ANIP - Earnings call transcript Q2 2018 | ANI Pharmaceuticals, Inc.

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Operator

Good morning, everyone, and welcome to ANI Second Quarter 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note, this call may be recorded. It is now my pleasure to turn today’s program over to Mr. Przybyl. Arthur ahead. go Please

Arthur Przybyl

our Welcome XXXX. earnings Przybyl, My with Stephen the everyone. the I call second CEO; Carey, is today quarter name me Financial to morning, Officer. conference ANI’s for am Chief Good is Art

those to begin, non-GAAP that of $X.XX; adjusted earnings and per call. the release financial forward-looking everyone second X% we release of found not important conference measures of each as certain will you of million, measures reported results. in Before non-GAAP Today, also accounting diluted compared X%, the accepted of to it refer morning’s context carefully quarter EBITDA in this and language as this $XX.X to in year prepared our accordance Discussions dated include want our I can prior generally increases were quarter. and press ask million of we statements earnings share to XX%, Reconciliation adjusted review financial be for with revenues respectively Net non-GAAP today. $XX principles.

our a products Year-to-date, XX as of generic completed transactions. the revenues. have we ANDAs increasing launch year. by compared XX% to successfully our XX% EBITDA key the IDT products methylphenidate combination. launched Today, pipeline In business and product provide of $XX launched during XX%, represent six results prior quarter, $ months non-GAAP acquired Steve the portfolio of we with per We billion. million, we X.XX; first a October highlights of numbers previously share two a platforms to generic of of we assets. five a to $X.X two entered us and strategy updated continued EBITDA forecast adjusted for products, we and his the share into market to the basket portfolio of generic the increases the Impax/Amneal generic aspirin/dipyridamole we our provide transfer. adjusted opportunity our execute $XX.X products, to our year, $XXX products model. second annual earnings our prior of date, size generic you million, and acquired better earnings business result $X.XX. generics, our acquired and capsules. In in XX combined revenues million agreement of announced XX% of of adjusted of buying ClarusOne, million date tech and our we that and increases require XX%, reflect generic have an products combined launch $XX.X the six generated will non-GAAP period. a advance To new consortium, year as of of of business extended-release brand over non-GAAP product an adjusted our will from XX that XXXX, detailed generic announced revenues respectively extended-release increase total These to non-GAAP further diluted XXXX our Our XX%, presentation. These over to guidance on of per grow six estimated and second month a with largest with midpoint We X, The represent order for quarter of tablets pipeline from guidance half of our for revolving recently date financial

label launch are term with to nine compelling of for an April ANDA review undisclosed near Casodex. we total priority those the the generic of of We portfolio recently products These a $XX date granted and market its current GDUFA XXXX increased Lastly, opportunities million. the products, three for product, announced in us. of our and size Arimidex brand ANI

with discussions site we assisting or accretive customer the U.S. of combined in acquisition capacity. expand press today’s announced Atacand organization with and of effort already material, adjusted with products launched launch substantial provides in ANI transaction over additional term us first opportunities different branded to September XXXX. are to manufacturing the these development approval our on commercial development a represent These dosage of gel $XX approval. revenues, XX contract results Services, manufacturing the require XXXX. currently supplemental and pipeline with XX tech XXX,XXX with awaiting Today, Corticotropin announced accelerate scale additional oral two HCT manufacturing revenues drug and us the generates begin XX manufactures as addressable combined development combined we drug us. in Cortrophin Canada two in that customers to for two the batches and and expect work, of currently XXXX. and begin and quarter Pharma annual that of Atacand of we $XX branded batches near commercial recommercialization on development raw both capabilities the Canadian the for In anticipate After finished of date label, supplement with for we approximately products associated When Toronto, ANDAs The plan WellSpring customers additional compelling our $X.X and XXXX. million our Cortrophin we solution manufacturing our WellSpring expanding providing our foot products have expect longer has in square EBITDA a contract The release, to a diverse in of WellSpring for FDA be base to million. We of billion. manufacturing to has the advanced first market for XXXX. located products NDA approved remain filing are product activities for the branded markets we our by prior non-GAAP Vancocin synergy, form Gel in products for the track advanced We acquisition and the October – transfer. manufactures already registration half FDA substantial file

employees customers recorded are the first Today We Yescarta. we and WellSpring ANI family. the our sales announced from commercial excited to of welcome royalties to WellSpring

Kite These a of portion certain will financial Pharma. second our as to are various Yescarta global ANI BioSante I and product in will Financial worth between of related and conference royalties originate We parties Officer, $XXX,XXX of net now as the recognized a assets entitled We details to milestones. who the arrangements royalties to more from quarter. the Chief our over including Yescarta percentage in licensing acquired with subsequent Stephen call Carey, transaction on streams well provide results. you sales turn

Stephen Carey

XXXX. second thank the you, Thank to and line, you to quarter the joining Good of Art. on call everyone for discuss morning ANI’s

three below leading posted non-GAAP revenues franchise $XX a towards shift net million, EPS lower a $XX.X XX, expectations XXXB non-GAAP due to ANI share. to average June selling mix per LA our adjusted price. EBITDA For XXXX, $X.XX of These months in of customer principally are our of ended diluted customers, Inderal results the million and of

Royalty addition, by more in product three tempered revising second well primarily as in launches quarter as Inderal solid purchased of relaunch sales revenues quarter the AstraZeneca branded morning by February was $X.X they by our tempered than our as the declined income revenue and declines which brand LA XX%. our Inderal Ezetimibe-Simvastatin, including the a in driven ended million, generic decrease In declines products offset XL May, shift as in the months were pharmaceutical December for June XXXX. of our in XXXX were driven of of as was million Branded in in Atacand, pharmaceutical are Casodex. million impact quarter, decrease sale generic HCT mix. X% million of product, in of year, revenue XXXX full this XX, modest are and and $X impact to to the in four $XX.X our Arimidex, XL products such for we million, Atacand XXXX, and products, propranolol contributions a ER. was result profit quarter, margin were sales label. our from Diphenoxylate-Atropine of the of million versus to four the late lower X% by were guidance Net our due products from during of Revenues $X.X InnoPran fenofibrate comparisons royalties. of unit declines year the the prior by acquired quarter, related $XX.X from year the of from Prior from launched These a direct which of prior this ANI a $XX.X or up

the as from first transition our during quarter XXXX on products of earnings highlighted of phase income As initial these the be ANI. will the revenues to AstraZeneca call, royalty reported

In the milestones certain approximately Gilead’s to highlighted in of period recognized royalties as $XXX,XXX relating sales addition, initial we of Art’s comments. of Yescarta, and

period of timing the million, million, to net or million $X.X of Cost purchased our in year customer revenues. Prior due of of manufacturing increase In to of of of principally addition, costs were certain of $X.X approximately contract inventory was the $XX.X XX% with revenues sales the acquisitions. recorded finished representing in included of orders. $XXX,XXX goods an for due the basis fulfillment conjunction services cost step-up sales

driven sales in of prior or is growth to WellSpring which FDA expenses and expenses the the recorded Research goods no products with API compared million and general sales This testing net increased million generic costs $XX.X related GAAP in-process support which to cost quarter, related by transaction. the the and and and this development in $XX sharing products to the of to royalty million to were research governing directly to $X.X decreased the corresponding conjunction amount, subject of has $X.X our Excluding acquisition of profit of under guideline, costs cost with income, year were our quarter in development asset revenues. of five impact include cost improvement legal XX% charges business, expenses finished as attributable year, of point new of prior from comply Selling, sales quarter arrangements. totaled million $XXX,XXX administrative the and employment Impax/Amneal. $X.X second million in of and recognized and

of program driven our quarter, underlying by generic prior Excluding R&D our organic XX% $X.X year, and related recommercialization work behind this increase accelerating investment in million to versus was the pipeline. amount an Cortrophin

diluted from flow the quarter IDT. cash as and benefited the the a and and of of commercialized and and on rate was operations XX%, behind non-GAAP income We and balance representing XX.X% sheet the Total Our the Impax/Amneal the as generic quarter, in tax invested This XX, XX.X% during had generated $XX XXXX. both a million adjusted million income, basis. impact XX-month cash we continues $XXX to from rate million, statutory in us perspective, in to corporate period, revolver of of metrics the two a net of date business forward-looking pursuing From XXXX. the Act effective year-to-date year The midpoint acquisition net of million senior as the sheet our prior Jobs in times balance $X.X million $XX.X debt opportunities quarter of federal pipeline nearly equivalents approximated new facility established leverage pretax flexibility times undrawn per share $XX utilizing our due of tax the is Cuts basis and on cash June and development the XXXX X.X net quarter. remains million that credit Tax for of our as guidance. primarily in transactions. secured favorable $X.X further trailing revised unrestricted rate of to provide balance we earnings with GAAP compared This of portion

year-to-date approximately net per a remaining total in rate to we On revenues, year-over-year on gains million representing current XX% of ratios. our we amount and beginning at of This of our the adjusted we of of basis, for generated portion X.X% of the million our fixes pay XX% $X.XX tenor interest initiated diluted term and respectively. the earnings synthetically have rate the interest April, of addition, In due adjusted loans. this XX%, $XX.X non-GAAP structure for $XX.X an non-GAAP instrument debt EBITDA share, leverage swaps

and be At our and to enthusiasm We non-GAAP $XX to they of XX% of year, gains we driven be spend, in XX% in first Despite for business second contract WellSpring proud net This over LA continued reset XX% label and and launch the driven the selling in Casodex potential year full ANI of we’re share and with year term by of results, our the diluted of our integration revenue at anticipate of products, price earnings half While, place representing revised revenues of to trail guidance. XXXX year an declines drivers, execution original LA launch million revenues. manufacturing July acquired between Atacand maximizing by between levels, our R&D and corresponding we the full the project and will anticipate XX% EBITDA second aforementioned our Inderal profit Atacand XXXX. increased contract half and the net near ClarusOne per ANI of our currently to adjusted do of over label half million, half XX% representing these between of the a increase average continued executed recently October a to expansion with $XX that in $XXX $XXX HCT million performance Arimidex health successful to recently prior year half generic planned the underlying the these $XXX corresponding and XX%. million. and We expectations Inderal in the leveraging reach our would coupled for have million increase revenue expectations full second revenues for second million, price. with $XXX currently

Finally, excited Toronto, our Pharma from speaking to business, we to of newly just be outside WellSpring very today you acquired Canada. are Services

our manufacturing offerings expect allow acquisition existing our market resources and building block yesterday WellSpring’s the $XX to in million our our cash expand driving stable entire we call a an transfer footprint gave conclusion, are and WellSpring the sheet. on across increasingly augment capabilities, In Przybyl. the the closed future we is CDMO and I Our will contract to ANI us President platform. the exciting WellSpring on leverage this, plan of we revenue With our our to CEO, of our more shareholder in the which execution generic pipeline towards back optimistic for of turn Art tech development we to leveraging long focused The expanding In In additional continued midterm, transaction manufacturing expand on of immediately about existing important capabilities the from to term of From and WellSpring addition plan the monetize term pipeline Corticotropin, near timely business manner. expertise both term, ANI. the balance generic with driving of the we’re maturation ANI. value. to technical opportunities will to to near

Arthur Przybyl

now the conference Moderator, to Thank we open you, Steve. will call questions.

Operator

first question line Dewey Thank you. Canaccord [Operator Your comes of the from Instructions] Steadman Genuity. of

Dewey Steadman

that just pretty at see it impact not? out guys. Hi, contract then ANDA acquisition. elaborate currently to the product. for future pipeline it guess interesting the manufacturing to business Thanks. margin WellSpring self-funded question. guess, leverage seems of the from WellSpring the Baudette I Can I does bit taking and any development a to And possible this also into – build longer Thanks a teams like on on is WellSpring, – you capabilities then has those WellSpring it’s term that

Arthur Przybyl

Dewey. morning, Good

more the does not developed The your to is of capabilities order Let from that to to pipeline me pipeline. first. company begin advance internally still internally in take the – leverage company. And part have its no. latter ANDA amount develop WellSpring of can the transaction, that formulation question reaction own we ANDA of an the to developed is ability My at an adequate

ANI So of. puzzle our to that of that is and investigate piece very the explore well that we And we aware a to remaining continue opportunities are puzzle. to piece add lead

establish beginning – to you company actually product a and believe and capabilities the regards of the center versus more Now in be pipeline. create its be what ANDA at the WellSpring or for in model capabilities for us advance, here acquiring and and an doing at will WellSpring it be internally possibilities order resemble versa. scratch excellence, And center hiring capabilities out vice looking the something question for starting will to an for could for your The development important of they’re would greater which from regards could the terms the In to house, individual of to excellence WellSpring, synonymous. very Baudette formulation certainly capabilities both one. of business be we we’re that future, to Baudette, that to formulation in if

here to that a business at transfer besides them WellSpring CDMO one of products us here move us. from is take Baudette tech so into expanding our the the synergies we site. That’s important and recognize to allow to And opportunity

capacity significant to at tends Baudette remote. Baudette, but have We be

and somewhat issue, a And people, work are technically more can so it’s of hiring really they resource remote capable human that Northern us in Minnesota. for

is us. have us Baudette, so opportunity an we open this tech the very Ultimately, next, instead up, as get product at to held out to and we important time projects advance one-time add these And That’s I like we in you think of transfer, as one-time if of we gives possible quickly be to very, choosing, product the to as know Baudette. CDMO can want as advance to with want addition several WellSpring’s generics, at capability. We what slot advance many we’d in money. to don’t because want at

more a Baudette this have double business and like out going manufacturing a CDMO a branded see now of be of from an us we Secondarily, to time, our potential the is established over we more where business is that This that platform products afterthought we’re generic at. is of to period really for capabilities.

that facility, the have But et that work, cetera. but with to probably Baudette really we acquisition solids, greater call about glove manufacturing expand we we of solids really we there box we oral So is are that oral – at also revenues. which today, site today, and and IDC Road business $XX drive could believe underutilized you the capable containment, million the say require opportunities that in

overall of we does how talked Lastly, CDMO we margins about revenue has I’m stream that combination and the generics. I to we lower the, to gross say, significantly would bit. revenue say, to though, have believe core we would let than going businesses, let’s that obviously, ANI, rate – the affect – and capability, opportunity Steve contract an the you manufacturing, little manufacturing brand so XX% margins. speak for than run a inherently our okay? have through on contract WellSpring And our expand margin like facility,

Stephen Carey

Right.

make the the that business So of willing stability we’re a margins lower, trade-off while that Dewey, think terms net-net, generates. to of a CDMO the we dollarized are margins it’s in

ANI of revenue think and about And so terms continued I very in balanced much of the base. it diversification

past two business, You’ve the And that diversify base. for brand is of journey seen our over in start expansion on towards a quest tail products. generics this through terms us the overall years both our diversification to balance just gross of revenue margin and and continued

terms into so in CDMO spending trade-off our business welcome sale we’ll And portfolio. the so and sticky take and quite margin and that’s generation, a of is that overall

Dewey Steadman

And Thanks. just quickly Vanco. Great. then on

margins ideal solution, if For the And patient? oral the for product? about we think promoted? how approved, how what’s that product the be And should will Thanks.

Arthur Przybyl

will That be a product promoted brand. as

would until an version hospital from, as margins So to obviously, with environment, in to whether one than my and we benefit a closer more the get that have branded market launch of as tiny a It’s going this we institution, as to that get branded until is liquid outpatient force, that’s both to The product. defer to absorption I’m potentially associated sales that such. well would reaction be in ideal product to that How that. patient And that, of after for that me road. we product. defer premature speak specialty going that we I’m a of a further treat down

Dewey Steadman

the Thanks for question. taking

Operator

comes Raymond of James. from Wilbur Your line next Elliot of question the

Elliot Wilbur

morning. good Thanks,

outside it their that, pressure. at provided markets of of Obviously, like if of consistent methylphenidate in aggressive me at touch update of market been is talked still a to pretty on seeing. kind all $XXX going on time with the to I’m the entry price It wondering call. generic bit assumptions grab it is maybe to just under million your about opportunity looks you’re on But Teva after today. set that what of the least wanted of looks terms Just like here. this come Trigen’s be the of based even expectations share. a opportunity to timing base little

Arthur Przybyl

so, $X.X until we this potentially the is at this of I it’s we the have who us, smaller margin a up our sake validating we return is approved company signed generation nowhere costing six revenue transaction. we significant in for a But It’s million, to to Elliot. for ANDA Amneal/Impax for – in we us margins. a mean, think product. advance Amneal/Impax, on look announce acquired as this little but considering didn’t that with aggregate, look I obviously at paid, launch. over that this go yes, And in us, large those we to products But million $X date for after the this and argument, we of market. it’s agreement from product terms Halo, us,

you, And of think product like our a this I or portfolio, so very product important call not our the is press we would we assure release. this in in can out body a

have three We or out potential generic many finish we – line, revenue we’re these to call these three earnings growth. catalysts think significant for have are products and we that but because the advancing

to we see one the can as stakeholders provide So us return that our with the still and company. significant opportunity

Elliot Wilbur

this and on the and of some guess, trends at into million of what that morning A there. a to of quarters. looking been in $XX results commentary, kind your lot morning three the of of $XX line, full yourself million in last of to well. thanks And I’m the kind revenue Steve as four a I not inquiries Art. kind looking the Okay, have this understanding business. has question sort And range of just for sure for happened And I just brand

new that of little is this level the mix, in up a moving customer numbers kind base there, should pricing, more of. detail terms talk we trends just about in bit sequential could off of about So that maybe you think guys a whether

on a there. the Just progression not sure of really handle business I good have the

Stephen Carey

business very most the utilization our was, Yes, customer our a shift brands It’s stated, in impact LA franchise. dramatic sequentially in as Inderal dramatic sure, for the Steve. Elliot. Really,

as at be in mix was admittedly and for imagine, customer So LA downward. can first for accounting And the course Inderal franchise of tail these trending trends as the XXXX, XXXX for XXXB of through certainly, we business, of brand you the are throughout products. dramatic quarter volume recent terms very we’re mix looking low the that the can

And were would of so for favorable our in we getting, quite I XXXX. dramatically the quarter pricing very price franchise. the selling in trend average say, second of That changed terms

was And change just really utilization. so a on purely mix it

And so in the that second quarter remainder utilization for we second quarter, honestly, of it’s a we also little impact bit impact the of to that, had assumed beyond. of mix and a the and the XXXX double whammy for account because will which new remain both

resetting sheet our And so for product that of quarter. kind in we’re bit the a second little balance

whammy we a sure. will how quarter, that So have in of trend And the little bit second quite a to out honestly, see moving for double plays forward.

have that the of terms reality reflective fully of mix, that change second revised we differential reset our this morning, recognized LA Inderal the and we in that quarter morning. guidance of pricing fully is this pricing took In guidance so and

Elliot Wilbur

I up want Okay. to you there to I just because Steve, understand. it’s important with follow think

So margin it’s be a the of two then a know new it’s mix that those the change can think any would it guess would specific observations in should impact sort on there, be status of of perhaps, If still I lower. although, incremental color of I if the I existing customer, there, if some commentary. make I sort the don’t a potential of change about And guess XXXB if provide but… terms sense revenue, you customers, of in

Stephen Carey

Yes, sure. I’ll Sure, try.

in downstream from impact brand been for So happens side. customers big the in on our there’s terms direct It’s of no terms brand all what an business. our our of the direct wholesalers change of three customers,

product because And for bit come loops so in little of in franchise, the you indirect of honestly, a accounting a that’s of get really utilization of it’s the terms then through why, that just that indirect and delay impacts sales quite reality downstream. the feedback

albeit new many lower in been low. customer, not the point revenues of years, it’s a there shift that a have but gross government your to really utilization brands extremely pricing is for is And many, be on margin, a a the for associated, And so it’s and reality mature incremental lot would mix. marketed XXXB on at

that’s this why as have we it And so year. can experienced second in of the a such impact dramatic quarter

Elliot Wilbur

Okay. talk those R&D trends a you the of of out Thank little well run investment the quarter? But in expense as current bit items makes, trending I clarification. rate? about how should little maybe just expectations. SG&A the incremental from about bit hence, think kind you. appreciate line Obviously, ahead Could we a

Stephen Carey

Sure.

discussed, is So what our Cortrophin on the of bulk terms this year R&D side, as the year we’ve perceive – our we to in be investment.

and that anticipate And in here quarter, trend start fourth so a you in in second see kick quarter. the that’s to we’ll to continue the and third

this for in products the accounted have called of item that it we Impax/Amneal that strip asset out about – acquisition at million. between item year. this $X.X in If it did accounting does million when talk chart, we script million initially put think R&D the didn’t we we organic out, while since I our we think, number just will $XX a quarter you second $XX be in guidance think if year with went February, GAAP in The guidance out to, we and back I

towards We I would that’s believe to say high go we’re the on the end right range, that of continue track to although range.

that costs costs I needs coupled around increased is second support SG&A, and in needed our expect our to third that million out costs quite you that’s the as that WellSpring, recorded the One quarter. first and would in this would number out fourth increasing business and we year. was called was $XX two-pronged. regulatory grow to of quarter as And the anticipate it’s posted tell the then, in and item quarter. just second growing time business relates support and a continue really for we to we with here somewhere business, ex-integration the I that honestly, excluding the again, it what for the that number on accounting And GAAP representative So is

our And have get the it the our regulatory an continues more matter cost environment that fact to does is complex, impact and on of so already-complex structure.

Elliot Wilbur

Thanks. Okay.

the Just just you question an new about a of an that or it’s current Art. not incremental little think a sort you one power. what time ClarusOne kind bit think of market modest rate. of relationship a one And just of generic maybe for the immediate if the of there’s will with terms little at big be a the just enhanced it’s whether or across-the-board name obviously, lots last potential new just you increase of one, and in give bit there, talk color in kind run Can and product I’m sort with relationship? Thanks. opportunities assuming for of

Arthur Przybyl

Sure. Sure, Elliot.

of of time recall, program, is we year argument, think dollars enter Red to of two, Oak was that consortiums sake that of the stores Rite take One, play last and other into to if we a of a I extract and So June, our said to – of they formation the business the they you came McKesson’s the to frank, came agreement groups. shifted last to other at and no fair enter the came and with that consortiums portion Walmart that program, amount of WBAD. we many And be ago steps. that and and to the Aid a into the in combination ClarusOne these couple significant consortium three ClarusOne. about OneStop decided, dollars wanted, that the two assorted they At the that some looking half other consortiums agreement. time, we a actually like to were together, into recognized of fore, it of different

really a saw doing business our We with business generic that blip the trend we with in And revenues or ClarusOne. not fact because were so of never ClarusOne. our lost you downward

be negative. could that So perceived as a

Now – but behind that’s us.

products So an that us, the portfolio they large were potentially have obviously, we this from with of a that ClarusOne, payment without business to gives ClarusOne, to runway us. looking and agreement to extract this effectively for compete upfront generic add

as upside. view And this we so

be will at and product looking national maintained, And newly least hopefully, folks, to add so have with revenues. our and, communications to agreement from a products generic account increasing our that formed a standpoint, advancing relationship who ClarusOne, obviously, always

effect that’s July I believe, ClarusOne. with so of signed, And the that agreement we the really in

Operator

Folkes Your next Fitzgerald. of the of from comes Cantor Brandon question line

Brandon Folkes

be in guidance. for seeing the back thanks But want taking what the Thank what the are of following go are in of my year? some know of Hi, lower may just we pushes LA. in half that may the launches on that, the guidance? what market achieving dynamics guidance, you’re And to the depth on level you. to question. guidance talked And and Inderal in pulls second you I from I reset new in to drive guidance? that

Stephen Carey

Brandon, Sure. Yes, Steve. it’s

pushes performing different products anticipated. as In other as the mix expected. are our terms the in always There’s of as product generics our our year the the pieces But various of of business operating goes in components business on terms on – side business, They’re of composition, largely in business. is net-net, and our prepared comments, the and on of as pulls other mentioned strong. largely the particularly

We’re the health the underlying very happy business. of with

absolutely significant has curveball moment LA us. generated talked second we now very and we’ve a was about overall guidance. second for it ramifications revenues significant that that it’s again, The the And embedded are the to from pricing and half As quarter, franchise our our for numbers. ago, gross one a into margins Inderal

AstraZeneca of they’re quite for that. the second making terms relaunch in I reset And label. the honestly, we’ve around two few products ANI the of the related in So already accomplished a those principally – of in of July. products there’s key catalysts, think half, We’ve and relaunch the

and X, and Atacand HCT of Arimidex July track this and of in Atacand October Casodex label, we operationalizing year. to relaunch As of ANI the on the we’re in currently relaunched

on the integrating generic coupled second team with will is less on focused that, results, the So of but to WellSpring. generation number Impax/Amneal, the key terms the products, or of And acquired side so execution in will then be – quarter. our from financial recently be the very particularly obviously,

morning, roughly integrate of this XXX we capabilities family. have employees, As new into the new ANI to

realize you that this of WellSpring, closed terms yesterday. to In got transaction

accretive our perspective, year. it’s from the XXXX. comments, modest prepared half revenues for we this a And very in become including guidance mentioned or months of Art back a his And line, of results small to so top of in a be our overall are expect accretive amount five to would in we as WellSpring very had amount but WellSpring

are we’re the second half. factors the that main those So in some of with dealing

Brandon Folkes

perhaps, great. on then, And the providing Okay, Corticotropin very – much for thanks today. additional color

rate-limiting So that between and filing? mean, for now line could second, product? discuss steps do you I expect review time you a normal any this just

Arthur Przybyl

Sure.

line is to time review months. an filing approval response months time. handicap filing whether we’re in FDA’s the and to PDUFA of So our date a receive I normal upon four can’t four going

manufacturing But think the to would can I process. dosage of want use that I material the both inspect facilities the envision product. certainly, raw form certainly expedited for that an and finished we they manufacturing contract

the I of $X.X discussions everybody think some product. associated a a D.C., costing Medicaid with break for the that not after after date billion can reimbursement Washington, action But with filing. discussions approval in of that that after me agency, an course drug taxpayer monopoly on to money the think our U.S. the it’s is of lawmakers with understands on significant handicap amounts importance of of I FDA’s

to successfully batches up we So – days into of and now we manufacturing, between Cortrophin scale that material the go what will of to We registration basically raw then? gel has amounts stability. happen on XXX which put need

the not announce of where of to target product, development meeting analytics been today’s to held as press comparators and with or this would timetable initial good the until well we in at in press work had we’ve we if date. date as this off – pretty has release so of could feel completed filing those that feel our conversations at But that that the activities so still modernization the development see of bridge back chart the the our you occur. And the the some the chemistry surrounding done old release the from from our about we’ve this in confident we announcing we’re or and FDA work

answers So I your question. that hope

Brandon Folkes

Thanks very much.

Operator

And the back there to comments. like audio any time. management this no I questions or closing other would turn over floor are for additional at to

Arthur Przybyl

ANI’s have everybody. We just and earnings you, Bye-bye. conference Thank attending a everybody nice call, thank for like to afternoon.

Stephen Carey

you. Thank

Operator

ANI’s concludes This second XXXX quarter earnings Call. you. Thank

at You have may and now wonderful disconnect time, this lines your a day.

ANI Pharmaceuticals (ANIP) 7 Aug 182018 Q2 Earnings call transcript