AMPH - Earnings call transcript Q1 2022 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals Incorporated First 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. These statements are based solely on information that is now available to us. review issued entitled on today website. to the statements the you release press and encourage the forward-looking Section in company’s We the presentation please performance. a discussion can numerous factors filings, website Also, impact the of our our may on future and for found our which website SEC’s that to refer be SEC

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

Our are VP you to Dan, Vice today the will Mr. speakers Dischner, Mr. Bill Communications. over Dan of now may Peters, begin. Dischner, your conference I Dan Corporate CFO; host, Mr. Corporate Communications. President, turn

Dan Dischner

Amphastar I quarter prepared our update Thank of After company's who my turn Pharmaceuticals will CFO call. President Finance, you, to provide and us will first and afternoon operator earnings Bill remarks, good call to the financials. an over everyone Vice Peters, the Executive for on joining

We will to then call open the Q&A.

This two plan Generic our product in Generic to in of will is launch to be further third reported $XXX.X same led sales our million as of and We increase optimistic momentum XX% remain an quarter strength AMP-XXX our continue strong margin XXXX, second execution in seen line The our base supply approval the basis. quarter resulted support. annualized final has The which portfolio. continued approved Amphastar with recently portfolio quarter coupled the that higher our our impressive attributed in bottom to quarter. can revenue products, Vasopressin in in a first with quarter. commercial XXXX, had launch to another portfolio the net represents factors. XX% commercial of period the for on has of financial As our build first increase a a the start the commercial an constant our to And over sales strengthened solid this results of earlier, Ganirelix of in

Mist in as First, towards product XX% by growth of million trending of XXXX, a has the year-over-year seen strong Primatene in XXX the sales QX. sales are annualized end

As previously, sampling frequent digital our radio marketing nationwide our and TV benefit to and more continues from campaigns the program. stated product physician

IMS our a on products an to these basis, our increase supply strategic saw to annual planning Secondly, our XX% notable reliable markets. thanks and

our persist On be Glucagon positive Glucagon the a that supply and for in annualized the current believe driver trend. conditions for our capacity of epinephrine, a from sales will both products our these manufacturing market benefitting will strength remain epinephrine We products furnish profitability, while reliable consistent products. topic of the on to and

first for that the GDUFA filing. further quarter review track to date Furthermore, was legal which us our was this fourth year. direction pleased the our Speaking a confidence priority granted the on day pleased filing status, regulatory Therefore, filing ANDA triggered not has AMP-XXX IV challenge. filings, on Paragraph to months a seen inhalation I'm no lend our XX traditional in this recently of and that will announce I'm remains submission announce

approval AMP-XXX we and to our the in quickly was GDUFA quarter date now On quarter. believe has dates, to good CRL near-term fourth on in of the is this had track MINOR which the that of topic a stated received responded We year. GDUFA a AMP-XXX previously third for

on date Teriparatide, second product product a the cycle. quarter its as remains still for on or track first review this AMP-XXX is For GDUFA

Therefore, forward a combination complex is to product discussed progressing product. previously, this we approval. this towards As look

filing product thereby Intranasal with second maintains and the an in discussions Intranasal transforming towards on On the established as agency. our the and fruitful next the we topic quarter from our building profile, towards of continue biopharmaceutical progression to re-filing track year, benefit towards proprietary path remains Epinephrine portfolio, Naloxone Amphastar's for its company positive biosimilar

to guidance To technology Most candidates our diabetes complex of insulin API our our interchangeable and achieve molecule our based all highly designation. in-house FDA peptides, using on characterization to accomplish notably, portfolio, extensive developed source achievements sophisticated this, Turning purified experience. along our aim of a we framework platform. with have

program and clinical Our is as on track file to progressing planned.

As this continued best a in could quarter of see, light as you can outward be past execution of pressures. characterized quarter

uncertainties up an geared insulated have been out towards platform year. the by investment company. our established for integrated Areas Corporate on kept primarily XXXX remains by vertically our Strategy self-sufficiency. built continued mitigated eventful track of by company's from Our self-funded control has the these long

discuss portfolio of shortsighted. execution We and launches results. the our quarter's and sustained long financial handled Bill maintain the As our will disciplined in pending if measured to to pressures with one that and I becomes our confidence approvals. unexpected commercial first expanded continued a reactionary outward call increasingly then or the now be that diverse turn is approach hopeful will

Bill Peters

Sales $XXX.X first Dan. increased XX% performance. million for you, from of to led Mist period. from the XX% million previous $XX.X million strong with the $XX.X to the in million again sales Thank $XXX Primatene quarter year's once

from $XX.X $X products sales sales Sales sales such while first XXXX growth strong quarter last sales million the million quarter finished of of launched sodium bicarbonate our million Epinephrine growth unit from remained of volumes in calcium $XX.X in chloride of higher as $X.X February due Phytonadione drove to shortages. which of $X.X of first in market sales of also slightly from result million XX% million demand, on with of to as down a in and $XX grew other Glucagon, XXXX. product increased selling million up $XX.X XX% year. due higher quarter $XX.X to to the portfolio unit million in strong of XX% million, the Continued pharmaceutical XXXX strong from comparable average Lidocaine prices.

the in as of year, reported booked to of from to income costs. amortization equity upcoming expenditures of an primarily $X.XX earnings of first net events. share the $X.XX in long-lived million quarter this relation in due XX% $XX.X the last to or legal due very million timing increased gain Gross provided for impairments certain company to expenditures used These of labor, first per marketing costs the $X.X to $X.X by sales income enoxaparin increased first offset increased General Board by margin due million of Q&A. to share in prior such to to anticipate week, primarily attributable million costs quarter, $XX.X and and components the a treasury API costs $XX.X first million $X.X the freight authorization. of million, our $XX.X reported $XX.X sales in to leaving products of our program. net from to repurchase or components. of in development shareholders million from flow company's $XX.X litigation. trends the the assets and begin Mist. and and quarter now $XX $X.X compensation, remaining of spending China per or the to and to Our other ANP. decreased on million an a Research We and The business to $X.XX to in over exclude pipeline. an compared million $X.X trend of had operations insulin adjusted of turn higher $X.X cash Primatene of or We a and and share $XX.X a $XX.X year. these buyback shipments. avoidance adjusted the down during million, of Selling, this income back additional the to were of decrease expenses Directors per the high increased call distribution heparin operator legal upward sales for to increased million share quarter, net lower XX% company income $X.XX Glucagon million for of quarters. partially Adjusted I lower In authorized $X.X million margins from cash onetime million XXXX. from $X quarter Regadenoson administrative Last was per our due due our to Amphastar will million. net continue We that to to million The flows for buyback purchases income a restructuring materials strong compared patent in due costs prices portion stock million

Operator

you. Thank

question-and-answer conducting now a from first be James. question [Operator Raymond proceed session. Instructions] is Elliot We your with Please will Our Wilbur with question.

Elliot Wilbur

Good Thanks. afternoon.

expected. in respect question is First I the think the to quarter, with content Primatene stronger, trends

trends and of would a you same March if last relatively couple quarters wondering expect quarter by next pattern sort years, over then of we seen we've the see of the followed Just strong couple continuing. flattish the

led to relatively out, was tease to a impacts quarter one-time or that there in or Just not trying affects strong whether Primatene? the

Dan Dischner

Yes.

where quarter, dropped off ahead similar strong And the be first the of it stock year expect quarter to trends in back first quarter. from retail year, there'll that. buying at allergies up fourth other some season of to lot is the And on there season of hitting. this the very we we a had with by are very be So again last the buying a the allergy cold really quarter then cough quarter spring the is also and third fourth in the the and inventory to level driven and and peaked and second in of people ahead

the do we same So as last year. see trend

Elliot Wilbur

couple a any pipeline will additional of With not of whether XXX inspection before approval? feedback an questions then here. or yet to the Okay. from required on And as agency respect be

Bill Peters

Yeah.

anything this be We that heard in at required would haven't inspection point.

they there therefore haven't year So but it's expected -- a pre-COVID, so report from here wasn't they of like, not for it. nothing that, that been is to couple ago

Elliot Wilbur

but that then we've you a generic, priority first assuming And the XX-day would correct? have review, on to be window, market is passed not XXX, this Okay. so I'm

Bill Peters

it's have the strategy. time that stick going and still -- we with this at I we're think Well, disclose and to product

add to So have I anything that. don't to

Elliot Wilbur

I just an existing but Glucagon obviously may or not brand unit give of were they may (ph) could your franchise argument whether market, make guess the what want not in simply see signed Generics guess, product? in teriparatide, pipeline generic you terms -- new heard response or has your may Lilly agreement that or last competitive Lilly's have the in you many what content a with from what there you not are expecting of contribute expectations I you positioning their question they to And to AGM that whether be erosion. of player they up you had Okay. are to or authorized customers are the

Bill Peters

not anything. We're of aware XX:XX

Operator

Thank you.

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

David Amsellem

Thanks.

entrants with Eagle's market will about dynamics are thinking wanted for here? the third a on with do of So you expiry the couple few XXX of you days be after ones. with stable start you Or when the other yours market relatively dynamics that of think have How might launch plan a then Vasopressin, question Are a there start that beyond So and be injectable exclusivity? to you enter? expecting additional quarter. I I'll

Dan Dischner

Yeah.

aware date coming are one other think of there is up we shortly. obviously, with GDUFA So and even good filers, a I

So there we're a either aware of competitors. that We're there other will be that prepared is way. possibility

So when at competing. generics you it at typical would how you a as look multiple look with market

David Amsellem

a supply as here. you able the as shakes to remind here -- market are to then And mean capacity just out Okay. I follow-up [indiscernible]? product? of you for us, Can going should much that demand how be

Bill Peters

plenty in Yeah, California API portion on, don't given the competitive and make the for the making capacity and any market -- this see were we a issue. being have here product, Vasopressin, finished one we capacity to the we take I situation, significant of we're both of is

Operator

your comes with question. Tim [Operator question Chiang proceed Instructions] from with Capital. Northland next Our Please

TimChiang

Hi. Thanks.

guess of -- pre-launch are first I manufacturing quantities couple that launched you product? already Ganirelix guys still the you one a have Just or questions, you guys on already is,

Bill Peters

Yeah.

and We launched launch plan for in gearing of process up the we're have that. now. We not right that June to

TimChiang

when biosimilar these and your Okay. guys biosimilar products? the able of of now little you of targets maybe might And programs where with programs a terms sort are interchangeable you about guys file some then any in have you to that like, you bit could talk be right you insulin have insulin

Dan Dischner

Well working filing. expect We we exact for progressing haven't our what the through were they and filings. still agency see certain disclosed on in phases the to development timeline with the of

the like So status. that we said, achieve, I can interchangeable

to think the we first two little and take lot follow that the quicker, may first framework So able but will same one be other the one filed. we get the longer, a a we'll move after

TimChiang

first the or is Is right four AMP-XXX, all is one XXX? that it

Dan Dischner

That's I a that's double check, but right. think

and X. AMP, X, it's X X, and think I X X

So X working we're first. on

TimChiang

okay. first, XXX

Dan Dischner

Yeah.

Operator

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

Dan Dischner

day. updating appreciate for look and our hosting forward today We next this QX wonderful this in quarter. on call. we Paul financials to you Have everybody participating Thank you a

Operator

This concludes conference. today's

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

Amphastar Pharmaceuticals (AMPH) 9 May 222022 Q1 Earnings call transcript