AMPH - Earnings call transcript Q3 2024 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals, Inc.

Third 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 and 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 on to U.S. information our use reconciliation and measures these of Important GAAP found may be in our release. earnings this note, conference is being Please recorded. call

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

Dan Dischner

the Ziko. and call third for XXXX. Today, million, reflecting reported increase Amphastar Peters, afternoon, you, Tony our Vice of third Vice of I'm marking revenues strategic Bill Marrs, a net X% us Thank business for joining and President which Executive to footing Regulatory and Good execution facing delays thanks by year of of and the remains challenges of diversified this product resulted core and delayed resilience quarter's portfolio of year-over-year, -- our leading $XXX.X the Affairs our the quarter as XXXX, robust, solid Finance; portfolio. of Executive Operations. In Amphastar President and earnings end strength with our in in and CFO joined Clinical for shipments, initiatives. Despite of a our logistics impact the the of the Hurricane growing such path impacted Helene,

will for MIST. performance products and we $XX sales. Primatene annual of revenue positioned sales growth program remains highest step the believe part achieved more And current are market's presence. To since through XXXX. visibility end in care quarterly which our BAQSIMI use Primatene to with arena. A for our expanding regarding key initiatives goal are a is meeting product XXXX, BAQSIMI. enhance performance as core this the sampling our expectations. We essential our program and for portfolio, This BAQSIMI, sales of targeting our This force innovative, hospital launch, well MIST, and transition regulatory in filings on physicians. million pilot we BAQSIMI reaching to The a quarter advancing with to pipeline. therefore, and highlight sales product are opportunities serve care strategic critical this MIST, an and the million our and we track, progressing the execution continue Our for physician of primary of with we toward key are portfolio the strive sales Primatene committed the commercial in smoothly kind by brand's strengthen initiating to to States, of there expand significant by $XXX its in is sales additional the the drivers in the a plan United our solutions benchmark growth products clinical we exemplifies our we remain develop was impactful user-friendly for dedicated

with believe options quarter our and the respiratory of the management albuterol the million launch We our we MDI of is our forward response entering are path by competition high-quality reflects As this we routine note, continue productive and occurring to hypoglycemia actively facility. This AMP-XXX, received to the of us market, our $XX.X end announce for we to On significant launch a the the pursue ANDA, management for glucagon business in we for leading are clear demand awareness increased to a a to expansion X% we portfolio kit continued regulatory intensified, third near. that different options, XXXX, believe pleased rising competitive the The product meet attractiveness marking has and market. competition year, decline market FDA the anticipated, of operations the this the a effective submit front, opportunities. seeing third the On year. sales in asthma positions growing CRL from teriparatide in sales and in discussions Armstrong AMP-XXX the to for a filing, regarding injection in approval on affordable, have previous of generic a the quarter. track

Turning diabetes portfolio. to our

insulin We refile BLA quarter for our our this are scheduled to Aspart year. AMP-XXX fourth of in first or Insulin product, the

designation which that of quarter the For pleased this our competitive announce filing generic was second review. GLP-X ANDA, was to we are therapeutic AMP-XXX, in and XXXX, priority granted filed

our date As GDUFA this for goal call, product a mentioned remains on quarter the last XXXX. on in of track second

number an XXXX, has this it and with a regarding and goal no announce application. the inhalation billion with limit new biosimilars. first pipeline. BLA of second note, the AMP-XXX, separate in second our to are there sales to target are experienced a addition our insulin. ANDA, previously $X introduce current AMP-XXX, has GDUFA currently the as the believe product agency IQVIA to date proud or marks potential of On in outside Regarding we biosimilar This no our items market, unique extension competitors will of plus capabilities of our the announced, quarter pending We

focus expertise strategic more Additionally, projects that therapeutic potential This our the efforts to growth and advanced resources. the transition impact. areas and and sustainable where shift represents in-house deliberate it our value a maximize move have on utilize towards we highlights can drive to high-value

pipelines, XXXX, close and we reduced us filings plan and year, our focus the positioning In and direction. sustainable we for biosimilars, on aligning coming our proprietary advancing through look towards XXXX areas candidates with our pressures. additional competitive high-value growth our to announce As like strategic proprietary remains in biosimilar portfolio in

from CFO self-funded and our and and a of the teriparatide, continue Finance, foundation. financial BAQSIMI to results. progress, MIST including investments call the Executive we pipeline, provide a the to Peters, projects, solid turn ANDA. potential excited our and our second that, expanding President sales ahead With to to clear opportunities AMP-XXX, confident remain quarter's to We're GLP-X committed of value. With drive delivering an in about strong like discuss strategy and and are while Primatene upcoming long-term Vice first expertise I'd R&D AMP-XXX the Our Bill

William Peters

$XXX.X the sales Revenues quarter third increased $XXX.X third Amphastar for previous of Dan. BAQSIMI in Thank $X the totaled million period. recorded same period, quarter. million the through net and economic net $X.X in X% the other during of Sales to million you, by totaled million BAQSIMI benefit $XX.X year's we Eli Lilly of of our a million, $X.X line their revenues expenses million. in from

countries net the Our benefit have over year while we the responsibilities various has sales the world. have distribution product increased as in throughout decreased around BAQSIMI for taken economic

the country-by-country this the year. BAQSIMI We end of of will on distribution assume through in a remaining territories basis

due such to subsidiary this on Helene as $X distribution to a faced BAQSIMI recognized million. in product pharmaceutical as million by expected and disruption temporary before supply this $X.X in X% $X units because This $XX.X $XX.X quarter recognized of deliveries. are sales XX entered products as shipped $XX.X of which our and of any impacted of X% the were $XX.X booked by while in labeled increase product. year. the were were represented decreased of third unit record the be a million syringe quarter, our cost $XX.X an quarter. was Lilly million declined European increased to quarter decreases well gross Gross as million transition and Phytonadione of of in million in prefilled higher $X to demand were goods. grew to which able most increased in due due of between net XXXX. Overall, sales Revenues sales the ran revenues by capacity in we negatively the sales more Other of we such ongoing, MDI of the from million in disruption albuterol limited new due decreased from sodium prior million for to quarter Primatene as we units Amphastar sales the unit XX% decreased by year, million MIST $XX.X the due increase primarily third to Enoxaparin Amphastar, previous $XX.X to to margins volumes. market International receive XX% to in these from million which as the in These contributed to BAQSIMI sales sales made goods, Glucagon to offset million Canadian hypoglycemia sales launch chloride. books from are a During in as this This million, a increased at to out and to labeled primarily were by were year, finished approximately from revenues in atropine X%. Epinephrine Hurricane in Medication were expected $XX.X due temporary margins million countries August sales million shipments $X ready-to-use prior BAQSIMI. of $XX.X last made of to sales third cost to Lilly quarter. that million European our increase compared bicarbonate million not decrease to in Cost from the moved partially calcium year patients sales $XX.X primarily delayed sales BAQSIMI lower of volumes to growth sales higher to year, of $XX.X naloxone product fourth in an million. and an products decrease $X.X quarter. XX% the

marketing increased to in due and to million costs Research $XX.X increased General our $XX.X our development expenses expenditures increases the an in expenses sales to XX% $X.X increase from expansion. force the due $X had pipeline million primarily administrative costs. Selling, BAQSIMI to distribution XX% year $XX.X million, component personnel. related spending BAQSIMI increased $XX.X in products. million from and related to Additionally, we insulin previous to million from million due expenses to labor to certain increased and material and XX% and

adjusted expense last per to third or Net $XX million. million onetime compared cash third third to XX% third XXXX. Adjusted the assets this or of per earnings of in income last Adjusted by equity shares. of income of quarter net to the million compared impairments per flow $XX to $XX.X operating repurchase compensation, per of long-lived share the $X.X XXX,XXX $X.XX or share quarter, quarter used of the Our In quarter decreased had the of from an in and $X third $X.XX million We year. $XX.X operations decreased $XX.X nonoperating income events. of of excludes an million $X.XX cash expense or million million share million we from in share quarter $XX.X to in approximately year. $X.XX net amortization,

We has of buyback today $XX turn call that million. I program also back Dan. authorized over additional will the an to now our announced Board

Dan Dischner

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

Operator

question Instructions] [Operator with first The comes Ekaterina Knyazkova JPMorgan. from

Ekaterina Knyazkova

X if questions, just So may. I

quarters several for first, you've on asset So just BAQSIMI, now. the had

you're is seeing about obviously have can Just You Can this where bigger bit you think surprises the then molecules a in competitive potential that market? we And AMP-XXX just more for XXXX, you're as some the about sales potentially in product? the the I any just GLP-X talk dynamics eventually And category terms second updates but of of question you're going uptake play seeing as that in little peak time? category. about thinking GLP-X any in the the on company over role coming or guess, generic.

Just color appreciated. there any would be

William Peters

right mentioned was my had relatively going smoothly far in in it's other supply to as So going I quarter. we disruption the slight what that as than BAQSIMI, Europe which comments, this now,

product the of Lilly out left all didn't countries. before get BAQSIMI ran with unfortunately, XX to in expecting to out. that labeled But those product time Amphastar the us countries which happen, were short labeled we in So

of deliver to lot countries. X were between weeks we a to X those weeks anywhere So unable for

things when center. transitioning a product but So a distribution happen these unfortunate, to -- that's new new from you're and

on surprises. we say what no sales, $XXX which in no. was peak $XXX had said as still now, peak sales, target So previously we're real as million to on big peak far sales. million And Right for I'll

So right base in close we time. sales case are that our the, put now, we're -- to that I'll really say, trending, at believe, we our annual

Dan Dischner

great a that's then the on And strategy, question. GLP-X

little to us of be market. now. we a to GLP-X that in too get up group coming as people discuss you thinking update right early that closer. things products. We're It's it. it's know, really about new But alone really people As lot we'll type not a There's a any in probably getting crowded for potential with

William Peters

have January. we'll Maybe your you conference at update in an Yes. for

Dan Dischner

Yes.

Operator

Piper with The next question comes Amsellem David from Sandler.

Dan Dischner

David, you there?

Operator

David, your your your may that to please? may we request unmute side, request you David, line, you we from line please? unmute

William Peters

think he's I gone.

So the go one. let's to on next

Dan Dischner

Yes.

Operator

America. comes The of Bank from Patel from next question Pavan

Pavan Patel

Is you onboarding BAQSIMI question is or are in where year. revenue should and And frame glucagon? you growth business can of the to what epinephrine, it speak And timing branded forward? the the to offset there? sales driver on of focus is the Pfizer be supply First, can products resolved? relative look business those decline on headwinds supply quarter? the year-over-year that other driving it Was investment competition and products? force BAQSIMI, on will in look start moving reps? the the going lower becoming smoother? areas competitive of shortage this the more may in maybe prior sales vial main fluctuations base BPI what generic to that like the the And it driving Or such second of booked then we shortages Will other other in competitor Lilly to or be What's

William Peters

Sure.

comparing quarter. second you're think to I Epi, So

the So this prices multi-dose year, as our there's multi-dose we a in of competitors have decrease vial and vial driving volumes been did X launched have down. some that

partially that began as increase epinephrine However, shipping quarter. and we offset this quarter was in year-over-year prefilled Canada this to sales syringes the

so As were XX out mentioned the the pricing partially It's is that issues. which driven because we had wholesalers. increased decline, this I by there. limited stock have which earlier Europe, the fees year, to sales what of that for this in BAQSIMI, the we I any in U.S. pay we decline have it's related a to far has mentioned year to I of that's the wouldn't And earlier, several competitive was year-over-year say what weeks countries in as

that's sales we digits I if get what high we So the single or on basis, expect said be up year to you at up would terms we a single in think in that look for something you should of units, said. that digits -- year-long down had to it single pricing. And low closer but

anything is of quarter an So I one aberration think more this than else.

have January, in force So as had in this a planning as the small goes, outsourced that an the in some very will far quarter but one. of that be quarter beginning investment sales will to once the force third be increase in -- And sales sales increase fourth hit we're but larger that we year, as our force that, there'll also well. expenses related a again,

more is about might starting new initiative right little we that so able we -- that And haven't later, be but this to just a disclose a bit we're now.

Dan Dischner

us that or said if the sense. And force, flexibility we we've outsourcing thought some where always gave to identified expand sales by make it we utilizing opportunities it would

sales allows And the so us force. it control to more keep over

So yes, excited of that we're increasing opportunity footprint. this about

Operator

from The Piper next Sandler. question is David Amsellem with

David Amsellem

that. about Sorry

So of a questions. couple

this, that you're latest a going you this I opportunity know product? First, across move product? for kind And that I a you did, the got you think couple to albuterol the through for two, footprint do asked know market, line? in there about about thoughts do or know just on But that And So HFA? that to anything just I about quarter. AMP-XXX, if lastly, And but confidence the entrants out I addressed one. can finish ahead you the number don't road loud, there you Number get 'XX? GDUFA I there lot, that if what generic, extended AMP-XXX, the we that any talk envision new anything then out then talk on that second the apologize wondering that the you sales-wise, you can that's given of gives for how are of that as albuterol

William Peters

a up footprint. start we and it'd sales as earlier bringing we -- that capacity also on some capacity be slow new we're That that the of issues as ramp albuterol, start little bit to said I'll we a had thought is with had the we facility.

should that So time up well.

XXXX, do a the this meaningful in not fourth to for we expect be product So company in the but quarter.

hopefully, that's you. helpful for So

market, slowly. at to an sales We generic try much when market there too share take that into the new disrupt market specific market not formation, like that you existing not reason haven't effort given guidance. generic a the we And and to launch is to you're

with what think we're So to trying that's I do that.

Dan Dischner

future, agency And dialogue. we in to should FDA should Yes. suspect soon they've But of we on be I'll receiving high-level action some and AMP-XXX, about we it's in application it, the to the we think continue kind I take I and of continue sort encouraging, more And make is have engaged officials, with move good with near been along. shake news know the be that free we repetitive statements feel the that. the encouraged. but meetings see the to some I things this that that for We

is of this a We gives a has product. been lot it, agency as seems provided simply talked AMP-XXX, us is For But it And cycle there cycle. And alarm. this cycle that any in colleagues, combination be IR. to agency and the our they've a has late extended would action the taking nothing the date. on first our many our lately. that of There's this first it again, a pattern that result

nothing So to on conversations them. the had that with us we've alarming

So optimistic we still are first we're as cycle. usually a for

David Amsellem

I actually, a in And follow-up. just if sneak may

Any does would it's or combo like combination just that actual might mean be might And color Advair, can I entrants think then for would there helpful. say AMP-XXX, there competition? there you when if that actually have secondly, I an mean there. been But already product, compounds like asserted is in that -- you instance? can X that you you share a device be mean mistaken you market say drug for

Dan Dischner

combination take question. product I'll the

it's our drug products. the combination device a like just of inhalation So majority

William Peters

not really competition haven't one. about we on competition, or -- And that as said as far said

time. answer to that one like not at this we'd So

Operator

Instructions] [Operator

Dan Dischner

wrap Ziko, up. it let's

Operator

the no comments. to closing to I over Dan are would Dischner now hand further questions, there for like conference As

Dan Dischner

joining confident today. for quarter, on have everyone, delivering you, look We and our a to We you pipeline again updating all on while Primatene and executing us MIST. next Thank in day. BAQSIMI remain forward great

Operator

concludes Thank teleconference. you. This today's

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

Amphastar Pharmaceuticals (AMPH) 6 Nov 242024 Q3 Earnings call transcript