ANI Pharmaceuticals (ANIP) 8 Nov 232023 Q3 Earnings call transcript

Good day, everyone, and welcome to the ANI Pharmaceuticals, Inc.

Third Quarter 2023 Earnings Results Call. [Operator Instructions] Please note, this call is being recorded. [Operator Instructions]

At this time, it is my pleasure to turn the conference over to Judy DiClemente with Investor Relations for ANI. ahead. go Please

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

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

express today's company's a events remind get expectation, everyone like that the conference Litigation Act. started, call forward-looking made statements and may Private we anticipation that Before forecast, Reform by considered to on belief, future projection, as or future I any regarding defined statements Securities be would intent performance the

the as noted not and including future with of and uncertainties, These our our morning, forward-looking in risks statements today those by law. performance. Actual update our are guarantees XX required available statements forward-looking on statements, as results webcast based in management on involve those obligation except or are any these release may ANI from SEC. Such website, days forward-looking filings information and of issued press to The differ the projected this disclaims Pharmaceuticals intent anipharmaceuticals.com. to ANI specifically be forward-looking for available will materially archived statements.

of SEC related announcements please press releases recorded November made recent X, on topics listening benefit filings. to then, this and held may the the the those have reference be the who may most discussed, webcast, XXXX. For was replay and or company's call archived to ANI so Since

to over Nikhil the Nikhil? with And turn that, I'll call Lalwani.

Earnings interest and ANI and Pharmaceuticals. thank in thank Pharmaceuticals morning, you Good Third for you Judy. your everyone, joining you, ANI for the Call, Quarter Thank

our like our improving team fulfill our to tremendous work First, of of our for investors suppliers customers, serving their I tirelessly lives. and Board to ANI strong purpose we patients, support to as and gratitude would express

always lives. putting excellence the compliance, as teamwork, striving improving us Our every day accountability keep patient innovation, we of commitment guide integrity, patients, time-tested first, and to values starting for

business will company's share the the Turning the built quarter. key confidence overall profitable momentum growth. in to to financial sustainable, for our we've Steve drive our across third and now ability performance business details our the segments results, of and I

I'm that over strong has another full of year million, guidance a strategy reported morning, of increase performance quarter XX% and over our for and delighted quarter to quarter adjusted enabled to us quarter. last of the net execution XXXX, up non-GAAP and also an in record This share row. This for to the we of clarity revenues record we third very EBITDA. third record revenue deliver $XXX.X the allowed ANI quarterly XXXX quarterly raise achieved record XX%

our year-over-year XXXX and adjusted XXXX. our results a raise was diluted adjusted XXX% representing $XX.X was the us and million, EBITDA impressive, XX% outlook our increase guidance. QX $X.XX, Equally non-GAAP again once allowed all to segments quarter nearly These of for have the over full EPS year increase non-GAAP third

$XXX of of the year-over-year total non-GAAP represents XXX%. net EBITDA company The million, to We in earnings non-GAAP million, between XXX% growth adjusted revised adjusted million of $XXX million between be $X.XX. $XXX adjusted to earnings to per of guidance share non-GAAP and and revenues net non-GAAP now adjusted share to to the revenues range EBITDA $X.XX per midpoint in expect remarkable be $XXX be XX%, of approximately and diluted

largest to our against with future rare a of Now and segments, will closer be driver disease key business imperatives rare disease ANI's We progress our starting let's business the for performance growth. business. strategic our take believe at continue look the made our

rare disease through as and that anchor momentum purified by leverage launch and growth adding this assets the deliver Gel our will capabilities. We Cortrophin infrastructure

in to million the third with Gel $XX.X prior continues Cortrophin of the quarter Cortrophin record new compared year second XX% an for to XXXX. over Gel increase accelerate initiated and of quarter starts. totaled the quarterly up XXX% Revenues cases patient and new

with who of overall The company's therapy increasing unique sales were prescribers, momentum awareness We effectiveness ACTH executive of and to quarters the X remains also The therapy. according to prescribers many category for robust year-over-year including salts. outlook naive increase of have patients with force improve new efforts saw appropriate for field ACTH growth to the IQVIA. yielded ACTH

nephrology targeted rheumatology. our in strength ongoing specialties urology, and saw We of

gouty addition, gains company's indicated approval X response. With $XXX early size million, XXX% for to And X for of arthritis $XX our the existing of with already mL quarter, are to The still purified good to vial year-over-year of from gouty Recently, represents for announced players. supported entry of FDA of receiving the million the we through Gel. progress previous The the from to guidance the by arthritis is new Also, raising X million initial million received specialties, ml in J-code acute the our and Cortrophin between in the VA. ANI's force. momentum flares while is range new The administration positive to X into launch company the priority treatment compared up revenue physician only X during Gel pulmonology $XXX a the specific of made commercial full commercial XXX% physician ACTH, it Cortrophin year response the availability million. vial XXXX. we $XXX for $XX launch, growth new and recognized made are sales acute and revenue to we Cortrophin support range the positive we the approved of In the passion specialty. mL specialties

committed disease XXXX, move in-licensing remains increasing infrastructure our of and rare financial and into XXXX, capabilities and company the built. leveraging our As we to end disease scope by we approached scale actively portfolio the and and A the of that through strength our rare have

also $XXX.X in year-over-year third the which and segment, delivered to quarter. now strong during growing XX% our by Turning quarter. other results million to brands the generics, by established

prior the shortages pharmaceutical with quarters, were the due and footprint chain the to leverage we supply company's in able excellence to operational gap X to disruptions. U.S.-based manufacturing As fill

While softened, on from future for reliable opportunities and capitalize as choice customers. current remain the established quarters past partner some opportunities of of have we our and X market an poised the to

Our organization continue new deliver strong colestipol and including hydrochloride to R&D with tablets. X.X% X Estradiol tablets, product launches, thyroid

ANDAs quarter. In addition, and new new the X we filed applications XXX(b)(X) during X

#X competitive We therapy ranking also in retained approvals. the generic

orientation. established segments of competitiveness company superior Going new and brands segment, growth excellence, the support this the ongoing growth operational aim cost generics, remain expanding XXXX. all the for our at execution patient-first be launch reliability in to that invested with forward, the in New build on our put is focused manufacturing Jersey confident XXXX other company supply and has we improving and we've to a to driving ability and the With lives. product footprint To during serving place are and across site to areas sustainable patients, a in by capacities biopharmaceutical early of all business, operational these the expect

over now detail. Steve, third I'll Steve? will revised quarter in to and turn who financial guidance walk our results more through

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

our we posted core of $XXX.X quarter results very As across We Nikhil third growth million. of saw XXXX. indicated, revenues third in quarter businesses, the generating record strong

XX% the brands of the our which generic prior and XXX% million from from a of Cortrophin across been segment Revenues million quarter, the in the in record. quarter, $XXX.X and or in segment, established disease launches on XX% product This previous the XXXX the over $XX.X reported Net to million the over $XXX.X $XX.X million our of XX% annualization increase year. were reported represents sequential reported volumes year. new launches the of revenue revenues and second the reflect company's an Revenues growth in quarter in of increase business, $XX from XXXX XXXX. increased prior base had $XX.X million segment third rose up other the gains million, rare

perspective, was tempered others. product in such by [ ], a driven nitrofurantoin revenues and performance from in as a CenoFibray, the mixtancetamine extended cirroid products of nebivolol by year-over-year famotidine, among and revenues prazosin, gains release saw colestipol, decrease From

fourth to XXXX. revenues key sequential our in growth issues molecules. in changed generic expect face of quarters for recently. market currently procurement tempered be a this revenues than to X of and The strong the year. that quarter ANI result, expect will brand throughout mentioned be chain see excellence supply manufacturing competitive However, As third certain this Nikhil established declines lower sales quarter to And and are U.S.-based we conditions products morning have earlier, enabled first the for meet generic reporting we for commitment demand ongoing and We marketing do in specific significantly R&D, by to have as in market that molecules it the of

our chain meet the enhance the Operating capabilities to service million to during million $XXX.X XXXX we September increased arise. XX, poised months in increased is for business compared by steps ended X they ability to well supply AI prior the expenses have third the and to future and these XX% period. as $XX.X opportunities our Importantly, quarter year the taken to of have disruptions, current

to amortization, $XX.X million $X.X associated from period. increase prior to of in the in XXXX the third disease quarter in sales, million $XX.X Research sales and of expenses higher Cost quarter a activity the filing to related compared volumes million in current growth projects million due with generic ongoing prior the expenses third of products. in and increased excluding year XXX(b)(X) of in $XX.X the year depreciation rare significant driven and an primarily the of were by level of by development pharmaceutical a period, new to period and year and $X.X million million XXXX, $XX.X

the September $XX $XX.X Depreciation primarily from third increased costs XXXX, prior period, in increase and general X growth the million was increased compared an expense by expenses to and for significant required million the in the increase employment-related administrative of business. the to million as to overall months ended prior $X quarter amortization our well activities in an XX, of as in XXXX period. $XX.X year million year due support XX% to Selling,

of an frame as to payment cash probability compared year change the contingent specifically quarter, from be a flows, passage as due the by increase to the for Navidien low in milestone payments. value $X.X time a will the which to cash During a of [ ] million over arising the fair we prior adjustment the development-based time the primarily in consideration of well and of product, recognized the gain extending million generated $X.X the period, anticipated product flows

period CAD Regarding restructuring of XXXX. year USD Canada expense XXXX, period. we the million agreement restructuring closure recorded the million sale of based On compared an the is or year of impact rate. P&L $X.X plan, of expected quarter activities to This to manufacturing Oakville the our million November for sale current prior site complete. as price X, are the approximately for no into exchange the essentially on in our Ontario in first there was occur currently a current Closing sales XX.XX the of the entered is total in XX

from EBITDA as shareholders loss in million prior record non-GAAP quarter gross new of net third Net year earnings Adjusted income XXXX of million, XXXX the per for per a the of strong compared company quarter $X.XX compared Diluted an common pull-through share non-GAAP period. period. reflects million compared the $X.X available of per had to $X.XX of prior was and $X.XX in diluted year was profit adjusted prior a to share the a year $XX.X period. GAAP to revenue basis, On we in third performance. the the for share reached $X.XX earnings as $X the to quarter for loss

the with XX, we quarter ] second XXXX. of our prior to million part Adjusted million driven XXXX. unrestricted million cash, $XX.X million increase $XXX.X in record compared the in $X.X sheet on during an posted a operations [ by non-GAAP sequential rose quarter year cash quarter $XX.X of million ended in recognized perspective, the up From of balance $XX.X from from is a in EBITDA This period. ended basis, also September previous $XX.X flow million the the

of we basis, operations. cash year-to-date $XX.X X-month have generated a On flow million from

value is We November which of debt, $XXX.X XXXX. face in outstanding of in million have due

trailing of gross our As EBITDA leverage Xx of $XXX.X our adjusted million. net XX-month than the non-GAAP sheet, X.Xx, is and leverage balance less is

raise mentioned up million, pleased guidance for million, XX% $XXX.X $XXX $XXX from of million be in and as Nikhil are we $XXX compared we release, previously to year XX% issued guidance $XXX to as net follows: approximately and full representing to the growth million million XXXX. XXXX press the recognized as company expected revenues year total Finally, are raising and this morning's as to between full outlined

We XXXX. issued and and up $XX.X to XXX% compared of million $XXX are to approximately be $XXX million, in growth recognized XXX% company as raising total adjusted guidance non-GAAP previously million, representing million between EBITDA the $XXX from million to $XXX

non-GAAP to XXX% to to issued the total guidance the adjusted $X.XX, from We of previously in $X.XX, to $X.XX are ] raising approximately company XXX% $X.XX earnings [ share growth to reported XXXX. per $X.XX as compared representing up

the of to non-GAAP XX.X% issued $XXX We to from Cortrophin guidance million, are to of previously between the and we representing the gross And be million $XXX XXXX. to range project million company million $XX.X guidance to issued compared XX% raising recognized in up specific previously margin be as revenue of growth guidance in and to XXX% XXX% as to $XXX million, XX.X%. total now $XX XX% compared

for million a XX%. The between to share for calculating of a rate tax per anticipate In company continue adjusted adjustments of between effect tax purpose outstanding will GAAP non-GAAP addition, and we U.S. of rate effective shares XX%. and of XX.X at and million earnings EPS, diluted X% currently computation XX.X tax

We will for Operator, announce the questions. open please call the now instructions. up

from with Securities. Sulewski Truist [Operator Les take first our Instructions] We'll question

a that, First, maybe bit the to which given manufacturing and front. market? that there's follow-up about reasoning that little bit exaggerated. the softness essentially. towards seeing. the little on the talk what be I It And to a that little you Or the want a is tone a Can categories the in a shift weakness seems to footprint just in a off it's in is, expansion you're bit generics of start gravitation behind

a you color, more Just you give little if can.

you Sure. question. your for Thank

competitors the to specifically on FDA arose that chain several specific supply first very think outcomes we've right? opportunities is that disruptions, us. structural issues, company-specific spoken as softnesses to that and arose site-related I softness, audit issues, level these the our issues because the had manufacturing, from all resulted look, opportunities about spoken from of in Remember, regards such financial with we opportunities product-specific factors from arising product for for to that

about when of brands So and established specific products these we're product level across speaking softening, talking multiple softening across opportunities. to generic we're specifically

question, softening again of so very to going that opportunities of right? return is opportunities -- our the is to opportunities, your mix came current of we have new evolving. supply and on Now overall sort opportunities focus chain guidance and And that dynamic gone specific Therefore, numbers, away related second which disruption-related up. company the is

that existing the market. in products the mentioned next New opportunities, the pipeline New we Steve growth, I of right? going the bring growth the in to to capacity our is multiyear have worth growth products that's to the remarks new and is So X, X in As support to that the on and based his that Jersey years' we're of is so that we our side business portfolio, Jersey that opportunities new in of so additional products, growth that continue at the to the and this addition in site generic expansion support believe

supporting it's growth. that So

I'll Are question supply Nikhil, you stabilizing? reframe way. you the essentially of market weakness? kind Perhaps just seeing are that's more Or and another chain resolving in the seeing of helpful.

financial is manufacturing So certain the issues, company-specific chain supply disruptions. which specific to issues, these still site-related trends give you're the product-specific of disruptions, the seeing rise of persisting. macro supply We think issues, resolution are the chain-related that that all

We're opportunities is had that trend the softening. to these So trends specific related market we persisting. macro seeing are that

are Some what speaking we're of softening towards. is those Yes.

at all. market overall talking not about weakness, we're So weakness

strength and of Of space, think our in in many reporting. the seen they heard what course, competitors are you've the from I you've generic

So...

yes. I is that And helpful. have,

Okay.

Just moving on.

there all dosage. shelf see ml the prescribing in would Is And you X kind this what what's essentially a for difference opportunity the And And so side, dosage? this life? label? the prescribers? consumption the potential a On is appeal of

acute And administration certain received the the to a guardly the physician patients specific for Look, X of availability launch mL. Yes. of bio support adjunctive recently, the with for of J-Code mL flares. company is and X treatment size the Cortrophin that arthritis the commercial of

and acute gouty patients arthritis for X for patients the players. treatment certain adjunctive of mL gave certain acute the arthritis vial with So is

received positive share next physician to as the we're would we early very we response, more . evolves. earnings or into love initial in the -- While launch, at this launch

Got it.

Okay. generics to And just to briefly. go back

what results, impact how given say, envision essentially the the shape do And was out. just sort inventory earlier, we XQ On kind channel stocking seasonality, discussed primarily of driven mix? some I'd by the then the strength, you 'XX to of of perhaps or product

Yes.

QX continued is launches, our the performance supply product and business. think chain opportunities the combination the I base performance new driven from of by with a [indiscernible] generics strong disruptions

question February. occur end as expense, that So come parts, that. growth invest would look, even as . But asked new moving to for from generics XXXX seasonality. call, and launches as towards which competitiveness future working plan have of it's And portfolio XXXX continue cost seen, the to, releasing guidance we on there's a we'll have, to then on the believe that R&D from will reliability. the and business around And year-end in those -- there's the the our earnings through our we impact will product supply seasonality you continue We financial we chain support on don't far we're R&D growth. the product in you many

guys. quarter, Congrats again, on the

Divan We'll with next take Securities. question our Vamil Guggenheim from

strong here. another on quarter Congrats

a for of questions So couple me.

leave that I'm is know curious First about in for that now. as one specific then back around the indication, is and I the of rather below you're unique kind in guess, not you things a at sort is see potential planning just feedback to to quantify, maybe leave And right the a gouty the year. initially what opportunity of it mentioned, also question thing is second you the that indication? of where I minimal quantify on number sort arthritis you're of going some look any if but in But I like main growth my really you sort And frankly circumstances you. comments that next going seeing, about interest on of does this you side. I sales XXXX, Can XXXX, opportunity now year. of until the the talked one doctor particular, Cortrophin in based sort very or actually give you're I guidance EPS February. for know looks to softness assuming where mean the and

So I'm just at year color all should sort that you any if will think about wondering trajectory for how different provide understanding this at can on businesses for of we the give point, from trajectory right it business there's numbers of for disconnect where more few now, and the from big detail are now seem but year? pretty consensus next like a months does a next the

All questions. right. And you thank your for

our of benefit first, arthritis, posters other gout think, In not around focused I are patients many flares, who gout current cetera, that to, on players, for an patients of arthritis question are indications, available. both option there we're from patients the other case sufficient. might your whom there rheumatoid are from therapeutics like are acute et the treatments additional

information community we're as It's investment this at received we we've why not consistently, have quantify at balance data. the to so between sharing We try giving again, we that to can physician positive this away not able competitively initial something and sensitive a assist find or point, done response to far.

on come more we and will please share -- So about to gout tuned launch. the back stay

material You out that guidance. XXXX assumed the know from have no in should we revenues

-- it's or the that because a could in So I days point launch. think early just to be

your back going question. then And to

is this you've we we've giving links around that I execution the guidance. the as that us that world know continued strong and Your do -- the conservative And to, of more long right, of our ongoing mean, the to PCG to business. consistently, we second what we enough being commit of done tax XXXX, one, deliver in evolution question guidance. with in continuation been we XXXX how and philosophy of while launch, terms see XXXX

rare leverage through the disease that about efforts right? moving as anchor making -- build and talked PCG also that our we're You've multiple on to the launch asset and the parts, in

right, Even that are the disruptions, we've as supply chain spoken had. opportunities I've about, there

are have them that current are There months gone persisting. are Some the away. new ones or of that bucket in

parts of forward. strong evolution, M&A, generics moving working on many we supply are plan the corrosion XXXX move the releasing the that chain status disease the growth our disruptions. financial there as So Cortrophin we're through evolution, guidance the And and rare we

Maybe on give more just Okay. seeing would specific sort any again just the of that on say commentary little seeing, bit of the sense sort us on you follow-up, generic there quick established where of you might around side is in brands? markets more softening impact. to just or of a more the be you're the X directional way Is

Sure.

both So his we that generics In in mentioned some new Steve remarks, products products, and we're the of established launches the of brands. seeing are decline. that is some other across in -- and growth impact the tempering from in generics, as seeing the the

numbers, you brand side QX the see the established . will So impact on on side. you generics than more the in the will

from We'll next take with our Livnat H.C. Wainright. Oren question

you I initial and a in how looking They you give to guess, surprising How much the guidance, the will Do when that are assume you rolling of already the is disrupting of you $XXX And guidance in anything that you've for of forward? from from I you those year the the benefit to from Obviously, extremely guidance, with from experienced opportunities? conservative just, I for you've have on looking the year raised million first-time you you or right? these this you year your have next But could -- year, different assuming discussion what way. hand really world mostly guess? asking follow-up. EPS durability -- are to new I'm be do some the to about raise, not do guidance build guidance, and you to guess, same end When disruptions regards think, have opportunities If your generics. conservative little bit are looking have? what guidance are at you have you in disruptions these Or being? ones approach visibility I all this the off, perspective. issue beginning forward last dramatically do I given you I come each expected of have shortly a don't opportunities quarter it's when forever. X%

Sure, for and subset right? question. with there's those. at we right? we've understanding, there's X If in opportunities shorter. have in I a and product spoken specific subsequent related you site Look this, takes issue market or know issue, those to a then -- given And to could we understanding that continue resolve assume of which thank when that the X-player guidance speak parts, when in it your player the a that, some level we've think quarter be of time quarters, we bake the If technical previous will is than our about that performance guidance, many with the of we moving obviously what best

deliver more, will we're what continue as we of baked that And philosophy why deliver our in and So to we give used not we guidance. assuming he's learn giving doing always in and forever, these the were bake share think we to we're saying. that as in that persist use that I describing we previous And of that's these Steve more before, has saying what . and try periods -- course, when and guidance. we'll worse we we're there's that as understanding

like the of products issue generics I of on comment you, or in that the legacy that's brands price cetera? in whether the have whether been think and I lead purely it And quarter-over-quarter to I year due Can is accordingly? moderating And you you the coming that's you've not you side. is general disruptions, going. going market biggest side, in come look, used on contracting, rising softening that, change the said that misheard the adjust if Okay. branded due a extent this be priced? payers products back, appreciate QX tailwinds a should had and the to benefit? similar dynamics, do seeing to and supply Is pricing guess, -- to I forward, it's et demand brand because we we're dynamic volume Or price mostly as a on

Yes. It's you to all pricing. driven related relates or volume No, question, thank for It's in that Oren. volume. portion not by large

part of second your the there's think question. . I So

generics, Yes. historically, And across I that portfolio year-over-year something double-digit we've pricing not. other mean, trends comment or in can I comment commentary can you your guess, Is on gotten declines about portfolio? general. you from players

Yes.

much I generic degree improvement some their players seen we it's commentary, in have like decline. the the think larger of in yes. pricing And

pricing base as I in that, they think that we've ensure lesser not are the is And customers, versus chain separated like past. we've supply to as on These erosion seen products #X solve our some seen patients. that macro periods, there of improvement. what a it disruptions. was in pricing the product is their is decline past their And from trend of available for for than objective

Are It's Can well. just historically, enormous, maybe about of encouraging. you've talk comment that I last how this pretty That's or products then you single Are pretty a portfolio And changed these a what's business. right. your portfolio? All year any think in a revenue that's concentration of of And gains? driven or handful pretty well-diversified spread not now? portfolio. some are on, handful guess, percentage have with benefits? outsized I X, you there generics on your able to of had is the X

Yes.

business product of across diversification portfolio generics the that the think I our persists.

let have are that there has multiple -- are the We that but products chain have generics in And products generic overall don't there sort -- different multiple that that seen not the scales business benefits one is of from disruptions. the supply with specific it, have -- seen our I is large business. Steve disproportionately in of think there benefit. of is I'll so a And product jump

Steve, think clarify? still XX%. But top you I it's can just

have Nikhil, generics time, moment years, correct, say rates . at the of That's quite the a no driven has, the on the we generics. product side diversify share throughout portfolio. the portfolio, single of I lion's any in And to portfolio. this taking and diverse company generic the would

right. you don't All about focus business well. as generics. bar on lastly, talk outperforming disease I just And Can the want the to has there. only been investment

I forward? spend upon XX% that Is been you've it year this that time approximately us business. spend to direct you safe to expected on assume think -- once told have year-over-year a you of more that actually support Or to than is more investing because to and behind demand more demand? are and going the that now investing necessary drive originally And you outperformance?

an our line Yes. Thank that XX%-ish you, numbers which with mind you think with from year-over-year invested in have SG&A I the increase. we perspective is mentioned, Oren. No, year-on that in

Congrats on impressive [indiscernible] another

At no I this Nikhil will we questions back comments. closing standing turn to any conference or Lalwani the time, as additional for over have by.

Thank to foundation this . everyone, interest morning. created efforts you. our Thank joining progress. XXXX our patients you improving a our in We look and appreciate ANI. strong purpose of updating that fulfilling you, serving have success for during believe for our time your call forward lives. We continued and We on

does Ladies you conclude Thank conference. participation. today's for your gentlemen, that and

time. You may disconnect at this