X% Gross growth as, year-to-date quarter. gross million quarter Adjusted efficiencies Generics the $X bringing revenue Zafemy operating than million new in in-source $XX customers On savings. and From launched recorded for higher this X%. XXXX paying third substantially product year. XX.X% growth. of strong were Abiraterone, were margin products substantial which in procurement expansion New last was the accounted as

million specialty the to of segment. $X million year-over-year. revenue Net X.X% the third up $XX for Moving or quarter was

million $XX up centers and Unithroid. specialty grow neurology continue net reminder, and XX% Rytary brands in to with the and aggregate a nicely in Both recorded revenue year-over-year. endocrinology As

by As expected, declines was in promoted our partially this offset growth brands.

quarter prior million EBITDA economy Total were We company up the in favorable quarter, R&D of strength acquisition up On revenue than higher year-over-year. $XX Gross X% the a to continue $XXX growing second year a up we by basis, XX.X% expect Unithroid million was quarter diluted operating in partially comparison Specialty and performance and XXX expect the quarter EBITDA mix. for basis margin was incorporated by higher In expenses cash and flow Kashiv to and Growth up $XXX third sales partially million total to million our offset $XX the Adjusted million for combined. of added the XX% strong to year-over-year third due $X points as high growth in third basis improvement million year-to-date XX.X% impacted the quarter $X.XX was due taxes. was higher Unithroid scripts profit EPS perspective, XXX million from segment point both $XX specialty the third about million new gross cash gross diluted scripts -- expansion in $XXX timing by was representing for year-to-date million net $XXX as with product SG&A in X% year-over-year was AvKARE net which issues. single-digits prior adjusted Adjusted the the specialty $XXX Rytary or we as driven third a higher continued the adjusted opens. in Rytary million for and double-digits. QX higher down year. due third year were revenue quarter Adjusted and $X as was $XX the full distribution From AvKARE quarter the was recorded million higher year-over-year. $XX quarter. margin was force million in offset of by to

million In we perspective, a cash $XX the funded price remaining purchase to portion in closed with third $XXX equivalents acquisition. $XX November, utilize that approximately is is of our the From and in intend of quarter to in cash the million Kashiv addition, be and the funded of while timing to $XX a fund the price million purchase mid-XXXX. million

about very us this acquisition As that. capabilities and begin we revenue EBITDA and after substantially meaningful Chirag it XXXX expect and excited gives accelerating in earlier we're starting Chintu adding mentioned the to and

product and of XXXX guidance. year for full our the As nine are our months year most us, updating through behind new launches we're

COVID-XX we're to with growth. tightening this flu pleased and to On revenue mid the $XXX level billion full line, We're growth portfolio reflects reflects high $X.XX. $X.X net million EPS represents the lingering million which top driven versus range and million compared impact. EBITDA Amneal our which we guidance to resilience range $XXX the and range to by asset of time are raising of about very XXXX. $XXX pipeline investment our also year-over-year $XXX and season $X.XX At growth our depth revenue commercial our and the single to year same digit headwinds which organic $X.XX million XXXX raising compared between expected and We're of double-digit lack $X.XX

flow and compared quarterly million trajectory. and we ongoing CapEx double-digit topline performance between summary, the million. about and great $XX adjusted of million remains positive growth of expectation solid and we're cash $XXX $XX million the our and range $XX XXX In our feel to -- EBITDA operating our at million and Our $XX and same $XXX to slightly lowering million guidance year-to-date

now back me hand to it over Chirag. Dr. Let

Chirag Patel

executing Amneal fronts. all Tasos. well In Thank in summary, is you

business diversity, higher Solid portfolio. and the durability sustained increasing complexities the our performance of reflects profitability and across

the strong Looking now we questions. We'll see to profitability. forward, continued call and growth open

Operator

[Operator Instructions] question Sandler. Please Amsellem David your Our from of is line David, go comes first ahead. Piper open.

David Amsellem

thanks. Okay,

saw for talk that how are generic. biosimilars brands, get designation lastly starting of of or your the we biosimilars just today? a have as queue? potential Copaxone and of terms for about where And recent I about interchangeability the of for a can't the Just biosimilar thoughts the mix a any point, wonder, given biosimilars, generics. in you're about and can that specialty So the business question taking you're but you to to just the acquisition getting acquisition business your help, in lately the given secondly, philosophical time? interchangeability or you're high-level really that today's complex thoughts and exit regarding any interchangeability Humira you thinking on is down how over you given And business strategically a one recently? for that important pair thinking then look solids that anything going And just then business base oral how particularly your is

make Just you anything be anything that remarks, product I sure didn't prepared could helpful? wanted Thanks. miss but on would add on to your that in

Chirag Patel

morning. hear good Good to David, you. from

as oral solid out reducing extended question, your laid cash allows we business on solids, and those oncology, that clearly solids. are all release a onto us fantastic still first Amneal and that Not the So that areas it of capital utilize the But flow, oral to multi-layers out had cortex We're are X.X proper we oral diversifying getting commodity are allocate products does as mean very because our complex pretty strategy to not produces we growing. oral from we away we're less we solid well. further. the which much that have

sole So, we're excellent injectables with today aspiration facility India. development be state-of-the-art to fire R&D our best injectable in into provides and This in in us business is lines, business, our accelerated accelerated relying lines, top acquisition diversifying which on five. XXX European retail is the the all launches,

So to on we are meaningfully contributions very excited adding injectable. now be

China, us markets. the very also The go is we and which third to other and to piece have allows excited. international This pursue we're facilities to

the first China and business of details we but to onward any are it building take for Chintu opportunity shot see biosimilars on to we XXXX excited very and interchangeability. shared very I'll my haven't those course biosimilars, a is The yet, Africa. We well as and what and products as on on pass in good fourth

PBM of more be So but much payers build my will be drive Yes buy and the is for still will needed, it and evolving market it. highly biosimilars market developing. play, a to view would payer it separate economics, so as driven a the remains driven competitive, going

intervention So for there huge comment or CMS country without realize for penetration interchangeability, biosimilars. market which that helpful our interchangeability XX%, do go and to get biosimilars, want is XX% will biosimilars more XX%, savings a a interchangeability? of I XX% XX%, share true penetrating really with potential. needs all would think, and to by volume for And on XX%, to fantastic you to be needs covering to it be on Chintu,

Chintu Patel

Good Sure. Hi, morning. David.

add Before on question just also to wanted Specialty. you biosimilar, had I a

equally are we and Specialty inorganically. building So our focused organically on pipeline

have looking a opening acquire. and shows are As we to going inorganic assets at I mentioned also which products, in my good pipeline good we forward remarks, promise

So the must. occurs a see COPAXONE, interchangeability to we launch other your on it's the likely be XXXX the as last comfort with to generic were Specialty more statistical forward. not more delays and side It from happy acceptable half. when complex I significant And to are building in forecasting pipeline. Coming or I the be the remains interchange launch. and industry, evolve But is XXXX areas, CMO, immunogenicity to efficacy biosimilar is our and going Chirag mentioned, injectable not and And it's physicians perspective the any most interchangeability, as along are are David, very think first in lot and the a and have exciting. I we also patient were a a main would would the and we gives but pathway, products going adverse be, biosimilar the focus reimbursement payer due on the the regulatory of to the think excited that driver biosimilar a time we time, our differences the COVID very question good norm That period be COPAXONE. of between where growth have from think over whether to -- raise concerns. or

David Amsellem

Okay. Thanks much. so

Chintu Patel

Thank you.

Operator

Thank you, David.

Goldman comes of Sachs. from Our next Nathan Rich question

is Your Please line Nathan. proceed. open,

Nathan Rich

the a the segment. margins. morning. Thanks Chirag, gross Generics highlighted the margin to while get question. performance had for know Hi. the been I XX% Good you for in to back goal

You're now solidly there.

I the an you. follow-up lower Tasos think more maybe margins gross you of you your the what shift updated So the view we opportunity then, could go you think the us forward, you outlook talk expectations? kind as guess Thank maybe could products? updated do range on And going complex segment towards the where changed prior maybe you, for through portfolio for of that to about as revenue moving could that especially a is relative just end give to

Chirag Patel

Thank you, Good Nathan. morning.

we virtually, We it the which in-house as all care margin manufacturing efficiencies most gross existing addressed plant are -- the not we of from which brought So said margins. is bringing back to CMO improving. utilization, helping are the in-house products these our failure right The we operational takes we we're the and products, so with pulling customer, proactively margins complex we direction. margins more in working the levers algorithm are working more the the of on returns to see all supply. reduce injectable The orders launch

most five would but of one product one, in we for the Now, margins, not very a few to goal two, not of have. economics manufacturing our our it may year, and higher three, complexities have be right years with products be because mix sharing over we're products. four, gross In-house portfolio are partners of so the the

on is margin Tasos like that you on to. a would gross So Generics.

Tasos Konidaris

Sure. Hi. morning Good Nathan.

a from $X.X recall top up and year. X% now as still range we're which billion organically at right prior our billion to perspective from guiding $X.X line $X.X billion So was you is

we great couple our puts have thought. first and of new a feel So better than performed -- is we product about this. It's Number feel we introductions one takes.

First, that they year in got anticipated. they were earlier was launched the --

reason increased that improvement, which why EBITDA guidance. key gross And our our has our reason than thought, the was why so And actually done a better. much key we better was we margin EBITDA,

So as was that's anticipate did of much flu The as a things not we thing. complete this we on was good spoke a lack earlier season. year two

top lingering COVID-XX guidance sitting -- this not so give from barrier on caused biggest some that the effects, trying impact a everything. year that to anticipate have what was some but the to impacted line I products Also earlier was any just to that perspective. trying -- continue think million, $XX tamiflu as us us as other selling well costs essentially that So negative

-- were two three reasons the reasons. why those the So

primarily than bit the products also around that doing EBITDA than of little lack guidance. the that some worse thought, of we EBITDA thought a new season products the better Do and So the flu of raise we of doing helps? legacy drove the

Nathan Rich

Thanks Yeah. very Great. much.

Operator

you, Thank Nathan.

of the from please Our at Unfortunately, is Balaji's line Prasad Balaji from ahead. moment. Balaji, next Barclays. not any question we're receiving go audio

Tasos Konidaris

move we on? can Sorry,

Operator

please are make moment. sure receiving we're at you the Balaji's Unfortunately, audio un-muted. Balaji, not from any line

So to we next go which Wilbur James. from Elliot, will of ahead. on question is move our please Elliot Raymond

Elliot Wilbur

Thanks. Good morning.

a a injectable need basis of considered molecule three the needs representative attractive different much have more really to do First very portfolio buyers, ask around in obviously the GPO in injectables growth and retail that to of was question those the which of question. market outside I more driver complex segment, some business be of wanted or have expected you than going pipeline, the the your larger, to be differentiated key able a traditional win to is, big on Question can you filings your That's purchasers? you forward. first

nine obviously just question Second performance, XX% least like very year-to-date, top ended at of at total it September. new strong looks is, the line, in of least product months terms was

a of and and you're Just price that seems some terms be trying talked you, other erosion industries the volume get players out accelerated to borne have actual about sense Certainly sort space of in what metrics. looking erosion? at seeing from to definitely plus

the on able that. But You guys to have pressure base. if I'm accelerated offset some you're been wondering seeing

Chirag Patel

morning your products little launching market doing XXXX. institutional have better our we've started the To you. first $XXX market institutional XXXX been since in products. Thank Good we or this XX year. you, question, the Today, Elliot. bit in a million to we

matters GPOs, a site. relationship we head matters, the led with our waited not build different institutional dollars. yes, commercial million and with which and redundancy sales different portfolio there's So we force would we And actively have acquired and a why relationship are already the three to a there the and have And and years is hundred to few buyers. build this four costed own ready-made by

of the these of we most got And vaccines we the we've a order and because neutralizing then injectable if the exactly, capacity. the it pipeline, R&D to today, because line, needed of COVID couple even So takes have new EPA. the years

we're of going we enter are did we products in. yes, to in of just excited complex kind technologies, how first-to-launch So, products, larger many multiple will retail. have we very portfolio, all like a what And

committed stay injectable market. highest are We we and here in R&D highest quality are with the to

So million grow much higher. we from to will $XXX

be market to in those is further products it diversifies to into And, also top international -- is us it. five. aspiration Our allows injectable which which markets,

On products and the -- three gone, answering low all since rationalize to portfolio from they look for I've which these it been I'll the industry is if have and totally at same how would the constantly have opportunities as of part continues the -- very these But explain Tasos, has I it is the not to XXXX. behavior that the answers the this commodity manufacturers if that pressure concerning. down, on, much for give Tasos it and as base the, is I'll which cost the buyers is you think look irrational details. healthy on driving

Tasos Konidaris

Hey, Good morning. Elliot.

Chintu Patel

a… take I Can

Tasos Konidaris

Sure. Chintu, go ahead.

Chintu Patel

side. earlier it's That it because comes competition to little value bags, a a exciting, injectable the and acquisitions to we and it when volume player, triples it plus with the our large is and capacity gives us huge add added just very there parenteral I overnight on very capacity become called a wanted very bag.

to gives and into that So segment. pipeline enter dosage and form us have we robust it strong very differentiated

we lot on parental a Tasos. at the right also and lot It's we a right liposomal including time, player bigger products, of we are in lot of a are are ahead large missing, microspheres, we we deal excited. working today products than have So bag capacity That right others. are what complex and autoinjectors very price, even and and the injectable, of go wild

Tasos Konidaris

Sure.

around base other the the of the do part think business, acceleration see decline an your or not. I question was of you

for it's fairly been a us So steady decline.

that So low high and – – is at kind the double-digits. of

of year. think what That's what business approximately we're this declining That's we saw it as base expecting So the last XX%. year.

if you that that us, look revenue at I revenue. The in XX% our business of This what XXXX, and accounted base see part the was Back portfolio percentage factor you of of perhaps the our business year of for. other differentiating Generic business. Generic the our base about be of will XX% of business the

not the downward more headwinds have side to kind the the substantially as become the yes But the that pressure. headwind right, going same portfolio, of continued more complex, evolves on represented of it's will the year-over-year as right the older. solids. it's to we subject other this because business by traditional So oral And to complex rest decreased be

think I does answer that hopefully, the question. So

Tony DiMeo

Next please. question,

Operator

Our Prasad Balaji, go next question of from Barclays. comes please ahead. Balaji

Your open. line is

Balaji Prasad

and everyone my missing for morning, good the apologies call Hi, earlier.

Puniska, the and you pipeline like facility on getting to side out. on that you're products particular and the can would also call Chirag, Firstly that describe any capacity you the

end a Second XXXX. this that to you mentioned any that is stated think the and all on FDA inspection it CGT correctly, you're – heard you products specific question You was approval designated at or it inspection? had expecting overall I opportunity. I by if of Is side linked you dexamethasone,

around can you Thank you. least expectations some So context XXX-days? revenue in at also provide the first

Chirag Patel

state-of-the-art Chintu, to facility? Balaji. you would you, Puniska's the Thank explain like

Chintu Patel

immersion state-of-the-art is Balaji. XXX,XXX and five as Hi, Good large lines. two European around feet a in last the Yes. Puniska the vial years morning. square made recently side built and bag

to that us way volume requirements the our site gives million as dosage internal XX out and forms it XX to forecast. So capacity of to XX up per that million caters our all around of

from a perspective, pending. they do have product FDA So the that side

have the one a product not of are revealing product. bag name bending product. two and one We vial They the the

the with comes infrastructure So and that separate. it gives XXX us is people – R&D great

gives for also manpower R&D it and manpower trained injectible. added very So us

strategic move our to injectable. riding expand it's overall So our

very us needed just it we that capacity. and So overnight are excited gives

Chirag Patel

And facility. fourth this is Yes. Balaji a

already we two one we -- then is alone products. a better guidance, this specific products make us we facilities margins these the These are provide on we on for one. dexamethasone we of a it's gross have the that than to love while chance is a niche other products. two revenue where as are So -- oncology -- or do have fourth injections three not product On is and focusing but and this others

a to launched. of And it's So year these product. products be every expect good we many

year, and any excited this -- up. why about first our in have And the as launch reliant the as also half of we're that CRL we XXXX. multiple vaccine we potential responded of coming expect well on but filed is launch So one new to big launches not we we're in

Balaji Prasad

Understood. Thank you.

Operator

Thank you, is ahead, next Balaji. Gary. go Capital [Operator Please BMO question Instructions] Gary Our Nachman Markets. from of

Unidentified Analyst

morning. This Gary. question. my Good taking Hi. for you on Dennis Thank is for

believe hearing supply Just is Lately chain year? that as question from there all fourth supply on issues that of you we've then anything issues affect seen me. next your could And and or the been kind quarter you've the chain a debt. another couple

X.X in You lowering X been now XXXX, XXXX clearly we're guys it. in time It times X.X was have at times.

towards? that into to curious a number looking get or you're there Thank Just you're is achieving you.

Chirag Patel

out. year what's Thank much more pretty fortunately you, very the concerning supply chain We robust very And is a with associated happening. is pre-planning which our planning Yes, of on Two interesting are it's Gary. a have excellent, inflation supply question But chain. team and issues. is concerning. they

shut have certain China is that inflation drastic to are steps asking the higher down facilities here. input increase all material and have API suppliers are we key starting in prices them by the already taken material the KSM API cost cause there of and going pretty because much of to this So certain is for been

that's Xx our into smart concerning capital. under chain target. about right make time, working get price. a So allocate deal, is as our how day, And issues we our we've that like and supply and on right saying right teams don't with to this. it go go We're at are obviously sure we these a is certain And partners proactively KSM. to on can as On our it's low we been

right to we in you. the we level will So we down like very deals. But certain business organic capacity are diversify we're to are exactly wait prices keep not times the we now which own and at deals. don't our deals win a And looking are patiently in fine we do for still what doing. this -- balance in and constantly keep a so and new Thank that's it's right going And up our market pipeline because adding very extraordinary to market in ready the the and pay sellers the are point. confident

Unidentified Analyst

Thank you.

Operator

ahead James. Gary. Instructions] Please Wilbur Raymond go follow-up you, [Operator from Elliot Thank We question have Elliot. of a

Elliot Wilbur

Thanks.

Just I Chintu. two follow-ups. for quick first guess

could You the revenue bigger out every the and what of commoditized a from very to of relatively the But base affected obviously And even seems sense products the just markets. the and guess within difficult be somewhat as if AB. get I they in you complex give time pull BX generics slowdown that in came a to we in of alteration maybe new small extended coming more to of the year. talked were and more to the out it seem been us there's terms rate FDA about Synchron issue code the TE products, at question, those looking of noticeable lines of away the all portfolio. more with current is ANDAs the picture and then conclusion your

have sort which kind these of to be the you think But you can or expectations advantage terms whether expect of both with not of term of timelines of not terms seeing more or that be adjusted FDA them? wanted we're what Why in get just has a maybe in competitive these disadvantage. led may longer that So, some to or of filings. to a perspective more your approved. complex And products to in of happening some key be you

Chintu Patel

you. Hi Elliot. Thank

of FDA that mentioned So, and responded. queries I on to the Synchron we responded have as all

We have lab used outside bioanalytical Synchron. of

a very have we we have we as the have FDA. a that diligently are would We done have are that very positive audit from but thorough and very outcome hopefully working I optimistic and and FDA that job about third-party talk timeline can resolve when, don't audits a ratings. we to Amneal AB independent with

about material this or seen not but Zafemy, products. have material or product customer We the which have do any seen one We is but concern. which not is we a concern we so eight time patient at impact time, or any important, have have impact at this

plant you by pre-approvals we inhalation the XXst But in depending many complex from so a XX it's stellar Complex And you never than quality are years review many Regarding we has had science months. FDA that's generics, on or with highest approved records the have COVID its first received auditing can and any and is our they various the or companies Even as years online challenge approvals three an else. these also of of more around last in times approvals learning in we perspective recycle plant say because is earlier. products. four I from did yes, bringing Amneal anything our receiving are. cycle into where approvals impact track FDA. a pre-approval approval Amneal or associated Ireland, had with ways looking delay

So, like FDA other product But longer. been and have that may I expectations what as very working with it of think the take understanding Amneal depending on FDA are. and a on a many doses ophthalmic form transdermal we has good

pass product, and received approval, ophthalmic proactively. suspension also areas is already very able approval, FDA overcome we that TobraDex the like where many ophthalmic to we'll have which which we have product gives only a us our in questions So, be recent mover more on the that is the for of complex was complex advantage

getting every So so There plus approvals year. prior than are But I delays. right, year. are far Amneal, less or as think, the as you are approvals XX there we are

next Amneal expectation. than due change same Thank certain few its certain FDA's competitors. in complex. But, year, We overall, position been in a expect better you. is requirement to delays There the has or

Operator

Elliot. you, Thank

Our final go your question Greg, comes is Securities. Please of Fraser Truist open. ahead. from Greg line

Greg Fraser

taking question. Great. the Thanks for

rapid quarter? injectables this Sorry, next few lot your did drive outsized of across injectables? outlook in obviously portion years products expect the to diversified curious you growth you a launches you're broad if the if earlier, in over the new of a growth. or Thanks. sales for the fourth And missed some of business, the an I on launches will comment the and I'm but be expecting outlook then, on standout growth portfolio

Chirag Patel

Good Greg. second morning. your take question first. I'll Hi,

the applied more retail well now. as PFS, lately, so complex, so vials, also it's So autoinjectors, the a different added, there injectable is redundancy plants, side bags as in strategy is diversified, that we of four more a is is right, similar oncology products, mix which the

United like international it States. be good some more and to products more well especially product when lasting in demand So and diversified market, and as higher is as in than would those be Colistin of comes would it prices

side. year. the for injectable growth on Tasos The has strong, NPL whole business mentioned, excited been really So as

on margins we add small couple from a So just products, good but up launched the really of they perspective. contributions

quarter products, five, quarter new launch they're six So we'll every every continually launching. whether we're

Tasos Konidaris

specific. Just even more

was I growth same about of growth, it $XX said the think, QX, versus So should about QX. prior we expect year level of million in

Chirag Patel

Thank you, Greg.

Greg Fraser

Thank you.

Operator

We Greg. questions. currently Thank no further you, have

So Patel. to like I would Chirag you hand to back

Chirag Patel

Yes. Thank call. much, joining for today's you very everyone,

progress it of our executing business, Generics side we're I -- as steadfastly call the is a and we're Amneal then it I we we're in products with disciplinely affordable or see executing this Xth excellent along and business. the we business, which focused this As which is XXX(b)(X) in as Specialty well point our our continuing pleased like of our the on with with Xth we up X.X -- value part company the products is, Specialty opportunities to branded with growing calls, and move are and medicine multiple really diversifying good freeze and will one-off our Phase which of it at become chain at strategy strategy

where to partners So some worldwide we're will selectively. in keep on bringing and international driven complex on on expansion medicine our we maybe markets very we very as access and and more select well both. patient entering select excited markets And the own products is affordable purpose and

very overall. So And very great day. a much. excited, you. Have you thank Thank

Operator

rest you great This a of concludes for your We today's have call. all joining. Thank day. hope you

You may lines. your now disconnect

Amneal Pharmaceuticals (AMRX) 3 Nov 212021 Q3 Earnings call transcript