Amphastar Pharmaceuticals (AMPH) 8 Aug 232023 Q2 Earnings call transcript

Greetings and welcome to the Amphastar Pharmaceuticals Second 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 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. solely that based to now are us. statements on is information available These to entitled on the the encourage review We you section issued and website. press today Forward-Looking the company's presentation the release in Statements

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

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

Please call being recorded. note is this

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

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

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

CFO be Finance; Clinical of will Operations. today and me Marrs, Bill Regulatory Executive Tony of Joining Executive President Vice Peters, Vice President and Affairs and

to pleased to focus completion our and added strategy Amphastar's I'm which of to diabetes proprietary portfolio start, products, advanced BAQSIMI, of highlight complex on biosimilars, has To acquisition and our successful products. the

acquisition's excited smooth to-date. experienced have We about transition opportunities a are this and

$XXX.X sales, same increase In the terms impressive last million we in an quarter year. compared of representing with period revenue, the ended XX% to

expanded demand anticipate market, growth injection sales our to standout quarter's an to $XX.X reaching increase, in XXX% resulting the glucagon milestone million. gaining exceptional on durable. space, capacity share market which We basis. an in performer and be This an remain our planned attributed diagnostic carefully This share annualized impressive the has achievement achieved been product, our in injection has remarkable can this glucagon market

been quarter products $XX.X quarterly million million, $XX.X Concerning that to the and Mist and usual other our our respectively. reached epinephrine, sales for high-margin contributors key Primatene success, have

Primatene with QX a last year. sales positive X% Mist We retail maintained of note weekly a from increase that in-store our growth trend

leading levels level. inventory readjusted at have to However, retailers sales the factory a in their decline

competitors As their that distribution total note levels. to to returning sales, attributable was for normal epinephrine's we this shift

focus to the from have increase. competitor especially pharmaceutical with products, increase sales, ending our a our our we Shifting finished seen XX% products our a portfolio in in quarter other significant benefiting shortages, regarding

we the that facility, nationwide the shortage, sterile will we recent of regarding are the addressing While a in play especially aware large disaster that significant affected in natural setting. products anticipate role injectable hospital used a Amphastar drug

careful opportunities to products. Ruxovi announce year that approved revenue delay manufacturing of the suite the for We to because fourth has the the assessment, products we quarter name to brand product our the to our needed are product. drug current launch it products this This capacity naloxone pleased will our [ph] the and this same recently during plan After FDA intranasal of augment allow emergency us supply as this maximize to utilizes critical impacted shortage. with the

the and our Having to I and complex drivers attention revenue our concerning products. to turn like regulatory activities covered our pipeline proprietary would for our biosimilar quarter,

unresolved to AMP-XXX recent date matters. regulatory was due a not development for action achieved In the

annualized a swiftly However, continues product of response. in be the this with us on dialogue a FDA to positive based commitment sales. has without are IQVIA successful This of application market and assured generic progress a to $XXX hopeful their and with million opportunity remain plus

received date our XXXX, a inhalation regard responded date, of is if to first CRL. we the filing to in a quarter with classified and quarter teriparatide minor With our For ANDA GDUFA an needed. the AMP-XXX the GDUFA standard subsequent the which review, CRL is under ANDA, inspection have or priority AMP-XXX, recently

we of XXXX this lead action date. the a to respond would to in third late expect plan quarter year, We which to

file in inhalation While AMP-XXX, second plan to ANDA fourth we our the quarter.

continue we with epinephrine, the proprietary working As development. FDA intranasal and the clinical with progressing for our product,

Turning to biosimilars our pipeline strategy.

AMP-XXX our shows we by this with we products advantage submit and expect product according have presented the to of our If progressing to plan, is flexibility and nothing the and status strength of insulin else, our the take interchangeable quarter aspart opportunities. end portfolio BLA to or Our of XXXX. adapt of

We margins part remain advancing to we strategies of believe development invest that product stay future, pipeline. our focused Research committed an our our will cash to for growth. on continue and integral and drive flow improve growth, and to remain

emerging opportunities our delivering growth to and products pipeline In remain strong ahead, with summary, consistently performance. we committed we from see significant new

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

result more to Thank from to $XX.X million year from continuing you, XX% million some of prior due shortages. million as $XXX.X demand Phytonadione market previous to million period. from primarily in $XX.X selling the Dan. Sales discontinued than glucagon. a sales strong increased $XX.X suppliers sales second quarter year's doubled Glucagon the $XX.X supplier in year, for $XXX.X last million the to increased of as million the quarter in

to to markets. year to retail returned retailers. declined at MIST inventory to competitor the grow million $XX from Primatene Sales the $XX.X sales saw declines as level, by Lidocaine increasing of epinephrine second by due in drawdown Primatene these in the and X% million previous quarter. MIST continued

well quarter. calcium higher also Since XX, we regadenoson. bicarbonate do products as such atropine, Our we closed BAQSIMI of strong volume chloride other vasopressin any acquisition sodium of sales of category June not finished dextrose, growth unit and had new XXXX to our as as ganirelix on in and sales due products have and sales the pharmaceutical BAQSIMI

million, $XX.X the However, Lilly recorded XXXX. from of second of up XX% quarter sales

items don't would talk out quarters. a our I trends, to there point for few sales and third are fourth quarterly about like usually we While

recording will behalf cost third they product. responsibility begin will Lilly's the BAQSIMI have BAQSIMI, we for of and over distribution, we distribution. quarter, economic the would be benefit any expenses over sales will First, on recording we as a in begin we other sales take for our until taken incur we Once less net which

of to adjusted be $X.XX on the will EPS have in impact BAQSIMI We XXXX. $X.XX estimated

this Second, glucagon in adding near injection sales. to we plan in launch the Canada, product future to

our selling products stop one of pharmaceutical medroxyprogesterone, products temporarily API larger to the our had supplier our product. because the we've finished manufacturing other Finally, category, discontinued has in

subsidiary of DMS. has API time which continues would this this AMP in approval We to relaunch half developed an the year, FDA obtain approval hope next at Our pursue and to first of the we product.

in $X.X the insulin Our down of to $X.X had million sales due API prior primarily business year million of shipments. timing from the

in As past, corporate our higher launched the in we've years ganirelix, margins regadenoson last and than few products have we've the vasopressin, including glucagon, discussed the average.

given of in assets, slightly UK our years be several from but XXXX IMS of to were in our to facility, year, quarter, in quarter sales were we've quarter made this products of of in market product which on these our last dropped the resulting as the While intangible second to trends XX% an ago impair US impairment purchased continued margins XX% products sales rights decided same focus gross we US, decided at These all opportunities of charge million. better there. $X.X to the

costs related $XX distribution Primatene BAQSIMI costs increased spending primarily marketing to $X.X million administrative personnel-related million, million, million from because primarily General of Mist. to increased from Selling, to $X.X acquisition. the and increased of expenses and advertising due $XX.X to and increased

of and year $XX.X expenditures last for million Research materials was in the and to prior our purchases due development XXXX year, to insulin as in and raw AMP-XXX elevated and to decreased from products. $XX.X adjustments acquisition, finance swaps. million related BAQSIMI $X.X pipeline spending Nonoperating related credit components due the from agreement mark-to-market $X.X expenses to to fluctuations currency increased to million our onetime our rate to interest costs used million

company in in of income The of Company the $XX.X of second quarter $X.XX recorded income income XXXX. $X.XX the reported compared to an share net $X.XX net compared quarter a million share million $XX.X or in adjusted share quarter increase second or $X.XX the to per or of or per of XX% second last in million $XX.X net $XX.X net per to adjusted per year. income share million

equity operations by year-to-date second cash events. amortization, provided bringing cash of to long-lived In $XX.X provided compensation, million, our onetime excludes and impairments operations million. earnings by flow was assets the $XX.X quarter, flows Adjusted

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

you. Thank

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

with your is One. question. from Our Chiang with Capital question first Please proceed Tim

a just you you've side. just just talk marketing closed quarter Maybe third going expect that Primatene that with strategy do questions given benefit do the year When And in on in product quarter? switchover talk to a Obviously, BAQSIMI, that you you Could few product? a third demand maybe sales product? school the Mist, new about the the acquisition. trends? is Thanks. recovery then expect the And with the about recently branded to bit in happen on little from

Yes.

doing this acquisition that now, can in branded of transition taking process going marketing phase hiring ground the Currently, hired going going we're after begin side everything were the BAQSIMI, they of force begun Lilly on and X. to prior on of that hit over where to and doing begin They've contract continue start running the me begin end detailing that BAQSIMI for so shortly in that the from product let to already training Right to a there. is Lilly. September. the sales the the they time, At until phases. We've that October we're us. is relatively will So they're

frame does trends the in resulting a with school higher see usually that back-to-school as As far is year the time BAQSIMI goes, product seasonal sales.

but the usually this September usually is that And year, for increase frame first of our quarter that we've year the sales the that seen period. third shows So the peak product. quarter is an time August, the of past in in

But Historically, Mist to As Primatene the expect going down level, flat. quarters, say far quarter, the seen quarter at the or sales it's the second up whether flat of be they've sales at from to do third the each decreased will as what the sales this last level. the increasing to we've been third from slightly. hard goes, two but trend quarter the retail seen to -- quarter, factory second down is -- we in we've

that can't continue forever. So trend we believe

to now an destocking to some point, at doing will retailers are come So end. the that the right have

So match -- store will sales match sales the to the the will sales. to factory have eventually have

now. that some the to say sales quarters, we for to So takes continue. two whether another point quarter But it's or right at hard expect growth us

of this benefit lot benefiting a one follow-up. ongoing you of selling the specific able the that to point? maybe you're And in you'll US are just supply squeeze that the products mean that be at I'll the are still I outside currently generic shortages side. you're think from Obviously, there from on in products

So this benefited have we the from that we're at there's sure what not I'm area past. point, products mean the selling because shortage that of in a not you products lot

the we're only hospital We expect selling to number a time future. see the into those benefits products the company least the now at being. There's, -- in for that of market right

up is our So we help plan to as out ramp those to can. the production best country of

a in helps back lot. another ask That after. queue. And question Okay. jump I'll

Tim. Thanks Yeah.

Thank you.

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

Thanks. Hi

institutional glucagon, this opportunity And mix. between the sales I'm could be? your can on I'm a not glucagon the talk about setting. talking just are penetrated So talk mix in to here BAQSIMI sense institutional you injection. retail of in of terms get just how you big about trying the and also how

helpful. the on complex for raised issues of any the the there? And CRL, provide Just color color you complex CRL on be were little AMP-XXX, how not that then secondly can more that there a or would nature

the on the benefit could should the shortage about then, half Carolina how impact of Pfizer could products, facility how at the of you North move damage through and in that? that And from how think we the as we back year,

best the impact to far And the I Thanks. first to what guess, maybe should of half XXXX. products we more back an seen the half the is of shortage year, thus see it we've -- in way of ask even the other compared in from

for market Let six which is the XX% one versus looked it me about last retail -- the retail us. take glucagon first The over was question. the the institutional -- we

penetrated other feel And we the that we of markets. have so some

Tony. a priced higher I'll kit the more package, extra And than little think people more remember, that. would bit to of convenient while the to unwilling our alternatives. it's that be for a I turn for CRL, the there are some And slightly is that product we pay then some convenient is

is Sure. as Hey think CRL. notable Dan it's be on our in minor I this And David response said quarter third most is item the year. said a that AMP-XXX, we've to for that going the

the an from CRL. should analogy complexity give So complexity the and the indication a I perspective response our think use, that of timeliness of funnel the kind on of just I

to work the products actually to regards the In pick shortage some there. David, anticipating are having up we yeah, of

should products products naloxone in in of increase the do where postpone think CCD that's setting there, our decided and why the launch an especially we and to we the hospital we So the intranasal product. see

are much full And an see increase it while material, pretty out those this. won't be because we suites were already we to going too running on

bit push some to a the looking doing and through So little ways there can to are of we here room steps is increase we small there. capacity increase that by for things there and

the quarter. this of But that there. going we that to we lines IMS planning incremental, of for factory It's out naloxone we already that shortages produced full where running sales XX% mentioned are to at this that factory. unfortunately product postponed isn't because were manufacturing the And intranasal because were the [ph] two as something boost start we out can Ruxovi But shifts Dan that. be be effectively going on that to by

had And process. so that we've stop to

just Okay. there. on back And going glucagon just

the of institutional or On how side? can quantify business, piece you glucagon institutional say the the on just the is -- there opportunity what

significant pickup the on been think side a had there institutional portion has of that I we've the

Okay

a a So the increase the Because from compared XX% had of year much so ago we year already remember pretty -- ago. market. retail to

So you of doubling of was portion side. I'd the more that than big doubled say some so say up that the picking mean we've I retail institutional a if

helpful. Okay. Thanks. All That’s right.

you. Thank

[Operator you. Thank Instructions]

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

Thanks. Hey.

FDA slight the had product think that this at on the and it Is on regulatory the that AMP-XX get I market there's possible of could a respond asked. still you question you that then mentioned to year? end

to to it's that respond us Tim not Yes is the for FDA waiting anything.

a provided to that them had for haven't response We some in we time this.

that that the that is application to The that a for as agency we I with So do agency it's upon we're FDA they're we seeing optimistic and not they're will just path this our the we working anything. that view see do do something assuring positive us having conversation just waiting the we forward anticipate -- for a path we is have very the of mean on had it's we that's having news and this. that. this. dialogue based And we're with that forward And way as us are that for this. hopeful have with diligently

see. I

BAQSIMI. you're will the there product. formulary I then October? And of occurs inheriting anything else Lilly has what I that to a handover obviously, Okay. already guess you think lot just for on access mean, do once back established the the need is I you around mean

Yes.

So the different and we're groups diabetes. and basically plan they also very working the other similar patients and did with that -- they working did. with their Juvenile like We're they following -- that the marketing following the they to keep have actions with groups country Foundation are playbook throughout Diabetes do way to

good a they think up So we set we're playbook. --

them a it done the we're of here. lot process they've and and have We implementing in to taking what learn from

we significantly from -- it's did. different expect anything they So what don't

it. Got

Great. Okay.

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

I thank want for to us everyone joining today.

addition role in launch the half again BAQSIMI, recent terms Have our again. helping to a our all highly We to second thank forward updating acquisition progression the in of quarter. day. our in of you. Ruxovi filings our be a our to of shortage The nationwide anticipated And you look XXXX in of drug upcoming fourth remains of great period address

This concludes conference. today's

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