AMPH - Earnings call transcript Q4 2024 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals' Fourth Quarter Earnings 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.

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

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

Please note, this conference call is being recorded.

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

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

Dan Dischner

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

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

our Earlier achieving million, of $XXX year, today, for the we year. fiscal XX% to announced the XXXX revenues compared prior strong financial a results increase

For franchise. growth. This we the and of our year-over-year portfolio, the Primatene of resilience key such solid highlights driven diabetes as BAQSIMI recorded demonstrating our a integration products fourth expanding Mist $XXX contributions performance X% from million, the quarter by into alone,

market. in and of has toward position a strategic in thrilled step X growth BAQSIMI amplifying our the Effective announce As completely MannKind. forward our diabetes distribution this are responsibility transitioned a this promoting represents strengthening year, under on collaboration with operations we is experienced new partnership This January our fourth sales MannKind's sales to force concluded to the quarter, trajectory we reach. momentum, now fully strategic expanding have started Amphastar and control. Building -- care BAQSIMI, BAQSIMI's

expanded build annual cornerstone of to million, of $XXX engagement penetration been physicians from of pilot that with program pleased to providers. a sales late market physician our has care our primary momentum, of Primatene milestone health announce XXXX. are MIST, our January, with XX% branded that sales Continuing and the increase on we program with sampling a has our as representing care enhancing targeting offering significant reached launch product a and

to we our revenue remain BAQSIMI confident products growth through commitment to highlight XXXX. sustaining be and to continue will Primatene products. future, contributors that Mist look key to As market growth innovate meet to our we reinforcing demands, the our through branded These and ability

$XXX Turning of million to recorded glucagon. We annual sales XXXX. in

as ready-to-use in which product. to seize pressures. Part space such a decline coming the we we previous of year. view new the we this this a the BAQSIMI, modest evolution in generic Glucagon market shift involves a believe to market dynamic positions products glucagon in evolution Nevertheless, X% the in a year, us increasing face expect While natural the opportunities competitive represents to for as

product Our shortages hospital continue fourth in of the areas quarter. competitive our Despite other drug and ongoing in we use clinic products obstacles, benefit pressures from also to portfolio. heightened these experienced

year. Given anticipate shortages, throughout dynamics coming market persist we the similar cyclical will these the nature that of

and designed in positioning portfolio strong supply structure market. vertically business navigate supported integrated to the chain by proactive are and competitive ensuring product diverse fluctuations, strategy Our supply consistent these a effectively our

product; developments, regulatory our AMP-XXX XXXX. in we approval about and AMP-XXX, teriparatide; marking products which to the Shifting AMP-XXX; ANDA. discussion our pipeline AMP-XXX, of potential key GLP-X and inhalation X are the is optimistic an

forward the coming with further in proactive clarification date AMP-XXX, continue discussions in to in Regarding senior-level GDUFA XXXX, months. still despite second the This we its delay the product of is path optimal and officials. FDA generic expect engage quarter on competitor, without a we a since

with of completely we For this year. anticipated an the goal quarter received GDUFA this we half the of this fourth the month, second CRL have in in date of to responded [indiscernible] -- AMP-XXX as

remaining AMP-XXX well in the cycle goal AMP-XXX, first year. with second dates both quarter GDUFA Regarding are ANDAs, progressing both and our of this

Turning this after the from AMP-XXX, requests refiled we application insulin insulin FDA. to have further aspart, BLA, our our

standards achieving Our interchangeability our towards firm, particularly to product. obtaining the remains commitment highest as work technical insulin for we status

finished business beyond like trade or and ANDAs significant of international on exceptionally us Moreover, XXX% shields our well policies tariffs where diabetes and robust U.S. us and our Turning goods. offer from brief integrated on manufacturing our Amphastar's current balances, produced concerning believe I'd trade business our vertically to of finished any footprint domestically recent future portfolio, U.S.-based comments impact. model to trade pharmaceutical developments are positions Regardless mitigate products current we strategy.

aligns capacity bolster production resilience and to domestic policy U.S. with ensures supply initiatives chain potential manufacturing. This

milestone our we with look as the in pipeline. we about Primatene million and Mist. The optimistic to future, year our shift is focus As XXXX our Amphastar sales of particularly our proprietary growth $XXX a proprietary we branded and portfolio for as significant us achieved product, towards was

BAQSIMI expected by announce also we proprietary to products. that pipeline end of the shown this and growth Additionally, potential pleased to for will positive we see has these I'm products trends year. the more continue introduce

We developments current products, updates approval launch. towards are eager on with share our the recent filings regarding progress these along to and of

year to the Executive quarter Bill Peters, call to Vice discuss I fourth results. financial our over and hand to President of CFO and ending the Finance, would like

William Peters

certain Thank sales which negative fourth of $XXX.X a of $XXX.X the grew after BAQSIMI BAQSIMI with $XXX,XXX, from a benefit $XXX,XXX you, true-up of Amphastar's net quarter expenses. XX%, to $XX.X in contributing increased Dan. of [indiscernible] fourth of to the million to net economic sales. factory product BAQSIMI led sales totaled million quarter Total million the Sales level XXXX. at for X% XXXX

over Throughout the year, in decreased various responsibilities around have Amphastar's economic of BAQSIMI as the net increased, while distribution the countries has taken sales we have benefit BAQSIMI world.

up strong X, million $XX.X the prior the in sales assume show million, sales Primatene we to January XX% quarter countries. XXXX, during year of from growth BAQSIMI continues the responsibilities in with distribution X As period. for of $XX.X final Mist

the there Glucagon in million were BAQSIMI. sales ago. $XXX to to to market increased Lilly's net million, of expenses set Epinephrine the sales For the XXXX, revenues a $XX.X move as $XX.X million declined due due BAQSIMI quarter product. previous period margins the sales. primarily from of million prior to in ready-to-use vial Gross X of quarter fourth the XX% million Mist year's so Primatene no fourth year, years the cost associated period to prior year to million our such of our revenues compared in of of were products competition $XXX declined for annual in to epinephrine and $XX.X recorded due we in XX.X% XXXX which sales, sales surpassing competition was increased goal $XX.X decreased from year,

expansion $XX.X million million due also expenses distribution the and component to higher expenses increased were to year. our administrative XX% to sales and compared impacted offset at from We $XX.X costs. $X.X of remained General unchanged and trend. million Strong sales marketing the Selling, in Mist of $XX.X efforts relatively BAQSIMI. marketing by higher-margin for and labor Primatene prior this million partially

interest and $X.X and primarily compared million the million in due expenditures quarter development $XX.X primarily million $XX.X the and trials materials swaps. fourth Non-operating period, cash to comparable the Lilly, to principal XXXX, June to quarter million rate prior supplies. in on from clinical and of expenses of the in payment to quarter in deferred balance related XXXX made our well which in year decreased the lower were $XXX foreign the adjustments XXXX as spending on million on $XX.X mark-to-market Research our fluctuations accretion XX% as debt, to lower was currency of

in of term we costs unamortized Additionally, to loans. related off our debt XXXX, wrote issuance one

compared to previous $XX.X of net of income income an per $XX.X per year. year's the $X.XX or fourth share of up adjusted net $XX.X million or X% or share, fourth approximately compared and with The the which reported share adjusted previous in million the an income quarter million company of reported per respectively. net X%, or $X.XX was $X.XX $X.XX of million share income quarter per company $XX net The

impairments and from $XXX.X for approximately million amortization, onetime In cash Adjusted quarter, operations were full equity compensation, $XX year, million. we flows fourth exclude earnings of events. had the [indiscernible] flow by operations provided cash the and

take few as financial forward the of we look are now assumptions time this we using a me beyond. to review to Let XXXX and

on the States, in X% anticipate BAQSIMI growth and in United took for We unit price single-digit high this product. increase range continued we a the

to For our expand high this program. grow continue Primatene physician Mist, in to as we expect sampling single we year the sales digits

flat in enoxaparin. are forecasting growth to FDA. declines epinephrine, the I before phytonadione products to rates later increased sales returning X sales This these will in We this lead on from trends due glucagon, file and year relatively be Offsetting be at to will growth for product double-digit competition XXXX launches XXXX.

are to margins products. pressures lower be on to [indiscernible] glucagon, gross due epinephrine which pricing higher-margin expect We and

Additionally, BAQSIMI our and in the so margin. with by sales will they have made cost these associated be Lilly them, sales this of gross portion of cost our thus XXXX will Amphastar did of year, not by sales recorded sales, lowering have

Our slightly to to vaccine. increased related a increase selling of efforts and as marketing expenses will percentage due sales

spending on and portfolio, research development. of we inhalation proprietary on candidates and and materials as We X clinical and supplies our spending to ramp plan to insulin up trials Turning our increased purchases products.

will to injectable in as and on capital break anticipate opportunities. Cucamonga prepare expansion year our complex insulin that at major as We a significantly commercialize increase increase look to capacity significant we also spending Ranch our this facility project ground we

in cash on flow major project expansion Spending will this but plan from up We year last began finance more to significantly operations. with ramp this XXXX.

stock. strong to plan continue back to we buy Additionally, our position cash utilize our to

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

Operator

of from Jason America. with Our [Operator Gerberry question first Instructions] Bank is

Jason Gerberry

glucagon the I I but wondering just I year. on in Primatene to into XXXX was any guidance, you advance products, know guys your you like Mist things speak seem I the head could key aren't and mean if -- Those outlook next offering

William Peters

Yes.

for we are Mist, single-digit sales going sales Primatene product. to -- single-digit high see we're that growth So to growth, expecting

we XX% is of the as a took that I United X% increase the The BAQSIMI, For price States. mentioned, product. in for sales States United about

drops see high to increased expecting single-digit glucagon, that . unit we're because product. volume growth of expecting the And unit that for for product. we're pricing both and Additionally, competition,

Operator

from is with question Wells next Our Chen Fargo. Cerena

Cerena Chen

QX, this been you review a GLP-X, AMP-XXX coming prepared you approvals? approved. you get solid have XXX, in dates product generally products Or and And if launch how get requires more on quarter. that they for are typically are think do competitors Congrats GDUFA the these to do for to up was aware cycles? products able for wondering with the I cycle

William Peters

first ready to be being wouldn't the we As to cycle, as quarter. probably our thought launch these launch preparing far products on with is until that their following

I'll quarter. other third quarter So if second would question. that launch approval, of it the [indiscernible] a to we turn the it's then in portion

Tony Marrs

Yes.

first . that For But reviews GLP-Xs, pet-type possible. that for we the cycle products, majority think for are optimistic given companies. these the are

Operator

Knyazkova next JPMorgan. Our with Ekaterina from question is

Ekaterina Knyazkova

know you beyond So kind seeing is XXXX. force kind how expecting? traction are AMP-XXX. from question thinking early, you just kind on MannKind. on in BAQSIMI. And latest with the Are you're second I it's of about And the collaboration the thoughts but is impact first kind sales of maybe you're of footprint question of seeing just then of the what commercial

launch timing, Just year? the could this size us latest XXXX? is Or opportunity? on potentially that this how about this you're remind something is And of thinking can you more just that later

Dan Dischner

the just than the the larger of it's but large -- started BAQSIMI question. of They exact of tell. what quite with January. utilizing. we number, been beginning little still reps But haven't number sales -- early in disclosed Obviously, start I'll detailing because it's we've a it a the quite to

point the I to expect want do experience have in and -- they space. So out we also actually that endocrinology

it's we a they in really product. and get for feel and fit promote us So like can the that great

keep forward that looking we'll updated as we're So goes on. And you to that.

AMP-XXX, kind that addressed have For issue. Tony of

Unknown Executive

Yes.

don't next to So as late year year. unlikely market, far that in get see probably participate as to getting ready or that it's getting until this we approved

for that something that's time. we'll be that prepared So at

Operator

Sandler. is question next Amsellem from Piper David with Our

David Amsellem

guidance come to topic the going back I'm to So or informal question.

Can couple kind expect products? are of got X say is products those competition products decline you any on to you've of and is color you got you guiding launches that XXX, be to how think and XXX, XXX launching And X from year. much . in questions the quantify Are much can launch? competition on from in that you way your helpful. So you expecting? you and GDUFA I factoring expect the this how a contribution of way the there then is new called would is between from to risk-adjusted you versus products in numbers guess which you're be of that out. X there's you that's I

William Peters

Sure.

got being a we've contribution candidates So possibility any all there's actually of X approved that And approved. possibility and having be of could them. that we think from of them

do So fourth a a basis for think, quarter this to X. for is potential look at expecting, we're this risk-adjusted the took decided X from things, year products. is what as we've we sales I timing And these

then launches on a new no guidance, So until our and that's risk-adjusted for basis.

we're at it's quarter. and possible products that these But way see we looking We quarter. uncertainty or based quarter certainly of fourth happens. think basis, the X some in a third fourth all So risk-adjusted X it some them get what that even the for of on things by for the the we some is on

David Amsellem

I X since if [indiscernible] I the kind XXXX. been in know may just in has which follow up, of went is GDUFA AMP-XXX, one those flux And of back Okay.

William Peters

risk-adjusted it's likely that's So I'll probably possible, a but that think say on XXXX a basis, event. it's quarter we of more first

Operator

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

Serge Belanger

you I what give targeting just in collaboration color guess some just it of be force you a your you can terms us market a BAQSIMI more [indiscernible]. and to at if additional And in estimates the guess, point? and overview they'll the prescribers. the what set on MannKind if sales first for represents on competitive different And of Pfizer update secondly, come questions. us and regarding And Few the had epinephrine I collaboration. previously peak you Can back of the sales increases product? on expect little whether

William Peters

Sure.

So in start the sales MannKind. let with me force

of to be With salespeople their sales force, are product. that that more the going number detailing than the doubles

So it of country more it had covers the previously. than

mind product for it's portion a the of secondary in keep them. that MannKind this for Now

it's you talk and can really offices. Afrezza while, BAQSIMI think long So the them product them else to a they're for second, gives about detailing something because talking good gets first think -- a for them then present been they've it doctors' I get but into them I about

So we're really too. and excited they're really about I it, it, think excited about

do going get and some time ramp-up we going. it takes that to that that think So

it So the sales is the the way into at that accelerate half the later we're as looking of should year going well.

at So there. that that's thing looking another we're

X multidose there's both why now as syringe far That's player and the epinephrine of epi the States the sales on players fourth multi-dose product. the goes, year. drop sell last we're in now in quarter remember, that As we saw file. But prefilled the that's now, And we right the file. of the the X United prefilled only as selling still or in syringe,

So right it's us. now,

back changed get competition when date there the has into repeatedly market. the expect Our to they

probably So the it's quarter hard but to it's don't say, or second think quarter first not event. I a

Operator

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

Dan Dischner

today's on joining for call. all us you Thank

about X GDUFA with in excited dates quarter. the are We upcoming opportunities the second especially ahead,

branded on products you. pipeline you provide information forward call. future look a proprietary also good Thank with the quarters. more will and to updates in day. Have We sharing our on our We next

Operator

This today's conference. concludes

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

Amphastar Pharmaceuticals (AMPH) 27 Feb 252024 Q4 Earnings call transcript