AMPH - Earnings call transcript Q1 2019 | Amphastar Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to Amphastar first quarter earnings conference call. [Operator Instructions] All statements on this conference call that are not historical are forward-looking statements, including, among other things, statements relating to the company's expectation regarding future financial performance, backlog, sales and marketing of its product, market size and growth, the timing of FDA filings or approvals, including the DMF of ANP, the timing of the product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar's historical performance and its current expectations, estimates and projections regarding Amphastar's business operations and other similar or related factors. Words such as may, might, will, could, would, should, anticipate, predict, potential, continue, expect, intend, plan, project, belief, estimate and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words.

You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Securities materially of in those number Amphastar's with differ as forward-looking described may filing result Commission. a of the results for the those statements in Actual Exchange and factors, including

or above can press on SEC's obligation release conference and the to or these at undertakes update or available subsequent referenced even www.sec.gov. would Jason if to events Amphastar's Amphastar. new the through to events your company's or the of circumstances the expectations website the becomes cause You website to in locate now information amphastar.com revise future, information Amphastar at reflect like no conference host, reports if change. I in President to call Shandell, turn over the

begin, may sir. You

Jason Shandell

call operator. CFO Pharmaceuticals and forward have. and We and today the R&D may appreciate My very start strong Amphastar. you, of Good call. earnings us look a Shandell, seeing Peters, you Amphastar with XXXX joined our you Amphastar. is off. to to you I'm quarter Bill of to answering strategy name colleague, organic welcome first questions had Jason with on We joining today are and my President any afternoon, Thank paying speaking

commercial current drive portfolio our addition, strong In to continues growth.

coming market. result continued our asthma in to strengths which sales our Our inhaler The Primatene quarter driven robust XXXX. our first of result commercial and a significantly with the FDA-approved products, is years. first trend margin XX% growth commercial only injectable pipeline, the We're growth approximately the of the sterile technically This rate had quarter quarter that compared portfolio Mist, by first gross and of over increased compared strong performance a of will confident XX% growth challenging for of profit of to in the is over-the-counter increase combination also our the launch XXXX. of

Primatene a Mist. sales positive trend for to of the continue see We

we've increase brand in commercials approximately we achieve calls, asthma. a peak remain powerful very to OTC significant confident Primatene Overall, a hope its the potential three $XX the in the and growth awareness As of next will FDA will and of to medicines, goal, this for brand mild who the of products. enoxaparin In million intermittent years. majority received offering believe the full long-established help remains of demand. reported we the to benefit to allows the its begin grow and Mist's long-term to of back that in two our March, enoxaparin medium approval which past we ease asthmatics we and experience of two earnings in months. commercials in national sales lead we national company symptoms OTC of the increase consumers running of given television sale to vial, access product line multiple-dose for begin Television To the

to maximize be FDA We with execute for our these of will our expect ability team's management agency, areas the file this additional approvals which opportunities, and and our and to on on which by focused current bring to we'll excited unmet look and driven significant are products In new ongoing the pipeline, includes proven of advancing promising year products these needs. we're our parallel, prospect market. by pipeline the

for does not disclose As generic many of reasons. know, you of competitive pipeline details the its typically company

a XXXX Paragraph December complicated million. greater Paragraph the discussed when triggered pipeline IV XX-month challenges. engage XXXX. IV more in disclosed we've discussed of the on more We as will the as peptide past, product Vasopressin in last became be sued with quarters we The a the lawsuit than by stay. in it were of public sales is innovator patent coming However, in vasopressin call we the as $XXX

fourth We that on the the XXXX. to call in innovator sue us also the the IV, by of chose deadline not filed discussed Paragraph another quarter we but last

So the it our ANDAs vial in finished an now investments good believe one the subsidiary subject China stay. pharmaceuticals in product application toward is will earnings could There's on our company. not entering by withdrawn innovator agency was epinephrine to eye currently subsidiary there recently significant as May China to in XXXX. that opportunity. so the is our on with where China for lines We call, driver meaningful underway quarterly public yield their the information was in market a which our of that is be work the they This work with also market XX-month filing our continue our impressive product, file growing another multiple-dose disclosed establishing from is returns. This

Finally, we profitable are changing evolve to to a over sustainable, long position term. in rapidly for the continuing best industry growth Amphastar

and our shareholders continue confident and beyond. by XXXX pleased patients. value we dealing limited growth competition our is industry technically shortages believe drug in our and of in to ongoing our potential patients with complex deliver are cost drug to growth needs to drugs challenging with our to We're very our and will the As and significant while as ability first quarter prospects strategy, the pricing, benefits In our that contribute for availability performance. summary, issues meeting for such we

of throughout We expect to our remainder the XXXX. momentum continue operational

to and generate Our growing pipeline. injectable to efforts that our and will now us complex health. company, to through pipeline including I and products, our public and positioned candidates develop commercial Peters, overall coupled shareholders to results. pass generate over very biosimilar believe with our and call the We resource returns disciplined go CFO, ongoing our our Bill to and medical inhalation strong unmet short- long-term execution, allocation for well deliver help the quarterly long-term value goal meet in strong strong through that has is investments needs,

William Peters

last million, Enoxaparin previous increase million $X second higher from again volumes biggest due Sales unit Jason. product, to $XX.X with biggest-selling $XX.X higher as this Primatene quarter was period. prices. customers. quarter $X.X product. increase also in up selling there of selling of declined $X.X Naloxone Sales average increased as selling as million had the we of begun we of both this of in quarter product this unit million million which $X.X increased Mist our implemented higher to $XX.X in selling saw million price launch from Cortrosyn to first prices Aid. from million a product year's you, higher shortages million million volumes to on for million $XX and product were the $X.X volumes. Thank Sales at million the sales first this XX% to the totaled increased sales unit quarter's began just Medroxyprogesterone from year. sales of from lower was Rite as the to we $X.X market sales certain $X.X Lidocaine, on average

of relatively Primatene business of due increased legal like related first Gross or $XX for Nanjing products to our share and net expenses launch flow to which equity and increased $X.X million the net inventory. higher the against XXXX. year. $XXX,XXX amortization, of Sandoz. for The to Selling, the impairments due had both $XX.X exclude million reported to: the of $XX.X costs. share first administration and assets. well million of quarter and $X.XX Amphastar antitrust long-lived one, expenses case NDA and of was at shareholders per of attributable personnel-related the and development These to approximately the loss to partially primarily related $X.XX spending two, million million Pharmaceuticals, cash expansion projects Research Momenta expenses $XX expenses subsidiary, per used Chinese from $X.XX quarter General in salaries expenditures because were first $X.X million, $X.X high-margin the from with first share by as increased for adjusted company and from as and reported earnings fees in was in unchanged had increased of of $X.X clinical sales ANDA pipelines or Adjusted or offset Amphastar of quarter, million. of trial as expenses pipeline Mist an of API million per FDA and quarter marketing or Amphastar. loss adjusted medroxyprogesterone, a operations prelaunch and net compared first increases distribution last to compensation Primatene increased share year. income to Mist quarter income to associated In costs per products company in last compared due the to sales an the quarter, of marketing primarily Cortrosyn. both $X.X insulin Our the lower margins freight increased we The increased million and $X.XX facility;

in additional million the May end, Amphastar's of Directors which $X million of stock. repurchase repurchase have $XX we by subsequent XXXX. the plan, authorized authorized confidence Board quarter, have repurchased an approximately Board the we The to million completing future. we now stock $X.X of During repurchased of quarter reflects the in And

During on quarter, the and this adopted items footnote financing few begin of we our now over of new the There accounting the as to our call assets. accounting about on disclosures. impact sheet, the see details new in long-term sheet ASC XXX, lease will liabilities operator including the our had lease will on new be The standard, adds I and balance more a the can press which, right-of-use addition our XX-Q to no P&L you release, lease lease operating the included and standard for standard adoption balance Q&A. this turn quarter. to short-

Operator

comes from Wells our Instructions] David from question first [Operator Maris And Fargo.

now Your open. line is

David Maris

Hi. few I questions. have

And Primatene the later did So part Or The epinephrine the those be are? update, lastly, I the to have is market second the - Sandoz be in what current status quarter is the how - - multiple-dose a in-depth - what the the TV Novartis you what are by first did spending The few, say you - give first is next The Walmart right Jason, the an ads, television? bit for that? Or perhaps, versus case on digital ads? us the on going What quarter? is that national what product is today. do to to can launch then or other way, little now? percentage big a Mist, item? going of a you of events

William Peters

Okay.

couple me take let there. first questions the So

certain dollars mentioned single allocating to as year percentage of to digital advertising. see going we've going TV, how and we of portion high digital right this certain to we're versus on to on in now. we as another mid- later TV. we're decide And perform the of - we But high going are millions a be percentage that the are spending the that markets So along, a to that these

that's all is spend initial thing. the kind the our digital, and of of So baseline

of the on of TV the just layering adding ads top we're Now that.

I think was question Walmart. on second your

Jason Shandell

Yes.

in process, it's Walmart, discussions. for on that last the our call, So I know discussed we

process. seeing so in we'll that And to give near was that on fruition. come I I'll Bill. Then be term, in it one remains the And to guess epi. next hopefully, the

William Peters

Yes.

according So IQVIA. that $XXX about to a right is million now, market

So we product that to us - and as had you the remove then their used sold after test product before. it asked sell We previously, approval. as it the and a gotten FDA grandfather know, to

was contributor well. as So was time big and it product a at at a the us the time to fairly high-margin

So...

Jason Shandell

the for in scheduled patent there XXXX. it's September. the on trial finally, which we trial proceeding jury won And the case case was then that for currently And appeal. course. is case, the the is under is jury The that antitrust And due lawsuit, in

before the is a However, possibility. trial settlement always

David Maris

Okay. Thank you very much.

Operator

Markets. from Gary comes Nachman from next question Capital BMO our And

is line open. Your now

Gary Nachman

guys. Hi

then First for the from on to any Rite Those Has gross you supposed nets to revenue there was Aid? be in currently? somewhere pull-through been of were reorders the related to range. Primatene. in are and XX% sort quarter what stocking seeing far of What the CVS XX% Walgreens? And much first How to are there? so the

William Peters

Sure.

increasing was, significant reorders. So individual break I'll positive We've by we're the sales started Rite portion company. trend of receive in data in in an out the sales to But from reasonably that trends there's not retailers. weekly we me start off the let couple we've That the we've any going to seen sales Aid. trends quarter, a although been with say, And seeing. a see specific

week-over-week And we launched that, increases but had we've since one so get we couple a to product. data every weekly on week the week clarify delay. And

if steady another not you So we're And sure and consistent had that the at about pleased end. question growth.

Gary Nachman

were supposed nets. XX%. XX% around to They gross to to The be

William Peters

That's correct. what Yes. getting. we're that's about Yes,

the on This So Primatene - on and very we're is also, you remind the a I'll high phone margin gross product. since subject.

Gary Nachman

on comment Just Last on couple And this now Okay. year? quarter, at comments, we And When be an then $XXX consensus naloxone? any around that be resubmit Could just a fallen million. able more. out? where will it's there. your update based have to intranasal sales

thinking So that? about what are you

Jason Shandell

the Jason. start out I'll with is This naloxone. intranasal

some feedback that resubmission that further for analysis, on believe, track, remain for the We working I've do would And are based So submitted, consensus... regarding I said on data the in early gave from we XXXX. we advice they the be on. in calls, most FDA currently which likely then the past but

William Peters

to way last in consensus, of that that the something. the that too some If we indicated previous were thought on comments. which off last little I high, they said then thought the or we have why kind were And had would we I sales prepared said call, estimates a is in my now, call high

pretty saying where we're with at I'm those So estimates time. are this comfortable

Operator

Jaffray. Piper from Amsellem David from comes question next our And

open. Your line is now

David Amsellem

a Just couple.

so So the first pipeline. just ANDA on

completed mentioned that back couple on had preapproval months FDA inspections the you think you two the of - I filings.

safe target in injectable? views us high-value approvals coming November. on action you potential maybe pace those mystery got just soon on us the year secondly, on are You update CRL your it dates can understand a those? an is give that that assume And the of And progresses. to as on So then the help

So I'm not - mistaken. if

- So way? same for characterizing dynamics dynamic new the And there? still anything is market you are still that market

Jason Shandell

Yes. Sure.

yes, So inspection, in terms correct. the you're of preapproval

that that date have those. the about some say quite been this GDUFA don't we've out. are call of good did the do typically I same. on we high-value yes, So But time, do year. had I and specific GDUFA a the remain new provide about dynamics, state does them the generic of dates, then in resubmitted last We that feel dates spread we that on we And And the and for two have talking now. terms market would

David Amsellem

on question last ANDAs. one then And Okay. the

now submit changes Just of between to filings the your any year-end? number and on to update you Any compared plan commentary? previous

Jason Shandell

track this be still Yes. on for two ANDAs filed. No to three change. We're year to

Operator

And Wilbur our from Elliot from Raymond question next comes James.

Your line open. is now

Young Lee

hear Can Hello. me? you

William Peters

Yes.

Young Lee

is So for this Elliot Wilbur. Lucas Lee on

It your enter stands? Amphastar impact to product. were Could your how prefilled if secondly, where medroxyprogesterone could well market? Pharma you in in you as on comment on XXX and And it the vials syringe view Sun currently the appears to they First could on facilities issued form. approval that this recently the received recent as share that decide

Jason Shandell

Sure.

syringe. did Depo-Provera, the get So the vial generic yes. With regard to yes, approval, both Sun prefilled and Pharma

specifically. Of our we'll to in and competition given consider that With minor, industry, fully share, to we market. the respect being we share the as to. enter. maintain And XXXs, a course, market major responded those expect continue think fair we our Amphastar don't to see were we of to a they it And impact

Operator

Jefferies. our from And Steinberg comes next from question David

David Steinberg

million I year. back $XX question. stock you First know bought in last

any And take how you early, quickly and it think you but will many thoughts additional I to then peak? got think to $XX it's of million. planned Primatene, full you how I this a years in authorization ramp just using new might of get on the launch terms know the on

William Peters

Sure.

we and year, a of plan So the on specific have of equity million. plans the authorized part authorize that our million the April mostly of in as to are May compensation that. We in to We a $XX we do last wide of over timing packages given the buyback, of year. don't last level that people this the $XX plan did here. We of plan finished offset

as it's we've back - on take consistently other peak three said we really to and depend It's Primatene it's as still was going things. that's far from to stock almost the And think just we believe the there. full getting a case. two to to for to there before, XX that part years of it going So months. price get And the

David Steinberg

Would valuations just perhaps, and question haven't you you what's final seeing current at a active What you thinking? I out then M&A. all. year? active, this reasonable are what's done something probability Are there? know you're doing or And the - less on say your of, you anything

Jason Shandell

Yes.

some are there. I out we think value attractive seeing

for years we things been have As you many where we thought were overvalued. know, disciplined

We used an that some clinical if can And were have be asset settle some move trials. recently. have litigation to also be But to if - for growth, organic an it the attractive seen for cash instance, or there our for we and value excess opportunity, would we that. isn't on willing

Operator

our Gilbert next Gregg SunTrust. And question comes from from

Gregory Gilbert

you talk about in whether whether differences there's filed FDA product the any product, can you the On there also filed, about you that then epi versus filing? product the the and been market? when interaction from talk can since you any the you removed on And are

Jason Shandell

typically XXXX. of Yes. details sued the that course, we of not don't which fourth the But was discuss we quarter timing. of deadline, state were We the by did

understanding have So details terms give into would of in of for that not you can the when may competitive some get we general filed. prefer But reasons. formulation, to that of we the

Operator

Belanger last Needham. question comes our from Serge And from

open. now Your line is

Chad Messer

This I on on Allergy a season the you on coming. I Primatene. coming. spend you treat the prescription since was advertising is inhaling ProAir to is question soon? just in is And season a were think another for Do XXXX, anytime Primatene expect their to of spring Chad be Serge. question had The advertising to lot taken asthmas. for the is, off patients increasing switched the market

asthma or you seeing of Primatene patients some back coming available? now Mist it's So these to hearing are that

William Peters

Jason?

Jason Shandell

yes. So

my national advertising, to months, prepared terms remarks, in the advertising in we said in begin. of approximately So two TV as the I expect

begin to well think increase the of that in demand, running and And time will good it be should we jive that a timing. So will terms commercial.

have - don't it intermittent that goes a of comments that examples directly. prescription to to. point to you well need lot so in without mild then we've we've to of had contacted about fact we product times a who excited generally product like are relief. really, that. by on And many able ProAir, accessibility who and And is quickly them symptoms as to of this such ease have that asthma really and former we're specific seen season, I temporary company do allergy know occasionally social And a media But excited and being respect get just the and they get the with Primatene as the of users back. any when So

we're So do the over-the-counter FDA there an think an we off unmet while now inhaler approved was And it the be need that was excited is and to asthma the market. on only unmet market, that need, we're that. addressing there

Operator

And at this further the turn there any to like questions remarks. now Shandell, call are no Jason of I back to President time. for further would Amphastar,

Jason Shandell

We appreciated the have happy good Thank to really a such quarter. you, operator. and all questions strong of

to everybody want have Just for day. their thank great and time, a

Operator

concludes thank program. Ladies for and today's today's participation This you gentlemen, conference. in your

great You Everyone, may all disconnect. day. have a

Amphastar Pharmaceuticals (AMPH) 12 May 192019 Q1 Earnings call transcript