AMPH - Earnings call transcript Q1 2018 | Amphastar Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Amphastar First Quarter Earnings Conference Call. At this time all participants are in a listen-only mode. Later we’ll conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. All statements in this conference call that are not historical are forward-looking statements, including, among other things, statements relating to the company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to the pipeline of product candidates, the timing for completion of construction at the company's IMS facility, its share for buyback programs and other future events. or historical current rather regarding expectations, operations other not historical on Amphastar's are and and performance estimates similar statements facts based but Amphastar's business, These factors. related and projections continue, related can might, although as not forward-looking estimate would, predict, project, will, Words contain used expect, similar to such plan, or may, intend, other statements, statements these are should, words. all could, anticipate, forward-looking potential, expressions and these believe, identify

control. because Actual predict, they undue with and Exchange uncertainties a Amphastar's place should forward-looking some statements unknown are of number the on You results cases, of Commission. known factors, the reliance in risks, Securities described involve forward-looking and may filings materially difficult those including as not and Amphastar's or result and from beyond statements that assumptions impossible to a in those differ in

no the the update and the in Jason President. circumstances You change. at the cause www.sec.gov. can Sir, at release reflect would press referenced website information locate conference undertakes http://ir.amphastar.com to company's or may these call through above to website if to SEC's company's in even if to the this subsequent obligation to or events events becomes available the like now begin. I conference expectations new over revise turn on reports or Amphastar future, information or you Shandell,

Jason Shandell

Pharmaceuticals any call. joining over of have. Good will first to CFO, CFO the us Peters, to look to quarter my Thank now name speaking turn on earnings appreciate questions the Bill and with forward welcome I'm and Jason call answering Amphastar We I financials. you quarter today, of our colleague, first discuss you, Operator. Amphastar. Bill the with Amphastar. Shandell, may today you call you joined afternoon, to and is My President Peters,

Bill Peters

prices. million the to from of XXXX these to that of we quarter today the sheet has would tables hope points. pointing Jason. With get $XX.X year's with the format that a the investors. in first on release more million million business. like also to I'll the increased the financial for time. by $XX.X normal increase million slightly call which and Sales quarter to out balance sales unit at of included our for our will that you, prefilled product $X enoxaparin selling of of I earnings $XX.X volumes the We from changes grandfather from press different declined product, start was $X.X period. selling up X% $X.X FDA I unit bullet the prices. from to discontinuation the epinephrine million Naloxone help Thank out Sales to newly the these portion selling quarter epinephrine sold in our on $X.X of to worth the under in Sales declined million to began lower second discontinue syringes of vial $XX.X million sales launched $X.X unit ramping products. the vials exception. we requested million volumes Medroxyprogesterone selling million Acetate our $X.X million average million that quarter's Lidocaine, of way, our as sales and lower on higher from lower $X.X saw previous volumes. higher biggest We've due approved after and and to average due declined

led recently and to the Amphastar to to from $XX.X began million, at gross API up from plant. revenues quarter, XX% due productivity We from of several lower our in insulin million sales primarily last which revenues by increased approved Cost certain which margins million, of temporarily year, of XX% the timing our of was decreased $X.X $XX.X customers. for of reasons. revenues had $XXX,XXX products Our business to manufacturing purchases

by required recently standards, quality increased new led USP, costs. implemented to which we labor Additionally,

or While legal of marketing and as minimum and per as expenditures net million loss first income to Research an quarter exception. higher primarily of increased of XXth million Selling, and wage net at the Adjusted compared the per row. requirements General quarter share share spending costs. In year. a distribution year. operations $XX.X we cash exclude loss for the million adjusted $XX.X filing materials the of expenditures in share equity expenses in approximately we positive due $X.XX time, earnings $X.XX last long-lived compensation rising first to flow higher amortization, share same to impairment from The freight increased $X.XX market of as expenses. or administrative of grandfather California. and a our to $X.X product, lower or in the subsidiary development $X.XX we quarter, reported was Nanjing which company experienced from company million $X.X or million in last and The Pharmaceuticals net $X.X well for increased $X.X assets. expenses decreased first and $XXX,XXX due currently costs quarter pipeline per an NDA of reported of at net because paid on labor under profit a for versus the million our Amphastar was per adjusted fee

about million cash the end our $X.X previous $XX completed to the of used we to additional program our authorized of of buy program. the board a million we quarter, stock. an Subsequent quarter, the back buyback During flow portion so

Turning to forecast.

timing for both Primatene the and for and to sales analyst on meet ability Our our income ANDAs. depends Mist of approvals estimates

the received the call Primatene resubmitted our currently As will an for on on Mist, file Jason. since now turn this, update FDA. back over our call, our X earnings I at ANDAs to last but of CRLs for we NDA

Jason Shandell

and to progress made Mist We after NDA good from very study. Bill. our Thanks, for have recent our good we resubmitted our that pipeline first receiving human quarter, the factor on announce in I'm pleased results Primatene

the collected in collected actual strongly our preparation producing supports year. in our a agency's to the With they next has data to NDA. for that volumes we While our pediatric plan with agency we begin that from populations to with we report down respect intranasal hospitals NDA inventory per date will recently conduct we don't agree used actual naloxone data to analyze country and for naloxone FDA a the yet, it filed have that to we recommendations, The NDA, timely are used intranasal our around typically If birth. a indicated the PDUFA used launch. our volume the proposed to the plan resubmit volume, data filling review. early a We intranasal

agency, plan on on applications applications we year. filing X grandfather drugs market, with remaining X are the our X Regarding the the this on file and

agency, products the an One over We with of X filed we market million. size quarter. of file NDA, a targeting currently applications have on is which first in ANDAs $XXX with the injectable the

We markets. have that the previously stated X ANDAs are of significant X

X has a only the and approved. has generic never had One approved other generic them of

As CRLs Bill receive did mentioned today, in we quarter. first the X

already GDUFA One of the CRLs was and minor, received and responded another we date. have quickly

has for noted that with of dates will needed. in the depending the the Therefore, GDUFA dates be significant other very should a agency. responding are be GDUFA that product sales. are now for the that to We that's but we products on X CRL, X on have process not file of ANDAs meaningful the the It whether facility one is to inspection

launches. Turning to new

Massachusetts our is shipping proceeding prefilled in and the Sandoz year. our third securing the denied litigation dismiss motion began the The quarter, achieved final that Momenta's patent entered customer XXXX, and of case. our and favor XX, March and have in vial first should the we believe Court Momenta of against District market in We to quarter generic this Depo-Provera case course. product both in a reflected share On contracts During antitrust be the more syringe. judgment strong normal fully also and we U.S. that by

we Following the pending final the $XXX appeal. a to bond. the in emergency motion to filed our bond seeking Momenta enforce case, delay response, an court's our million judgment their In motion filed issuance of motion patent

their of emergency patent both cases. We and in We motion antitrust is the court. confident consideration and under the the have issue remain merits with opposed the currently

Finally, as authorized million board additional Amphastar another buy stock. has Bill $XX back mentioned, the to

of the the that to turn long-term With buyback program operator in company. continued Our belief value I call the to now Q&A. demonstrates over board's will begin the update, strong the

Operator

our first from David [Operator question Instructions] comes with And Amsellem Piper Jaffray.

David Amsellem

So, that market the just termed first the then much number best that's share talked that number business can think that us next the the generic on And of be CRL and terms could you in ask you is, And garner how about the to of the you the market? one. few you over you on refiling, wanted it two, CRL on much that remind Depo-Provera, Or can is do just months? to can you just minor supply? the how way about, clear to maybe for be just talk then you ramp, that the product So want?

Bill Peters

I'll the from could of so we second Yes, [indiscernible] this and a standpoint. could how market we on first shift, the have could NPA, portion supply, yet not The the market if the but to much significant API we take of an a were NPA. strongly supply add facility, we very question at we which supply

But and very don't we for as as mentioned, Jason positive. to meeting say good what we because, contracts. our have I'll I today, our talk market exact So achieved of that's kind of share want it's secured expectations. a of we've is today, but it share, very about and think as market

having those significant of purchases or June won't maybe be so. Some really until

really reflected uptick quarter. you won't August, so, the see sales in full July, And September our until

in in quarter several didn't syringe There we bid we involved February. first until was we the customers to in both prefilled launched launched the available. there so, And who vial the had ramp as that several customers really want -- was up, a January, take were

willing it products. that even even of suggested were to the So, bid the that on really wait until March some or until wasn't beginning customers March we

with in So, the of bit happy anticipated slower up. today, little as outcome. was than we we're pretty the a process ramp the But

Jason Shandell

got respect CRLs, already, where question for market. the and that's on the this one is one actually Jason. GDUFA And to generic be date your to the minor, the it'll being two With second we've a

David Amsellem

Okay.

no be you CRL on have just that? there other a you GDUFA, is market you not a have that on clear where right? to So received the formation, could at generic words, CRL, In be

Jason Shandell

two in under one received is referred cycle of review first not from to, last the That's a correct. the it second that quarter. That's But Bill year.

Operator

Maris from comes David with question Wells next Fargo. Our

Your open. is now line

David Maris

questions. few A

And the is, increased what The can those down So other like you then Bill, Momenta think R&D are? GDUFA increased? the Jason, components were that's your when the where for fee And us you of to first then, update give on that you through expect break on flow, year? the lastly, bit just cash you much you more what to an increase dates with expenses. with do and the other the Can and get us going stands little continue components how update. on on Can cash? that PDUFA provide the a positive

Bill Peters

right. All

and So, I'll start question. flow with cash R&D then the the

actually it's million. did million $X.X a So, clinical fee, for $X.X to was the have the there a PDUFA product, because run that where not so XXX(b)(X), only we the fee a fee is trial

So what was. that was that

also big table uptick that that about $X the the goes probably also, you put reference R&D But have see where we tomorrow by put lab when And we make million. was a -- have can you filed the up reason testing, -- will purchase the list MD&A -- up our the is other to in breakout. and that supplies of we before XX-Q -- the the be both where market that's should And The we the opens operating products. we goes API the where either test morning, drugs. line we'll

line. have So, future, RLDs those trial that up in in clinical we for buy the show to

clinical of X Nanjing the third that those will increases And Amphastar higher. which reference drugs, we drove amount So we really so parties in using drivers expenses significant had facility API, as as significant purchased are in types as brand manufactured we we that were trials the a Those at be the did later had drugs listed material our year. this purchase that of really those then that quarter big of from the increase. some well

now continued quarter the and far each low we flow that cash anticipate As cash will every the of be throughout right and a and in do are goes, kind at as results the that the expect throughout we year that quarter, a watermark year. flow positive better

Jason Shandell

prepared And And as dates we an GDUFA has remarks, Jason. this respect necessary. in one is dates. inspection actually for With our yes, dates, on I is the X saying to of so my X GDUFA was significant have of depending whether products, them

press providing next those third we'll not the you. of was believe approvals. terms -- was be at releases one, regarding I Hopefully, question this Then time. there I unless However, Momenta providing issuing for upon specific on But dates dates. not we're we're the a think,

Bill Peters

already I think, answered. I

Jason Shandell

for is difficult with has asked The respect And efficiencies. and verdict. for of bond. motion this, And is with asked all not strongly them courts yes, million purposes real a to appeal. we currently The the I So, the gating feel the until accepts court. respect appeal very to a wait or jury appeal. strong Momenta's for their holding on is know; verdict court wait Essentially, wait the the item pending Momenta court with the cash, $XXX completed. to but the to it's as very whether have to jury appeal They to

issue, fully once which the the this cases have that the was judgment. there a final invalid. in opinion, on in a is where over, last motion. some we our of interlocutory patent law, safe move decided harbor and and We case issues that law. and judgment the the They've is it's shows involving however, unsettled is bond on like my case many or case have the to really jury should law, Their found an here, briefed you side, final a it verdict But was appeals time, aspect

brief, that into it's likely. then of you step next delay and and after next to judge with do that's were would several believe briefing. but be that, rounds would not to wait time them would that judge motion, year, for year the the this money the to And If believe the it agrees I respond agree move so, our If forward. we for appeal our expect to

Operator

comes Nachman with question from BMO Markets. Gary Our next Capital

line Your open. is now

Gary Nachman

And study? first from guys the for thinking you How sufficient And some for also, you the you the results for human this launch? this first Jason, on review the of are type of the what in for factor are understanding what Bill. margins be the How will you preparations is trend And were commercial will Primatene. Could that quarter? you then at for gross of confident FDA? rest one-timers type point? doing year, review there

Jason Shandell

Sure.

the are feel very we Primatene, with off starting So, results good.

low quantitative, much to in but was about of the talked all and I've they this As the literacy past, the almost XX% more very qualitative found were participants than label easy understand.

I why in And a time, that's respectfully review so, of consider we extremely would priority and review. had the an study, very inventory we making preparation minor And terms we're launch. issues. for in requested successful secondly,

it's explain unmet the two-month setting. product to there believe six-month. OTC As the a our a or we we that FDA. could left did We need know, be in it cover letter We an has an in that important medical

in year, we engaged at XXXX terms did it a guess, where that to CRL, a So, And finally, of looked is FDA's again. firm review, last the hands. and asked so actually. the leave all we've up be would of I preparation of in a lot for the the end that at but fast marketing capable being leading we we preparation,

bring they in So, It by level. retailers of we a the the be also marketing at we've and a prepared will regional excited always the this aspect had year very foot it's there does to and ago. help same And the traffic retail are marketing that said, product. from as lot marketing with so plan are

Bill Peters

for and -- ramp-up margin some margin And some of the weren't the trends, also be costs. things we just mark that did couple think wrong should as a had things have this year went the gross onetime we And low as I far as expected. is that

were a was For the had but batch were end co-power we example, making the reclean to the to we had actually one the batch, went area. finally in We scrap out there the day and room. to in up middle of having

spent for recleaning for unusual days is production lot money a X like we and of and in and which us for the So, a nonplanned were shutdown out a revalidating about that. row, we of room,

that some things in is quarter. like there So, the onetime

I is to later this later like be of year quarters. as will as higher expecting we levels mentioned we're selling be well. the for NPA in -- Additionally, -- products our that be goal higher-margin to new before, are going And margins higher launches

Gary Nachman

If Okay. squeeze in just a I could questions. of product-specific follow-up, quick couple

$X.X that is rate? Just The last I'm run new at million, Medroxy, of assuming lot sort a $X one... Lovenox the of was million, that the stocking.

Bill Peters

it's stocking because really NPA generic. no the the as There's No. market already in out on

stocking. no really So

up finish as ship that go issue were We some far So, came sent batches with of had few significant it were onetime a to label to a our of mistake product amount which wrong, at us ship a some that vendor a back we -- to and -- actually to it unable were of we should unable because wrong the unable unlabeled and packaging the there. a as the with with in quarter from end goes some it. the -- of ended And enoxaparin, on hiccups. labels up

more several for that. actually as that had things some thousand other than if product onetime dollars there's would've would So, well. we shipped been like out have it We hundred

from that so -- should is level. tick up little I there So, it think a bit

Operator

[Operator our Steinberg comes Instructions] And question from next Jefferies. David with

David Steinberg

the nice couple When prepared the to And a is review, lag? where a time or questions right the that Primatene. with you year, will in a you prepared review to to you X on the clarification. priority to a X-month wanted to the similar the it CFC past point sales or I a reach second -- cycle you that the get see sales? more Class not you long after or then million launch there a get in a that could time? sort filings, be at I you long cycle? are the progression? a was take the just obviously, approved us in a you think said And $XX peak different of X-month of help do of away see that coming. finally, wanted are And to think a and you will range It's just from were sales it you say in product progress would product the excuse have you I certainly you an to in that you with peak Could And product. very annual It's, half when peak and what Or ramp a is a get expect me, expect? HFA peak generic clarify it of how think few years? Could final

Jason Shandell

question, the the the on the of any that or we but X was Initially, sort first the consultants. of suggest On X-month going we punted categories into of specific guidance. advice really fit didn't it were X to review, our months per under

So, called by we that priority review. of at flexibility. they we that, as feel we hope by -- just But we doing that it, -- with FDA sort do, left -- provide it a the we

X-month So, or sooner. perhaps it be could a review

didn't really category per it So, a fall se. specific into

the we need a and be there fact the market a for a as basically a you've standard asthma but I nebulizers on over it true couched counter. metered X-month, be guidance, really think is got dose what lot inhaler under we for that a may is believed these of to it

respectfully that they it just as possible. fast So, requested as review we've

is making Secondly, get the for when will the happen now, finally preparation what have but approved. label to we obviously, we of right launch, in are terms for wait, we'll inventory

between So, lag and launch. a there'll approval probably about to X-week be X-

Bill Peters

$XX previously. we've than believe the peak several at ramp And selling sales as the goes, we up is reasons. and that just could the we we'll and and little that we a so you're surpass was right said had we because -- had, higher amount factor, be price One before price as million that of far

doses because actually factor that fewer that second there unit per indicator, is sell. the The of dose will was

that over strong shelves. units So, the to get out year. more very two anxious that a course to loading purchase sales get because chains more channels will on the into be the basis of there have the will this their are uses the on anybody major to initial the We regular drugstore think

would so, be think And sales that very the quick. we initial

initially beyond marketing have be we As far as believe in that, required get there, planned scope multimillion or do online for will XX some and mean, have really get But do that will will online to moving, million. sales that primarily down X%, percentage potentially if will I'm be $XX to it dollar this of of at we get think us that. to we order there spend sales using tools, ad level. much to be going the ramping ramping on some to sure up that's spent amount from to not keep a I the point. a to to sales not spent XX% have that million but to that to it campaign XX% maybe require venturing is

three-year time probably on that the that. annualized But an to it the depending think to of run on acceptance, two customer could end I short at be a line to rate. that's get

David Steinberg

Okay. a And quick just follow-up.

the or either the pricing price or price per you removed? price to product price the us sense point you're the post it last planning approval? And a it the per was that before when was original mentioned on give what dose unit, market. be higher CFC Could will than what You

Bill Peters

or I a believe unit. our $XX was price $XX around

Jason Shandell

of it price, think the then, in we was up. course, XXs. there We And then, -- time the was by take which low retail can

One when very don't FDA monograph. these positives approved, really nebulizers, the work not they're the well, I of they're through which referenced

expensive. on at If products, of the these quite prices you look retail some they're

out higher what we it much CFC version. it'll the if be was even than come under as so those, And

Operator

Needham comes And with question next & our from Belanger Serge Company.

open. now is line Your

Serge Belanger

they couple covered produced ANDA represent? I products there past. grandfather still filing you've many products the to I a in marketed of revenues know already the if under was wanted how NDA this, And Apologies but exception believe and or are kind what

and to are know that rest year? the where you for the [indiscernible] with of wanted Just

Jason Shandell

but there, the to approved. speak the terms what's got of I'll bicarbonate Bill still let revenues, we sodium in out

off. approved an enoxaparin course, that's the went So product. vial And of then,

that took seven from five it unapproved So products. to

So, file, year. five speak have in five, can this get and on file Bill, we those to you applications those the products. as we'll we're remarks, And was currently review my the unapproved three two And I marketing unapproved saying of on of products? other

Bill Peters

Yes.

So, the two for it million months, unapproved about products. we from in have recent the was quarter, $XX the

Jason Shandell

From those products. X

Operator

you. any time, Thank further I'd questions. now Shandell, this I'm Jason not to to like showing At President, turn further the back remarks. call any for

Jason Shandell

everyone very concludes operator. This day. you hope Thank a our you. Thank call. much, just And has great

Operator

Ladies and today's gentlemen, in conference. concludes thank you participating today's for This program.

disconnect. You day. all have great Everyone, may a

Amphastar Pharmaceuticals (AMPH) 14 May 182018 Q1 Earnings call transcript