ANIP - Earnings call transcript Q3 2020 | ANI Pharmaceuticals, Inc.

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Operator

[00:00:04] Good morning and welcome to today's program. My name is Nicole and I will be your conference operator. At the time. I would like to welcome everyone to the Alien Pharmaceuticals third quarter TWENTY TWENTY Earnings Results Conference call. All eyes have been placed on me to prevent any background noise after the Speaker's remarks. question period a that be will and at answer time. There

press have on a you star question, If please one phone. your touchtone

As over Please to go being is Wilson. Investor twenty. my this Anni November Mr. to reminder, Pharmaceuticals. for pleasure floor Twenty now It recorded the turn ahead. Relations Xth, is a today, call

Lisa Wilson

Ani's. today's Thank operator. Welcome Inside twenty our this call results Wilson our you, and to of Twenty new on Chief [XX:XX:XX] Chief and is Investor Officer Communications With Nikil Lalwani, for Executive Relations Earnings Anei. of call, Stephen A&E Pharmaceutical's me Financial Lisa President QX Carey, Officer,

of of can access at Dotcom's. website You through the Pharmaceuticals this the the ANC investor section webcast Anei also call

available everyone our Before express we Such may statements looking regarding on future are performance, press of Securities uncertainties, filings. listening with guarantees press on and the information And as any on management These The risks dotcom call pharmaceuticals involve reference SEC archive twenty results that the morning and defined actual to FCC. call turn those statements projected differ required law. I'll today's recent of announcements except these the be company's belief, will to November benefit made a future statements I the Reform today the was be most replay Since company's pharmaceutical's those and Nikhil I based by and forward disclaims to Act. the be made forward as archived looking get may this those specifically anticipation that over and call twenty. related issued conference may releases discussed, any intent looking noted Xth, the forward in including have are release update so I on topics events forward available then our from for or started, looking webcast. to to our recorded forward future filings statements with I obligation or remind in who not the performance and projection, considered held to and any materially for forecast and expectation that, Lalwani. the days statements, intent Litigation by as of and website XX webcast looking would This or statements Private please like

Nikhil Lalwani

[XX:XX:XX] with to Pharmaceuticals. CEO and Lisa. of call. in everyone, president honor Good Thank as you, an role thank our ENI morning, you you be joining and is for today It my

also update, teachers quarter Before dove into scientists my with I'd suppliers our I'm we entire manufacturing unstinted that patients. the shown to workers, customers, and grateful ensure results efforts continue we the express during appreciation by partners for for and in first our care pandemic. covid-XX our strong the conjunction health supply providers, team responders, third commitment business essential to and everywhere like to to to medicines

I These several the and functionally products, health overall and September, of of and joining FDA with of leadership I the biopharma why period proud at both of diverse most organically care initial roughly [XX:XX:XX] a that generic a share decades of held products immediately caucus business. spent and and ionized teams oriented promising the I've been have of thoughts sheet a on growth Prior I business track and with generics launch women Ani's in the lines, kvell attractive. and and capacity oversaw and consider the piano portfolio inorganically, about pharmaceutical. little that several in background, opportunities. to on and the commercialization, leader, commercialized, record USA, also will balance development, a I. industry portfolio believe found broad, discuss I cohesive responsibilities CEO Joe, moments. with I very of branded potential for joined competition. with aligned robust I to growth several brings excellent me have I growth, experiences limited Cipla, why Let I goals. to included multiyear to roles the My time opportunities of enormous some more my the of specialty products. Which all and on majority in branded deliver me I my the which bit be a build strengths few of complex And Enda's, recently and has for as rapid I'm which I opportunity two results, I've my I and relevant also in the growth. energy worked functional have in And optimization. see a core building strategic are here, development and myself a closely productive where business portfolio that and experience of planning, so on in and spans significant

toward strong support with organic leveraged generics can are of have manufacturing And and of months subsequent of government. Twenty the drug creative growth. valuable refiling to a two for have new and Cockroft you U.S. one QX includes launch. high a all date, or application myself a in since Manufacturing I NDA. familiarizing American North record customers, great also hormone supplemental a the and more starting We finding twenty and both my lastly, joining confirm a time to and serving that facility deals be successful I invested a the organic on my observations the branded potency and further become a can has first commercial track intricacies and in stakeholders Based Baudette. working deal strong In that have CDXX footprint Creedmore in very clients

stakeholders. to plant of virtually one person In ones have constraints worked understand performance, and Canada, Creedmore to facility discussions of of realize need Cobus moving due customers, get some toured conducted be need we addition, with to small I team. do the business Minnesota key improvements This better capabilities, and dozens to and to talent we speaking opportunities Opal to I on to ahead been have quarter culture. made drivers where understanding other me Baudette, I operating our where and execution the several diligently toward Quiet's suppliers third commercial group [XX:XX:XX] the what us in and with and importantly, in I are preliminary a results the strong, allowed also our and has of have update.

on million rebound EBITDA dollars of and quarter of share third non-GAAP of and begun some dynamics diluted in adjusted of seventeen have branded after business cents. We have operations earnings QX moments. portfolios. plans our a to twenty dollars continued more We seven And adjusted non-GAAP results select million generic reported we net to impact will with of its revenues deal XX and has QX ninety adopted detailed monitor of coalbed our closely see parts our the in share a impact, per overview to twenty our related Steve few

turn now registry and process. first court to me the work on our Let program, on the

Ascender We in are focused resubmitting on QX Twenty twenty our one.

for commercial the demand our generation and both are robust assembling working progress to on Cockroft. operational readiness [XX:XX:XX] filing significant plans of in and patient and and for to the support confident submit in package making remain In we launch. We FDA. market quality compelling access FDA a parallel, continue the We our

I want begin share thoughts CEO. as few the my over as Steve, Before to I tenure to a turn final call I

First, this our members longstanding the new trust in our appreciate members. and with placed I me members, board truly board in together role, both the

the started. returns. I shareholder driving on results waiting focused get February and laser year till said, full strategy are in term long will That along be with will plan, February. to We we our twenty ambition, twenty share not operational

are inorganic a And opportunities, Corporal increasing and and and and and to and perspective patients between have priority here. prescribers to turn Angelilli will bring and capture the working carbon therapeutics. our for I I'll new As I I'll library, investment launches call we company. placing our remain value that, the bring tirelessly resources pace saying With on our our our and towards of as that required manufacturing focused work from excited the speak, refiling and by believe maximizing and I I and products. value the crucial network the from strategic commercialization, we conclude leveraging be necessary attention relationships the further that build to access fresh to I I'm I over Steve. stakeholders, ensure the energy community to to to evaluating

Stephen Carey

future. [XX:XX:XX] you, partnership morning, and is Nikhil, Thank We are of entire on as good we and I Nicole working to to formed look to level confident build a team team. as very A&E excited alongside already we very have significant we strengthen. be behalf [XX:XX:XX] And the continue the of the everyone, and

Sales the that to twenty Philomene three XX due fifty of for revenues three generic Perineum. that quarter point twenty sales January third in million million quarter of thirty Twenty Twenty quarter [XX:XX:XX] the in to versus increases same primarily quarter, the third due products. to point from were million principally of Pallo of nineteen, our up fifty of generic seven Turning of percent the products the in during period seven XXXX, were launch megaliths the and one thousand

compared revenues twenty, increased decline OLUMIDE, to twelve the which of and in All twenty Excel four year. and last to to vancomycin for of unit quarter the point products by from down mainly period, and these competition were excel the revenues from atkins'. were Inderal, of were five period perform of simvastatin, Twenty mainly acquired due Net during The Zezima million well. third methods have our year continued revenues sales branded a as in percent declines products American of the Operation prior lower in of in increases offset had capsules all

amortization, higher point percent a from Twenty acquired reduction and twenty and down products due increased principally mix year, increased one will eight and products Adjusted period in XX the twenty towards million third on of was thirty Our volumes the sharing during million of driven profit cost emerging. profit. gross non-GAAP Twenty sales related of primarily nineteen. same of of to expenses two to net quarter increased third supplemental moderately in excluding negative NDA EBITDA in quarter Twenty the [XX:XX:XX] the from a of the be to XXXX, twenty subject increased twenty, the million a currently complete twenty percentage and sales, twenty the sales due to quarter X.X in related with primarily during expenses our that Research point related to quarter to percent third of the to point decreased as million development twenty we We decrease begin Quattrocchi eight products quarter million of compared generic by of to Cost twenty revenues in QX development arrangements by due than depreciation nine to to expense third focus to as prior two point anticipate our the third Khorosan we continue in of million, resubmission from those efforts. nine five in efforts. two as

on for the press cents morning's did period. detailed release, cents share is four three quarter and as the a huntings non-GAAP per As dollar seven prior twenty of we table to in our year ninety this adjusted compared

September had As equivalents. nine cash and XXth, seventeen we cash of point million restricted of

times twenty of repayments Our balance is the million from seven of year reflective transactions to [XX:XX:XX] generated point one of invest Total development nine Currently, net one of million and business of continue months borrowings half leverage as four capital pursue month facility American cash the flexibility twenty undrawn one half This development dollars the hundred balance to and a of flow XX acquisition. year. and in XXth cash to credit trailing seventy million the million net during as activities QX a as four of opportunities. September five healthy selectively million dollar twenty. the in million net business seven expect debt a further revolver of positive standpoint, and of cash from provides five of the from two first compared represents operating point of continuing remains to operations portion with of a our one allocation with is revolver sixty levels to of basis. this hundred flow on generate From figure increased Twenty XXth, we and sixty June and seventy and associated in twenty us

of impact of closely role the and to continue monitor businessman. terrorists We the the

due open go during significant now and its and that, While we business, of the three for encourage operations please impact financial actions not uncertainties. for call months With ahead. condition did numerous the questions. results to Operator, I'll

Operator

your pressing so Star you We'll keypad. [XX:XX:XX] just telephone time, if one star At ask one. pause would do moment. to and by number a this the for on you the is Again, like question, may that

Flanders question of The line the Dana from comes with Guggenheim. first

Dana Flanders

you you wanted year broader focus much an to seeing and pockets wondering prepared in two on more strikes Great. bringing landscape. the opportunities around comments do for I as priorities brands, remarks number generic questions, them products on if so. pipeline, getting And talk on you two your on to that I the focus your of and get Nikil, of opportunity for. gate and evaluate for you then your changed you. more stable maybe was And of said [XX:XX:XX] two, what's little were leverage of could you're as Thank the accelerating And what you competition, on ready generics very bit curious maybe of you Are during attractive mentioned the of to strategic allow and up the you just you out competition kind the inorganic to particularly philosophy guess comment you you market Thank and stability was how opportunity? those big kind opening in market across or is. a to M&A. on I that

Nikhil Lalwani

[XX:XX:XX] you. Thank

the parts and into various I'll accelerating XX is one of the large vendors your [XX:XX:XX] of three first the through acquisitions we plus it to about NBA pipeline a And question, deals. of So terms but library customers. the So take a big that of this and have competition a happening NBA. our of we're conversations higher are with market, several the in basis, that in limited on with is potentially what's regular products both also have competitors value. these understanding on monitoring and something the And on

these market is I And something so This we're bring done successfully I'll in to for time here. past, that working to prioritize experience that and and accelerate the launches. have

evidence the improvement overall market the asked the in I of of think then and some the about decline. in slope You generic trend there's

supply. more of quality the think conscious the of I Kobe has buying made groups

to competitive of, wins know, president cost you be election, remains push, And opportunities intensity are wins, to addition today third take deal footprint think Having a six those manufacturing the lines. of capabilities part it acquisitions, continue the There In the good with election still price answer part high. the is broad the opportunities said who sector. consideration, in And the that continue the of When Canada. know, capabilities will of the which disciplined, regardless you especially bringing pipeline This path down business the US definitely products of that. feet [XX:XX:XX] is to a feet to percent right to in XXXXXX evaluating footprint manufacturing to of in us in measured in months in entry will approach of and to is the about includes strategic US comes U.S. XXXXXX is our now to XX ago. I think Dana, push was there the opportunities. drugs overall forward. scale, of at both to activity there generics DMO square help well I volume more on rich, US engineers and but very is and almost question, commercial our than and scale significant us positioned was allow manufacturing square capture that, and plus that very there on and environment a enhance With pursuing branded we enhance your nine

map process are performance, my of strong, the I assessment where a we capabilities, to drivers So, attractive made where some putting culture, look, be our mentioned the conducting where as our market. assessment opportunities and of improvements prepared of of are of in remarks, and execution in comprehensive the a together need operating

long along twenty the share and ambition, with our February. term year results plan, full strategy all operational For the twenty and in I

Dana Flanders

[XX:XX:XX] All right. Thank you.

Operator

comes question next The line [XX:XX:XX] with from Wilbur James. Raymond the of Elliot

Elliot Wilbur

Thanks. morning. Good Welcome. [XX:XX:XX]

that. quarter? trends financial want walk sure in the flow of that million. flow questions, just You real XX led cash cash necessarily maybe Not to the operations like Looks Steve, specifically, negative, can of I to was some could ask couple the all components a elements operating you quickly of see from through just of

early that perspective the in there. get getting want key of and I resurgence the back And of based then in levels in covered wondering currently. growth some to we're that's areas. pandemic I on you just talked year. pre if earlier kind still a throughout Just quarter four kind numbers realistic guess, of expectation sequential fourth I'm on what of to light know the about trends, the seeing the the certain commentary

Stephen Carey

[XX:XX:XX] circuit. so Good cash just and misquoted. the Elliot, say the insightful Short so thanks morning, flow and think for I on you question,

was said you the looks it quarter think XX like negative, I million.

XXXXXX. more I think like it's

So, date zero worries but a Yazd, at generation with flow just two, No, yeah, But no that. yet. they're cash that's little our or fine. fine. That's early our It's year to yeah. But it's off.

observation. good So

So first equal the that it from cash the American of call hangover to of is the flow of from really for part the of continued the flow the year for cash phenomenon months main ops year. flow cash six ops And first acquisition. from kind nine months is a a essentially

you if entire and while on January from we're Even into, we They kind we slotted those we purchased selling into know, group, directly portfolio. that a sales you do want launch essentially standpoint, And gate. though currently day of you it's a Xth, them know, out products. them portfolio that So, operating portfolio. of of products, the commercial that as one and Right. marketing know, our marketed

cash of of know, in [XX:XX:XX] a Right. launch quote And consortiums clauses of products, in the those, And the, get from you customers from given environment. strength unquote do flow and this delay launches. certain terms given so, the the you you know,

and the into corner corner here round do I the as we that round turning the the fourth start first as we into so of quarter anticipate year. quarter the coming certainly And to

So the phenomenon quarter that's terms in there fourth the of trends.

sequential I not we're we third immune the impacts that the manner. levels. rebound seen But, covid-XX to about QX, to And quarter not as we're likewise prescription you to we've kind a sequentially. of numbers, call. just look, Right. know, QX the know, think volume fairly nice today, You see In you seeing and, in we're the talked the terms I in know, as right, quarter, as we on covid-XX industrywide pre you compared still know, you third of of numbers strong in it's the levels industry a

wild how everybody forward develop, more occur, looks or in fourth wildcard You covid-XX rate, that as U.S. but nationally? the all so the card hoping it's [XX:XX:XX] the to And the obviously, the we're for whether quarter, across I and that clearly But for that's not is the does any pockets the we're does we the the extension, know, by card for And know, couple evolving situation. as trends we given going cautious be remain here. to it's you wild optimistic look you always there, significant out barring we know, to quarters covid-XX next industry. so,

Elliot Wilbur

And of couple Ok, a for thanks. as then questions you just [XX:XX:XX] well.

companies to turning have declining and the obviously, that, real line around. frankly, get whether financial of with, be and, and to able reintroduce, company short larger sort your been the the company drive you you the pipeline that mean, seem to itself the relative I the sufficient know, of in acquired various has value you have of of that you opportunities terms of businesses perspective know, generic not, a in it growth of would no in over other know, those assets being want Just And in prospect sense or markets years. front of term. know, to in in

is in growth think on is your know, on, assets that, in know, positive whether not in of business. there know, I go assets actually to books kind a at or growth maybe So know, you you to are perspective here you or you a, later short out based the of just outlook the buy the drive know, a transactions a get term you there stage valuation and, you that to want versus, a having

Nikhil Lalwani

[XX:XX:XX] you. Yes. Thank

opportunity drivers growth are for growth, of expect think one for I preparing is the will [XX:XX:XX] launch. general QX a package robust of be ready what subsequent terms of is and Twenty in company. in twenty look, a So, rickrolling We a crucial in we

number know, So are I the other the consider one including increasingly North driver. would that a growth leveraging think, hormone think U.S. Baudette. areas America is in which Number I manufacturing you the we one, important that important growth of and have be footprint, to is facility

we that know, more So us can to lot you value given assigned this is that manufacturing. a manufacturing importance a is the, increasing being network and leverage

kept from bringing year. As maximizing step our It and accelerated competition. before, remember, assets be portfolio the business branded the CMO opportunity new important of some revenues our emerging value know, a those more about our existing limited those capture we I pipeline generic launches an products spoke from of launched will deliver with especially vendors to products. and and her still the and, value library, share those and from number were and and acquired you There's clients. from we the this mean, to

we so that even And to to, very something I disciplined, and me tremendous that's doing. it look, job to deals. look know, a showing thoughtfully, of up done has prior And doing executed you continue will

scale capabilities products, segments brand and evaluate strategic opportunities all enhance businesses. the So to generics three continue in inorganic we to small and

Elliot Wilbur

I maybe in see you pure returns, job terms if good your above. generate that have branded have the don't be or where high five Nikki, associated growth [XX:XX:XX] assets, relative of of significant you doing, I historically know, you with kind buying in opportunities and of capital it necessarily the company them. to ROIC done know, just guess ask obviously, the best you of know, deals a arena, any assets, but you whether And with has necessarily question know, of up know, you Ok, is, betas, the all or branded in very sort terms could question, respect to or of deployment, [XX:XX:XX] discretionary follow the five generic the you products

how high these of you you're days, opportunities, growth sort to know, be of from just from ROIC for So metrics. financial you kind know, of of, versus seems those what demand an evidence for viewing markets you wondering increasing know, just

Nikhil Lalwani

so that's good question. Yeah, [XX:XX:XX] a

I a evaluating. questions One look, good responses. of is, think couple are that these I'm

strategy in previously, mentioned our results ambition, long I share with and Twenty February. plan, will twenty operational I along Foleo As the term

do I you U.S. know, you leader. And the know, mentioned markets growth as am growth a that's then, of am oriented And you oriented. it's the too. rapid oversaw that. remarks, as I will So reward I the in CEO know, I It's that of And, prepared period that, a in fortunate that's how I

strong to delivering year of full So growth. with do share, will and relative. know, plan that to And results I the continue record that results our twenty along you track and the delivering twenty I path

I resources and question lines. between the twenty capital way February. think results will of is, we twenty share allocation more business allocation about you in the that the of in the full I know, year share

Elliot Wilbur

question. [XX:XX:XX] Ok, my you. Thank was that

Operator

on telephone so an Cantor do ask you to Star The by line in will with from next your number question, Fitzgerald. come may one of the Brandon Folkes reminder pressing a keypad. audio the As [XX:XX:XX] question

Brandon Folkes

think appointment behind and for capacity just talked [XX:XX:XX] questions should about we in you your those you on how potentially the to. as you there? about thanks as your spare do replacing with I revolver, to taking some secondly, feel Hi, higher current facilities? execute there color manufacturing terms Is flexibility invest undrawn capacity well lines you the financial give country And value about talked know then footprint. on or M&A in utilization my about but maybe congratulations Can and next launch your of and line Steve the

Nikhil Lalwani

Brendan. [XX:XX:XX] Thank you,

there two think questions ask. to was I

the. think I

capacity share First you happy all sites, as one I'm as that, north Canada. sides with site both across manufacturing was well there know is capacity. the do three to on that of to the available

to that further the talk we to a opportunities. it's is then, you the want to you or with If through, growth and a you work the and Steve, to continue material to allocate disciplined, leveraging where coming to to then, if there. Obviously, to areas, leveraging know, across how the capital to I'll Crawford we Crawford by there's the to by continue that we when And take some to take increasing this have you're there capital to manufacturing a regards aware operationalize jump appropriately network, of as so, opportunity resources to we measured we for to have regards those plan know, opportunities the approach core allocation. as capture different network industry. utilization in. the are. as and drive doing manufacturing advance product our crucial about start priority dedicated But So and

ready This market force for readiness in You support patient commercial know, robust plans. started and getting in a submission and working generation NDA access, for QX launch. and operational on we've parallel, the demand includes

So of for absolutely, Kordofan is, course, a opportunity priority any.

Stephen Carey

getting you to of discipline diligence you terms in discipline the sheet you skis of of profile. [XX:XX:XX] the leverage and our Yeah, know, opportunities too the I'm that, continue you'll see you know, the the not to know, balance front, clearly sure. on Yeah, the, know, in with over I'll add M&A not far just add balancing terms clearly, kind and

Right. that. pursue seen historically within what And and I do that think assets EBITDA of is to Right. you've generating. I kind are

Takins know, Ani's you capabilities. that's so, structural enhance whether that continued in form the And and broader, or of organizational portfolio starts something that to

towards I eye, it's towards phase, always cash EBITDA with assets. going an generating to generating think in and this be in flow

that the we're to focused successfully organization of readying for not as only that's filing as required you Petrosian, as embedded Right, and but question that obviously will and part on laser your launch balance efforts there, pushing and says. that So brand. also Nikil in regulatory know, that that's the the And, the to success, be product.

I of point the starting And so in capital plan terms out there. that's from dollars know, zero of spend that's allocation, would you that we're not But evaluating. part we're

XXXX Right. eight basis. the a And roughly. picture, Big on inventories, invest little in million a date. behind seen full know, bit company over you year you've know, a You prelaunch dollars year to

break and how XX, a XX rate. between have I of the fall forecast timing of around depending We December and the shipments thirty first on think certain

need of some that the of replicated to advance not rate. So in be launch will spend

some be of and able sales allocate towards So that and there. build the we'll spend from efforts to marketing

Brandon Folkes

may, [XX:XX:XX] terms referenced that follow across eight or of you Steve, up, and one that if control? million the was I in is portfolio inventory, that

Stephen Carey

Twenty specific, I'm of building [XX:XX:XX] be towards would not type to start That's we twenty prelaunch inventories, moderate that they'll so So I pivot in that if is one, DNA to right? zero of activities. expect twenty kind saying as but culturally

Brandon Folkes

the any XX following or think twenty. just shelf you. maybe show color up is Thank life months great. your I that, what twenty on Yeah, be on that would just [XX:XX:XX] And your of culture?

Nikhil Lalwani

our and also information [XX:XX:XX] And the product. I now. the is FDA what know FDA this will thing you We're of the of exactly be will from that. is best same So competitive with confident that us of [XX:XX:XX] that, the as to aware, our to to as you share of this with you're for and adjudicate FDA right you're standpoint, as not quality quality say or filing a specifics know, the it the of don't gets appreciate,

specifics So now. on on right we would prefer to that not share

Brandon Folkes

[XX:XX:XX] Enough, I appreciate that. Thanks for listening on.

Stephen Carey

Brendan. Thanks, [XX:XX:XX]

Operator

conference to for further are I him back over we audio no that, closing With [XX:XX:XX] showing will to remarks. you questions.

Nikhil Lalwani

getting Please enter uncertain taking advantage to time families this we your our take appreciate we cadence to for for your of all these in you to and as achieve and safe. support. you the and personally, new your times. chapter, stay great regular deliver care full of our communications many yourselves that to and I value look friends thank expectation Nickelodeon. I every have core is and of and shareholders to can I the today. things of and of opportunity business. Thank and Yeah, unprecedented [XX:XX:XX] forward lead our know strengths you invigorating to This

Operator

you your conference [XX:XX:XX] appreciate We Thank conclude patience call. today's move This does on. you. and asked to

ANI Pharmaceuticals (ANIP) 5 Nov 202020 Q3 Earnings call transcript