AMPH - Earnings call transcript Q3 2017 | Amphastar Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Amphastar's Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. All statements in this conference call that are not historical are forward-looking statements, including among other things statements relating to the company's expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, the timeline for completion of construction at the company’s IMS facility, its share buyback program, and other future events. other historical and rather and its Amphastar's operations, not Amphastar's based projections are factors. business, performance related historical current and statements facts, are but on regarding These or similar expectations, estimates Words such would, predict, or estimate, continue, potential, forward-looking related believe, will, expressions intend, project, to other should, statements. identify plan, these anticipate, expect, and may, as might, could, similar are used

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

You undertakes events or can on or through website and reports press reflect this referenced SEC's at conference company's obligation http://ir.amphastar.com at release call no above the website locate information in these to www.sec.gov. or to Amphastar the update revise I conference in now your President. even if new change. subsequent events begin. to information like circumstances Sir, Mr. today's cause Jason the may the Shandell, host expectations you to available for or introduce company's becomes future, if would Amphastar’s

Jason B. Shandell

to I'm joining quarter Good Thank Amphastar. to with My you today look call. financials. earnings turn will third We may the is Peters colleague and and call appreciate with name any the the of our questions you you Shandell Bill Pharmaceuticals Amphastar. you to Bill afternoon now of and joined quarter today discuss operator. Amphastar Peters, my Jason speaking I to President CFO welcome CFO third on us call over forward have. answering

Bill Peters

activists previous to high the year lower our from for the increased prices. to sales in lower the the volumes of million which the from and all to Those fourth million XX% due average of selling quarter. retail both of of last period. selling sales million from million for on third unit $XX.X of higher remember Sales at to quarter both that in because $XX.X almost Jason. retail declined was selling in $X.X for shipments were quarter decreased $XX.X our quarter million volumes recognized $XX.X prices. third year's year. product final to Please quarter lower that third biggest shipments XXXX our in average the we Sales this $XX.X million you Thank market enoxaparin saw volumes and enoxaparin last Naloxone covered

we sales epinephrine As quarter. million epinephrine the discontinue vial we've to a second This previously the to XXXX. of quarter third product from decrease disclosed led in $X in our of million had to $X.X our

share Momenta to due volume to Our Selling, $XX.X in finished distribution, from million year's with quarter $XX.X million materials. increases last Sales million to and vials. was lower the per million quarter million $XX marketing $X.X million XX% primarily compared positive to to and epinephrine and pharmaceutical now third turn quarter. up in other of third In an slightly previous row. million period net net $X.X cash equivalents, adjusted approximately income the of revenues net due was in XXth Adjusted million increased a sales for reported of from in the approximately discontinuation The to back or to from of margins $XX.X had restricted enoxaparin quarter share Jason. trial expenses quarter million million share. $X.X or and increased call previous investments. net increased which in Gross to which shortages to of spending income as to General flow $XXX,XXX $X.X and the development per year's income expenditures due an and expenses the related adjusted of patent $XX.X million last million against $X year. declined from we to on administrative and of comparable from amortization share to increased $X.XX million Research company the Sandoz. The $X.X year. period. to of short-term XX% from or increased a the legal third the I cash, $X.X for $XX.X expenditures non-cash APIs short-term operations $X.XX million primarily quarter will of no for approximately million competitor lead the company to MannKind of XXXX revenues from declined the $X.XX company income insulin the to On per revenues had September and $X.X year's million. margins of $X.XX had profitable current compared to Cost rounds over quarter cash and last to earnings equity shipments compensation. investments, products increased $X.X in $XX.X $X.X reported increase from per million exclude XX, of

Jason B. Shandell

quarter Then of we With approvals, Neostigmine two products ANDA Methylsulfate. received approval on September XXth you was which on of FDA approval shortage unapproved our which Thank Bill. received September bicarbonate FDA for on ANDA a very our sodium in good list. XXth the of one drug we for our third we received commercial

the as review We Data, IMS million U.S. in to was Neostigmine months are on XX, the approved Neostigmine According and ended FDA plan proud especially brand XXXX. launching of approximately cycle. in of generic We Health $XXX December. first by for the September XX Neostigmine sales it were approval

FDA or October subsidiary XXXs. was in Pharmaceuticals received zero by owned Nanjing Amphastar inspected and ANP wholly Our

strategy. have ANP important is previously integration for As vertical our discussed we

We heparin outstanding that ANDA the we which for DMFs to a for there pending With use ANP have the We quarter remain agency. approval ANDAs this target as well file respect that no FDA we date supplement the have year. confident have as receive pre-GDUFA an received and we alternative will FDA. have we to fourth for currently action two are on source been expecting the with ANDA from approval as new a questions

continue regarding to Mist, human communications these protocol to with FDA small communications study submitted more feedback. Based on we the for Next, agency. and plan our we positive factor have perform Primatene one have already

at NDA speed has which this half XXXX. expect the been the handling agency's Given the FDA the and perform matter our we of first to comments resubmit receive to study in

to call turn to Q&A. intranasal over to to plan. I update discuss respond the With respect Naloxone have FDA a the have Finally the month for with operator meeting to formulated scheduled to begin plan a this that the we and CRL later NDA our the will now with

Operator

Instructions]. [Operator

Our first Elliot James. Raymond question Wilbur comes from with

Your line is now open.

Elliot Wilbur

Thanks and good afternoon.

factor for comments work to something study. is done? First with Jason clarify previously the just that that's Is asking you just your and that some that new been Primatene Mist to at or looking question or additional respect verify human around

Jason B. Shandell

sure. Yeah,

nothing is done. it clarify really it that work So new, the was previous to is

analysis On on additional we the and last call revised that have I label. based a talked the slightly about with that some submitted we data risk had

be and we perform And about understand in at with label so very tweaks point been minor next that our they candidate study more label. had we FDA much of should it. fast. is the the to these the suggested this this the the should the as in be with planning but half we long it's that can are we've first of to feel But confident really one year increased discussions as this study easy to care And they last study essentially product small with the year. on so this over take we NDA very are communication again FDA and haul a do feel And resubmit we that

Elliot Wilbur

update can returning there and intranasal terms what Okay, also is happening product Naloxone status in to that of on you respect market? then to with regarding us the of potentially dialogue just ongoing epinephrine and

Jason B. Shandell

both issues CRL the to Naloxone so Sure, and volume. were the several there with respect intranasal in device the the including

those We've essentially address plan put in addressed up come and we with we they the internally. what together agreeing are CRL have issues. to a those acceptable we So I be with have believe issues to the plan will mean very FDA. stated a that

So month FDA and a discuss plan forward program. with meeting to that with this we then move actually have the that

Elliot Wilbur

epinephrine? Okay and then

Jason B. Shandell

our was of filed So previously had FDA. we with products respect with disclosed the to epinephrine, four what that unapproved seven we've

which those bicarbonate. of has been was sodium One now approved

are there three on file. So

whether the agency We with or on vial epinephrine on epinephrine said not but said publicly and vial we not the it one shortage have not be that that's are back. continue the we file are currently is but vial we disclosed to committed syringe the have have we will back of three but the those bringing we whether on which prefilled epinephrine file bringing sell is to drug

Elliot Wilbur

pre-GDUFA how year-end, in this but what's apologize, and of approvals the may comments is then Okay, many file? possibilities before to missed question, I with on that I are status last the your then respect prepared still have

Jason B. Shandell

an important is It question.

in quarter. fourth So, we on have goal three the shots

dates pre-GDUFA of fourth addition said do One the fourth are And as the quarter that GDUFA confident that the as date, there's in and questions those I no have quarter so be quarter. so fourth we will have in a outstanding FDA, new to is we two target product date we with approved the well. action that in target

Elliot Wilbur

Okay, thank you.

Operator

Wells My open. next line David question Fargo, comes with your Maris from now is

David Maris

in expect and a filed any year-end, end in have of of more big you mentioned few with so A by the of than are usual filed many you ANDAs, be respiratory average XX your have three of those -- press that products release the four market to the Of have billion, afternoon. do product, products. ANDAs any very per And then a -- mentioned by pretty there filed development, the be also there products so you FDA pipeline some proprietary the on ones cap products you market that biosimilars have Good market are first have $XX you you'll value must you think seems next larger lastly those you questions, now, there? that how XX of year? much to in because that

Jason B. Shandell

correct, all good Correct, questions.

know, are filings more to start issues delayed We had this in terms me that slightly. intended any year not year. to actually going external with, there of let supply more were but file this So some you we us

So file year one respiratory. of and those next we're to four Conservatively will will looking those to applications be pushed year. be next

David Maris

targeting are larger XX you I it and of Great, and think all one is of fair is the it? the or it like big things up that's much taking that to bulk billion Advair mean

Jason B. Shandell

side several correct inhalation that ones. ones And in significant you're on big there's Well, the there are some there.

So, it's not products are just one, there very that big. are several

Bill Peters

are these Yes, are three $X billion. over But than them. probably of million, almost $XXX that more there all most is of

David Maris

much. Great, thanks very

Operator

Instructions]. [Operator

question comes David next Piper Jaffray. from Our Amsellem with

open. line now is Your

David Amsellem

have your expand to intranasal of on Naloxone given just to could the assuming adapter, a the product first sense just you sales you free offset about that needle that position a could Thanks, think you Naloxone how you with see you intranasal opportunity to so getting product commercialization? get already whether nasal talk just wanted so overall that developing the get actually market a

Jason B. Shandell

look can a so and in Sure, from do us. for the we at the FDA market think better. taken it and the expand that make comments CRL think actually the are We've the reasonable product we detail

there's and an So an for discussion OTC well. think we we're looking to actual about having do approval that as opportunity also

with still a think see elevated intranasal approved we At that's to first least emergency it market we especially in prescription to been a point currently given current to adapts lot there's this at [ph] moment of more the responders the and clearly product their product. that come. states expensive. national overall and expand. and arming that's more there's the does are market room FDA this However, But has continue We the one

go further to FDA but with units we see can up expansion. we an product we continue So see improved the that's think approved

Bill Peters

penetration say because And that's I retail the now. expand new now very little have the think right right a market I more would is have of the we retail think that, I'd in on to where expanding And fastest product market. the just that's

Jason B. Shandell

does where many that product tie the and into comment even orders. prescription OTC standing right have of the That's

easier to prescription. and So than of your typical behind it's get sort counter the

so already And OTC. of that they're sort quasi in

is point there. opportunity on retail there's So Bill's

David Amsellem

of Okay, this with Primatene this got so earlier factor up work? I I nature thanks study, human on accomplish FDA human to and the and you're guess have on just what and I factor apologize. hung just latest secondly trying Can discuss may the you missed on the elaborate what

Jason B. Shandell

OTC you shaking and study is this. and Sure, I want so clear it have to made the to The comes sure factor achieve very and human to people this the it all again appropriately. the that down shake most to some made that in as earlier we very, very as just to use understand critical it we've which they crystal fact which label monitoring easy be important the will can need is step be said and changes label

more things getting two tuning it were where that that's priming it, of other issues The for are this fine we're last difficult ready and a cleaning use. for little study and it

have FDA would issues do as that those has two that not factors so as data we However, at are review those critical and be the after shaking that other looking agreed shows analysis risk less score our purposes may human important studies. review we our factor be the but But they they be those of once will study. still bench for determined ultimately to

David Amsellem

really instructions instructions the be goal wants here to adhering here? that's what out clear, FDA the main teeth is shaking, just So to to regarding

Jason B. Shandell

bench the two they and -- that they'll being they those things. once the have just They see less data out we complicated Yeah, much want which application had priming science believe been the so review we we after but I emphasis the factors. based resubmitted and tease critical. And may the mean will start cleaning the that we two put other to used is still to a that are a model onto statistical past had company -- in very

more So now straightforward in essentially will be this study nature. qualitative and

and rounds vendor, we've studies discussed factor and gone confident with several through of feel as human So we're they well. these and with confident outside the communications our recent most FDA obviously we've

the that communication know this are before been hopefully be has really that study. the -- enhanced. So believe will said we I but last we've

feel we study. of exactly last have in understanding better we they this what So a want

David Amsellem

Okay, thank you.

Operator

next question Gary Capital BMO Our Markets. with from comes Nachman

line Your is now open.

Gary Nachman

Hi, afternoon. next bicarbonate Neostigmine and much contribute fourth year. into How good sodium and in the quarter

turnaround next your to market expect all Just Primatene talk a product? market resubmit about be of does in dynamics for that be that six to year, change first those half it opportunity the at the would if you've in you delay and month with then been you products what that and experiencing mind

Bill Peters

products in So from me $X selling months bicarbonate. a sales the product. new already let so year And about product start first the million with of had there's product. for of we That's nine come the that no sodium that where we're revenues that

an just come is the thing. a bit say on are that's generic to because in. So Neostigmine fourth to It little we hard ongoing the

fourth always these and large we in to market markets. hard filed So was while relatively it a when it, it is the be player

that So, be remains seen. to

will of be to going company change it I incremental, not think we say to while So the year. am it's fundamentally going the outlook earnings next

Jason B. Shandell

as reviewed But a after Primatene we out a to would do lot any believe our be of control they've the of it review. the and we period And already of terms review not confirmation be data, the gotten should resubmission. and then period our to month that a the down two we're to with review we factor to is what need issue have with believe really human we discussion study in have because on one But respect will FDA.

especially checking had and foot the date and it among done generate by two has recognition in the traffic but marketing, six same a that strong are was it's review. And be that it research them. we're still So, has recognition. retailers market it very had showed the because long the some off engaged it market of us a time terms will marketing And GDUFA name it it been that in we excited name but the month last hopeful Prior for boomers. company does be constantly for the plan to marketing could baby that with a months

of well. the supportive very product they're as So

Bill Peters

to putting with asking it us can. remain they just to had even of retailers about the They shelf a And the soon on plan. committed and meeting it this the discuss week one as as

Jason B. Shandell

And very supportive.

to I one the had mentioned GDUFA retailers the of looking three on putting of think I a actually it store. at was prior call previous date, sections last the in

retailers. the for important is it So

Gary Nachman

trend the couple hear will how a quarter? do same court's third bond the the the decision on Okay, of expect saw Momenta/Sandoz that more And quarter, and you level the gross we litigation? just fourth just, then from then margins stay at million sort Jason, into it just will $XXX when Bill the in to

Jason B. Shandell

start I So the good will with litigation, question.

briefing before October So completed precise the was been conduct and a the the first USP. issue on briefing very actually we've inequitable XXth, regarding

So point any time that I'm never on court. time, the final was is one at you so not step, the invalidity believe The this enter the of next judgment. delayed with at Thanksgiving early year, our next year around see that judgment. defenses. so But the equitable It XX, end but process. they regarding ended we final I the know October a predicting That's of could any briefing

have also in antitrust We we're We've bond. been case. judgment the waiting our move the judgment. very not proceed the comes moved final final we for will then Once conservative, on on the and with bond

Bill Peters

third the trend we and relatively be higher gross rest But, that On small the was The be flat much the will the a be gross compared should in we to the as believe revenues quarter. it revenues December a have Neostigmine of amount the we the pretty quarter. margin. margins, of at get will in third same business should

Gary Nachman

thanks. Okay,

Operator

And Raymond James. question Wilbur we Elliot follow-up have from with a

open. line Your is

Elliot Wilbur

movement those a little in for just off million can XX XX maybe like quick looks trying bit reconcile to the about Bill, then two? you talk just it quarter. OCF but question or modest sheet, the you balance had came just the Sure, a million Obviously cash positive

Bill Peters

Sure, in in quarter. $X.X buyback so we the the program about spend million did

of in the general it So when stock rises. future was lower buy very and than and when it be active believe we we less buy the it that will in it's

the we the low for relatively was overall buyback. in very so active stock quarter So, did of most the

still levels, that very in large some the changes we have both cash in The other France. China and capital expenditures thing

So those cash drivers also are change. of the

Elliot Wilbur

question of see us a of the sort little bit versus for space. to high an a terms I of certainly would perspective equity for then wait when attractive company potential in return got market current of to And us valuation lot a your and you've both assets of follow-up just some the aggressive external give more what opportunities, of to like as opportunities environment, maybe other seeing acquisition think this pursuing in growth in the BD you, these companies terms kind you're come on be many of you

and to there's of the kind of over seems like cash got lot it a You've surface. assets starting bubble

kind what So or just there whether to resources of assets? dedicate curious towards opportunities we be thinking you're about as of a you not seeing and pipeline should continue your some lot external

Bill Peters

we Sure, always we very say did have last so we looked high we internal of thought that been But that somewhat bid on is activities. there's first because on But focused of on said there the have of would I'd with easily are even our are our not things bidder. things were that a come we are things that then really we our couple sort way businesses. -- we things though even that those rates the and are that probably digestible. on some more were not over attractive that But get synergies that And they couple all we focused BD just pass than found very at R&D the reasonable. quarters and are more at growth we've we

or of companies. opposed as products So groups sized products either or to they're reasonably individual

as for when are by now for prices relatively So high haven't our people those things of that's down those the things valuations the think and that still expectations remain willing to we come that I seen the trading significantly assets. evaluate come dispose for we of been. to are focus where but things those look to are And has they and committed

Elliot Wilbur

respect Okay, about Mist, FDA of the rescue usage conversations the particular and clarified part with mentioned conversation then of of think some for follow-up calls or not if some dialogue and the it agency interpretation to just question have the to issue you FDA one for fully exacerbations as has on on appropriate an I intended confusion that been wondering that well Jason acute and product you based Primatene usage. now? recent involves intermittent past I'm think on is interpretation that [ph]

Jason B. Shandell

Yeah, it point. is a good

fact the consistent very point issue dosages. person So and we on had we that through monograph good that talked I up through delivering was clarified. market where important the made currently It OTC discussion in there's epinephrine more has do that the of believe gone was about nebulizers and meeting trials our course in clinical an much the and Primatene is in a

asthma. lot they last get the it that they clarity got of clarity both to T. made FDA sure and market So and intermittent because severe our clear the cross months company I I people may product we that it's right have meetings we every want more six is that to dot in albeit asthma the to to as and want think that and try a and this some But they a to want over controversial every on it make for perhaps receive that just use the it did is -- indication

thus need extra to and be do So another cautious study. the just

Elliot Wilbur

Right, thank you.

Operator

showing over Shandell I like for this remarks. closing Jason the At turn call am further back to questions. I Mr. to no would time

Jason B. Shandell

This operator. Thank much and a day. for everybody our you. hope call I the good day very you a Thank concludes great evening. has

Operator

thank participation your gentlemen the and does in for Ladies today's conclude conference. you program. This

disconnect. great now Everyone day. a may have You

Amphastar Pharmaceuticals (AMPH) 8 Nov 172017 Q3 Earnings call transcript