AMRX - Earnings call transcript Q1 2020 | Amneal Pharmaceuticals, Inc.

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Operator

Good morning and welcome to the Amneal Pharmaceuticals’ First Quarter 2020 Earnings Conference Call. Please note this event is being recorded.

At this time, I'd like to turn the conference over to Tasos Konidaris, Chief Financial Officer at Amneal. Please go ahead.

Tasos Konidaris

Good morning. issued reporting we quarterly morning, this press our release results. Earlier the releases website this as press slides at well our The on as on available call www.amneal.com. are

replay of are website our conclusion. call We live its will webcast a and available conducting after a of on it be this

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

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

We also certain non-GAAP discuss measures.

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

the Patel, and our Chintu this Co-CEOs. Chirag are Patel On call morning

Todisco, available Q&A of line, are Commercial; and Senior our and our Corporate the Executive Vice Secretary President session. and In will General of Specialty , President Operations; Boyer, be the addition, Joe Counsel Commercial for Andy Steve on Manzano Vice

different to locations I of would are to all COVID-XX. due note at us that like

please bear technical if with there us any are issues. So,

the to Chirag. call that, over with turn I'd to like And

Chirag Patel

we March a are him on Amneal and you. our morning Thank pleased joined in team. Thank everyone. have good CFO Tasos and as you, Tasos to

I to by response addressing will begin our COVID-XX.

navigating, we in our environment communities First, company, I the all want individuals, to a as difficult are world. as around the acknowledge and

impacted Our pandemic and hope by this to healthy all thoughts safe. go you of we are out and those global

Amneal respond COVID-XX We were to continue evolve are of and has communities, the and to business and our the supply patients. the how mobilized medicines crisis. proactive health to colleagues of proud our We to sustaining protect while deeply for of quickly

established our mitigation of oversee ensure We functions strategic business across across to top preparedness, the all and up our continuity operations. enable made and response, task business force leaders our

to our I exceptional the of want recognize efforts employees.

Our operational teams have facilities finish running line. products to kept across the our our ensure get

certain production have ramped We new demand. areas up also help meet in to

getting distribution job teams have out products Our terrific our done customers. our to a

they productive have sales In as addition, teams and innovative and our remotely. been marketing work

For procedures automated and samples example, they to continue deliver and learns new processes virtual physicians launch engagement. to to created have and launched physician

also supply our Importantly, to chain well. perform continued

Our and possible. needed procurement of that running our great sourcing manufacturing ingredients assuming a the pharmaceutical operations as smoothly job have to and production teams done keep as

with pleased are we ability quarter procuring confident delivering our we and how in and chain, supply continue products. our during strengthening materials continue finished operated we As the to

beyond help lupus this of meet RA hydroxychloroquine patient business market demand states which nature production believe share, to accelerated our medication and and agencies global helped continue to is our to supplying government Given X% quickly Amneal's combat We access, responsibility our commitment traditional us pandemic. we of and it the COVID-XX patients. to sulfate and move from the

for involved supply With minimizing footprint, -- the a of customers, impact quality, position track some have Amneal. challenges and manufacturing the While as incredible of we have pandemic, substantial seen record patients, COVID-XX. and in U.S. a result unique done chain, an diversified we're of teams disruptions this our we're to well job

crisis U.S. production American The for reliant the finished almost foreign pharmaceutical That supply key to and manufacturing. on chain completely shining spotlight of said, APIs materials on of manufacturing this chains a and the is produce starting dependency the other drugs. on is countries' supply

more It ever, is than more that manufacturing and want for emergency the We United up this in know We need savings drug bipartisan issue production the be apparent we around to able are is there ready a ensure another and global medicines. when States. sides along, to to its ramp people for support both national importance is security. and of a life aisle there understand on manufacture comes

uniquely forward generic to U.S. positioned is manufacturer, to the participating drug believe the key the solution. Amneal a of dialogue. in As be domicile part we largest look We

Now, let quarter. me review the first

pleased demonstrates efforts which are and our Amneal with progress to financial X.X. performance, continued in our We build operational

We improving inefficiencies. are chain, our operational by supply our reducing focused execution costs, ever strengthening on utilization, plant increasing and addressing as

expanding is your this margins. of All

and revitalizing franchise, We specialty also the business, we quarter. our against include are intelligently. continuing our strategic to last growing execute These the laid business diversifying generic out priorities

focused on navigate even created these will XXXX and momentum building we by our the remain We and challenges as continue in initiatives; beyond. believe we COVID-XX

business our provide the start XX%. solid It me ahead is gross to adjusted goal Generics Let now which year. during an update long-term quarter, segments. on notably of achieved the margin our status XX% of

and business, drive enhanced preparedness in the new execution. two base this strengthen and main product have launches We with business priorities

We portfolio product and large new building on in launches. on products remain of track have of our continued terms

continue commercializing our products. to are more growing share high complex shifting market developing as value focus we and We our

Butrans most at set five we value recently And XX products XXXX. to generic August, already launched Last out least have system. August by high launch transdermal generics including we

running of we more we and the to-date. Chintu and NuvaRing Our and results up of generic launches details will in recent are versions generics. and R&D are our up provide with have pipeline pleased Carafate coming first-to-market on two what

specialty, are We all the to on In our franchise. products continuing during first expectations we our almost outperformed grow quarter.

respectively, driven XX% continued by in initiatives. XX% some saw our growth and Looking highlights, of dietary at revenue marketing TRx in year-over-year traction approximately

XX% by programs Unithroid revenues marketing success increase year of XX% and reflects period. continued This existing to our favorable comparison and prescription prior also and respectively. year-over-year

from Through products. starts same have expect Xst, we the strong, Post-COVID-XX, dipped on May negative experienced major patient growth the Prescription have slightly. patients minimal COVID-XX remained all impact starts refills a in new while new we rate have not to at first weekend, specialty it we resume seen the quarter.

to January now through on our the new Turning business acquisition channels. our to completed in intelligently efforts stake diversify of majority We AvKARE a XXst. distribution

subsidiary planned, operating have independent and completed essentially the as it As we integration. is an

be of our platform. strategy this which continues to better identifying more part for unit opportunities serve our agencies we With is a products, platform, of are AvKARE and differentiated niche business, strategy to selling dose new government a

a new of continue business. will opportunities Amneal We recent through for continued market. will and partnerships it positions in opportunistic our the transactions. complimentary We growth disciplined, for additions dislocation result believe us evaluate be there inorganic to new and which believe growth, or value-creating geographies, M&A smart distribution exciting remains opportunities as we specialty channels, be accretive to

to of uncertainty As is a we complexity has there added COVID-XX our question business overall. look year, ahead no the rest industry and of to the and our degree

and volumes and reduction social distancing products the elective both generics. For specialty certain may in visits physician the of quarter, second example, surgeries across impact and in

our quarter this however, results working. that Importantly, to business revitalize strategy solid a we our is first have demonstrate business diverse and

goals. to team focus resilience We achieve and on our and us financial operating are will our enable confident our the strength execution and of

call now turn over With that, Chintu. I'll to the

Chintu Patel

Good everyone. like I morning acknowledge efforts of Chirag. COVID-XX team Thank tremendous our also would pandemic. the to the you, during

can. and essential impact company the stakeholders and and closely We mitigate support of help crisis includes on This drugs. provide own a number working our where industry avoid our and the local to taken we have supply of with of federal to strengthening the actions agencies government to to shortages chain and

been of have making always we and possible a core, today. healthy organization never culture than been our more mission-driven At has important our

on from As results, first you see focus can excellence bearing operational quarter fruit. our is our

and our the strengthened processes and products our by chain systems have which come market. improved We to supply

suppliers We efficiently with have and forecast. worked manage more volume inventory to managed customers and

progress efforts done, of we proud are While not these are our to-date.

our strong results business recent in all both have Our business cylinders we and is firing and seen generic on base very launches.

XXX worked aggressively have the base have expand to in currently business approximately products we We where sales marketed.

grow and the remain launches. time, to with same we customers to share. We new opportunities our work At continue closely on hyper-focused analyze market

products margin. gross six Over have high-value multiple we have our last the XX complex launched including generic, months, improved these substantially efforts

current the crisis more are manufacturing has as demonstrated, and Finally, quality infrastructure in-house than ever. important

and products Our in in-house ability manufacture of positions to the advantage develop very to market changes take swiftly. us

address months, have we result, able the to product from in been last pandemic. shortages a resulting numerous few the As

which pipeline our inhalation Earlier On generics progressing a first filed is the we is this our year, R&D product, device combination. drug nicely. front,

barriers Tokyo develop more it and latest value first-to-file have complex commitment products for entry the exclusive to launch Regulatory margins. our status product procured example and have to Approval offer We that high is high of just and this attractive

meet track We have products target and our filing first-to-market on XX XX development. approximately these we XX Moreover, opportunities. are of many in in FDA And approval, XX potential products products pipeline, XXXX. currently are of awaiting the in to to

and many Our R&D organization. and ability the new high value to develop reflects strength breadth these our products of

multiple of decentralized specialization Our and to excellence dosage across take allows form centers advantage us globe. create the model R&D of

already sterile since focused launched a few R&D its our and multiple and instance, injectable inception developed products has ago. For center manufacturing successfully years

to a have and gives attractive As access based hospital growing markets. we that a result, business injectable and institutional us

to working U.S. our key increase our capacity to actively growth the a the U.S. and become injectables are manufacturing market. plans longer both as we India, in term Importantly, of part in player

the this growth expect significant coming will driver We be over years. a

R&D Finally, the we utilize to our pursue opportunity evaluate infrastructure outside continue and regulatory to to opportunities U.S.

impacted still R&D. of extent process has geographically starts this those efforts COVID-XX the an with While quarter, to expanding

help As last with which grow into we Fosun international will a partnership a presence. entered our year, reminder, us

more first to coming We expect weeks with product file follow. our to the in are

and touch our our continues of allocate continue will will where more which I business, substantially R&D budget. we grow on to to specialty

acquire well of strategic a opportunities from as strong external make leveraging accretive would be as selectively on to focused that ours are and products and products our enlightened strategic to infrastructure, partners and selection businesses sense. We

have pipeline topline this still potential the about IPX-XXX Phase remain expect XXXX. One half Though of our in study in X excited the program. we response commercialization product's COVID-XX, of assets enrollment We and key expect in we second patient our XXXX. is in slowed to development data

pipeline to CNS has the drug new have of the application our we the our expect commercialization XXXX. into As Gravis, BioSciences exclusive last to K-XXX neuromuscular fourth treatment agreement of which Kashiv we with the of by rights now quarter, and Myasthenia file We disorder. expanded for announced quarter

player candidates With area become in growth for the we our and additional respect biosimilar biosimilar Avastin are of Neupogen, products. to forward to advancing market. and an are working Neulasta, States we are pipeline, to exciting of and United add in actively three is biosimilars, versions the This one key pushing

Our risk. assets goal not towards through capital partnerships and significant spend late-stage and allocate sum and to stage on is early mid manufacturing to a development

our our to support business summary, business to this everything to In forward specialty look done again we as they operations about employees want commercial we grow. and to crisis. dedicated passionate have I leveraging continue we our work to confront for thank our as remain

I also partnership. for customers continued our thank and suppliers their

and same soldiers are are the Together a industry, overcome we as Americans, to in going We as fight. pandemic. all company, this and

Now, to turn discuss the call the financial let for me results our to quarter Tasos Tasos? over

Tasos Konidaris

Thank Chintu. you,

From XXXX first XXXX million, to just XX% into results. revenue me $XXX topline Let in a the compared and straight sequentially. was net QX up perspective, X% the up of quarter dive

the by growth products last our factor the driven donated offset the our new mostly competition business and not the sales of generic we acquisition as was production. in year. were sale specialty and which and international AvKARE a growth of meaningful quarter brands, of This generic Hydrochloroquine

Wholesaler prescriptions for was ahead substantial But QX supply revenue normal commercial mostly customer AvKARE, due net our were concerns the XXXX. needs. execution may have by filter of and reflects supply it teams levels with our Our volatility in at products slightly COVID-XX. early to of our there levels at at chain customer some strong of expectations, and end meeting inventory been

XX% and profit of X% up topline XXXX to gross million the Adjusted driven compared growth. by sequentially was $XXX QX

product inclusion from higher addition partially of as our expansion who XXXX, First of The margin XX% margin products margin favorable AvKARE and sequential quarter was lower of absorption manufacturing down rates, profile. reflects the the new offset a AvKARE. higher partially QX and offset by has price XXXX of mix, profitability erosion

geared the of more to $XX of due R&D towards timing first unproductive SG&A year. been on R&D has due our and reduce expenses. efforts of expense $XX lower million COVID-XX the and and to part was spend project declined operating activities in of to our Moving to million the disruption R&D focus spend. slightly quarter, latter

which is $XX and in year. last Adjusted $XXX of million XXXX EBITDA million trajectory, respectively. growth EPS positive operating from and This fourth contributed expenses our substantially the QX and $X.XX the in the QX AvKARE $X of QX quarter revenue million where reflects focus the is $XXX $X.XX XXXX and of million $X.XX diluted quarter. up Adjusted up we of on delivered from

improvement a the favorable to we're along year growth Finally, pleased solid good cash reflects and very comparison operating flow was to topline summary, our strategy substantial This periods. our sound QX expenses. In integration reflecting this of start $XX restructuring with with lower and million, prior XXXX a execution.

dynamics, The due year three down international a oxymorphone generics revenue $XX reductions move results operations shifting to from specialty the segment starting now were of first up million million prior was but sequentially. to and million divestment our segment the to XXXX, primarily million with decline year. $XXX me Let of reflects last QX net $XX of $XX our

Second, the due which sales that late and to versions offset competition generic increase emerged of of from NuvaRing sales launch year. Diclofenac and Gel Levothyroxine Carafate, Sodium last of lower

was of to efficiencies. new compared of QX manufacturing absorption, relative and of QX last The XX.X% of Adjusted year was operational substantially and to stable growth by higher gross ahead XXXX driven QX. launches, product margin

plus in As with done XX% generic gross the business. for more be way. long-term XX% we're we we is to quarter, the there have And before growth, we're sustainable long-term first discussed, plus targeting achieve a while pleased margin

topline mix, investments product focused growth, of income expense favorable $XXX favorable our operating timing. in some million reflects adjusted Finally,

oxymorphone, with me segment now up revenue revenues grew XX% to remotely of quarter, of such performance reflects of net and Let virtual net QX working decline in the factors. and compared basis. to to by to our $XX our Adjusting XXXX. specialty and turn a the and sales as million productive, driven was teams shift Unithroid. XX% for Rytary This expected sampling from marketing the reflects activities while seasonal the training ability quarter The stay and classification prior

line expectations. oxymorphone, the was lower in a Adjusted And XX.X% is margin of the with gross reclassification variance profile. by year of unfavorable margin which our prior has driven the

seasonality topline million compared quarter. income of prior operating of growth, reflects Finally, management to $XX tight and expenses,

Let move in sales. reflects sold The account the me consistent now revenue AvKARE's new third-party channel product healthcare, in sales, in which segment only this with years. approximately $XX the net generic with for to products million via on reported XX% segment total quarter. This are Amneal prior

XX. As we you may recall, close this acquisition January on

While business demand this we Defense the two months Department DA includes anticipation the supply just sales, the period challenges. in strong COVID-XX inventory build by of by believe to benefited of of and

events balance discrete Let me flow our cash and turn in to sheet quarter. the now discuss two also

COVID-XX facility. million reflects to in First, the led million markets. as ABL temporary This and you financial as by we can an million $XXX was QX see, disruption caution abundant This performance with cash. borrowing ballroom of solid temporarily $XXX ended of our operational driven $XXX from substantial

in and to $XXX remaining next function the As expect $XXX return properly. markets markets million providing to months, few continue the million we improved, return

AvKARE approximately from we existing the the tax utilize $XXX step to event income this flow taken we nature operating net it tax discrete to driven second the plan to cash in operating new net cash This support to which half companies our discrete $XXX paid event, losses and by of in to The refund receive relates we Consequently, legislation years. losses taxes of back guidance. taxable prudent to five a carry this and Considering million last have allows XXXX. guidance, offset IRS the operating second over million exclude of of is expect refund.

sheet. balance our to on Moving

we and near financial see, As $XXX substantial no million debt liquidity excess can of in term you maturities. have

strong addition, uses performance In reduction leverage will over time. smart continued financial and of cash a natural of provide

financial the provide our February. Looking helpful ahead, we to And it provided remain insight may with in thinking. we be comfortable some guidance to

care health in is a patients robust that, overly in to we have one chain. slowdown second First, not said portfolio we that due product Having postpone care broad as have concentrated COVID-XX. two preventive products the in or or generic may supply visits quarter a assumed a

commercial new business within Second, and and we're opportunistic in overly our administered to plan product leverage reliant teams new not introductions. pharmaceuticals be hospitals, pursuing

Third, increase visibility. and long-term typically growth with a can AvKARE business for and volumes contracts over five good provides are platform stable we [Indiscernible] years time.

we Finally, on improving expenses. be and continue to operating focused our efficiency

With that, over let turn me to the phone Chirag.

Chirag Patel

Thank you, Tasos.

are and we the are relentlessly building company Before floor goals uncertainty resiliency we open that And our reinvigorating XXXX you. on strong quarter. complexity to in we positioned new by drive and and the emphasize of Despite a want hard our X.X. the growth to thanks the I Thank to and created Q&A, added to COVID-XX, focused we delivered team, a achieve beyond. and to work

up the With to call operator that, to turn for open the I'll it questions.

Operator

Instruction] [Operator

comes Our Please from first go question SunTrust. Greg from Gilbert ahead.

Greg Gilbert

Tasos. Hi, welcome supply is with have already do good wanted you centric have? your to to feasible company about chain, a a On a as practical I Chirag. a chain? to and how more it do way to centric morning, and guys start that than U.S. bigger comments make what supply you you plan in happen And U.S.

brought not Thank inhaled be color the can about will there Chintu, follow-up say sued. opportunity. to you filed about up anything my product? more more Can that since you give Presumably file Is first you you. and that? we're us And you for any

Chirag Patel

supply in It reliant you good to going it are took is then history level, event. much the Greg, a U.S. U.S. to and for XX Thank -- and centric a we position there you, look, this lot this not it long-term last It no reasons morning. to API then there in years, chain, not know manufacturing. chain is highly where and guys The moved years and China, get supply happen goods concentrated of overnight. how production and have of overseas, Europe antibiotics India, the finish is

But and the bring hearing XX%, what administration -- not capacity, the is from or from say want Congress obviously, as, XX% XXX% maybe to back certain essential we a are they such medicines, do let's but XX%. that

So, we reliant can completely of on case production, in foreign are we the and sources. emergency ramp-up not

drug So, supply that know United to probably, in for to States could It changes. list invest and temporary. products. term would has would have be those -- to XXX don't be have It incentives long manufacturers products, be be permanent big we the the chain XX essential the how cannot

are a Amneal because Congress. facilities site not as do we molecule. in support API the whether it's We have position or we build We well have with of those do a production small already India We would it would project start to have large it that on Again, a API fermentation here. facilities facility. is have and will,

years, And that but then to continue sets Chintu, certain years, people seven bring five it bring believe on and answer we the after for certain capacity back well that here do want we will that then because train well. the you can to XX need years capabilities and we three production skill years, as in timeframe, FTF? as the

Chintu Patel

Sure. Hi, Greg. Good morning.

remarks, I FTF mentioned one on in inhalation my product. As the first our have procured opening exclusive we of

can sued public been as from not have We events. see we

approval. a is potential it So, launch and

DPI But we the name in at Ireland this product. We we not an for of are MDI hydride infrastructure will are disclose this and and time, release do the time on product. beautiful disclosing press a both appropriate and

Greg Gilbert

opportunity? potential a XXXX we about this think Should as

Chintu Patel

Yes.

Greg Gilbert

back I'll get line. Okay. Thanks, in gentlemen.

Chirag Patel

Greg. you, Thank

Greg Gilbert

Thank you.

Operator

next comes question Please RBC. Stanicky ahead. from The from Randall go

Randall Stanicky

Chirag. Great. pull the last I on to Hey, Thanks, up question. guys. want

generic that's limited economic be manufacturers. that the Amneal us the one any out first the could companies? U.S. from Is domiciled largest question. So to called You view incentives of your it being government

into you're them on margin Tasos at holding for coming like in to some gross then puts detail this get you margin sounds generic on takes XX%, you're And year? what some can XX% around that of the expecting more target. the and It still

that could higher? that generic push Now, margin Thanks. what are gross factors the

Chirag Patel

all company, don't in work The I and morning. incentives progress. good the this Randall, certain yes, be to where us So, domiciled will is there domiciled U.S. believe, given is largest

work and to Tasos? need, companies obviously companies, at going sell We to are expertise faster dialogue. need the make it's bring already U.S. production capabilities than back a rather of it's certain to else more part a together than have But this need somewhere faster the this is happen. to entire slower pace pace ways that industry we to going and to

Tasos Konidaris

is Hey, Randall, Tasos. this

of a things. So couple

context last generic So period as to of QX as And And pressures. that's flat to overall you in gross the adjusted said margin just you XX%. dynamic price kind we was put had is there year. essentially it same

the the some the had year generic came-in latter part will products, that As Sucralfate. last last our you that Carafate and year. of of And of to our was competition. know, key in offset products We launch new generic launch

one that's that's, So drive.

thing benefited is absorption. QX manufacturing, second some The in favorable for we also

So teams up the hard worked the in demand our to keep incredibly manufacturing with marketplace.

benefited So there And us that in may of in QX. QX. kind be offset slight no

So on that's gross the generic timing QX more QX margin. a of

still that, the kind the plus, I you a increase in is Last for margins. margin and just twofold. great the gross to growth. XX.X%. towards of driver this adjusted progress we're year, a making key terms year, looking This it's gross targeting, stepping But of a were meaningful as We're feel back think know, for meaningful XX% second we year, about

our is one market. the ability to products Number get new to

talked that. feel of of That's that. about seemed will going good key So R&D feel the products be and driver. about make to approvals good to what that hard we focus to produce good get a to about That's generic

we're to year erosion The price driver, prior frankly, key had year. as hoping seen second we what this is, lower see

commercial this marketplace, a projects. competitive lot or new is for bidding are teams spending of So a time

the in price marketplace. in is the to second So erosion the that's going be driver the

to those -- one which a opinion, put has have and point that at supply products. COVID-XX that my in that's premium says, time pricing it's opinion, of diversified has the this companies man's some chains, Now, diversified up show on in

hopefully stop me let So answered that And your question. here.

Randall Stanicky

couple market is from COVID-XX seem back this generic to have ability pricing the seeing years? power, you the the over maybe take current lost price are last to brought the in Yes,

Chirag Patel

I Randall, take So that one. will

you focused on a our higher and launches year gross we have So, and quarter every utilization just since fourth we at new to to we as as the has up increasing August now which that reiterate well that continue plant. of along first increase as the last business margin do know, ramped quarter, with base

price The increase to but not from market able are still a increases are to pass is is the increases API price our and costs, visit those our facing customers. we we suppliers freight not there,

are will We in a work get dialogue that with them. to we And hopefully, done.

The industry the still from buying concentrated is power. highly

are are good is what And we So, prices. reason bottom seeing already challenges, is way could prices is that is down that one rock, not which many a two news. -- ones be

is So, to products down or there products. more the go no of and most many place

is now the reliable about partners. more thinking supply about reason customers securing are second And chain,

more seeing to improve that do may generics. that we're the So partnership in and pricing environment

Unidentified Analyst

Got it. Thanks guys.

Operator

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

Balaji Prasad

Good taking to morning, again, Chirag. Good for the questions. speak everyone. Thanks Hi.

questions couple generic on side. So of a the

started lead you since you're the of what two on erosion your on kind recede products there, last from so you versus pricing it years? Firstly, one as see commented did the what existing seeing erosion to or on of

are these think buyer-seller how that just relationships? on the seeing you of the had should forward? going just Randall dynamics change fundamental we asked any And question between now, And

impact range the comment just competitor providers? what also Thanks. and especially of it you can may Lastly, the Carafate guidance into launches you’ve NuvaRing into thought of how and on

Chirag Patel

morning. Good Balaji. Hi,

as that than are So price continue and to the first less said, let we question. seeing Otherwise trend, not The prior have erosions, products. to discontinue we your frankly, any I that see we room because there's me hope left. take we would years

phase I so go is don't there don't big with product it's them API, customers And three the having about is you your all now to, but know talked for need six are to we evaluating change, more worry months. to partnering chain that about having fundamental supply going in their longer-term which losing happening. on

So plan we properly. can

So well. works longer-term contracts are as in

sources record, so asked quality our places we those the have because API, of win all U.S., alternate business, sources, Amneal sources the having More obviously products, manufacturing questions API and with diversified products so being than to we India having strength. more so alternate dual are business finished And real in maybe dual multiple competitors. of able are track where with

that But focus fundamental I chain believe we with and certain the do long-term on more are partner reliable as changes securing supply coming sources.

continue and NuvaRing build question and had Your quarter it. first Carafate, we to on third a solid on

already we share almost up doing that XX%, get market we'll which the start we XX%. Carafate a So great NuvaRing, have to to build capacity now.

FDA automated have approved and you. We the already Thank more producing products. process by

Operator

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

Ami Fadia

my question. Good Hi. morning. Thanks for

of products, cost? either the government regards the bringing Just with help regards to in increased the U.S. of with if certain manufacturing appetite key you increase sort quantify we you in to brought the or to manufacturing kind -- buyers me of back can the U.S. that Can talk what cost, do about the the to what's and

an you or but regard that new U.S.? products on certain in timelines, is faster given with certain the to footprint physicians a the this just respond manufacturing existing And mentioned process, is to long-term trans

business or prioritize development on you if partnerships? Would that? that? you what thoughts in to or regards be separately, your it And would where sort the then current Thank side with could And generic, of are you. elaborate specialty

Chirag Patel

morning, Good Ami.

So, and with manufacturing, Academies be exploring some here National essential Science is list. capabilities up coming is as built back task I They bills. and progress, force in said, said, to Congress with to capacity needs product various certain it as -- of the putting putting I U.S. work be and may

I When for timing. Again, they it's early involve As industry. the it it It's the will input, being we ask in process. said, a considered I entire input. pretty our seriously. don't provide large is undertaking, but know our

or be higher cost cost to it's here material the The have U.S. costs. same, would and and The of should in be analysis would Europe, costs And raw China, undertaken. operating material labor be basic the whether

free So a enterprise that process will how in playing we quantified and Amneal we need a haven't many as role which world. of a it, products, would competitive products essential in one the it be be list

And is focused Amneal would on market. act fast, U.S. solely Amneal because

is do we geared for position this and market dosage manufacturing is Amneal we X.X. States we strong built X.X, it form. execution everything a for a have our how in toward Amneal on United So are known finished we always and doing again And

would in and participate we process. competitive So faster a act

singles business the assets franchise, have accretive our look, complementary It I at We focus. -- bigger would to remains point. some again, said it genetics hit upon On we as we both would assets front, looking our a a that this endocrinology. already We before, are not for specialty. and disorder well and for looking have so development looking can transaction still to to R&D on as doubles movement execute be many and for, specialty within not going

So, there well. you, very Ami. Thank as focused

Operator

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

Elliot Wilbur

morning. Good Thanks.

Just about questions thinking a couple pipeline future disruption around opportunities wanted and to potential of to review. ask specifically ongoing

of the inability of you're impact slow seems but noticing you're such of if lot generics, the to wondering of or certainly respect seeing, just wondering Just timelines, a FDA continues terms for as review timelines the in complicated conduct entry higher generic some barrier products, your more FDA inspections maybe products particularly to to and like any with to some complex like. issues, seeing if approve of considering

still talked And of in whether see some generic mentioned of Thanks. then versions that calls but you specifically as not maybe been last thinking about update Restasis, on you've an those pipeline opportunities. couple and or products maybe Copaxone, just XXXX previously, about haven't the

Chirag Patel

want to--? you Chintu,

Chintu Patel

Yes. morning, Elliot. good Hi, Hi, Elliot.

FDA. not on seen we our first goal your any Regarding questions, delays from dates have

XX record you be enjoys and that it that and over think last years, specific, company As long a see Amneal quality I goes way. a a track fantastic will the

product, regular a FDA and it's complex situation. in working goal shift been really for diligently the I we work to really and And in agency our have any or dates is doing circumstances not and doing whether they want all given are thank

of year. positive we launches for the remain So our on new remainder the

on a limbo. Copaxone kind Regarding your and Restasis second of Restasis; question regulatory in is

it the a out and is. be agency of in position not regarding ways to would I'm So the It’s pay comes to applicable whatever industry entire decision everybody. what

XXXX the a Copaxone I have launch a us. So for don't is for timeline

Operator

Sandler. Please Piper from go Amsellem David from ahead. comes question next The

David Amsellem

Thanks.

the which expect near-term to challenges, believe That's, that pipeline, on dose given an expanding that's interesting you a your unique is a off-patent, launch? just cited but what of of and filing, and I thoughts think as competition the So that opportunity? be upon theme an are potential limited I for do going also product potentially you

injectable and then of priority you injectables want Copaxone. which a internal development thinking in bizdev business? beyond injectable a your And your the perspective, hospital franchises context further secondly, overall pipeline, big or your from to a Thanks. hospital how the of view in buildout I to on am extent is What's

Chintu Patel

David. Hi, Good Chintu. is morning. Yes. This

and Regarding that you a don't see entry. very It Durezole is product many complex much has of barriers competition.

fourth or tracking are expect early late next launch. nicely XXXX we We maybe and quarter FDA with

we Regarding our pipeline. are excited as building are we and injectable our injectable about pipeline, our portfolio I mentioned,

in certain our We have different certain XXX (b)(X) drug-device areas opened a up more products, within injectables in products pipeline to many products, hospital suspension are are today working injectable combination on we many injectable including and chains. aggressively so focused ophthalmic that we complex DEPO

we So, all at looking aspects. are

time, XX injectable on value injectable We a are the expanding and differentiated going bring pipeline high-end certain will Same very XX key pipeline. doctors. to already it's patient about to portfolio, India to be in for the have manufacturing we product products for that and U.S. injectable also in but

David Amsellem

you. Thank

Operator

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

Gary Nachman

Thanks. Good morning.

And opportunities color much for you would drive two helpful? some what incremental more Thank network? identified much how now on you've How quantify AvKARE the could in Amneal the that that you COVID AvKARE's you've volume you. the for How that in potentially are XQ? benefited Phase X much reverse months, for in owned stockpiling be can business? that of was much could few coming quarter? And there First, how quarters,

Chirag Patel

COVID-XX a to we very it the From morning. impact to avoid were way the Good managed support, was socially try responsible commercial marketplace. in stockpiling inventory at material no to our We QX.

no So COVID-XX. material QX there from was impact in

Chintu Patel

Tasos, COVID-XX you impact. to want may color give more on

Tasos Konidaris

Yes.

bit provide can a just on puts So takes. color so little the what I've more reiterate said, some this to Andy and of

data trade nothing in there of out So and company. get one in same is, wholesaler was number we the do inventory abnormal total the terms

because the abnormal typically So, the nothing weeks one. typical the versus end there declined end so hand extra of year is end order there, the of which the year, actually QX is on an they week, number at of

of had that of a internally fill. two, we number Number because not discrepancy of the the positions business, in did open impact we the

manufacturing However, substantial the with we with the related the plants overtime to overtime manufacturing more had substantial favorability plant, so operating expense, offset some related headcount costs.

incremental every costs was company that. which We freight, by incremental I also substantial think -- impacted have regarding

quarter some the material the for saw is expenses we get thing of final and were couldn't in some that's slightly we of as our that favorable we projects. and the active wanted much trials because R&D The

would input in is no and reversing be say to the says was material will QX. I in quarter that our the overall, So head there that nothing

Chirag Patel

it cover? Does

Gary Nachman

Yes.

Chirag Patel

Thank Gary? you, Tasos. Chirag, is This

Gary Nachman

That's helpful.

Chirag Patel

add want good that that's question. I Gary, to yes, just a

last to with products, quarter by And performance we've solely is higher efficiencies, excellent what been AvKARE their launching since first performance -- is superb a is base treated having very August. which performance Amneal's on add all like Amneal increasing is doing these complimentary. business, a initiatives. new specialty The It adds marketing

Carafate is AvKARE, to by this more your due in renovated question, Gary? demand diverted to that has pulled Zantac with and increased demand out products was yet market Carafatehas Hopefully Carafate. the answers sold not of being

Gary Nachman

business? that do how little more a that more on was just going AvKARE that is business you we Yes. previously, drive forward, think should anything to what could and And there growth more trajectory for I with about just saying

Chirag Patel

often a growth long-term at they're is as one used other bit in so getting looking stockpile government current specialty selling demand initiatives is there more any pandemic, and set the now sell BARDA in or well. so products products contracts in that in biosimilar specialty. growth as generics And well. stockpile strategic with with well about very are that future they're through concerned products initiatives has and is AvKARE, Yes, generics or more of then to product, along our they're looking to but

these, up will we putting in but at unit are the small this unit point, avenues all dose the the business. grow by liquid probably growth AvKARE Multiple -- take will by business year liquid dose next then come these dose unit AvKARE. to So, businesses for opportunities and are a liquid which infrastructure,

Gary Nachman

Thank you. Okay.

Chirag Patel

Thanks.

Operator

from ahead. go The Schott Please Chris next question JPMorgan. comes from

Chris Schott

much so the questions. Thanks for Great.

two Just me. for

you First, on just going helping importantly, elaborate you're you businesses trends more a the more seeing And forward mentioned on there generic the improve Can existing opportunity to share as some on there? is portfolio? the bit share base further we more recapture the results. think about,

second here, on launches deals and think partnership as a then little pursue a And do or referenced you to licensing and you you near-term completed deals have clinical bit about step there? opportunities up so or biosimilars, question Thanks just color think go was desire more or we deals I conceptually a longer-term my these in do in spends, product about resulting think targeting already programs could think that company much. the forward business? R&D Should about these the assets

Chirag Patel

Good morning, Chris.

first Your as continues COVID-XX base diversified with and on supply customers diversify. business, to trend Amneal chain question a are has the actually, looking

manufacturing, to percentages the you're based So they're well. buying business Europe or as their want of in they looking or U.S. And products of XXX% if if add India certain versa, to their diversify. U.S. from they're vice

very continue have are our win large keep products have products, record trend pipeline. business well. of a to Biosimilars, we also quality very businesses of the very generic new So track plus and our as three of as XXX handy portfolio in strong comes and in liability because launching we and products a is products positive new we the

we carefully the need as XXXX those launches you effort. and learning so more it XXXX, and more about lots expect market call of behaves. -- how products and I It's are adding market, products We are quasi we quasi-branded it for

we very have and So, infrastructure branded more have a we focuses where small on building infrastructure. nice specialty would oncology our some to, we started already will add-on

that further well leverage cost any we'll without there. So adding as

goal in-license XX So are products view. we where to years and is is our the this

We over our always we to is say in-licensed that be that. we build were potentially be we do this a but long fourth, point, are second, going we would at want first after third, hard to not which let's company could time products be,

IP beyond competitive looking is so are any pipeline or So, as oncology layer, driven to what other that build becomes interesting it opportunistic because you, fourth well. very pipeline going Chris Thank forward we

Chris Schott

Thank you.

Operator

question-and-answer I for I'm like session. to would closing back sorry. conference to the over This any remarks. Tasos our Konidaris turn concludes

Tasos Konidaris

for night. focused and with of thank our being Thank for year. to that and our really us want job products number And one, and the staying services. for want and the I great rest on an on doing business thank investors our in I you QX rely incredible team a have the really to customers our

Chirag Patel

Thank you.

Chintu Patel

Thank you.

Operator

you now presentation. The for conference concluded. has today's attending Thank

disconnect. now may You

Amneal Pharmaceuticals (AMRX) 11 May 202020 Q1 Earnings call transcript