ANIP - Earnings call transcript Q4 2019 | ANI Pharmaceuticals, Inc.

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Operator

Good morning, everyone, and welcome to ANI's Fourth Quarter 2019 Earnings Call. [Operator Instructions]. Please note, this call may be recorded. It is now my pleasure to turn today's program over to Mr. Arthur Przybyl. sir. ahead, go Please

Arthur Przybyl

joining Good the Welcome quarter full Art CEO. name Laurie. our Stephen conference Financial Chief XXXX. ANI's call is Officer. And the I'm for year Przybyl, today morning, you, is to Carey, everyone. earnings My me Thank and fourth

forward-looking that carefully this and begin, of ask I measures measures generally earnings the you financial not found refer certain as prepared Reconciliation with include this for also today. in to everyone will to our we language call. accordance were morning's it important accepted each of in conference Discussions in dated context release those Before can principles. accounting to review non-GAAP want statements press financial release be

revenues profit net non-GAAP revenues. ANI of $XXX.X of EBITDA reported adjusted its of XX% $XXX.X of XX% million, $XX.X gross full revenues, or and of net million non-GAAP net XXXX or a adjusted million, year

revenues and net XXXX increased dollars Gross record Profit ANI. are Our for both by X.X%. X% by increased amounts

net the generic impacted erosion products price three by quarter competitive and were in of our gross Our and XXXX. significantly fourth of profit third on revenues

of The resulting $XX.X an in million solution the declines these of launch estimated marketed Vancomycin estimated impact recent annual and of Amerigen's and acquisition expect $XX products In subsequent revenues, oral in and the an decline of profit. XXXX, impact of decline annual gross pipeline. January net we million offset was to through XXXX the

XXXX. same number guidance of $XX the For revenue compared of non-GAAP X% to XXXX, guidance increase million and $XXX are adjusted of we and EBITDA net providing million, as midpoint

you Steve from Cortrophin any not potential from Our results. launch commentary of financial provide XXXX our effect effect Gel. additional and acquisitions, does does with on include guidance include not the quarter will additional any

acquisition been pipeline cash US ANIs included be the will The has entirely on which for of recently from Amerigen's $XX.X commercialized assets growth products, and are XX acquired achieved drugs. we or products acquisitions. funded products hand. through continue currently We XX to generic million, and Much XX

accretive immediately portfolio and was XX expanded profit, acquisition revenues drug products. generic our to gross to and since The has commercial

Our IQVIA. on with combined of a XXX from based data $X size now pipeline billion generic annual includes products market

Over the deals drug In $XXX for XX alone, years, total contributed in we've revenues. completed these several last generic generic million. a deals $XX million XXXX drug of

million revenues most have eight been opportunity, largest in million for of Gel pipeline our filing regulatory approaching $XXX deals targeted is of branded which $XX our a its for acquired Additionally, not date. including total Cortrophin the rapidly

XXXX, approximately to these revenues From gross with has minimal XX% expense. cumulative the XXXX deals yielding SG&A been margins from better branded $XXX of million than

time important our to of continue time. an assets acquire to part ANI to As intends strategy, from

who highly the through are consortium remains such oral environment However, drugs that three as XX% current share sold volatile. market generic solid for drugs control

addition to levered is having industry many littered manufacturers with simply over few generic the of In too customers, undercapitalized. chasing companies too

amongst achieved generic must be within Leading in companies than real unduly drug the to business that Consolidation business more the three before. ever doing with before stability those pricing pressures profit the consortiums. happen desperation margins marketplace generic can

drugs the such risk explore to for explore and generic the and specialty acquisition our as in pivot as intends of our the injectables result Nonetheless, to tucking continue in growth will model. ANI both can opportunities and created that evaluation highly strategic acquisition space criteria. business that provide market meet a by opportunities diversification also consortiums areas opportunities competitive ANI three

these not three are words, sold through drug products consortiums. that other In

product Bretylium term drug. solution, and critical us You launched care have the over pursue injection, hospital pipeline launch and strategy hospital seen our oral a past year, as we the injectable expanded have long Vancomycin a

is opportunity this in of course, Cortrophin biggest Gel. effort Our

as a our Supplement and target for known days XX time activities approximately Gel or product. supplemental has for all Cortrophin PAS away date filing Prior to We some filing drug continue been planned. now Approval are is as from now NDA This a advance

filing Recall in that in approval supplemental is the approximately drug. advance prior filing. order million and years a is and marketed four of $XXX over NDA the recommercialize The development to result XXXXs Cortrophin already regulatory drug by million; supplement NDA last approved over requires Gel to that acquire $XX the to FDA investment an NDA $XX million of to of the the

includes employed understanding of were is Corticotropin methods process validated analytical purity batches unparalleled were effort the new scale employed quality that of methods and modernization from to The the the active characterize Corticotropin Several demonstrate and a ingredients. POS result an NDA of active pharmaceutical of commercial methods to the XX as our part of ingredients. depth development filing approved in ANI's pharmaceutical

major Another validation, Corticotropin approved. originally ANI's modernization this clearance the clearance viral process was required of was successfully has not component viral completed effort was product validation. which when manufacturing API

to all X is ingredient mixture ACTH, batches. peptides completed known than of related validation in XX. has process pharmaceutical the primarily peptides, to identify ANI mapping at greater to X.X% peptide a complex active be presence Corticotropin

demonstrate specifications, and have new indicate scale the modernized in manufacturing validation Corticotropin of and results that historical process the met consistent peptide a batches NDA All and batches, process specifications. scale consistently The controlled also levels API all commercial commercial consistent. is API three well both

part development active and pig dosage harvesting of of to an pharmaceutical the finished entirely in for ANI chain manufacturer supply all from been have slaughterhouse comprehensive product Cortrophin ingredient for methods the foreign file a and PIS. is commercial package to the scale intends effort. Results intentional assembled in The API Gel characterization States, batches API with our based these that from pituitaries integral United

and batches drug We commercial doses three scale consistently of Gel. finished of specifications Gel the Cortrophin have NDA historical both also All new commercial have specifications. for process manufactured successfully modernized scale product validation batches the Cortrophin met

and specifications. yield the stability and quality release commercial to stable and have at six have real met with Two batches are consistent all analytically months regards of been scale time

batch The to third expect the other batch and results with consistent batches. we two stability yield post this today,

have only to cell been API manufacture briefing Filter what commercial We March to comments two simulations the order have manufacturing market we needed demand. product also and validated Additionally, by FDA and in FDA to completed. sizes address to target meet validation needs is flexibility batch file drug bracketing facilitate and successfully conserve the and in our types XXXX PAS remain from radio book on to meet meetings. and

we have ingredient. effort. both against In Commercial activities active inventory for fourth that And third Cortrophin $X.X of the begun. launch XXXX pig building million of pituitaries Gel pharmaceutical quarter an invested and began we already

in in market XXXX and additional million for dosage opportunity inventory continue will inventory launch to effectively pituitaries, for API commercial launch. pig an We allow invest estimate upon Gel. will compete finish This XX% share and the Cortrophin for to us spending $XX.X investment

strategy FDA model Our Cortrophin be Gel approval. will at commercial and launch time for of before placed and business implemented the and

do to For to Gel launch pricing. for ANI to describe publicly Gel Acthar a but competitive our substantial on not we be as discount that record reasons, plan, intend Cortrophin market compared continue will offer

that strongly marketplace. in economics important We today's drug utilization dynamic market the drive believe of pharmaceutical that and pricing an helps share is

over more see specifically As continue and the public Gel. drugs, of outcry Acthar the such, to price we

unconscionable describe not, illegal this continued kickbacks filed Mallinckrodt true out of by in and Gel. As and went XXXX Marietta, far doctors. is or And even exorbitant as public to drug price. this Georgia to Whether to Acthar's the instance, complaint complaint February was so recently to that pricing representative work set used as accuse Acthar towards

press companies in In two We in action, development call the acquired FTC past, are abandoning who saw product Mallinckrodt we In synthetic now the the versions your their a abandoned potentially they products synthetic have they synthetic Cortrophin release. and efforts. I recent our were that We know Corticotropin they their from in have that synaptic efforts. Gel. heard announced that compete synapt development against advancing

as This Mallinckrodt effectively to the the drug successfully with against in ANI back Gel XXXXs. opportunity near-term the did compete only leads Acthar

Our ANI, Gel a Cortrophin transformational opportunity. remains

Not believe Cortrophin a generic We potentially dollars, Gel help potential a potentially Gel but for outside could also only returns model. of commercialize to to unlikely that our we that provide is ANI, the can of can healthcare annuity business version. shareholders like because competitor believe save Cortrophin that highly our has advance provide revenues and once commercial successfully we hundreds millions

$XXX Cortrophin flow cash described for Gel a million free ANI. opportunity I've as potential

the effect ascribed AIN's that after half number, market share discounted which market XX% Let's to $XXX of examine XX% million would price. approximately

development addition engineer infrastructure. our deployed activities value, our to could business than equity further to current product ANI's and likely In doubling more free flow leverage our broaden flow portfolio cash brand commercial the and in development additional cash and be incremental

like opportunity our we companies too size Not a continue as Gel. scale near-term and current describe Cortrophin ANI's opportunity have Gel many Cortrophin This is transformational. why pharmaceutical to with

important to job. market. Cortrophin Gel dedicated efforts hearty Lastly, the individuals back drug to all healthcare to helping and a our this their great a and for well-deserved congratulations development regulatory advance What

the to now provide turn I conference over will Stephen Carey, you more financials. on details will our with who our call CFO,

Stephen Carey

And morning you, line Thank good morning. everyone on to Art. the this

net year non-GAAP margins margin. X.X% net non-GAAP gross XXXX, record ANI year. reached and or gross adjusted million, For adjusted gross prior XX, or from $XXX.X revenues, $X million, profit Annual posted X% $XXX.X and $XX.X adjusted the XX%. were Adjusted over were gross December profit ended revenues up up million million non-GAAP

Adjusted while EPS of million maintaining was EBITDA non-GAAP adjusted continued $X.XX operation the and at off and million into prior $X.XX per share. levels discipline. $XX.X significant cash down generated diluted cash from of importantly We was year invest while sheet million from $XX.X business, balance at levels financial $X.X to back

had million balance and year million As prior in the $X.X of $XX.X made sheet opportunities closed million of of expenditures $XX.X development plans. of during advancing September. year cash, from our $XX.X capabilities and December X business $X.X our from unrestricted net date, balance the of future up is manufacturing we million XXst expanding of up pipeline to capital of This million support support in of

loan maturity $XXX.XX debt Xst, borrow secured to credit the of December delayed our million convertible $XXX million million we option facility. senior in by to term the our $XXX pursuant successfully our job exercising On feature refinance

the trailing no date Total the times on leverage was reduced net month balance net to XX The X.X company a times the sheet basis. as maturity experience representing debt equity related X.X to of $XXX.X notes. dilution of gross million, convertible leverage and

$XX.X of continue expect and commercialized In from XX we our XXXX, cash opportunities cash in balance acquire from we sheet of Amerigen. operations to used forward, development currently reinvest from XX business the opportunities. pipeline Looking to January flow to

portion with pursue million us In addition of the transactions development remains our and undrawn facility to XXXX. revolver credit flexibility in continuing business in provides $XX further

$XX.X million in invested filing. our towards we research we progress supplemental development XXXX Cortrophin related March XXXX, to NDA During as continue approximately and

approval FDA API invested launch We the after addition, that Cortrophin additional in material investing order million of XXXX. ready In of the currently filing. are pre-launch $XX.X and inventory, to our to pre-launch upwards in we anticipate raw ensure market $X.X behind into million in we shortly inventory

pre-launch saleable discussed as for will our that so goods be call utilized inventory. commercial quarter upon materials batches that recall as commercial FDA on these approval. inventories purchased capitalized would third Please Ordinarily sale be represent in earnings

a that However, the with product with must the GAAP regulatory since must dictates novel expensed NDA that be pathway expenditures and we clear capitalized FDA purchase. are cannot dealing supplemental be when such

transparency footnote statements. Cortrophin physical information our broken number disclosed to on on activity financial in the inventory, line we shed this order In separate a have to P&L out of build and item XX on the further

activities, In $X.X invested generic addition related development. to research XXXX, and these million we in during Cortrophin

manufacturing transfers and plant capabilities. and a nearing our to subsidiary continue new tech for behind the completion ANI integrate three into recently completing also our invest We business third-party with facility Canada of forced manufacturing securing and product contract ANI

significant These most weathering despite important franchises. accomplishments achieved quarter figures and our fourth against annual of competition one generic were

in fourth quarter, within against took of and one stock During another defend our of adjustment order in competitors November. price we days that the significant share shelf two to reduction EES launched early

$X.XX and volume continued December year be from adjusted led to $XX.X revenue and declines $X.XX the down down XX% LA prior led $XX three Inderal with EEMT prior million non-GAAP to adjusted EPS XXXX for from EBITDA coupled XX, of ended diluted $X.X months in prior million. actions or year. to from These net Resulting share, down per non-GAAP fourth declines year $X.X of profit gross quarter million, million

unattractive exit to fact addition, market, decided highly dynamics. leading by driven to become this price has commoditized, methylphenidate market the In during quarter, ER the fourth we that the

product industry In to addition, of remedy vast the compound. impurities wide exited the we drug due NDMA in of investigations FDA voluntarily found market, this generic majority for

the million these reserve products. conjunction In charge to inventory P&L related all with actions for we $X.X to remaining recognized these

non-GAAP We have back purposes added the of this for our measures.

net of of goods fourth this or as million revenues or in million Excluding the $XX.X year of quarter sold prior cost our was period. XX% compared charge, XX% $XX.X to revenues

not Vancomycin which XXXX we build by we pharmacies. related virtual AV period is This generic launch. market These adoption launch a during It currently September as an momentum product awareness largely market alternative behind over FDA and our And our therefore anticipate marketing is product that Solution. and a occurred provides to time of to are building approved challenges through ramp revenues in typical a we served campaign. up awareness compounding Oral

commercial These we In In addition, to offering. health campaign launched conjunction launched and makers. first is are products care we injectable a diverse prime in product emergency of room in saving product, to December, Tosylate our providers, life this examples product, as reintroduce Bretylium hospital Injection, therapy which with increasingly decision settings. marketed this formulary used

Cortrophin to marketing know and our guidance of to attention exclusive important that XXXX sales pre-launch our is and is guidance. revenues It Turning expenses.

believe potential approval timing inherently most product to is company's of the history, meaningful uptake the FDA firmly be of in we has Cortrophin demand the that uncertain. and While the

As spend, such cost inventories. and reflects presented the pre-launch only XXXX R&D residual continue build guidance, the to commercial to remaining as anticipated today

we back continue actual the inventories, in expenses back commercial sales and pre-launch to to add add will begin marketing of XXXX will We our build results. non-GAAP and

Our guidance generic our franchises. of XXXX of the negative three competitive reflects impacts net largest annualization against revenue

First, of midyear which the volume customer XXXX in will key and annualize of XXXX. a began loss around from Ezetimibe-Simvastatin

EVMT of quarter which in for third in the of franchise price the January reductions in to competitive average aforementioned beginning the EES resulted recent price challenges XXXX. Secondly, of which significant have And XXXX. the fourth reduction occurred

and the declines as demand be the from Vancomycin products annual volume of to These in addition pipeline declines January, acquired in as course well generic brand organic uptake by generic Solution are and for in Amerigen than business normal expected Oral our offset more launches. Bretylium continued

we essentially XXXX. flat X% to $XX X% compared net and revenues EBITDA factors posted XXXX. currently $XXX over million $XXX and the to in between between project Given be these increase $XX.X or million be $XX non-GAAP is to projected representing a million, million as million Adjusted to

achieved guidance the by and program. by Gel in X will development this to margins principally wind product from anticipation spending, lower approximately XXXX, in in non-GAAP X activity in In are following. contract price points gross that XX% Inherent driven down research the resulting mix. re-commercialization and points unfavorable the Cortrophin reduction from A of our

as to portion earnings between of XX% effective diluted share tax and and of reallocated XX.X per be finally, non-GAAP anticipated expense. A reduction the opportunities. Resulted growth generic is this And toward diluted $X.XX million an rate per of income pipeline is reflects be projected moderation SG&A approximately in anticipated non-Cortrophin share to shares and adjusted related outstanding. $X.XX

non-GAAP Xst anticipate debt, carried of we the interest cash the debt which rate X.X%. EPS impact that convertible resulting the coupon our all currently which and of changes Note a year-over-year to approximately December metrics bank from for of additional our X% in include for cash refinancing

$X.XX or structure dilution high future change longer The are protect the The potential million the EPS of upfront of this is term shareholders reflected coupon with in which costs debt. not This benefit is our rate. after-tax associated worth to debt convertible approximately for to from roughly and change the avoid $X.X in equity costs calculation.

to rate, the benefit taking bridge our an with When in combination effective factors tax addition, an $X.XX XXXX two straight recorded actual the results. XX% for one actual over accounts share income EPS compared include guidance another, expense In calculations. in as ranges per to it a tax these

XXXX product Amerigen through continuing offerings the term exit FDA our recently and acquired opportunities, expanding ongoing CMO development, importantly, and approval to a business for Bretylium Pharmaceuticals generic LS the potential our near with portfolio Cortrophin. focus gaining ANI we summary, diversify business Vancomycin In leveraging maximizing on and most Canada for

call the turn President to Przybyl. will I and this, CEO With back our Art

Arthur Przybyl

that, will call Thank open to we the Laurie, you for Steve. now conference questions.

Operator

Guggenheim. from Flanders Dana question you. Instructions] Thank Your comes with first [Operator

Dana Flanders

you I a thank ones I if could. quick Hi, just much the very questions. had couple for

And relative kind to the Amerigen could outlook forward? what be of provide First, that portfolio kind contribution helpful. context you for of is Any going year? would the portfolio this of growth the guidance

we just peers. it's still we range. know versus about margin attractive mid-XX% how sustainability? just relatively two, to That's how margin do ticking the - generic should I think down this Number gross profile a year the

curious the launching So just and if down mid-XX% can base you're you that is sustain products enough, that enough margins. valuable gross

how if approved third this how much I much planning inventory filing. are but you the are just And Cortrophin demand you this. just for But meet have after I may and missed four Thank you. any you're understand not you year? curious can one, revenue including guidance, months build

Arthur Przybyl

let builds X.X another anticipate again the last last So for take of top year. the million spending Cortrophin $XX.X this inventory me me on the question let first, year and

the of the importantly more stockpile than inventory Cortrophin important active So pig is of most and stockpile that, part of for ingredient. really pharmaceutical the the pituitaries

We have very, of invest XX% that the is to very investment pharmaceutical that but of a ingredient will close we total after active stockpile a market.

If be the biles almost generate we're biles, that finish very to close going our dosage to you're if - market of estimating XX,XXX form. is stockpile being - XX,XXX from to API able we're

have gross sustainability our where We moment this an recently. business reflection the top is three after Your We heavy the generic those the hits that's accurate on took contributors at second in really, time. in of product I'll think no mid-XXs. longer we say question, margin products

the on cetera. any an Amerigen, last of is that that's address Steve, you of maybe feel the et ex additional really could question, could we accurate portfolio business so that, where the And today And reflection please? acquisitions you

Stephen Carey

not that I right. be And Amerigen the a portfolio contribution the to thanks we portfolio. the in particular speak for the And I typical approach, do the going Dana. mean, significant are morning, would we for guidance. to a anticipate think Amerigen Good from Yeah, sure. numbers Yeah, questions.

in say portfolio And expectations our for that were the qualitatively I that when with would is very much what purchased it. contribution keeping we

the to very to move of over ANI volume contracts transition plans Amerigen customer has contracts gone the stood as smoothly. of in All the hands it and

And so for we're quite with expectations pleased our portfolio. that

Dana Flanders

very Okay, thank much. you

Arthur Przybyl

You're welcome, Dana.

Operator

question line James. from next of Elliot of comes Wilbur Your a Raymond

Elliot Wilbur

morning. Thanks. Good

upcoming Art, the hear be Corticotropin First the application. we yourself the before question Likely regarding you last from for filing. you actually submit time

a something acceptance couple a release? just do you they if of clarification. press that would you so, So official that And you that When is points file, day of actually is timeline? and notify XX

Second of you think qualify smoothly, expedited individual do here these of applications other themselves? the filing reviewer folks review? efficiently question, seem move part potentially through an is when kind the they the part the attention the than to of division and should portal agency outside And more for types and expeditiously have last much review generally from

could that the maybe, might any if activities you that, become or So visible that post this going is high to filling describe place there priority suggests FDA? taking ahead for be to endeavor us, that were of filing a

Arthur Przybyl

Good morning. Thank you, Ellie.

the be question filing, yes, the your I’ll there of In outside be. activities take will of last first. will areas part So there

are fact I that, the very your Senate - FDA, Very in Representatives, our well of Cortrophin filed House think to it's as well have HHS, officials, we point approved important cognizant supplemental both of is as drug. our to the very that government Gel several and taken.

of Gel. approach Acthar pricing associated approach a and noise monopolistic amount over obviously, the of There's the with years significant

officials that And in important associated an that so our it's would notification these there's product we think the why important. I filing NDA to division government FDA with provide and certainly

that their think on have to but have this after writing a certainly approval, arrived years. we understanding we four So desk influence nevertheless, campaign cannot an will officials respective letter has

we for already little product eligible why months expedited bit we date about this This expedite PDUFA review, a four on review, a an is it's approved. date. not the asked filing the receive will You will is of

- And four the so approved in theory, within be the be product could months. could itself supplemental

such certainly not eligible for a possibility. but as But potential as handicapping not expedited We're that review. is that

we're However, of in important biosimilar. a out generic drugs. it's not NDA This in We're that division. point very office is to not

the the some these that expeditious of is is perspective division NDA my more office for products. a of than drugs maybe typically, generic type complex And division

I that so let And hopefully of me the your - If extent answers know. miss something, questions. I

Elliot Wilbur

review? here. one just actually the a point supplement follow for ready Sure. submission up Is there that No, is notification post

Arthur Przybyl

I point. very forgot. A good

So de our We yes, within filing. they they reason and approximately why kind we're see the a wouldn't days there we of this accepted with filing see notification will XX be as rigueur that that no have submitting.

this If they that not to - internalize debatable. I whether nature, with Whether of we filing so, we think a associated that is accepted the certainly issue that or will will we expect we release fact our we again, is press do they've But it is accept important second not sort and XXX%, if filing. feel we this that or will.

Elliot Wilbur

And a the Steve questions about course the couple I well. numbers just as for Okay. or balance thinking of am just yourself cadence year. and financial sort the of

obviously expect, half be stronger second first than half. We the to

more that that and incremental half you experienced specifically, and impact year the EES? Oral would both Vancomycin the Solution, is on ramp in Amerigen we the offsetting of think maybe also negative effectively by contribution portfolio, from the that Bretylium you the But the get incremental benefit to time EEMT the of the second

Arthur Przybyl

business sake is, The that. of argument, on our anticipate Amerigen instantaneous. certainly of effect we Well,

bought and profit. gross day we we it, the on their So picked revenues up

from portfolio. Now additional subsequently that products we some have Amerigen launched

and we obviously is spoke - bill. Steve from acquire an didn't think immediate Amerigen constant to on Xst. is But I effect I that's Bretylium both and there's a January And Vancomycin Amerigen.

And I'll the so see - Solution that. from Vancomycin Oral of and importance

Vancomycin Solution time. scripts a steady bill see Oral of we From over

that for very And out of We've good. that extrapolated very product. good we what we annualized means revenue sort the feel feel about forecasted so number

take it hospitals that critical emergency is for this crash We a Bretylium drug all be longer that and as has past market Bretylium the time. on some bit is little believe been going because for Bretylium. off should carts services. a in For to was care certainly the

out in be 'the and actually and But it Bretylium. be of hospitals and that by coming have to going will father that - PMT take an shortly the help paper guide bit opinion will to Bretylium', a that little significance the was one's continued committees longer. understand authored will of that We that

And have a ramp frankly, so slower product. on we quite that

is Steve, that you'd to there at to add And anything all? like

Stephen Carey

that's spot currently end. then I'd third say And question and think the anticipate we first be also you more comps I the quarter in being on of No, reflective growth. difficult. the for our Elliot get described lead factors your we in anticipate the when would here, spot to on and second obviously And of big the fourth quarter to

Elliot Wilbur

Okay. expenses year. Two that. EBITDA including the that excluded Cortrophin some With quick sure adjusted and Steve. respect back up, financial Obviously, expenses to all potential potential of guidance. But follow the relating marketing in fact activities from wasn't to half are if sales launch most excluded I in

terms generic the just lines an pressure portfolio more established the And color a bit market? softness brand little at and more are the you're customer little of bit business, a could couple seeing in if of what what's of a as branded you in just and kind dynamics incremental maybe competition the provide happening of why there the brand mix, the and

Arthur Przybyl

ourselves first our have drugs mature They I'd acquired, brand I'll brand. many margins great against has cash authorized and have first versions are take flow. question. They they - brands. So, let like you and decline. primarily the they these great Overtime generic been of and generic been Elli, leaving and launching times the you

X% market know, less So, sake of or share. brands our you as have argument

see decline. So our will brands you overtime,

the we've seen cover have in is sort the that not okay. might brand that but on of you branded so acquisitions done existing declines And up the because past, that sales,

those fact that cash or payers and and And margins flows. the significant for more a Nevertheless, going available. revenues represent there's more and still declines maybe to generics, more to brands refer obviously, pharmacies continuing driven again or are and more by version people - to generic us just

really, minimis perspective, to amount. And has nothing cost very service. SG&A an de from It's

still So in to mature we we acquire where are can. brands active attempting

Rob Rob opportunities from is on they as Schrepfer when to of know those you And up present time. so those top time themselves. - opportunities And is pop

question. Steve, tackle you Okay. maybe to the Cortrophin want

Stephen Carey

Yeah, sure thanks.

think So Elliot of the I think can probably in buckets. expenses three Cortrophin we

R&D first expense the on So side. is the

decline there we is in an what the significant it somewhere around R&D anticipate plus declines. a of million So basis year-over-year certainly spend, $Xish annual call annualized on

spend this And the that anticipate from it, the call year. a Asian, in remaining of the occur calendar first we will principally quarter

little the reductions expense back optimist those generic And half year are About half that perspective. an the of in be so from we're running. reallocating currently in programs We that'll declines towards spend. a bit of the of anticipate

The that the second main prepared bucket prelaunch would inventories the about we in comments. spoke be

we prelaunch of XXXX compared so the $XX million inventory $XX in to project do as million And million builds to year. this $X.X spend

those expenditures that Obviously purposes. for under are, is product we our once inventory non-GAAP that adding those And back this would right P&L. are wouldn't be approved premise the and sufficient [ph] be kidding

gave spend the any in marketing we the and do spend side. sales the figures include significant in this marketing not in that we're morning numbers. and sales kind figures. It's And of marketing on We're those premise not guidance is the sales either. lastly putting then not and And under sales putting

our that expect should back launching of reach add we we non-GAAP product. to point the figures the as see so, until And to

Elliot Wilbur

Art, very question good very, Missouri taking company's over in One job Okay. in last distress and through the business for acquisitions, done generic space. brand The a strategic terms the advantage about the in question. opportunistic a of of years products building

in from the listening some of companies sector talked opportunity assets growth of rhetoric the area interest that's to in One strong an and injectables. where the that that But for growth quite for having the a are time a around few areas though in industry, looking or as about also a and sort of actively terms space. see you've still

use sort of do highlight I'm of you characterize just opportunities think as as or sort your that within area? the industry wondering, still for or ANI injectables of would attractive context the an you what what

Arthur Przybyl

we a of revenues time question, largest good long, as anticipated, mean, it's a - be probably a like maybe as sort product. the to long injectable will Elliot. come So since for for - our on us segue that's annuity I product talked about for natural Cortrophin our we've Gel obviously

so related far opportunities, development injectable areas. been product have more in Our

collectives on again, we are So, part because development. there did injectable [ph] the certainly out injectables maybe with for the And several deal opportunities, think we a see, need I cetera. of as picked you for up seller commercialize there opportunities or et capital, some mentioned, and the

we folks very that well aware some yes, of chasing those opportunities. are lot And of a are

seen calcium Some And alike. on mean make. ridiculous actually to has to and government associated I been price I just gluconate of frank be by you've opportunities product nothing some have created a with the products think costs those that like on of XXX(b)Xs absolutely them

still And out are so, those there. opportunities

I think And we've sort the Bolts been way business a generics say, in us and we to is been look careful We've brands. out one mature Company. model how always very Nuts to at okay, built of

we papers. debt a bunch our a down took been for how high for spend money. leverage. But been company fruition $XX But our opportunity, plumped million levels coming We've on very of those careful careful are to significant time, the at and papers risk, we and the We've same very reward now high us.

trying pipeline. longer defined the do could our on short-term, point high we Cortrophin it for but make reward our risk, the My into incredibly and Gel think in obviously And I'm term investors the is have and are bullish opportunities future. then that what company in high and I we additional to

they where as on those, having all out discussions other to And and knowing they're we're certainly them are, levels, our there. And some we we we going for them look fund and can speak. of that keep

high we And public sort opportunities so we risk, pipeline, alongside that have from have tuck-in has of of more - growth all - a want our we our opportunities, fuel to our have some fueled time reward what because time we a that additional of since today. call want high been

us. like And a I some important Cortrophin add so way looking of that we're to that's our now the model. scenarios of reward it's flow some high the business us forward. going cash for said, I And to Cortrophin, with. to [indiscernible] opportunities think risk, as going really revenues replace just And these opportunity gives and What's at company high obviously those,

really flow, as has XX% available generic line, Elliot, throws of its We're to and down company drawn - of credit its available and margins to them. generic we're to company. revenues aren't has cash lines there not pharmaceutical today XX% EBITDA and a out pharmaceutical XX% described, that What

one. I hard find pressed to think be you'd

And last continue we so to over forward to say. apply that's that needless opportunities, our the intent. we to the have to disciplines same want And years several looking

future those I Rob base. will his so I is from day every also to with And at our our run to a looking for high president ones confidence them. our find feel value we'll of out degree things. shareholder bring continue team have And transactions there

Elliot Wilbur

Thanks.

Arthur Przybyl

Thank you, Elliot.

Operator

Your question next of Folkes Fitzgerald. Cantor comes line Brandon from the of

Brandon Folkes

injectable Art, mentioned Maybe Thanks on that. continue to generics drugs. you the the focused If that right. sort on that and think specialty consolidate going generics taking the still whilst following your to should think business needs you opportunity industry really question. as development the presents pivoting All have … grow injectable consolidation for you or of or you just my - forward through believe towards business itself, would specialty we of

Arthur Przybyl

that thanks question. - think I Brandon, for No,

we that, will we think look to certainly continue for in mentioned that acquisitions. I tuck

acquisitions we've the I our to key regards that of And, numbers in of Okay. for that million. we've the done that total $XXX XX think done generic is key, kind

revenues just nice those And margins. very million at obviously from transaction those $XX transactions in XXXX, in contributed

that. we stop And wouldn't so with

companies strapped been cash. many Okay. that still There are But just - type of we've a acquisitions, vibrant. for these marketplace buyer. And today's there so it's always value are for are

traditional There but 'XX And when started. high entrepreneurial people companies always on We And all it type an development thought products of the lot 'XX did was a are and market entrepreneurs way. and short generics in flying going many see A companies prices bit approvals, drugs. getting smaller were the cash and they're now entrepreneurial up forever. been has - time. generic of some they're to the up launch propped little these on business

builds the inventory waiting wholesalers and if dollars receivable to And for drug. your more launch obviously money than as much it cost does us not maybe than it the develop from drugs, to

where And lie. of opportunities so our some that's

certainly to still mentioned for will won’t look value our for opportunity is which good I opportunities. turn these blind good that a we tucking a we we So the why shareholders, - acquisition or eye

diversify from However, it the to the important is very bulk away just question our without three business us primary consortiums. with - for doing of

obviously, to over to have not business the purchasing do that, to going power they same And are consortiums Cortrophin our Gel. today. three we're Now of do going level the model than

because Okay, of that one drug.

to the - morning. earlier But one well. Amerigen did And Year. the to a for just we to We talking New it and just the need we our they run be thought thing - buy we going because I that have EBITDA They effect contribute to were rate can't rate would as was be so drugs we. platform investor add Well, think products, to more essentially our run need ascribed greater diversified new that and dismayed. more more this that to were

it we solid consortiums And is oral where And with never that, know, it three I in competition from. hard. by hits mean space coming hits, the the when

all we a nicely gross for EES overnight. margin competitors, did XX% two you three drops get of product years if like So at sudden running price a and very have we

rate to we've was That's last that been is line. there's backstop right we offset able powerful. XX% to is your products representative to It you run that, revenue certainly price. drop so it year. your launch do our from fortunate our still that of can And And an attempt filling that. do to share And enough and to but where maintain were of market have nothing EBITDA

for great that's so us. And

the we us. point And mean is, any competition just in coming fact at But a these acquisitions from, don't time. know lot to is where

to and business generic XXX(b)Xs opportunities platforms different is the industry important et so across like within us diversification cetera. So are

company, as money these and Cortrophin of we've where in a as our So scale areas of that’s well. the to spent money a of other pivot fact some allows argument that lot our to now sake to development, us that

us got XX there quarters we've days shape. the and for moments to don't duration. cash think of business. are long-term That's in to the so. excellent represent These we're our But flow in they types fortunately, allow liquidity do I And are in potential why the time, they

marketplace feel this going And a forward, as in management to confident obviously. so we approach team our very

Brandon Folkes

very thanks much. Great,

Arthur Przybyl

you there's other a you. very ANI’s attending you XXXX questions, thank conference for everybody to Thank earnings all I if wish no just like call Thank much. Moderator Bye-bye. good and afternoon.

Operator

fourth ANI’s quarter XXXX earnings concludes This you. call. Thank

You this disconnect and lines a have time may at now your wonderful day.

ANI Pharmaceuticals (ANIP) 27 Feb 202019 Q4 Earnings call transcript