AMPH - Earnings call transcript Q3 2021 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Amphastar Pharmaceuticals Incorporated Third 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 a for numerous impact can our please may of and SEC that future Also, be SEC’s to discussion found our our factors website website the which performance.

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

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

Dan Dischner

you, joining for thank Paul. us this to I’d Thank everybody like afternoon.

to third foundation is our performances for our enhance perspective, Primatene from products. on want with to a of Vice I integrated call, After company’s quarters pipeline Bill’s equally an revenue, expenses where an Tony momentum million, to of Bill Again, annualized specific deliver continue quarter net basis. questions. last the our which provide am I Regulatory begin remarks, Finance, Amphastar’s our profit, seen myself on execution validating and net with the basis, announce and while strategy will highlighting President the As and core a we’ll platforms key that great our launched operations share. Operations, any Affairs have financial annualized platform to over revenues Vice facing of we carried the With call results, our where been and R&D from you results, increase vertical that commercial glucagon, third growth upward who’ll commercial by Senior Clinical to insulated Peters, the our last Amphastar XX% Bill increase reported into base continues the XXXX, quarter. a per Amphastar sector line have an of vertical saw that drivers. a bright want over Executive trajectory, – and strategy, revenue more to challenges and pharmaceutical pleased to will on with and in up CFO the recently a quarter, President sustainable XX% XXXX on earnings line will another on coupled successful remarkable remain another setting saw answer impressive the strengths proven generally growth, as from an proficiencies. the move in based Marrs, our just Mist future as this and Since vision, typical my quarterly from said, bottom to that important turn I over business is quarters’ is our our our growing be integrated $XXX have has on gross ahead and Amphastar vision in After seen, our portion the income recently I the beginning has space. we of we Q&A portion, and observed was this products epinephrine and strong top importance emphasize quarter, quarter financials. update of regards more

the growth due the three remainder drivers We products will year, performance. of for continue to believe significant recent to be their that these

third quarter. our million Regarding of were product glucagon the $XX.X product. the Sales in

positive is to this year. of glucagon the February have still since With that we remainder with of product pleased the capture a and share ability said, year. very this in believe of for the market its trajectory positioned We’re performance to the launch

the XXXX. seeing trend, QX a of increase XX% a compared Primatene in to positive maintain On topic sales Mist,

Primatene On epinephrine, sales both effective. and ability digital with multi and due syringe physician opportunities likely million our to presentations marketing prefilled the grew goal will vial as Mist’s radio efforts, proven As this TV, trends program annualized our exceed continue, sales sampling our are to presented. have of the our of coupled nationwide million continued capitalize on to $XX.X they $XX year dose when

is XXXX. supply Amphastar our state-of-the-art production portfolio As On in to can our allowed product investment remain said impact to strong and COVID-XX. recently We competitors careful our consistently our felt note, This from before, of line. has another anticipate opportunities supply the management planning continuing have we the commercial into sales mainly when cannot. added due regardless similar our

the without was impact. limitations, the not in regards site from COVID However, clinical its especially to impact

of for On said face of clinical naloxone out control. epinephrine, are which filing XXXX. can COVID-related same the clinical other is front, a and our our vendors we continue third-party our QX that now restraints XXXX. to anticipate be refiling The intranasal various for expected intranasal in in Therefore,

two on AMP-XXX, a a filed inspection is date – GDUFA for XXXX. either both AMP-XXX preapproval may As ANDAs, GDUFA track quarter date product, If have our the of for to be postponed remain months. and the necessary first for for

year. have our review, It continued products, to is filed anticipated still be which Concerning with this a first had filings, our – XX XXXX. now fourth GDUFA is first quarter in our dialogue Paragraph ANDA, ANDA cycle teriparatide’s quarter For IV inhalation the agency. anticipated the we the AMP-XXX, of a in second to is date our have first of on

have specifically currently Likewise, a With AMP-XXX, IV regard Paragraph products with a have more developed, can continue process is portfolio, products experience. another position. closing, complex would create on I program, strong insulin with we further our sees accomplish being and developed reiterate interchangeable portfolio. to in progress developing continue proprietary a significant progress future this, like that To that pipeline. make technologies commercial these biosimilar types our portfolios’ to same a non-infringement in standardized we trajectory, revenue products. we based our our to that that our believe advanced diabetes and filing extensive guidance We through litigated. emphasis growth we towards the to to FDA have have Amphastar framework In the a we molecule we in we on of our feel believe robust our though diabetes

results. future vision, complementary start. confident serve goals head with to towards are we the to We we I building vertically into the XXXX integrated can financial as momentum third forces a achieve as Bill call long-term discuss our platform these strategy great proven its turn off as will and in quarter’s

Bill Peters

third in all and last multi sales both the sales of strong to with year, $XX.X increased prefilled the $XXX.X to at from Glucagon, saw in the strong quarter latter XX% year’s our million to again surge third sales increased which period. the quarter million Primatene a Thank $XX.X which launched $XX.X in million first of of dose of million customers. shortages. million. with from current to due led quarter you, the the sales of competitor demand growth, of Epinephrine $XX.X vial syringe, Mist Dan. sales Sales growth the $XX XX% to million on in once previous for to we saw

sales quarter-after-quarter, We to is drug have Other selling caused led by pharmaceutical decreased in $X we been shortages increased the increased a volumes Cortrosyn competitive million competition, why average primarily consistently $X.X products finished and able reduce to of increases sales which to meet which demand and facility. our prices. capacity driven in due Amphadase. lower by saw the Medroxyprogesterone, increase million, to Enoxaparin IMS

costs million of sales had business margins improved API the increased and Mist timing epinephrine offset margin up multi $X.X expenses. $XX.X the enoxaparin. increased development as Research of primarily dose Primatene XX% Mist. glucagon, commercials to million as marketing X% million, Nanjing Insulin Our spending decreased ANP, pricing $X.X year from our including million restructuring expenses Hanxin. million Primatene and from Selling, clinical $XX.X increased as $XX.X of and or trial revenues of the million XX% due from $X.X distribution products, and and to lower China the subsidiary, than of from deconsolidation television to vials Amphastar expenditures to decreased of for to a from $XX R&D due revenues million. distribution such and administrative Cost in legal decrease million lower orders. its to $XX.X advertising subsidiary, General of Pharmaceuticals from XX% costs, lower and expenses last due XX% million $XX.X to for newer to million, Gross higher more due $X.X to

cash per on income line per and the expenses. income compensation, quarter reported million this company results or In million. the net one-time subsidiary, to million sales the flow or cash million long-lived million interests to includes company an stock. $X.XX XX% company per used available or a including XX% increase And of income ANP’s third share equity leverage attributable quarter, third operations gain adjusted significant share to $X.X one-time a divestiture of compared quarter of back impairments $X.X of non-operating $X.X show gain of the the in as of we Amphastar’s faster the in divestiture third of our exclude reported Hanxin. Adjusted quarter net the approximately net $X.XX events, third grow of to The of quarter, year. per operating $XX our in of our $X.X an last assets from Hanxin. in a The XXXX. significant $X.XX $X.XX we share, $XX.X of earnings strong million The of had the from income Our than on we shareholders amortization, share of the adjusted buy approximately portion or

a million credit the million. call in higher we will quarter, I lowered the $XX and completed and process, Dan. over borrowing our offering now turn third on $XX of increasing interest conference we lines rate the million our last back interest $XX mentioned significantly, rates debt. of it debt off call, approximately As paid In to the to syndicated

Dan Dischner

can we If our now presentation. Bill. section to of the Thanks, turn Q&A

Operator

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

question. from Hughes Securities. with Fargo Our proceed your Wells Jacob first Please question comes with

Jacob Hughes

On just my the couple. Hey, guys, I in quarter-over-quarter. sales questions. thanks a quarter taking Mist the for think flattish Primatene our were I’ve

call is $XX at should be You there anything providing new the quarter? since the And basically we’re to that will you fourth know million? already for And how think than greater we quarter? target a about

Bill Peters

a we flat did were good relatively we very well. or the we took know just quarter strong pretty the as sales started strong growth pretty year-over-year up as the say, see so from But you little sign. second I’ll And Yeah, quarter. a off, bit fourth which

our on not point, the above be time any $XX call. about might targets give feel we formal our we’re March this year. to sales do we mark different going million while at address we And further will target, probably that very So guidance at this confident this

Jacob Hughes

on and Okay, got for you then other be called expect a – finished know that to benefit those resolved pharmaceutical or epinephrine out the that it. you And you the to similar fourth have going quarter is Do shortages been now? products.

Bill Peters

So strong demand continuing very trend not epinephrine into and we see for that been that resolved specifically, see the has we today. next still that year product

like back year. on track our get from they’ve So, doesn’t going at shortage what they drug FDA it until to seem next competition doesn’t be look to like they’re indicated will

capacity money have here Some Dan increased they’ve we mentioned, for to important to and resolved, you by spent IMS. you I’ve the we’re able of years, honestly, of – and to we seven our which that, And been is I the know, the been a for the lot of quarter, some sort supply both think products of doing been. over I been much occur. here they things one take and those ability other you you And competitor at But is haven’t increase now that. now another – I point every take some of facility we and have been think at capture know do issue company know, advantage from demand this of know that or real what there’s some care pretty when the

that we So think really delivered quarter. on I this

Jacob Hughes

slide anything the say saw new there you just Is deck then in the AMPXXX. can the that saw lastly disclosure program? on I is And about for pipeline.

Bill Peters

the development disclosure. as that’s That’s just we’ll – the as added one development that But one we’re products And that one. give that’s development further billion and a to of that the while. new just today further for that along, we’re part unfiled We’ve – just where deck recently the of information injectable in there of instigating further IQVIA in it’s about of it sales. deck. little to $X.X we’ve has added been And time one here out just moves just that

Jacob Hughes

it. very Thanks much. Got

Operator

Thank you.

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

Elliot Wilbur

afternoon. good Thanks,

trends Mist Then before. the couponing on chart want starts from wondering you performance on anecdotes saw continued in obviously, Just whether to new or though sense the really on been program, in just there’s question deck, I you’ve I a terms been even revenue, a of follow-up trend initiate mean, was your that’s in I if believe it are not of flattish to a in or to don’t sampling? increase that whether and looks asset sense you the terms the terms effective utilized patients at like what sales been to just of it looking get not share any how the higher you and unit you can haven’t you product sampling have able just but an impact there pricing, in know know sequential of in may Primatene

Bill Peters

Yeah.

of So data sampling don’t say it’s really we that first think cases we have mild way people have the you effective a get while on some who will all, know I give of sample program, hard to can and a the try you doctor then product them just out their of afterwards. when doctor, they and go product go the asthma it to their on their free know

So doing not go, as any as actually coupons couponing. are far we

product. continued sales led there the the the that in as by growth know none the was you of growth for And updated trend So mentioning slide unit that sales know, the growth. of you thanks deck on shows that steady or

that we’re about very trend. happy So

Elliot Wilbur

sort been Okay. good and the a representation cash implications the Now, implications run the significant you spend? products out walk tried sure quarter know for new of just in that the will subs or Bill. Can How question And change deconsolidated? R&D by of of some number, to change the fully terms figure your the have line? I us just Obviously, of flow line? understand then in you, a through baseline to rate things a is change rights you of – not in development that this the

Bill Peters

Yeah, good question.

out did had year, $X.XX – savings a we $X.XX – think about announced we when the mentioned was on I we’d we So weren’t of trend. that’s a big projects – so for part we the the get year year R&D moved next income reorganization, and of was line, lower that that weren’t a that back the part this of that that it some cost line, really as we this us savings of our $X.XX R&D

slightly we is, facility the our well. lower trend other did The headcount at AMP as

in of had less So there’s and clinical a is We’ve part there thing script, timing had really of out to mentioned was goes of what little that. which back the certain timing R&D And part projects. the on trials. third bit that his of some of Dan delays some the expense it, the

that one large be clinical So and trial expenses, the can at time. variable

you should clinical a quarter expenses that line number move floor as the and from this only more of trials you know is increased that of forward. expect you more So see up

Operator

you. Thank

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

Serge Belanger

A Hi, afternoon. also. on for good couple me Primatene

expect And you do then secondly, major is stores. season all winter product Box any now seasonality? the in Big First,

to So within where foresee segments these the here? of segments just additional next there’s it you or leg penetration penetrate? more Is growth

Bill Peters

still Yeah, determine. a to is hard with seasonality Primatene little Mist

a quarter a year good is good QX You typically it. for know – is

that situation. And so we’ll monitoring be

as – growth all commercial. major far hit, we As we for retail were in the we’re Yeah, Primatene.

younger you strategy marketing recognition the the of back the gen that and is, maybe people the I product we we with market. demographic expand letting team product, the next big into that brand efforts our as some and know marketing more a growth And has on concentrated think our is develop know getting in planned.

think see where some we moving I that’s could growth So, forward.

Serge Belanger

market to you expect And continue that market product just of a then of or the on grow growing? glucagon, question continuing expanding Is product your similarly that the to size share? this

Bill Peters

Yes.

So And there’ll market We that large we have that growing glucagon now injectable to that likely this, share. which at with for we we product believe we out significant provide. an the is get people one or for a a because – are there, filled, data, couple generic a the fact see market of be of the that, don’t already see We the a majority that a market version. have script When the – for take the past. IQVIA already overall reasons. the alternative think it was in market much this more you share changing we look given expensive

growing but about So market, remaining we where a market is. see probably we it share see our this as

Operator

you. Thank

next Capital. with is with Northland proceed from Our question. question Tim your Chiang Please

Tim Chiang

could your you Bill, talk sustaining seemed just financial sort well, of that it that thanks. apparent, Do the be quarter just type of were given you XX% leverage fact see – quarter? north margins? the about margins operating into as pretty the operating of and Hi, these the fourth to highlighted this you

Bill Peters

trending see quarter. Yes, kind they the so third way same do in now right of the we sales were

So the again, you bit be had line the is a SG&A know of think bit be mentioned, can We margins clinical another strong I The quarter more variable be delays similar we will sales. and trials. our as little that our a of line gross little pretty lines in one relatively very some R&D of similar. will

So the in little trial third expense this was clinical quarter. a low bit

we that likelihood, little where are So, fourth in bit up all the in today. a goes quarter from

Tim Chiang

pipeline. maybe on And just see. the I follow-up a

right? slide guys GDUFA bigger is ticket the I guess a what second one I items. in XXXX, quarter that’s update your pipeline of you’ve of that set data did think that think you AMP-XXX, I

Bill Peters

Correct.

Dan Dischner

is the we as through – This on. our is action until complex haven’t CRL, quarter. product just that a this is time, which communication and them, an just They progress that this correct. agency with work interesting as extended they’ve is that that’s date yeah Yeah, we a not

Tim Chiang

for you you’ll I do mean, supply the assuming you little have think year? comment next quarter mean, a ample product? can just you on capacity in approval I to sometime second meet get bit that capacity

Dan Dischner

part of think I it’s planning. our

the So capacity. we invested have in

it’s, think say I you you know, So Bill, to do want else? anything

Bill Peters

we not relatively Yeah, volume very do big high-priced It’s a item. yeah item. unit it’s a

the that capacity that Amphastar to that still our and capacity the share market product to. So we get believe headquarters – we able at make be to we’ll the have here

an being don’t see So, as that we issue.

Dan Dischner

a separate it Tim, it’s dedicated, reiterate And that, product. a It’s to pen line. is because a

other it that be product would So this some from our of products, in just encroaching on line.

Operator

you. Thank

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

David Steinberg

good and I already apologize and Thanks simultaneously. calls of you’ve addressed on if afternoon going sorry this, couple

lot your at view? quarterly going you they on, waned? level high are you near-term? The the still could to on in when of the prices that are this have been you there’s pipeline-wise, just the any is at do any do brand last first have competition generic plate calls, long one – much actively potential you few patent know competition? And And market And looking in have like you looking, your You so you buy foresee anything? XXX. on you How seems candidates? Are then on all? Thanks. Or remind without any come know, a your has interest you get Do in on us size product? relatively has off obviously M&A. it you the if no need secondly

Bill Peters

has it’s size patent sales $XXX market, the for a million long a about been that About very market time. and off XXX the of IQVIA

And to So early that have date near that future. on up we the to in next GFUDA reiterate, coming do anybody something approval expect it’s else not would we year. just get

your question forward looking we’re So second was – that. And to

Dan Dischner

M&A. On

Bill Peters

M&A. Yeah,

to take So Dan, that? M&A, on the want you

Dan Dischner

I mean, it’s Yeah, fine.

have we’re on – before, what very very we we’ve focused are We here. mentioned as going on

pipeline. think our to We would presented very very And balance opportunity on you we that it’s we’re have there’s focused But solid to. always if we us, and I robust itself know that a attention pay pipeline. something the very on a executing right sheet said, have

that regard, hasn’t in – really that that much. changed So,

David Steinberg

patent And you has years, million sales just you expect to competition. for indicated over no to been that Bill, off follow-up were $XXX

math the it? reasonable So if to product biggest on you time. out That become a should over Is your that think about that. way work

Bill Peters

that’s become think math to time. I I I extrapolation. now Right hold there. how your it our really do you not that gets would going off I’m remain does – Mist. we sure making I that Primatene over biggest see product on think

leave it for just now. I’ll that So at

Operator

you. Thank

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

Elliot Wilbur

Just a follow-ups. of couple quick

have seeing did with from category, in any there quarter? are follow-up [indiscernible] You And quick just know injectables that market wondering benefit I thinking how light off of guys now a market? the just the that today? pricing And on in contract the respect about you guess incremental naloxone? of to been then a shortage products, of those you’re Obviously just in terms how recent couple approvals of sort in competition opportunity the

Bill Peters

Let’s see.

– So

Dan Dischner

with I’ll you the market can On and start then to the answer on or – one. that seeing keep Bill know the contract that shortage growing. we we for program naloxone that that that go naloxone, product that can pricing term,

room believe still us. we that there are So for

We in experience market. this have

You – I drug pricing is Then there – or continues grow, crowded, contract there’s the do off you’re room to is market shortage, with it But the then contract pricing. shortage think the still product. right. for the as as on our getting know, think I off

Bill Peters

Yes.

shortage contract, have to So were did of shortage that sales most and on not benefit. the that that off related we had on, the products

So they’re straight normal pricing, because multi-sourced they products. were

wasn’t really with issue So any that. there

Operator

further closing would to time. no turn management this comments. back at questions over Thank are you. the to There like any floor I for

Dan Dischner

look we again Okay. to of you shortly. we forward Paul remainder with We the us very on to to year. the you, you, for this momentum pleased joining forward great everybody able quarter And a today. carrying know you quarter. very thank talking were and have Well, all to be the for thank look And

Operator

concludes This today’s conference.

for disconnect Thank you your now lines. may You participation. your

Dan Dischner

Thank you.

Amphastar Pharmaceuticals (AMPH) 9 Nov 212021 Q3 Earnings call transcript