Earnings call transcript Q1 2023

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals, Inc.

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

will of measures be use found discuss on GAAP earnings our to these non-GAAP Important and measures. We information also release. our in U.S. reconciliations may certain

Please note, this conference call is being recorded.

and Corporate EVP today and Mr. SVP Affairs of CFO; of Mr. Marrs, Dan Tony Peters, Communications; Operations. Bill are Mr. Our speakers and Clinical Regulatory Dischner,

I Dan, will conference the over to Dischner, SVP our Dan now turn begin. host, of you Mr. Corporate Communications. may

Dan Dischner

Thank Pharmaceuticals you XXXX thank you, all Amphastar Earnings Quarter us Call. for afternoon. Karen. First Good for and joining

Finance; Affairs today President call Joining on and Clinical CFO and are Marrs, the and Executive of Peters, Vice President Regulatory me Bill Tony Operations. of Executive Vice

first that announce a revenue strong in For million in pleased XXXX, on Amphastar year-over-year as $XXX has of our our the am a increase another on continued a execution XX% year resulted note I to basis. quarter portfolio or begun in

seeing MIST, sustained XX% the and by million XXXX. product gross in-store a million strategic X% sales $X growth product of to our we impressive saw our on an this basis. spend on end in its is remain this high-margin for of we an towards the growth. annualized compared marketing in quarter. path million key, Concerning to Primatene investment that previous additional quarter continue Primatene to annualized the the important, XXXX profit Once products, confident an $XXX success in $X for We our for epinephrine again, Equally notable sales increase increases attribute glucagon MIST, had as

and we program. advertising consumer already is remain committed across are multiple increasing sampling to investment physician our This in platforms and awareness progress,

remain output to our Regarding we capacity demand. optimistic meet strong to now recent approved is our continue that glucagon increase we with doubled, glucagon, which can

and have previous a increase sales compared a XX% increase meaningful seen sales year-over-year to our XXX% in quarter. such, As glucagon

due the To to this capacity durable the that due to high-margin as have increase sales fill outlook that epinephrine, on see gaps For multi-dose maintain products its short. continue ability and positive presentation efforts by our other is by as duration increased to increasing syringe we we previous meet competitors XX% the suppliers. our acknowledge sales our for of this annually. prefilled demand falling our vials despite a our to end, epinephrine to product one our key, for and increase of to significant for Again, year. opportunity growth a remain product potential this driver left We the to

the business drivers pending After our for development and focus shift regulatory our pipeline quarter, activities. key covering towards opportunity, like to revenue launches, product our I'd

purchase Lilly. an of being diabetes expanding Amphastar currently products has proprietary and As buy move portfolio. our further our this with X of BAQSIMI This asset our developed signed year portfolio is strengthening from previously communicated, aligns to agreement strategic goals which

development our future through the add marketing advantages, with disciplined Moreover, in capabilities. having international international of footprint space. It in transaction aligns support and with to product XX scale comes proprietary our the expands strengthens primarily goals many strategic acquisition X to our this approach countries Amphastar's business goals. internal fulfilling long-standing strategic while base would these Fulfilling offerings significant solid BAQSIMI a Amphastar with

diabetes proprietary our are in therapeutic strong portfolio, a to of and we the assessment we is and in its in progressing part product year. our a long-standing of potentially space With is closure quarter or third that smoothly, goals it poised BAQSIMI the contender being transaction anticipate Our leader accelerate the of second this market. being the

of turn like Moving a approval launch intranasal recent our and to portfolio. our to naloxone in attention our I'd new forward, product

in approved anticipated third was product launch in the March naloxone, quarter. intranasal the with an For

we it that facilities. more be device highlight incremental manufacturing exclusively important competitive that at thus and and developed that product to While our potentially we sales, the have be deliver intranasal may our this is technology proprietary will market for the recognize condition approval included

model to reinforces intranasal our development our and crisis. This commitment will it our the We opioid to strengthen strong Nonetheless, and potentially vertical unique a community the capabilities. quality. integrated innovation enhance and product business strengthens believe our address need to pipeline commercial continues address

expect to of we to this to product recently competitive will announce this new we more key I other revenue for in launched sales product April. enter Therefore, was be terms that In regadenoson added portfolio, our a market. our acknowledge will pleased compared our products annualized am Likewise, -- drivers. be incremental

approval business turn Having BAQSIMI, product to regulatory to our activity. I our and our development opportunity pipeline want with launches, and attention covered

ANDA to For track of portfolio, end To the with the file CRL we track to our aspart, on our XXXX in quarter. BLA for or goal are we diabetes teriparatide respond AMP-XXX, insulin the are AMP-XXX, by on second of achieving status. a interchangeable to our our

year. of GDUFA date for second in remains it As for this the AMP-XXX, quarter

our for third year. this expect inhalation which is we of AMP-XXX second ANDA, quarter As product, the filing in

third as proprietary work pipeline, be developed. our GDUFA for it finally, continue AMP-XXX remains continues on our in we product AMP-XXX product our or a to with for date. the As on quarter this And to track agency epinephrine, intranasal ANDA product actively

at year. pending diabetes biosimilar being product proprietary BAQSIMI, performance, has like of with dates, opportunities to gaining filed first final to possibly BLA a in upcoming this interchangeable a and start of of reiterate our terms XXXX sales as we'd and great our ahead end how point, momentum GDUFA excited we portfolio are the been the off filings us As insulin about and

the Vice further quarter's BAQSIMI over to President transaction. our and details of to Bill provide discuss the turn Executive now Finance, Peters, will regarding financial call CFO I and first results the

William Peters

to you, $XX.X million, million to million $XX.X market demand. from XX% to XXX% of to from $XX.X sales XXXX strong unit XX% increased grew demand. million lidocaine $XXX to million in first both first $XX.X in the due on increased the from Glucagon Epinephrine $XX sales for Sales quarter the period. year's grew million while million $XX.X from Dan. Thank sales million previous quarter $XXX.X

MIST saw to of million sales from in quarter. growth X% we $XX.X Primatene the million X% $XX.X in-store saw declined but

So to $XX.X of sales in of products were issue. due higher portfolio $X.X million of we this vasopressin, new Phytonadione Ganirelix timing other Sales XXXX. in unit a both quarter believe full as and finished dropped product entered pharmaceutical from to dextrose market. launched sales volumes is which a and million grew XX% a supplier the of our

were shipments. the from products due prior sales the to margins grew glucagon million million year, timing in XX% of XX% Gross increased increased and million, to sales Ganirelix as Selling, such advertising partially by epinephrine costs. and from primarily as sales material of $X.X vasopressin. costs. of increased These to API offset and $X to from of and well Insulin trends due higher primarily to labor due million marketing $X.X high-margin expenses distribution as sales $X.X increased

spending in and increased from to million due increased legal trend for our the acquisition we will General $X.X increased $XX.X these in We $X.X our the from pipeline. was coming our legal trials our increased compared million insulin anticipate to when upward for patent litigation. for million inhalation components quarter booked to first and relation costs $XX.X this continue planned increased and to to and prior to clinical due million million $XXX,XXX $XX.X of expenses quarter labor related of expenditures to costs, gain avoidance million the related $XX.X and development Research purchases in administrative programs for to quarters. materials expenditures year's costs a income regadenoson BAQSIMI. Nonoperating

the million year, of XXXX. compared net million The $X.XX quarter per reported income in $XX.X of in company growth first income to net $XX.X net per first the The $X.XX the company an or or adjusted income share or income of of reported adjusted compared $XX share $X.XX share an per to a per quarter of last of XX%. first $X.XX share or million a of million $XX.X net in quarter

the very of million. the operations a strong events. assets quarter, of this amortization, cash of treasury million used equity $X $XX.X and compensation, quarter. stock flow We long-lived to exclude earnings impairments by repurchase onetime a Adjusted cash was provided In portion first during

asset on from Lilly. give filing you this we agreement Eli on an At time, like April have As an XX. the to progress BAQSIMI our purchase update FTC this We of know, you to you buy I'd completed signed transaction.

we financing working finalize are for line Additionally, credit. of the to the and revolving loan

a reminder, have X As we group financing strong a from of banks. fully committed

in year. either over where At are second of believe we transition We take after this to as possible third this on of can involved aligned the prepared close the rescue that goal with we are closing a with we soon be or with to glucagon insulin enabling as operations quarter also deal people planning treatment. point, Lilly in the

over back begin I the will call now to operator turn to the Q&A.

Operator

Chiang we'll One. Capital And take question Instructions] [Operator our from from Tim first

Tim Chiang

type Maybe you that? this sustainable Obviously, could for you? be mean product. sales with year? quarter this Could bit the do product that the little How you million rate make I about quarter $XX you you comments did think run really a talk will a well a to glucagon. glucagon some about in $XX is million

William Peters

that able have increased the demand keep inventory of going rest the this quarter believe of doubling year. the rate quarter. the to is mind were until into end capacity are not the up quarter, going the this that going but build the Yes. product knowing just be the we of for have to We And did that in the of run online we we to

the And able have on we that job that inventory quarter. So our for demand great now an and capacity, getting operations did basis. that readying of to the meet additional a built ongoing we're

Tim Chiang

of just did Is X forward run for this margins? maybe margins gross adequate also quarter. guys follow-up. gross an XX% that XX%, going you rate sort And

William Peters

Yes.

to the rest had think, to for range a to look good be to year, said going the we'd number at year. be, flat it's last the year range, again I the year, is but that So we from for -- the XX% of XX% relatively for that close

Operator

take David from Piper Amsellem Sandler. from And our question we'll next

David Amsellem

on volume is others. looked feature know there, a It just And shortages. have you're side. So the benefiting then where on like than Primatene. just a couple this recurring about weakness shortages. you it least me. this larger maybe, the that I at secondly, from for perhaps, was One Can quarter on talk something

contribution shortages And about market thinking progresses? are quantify that? that dextrose are from you benefiting can like year you products from as how the So

and I then mix you expanded Can the diagnostic on capacity. institutional was glucagon. that were setting know is between the a something say that you missed of And what but context sorry as if noninstitutional institutional is? I this prioritizing in the

orders where talk you're just glucagon? from about getting your regarding So

William Peters

the saw I'll Primatene. sales the our we our were mentioned was that was in-store take had X%. in retailers from And the what data I first the up actually -- one unit the down while on sales quarter,

have think quarter quarter. in when So they of bought they it's bit a and the just during their maybe issue out primarily than a levels normally fourth would I or timing just the orders more went lowered inventory little

But did some of were what to and the upwards, that the retailers we keep trending bought year. a knowing January. that's that that increase little in even trend in-store an to really during in more bit Maybe price price upwards we that make it's with on volume the we is the eye increasing that sure instituted December it continue possible

of half at down see but that well so. second those we side, demand yes, lidocaine. also seeing as of I a least a dextrose definitely little And numbers in some level come there's in for year, -- they'll we're strong the did time. for be still I shortages and that -- some there the up possibility bit epi the the some might keep On spike think probably

where move different we've quarter, always we almost be any coming these it's coming here, advantage from capacity ability few And products, certainly like is on said, to and able epinephrine, to We're the years to back in to increased said have demand. depending as will we but that lidocaine next take And a it shortages sure somewhere. be our of from And demand production where quarter, dextrose. it this was time. at I not

that. here versus institutional shoot the And see don't data e-mail, an the But if glucagon, I on me follow on I'll could up Jacob have I noninstitutional. with

Operator

And for remarks. to back Instructions] to appear at this no management floor time. be to like the [Operator questions further turn closing over there I'd

Dan Dischner

this look Yes. I We you want we today. opportunities. our forward us and joining about thank on call, excited updating to to next for upcoming everyone remain year's

great again, thank So you and have day. a

Operator

and Ladies gentlemen, your you you. teleconference. participation. conclude this We does Thank for today's thank

day. You your lines may have this you. and disconnect a at time, great Thank

William Peters

you. Thank

Amphastar Pharmaceuticals (AMPH) 9 May 232023 Q1 Earnings call transcript