ANIP - Earnings call transcript Q4 2024 | ANI Pharmaceuticals, Inc.

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Operator

Good morning, everyone. Welcome to today's ANI Pharmaceuticals Fourth Quarter 2024 Earnings Results Call. Please note, this call is being recorded [Operator Instructions] Now at this time, it's my pleasure to turn the call over to Ms. Lisa Wilson, Investor Relations of ANI Pharmaceuticals. Please go ahead, ma'am.

Lisa Wilson

you. Thank Pharmaceuticals Results ANI XXXX QX to Call. Earnings Welcome Insight Relations for is Lisa Investor of Wilson This ANI. Communications, Chris Chief me With on Officer; Head Carey, Chief Rare Disease today's Lalwani, Vice-President business. and of Financial ANI's Nikhil President call and Officer; Executive Mutz, and Senior are Stephen

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

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

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

Nikhil Lalwani

provide Chris Thank and by and we thank quarter XXXX ILUVIEN, including and through Alimera. our lead business, added Gel guidance. and which us. Good Rare of our acquisition start highlights performance everyone, color morning, our I'll on YUTIQ, and additional discussing you Disease the year you, will and our joining Today, Cortrophin for full fourth recently asset, Lisa.

our fourth in guidance XXXX review quarter results will more Steve Finally, and detail.

brands we'll have to our guidance prior based launch structure. We to XXXX million for pleased reporting start in and to and in for on XXXX XXXX in adjusted first demand total confidence results seen now our of quarter raising under past year full revenue generics of record for to your are increased a report of fourth XX% remarks, represents Prucalopride expect quarter our XXXX and over strong further Following XX% our now guidance exclusivity, million. our upward in The the as Gel, Cortrophin versus growth with the non-GAAP questions. We're is we $XXX of million is guidance take referred segment XXX-day our the higher as demand $XXX and new established revenues portfolio, revision to brands which $XXX for with million, which $XXX EBITDA.

with of quarter growth of over in another capped We of non-GAAP $XXX of asset, this for excellence Gel, and to above record guidance launches, adjusted strong third double-digit for was guidance. of growth, our rare prior business. by business just straight previously operational generating delivered diluted EBITDA, our in in Generics of of growth by to specifics making net year XXXX revenue sales adjusted to primary XX% was $XXX XXXX financial Cortrophin disease our our EPS, execution provide lead and fourth revenues, our coming XXXX million. on Disease will guidance close $XXX reflects adjusted growth year. Rare XXXX announced ANI $XXX total full to the the million, non-GAAP driven with non-GAAP EBITDA driver our million which for top-line versus million Steve expect year our more And $XXX launch. since year product XX% achieving million the all new third XX%

disease Alimera with our our with Sciences the expanded the in we in franchise presence to keeping of rare space. September acquisition rare in XXXX longer-term our broaden disease addition, In in strategy

executed prior We refinancing and also successfully capital the and put place structure. efficient our effective a of in debt more

quarter Turning now results. to our fourth

ACTH trajectory. therapy growth remains still substantially plenty as-reported YUTIQ we is providing quarter multiyear on saw Our EPS in financial were several strongest higher with We Total The was XXXX. on a reflected XXXX. rheumatology, full contribution for product EBITDA highest XX% performance and in million, momentum today of demand quarter launched ILUVIEN strong on the a the in number XX% was increase category cases fourth Gel quarter, an $XXX.X of in targeted by representing quarterly XXXX, over years the of new January accelerating and organic starts ACTH continued on increased Cortrophin revenues $X.XX. pulmonology across continued basis, during strong to Gel ago, quarter patients all history. specialties, since an in while revenues neurology, the returned non-GAAP headroom brands. Adjusted the for overall our basis of was quarter growth and year-over-year The new driven fourth the for from lower $XX nephrology, both million the and million, number ophthalmology. Cortrophin expansion. up than generated Cortrophin growth our demand for non-GAAP initiated XX% and patient generics, adjusted $XX.X Gel, demand and of

$XXX our initiatives and for appropriate grow strong will in continue XX% between expect the of benefits forecasts talk revenues therapy to further ACTH increase Cortrophin Gel. and demand more to We momentum the in and drive our guidance $XXX XXXX about XXXX. Chris new of to awareness million patients Cortrophin for million to XX% Gel to

and the generated in revenues quarter. YUTIQ, Our new products, $XX.X of ophthalmology ILUVIEN fourth million

of acquisition Alimera. of the full first quarter Our ownership following

as to rationale order in are that which potential as Cortrophin ILUVIEN proven well ophthalmology. We A synergistic versus room and of capabilities YUTIQ, the Our expanded strategic growth ophthalmology, -- Cortrophin is the of disease leverage growth in team new ILUVIEN add the of Cortrophin rare and our for and the products was as QX. the Gel of believe for accelerate starts assets doubled ophthalmology in both QX with in infrastructure, and accelerate Gel unlock given core significant commercial there YUTIQ also market. Alimera to Cortrophin acquiring and novel size in addressable growth significant well drove the of sorry, nature as patient execution Gel for long-acting

taken initiatives. are We on these initiatives and growth to to execute capture have will steps us continuing enable that

sales acquired from Alimera you. expanded representatives XX XX we and team promoting these lay me we XXXX. sales in Commercially, YUTIQ, that approximately out Gel Let for mid-October of who to Cortrophin of began U.S. reps, the ophthalmology ILUVIEN,

drive the trial to markets, as and and international clinical NEW markets We partner growth clinical are continue in SYNCHRONICITY Germany both to markets such DAY for as invest continuing we such Clinically, invest direct for Spain. behind France to trial and ILUVIEN YUTIQ.

are For NEW DAY, expand journey ILUVIEN the of DME clinical could use positive, results anti-VEGF patient the earlier it if in trial in the therapy. with significantly combination

data supply we steps and of We from ILUVIEN XXXX. Operationally, for trials increase security quarter the in second both YUTIQ. both have to taken expect preliminary top-line

manufacturer for contract Siegfried a we with has ILUVIEN, for our partner years over For been ILUVIEN our for years. until Siegfried reliable partnership extended X XX XXXX.

through part to manufacturing Irvine, in Siegfried upgrade existing addition capacity the a upgrade manufacturing California are on-track. equipment to line significantly on this expansion of Both and the As of with expand a expansion, and equipment capacity line. agreed the partner we second initiatives

of a label. ophthalmic acetonide. with with of same submitted to And prior both approval of milligrams eye We and the fluocinolone. PAS transition ILUVIEN almost identical ingredient, X.XX Siegfried non-infectious in of chronic X.XX fluocinolone and or ILUVIEN the active or been are executing the YUTIQ XXXX. We YUTIQ's FDA NIU-PS to affecting substantially manufacturing also indication the have posterior of YUTIQ a ILUVIEN similar to uveitis having the strategy milligram the add to supplement Note, segment having fluocinolone implants YUTIQ strengths to

submitted fact, both X.XX used implant. manufacturing milligrams with fluocinolone on results for of prior with acetonide. The FDA engaged milligrams engaged the to been per the ILUVIEN in submission, period run FDA's In a We the DME clinical the were we X.XX NIU-PS implants of during newer review strength on and for the Since exclusively order understand an process requirements aligned the submission agency in second action the trials and quarter. PAS in regulatory the have expect application guidance. with and PAS with to

approval, efforts plan transition we for to chronic Following ILUVIEN. indications NIU-PS commercialization to both product, DME a and the single

the already a will for agreement supply and of XXXX. the reminder, positioning U.S., a including for both these and As and agreed Operationally, effective for supply multiyear Middle and European an nonrenewal to ILUVIEN with above initiatives outside East. NIU-PS with X the both in and for security ANI the conjunction franchise May significantly countries growth of current YUTIQ, is trajectory. In EyePoint have ILUVIEN YUTIQ enhance the DME approved XXst, date initiatives, strong marketed

to our guidance now YUTIQ. ILUVIEN Moving XXXX and for

QX ILUVIEN YUTIQ that by YUTIQ products. and by insurance QX, QX sales Typical be resets are QX Our impact lower to similar million. than patterns net as driven was ILUVIEN for products and QX $XX.X causes for such purchasing and other to levels

the in In important of for ILUVIEN's addition, the Medicare reduced January that particularly U.S. YUTIQ ILUVIEN will have QX impact patients, since for DME access added has change which early and for is market XXXX access dynamics indication.

to and YUTIQ each understand market ILUVIEN epidemiological Xx higher population commercial to their refining for working and fewer changes accordingly. the approach and of back estimate addressable that approximately there each X,XXX We with XXx the the for overall to on therapy picture, is HCPs patients are data. response currently are to based drug we on than patient Stepping our access

to are prospects while products and remain growth in we our So NIU-PS. of DME confident both through, there work topics for the near-term

ophthalmology YUTIQ. drive the runway commercial million our sales clinical in we will we about we that we significant for strengthen further ILUVIEN $XXX detail and beyond. business, Chris foundation deliver expect product's enthusiastic And XXXX to and will transitions for the growth our and these remain dynamics initiatives expect through to XXXX, $XX growth. As market through million of and in quarter-on-quarter long-term

delivered the our from strength an to with quarter coupled product fourth now $XX.X launches. of new X% another business. with Turning contribution of million, performance quarter of our in over business, reflected increase XXXX. Generics We solid The revenues base

We deliver our billion to to footprint manufacturing continue U.S.-based X patients the in leverage U.S. doses over to

and X submitting securing was XXXX team or approvals, new competitive productive in ANDAs new including R&D with Our XX CGT multiple designation. generic product therapy highly

in XXXX. We are the retained in that approvals #X we proud ranking CGT

early these tablets, million branded December, $XXX in days XXX approvals we into a launched with exclusivity. Prucalopride which of of One late was January market

to market with be our of testament generic to quality is team. this important R&D ability the Our a to first product

growth excellence, high-performing R&D low manufacturing our by XXXX, double-digit expect our operational year We footprint. another engine, business U.S.-based supported for in of generics and

patient address and to which portfolio, supply, development with established of needs referred brands Our we continues to commercial to previously opportunistic set portfolio. the capabilities, unique reliability as business of brands, a expand

and margin, portfolio businesses Our this capital generation high strengthened overall is low gross strong business. flow cash of by working

quarter XXXX first we seen periodically fourth increase in and experienced in as portfolio During into past. the of of have XXXX, quarter the our the brands' an demand we for some of

demand by Our guidance reflects quarter in new normalized return more a quarter. XXXX run-rate increased in a followed the the second to first this

Chris? forward accomplishments team in As of patients, the collaboration customers, XXXX, significant now the Mutz, purpose look improving lives. I'll company's I and our Disease. delivering ANI serving and thank over Head of for reflect call entire to our our to would partners, contribution Rare Chris on I suppliers, turn like our on year investors, of their and to

Christopher Mutz

Thank you, Nikhil, good morning, and everyone.

reached demand Our newer pulmonology, as and initiated demand both arthritis particularly momentum physicians. Prescribing roughly starts for and starts of is ramp gouty to targeted in new flares in indication gateway many the patient a growth new of Cortrophin team represents the Notably, Gel continued cases expanded pleased to serving quarter from for disease prescribers, across to and doubled quarter. therapeutic existing Gel across therapy. number of approximately strong broader larger areas. as Gel XX% neurology, ACTH sales from Cortrophin only ophthalmology, see the our Cortrophin growth ophthalmology. which specialties, new a We're of our to group drove gout third the all acute nephrology, fourth ACTH We and is patient now that record our quarter. are and approved continued activities the Prescribing rheumatology, rare team therapy In also for the use. new ophthalmology physicians for new saw levels number strong promotional

health gout of the Gel XX% approximately patient a for For therapy. prescribing their Cortrophin care time, is patient first professionals on first

XXXX. the Cortrophin gout driver We indication a expect key to remain growth Gel for in

sales ACTH market product ACTH treatment and recognition of recent appropriate a for competitor. given approximately is reported XXXX believe on on based The As for is Gel Cortrophin about as multiyear safe We the overall overall a the Gel and Nikhil mentioned, growth effective the to million trajectory. by our expected Cortrophin to the guidance growing Cortrophin XX% is other we category. grown the strong by for believe $XXX in reflected the growth for dynamics Gel patients option ACTH have

the diseases. for peaked previous and a be is well exacerbations ACTH of historical of and levels. flares of our level data, in X addressable could many While below growing, years for on disorders high on patients ago. believe the prescribing significant we patient of the to analysis therapy be the is number category on XXXX. Treatment autoimmune therapy patients market than need claims times population half inflammatory continues unmet ACTH now approximately of is the larger We previously the still ACTH therapy when believe Based

is for to therapy indicated Our our of It's expand noting ACTH need and options that to certain disorders are the approximately new which Gel our category, in the and need the for treatment patients in that the of worth ability for the anchored Cortrophin prescribers for. illustrates market. Cortrophin autoimmune prevalence alternative belief is XX%

with has taken and steps dedicated flares acquisition, is strengthen And driving ophthalmology much targeted therapeutic therapies over growth and have nephrology. who alternative see therapeutic We've greater strong we area. We've quarters. also in in messaging We several with already continued a larger exacerbations. prescribing teams with resonated grow that also the pulmonology rheumatology, franchise patients Our and physicians launched who sales important autoimmune in team the important Alimera severe disorders for sales continued seen of Gel Cortrophin this our last and need to ophthalmology. the initially now neurology, areas

the for and therapies disease and the therapy, be and additional physicians. quarter due investing of of our unmet the these team rare February dynamics. We're initiated initiatives all-time the seasonally in and size The recently improve areas on largest increased help to number physician also new high team to sales of tending Cortrophin cases promotional our patient need quarter, we the already resets to first in view sales Gel expand of our in Gel to monthly new Cortrophin other the reached to market ACTH contributed a growing and to in Given has the utility efforts despite low convenience. insurance number prescribers

initiatives that continue have prefilled benefits self-administration. forward Gel the patients presentation we prefilled for expect as on to second in who prefilled to the the franchise new Cortrophin this syringe in also Cortrophin more launch exploring to a convenience the the to treat in potential providers and multiyear We XXXX. the enhance [Technical committed about ideas reducing starting to Gel quarter patients growth Difficulty] We're and them, in investing the physicians our of we believe these and review sharing FDA to We're for are needed under The the continuing of we health provide steps strong details deliver in Cortrophin care available forward Gel Overall, syringe look advance excited other the by to making to on for and second look we and will product. future. syringe quarter and

products, now Turning YUTIQ. ophthalmology new ILUVIEN to and our

can is is the diabetic of disease up through ILUVIEN used And significant cause edema X long-term room products. patients. reminder, in and YUTIQ YUTIQ As for control chronic uveitis years. We DME, loss intravitreal macular both or eye affecting the or leading a treat YUTIQ believe disease to non-infectious to long-acting ILUVIEN implants. novel of extended is In the the growth are available diabetic U.S., the both only durable used therapies and NIU-PS. treat are there for that for posterior recurrence to reduce segment ILUVIEN vision

fully the increasingly and As XX acumen move expect success driven we we are complete. and key with that same sales, Gel. to of transitioned through customer footprint XXXX, handoffs Cortrophin have has territories YUTIQ commercial into In the now larger we our with new deploy ILUVIEN

ILUVIEN meaningful conference in we also commitment increasing increase YUTIQ investments in remainder activity, to In peer-to-peer we significant We of are ANI's XXXX. to throughout well are awareness performance of amplifying Congress engagements, and both beginning expect see making the as which as and further drive to marketing, ophthalmology call in education the space.

uveitis NEW of weeks, trials continued coming investigating for of is new the patients and to NEW patients DAY are in the top-line significant second-quarter current enrolled the and of last marketing clinical research and patient's DAY last with better launching early with across the our to results the treatment year. specialists occurred SYNCHRONICITY in use we YUTIQ XX informed DAY NEW patients enhanced the SYNCHRONICITY. of ILUVIEN Is to with of anti-VEGF Additionally, January, utility a a help enrolled XX XXX by fully in this is around retina implants. We've in U.S. approximately XXX expect standard broader chronic approximately physicians visit combination of The in the clinical in sites care trial market on long-acting sense with designed we of DME. in appropriate for has materials make NIU-PS. The investment identify and progress a the sites. variety provide patients

We the year. of preliminary top-line quarter results expect second this in also

strategy and Disease for ILUVIEN we we across continued pleased performance Rare remain security the these are products. with Furthermore, our of overall growth supply for the strong and and long-term commercial optimizing business, on excited are laser-focused increasing Cortrophin Looking about we Gel. YUTIQ, runway our

mid-October, products to we and team expect from team can patients new the treatment. products has been ophthalmology sales the of awareness Our the greater X all drive and promoting benefit since that

Gel, ANI's Steve? call to over for Cortrophin includes which that, I'll ILUVIEN business, Steve be Disease financial Rare to growth driver. With our the expect the update. largest and we turn XXXX, For YUTIQ

Stephen Carey

review revenues the I'll morning then quarter ANI XX% period, everyone with Thanks, period. year fourth Beginning have fourth segment. on our quarter $XXX.X our to discuss the we guidance over reporting prior XXXX good of million, Chris, redefined detail. up in results our call. and generated reporting this and

We segments. continue X to have

Disease XX% change other. defined $XX.X as period $XXX.X prior The up this basis, Form quarter, go-forward our been found the in segment disclosures organic than driven and from statements starts. the from have fourth be revenues Rare consistent and Rare filed can on Brands are driven our year the with new by number be patient our acquisition. from doubled were by However, and were YUTIQ and analyze record gains ophthalmology of release, our recast from Rare business period Disease new This MD&A Prior in financial an reflects Revenues they ILUVIEN new the period, to primarily the $XX.X Generics presentation XX-K, the were earnings from and in year as prior Disease million, a Alimera disease up the now and to million. and Revenues Rare $XX million. footnotes we morning. to reported on Gel more Cortrophin Brands. XX% Brands post increased XX% million volume how products, and both in presentation. Revenues

and to As portfolio million segment year an Revenue in similar therefore, XXXX. Other brands a full were the first the $XX.X products, in XXXX for reminder, year we Alimera increase market on the fourth increased higher these to quarter in the of experienced over demand product represents $XX.X launched in were period, completed products contributions impact launches has for certain the an for by XX% assets. and new full changes of volumes in the million, X% our this The quarter, owning over and of dynamics prior acquisition Revenues of our XX, from what prior period. related from driven Generics past. year September quarter increase on benefited of the quarter

to the P&L. Now down move

Gel to a compared operating our and expenditures. Non-GAAP related costs reconciliation to amortization exclude earnings growth X of to of an product I $XX.X excluding primarily and detailed As of the sales our to products Table depreciation to products which increase the Please prior sales. of approximately prior this in and pharmaceutical expenses when and period be Generally, from a of driven non-GAAP litigation million and percentage the was net and ILUVIEN and the depreciation reminder, of in a our press volumes Table gross quarter YUTIQ cost-of-sales, certain points XXXX $XX.X of release. period royalty-bearing operating due margin ended ILUVIEN our sales ongoing expenses activities, YUTIQ, ophthalmology expenses, the a speak per selling, R&D for our We $XX.X quarter X.Xx activities to basis. XX% increased disease new guidance. and is midpoint at and rare principal fourth overall approximately an on in driven to full end a the spend Gel, period. investments business. Adjusted tied of incentive-based sales the forward prior $XXX.X $X debt, and the term required financial loan. syringe growth due to fourth Cortrophin compensation, quarter of programs. of for development non-GAAP Adjusted refer unrestricted our non-GAAP Utilizing Cortrophin primarily to for in net investment favorable was million on inclusive marketing expenses revenues research convertible including million NEW to ILUVIEN SYNCHRONICITY quarter, $XXX.X $XXX.X compensation and full-quarter of XX% in X.X leverage share the diluted sales. Non-GAAP and to to notes and our Cortrophin for senior ongoing quarter, the referring the will $XX.X our per year the Non-GAAP continued administrative fourth our quarter employment-related adjusted in increased activity. the year general and a to in costs expenses of comprised earnings million revised of force full debt, million, of record million the to higher in I larger support by GAAP for quarter prior $XX year EBITDA amortization, in purposes non-GAAP year outstanding non-GAAP generic XX.X%, compared our quarter promoting by of and YUTIQ from the net mix increase of the million due in Gel trials, M&A costs development increased fourth value stock-based to quarter the compared call, to and DAY million fourth of clinical and EBITDA of inclusion was XX% increased related to our brands, prefilled XXXX in are with our $X.XX in performance XXXX and period. X cash share Non-GAAP the

XXXX Turning to our financial guidance.

As and the Nikhil quarter we to million and higher strong targets from guidance previewed, XX, revenue our for evolution business raising we which non-GAAP Gel, total for Cortrophin adjusted Brands We announced are portfolio. the million, of recent that XX% revenue January XXXX. over continued preliminary our based to EBITDA now trends $XXX growth $XXX represents on of generics our expect demand XX% total of for first on

of by of million growth growth adoption in million, $XXX to ophthalmology we team as the gout the and of of commercial neurology, helped XX% $XXX Gel representing to revenue expanded rheumatology, part anticipate well in as in for For XX%. areas Cortrophin our Cortrophin expect Gel, We nephrology, continued and indication. strong therapeutic

growth continued market expect for also the in ACTH overall We XXXX.

first is is pattern in quarter. This due quarter followed of general disease in second XXXX prescription generally progression in the revenue consistent reauthorizations consider strong to you for be the XXXX sequential similar the please reported drugs. to Cortrophin quarterly note in that to the rare pattern As other with growth with by Gel, quarter-over-quarter a expected decline that

the net transitions they call which operational We and and combined of dynamics reflects of outlined by revenues expect as $XX in ILUVIEN Nikhil as $XXX Chris million the the discussed. earlier million, to YUTIQ and first the impact well commercial quarter

First disease impacted as revenues by be in since impact quarter both QX as in change drop the U.S. early expected seen the are to access well added to products QX net ILUVIEN the of YUTIQ and market dynamics rare January. typical of both --

quarter to second of We growth expect to in franchise this XXXX. the sequential return

Prucalopride driven January revenue double-digit growth days including launch low contribution strength anticipate base we with in from our generics, by early XXX the of new and For exclusivity. full business launches, in

increased experienced of fourth first For X products X has demand increased over periodically the quarter saw XXXX. we certain Brands, for the persisted past we in the have demand months years. as in This

that quarters quarter, demand assumes and does persist the guidance X increased thus, we normalized in through not assume X. this Our beyond first performance

Moving down the P&L.

margin gross modest company primarily between by which We for to expect be our total and relative higher XX% rare growth XXXX, reflects to XX%, franchise. non-GAAP driven sales disease

and of effective EPS. With our factors the for non-GAAP share to will expect growth earnings of of to using year, these we million with share non-GAAP year XXXX tax computation of growth and adjusted estimated $XXX rate rate reflects XX%, tax into non-GAAP full to expect XX% ILUVIEN $XXX effect per marketing U.S. million million adjusted adjusted We and $XXX Taking GAAP between whole of adjustments calculating EBITDA approximately reflects expect to XX.X to of and earnings Nikhil. our for XX.X account, over $XXX adjusted investments consistent XXXX disease We which we million, nontax item associated being $X.XX deductible and XX% per non-GAAP prior adjusted currently and I'll purpose be between statutory unless $X.XX. We XX% R&D to diluted SG&A which and the the shares outstanding of diluted and with in rare million, that, back operating a call drive expenses non-GAAP anticipate or sales part. million YUTIQ. all is turn

Nikhil Lalwani

for Thank up questions. We'll Steve. open you, it

Operator

morning Piper this Amsellem Sandler. at David first go We Instructions] to [Operator

David Amsellem

couple. a got just So

-- here. right execute net brand you've Cortrophin, deal the more its And mix the Rare forma take growth looking of thinking pro mix are how -- I drill the capacity that development and on First, and opportunity. the one. And now? how just the brand and you you out then cited much How sizing could 'XX where the XX-XX, on up about So to deal? terms obviously, business of or business how secondly, beyond. opportunity much just M&A, of talk Disease has high Generics, you and on you're about sort the XX-XX take on business business of mix? a mean, now, gout of to is in terms presence? your it how mere wondering company want built we just ultimately, I'm right of deeply longer-term as in business down it's and would you a just over And overall. maybe think -- little but You Can drive it the about I to brand in kind higher a that Brand, time? been then that's the also number particular in should leverage

Nikhil Lalwani

you thank questions. David, for your

question BD and M&A, your efforts willing focus what in the disease. BD is capacity as rare deal we the and before, to So take terms we your and our part leverage. have are was, M&A shared where of pro the of we second would then And areas first question forma on on

balance it periods refinancing that our the we went ability to did such gives X during and points under the and it's thoughtful as if team efficient Cortrophin, that Alimera leverage the at of capital intent and about not how see been we history you loan ratio, of M&A, net our sheet. you what as for the this above, but place look, it then delevered. And of company launch well as believe look that extend and we've will at always and BD as ANI's you we're leverage historically, I And at management additional pursue And putting to. rare the done structure, product, built and acquisitions So launched time, the acquisition look X. and ratio some the quickly very straining while disease it in us the to a short think more as lead kept is willing has slightly

the So on question answer would that's how I M&A. BD,

as on very growing. BD, primary we ANI business the X question allocation, business Generics terms the second what continue portfolio driver the working Your we will Disease high-margin, to and has this are taking where M&A. disease refer strong of used rights terms area a But and are Rare low And flow area as a company, well has role as of to of business, in being and through build we -- brands capital. strong capital growth brands businesses. generation, will to Both focus established be the plays the of through rare cash in which in strong

growth evolution, in We a coming if Rare double-digit the gravity Generics of from and business. fuel percentage and to But Disease single-digit, look time low high just of natural over with will greater shift Brands. invest R&D period will you center for the

third So number the on that's two. And point gout. question then

for gout of Cortrophin up points from first XX% X moving it types think of with is gateway their being their consider -- prescription were ACTH, of they volume writing coming gout. talked ways gout to on in as other and then XX% about, Thank prescribers ending just And Chris to some naive David. I data then to writing share, in is first a currently the you, of patients.

Operator

next go We Securities. Guggenheim now Vamil to Divan at

Vamil Divan

terms year growth much this a resolution I can how midpoint little you issues time your we just around guess from and So the assets guidance sort just the the to I are there terms that the insight not have. more where access provide the Maybe you for suggests the quarter. of of so on that should since million $XXX what a January. comments plans is look of really in -- couple year-over-year left in fourth One, of or kind Alimera and in the in

Cortrophin, think longer-term you question more and should how with impact seasonality So the looking of talked for kind the example? And for XXXX on the sounds other this that maybe issue lot for initial XXXX, trends your partially we the that. obviously, if are year, and your based think access should the like Cortrophin, of given good. very at the about assets, growth on guidance, It it then year-over-year you're has a about about raising Alimera good like been looks how growth, we

So should seasonality that can in about think just comment for And of sort well? sort quarter-over-quarter should growth you franchise any XQ? on how impact we as think maybe we of about

Nikhil Lalwani

offsetting funding these so adequate of on XXXX. issues, patients in the access plans YUTIQ received yet past, Medicare need, some the access -- the and ILUVIEN, the cost with based the had with programs Advantage on assisted not in Medicare question to have first programs on and of financial responsibility, that your So based

are assistance drug doing the our to as about on and patients for about, currently picture, back accordingly. patient each with approach data. patient Look, for addressable based epidemiological great access higher what understand we and it? estimate YUTIQ with has therapy the response there changes and outlook. to time about in program ILUVIEN and to that are In ANI a there looking terms we XXx place we've what's of at free YUTIQ Xx financial a needed. And foremost, first ILUVIEN and then each need are and fewer on for stepping their in currently overall provides is secondly, access ANI spending approximately And market patients the our HCPs than X,XXX asked population these question commercial you of And that is talked as refining

remain a while our So the growth for and confident products work through, DME topic near-term to in prospects this we NIU-PS. is both of

seasonality growth PCG typical then around early to guidance for one on QX there. in had typical number and February, cases sequential highest shared we ago. as in of purchasing What we do building well right? So resets. we've by also insurance our the weeks you that, drop, built a a initiated, -- PCG, but we the right, we as see momentum why all of driven dynamic rare was And that have see reasons shared in we is question new second there'll QX patterns as The be from disease you will is few will is and had raised drugs

in sales terms Thank dynamic of QX type typical for Vamil. -- again to PCG. you, Just for QX

Operator

now to We Nachman Raymond go Gary James. at next

Gary Nachman

that understand to and to to parts million lot in the back yes, moving also better So of I'm $XX you trying given the of million ILUVIEN guidance that different through near-term. the $XXX a working YUTIQ. you're have

or also And help? one overall will could you with then how for do indication factored I think you those Cortrophin. from those franchise? how soon to much as those do uveitis supply additional And YUTIQ all? EyePoint have data transition you think adding Siegfried? benefit how at for Is in sets the issues hiccups guess, I much And any And that help? the there So could then coming,

Nikhil Lalwani

clinical, continuing our team And also investing work activities about, partner you Gary. made you commercial, in on retina. beyond to we drive Got like programs selling across providing peer-to-peer the Thank awareness and Chris and acquisition guidance. that for a your Yes, increasing markets, will And expect commitment access your international little to YUTIQ, and question. such changes with this, for of of first the ANI's is amplifying and as and -- bit rest there spoke the you, the are physicians ROI as seeing materials patients in support education the refine products and expansion for as and for in Germany transitions. Commercially, the that ILUVIEN in it. identify several appropriate initiatives to strengthened further Thank significant U.S. operational and and approach about we're to and we've of Marketing we're integration X talked that this higher the question products. quarter-on-quarter XXXX through help our ophthalmology increased the January to as an as early positive we've would well as the issues ramp

You then DAY. about asked NEW

just significantly push key robust quarter in of the year a are we the earlier guidance. And building clinical NEW retina DAY from and the our are read-out top-line are in to earlier about who how commercially. with results the the XXXX amongst programs work patient positive, XXXX. Having DME the asked I'll of we've forward results So the question, said Look, for results. expand place in been combination we've SYNCHRONICITY, on things. the resumed preliminary back -- continued full of guidance NEW to a will and could eagerly both the in tailwind results second DAY come these a awareness NEW will clinical have I label publishing front, that you to we'll think DAY measured look and and also awaiting in pleased plan community, programs, And of the If journey. our ILUVIEN that, then that and couple not it we use data

and transition support and with First -- continued to working us is, committed the patients EyePoint security. is ensure supply to ensure

And So we ago. this while that's the obviously, submitted coming. knew perspective from transition was a and a supply transition. PAS We

this add and office. sales -- I real to and right, between will messaging talked will So building inventory and the the for value-added on is the Siegfried And perspective, gradually merge there. ILUVIEN, label -- we about we period. We'll ordering YUTIQ accounts. from difference But transition whilst to ILUVIEN communication the label customers consolidation awareness the up of the the to community. expansion lot look, are and broad capacity only ILUVIEN consolidate fast distributor through and injector, consolidated that, we'll a And NIU-PS, transitioning from and mean, do drive ILUVIEN commercial and uveitis and team, the we processes implants. for it you when you a label marketing the the the succinct also one initiatives, simplifies to introduce deliver when these which YUTIQ accounts retina new do to during label and the YUTIQ you X

to will the reinforce. we value-add there's customers, So which

that DAY answered Your NEW also factored a I data in in? question sets next as question Thank around Gary. what's guidance talking the you, you was in on, about and was had and sorry, the hopefully what's not I think and I factored

Gary Nachman

great. gout. and in just Yes. mean, And a a benefit I No, on had I Cortrophin. you're seeing in that's then follow-up nice acceleration ophthalmology

to Just even maybe you much should that that much grow really what market add you think point further? that sales how the did indications? could just if how about evaluate to talk at you what And you force the add across ROI

Nikhil Lalwani

question, that for you Thank you. thank Gary. Yes,

driven the $X as X ophthalmology. to targeted as from pulmonology million as specialties and million nephrology, over we've is at and of that sales newer launch years terms to in XX-ish both product the we ROI, Cortrophin rheumatology, from the growth area $XXX business across specialties neurology directors, with think So between indications grown we are of nephrology, as which in reps launched initially increase we've added these well focused the force, core and -- I about And well the the this neurology. on XX largely as we've and rheumatology,

of like place. And we've right, think the disease of leveraging the ROI and that -- that to investments, an also product a Chris' leadership understanding high sales under developed the with we good profile how succeeds understanding sort -- Cortrophin. a I have developed commercial of of infrastructure of in also type drive rare

So those sort I help continue to here. of growth together us and of think all come driving

patient obviously for you, specialties we Now of and investing spend the that improving for on support in in Cortrophin growth of for talked Gary. that the growth And investing the the progress prefilled in this about these in approval the things getting in that of having syringe there's high launching ROI core that and and projects we expansion R&D physician to We're other number drive project quarter. the second research We've obviously, as franchise, targeted of at that, then we're commercial which what them. launching talked spend additional already such the doing use about, our sales of share and to provide said as we'll Cortrophin team support launch. right? updates a also convenience, Thank is to we're

Operator

Leerink at Partners. Khurshid Faisal to now next go We'll

Faisal Khurshid

factors a bit about bit the Medicare. to regards the affect about spoke a and that how reimbursement other kind the Like, of little wanted Medicare product-specific that to play of you with kind the then Can you Part be ask, reimbursement at products? we should considering? there impact? that does D kind more changes that just is talk redesign? little of I are And And just with

Nikhil Lalwani

you for your Thank Yes. question.

to redesign. some co-pay -- in cost of based the XXXX. need. So received and that not have programs financial with And assisted these of offsetting to funding Medicare or yet a had not is with this Medicare responsibility programs is adequate What the Advantage access the patient the patients that on in these plans it

of market right, XXx to Xx ILUVIEN is this, as with Now, the in we've either or terms we're is of the patients number YUTIQ. doing treated addressable than on than you being -- what now, what less higher about patients right discussed look, or X,XXX Medicare

the much market addressable higher. And so much, is

remain prescribers for thinking while products near-term in growth -- through through, to while working a we're confident short-term to so DME our issue how of trying understand this both and and of in the this are And But the NIU-PS. prospects is we're work too. we this

Faisal Khurshid

And dynamic ILUVIEN impact and is well? Or this it. as Cortrophin specific to YUTIQ? this Got does

Nikhil Lalwani

$X,XXX then Cortrophin because and Part of it's tailwinds the [ changes at for not This allowing B, for impact ] positive Part D the some and from IRA such smoothing. the co-pay has then does maximizing as

So that's Part -- those changes are impacting the of D Medicare.

the setting, these pure YUTIQ. is cost and ILUVIEN this your of just provide programs cost assist However, question, other with to patient products, also the responsibilities for not

Operator

at next to go now H.C. Livnat Oren Wainwright. We

Oren Livnat

button in YUTIQ Apologies so might and mute the have want use to I confused. to little have if advance, I really drop a talk periodically. bad about I cough again. just off now, ILUVIEN I'm a

help transition. understand this hopefully you can So me

we to transitioning product. to had also mentioned YUTIQ planning promoting manufacturing which You the stop expected, but Siegfried,

supply new as I'm how you long-term YUTIQ just with and just are agreement regarding -- threading then close this needle is switch. indication intend at to continue transition? Siegfried? Also, understand, Or EyePoint you to manufacturing do trying this So supply and the this you and

I [ Is and a well? maybe some difference as new cause there technique? have training then sorry, could with be ] disruptive if this training different Cortrophin these new And And or have happen and may. in I insurance third-part, would terms follow-up. of transition applicators any How which access, to these costs And required? a do period

Nikhil Lalwani

thank despite weather. Got you you question, for and under it. being the joining for Thank your

Siegfried question chronic first on the we ILUVIEN That label. the of posterior similar. is the manufacturing of are segment affecting transferring these -- possible uveitis X to because manufacturing Siegfried. think label, indication are uveitis the adding by the is the sorry, to was non-infectious of The extremely I transfer products the eye to way So

on run the trials as of the fluocinolone mentioned, fact, clinical acetonide. In I were both X.XX milligrams

has ILUVIEN newer process has a manufacturing the strength. that different difference only so And the slightly is between real X a

on consolidation, indications ILUVIEN on chronic extended are product the upgraded manufacturing already we non-infectious that line. we'll and eye. segment by second continue diabetic this committed continue inventory, posterior to track. to known up and as well initiatives EyePoint so us ILUVIEN the I Having Anticipating with we ensure both and which as manufactures we've XX, potential allow XXXX, the consolidation ILUVIEN. building agreement right, as coming, and you, -- are edema changes. to label affecting transition. And have those will is to ANI well the to on right, manufacturing Siegfried May one the that said agreement us manufacturing non-renewal product, label, as EyePoint adding this So work work Siegfried That with X for -- starting manufacturing have We've macular essentially for that, all we've been is a as the will equipment years existing have of to ILUVIEN has label for these patients, said line supply both for ILUVIEN. the with And agreed them through XXXX. agreed continuity

we've the indication been wanted having for. you questions the addition, the right, inventory dialogue the that and read they're been satisfactory through right, talked ongoing been understand transition the with we've asking that the can the label. And answering we've have what what asking the we've they And to preparing we with -- support been So and even PAS. look, ensure FDA. tea knew on then they've leaves them exactly We engaged before for also, it. And we regarding timing to look, submitted

customers injector your they and X only who SKUs only can the ordering one. question to for the believe PAS, simplifies and was transition third X buy physicians both expect from this because and fact processes. they So ILUVIEN there the that don't one to community. offices, -- have and And on this, that's maintain, ILUVIEN. And are implanters. is selling to simplicity from to value-add -- the we'll selling and why -- into YUTIQ But of QX, for significant They that and actually use YUTIQ it there what approval and they there's consolidation we retina we to build then can maintain

is So we value-add to retina customers this community. Thank the that our you, Oren. think actually a and

Oren Livnat

simplicity the same instead different, point, using can indication I already X do doctors across of that each for Okay. injectors? to on who And the some of X, are to anything product last from the switching YUTIQ Is I for now so relative is just differently? any guess, there having have -- NIU aside procedure ILUVIEN clarity reason get would

Nikhil Lalwani

I there's for of Not mean, of inserts, have slight in any ability different the not kinds material. only And inserts products. -- way. This retina so is of use physicians to nothing lot difference, material kind right? different use the but do they the

So the ability to similar. -- and these are substantially

to this learn of the ANI as So our Alimera, ability tweak this exactly look, to consolidation even they never obviously, we've clear they in they picked slight material. that contemplated And up merge and acquired well be sort had that's terms right, have what left change, off, of of obviously And would X the before don't done. again, -- If acquisition. -- just or to think Alimera the is we labels. where from

Oren Livnat

for the even identical or cost disruptive in pricing products? these And be similar with differences? tailwinds again, So the shouldn't insurance or to front, theory, clarify, coverage on transition is be there and could that

Nikhil Lalwani

reasonably market any coverage price is listed access pricing issues to perspective. foresee The close cause the Yes. do not both -- for we from to a be and

Oren Livnat

X-milliliter switching the be or uptake patient appreciate all know any Acthar's syringe, milliliter time. Okay. it's vial, per price And what material to from you is approved? lastly, similar has potentially? Cortrophin, on X new net your On Do some average selling launch important prefilled syringe assuming that And the launch? I would since achieved how share prefilled product SelfJect there impact assuming

Nikhil Lalwani

we question. are multi-step convenience. a X and Yes. no, syringe prefilled your physician -- And requires a thank is the Look, you introducing patient for administration. enhance ml vial But to the

And for one patients. the step is in prefilled so does the syringe administration reduces process what the

helpful that's to so And them.

focused have we flares. We that the vial there's on that's X so gouty bringing arthritis that one believe less acute for for gouty presentations new whom -- look forward progress step this launched for the present market. to as And segments of into will convenience, helpful how ideas explore the of and the have administration we we overall on new a we're other the launch this to different approval was that of and will growth the continuing that And options to that And we'll said, that we're see continue the believe to And subset we to flare, patients and that's of for and the presentation improving with look as we and it other sharing acute prefilled market. projects -- patients ACTH it physician continue is offer ml arthritis will where launch drive We of them. as done in updates patient -- had syringe. these process.

Operator

We'll go next now Truist Les Securities. at Sulewski to

Jeevan Larson

for for competitors? Jeevan could pipeline on or market And the potentially there any potentially that from This versions synthetic its products Les. Cortrophin growth? do is Are given developments potential you see disrupt overseas other

Nikhil Lalwani

it's therapy market ACTH data market the seeing again, last thank right? So that we rhetoric prescribers opportunity market epidemiological both you talking our then to is awareness the And the to reported we of a than today patients that their was, from today, our naive you if that I the -- this Yes. for substantial. -- ] Yes. -- the lower take you north you, peak. the essentially, much perspective, of point they of were shared that has when what growth point the add think XX% guide add that almost a and number what [ patients an Jeevan. actuals And appropriate of on November, half, No, point -- of is, all very the look seeing, which growth. is than ACTH. $XXX around if first time data And competitor's and to at that patients. HCPs data is therapy about -- guidance therapy about are we're at on new were addressable about hear the number talking the addressable we're and for our you increasing shared, XX% And returned million. The ACTH -- in Look, the we're we're the

and So ability our get to I it's appropriate proven talk to -- the think the physicians X patients, years. market when the about addressable to get epidemiological reach last and ability you -- to to as over our newer

that a continue to this market. And think trajectory product. behind look, to why is would tough just invest generic or and both to for bring products, competitor continue I sort the this say multiyear you biosimilar regarding I the to believe of we've -- we competition, tells the that ours, and ACTH long-term about So that of to a continued time the over it see growth

think to keep we we and and a strengthen, added I tracking competitive just So from to and that have path that do in ACTH the to continue and Thank need. competitors trying it X -- both so obviously, build you, Jeevan. is IP genericization this standpoint. -- to therapy outlook of the the competitor will one -- -- We us see bring for awareness where this be our category the to X patients

Operator

Santangelo Glen Jefferies. Instructions] to [Operator now We'll go with next

Glen Santangelo

product to of you on much comments mean, XXXs uptick second and on half? come certain ask I probably that kind I'm shortages. led that maybe us how on business, versus the appreciating of Prucalopride, first quick Generics algorithm on launches, could terms price organic versus an that made And some comments and maybe recently timing I'm 'XX fully respect that. made we've a you you Form the sense hoping of growth launched you half I'll I for the and may that from sort tablets the seen new the Maybe assuming that in you you a the And to continued impact just and just your do reconcile expect just was really me touched fiscal unpack is curious, double-digit of trying to outlook volumes maybe just in for one maybe with of to that what how growth. that's for give the

Nikhil Lalwani

Yes. Thank call you. our the first you, on Great for Glen, have and thank you to time.

So appreciate that.

year. generics think business, this look, a growth drive I helping it's things combination or the double-digit low us of X that's Regarding X

think see impact launched the product have. of XXXX, in those different obviously full and new foremost we'll year XX We We year. the cadence launches. that them launch we the new products I in first is launched points at

days a Second and exclusivity. will days we'll sales of of see see is we'll gives us What year, the right, launches -- QX in this which XXX exclusivity, that business XXX of do you right, generics because including with a Prucalopride, is the jump the that QX.

launches are And so -- but there other through the year.

launches, you're So I well class of. products competition. we'll of see generic annualization aware from before the new I erosion I the that's combination the a the, in think as of the you that XXXX XXXX and call, the additional it's XX And what typical -- from pricing that's of balance XXXX think and launches

is issues competitors -- But there supply that the positive material for. in that any growth sort double-digit, launches have. in question, new the in from or of any our from we've rather market there new already may your from [Indiscernible] share -- volumes guidance -- additional from of that to will whatever Now the isn't products volumes, benefit product all shared of low related largely either were letters taking come warning

Operator

morning. Mr. Thank questions things you. have turn appears closing any I'll back we it And and to further this you gentlemen, Lalwani, for no comments. ladies

Nikhil Lalwani

growth joining deliver in another and Health and today. XXXX. We Global in look revenue to our us to us continue well-positioned I'm in ophthalmology seeing this you Beach. are James is Leerink of on ANI for confident Cortrophin good raise Raymond strong our business forward generics Thank Thank a Conference the XXXX. you, and already year in Orlando XXXX start you outlook. we expect and to and that franchise to you. profitability Conference to Both Annual a leading Miami Gel for many of month our was momentum Investor the Thank next building are at and Institutional in-person record XXXX Bo. year off care

Operator

Goodbye. much you gentlemen, we Earnings us, day. will Fourth wish you joining Pharmaceuticals great Thank a Mr. conclude so and thanks for very ANI much, Lalwani. that Again, and ladies Results today's Quarter all Again, Call. XXXX everyone,

ANI Pharmaceuticals (ANIP) 28 Feb 252024 Q4 Earnings call transcript