ATRS - Earnings call transcript Q4 2017

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Operator

Ladies and gentlemen welcome to the Antares Pharma Fourth Quarter and Full Year 2017 operating and financial results conference call. Throughout today's recorded presentation all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions [Operator Instructions] I would now hand to conference over to Mr. Jack Howarth, Antares' Vice President of Corporate Affairs. Please go ahead, sir.

Jack Howarth

good and Rina you, morning everyone. Thank on we XXXX financial morning, copy for the be Investors released under at achievements our year full of found can release and section. quarter press Antares' results the a website www.antarespharma.com fourth and This the and operating recent

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and in Form review in slide the growth the the to SEC updated and expectation available filings of on Investor periodic to could the two of company's Antares' filings to, of as type on these time NDA including Securities letter also filings these and materials. to of other website A the or development, XYOSTED. the differ our we recent approval outcome factors or made timing XX-K ability are Antares' to Form and identified X-K and and the documents results events. and the with on today's presentation encourage CRL; the Commission. Factors with clinical new complete adequately research, future the CRL; of company's product FDA; deficiencies that the to respond the XX-Q with you Exchange response about on and Information the statements section are other Links and CRL; trials OTREXUP, Makena, conference resubmit not time revenue and from and is performance to Forward-looking opportunities, investors to as XYOSTED provide timing resubmitted or the any events information required any but on these statements. are ability statements action, company's The undue which conference in FDA the call financial cause Antares this providing to the the new responses of including undertake forward-looking by Future date from and current to cautions results hereof, the otherwise. and contained after limited statements circumstances XYOSTED does obligation and a XYOSTED to not actual FDA as forward-looking update to forecast of company call future of Sumatriptan, of include, today's not any or information, reliance this date approvals of timely result responses the law and revenue as except company's for in acceptance and place meeting

Vice Bob President and President Executive the and are Apple, on Powell, Fred Chief call Chief me Officer; Joining today Officer. Executive Financial and

progress, fourth Bob call open presentation, our Bob? the the Bob four, agenda on operating Alliance we Bob for will a I'll will Fred Apple. questions. the present will and results, turn give quarter After business begin the over now financial update. will Please three. lines your slide number an now of to the today's recent you fourth to slide turn quarter then call full year and and review Let's with for review

Bob Apple

a products on this proprietary and reported fourth chance today's good results We revenues Thanks to partnered morning's and company. and press the $XX by all release, quarter operating joining us of of annual highlighted had to which for product morning I record our review devices. you revenue everyone Jack million, call. sales financial mainly hope driven

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now consisting auto rights the seven. million million. four purchase injector which device year, a the The to of Moving will ZOMAJET installments, be of we upfront was $X slide of worldwide for the last installments, to by $XX.X upon needle-free for conditions. Ferring announced In totaling quarter. payment, October additional be paid believe of Pharmaceuticals sale subject million, be was in in completed We and payment to transaction completion $X.XX be will closing earlier XXXX. $X.XX and milestones can paid will received October the end of customary this the a the contractual which million Two price received

to transaction. several had which asset, The averaged and receive sales until will to products of those continue completion non-core sale on approximately in strategic will allow to ship near-term the resources annual ZOMAJET legacy Please $X.X on this royalties company million We past our eight. the pipeline. revenue partners building better years, three number to of turn the slide for objectives, including the focus our

commercial and share market I'm believe $XX.X injection, XX% to fourth and revenue increased side In a the the our fully Sumatriptan XXXX business, and contributed XX% pleased to that now presence distribution achieved the has packaged CVS commercial full of report quarter strong profit Health with that the Walgreens to existing remain acceptance market in sharing market our TRx year with strong share. of pleased XXXX, Teva, to full a Moving Sumatriptan XX% share has Symphony we TRx sales the according from to the the Sumatriptan Teva's of generated of partner, year from the combined Solutions. million. of Teva's We distribution for of auto product injector

full Turning the nine. of over increase with revenue the $XX.X growth steady number XX% year. million, year fourth increase $X.X quarter revenue fourth now its a million, to of of continues of and OTREXUP XXXX XX% over last slide an quarter

be targeting auto coverage. have salesforce insurance in adopters where areas Our will good we injector

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our update give will complete get slide on discussion the process. into a XX, to we brief response financials, before received FDA application, XYOSTED on On new from cause increase concerned Based XX, with XYOSTED a turn two regulatory and in letter, deficiencies the on the the could clinically FDA, data. related results from studies with to our Now, detailed CRL beginning pipeline or you we which blood I identified a clinical clinical that was pressure. October please the drug filed XYOSTED meaningful our two

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product pipeline development of work to opportunities have on add a opportunities. conducted Finally, potential we've to and significant number reviewing amount of proprietary these been our a preclinical

a I'm with promising progress has on development have as well our second device our developing encouraged a made drug team very candidate identified as lead combination We products. next the proprietary candidate.

add Fred year-to-date who this I year. a would to now candidate discuss our Fred? call and to half to the in expect turn to will second our the fourth lead over of pipeline like quarter financial results. We

Fred Powell

Thanks Bob.

X%. the sales December the products December ended XXXX XXXX. XXst, for million in XXXX the by driven Total sales of XXXX Product to XXXX compared product was proprietary the for represent the for revenue comparable on increases sales year in XXst, increase slide same full months components to full ended $XX for quarter fourth XXst, the period million device for compared at The partners. or begin for $XX.X million to XXst, million $XX.X period fourth year revenue December XXXX and XXXX ended the looking revenue of were ended million sales of $X.X devices XXXX. of XXXX, over our to revenue $XX.X $XX.X compared quarter XX XXXX and number $XX.X the details Product Total by XXXX was in to year the our in in months OTREXUP for XX. AMAG's million an were to months three XXXX, was of million million $XX auto the Sumatriptan three Let's and Makena. December the $XX.X to for increased commercial year XX% of million of and revenue our in of year over XXXX. XX% products XXXX million sales while over injectors OTREXUP for of the full pre-launched $XX.X revenue of and full increased Sumatriptan compared XXXX improvement

and The XX the months was December million of over XXXX fourth XXXX of year $X.X fourth for development third driver Partially was increases full Teva's XX% sales which Development months for of devices decrease the The December of $X.X revenue million quarter for $X.X was development $XX.X to for XXXX of reused auto to ended growth $XX.X prelaunch revenue programs. XXXX sales full compared for ended to significant increased for the product. quarter reduction XXst, Makena, revenue injector a the device compared epinephrine XXXX. these to a lower year the pen primarily million XXst, XXXX to the million result injector in three related XXXX. offsetting in generic was compared of XXXX in revenue million product with the

development reduction fourth the quarter XX-month costs million sales to in reduction in for to Operating the marketing three operating the compared $XX.X slide our now to the for in was external $X.XX clinical to $X.XX fourth to quarter per and million The year for XYOSTED, of a the in in and and comparable in primarily X%. as the full $X.XX XX. XXXX as period of to year related an due quarter compared potential XXXX XXXX the periods XXXX for expenses reduction and of $XX.X preparations by period X% XXXX for of with expenses a comparable of a Net $XX were was of increase in for full compared compared XXXX. fourth loss million the million of launch the associated and XXXX, for Turning to XXXX share XYOSTED. partially XXXX, initial decrease offset $XX.X $X.XX loss expenses

in quarter received Bob? As first equivalents, $XX.X connection cash, Ferring XXXX the back XXXX to from And did the of compared earlier, short-term million December we $XX.X to the $X.XX million of with totaled of cash December end XXst, and sale XXXX, cash XXst, at the XXXX. include Bob now the ZOMAJET. balance mentioned investments not Bob. million at turn I'll of call in the as

Bob Apple

Fred. Thanks

up mid-to Teva AB-rated potential with EpiPen overall review of for under and continues generic upon a to to according single-digit by launch. a we with a high potential for slide for provide for a Teva epinephrine, and be product. visibility working need XXXX product of towards Alliance a the will of approval, I and and device in dollar XX shifted our on update injectors wrap is fourth the receive $X.X to Teva XXXX the is auto on to number we approximately business. Antares Let's Teva, milestone sales. as are FDA will a an FDA active remains royalty assuming shipped $X.X payment margin to Teva, epinephrine which well approximately of the amount the turning a million approval device these closely million Antares approval And with by ANDA, has on Total a to-date full received There perception to quarter FDA with an million. public high worth XXXX. as the net Beginning $XX year for prelaunch sales

process the to work to approval, for now ANDA Exenatide, to pursuant continues the through to regulatory Teva FDA Turning pathway.

means has on and to following approval, to AstraZeneca Teva work Teva through single-digit once been has first-to-file settled, net and exclusivity respect status devices an therefore, continues litigation and ANDA the cost sales Antares believe a high Teva to post-approval. pathway. With has a which product. all process of that Teva's mid-teen launch that market the XXX received supply FDA the with margin Amylin royalty at that days approval. We can regulatory they recall You'll receive plus FDA will using Teriparatide,

U.S. During Teva and settled. quarter patent the XXXX, was litigation the between fourth Lilly

in clearance a settlement the to by Outside of However, and Teva prior were the EU in is completed U.S., patent Europe launching. process terms awaiting disclosed party. not countries either registration in decentralized the XX

As we Exenatide Teva for case with days marketing approval. post is Teriparatide the first-to-file and of status that XXX epinephrine, believe and has exclusivity therefore,

We royalty to will on Lilly mid-teen net product. of plus Forteo of receive and million XXXX that Makena $X.X finally, as We're with launch. we AMAG supply as timeline sales receives quarter royalty particularly from injector following high year on million in has for anticipates fully U.S. milestones. product to full supply devices during we'll XXXX. global a to and the to shipping full late of addition We're devices billion sales recently their and with continuing Antares I their the $XXX at with risk March a Teva packaged on a cost XXXX March supplies XXXX additional packaged launch. pleased sales be of high in launching product fourth certain FDA approximately in fully we coming prefilled am sales $X.XX And to devices increased a finished Makena in about at mode plus as single-digit sales-based Teva's Overall, the AMAG, performance product operational aggressive made this progress well a that a XXXX. net the reported low to with Makena single-digit payment AMAG double-digit the they collaboration can of injector production of to auto AMAG the finished so margin of with auto the for margin support approval. Antares excited meet ready syringe shipment. order produce is of in produced recent subcutaneous AMAG in approval. a cost

XYOSTED FDA forward. of receipt to a While discuss the had path with the disappointed the a constructive we CRL, with meeting

remain excited Alliance to our about continue opportunities. business We near-term

anticipate we in due forward, approval XXXX revenue further Makena. Looking the growth recent part seeing in of large to

for operational be remarks in products open regulatory concludes I by the also you forward look for session? could impacted currently our the could for the you revenue to regulatory XXXX Thank partner investors your positively and That ANDA at our and our now to addition, pathway updates prepared today. attention, question-and-answer lines XXXX. FDA. Operator, In filing providing the

Operator

will Wilbur Please And you. take Thank question ahead. James. Elliot [Operator from go our in first Raymond Instructions] we

Elliot Wilbur

you. could commercialization really just with first to is current about I commercialization Bob, company's morning. a respect My Makena. Good and, talk specifically, guess, Thank efforts maybe little question more bit you the readiness.

AMAG -- requirements XXXX, Sounds notice purchased via some company's advance is full readiness your supporting of you maybe what already you at think there. could in but how don't I like product orders. the just terms that gives you visibility long about and know of whether you'll or sort terms in be for talk product that not capacity or requirements launch of or of

Bob Apple

Yes.

Elliot. thanks So,

as like, we did devices XXXX the for As us prepared fully final has to in the the so I final the labeling, manufacture the Like get once forth do after the what of obviously ability give or approval AMAG the are And was far anticipation of had support to the the the agency mentioned, production packaging launch done complete, capabilities, inserts review. AMAG. we Makena and completed our approval. to package

that's what we're so now. right doing And

PIs putting and the shipping devices, this the the month. into labeling are those be box, we'll products We

there sub-Q, their potential get launch a this line there is AMAG as much the year, converting is switch we're generic here show because new patients their up think that that in sometime to product IM the them knows, strategy, a and value more to we're and is important of as see they for and which do from and everyone possible. really a could really well I strategy as to as really ready getting needs, produce current willing function out be patients AMAG's or and hopefully the So, of to meet

Elliot Wilbur

Okay. you, a as Bob, question follow-up And then well. for

if devices. sort of opportunities generics disclose proprietary the filing? with partnering BD company's filing wait side. your hear of companies ready lot opportunities Obviously, It seems actually couple And year. moving which the this be of the have to like Or many a delivery being sort the the of point a But specifically that might ranks explored where are mentioned the biosimilars, IND this opportunity I'd complex on that? You new on set you're kind in which increased at terms terms priorities on interest. of of or kind sure I'm that dramatically. additional require possible of perspective sophisticated in side, of to into the wondering of when partnerships, year. for really the to area would just get do more we -- and be of we of all IND curious for Not

Bob Apple

Well, and first your about question first let Sure. me tackle their our proprietary products development.

those that is so urology opportunity other neurology well of develop so the we that on. we XX approved. to for that with we And the in correct then we until believe the obviously, neurology file as is area fits in product focused -- an we've bag IND a believe time force we're because, mentioned will -- we will that But public sales also basically that to we're could franchise. really obviously, get not numerous and filling there out that ultimately we going important. The it's are And working in is what reps, with urology disclose a You're have Street or is XYOSTED and what on products

development say of the product our control So, that key we really far our own important business. We grow as company. that's the as of all believe -- for focusing. having where strategic to products really at product is control Developing we're can having aspect that is in launch process, our of continuing

devices and the expect in business get interest Alliance near approval as partner, What that of Teva, we business lot a that from our as in opposed of other important opportunities and hopefully, potential in bringing That's I the some -- injectors. the you recent regulatory approved will will would opportunistic. -- the And Makena think an really getting future, product with approvals that's our frankly, value say, the with partners. the element. bring I the Alliance as the process on to is that auto We

product think I that this combination that navigate our major organizations area is bring help have the a are that into value we we partner. ability think But for great to FDA the platform. moving really process I to complex

So, commercial again, additional we -- other OTREXUP; create think developed we our I own; as filling focus products: into in indications. And is our developing XXX% areas XYOSTED. the bag on moving Sumatriptan, obviously, or certain is presence and then like a

Elliot Wilbur

when yielded Okay. testosterone time And testosterone heard you you from this terms a XQ issues dive as update company briefing reinforces one forward your class what in of anything an very just sort or a between you with, But prior actually of today, the in do some well, class. then guess are from just we a The around FDA And in final of submitted wondering the Bob. observation issues? perspective, that receipt or if your you obviously, altered on last kind guys get meeting. of the we'll guess specific deep at document. as a I to and the product had path update exercise, chance XYOSTED profile looking Thanks. question for or a and a in we're detailed I commentary and more dealing of minutes from

Bob Apple

a data why it's from we briefing that book developed, that that function I approvable. mean, we I think supportive of Yes, as believe the to the really XYOSTED is NDA

stayed testosterone. and opportunity a good for once-weekly the products, we it's the at of And think patients very same. product look so to when attributes We a have the physicians injection

the patients XX is did I It data, an physicians. extended in that which peaks products, PK weeks, looking were and curve they key things focused remains see as those. AdComs we one on gave the was and testosterone oral was how difficult to is very when really –various of it and IM they got PK patients think, over for for manage the it held why were thing a valleys of that at for period with up important was Our testimonies with injection and time other they flat One the to that obviously same. learn alternatives, the

they and who think in discussing briefing that the potentially we've very product positive are and our I there. it so have is are so what still patients -- still a the attributes And AdComs positive hypogonadism. forth that in I for is product still -- mean book in learned

getting to those the committed few we're we'll And the minutes, the meeting to be of in able approved. earlier said have the that, I next with so And disclose a to and product weeks, very tell that was. in that what we'll like what again, outcome And productive able happen. call, those going forward are The to Street looking to we get were collaborative eventually to to to meeting be approved steps it was and XYOSTED once and as getting

Jack Howarth

Could take the we question? next Thanks.

Operator

And our Anthony next Jefferies. in question comes from Petrone

Anthony Petrone

a when thoughts peak obviously, for that going those point just version given product you to The this lifecycle a discussions this forward, are Maybe on estimates there and maybe plans few with in morning. their little achieved? out in and just your any thought share brand Good the on sales, Maybe pricing pipeline, Makena? Potentially, generic, couple Makena on for bit jump but the you. maybe on of pricing anything but sales we'll AMAG. Makena maybe what a others extension. If subcutaneous there are there at there. for Thank Can is is then Thanks. begin into subcutaneous Street there a on peak declines

Bob Apple

Yes. Thanks Anthony.

IM a an is the injection, going though it want has so well that think a gives to believes and to overall pricing, injection the play parity possibly payer as the typically to IM Obviously, IM sales has the far as generic what to AMAG for the as discount their make that Street a a relative and standpoint reason be they into best what is, AMAG large to to potentially obviously, there's best And keeping price and for as communicated in they're injection. to product believe from can. number achieve, opportunity their happening generic the they coming at to this as sure particular, switching are price even current product the that As the at advantage, the well. opportunity to that, the to they barriers of us advantages they the the parity no is they as The strategies that price want switch, with that

are As $XXX that a year, this really or injection, market one hard tell market versus could or the the CVS last expectations as in our that, did be, as their the comes is compliance But with and of it's injector that I It's do about around overall, traditional pick expectations product, the given and to the all patients, stressed market. your you will IM obviously which that XX% it's I Makena product. not million XXXX, for different is to the until The has auto generic is potentially the for drug. trends, or even I product buy start far IM to Walgreens impact product goes AMAG a that what AMAG can what or for as what sales you or bit space, bill ultimate is Makena predict for of potentially so different an that guided I is where believe had is patient generic, given AMAG think a payers. to Street think up see What this it this around difficult predict down. AMAG's better extend the share far But particularly has think if even to I a

go buy to the patient. of maintain for and of product basically you that XX And an course that obviously they vial for the around your doses or as advance patient the they and dispense use in to and course doctor's, the were XX therapy multiple is go to therapy, vial, individual weeks. product over single-dose have You the they

a it's it's and market to a physicians and selling think generics to to go so traditional into isn't -- CVS difficult, Walgreens opposed or I potentially, market. as so And believes difficult forth. that AMAG selling They're to that for

market they a and that, this just or believe a grown again, for that at continues guidance partner a with can they -- a done think and continue commercial product, we least product strong commercial we at that they've hopefully that to term, generic hope we And the the the Makena. can growing the But in AMAG that generic of thing and on if being we grow that could success is with if product them organization, barrier, may good commercial nice specific nor ago. great I that a product one good in marketplace. their have in and see So, possible, itself, a haven't job they count purchased erosion market. dramatically decrease comes since few that, to -- on And maintain near years least given create and

Anthony Petrone

CRL, Fair XYOSTED -- occurred I to FDA on very that then of to weeks specific risks. maybe in at couple that's that the your and pipeline, that move on meeting, what this concerns anything the that maybe elevated we're the point. three pattern helpful. circle from to up understand away around particular Thanks. But depression, here. the maybe enough. on suicidality from the sort A Maybe couple comfort those a how out level on just of meeting the And walked ago, hypertension, that on in the and holding back a anything FDA specific came front? thoughts meeting

Bob Apple

topics February. But outcome disagree minutes is was. Yes, or we thanks writing the the -- we with I the which different official place. the in until until understand meeting. from been we've meeting any that walkaway release we meeting you get what the days, of FDA, Anthony. we you get open the in typically, discussions give specifics a forward to those the going The when CRL, that very address get give the about on the that of any concerns we comment XX have Statutorily, two until could Obviously, issues We're on believe that in during case. them, even was the they Obviously, think receive as had those. we I -- and not the or don't what ours, meeting the it's But really to give at of they were was can't path be and FDA's issues basically and X-K which we within minutes XXst we'll they meeting XXth press or perception us -- the FDA's they the on to than day. presented once as that minutes either their minutes as far

communicate those able minutes what path to we'll Street productive, so reflect a and time was and that that. on The was is forward for collaborative And it get be we're we'll again, the to But hopefully, XYOSTED. it meeting, the hoping

Anthony Petrone

last one again. on just Thanks EpiPen. And

generic little Just the in an shifted bit, to a a alternative device easier on come seems, there late making bit it a guidelines with November. version for

maybe on faster Teva. collaboration calling it so be And there So just those know an they're seems but a Thanks be for I in the should again. late it given little will update now, pathway a with bit still color more XXXX, just November, changes helpful.

Bob Apple

the Teva out, we give the believe those of that all the file. in the think of or we continue Teva were the that devices answers of the And -- we can And to I launch. that the addressed we mean update or CRL came XXXX, -- file in you only that is that end ship guidelines items throughout I to actually Sure. a anticipation to QX, a we're product an really hit And a fact a comprehensive be that the said launched. launch Teva all. It's they launch. But would they again, obviously, difficult March. It in received was or their is QX and approved for XXXX that opportunity ago might hasn't in the changed still guidance answer. to at get to so originally and just they year Teva clearly

support we continue Teva. us, And so to for

approval until the for can't comment. -- it's FDA that, any. and are, we to on have in if it's weighs as But sometime us steps We what in really to ANDA an XXXX. the difficult clarity full Teva's It's expect next

to for continues or the still do be it'd it'll could in the still so that that AB over given continues I for we've that's market I And ready large And has no launch, to think EpiPen And very be that well. received large $XX very at million a us. key and -- already has opportunity does launch. which, be is the be one substitutable devices can again, mentioned rating, for quite a all for the again, and anyone And because, us, quite and pharmacy. market believe call see, could be a and to-date, of large we market we opportunity AB-rated for as meaningful supplied Teva our with there

Anthony Petrone

Thank you.

Operator

H.C. Our ahead. next Livnat Wainwright. in question Oren go Please from

Oren Livnat

questions. I pile couple the taking to onto for Thanks a topics. guys. Hi popular wanted of

all color, it forward, or 's about done, and package for these versus the I your to based about stacks us same I what your understand know think waiting some do companies we these least reticence companies too of package? others you're commenting safety beyond at maybe they on what different XYOSTED, seen those forward what how in struggling you know ambulatory on studies data AdComs mean, you is your or said on be publicly, think pressure some some much can area have publicly not? path think path therapeutic public be and give saying. is several versus from forward have what their that First that But comment might And that. others just up clearly, you you and minutes, given your we've what that Maybe you just I'm what could catch blood I if guess what

Bob Apple

it. if is address issues If areas I that's it, What to about in that from. our I CRL us for are that. it's -- right they've under consider difficult really pressure doing else's profile without orals, Thanks NDAs that, obviously, a that to Oren, Yes. not -- doesn't I'm comment clearly, and concerned to even question. class it's question, now coming the that think because have. But to can we they me is have focused want what is our host really other products, matter products to for it defer a I CRLs on someone the the the comment two that only on these depression. not of for don't safety the other is their and to say those that of seeing of I FDA on blood disclosed even mean, have issue have or review going we issue where and don't

value what we're a only steps guidance be to to that'll give is from done I discussing -- a adds provide productive And I once able what focused had the it comparing so investors. products clinical with And like away it said will few Street communicate they've believe from collaborative standpoint and our think meeting and on we're the to that as earlier, FDA. get -- we'll those ourselves really for we our we and and to we some weeks But we'll other minutes, The clarity meeting minutes are we our outcome some and to -- of no what doesn't a product. And XYOSTED the was.

Oren Livnat

right. I dumb appreciate Thanks. question. congrats on And it. Maybe a on All approval. Makena, again that

injector I AMAG out? that to around the currently and the now auto wondering Do now You it's understanding guess, auto talked Are the possible vial? Do what by is they doctor Makena have about they it with that be requesting substitutability play script with request when about idea you I'm injector? formulation? any dynamic could If automatically that have would a talking fulfilled, a EpiPen is the prescribed switched would or how just -- intramuscular. now, we're writes your way a

Bob Apple

would That's Actually, pharmacy AMAG. therefore, Makena IM Makena know the then I doctor that write it'll assume the I would such. question filled or a for don't XXX%. be subcutaneous as at and

because generic. to writing can't start be try to the AMAG with that what they injectors trying subcutaneous it's physicians or subcutaneous, auto written to doing all switched then So, if IM is an of do vis-à-vis current get communicated what is to the and

we can know for for to and use -- it's out get I again, in write to step about if And and another way But the to have only that clearly, to you made patients the even it's the it back be thing the be product There have is IM. active before better switch the would -- dispensed structure of there Makena, talk that's what they at to the that is step generic and and benefits so why only sub-cue, injector sub-cue patients, plan IM idea but don't an so forth. office why IM. Makena plan And covers no AMAG the subcutaneous through the the the again, Makena the to going better place to go auto the versus pharmacy. is to physicians in for got order

Oren Livnat

a pathway candidate, similar Or clinical see any we us on could lastly, is on whether you lead -- like I possible the whether give comment least to I we more we may, color at understand a the should approach, more pipeline. it you're And IND. Okay. XYOSTED? if full new until that be and/or second Can file a bioequivalence not OTREXUP? you expecting saw an what you with

Bob Apple

right. All

you we're a function try always in determine value a see get do OTREXUP-type we -- first doing to with the as because can is shorter typically There PK the do basis program pathway, can a program. FDA that where pre-IND study. a clinical to you And is the versus meeting and such pathway go clinical program, if a PK of a to -- So, exclusive. or with get clinical the but to agrees

again, the would Street and with, once believe that do is have this to to meeting talked But to for that, with we've in these we're we to label the meeting. the we program. if the then year. in the try about go worth smaller able -- initially, clinical in tone communicate FDA that IND be it's going what to studies second You XYOSTED get PK still we But in always saw going we clinics of products, are initially, type But the like as to is resources these again, to going a particularly with the second required, well being products. is And lead to areas, be The either as the a be looking -- it comfortable that different so set to and forth. do the PK, product potentially of we'll

Oren Livnat

All right. much. so Thanks

Operator

Thank you.

Please go Thalmann. Ladenburg in Kaplan Matt from question Next ahead.

Matt Kaplan

Hi, good guys. morning

Bob Apple

Matt. Hey

Matt Kaplan

horse, in dig -- more. XYOSTED to Just dead not beat wanted bit a a to to little but

was major data. focus hand tell you about where of that the a what studies? have FDA's that in example, have that? discussion blood Obviously, little the questions us So, being you with able AdComs in the pressure stand held have your some respect the do January CRL? already you with pressure address have blood Do you to already -- can already a in And data? in was there bit and you that ambulatory ambulatory do For to were for

Bob Apple

the try clinical can. So, -- answer haven't as the would've I what we're dead submitted briefing CRL, of program go to back program a can obviously, book that to clinical answer or say when within in did so we month do not really is time. best the disclosed that, to obviously, we another short and really period the going full horse We What of entailed. I

maybe basis briefing we brought or, of two our supportive data of felt focus key those book current had And that so areas studies we that the in didn't were at up essentially in areas two FDA the they that CRL. where X from the our Phase was least,

this The program. broken announce Street in strategy at is And sounding like so how the and but to like to get going another we'll record, what a believe the briefing we're hate But said and keep we do to we again, didn't that. point, minutes I to I clinical the we're book, accomplish going

our that we're to that on we And so with had in FDA. have discussion relying the hand data

supplemental study at back XXX additional the you -- in an patients as where study, XXXX request the remember FDA really XXXX. If safety added was the XXX we of or

felt we really did book, in that they package areas of side on programs the FDA so see the safety, focusing we felt -- of interest and and that then XXX, product of appropriate the was between we two XXX focused our with the the that just efficacy again, XXX mainstay we didn't the being the And filing. was on and maybe briefing that XXX NDA

few a good frustrating are it's know where I we we for we as understanding all but weeks point. a that's away. everybody this so say not we're with only to to Again, weeks, XYOSTED, talking And months. are have at not can

minutes. So, we'll we give those once you an receive update

Matt Kaplan

can my the perception Okay. of and the help in XYOSTED Antares us then. main each you on terms other of three Teva, hold for think off in I'll the programs about And ones, on impact those with of the them yes? of your terms potential partner questions -- potential

Bob Apple

Yes.

developing think I into that Sumatriptan the -- was entered you a that for FDA products in market that give and market a heavier they and tends -- is now be there's had currently The half. status. a one in us for so able much that's goes to it we market them then rate generic price with XX% much I And first-to-file different review, about and nice that we're the share and Sumatriptan, only can very see a market have, market. Teva the a different substitution are Teva three we achieve surrogate has the been with market. Sumatriptan under to The that and rise generic. very first satisfied a a a and a much all the year market potentially, fourth also being was quicker generic, as into pressure, share not as when as

the in were hard -- million of XXXX, when by at generic epinephrine, million they the individual don't EpiPen the guess is it I for Mylan they're $XXX authorized to because an EpiPen launched look say doing now it's is they probably so product anymore. disclose Best to $XXX around the And they market really what that because themselves.

that as there's their the not AB-rated, of AG. out out products another that the done is player Adrenaclick there play. which and so as with is a are two price And is And in then well there CVS-dominated it's brand name EpiPen, that's their there well

very opportunity soon. it's not And as is the going material so anaphylactic cure there And the no as I EpiPen value. market think anytime away shock, for a that obviously, is still so far

could possibly Walgreens, can a There the they amounts that authorized have with we a market so and really as actually been we XX%. patients Teva on done launch how that dollar really Mylan as hasn't Sumatriptan as will in they when felt much that. really the the approximately they've with stated in generic, converting mainstay by of but pharmacies, that focus well had EpiPen. erode believe function best obviously the Mylan publicly that would the the that lately, products translates such already Teva which with a of an to job business market, their But success and do CVS generic generic is is with the the U.S. And

would far a IMS from concerned, year. substitutable determine that's still product that difficult is. really there, Symphony, As we it's AB again, market last $XXX fully called first a and that's that's did is do about a Byetta what's an -- the rating, They that which but we get to did long-acting stick it, with they're -- billion be or happy we according $X Byetta, by if million But as patients. number out what is reviewed. a have with it's about we being being it's Byetta filed -- net retail, to what -- It obviously, If it. Amylin diabetic really the Bydureon. have product does used on a they

of the $X that Teva, They of And could still impact and filed line sales for a have given possibly they with and a us then can now ANDA. product and substitution again, there -- as that's so bottom they almost which really Epi Obviously, global quick a or well product. billion, Forteo, fully Antares U.S. Teriparatide, as an see very Teva. could it Teriparatide with rate is Lilly's product And the of but it a opportunity, an that substitutable a again, could large dwarfing be be obviously not it meaningful with even AB-rated they for a about nice the opportunity opportunity. substitution, billion be And large finally, product, a positive adoption with $X.XX generic. big both that is was be as of believe

them exciting any The towards to that work Street, approval, So, Lilly, helping the haven't guidance opportunity. results litigation working settlement. Teva, any given an Lilly of that with settled that's an we're kind in Europe market the of approval, a that in the product hopefully, they of and still really or countries. But either to They as towards waiting obviously, and major there to they're will is a already be proposition approved It's can fall there smaller and patents Europe all launch in for XX launched. market approved value be markets part in that a to product. the globally, the but and

be as So, those an on is in all to approval again, I still those think products, the that as space short-term. possible. with the and partner opportunities for us opportunity a right big really making excited hope far as in And about playing hopefully, this Teva it as we're

Matt Kaplan

in And that middle of September just something with correct? Lilly's patents expire like XXXX, XXXX. on Teriparatide, they that, Is

Bob Apple

That's correct.

agreed on reduce which understanding there during And until product the that out is I process, us so patent in Our is expire IP, this therefore, and timeframe that that was Lilly they can we it believe, product. that that's we And device an additional that not a infringe XXXX. really in of five litigation the positive there XXXX, launch the element years. did with so working

obviously, And so if approved. --

anyone And a so many the XXXX, period not from additional us. of for huge we but -- Teva has -- seen reduce expiring behind think to time for line I because potentially think, us a with able one I from any be think know And that long value and to that I'm we that saying for there's in litigation been to potentially, going I not by being there's driver, haven't don't -- Lilly. late XXXX to not we're ourselves time, market us, obviously,

Matt Kaplan

added guys. All for the Thanks detail right, Bob.

Bob Apple

Absolutely.

Operator

Thanks.

Please Amsellem in Jaffray. Next David from go ahead. question Piper is

David Amsellem

have Most want answered. my did I pipeline. little Thanks. of questions ask been the bit a to about

may of be we additional so that products when the hear for necessarily get for XXXX -- should on, partnered color year, what again, eye bit other opportunities? but products other pipeline? maybe and about I'm keeping that Beyond general a a the not partnered portion what this flavor give I us we And an about, bag, the on talked sure kind opportunities of in of XXXX, more are we just of want in to little

Bob Apple

be device. our Alliance a to of Antares efficacy, where is we is So, But allow really I transaction we we can what for company and the be business a internally months down until thorough But number that on, royalties on Alliance I -- through they what team or the the level we subcutaneous those. elements of can as develop value the burden us we on internal pretty any opposed opportunities beauty really value the make drugs that I first, the is where focus the and weekly a things I as we commercial like can size look more the an to show deals better of think opportunity, want When again, not weekly be PK of products. can't that improved process which can PK allowed driver it's a we we sure take in want we technology on those therapeutic build number partnership that because standpoint testosterone, at -- do the can really an get efficacy us that ones results we well, documents we that pursuing one company the And a wouldn't business wouldn't served that from transaction And long-acting focus to do and driver and a safety our The sale. improved I development that area, do we think, other really that say the do for that Other focused a doing that that potentially a anyone on auto particular sure is like of We patients. our value is types that improved Makena, And product on for really internal a be to have that are neurology side in it in a is of Teva's go infinite to another screening think standpoint the in making working we're device or for our and improving forth. a type improved if product an would injector is in hard-pressed bag programs economics mid-teen elements that as worth done. efficacy. the for what the look speak forward. get to well product pen platform that or, it'd programs, opportunities. and external use isn't have transactions we otherwise, we're amount technology of of our overall, be new there those as to so add From of programs. us injectors single-digit is just or of to And think to to maintain high to we AMAG's, that Alliance. those proper of for thing believe

business And so what table in with potential programs still because that value sides get area, pipeline. business approvals complex we minimizes through think continue those to of proposition if even the our deals both a with to our Alliance demand I on the in get can say that and is very things that to FDA, these these other in interest partners allows there's our we've risks with more risk a Alliance trying disciplined more internal us in in very on doing take I and area that

have. And so with still I say we I that think we the shareholders those. we I and value a will business of that on of component that future to a real partners, particularly it's nice can't And but the it's can comment in get that pursue think we may to business our bring balance areas continue

David Amsellem

Thanks.

Operator

Thanks.

Zacks Small Research. ahead. Cap Next go Vandermosten question Please from in John

John Vandermosten

what forward? see your wanted Good first, I were questions help My of What I to are related and We're Fred, that terms had noticed might that market much discontinued high product, share. right Sumatriptan. going their XX%. and And how we Bob, at pretty to in now Jack. expect can thoughts morning Endo

Bob Apple

Yes, was small market. that Endo relative believe quite the the product to I

in market has which us now, we're Dr. market same there larger is company share. is Reddy's to I rather it's close think that share than that one and -- getting a being that right other

more one the you goes to forward, expectations As as price far going share the drive down. market product, more the

a to so there knows Teva bit an almost a this is are I little points, they good that believe art those at and pinch of and And it. pretty --

they value really share maintain forward, So, could in what because obviously, and the as to profit going as get, in at, we we price type look of the potentially much don't the product. possible want market selling in

share. market as And really guide to don't so we what

we really market, focus has crowded what products show done the a any they the with be will first-to-file, the development working into a three share -- could on Teva as just saturated what we're in if a and market, market that other to with And to it's show those successful opportunity think with that at that enter I they that think we market of are with those in very are I market potential be Teva no products. this in potentially believe generic not Teva, point. other products the there's different

at again, those share, impressed market approvals as they've can got get got but this or when But we the Teva's to entered we to market. get is Sumatriptan, do thing products. launch approvals we as -- first the the those really given far so so And with point, done what I'm

already So, expectations. exceeded they've my

John Vandermosten

mentioned they recently. yes. that of seem disconnect again, moving the about you've that's bit and price me just market little the be you And could Sumatriptan, those many disconnect? between understand to maybe And I Okay, factors; competitors, with think I on that more achieve And is so that. great there help can mean revenues share one a most a

Bob Apple

down was I think that that and mentioned on based the of to of the mean, market so able to what I I've forth time market in presentations that price, Teva achieve over and other the Yes, because is share, competition obviously, some Sumatriptan market goes value degree.

but their inflection for. Teva products share And point, -- better market, we than was players to a price it's where were stays where it the what hopefully, able market it is achieve at that the -- other kind of offering is, so through

to the basically. we're status wants the forth, market the a and so so they what hopefully, And it, at companies that can quo split standpoint but is. change. someone get is get to way four And the pricing market more share, it It's is on up between If price. reduce

So, that's that.

John Vandermosten

the answers. you Thank for Okay.

Bob Apple

question. Thanks John. for Operator, more I think time we one

Operator

Elliot Raymond Sure. ahead. question Wilbur go We'll Please take from in James. a follow-up

Elliot Wilbur

Thanks.

programs Just think a quick us specifically be a levels trends going OpEx question at SG&A similar and movement flow help to down of about not R&D, lot there's the assume directional back guess, I of quarterly maybe time. on XXXX. half potentially cost bit little of of there. for financials some quite for help in been in maybe us the I for the Fred, some has Thanks. a But escalating given the the then wind year? in about think

Fred Powell

Sure, the expenses of no we expenses -- as we -- half problem. year, the at looking XXXX, And I Bob on will see announced. back operating additional the as R&D for right. think really, you're It's

we be with time. no as that where on expenses the side. expect expect the there's those would IND would R&D of year, not R&D the see stay going in expenses be. is yet much to that -- Looking increase to we that the at XYOSTED decision fluctuation we the beginning we At -- With is to will would can't

year. that last side, to was the that. R&D looking it the this those year, think when certainly, were have about on our we increase. comment will and we're right, FDA, add increases not general expenses, the going comes item comes time when can't December I last the going through still as that continue So, R&D when the had the of embark because it NDA administrative waiting that When all see pipeline, was submitted and But And and more you're to it from we be And for significant at last admin you to expenses. to the significant relatively to expect XXXX, flat year in products to trials. line we expenses, we XYOSTED clinical

does line be that'll that So, increase item last a year. over

Elliot Wilbur

Okay. And quick just Fred. real a follow-up,

averaged has incremental $X the million be that? of the all rate low It's in programs R&D basically additional would in XXXX. then to quarter potentially kind that's basically, So, to say fair baseline per number,

Fred Powell

That's fair Yes. accounting.

Elliot Wilbur

you. Okay. Thank

Operator

you. Thank

back more the hand Mr. ahead. are there I no Howarth. to to like Jack call So, go this questions at Please just time.

Jack Howarth

today's on us joining for again thanks call. conference and Rina Thanks

follow-up If XXX-XXX-XXXX. you That call. reach me you any today's completes have questions, can at

Operator

participation. for you disconnect. and may Thank your now Ladies you gentlemen,

Antares Pharma (ATRS) 13 Mar 182017 Q4 Earnings call transcript