AMPH - Earnings call 3 2023 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals' Third Quarter Earnings Conference 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 company 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 reconciliations and measures these of Important GAAP found may be in our release. earnings this note, conference is being Please recorded. call

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

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

Dan Dischner

us joining on and thank you quarter you, call our Thank Good earnings for third Paul. afternoon, all today of XXXX.

high-margin Bill segments. today will Vice by commitment CFO me and President of product been Joining portfolio's products, Vice our Regulatory maintaining advancing key of of and be Clinical biosimilar while Executive Peters, Mars, fulfilling by and and has complex XXXX momentum characterized Tony our Executive proprietary, Operations. Affairs Finance; the President our

third-party XX we've Around the a world, we the been United and our sales third distribution up networks. of team. hard our contract companies products, and revenue, increase strength core with a logistics internal the specifically with countries local XX% us transferring sales, set June terms we million added of epinephrine. States sales closed Mist on the the $XXX.X glucagon, we product worldwide. in sales . Since In annualized XX, the in BAQSIMI the signed working product the and On ended X, using marketing to our vaccine representing October acquired operations with needed proprietary acquisition net an quarter began on continued in force help agreements with Primatene basis combined recently have of

plan continuing on this approximately quarter quarter other the NDA highest the United we we United first are a seasonality recorded and to the -- to annual next quickly as authorizations third other the possible countries after Vaccine of to in transfer transferred of that. distribution we the the ever marketing as and the sales represents States we expected. the in States already year in Due have XX% soon transferring Amphastar quarter, as in its We of growth the sales. countries as product, trend working

Primatene on to these the addition notable, the the specifically XXX% glucagon commentary over in financial sustained a which and last million of substantial our quarters increase offerings, previous products performance the year. Mist glucagon, revenue, from generated $XX.X same period marking In is

seasonal the to However, in demand third and we increased period. glucagon the due the note that sales will back-to-school peak was normalize after quarter typically

an the retailers. sales due compared Mist, for corresponding year, quarter. impressive realized in the period product noteworthy third $XX.X previous in a As million Primatene restocking to primarily increase the the represents in This to XX% by

unit Primate reach see and milestone in to $XXX will retail million by sales in X% of growth project Mist to continue range the We that end still X% the the XXXX. of

to epinephrine capitalize the pharmaceutical a in finished which our able sales. amounting products, we $XX.X supply a increase once other again, prior been and sales epinephrine, specifically million X% increase on Regarding competitor achieved XX% in over and shortages, quarter annually, notable have to

products response effectively. agile within serve reflects performance the to of strategic Our also market last and quarter. to injectable growth products positioning Lidocaine saw needs market and the This unmet a sales product over increase our registering XX% dynamics our our shortage,

competitor and as landscape shortage provider a providing exemplifies in to pharmaceutical supports our sustained supply reliable the role during continuity performance. our for projection commitment Our of of periods

sales we production products. and discontinued supplier the our of projects NPA address Rex for API market conditions, we nasal our API quarter to Toby, the needs now be no Furthermore, demand. adaptive release having approval the at new capabilities, to resume for for to to shortages which incurring the quarters. leverage of launch our qualification due our our will manufacturing will anticipated our response injection, first the minimal meet the of scheduled FDA API, -- spray supply XXXX plan naloxone a for proprietary production reduced have is ensuring FDA evolving in-house in to We steady NPA MPA manufacturing As to due us over A&P following to will this of The enable authorization facility. market

the biosimilar our like I would pipeline and to our proprietary related complex now the and our generic shift to on dialogue progress endeavors regulatory products. within

beyond and XXX we initial the progress date. regulatory Regarding delay goal GDUFA its acknowledge of AMP the

We the remains this quickly market product, the agency the first as the agency. million market $XXX The in niche represent in which the regulatory generic Equivia. possible. committed forward are currently review with significant discussions There itself exceeding would a engaged according as to application process in remains to for moving demand as

for advancing the need we are generic FDA. dedicated dialogue our Recognizing the options, to with

review quarter identified stated, an should ANDA for to a CRL. in teriparatide which a conventional of to to the date our This believe is be -- minor For inhalation in the have responded In have we our inspection the schedule, referenced first received quarter's goal date necessary. we as AMP-XXX, ANDA, XXXX. allowing previously we reference we adheres the status, priority XXX addressed have preapproval AMP extension additional the issues CRL

quarter scheduled GDUFA and of Concurrently, this end submission a progressing is is set result, year. AMP date for goal a application this the by for our fourth As of we XXX year. planned as have the

AMP our our progress as FDA. development through product, collaboration insulin biosimilars, clinical XXX, biosimilar the today I in are Regarding XXX, am with advancing objectives the candidate. for with to proprietary our AMP alignment phases identified our intranasal pleased In strategic steady Aspart epinephrine diligently with we report

end to this track intent by securing of for with this the of the BLA status. interchangeable product the submit year on are We

advancement within. our and In summary, in we detailed and regulatory today adaptability competitive performance strategic the response strength solid the of environments portfolio operate underscore to the and product

medical invest proprietary high-margin biosimilar to and complex as and Our value strong our with aligned needs unmet innovate growth, and continue remain vision. regulatory products. in sustained advancing to pipeline our and strategic We sales products growth foresight company's advancements we creation dedicated in

We are ability strategically. opportunities our on industry confident market challenges and to capitalize in navigate

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

William Peters

Dan. Phytonadione $XX.X increased such This on increased million sales of million you, period. increased ganirelix the and Glucagon retailers XX% from to for as competition XX% Thank year replenished legacy of due including quarter and revenues a million of pharmaceutical of strong sales the products million million decreased $XX.X increased volumes Lidocaine third as new grew and during million $XX growth from represents $XX.X the marks back-to-school sales. increased their $XX.X of of a million which Revenues as dextrose, sales saw Mist in $XXX.X inventories. the seasonally bicarbonate in quarter to to newer third Primatene left a sodium product million XX% increased as from million and of $XX.X result shortages launches, the calcium to sales from of sales from sales and $XX.X last experienced sales atropine, million $XX.X to record as quarter chloride third million. finished vasopressin. $XX.X XXX% in unit we first previous to X to supplier $XXX.X year's suppliers quarter the regadenoson, from sales on million sales vaccine. market, $X.X the quarter. Other continued higher

expenses. net benefit development which net selling million, This revenues of of of vaccine. and economic calculated corresponds research sales net from $XX Lilly's economic less based expenses Amphastar's recorded was and on $XX.X cost their benefit to million, goods which We million included expenses $XX.X Eli of

change to will will We a basis. basis continue distributing book on net XXXX. occur country-by-country a begin until in revenues we This on BACSIMI

$X.X revenues such million insulin and business higher-margin sales margins vasopressin. $XX.X Our of from increased to to XX% $XX.X orders. of $X.X glucagon as up on from Mist, million. had API year, Gross of million, due million Primatene to sales increased primarily from of Cost timing improved the products XX% ganirelix of revenues last

revenues Additionally, net related expenses. reported BACSIMI from of

lower and General advertising increased sales and related increased previous period from $XX million and expansion due increased distribution X% year's BACSIMI to related million expenditures offset spending to development pipeline to due $XX.X $X.X trials due timing marketing products. force million $XX.X and $XX.X Selling, million expenses material expenses inhalation to from the million compensation clinical for BACSIMI, insulin by million and the Research which expenses administrative to of to XX% expenses from and to expenses XX% and expenses Primatene and Mist. related in legal our increased decreased $X.X were to partially to

swaps. primarily Our were compared to mark-to-market of expense due to expense year a related million loan partially BACSIMI the incurred and interest debt our entered These adjustments into issued by $XXX,XXX, term this of expense for convertible to interest and quarter. acquisition complete costs nonoperating nonoperating the rate we last expenses offset to $X

$X.XX loan net buy down $XX.X us of back quarter million more onetime we quarter, into point, our our million. adjusted loan. from to a term compensation, $XXX and to not million coming and the term excludes X.X third have approximately quarter, last XXX% an over compared million share enable significantly the years. the for million our long-lived the the do events. approximately share entered flow convertible used amortization, earnings per or stock per third of shares million equity rate expense or of to in our increased operations of $XX income income which we from Adjusted in to we debt, down also increased per floating million We At loan of into we net concurrently issued the When year. or swapping years. hedged million million third income quarter and any common September in fixed and or lower quarter by paid $XX.X $XXX will to we interest $XXX $XX.X share Adjusted Subsequent proceeds million XXXX. $X.XX the the had of assets an share end of rate loan, $X.XX of $X.XX $XX.X per of to the additional of $XX impairment notes Net In to this in term X $XX.X pay the in million of cash

the to call Dan. I'll turn back now over

Dan Dischner

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

Operator

first Instructions] question from Glen with [Operator Jefferies. Our is Santangelo

Glen Santangelo

quarter? look of your nearly at start you where this result recent marketing the I we're mean, targets about think relative obviously, $XX most out that a about to that million do million you I out at of think $XXX you million. than how get were did talking in I with talking fact I annualized in expecting. $XX out $X.XX because mean year to generated potential to Bacci sales Bill, I about peak thought laid those to all previously closing $X.XX. almost resi $XX is the the want of this the at had by this to sort most Lilly sales million, million $XXX least When deck, of us bigger

William Peters

the Well, slightly. this a things. this for One, projections thing to saying because the first update X increase the did quarter. thanks of is updated we deck slide projections is noticing that from all, big previous number that back-to-school the And about in

the So quarter has the the third been high year. point of historically

sales just expect and been we the the trend. drop that's quarter, will So going into fourth

script, you time the have HVaScript the take of If September in really frame. a August, does it you big graph data, a see look the peak at the

that. plan could. So million to forecast, we still we to at have have is good said, we that possibly But we to is $XXX a very the we just decrease. and think expect million forecast I get think to the beat point, that it this we Could that $XXX

lower. it's something -- was that it's could that certainly to that we'd didn't and something just a to do, set now, ever So want we have forecast right we

did to it . we So say increase once I'm glad that already.

Glen Santangelo

from question. I The in All little product opposite. bit X Pfizer question. might is on Like But market helpful. the to hard to of little benefited going one benefits there sitting of more it. there or in and anything may out had that. other obviously, unfortunate duration benefited issues. know impact call a specifically appreciate it quarter? high-level forecast that you'd shortages some right. out quarter always that I some icono you it's call That's to extent sort or epinephrine was seat ones. a to specifically manufacturing always have quarter, Maybe some another, this sustained quick which a shorter our a the opposite Maybe in just the lidocaine ask this we And issues, a more that anything something bit may obviously, again, have Is

William Peters

Yes.

we're possible. prefilled So emergency But them, much by X the the you the also did now, only SKUs carbonate as country epi -- of we're the used Lidocaine syringe there's that's mention that's and shortage right syringe Lidocaine X -- our where making that X producing as rooms. and and dextrose as in in

those don't understand So those at will year to are we our as back just market, products. into as things -- of it know second can. what for we're go making X competition that's when going on we at like much of those from but the things be quarter least the And next we looks least

these it garner intranasaloxone we our IMS at what mentioned as of that. So on because of presentation our we to delay think facility. same had we've the out that's of in because to again, shortages, the can and And also take of equipment I our market for the the attempt once care runs launch

more decided of more help the to make some So we for we the the opportunity shortage it to situation to products the these market of demand was now. it's had an shortage that in to that . right and of products out prudent try or satisfy launch

Operator

Our from Chiang with next Capital One. question Tim is

Timothy Chiang

SPXXXXXXXXX you a Maybe gross quarter Good about margins well? rebound the might your could miss quarter. sales, that to in this how talk contributed higher little have Primatene bit as just

William Peters

Yes.

net gross really, things. the is vaccine biggest fact a the thing margin X to that was the So on One, basis.

So it's product right now. a margin XXX%

expenses book follow. guidance the that of out we before that because So all revenue accounting we the to have are taken

the It last as So basically quarter, level the the miss but down. was That at but level were XX% in it down. that retail that's and were get driver as first growing X sales the to it's quarters growing we've in really was our at privacy retail been the big seeing to is quarter, but the what in sales our quarter goes, relatively seen And far with -- there fluctuation has us quarter. of or volumes, that this indicated been The year, contraction about our the in X% level X% steady year. has a in X% inventory. actually but do and really big growth it at to you've every or this a was inventory quarter just reversed retailers, the X% to that's at this this second

So this usually usually Primatene year quarters the quarter. quarter an inventory we of the biggest fourth ahead believe, the for X the of stocking Mist what's and is, first

we think into bit because a of carryover first quarter lowered I levels going retailers this So the inventory quarter. the little that had into . got their

Timothy Chiang

from right? with quarter benefit report will fourth guess the I probably still obviously, Is less, And Because you're that going was the But quarter it. Got the to right? for be number economic BACSIMI, quarter. that net obviously BACSIMI . in third strongest the year.

William Peters

correct. That's

are there's The other for thing in our go our directions quarter, different be to in we selling because forces the -- a own starting marketing, that. couple of for of well, that doing own fourth kind going that

our by of it So that's that be selling will be going expense will borne line not the now -- and Lilly.

deduct So have expense used lower to that's they will a that.

as Lilly million. there, close So $XX saw we to sales the were

decrease. mentioned, the it's been as to top number quarter. that, into line Dan And expect annual XX% third of historically the about their sales -- we So that had

than will quarters. So well. the deductions be other little bit higher as it's lower the But a definitely

will So as selling be expense not the that deduct they high.

their have studies expenses cost still of bit ongoing. work they we'll of continue that a their out R&D and goods, So little R&D as a of the couple were distribution

confusing, but we're year. I of to born the we in it's in bit it's little States the piece. we've a And So still going be moving take those that in quarter And -- gross mentioned, know expenses United our as number. will next first distribution plan a to

contracts various on . rest hotels. of -- marketing of depending of timing certain of world the the in the will also and the authorizations transfer signing and the So then follow

Timothy Chiang

Okay.

the question run new margin, . Bill. gross X your is of Is Vaca Just that now have XX% going forward sort type last you of then, rate that

William Peters

neconomic because Because No. margin. our benefit at remember, Bacci, XXX% had, that was we

-- So the cost and we of will the margin. goods. incurring get at quarter forward, But that next start will we net move be the we economic have benefit also as -- XXX% we'll revenues

goods So revenue but up, as goes our the future, our cost goes in well. number up of

above it's going it that's little in that's we and corporate going a little a around with bit it's instead something of to average, distributing -- still basis. country-by-country know vaccine have cost well once product, be to it locales, but associated will the world. And a margin XXX% being bit So I our complicated begin be

not it's at So all once. -- doesn't happen all . it

Timothy Chiang

Right. Got it.

the Okay. I what total vaccine . U.S. think made historically, had spec That's XX% what, sales of up about, high? semi

Operator

from is with Piper Sandler. David Our next question Anselm

Unknown Analyst

is This for if A apologies on overlap little here. Tim a few there's from David. and us,

to in you've to then do expanded you last, time, able the the to setting? big which is over continue leverage can to talk the you which how products, capacity. shortage been extent on you'll our is you year making And you extent And that, right to growth benefit the vaccine, that in be and I are your field longer that on be So second, to a terms injection to glucagon to you view the with sales it back, on Is will in them near internal? penetrated your sizing? could what's respect think year? contract called competitors from And the -- And opportunity relative going market organization? expect of rescue now, look this to to then you next speak shortages institutional know when impact going what the guess, and in overall is Or the of out both shortage term sales do products beyond generic, to those term. but the that what for are like XXXX? I hit how force, on you X stepping aren't setting thinking the the glucagon manufacturing and

Dan Dischner

Okay.

got growth. first overall one glucagon was overall the I So

the product range revenue going going for said, we've million million to think $XXX is us be somewhere vaccine for to grow to as at in we us peak. $XXX So the

So where around traditional that's today. of market strong glucagon are growth some that but share a the we the do We that think really $XXX are selling million today, glucagon, we're from some that annualizing of revenues. in out just comes generic

it's And glucagon it's for conversion BACSIMI not used is current the a at. generic indicated diagnosticate, doesn't because used the also . backings -- that to our diagnostic because with However, away a that. as go as

that engage on we how force the have marking selling sales they have in that in expense we people -- salespeople that but we line so P&L now of the so now began said in out as sales contract force, well. product, from right repurpose selling we we'll do internal said they're We've our sales sales -- be some a have there our vaccine and many force to we did On haven't the have, October X, that expense also on.

the the job, already of during trained doing running the on hit all at quarter. also of people third these to trained the the ground they're So the and They beginning but this. ready fourth quarter were they're

So that's ongoing. definitely something that's

XX% XX% space. think segmented glue the retail injection, On nonretail in the glucagon space the the sale injected and the gun I in about is about

the We -- our was then the that's the shortage see reporting different shortage as for long sales. on breakup products. So single the question, as shortage we've last there. been what quarter And products every

in -- So at because those needs products time. more this accordingly is somehow -- we're a to meet we that little just some certain products, planned we and happy of need shortage and somewhere have are able issues currently always

William Peters

And to the elaborate we've at having on frequently and I've said, now dextrose had problems. some X.X from card. just been every And then back company Dan by benefit the other going years. competitors sodium quarter, And it's shortage what Yes. the

sometimes it's built And been something the capitalize epinephrine, chloride. And it's market. years. capacity as it that we've going always decision. years for calcium about sometimes in able us. it's the X something ago, . working there's on latin, on X, it But atropine last pitonodyne, that's we've over we out did it's or that sometimes extra Sometimes it's well because strategic a to several And

Operator

to this like would are comments. I closing Mr. SPX Dishner any the over Dan questions further no There time. floor at back to Great for hand

Dan Dischner

characterize to further key enhancement for of again. look high-margin to updating especially you want We products as portfolio I like the We product proprietary amongst our segment, day. within us company today. a forward thank and of Have . to would XXXX a year with all great everyone the joining execution Vaccine. our

Operator

This conference. concludes today's

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

Amphastar Pharmaceuticals (AMPH) 8 Nov 232023 Q3 Earnings call transcript