Earnings call transcript Q1 2023

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Operator

Good day, everyone. And welcome to today’s ANI Pharmaceuticals Q1 2023 Earnings Call. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer period. [Operator Instructions]

will you and need call standing will this should by any note be I recorded be Please assistance. It turn is today’s to call over now to Judy my pleasure DiClemente. ahead. go Please

Judy DiClemente

earnings Financial of Insight and Chief Investor Welcome Pharmaceuticals to today’s Thank me ANI. Executive Officer Stephen Communications This Lalwani, call you, DiClemente QX Officer; are Relations Ashley. Nikhil XXXX of Judy ANI. is results With ANI Chief on for Carey, call. and President

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

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

issued forward-looking ANI are our risks uncertainties, to including These those and filings Pharmaceuticals’ management release morning on available in involve based of today with the and this statements noted SEC. and our information as press

guarantees statements law. are will days or in may projected available results materially forward-looking ANI differ required statements as our these on Actual performance. webcast anipharmaceuticals.com. for those of forward-looking update forward-looking disclaims to website future any from obligation statements. specifically The intent archived except by the XX Such be not

may since ANI this archived For held the then benefit topics of made and X, those discussed. listening to to call the was webcast XXXX, on who replay or announcements may the be recorded related May have

recent So please and the press SEC releases most company’s reference filings.

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

Nikhil Lalwani

strategic patients designed remained you and growth. for profitable in focused and to and help Judy. you, on our joining thank serve Thank call. morning, need competitive drive us everyone, ANI imperatives two Good

add business be of Firstly, the to driver Rare Purified the built. and This of Rare ANI’s we Cortrophin successful our Gel of business lead will growth. the launch Disease potential that Disease scale infrastructure assets leverage have Disease the Rare our asset, the with up largest

execution, to The and enhanced across compete growth reliability. quarterly is quarter ANI and to efforts and quarterly record business of These launch million. excellence cost segments driving the product $XX our new $XXX.X revenues second supply business imperative million adjusted with have generate Generics and win net record operational excellence core our EBITDA enabled through for non-GAAP superior of coupled

hard the outstanding strength in we announced outstanding built congratulate core operational achieving results these I our morning. and demonstrates this their performance business work have Our the team segments in for

the of On disease the Rare in launch Disease rare our asset invest Purified foundational Cortrophin front, to Gel. we continue

team and payers, and need. have access are servicing We our strengthened the patients, improved increased launch accelerated has momentum for therapy patients and ACTH how to we in which physicians

on longer metrics providing last Cortrophin. quarter’s detailed we sensitivity noted earnings more for As be will no competitive call, reasons, on

the report patient we April of However, number in our of quarterly new acceleration and record in evidenced monthly launch QX, pleased to new of initiated and are record momentum the XXXX initiated XXXX. is that cases starts by cases

growth prescribers. seeing prescribers also in the new of and continued unique are number We repeat

of use discontinued ACTH after their of of therapy Gel. or slowed use the Cortrophin ACTH previously had launch have who prescribers Purified many class fact, In restarted the

neurology, Our pulmonology. are and on promotional nephrology focused efforts rheumatology,

nephrology programs Cortrophin peer-to-peer across to three We of target our neurology rheumatology, increase education up specialties have ramped and Gel. of awareness further

team. and have a dedicated addition, onboarded modest In recruitment and of completed sales we pulmonology

unit had overall the decline not Prior in growth Cortrophin increase class since for to ACTH critical highlight the ACTH relevant Cortrophin the our efforts the to the for shown our need. access XXXX. the has to launch Gel ACTH is category. growth year-over-year market appropriate according and for category trend A patients in to to had launch Central IQVIA launch continued to Gel in

for from the XX June Gel year-over-year ANI January ACTH Cortrophin has unit of growth category XXXX and to XXXX consecutive according in XXXX IQVIA. months, March of launched of shown to

been growth in unit In double-digits. months year-on-year in the first the XXXX, category of three fact, the has

First expectations year Cortrophin $XX Gel $XX quarter million, bolsters net revenues in of our and million. line Gel of full Cortrophin our confidence revenue our guidance in was million which $XX.X was to with

are of launch enhancing and pleased and to Disease of the look We forward with scale progress the scope Rare our this business.

We explore can Rare assets other actively our continue to that adding infrastructure. leverage Disease

customers. the results our Generics timely will our U.S. prior our to segment, the ability increased showcase operations and and to to which to XX% footprint of year. deliver million, increase turn manufacturing brands solutions $XX.X I an to revenue These other Next, use established over agile

During the patient ANI’s manufacturing all and access track by the capabilities, research much from disruptions, record development with and has the our to GMP strong numerous in medicines. orientation. supply enhanced first to years, market best-in-class we past operational combining excellence This impacting patient us had capture enabled arising the demand two longstanding strength needed with

increased R&D had with We on niche focus our opportunities. investments

-- new retained the first and in in new quarter top ranking of XXXX multiple ANDA XX number our of the We continue ANDAs file approvals. to

XXXX. approvals also retained have Generic in ranking two We our in competitive number Therapy

have efforts the operations which is Oakville, manufacturing our with the cost the buyers in for completed. potential now excellence of site are of to included consolidation rationalization Our drive Oakville Discussions ongoing. with manufacturing network

India and skilled our Chennai, XX augmented have facility we over colleagues. addition, analytical with development In in

recent three and supply strong audit compliance important, with further record -- audits our FDA to sites. reliability by ensure enhanced of across a successful Equally efforts track supply, all

and of fact, In NAI in had March New XXXs and inspected Jersey an status. zero our XXXX was site

These at from we the to ability keeping of center growth, opportunities healthy for patient the continue do. market but capture competitive not while finished levels we disruptions. least, the goods everything inventory sustainable, and allowing ANI’s profitable materials deliver to and demonstrate raw any Last, to achievements maintain arising us

adjusted to the and non-GAAP year million, are revenue between adjusted to overall and to The our million trajectory business to our $XXX guidance full we and $XXX EPS and $X.XX non-GAAP confidence to EBITDA in million of boosts therefore raising guidance between XXXX million $XX guidance $XXX outlook $X.XX.

the quarter discuss the in first and through detail. for year now our revised will Steve more Steve? guidance walk financial results detailed

Stephen Carey

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

groundwork quarter XXXX, build the the capitalizing strengthen and results growth of on indicated, of years posted laid sustainable platforms to the two Nikhil in ANI. As the we past capabilities we very have first over strong

We sequentially reported record of or first revenues the marking quarterly our $XX.X XX% and first surpassed has generating $XX.X of fourth million of XXXX. $XXX.X quarter million the growth $XX.X XX% saw across in revenues the record businesses, revenue up our growth first reported is million. previous over quarter represents ANI’s in This million, that our of time XXXX the quarter from million core the history $XXX in

is of are on reporting period, of XXXX. quarterly Cortrophin that with Purified catalysts. results and consistent launch of our which basis occurred of quarter the note growth where to important acquisition the closed is Gel this which the November XXXX The first in first Novitium, a It two in

quarter the is growth organic at reflective such, XXXX first performance of As company. of

from segment Revenues Rare our Cortrophin $XX in were reported from in prior million $XX.X year. Disease up the million quarter,

full goals. with and Further, believe with our Cortrophin strong in quarter pleased our of this a for line result are level is we expectation. it foundation achievement XXXX We this first revenue year performance of creates

$XX.X increase segment of million, million as Revenues of These increases and compared million other $XX.X the $XX.X prior or Generics and year quarter rose established XX% $XX.X XX% increase of to an and nearly fourth of our gain over the brands XXXX. increase gain pharmaceutical products, established a XX% by a in million an our brands, year-over-year. for category of $XX.X Generic in million and an driven XX% other year-over-year were our royalties to

nimble based to driven U.S. The R&D, and to volume and manufacturing, ANI’s These excellence team. strong combined was growth quickly in informed commitment when evolving increased market product and enabled and efficiently selection an meet attributes by this needs. in generic segment ANI and

March XXXX prior XX% three year from $XX.X months to for ended Operating increased period. XX, the million million expenses by the $XX.X in

of compared sales the the $X.X due amortization excluding of in volumes and Cost year and in of Rare product period, a to in products. primarily million million Generic of $XX.X and increased Disease first prior mix to sales, $XX.X pharmaceutical XXXX, to shift increased quarter depreciation million by

the prior over of current the during period. acquisitions. were excess addition, cost period, in cost no in inventory in value fair for million of There expenses $X.X the In recognized comparable acquired sales we representing year year

stock closure, in the impact all contained which detailed in release. of compensation accounting, plant of morning’s are the tables effects Excluding of Oakville our press this and Ontario acquisition the

decreased brands our of revenues Generic points sales period, first quarter primarily mix non-GAAP product in Cost impact a franchise. the XX% of on result the sales of of in total XX and non-GAAP the sales established Cortrophin of basis net the net of percentage impact a current percentage new as to XXXX in of XX% year a from launches as annualization higher from favorable of

products, year prior Gel in quarter first increase of were Cortrophin with year-over-year from work million with in an to expenses March the three to period, related million $X.X the development ended of an and coupled primarily increase Research associated generic XX, the of XXXX. timing $X.X months XXXX, due in projects

general the Selling, by count in and increase the increased a acquisition. $XX.X million and prior transaction the year Cortrophin XX% million to XXXX, to quarter a $XX.X expenses $X.X Novitium primarily in expenses in tempered cost, administrative period, million related first million marketing $X.X Gel by head increased and compared to to in of sales expenses decrease due to related

with expense amortization ended in March XX, the three prior XXXX, million months and line for was Depreciation essentially $XX.X year.

million recognized prior we related fair compared in value the ended $X.X related contingent in quarter with reported consideration million of March the a to conjunction to accounting. this year During period Novitium to adjustment $X item. XXXX, recorded non-cash This is purchase XX, the

quarter prior recognized restructuring Ontario recognized our we in $X.X In were with period. of year facility. the addition, of associated restructuring of first the in expense activities XXXX, the million closure No Oakville

portions our action, in resulting have tables expected post-closure detailed morning’s results financial to both as the Canada in of non-GAAP one-time from be well the the non-recurring We from excluded as were this that measures charges as this release.

to available quarter $X million, million $XX.X as a first of income the period. common of was year to compared loss in prior for XXXX the net Net shareholders

compared per GAAP related Oakville was purchase to to the amortization Diluted as results related year restructuring $X.XX with -- coupled the Novitium in acquisition charges period. share related per $X.XX accounting prior a GAAP reflects per significant loss earnings share and share, activities. earnings

prior non-GAAP per quarter, to compared of a per share the the period. diluted share share for $X.XX On of an loss for per $X.XX adjusted we basis, had year earnings

XXXX an of million $XX compared new EBITDA million, reached $X.X increase for reflects from pull-through period. quarter Adjusted million performance. first prior This company of the the profit strong and revenue of record significant to the in the a gross $XX.X year reported non-GAAP is

a adjusted rose basis, EBITDA XX% million Importantly, our million previous of $X.X quarter in the record up non-GAAP $XX.X XXXX. sequential fourth on also from

cash unrestricted used sheet of in $XX.X from period. driven balance perspective, the by the in $XX.X operations million we cash to quarter $XX.X in cash compares a million. This From year quarter flow ended prior with of favorably the in million operations

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

In in addition, facility. we credit capacity our have of $XX million revolving untapped

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

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

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

for sales million Cortrophin’s growth, XXXX $XX between as to increase to SG&A revenue over at force $XX in maintain expansion. the specific we XXX% to representing We modest approximately to to XXXX. to XXXX account expect million, And $XX.X XX% XX% million compared continue recognized Cortrophin guidance a

we company guidance project of previously between XX% non-GAAP to gross as total now of And and issued compared XX.X% XX.X%, margin XX%. and

we and and tax XX%. XX.X an of million shares currently million XX.X outstanding effective continue rate addition, between to anticipate In approximately

questions. instructions. to we will that, announce up now call open please Operator, the the With

Operator

Instructions] our Wilbur from James. Raymond with Please Elliot [Operator We ahead. question Certainly. go will first take

Elliot Wilbur

Thanks. Good morning.

question Nikhil Steve First for and well. as

generics guess, drivers, the a do in or had in on dive new little of that granularity business, have emerged and on that or loyalty late have to little business, are bit base initial specifically. provide the the just line guidance? where follow-ups. March benefit continuation deeper Maybe in Was the anticipated, when of wanted into Just bit actual more bit whether you versus competitive some a trends XXXX favorable dynamic performance of I quarter brands that wins performance the over a you key then provided a what of and got over more in granularity you now seeing some simply And visibility just coming we you of early just the previously in the you are could terms launch from? I about is more a Generics perhaps if of little couple And dynamics? pricing off-contract talking the

Nikhil Lalwani

Elliot. and Sure. you, thank Good morning,

the to question, maybe So, I which take of second first the of these the of will special effects around part question, your your trends. is part what

ANI’s to look our and deliver to U.S. customers. brand operations ability established our Generics leverage other results showcases robust in So manufacturing in our to our solutions footprint segment and our agility

impacting medicines. trend We a demand our supply due factors, Now this right? this arising impacting and us there to access a needed structural to several patient business as to from market the positive much factors see of is mix disruptions has enabled capture

product audit manufacturing are site-related as XX issues company FDA are driven financial broader market Chapter there outcomes, from issues and Chapter situations specific opportunities. are and are such issues, there specific arising there There X

mix to to here and is remains and maybe excellence U.S. capture dedication is -- well and nimbleness will organization and and opportunities. with of chain manufacturing continue manufacturing, an these likely trend our these ANI as positioned the change. based While supply is to there This issues --

new reflective of represents first Steve our would organic businesses, Now brands this company, launch right? that, I four and our strength reiterate across quarter also of in continued growth as the foremost, established go-to-market Cortrophin include innovative all in of launches the Generics, impact his first remarks, these of the is performance product evolution And strategies the noted and and strength in business. of

So part of second that’s Elliot. question, the your

And March did the -- then on versus in now. we your first know part what on

reflected ahead we as wanted is and right? guidance. So point gave this time give we available and may any giving went March had trend So while visibility started we best the we more look to -- thinking best have given the right? earlier our the it the in some we in guidance So to have are we information that, at are us, reflected we quarter, raised in before

Elliot Wilbur

versus like Steve being Okay. as and I to you than Thanks, operating looks cash the quarter. increases, flow. for Nikhil. you the And a it’s a back of as well, in I guess, several just capital, generated matter, million like the more working usual going a we cash been guess, negative that follow-up for discussed of some subject quarter neutral Working $XX now, it’s it last Looks flow now capital asset periods but accounts. larger over seeing are in still

saw on course $XX performance contingent of balance be in liability the first that items we got EBITDA chunkier we plus full over other wondering and now have just increase the and you with versus that benefit that any what thinking to there the may year million how work your year, sheet? cash about So the should cash flow guidance, in conversion are the quarter

Stephen Carey

morning. question. thanks Yeah. the and Elliot, Thanks for good

rear amounts significant stand stand of within to the the so business are cash and XXXX year-end speak, XXXX Rare obviously, chapters that with be first of starting conversion So, we was just cash Gel the that to those have up with right throughout in mirror launch back line Cortrophin and on the ANI is we from pleased evolving dramatically to right, the right? in posted Again, $XX.X cash everything the where company in quarter. view it that very are using call we the and operations era discussed the Disease the March, to in calls million up

track a that healthy couple you that significant with and you a in were unlock we very have of cash when significant on the quarter, quarter. So first

would Looking to that forward, guidance. obviously with track we expect our P&L

the look confident by P&L very are increasing cash that having as expect in we Obviously, of business from think forward level I terms the we the performance of bit. lags the to So quarters. a cash and and generation track, an three we it next confidence

right? I your contingent highlight, I the I think, would about question the prepared comments about talked consideration. that few the And to -- So only Novitium chunky items, in

anticipate, So this the off of leg anniversary of in of we right, will transaction year payments the consideration selling we first have November shareholders. two-year kick and that do Novitium to will the contingent the

early about $XX.X second currently amount and a similar are we payment be So shareholders very due in anticipating a there to this XXXX. payment million would the year in would a be of first that payment selling and

we for clearly of great than and Novitium transaction the events of the as So are strengths indication only that has combined the present that our those planning ANI. expectations business pay outflows, but contingent to a and we fulfilled the have fact we happy it’s our into more clearly very because expectations, exceeded not transaction those are

the on the is from perspective which we outflow, about fully obviously and time. one then, right, that’s this an So is have talked at complete operational Oakville closure,

So to are target when track in exact Obviously, expect sale timelines. of the from for close, be that on That we our predict with Canada. facility continues completed will held but that can’t a and cash inflow nice it was on sale timing transaction. we

Elliot Wilbur

Nikhil. And question then Thanks. Okay. for last

levels continued sharp treatment these and positive asked initiations that in highlighted some thinking but from of of switches question? of if starts, potential You have be data new I in the relatively sense versus Cortrophin. the what new about any high is the as frequency, whether not its April. if Thanks. Do switches patients data low therapy there to to patient seeing, accurate and out of reason, that and terms in of what Cortrophin lot the are fairly from the you shows or terms any of new quality, indications that thoughts uptick marketplace, Some may so, are that? in to to competitor not you the competitor or and And trends the have naive impacted not uptake specifically sure your and as that’s were or your a pace, at patient not may record

Nikhil Lalwani

I you, think Look, Elliot. No. it’s Yes. Thank mix. a

So it’s in of patients there an there will ramped a awareness increase repeat increase as was up I patients number as say as we I our saying, is, prescribers, of that of to mix are as as well therapy, What obviously, naive and prescribers. the to switching. Gel, that the is, efforts Cortrophin are is well new

will is, Gel, with as see using that the the And and start prescribers, time so you parameters patient, engagement company. to what the many see repeat right? the enrollment they the The impact with from of fulfillment, the Cortrophin they use, of

think their their to right? shifting I those factors of the drives HCP usage, all -- about think

their mentioned in remarks of use a that, had years also the number reduced I significantly. that that prescribers over to ACTH or as And therapy just is usage my there stopped have used prepared

up for year-on-year, And are suite we of as awareness for in have you patients, monthly of so. and sort our according they use unit Gel, reintroduced ramped of why consecutive course, IQVIA, right, of ACTH seeing XX that that’s have Cortrophin the appropriate treatments for to they months increased need their patients into growth,

Operator

Okay.

We will from ahead. go next Guggenheim Divan Please with question Vamil Securities. take our

Vamil Divan

year. taking for Great. the my of results Thanks questions. Nice

competitive this saying in just but how more general back people And of launch maybe providers your added be then $XXX wondering place feedback I of or I a so in your what more a on any time of sounds are leverage think over to Disease So anything you potentially, the just One your sort dig about little you terms in and too questions, close sort to of getting the some there then additional if but leverage returning million providers, bringing a about much into the of the million, the but just any from your sort you just product or accounts you. now, taking? returning of, marketing the Rare little terms on to cost, run new discussion. increases is $XXX patients am experience bit the the the else to the added sort think, just to are would is assume on also What as rest Cortrophin behind bit behind also we the I for not of prior with getting year appreciate level, which like there reasons. some as cash in the talk all second also may if general, XQ? share side saw am debt competitor? Thank is for more. investing comfortable how you relative market, I and be performing sales meaningful couple up, your curious And could again, question much I receivable, level wanted of ratio, so in comfort Cortrophin, cash added you just curious or you assets? force plus kind potentially just can feedback

Nikhil Lalwani

Got it.

So, and good thank you, Vamil, morning.

one me your second on around ratio. last question answer and Steve your leverage let then let will first, the then So the and start I

have we costs. adding not any So,

no spoken When maintain in and we indicated XX% SG&A asset, Cortrophin added quarter’s at had previous earnings press SG&A than had call SG&A it’s we for so the year that that costs. we release we expand higher will through think our I expect last

that So that’s answer question. to the

in terms And things. it’s think, of general a prescribers, look few feedback from I

the discussions and that experienced, highly So our comment on they on focus on need, is category. and first right, the sales on our highly force and patient is trained sales the ACTH force -- they

identifying And is highly is it’s they for appropriate of, Disease a speak in need. right, I patients one this Rare right, engagement the product, think that that very because and

So I about. think the thing speak that’s first they

that think central reduced that to process, and market to of Cortrophin efforts I enrollment improving they the and launch comment the been as and in remarks I burden think our they access about the around second, has my mentioned our I sort Gel have that, they fulfillment there.

I patient of talk I they of all patient, And the that complex they course, of the and treating those that. to the of are and the the And impact with this about and be dealing have of part that of patients important, seeing third, reduced is I and complex is cost careful patients about and on equally cases again, to the the but co-morbidities of it. the what reduced healthcare is indications patients say system think these here, the underlying favorability right, are are because impact and they cost

I think those the would feedback from are be that the points, we the HCPs. getting

ratios, And forward. then which that on million favorable impact that will leverage your going of impact is the on last on Steve in with EBITDA ratio. a question let also -- and think very obviously, our $XX jump has Steve as our a I leverage very how favorable about will guidance we comment

Stephen Carey

Sure. morning, Thanks Yeah. and good Vamil.

your because trial important, the it’s of two just aspects, right? also to kind together right as we build rare leads and it leverage think look of business. kind then The I the disease cash, B.V. I the think question, out

There there is white. it’s this, that So answer as know, black to no absolute. no right, and think I I is important

of approach as business are We right, are flow obviously going different in flexibility, asset would right, is a read development that to terms profile. opportunity, its have profile retain we what we different approaching, every the cash and opportunities

pleased made and that caveats, with the those XXst the with there. kind see, we obviously, I as of position have we cash So of March are progress

and will we and -- for in we position. remain that this position focused with always of answered future just question, quarters our leverage as Elliot’s us build cash a strong to terms platform look we I is balanced to As

is hallmarks company for time, one we been of I some the have that bit years the have following leverage. folks of and to navigated the For remain market throughout how a think, conservative on the

we forced these XXXX, we with on to will, go do calls standup with order strength that of about comfort pleased right? very Disease gate launch business correctly are you Cortrophin in were Rare and Cortrophin eye for In we and forward. we the an beyond a out constituents, as bit right towards to eye and right our to an the And with doing and a launch of and was so look our zone as spoke if the what towards

are projected will and very we moment, here that occur pleased XXXX. are in current the as At organically to delevering continue that, we

position are $XX cite a a All of right, million. us of in these right -- prepared comments in know, going you the today, I position may better And business you opportunities. of untapped for back strength to credit factors did put through development the as approach facility better

wasn’t the in a Nikhil calls, right, given first in I time leverage XXXX that and That’s because would levels our that tapping be the citing while, at in into were I not XXXX. earnings that we comfortable

so, we right, another maybe the as would facility, looking that business. factors for grow at forward, credit all look And of to puzzle again, these the continue expect us piece we to

Vamil Divan

helpful. Thanks. you. Okay. Thank Very

Operator

we from go And Cantor will take Please ahead. Folkes question next with our Brandon Fitzgerald.

Brandon Folkes

the guidance, would quarter. you just better the Can those just can products? given why year of taking benefits revenue. firstly brands add and margin, questions million low end business, of strong we very you the congratulations XQ in margin for your lines, the help you Thanks expect and Hi. my run guidance? talk me if and Cortrophin rate if will there expansion that. through margins have I question, mentioned? were than this is close elaborate in second established not disruptions are the further updated base I about on the very any one-time with gross in on the just hand-in-hand you how to strong may the Along of understand see, base maybe rest due in getting expecting just I of increased the the we on it to gross quarter results. Maybe contribution the take are I further from the guidance, supply the Cortrophin the because just me, price on gross $XXX ask go Cortrophin And business, Can of just some the to the you especially sort

either about are in the early of of just perhaps talk business given the or XQ you. is of headwinds year? some just this you the conservatism in can one-timers in sort So base Thank the year how the we rest for

Nikhil Lalwani

Steve and and start you really can three guidance. I gross is the -- margin look, on in? guidance question of one implicit don’t our guidance Why your So, Brandon. evolution Thanks, Yeah. on question and question then the on in jump

new several where guidance new number with you also eight are record as factors, Cortrophin would our a this QX patient that on includes which and in based initiated new number but of XXXX, is And that the initiated of cases is month a we of had momentum record right in accelerated ago. XXXX, we right, finished appreciate, days April launch starts and Gel have seeing cases

first -- set the that’s factor so of And factors.

second And and of favorable issues, structural are specific of outcomes, established then arising from company-specific trend and Generics thing, such Chapter one question answers as situations product several across -- issues I guidance and the of audit our is Chapter issues, as impact factors site-related broader upsides such brands the the that opportunity. hopefully we sort And manufacturing from calibrate three. FDA right? seeing so X the this and financial market-driven XX And that

And question to question give like look, around benefits, a that reasons, for sensitivity to then your again would we pass. competitive price

would add around right? the wouldn’t price. it’s is Yeah I you and the driven add volume, more Yeah. think specifics favorability to Steve, largely anything? I like by want to

Stephen Carey

All right.

prepared Nikhil the are to this covered we I think to what question one. you speak and

Nikhil Lalwani

Okay.

Operator

with And Truist take next Fraser Greg we our Please go ahead. from question will Securities.

Greg Fraser

on of Good in on sure And established contract are something just this, balance missed outperformance? comment if not as wanted questions. morning, you. drove folks. that year? looks of have to to it out you you not, am first significant was how longer but that opposed revenue, XXX(b)(X) if there’s by the taking the like for other give for your us segments or think growth there the the if primarily any sales the brands those? other chunky to the Thank those and did know I about quarter the can update on the you the an And on Generic and breaking royalties on then brands updates programs, and driven growth I timeline no the comment quarterly separately, for you established Thanks give cadence manufacturing, Can

Nikhil Lalwani

All right.

The and Greg. thank morning, -- -- questions. So and you, three good

do on not are sharing We it, XXX(b)(X). comment that. for timeline information and not is, this on question first at the point, So we

the is there we will when XXX(b)(X) back So share more launches. to come on

on first -- R&D the we sustainable think, able being continue engine, stay continue with really about cadence by about talked and supply for Generics continue we ensuring reducing quarterly to always new look, strong our delivering therefore have launches, focusing growth costs on for that Generics, right, Your to and it’s question and growth excellence the competitive. the I cost continuously

the all that to -- the security, strategies, is And of it, center the three the with really we that product with at and then from from see will the launch security right? our believe business third able be supply we new And forward. that will we erosion heart of be sort business of from three in Generics and moving get so cost by growth the launches, we we new supply grow keep Generics right? from the will overcome excellence, And as

cadence. So that tells the a you about little bit quarterly

brands, established the upside is the And then within the question where from other royalties segment. and on regarding

mixed, it’s it I part from established a is brands. the think of while good

Greg Fraser

you. Thank

Nikhil Lalwani

Thanks, Greg.

Operator

And Livnat go we next H.C. ahead. will Please with Wainwright. go Oren to

Oren Livnat

everyone. Thanks,

is the prior have if implied guidance about Generics again, your you visibility, every in forward questions we But build guess, on going forward. line. looking I first, outperformance with had some start conservatism Just, from

do that high business think Cortrophin And stable benefits, a eroded pricing we going ups. Just expect in going then a talk forward forward? Does in disruptions a can brand normalization that guidance landscape, has obviously the volume, or brand competitive legacy margin And have on follows supply, et happened, a forward? conservatively whatever about, the that some which contributor, your is by you line bankruptcy, is I still -- business, revenue some cetera. offset you if going declining assume is

Nikhil Lalwani

Okay.

question I the was think your trend. on So first

trend, right? So, issues, broader impact market-driven spoke from the the and product-specific look, has Chapter right, issues issues, I financial times, outcomes, and structural with company-specific type factors, It FDA of audit couple issues of about manufacturing several that XX favorable opportunities. Chapter factors X

how is a upside calibration that understanding guidance And the the the mix cadence will so and persist. of in of from issues then and what see of these our you

the that that’s continuity. question on answer So

the acquired strategies full we we of of Sandoz from to business, So And about brands had go-to-market for established our brands, at in that’s bulk launched our number is to innovative years do partnership -- of right? brands then co-promotion. now for flow steps before, our there we established are of that on established as a spoken derm-specific have a taking with company sort that couple brands, we another ago, a

able So a insured local have full being can and customers. that provide excellence to our and a obviously, robust to a being the flow, that’s in products as timely that timely chain need customers supply basis as on on basis operational products talked we to ensure about, these these right,

Oren Livnat

get about no I percent follow-ups on, single in I wise concentration of in there, before the Can largest talked have Okay. Then percentage size the to you update revenue. And Cortrophin. contributor total product, exceeding past single Cortrophin, X you guess, product us actually I QX? product and have

Nikhil Lalwani

Cortrophin long by distance, a think, I right? it’s

Oren Livnat

Yeah.

Cortrophin. from Aside

Stephen Carey

with products diversification And I’d the in are in highlighted say, I’d very Yeah. Nikhil, we we product haven’t the say, past. pleased those still portfolio. the

Oren Livnat

Okay.

are et of I actual to demand appreciate really I on outpaced, end doctor you sort prior organic -- whether its and adds the coming higher just in sort QX, Moving quarter granularity But guess, growth? catch-up that front accelerated initiations that in you adds, if of conversion user if that you so more pull-through, patient guess steady through you giving giving about I new had new you the I is it’s a pace are specific are lower demand I characterize insurance And does terms that or I on this referrals launch on Has or think they or just as as wherever adds. you cetera. us can of adjudication, therapy not state may. than as is Cortrophin not pulled patient from? prescribing of existing of know

Nikhil Lalwani

the patients, are It’s the that per to Look, a Yeah. revenue and as the patients other saying, to right? Because patient, the new patients, right? growth simple pace seeing, adds, mix factors that it’s of revenue that initiated right, actually cases from generating the new as generating -- of of number it’s therapy. vials number not our there’s the time what’s go of it’s patient are of we number

number So there’s of different a factors.

reiterating it’s look high the our QX at and You -- the And look, we for year, in, in are right? of rest I done that, we have what straightforward say what continue. guidance confidence have will the that would we that mix

continue one we is the And while to are very we important specific month point simple best have clear yeah. look, that, are record that, making of intention of available number, you it April, giving that don’t as a I in our initiated information, and the giving investors and not and think the number we had launch cases have that, as unless new starts momentum, patient even new you accelerating is had

Oren Livnat

Okay.

into next question. segued of kind actually You my

sort are some forward higher -- just into patient, patient have with call units the indications I it of terms You on comment or looking pricing of We dosing others. pull-through? per in but in not indications range sort per have are mentioning of in of -- and long per increase value material can Can a obviously a you seeing getting kinds per prescribed longer se, the than that big guess, vials QX patient. you you

Nikhil Lalwani

difference no And are in not There’s dynamic. that seeing a No. necessarily -- we then… Yeah.

Oren Livnat

Okay.

Nikhil Lalwani

to are reasons. for we that talk seeing what something is not competitive prepared I am And Yeah.

Oren Livnat

And product underperforming acquisitions or the Are so, you you curious company integration about lastly, products, new I a as products a on well interested launch M&A. just might are kinds not really are pretty partnership, maybe the co-promoting you And things thinking that’s but the commercialize that in involve talk apologize for you the more looking or questions, at of if Disease set for that that to about up we more And all are looking company just space, situations? on-market could at. inclined or sound quite you activities? towards Rare you helping explicit I as are do am and/or

Nikhil Lalwani

Yeah. Thank question, you Oren. that for

what feedback. are So, that was mean, Rare have I the can leverage we been -- Disease strong was looking HCP I look, you earlier we infrastructure when for question infrastructure built. remember that asked And the I say about assets that do

expert I that The was highlighted the highly sales thing and we first have. experienced force

different three force and different nephrology So sales the and three we stands, neurology, into indications go rheumatology.

asset call and sort of the first and to of these you an three that’s that is a obvious of dedicated right? so pulmonology, that So modest obviously, So one asset just -- is goes points, person although into either it’s these pick that would be an then, one. team one

so is are too. just patient that, Disease leverages distribution, specialty can think right, assets I pharmacy that that that all -- market And support, of affairs, medical leverage one it the infrastructure, and Rare access, compliance, of second part

deploying we sets So at them are both looking actively of opportunities.

are your Yeah. are think best to sort of of from are we around asset, here, trying kind what no for question evaluating I -- so we ANI, and all that perspective. right? find what’s look, And blocking there’s that there nothing

Oren Livnat

so Appreciate right. big quarter. much. All Thanks it. a on Congrats

Nikhil Lalwani

Thank you.

Operator

I And Nikhil for over no call closing the turn at questions back to will there Lalwani are time. remarks. this further

Nikhil Lalwani

asked to you. and ANI and We on serving you everyone we the folks to reiterate in is need appreciate like questions. delivering patients thank well-positioned for in growth and interest updating you progress. our ANI continue you this who just Thank and joining Thank the sustainable time to And we forward that look to Yeah. your call We our morning. appreciate look, it.

Operator

you. Thank

Stephen Carey

you. Thank

Operator

conclude And for participation. today’s your program. this Thank does you

You may disconnect…

ANI Pharmaceuticals (ANIP) 8 May 232023 Q1 Earnings call transcript