Earnings call transcript Q4 2022

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Operator

Hello, everyone. And welcome to the Amneal Fourth Quarter 2022 Earnings Conference Call. My name is Bruno, and I'll be operating your call today. [Operator Instructions]

I will now turn the call over to Amneal’s Head of Investor Relations, Tony DiMeo. ahead. go Please

Anthony DiMeo

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

matters based Certain historical are that solely to outlook on facts, presentation call forward-looking future are limited not see Please or Statements available not section information that predictions, statements our but statements this Cautionary made management's Statements on regarding for including us. that Forward-Looking discussion may is earnings now on factors in the a entitled the and filings performance. SEC that to of impact are our

discuss and presentation. also of measures. U.S. use the our these reconciliation earnings We measures Information GAAP non-GAAP on to are in

and Chief Legal call Co-CEOs; Generics; are Patel, Boyer, Andy the Tasos Officer. Daly, Singh, CFO; today Biosciences; Jason Harsher Chirag Chintu and Konidaris, On

the turn now Chirag. I'll over call to

Chirag Patel

We with out adjusted strong $XXX three you, morning, a growth across closed in fourth Tony, business and revenue well. delivered of all segments results everyone. QX quarter EBITDA We million saw and good and XXXX million. Thank of $XXX

for our long-term continued, XXXX outlook positioned and top performance. growth. we forward, believe is uniquely resilient Overall, Amneal Looking bottom-line reflects sustainable

and robust Generics business each The is growing year.

is our our on complex, launch IPXXXX pipeline. the are injectables, focused each medicines through new portfolio diversified. advancing high complex our are high launch In business we expanding generics towards We increasing shifting impact the more affordable and of in and Specialty, growth products. With branded and upcoming biosimilars,

needs, and how priorities. now Like our on strategic creation medicines essential consistently and see providing that heart key advancing Together access strategy we multiple we of affordability growing patient to with our vectors value we focus about business, the unmet is talk are growth the the healthcare globally. of

we expanding complexity Generics, patients. value are of impact up the our moving constantly and chain in innovating, on First, product

creates such engine, Since and continues injectables as our Our medicines has R&D business. be biologics patients, team the ensuring our commercial driving of next innovations, frontier the complex job extraordinary and of it developing that operational an [Indiscernible] execution success strong international. tremendous strategic focus XXXX, value has and affordable to in the done our [Indiscernible] been for journey and

diversified As result, durable generating increasing our growth. portfolio top is a line

Over saving consistently the the every terms we last U.S. years, fourth U.S. year. Amneal and faster Generics market. have American company than is $XX over three Today, of overall prescriptions, patients billion grown responsible our largest for the is in annual Generics the

topline We expect long-term. Generics endure our growth will algorithm in

adding focused we with capacity about launches new our have and products very are building portfolio, we revenue, in In with over U.S. the our standpoint, From institutional XXXX, our than more are XX key expanding $XXX doubling an on capacity, product expected operational new successful, we capabilities. two injectables, today, was In generating million XXXX. XX by business sites.

launch next bring and XXXX. products expect new during revenues capacity As online we we in come inflection new of will XXXX, the

We by goal million achieving XXXX. are track of $XXX on over revenue in to our injectable

mission our of represent and quality, medicines. are to affordable next affordable Biosimilars with aligned providing of Next, medicines wave the access highly high

about we Biosimilars. for the So, so excited are growth prospects

As the XXXX. expected to alone billion in sales net approach U.S. market $XX is by

new we biologics to be as a cost strong horizon, less this down, the see will we long-term very competitive market the With to ROI develop expect continue others. come than

biosimilar biosimilar of of our RELEUKO, ALYMSYS, Neupogen. launched we Avastin; QX, In our

commercial drive first-year of channels providers, team payers, launch of Similar biosimilars, adoption months biosimilar to across our FYLNETRA, as third few uptake. the will other our with works to the product Neulasta expect reimbursement our we year curve next to and expect conjunction busy XXXX be We in coverage. a in the

and be sales look to over For time. expand peak million. $XXX vertically over these see portfolio of three biosimilars, our We integrated we strategically

our profits the fast globally, in the market as in and expanding get local five are strategy essential a top focus time medicines believe be a our to expansion generics, To injectables, to In leveraging product India. will team leveraging billion expect and add like that. we market, U.S. to access player are international $XX hospital pharmaceutical is considerable and We and moving we presence we brand FDA specialty, in U.S. biosimilars. new revenues the expand commercial Biosimilars of market, complex we goal over our Generics with global Indian Our time. U.S. portfolio on approved diverse our

we agreement long-term Orion distribution Europe, a signed In with at year-end.

in year commercializing Europe We this and late look complex will to starting year. generic next begin register products

distribution we are recently share we’ve Canada. in that In partner pleased addition, long-term to agreement signed another

partnering are to portfolio Canada. injectable to Sterimax We with bring our

opportunities additional partnership We pursue to will the around world. continue

Second, much in and time. be sustainable player to we expect bigger more over Specialty,

Our hypothyroidism combined. our strategy low continued Today, for grow therapies patients. on provide to for and opportunities focuses that branded technologies medicines double-digits reformulation improve Rytary products existing XXX(b)(X) Parkinson's for leverage innovative new Unithroid to and key our

IPXXXX. is up Next

so are Parkinson's IPXXXX the excited about therapy for be of a We to best-in-class patients. potential

-- in look are by expand Beyond advancing programs. XXXX. we specialty and of neurology revenue IPXXXX, we our over our -- to forward look endocrinology pipeline We $XXX million

XXXX, AvKARE, unit in business has expand the double-digits. Government, revenue across multiple Federal to we channels, the and dose. To-date, look its acquisition grown of since Third, distribution, in the

revenue momentum will expect durable $XXX continue this plus million business going in forward. We

higher financial accumulate growth and business our time. levels areas, and these high now to believe over about is strategy continues IPXXXX execute of billion launching excited products we that key Amneal's this specialty, in our across particularly drivers are grow. planned We as ahead, performance and our very our more in happening launch catalysts of we as generate such durable summary, growth business the In Biosimilars will future

to it will over I Chintu. hand now

Chintu Patel

everyone. you, Chirag. Thank morning, Good

Amneal family, worked for who possible First, to hard many. to you the healthy thank make so so

on team in such such Let key footprint. global the of record operational with operational me XXXX, as achieved we efficiencies injectables. and infrastructure expanded focused excellence as production optimizing start key areas and are out In operations, drove our products Adrenaclick,

highly we technology a shift as products in-license development we soft inhalers. engine as Next in towards productive the our for drive R&D, such pipeline of Respimat a the R&D platform Inhalation, continues to efforts products. pipeline complex array our [Indiscernible] partnership of to global innovation inhalation wide recently a team In entered

is always, upon Amneal standards of our quality. record highest commitment quality strong the and track built to As

FDA in has over founding sites. XXXX, inspections our Since successful XX the conducted of our

We are continuously push to quality bar looking higher best the investments for ways practices. to and

opportunity over of launched new focus through generic half With on Generics, Let the first-to-file walk already improve me presentation expected first pipeline. products. also of about slide in is a five our over we access In Branchburg, expect for now new to launches list we with New this XXXX, In the our Today, the critical In or be We months. aspects treatment. of innovation XX Please innovations agenda. our different notable of a FDA to our complex manufactured XX% launches. XXXX, in overdose launched at two see facility. key submission for announced first-to-market, our generic meaningful XX opioid to refer XXX(b)(X). earnings Narcan, we to catalyst Jersey our

portfolio. are and as In we Injectables, our scaling infrastructure up we add expand to

produce forms, innovation leading Our expanded Once With syringes, shifted dosage focus later all FDA inspection key month, of have capabilities, we to our injectables with newest towards a with company we year. injectables. approved, vials, ability next on site our and injectable cartridges, prefilled across the the have track will this LVP approval capabilities expected for is bags.

we Esmolol for received XX There and first few and products XX last sulphate. In the injectables in approval pending Magnesium two the months, are our LVP ANDA's bags, another pipeline.

expect peptide, drug-device made programs products. several in combination, progress long-acting injectables, file including to XX complex areas XXXX. in advancing XXXX, to We bags, we and more XXX(b)(X) to XX our good liposomals, LVP have ANDAs Similar

well on to business injectables are a our our major scaling We player. way to be

space. start, our are we first QX are potential in about launching biosimilars soon. with this we one Biosimilars, two pleased launch To excited In more in Amneal's very to

portfolio with there molecules, branded is number approximately coming Beyond total a patent molecules XX years. billion are come additional for biosimilars large $XXX biologics expand for biologics in $XX tremendous of of U.S. development market to the representing IQVIA. as the opportunity in this, billion off Currently, our

manufacturing with development innovative cost-effective partners. at and We are and looking pathways

As business scale first is in second time, to to we biosimilars. look or goal our this market be Over to integrated to effectively. be future vertically

be for long-term. biosimilar Amneal We will area expect growth key a

we in international our executing strategy. as expansion XXXX see year globally, a foundational Looking

beyond key focus initiatives effort India, the in extend Our Europe, Chirag highlighted. and and which China

entire analyzed we portfolio the of emerging our all have markets. product comprehensively addition, in In context

across As result, opportunities a we have identified XX different over product emerging countries. systematically market

In XXXX, registering begun locally. have we products

specialty, a driving expansion. we are Amneal focused team international our to branded In pipeline. expanding our advancing portfolio have We dedicated at on

up XX. date June PDUFA on IPXXXX for is Our coming

U.S. opportunity We peak this as continue to million $XXX of Parkinson's $XXX as a we million broader to a sales look to patients. impact see portion

looking also opportunities. are licensing at international We

several broad potential advanced K-XXX our hypotension. diseases. and for branded use pipeline our of population, is other chronic retention delivery have Beyond Parkinson's R&D to a the is to GRANDE, an the program new to There This system. program gastric technology are IPXXXX, drug advance our pipeline. utilizes is platform, proprietary XXX(b)(X) addition orthostatic neurogenic across K-XXX share case we including which continued and patient pleased specialty symptomatic

innovation in high are summary, preclinical executing We pipeline, phase. additional are advancing the particularly our we working on In growth pipe strategy the R&D in -- program and in our areas.

it Tasos. now will hand I over to

Tasos Konidaris

followed I fourth then full-year move guidance. on you, quarter by to our results, will XXXX, Thank start with our Chintu. XXXX

growing XX%, million, quarter results revenue XX%. was adjusted net and Generics' of of growing $XXX with revenue pleased net million, very the XX%, versus XX% period. We're QX fourth EBITDA of million an prior our increase diluted $XX $XXX total or year adjusted of with $X.XX, up EPS million, $XXX

comparisons, the growth launches. new Our solid prior-year results of of and product reflect our favorable Zafemy, breadth

XXXX final spray. from specialty X% launched of loss of for As XX%, exclusivity our or revenue by versus products XX% increased prior a this impact in Unithroid, million the XX%, of driven up period, new growth the Zomig $X of million, by quarter. reference, nasal for accounted QX or Rytary, and $XX $XXX quarter partially XXXX year million net offset up point the

revenue year new $XX of million, of million our products with compared Our continues our growth perform customers. demands of to the up better meet period, to prior due AvKARE to net channel or XX%, exceedingly continued business $XXX well and distribution to QX the

from earnings sequential as out revenue As QX we to expected. outlined the QX played on drivers our QX call, acceleration of

to diversified expansive resiliency and our Our perform financial well and portfolio predictiveness. and continues increases

slightly prior was QX period. strong profitability. to adjusted solid believe up, are robust operating year generating gross EBITDA $XX was time XX.X% line, gross QX indicative with greater of profile than the period. margin leverage, faster-growing P&L million or adjusted expense XX% year prior of QX top million and a our results compared margin $XXX We over of XXXX the

injector. driven where grew Full-year growth by new revenue of or net ‘XX channel, Total guidance Now million [Healthcare] results, (ph) billion and loss now XXXX and declined XX% met net looking revenue is distribution or grew Adrenaclick X%, we at of Unithroid, X%. line we the generics in a portfolio while $X.X top specialty annualize. our impact growth injectable XX% X%, metrics. million our $X launches, the up by Zomig epinephrine an financial our which up strong offset X% could product full-year auto grew exclusivity, Rytary revenue driven of net on $XXX

adjusted growth EBITDA by line top up $XXX in support in marketing and XXXX was Full-year million, $X and offset partially product numerous reflecting year-over-year, of inflationary launches. our growth sales pressures being functions million

to legal of interest $XXX an used flow to Full-year due higher million, cash declined $X.XX part of XXXX diluted generated million legacy in operating EPS settle adjusted which we From was matters. $XXX perspective, certain expense. XX%,

to As Earlier opioid fourth we manufacturer $XX in amount we cases. matter, consistent believe legal very recorded various XXXX, our as this position Opana an past, is million on legacy We limited discussed focused year market of with resolved expeditiously majority issues. share. and the the we a quarter generic XXXX, related the resolving in with of charge in we're

growth finished refinance From down. Loan of to years Term to and and a XXXX net of our over X.X debt through ago. billion time pay EBITDA continue $X.X billion In balance to times we net and debt debt X expect $X.X we perspective, sheet delever EBITDA adjusted times, to three B compared XXXX, with

total expect driven stable of as XXXX year From $X,XXX growth. continued Let mid-single-digit guidance revenue a reflects all $X,XXX our build we company million, me and now long-term where turn expect another of segments. growth we net line to top by which XXXX perspective, for million results sustainable we

reflective the In growth, dynamics. generics, single-digit of expect we following low four

driven to year, can First, represents three value $XX our we our commercial believe biosimilars by this in to of add teams year should substantial this products our customers. million we new commercialization million market our XXXX ALYMSYS. and add products $XX first and believe

R&D generics already with products our expect having these been to in strength the of approved. we Second, sales million pipeline net add of over new $XXX many

substance resolution our injectable volume impact expect of expect price nature well we the segment our supply products, perspective. to that generics chain products. issues a competitive from Third, persist future controlled as the Fourth, as capital pipeline few a we of and

We're and sales specialty, ongoing continued approval in In hospital expect growth driven expect and product guidance. Rytary At in by about well not we segment, as of included IPX-XXX, very we but by FDA mid-single-digit new excited our the net segments. Unithroid. the double-digit growth that the potential innovations have the government we AvKARE, expansion as distribution of driven

P&L. the down Moving

We million to adjusted EBITDA XXXX expect $XXX $XXX of million.

we and reflects From perspective, inflation our $X.XX refinance. of scale $XX which of marketing likely Loan up interest million and $XX related expect such higher specialty, injectables. investments areas, biosimilars Our Term to expense approximately in higher growth adjusted $X.XX, outlook an includes and million B EPS sales incremental to in as to

cash any in expect million $XX the cash in which operating flow, despite settlements higher to Furthermore, capital On line XXXX, costs. million between we legal million is spend. $XXX million interest $XXX and expect XXXX million, side, we $XX with delivered in we excluding the $XXX

we phasing a XXXX perspective, develop in Finally, XXXX. similar of from to expect a manner

me let that, Chirag. back With hand to it

Chirag Patel

Thank you, were is portfolio. a diversified came into -- The summary, strategic and our year, investment focus, business year was of high-growth The is global injectables our strong and the XXXX areas company back. expanding performance Tasos. the high-impact provide different Amneal each energy and in fundamentally Chintu a when XXXX, had I across generics. we to top such pharmaceutical as growing devoting biosimilars, of areas is industry. line specialty, complex In

continue envision even biosimilar we Looking financial with inflecting out of double-digits, a specialty that a has injectables, innovations, business on higher, a with all basket accelerating now, profile. Amneal flourishing complex grow new one our from to whole healthcare an generics stronger year durable building IPX-XXX, consistent business,

is Amneal Over to the sustainable society. drive stakeholders we long-term, all growth value and positioned believe create and uniquely well for

We will now open the questions. call to

Operator

question first ahead. from from Our is open. Elliot, Wilbur line Instructions] your go now [Operator Elliot Raymond is Please James.

Elliot Wilbur

about referring Thank on had the billion. thinking Good five pipeline for I sales guess segment everyone. Good pipeline, assets specifically real the morning, and I'm $XXX potential million deck. the the segment slide talked company morning. Question in of in specialty quickly to Previously, peak specialty you. $X the and about being to

Now the no your bit change million to by that? there's terms more that's granular just is but desire confirm and presuming the XXXX. $XXX language a there, I'm of I wanted part on timing, to little be a in

a investments they kind fact and roughly of as industry And I investors not in up scaled of as one-offs the They to prevented diluted but certainly and managed getting best its in conversion necessarily line only for then the with of in express kind last the has worse. been attacking the a better been companies at getting of this not prevented growth kind looked of have Amneal whole, this the any that cash of closing of commentary. EBITDA and conversations -- question, sends couple But in able has that’s load. years. company debt of Chirag, one has of company the frustration the think a of from couple clearly kind morning, metrics landscape, the addressed lot the sort follow-up, sort But top change produce a generics you maybe as years last big-picture you organic flat your

growth XXXX in, relative EBITDA to really to -- as gross a of, I investment the and see we think and to I a that beyond, also guess, leverage kind start on do where that's relative and kick guess mean, top question meaning they where and point margin to I Thanks. mix. I So line we get spend out both dynamics

Chirag Patel

over continue from. we the believe Thank where United the It are have States which Elliot, for that over and you, compliments we pipeline, to done team thank market, your We’ll in strong Amneal. investment on culture, is people years. you is X,XXX

the let can to the [$X] billion as billion to granularity picture So million nothing first [Technical we soon hope different big Difficulty] there. question on specialty. (ph) get in on me $X your clarification We $XXX then and answer just as

So of now year picture, from a big we vectors mentioned, two as have growth. I now, from and years see, what multiple or we

So reached take out. let's each It of Generics, right, one you're getting have may where them. a buyers we it's be worse. getting not responsible better certain bit

say buyers, not rooms, You so thousands. buying I know when the big they're three

And some has Teva, Indian goes there of no generics companies business, pushing that And getting that is is R&D anything companies low-priced have those like drugs. done [Indiscernible] risk further going of us, that price any as reduction in any them shortages well out are and for we companies, it, room for the investments, as automation if already These hear other said further. leaves extremely investment for quality There down, is of it. in molecules, even manufacturing FDA you.

it's not government So and prices work buyers consolidated. even an And that large of has right? about because consolidation, consolidate who allowed that these are been to if patient. are, it, do just ruthlessly a It to the is these for industry, going change. companies three have very unfair suppliers, for the And as small do down, all keep vocal the has we cannot and

happens a different will States, going if you those suppliers are the about patient, think and reliable chain. on it, companies XX% the but away, who in avenues of dividing If supply on what move Then quality United that you be fill lower prescription to will to find the how prescriptions.

mature products. and behavior we for seeing So a certain biggest And that. we responsible in believe the appreciate from the bottle groups, picked we generics it sense fine that are have

we the you by – not we up we them. that, if will have products. continue And that introduced to D, and where on, within But we of enter the moved as at market company, non-commodity the products many the up medicine chain. and creating generics, have are value products. us, to look is frontier because generics products for on Those been the we working includes the moved affordable we have the XX we are going have will mean needed commodity have XXX. are of What For got obviously, I Plan which XX, where next competitors the to we

[Indiscernible] the injectables of trial that's products, So products, up. complex injectable coming inhalation the

pipeline is a about [relating] generics being of medicine So the globally (ph) XX-year part entire and we're that very next within affordable excited company biosimilars. a

And those next two, to you seven next XX-years. know, over five, biologics see use globally are exclusively the four, companies products if you will from, three, have as of plenty $XXX billion years, the lose of

eventually to requirements So very of complicated even difficult, XX XX it's a work European companies States expect in products It We of XX markets, are which very the regulated to plenty do are [Indiscernible]. be not stays competitors and stringent. more most Western and United would manufacturing. it's the

company So next very lead and that. XX-year in excited that affordable the medicine building

[Indiscernible] we have The excellent underestimate pipeline. IPXXXX, but ready. People we an second added Specialty, is specialty. we do K-XXX, the we that don't are

As a Rytary. relaunching we you have in of Rytary, experience know, launching lot

XX-years are meaningful a We dose, time, and good on should X.XX should have hours almost [IR] per patient think Parkinson this, They giving lives. don't you (ph) IR It's you very need when you take improvement the a in patients providers. I Parkinson's to close technology. product that's Why that's old exist.

big for conversion go of a to patient going prices. as as are affordable can we with we think I

is excited So -- business. specialty really we're on the that

superbly double-digit. is well, performing Healthcare

to market. it's and and know, the market, in As distribution our missions large love you we compete find a distribution

great to and we'll We to business, to that middleman And and for us led the it reusing have allows continue direct avoid team also go [Indiscernible] customer. excellent us. opportunities grow Steve [Indiscernible] by

it; And high-quality highlights are we on been picture last quarters, mention they I saying because We've next we what expansion India, And are products, for about rare saw as to of hardly to been giving our next XX-years keen are are will. many then the is, advanced affordable international products, of not make The medicines. not we you the these it we plans therapies need, go some the working thing in these in would to diseases pharma And are Middle unmet it. you are East, full know the why on we doing. those few talked complex do have growth countries. very

leaps business -- everything we has commercial we signings So and Mumbai. strategy, living, our India the you up and and the living commercial of covered more I few as of mean, India's are already a going is with Amneal people in And well. know, is economy launched already insurance hundred great by as people cost and in bounds in growing

about excited really that. So

after as Europe forward look remains forward. like early other we obviously we'll as are [Indiscernible] partners market partner go we'll expanding, United States largest we for and Brazil, look and second well. And partners countries on to

awesome, had but very give to I So -- question so your answer, excited very long it was long answer. a

you thank So Elliot.

Operator

question Capital Nachman is Markets. your next from Please from Our Gary, ahead. go now BMO line is open. Gary

Gary Nachman

Great. Okay.

question. Just to the last of following answers on couple a

IPX-XXX, FDA for launch? for have you prepare obviously excited are You're So doing pretty What about been conversations it. how going? that with to

or I think then about to is for cannibalize talk but peak guidance it said in -- it And you're time. for new you patients how this will additive spending anything the the million guidance? the it million year, over will $XXX $XXX factoring much be you Rytary in when ultimately, revenue not

you just it's all start on think expansion. little more that contribute? international a give And said to the I incremental. bit Maybe could color when

So the year, in for I that case? this there's the want that's to nothing for confirm guidance if

margin gross And specifically, weighing year? gross that in is we What how behind EBITDA on came on much you XXXX? are than trends what in drivers are this And thought And quarter. fourth assuming lastly, the margin. that? then the big in weaker That Thanks. for

Chirag Patel

give regulatory you Chintu, would update? Gary. to you, IPX-XXX Thank like

Chintu Patel

Sure. Gary. Good morning,

very process. moving a regulatory well in is IPX-XXX So

very moving optimistic been showstopper. is has of And We far, and it's and nothing to in its are -- June FDA there have there date on we engaged a so a very XXth. with are goal positive approval direction,

right place a on perspective. it's from direction, FDA in IPX-XXX So right

Chirag Patel

cannibalization. IR. see to a We're all don't market. the Gary, your on them were as Rytary has believe that's but question market. second patients switch broader prescriptions broader We of with we're will see penetrated it our not general not so use going that over some way. IPX-XXX, strategy. million of IPX-XXX for much And Rytary X neurologists, We a We XX% going the up to

We are for bigger much excellent strategy with bigger for going that it so both commercial patients, pricing the penetration as patients, as very affordable excited. market, well the medicare makes

margin me On million question, that going Tasos. see within I'll three, answer We before zero -- five several the I again you that from let years. said to international, dollars it to give hundred four, next

approved it's using would our for all on in own portfolios be the embedded products, and may of exciting and over it own command forward, globally. United that working -- doing go the FDA to bring certain complex filing world. to but be portfolio international market in are our partners our India. exciting in expansion, that We and respect all it's And the all proud very as the from So very premium we we're own States we we're commercialization opportunistically products beginning incremental,

do and complex timing injectables. out we a biosimilars [Indiscernible] So Tasos? such in not

Tasos Konidaris

to line morning. pretty our Regards Hey, margins, so with much Gary. expectations. was QX Good in

up basis So Specialty XXX-some XX.X%, up points. points. was generic margins basis were XXX

mix the is happening company was actually what's think -- we have our flat margin QX. and where total at the I to XX.X%

double a margin rest that's growing business, bit much growth, the business. And here of, we digit, top is business. lower gross little the of more happening line (ph) so where [healthcare] a kind So of than have margin I the mix what's think

talking great expansion real in segments So think margin weakness I the kind of you generics a be the and terrific of specialty, QX. but bit that's profitable may little about, -- perhaps

probably of Looking be between competitive new XXXX about and so low-XX in own budgets XX% neighborhood. at is My is at something to within going happens their is of, in XX% product this because their and, be gross XXXX about generic a growing margins function standpoint. XX%, just that introductions gut XX% feel XXXX, the business Healthcare you cadence distribution versus all It's about what think to a probably year, from kind XX.X%. is going if segment. of were about faster

specialty XX%. finally, them the stay are And expect profitable, business, which at we to incredibly

overall So much in to not big ‘XX a the margins. gross that overall difference ‘XX, helps. Hopefully,

Gary Nachman

how Speakers] does. Yes, just -- I didn't [Multiple the terms of And factored the spend, on address in launch much in you for there? it yes. of guidance the but Yes, before,

Tasos Konidaris

Yes.

spend you there. all one line, point -- alright we reasons have right? business. EBITDA, Elliot's previous in business, growing you the making is what guys, the -- created it you of the of So finally stability, keep That's to and the and like to question, top to the on investments keep your the diversifying right, is see we're but don't the growth, part big to It's

expenses. So our $XX guidance includes, marketing and as I mentioned before million of sales incremental

and IPX-XXX. biosimilars all commercialization the commercialization of the our full-year full-year for of expenses has the that expense So incremental

know, that an opportunity gross the as the provides approval, quickly depending after -- XX, June quickly us. a uptake obviously, depending of on as on right So we PDUFA revenues, we as margin on intend to timing of date launch you incremental possible, the for on have depending

Gary Nachman

you. Thank Great.

Operator

Our Chris your JPMorgan. Please from question Chris, is line Schott is next go from now ahead. open.

Chris Schott

for questions. much the so Thanks Great.

low it Just a the generic only decent here. on but me like a couple sounds rate before the on is And made guess this you like the for getting of launches. growth new biosimilars environment, optimistic seems some that more I overall contribution you're maybe comments the from first single-digits. growth and year. you're for It

in to business you just this me terms need balance what generic could year? the of help keep headwinds like So we for in mind

think in just, rate down of all you maybe kind as two on development environment higher versus we're or follow-up how question about, second my of, kind business with those pay from then rate And environment interest Does was debt of, capital one at the incremental start kind about how and allocation here. think just change you there.

Tasos Konidaris

Yes. Yes, Chris. Good morning, you're spot on.

that's So single-digits have said about we're which expect seeing for generics we XXXX, low talk we you that when mid-single-digits. overall, why

we is right? think planning competitive Part little not a a is cadence grow as as similar of both is XXXX price of of products. new of we terms volume can in it historically, A growing part of for bit So we're fast the and it business. as pressures,

So think persist line. and we profitability price as it incremental believe both we'll may if guidance improves, this is said, you drop continues If had pressures environment covered. year. to competition, I the then in terms improve environment of bottom the the our And

topic. kind that's first the So of

allocation. The I kind think everyone interest ourselves; think rate topic think second higher I right? about, costs only I not of everyone reassessing capital of, everyone, is

mean, M&A, So we our $XXX specialty And in made portfolio, of pipeline. of years, I right? that, our our investments as said, obviously, out the out have last kind million and build infrastructure we over pipeline, built to been put terms number in expand biosimilars have Chirag injectable substantial our of, we fortunate Chintu

year next And now reap to those we're this rewards going late and year.

So substantial a and issues, us. -- lot investments, also, right? we settle legal and behind we're legacy amount a that fortunate a is bunch of a of lot of So of

return. expectations terms right, our think will So terms own raising, of of the now expected be in of I M&A, in we rate

the pay the in terms number So past. to priority disciplined, of more even be two, debt we're becomes going was overall number kind think I And most down, of in of one. than

So helps. hopefully, that

Chirag Patel

do Speaker] pipeline, M&A. such pipeline, to be any an awesome we we the organic [Multiple have need not changing

Chris Schott

we guidance that this quarters kind that touched of of this know the kind product -- have of, you. get, something this that year. place a was and know you've for maybe the should quick conservative in I of takes it Thanks not But be bit quick Or kind assuming this few a being in thinking and just little Thank you're product? a approach on assuming uptake on just IPX-XXX. then one goes around actually of that a but approved And for reimbursement physicians couple just prior questions, could PDUFA. approval around prepped clarification the the in Perfect. well color is PDUFA, to there. about of, fairly, a I the including all

Tasos Konidaris

Yes.

couple things. a think of I

as speak. are I -- teams will with assume our commercial our already we think with can reimbursement payers even our begin -- you now engaging team;

considering unmet think product the one. need, number that's profile, ability, the expectation. our I two, my So Number

time It's to As one, you day know, it's be on reimbursement. going to some build right? not reimbursed to take going

I So to that's happen. think going

that And in is starts, which will year-old the our of course primary be new switches and think be we're over from focus revenues technology. of thing I the patient which the over I and the from we that a see think think time, a is, going well will because time, is very other IR, to patient buildup resonate population a nice other will

it's part think acceleration incredibly So of this be revenues latter I at don't to year. an rapid the of going

over build -- part out into build to in the going it's and beyond. and time think latter XXXX I

Chris Schott

Great. Thanks much. so

Operator

Amsellem Our next question David now from Please Sandler. line Piper from ahead. go is David, your is open.

David Amsellem

Hey, thanks.

you about couple how talk product-specific unique some growth, I So the had of through questions. there's I know just Unithroid market. long-term features thinking regarding Can you're a of the sustainability levothyroxine

So what's just but not you continue grow number XXXX, your beyond one. of just level significantly XXXX. business confidence only to that beyond That's

Do the development? in disruptive other of formulations over injectable a be with that of In are Adrenaclick epinephrine two, number words, that formulations? you the could think long-term? Adrenaclick to Number different

IPX-XXX. And about to over? most What's you lastly, you. the Rytary switching you versus envision patients right opportunity there Thank maybe do expansion. expansion? question overall then you do another the And Do way think vis-a-vis switching market -- vision on or market

Chirag Patel

Thank morning. you, David and good

in on study very Unithroid. over Unithroid continuing some like patients know, So hard do and generics the know, small to their switching the Unithroid and market multiple in providers We time and more and of that market let's use not a on there a than be over growing to share, say consistent they're multiple switching It's -- have physicians large a patients keeps like to believe it. products over drug that you rather be generics patients and and want is, market more X.XX, patient -- to are and subject to the you how switching is products.

the approved [Indiscernible] clinical. we done [Indiscernible] spray Adrenaclick, nasal of to possible. have have it's it, through will it's gets Unithroid, have any mothers for use kind sports have parents new not to with It not time. They it a take for even not --

be Adrenaclick, knowing while. will a a So carry chance in take maybe parent, versus I both softening spray bet I just nasal that for parents not my and will epiband

to Are penetration. brings if slower It will pricing -- even it And will time, that's Adrenaclick. be a another one. any And competitive penetration. have be be going we over they to dynamic. So see it to and we see the

half IPX-XXX, million time, earlier, XXX,XXX have X CDLD, mentioned over is for prescriptions broader it to IPX-XXX, as for market, going there move obviously. product, we market, only. of over I much expect are so we And would patients the Rytary, the Rytary a better on for have broader

awesome, go to a much and can. coverage many we be both IPX-XXX. unique is will strategy And for into we X% really excited the the received that bigger much try medicare So commercial penetration, pricing we're and converting going grow on our to as patients, pretty so for believe well we as business which

Operator

question from line ahead. Balaji is Barclays. go your Balaji, Please next from Our now Prasad open. is

Balaji Prasad

Good morning, [Technical Difficulty]

Anthony DiMeo

-- that? if I don’t some anything on there Balaji, your Balaji. you there’s your about interference is know could line, do

Tasos Konidaris

lost can Balaji. very you Hey, across if a kind mind of We little clear. you Do you come bit.

if question, you you do mind repeat So your please?

Balaji Prasad

it. Got Absolutely.

So couple of questions for me.

on kind it mentioned just this kind see [Technical market seems you doesn't Chirag the IPX-XXX, Difficulty] information model with to product. much where Firstly We of of that

Anthony DiMeo

you Sorry, the perhaps to hard to follow-up still after Balaji, this Tony. Happy you. hear is call. It's with

Tasos Konidaris

Balaji, give get Or Tony, call will the you even you can the okay? we to answer. maybe and in we an the you Tony on e-mail over time, if that it address And can in if e-mail question. Is question can it

Balaji Prasad

[Technical Yes. Difficulty]

Tasos Konidaris

Speakers] [Multiple go next Alright. you. the to Thank please. one,

Operator

Sure.

Greg from from Securities. ahead. Please is go question Truist your next line now Fraser Our Greg, is open.

Greg Fraser

the taking Great, question. thanks for

approved million to any will you. that this would number. out the contributors material that significant products are new business, there that $XXX generics Thank And could be that particularly are there product as are the the any that call On of plus be to contributors launched sales? year, being generics among approval you pending

Tasos Konidaris

want Chintu, take one? do to this you

Chintu Patel

some are IP-driven The and (ph) big hi. the Hi others. approved ones products have alginate launches. in Yes, [Livtech] Greg, yes, of sodium their Sure. few the notable we and there a are

are not -- ones upcoming have another near to that launch approved are are and quarter. we are to new got have those in five three all very we launches, -- a almost by clear products LVP approve We the injectable bags two disclosed but And space. second in expecting

new So launches throughout launches we we year, total are XX very our the in new over are optimistic expecting XXXX. about

Anthony DiMeo

Tony. I in And launches only product The had this of XX in ’XX. back-half would thing a new more XXXX, contribution is weighted add, too, fiscal is you

launches to a list. long It's So XX-plus the this in year. addition year that will annualize this Chintu’s,

in the product as has catalyst is year new But -- million. slide have contribution also mentioned key the $XXX seven. growth We Tasos slide revenue this from over

top new year ‘XX more it's double in will versus contribute list product with that products of So even than for the a a launches potentially -- long line. so great to

Operator

from Our is open. Elliot question now your is Please Elliot, Raymond next line ahead. James. from Wilbur go

Elliot Wilbur

Yes, thanks. Two quick follow-ups.

it around getting the catch in seems issue. timing, didn't your that in commentary a auto-injector to keep hard commentary or I prepared terms any Q&A. pushed molecule formulation it's But believe First, to the back dihydroergotamine expected just filing, of

time why being in wondering of Just extended? give if terms are there color the lines there you any can

to say know question And then kind for interest of you I on say outlook about expense for XXXX? real Anything in Tasos when it's the a can the hard quick just debt. rates to SOFR at we're rate in X%. around refinance. would far market be about it your talking spread, you're seem like But somewhere today just so and looking -- effective current looking

Thanks. that's you're currently in what Just wondering of thinking? ballpark the if

Chirag Patel

Speakers] [Multiple refinancing. the take impact I’ll on DHE to

one not been CMOs the complex been working of stuck CMO issues but we've transfer. for is It So has GMV-related on product DHE product. autoinjector device-based -- site executive the the and was related, with from a

and it's moved. is why has the Tasos? So than had expected, taking longer we that date

Tasos Konidaris

Yes. thinking the you're interest about way. expense the Eliot, rate right

we're you're this Obviously, around choose way. going to about So it depends X%. probably thinking right and the in the somewhere instruments exactly what

Anthony DiMeo

the you final A then for today. question question, Balaji. Thank final for sending it. And

With plan? the a in XX-year a over being pipeline, road of et player is get to time, biosimilars map goal the five-year this a what's plan, cetera? five top there And

Chirag Patel

Great.

launches, first that. which the check for three requirement So marks

to As XXXX bit we it it would take build the, get top I business, XX-years to we building that Amneal started five. Generics I took in a mean, little

this So we progress. XX-years lot of as every expect do a journey, year, a there’s also but

the after are strategy second we working a only proven more obviously [Indiscernible] companies. licensing, So few the on licensing these from

And of we're then our we products own have being working on integrated R&D. would for to the -- some vertically

India the that manufacturing that well So emerging for we markets we with or any markets can would and in-house, or couple our other probably well love U.S. we as even from manufacturing, India own bring ship as U.S. manufacturing,

and to set is approaches, obviously, that be pipeline. all multiple the plan -- starting should we'll smooth So next and continue at year. add brings, to so we bring

mentioned earlier, did many to in be to we is Chintu as want what market. And cost like we market just the generics in

there outside oncology we at So a missions lot kickass. first those not of biosimilar And of we're [Indiscernible] second touching square would most, within be well. where is eight [Indiscernible] infrastructure within and a the commercial as or are weaker immunology, two

even the keep we're and position them, one our probably made building really the -- with That's all we top it. though trusted something love them still became we on of generics partner for groups. we for business, best We the still customers, have enjoy well buy a we they and kept consolidating,

just company. groups, here, oncology the doing we're And cancer same centers, thing hospitals, likeable with we're

our are on. on they recalling supply and count others, we can So they count -- can

So to global and out because Korean the the and years, seven players. taking see going know large this play three, very then in always that with us like beginning, how two five, will build as has over Teva probably, you a Sandoz and and it playing this well obviously build to committed business we and and to all from excited very it’s companies division

branded much see all. won't you companies playing in But this at

and XX-year of that I as next earlier, one business, of are more, the the to leaves it actually going be there called affordable it forward. those So the companies going medicine leaders

I Harsher, to anything missed. add if you want

Harsher Singh

it a We focus sort is -- is think and pipeline are our our more the context build I B is and Part Balaji of think Hey, more buy do then interesting. chasing. we're those bit of what markets and in

you how about it should pipeline right public that's So we're now. on think though not

Chirag Patel

Thank you.

Operator

like and remarks. further no to gentlemen, to questions. would final over Chirag have Patel currently Ladies for we hand I now

Chirag Patel

day. a great Have everyone. you, Thank

Operator

for joining. you call. Thank today's Ladies this concludes and gentlemen,

disconnect may You your Thank lines. now you.

Amneal Pharmaceuticals (AMRX) 2 Mar 232022 Q4 Earnings call transcript