ANIP - Earnings call transcript Q1 2022 | ANI Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, everyone, and welcome to First Quarter 2022 Call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during question-and-answer session. [Operator Instructions] Please note this call may be recorded. It is now my pleasure to turn today's program over to Lisa Wilson, Investor Relations for ANI.

Lisa Wilson

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

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

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

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

Nikhil Lalwani

Good ANI it's interest call our you you, the company. in Thank morning, join for Pharmaceutical's great and everyone, and have all to today, your Lisa.

headed updating First, finally, XXXX you and organizational second, on growth evolution ANI. QX the ahead four guidance opportunities capture providing you to have lie key the performance; key forward and that are today: looking total topics sharing covering are third, what we company; discussing on initiatives; We accomplished with for the we XXXX to for where full-year

quarterly million First, the an first performance, delivered of net revenues on we increase of in XXXX, year-over-year. XX% $XX.X quarter of

legacy result, As Steve Novitium revenues both year would will acquisition. the launches detail year-over-year. royalty the increased acquisition and Novitium, ANI product growth prior total the nearly have excluding and Yescarta was driven from new later, business the This by XX% of the from net

the autoimmune we this launched our a Cortrophin patients During suffering offering Disease purified and conditions, from Gel, quarter, Rare therapy. ACTH certain in lead business, choice asset in began

launch, Cortrophin During Gel achieved $X.X the first we quarter, revenues. net in million after

the driven the $X.X SG&A. in was year-on-year EBITDA by And adjusted non-GAAP million was the non-GAAP million. primarily EBITDA Our for Cortrophin launch-related $XX approximately quarter reduction of

Now, with you are accomplished headed what key and where initiatives. share let growth on have me we we

only nephritic over and XX chronic the due the Cortrophin treatment Cortrophin U.S. Our and for exacerbations patients option. first and Rare sclerosis one the further of Cortrophin protein acute our build announced multiple with XXXX, ACTH Gel and syndrome. to unit. potential lead Cortrophin including help Gel Disease excess rheumatoid On franchise, asset patients arthritis, available of urinary XX, disorders, commercial a purified Gel certain initiative is successful business of reintroduction has to to Gel. we years, autoimmune January had of availability The launch

almost with XX% XX% dedicated sales force our sold, Disease XX executives, And progress launch reached since of and our account and sales already Rare and teams, therapies much commercial sales our be We cross-functional of credit approximately are force. i.e., with weeks our to Initially generated must and prescribers a clinical enrollments given new pleased XXX ago. world-class patient. of Gel have relatively of including Cortrophin are already more than across are experienced patient since and distributed of for having nephrology. cases rheumatology, in one launch evenly specialties our unique enrolled awareness Over Cortrophin XX% targeted unique targeted therapy has XXX and over initiated approximately Gel. interest the prescribers prescribers neurology,

are formulary we million been over Our case our one last or and lives XXX trajectory where initiation average more of Equally million a important, growth patient XX resulted lives and new number approved in has from per market strong efforts in with have cases to new the reduction dispense. week coverage the advantaged. in for for FDA indications patient access time

XX% Our cost other ACTH acquisition only available. therapy the lower cost wholesale than approximately is wholesale acquisition of the

patient addition, for expanded patients organization the and journey. Cortrophin access remains our Gel on throughout caregivers establishing to In their services treatment focused

Finally, launch sales and performance the early our in May in trajectory. reflects April strong

is to made have time. XXXX of a in $XX growth next issue The to pleased for progress has on to about from revenue Gel our well of will initiative combined our business We and speak we are continuity R&D very in continued acquisition. execute million the range of team such ensuring synergy capturing good million. the short combination. I through And growth capability driving operations Novitium key The by generics Cortrophin enhancing the $XX guidance business

IQVIA the Misoprostol, of successfully such or $XXX fewer counter three and several of majority business as we XXXX, helped of Successful and new of Rifabutin, quarter impact first these the size of having Bisoprolol products million total erosion. launches launched market the with competitors. launches these During with execution

Shanmugam leadership help pace deliver in expect business new of R&D ANDA to and the The new continues with growth in for of the We to QX. under filings subsequent quarters. generics launches our six Samy value drive organization the

of securing sustainability increase our the products remains in ANI its approval Today, therapy, and the files leadership CGT applications to the anhydrous betaine competitive pending solution. In company CGT product The generics of retained over ANDA focused the FDA on development. approvals pipeline XX generic XX multiple over under addition, has XXX(b)X business. company and strengthening with with further

operations, progress our We efficiencies distribution. very procurement have good also made on and combined in driving

efforts the to increase area further cost drive will in We competitiveness.

I brands turn to Next, our will business. established

for and augment to through capabilities. are are continuing In organizational asset parallel, fit bandwidth well capability inflection the innovative evaluate portfolio to commercial past on invested commercialization acquisitions and in becoming of to ANI a our has purpose and We organizational potential current support we biopharmaceutical value capitalize towards evolution and accretive point significantly the our maximizing leadership is and strategies. leading company.

rare over recent of President's Rare top Our has sales XX% Club Chris team XX lead nearly a Disease equivalent product And leadership launches. Multz, has years. award by team won the in or experience sales XX disease

With me turn a to of let the it record has guidance. full-year team track new to financial Steve delivering company over R&D generic Our prolific launches. and share the limited results competition that, total

Steve Carey

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

please results, I mind quarter first was our of keep As in first full review Novitium operations in the results. quarter that this our financial consolidated

Cortrophin sales addition, first launch the which marketing we In in reflecting marketing are sales is are cost measures and in quarter in period. our we cost non-GAAP profitability and post the it now that

occurred ended of driven product Novitium first royalties For significant net quarter $XX $XX.X launches million the across $XX.X XX, the development March Kite revenues the In tempered posted period product non-recurrence total the total, of manufacturing, to from was acquisition This contract Pharma. million from our resulting royalties, of as services the final revenues the prior XXXX, the million. first from year or generic Yescarta-related that the and and in of the compared pharmaceuticals, of the of we by new royalty Novitium recognized somewhat three of months quarter item XX.X% by XXXX. royalty $XX.X material acquisition Up by comparisons revenue. offset benefited categories million income non-recurrence approximately gain net revenue XXXX, by nearly in

net prior nearly pharmaceutical $XX which driven XXXX the was principally year-over-year. period. launched from XXXX. revenues associated during revenues September acquisition ANI sorry, in products result, $XX.X million September am net Novitium or prior the were in of $XX.X as the months March of generic The sales XXXX, as total for million Excluding in of would an the Nebivolol Yescarta -- have year with royalty million from $XX.X increased XX% three well ended Net the year of increase by XX, XX% I revenues increase million

early million in royalty the revenues were XXXX from revenues April continued products, revenues and branded product selling million during million Sandoz months prior pharmaceutical the entirely and in XX, prices. during increase during for case XX, months mix ended three XX, from service Pharma of $X.X ended market inherent Net were higher rare three orders, XXXX. including $X.X the $X.X revenues million and an dispensing for arrangements, natural Royalty payment for days million XXXX, The modest overall a in three These products Gel, increase million figures manufacturing to increases of the sales March same million final aforementioned for several other from March of $X.X other of license revenues rare year product that and lag Contract a March volumes the development $X.X recognized an due net the a of period Kite in the ended the that those ended the million March the the Cortrophin consist of launched million products during during quarter generic first launch. average XXXX, Novitium $X.X in with reflect recover in acquired in in XXXX, XXXX. agreement period, due XXXX. royalty in new increase as new primarily $X.X towards of months $X.X months compared saw million in COVID-related revenues across shift revenues. XX% including portfolio increase $XX.X related totaled the consisted of XX, and driven were Net to and of XXXX March prior volume the to a three product and the initiation disease a $X.X XXXX. products compared under of of XX% year experienced ended XX, disease of the segment the contract to Novitium also decrease An pharmaceutical by suppression Royalty between was sales Yescarta of period, manufacturing sales XXXX. to is recognized revenues. three to the We an million in the for $X.X months in and the was increase

million during and period. of XXXX, the the increased the increased million sequential expenses no million XX, $X.X XX% very arrangements. million pharmaceutical XXXX, year in depreciation quarter to costs sales the by value to up increased Cost including of were comparable period. cost by products. first prior prior Looking ended to tied three related of million representing primarily in sales, sales of excluding Novitium to million for $XX.X as by There compared Novitium excess the in in remainder amortization, from strong included a result The anticipate period, year. growth rare $XX.X the $XX.X products the of forward, $XX.X of of March year charge in during a volumes, inventory months partially of sales million $X.X disease for $XX.X prior to business profit-sharing decline quarter-over-quarter the acquired Operating we year fair offset over combination, cost the

by impact prior accounting, to which generic Excluding basis XX% mix sold, sales. increased goods year no compensation, in had the points percentage XX.X% non-GAAP a in year of net driven of and was period. increase XX.X higher royalties, revenues cost total acquisition, as the on from the of Yescarta stock cost a of sales non-recurrence the a of of and corresponding current This

primarily expenses Cortrophin the cost tempered Research an XX% $X been million of from Novitium increased decrease flat of first approximately efforts. to of Yescarta associated basis cost $X.X a XXXX, with in completion XX.X%, quarter prior a the development have calculation, development with non-GAAP of would essentially year. the million, in due the of from on and expenses current good addition the increase Excluding to by our year

transaction decrease to and ended to expenses XXXX. strength the by During expense to quarter intangible on $XX.X compared $XX.X million to related in increase with period first in to the a $X.X of we increase amortization expenses activities, the same XXXX. million an addition of $XX.X general, marketing increased compared partially the expense $XX.X ANDAs Novitium primarily by to XX, and primarily transaction. increase R&D FDA the XXXX, related $X.X million the of expenses quarter, offset XXXX, and million primarily result of six our related million Selling, This assets a for three the of filed acquisition. new million million $XX.X Novitium was administrative in in quarter of launch, the in and for Depreciation months March the is headcount the in amortization $XX.X acquired and Novitium increase the in of The sales reflects efforts. Cortrophin comparable million

Our reflects commercial with step up Cortrophin. and share $X.XX expense GAAP from Novitium launch inventory the initial and acquisition, coupled our net charge, significant loss per amortization behind sales resulting marketing of the

the to first the quarter was $X.XX cost to the was for non-GAAP Cortrophin quarter it quarter $X.XX diluted As our quarter, related Adjusted $X.X in compared non-GAAP of XXX% relates that share to costs, XXXX. for pre-launch first and such first of were million this sales And our the share of diluted $XX.X the for earnings expenditures. profitability as XXXX. compared to million EBITDA added non-GAAP of per loss marketing adjusted reflecting period first quarter the per we period, as for current are back prior measures,

sheet, cash debt balance March of million quarter reflective lower net million, million XX, face of utilizing support cash efforts. our value in cash unrestricted total of XX, net of we launch to XX.X compared cash and debt March to Cortrophin $XXX.X we as December As cash, XX $XXX.X utilize of the equivalents, unrestricted was had hand as as XXXX, on on hand of and of the the

our momentum, for On release. guidance projected attention Cortrophin we company guidance, compared development to between in million forward-looking today's non-GAAP adjusted and $X.XX total basis, increased $XXX the and diluted $XX million to million, non-GAAP EBITDA are between million and XX% months representing expenses currently $XXX.X XXXX, company total $XXX recognized and turning million and providing visibility revenue as due net to ended Now, and share the launch $XX Research XX XX, anticipate million, XX% XXXX. $XX December with between per $XX a million, growth approximately adjusted to $X.XX. between we earnings

and specific million. selling, million addition, measures: and $XX providing general and the direct expenses $XX million Revenue between Cortrophin we million, between purified $XX Gel administrative are In following Net $XX and

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

Operator

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

Elliot Wilbur

Thanks. Good morning.

change given for the like Just a business, should doesn't we think to looking couple your with Steve, well. to cash back to there about was need versus confirm the wanted as guidance of Nikhil upfront how Cortrophin to then, for connect generation balance first, that. support have on respect just guidance just operating the quick early a ones And for over anticipated outlook then, launch? flow provided the of look to couple it but in initial updated I base March, any EBITDA And the continue year, got the

Steve Carey

the question. Good Elliot. Sure, and morning, for thanks

morning So, yes, this are guidance your spot regarding observations on.

support selling as the in initiatives to cash, that all business in of The are is look lift for trajectory know, the for projections, our essentially are business the regarding So, there. spend quarter the are and obviously on then, outlook, ex-Cortrophin, heavy Cortrophin confident to we basis, starting business, ability confident and we the business. guidance. the terms are at like flow occurs well we overlaying very provided really associated quarters, expect the revenue earnings as that of base from you you morning, regarding guidance remain as of remains quarterly the the yes, first seeing on as recall, how support streams, right, of P&L the guidance the to guidance profit expected, the previous gross unchanged where from you cash key the cash and guidance, over we and call And product Cortrophin in divide-by-four given very will quarterly days so which portion standalone our develop the in we marketing when three next early of when the and and the the zero, that the position then the this completely overall last launch, Cortrophin we you the and our building operating

degree And we support turn the I the back there. questions to it ask two in a and the -- quarters, first So, quarter, four, for confidence your to will through nothing you in in have unexpected to forthcoming following business. high of Nikhil the

Elliot Wilbur

the ACTH that to some the during the just of expansion Not the you a early Cortrophin maybe maybe to seeing on Cortrophin just point other -- the the that launch pushed of if these perhaps -- of at diagnosed [forges] respect questions trying out that thanks. are respect respective or therapy initial between maybe Nikhil, ailment bit with So, to they've if new Yes, get of from in due to therapy, indications patients. the been switches seeing in Are just with actually surprisingly are been of with a wondering have Gel therapy just leading provide time sense their patients that some [Ph] the detail they some issues? could terms had the couple to is market marketplace? the as of you these to and on of launch. are been opposed a to are competitive sort market early product source market, little the success you just the Cortrophin access more patients

Nikhil Lalwani

have I'll he additional Rare so, call, with Yes, of and chime you thank Disease, for Head start in the Elliot, and Chris good morning, so your we on commentary. then, our questions. Mutz can

intent early our areas is and new it's or on I focus is going target neurology, target the just have we not But the dynamic that enrollments prior what right new the that to volumes gate, your so and have in not that that, back days know, patient us the the months, at other starts. of that of seen, launch, are XX current, therapeutic thing higher of the out prescribers did is purified with we ACTH prescribers, but that clarify of reach well as believers we interesting, of we periods, therapy. question, that additional that prior so, to you to prescriptions, think prescription I prescribers the the had period that believe, definitely to launch nephrology, is think to expanding Gel, and seeing answers with in prescriber leads and specialties confirm is, the we've answer benefit And the our last both are that that is number rheumatology, this us right, I question through giving access started there. the the What from think first group, the the therapy, which was patients your looking and within of in -- we the question, your to right? Cortrophin in are there can

at refractory when analysis, said who would last Chris, which see of who than epidemiological [reframe] primary the I earnings need therapy. ACTH how the shows you indications claims-based call, right, like the something therapy. I a and look That's market [Ph] XX% Now, patients you that this were at resistance and receive across that less is steroid add patients that we anything? to

Chris Mutz

thanks Thank question, you, Nikhil, the Yes, sure. for Elliot. and

identify in conversations on Disease patients very who with benefit And sales are dedicated has patients from really physicians focusing really focused from could been that clinical Cortrophin we past the and will are think on focusing focus. with experience primary I our Rare new therapy the more who that ACTH-based a comfortable clinical I who are Gel. discussion team. as am

are to [indiscernible] of currently said, leading vast Nikhil starts as so, patients majority and And launch. new these conservations the

Elliot Wilbur

and sort identifying can into terms capturing in that at occurs. morning maybe ultimately Rx And [this] Chris, which a encumbrances of hurdles [Ph] of us of in to simply the give those cases. just just are talk ultimately follow-up looking Could the mindshare you about some and Okay. you release in then turning patient just just insight on into what little level language getting bit -- one the for and new you, physician then talks generating Rx And about patient of therapy. then the this shorten your question period

Chris Mutz

Certainly, and from product turn expensive, Yes, of are these rare we therapies into often the of the few headwinds in initial first in new commercial any denials space sure. quite insurance months launch especially plan. disease where

denials reimbursement that been of has work that really has Cortrophin internal the been the of to And needed with to have and get trends key on. headwind kind as -- package the data and using that's and so, I in office experts those well the as prepare our initial denial kind think ultimately really managing overcome early to business team approved we hub field our

the So, that that's patients, that in what we pathway confident we in [art have sure. to have But place and [Ph] that experiencing, are for really improvement. teams for are we of terms for] we improve fulfillment seen

Elliot Wilbur

are Okay. And just you -- that's seeing

Nikhil Lalwani

Elliot -- So,

Elliot Wilbur

Sorry. products to? we products first XX just cover standard your Is in the the in hurdles were that new new payer, you that don't -- of type referring months

Chris Mutz

Yes. that certainly say I sure. would for period [indiscernible] that mean in I months, of three-plus first this we're

Nikhil Lalwani

may I that things. One written prescriptions think clear, if what of new are to to build I Chris be XXX just case the is XXX for. patients over initiations Elliot, couple have prescribers So, said, just

have million approved getting or formally thing for So, indication. good Then over XXX second the one least to for progress FDA made I at think on lives just coverage clarify. thing more they are is that's the we one where

as Chris as Gel as in by obviously, helping we takes So, the in The it Cortrophin the average process. been cases new fast to look, part But, the launch. from when to months And are on seen last and very coverage we time dispense I progress first is improving payoff initiation place. we encouraged vials to new of think has X+ case the have approved XX and to fulfillment initiation has hours case some varied shipped in move by have that's during enrollment said. the dependent say the fulfillment made coverages time to from patients the

classic. classic And acceleration as this said, read pointing we the right And you the of we this too, full-year factored is disease for out as out So, of this rare guidance. time as to is our gate. enrollment this is -- fulfillment Chris were out

Chris Mutz

you questions. thank All for right, the

Operator

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

Brandon Folkes

Hi, the at can talk cases maybe patient questions. from any taking on out cases about the stocking you many actually XXX many just quarter? initiated the first quarter, prior stage are in and Maybe my scripts this versus thanks color they're XXX paid maybe not building question, how on any for first of funding, patient how of in

Nikhil Lalwani

Thank Yes. you, Brandon, and good morning to you.

just all I cases paid I how your make to And many quarter questions, second for how you apologies, repeat XXX -- I XXX were after is think initiated the that, end. could of sure question how me, of of your got first cases; your please? is, third think the are question one second three was the many many XXX the the

Brandon Folkes

the the Yes, recognized quarter, million color revenue in $X.X just on any stocking?

Nikhil Lalwani

Got yes. All it. so, right, Yes. yes,

the product. the are $X.X of will cases these XXX revenue clarify on the the cases processing right? the you these clearly on I that answer seeing patients of versus with anticipated those patients of is for therapy, on paid expect, versus we terms the give moving of had right? how line on portion we're However, non-revenue off of not, think what is the quarter paid have what we generating of fulfillment is a cases one, therapy, we're what million a many patients you as will the in in as number I mix of reflective holistic majority I first one, we that not therapy, vials, obviously can't in that are of be cases, launch versus on is and this So, to paid XXX, right, enrollment for So, would

So, that's first.

I split, second the is the the an of of think the the per enrollments don't weekly week have have of after this, increased trend, number the but XXX, close many inpatient new quarter? how have week-on-week. exact I been of initiated

about, there and eight, on is were the of a weeks January XX, as us, you they launched first remember, clearly trajectory, clear it, we let's call quarter. so For nine upward

new that in April data full-year million and on So, that May, seeing that's the case $X.X there $X.X like, we million not we IDMs. a revenue, improvement also increase a looked majority I a the specialty have first there of and indicated the for my And we trajectory, -- been in of I network guidance. to first and of distribution, question we that that then, comments at we that has the And pharmacies we -- are in and clearly the significant highlighted part prepared in stocking the sales, during in momentum, revenues seen quarter, an and and third number. are as hospitals was our our give in a using almost Remember, the quarter, and large the is distributor then think for generation.

of first limited stocking, is quarter to our understanding. And so, number best the the is -- in there there

Steve Carey

Yes.

been upon to right, if we've it safe units add also that, quarter largely, consumed. be the that seen in April have suggests would that think it that the May, Nikhil, to first I entirely reorders based and not

angle that So, I think well. question that's on as another

Brandon Folkes

that, for you thank Yes, Steve.

Steve Carey

very much. thank Okay, you

Operator

time. this further There at are questions no

Nikhil Lalwani

Well, to journey for being it's unreserved deliver us and call, quality joining to on patients, while high you this Thank the everyone on us yes, right. me. creating medicines All to shareholder back value. with

with begun. and Thanks are stay how We again, XXXX well. pleased had

Operator

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

any time. may disconnect at You

ANI Pharmaceuticals (ANIP) 10 May 222022 Q1 Earnings call transcript