ATRS - Earnings call transcript Q3 2018

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Operator

Ladies and gentlemen, welcome to the Antares Pharma Third Quarter 2018 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. I will now hand the conference call over to Jack Howarth, Antares’ Vice President of Corporate Affairs. Please go ahead, sir.

Jack Howarth

good and Cathy, you, morning everyone. Thank website we and recent morning, press can the announced Investors the copy our results financial release Antares on found XXXX quarter be www.antarespharma.com operating section. the under For third of This at achievements, a and

this teleconference presentation. morning’s addition, contains an In slide interactive also

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you under today’s If the archived the website, Webcasts our and call. at to currently of are Presentations access conclusion be slide presentation will tab unable the

you of like some meaning Securities materially during U.S. remind actual statements. risks forward-looking we made statements and will results provisions I’d projected uncertainties, the and Litigation statements Act are conference XXXX. differ within our Harbor the in certain Before this Safe begin, from any These to of call could statements of of subject Private those Reform forward-looking the contain that to

trials, performance Sumatriptan, EpiPen, factors to and filings Antares’ partnered we and with from as Antares’ and XX-K acceptance Commission. and presentation providing new time Form on Information Teva, not Antares results and review on our reimbursement, could as not you circumstances in forecast and obligation in as the and the and timing the Factors the company’s research, FDA undue or current cause encourage Otrexup, filings documents to call and pen of this today’s update product with Links market identified the today’s date action, revenue X-K, conference approvals provide and Securities future future which required timing information, the but clinical and company’s statements and development launch these statements. available Makena, to Exchange projects with are the does a in from reliance other proprietary place and Pfizer company limited new revenue approval other to successful the with and this financial after information and including time filings updated or about include of these of rescue in periodic and section are and XX-Q same, FDA undertake development of of events. recent of The generic hereof, Investor the as actual date and Xyosted future website statements result Forward-looking to to call Teva’s expectation market made SEC adequate and statements materials. results the differ successful these forward-looking on investors except are that acceptance, otherwise. events from from development revenue Form and is on not by cautions of or contained conference future any any to law future forward-looking

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

we Slide year-to-date Bob? will presentation, to Please I and for X. quarter third the review to Slide the your results, detailed achievements. up a Bob review give and Fred update on review business present level turn today’s third commercial agenda the then of No. high of will and Let’s turn a Bob will the for with quarter catalysts. will lines Bob open call a questions. the will begin X. Apple. future call you After now our over No. financial

Robert Apple

release today’s our call. progress joining highlighted XXXX to morning’s revenues This everyone morning quarterly against Thanks goals. and Jack, and record on earnings good us significant

product predictable transitioning financial from to to continue and royalty commercial we our front, progress great make development from the revenue On more unpredictable business. revenue

revenue Teva with our been was by results first quarter compared boost and XX% we and in FDA’s this growth sold reported only Makena was approval launch the on see provided The and our year-to-date our payment EpiPen. period of are Mylan’s have A year-to-date generic product to revenue driven just now quarter to by further XX% both a this recent million injector to $XX.X efforts for increased starting revenue the and building milestone the to in last mostly AMAG. the increased million, connection to revenue We auto years from partner by the the year. authorized to We of of third $X products. $XX.X of number proprietary a partner, towards same products and million

the X% internal pipeline of down products. and quarter increased and mostly expand were the operating for development due expenses and to X% in up respectively to investment we we period our both year-to-date total our P&L, continued loss third Moving $XX.X narrowed of research little million, as with to of Year-to-date, quarter compares in XXXX. $XX.X grown at with have second $X.XX. of business the the ended on our balance. our the cash million to cash which quarter quarter we third impact end the We Overall,

was million. Our will just Fred burn approximately in take results you a few nine-month financial minutes. detailed $X.X through cash the

business, pipeline. announcement to the Turning another partner August our operations to with the now had the of beginning of side a we the quarter, addition opportunity product of fantastic

device are pen. they drug, be a Pfizer and combination We rescue is and an combined the FDA. our track competitive with uniquely injector due utilize keeping Antares expertise given auto and QuickShot Pfizer products combination rescue to Antares note pen Pfizer auto at drug our which Pfizer approved platform, we division record to drug with with device is to develop of a designed getting that reasons. will Important working has pen confidential owned a partner wholly the This believe decided to with rescue injector

pay costs approval, combination Antares market. and, be the Of of the two the other commercial device, for providing will assuming basis fully plus to is and product on auto our responsible FDA also at Pfizer Pfizer development believe FDA-approved will QuickShot injector margin. course, product products, we the for combination cost packaged design best the of

large containing generic rescue royalties and working sales treat net severe the FDA-approved This products, the to days on what of be the allergic by auto with pen. other year to such FDA. Vibex Within partner recent receive very closely for an expanding the that market. to two program lifesaving we of from for is anaphylactic are our received which second Makena February on reactions. of Pfizer the injector was FDA this to or Utilizing also we this designed combination say, the we of approval Pfizer Teva of to we believe and as with application was and of following a rescue guidelines approval important a injector. that Teva approval news will pen We also AMAG’s throughout company epinephrine a We Teva, in robust the basis auto our a a device, device announcement, the device. be conformed prestigious needed approved excited partner, our demonstrated the anticipated worked very for highly review their process to very EpiPen Needless product all

believe significant significantly the this designed team’s you product. once margin efforts administration call XXXX. the I on auto more Xyosted will option by subcutaneous I at painless milestone for September company virtually like and testosterone. replacement turn for our of As a tremendous received enhances approved royalty injector of since plus for and product. novel therapy QuickShot Xyosted, indicated utilizing the patient’s Fred product sales development the taking approval weekly the finishes new Xyosted first over This in successful home, for of in to now a I’m adult treatment of FDA is provide and Xyosted We males. testosterone device self testosterone and Fred? treatment was off Teva the we the launch proud devices through cost third epinephrine Capping the the FDA a we for XX of on quarter Fred. digit year-to-date manufacture quarter, to a single to After the receive would in-market high an reminder, important a detail mid at plans. about new already financials, our

Fred Powell

Thanks Bob.

million a September EpiPen. and by and injectors XXXX, to primarily by Licensing and million an XX% to periods increased an Total for of begin XX, in received approval $XX.X XXXX, ended year-to-date revenue with three $X.X revenue compared period $X.X in was XX, the Makena the months XXXX XX, the in in ended for sales Slide Total quarter February million development were AMAG XX%. our to million on to Makena XX, and the the compared the three third XXXX, Makena nine to three $XX.X was million XXXX. XXXX. an as XX, for with to highest of was nine-month to sales were periods to as due or potential the for and FDA lower $XX.X associated XXXX Teva’s months month AMAG. same was XXXX tied a $XX respectively, in XX, Royalty and now to through product. million $XX.X result for XX development to the of $XX.X third ended months months for XXXX the by the XX, The to nine Net and by totals totaled offset the nine XX, $X.X for sales the Let’s the increase burn $X.XX to XXXX. the in for achievement at primarily of driven the months goals $XX.X three the compared $X same period same proprietary period our decrease for for the $XXX,XXX by million compared month in partner, sales million and for month licensing nine was to the result months three connection months Sumatriptan device for long-term increase in and three was of AMAG XXXX. approved September first for same million $X.XX nine $X.X XXXX, and with sales to investments XXXX XXXX, licensing development for September pipeline for compared the nine XXXX Net sales ended million increase the XX, XXXX product, looking for were stock At injector of increase auto comparable revenues increase X. due and and for XX, period December ended for $XX.X generic compared the of auto $XX.X operating Total XX, and compared for XX% million third company. XXXX a XXXX. in expenses period of and attributable XXXX $XXX,XXX. was the to September at of injection operating third in respectively. compensation results ended to increase of $XX.X for sales is compared the for XXXX comparable periods nine Operating nine share ended expense periods financial and third XXXX September revenue respectively, compared million nine activities XX, and the development September was XXXX September expenses $XX.X of Product $XX.X September million the $X.X the were revenue $X.X quarter XXXX nine-month primarily in $XX.X AMAG. to was $X.X period to months marketed months product to quarter were was million periods revenue in ended approvals. in of increase ended cash $X.XX compared performance was of the million three principally and Makena milestone month in-market XXXX sales driven in was the additional by the in for September XXXX auto ended XXXX, injectors FDA was XXXX $XX.X Otrexup loss million in September product compared The XXXX injector product Product three auto of spending cash, XXXX and the compared and XXXX. $XXX,XXX month XX, for ended in development the September September equivalents ended and date million revenue primary in the million the $XX.X revenue XXXX period September as months payment million and of to the represent were reduction which and in No. million per $XX.X The products nine respectively. the the XXXX The partners. and our the of million XX, product months the for three period revenue expenses in increase. for Both in The by same nine year-to-date months million recent and months in The the Pharmaceuticals. products and decrease in commercial for loss million royalty million quarter for September to components nine $X.XX the research Cash XXXX quarter

approvals milestones: and Antares as The due part of transformational rescue first to Makena collaboration have in for subcu, been generic EpiPen the the three operational the large quarters well a this of as pen. Xyosted, for Pfizer achievement significant of four year

side, On year, for first revenue of pleased with continuing quarter we were revenue commercial. the the the months our development very of and to the record the transition third and financial nine from

If of approximately from revenue XX% you our was Otrexup, reported of Makena, Sumatriptan total current from $XX.X revenue we which quarter, revenue. analyze is our million, commercial which total this was business, comprised and what

and in from You and will our believe the predictable a more commercial EpiPen launches. revenue. generic on same of split annual Xyosted increasing we’ll calculate the quarterly this benefit trend continue soon revenue will and basis We year-to-date

be expect to turn in guidance for now $XX I’ll year of to of Bob? that call first $XX.X can million as to in As will million to total million XX% we and XXXX $XX equates range range the a revenue the provide result, the XXXX. compared back to full This year-over-year Bob. our time we growth. revenue XX a

Robert Apple

Fred. X. Slide Thanks Please turn to

eliminate adds third earlier, approval As revenue the intramuscular our received generator injection believe at concerns products the quarter another both gel company of end of news with injection Xyosted. dosing subcutaneous with may portfolio commonly exciting of Xyosted FDA We of combination painful the I approval mentioned the device potentially to testosterone the products. the associated with the transfer and products. This associated drug

to testosterone is narrow as been peak-to-trough testosterone existing treatment steady, with this a levels therapies. physiologically We Xyosted produce Additionally, has their new clinically as great well patients normal with ratio. option a of dissatisfied patients shown for believe currently

milligrams, easy treatment. No. per XX three painless XX and injector the XXX Slide for X, testosterone. is been were needle recommended percent weeks weekly as Turning the is patient. virtually injections has observed and and starting approved fine allows of rapid be stored at auto and safety XX-gauge in The a now to dispensed in and delivery box is milligrams dose strengths: use Xyosted study milligrams. of of for Ninety-nine dosage four-pack were reported of The to can room XX The milligrams, as injectors by auto efficacy painless the four XX-week temperature. that

packaging identified, began December positions, highly The of month. urology, the new possess launch. experienced onboarding offered in sales replacement background professionals been majority to of and many are recently reps a No. preparation X, launches. begin Slide this scheduled Many reps late we these product have are to Xyosted new pharmaceutical and a therapy, in testosterone and Moving for

plan start Our trained to in to reps positions December. and is ready have detailing Xyosted current the

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designed most assistance commercially patients. program support that We patient will have also offer comprehensive co-pay to a insured

and through we had experienced plans and vendor. with insurance known prior an and has meetings will for The company provide third initial managers. offices physician authorization In addition, service benefit Xyosted well support already benefits investigation pharmacy party

our As Xyosted all we covered XXXX. to pre-launch have lives of end by targeting access of contracting a result are two-thirds work, of the to

market recently price acceptance. and of with were brand of settled testosterone analysis the has market and X. discussions that month approximately acquisition generic on Health price believe that in of per No. and cost a has a based product $XXX X.X reasonable Importantly Solutions, point price to According in we profile filled the party third and Xyosted per of have of excellent a therapy prescriptions Androgel, wholesale $XXX approved market Slide turn combination The leader, Symphony the payors, on replacement $XXX of a will per month. million a We XXXX. retail enhance to Please product there month.

can very our factors be you now on million from writers help approximately who we initially have to Xyosted. on auto one X testosterone our biggest pleased to grow high territory the about Slide to products. attributes from physicians talk No. rate and XX. a QuickShot’s when with subcu Makena driving of this believe current launch Recognition targeting see of XX,XXX Makena of Revenue physician we plan more and received mapping the TRT continues year. patient strategic injector strategy partner. I’d maximize to demand. with we is like this from coupled are feedback prescriptions of roughly market run the We continue the slide, As should are reach We this target

United year-to-date our and product Slide the to upcoming XX, the substitutable than Teva’s has commercial another to AMAG the Teva’s injector this revenue seven about Shifting life product, therapeutically auto progress to have patients excited the to a across patients the bringing equivalent need another yet auto to on the all forward. EpiPen revenue product. issue has The source will through product is injector significant total continued shortages quarter, EpiPen of recent quarter branded to need on there and months approval for fully an generic totaled switching contributor been Makena business less million, are the going revenue We third who this as a and third growth. made and lead Our Makena sparing market believe been million. $X.X tremendous $XX of for generic States is believe royalty now we

that part $XX and this that of Slide are You’ll more month two can product, auto XXXX. significant and a devices. in defend the orders years, and shipped of will the recently that of pre-launch driver we of we the market. our the past them terms Xyosted, their Makena importantly in No. look on we guided year generic believe the the XXXX. Makena launch results support launch, launch very XXXX. quantities injectable a of Vibex $XX to anticipated to Epi investors important Teva penetrate forward. significant already far recall revenue EpiPen. quarter up was over We per past auto and of to replacement we AMAG a to injector momentum to have AMAG had we for pre-launch resupply auto to is the devices we quantities million additional Makena has shipment significant going building brand, both years have to favorable forward and impressive revenue launching approved, received AMAG the the achievements, be has indicated into Part that profile Antares guided testosterone third quarter injector big million reported Wrapping of of much devices and quarter the large now should for from is fourth strategy. market, the deliver growth for very injector XX, we going great potentially the the Makena a two and in making topical segments it’s given of thus product into Xyosted to next purchase

fill in devices. revenue going balance We XXXX begin recording product will and new additional purchase as of for we the orders now forward

yet by on in-market Pfizer to and We will of will market, quarter. launched a approval. once our With collaboration, this potentially derive for have assuming have in we device rescue to initiated large but compete We from royalties modifying work the pen. product respect Pfizer’s growing pen the benefit sales Teva QuickShot believe rescue the this FDA is

project the to On the plan results. the front, forward product the have from R&D coming the of in end, receive product The studies $X to the the late in proprietary nearing months combination drug an Zomajet internal look pivotal Ferring that and first volunteers with the healthy the regarding we closing been potential drug final PK and of expect our conditions is progressing we pipeline divestiture dosed when XXXX. in with next await have disclose sized. device next installment device million our We transaction and to

ANDA Finally first continue a development Forteo. develop turning to help progress team’s this believe I’m pending our year. made half a generic the Teva, Once to operational of in pathway the in also I financial generic therapy patients’ expect of to second improve competitor and designed on treatment novel sometime and version to generic continuing next following teriparatide. of proud approval teriparatide, and we Lilly’s projects a nine of work tremendous to ANDA Teva a they the Lilly the partner, file quarter combination they Byetta of indicated commitment are as is to XXXX. have our has awaiting with pathway same options. again, our months

XXXX the the and and time Antares the for believe session? in exciting upcoming potential the pipeline, Operator, question approved open answer remarks now recently launch growth continued an for revenue That you from of and a today. be developing concludes for our prepared could for shareholders. can resulting the products on our we of With beyond balance continued our focus and lines the

Operator

of from Raymond [Operator James. instructions] The question Wilbur first Elliot comes

Elliot Wilbur

when may guys I any did actually shipments, this initial commentary, in and begin, but expect the morning. apologize have Thanks, will around - missed I wouldn’t fact you the your shipments good year indicate reason to in you occur Xyosted revenue before you forthcoming that Several recognize end? that launch. trade prepared from Bob, questions assuming

Robert Apple

Sure, the expect of this December, in of reps in shipments happen towards November, trade so being back first to the month, end in the weeks December month, starting couple sometime the we position. detailing want the make also there out they the the to to We physicians field. are the provide for the sure and is able once be it write the to this with reps in field samples when product physicians

the that As Fred I’ll revenue, far as let answer question.

Fred Powell

Sure, the Elliot. don’t shipment quarter. in revenue We there. the recognizing based on certainly the upon to see plan We issues fourth distributors any

Elliot Wilbur

Okay, is so to when actual street December, on meeting launch to scheduled? assume have going early fair to mid sales but the that feet the you’re

Robert Apple

The be group, meeting believe--I then after the right is second a or we week. at-home sales as They’ll have beginning scheduled sales December, then training field actual that. guess they’ll of of be the week our and launch doing two I in in-house out weeks training for first the and the for

Elliot Wilbur

Okay.

seen of the we’ve commentary launch the launch market on As thinking dynamics months what about drug just XX curve depressed the get an or maybe versus specifically shape historical anything the Xyosted a more than you to dynamics modeling to pronounced of we launch restrictions guys with it in be you Obviously current unique think at seems perspective, respect historical a and kind historically, least the product first seem that you terms have but the that curve heavy like think in and about helpful. payor launches, more of of line benchmark around be some just impact from color any might precedents? upfront external much as more against ramp,

Robert Apple

and is Elliot, be Yes provide of out way products unfortunately gate access right and it you different today the have launch and plans plans having formulary just of more the more the of quarters, already access vast Tier the plans as then and more and that you payor by more on beyond covered, the really--it’s there if that can first restraints a today coverage. don’t and see will We we any any predicated and there’s of plans give launch think to majority covered I Xyosted know, than be--you in on the really formulary the along uptake, you market likely certain for that. exist the think you is rebate, payor the based the lives the works us and other in available on all market being an and number that will quarter coverage. will do product will not be much the anticipate as I them our X in to don’t having move access, do

but There’s that in We’re going number then testosterone other would an adjudication be through to the new claims, think onboard market, for and treatment. come really going if free - a you this the go as that end option their we’re our regular for given the of for in products a new - process year. obviously going see or patients replacement any the typical them, switch from doctors Xyosted I be provide lot likely patients therapy product there’s product getting see therapy. quite to it patients they’ll of basis no to that patients while on provide some fortunately happen a will market their of as launch samples, otherwise, product particularly are out current product ramp right up co-pay support, suggest you’re precedent out where it’s curve are the the as towards a sloping to in a to There there,

and as have profile, reaction regarding look think possible, but I the us, and adjudication be the from physicians seen to see good product’s expectations, feel month. right into forward getting about the payors the we’ve going our to sure marketplace will it it’s I we as providing to the help good meets the the we Hopefully opportunity heard soon physicians for we’ll co-pay and making have the we next very and and slope. be offices, the support about that the one coverage now traditional so a matter really of Xyosted, think and to feel

Elliot Wilbur

you. thank right, All

Operator

Our Petrone from next Anthony Jefferies. question of comes

Anthony Petrone

will a look and and think blood Anything prior the what progress the insurance, congrats front? on as pressure EpiPen. on you Thank on at but on can of Maybe label around would the piggyback and you bit that a you to here that we maybe authorization authorization coverage, like, fronts. share follow-up little like. considering Then be just just good number mentioned off X monitoring Tier you of Xyosted be on prior hurdles,

a marketplace, Maybe As we the as know, there a just the serves in shortage about gets talking how is fourth shortage out on Thanks. market? Teva quarter headwind as there’s a Teva potentially launch.

Robert Apple

Sure. On products that can just deficiency. that testosterone show the product. you fortunately, prior authorization, is to that prior Xyosted, being our you and or tell it’s a don’t We blood authorization and a two see I essentially all of have draws what have different any for reality market, testosterone that is hypogonadism

uncontrolled authorizations but product. to similar also see you any products pressure will right go because isn’t it’s have of The the don’t shouldn’t any blood if market. believe criteria because than We other you the we doctors additional onto hypertension authorizations if that will Xyosted, there be the patient prior for other specific our on label prior our around determine

the been don’t prescription. running, we’re a they part early well do They’ll obstacles covered, see particularly minimize and to claim is--if have it’s what help known those in a coverage so is space Cover process, up some a we’re the what do the launch a bit in go-forward but that that product bit quite so and We get this basis prior which products use space. getting the intend help to as long of the any on My products and on particular of with to Now, offices going market not lean to for the significant coverage this generally the third will to on we physician Meds, then if authorizations other process. easier to time that that a adjudication party is try vendor, see in little is beyond the

co-pay - the free My free and support, our putting again I of Meds. services Cover think resources like vast for majority samples, Xyosted, that again we’re drug, marketing adjudication

Anthony Petrone

helpful. that’s it, Got

Robert Apple

was question Epi? on your What

Anthony Petrone

is talk fourth serves so of wondering terms and in what potentially On marketplace hearing Epi, launch to you’re getting there, a just and of the a capacity the as in tailwind. how shortage supply ready there’s out Teva this in quarter,

Robert Apple

to can’t very still since with XX% we both EpiPen to you product, Epi, Antares, about been and the to market. the gearing combination not about able to shortages for demand at of as that exists to branded a approval. significant and that we the both satisfy such up issues. Unfortunately believe is right and coming that waiting and supply launch, that solve the We the but are feel We’re time those to approval. we Teva amount has with Teva already stockpile does have of in product a for help for sure a substitutable go EpiPen both excited manufactured another There be devices issues continues which today. be Adrenaclick, will provide at

day of you the comments, in the You’ve the process run so last announcing very have then ready soon. Hopefully through then which product. that are literally they’re labeling already manufacture got drug, the the you’ve to the wait the label now you be and for will to releasing devices were and that a got to go approval, launch to of

We’re really excited.

for for comfortable with very for We XXXX continue those we’re providing capacity to beyond, the resupply and our so get devices. orders

products and it For is products we with Teva. the package devices Epi, don’t the we we whereas to provide do we it’s all other do AMAG of have the one everything. that we Sumatriptan don’t where everything, provide We with do like drug,

and they’re they an these probably going where a us. a the into just devices, for generic the opportunity right first is world. like feel largest the which comfortable the is in very really markets that position successful the in and able with company market, excel, something This being believe provide generic EpiPen, we both we we in area we that, large to for and launch very of are given Teva is for very that where Here, supply

Anthony Petrone

Thanks again.

Operator

Amsellem David of question comes next Piper Our from Jaffray.

Mickey Ingerman

This for on is morning. Ingerman Mickey good Hi, David.

price you to planning then the the on for $XXX expected that do and contract list follow-up. guys can one extent to to the the color month, with a which which can any provide I discuss extent On to have payors, gross spread? Xyosted, into translates contract, you’re you you net

Robert Apple

the question. of part first the cover I’ll

from the with to WAC, my On a major we’re large believe one, earlier to $XXX a we the access, in we at as coverage. going I so obviously coverage opportunities. in go-forward try plans, focus and to are we’re down mentioned to the going pay reasonable target well access, that looking path some like insurance the to want early Tier we rebate as For Again plans day order X PBMs. get pretty prepared basis, the comments, have on larger

We’re position. really a not looking preferred for

the preferred to have co-pay you’re amount. we’ll co-pay support at that of Fred. help patients With it I’ll with right payors, a to be will far to gross over the to rebate we feel on to Tier net, the order give much a a believe for for up You of pretty benefits and demand of product. as the tend be price $XX force the with too turn We a $XX that and driving and product features certain average be right will to to as patient, X, Xyosted, a price strongly looking and a in

Fred Powell

we planning not that That’s and not something disclose are disclosing. we on do

our be have, we a the calculation. disclosing will that will distribution to As but net Bob provide said, will not discounts rebate. we be reasonable we There typical gross

Robert Apple

get the contracted, as rebate those we this rebate target see point, plans give little this we we’ll not where been at and have one we some which targeting know mind in contract. I you whether at you’re access plan still possible, do we’re point where at have front it’s But but look coverage. you and be you’re just a X, to and haven’t in Tier to obviously to covered, a just but because low under until to going do be meet product meet order to as they want not them they’re--what that give try both really that we next how as It really think for again, of they’re come could as in the or you in it’s premature story we’ll and when is we actually thinking, those the in a see large payors think have so profile obviously compelling with decide with such plans. rebate of or payors, force different not possible, that that as few is keep months a the our along; the patients, goes to it number as but we

Mickey Ingerman

which or Got demand it. be injector, auto the AMAG auto to supply [indiscernible] be the on the increased you may suggests that could Makena given supply injector? discussed the constraints extent Have there are for constraints. there guys

Robert Apple

product talking about Their supply branded earnings as IM call, constraints. they specifically their were having

The They’re there, around been I syringe the there hand switching over injector, our what successful market. believe a and constraints the on side, AMAG because is for and this and six control. a for still sell in though, with over to I very getting drug see injector supply their product last the joint don’t have But against auto on prefilled we injector so partnership been they’ve months AMAG from have but competing again, their they job order market. think has positive the continue been shortages, is great demand really all auto to product to clearly supply out end, control be in that side, patients on, don’t their that any they're the generic We provides so our and everyone’s working product, this and clearly auto to the the point. still and for both ours, really glove a we the in manage will that outpaced that we brand, what think doing handled focusing we’ve that the intramuscular AMAG demand effectively AMAG it. expectations, we that device to not

Mickey Ingerman

Okay, thanks.

Operator

comes next Matt of Our from question Thalmann. Kaplan Ladenburg

Matt Kaplan

guys. on Wanted little all more. morning to Congrats a Good progress. Xyosted focus the on bit

mentioned, in issue be to you forward year the is you help you uptake. an will PBMs reimbursement When things typically major launches think into an coverage other when As do not that path the headwind or and place? component reimbursement get and as think--can and understand cease the here, do contracted in issue you next to be the looking plans you

Robert Apple

so mentioned number lives. quarter, substantial which earlier, certain it in to we believe tend fortunately the is covered across Like of on lives number a expect Testosterone I product board, payors first we of a have the is formulary. a

we’re get as shape I internally of a say would order the higher our our going year this every more I be on of by that coverage projections. that able always we’re Xyosted. to XXXX target be the have if as to far be covered least quarter majority be possible, over of you to of It at by period calls. to the will and probably on Obviously think numbers it’s end will quarter quarter but guide XX% to any having contemplated vast a standpoint as and of thousands an to of but you For our get to earnings It’s of for Xyosted. are, good don’t for to covered of that we’ll or definitely have we time, get really the in expectations function lives in an going where to again internal going the from more all think going have lives, I as we’d to how generally like provide a it to issue we be lives basis able it’s type is us, be our of and add but a update be coverage. been it have street sure to are I’m things the to we’ll end coverage deal that in not plans with think I when

Matt Kaplan

with Then in injector, auto XXXX. to good. the Very quarter million per you to respect provided million guidance AMAG that Makena $XX mentioned $XX

for low to the about what think Antares? translate of you that If million $XXX that, the would end year,

Robert Apple

to their is in-sell, that complicated. get product on the margin, last if low figure to obviously There’s a could of get disclosed time, I then combination that and digit to did sales did a nice and out royalty we said royalty. double our what think royalties. and digit based we we’ve in It’s probably a quarter the what on you royalty of that that’s a wanted we single high they you that also spend not the calculation What and street kind they

on we to if of think opportunity the injector have, early a generics that forward, very market the lot product on doctors physicians. injector, meaningful of the move they product. money no a currently of know, I order direct drops for type if do expect and very bottom come the an into for more maintain to it if the because bill than there’s you more is was difficult transition don’t that marketing now, their to happens all impact than product the includes Going Then auto good one to fact those have. generic we the which Quite It’s numbers. year, more indicated and that of before news attributes market don’t give think in we clearly and next for ’XX. right access the margin IM. market you their to a injector, I and their is a patients be compelling when it’s know the the that We far our they has know that guidance well rate that a that not our for price any, us, guidance the that it’s as devices that run generic. the IM We we has don’t a positive are the that really our feel kept on so of achieve product a and patients know achieve guidance have think as AMAG What easy end an what and on I but us. a I there’s the in end generic if royalty million, significant auto generic brand, erosion of is to just market, had so low they would on the generics and it’s yet of onto the $XXX all on big make end the is honestly, we smart AMAG with line, think same amount delivering as to as don’t delivering could auto for impact the Right whatsoever physicians, it’s price as there it year, AMAG to not a typically more that what provides, share so move

that guidance in it’s the really far, order and I in So the yielded process to there about in gave, supply those really some feel results market and going continuing the to assuming devices nice isn’t those of for to are really they marketplace. for forward we the think manufacturing XXXX. and to look meet We demands we it’s any good AMAG continue and significant us, change in

Matt Kaplan

terms pivotal on that next you Can mentioned your of pipeline us in studies in associated with market year. enter give next question terms Last opportunity of a sense could pipeline, project? later project Right. focusing you that your

Robert Apple

establish try neurology to It depends it’s the the on you really I and type The said far as pretty studies only is wind product a as size the product, is to we thing pen a market really proposition. the up so what in rescue seeing think that product, attributes, difficult. value

PK will and have opportunity to the premature dosing, we us talk what the think early studies, into I and move disclose really show of of is to I conducting that meet opportunity PK on we’re But the going We and through year get have to the the once studies right market it’s a by the requirements, the actually end think it’s the is really for results the opportunity market is product. think great can actual be to these depending this is then into then product able that that is we established, product about market and what here. goal in analysts Our the that what the the it effectively, view success for hopefully we’ll to it landscape pivotal early until deliver product the better studies. a potential it’s now, concept,

Matt Kaplan

Great, thanks questions. for taking the

Operator

comes of Zacks Small question next John Vandermosten Our from Cap.

John Vandermosten

benefits hold-ups the competitors the wanted something perhaps I option, follow one that Makena was I IM on side the to that more? win or other Is move over for some the that there of generic guess other from for on of questions is to callers morning. a Good subcu the business. as product. docs one there of Antares that

Robert Apple

that or with The to and a has have auto to been for question or negative to from predict the IM, constraint hard a end the supply That’s injector. switch it’s a auto for fact whether Makena successful really potential The they not injector a positive strong. as my that’s AMAG.

effectively think trying switch to mindset answer I auto the vast their that product’s that the their internal I injector. in they’ve the of patients really been the can’t - I area. majority from to just been that know time marketing don’t approved, that

You’d have to ask AMAG.

John Vandermosten

Okay.

just Are first say there approved a Next first XXXX an of on deliveries the question product not to XXXX deliveries, deal. I event mean is the And I or ready, event? Pfizer get product. a when

Robert Apple

an around the area usually that in then was user faster much I where think combination a for around same route XXXX. no the time. which traditional clearly do and August patients, than go just in work generally but itself have is just and complex the is still device, you NCE to products developing your ready it’s C-section to process, the studies development signed is It a scenario there’s requires

tell as majority the meetings that what them, the so me studies a right any high is, some the it’s will is Pfizer the on of joint the XXXX, decides or to it’s guidance think We’ll a that they’re approval, into be timing regular product in give with numerous approval. until can for vast into disclose priority I really hard next to the speak, development the as XXXX, it’s and of an that for time really Pfizer a we’re be product what to working moving filing user on having device and working going we I earlier we’re but on you basis and year, CMC.

clin format. based development or That’s as disclose how moving and really get next it’s you’ll right a a is, it’s of trials decides function we’re product whether other see that. some and time that, year, whether think on to to through going then it’s what not that respect along the revenue I you’ll it’s or their call, to Pfizer sense

John Vandermosten

Okay, one. question financial Last that helpful. is actually is very a

million guidance some year, million. between for provided You $XX and $XX this

rate we If into and in year take you at look cash the for of does exit for force, that then also the that the at burn account end an what increase XXXX? sales mean

Fred Powell

question, great a That’s John.

at a next this you look projecting variables of year, our in taking would what going would we’re be. You’re where right have into we and expect number for year budget the a at end of -

that’s product, variable us to process We’re take expect while we know would for a before may ramp revenue. that deep Xyosted are product. launching us. we significant a the you now, We it for for be that budget could has for that coverage Bob call, in ramp a a of in at burn the the on start the earlier get see discussed XXXX initial and time take the looking have and Xyosted of for we cash Any you year launch to place XXXX

as has in to now will now, not the revenue with where right there to we addition we’re in cash be the we we’ll good difficult Epi XXXX, now well royalties right it’s of we and after monitor going to where have but In so a the model what for would that launched potential position terms requirements bit premature launches. to It’s us that forward. a as of be cash say device continue for the it sit Epi, as very yet, until even is again on going right

John Vandermosten

right, thank you. All

Operator

Oren Our final Wainwright. Livnat question of from comes

Oren Livnat

split Hi, guess last heading on want streams, do variables. there projections, up first thanks a giving for taking follow earlier of anticipate year any guidance the or revenue stolen year, did you and that’s - to the have question. of predictable room until big on we guidance. going I or visibility businesses, might a there, picture, guidance sort Xyosted business, the said, on some the that we obviously revenue we well floor even this hey, appreciate to and we’re depending in where Thanks. more I like as and obviously one. into year, say getting and time are part on next Sumatriptan out have a of you base XXXX thunder for launch are is timing-wise? give almost and do of lot I my I having had while now to can you of business AMAG dividend lot into leaving wait that year, the wiggle the that EpiPen, Otrexup on

Fred Powell

we have of product, Oren, at in that different year year, with of beginning revenue the development, at looking at the guidance make-up I splitting many so year. the with royalty, our will next full but see it think, be us well don’t for giving I do since the out we beginning with as components

of visibility, just would at but As beginning during I we giving us greater as XXXX. see that, overall may year, we guidance we get the go the do

Oren Livnat

a so early you’re you’re as and right, that the Xyosted Okay, have move conservative presumably the through in the given to days be you launch, going going to to lot learn year. though,

Robert Apple

conservative not right think is the maybe I word.

new growth think in the we’re we’ve right, that. last around few time conservative because any much we’re going years expecting, had growth for never our accelerated the mind, to giving it’s to pretty guidance, you’re continue it’s I and that particularly do

us the the a obviously quantity like assume is particularly the then and in gives There to do revenue predictable in there and for give being rate is have to based for the for remarks, have when risk Xyosted more don’t that Epi, POs I your comfort able for you to history. products, prepared devices, major forecast have guidance penetration is going what be. able that in being guidance, you that Xyosted on of and think launch we’re is to two we and becoming we said what our Makena, is Epi, that comfort

how assuming until what sense as where what have accurate. now We any reference that’s is real on AMAG selling is AMAG, don’t know in as been we we have their Epi, as historical that many we’ve guidance because is, don’t their What visibility guidance some price we penetration you for be units successful it some really have, have to for but all a is operations it’s there a product is delivering going generic if well the other standpoint. different a right the you branded to business on going how we fast that to are where would the products more are has Again we’re obviously level market than recurring very any we up, in coverage be product, take, see manage in generally the going a a market. it’s see the at for guidance point got to to attributes royalty until really they’re rates their past bit than at are anything What as with believe years. because it that guidance is--I now gauge any Xyosted. Epi not well the we I can’t are say of of barriers this a payors revenues five just can But what as again it’s elements or more which really the market market, we different put the anticipating XX established give think going call effectively or we’re the conservative, from where risky the because we wouldn’t but Xyosted, we’re than the

Oren Livnat

it. appreciate Thanks. right, All

Operator

back would Jack turn over At to this Howarth. to it like I time, Mr.

Jack Howarth

on Thanks joining for call. thanks again today’s Cathy, conference and us

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

Operator

this you. Thank today’s Ladies teleconference. gentlemen, concludes and

disconnect. now may You

Antares Pharma (ATRS) 6 Nov 182018 Q3 Earnings call transcript