AMRX - Earnings call transcript Q1 2022 | Amneal Pharmaceuticals, Inc.

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Operator

Hello and welcome to Amneal's First Quarter 2022 Conference Call. My name is Alex and I will be coordinating the call today. [Operator Instructions] I would now like to turn the call over to Amneal's Head of Investor Relations, Tony DiMeo. Over to you Tony?

Tony DiMeo

Good morning and thank you for joining Amneal's first quarter 2022 earnings call. press our a results. issued we release financial reporting Today, available a website The and are on press release presentation our at amneal.com. And be posted this call call. of a after replay the will not this management's us. to, or available on predictions that matters Certain information not statements outlook call forward-looking based made including but on that statements to are are historical are that facts, limited now regarding solely is discussion section SEC in the review a factors the filings entitled our presentation and on impact statements Please may cautionary forward-looking earnings for our of that performance. statements future

no non-GAAP provide change. We also U.S. from expense Important discuss revised this in is the we use our measures. longer of financial be non-GAAP reflecting will quarter may measures certain our our prior to exclude measures. reconciliation R&A first press information presentation. results release Beginning XXXX the on milestone and earnings period In found these of GAAP company

this CFO; turn Legal call Corporate the over our morning Chief I Patel Officer and Generics; Chintu Chirag. to and call Daly, Specialty; now will Boyer, On Todisco, Secretary. Andy Tasos Jason Chirag Konidaris, the and are Co-CEOs; Joe

Chirag Patel

everyone. you, And Thank Tony. morning, good

The to with revenue EBITDA the $XXX good a the adjusted first as of million year and expected. million was of $XXX quarter start

and and We we results including now areas, years, top continued to guidance in several success and strategy Injectables, are XXXX executing the on achieve expanding continued last consistent on in Biosimilars. track commitments high bottom Building Specialty, of our year, full our line over are growth. growth our

needs. access underlying on and patient our unmet As strategy a is affordability, company, global focus essential addressing medicines our

healthcare mix our our on impact diversifying our as we forward, continue Looking and see execute, we increasingly expanding. growth accelerating, profile business to global

complex as our productive new provide now updates the Let grow engine our Generics, me few business portfolio R&D continues continues with to medicines. diversify businesses. Starting to our across with a

more as revenues. represents product total is towards Generics over solids. key only is of the result, a pipeline barrier complex product Accordingly, With business, growth medicines regards Generics products XX% we durable few The our growth continue into ago. areas. this with is Generics non-oral have complex business, in you and continuing to area in mix largest on company Amneal a high injectable XX% In And expect X% of with five As concentration shared is as shift our our non-oral are products allocating XX%. returns our and today solids of Amneal. has a to as we compared top growth we focus years higher past, for revenue only a low half our this

first million grow revenue in Injectables to We in scale by $XXX We look are our U.S. drive the as more our three to approximately to believe portfolio. way that years. plus will oncology and on In we of excited for products pleased than new this achieving biosimilar sustainable growth enter and our we launch expanded We will XXXX. year upcoming business Injectables substantial in our $XXX capacity with very well the increased with are Biosimilars, market XX% million are products. these of initiatives capabilities,

wonderful of a a and which and filgrastim with biosimilar, partners. bevacizumab team RELEUKO, approvals pleased are biosimilar are Amneal We the Alymsys by our achievements

few next third for a expect In addition, biosimilar weeks. filgrastim approval like we in the

We we market for estimate in large, for we a to of in see us. a are these time peak revenue This on is Biosimilars’ we role three positioning have which As long-term net sharing revenue the half three of products biosimilars $XX critical billion for U.S. play U.S. first shared biosimilar Amneal is with is approximately the based about market. size $X we million. fast and growing past, estimate these have the you Together, $XXX billion the cells Biosimilars.

We through in growth and meaningful licensing we we portfolio saw build are can in continued our healthcare our to we QX. early-to-market where nice become biosimilars. as start In business, additional a for vertical to player opportunities integration distribution in be looking also in time

pursuing million commercial meet are or We expanding leveraging XX the execution expect branded sustainable early portfolio as international, In growth generics generic, In market we and distribution our complex and of across driven next a Biosimilars key needs. Specialty multiple by our year. we expand we later and medicines label world, strong year operational rest progress. channels. market, you are strong launched share advancing as we our add the Injectables, presence. to In in of China, commercial as strategy on be remained highly make our and India we to the agreements believe the look time will have We we Specialty, we revenues we this be commercial with of are In making branded profitable and and our progress partnership existing and there with good to utilize pipeline. our we in distribution focused driving this partners and look are products considerable Fosun execution infrastructure. local Around

We Unithroid expect hypothyroidism. continued in full year growth from Rytary Parkinson's and

over delivers branded DHE including see the next products, As [indiscernible] we new year, this a Specialty expanding and next business IPX-XXX very several pipeline year our and meaningfully years.

And I'll Amneal leadership. years He and and with wish has in his contribution great who awesome like Amneal team strong want a it contributed to here is a built in his company that, Chintu. to the of I it over We acknowledge, for Jersey. would thank hand on to CEO has Joe be XX great to to way. moving a biopharmaceutical a from over Joe Amneal to pass over I all Todisco, New Before to best. Chintu, I

Chintu Patel

And everyone. Chirag. morning, good you, Thank

generics. spend our members and of areas, and Amneal towards fast-driven more sincere operations, Specialty, complex R&D, to innovation are We directing supply particularly Through on In growth cost the chain, day programs high focus X,XXX are excellence work excellence who differentiates healthy Amneal. Biosimilars, my efficiencies. relentless quality plus reducing thanks every our First, we believe to hard constantly family possible. make and across Injectable, improving we

great me now our innovation Let our through we and aspect Generics, categories. about feel pipeline In different complex continued walk the of in business.

XXXX, we have in far eight launches. new So

XX expect year this to year launches going We forward. and XX new each

past approvals. the forms we pipeline leader received this be approval our we are generics XX% bexarotene and expected non-oral have XXX is to solids in Overall, XXX dosage first-to-market, approximately CGT another year. are in CGT spending industry all this most Amneal for [indiscernible]. products, Just and to file ANDAs gel. week, of ANDAs In expect XX more across

complex is that continue move over portfolio increasingly molecules driving XXX differentiated of We towards to growth. an sustainable

product which Paxlovid. ritonavir, is co-administered launches One of XXXX is the with key in

hard to U.S. is fulfill COVID-XX for ANDA excited an main the one has are this be of team approved We key demand. been working already suppliers our substantial treatment. to that Ritonavir

we Adrenaclick epinephrine improved chain expect addition, supply auto-injector, more and XXXX. In revenue for in

we launches will drive more including XXXX, for As key and see me there among products are sulfate. horizon we we depth of disclose inhalation growth injectable and our portfolio late our beyond. We capacity and many commercial products pending look the consistent ANDAs reasons. development. let seven the have significant XX in expect otics, we pipeline But magnesium and expect to retail of on to and ophthalmics four [indiscernible] the drive in that into we pending competitive eight our this to XXXX ophthalmics launches nasal, In ones many capabilities. don't add others, upcoming XXXX materialize under we year financial few and start presence and the otics ANDAs leading pipeline performance. expand In In substantial share generics rest and growth in in new as a and

XXXX. reminder Healthcare, live preparing sites. manufacturing the in The production we capacity and ability well, which multiple lines additional R&D from Saol added state-of-the-art and sites This in commercial result and and capabilities XX commercial do are other our doubles a we Amneal's we of going As Puniska our acquisition Baclofen has is expansion commercial supply which enhanced franchise, institutional January, very total. acquired to to production for acquired more product bag to Last November, and capabilities. added in integration

five XX with we already innovation new Injectables in in of launches year. In this expect terms four to XXXX

products. peptides, over drug areas We have XXX(b)(X) on another LVP and are bags They're XX a spending of through launches from XX combination, we XX liposomes, including: pipeline injectable for track injectables, complex in Overall, ANDAs device XXXX. long-acting products. and variety XXXX

long-term we positions the have supplier the scale a and of business Injectables robust track past, quality shared be record, very us increasing believe sustainable innovation in we globally. combination to continued As our capacity and our well supply

Amneal. first the one positioned later near for We long-term mark large of more is is Amneal growth. recent approvals this biosimilars excited expected market well two about month are and a watershed how for years and biosimilars The very and and approval our growing

launch planning are Alymsys. We and for Releuko QX of

this on received first of path, the success from competencies needed space. Alymsys expect three having to approval. over few We commercialization. capabilities integrated in oncology companies and the key that with Biosimilars. core science, manufacturing the commercial Combined in demonstrates partners one are market We biosimilars the in our We space. team to being tremendous development have a and with be a and right vertically time substantial our development were regulatory U.S. we to believe manufacturing pleased the accomplishment capabilities is by This cycle

growth working expand key capabilities inorganically. drive actually to organically are enhance to and We portfolio our our and

biosimilar launches ahead. years in target we As new add the to

one with XXXX time. to have China of biopharmaceuticals for global in were Biosimilars be as five end growth. currently manufacture we We and and of Paxlovid now see commercialize We to opportunity XX the strategies expected international, are advancing pleased another of we for China about long-term the the a In to in in to very sub-license sustainable and March future coming XX our In the fruition companies XX over particularly by and vector In to countries. middle-income products XX receive are we the our low- rest enthusiastic XX as and to is filed world. expansion us. India

expanding evaluating portfolio are treatment. are COVID-XX strategies of access and Specialty, drive drivers. a distribution We number In growth we to see we branded to our this

peak pipeline Specialty $X current billion million to Our represents U.S. $XXX sales.

specifically to for LYVISPAH June. in First, launch we expect

Next, Autoinjector for approval. launch to year cluster upon this look migraines headaches DHE and our we later

showing on our At abstracts sharing April For top-line Academy efficacy good two and analysis time hour Neurology in we hoc post is completed those. IPX-XXX, FDA. more pre-NDA we presented meeting Meeting the of for with results X.XX clinical American

look IPX-XXX. our remain other we Specialty million see K-XXX progressing expect Myasthenia are well. We more NDA are and Also pursuing peak to other submit for in indications. approval in expanding K-XXX mid-XXXX. share expect sales by NDA Gravis our We pipeline. our and end million on U.S. QX of on to and for XXXX, $XXX to pipeline pending launch in file track for to K-XXX programs, We On $XXX FDA our

look that one launch our we prospects drug We are and and To existing repurpose the Across of business billing per remained our programs year going I for XXX(b)(X) at expect and year. growth Overall KRONOTEC. quality least over to execution it built about forward. Specialty. Specialty growth us new our accelerated We molecules, upon excellence. technologies new platforms, is on are will very to GRANDE adding these innovation, our excited delivery differentiates this technology hand utilizing focus super Tasos. strong operational foundation we laser strategy now summarize in

Tasos Konidaris

Chintu. you, Thank

line by are Our XXXX continued all bottom year colleagues to top pleased thanks financial and who line in full was good for to with first quarter our work and our the re-affirm guidance growth. performance expectations, our

EBITDA revenue net $X.XX. over For EPS the total first reported of $XXX adjusted million, diluted $XXX of and quarter, million, adjusted we

milestone Our is advance our external million $XX million R&D results. rate which represents longer we expenses, of run and R&D results to collaborations pipeline. these non-GAAP of from $XX no annual our to include expenses exclude $X The million

and network impact $X As million business. grew there declines $XX Products in of the offsetting economic QX no or million XXXX policy X%. is in the change launched XXXX portfolio. typical million of growth generics remaining $XXX [indiscernible] contributed to our

about factor line past, XX% enables on and of top fast. growth. more declining prior reliance have we reduced is generics products prone said accounts in now our and net strong in focus to This revenue Consequently As XXXX a innovation Lannett. declined that performance the differentiating competition continued our for to launched older, sustainable low for as key commercial revenue Zomig's $XX typical reimbursement XX%, for cost million $XX represent and products to the exclusivity growth the well year. QX Specialty, bodes of than profitability. million This and quarterly quarterly In net reflects loss higher point or well of as revenue related execution of

and excited like be by LYVISPAH X% Unithroid as to continue of DHT and prescription Rytary of launches total the We respectively, XX% the upcoming as up growth Autoinjector. well and

$XX million margin non-federal the grew adjusted in Our gross QX quarter and of $XX XX% reflects success of channel. was AvKARE prior XX.X% or acquisition the reflecting revenue in net line million with XXXX dynamics. strong customer distribution

gross generics of First, from margin quarter. points basis XXX a XX%, improvement prior

issue prior margin or is and gross of a our to adjusted of quarters gross of the production million manufacturing we item business. margin points XXX few costs basis you actually AvKARE expectations of substance improve last XX% higher quarter finally, EBITDA of Second, $XX schedule. related providing and to will was million future And QX profitability. early than declined due during mix million from our timing February additional call. $XXX with a timing shared the The

the of overhead reporting From and we related million Kashiv As an I and acquisitions driving deploy million mentioned allocation. to Puniska in we the million $XXX first Healthcare. cash, policy perspective continue fully Saol, we to million sustainable $X also to previously our fund includes quarter Consequently, customer announced earlier, long-term $XXX growth. of it invested operating of change manufacturing which $XX generated in

This and will discussion bottom four ahead over this our course line February earning growth top year. be of growth the our Looking of by we driven substantial with acceleration and in factors. consistent expect call,

new Lioresal LYVISPAH, such other and biosimilars. new RELEUKO, product as multiple First, introductions

as underlying brands strong of demand such Second, key growth unit [indiscernible] growth.

fixed guidance. absorption, overhead in understood finally XXXX confidence our and favorable gives well financial within operating our and expenses. Third, stability [Indiscernible] control, in us manufacturing delivering

back hand right me now. Let call the Chirag to

Chirag Patel

biosimilar this I'll In approval. XXXX. momentum track the these beyond. our on year you, growth accelerating performance including to Tasos. company U.S. and our next our great and year summary, open see see first year, Thank business, building are We for in another We drivers across call we now questions.

Operator

Nachman for Capital today Thank open. question Markets. you. muted. from of comes Oh might first Gary be you [Operator Instructions] your Gary, Our sorry, Gary, now light BMO is

any receiving [Operator not Could still I'm make Gary you Instructions] sure? Sorry, audio.

Chirag Patel

Operator, next question.

Operator

your Mikaela comes Barclays. question Franceschina [Operator next Instructions] from is Our open. from now Mikaela, line

Mikaela Franceschina

Hi, Prasad. Balaji I'm Mikaela on for from Barclays on

do your U.S. guided and when of what million about by how $XXX when wondering realize plan get And plus to you can thinking three over integrated Just for your you peak vertically Biosimilars sales timeframe? biosimilars? your

Chirag Patel

and you good morning. thank Mikaela,

working be the place reimbursement infrastructure in would in in we place. January you getting in X, should sales place, a XXXX. know So as is by peak with – Commercial which are be

would second achieve XXXX should be question expect integration. we year this else between peak So say a XXXX more had somewhere in contributions and adding on you XXXX, to up And we I political to that. contribution able

that So license – as to as capabilities. build are we for is own our biosimilar is and committed in trusted long-term, strategy one a key partners we have from partners previously stated our dual,

we by vertically should or be the year. year of and different to options able exploring next integrated this of So end be are beginning

Mikaela Franceschina

you. Thank

Operator

Thank you.

line question next is comes Amsellem Our David, Piper open. David your now from from Sandler.

David Amsellem

on bigger had have and the question the picture joined that I I I the the AvKARE about know AvKARE if late, organization this. margins, But I being thanks. to role a of mix. the extent bigger where Hey, in just talked of you you periods the part part Biosimilars. so it's to taking apologize just So on missed a the you I some about of compression. margin and I is get acceptable? AvKARE you're of Number is that's where the guess margin a one. better problematic, see Do given two sense that there's and bigger I'm fits a number as where trying the profile business, where mix,

about some out think I you assumptions laid peak sales.

– assumptions penetration, Biosimilars, share the markets that to really PEG-Filgrastim ultimately would share are your what your out just you're pricing regarding erosion, on how and view I helpful? Filgrastim and and bevacizumab Thank be get on playing and and seeing underlying you, your in So overall of wanted penetration your thoughts share volume

Chirag Patel

good David, morning.

picture start top So in two market, cash on we I'll a you products DoD also us to is and AvKARE. business the there. with excellent allows AvKARE us and of the big federal one flow is VA know for which more as are healthcare put

growing, fluctuate is business. dose few have could margin Philadelphia, is three business of and within So they for is they cities. margins, One federal They the which and have and government, unit steady which is the distribution City then business and added AvKARE. third in business businesses pure have it that more

will a and keep adding the between we It fluctuate gross to line. it's XX% margin great So XX% business. of top

as AvKARE should on on else be So we Tasos. focused top Anything well. line

Tasos Konidaris

No, less there. the rest you so overall are we're business, It spot business dollars but that is top is is on. bottom our It's of and sustainable line line. a business. of total David growing The absolute both return really margin focused on than correct.

Chirag Patel

Yes.

Tasos Konidaris

that's in to gross that XX%, company quarter going And from it's a versus the AvKARE total whether really perspective. one or much fluctuate doesn't this where needle situation not margin XX% and move

which the more will the last almost three driver be key mid-XXs So that it continues which know XX% then. than to there years, you in is we've our grown be as over Specialty, from substantially generics, XX%,so to

Chirag Patel

thank Tasos, and by excellent is with people our and the other a you, salesforce. which place, The and from small XX team in Yes, on in team, part And institutional contracting plus ADC Singh sales is team excellent commercial second Harsher added led Pfizer. added a couple Biosimilars. people question,

we job great have in a do the have a As understood great in we as commercialization well. market. always commercialization, done we And job here will

regional avenues would code So in about there the and XX% quasi on with we maximize as know, XX%. well. our place. try branded clinics, Amgen get so. and Bevacizumab focusing oncologic we’re to as are more say share you systems, to many integrated going obviously the Pfizer you to We’ll and to innovator products, get reimbursement We're market so and competing we do

GCSF, is active the And for players. it’s bit pass-through which helpful. have status, pass-through little the the status competitive we'll But And a as will Filgrastim. three We more with the always have we well, XXXB unique XXXB to to XX% are active for XX% we our be And five share players. little or more PEG-Filgrastim since bit competitive market be may position, with to get there able would more. then try again a

will penetrate PEG-Filgrastim. different we with And try to [indiscernible] helpful be it have very So channels. to should

a would nice that So as be well. launch

excited future So of excited are all and the very three biosimilar we very well. as

David Amsellem

me operating And I not on profile I just the margins you think be net be going that's economics, right. fair Okay. That's to to higher follow-up, a Is clear than may be just margin corporate way shared remind it? of going biosims. about to mean, just to the margins, helpful. if are that the that

Andy Boyer

be so be PEGNG the because And bigger would corporate [indiscernible] higher market. margins. line in would Yes, may [ph] with be

David Amsellem

it. Got

you. Thank Okay.

Operator

Thank you.

Our final Capital question from line your Markets. is for BMO Nachman today comes from Gary now Gary, open.

Gary Nachman

great. Okay,

overall much to And then are will to just respect over you bringing further how your this Specialty relatively on sort beyond and with of you modest Sorry, how of I to talk or commercial gross company? the taking missed you trend year? that know years, business terms one year if that obviously you the the of you business jumped respect few don't point? infrastructure? front? expect this. what you I in more gross is new do you the couple in? And bigger yes, additional there this that a become more, with to about calls. you think products it sort think margin jumping be margins more the of levers remainder to Is the of think you have Thanks. you much at to do for Just just the when much initiatives late. around touched you on want Specialty But part a how are guys this leverage before going with improve did next – just to of I what on comfortable of How

Tasos Konidaris

one. the morning. take Hey, I'll first Gary, Good

our margin So as know gross was you QX XX%.

the full in the one. looking increase My where number is, about which of gut year, we’ll feel with probably last were are to XX%, rest in the year. line We year. for That's we finish is

the the manufacturing about drivers, go think from just production how growth Number there let's QX of is the is about things. year we are Now, a do one piece of plan. XX%, say first rest if XX% you internal couple our of to

we're the So of and and better in fixed It reflects absorption just control overhead manufacturing operations. demand that.

on getting confidence high So that benefit.

is launches. Second, NPLs new product

year of know, products, new more months of had nature So, by greater with Specialty margin as QX, when said products pro than a as growth product end the the the And right. the rest you back margins. those few are shared expect year I the growth this Unit of of you revenue, have have launches gross expected of terms to accelerate complexity on ago, they we and the those portfolio. that's end. then, to the you be substantial, we third the business, and low our is point as at look the of higher gross in And

the So three are those levers.

Gary Nachman

Yes.

Chirag Patel

impacts that know, as had Specialty, Thank And platform. our XXXX committed, in you, Tasos. you we Specialty Gary on back form we acquired

well capabilities for So place excellent endocrinology. as commercial Parkinson’s, for movement already in as disorders,

have much to results And next by a will for which teams excited the higher product year fixed seen. we XX% you launched XX%. we place. right very product, outcome launched grow this units DHE place, got IPX-XXX Gravis year. filing what pipeline. we're organic And core in be this X% KXXX with being of partner’s and excellent So have have we our the to market relationship site great see, have on are marketing June place will to We by year, [indiscernible] from to team a Myasthenia continue profile sales in FDA, every autoinjector can X% based should penetration, access in as at on year. X, because the

K-XXX, We on along expected more team R&D. Specialty. we we couple separate XXXX. adding are we K-XXX, have for assets pipeline government K-XXX, launch and and is to programs also well. with that in Kashiv that Specialty, And two as Specialty acquired a in have these, also focusing have from then additional, we And And

tested have been which well over platforms We two have last XX technology years.

the opportunities. open we million specialty. is deals adding for these for to will in So are And within Specialty. available this keep conditions with that These a and like other adding our us evaluating constantly us with seat revenue these are sustain two business, constant the pool our market driver's we in $XXX driving and biotech certain think Injectables business, of from business pipeline Specialty today, companies cash our to better those because it, assets. a add and of about And substantial in business flow allows are which I Generics being more tuck-in growth organic are

very So excited.

If me How like go but in $X yes, get long Specialty to May on you drivers. ask a we numbers, will to take? billion it sales. excellent years, a growth be few more

You contribution are very the higher the absolutely becoming of business part right. and is significant That Generics. than much

Gary Nachman

Thank helpful. very That's you.

Operator

you. Thank

no have today. We further for questions

So I'll Chirag closing hand back to for any Patel remarks.

Chirag Patel

could everyone. day. a Well, so a great you busy would you very join not And morning, join. know people have was I thank thank many much. everybody But it

Operator

for Thank call. joining today's you

You may disconnect. now

Amneal Pharmaceuticals (AMRX) 4 May 222022 Q1 Earnings call transcript