Earnings call transcript Q4 2022

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals Fourth 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 a 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 is found of discuss may release U.S. to certain call measures. earnings note measures will Please reconciliations We our and conference release. that our be on this recorded. being

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

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

Dan Dischner

Good us joining Paul. all you, today. afternoon, and you thank for Thank

call On Clinical Finance; will and of Peters, Bill President of the Affairs Vice President Marrs, with Executive me Vice Regulatory Tony CFO and be Executive Operations. and

Following updates, will where questions. Q&A answer your the the move Bill's call we team financial to will

press significant and a XX% in new our have increase at gross a today, reflecting the fiscal release revenues with announced financial year reached earlier results high million, profit. $XXX our XX% As increase net a published for in corresponding

solid our a In margin maintaining products, net alone, Again, MIST, growth share revenues for and throughout our the demonstrated the impressive epinephrine success high year. quarter we with fourth hit and $XXX attribute the million. glucagon having Primatene market

increase thus the our sales XXXX. $X year. sales in note $X by we anticipated towards trending millions the $XXX We our by low bringing Primatene million, an spend end annualized for to MIST, additional the brief to a marketing million of total double-digit about plan to On million still

retail the higher cost adjusted accommodate price to have inputs. We

Shifting focus glucagon. to our

period. increase compared the We notable and the compared to same a previous have XX% increase to quarter sales seen in XX% a

dynamics our opportunity market both the and our markets, growth As the retail glucagon. mentioned aid call, of diagnostic for in market, generic the a in changing last glucagon presented have

pleased I approved output us to has FDA the market demand. to significantly am glucagon the capacity, Additionally, increased announce allowing double additional our and manufacturing that meet our

revenue the the to topic for drivers quarter. of on other Moving

to shortfalls. other experienced notable ability residual have portfolio our meet XX% strength our of throughout finished our to XXXX. pleased increasing significant products validates report compared are further We in the this same that We sales that products to period. anticipate portion these to a demand pharmaceutical competitor increase continue the due for growth This will to

we However, by these we unpredictable expect at same remain Nonetheless, potential their and as growth about trajectory. the time, and could growth fluctuation products competitor our influenced optimistic drivers demand. are capacity

our activities. I'll revenue our overview and proprietary for start, drivers in products biosimilars we now our Having To and can discuss the covered regulatory pipeline. pipeline quarter, the briefly

Our intranasal the ahead first PDUFA naloxone NDA date. of received a quarter preapproval inspection in the

This innovative While platform we as with acknowledge encouraged our of intranasal utilizing proprietary integrated potential for strategy our approach demand remain this model. time-tested we serve coincides a our pipeline market, device. crowded for will approval product public the an in that business as with innovative our vertically persists

another anticipate following making product, now XXXX changes to We our we the in epinephrine. Turning filing to proprietary are product. intranasal

this filing and we insulin aspart biosimilar progress it track, interchangeable or expect AMP-XXX, first our year. filing on Regarding occur is for insulin or to

to our have I'm our inhalation first that for CRL. pleased announce to responded filing, generic our AMP-XXX product, As pipeline, we the

quarter in granting the the GDUFA new year, the third action preapproval we the extending With date date priority the FDA's to inspection with quarter. this of a review, goal have following

occur now AMP-XXX anticipate now pipeline, in filed quarter. to the the filing quarter. this in product second anticipate in inhalation be Likewise, second second our the we to Regarding AMP-XXX, we

are seeing of refiling this we refiled and generic to as in refile second anticipate pending it we our to progress AMP-XXX, occur quarter Pivoting towards year. teriparatide, our ANDAs. the or

year, of preapproval GDUFA For inspection, action the quarter if in needed. second date our a planned third remains quarter occurred refiling our or that third on AMP-XXX depending last in the

to year-over-year I turn I XXXX that call to would like the a saw growth. reiterate Bill, Before sustained

While can R&D, expect increasing facilities approval. investment in closer total progress our continue. at experience require which may to track all to our remain those from of as and our portfolio growth we annualized we from some to an filing we increase fluctuations, Sustaining will upon building on we our ultimately and capacity achievements in

Peters, and President to like Vice discuss would financial call CFO quarter Finance, the the Bill to fourth turn results. now of year-end over and Executive I to the

Bill Peters

quarter you, glucagon Thank period. from million $XXX fourth growth year's sales XX% million in Glucagon $XX.X to as increase the million the led XX% to other products increased XXXX $XXX.X an previous impacted Dan. of the the positively $XX.X demand. Sales for with of the of discontinuation XXXX the end of from million at

up during million, by $XX.X $XX.X in in the year's previous period. in sales prior million with sales growth quarter shortages fourth Epinephrine sales strong strong continued up show amid competitors, the $XX.X growing to to the $XX.X continues quarter from MIST from showed year. the our million Primatene of million

of vasopressin to Other bicarbonate, isoproterenol, decreased from XXXX $X.X API million while the other finished from and million due from customers. $XX.X and to pharmaceutical from MannKind timing of $X.X XX% ganirelix. million, launches sales product stronger totaled XXXX dextrose of as orders sales company sales benefiting the the sodium recorded up and

margin Primatene XX% in fourth the from quarter products strong in Gross of to margins XX% XXXX to glucagon, significantly the of of like of XXXX MIST, epinephrine. due revenues quarter fourth of and revenues increased sales higher

television, increased costs. and marketing MIST and increased from Selling, $X.X Primatene to million to expenses increased and digital $X.X radio due freight for expenses million marketing distribution

materials were on and clinical spending administrative General offset and million decrease was and increase our essentially essentially expenses Research and for million. $XX.X expenses supplies. unchanged insulin inhalation as were product at a unchanged an $XX.X in at trial development also by pipelines in expenditures

-- currency compared was foreign income primarily to legal fourth to Non-operating the of the quarter's prior on million, which the $X.X related to quarter income of settlement. XXXX in related non-operating gain primarily a $X.X was million,

million $XX.X is of $X.XX million per respectively, or compared income year's per which net XX% share, recorded fourth or previous $XX.X the of company $X.XX XX% income and The share. to net quarter up

of of fourth excludes million assets $XX.X earnings reported net an compared per $X.XX net or $X.XX equity approximately per one-time company events. and to adjusted or $XX.X year. income compensation, the million of previous share The an the share adjusted impairments long-lived in Adjusted quarter amortization, of income

the the from flow full-year, we quarter, provided And flow for In $XX.X operations cash million. positive fourth cash $XX.X had million. approximately operations of by was

$XX.X the year quarter, of total the million. the repurchased over $XX.X stock repurchases the bring for to million approximately During to company

beyond. of two Glucagon grow let financial four in are Now drive me from we XXXX benefit continue new using increase. launches. we contributions product we MIST also review to our the have as a will We XXXX benefit to growth Primatene competitors to sales first could look will assumptions price leaving and from market. few as from the and sales

gross margins will mix be higher the to expect and as increased flat year-over-year remain offset labor We costs. of by input margin products

MIST will advertising plan will rise constant and for of sales. selling, Primatene a MIST to our increase we remain expenses marketing distribution Primatene percentage but as Our

similar expect percentage sales. We to remain administrative general but a and of spending increase

spending We and insulin spending as portfolio, development. epinephrine this year and and on inhalation we candidates research our trials clinical our ramp-up material product. supplies plan to two purchases to increase Turning intranasal on and of

API year We capacity insulin development. a our to align year capital our also double at production finish ANP plan anticipate facility in well. significant with China as to continue pipeline this this as inhalation project our expansion spending We increase we in products to for our capacity

Amphastar major utilize injectable an quadruple we same finance capacity We cash insulin position from to continue that we operations. and complex time, are program. cash our opportunities. At expansion plan we in facility, to stock to the process Cucamonga our expansion the strong in Rancho At look as of our our buyback this will will with project flows ultimately

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

Operator

Thank you.

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

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

Timothy Chiang

in were fourth up a lot quarter. I thanks. the your finished noticed product other Hi, that sales

I provide bit sort And XX% the that were just more. date on Could the in little what's of AMP-XXX. action driving or of they just noticed color on think then target you growth the second comment line? is that I up of a like sort in quarter.

guys So you it's a Are up feeling about only good that to months product leading pretty date? away. of couple potential approval the

Bill Peters

start as products let Yes, strong one, bicarbonate, other me dextrose, sodium with in some And both like so market. shortages yes, there sales. had pharmaceutical had product we that the sales the very finished

on of our we able were we our years-ago. that that so capacity And to at sales increased because put factory a couple of ramp-up

and Vasopressin pick be actually pickup been what in isoproterenol starting Additionally, they than we And also had sales than sales some we up stronger expected. the was that previously. to are and higher have short-term Ganirelix

of products, as However, the we out. we none sales levels them break that those of the to do products are look all of reaching

those other we'll Tony? that's to why So the finished pharmaceutical product in continue category. include

Tony Marrs

Yes.

optimistic For AMP-XXX, we product. the remain about

and with we product. agency we agency, have to the on engagement As the continue continue before, we've said dialog the with

second So quarter optimistic. with this date, GDUFA we remain

Timothy Chiang

just one maybe follow-up. And

to I Is think that epinephrine next intranasal out year. filing the right? you pushed

Tony Marrs

date engaged plan did, additional our additional They've them. And XXXX. We've back it have to with for we come that the continue correct. until us, meet back That's push an and with and dialog agency Yes. submission with request request. to unfortunately,

Timothy Chiang

Great. Okay.

Solid quarter guys. for you

Tony Marrs

Thanks.

Bill Peters

Thanks, Tim.

Operator

with Amsellem Please David Piper from is question. question next proceed Sandler. Our Instructions] your [Operator with

David Amsellem

few. just a Hey,

it's first Glucagon trajectory comment talk talk you the for product. extent and opportunity but think I added guess I Is calling hospital So see an with just a guess, where out on maybe the just There's to say, can growth as quantitatively driver setting. that setting, XXXX. on capacity, or about grow the you're I should institutional not the it it the year-over-year? you which about to you -- going higher of opportunity.

as XXXX. a driver in You is growth Vasopressin also market. highlighted crowded a It

sense thought so just that. about of I'm there, process trying talk if a can to your you So get

one underlying some And and it's there? on then of some you us PX give expect XXX, what's a a that on else. Is the of there. you these filings, be that's Can us in I'm sales litigated not color if lastly, mistaken? brand XXX? a about there that Thanks. where filing, give or whether terms Just you can talk refresher a and to PX And something couple

Tony Marrs

Yes.

the question. glucagon start Hi, David, market start. with I'll I'll So

As out last happened quarter, we dropped really what's of is some competitors that the talked market. about have

That's share the market given long the we expand And so opportunity us important. the of it. of was to as so can it's our expansion meet why the as capacity

The in, as well. now marketing it and with seeing we diagnostic aid also it originally competitors that of market drop it then opportunity also all, market out were us that the allows

doubling as we said, market, it current the able a of it both our we've or that as and our the as being as capacity basically, lead side doing. expand Vasopressin? side were So diagnostic think well think we we to as to other way already of

Dan Dischner

bit we market picked the of over Vasopressin, share last a quarter. little up

it's we're quarter product it half the should to not a year-ago, as only might than a fourth from grow so a quarter. have big it for be And we still product And third thought full-year as a had that quarter. was we'll did because of it sales, be but every the it's this a higher year, we and

growth. driver. definitely XXX. think not there's to question one that third on the why still that contribute That's I a going is it's large to Even So product, though growth a was it's growth. And

David Amsellem

Yes. Correct.

Dan Dischner

Yes.

a about quarter going litigation, relatively be filing. to have is say And product. So XXX filing a possibility. XXX, that's that for planned yes, always this a to but we small that's PX a Hard

two go majority there to QX. filed vast show are total of our that those both adjusted $X planned that the be sales the to of to in XXX we've XXX the of products, the And XXX. So presentation the and billion, them

David Amsellem

you. thank Terrific,

Dan Dischner

XXX and XXX, XXX, not to and XXX clarify. -- just XXX

David Amsellem

Thank you. it. got Yes,

Operator

in Thank to the queue. floor questions management like you. There hand the to are back I'd no closing over comments. for any further

Dan Dischner

increase our our We in joining We the to I in thanks further thank pipeline. Yes. to for market, opportunity two approvals. our grow look optimistic you remain you. Thank for want on forward capacity four call. about further advancement to next in today. XXXX updating seeing track addition us Glucagon to everybody to to an remains on

Operator

This concludes today's conference.

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

Amphastar Pharmaceuticals (AMPH) 28 Feb 232022 Q4 Earnings call transcript