Amphastar Pharmaceuticals (AMPH) 7 Aug 242024 Q2 Earnings call transcript

Greetings, and welcome to the Amphastar Pharmaceuticals Second Quarter Earnings Call.

[Operator Instructions] Please note that certain statements made during this 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. We encourage you to review the section entitled forward-looking statements in the press release issued today in the presentation on the company's website.

Also, please refer to our SEC filings, which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance.

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

Dischner, Executive Vice are CFO; of Regulatory Corporate today Bill Clinical President and Senior Operations. and Dan Communications; Marrs, speakers of Vice Tony Our Mr. Affairs President Mr. Mr. Peters,

the to President now your Communications. Corporate I of Dan you Mr. turn Dan, will begin. host, call over may Vice Dischner, Senior

of afternoon, Good second and thanks us joining our call Paul. for quarter for earnings you, XXXX. Thank

today Tony President me Operations. It Finance; biosimilars products, Affairs our and BAQSIMI, a Bill Executive Vice CFO products. Amphastar's complex of Joining and acquisition over Clinical underscoring will expanding Peters, portfolio Marrs, year strategic be with President and successful on since has been proprietary of of and now Vice the Executive Regulatory focus

driving emerged compared sales worldwide representing This growth. Overall, sales with solid a quarter, of a the have XX% the basis, and million, Primatene impressive quarter BAQSIMI and concluded this to This which increase year-over-year. sales XX% by strengthened representing growth annualized increases XX% MIST year same $XXX.X for total $XX.X has achieving is revenues key XX% last revenue of highlighting by epinephrine, quarter, driver, an impressive increase the on significant growth, an and risen to as million in respectively. product's period

end have MIST it of target growth to a that of the show of the track trend, XX% to MIST's sales remain We million XXXX. QX meet continued confident increase on XXXX. sales a in-store from Primatene in by Specifically, is $XXX trajectory experiencing Primatene

and These products, production focused current strategically on us improvements leading future to of we to facility, our efficiencies enhancing IMS capacity. demand. have in market our and positioned meet have increased the other epinephrine At

significantly manufacturing have of square need additional our without ongoing footage. boosted enhancements capabilities the and efficiency Our

is approval manufacturing of capacity manufactured, product where the currently the that will and another MIST horizon. Massachusetts product third our our on Primatene facility our utilization a efficiencies with AMP-XXX Furthermore, at we albuterol optimizing believe recent one, improve our

glucagon sales remained Our have strong. injection

a we diabetes to aligns emphasis diagnostic decline due particularly levels strategic on of the market. with availability anticipate competitor peak in BAQSIMI. However, the of from the This focus trend sector, with products the our increased

branded are to opportunities The for BAQSIMI, growth. strategy an with dedicated We amongst underutilization advancing diabetics in us our positions presents advantages intranasal combined product BAQSIMI's of retail significant with which glucagon current market. product the as well

ANDA by July for approval We approval The want Armstrong's to filed filing briefly albuterol. already had respect At product. of the of lawsuit time to lawsuit or the the for approved XX. Teva we and FDA on have lawsuit, launched filed received generic with address was ANDA, Armstrong this its Teva's

against we likelihood about prevailing the we While pending confident of are further our cannot litigation, comment about Teva.

regulatory since this attention We generic vigorously matter and inhalers. Having affordable defend to like will patients access in importance now the our I turn would we and versions albuterol drivers the our to our key activities. recognize of covered more quarter, events to for significant pipeline revenue providing ourselves with of

discussions topic ANDAs, future. FDA the and positive filed AMP-XXX, On for are our anticipated near in ongoing with of in the engaged progress we with the

fourth the we CRL, teriparatide assigned address quarter. minor have the date our FDA response goal the submitted in ANDA, GDUFA For our to and the AMP-XXX, has

goal regards GLP-X XXXX. for quarter date second a and Additionally, filed fourth AMP-XXX, our generic diabetes the a we the date. AMP-XXX, GDUFA our announce that our products, is in I'm ANDA, second -- track ANDA to which FDA has with product, pleased review of With the quarter inhalation goal accepted have for to of remains on GDUFA

promising are Teriparatide, that XXXX. approvals market contribute approvals: to In These AMP-XXX; second Amphastar AMP-XXX; for anticipated expected to and is substantially be XXXX, third to potential of note to AMP-XXX. product is our with and or the refiled enhance presence. for quarter expected significant product X our I'd for insulin in As the half revenue growth positioned aspart for well the a of our like BLA AMP-XXX, closing,

we to Our our efficiencies strengthen will offerings, the By our products, capabilities products higher-value generics transitioning strategically manufacturing improve from to for current and deliver further barriers are to including optimize to efforts pipeline, operational entry. and continuing branded product and complex drive BAQSIMI biosimilars ability branded to to long-term significant Primatene foundation our our confident resources commitment our with value. grow advancing and product our in along offerings, with growth while MIST,

With CFO like President of to to the quarter's discuss results. financial Finance, Peters, Bill Vice to that, second turn would call our over I now and Executive the

the which Revenues we retailers, the $XXX.X quarter year's from quarter by $XX.X million in XX% Dan. back million onetime previous in Primatene million from of experienced MIST to second in period. year. year, sales that XX% million that of second drawdown quarter $XXX.X in for you, grew quarter inventory $XX.X last Thank MIST last Remember second the Primatene sales held period. increased a in second to the the of

Epinephrine competition. Enoxaparin were $XX.X XX% the from also Canada decline million as saw quarter. sales million increased to Glucagon $XX.X shortages quarter. sales the States to naloxone in the to increased flat injection due decline offset sales Phytonadione to other and $XX.X in supplier the during in increased million a sales competition. due due United $XX.X to decreased from million sales

which to previous medroxyprogesterone us primarily sales in $XX.X due the product partially was by in other a product. dextrose the million finished by stop has sodium the to to and pharmaceutical as selling finished million This such products due Other decrease from offset caused of of sales million, $X.X increased to bicarbonate. discontinuation temporarily sales our $XX.X supplier, decreased API

United quarter countries begin year. the X first few States BAQSIMI the revenues into the fall this and categories as a we European product in of in shipping

on our $XX.X statement. revenues are These The net in first category directly which to the to line revenues ship income of relates million. product recorded for we net revenue's we customers, recorded our product

to of of expenses our relates service of by had $X.X revenues totaling Lilly to million worldwide resulted BAQSIMI. second other quarter, on million. the transition This up category agreement revenues and corresponds second a category, from products $X.X million sales Total $X under of XXXX. our sold in in which sales the reported quarter benefit net million, economic sales for XX% behalf The for in BAQSIMI Lilly $XX.X the $XX.X Amphastar's which million were in by cost net

We Lilly basis will distribute to on the those book countries behalf. where on revenue our continues a continue net for to product revenues

wound the and we label as XXXX will an a For in This increase inventory our recognized own will have their revenues. ] it on result benefit country-by-country on product Lilly basis down our [ available. economic inventory, Amphastar has decline of throughout net distribution based in increase a other and in local BAQSIMI, in sales regulations

payments the none We year Cumulative sales first period first cumulative $XXX.X milestone would note just like BAQSIMI X are sales the for in million, contract Lilly. to potential these payments that of of potential X the payments and of milestone BAQSIMI. totaled first annual so year triggered. year The the on we were X-year contract milestone quarter to completed based or

we million, insulin have API last they $X.X up from have as sales had our Our year time the last $X.X material. for of demand until qualified shipped updated kind business RHI API million

of component in by million, certain margins in million BAQSIMI Cost BAQSIMI, increases sales and partially and MIST the and products improved labor and depreciation were gross The XX.X% related benefit of year. of costs. XX.X% amortization epinephrine such $XX offset and from Primatene revenues previous increased increased to to $XX.X from as higher-margin to increased

period Selling, distribution primarily and $XX.X to $XX.X spending to BAQSIMI. $X.X marketing expansion to to related million previous force marketing expenses $X expenses year's XX% million due related from increased and increased General due and administrative the million BAQSIMI. in expenses sales X% to from million increased to

and expenses increase ANDA the from trials. These to decreases due expenditures from offset X% Research fee an acquisition timing by primarily for were in as with clinical the AMP-XXX. as to to million and the by due $XX.X in loans filing million development expenses well personnel-related associated increases BAQSIMI. partially $X salary increased of $XX.X expense expenses increased increased million, interest $X.X trial driven Nonoperating on clinical of million to

$XX.X or Adjusted from income per the $X.XX to compared million quarter XXXX. share per in XX% the net or Adjusted impairments million $X.XX of $X.XX of quarter onetime $XX.X share an or second earnings of second to share million last of year. the or increased long-lived per and million events. adjusted quarter equity $XX.X second net to in in income income increased compensation, share assets $XX.X $X.XX Net per amortization, exclude

operations In had we the cash approximately million. of second flow quarter, from $XX.X

During the BAQSIMI the made payment for the million to quarter, acquisition. $XXX required we Lilly

$X for million $X.X our Dan. and In a to shares call addition, mortgage of down turn back over I a we back cash the to used portion of will now pay worth buy million. to

the line for for With update. the Bill, now take Q&A. that, will open your you, Operator, we please Thank questions.

first [Operator with question from Knyazkova Instructions] Our JPMorgan. Ekaterina is

Just if may. X for me, I

So the epinephrine, like potentially for if supply as entering about a well franchise in that over there? another filing a just very Can competitor strong first, or both for that shortage players, other just time, expectations market? product. quarter you're or As either with seems on maybe changes talk application you standpoint, seeing an from any

decide as And to And help can ProAir. about you how [ thinking then get you you're product? opportunity? the just can, just size that is do so? when how you And generic ] quickly I that frame and for us uptake second launch you guess, question Can of how quickly

have the that product. -- for we presentations different epi, X we for So do have

prefilled multi-dose now and for on of now that drug on shortage year has about one First a a almost all, our been And prefilled there's of or file a hurricane competitors. hit the year a syringe. a supply the based syringe list

business the that So of relatively portion remained robust. has

Dan different as of to is some done the efficiency increasing taken However, in steps increase of of we've that mentioned the labor plant packaging comments, his we've steps. some some what the of the by had capacity in

product able So pump we we've that showed and more increase to as quarter. production sales out of this been the

that start expect they're the seeing fourth the do competitors in So from that returning the to to we for now. be product -- market will we're shortage quarter that going

they the I said third think last quarter. quarter,

This same quarter was fourth the quarter. the in

returning -- regular sometime a supply to So but next year.

much to to we take industry. can this advantage it's say that as needed but make can to supply ourselves right preparing we're of sure we and So the just hard exactly, as now,

out is new there file, multi-dose a the as one competitor that to there. far As

So we X gone presentation the to that market the expect suppliers. will do X of as drop that somewhat has from sales

the generic we on And call, ProAir, Yes. in product. we the mentioned the launched have as

So we've still business already competitors there. working securing we're with the market, got on it out other that, are in going obviously, there there. and Where we're

really don't so well So received know now, been it's -- good have I far. we that we but a right idea,

able So hopefully, better update -- we'll be to an update a give later.

the increasing we're And the one that things that of over of the with packaging capacity is one time.

we course for meet but increase product don't So be a I ability to off moderate the want say, that to, of that expect over -- demand the to more might we to start, next the few quarters. then the

question Piper with next Sandler. David is Our from Amsellem

questions. So I got couple a pipeline of

but kind head, one. you hung interactions they're So up FDA? new add of on? I beaten specifically, the is more know been the there with anything number what over your XXX has regarding that Or could That's

the that you're that's that remind you others two. there GLP-X, Or on P-IV there launch? when to already anticipate filing? a And litigated two, a number a Number Is a or be generic is So P-III? us, competition? position is will that in just do

PX? be a about that nature competition number that three, to XXX, talk in litigated kind going And market. that And of on then the Is is a of similar filing? question,

Yes.

just For maybe have of guess I The kind get agency. the to they're a that to stepping an what to of have doing back, they're we've last to and on AMP-XXX, with -- been those the end be issue. we what that the the conversations had conversations, is routine idea and continue sense we is. progress think they're we issue. And able to We their issue resolve for their feel making based understand coming conversations

on the them that have it'll future And we that a so take feel calls with we routinely application. why believe that be we is those action they'll on based near

it And we're a AMP-XXX, filing that launch be competition we're a of been within well. still is a sued Paragraph For do the when still we we date, to where could position the the Paragraph that to this not And and AMP-XXX, one expect is product. but time on in filing the IV product. have on period as that GLP, we IV

And expect do competition? you

point. this at say to hard It's

not rather We'd say this point. at

question Bank is Jason America. next of from Our Gerberry with

Two for me.

margin we in first degradation First, in bit with half, long gross presumably, it's as saw this to half versus BAQSIMI, overall XQ. half, as margins going second the little grow XQ a of company second versus

So in to the BAQSIMI gross just about dropping profit how think the the mix revenues wondering line. of more we impact and

about something asset XX% like by wondering ] that maybe development, goal you're then as your versus market-ready to might that thinking And business kickstart proprietary [ pipeline, getting BD how I'm a year programs BAQSIMI? tool on using add complementary to more of as a next

Yes.

and So quarter. first market BAQSIMI always there. the the one quarter on third Yes, the biggest is spend

So the accounting, is other that net. getting basis. no cost remember that's they're thing second up goods Eli and of we're from on at expecting so And benefit, economic associated the margin. to the with ramp on the net gross the distributor it certainly sale that we're Lilly books There's the XXX% when that that we that, get when quarter

we to sell of a that start has having So for goods when move revenues. majority margin cost Therefore, more from BAQSIMI, trend the sell those gross dropped. we incurring BAQSIMI them majority significantly of of the us having the

of one continue the so make next as things to sure is the we quarter. more trend people want quarter into up on that And that, the I countries in start realize picking will

as at and things, both that actually like on are for in we far we've and we're things already looked the more actively are development business goes, BAQSIMI As market. yes, the looking development so --

we've So to time. at And announce in anything. of with those to things. discussions want There's been don't this say I on both close we're nothing actually

to and the right for But that we these remain assets. diligent make we're price sure also paying want

where that have we're competitive necessarily to okay processes want a with that bidder, year So been the looked highest the processes remain couple we're this not because we but disciplined. at of we've

We pipeline. our R&D in have a strong base

business So #X we cake. any that's icing of top really our that, we really on focus. want that's to make sure on just development first do that, And if the

Chiang One. from Our next Capital question with is Tim

fully on knew how and the will to the marketing back how you just comment half I and you sort of the versus for think you comment on quarter. over you in these first shape -- well, BAQSIMI REXTOVY take do in in other up just that not selling of expect a launched year Just couple. And the the costs secondly, just Could U.S. guys? as U.S. in second of you then the some you half

the Yes. using discussed before, is thing, and our government is REXTOVY, as crowded one is responders focus a or municipalities field. more as -- first responders. you know, first proprietary our product And also on We're And device. we've is of different. our

don't still time being to it's competitive we're nature environment the because for to really of too So just those of early how product say But a secure to going do anticipate it there. there. we that takes big contracts. really us It

goods cost and have cost agreement, most X expense It's for category And sales to then distribution trends, have and there. we marketing there. the the significant fall a of sales of things foreign the that's we into on is will that don't really One distribution of a going marketing entities, mostly trends. so

a about to similar BAQSIMI a United However, to sales add slated in as some cover growing ramp covered say or we we is the think the that. incremental up, to not past, more territories make sales as And growth we we And some going that percentage grow to we as that's sales third we're way spend we quarter. were I'll and that did that States force as people one probably so is look are ago. are at we sure planning it for on an the force in to well year the the

So the are about XX%. sales up

the expense XX% sales well. marketing and about grow as so And should

Needham Serge Our next question with & Company. from Belanger is

of questions. A couple

on First BAQSIMI.

this mentioned up quarter. were about XX% year-over-year think I sales you

Amphastar's talk Maybe the top in that was if or for that volume there to you're that share compare expecting over impactful a to ANDA increase approvals Just line. each and on and growth. market And the curious ProAir how half. price opportunity terms the then being market they secondly, second of generic in X about opportunity highlighted driven the involved you was pipeline,

Sure.

selling So have units States have that were the first actually in is that that there United -- States fees we a net it thing we're United is the pay wholesalers. to to had The pricing main decrease the now because we I'll the the take remember, we thing. in higher

gross and items. net a So -- that's to

So in quarter. price second we the United for actually year this reduction see the a States

So of all that more unit and growth. is

And pricing because from that's material change, changed the outside there's other much country had to a that moved only it than government-paid a of U.S. price hasn't really one a at the negotiations. over all some and nongovernment-paid maybe

units down. price went went but So the the up

know, market. so And it's share, as multiplayer already teriparatide, you as market for ANDAs as the far the a

So we'll as to be but had big market reasonable a it's share point. at get not one are I that of product, think that our expectations thought as going we

in what said capacity-constrained the AMP-XXX, for a relatively past market, it's going we've large I to is think that somewhat we're but that market. be

get lower still for market, what -- is have as market don't somewhat because the going said what we're we've consider good us. And the we So competitive [ been a we than clouding want market let a it haven't probably issue market for reasons. AMP-XXX, know in you don't we large we would normally there people because see then to to product but X-player and being a to share consciously ] a

see we So I good us as though. a -- will for market a this say that very opportunity

Santangelo with next is Glen Our question Jefferies. from

is wanted expecting. think, I were I bit, BAQSIMI better were to we results unpack than, Bill, little the a what's interesting also because probably

made it price numbers like more for trending response than driven. Looking driven in kind territory sound volume question, the quarter was of your like on at some it of the based negative script to looked data, the were first it you the previous

And related data the little will to reconcile the can and transition we Amphastar look then quarter? you more think those us to back on maybe be to a what a half that, when could the year, in maybe strength points and maybe of the as So the fully you give complete? drove you country-by-country color transition

Sure.

So government I hiccups couple of quarter numbers chains ours, NDC in and Lilly that certain store will certain as drug to units numbers yes, a yes, the -- in transitioned say the had we so from we programs. supply

But of a did should quarter. the a where second I the bit we hiccup resolved every quarter of of by think during script getting been all we the a little we was and were have So getting. there time end weren't those problems have

we're think tick I be. quarter it the the expecting so to And up way third back should

certain some the sure a to extent, think, make more in make were, of To enough gear surge up wholesalers want sure the had usually units because of inventory quarter large in they later that's in to the for they enough had sold channel they back-to-school to August. trying the the some I of that happening

So of I part that's think it.

trends nice And U.S., there. still some we ex had

been well. going that's well So as

As by basis, by a countries far our this as the end other the majority distribution goal that to get of Amphastar are to of country-by-country quarter. over our is distributed not

countries for and So September. we cutover of have a August in lot planned

is those are going going mixed be It's quarters. that this. of another one cutting to multiple throughout this that countries So there's a over in little be to bit

still Lilly. fourth that be that will So our X there by expectation by are is only quarter, the being distributed countries

X. probably, the -- over on goal not them Our they distribution until we January X, to might final is, might take

most from should little final quarter quarter, countries transition It'll still a our little means [ ]. looking December the countries X, that so. at a be a be third But that will -- by X for be which the fourth cleaner distribution standpoint. end either will we're maybe or the So the churn January of we're

categories, quick the big the details. the follow-up. the see and these about, we all issues just product and think appreciate some that the we market of like, when phytonadione, results. Maybe I in I if like creates one ebbing other could in and On lidocaine of supply Perfect. ask swings flowing sort

in and half, to I'll where you're of sort back some influence any are without the out maybe shortages online giving or specific product categories as you'd guidance, there call coming you back those of half? competitors And And stop seeing so back of look areas product either there. the sort

Yes.

competitor of the of supply So last will the the constrained as begin fourth that has problems I mentioned, they some over these quarter. had distribution the that supply products said in year

of So they we -- be that do their that some do to will disclosures. able for expect

off So the in any of fourth those quarter. things could drop

that We're yet. third not seeing the quarter in

could is But those the had and in of epinephrine quarter holding think We that Dan third and steady. sales that better so again, the of -- all the take drove reasons the mentioned, of dextrose the probably of was point that makes And out So bicarbonate in higher, of it increased quarter. one as have I'll we we those. advantage should sales third this drive capacity products kind just the that certainly facility quarter.

make So they product of things with taking facility, up. more that that, of advantage hopefully, come we these as can out

And able a so that we entire in we're these market. so that if position on want shortage by products, to that be supply a competitor to another supply there is the

do So that. be able to up we're to kind of gearing

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

I want us thank to for today. joining everyone

again. and day. of have launches. anticipated The second highly you, updating thank period a X you potential all with XXXX forward great again, We look to And half be a to remains

conference. today's concludes This

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