ANIP - Earnings call transcript Q4 2021 | ANI Pharmaceuticals, Inc.

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Operator

Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. Fourth Quarter 2021 Earnings Results Call. [Operator Instructions] Please note this call may be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn today's program over to Judy DiClemente.

Judy DiClemente

Thank you, Britney. QX Results Pharmaceuticals' ANI to XXXX Call. Earnings Welcome In-Site Relations for is Judy Investor of DiClemente This ANI. Communications, of Carey, me With on Financial Stephen Chief today's Lalwani, Officer Chief Nikhil President call and Officer; Executive ANI. are and

You can this the www.anipharmaceuticals.com. section Investors at webcast the website call ANI through of access also the of

be future any today's are may company's would release may in forecast, to as express guarantees that ANI forward-looking by a expectation, those projection, information started, webcast performance today Before remind that forward-looking considered are call we defined I specifically get or materially the required any statements issued morning conference everyone for or Act. to be law. The noted Such the results and website, update not projected events except uncertainties, intent with of the the statements, Reform statements, XX Litigation those and our statements. These Actual our Private regarding anticipation as and involve available anipharmaceuticals.com. differ SEC. disclaims performance. this Pharmaceuticals' to filings these available future based will including on forward-looking in Securities from management as like statements archived of forward-looking forward-looking our by risks ANI future intent and made days press obligation on statements belief, on

SEC the with on so Lalwani. webcast, company's related turn replay call announcements And ANI For the reference March topics have then, archived to Since and releases recent who the over press discussed, benefit XXXX. I'll may or listening to those call be Nikhil and Nikhil? most the XX, filings. was of this that, the may to held please recorded made

Nikhil Lalwani

I the with $XXX.X I'll stay colleagues EBITDA ANI you, the today million and Pharmaceuticals commenting families, you, overall call for non-GAAP XXXX Good and in everyone, revenues joining XXXX, million. for well. ANI performance. $XX.X start morning, adjusted safe and of continue and and Judy. to your our hope In you interest your of company. thank Thank friends on delivered

adjusted the increased Our $X.XX diluted number of of outstanding. share per non-GAAP shares reflects earnings

suppliers period, this generic our key important patients brands to company. am well In as of medications towards business of prescriptions of established pressures point COVID proud of resulting I leading our face pricing as we pillars work to our all of increased the to During evolution past continued need. for the we both deliver an and competitive our side appreciative goals in against the growth of employees, in and achieved inflection businesses. biopharmaceutical as becoming in and intensity impact also to and the hard a we customers, high-quality ANI on strategy partners generics the continue XXXX, drive

approximately certain additional considered guidelines including sclerosis chronic on disease we nephrotic XX, has treatment a protein for daily our Gel and rheumatoid exacerbations growth of patients, therapy. in only of significant These in analysis be Multiple acute disease syndrome. January full-scale Cortrophin pandemic less the the ACTH patients the the A a Cortrophin may claims-based steroids. the urinary Purified which Cortrophin in prescribers $XXX across standard visible patients arthritis COVID-XX autoimmune reintroduction victory basis. are for another with ACTH launch and and, business, is for devastating gives lead impact for a XXXX who The to patients. of of between market chance to announced or Gel beyond Gel and indications revenues, on includes with evidence-based of excess patients impact QX market of for treatment rare help as Bringing multiple the some an indications million cope that forced COVID primary potential than due patients the market XX% refractory epidemiology treatment seen First, corticotropin, was often was which therapy, QX The select commercial on ACTH, of to suggests are indicate mean steroid-resistant care, require in can the to ACTH the alleviation who The importantly, the Cortrophin XXXX, of that and effective competitor asset receive XXXX. more ANI for disorders, ACTH of Gel. in greater class. reflecting a

to about that have Gel Cortrophin launch, more information in reveal bear held the we our plans please share we mind As competitor. not our back to

a building drive significantly the needed and in infrastructure team launch. We have world-class rare to disease invested successful a

disease additions to Our and disease Officer; Elizabeth Recent as by Dr. include Mutz, experienced launches. as has Chief led team, rare the Chief Chris Medical product and rare Officer Pao XX Legal. Head leadership team Powell Mary Compliance of leadership over

will XX-person approximately their sales led Our force inspirational winning Zickler. be strong and Holly leader, by

has them XX won rare clinical of ground sales the running Nearly in and areas, launch, product XX such fully successful to through In with a of of hit for went President's training day experienced companies this average Horizon, Gilead. Club recent Alexion, to rare over and biopharmaceutical years. preparation account launch. comprehensive and sales on prepare clinical X award or in team Alnylam of equivalent top team the the have sales including Our years an disease disease-focused leading as XX% specialty executives experience

We and medical, have strong also in commercial marketing, functional market compliance. operations, finance place analytics, including access, teams,

providers visiting www.cortrophin.com. a now treatment specialty to starting have committed ensured patient payer plans, footprint materials, processes patients. and government sustainable U.S.-based and Gel network to established pharmacy finished ANI key is meaningful specialty and appropriate API Cortrophin our a a a We've by and for supply In supply a affordable to access for and addition, Gel the and updated and distribution secured Cortrophin to ACTH supporting manufacturing pharmacies submit to more and is bringing and goods. therapy health and prescribers prescription access to commercial distributors also we chain. of available initiate through U.S.-based patients, care

ongoing by very as payers pharmacy our as encouraged conversations managers, with benefit PBMs. the or well are We

In part Your caregivers of to for that As Corner, commitment created treatment financial support, eligible staff. throughout dedicated also provides reimbursement meaningful one-on-one the support we've health Corner their professionals assistance injection Your for Cortrophin nurse-provided a Cortrophin training. care Gel, and patients establishing their and In program our and includes for journey to access patients and access, Cortrophin access reimbursement

to It's Finally, we We're strong initiations in-person most focus are with a Gel ready Cortrophin. weekly very confident Cortrophin timing our we continues to prescriptions response expect trend and force visits. new Overall, the as case accelerate initial good to sales is that are the have significant seeing for pleased and physicians for for be start, with early physician in patient we specialty meeting the commercial driver seen areas. with our as weeks Cortrophin physicians X past launch off growth perfect to longevity. very the is continue Gel over a

we specific traction While to are ready are are yet seeing. Cortrophin not by this the in guidance early provide we early-stage we encouraged launch,

new and to X The acquisition to pillar November, CGT, and XXXX. ANI in designation continues product. new FDA products applications therapy, R&D the our launch over received to the deal and received of Pharma, CGT of our engine XXX(b)(X) of Today, associated our of of to strategy, high-performance the days ANDA XX for the R&D generic Equally XX associated approval pending of strengthened important, ANDA solution second focus ANI approvals. competitive In designation number with and ANI. over -- to and filings now niche CGT since exclusivity recently, multiple with engine X has strengthen anhydrous the completed in we products its product the with deliver addition already most ANI's R&D record our enhanced to generics files of engine XXX limited development. recently, betaine closure growth Turning under largest launches first Novitium XXX(b)(X) track on opportunities. bringing increased competition R&D a ANI bringing capabilities the market business receiving and with Most

Samy bring strategy the the across increase productivity development need new leads are to and and leadership generics now along with Jersey business increasing in teams strengthening much-needed are on pipeline affordable we our with our corporate R&D our R&D to under Chad functions, fully product [indiscernible] New the integrated who Our portfolio our efforts Gassert, of of to focused launches. quality patients sustainability product of medications and Shanmugam,

place defined integration As clearly such we XXX-day quality, in had operations, a chain across key functions you as and finance. supply would expect, plan commercial, HR,

operation Our capturing and a highlight service effectiveness on from positive consistently the levels these business of combination. new teams product integration. synergies continue plans, against continuity launches, to execute the from customers our our The dual of ensuring X high feedback with well and focus

Pharma Novitium operational capture productivity, start. efficiencies a Overall, procurement R&D efforts the to acquisition earlier. cover Our and as and is distribution synergy great mentioned enhanced off savings,

maximize growth has X brands which through commercialization ANI. value pillar from established and to development, been strength from acquired successfully long-standing third strategy business XXXX, of The we a integrated Sandoz. our of and dermatology brands innovative In strong is strategies

manufacturing further customers to deals here from North the of evaluate headwinds certain our commercial and pillar business, are and area manufacturing our increased Several this and We The pricing competition. America unique augment continue to is capabilities. asset our accretive fourth footprint our strategy unique acquisition CDMO organizational leveraging in expand of capabilities. growth facing our

by Novitium become in New I'd elements X sharing and serve biopharmaceutical addition Novitium of to customers strong to that serving patients need. with close site opportunities continue leading new in We foundation the explore enables a of growth to sustainable the that deliver and us company bring. ANI's like Jersey

recently closure propel Purified and a commercial company ANI. $XXX new of First, into the growth phase next Loan pipe for Novitium ANI the comprised the ANI's completed million Cortrophin raise of strong gives new $XX of equity million of ensuring structure million in $XX Gel the $XX supporting flexibility integration launch, capital significant and and Term the the million revolver B,

have our and businesses. and of in we high-performing across with leadership experience place diversified expertise Second, a teams nest

are and can Finally, them. we're to culture that patients to medicines need identify united continuing and an serve our patient populations that physicians ANI cultivating in help underserved by

behind QX provide Now details Steve will the financials. Steve? our XXXX

Stephen Carey

to the call. Nikhil, and you, morning Thank good on everyone

XX, the mentioned, approval refinancing numerous structure spend and the October fully the the purified Cortrophin, of strategic quarter our to rare initiatives have On response, we of the of build in just final acquisition equity fourth our Gel Novitium, disease most and events debt our statements. received secondary quarter had corresponding fourth financial significant of These sales on Cortrophin of out for Nikhil approval the with public team. we FDA notably, a FDA our proceeded product. marketing impacts necessary raise. company As In XXXX, completed our prelaunch close

These we field recruitment of fast-tracked office back and account efforts non-GAAP we of closed out as resulted the of our results in recruitment marketing metrics quarter Novitium. spend, November Cortrophin-specific XXXX, in personnel the full in added fourth as spend fourth to XX, consolidated the first SG&A which XX home million materials, of launch. Beginning our prelaunch for will $X.X our Cortrophin are the has force XXXX, rounded reflect advance quarter and reflected be of in continued our such, During the year results. we non-GAAP expenditures. of days quarter, in January metrics. On Novitium's plans XX, final acquisition clinical full-scale finalized our key And executives to of our

$XXX partially The The million point with a XX A loan close, credit conjunction reflected as a GAAP $XXX.X finance previous agreement interest million for in preliminary floor. measures. statements goodwill plus our expensed $XXX.X we incurred new value of fair in debt of acquisition. were consideration with Term balance We debt utilized Loan $XX.X purchase B B Term basis reflected to million in financial credit December $X.X and assets In the facility. bears are new our $XX is X%, been GAAP Term of and XXXX, reflects and of added have transaction intangible was approximately of A and $XXX.X million. refinanced non-GAAP Loan of revolving our back incurred which loan SG&A fully allocation to and Our a LIBOR with and sheet million our at XX, LIBOR term million Novitium price repay million, market the costs,

restrictions In completion the on of common addition, X.X months restricted selling from post-close following we stock shareholders to issued of transfer XX to the approximately ranging Novitium. acquisition. shares contain of million their X shares These

of resulting common $XX.X million Capital million cash unrestricted placed at shares transaction. stock activities shares and XX. our Ampersand issuance. of placed These X.X in million X.X% to on as sheet kind. we proceeds along resulted $XXX.X these public December our the the Cortrophin $XX equity in Lastly, in of shares tuck-in of million revolving million XXXX, us undrawn, recorded of in the rate In XX, our of in strong and are of Novitium balance of financing cash secondary A are mezzanine Series XXXX. launch, issuance integration of net The accrued of The December during cost fund explore PIPE to a or year after offering, course the the product-level culmination common million a stock November, as remains with and $XX sheet. and preferred This we preferred on of in places facility, payable either convertible balance, which credit support to efforts balance dividends position in company allow acquisitions a cash a per a $XX

the in million also revenues of of $XX.X X the sold increased million increased offset in prior Novitium-related of to to value same compared increase. partially acquisition, XXXX, Contract the by was significant million period of including These million, revenues were products arrangements. increase XX, year increased XL, through months the quarter in XX% by excluding ended $XX.X million of Arimidex XXXX XXXX, items XXXX a December $XX.X the the $XX.X XXXX. Novitium Operating units million net quarter and for XX, fair $XX.X and litigation to December in will manufacturing were with Nebivolol, recorded declines of generic from related and products a X million and result ended contributed launch pressure, up charge Now products X% Despite Sandoz. XXXX net November XXXX, excess period partially a million million the sales quarter $XX.X posted Net primarily has revenues revenues pharmaceutical Novitium for during to fourth an by revenues $X.X months a period selling the million the in increase second incremental during brand period, quarter months volumes. to acquired change industry for to gains. The of pharmaceutical of a The revenues year of were Tolterodine million the Vancomycin $XX.X the grow basis XX, months price generic for of which the settlement, ANI headwinds, the as $X.X $XX.X offset of results. acquisition of results. for a by to Inderal acquired the for expenses X% of assets a compared increase million The due XXXX X the we of fourth turn the $X.X over due increase for from to XXXX, million ended XXXX with generic decrease quarter million royalty sales, average of an Net the to products. of launch $XX.X XXXX, was XX Novitium part of sales by or decrease compared million to December $X.X in quarter million days million compared $X.X consolidation during December for fourth result of profit-sharing from fourth in of continued ended were on the financial branded the includes partially cost CDMO primarily X% as of XXXX. to fewer of amortization, Novitium GAAP products initial $X.X a $XX.X prior XX% the during and to net XX same for subject was and to for transaction Cost as X price the period. XX, of of third tempered decrease a same $X.X to depreciation expense. compared recognize ongoing

decrease comparable The development basis, quarter in Cortrophin X Excluding of and in costs, of of acquisition, Depreciation Novitium compression of increased increase million expenses to XXXX. were recommercialization a of the for $XX.X Novitium fourth to $XX.X those result the of initial of a cost the price to XXXX, marketing from primarily the R&D to stock is reduction Research X.X associated on XXXX. million by principally for the fourth count and prelaunch the to related these with in negative general $X.X fourth revenues percentage XX.X% sales in Selling, expenses for the and compensation December project. our expenses of the XXXX to expenses the quarter impacts decrease $XX.X quarter months in increase subsequent amortization million, of like expenses non-GAAP compared to result was and non-GAAP and million including transaction. X.X%. million timing point $X.X in XXXX. generic mix. $X.X EBITDA primarily offerings XX% million compared in completion an product the compared $XX.X $XX.X $X.X head related and increased fourth a administrative Cortrophin is XXXX, the and acquisition. ended and acquired million the on $X.X of as to XX.X% the The Adjusted the a XX, due primarily declined projects sales of transaction amortization of a for activities same reflects period the generic Novitium $XX.X was a quarter of assets phase of intangible of the to compared The million million increase to margin million in quarter R&D basis million

fourth XX.X related reflect the to additional adjusted the a $X.XX worth non-GAAP of equity shares quarter the $X.XX EPS quarter acquisition Novitium compared quarter partial that outstanding and share metrics representing is raise. the It Our for quarter fourth XXXX. million of highlighting to diluted quarter shares, was diluted earnings for non-GAAP per fourth

million from cash acquisition from Novitium of on increase the XXXX cash royalties. million as million, the of during Total the of face $X.X on cash transaction litigation to of year, we Novitium utilizing the of items as $XX.X cash-settled was During balance the by resulting approximately Cortrophin incremental by constricted raise. XX-month related prelaunch cash additional the quarter of XXXX, debt principally by we in was approximately debt, $XX of $XX of Net unrestricted equivalents. were XX, the million settlements. million These million leverage had cash XX, million from $X.X sheet, Yescarta-related cash our operations. of settled was equity costs a and generated activities, net flow tempered driven of as turns $X.X collected the flow XX, by and tempered an debt million December second net $XXX.X And cash with value hand sheet as trailing basis Cash of final December of $XXX.X from date. the balance public incurred on X.X September operations

our guidance. attention turning to Now forward-looking

For research ended Cortrophin providing Cortrophin the December and The projected and development summarizes x XX guidance company XX, net ANI is guidance. expense adjusted revenue EBITDA, XXXX on months Cortrophin-specific non-GAAP total XXXX, following x SG&A. and

administrative to and as expense Gel, $XX we million compared million, anticipate specifically expenses Purified growth non-GAAP currently company growth revenues between On compared relating and Gel, $XXX of x $XX XX% $XX of of million $XX And a total Cortrophin $XX adjusted net direct and as For expect million, million representing research and we we selling, to company XXXX; Purified Cortrophin $XX XX% general to between million of XXXX. between to XX% X% between $XXX anticipate EBITDA and and to representing basis, million. total million. and development approximately

federal million of million with addition, rate an call Operator, outstanding ahead the that, to tax up go between XX.X the we'll prior currently open XX.X In approximately and now XX% reform. for With tax and shares effective questions. we any instructions. please project

Operator

And we Fitzgerald. first Instructions]. will with [Operator Folkes Brandon our take question from Cantor

Brandon Folkes

I Maybe about just about we talk on of there? may should stage, this see just to seeing that in Can I to think in Novitium. that from terms initial And on acquisition launch willing guess, of maybe guess from answer Cortrophin in XQ, this accretive, you . million recorded XXXX? two $X.X you accretive willing just I said then the are me. at to loss just -- are where you be but net being of December us remind know I XX. you not a being close it you Just reception what you've

in way accretive think any forward? how being and operating impact flow just its to cash going Novitium about on So XXXX

Nikhil Lalwani

and Yes. I Thanks, from -- hear then Brandon. question take Sounds Good good? second? you. Steve, take can why to the tackle don't the you first

Stephen Carey

good. Sounds

Nikhil Lalwani

right. All

pointed are for So this weekly competitor and us willing may The early we share of regarding be we we're point to stage to perfect what week-on-week case our and ready prescriptions traction rightfully about strong launch, Cortrophin, given been visits. listening, initiations. want what you new early for seeing growth out, a thoughtful . at our it's be most so for trend our as say is, We're and competitors. look, and in-person timing as physicians patient of

stage And guidance traction this seeing. of by encouraged very early the so provide early while we're specific in Steve? not we're to we launch, are ready yet Cortrophin

Stephen Carey

Thanks, and Yes, morning. so -- sorry, is our overall generating generic I'm Novitium. brand on modest overall for overall a business. our Novitium Brandon, good growth

do However, pricing right, base business, continued have to we erosion. our expect

on generic-based generic launches it's house, erosion business. right, talked our the about the of past, having our in lot we've generic a the as side in outpace a So the of game

do expect development. does that tuck-in around we've in as is expect, historically done that for so ANI do continue look typical closed, continue And you as as portfolio. my any assumptions the growth consistent business on to guidance, in in established to acquisitions overall right, brand said the And our XXXX. business would I that And now not in product-level past business, guidance does practices, comments, In posting with see erosion to Novitium we prepared we generic the reflect remember our have however, past. and that

x that's Cortrophin brand, guidance the side in so we the of house. And do the on reflected, have the reductions

quarter. in speaking I the quarter, expenses, in think loss expense you Novitium a alluded significant my And I yes, the transaction, raise. debt to last obviously, fourth prepared comment, it was that's think the fourth as -- point. amount the relates side, I to right, you're on whether So seeing GAAP and Brandon, the of the the overall net transaction-related guidance. very in I refinancing And There's to equity a comments, think what

to would and And where, release press some to so to press provide we non-GAAP metrics, point reconciliation but the the functional tables we the have everyone I reconciliation of the the a release, to key only get the for EBITDA not also expense areas.

And SG&A so side, would point reconciliations. particularly I the those on non-GAAP you to

Brandon Folkes

can follow up there. And particular. if about operations, I talking I'm in just I Novitium just --

factor the Just a of for think looking in K $X.X they million that months. we of here, loss sort I X.X Should recorded net those?

Stephen Carey

you're -- from the that K, disclosures Brandon? pro in forma if Yes, the up yes, picking

Brandon Folkes

Correct.

the yes. of pro forma, ahead Just

Stephen Carey

Yes.

in that... so And

Brandon Folkes

generates Novitium And X.X...

Stephen Carey

GAAP step-up inclusive amortization intangibles, of Right. would in accounting so GAAP do adjustments disclosure, -- et of In has on have the footnote that all and of combinations, that purchase inventory done that's assumptions, business you -- that cetera. overlays

GAAP fully a And so on yes, that's so baked basis.

Brandon Folkes

with Cortrophin reverse. COVID lifting? how can in about you terms you it thinking much given, your touch decline, very on helpful. on and hopefully, coming I you Nikhil, how But way Acthar beg in Can this put of help That's Okay. Cortrophin, out the market, did it you're did in more, to numbers frame seeing could Acthar, us back morning. general And reverse in Any this, that mean, your the mentioned competitor I are one just XXXX market I pardon. sneak you

Nikhil Lalwani

think of point, this points to I couple things data at couple a Look, -- of Yes. share. a

market $XXX think think So in that's I I was I -- all you know point. million-ish, right? what one in, it data the XXXX, we was ACTH believe

the steroid-resistant has suggested this the are less is And only patients epidemiology a price refractory and domain points increase You right, shared, primary ACTH claims-based indications this also in taken I than receive the that recently data product. the XX% player across therapy. know that that analysis that of other public for other that who

what And at points, opportunity product just willing in share that's tremendous to point. So benefit I of data X think drives we're and those patients understanding our need. to in this the this

Operator

next question our Fraser with Securities. Truist take will Greg We from

Gregory Fraser

comments thinking how business, erosion also Following comment base the some for you XXXX? in business? business in about you're price can the much on provide up you you And erosion on saw the generics how on on the color QX can for base

Nikhil Lalwani

Greg. Sure,

many earlier, growth New to approvals from have of as erosion We're So Novitium I'll Steve ANI that heard first have reported a acquisition increased launches. low for we've take achieve from about, that for more double varies. products lot the I in larger on and single already the new as competitive second. you that -- players. chime pipeline X X There we it have high counting to I'll these from portfolio of in Jersey the and let think and the we the in sort bounce Obviously, intensity, business be that have base is digits, the Look, our the players the see part, digits. and to drive growth

So that's you in where I of would sort terms orient erosion. of

Regarding QX, Steve?

Stephen Carey

prior in generic Greg. experienced we to erosion range actuals, Yes, QX the base Yes, in low product double-digit launches.

assumptions with 'XX. quarter is fourth experience planning line essentially our in So for the

Gregory Fraser

it. Got

SG&A million on that as drive the level to the much Cortrophin, up then should we spend spend product that is demand you'll temporary wind of will of grows? a over Okay. to that launch about base spend think Or necessary how as ramp time? And $XX for that down million $XX

Nikhil Lalwani

Yes. No, good question.

we're So before, we'll what sharing important look, as limit to information. not over hand mentioned

can give of major people. two color, as you people bucket, have first to into more groups. is on more million We just to this a divide far bit bit spend our a the spend obviously, As to $XX million, and $XX spend this

team. We strong an have almost XX% sales

are executives earlier, XX% the and XX Club over years. experience from won account companies as highly President's equivalent such them mentioned in Gilead. recent have Horizon, years clinical disease, we in rare of our Alexion, Alnylam As experienced disease leading of or rare

please that to as rep. your So you sales company factor if think disease understanding, rare in of cost per

So that's one.

point, setup there's of the operational a operational we've access, addition, as These system and such analytics operations a scratch. had also spend infrastructure to key and expense, we've services. and and build And for systems your a in and compliance, marketing, hub, medical, Veeva, lot which is the on team, had infrastructure to organizational and other including this some CoverMyMeds of sales from commercial significant analytics. as include In infrastructure, to data bolster market areas then

that there launch we the OpEx marketing, of the prefer cetera. I color And these but of our et the are the areas this think Finally, programs a that SG&A. that guess, disease other clear to -- for typical of hopefully you Again, overall, directionally, compliance, steer would of are on mix, and rare of gives medical, be specifics key I ballpark. across a bit

we significantly. Of can that as you our course, increasing, see not coverage, expand but

this think are we that of for planning currently indications we in be year-on-year, after are the pursuing. the I range going what would

we just to see, Greg, -- last I So hope one sorry, guess thought.

we So going will years So yes. leverage forward, the in see right? the

Gregory Fraser

payer If Understood. how on Yes. expect year. covered terms this stands? you On you can and to that comments. lives you evolve coverage some Curious of coverage where coverage, made comment in

there target by a for would helpful. be have any color you year-end, lives just covered If additional

Nikhil Lalwani

plans, affordable and -- meaningful area. as and to and committed we're important we're and you're government therapy And bring supporting to more Greg, ACTH payer patient Yes. to an patients. aware, critical this both we commercial having access this is -- prescribers

more encouraged with to payers forward We benefit or are And in managers, are as PBMs. by having details we the pharmacy we're discussions well in sharing the as ongoing and future. look discussions the

Operator

Elliot we with Raymond question our from will James. Wilbur take And next

Elliot Wilbur

guidance. rate million. run the business. which around little to rates, clients for rates And the about on for $XX first is allowing work an the step-up months X a the I'm those for for XXXX of year X of lot simple bit Steve. erosion initial the $XX even the the to us XQ of $XX bridging in run exiting numbers, or First almost $XX this. gap and you out guys top terms of base million about Getting guide pro XXXX to in basis. and annualized million, full talked question million inbounds would difficulty then having When closed, of a help deal EBITDA asking sort question between And is run EBITDA Novitium XQ questions bridge line forma in a

two think various parts So just be? some me the reconcile of of sort may those can you numbers what and about for help moving

Stephen Carey

thing, Sure Elliot. Yes.

this math $XX if of that about look many do is kind So just the fourth EBITDA. rate are factors run and erosion year basis, at to is clients company comes continued is the One your pro done, when the announced think the on discussed. than And really roughly time transaction. the a to back-of-the-envelope generic tougher last that you've quarter probably environment that absolutely pricing Novitium of The producing the of couple million space. doing, refine the I I forma format, right, we times in we've down today of it

is the plan just the then, erosion in the more negative results and declining. right, -- together, and brands on when you price and two the pricing have significant continued the growing again, -- a they impact established business that the business So established company's guidance Those pretty factors mix And significant. the for brand generic is business. combine and negative is mix negative because

the of And the seeing the so meaningful story. margin is we're That bulk gross percentages. really in compressions

the when spend, side projecting On guidance, SG&A essentially pro run relatively look R&D. and I rates in both quarter equation, of at flat fourth the we're expense to compared forma the

effect really is on that it gross EBITDA line. So the profit

Nikhil Lalwani

think And business which XXXX, full year milestones the said Yescarta events on just number, to number. the were nonrecurring for that Steve nonrecurring overall year substantial, in in with there and I is and certain build that's reflected was that royalty the Novitium what CDMO what's full

Stephen Carey

Right.

So if point, Nikhil. you -- yes, great

adjust would items, for low the for EBITDA those business generation XXs pro you 'XX. If combined be the for forma Elliot, in

Elliot Wilbur

Okay.

So not not the high right, XXs, mid -- mid-XXs?

Stephen Carey

Yes.

from in last right, -- million the closeout. $XX had the first quarter year final ANI remember remember, in royalty million, the fourth of in pickup the $XX the So Yescarta

So of they that plain takes bit million vanilla more development more equation is manufacturing And $XX ANI focused more base of a that $XX of kind portfolio, then portion. CDMO remember, arrangements to are in on the Novitium side CDMO, the the the as which have million.

bit So achievement in house. of the side of can a certain you look little when on quarterly of be revenue milestone terms their the at chunkiness in performance, portfolio, and triggers Novitium CDMO there for

that events, low would adjust down you a if the you couple XX-ish. into $XX those of So probably take million to XXs, for were

Elliot Wilbur

understand The seeing initial guys. about those Okay. all I where required are policies expectations place. where quite all here, question, Tier from payers mean, seen -- can I stages policies you're similar your do, just and is I appear. help you this coverage before to then expectation, respect we're Cortrophin favorable that actually about prior get wasn't think of starting bit adjustments. see still maybe eventually follow-up for what's for evolved placement. a Cortrophin these Acthar. Acthar, placed in a X to all step-through kind kind Nikhil. over And coverage, reasonable guess, with guess we've Or on you honestly, like assuming in is requiring I'm in the on I where patients sort making formulary public placement formulary the trying Understood. But I'm of expect Acthar down And to various of just I with Cortrophin? could it's terms obviously, you domain, just authorization to kind as the and like the coverage with little of of and to the mean, where Cortrophin which, that early majority But -- terms of us coverage fall formulary of the they're to I think enter way therapy bumped it altogether. they

Nikhil Lalwani

details, commercial reflected of as I to both you And future I forward plans. the specifics Elliot. achieved Thank government affordable more brought the the more giving ongoing you, covered, more I Look, specifics status and steer in the the committed encouraged sharing access before, said lives in by conversations. ask, of are clear Yes. ACTH we conversations. but to payer to about patient and that to -- understand I we've have look supporting prefer what formulary and we're therapy that meaningful we were very that's

Elliot Wilbur

question terms of just in Okay. a just -- last maybe And then quick clarification question.

XXXX So all financials, recognize channel? you'll for fair to Cortrophin with respect the to revenue shipments that distribution assume into first quarter

Stephen Carey

correct. Elliot, Yes, that's

Nikhil Lalwani

That's correct.

Stephen Carey

Yes.

Operator

We over any further to at for the or line back will this I additional remarks. on have the no program Nikhil questions turn closing time.

Nikhil Lalwani

you. Thank Yes.

the path us for to support delivering thank joining we of on morning. this and move the call We your forward patients bringing shareholder everyone, high-quality as them you, medicines need So value. who on our appreciate

While stay XXXX was a momentous year again, for ANI, well. it's Thanks only the and beginning.

Operator

program. today's for conclude your does Thank This participation. you

at any may have wonderful a time, You disconnect day. and

ANI Pharmaceuticals (ANIP) 15 Mar 222021 Q4 Earnings call transcript