ANI Pharmaceuticals (ANIP) 9 Aug 232023 Q2 Earnings call transcript

Good morning, everyone. My name is Chelsea and I will be your conference operator. At this time, I would like to welcome everyone to ANI Pharmaceuticals Second Quarter 2023 Financial Results. [Operator Instructions] As a reminder, this conference call is being recorded today, August 9, 2023.

It is now my pleasure to turn the floor over to Ms. for Relations Investor DiClemente, ANI Pharmaceuticals. Judy go please ahead. Ma'am,

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

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

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

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

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

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

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

call interest ANI and morning, everyone, and your Pharmaceuticals. Thank you in thank joining Good you, our for Judy. for

very all ANI of shareholders to several call our their morning's in past business quarter momentum for family am in and second pleased and us customers, I would suppliers, to and share like into strong to this XXXX the the seeing patients I with has across enabling by over efforts quarters need. all continued partners, serve thanking segments. start the

year X% This of net over a approximately this first and the $XXX.X revenues an also over quarterly reported XXXX, we of million, growth was increase quarter. record of morning, last nearly XX% quarter

non-GAAP increase. adjusted EBITDA a $XX.X also year-over-year nearly and represents a XXX% Our company of million record

diluted $X.XX of adjusted and generated tenfold cash the year. during the growth of second Our $XX operations second the of almost the represents EPS over during -- a XXXX of non-GAAP million half from first quarter the company

allowed XXXX These of to in be our the the now have to EBITDA for be million $XXX million us and million, to all revenues share adjusted to raise our $X.XX net and earnings results $XXX $XXX adjusted range once guidance. and between segments per $X.XX. million, full-year between outlook again of business non-GAAP to We to expect $XXX be non-GAAP

on Starting take and imperatives segment. our each our made now look in performance Rare the progress with a at Disease business. Let's closer strategic

of goal assets Our XXX% successful with the Disease Cortrophin the Gel business compared built. Disease is add million year leverage Gel, the -- we Rare that quarter, XX% increase infrastructure over first increase to totaled have the the Purified Rare $XX.X to to an Cortrophin an prior lead quarter. Revenues up and our in for launch and first our asset, scale up of

new During across patient record quarter, areas initiated, prescribers. unique numbers several and the saw including new we new starts, cases

targeted all repeat and growth continued in have prescribers. was rheumatology. specialties nephrology, including also neurology, Growth We achieved across

to with into all modest months is year-over-year XX The second also XXXX. expansion the double-digit during momentum. robust XXXX of overall the of quarter, began team pulmonology sales ACTH Also growth and consecutive gaining from for XXXX June to our outlook category May already growth

and we for service access patients in to ACTH to on payers focused continuing need. improve therapy to remain how patients, We physicians, increase

up Cortrophin to from Gel our range XXX% raising revenue $XX The are represents XXX%. year-over-year $XXX million. for between growth million, guidance $XX and revenue $XX million of to We full-year to new million

we area scale Increasing remains of key Disease ANI portfolio Disease growth. our focus Rare for will and the largest critical a is and it expect be the a scope of the priority. Rare driver ANI's

recent equity raise in successful M&A net positioned opportunities. actively and platform we of the believe generation, cash million proceeds flow we strong our pursuing our are Rare Following resulting licensing Disease in and $XX.X and well build upon to we are of our strength

during results by in the our year-over-year growing to to now XX% $XX.X Others quarter. also segments, delivered Established second Generics, Brands which Turning the and strong million quarter

footprint track and to We manufacturing capture inventory established by leveraging to patient goods to as across numerous for supplier This opportunities GMP disruptions maintaining brands. levels have medicines and continued build our strong us across materials. sites finished from healthy continue arising a to impact that and access record very both supply our reliable Generics enables a raw U.S. reputation maintaining much-needed

patient-first excellence, a Generics with our always. and through launch cost focused operational For business, reliability driving we product supply remain execution, on superior orientation competitiveness, new growth

During received Suspension. the Nitrofurantoin organization four drug or new Hydrochloride approvals strong application ANDA our and Colestipol abbreviated quarter, R&D Oral including

multiple on products the fuel Akorn and of Pharma growth our the development continue opportunities with investing generics business. niche active on auction. the from found business we'll front continued acquiring R&D addition, be company to In new we to The in ANDAs three a also focus

we patients more we commercialization our quarter, take channels sales efforts product striving XXX need. new in and than continue to families expanded also will During into the to

for ongoing. Oakville, the products site site Oakville January previously successful announced, Oakville ceased facilities of relocation Ontario, remain operations XXXX, the -- at and the discussions buyers in potential with our the U.S. the with to As manufacturing for

For across success. the our spoken have earlier with that reliability efforts about products. continue supply our commercialization driven innovate we coupled business, efforts our have to established These we brands

we're the heard As into multiple half to was across you've quarter second today, an the it the continue second momentum of impressive year. fronts excited and

call quarter Steve? turn detail. walk will financial who will results our in Steve, over now guidance revised I to more through and the second

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

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

$XXX.X core million generating or second-quarter of X% record XXXX. of represents million. over our $XX.X is of revenues million We of record saw million XXXX sequentially the quarter from the $XX.X second reported revenues businesses, $XXX.X and across quarter the first XX% growth our up growth in reported This in previous

half Revenues the our $XX.X million from performance foundation we our Cortrophin were morning. upwards Rare XXXX full-year We a up goals strong quarter, of believe reported prior for Disease revised which segment this in $XX.X in our achieving million first revenue from creates Cortrophin the year.

launches, Other to prior million volumes of gains increase our XX% million, segment year to and $XX.X annualization Revenues increased of $XX.X needs. evolving and ability reflect of the segment Brands over Generics Business, an by our quickly Net launches, and revenue year. rose effectively market this current XXXX respond driven Established across to

nimble U.S.-based excellence competitive marketing to informed and the R&D, key face products and demand and procurement to manufacturing, have commitment generic teams supply enabled chain ANI issues. of in an in strong Our sales meet market for

XXXX significant products. of Disease prior-year due to second Generic year expenses ended period, million in compared $XXX.X for quarter a of million and sales by the primarily to increase to by prior in $X depreciation XXXX, sales increased XX% excluding pharmaceutical to increased of in months in Operating the and compared amortization million to $XX.X million million $XX.X the volumes Cost June $XX.X the period. Rare three XXth,

with in were development associated generic the $X.X with the to increase increase and prior-year level coupled an higher expenses to Gel of the quarter $X.X period, year with of of due period. Research second activity Cortrophin million projects projects in an million current XXXX, primarily from a associated related

increased expenses increased in prior legal costs in to primarily XX% expenditures administrative and by quarter of period, to increased due $XX.X million XXXX during the the and the second general Selling, $XX to compared employment-related million quarter. year

year amortization approximately year income year XXth, an the million months the was fair for prior $X $X.X period. expense the expense We period. as of and acquisition million in current our consideration Novitium contingent ended period prior three value million XXXX compared $XXX,XXX adjustment Depreciation recognized in to of from of of $XX.X increase related XXXX, of to June the

Canada wound our restructuring This de compared year prior remain and P&L period. our the to there land closure recorded The as time. expense Oakville, of was million plant, $X.X the of in impact manufacturing building down. year Regarding period in this is restructuring essentially Ontario, are the current for minimis at a activities sale

$X.XX shareholders the quarter of as $XX.X per prior year compared share per earnings $X.XX earnings share to basis, for GAAP to was to as period. the an for of quarter compared compared prior the second per we common had Diluted income $X.XX share non-GAAP million net the was available adjusted loss for year period. in a diluted of prior $X.XX On a XXXX year the period. $X.X million Net loss to in

gross $X.X the a posted Adjusted million in recognized million quarter also first increase Adjusted from the reflects a million non-GAAP of of million year company basis, in of record the XXXX. period. on EBITDA an for compared non-GAAP the XXXX is profit pull-through reached of $XX revenue sequential million strong prior $X.X previous second $XX.X EBITDA $XX.X from new our the performance. This rose record to up quarter and

unrestricted the XXXX. flow cash, year-to-date generated ended during we cash the million cash have sheet $XX.X On in part of ended six-month of June $XXX.X flow quarter from operations. perspective, a operations balance XXth, million driven a From quarter in with we from million basis, by $XX

of pursue us proceeds million raised business facility million our in place The our flows along ending second-half position May. $XX reflects our revolving development and balance strategic untapped net initiatives. equity cash in completed $XX.X to balance offering expected with capacity cash in also healthy secondary credit in This of

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

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

Finally, raise outlined are in morning's pleased this guidance we to release, full-year as press as follows. XXXX

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

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

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

raising million guidance up Cortrophin-specific $XXX million XXX% $XX to are guidance in $XX recognized XXXX. compared million the in million to a representing issued $XX from $XX.X of to as revenue previously of the to million, growth range We XXX%

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

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

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

[Operator Instructions] Vamil first from Divan our question will come with Guggenheim Securities. And

taking for thanks my Great, questions.

brand if Established in to level performing as performance quarters of for how again to see see strong the if bit into better have helpful. I'm that's Obviously, us So couple be sustainability as the One even you next the could. what would details? a of segment, that on I obviously externally a get a this you to very next of little trying very that model the year tougher couple just just results sense there. of

expect around the built detail more Rare -- second to then Diseases something based? also wondering cash an additional terms on we kind your with a one if doing of opposed pace little you build the Thank and for bit to of I'm your what as -- comments your assets should you willingness introduce in and Cortrophin. acquisition in equity give And what there you. of and just assets deals to of around looking picking just or Disease what Rare you're terms during up more

has in Rare take So, us. and development evaluating been our opportunities question good team very first. the of morning, range Gassert Vamil, corporate to by the Look available question. Chad I'll led active team your you Disease for and thank the executive

-- built We assets remain have companies that we finding And Purified significant leveraging Gel. around focused both infrastructure as Disease it, Cortrophin in distribution the synergy access terms that's the could market target currently as infrastructure hub, on call Rare patient specialties support all the specialty and around that we pharmacy infrastructure right. on the or of provide around the that of well

So the we the can sales and place. force basically leverage infrastructure assets Rare have remaining that that in Disease

We are the forward. encouraged path by potential

Obviously, capital it, towards our choice selective highly ensuring seek fund sort this earlier our - with diligent how deploy right, to to and year of business. the of Rare However, with that's what the expanding imperative expansion this strategic intent drives we remain we that this in right. Disease we the steadfast was also as of are and about, in and raise the that's did answer. that that equity scope of so the we scale fueling and And

second medicines. other and It leverage your first segments arising established ability access market much-needed results The in and capture our in from U.S. our demand agility ANI's question impacting brands is, to manufacturing our brands, our to disruptions timely deliver established to Generics look, to to on patient footprint supply just showcases operations customers. solutions enabled us robust

to as the into then expect said what We trend positive see what this in I reliability, what's as And Thank earlier to given. across couple we that driving a brands we've the you, and this innovate the The we Vamil. impacting is our success. And success what's driven degree factored efforts is with supply established addition our commercialization to continue. on products we've guidance, the our continue business. trend that's

you. thank Okay,

Thank you.

Securities. next Sulewski come with question Our from will Les Truist

the I or patients been my drive the any new Thank market internal for growth? comments been starts, dosing to to repeats And able areas pull If Which follow-up. a levers how's what you. that questions around I are driving guess the the some on give on early been the pulmonology? Thank of you morning. averages? have growth the you've taking have congrats And progress. Good ACTH Cortrophin can you of uptake and particular and

to good Welcome morning, first ANI your call. the Yes, welcome. this is here, so thank you, I Les. and believe time

driven a and of it the look prescribers nephrology, of and by was unique what was record growth, new your growth seen In sales we'd number And early team, the neurology terms pulmonology our prescribers. number that of from a record targeted and regarding drove also came Purified PCG Gel growth, initiated. repeat This by cases highlight Cortrophin to continued specialty, question all new in which across growth of rheumatology, specialties growth right. traction

So record new of quarter we've increased patient momentum had with addition, and that traction but strong in that infrastructure spoken we're to case and and support patient expansion in translate of a new our last sales about And the seen hub in pulmonology modest we've investment for we to early a the able number starts. -- a our team team indication. done then

So driven Gel. what's Cortrophin you the follow-up, right. growth I believe that's a in had

is of Yes. Very helpful, you. thank R&D mean, you for that, Nikhil. And are then at which in product pipeline, regards the what you to stage? to interest or therapeutic this within specifically of Generics, Thank some -- areas I tied

niche to on R&D Yes. invest we areas. are Generics, Look, opportunities, in a rational so continuing in focus with competition

opportunities record track and of market business we we We we the We haven't business. years to keep niche and launches the -- the that in have acquired and successful seen the we defined record but looking to we've bring growth the brought Novitium track Generics we two a of forms, that for it's really company. had growth dosage ago that know Generics our our the to you've the continued and fuel in

pipeline business continue record We active the development our smaller combination on be and of strong for business track smaller business. deals front along the business fuel the an also type with opportunistically development of organization asset that's Generics the drive the established R&D Generics what with and level will of to the yields growth asset the

this Thank the right. you. questions time. queue There in further are at All no

Lalwani turn closing So, additional Nikhil the any remarks. back for over to or I call would like to

sustainable updating progress continue you our ANI morning. everyone we need. you. is Thank thank in patients your And this to our call in forward and serving and on delivering for look time interest well-positioned We you Chelsea. you, to growth joining Thank ANI. appreciate and

Thank participation. conclude does appreciate and your and This you, today's we ladies gentlemen. call

You may time. disconnect any at