AMPH - Earnings call transcript Q4 2021 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Amphastar Pharmaceuticals Incorporated Fourth Quarter Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that certain statements made during the call regarding matters that are not historical facts, including, but not limited to management’s outlook or predictions for future periods are forward-looking statements. These statements are based solely on information that is now available to us. review we entitled presentation issued company’s to the statements on you website. release press today encourage the forward-looking Section in the We and the on filings, refer the and impact for numerous can our our please of website -- SEC discussion that Also, be our to SEC’s found factors the a website future company's on which may performance.

and earnings be certain on this is our Please these measures We found that information use may GAAP our Important will reconciliations non-GAAP also conference U.S. measures. being release. discuss note, recorded. on to of call

Our over begin. Mr. Clinical Communications; and speakers President your Dischner, Dan to may President today of and are Dischner, Corporate Affairs conference Mr. Regulatory Operations. Bill host, Communications. Mr. I Vice Peters, of Dan, President Senior you of Dan Vice CFO; will Mr. now Corporate Marrs, Tony the Vice turn

Dan Dischner

call everyone. operator. and Peters, I'll Amphastar earnings call Bill fourth our quarter Good you you commentary over Executive turn welcome CFO Amphastar's Thank my covering to afternoon for Vice want to XXXX, Pharmaceuticals' year's his of remarks performance regarding After I call. the the to and company's concludes prepared answering full questions. and Affairs update quarter and Finance, will an will Bill where myself remarks, Marrs, Q&A our on be we your President who move Bill After President of Regulatory portion financials. will the Tony to Vice provide Senior Clinical Operations,

call, quarter filed Primatene stated our last XXXX. products was the fourth And it inhalation pleased the file due ANDA increase at during Mist, On would of and that that at epinephrine. year. million press XX% fiscal release in all-time for our announce AMP-XXX in results XX% in profit, Glucagon, and like in earlier, first gross its a represents revenues stated financial $XXX.XX company I'm a revenue This primarily to increase high-margin an in As that to published our net earnings high, coming and time. were the

being we IV possibility this in GDUFA plus billion Nonetheless, of have IQVIA sales. a strong our triggered. year. one targeting market our with mentioned before, AMP-XXX represents four-quarter XX-month the Paragraph and is combined usual inhalation a in believe pipeline $X ANDAs a As this date position filing in stay of annualized a multiple non-infringement

Our an each on file, is any dialogue an on intranasal AMP-XXX, positive with postponed GDUFA to in anticipated be of eventful as first our chronological refiled receive Concerning I XXXX second four we and our Concerning as observed date. quarter. be good this productive of following naloxone agency for in quarter may a can the provide other as products a and time be a will the on product GDUFA guidance. the ANDAs product, or order. XXXX maintain the necessary date products, update inspection a ANDA first the track pre-approval remains If is by quarter product with for

million a product, second remains AMP-XXX, of market with sales, a GDUFA on track which date. in $XX second Our IQVIA quarter represents

quarter second AMP-XXX, GDUFA quarter third a remains first fourth this is our on has finally, product teriparatide, previously date which the had AMP-XXX, year. again our fourth a filing, with date. GDUFA For product or I product, And mentioned track our inhalation

products. will year, approval the products our of we The QX finished integration and in and strength the biosimilar received vasopressin, Two Regarding vertical States. of components long-term main strategy which tentative last produce include product year. the United late we demonstrates anticipate this proprietary API our launching as

in an surpassing a Therefore, interchangeable we was company with a a prior that to remains seeing positive last on in work peak be X% continue the our million annualized $XX filed company A over product, quarter digital, on XXXX. increase sampling reach to In-store XX% maintain and next and investing remain the epinephrine schedule upward, CFC. the $XXX to by milestone trend, Primatene sales frequent with product as sales, from basis. million marketing agency can dialogue anticipates to in Primatene Mist campaigns, year coupled The under confident continues weekly Primatene insulin. radio original trend annualized obtain our the more with increase $XX physician million we and intranasal have reached Mist TV sales Mist sales nationwide with program. positive as Our a

to that has Glucagon our With increase impressive existing with growth. for meet for Amphastar's supplier pipeline our epinephrine strategy potential the that demands. with we GDUFA To pipeline in and the my has believe reliable in current the and quarter Glucagon anticipate further and time, its we are these epinephrine self-funded The XXXX the the XX% XX% we in compared same organically. and previous With continue order into seen accommodate robustness said, remarks, seen to dates two for Regarding will possibility maintain an current investment of and current several where Therefore, expect to to other pending of the increase high-margin company schedule compared same has position conditions long-term you to said, remain is capacity cannot. capital products, towards scaling grow period. a to the diversification product be line a end competitors launches. capacity see to our Amphastar action that launches. growth company's room the increase up we already investment prepared future expenditures new with our can At headed to market market

becomes discuss biopharmaceutical well-positioned catered biosimilars. I transforming treatments and and financial novel our over to As continue Bill significant towards company the the will company call now turn continues strategy, to and on quarter U.S. vision to year-end into a to execute fourth Amphastar results. our

Bill Peters

the year's million Sales to XX% previous Dan. you, the million from $XXX.X Thank $XX.X quarter increased for XXXX in of period. fourth

period gain amid Selling, increased sales continued expenses Epinephrine also fourth of in at in a and the amortization, quarter we revenues income Glucagon, net marketing net quarter XX% General higher-margin as to as quarter continued competitors, as loss lower contingent had $X.X per of increased to to operations $X In legal program. see million China market. due continue $X.XX XXXX dropped decreased Mist there. fourth reported Glucagon compared year's long-term expenses the an sales sales share Enoxaparin $XX excludes and $X.X impairments X% same due shortages dispute, million settlement for to in of the of amid million million, significantly to sales lawsuits. in expenditures of $XX.X -- $X.X quarter $X.XX primarily in long-lived our national the $XX.X from during due our to XX% to $XX.X XX% and the growth of of XXXX approximately MannKind by orders of $XX.X an of Mist. competition ongoing the with due earnings fourth distribution margin operations in flow fourth to from surpassed settled a to previous to restructuring the fourth And expenses timing million $XX Primatene million share to assets legal or XXXX. income million year. had million. in sales and to by of $XX.X of our per share. million $X.XX Importantly, expenses decreased or television, we onetime of Adjusted the compensation million, result the customers. adjusted from that annual from XXXX previous $XX of per $XX.X development of cash strong of than net of full net strong $XX.X million Primatene The Research benefits company Gross $XX.X target cash API $XX.X the Primatene to of for revenues from approximately due spending the share sales epinephrine. several to from on The million million we decreased of legal a million a adjusted flow the fourth per to or a Other $X.XX million company quarter fourth million advertising income Mist, decrease other strong of decreased $X.X our $XX.X in $XX.X of equity sales million. quarter, from of marketing fees. sales, in reported showed quarter year, XX% million income quarter growing and in from included radio rate rising the million digital for from were events. products or provided million our compared and to $X.X $X.X administrative like and net million $X.X million.

the the year company approximately $XX.X During of repurchased repurchases the $XX.X the total over million. for to stock quarter, during million

as using are me beyond. the financial to we that assumptions XXXX Let look and review we

sales year. far First, $XXX exceeded by of we that core grow last to Mist the quarter second of These as We year, sales significant sales now in of second million could a and year. half with vasopressin Primatene have in and half dates sales to of launch XXXX. from grow to could sales compared million, our contributions ANDAs, XXXX goal continue this will long-discussed let sales continue this three sales Glucagon second from hit XXXX. increases forecast first plus which We to GDUFA million $XX that year. of year will product this state me $XX in have full the trends in in lead sales have the of of the the

we gross to the pending launch ANDAs expect are currently increase We to margins able once approval.

for and companies challenged As both labor been costs these for have we with lead-times inputs. and with certain days, higher costs most longer higher

expenses to marketing Mist. for plan and as distribution our selling, Primatene Our advertising rise we increase

Mist a However, as the percentage earnings decrease expense will to sales leverage. Primatene provide of advertising

sales. remain G&A percent a increase, similar to expect spending of We but

to trials that payment candidates, first other COVID. We in a as candidates, booked to note insulin this for of XXXX. includes due epinephrine on product. year spending of $X.X Turning and in I trials clinical the recently Gilead adjust to for with to onetime development. received be avoidance trials million, and plan two intranasal timing our like inhalation the we litigation and our research ramp would we This delayed Astellas regadenoson and XXXX quarter which our settled we for also litigation to income will up

spending continue double to our products pipeline our a We as capital with increase we aligned development. year be for capacity in to in order also this significant inhalation anticipate

production our our At China. plan cash same operator now will I At stock turn finance time, our cash this we the and the as to buy to API position buyback call to flow insulin Cucamonga, of the to capacity to operations. will program. capacity Q&A. strong Amphastar an from beginning at the major will expanding injectable ultimately ANP in also complex are project our that in facility facility, we expansion and look are we Rancho opportunities. insulin We quadruple our continue utilize expansion stock We with our for over

Operator

Thank you.

will be a [Operator now Thank session. conducting you. Instructions] question-and-answer We

Our David question first Please from proceed question. is Piper Sandler. with Amsellem your with

David Amsellem

Hey thanks.

pipeline a related. So, just have mostly few

of perhaps XXXX, in relatedly, and first two sort wanted to be more crowded you you So, that's -- in fluid a competitive the And be market will on here. of dynamics wanted much dynamics review. of can think is -- you that the Teva. then to ahead on a midyear? this this level get Number vasopressin, significant enter about on to sense you're term? not competitive But Can what's market talk number guys obviously, How but market thinking which us about you teriparatide. I of is that a you can is market So, your confirm dynamics and the I how is you become? to just the just that And when cycle do longer confidence contributor, just remind think there one. extent going

what it's you're on has that's expected. how about it a then give promotion? Is just more happening and sort greater-than-expected think switching demand? function talk just gears of the you're a of? about us of granularity you there. Primatene. what Thanks. you done of thinking on better think something advertising you know had that some Can Is Maybe else function is product? sort there seeing driving Just the product that than just And I initially you

Dan Dischner

basically vasopressin I'm think on we already, at there Thanks looking generics David. of market two market with vasopressin first. we're market. -- thinking about And the aware the the dynamics

you typical with the We at we look feel So, look generics we it. as multiple probably it way compete. same can the any is market on at would

the On in in We we I market. the what think to-- like typically want -- said, United product a and help make see will we generic little But TOX, you API have bit. us finished overall, think And States. we a you the that would it's

Bill Peters

Yes. Sure.

Recall review encouraging goal look complex cycle And them first that's that more this. time for a agency to date is on give it bit us, the action the had teriparatide, product. is This or our a a For little one. at extended the data

that we a And are is product in to we has there, as amount their they that So, about of Teva process, they've around speak course, where know optimistic but significant know always We the been that uncertainty far we years also process. remain an been it. can't a but very ANDA. of it's the in really do as

Tony Marrs

approval believe we legal if enable And should right to say. be it that can will believe market we get our before we I first, to -- if our we strategy even us are we market away,

Dan Dischner

we're around results spending that demographics that the not think Primatene added on or different couple And been out another Primatene and see focused We're commercial. of there's Mist, I amount changing may with demographics lot increased to exposed have We commercials putting things. focusing positive our We a before. there. a increasing of on of

we're And mean sort to We of I there. confidence. don't drop so see in-store our that's sales rise. any we the where getting see continue

And Mist. Primatene sure. trends But going so far, not so there's for we're positive

David Amsellem

you. Thank Great.

Operator

you. Thank

comes from Elliot James. Raymond with Please proceed Our next with question. your question Wilbur

Elliot Wilbur

afternoon. Good Thanks.

sales $X.X to respect you commence well. which that sort product potentially XX-day And product a with the I on couple of first-to-market? you're are genericized maybe the XXX, in base has potentially is this couple litigation. a in whether not period? if our could as indication we billion that Or to And within targeting larger any questions you as I've us Can or that. the or that products? the of to already just within question, filing a then inhalation First is innovator give what guess this is of got follow-ups And passed? still has around window confirm

Bill Peters

within window Well, I to can still say we're that sure. that be

not get ourselves right now, And as closer. has passed market we rather we'd far the yet. So, that so size, as little that to keep a

So, we as well-- more get information

Dan Dischner

competitive possible. want the competitive if We landscape. As protect to position, our

Elliot Wilbur

new couple confidence Okay. specifically products questions at a epinephrine. like stronger of -- It of you're the generics around And or to see then a as going of you I base reasonably want some well, have Glucagon there. least have sounds better high incremental of performing competition, terms that to and performing the not degree in

to incremental to think saw you to epinephrine trying Just news in the of incremental Hospira both wondering curious prefilled how sort competition line but out for market? of some gauge the of of if sight syringe just good the the market, in additional not is do there's of your the see likely there's terms you bio a be market you be able into can time, and you dynamics Obviously, on that on into degree there you confidence give players competition. read come market. out of that of And sort pretty that give similar If reasonably intelligence a may Glucagon. a that other might potential that anything good terms high in question could gather you competitive

XXXX grow versus fact, sales XXXX? may In in

Dan Dischner

think market We questions us lot specifically, won't anything we that, a has because market to epinephrine the at little for time. have answered -- expanded now expect any you grow change And think yes, market I possibly. don't reason in market where too with that being bit. seen the that that happen this else generic of confident to on feel much. We've there the Glucagon, to the Yes, continuing of is that a we

that down. seen haven't we So, slow

have all yes, either to with we any products. expect of other to into those insight we kind And that So, continue move direction. at of it don't competition

Bill Peters

it'd so given such to product fact players do the other for especially hard was a into very difficult complicated, that get and to with glucagon that. be it's And

Elliot Wilbur

not question, reasonable XXXX, on growth last would if quarter. the that given then kind first in of sequential the the XXXX. And in actually within very Okay. Primatene expect just it just has And declined the be quarter. in XQ Historically, first performance trend Obviously, I'm of quarter in fourth still results wondering the to XXXX? strong product

Dan Dischner

Yes.

the I seasonal did really don't the do quarter. the but we really in So, see enough trends, right strong market long also fourth been see bit the timeframe and April trends the in think sales now, have And timeframe. little quarter-by-quarter of product's March, we December to very some a on

So, we a did see pickup there.

as but long-term that's big So not trend. as the --

So, basically, are buying I wire than think those the we times. times. pickup market bit other And have see of to ahead to it more if have on two there's a other little those sales trends

shipping we're I to when update did today. presentation, that drug the those times. So will ahead the we stores in of graph say the But

can on just a chart I the upward little bit the blips overall, But you with upward a with momentum the it's website, there's -- trend. of a see seasonality it's nice think and So, there. still continued in

Elliot Wilbur

for questions. taking Okay. you Thank the

Operator

Thank you.

your from next Hughes Wells Jacob Fargo. Our question is with question. with Please proceed

Jacob Hughes

Hey, a thanks had follow-ups I just the margins. and guys teriparatide for taking my couple question. of gross on

of XXX, -- you have first Lilly immediately? know why then so can speak do do product, part think you maybe But I And it. on the could believe to expect that? here? be Teva market? filer -- And And clarification, still For clarify then for launch maybe you that the more you you is curve And consented, generic just exclusivity that's could one than on does a to just does I launch what that.

Bill Peters

Lilly of teriparatide, first strategy for the sure enabled confirmation to So, us the Teva not legal that filer. from make getting the whole was

that that anymore they -- status. So lost had

upon will lost they that enable launch have which believe that status, we So, us approval. to

of first the that's question. that part So,

you don't we their -- mean, know is know the filed I time. that patent really someone of this filers. else been not not Teva now, landscape, right and aware other we ago, obviously, long really we're would at The and I possibly. was a part anybody else. on while, It application time expect any competitive But has for second we're And a think of aware where

Jacob Hughes

gross approximately they up XXX basis points versus Bill, then, Okay. And are on margins, the XXXX.

an cost talked think there expansion for gross I labor and that? there some comp is of the we from any that easy But in how was margin about way can XXXX? about you offsets XQ should but think some inputs, quantify And XXXX. you

Bill Peters

as far new Yes, as not expecting we're we expansion products. any launch expansion until goes,

be would the year. half that of the So, in second

will margins overall, or could a of little have We will the new quarters, be we at maybe products. couple -- up up first gross go once cost-constrained but go

Operator

you. Thank

from Please proceed Needham Our next with with & question question. your Belanger Company. Serge comes

Serge Belanger

taking good Hi afternoon. Thanks for my questions.

think potential Jacob the one, I First mentioned Bill or pre-approval for inspection.

Just curious expect one do from [ph]? about all is specific the the needed, to hear you -- about affect the does that? And when just it products or FDA if ANDAs

Dan Dischner

we Yes, be would the time be would not it that for of applications some don't others. of necessarily just had the wouldn't or not any just filed. exception we for that trigger inspections any the And product filed, one, necessarily -- pre-approval They any trigger that linked. anticipate have did we we've to inhaled with there if the products one we it

Serge Belanger

it. Got

the of shortages on capitalize then products. to various secondly, market And Okay. past, able you've been in

curious if in Just what XXXX? that will the to whether in fourth you continue were on and able capitalize quarter

Bill Peters

The primary was that, syringe. epinephrine prefilled that the beneficiary of

was that of not So, that's supply. our something one to competitors able

year, why opportunity million that's about And we that's is why market shortage much -- year, for for was believe. of those what the epinephrine we year-over-year. a And So, up about we've $XX making previously the we the our overall so had and that shortages. said one up reasons

in for a near that they're the as the said publicly to future. has expect time shortage continue Hospira that resolution not We expecting epinephrine some

expect second first go least on of that this year. at we to the and So, quarters

Operator

you. Thank

proceed comes with Chiang next Tim question. with Northland Our question Please from your Securities.

Tim Chiang

guys you FDA insulin talking diabetes Hi making And been are know on on you sort thanks. your I what with any progress side? this are the pipeline. about sort there Has -- of insulin your update and that With interchangeability products? portfolio, from of guys

Bill Peters

very good with the dialogue Yes, we continue agency. have to

the from I situation. interchangeability think

from a those. expectations handle We are as to those agency good the have our ability conversations as what on through well the meet

products be the be in that those. We going following and our portfolio you product shortly trailblazer, have will, is diabetes to if the one will other behind

two have spectrum if first behind one are So, then we development, not a you along far have the and of the pretty that's that other far it.

in ahead three all relatively with stages advanced further than those So, the of one are others.

Tim Chiang

see that. interchangeability Does that And maybe Is I that to definition. it a I'm will And follow-up biosimilars be physician how your I'm your of with some just their any get wondering Interchangeability, labels of sort mean to switch right? for insulin? pharmacists sort guess, to that on starting without product basically that approval. biosimilar can that important

Bill Peters

approval. Yes, that's correct, physician or pharmacist

they if case. So, Whereas likely certain to if could write the interchangeable. you were insulin, is it the a not script substitutable, biosimilar, for be of a for will, the type with that

Operator

you. Thank

question David comes Steinberg question. with Our proceed Please with next from your Jefferies.

David Steinberg

lot. a a questions. I of have afternoon. couple Thanks Good

that sales So, back reach could thought million to said your you in you by think remarks Primatene, I prepared XXXX. approach $XXX or

On million and hand, past this annualized $XX $XX QX you million. the is year other around did

And $XXX million So, taken look just couldn't gross that increased to baseline about reach know slow if XXX that I the or at XXXX at grew you of just and based the understand out. so about on you basis you've new not growth know points, trying in trends, XXX then years. most give maxed they've also And the down and on last what last XXXX? but points I'm three year, you've you threw -- the margin over why if I much take, would to initiatives. out change, margin, some XXXX you gross in not, basis those

Could they are say, road, Thanks. by get or you XXXX for margins something like for lining be mid-XXs in approvals that new If be the that? two say, up could down you, years these or example, three gross where theoretically? the all

Bill Peters

expect than to timeframe, It's we them are XXXX and be while in that XXXX today. a higher bit aggressive do they for

there confuses will believe that a be I think over we by time. that, -- that where bit probably that above

biosimilars I it's think maybe numbers, have working have now of have and be more but our look some well. more we -- possible sort if launch, we're our out, -- However, and to to products the hit as proprietary of of those of that we further on

that's So, a number, those just year. that think I -- that I don't doable by think but

Dan Dischner

with chains is we in We guidance and XXXX different all We mark. This kind sure all that to how that to the market $XXX Primatene, to retail And expand we is as -- -- place and have pretty And I'm question. for mentioned, that help have us strategy much got elements. box need answer million you for it not will our we get the this $XXX in of to think the that. get XXXX. that by achieve there million for big

David Steinberg

the Fair And it leveraging relates be as API FDA's the facility. market or you'd for your where would enough. help biosimilar could how strategy, that process approval? accelerate just your that guidelines The insulin recent immunogenicity, on particularly insulin in French to

Dan Dischner

Yes.

that for it the are. them a will expectations While to they've guidance, policy technical do give that, from given open the allowed that they've very the on statutory made clear conversations perspective foundation it's some a use is with as to And our a expectations through what agency. references what what us that are

doesn't that Of work products. conversations on that was the our technical very we've some specifically for to our gaps done fill detailed different a knowledge other guidance in based historically the for current as broadly the what foundation of in you characterization those and tell leverage a we're some of but about it on all of talks need level, do and everything to And able categories. course, it you do that

Operator

further no for are questions at like There back any floor turn to time. you. this I'd management closing to Thank remarks. the

Dan Dischner

you here Great. much many progress Thank forward and fronts look We we it, as forward. Paul, on updating on very you, we for and us you our joining appreciate move thank all to today.

if you us always, questions today. again, have those questions, hesitate when any to not your for additional arise. you As do time thank And please contact

Operator

This concludes conference. today's

You your for your Thank at may you lines participation. disconnect time. this

Amphastar Pharmaceuticals (AMPH) 11 Mar 222021 Q4 Earnings call transcript