ANIP - Earnings call transcript Q1 2018 | ANI Pharmaceuticals, Inc.

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Operator

Good morning, everyone, and welcome to ANI's First 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

is and quarter ANI's is of the me I everyone, Officer. Chief for Art conference the am today joining And first XXXX. CEO. Carey, welcome morning, our earnings Financial to call Przybyl. Stephen Good My name

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

increase timing series two and of to pharmaceutical and since revenues launches. transactions of the you First effects reform. during a of based December. both include primary on last the long generic and transactions four recent we’ve from products from this in through at with strengthened provide relative our results term the platforms, designed Strategically the financial of Steve presentation. XXXX, royalties will platform business acquired tax end products, quarter short profits These are branded impact positive branded highlights product our and

we will product of acquired been new profit that transaction of generic announced branded to Specifically, beginning our on comprising SKUs, last a receiving year. with launches of revenue and products three the of immediate XX us Since year, portfolio products. launched the royalties the generic commercialized four provide increased close products total in XX contribution. December These we’ve yesterday’s that we've

For the approximately totaled royalty the first quarter revenue $X.X million.

products label to increase our in will products. expect of launch We the four XX XXXX and that a in these ANI portfolio total commercialized to brand to serve

includes continued opportunities data billion in Health. competition. exist XX growth now see our pipeline through opportunities believe acquired to IMS products and total pipeline Of of extended-release and extended methylphenidate on products based tablets pipeline XX an annual addressing validation environment X.X require products large from XX size future limited these prior market approved, today products capsules, Our acquisitions. were compelling the we generic to for launch. two are for release existing with efforts, market We products, aspirin/dipyridamole Both continues

validation options certain date about which We approximately one Currently, own has are XXXX launch provides only for regardless excited effort. X, of very us Aspirin/Dipyridamole $XXX our date generates product million. our the product competitor generic with of and October revenues of the a annual

process conference track manufacturing Gel Our Cortrophin the continued and re-commercialization manufacturing XXXX second registration the FDA scale with a in internal progress end Gel in initiate of the to product cadence end are of of of fourth still Vancocin advance to are press qualifying with XXXX. pipeline as information advance Financial a expected our commercial manufacturing. scale our XXXX. by in batch milestone of second in C target the you product will to on will the results. are to We regulatory ingredient plan plan in API and manufacture the XXXX. scale supplement also before and meeting quarter Stephen Officer, to commercial of to Carey our process prior API equipment its batches ordered pharmaceutical with of Chief the quarter on call provided intended validation half and batches manufacture quarter XXXX. Vancocin FDA We’ve the XXXX Corticotropin over requested to and for certain of We API. year. have course solution In and We events supplemental we the timing Table second approval our with solution the release necessary The I In us now granted Type or active that Cortrophin financial continues in to provide still to initiate communications first response provide drug more track today, provide the and March commercial API NDA Cortrophin quarter continued capital installing we of on this Gel XXXX, effort FDA for filing. the product remains manufacture included turn initial has Gel. who and With we’ve two Cortrophin branded Cortrophin meeting further of on of opportunities the during for relevant regulatory file oral details re-commercialization the forecasted is oral compelling of the update Gel. of to timeline. re-commercialization our X to drug

Stephen Carey

non-GAAP morning million up XX% Net new $XX.X everyone share ANI record increased million EBITDA for EBITDA the label to XXXX to non-GAAP share. of in compared diluted by million, relaunch XX.X strength prior by on reach and driven performance ANI's of portfolio. to and XX, At doubled strong representing continued of call Inderal million, February our $XX.X increased our started line quarter as a Thank the ANI EBITDA or discuss non-GAAP adjusted franchise. than XX% earnings-per-share the representing XX.X versus on Good for the the Art. LA first million the driven per on in year. March growth new or to branded financial XXXX of XXXX more brands. $X.XX or to This prior adjusted and $X.XX company year, joining you, XL was ended you per $XX.X was in is our months note, the up products adjusted a non-GAAP revenue pharmaceutical for XX%, diluted million XL $X.XX posting and XXXX diluted the results. thank GAAP nearly InnoPran X margin. $X.XX three a X.X million record reach Inderal strong XX% Revenues revenue record to of EPS

to transition of such decline products HCT the of will in phase in recognized ER. In lower million pharmaceutical Propranolol million, quarter driven ANI. of the brand $X.X royalty initial to of from declined year, as initial products, Fenofibrate to the our Casodex and purchase addition, be four royalty income XXXX Atacand products the from AstraZeneca of we prior Revenues revenues These December of XX% AstraZeneca. Arimidex, $XX.X related by from product, Atacand, our recorded income revenues as margin Generic during and

XXX,XXX includes principally of to addition, from customer contract the GAAP $X.X the orders. services cost were manufacturing In a fulfillment of our to sale Cost million on due of basis, down timing as revenues of of the to the for million inventory due purchased in included XXXX of InnoPran Inderal up step product the acquisitions. recorded such basis first goods Comparatively, with conjunction costs. and $X.X quarter finished XL XL recorded

XX% driven year, to development expenses. sale. no in toward driven and corresponding XX.X% of and favorable year, sales has XXXX, Research support $X.X increase XXXX. well This year of amounts, of first by of the growth Excluding in XX.X% to these mix employment expenses million Cortrophin brand represented legal improvement of administrative income to prior the the at prior Re-commercialization XX% costs quarter year behind were general the million which and and cost of revenues program. continued quarter of first Selling, by as cost percentage as from impact revenues attributable is of in investment an quarter related the over $X our for the totaled royalty as period. net XX% compared million as compared momentum to for prior our $X.X costs and as directly prior of the in to business, goods a increased SG&A decreased sold

representing new established favorably Tax sheet. during tax Driven we Federal was of unrestricted December free the reporting million the cash effective by and cash from Jobs compares the in XX.X% that flow our impact metrics cash March The per as are second fourth sheet our from as the of in XX% of period in of This the and rate quarter increase and realized the flow with first in $XX cash Our XXXX. of flow of earnings reflective quarter. non-GAAP year quarter. cash share a perspective, diluted of XXXX, an million expenditures. $XX.X million payments. XX, $XX.X of million tax cash be rate from XX.X prior the or XXXX new to $XX.X first million flow the million conjunction period the favorable adjusted the in estimated first of $X.X of as benefited the initially balance cash flow net This we both of in capital GAAP operations generated generated XXXX. million rate XX.X% will operations, under of XX, balance equivalents the quarter compared free on Cuts for tax X.X and it income is XX% statutory generated in the the as of Act quarter XXXX quarter We From nearly of to had

basis and pursuing secured and of times leverage XXX the paid senior of approximated flexibility leaving on forward the provide X.XX also looking in $XX two balance Total development net guidance. in our payments XX.X XXXX facility we XX-month balance times scheduled million remains trailing credit continues our against quarter transactions. million. representing to of midpoint revolver the the with us million date XXX,XXX utilizing net of remaining as business loan, a portion further The term undrawn During principal debt sheet

remaining April approximately synthetically the In This due total leverage our at we the debt current pay to for addition, structure ratios. in interest portion tenure fixes the rate loan. amount swap interest of of instrument we an our on for our initiated rate this the of beginning X.X% term

the guidance to our expansion maximizing in year. XXXX. increase three of will reiterating of revenue of base, of in anticipate to potential are announced half currently figures our XXX and portfolio continue million, annual to Finally, recently XX% revenues reach to currently the and the XX% continued the this purchase of commercialized greater net successful a product that from morning XXX execution we product generic between execution which by brand the impact and driven representing second impacts these over We generic million a be products of and result project have launches our commercialized ongoing will transition XXXX

to XX against XXXX business XXX XX% $X.XX over and continue between reach we our to XXXX XXXX are between upon expect and while executing non-GAAP per to adjusted $X.XX with we forward to look addition, recent be to XX% continue EBITDA summary earnings-per-share million In deliver In non-GAAP diluted reflecting share. we Cortrophin growth to adjusted million diluted invest our in pleased transactions and start goals. the and of and development

We build Przybyl. will sheet order this value our long-term in development and the further utilize to I and stakeholders. capabilities ongoing continue Art to back our CEO, out President to support drive balance With turn call our judiciously to and will shareholders business our opportunities to

Arthur Przybyl

Thank call you, open Steve. Nicole, we’ll conference questions. to now the

Operator

Certainly. Instructions]. [Operator

from first line Steadman of Canaccord. comes Your question the Dewey with

Dewey Steadman

results the morning. just guys Thanks. assume meeting. clinical opine PAS on Can are you point review. a that there four-month since there a that FDA of we the left required Cortrophin? Should good indicates release trials at What's for are you Hi, still in this expecting the and no discuss and the table press bit with the to contents

Arthur Przybyl

question. a So, current Dewey based PDUFA we part months' The of legislation. for your put current review four the legislation, on is PAS later a timetable

placeholder, months be XX to PDUFA generic different will legislation. under that’s than that drug a no So it's approved a saying

So that remains to be determined.

an regards agency say older product letter on in of there had standards the bridge regarding are let's opined to opined best what the term discussions they that from the as ongoing view initially still to or today’s we questions the we bridge, FDA and to Cortrophin that. drug the In with necessary are product I so would of of awaiting, modernization our gel on, chemistry terms what some associated and to advice an

Dewey Steadman

bridge, would bridge, CMV... or that a so that be and Okay, does clinical the

Arthur Przybyl

to I answer question. that early that too it's think

have a perhaps more insight, the as you to unfortunately, to So wait next earnings we till are call, as get well.

with the then Okay, well there -- as communication. expect return additional and additional ongoing discussions as have telephonically agency, we been

answer too your just it's So, to question. early

Dewey Steadman

that on more commercial The the to be batches year, by the you the those expecting for are produce at one then used of and can studies end stability required are that Okay Cortrophin. FDA?

Arthur Przybyl

a correct. are correct. registration that we batch That is intending. That’s That’s

Dewey Steadman

guidance Okay, received? full just year my great. question products that on now into your are baked those And acquired final impacts, just we recently, those

Arthur Przybyl

standpoint the see, so understand guidance wait product entire our and try that we and very comfortable that. typically our we From just we conditions market portfolio compel unless we one really after us guidance as change They after not. today that the are increase for to don’t typically a there We do would jump company, feel right we quarter reaffirmed to market decrease with some or obviously. are on But we guidance dynamics the gun that. that and

we’re we’ll thing I progresses. we quarter because as to down, But, adjust dynamic looksie seen avoid of and So, get the to only we it market the the a conditions. companies guidance year do in one going have take want up is adjusting following guidance whipsawed or appropriately think other pharma to our

as reasonably you So, know approach a our numbers. to we to tend take conservative to try really

Dewey Steadman

Great, thanks.

Arthur Przybyl

welcome. You

Operator

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

Elliot Wilbur

good Thanks, morning.

sequential at would on if buying generics party suggested of really sources the patterns specifically segment of similar roughly third bit in a call been sort the or it's of of couple have in trends the the some just generic XQ, data in out sure a trends seasonality question just so in last line top maybe give I'm of or initially suppose a Just quarters color from I adjustments in function to just little that but didn't that number looking not maybe terms business, would've specifically? the you quick

Drew Alexander

they’re let’s Specifically, called of us. looking two at for two decline there products, it lower you’re Steve's margin there are year-over-year were so really items a products, out, XX%, call

associated stopped to generating product. agreement us. kind two approximately little bit sales, did, with is but consortium in for is generic of increases Fenofibrate There no improved So, Fenofibrate. SKU, and distribute brand make X% particular of particular our one they it. margins why that the a it's the for products distribution north buying a that of We

decreases that Inderal affects our that affect and with our again so business. generated tend revenues, of product and generic a seen by but called of that’s in the is so And product way. extended the propranolol overall certainly but margin over affect do product the associated just business, doesn't the would product And price a affect not that other really material the is our the release, margins revenues margins the to time

Unidentified Analyst

were a give course in specifically package a in of envy out a you think lack second I deal some package follow-up give of for then of folks of bit term, interest some like recent lot there, or I of hand or with unique including us FTC product some bit question a in product or the you terms looking in of transaction of you on us of ANI better at through And your ultimately probably that just a lot with maybe a terms up industry, the guess the gating upside getting interested could and of that factors so could little little the you ended folks capabilities in back acquired just terms announcement. color ANI, then just of maybe was of company a are guess process, significant that who market? speaking talk divesture maybe how Concerta, what of potentially seems on more flavor size in a requirements that little a and of on for bit assets

Arthur Przybyl

is and not forward, your gating this Trade and three FTC in Federal overlap that there Amneal/Impax through opportunities FTC, choose different, is a to five imbalance. company these the past competitive making interested years to process Commission very-very ANI type is did is as company primarily through it take why sure the the So not and the a

to extremely believe presentations the the market able the they course FTC choose understand capabilities to been business. potential get with bear company's their things, very that product or and to it same to of combination the of of urgency in a with they Amneal/Impax done the I relative balance the they somebody transfer And in the years think for the discussions to competitive us successfully some they products of the that for. to of of capture FTC, regards sense they saw being saw and the much Amneal/Impax, choosing in some interested to establish on is and vendor our I get that the nature several understanding after felt have came finish line us, and as accomplish it share. terms think with looking made, is forward to We’ve these I of to and we can't mind with In merger in done that discussions FTC take doing done. so, And comfortable obviously, FTC that's go they business

equipment, So, deal -- mean a this we to see the resources, for all technical to products too we is great I good what be really many deal true, got got those of significant got several three represent took people launch as that opportunities. factors and away, too we I we maybe sounds led a ANI. we’ve for right really we got got products consulting,

on understate so opportunities. too can’t it it’s the And but a just capabilities top the that return three okay. tremendous deal The are that true here, generic have done, And products of certainly deal this out born that. sound launched, it that you of a get was for to the monies good ANI, on completely these from opportunity overshadows does paid I be and certainly, it additional to maybe was our

$XXX are and one million. that think not two product a big into ER, that regardless understate a X aspirin/dipyridamole launching require we realistically are launch that but say before can’t when a sales generating efforts and this very sale high aspirin/dipyridamole player to you on if the of sales people can’t we the us, less we products not market be competitive validation but might you methylphenidate deal not net So, to that’s fact that net the That’s health, X. I it is IMS of launch of that about going XXXX is excited fact that that understate market margin October the October

Now first midterm and foremost not is the overlook. be that probably should that opportunity

a assure that time. Now unfolds, that the market. of we and of but other I methylphenidate resources the on your to to detail associated about much ER question us available any just and is that amount there are get Nicole, go don’t have validated with Elliot, second And over product to part talking questions? rest want opportunity that into we’ll as can you be yet, fair that

Operator

We no are are time. questions further audio showing this at there

you If with wanted to remarks. proceed closing

Arthur Przybyl

quarter I bye first Wish just a much, call. good want and everybody joining conference bye. for again you to Thank ANIs XXXX to you thank earnings very listening all day.

Stephen Carey

Thank you.

Operator

Thank concludes call. quarter XXXX earnings ANIs This first you.

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

ANI Pharmaceuticals (ANIP) 8 May 182018 Q1 Earnings call transcript