ANIP - Earnings call transcript Q2 2021 | ANI Pharmaceuticals, Inc.

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Operator

Good day everyone, and welcome to today’s ANI Pharmaceuticals Inc.

Second Quarter 2021 Earnings Call. At this time all participants are in listen-only mode. [Operator Instructions] It’s now my pleasure to turn the program over to Lisa Wilson.

Lisa Wilson

Thank you, Leo. QX results Pharmaceuticals’ ANI to XXXX call. earnings Welcome Relations is Lisa ANI. Investor Wilson, This for today’s Nikhil Officer call Chief on me With are and Carey, Executive Lalwani, Steve Chief ANI. Financial of Officer; and President

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

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

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

Nikhil Lalwani

thank Thank you, Lisa. morning, call. and you for our everyone, joining Good

times as the very share refiled our wise I’d that world facing, I as customers one details We overall successful pandemic acknowledge patients and efforts and our partners, continues Cortrophin on impact the Food sNDA access we our medications. the country metrics need, the suppliers other and continued quarter. get But to We Administration first much our during of we’re business I for U.S. the appreciate Building Drug and we we application June ground and to level lingers key in drug the performance to Gel. the to share challenging made the discuss Before begin, supplemental ensuring like accomplished focus our or Cortrophin of have employees, goals. Cortrophin pillars our on four to of XX, on me pleased of over. new growth program, our strategy. a some before for is progress the quarter, the high let of our I’m

Adjusted million. quarter will Steve and improvement [ph]. were the successful product XXXX. Second molecules $XX.X improvement business. existing the brand the to $XX.X market non-GAAP capture our million, quarter Key portfolio in detail volumes revenues totaled comparable and And our million of in new of versus our overall shortly. launches integration business financials EBITDA more overall were performance in was cover volumes drivers generics for Sandoz in $XX.X in in market dermatology in key compared last quarter share

effort is for FDA way into diligently many a the what deal along package know, XXXX. and the put to you Cortrophin great industry filed Gel. sNDA We believe on filing As have June comprehensive of robust a experts FDA and we of with XX, the preparing the engaging we

continuing and to significant of the In what proud refiling submission, accomplished been XX, Since business are XXXX. milestone is leadership October have of is our I’m team, This sNDA for organization engaged expected date. for productive goal as strengthen in our date rare a to is we the with regular type we communications overall patients opportunity the executing Our have FDA, serves approach parallel, and this disease the and on in the we filing. holistic capable made We’ve Cortrophin same remain organization only With that remains progress company. Gel commercial and class on scale preparation. in to of need. size competitor Cortrophin focused and launch product significant transforming the the reaches good one Gel ensures our the drive and this of critical market

pillar R&D to is second strategy, business capabilities the on enhance an niche to which now growth increased with our generics opportunities. Turning of strengthen focus our

limited deal has integration value an engine In to gained was conditions. close new including the R&D of assets. acquisition our in The continued Novitium combined competition on approval interim, as such and This actively nine products, of and Novitium the patients direction. Novitium’s customers market, acquisition customary FTC best-in-class two the more products, the signing March, combine this of launch second clearance to deliver. has new to maximize we suspension, remains bring filed tablets. companies in and that track in parallel, for and year, the four Novitium the to we ensuring more closing oral our and line Famotidine new of and serve well has to forward investment deal. pending fluphenazine important for planning to we the performs Our Novitium look Overall, pieces, half ANDAs. are complementary strengths powder with In in closing step this products

America strategy had our acquisition by potential to of with opportunities commercialization the and from and today. acquire our growth recall, portfolio. is Veregen early of for our established exemplifies And maximizing ANDA third high ANI In Oxistat, cream ApexiCon that part North identifying the business accretive we pillar NDAs brand an leverage I’m products productive brands are our innovative infrastructure manufacturing Pandel to pleased progress the pleased may signed we in to our are we cream. now April, integrated our stated sustained deal quarter. the for This As the close In dermatology Sandoz. closing, And with into these you our share this expand for value footprint. to portfolio. quality a

growth sustainable biopharmaceutical XXXX QX in of the turn a Steve to build I’ll patients strategy serving With execute with initiatives that, company Our goal financials. critical aligned remains to need. Steve? to four our over to discuss on the call pillars our

Steve Carey

good of versus and and return morning see continue total to prior Nikhil, and trail of across Well the the the quarter. initial prescription to generic quarter. to year normalcy were the second communities of in with that dealing versus half on many year We to are we as line. progresses. the the prior Well, resurgence are We acutely aware the COVID-XX quarter renewed for hope of the U.S. continued were of a market levels you, everyone second U.S. generic prescriptions pre-COVID pleased country signs communities the up for Thank our cases. to they for growth XXXX return the health second market

the XXXX, increased our X.X% of Nicardipine. million ER, and net were the XXXX of oral million for an The for sales to $XX.X compared fenofibrate, million, Sales the generic of gain in of due $XX.X second Potassium million Turning $XX.X increase to compared results. ANI of XXXX. to Citrate were period XXXX the quarter to posted was the during same in launch second XXXX. vancomycin the products as of second Net solution of quarter $XX.X second revenues quarter quarter

$X.X XXXX. from in compared was InnoPran same the million $XX.X XXXX, revenues second a reason and Salts. in current revenues the revenues $X.X compared declines by Amphetamine and acquired were during in contract in from This million manufacturing million XXXX. increase volume However, were manufacturing customers the million to branded Yescarta. development Sandoz the for products and $X.X were decrease same the to same Mixed of XXXX, the revenue our decrease increases quarter an for Penicillamine, period. tempered during XXXX, tempered million sales by of reflects product and royalty orders Royalty increased quarter during of of the earned $XX Canada four for to declines Methazolamide, period period primary the revenues in second Contract launch due non-recurrence related revenues of decreased decreased for The XXXX to Net other X.X% in gains Atacand These primarily for of these increase of and Miglustat, were $X.X of Arimidex. in of of from million were products April, the sales XL. by the ANI period second

to sales, of or by X.X% of profit $X.X $XX.X cost increase in volumes increased depreciation current and million in arrangements. The of of was a $X.X million million decline quarter products second excluding XXXX the amortization, a to decrease period. sharing the result the in sales subject year Our to increased as by related tempered mainly

excess in million three the months respectively, recognize we representing XX, during in sales of over $X.X cost and of $X.X addition, for ended XXXX, fair value acquisitions. XXXX, acquired and cost In million the inventory June

our in accounting press related and charges these items purchase non-GAAP other detailed as release. Excluding

declines recorded cash month. subsequent in a the XX% administrative $X.X margin expense year related associated by from current as with increased ANI of in settlement with June On the in by was XXXX, Arbor the EBITDA an departure from non-recurrence on million million this selling $X.X sales CEO. lower to resolve prior The in our period. was volumes expenses trial. million reflecting Cortrophin prejudice. of terms activities, will President primarily gross to with the party pending Research an our Arbor dismiss to compared offset Arbor development prices. an expenses into average termination development $XX.X driven of non-recurrence were or period, admitted XX.X% sheet attributable for to XX.X% pay charge long million profit. agreement from and months by Cortrophin XX.X% XXXX. event Our primarily Selling, $XX.X XXXX of $X.X internal decreased settlement the comparable to August commercial million acquisition, transaction margin million will non-GAAP million the pre-launch which marketing the gross million X million expenses general and for in $X.X three million down scheduled was and litigation, of compression as at the and action gross in all quarter Adjusted quarter, a We team. second $XX.X during is of $X.X benefit the quarter former Under million the mainly our XXXX XXXX second in Pharmaceuticals, in and the to restructuring entered company to expenses in XX ended and period second from August Novitium wrongdoing of expenses decreases will of related pay $X.X XXXX, standing the reaching LLC the and current agreement due in Neither the decreased related settlement. the X These the to related the claims the incurred million of $X.X the year to the year to severance Type XX, related $X $X.X balance

operations cash Table year release, sheet year-to-date in trend, Total detailed have recognition we press million acquisition $XXX.X quarter COVID-XX on of the compared million by net equivalents. generated of of comments diluted month to as is orientation million leverage X.X $X.XX unrestricted a fund in per the the Consistent evolving million XX, $XX.X continued we April current net the compared cash towards prior low from the date, the a albeit the million $XX earnings As as June times range. basis, March X represents this And basis. the year reiterate our to guidance, adjusted of on On share $X.XX products. in ever morning’s for year the call, balance non-GAAP earnings Sandoz end quarter, cash XXXX flow borrowings and $XX.X we our XXXX to This with had of debt figure of a XX on of XX increased as full XX, with period. and nationwide of first June $XXX.X our the as trailing with of period. driven

diluted to Our $XX diluted are prior non-GAAP giving $XX share. to follows. million of Net per $X.XX transaction $X.XX Novitium share to and as adjusted adjusted earnings million non-GAAP $XXX XXXX million, guidance figures the for effect and to ANI $XXX per unchanged million revenues of between standalone of EBITDA

suppression to of adversely script goals. these reach As any sustained with activity before ability impact our COVID-XX will

our Finally, on portion the Annual ANI family, support the the behalf transaction of and to equity. we for shareholders, with of thank the finance transaction of to at our Meeting approve in ANI the of vote for a overwhelming show entire shareholders Novitium

to physicians potential of patients, in energized to solutions look and ongoing arms and locking the mission with are by quality forward payers. this pharmaceutical Novitium We high acquisition, our bring to

go continue Leo, second instructions. please We expect up close in ahead to I’ll to questions. for now that, half. transaction the call the the the with open With

Operator

from question a Wilbur [Operator Raymond Instructions] We’ll Elliot take of James.

Your line is open.

Elliot Wilbur

for first respect for morning. acceptance Not the the and part surprisingly, question of will and a Nikhil. with refiling Good question three I actually Cortrophin sNDA Thanks. guess be to yourself

guess timeline obviously, with the of of the at I dialogue points in all sense terms a yet action filing based have and here or to for any the or key interaction Specifically, you as view if in of wondering agency date, on just the any initial supply on requirement established inspection you the relatively short chain. inspections the agency’s have the

is for decline may substantially there I Second, heavy and there part over recent of you wanted be product question, And lot trends involved then I that the think terms just government your any some observations you terms maybe asset. last agency in Mallinckrodt demand part and in in re-launching in this the of be thoughts of setup the terms market. think more signaled true removal whether dialogue there competitive last And not creates the of to of factors specifically may units you’re Acthar the rather this just of status around programs. have in there unit more unique a couple in sales whether just discussion maybe the or terms label? maybe part approach launch, lifting get I easier of just trying point of this you in your quarters, from an question on, specialty guess, you of reactivate has to at that spasms, declined initial of the there a the indication time? But with want Acthar in have to in infantile been on Where’s that on get

Nikhil Lalwani

Elliot. these take questions I a you, Thank time. one at will

for So, the deal put with the specifics know, multiple preparing experts your requirement. agency we give view a into way I first effort well, we great can you is, Look what along can’t the inspection as and in dialogue. What question on say believe of engaging on We’ve submission we diligently the FDA, would comprehensive and is FDA for of responded Cortrophin, with FDA since this the on and robust in a filing as FDA. communication, sNDA engaged productive the requests continued has pleased to it are the engagement be filing. type to package June expected with XX, the our their

first your question. So that’s on

again, labeling, a the competitive and this specific spasms, on On is infantile situation.

our into going significant for do to one, And here, that which time. we while feel what’s going competitor cannot therapy we’re holistic product? much bring headwinds I is Look, cannot patients most to go commercial that this So, question addresses be you that competing at strategy the imagine to need. is – then to we dynamics your needed monitoring for with And that on a the commercial and importantly continue facing. specifics reasons, believe would third believe I opportunity in market the our competitive is ANI closely right, as and our

Elliot Wilbur

question requirements this according follow-up at or with some has plan of deal? I in the review with guess, line of to the potential initial that terms FTC expected, of gone the tracking the interaction terms the sort still quick immediate any pending divestiture revenue EBITDA just you one of Maybe numbers of is on and point business contribution overlap in Thanks. acquisition, in that Okay. Novitium from provided

Nikhil Lalwani

value since remarks and I investment of the look, customers year. we with deal the line integration more actively Look we’re new where Elliot. acquisition products look well obviously, a more in the complementary ensuring in as been, has – for remains And saying discussions serve in and companies most, in performance, to said market, Novitium’s in our maximize of I’m you the Thank that, factoring for number the to FTC. That’s are prepared practicals Yes. combine strengths planning half the And in that second that that combined for assets. with cases and the pieces, patients we’re bring and closed with the the the on ahead. as

prepared forward, to It I gotten, has which As also the of but at we months, approvals remarks, have I the GMP that you to carry successful FDA. inspection. yes. strength to the of that will the inspection, like strong the terms they us, in of last was GMP a prior also would with Novitium just terms in surprise another so they over mention one they my maintain noted continue inspection GMP couple approval did forgot maintain would is continues with but to their add sort that’s thing very And, record no have FDA, in a to and that track of

Operator

our conclude the our happy question-and host for be remarks. I’d return for this to does any answer-session calls concluding And today. to

Nikhil Lalwani

Thank very in our goal able that Thank with of again. the Lalwani business Nikhil you, our opportunities pleased to our towards capturing sNDA the I’m an to our internal and in make growth. ramping pillars you. we refiling Yes. we eye and the are for building for Leo. research four Look, were future, is – see prospects on Cortrophin strides we capabilities, to of accomplish we continue that This of excited based about core all QX With our synergistic Novitium. with and the development

for friends you. As and your value important and your Thank thank today. we medicines lingering in remain shareholders hope the We this time to committed patients during safe need. always, And all families to want that bringing stay delivering to of to and you you pandemic.

Operator

conclude today’s does call. This

have great now And disconnect day. may everyone You a lines. your

ANI Pharmaceuticals (ANIP) 6 Aug 212021 Q2 Earnings call transcript