AMPH - Earnings call transcript Q1 2021 | Amphastar Pharmaceuticals, Inc.

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Operator

Welcome to the Amphastar Pharmaceuticals Inc.

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] All statements on this conference call that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance, backlog, sales and marketing of our products, market size and growth, product development, the timing of FDA filings or approvals, including the DMF of AMP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, our share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations, and results of operations. similar facts, our are projections current business, and not historical on regarding are operations and factors. performance expectations, other statements but based rather Amphastar's our These related or estimates and forward-looking such identify continue, intend, other these although potential, similar forward-looking may, anticipate, estimate, expressions related all and, expect, will, would, statements, plan, could, Words should, statements as are words. predict, or believe, project contain these and might, used not to

response the ended impact with XX-K on Form COVID-XX's several XXXX, will XXXX. because Amphastar's on predict, materially a Securities they our and of undue March uncertainties duration factors, which Amphastar's the filed place the filings reliance a SEC those and some statements, unknown are well in business the as from severity, our depend actions pandemic, by on forward-looking at extent governments, and not consumers, cases, and all pandemic, taken the results known Exchange result of should Commission, risks, differ remain year including involve number statements, Report forward-looking including evolve of factors, particular, extent in continue and the businesses XX, on difficult You for on time. to In as the uncertain as of in and including with or to and beyond may this that assumptions Actual December impossible of Annual the control. to in XX, in described those

at www.sec.gov. locate on ir.amphastar.com, through SEC's You website, and these website at reports can our the

future, being Amphastar conference forward-looking to or if if of the cause new becomes this to or subsequent Forward-looking call statements only note, referenced events events in update the information information statements recorded. undertakes in change. the as speak Please is the any circumstances release. revise or release expectations in reflect above, even our conference available, or to date obligation no this of

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

begin. may You

Dan Dischner

Thank Earlier strategy, solid start another this a regarding a and everyone. forward the strong executing reported growth with We very to quarter's good growth behind look provide revenue details year, update quarter and you, operator, afternoon our to growth. and afternoon Amphastar our pipeline. company's the of sharing

our revenue on Clinical and successful of glucagon's substantially epinephrine and line for record begin, Tony my open Following remarks, X% Against of net MIST with will Operations, and the continuing in and Bill trend saw to a launch, the we'll with products, we prepared materializing the net provide first top seeing $X the portfolio, in quarter, back-to-back line This to Primatene update our diverse sales revenues Regulatory first a represents top growth, gain to revenues. bottom and momentum. increase financials, Affairs with Q&A, the versus myself. drive Bill bottom of fourth million the increasing Peters, the continuing execution President quarter line quarter million. Vice Senior with up $XXX our growth period of of backdrop and ended CFO, To an line company's Marrs, we've

when increase can Likewise, by platforms, we've observed cannot. in the Seeing competitor this Regarding medroxyprogesterone expect and quarter. epinephrine our and same trend glucagon, unit the in while to the be the its we pharmacy year. Though launch in progress the resolve retail shortages product growth the a seen this compared to as higher be intake executed in saw with durable as organically enoxaparin sales on same prompted to our shortage. can tend product a XX% its themselves, mid-February, our area as total products, we've launch previous into with driven competitors tremendous trend by was space, competitor consistently volumes, products, supply

launch, to important to retail we such share are launch an back mid-quarter seen glucagon, according March eye keeping the Turning as believe XXXX. market while glucagon, its epinephrine, XX% we're factors IQVIA and can as loading at initial for on to in Primatene. of data a strong offset its the continue to Nonetheless, be fundamentals and

planning bottlenecks, product's Our support around growth and reasonable vertically business afford to chain suppliers. the the potential and seen a integrated demand resiliency among efforts supply

re-launching slide MIST, a fourth sales Turning the quarter, trend year, retail reached sales seeing product have $XX this to week-over-week strongly significant as by continued million those year to COVID to before reached organically, in as XX% Recall through first the updated of digital as retail closely increase the continue We've the to radio pantry we increase quarter the Primatene in Primatene strong in be media digital Target's with compared annualized TV, demographic. into of levels launching awareness our that asthmatics and last updated a XX was loading. program advertising sampling driven presentation. observed strategy strategy, in physician month campaign, company our consumer of another nationwide our layer old this year will to campaigns, our in product, our to XX add the to to marketing Adding among we stores. awareness

have the for and we pipeline; products already AMP-XXX to in a we CRL it. received in MINOR late responded April Turning to

continues are GDUFA of to that no plus believe are $XX CRL million product product. earlier announced the on GDUFA third second based this we this a of stage confident after Pending million usual We date. data year. opportunity agency $XXX to the in a the anticipate a this quarter still in opportunity now has generic IQVIA response have within the based days. roughly, quarter annualized have closing reclassified on has we April this MINOR. annualized plus our for Therefore, a development. FDA AMP-XXX, product's date status sales, MINOR in CRLs, is We to While we IQVIA XX

not that no action reason to meet will have date. newly We this product established believe the

there is this that questions product, that could AMP-XXX. the given about be additional complex a of development However,

was As window product same in expired XX-day opportunity mid-April that challenges no a we from for remains our the anticipate Again, the a this review year as intranasal the million this on second the well in XXXX we our preapproval quarter we inspection clinical complex has on AMP-XXX as for is epinephrine product product, complexity. further development, the another continues FDA $XXX the plus received its filing proprietary and have generics safety Paragraph IV and to needed. in next Likewise filing saw in legal of the announced product year planned. this remains our study a same market. is date time, no given Concerning product's or quarter of GDUFA a the first with can't positive track profile. the response Therefore, fourth as regarding in after if At product month. started efficacy progress

intranasal Finally be stability our completing quarter AMP-XXX, still we are naloxone with anticipate closer in naloxone in refiled studies. to fourth the updates intranasal and our to as we

product non-infringement quarter. Regarding filed is another coming still is in to strong be we stated the filing as we on AMP months have Paragraph last where believe track position XXX, the IV as this

strength. stay notwithstanding our triggered However, XX-month of be usual a could possibility IP the of regardless

quarter now previously year. restrictions as more the the occur of IMS in subsided discussed to of half still anticipated third this business in afforded insulin MHRA second update anticipated the launch to the occur our being UK. UK Regarding has program in following flexibility items, is year And is our products COVID

for legal our Glucagon on insulin noting launched progression announced growth Lastly, market drivers epinephrine recent naloxone financial clearing be product now through and success I'd epinephrine on mature ambitious that our programs to which the growth our update turn achievable with its durable Bill call already news like soon continues our have quarter's of an turn intranasal yet trend and the strengthens to Meanwhile, CFO, our the first seen the Mist, the by AMP-XXX's portfolio. reclassification, for to results. be filing pipeline, their will execution clear sets schedule. to expected on discuss clinical in a progression tremendous Peters to pipeline while our in anticipate aligning I process driver We've an ultimately continued this time to with Primatene a AMP-XXX, share. intranasal conclude our and gaining of path forward. the

Bill Peters

to shortage to a products saw new lidocaine XXXX. a market market was had million XX% declines Sales increase $XX.X in unable Primatene a once February Glucagon quarter $XX.X with increased to up $X.X to retailers. our pressures prior in due $XX.X left market the in sales million $X year. first sales the competitive in from sales $X million to showed launch prior this million quadrupled penetration from as Teva increased to year Thank major prior driver on weaker $X.X after syringe million to Epinephrine inventory as the The $XX.X including customer sales product buildup of the most the million sales multi-dose from due $X.X by million you, vials in demand Naloxone $XXX biggest saw we million situation pickup million million with strong for again from nearly growth in the strong Mist primarily declined the while fill of XX% period. of in was to of million, and it $XX.X competitors for the sales Dan. prefilled an previous demand. of increased to year, orders. phytonadione with year's Enoxaparin increase in

costs million we and we $XX.X Paragraph million $X.X additional Our such General to increased excludes On enoxaparin. $X.X timing of earnings spending due million to prices income increased lower Primatene business quarter and Amphastar and as We XX% million long-lived impairment for million reported for attributable due of the $X.X or Research $X.X of to million of last shareholders events. quarters. the $X.XX marketing the this Selling, of reserve I of expenses more million development $X.X the amortization, $XX.X begin as administrative the quarter, to Subsequent income costs million will Glucagon, $XX.X up share in employment to an operator Primatene expenditures of and will and per prior million had Mist. We insulin We stock timing to lawsuits treasury Adjusted an legal increased $XX.X to share increased The high-margin or from these case. to to for from equity arbitrations XXXX. to portion order net from the million, to expenditures sales various to increased as due clinical in our share $X net shipments. $X.X primarily IV increased our to quarter, authorization. Mist year. the now due to per $X.X after of appeal adjusted onetime API million buyback court share Gross higher from Q&A. the increase $XX.X intend sales was marketing quarter in commercial expense. we the over fees which income In cash million G&A and compensation, or $X.XX that cases per the a of for upcoming the primarily $X.XX turn and leaving products remaining million, the The to operations a on call employment-related campaign epinephrine related in first per costs. cash booked of distribution $X.X first during interest $X.XX for trials. to anticipate to a reported from of flow lawsuits. the or company implemented costs million of million. XX% year than back $X.X booked net quarter assets from settled offset used charge first to other second was from and flow and sales repurchase million of in adjusted company quarter compared margins a net increased first compared litigation a to $XX.X income this $XX.X Aventis note, with related million the expenses

Operator

We Markets. first BMO Nachman Capital Gary question from our will take from

Your open. line is

Evan Hua

for in and Thanks taking filling for thanks the This update my question. Gary. Hi. Hua is Evan for

in Primatene, there quarter the allergy? next there March? was XQ for stocking And secondly, quarters do for as with first much that Thanks. And the how should be expect And target we asthma XQ? down seasonality you any or component few considering is launch So any or well? for step sort in in of

Bill Peters

target we of for $X because there So load first quarter. million million the question, for their the all the into stocking and to of some this impact for was stores would the that is across had country. they say $X.X between product And

Dan Dischner

correct? that Is seasonality. around was question next the think I

Evan Hua

Yes.

Dan Dischner

It's to see say. of a seasonality, seasonality, still nothing hard little On bit but we do definitive.

Bill Peters

the on to the I'll corporate updated thing, presentation -- point website. our we've One is

has strong the right uptrend can see now. been there that So Primatene you very

take So, to look I you advise all that. a at

Evan Hua

have provide And also you take where were that of follow-up. strength of price? on Can revenue Yes. color share? exactly Was And and from? epinephrine came you volume more I another some to able more it the more

Dan Dischner

was all And -- not issue two It volume the things. Yes. price. was

we're picked consider First -- good what up up prefilled now assurance of was an all, for we vials. we a volume multi-dose our to the But the syringe situation. --

So, of that very that. we And of trend quarter. but this ended, to competitors quarter our because some had weren't shipping has strong a the subsequent quarter

Evan Hua

my taking for Thanks question.

Dan Dischner

Sure.

Operator

Elliot our take next will We question from from James. Raymond Wilbur

Your line is open.

Lucas Lee

news I any have you follow-up. on on And Lee ultimately entries share Elliot regarding I to and Lucas And taking or where questions. thanks Are from question response the competitive Glucagon. the for a settle? for is there first Lilly? is have your do expect This afternoon. good Hi

Dan Dischner

Right any now, we other entries. haven't seen

doing sustainable. this about it's it's that generic right think was very It's that The and haven't any sustainable product. and As off-patent we not we we've us. talked seen many really a is We that complex much XX-plus else time. we're times fairly generic no was feel at other and share It seeing there other for this well now years for market there.

Lucas Lee

That's Thank you. helpful. very

a Thank And XXX(b)(X) filers ahead you question AMP-XXX. XXX any are with blocking potentially (NYSE:J) Next is exclusivity? there Is of regarding or other you. this filing?

Dan Dischner

It's not XXX Yes, (b)(X). this a product. ANDA an is

know see there's don't for has that. We but in it's that time weren't when had -- in, notice product they potential we And and is application not We so an a been litigation that IV, and the for product. have generic a has expired. Paragraph do quite that some there for opportunity did another that. time an is any this coming we So, from provided

Operator

Instruction] question take David will We next [Operator our Amsellem from from Piper Sandler.

line Your open. is

David Amsellem

few a have I questions. pipeline thanks. Hey

we else? about on -- I epi that secondly then if So I -- late. just year this joined a filing you -- the for update And you're what Is the inhalation I path And on and something expect timeline as envisioning terms also year the well? But in how pace Can or on on us should that? development? is it filings just talk pipeline just because apologize one program. number missed clinical PK but the just of us forward this Thanks. next on of not remind

Dan Dischner

Yes.

then For in to more the anticipate first one, three two for or the inhalation, we to three one years. two this subsequent year and and

an So, focus it us. of a is and emphasis

them agency a of are the with multiple in measuring we've around second For directly. of lot -- That PK your circumstances type not of the question specifically intranasal more it epinephrine, it a special clinical special use got is trials of around that program. efficacy population We've a to the we're occasions. is product. And clinical the presented the with we've plan discussed and

strategy they're Most the grasp in think physicians And have of are aware we good is. and arena. on so And it. that we the of a pretty sites what this our

people are knowledgeable great have we've relationships in We're consulting We been with with. and that highly it. working

So, we in plan feel clinical our confident looks what pretty like.

Operator

our take Steinberg next question We'll from David from Jefferies.

is line Your open.

David Steinberg

and have Thanks, of a I good couple questions. afternoon.

Primatene on is First Mist.

think through even about million So, $X it I adjust, was you $X.X target. to million in when stocking said you

it's million. $XX expectations your like annualizing think the or looks it more. million And for $XX slightly I that for adjust you around the when even So, at year around --

generic out? then any reviews off remind addition year, Thanks. product. of through lived both And have think chains And product got Primatene peak you'll besides What's much year? goal that So, do entering are? line. them conviction on generic the get GDUFA target that chain XXX the you on entries Definitely actually And In Glucagon could be the on for across current what can pretty planning major for the patent? given how be we've less since then sales also are then first played date? sales three the achieved or or this been has and years big you it there with cycles cycle that what that would many and this other you're your us approval you this secondly you

Bill Peters

Yes year the as much we -- very while sales first $XX the some target yes -- quarter quarter year Mist to how got may to the of for had sales first a strong. We're -- Primatene that sure in start. was seasonality million. well. some one the off have first Not that We still rate our -- involved still is

grow factors we be. in million as think on it $XX remains there's million. point There's can used due the it's before. that and And do we've canister asthmatics major price that $XX than less the to target our more it So, doses three higher being said to

still So, room we do to believe grow. there's

Dan Dischner

-- The several remind next questions. question asked me you again

Bill Peters

Dan chains there's there's program major major little the of to think the the a and even have through wholesalers. smaller bit our there, a room there. out -- through Yes, we sales have retailers into now all the with online availability we target grow for I

Dan Dischner

the on patent. This that's XXX, we off question product remain been a IPO For confident. complex is

a just I but Quite if it's long Yes. we know have a at we to exactly It having as confidence, would I I gauge be when, it's extremely -- categorized point. think very and time. been And minor level maybe CRL of time. response. to longer. think was I a some happy this approval, satisfied this think don't one for

views agency that how gauge minor in I speaks can for a this product. of quite that think what a And us, I you So CRL, that to think think lot the kind so means. I

David Steinberg

$X pipeline there first quarter. fill Was that looks number? Glucagon you And On Glucagon, Thanks. just based, all in or did it million one some its that demand was about like in seems follow-up.

Bill Peters

pipeline there number. didn't involved say is that I'll through But definitely remember, about until the we halfway a in launch still quarter.

a even of worth month there's there pipeline the a pipeline probably So, stock was launch, though that. in

Operator

Tim [Operator Instructions] comes from Our question Chiang Northland from Securities. next

Your line is open.

Tim Chiang

Hi, thanks.

might Amazon. of mean, additional Primatene you you've thought have mean, retailers, any obviously Mist for you're mean hit hasn't on been in major to available? all on any the -- I product? other about where you able take Primatene channels advantage guys there distribution Mist, that Just I are avenues really be made side other the I haven't that

Dan Dischner

hasn't as ones, Amazon major the been long. hit we've mean you know. And I very

I growth changing the it we're the focus. Initially, product the biggest as for of just was think is reintroduce kind expanding product. demographics the point to of

the strategy to Our recapture initial product of really into that's mediums was even TV. have be but the other marketing demographic The such TV into And added demographic knew been ad, the introduce product then different demographics, now, the where TV the we We groups. kind and ads of that expanded so different kind another media as think using well. growth branching working, most. really will

Tim Chiang

profit And mean were mean opportunity gross this it the the gross then Bill. sort maybe Is that at I of I think of later year? going that do margins your do margin? of I XX%. think this question, course of is some year? you gross to just think rest stay increase XX% you sort to at margins or a through level, the financial of has quarter around this How

Bill Peters

the buy Yes. we there's low take cost. -- a It have have selling -- Part write-down, enoxaparin, we opportunity with do to has to inventory, because at of some we're we whenever -- increase. the

lumpy, be it. same we're not buying rate can we're process that in exactly selling it because So that the

that is So more reserve of probably little this quarter. that there on quarter average bit the involved a than in there's

approved. up that We these margin that. a some other high of we go that's rest we opportunity should at well. one And the believe a FDA that, also, product benefit the that for of there's because get out And year. sales as we'll Glucagon now from think area the products get So as of

than it that as All that we then up of will grow it an is That's average for our margin corporate further. if product believe from them a higher average, opportunity go further can And have that where well. higher Mist, also, too. reason margins today and there's Primatene than as grow to so

Tim Chiang

question. last one Just

Just you meaningful mean to guys in number when I of expect do actually mean, you Chinese to this start the facility generate a on I China. revenue some guys filed you market? out have obviously, have of DMFs there.

Bill Peters

Yes.

So APIs is Amphastar last all, our to of contract them of them buy year was us sales, last number year US that R&D – But do biggest year $X and prior we APIs. year. said some we and facility up some work also the around to first what we year. the was had I we from of that which million from for customer we that And we expect R&D significantly think this over had the double this in mostly

And this in press the It have but release year. so facility from revenues sales first over a had we the we reported year. million more that quarter $X little should third-party this wasn't of in in

on out a and already rate facility. growth trend expect continued it's So year higher do quarterly than from run the of we last that

Tim Chiang

Okay. Great. Thanks.

Operator

take will & Needham Company. Belanger question from from last our Serge We

open. is line Your

Serge Belanger

afternoon. good for Hi, squeezing Thanks in.

the you of earlier Bill, product more week. you us an in a in and and of the products. XXX, in which now? ones give XXX grandfathered talked of the Maybe QX the approval about XXXX? then of the And does received grandfather pipeline, expect just to Any rest right of front idea extensively terms receive So FDA these this some approval you've XXX, for of could

Bill Peters

that address question me, you since Well to that. first I'll take

is more syringe, product we the it a product out So very [ph] EpiNova have one do us. is there to but important which grandfathered prefilled

an we NDA, ANDA. as However have an not filed that

So rest that to application for turn Tony And pending. over of it is the I'll that question. then

Tony Marrs

fourth Yes. quarter and has goal date this had We – of the AMP-XXX you that year. one a mentioned in

other third AMP-XXX, the action is which We quarter of or anticipated couple date. have a products

there'll that those. approval issues perspective, year AMP-XXX, filings are surrounding But AMP-XXX The from what well. later we later an date year. those an this are We that which action action have some their an Paragraph date as anticipating. filings has are those so two then another this and last be we And IV have of

Dan Dischner

We GDUFA date a XXX. for have also

QX sorry. also is one No it's think. that QX. So – I QX

You're right. mistake. A

Serge Belanger

program. on or developments development And path that the insulin Any for regarding program? then new the just biosimilar FDA interactions

Dan Dischner

sorry, repeat the I'm can you question?

Serge Belanger

Yes.

the program, the new or biosimilar tool interactions Regarding development developments FDA insulin any regarding pathway?

Dan Dischner

to the and more program providing out second of on to a program roll a planning complete want the entire insulin update We're that at time. kind of year. color half give this more in We that

Serge Belanger

right. All Thanks.

Operator

this We further at no have questions time.

Dan Dischner

Thank – Okay. on Jamie hope was us next day. QX for or call. quarter year good and that a and that you everybody thanks to good was to today a It a the it joining to into We our you look continue quarter sharing forward success time. for great it us. Have at

Amphastar Pharmaceuticals (AMPH) 9 May 212021 Q1 Earnings call transcript