ANIP - Earnings call transcript Q1 2019 | ANI Pharmaceuticals, Inc.

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Operator

Good morning, everyone, and welcome to ANI's First Quarter 2019 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

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

begin, were that to Accounting refer those financial in everyone I measures certain this as context review first language in it Forward-Looking to Accepted results. ask and conference to press will to morning's measures carefully today. this release prepared found quarter financial with Generally dated want our not also call. Principles. accordance be each we we the release Reconciliation non-GAAP Statements Before reported our in XXXX Today, of of include earnings can Discussions you important

reported the the net net non-GAAP adjusted of EBITDA XX% period. of quarter For million, XX% was of an and X% revenues ANI year increase record an record first increase non-GAAP over $XX.X million, EBITDA Adjusted prior revenues. $XX.X of

XXXX can .And First result the research of that we our product launches the quarter XXXX and product by of a the several such first ANDAs quarter, targeted FDA as remainder efforts anticipate re-commercialized In gel Cortrophin period million expenses prior guidance. our for transfer several development assembled increase product year remains effort, new the re-commercialization XX% prior compared a direct We’ve by track quarter months. our year reaffirm today, we to through period $X.X throughout the revenues primarily for several library over financial the on million, which year to filing. as generic first tech launches be last XXX% generic increased an of and for $XX.X increased over attributed to

continued turn types strategic flow with for environment target exist immediate availability represent Stephen our for will I our our pursue more and ANI. now we require conference to you perspective, the cash use cash over to our will Officer, partner firepower on a to details to and opportunities to revenue these that results. future and they're financial We provide have and cash intend who continue Financial to and rich opportunities call substantial Carey, of assets opportunities. Chief From

Stephen Carey

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

while research $X.XX is or was ANI due million the to adjusted generic basis Revenues million these and of pharmaceutical label laboratory of driven were by the Canada. goods generic and Atacand XXXX launched categories. per to Inderal as InnoPran of Sanofi to certain and $X.X unit ANI in by sales quarterly sales XXXX. and And on products from product XX% Ezetimibe-Simvastatin, We this sales Branded related HCT were products $XX.X sales acquisitions. as increased for ANI to our contract quarter, was posting growth million, purchased morning XXXX true were XX% Royalty current Vancomycin. revenues and tempered non-GAAP pharmaceutical the year of Royalty XXXX. development October income the former authorized quarter Yescarta as ANI March in of were revenues. were July marketing in of incremental label and $X.X EPS was gains Gains Arimidex from on to XL. the of Atacand of cost in principally inventory, revenue net manufacturing relatively of services third-party a generic diluted the low Gilead's for which up other $X.X EBITDA of the related year-over-year contract to XX, of sales are services report ended revenue that $XX.X and conjunction Cost of of tempered months by royalties driven and adjusted version lower and has spend. manufacturing pharmaceutical XXXX generic increase which which by launch million well the sales gains LA which Candesartan product acquired These started sales our our August recorded launched Pharmaceuticals record off period up products Prior reflective due of primarily an in from year margin Canada, X%, Casodex ANI net versus well a in due lower Corresponding for development was XX% the authorized in us. as our prior prior strong significantly $XX.X net Revenues the million than million income in increasing included $XX.X was for million non-GAAP pleased XXXX. $XX.X of finish $X.X XX% for impact million or the share. other more our the million of a At to products cost in year in to three revenue with of partner sales note, Vancocin. step-up doubled

portfolio, our four resulting quarter in Excluding prior year-over-year re-commercialization Selling, margin underlying as prior were user quarter, completed Canada subsidiary, and FDA, million in lower sales second royalty XXXX is to based this U.S. general of from related marketing expenses investment our to due of from million cost expense the $XX our cost legal GDUFA by U.S.- sales related by and and headcount Cortrophin projects was our and fees levels. to our higher purchase including royalty acquired and buyout year asset amount, increase The prior development or improvement generic This work than the $XX.X to pharmacovigilance related in XX% or year double increased net cost. driven continued million, in expansion and year, Amneal. the compared more $X million PDUFA approximate principally new behind of program in $X.X point and driven support our totaled Research revenues. administrative pipeline ANI cost to was increase up cost the in million higher paid $X.X of cost commercial the quarter.

GAAP tax for to Our XX% prior pre-tax the in as Canadian allowance loss. quarter recognized by period. subsidiaries, the of rate compared valuation the [DX] benefit year consolidated XX% our pre-tax was income net generated effective against tax

tax rate statutory significantly U.S. year effective approximate will anticipate we moderate the that GAAP Our progresses. continues XX% and to our as rate

incremental basis, $X.XX activity business $X.X a GAAP largely development on was share of the share the period. The notably per charge fully $X.XX related the ago amortization one-off by of compared amortization royalty year decrease to earnings per On million in as per year-over-year share aforementioned diluted to were driven buyouts.

share, facilities bank utilizing be credit in $XXX achieved turns five-year leverage and the million This X.X recall million down million delayed the period. restated approximately Total from through adjusted a previously diluted remaining XXXX. ago Please per reflected assets trailing announced balance entered in of rate senior full from for XX of draw as and a anytime representing the $XX.X current and quarter. balance and million financing $X.XX XXXX of amended flow had net sheet through a of December our date period X.X was XXXX that From specifically and $XXX of is and loan lenders. bank by as is intangible at accessed syndicate to and sheet cash approximated $X.XX the amended cash discussed, ANI share is cash facility during of group million committed of the of secured XXXX, the $XX.X million senior net notes. Our XXXX. balance by on just midpoint under of This tax new months of $XXX our to guidance. maturity unrestricted our utilized the with transaction share structured earnings an debt by March term was that times balance ANDA-related the driven we when XX, of operations existing the of as basis perspective, cash acquire is year income convertible December X, slightly we the previous year year in per December This per fully address higher into of $XX.X non-GAAP effective equivalents million $XXX net can

Term of our portion XXXX business the cash the flow to with of our and This addition, includes facility revolver flexibility transactions. also development reiterate credit coupled pursuing our and guidance. with us year further remains and extension pre-existing A a Loan undrawn $XX morning, our In facility This in million from continues full facility. provide cash we existing operations, revolving

of increase million million share we first the per to per full reflect results over solid In adjusted quarter very view base XXXX our $X.XX earnings year XX% outstanding. million diluted to $X.XX of $XX guidance to build quarter million expectations, million approximately first share reflecting This representing internal $XXX and Adjusted full of a of XX% XX% a ANI were which rate income an net continue summary, year projections non-GAAP current and $XXX tax upon. revenues EBITDA While a XX% provides and anticipated continues non-GAAP a on diluted plan growth, our XX% to and XX.X and share. of remained to between unchanged $XXX XXXX. that ahead of

Pharmaceuticals to to and exciting product increasingly diligently have working add to at capabilities pipeline diverse Canada. ANI base our are We opportunities we new work

importantly, and flow have we to which We healthy us we the cash strong as access flexibility balance Cortrophin, to development allows a fully asset, grow out and Company. transformational advance sheet, to committed capital continue our continue

to drive Przybyl. call the I turn our look As this, forward CEO, value will stakeholders. and to always, for back With our we continuing to long-term Art President

Arthur Przybyl

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

Operator

Instructions] question of Thank from your Elliot Wilbur first is you. Raymond [Operator And James.

Lucas Lee

Congrats and couple questions. Elliot. for the on have quarter Lee a of Lucas is This on I

market? generic given in What competitive of the, your winning? both of level in you Aggrenox to entries share fair Would Concerta So your and confidence is the recent market. consider

Arthur Przybyl

two We’ve third of products, strengths, and the end the launched we beginning methylphenidate lower [indiscernible] quarter, anticipate higher of launching SKUs strengths at second the the quarter. the the

for ability the that There’ll Lenus think dollars keeping million. markets. we the market. the market, methylphenidate. additional Ezetimibe-Simvastatin Alvogen, market we And gross two competitors will paid and It’s others, launch, mind to Keeping to going lower approximately a additional to for eight more that far with is for in competitors the in profit on we the be time same as those mind, in well be those forecasted two and in competition in entered the those aspirin-dipyridamole. $X.X Admittedly, competitive mind for have capture products going drive to that bear is enter by more that, the we think We we thing I to those as be us going competitors there as A anticipated. we products two for but strengths targeted that’s important the even strengths. share that us

And profit substantial as dollar opportunity we lower out look gross percentage profit this substantial so, markets. for at a -- gross continue buy

Operator

you. Thank

is question Dewey next Steadman of Canaccord. from Our

Dewey Steadman

margin, obviously, buyback. throughout year? margin guess we’d the of in gross gross but bit on expected maybe the yes, bit was royalty because that the color year, I the generic there step-up would in even essential more we've Can was a half product I the And at the whether on step second royalty expect or more look come was gross us appreciated? itself? you or second buyback but half, generic detail to on give then of by the And margins think product? got the be a then, just Obviously, driven launch maybe little we should up it brand details it how

Arthur Przybyl

Sure. part I’ll then and first latter answer let I’ll question part. take that the of the Steve

for we that that you was Teva buyout So, royalty tranches, if accomplished quarter last the acquired products we the over years. the the Dewey, in over recall, several several fourth

And, that So, those that that those Dewey's margins from going -- address forward I’ll we products is the up related baskets. let have primarily you question. of Steve, margin royal generic part launched to step Teva

Stephen Carey

mix just the I and And say as Dewey. the a and moderate any goes quarter between generic XX%. bit well. expect would certainly the slightly particularly brand XX so but point to I as thing, your moderate year in Yes, progresses. launches slight at come Sure, a given to XX and morning, as But sales be to as in to first good percentile. that upper always generic strong on on, essentially expect question it in do year predicated were margins

Dewey Steadman

Is product. OS? And player on there timing updates on product-related is that undisclosed generic And then, launching you’re Vanco questions you. then, you the two into? do review have market one a any or Thank priority that anything on

Arthur Przybyl

undisclosed that to products. on back players of get number will I So, the you regarding

FDA not launch really of publicly And product. the regards first OS have that launch so that currently, possible on the and a can with this date year is it a We product, spoken are launch in occur about predicated the to that. for submission. FDA quarter that But a that, is have Vanco approval, on associated we before In that. July we anticipating that

hopeful are forecasting And obviously fourth so, quarter we’re that nevertheless, will we launch. for occur,

Operator

you. Thank

question next Cantor Fitzgerald. from Folkes with Our is Brandon

Brandon Folkes

taking my quarter. On last provide on the you products you've pipeline, you've for additional on I versus color you. this pipeline your XX see that thanks Thank Hi, that the some products question. disclosed have Congratulations you disclosed XXX in XX quarter. Could quarter required?

Arthur Przybyl

them. significant had in the purchase XX a of time additional our opportunities a of attached of think a to perspective, them I and ANDA's, bought products from We basket basket any commercial like three

basis basket find our way up, to transfer all in of tech product that commercial we're and product. a we monitor ANDA it’s our a products can opportunities we'll terms maybe on sudden and higher the sometimes Now, of consistent because launch of eventual of priority its

is right PD leading Our now. team

approximately CBE-XX to with try ANDA or associated associated And ranks those we filings slot gross have in commercial approval products, on opportunities activities obviously, dollars. with XX supplements. and supplemental profit prior slots some then, We based of them so, for those products

is these the because we tech purchased now slots ANDA is important that, open this pipeline opportunities for from thing to we there have transfer The XX reason us Canada.

opportunities expect us see baskets of next products that to XX months. up provides now to out our ramp we Canada so, And in greater faster. over And with launch

Brandon Folkes

give And commercializing us you’re investment you color pipeline? then, could continued just in some maybe prioritizing products business development over -- growing how those and the

Arthur Przybyl

this in at we -- question your I a for current center call time have the manner, Company at take to would don’t Brandon, excellence. what the

our that -- has in, and a as developing are own for not the company filing own of ANDAs. in filings moment We invested the

that don’t today. our company excellence, and and baskets we at generic own a ANDA as acquired you purchased sum a of moment in in together our we lot As opportunities putting to tough as know, or we and center these as It's cetera. have interested gone have we out we're product et grow that for putting not the either acquiring place just say,

Cortrophin X re-commercialization All the to it’s that development solely concentrated can our, project, of have project certainly development eventual one And that project. you gel Skunkworks on for and bring I’ll next and the engaged effort to it, see, order FDA the people as exclusively We year complex call has as been our somewhere are worked neighborhood -- in and on a product it filing in us. or in that that X re-commercialization. project, very

that’s And now. so, where stand we right

dollars. our it to our opportunities profit take augment available continue we gross in we think strategic that and cash and invest product flow will our pipelines, So, our and dollars our sales

the product higher investment dollar amount compared near so, And with expect traditional for would give continue development. a I in more foreseeable to associated to as the that us future, to much

Operator

Thank you.

return further no will for have closing any management at time. this call the questions remarks. We or to additional I

Arthur Przybyl

call I ANI's for Thank moderator. everybody to just you, attending today. would like thank conference

off XXXX the We’re Bye, you a solid look build to and to quarter momentum. first very start forward on much. bye. for Thank

Stephen Carey

Thank you.

Operator

concludes ANI's you. XXXX the earnings Thank first call. This quarter

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

ANI Pharmaceuticals (ANIP) 9 May 192019 Q1 Earnings call transcript