- Earnings call transcript Q3 2022

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals, Inc.

Third 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 discussion our our future

in these GAAP non-GAAP also Important information is found of discuss may use U.S. to certain call measures. earnings note measures will Please reconciliations We the and conference release. that our be on this recorded. being

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

Dan Dischner

Thank you, today. like us I'd thank joining for to everyone Paul. And

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

up further then from at products and by open million, our high revenues and start highlighting the we'll on team. financials financial third regarding year. encouraged our market update, same I last pipeline discussion X% Q&A some We net evolving $XXX.X provide of by remain with period dynamics. for Following my quarter's the glucagon's remarks want with and our with Bill's to level remarks up our management progress a

seen our approval our pipeline. remain stronger inhalation, us to a insulin continue investing to committed Therefore, is priority quarter, of regard we for investments, and and flexibility as to to continue the third Our special us our than provides toward and advancing ever in internasal be balance products. pipeline launch robust the as R&D in sheet

perform to the grown for epinephrine Mist, again of have for at remain we as Likewise, provided XXXX. Primatene Mist these products, epinephrine, XX% that and a the calls, to in demand glucagon existing remain remainder and continues year quarter. support. confident previous seasonality demand. some Primatene will stated robust in As products respectively, baseline compared solid previous Glucagon and X%, projected of our with the have once into and the

developing Regarding and like discussion innovative our scope review. activities, pipeline our delivery regulatory CRL month of which raised with bring systems. during inhalation I'd on addressable its focus our received within are and filing, We products towards issues and the to relatively our complex believe last simple cycle are first the AMP-XXX a pipeline's

to that issues As teriparatide such, the of we Likewise, intend we plan we believe are to refile in our year. and of quarter the to fourth quarter first respond clear application, XXXX. CRL the with in this

in with a product, CRL quarter XXXX. been to product's products July responded new received to fully scheduled ANDA I The GDUFA our we note that the complexity. the generic to generic Turning teriparatide for are to our pipeline filings AMP-XXX the second of that due want and date action remain without AMP-XXX. has in

inspection extended is of the is our following date goal preapproval to needed a if for typically previously, stated As quarter. any the filings,

Our remains AMP-XXX, filing quarter call, for on in product second pipeline track XXXX. of the our inhalation generic on disclosed first last

and finalize dialogue a XXXX. in for our generic continue interchangeable positive As for agency application a in the maintain of AMP-XXX, remain with the our insulin track details on product development, we we to aspart as filing

a September first of our to intranasal in turn XXXX. goal been refiling quarter the we date naloxone issued our has products, As pipeline proprietary in

fourth this with quarter in Our anticipate the product the agency year. intranasal on for this product we epinephrine XXXX, remains in of track discussion and on filing further

Bill, more detail turn with to speak to want over I I Before the glucagon. in call

the With this product. towards market reliable a to product changing working dynamics for agency FDA Nordisk product. by market. this dialogue we for provide evolved retail significant aware, changing well and for in spaces Boehringer equate be Eli this the planned the have in of due or to are Company the potential remain to our increase of supply with market strong planned As glucagon year end Lilly's diagnostic our growth and to Ingelheim's market, their accommodate These and their evolving glucagon glucagon may position production you with glucagon to capacity the closely of glucagon the Novo a increasingly discontinuation dynamics discontinuation fruitful

to our demand. are Finance, We the discuss in our and maximizing Peters, financial to would Bill call Vice glucagon's like turn increase quarter's projected of to Executive the I CFO committed to results. over supply third opportunity to President

Bill Peters

and the from sales sales of which increased demand on strong prefilled of ganirelix $X.X finished million saw dextrose due syringe, as shortages. of increased Other for Sales $XXX.X and XX% $XX.X year's million strong to million. million quarter in launches by $XX.X to on of offset stronger million growth million of million to Thank of the on chloride million previous in from sales decrease Phytonadione sales from Epinephrine customers. million competitor sales current XX% $XX.X last million strong Mist to lower our year $XX.X from strong quarter pharmaceutical saw back-to-school to X% $XX.X to with $XXX.X of calcium $XX.X third and the both million sales multi-dose atropine the sales partially file quarter and XX% Dan. all recent sales sales vasopressin. saw saw the you, demand Primatene period. increased $XX.X of the Glucagon $XX from increased to this the $XX.X million third as of and a products latter sales. increased were

than as ganirelix well down $X.X increased improved higher-margin as epinephrine launched vasopressin to from increased to of Our and $XX.X XX% increased had more $XX from products, sales administrative sales $X.X XX% expenses General were as such $XX.X sales of Mist, due Gross costs. from to business distribution of revenues Selling, million. at Primatene inhalation million. and newly higher million our and slightly last glucagon, due spending compensation increased year, phytonadione margins revenues as legal relatively million as XX% to $XX.X expenses. of clinical of offset and and million, and increased million related to products. significant $X and trial labor insulin marketing primarily $XX from API development to expenditures orders. we had insulin $XX.X XX% to million timing expenses and million unchanged Research material Cost million of the from

including share $XXX,XXX Hansen. amount net The on $XX.X income share earnings divestiture compared attributable the increased in million equity reported the non-operating the share year in Adjusted of $X.XX $XX AMP's long-lived one-time adjusted assets in last approximately we to income events, as third our to decrease of XXXX. third per cash quarter, to income million XX% portion divestiture benefited million the in of a Amphastar of the per million, of quarter Company $X.XX stock. year, of reported and spending. we of Hansen R&D a buy of the interest our to back net income subsidiary, In of adjusted $XX.X $XX.X one-time third exclude of or gain on of flow a quarter, expense The last amortization, net $XX.X a Our $X.XX included from cash XXXX million Company XXXX, one-time $XX.X which the Hansen. and $X.XX on due million XX% gain compensation, an of non-operating to the or the the or third had of gain impairment shareholders from the of compares $XX.X or from of quarter primarily per in million the used approximately divestiture operations of share per

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

Dan Dischner

the the will we Paul, any With for now will update. Bill, questions take line Thanks, open for have. please that, you Q&A.

Operator

you. Thank [Operator Instructions]

Sandler. question is first from Piper David with Amsellem Our

David Amsellem

just So a few. had

wanted trying come there. and Gvoke back the just dynamics. kits Lilly ultimately comments the discontinuation to of generics I'm market the glucagon wondering thought process I just to that kids. understand the the I or wouldn't by rather to formulations are Novo I'm product your loud, Xeris' your available ready-to-use like So of the intranasal mean out benefit than on

do anticipate FDA Just help on two, needs turnaround, complete just you there human a sooner there's action can rather So might an XXX. quick any issues a work action response, talk whether question in you with Number later to -- on be what the the be that done? target that's here XXX the with one. And factor us is about number XXXX? than guess understand I

Bill Peters

Sure.

Let shift think of to right. very newer you're entrants. And with market of the some me the question. that likely will some start that glucagon We

product believe we more effort. scripts a opportunity lower of year. and percentage where say for position percentage this right have the However, us those the we to for will provides is and move will in what what a hard to over some now, other cost than Company sales new that next entrants that will our the we're products, potentially significant other believe exactly a people but conscious It's increase to to go price that our

Marrs As for that the one. to to turn I'd over answer to that like Tony second question,

Tony Marrs

to date goes, label-type turn more their far predict. any or the difficult AMP-XXX issue. FDA's human issue. As so a for device-related as is to far it's it'd And is, it when say us related study be factor not as action I'd -- as a on

we want be speedy not what for a always -- them. I predict it really course, Of really might we're but can't time, turn

David Amsellem

a the the Viatris that disclosed That's Okay. helpful. they in FDA. that's queue product at glucagon have

into there suppose is So about your your let's there. thinking How opportunity? play that does long-term think competition glucagon

Dan Dischner

we opportunity have to of an far this the of as get what good advantage in advantage we're think companies as projected our an and we discontinued we be there we -- what expanding as our as we product, product now, I market, now. might demand opportunities and their Well, opportunity share. have but can't taking competitors control we're other and capacity Any happens have, think meet have other -- may because to the the the take -- or we position approval the in a the market we're gather opportunity

Operator

you. Thank

is Serge question with next proceed Needham with Our Please question. your Belanger Company. from &

Serge Belanger

of questions. couple A

talk was about we you third you're mentioned vasopressin you're First quarter. on just and maybe outlook on secondly, both the some seasonality these Primatene. trends? recent what fourth Can launches products now rebound ganirelix the then the for seeing and significant in that you I competitive just in for a the about kind talk recent And of there should market. expect Does think quarter? that mean

Dan Dischner

with trend, difficult sort it's COVID-XX had we since of we we Primatene, looking situation. been launched where the it, So had at seasonal

product. that tea more are seeing or as have as that we move situation. now quarter, trying always clearly leaves on were seeing seasonality little be read So with we project we a But with tend good quarters to And some that fourth Primatene. through progress seasonality we fourth pretty to into more

I expecting bit there. think rebound of of So, little we're a a sort

Bill Peters

to just comment. Yes,

you on take was the was quarter a the the Primatene seasonality the the highest. last look third and If quarter at the quarter fourth lowest year,

as that going we thought, see but gained And follow probably expecting products the something of launched trend markets, those growth those forward. opportunity we've competitive will as again. much launches we in so market do products both both we're some haven't go, for that And as as recent into far share

Operator

[Operator James. Please question. Wilbur from your Raymond Instructions] is Our with question with next Elliot proceed

Elliot Wilbur

back around has around It units. to looks to go share of injectable want Company like currently earlier commentary XX% the glucagon. Just your

supplied Or balance not significant of or limitations by portion the from capturing the a So able competitors, some be being you to prohibit had due some you capabilities? a limitations? any about seems see be really what phytonadione. price, of chosen of not are and where to Is your as that it it supplied overperformance some of finished that to chain at versus to do API of supply external on epinephrine couple would you think And the be least balance? not products you then or the estimates, primarily

going sustainable on price in the levels those for that wondering is quarter if that you with or recent run pricing increases Just rate forward. both products the relatively think

Bill Peters

Okay.

glucagon first. question let take me So the

So API an is not definitely issue.

now, though, plenty capacity. issue, there an have Right our is that. of We of

So but we that on take to have volume, in the planning already we much for capacity, year. more had earlier will -- been in need increase from our to we order to

market of have by share to And as to ability first of quarter, so, that will we end that have take the believe much the the as that capacity we needed. of the

generally, overperformance, not thing, fourth really we're see the increase. but very So the yes, -- the in in seasonal, increase I any think we'll price there. so phytonadione and more second the that, first after pricing quarter, and the not And on phytonadione, the the FI have we large quarter, not a capacity is don't --

that is in been to see shortages XXXX continue one past taken shortages where competitors, into be there for product. and on some and have we from our continuing have the well We competitors, at point. there those Epinephrine our this shortages

Elliot Wilbur

you XXX. additional Can with respect facility there there on are just talk question inspection, regulatory One to about if any? potential hurdles

Dan Dischner

want you handle one? do Tony, to that

Tony Marrs

hurdle, From long. CRL, it's product. complexity us that first we is will of CRL just think is that that it's kind we It's simple. don't for received something a part regulatory Yes, a sure. something It's we product very the -- view relatively of of the the take

CRL. have, in a we're to So, anticipating quarter, to respond to that this resubmission

through at facility. we not and trial, our there, sites went of the And a inspection the of far though, trials an manufacturing clinical inspection the those And We've through do did don't we one. we've for as we chose recent when they our initial had inspection clinical a an additional are stage at. anticipate GMP so to additional the any anticipating gone that additional already we inspections application the number not As inspections.

Operator

for further There you. like over back this the management turn to Thank no I'd floor questions closing at comments. time. to are any

Dan Dischner

I Again, thank us for today. everybody to joining want

ahead our an you next market and upcoming addition of forward updating year We XXXX on exciting look to dates. to We with glucagon all the have the GDUFA development call. of the end us in

Operator

conference. today's concludes This

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

Amphastar Pharmaceuticals (AMPH) 8 Nov 222022 Q3 Earnings call transcript