ATRS - Earnings call transcript Q3 2017

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Operator

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

Jack Howarth

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

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

open call the will to through the recent turn agenda take a X. I'll Please your give you Bob and and slide then review operating business to up Bob questions. After quarter activities. for begin will Let's the will turn the lines of X. year-to-date update. Apple. results Bob third that on over then with we a and Bob? call financial now you will third review for Fred today's quarter slide the

Bob Apple

everyone and had the revenues review record had press Thanks call. company. quarterly this participants Jack for and today’s the operating to morning’s highlighted release, good morning on to results hope financial all which chance I

before XYOSTED part was findings application, call target morning’s been the XX, Letter driving on revenue concerned review CRL, identified FDA the had On details of was which and which start the precluded received drug this get previously our the on labeling on which stated the deficiencies the our communicated continuation XYOSTED as received of application. to that the commitments time. XX-XXX, the week on On deficiencies our blood and Preclude we could in post-marketing company increase XX, data. discussion at Before Based action a later from ongoing XX. a a October date I’d pressure. to discussion requirements or QST-XX-XXX clinically in cause in the Deficiencies the identified with meaningful that Discussion to two a clinical related growth, XYOSTED October new week The of of letter studies October that like FDA we

the letter raised regarding addition, of and occurrence also depression the a suicidality. In concern

in path are potential however, with to the FDA communicate approval. the work establishing thereby very is with We disappointed and obviously of the the further cited forward outcome to resolve review, a intent CRL, our it understand for deficiency to

table currently getting in detailed of meeting. on CRL. from the issues, for the responding FDA the CRL, anticipate face-to-face a outstanding identified the to we to further the two this well determine as to resolve intend as response clarification a for to are We briefing to a test requesting developing We and required time the submit process book in a deficiencies the FDA

had X of in million and results, quarter outstanding sales. product slide which another of moving record million on XX.X Joining we XX.X the with third quarter comprised at revenue now

growth the short quarter business product in to for measuring to time, made in Ferring Pharmaceuticals in were of XX.X and was Sumatriptan The announced sales to upfront business device million. sense auto This additional some $XX.X which paid in price progress minutes. than Fred ZOMAJET OTREXUP less injection be diversified for October consisting of will As as will through quarter, million how from a conditions. can the years. a and for instalments million. details the past instalments worldwide in upon milestones that take benchmark of a in full $X completion XXXX. the our products we’ve model, you needle-free present by a for three purchase in our just injector the Both the much three will four the sale paid year and drivers believe we of progress period product give our received XX.X million, be revenue XXXX in We contractual commercial closing and completed customary commercialized growth, be believe We of end and to primary which transaction and subject totaling revenue were those you payment third rights

on until the over years now would product walk The focus the value. call partners will sales financial of completion turn three ZOMAJET on the to to approximately quarter which shift like strategic our near-term you receive the this over Fred, our in transaction. and of past represented of will several believe continue year-to-date better who million We to the annual royalties each legacy company divestment revenue I resources objectives will X.X to asset continue as non-core to results. those through allow Fred? the shareholder make to we and has third

Fred Powell

Thanks Bob.

compared September September same X%. X. for in XXXX, to September the million product $XX.X XXXX the for Total the of to months three million XX, Product XX, in September Sumatriptan million September XXXX, products, was for XXXX ended proprietary compared ended as our from an XX, in in million for three profit million for September the the for Teva. devices $XX.X three sales revenue for sales as at ended under the months both, as months and XXXX our on XX, compared the million nine to months months an as September XXXX XX, million to million for ended device months XXXX, begin Sumatriptan as of and by compared or million Revenue compared nine the $X.X XXXX, XX, was $X.X September OTREXUP profit as period to XX%. of XXXX, compared with XX, of XXXX, the XXXX. ended ended the million $XX.X XXXX, was was XXXX, the an September the ended Product sharing in the The three XXXX related number attributed shipments represented increase XX.X the earned and Revenue million in slide of months partners. for to Let’s XXXX. $XX OTREXUP million compared XXXX. quarter months looking in XXXX, in million $X.X million increase $XX compared to in as revenue to $XX.X for compared driven nine increase $XX.X ended in Total months sales $XX.X revenue, well to of third XX, sales ended XXXX, $X.X million arrangement primarily $XX.X revenue $X.X million XX, injection, details to components $XX.X in was increase the three by to were and nine sales

for in program. increased the revenue of XX, syringes XXXX, of the for September development to development of million XXXX product is Sumatriptan million with The the with $X.X activities from forecast month decrease was is three the XX, auto Teva development injector quarter revenue pre-filled on Our months third Development and result September upon was compared injector injector in programs received development quarterly ended the primarily XXXX offset injector a for The and to million AMAG nine variable to in result for and the that XXXX, months lower million in auto lower was XXXX related we primarily the XXXX. dependent $X.X revenue basis. $X.X highly and by for from pen period the compared revenue ended therefore on $X.X revenue compared revenue to development nine Makena Teva. Exenatide increase

expenses share potential to months $X.XX in were nine and XXXX launch for was months slide the first to reduction $X.XX XXXX, The partially to XXXX. increase XXXX, external offset as loss an operating $XX.X to to periods ’XX, XX.X in and nine three third the nine $XX.X months $X.XX clinical first in $X.XX for the decrease of the compared sales primarily in XXXX. of million in marketing for operating of compared and as to of million by expenses for compared $XX.X third of XYOSTED, development quarter in Turning number now XXXX, in in preparation period expenses per in for cost Net XXXX, to XYOSTED. was comparable million the and related of compared and X; for a XXXX due quarter million the

short-term XX, cash, equivalents and back totaled September December call at the I’ll XX, to of to Bob? turn As now $XX.X XXXX Bob. million compared cash investments million XXXX. $XX.X

Bob Apple

Fred. Thanks

since continue Sumatriptan distribution products. for been continues our injection our quarters. We with very was product, of weekly market to ending product data share turn we reach partner, market in to the contribute our to product Walgreens has its the that Teva’s of our was In acceptance with commercial Sumatriptan the Symphony in in with a XX Antares. year. over is Lets’ help not data be months of gain has commercial XX%. noting revenue most remain launched the from X, date a XX%, broad and pleased October million be strong second share. strong slide recent accurate product of worth we while share extremely To market share Teva’s quarter this available, injection now our recorded to up we and key market the market the XX% the to believe the Health the we Solutions, XX Sumatriptan growth CVS impressive. six And for third presence pleased obviously According that most of quarter week always XX distribution

potentially Teva. of with may other launch the hopeful We’re to that three product translate product successes strength our collaborations in future this

and Turning quarters. to easy-to-use both and slide can chart, has last continue year. sales third sales affordability from is should as total versus to coming growth the grow. X, We access nine same device OTREXUP the program According helped product the drive year-to-date total Symphony pull-through of support number perception help in period to believe and grew prescription in prescription XX% our improved prescriptions and messaging, quarter this months drive continuing bar care to see you and OTREXUP data, utilizing

profitable. Importantly, XXXX of be for to the on first business nine standalone basis, a the months OTREXUP continues

wrap review devices are commercial on Exenatide, Beginning FDA. let’s turning still by and for I’ll slide order we for business. the purchase provide to on Teva’s ANDA update Exenatide Teva. alliance Now XX, number active our executing under is with with up a an at

has You’ll that been of recall AstraZeneca a with date of year. all settlement settled Teva and litigation October launch negotiated this XX

approval. of exclusivity devices other we potential post pre-launched quantities October Teva of While the continue marketing FDA in date XX anticipates receiving to anticipation has days approval. of manufacture passed, XXX

$XXX,XXX in at of dollar total pre-launched Epinephrine, third devices approximately for to Teva to amount approximately bringing to shipped worth the date the devices quarter, $XX now Turning shipped million. we

with in paragraph approved a in within still ANDA, We review review under the Teva continue XXXX. active in date is months, at previously granted February that also litigation a approval potential action ongoing FDA. believe the resulted XX work US overall finally, And could of with We existing towards at Europe, a to had as anticipating in on XXXX remains stay countries XXXX. target respect been XX, to patents. X, XX December. With active ANDA but the reported period Epinephrine of August timing their FDA our Teva the the by the the Teriparatide, which of those in in exact US. AMAG in countries ending well With is of sent launches has review XX sNDA patent be EU Globally, launch Teriparatide certain authorizations US as last marketing which months Teva’s European impacted currently

to are the I made past am subcutaneous product, auto-injector our work regulatory potential to excited purchase our as a review commercial a XYOSTED’s with active alliance plan AMAG while approvals business path extremely they approval. as we near-term with of with remaining their for progress to the applications open question-and-answer move Operator, the we at And are for the grow marketed now commercial and executing Overall, to partners we We business order setup FDA. will the our and Teva quarter We progress continue and work AMAG devices in action today. for for XYOSTED, remain for currently FDA session. continue prepared quarterly the pleased to you providing to concludes the their our with on our our opportunities. our an under FDA call. develop forward forward disappointed next about update to on on operational towards in look sNDA. use That I on remarks could lines our Makena awaits progress during currently

Operator

And H.C. [Operator to go [Operator Livnat first Instructions]. Wainwright. Instructions] Oren with we’ll

Jack Howarth

maybe can get go next in lets to Oren the Tracy one, back the queue.

Operator

next to with go Petrone Jefferies. we’ll And Anthony

Christian Moore

now This to prior in-depth just earnings provide we updates step to with is and for a specifically of the at could we Christian the timing there. revenue the update on Moore then just help contribute Jefferies. the discussion quick from any May a terms if in if FDA perspective you next hearing of you else would or the call XYOSTED on earliest anything maybe more a could Anthony and anything us understand go-forward from regarding could see where be update point, XYOSTED,

Bob Apple

to a process dialog so to this have do So pretty tell receive is completed. CRL to thing officially a order at point you a the have only briefing book can have in meeting. we’ve no FDA you had point. you I with this The is comprehensive And you the to after that you

target XX completed year to a have meeting they And request that this of is the so that to date days request. meeting have have typically and and within our

So really to what until how looking we that that have as have proceed don’t clarity is the data for meeting, going data. any to or we’re we getting FDA

for request can for briefing with prepared to basically again is intent meeting. a comprehensive there a fully a file that book, in go we that complete very Our meeting that

this and kind when cannot timing approved I if launched So will and as to on guidance or timing any give XYOSTED any time. at be of

Christian Moore

been sales been mentioned this hiring paused managers then actively, company then regional cash had front delay seven as point what time the the with has the is XX and full in on that them XYOSTED of hires. that reps August regional with impact hired And has for recruiting with sales the back on maybe managers now burn you the those

Bob Apple

that’s the was contingent the did. the So upon always be sales we the approval plan to make and to to reps offers what

have we no sales additional reps. therefore to related so any And liability

them hopefully near are the get our and in we go and forth. company seven ways our to we to so as to resubmission will and managers, continue use ready future things if hopefully for and district continue that they XYOSTED in are with so them As able with well we’ll the other launch utilizing

concerned, of in don’t did how cancelling obligations again, forward the it’s related be with new as that of expenses the we our then anticipation expenses far and it’s material prudent for at things As of we were kind and think incur process. that certain burn large I think launch is the were all But went kind to number in potential of QX what because of QX in looking reasonable approval we really in we’ll we a we timing XYOSTED. in have

Christian Moore

And something sorry this just forth of on between higher then, back mornings, but few from a a and given EpiPen timing updates just this, I if the missed level? generic the the

Bob Apple

thing that updated hasn’t review tell than are for that only and can there’s come. we’ll I those making preparing guidance ready devices active and and all those under ANDAs so when say are Teva. any The new And other the on three approvals if programs of given Teva launch the we the you, is by to products be for of nothing

Operator

we’ll go Kaplan with Ladenburg Matt next And Thalmann. to Instructions] [Operator

Matt Kaplan

The have respect pressure? driven to significant pressure and in dig to long were it us or your outliers be to outliers items. pressure, weeks. you the the to outstanding unremarkable in there changes respect with blood blood that the Could change there’s questions more as pressure suicidality understand around you were could at if wanted little see you you’ve Just data that XX over CRL? depression obviously the that in two that already data With presented help term in what were and mentioned seems blood then a look the to to items XYOSTED the blood

Bob Apple

What late discussions, we to the through see pretty you’re and (inaudible) obviously approval CRL content XYOSTED, we can so on when in CRL. surprised the were the is of going by that, were and process the we

we their pressure the you, labels FDA think When class regards and other a towards of on this have with product think information are we comment. how until we to really in to our we and fully this XYOSTED, briefing understand there’s by preparing the market. what the until any it’s that we specific that, information is get we can’t work the we to you give XYOSTED resolve we’re so their FDA, understand FDA don’t I great with mentioned is we in are, if to I what like surprised in meet data were of go we I done, really But still blood our meet with forward the can the with I a believe and them. additional give of it, already any product can’t most prepared like or and products Other we if CRL So all very not to and said sensitivities additional you is about because be looking book. than if depression meeting concerns comprehensive are to

of in this with to best delay for get try mitigate any type forward we and our long So foot to product. the term FDA

Matt Kaplan

your in mentions current also and suicide different label as any of discussion is you And of there effects. your any labeling label potential said on much labels mention then you and hypertension the and than than labels? as as and Was mentioned we’re side depression seeing different discussions pretty discussion, all you’re

Bob Apple

FDA, about and by We every we our itself. of and so data clinical of that only endpoint stick felt you off the excursions I filed of, When you say our XXX requested everyone very what product now tend and strong. met strong would working references product was again efficacy PK knows (b) and so we you’re (X), label PK that a to was standpoint data the we from had the pretty the difference are the to

device (X) would syringe opposed as XXX that labeling was I (b) to was a the differences a or a a with was, labeling as PK it and say, the gel. generally and the just So needle characterized in traditional fact

enough the CRL. stress can’t words the as I So apprised far as

are on working we market. to So approved to to and potentially the move it committed and FDA the with get on track forward back

Matt Kaplan

The then hasn’t of that with remains? timing just three And right ANDAs in really respect under review now. are changed terms those to the or

Bob Apple

ANDAs I not rely are has try they as we As they and just on earlier, recently. far as of having, said guidance ANDAs Teva’s and the are to knows as those – everyone their it, are changed none their really guidance and

And one FDA respond. is they is devices our working make we’re have the that come don’t how to on learn know thing launch to obviously have for end so and going the sure to you

going XYOSTED So do me best point, thing at somebody trying not to this me probably us. ANDAs guess else’s what event is to to given for do for the the

So sNDA excited you we’re and although one the - period evolving short of representative and and those those doing as or ANDAs we can product get product revenue hopefully. AMAG business see so with launch, those in we’re the in a the for time our well our all everything that’s whilst all to of as think of that I sales

Operator

with And next John to we’ll Zacks. go Vandermosten

John Vandermosten

give forecast? there’s where based around First and moved quite was of anticipating gross forward quarters, revenue wondering few if terms question last us help margin, be you going this could on in a on bit any the the over I its will

Fred Powell

the products, development revenue OTREXUP. on I think margins’ going particular if versus we’re at with revenue in revenue our product with product forward, looking own dependent for

to as oppose margin larger Sumatriptan. a have We

as it’s at forward margin looking were than around XX% normalized said now, margin Going at the quarter. were I looking than for think at year-to-date be of about are you right we more looking to going a XX.X%. we We rather right

we to higher mix revenue going in on closer that it’s have dependent quarter. all the mid-XXs, be margins Again, individual to maybe going a forward. the for bit little any it’s think I So the

John Vandermosten

OTREXUP. was question on Second

trend terms quarter? I the or the a decline in of for think saw last little quarter the quarter-over-quarter was realized third we What price.

Fred Powell

at very as upon versus we had actually we had the the you Quarter-over-quarter and place we additional we products up based strong price, the Again, with growth true-ups going an taking place more quarter ended increase selling price in third actuals, suggested. for true-ups had looking OTREXUP. trend some out, that estimates the OTREXUP for take product; so

be forget also Looking QX in increase we’re we at looking a remainder effect going the I for somewhere of we at had QX between this think were that price Don’t year, as QX-QX. well. to took

it So factors was a of combination there.

Bob Apple

expect guess that can to year. on the I And over layer we that next

Fred Powell

as That as selling being number you look a see is price we that year-to-date up, year-to-date result to go take will a we continue our number, have. higher at be and that a now will the

John Vandermosten

injector And much that the income finally variable a needle-free it at when down gets you on how segment, basis? of to pre-tax on look

Bob Apple

accounting the think offsets now. as because in some from still the accounting has we that be far believe we be on out it lot for market a have of of sale, on a is been gain a asset standpoint. that whole obviously There gain it I the but that will we’re working And as will the price. not time, quite relative pretty large to the

for great it going allows to and our year, a over So cash in next and this us the pen-injector transaction, auto-injector it’s to focus technology. was on bring us

more the and quality XX the at speak of and it’s where plus of is been. its where for to us for at device and oppose business think cash bring again some business is our a importance but to great So to end we’ve (inaudible), going been as focus allow that the the a asset percentage transaction and large of really day, where it the the it in business selling currently the years, on I the has transaction of was

John Vandermosten

I then your to or just our Exactly to maybe line? of free then agree that like fix in any that line related anything that cost with SG&A assessment. terms that And

Bob Apple

There’s run our that almost of it’s line devices cost SG&A obviously purely will no go gross cost the all eventually royalty the the net the and the other sales line of was the and as is that we that items both the through sales, for below transaction the and cost But cited whatsoever would disposables and in away needle-free sales as X.X royalty. done. included that and when well device,

Operator

next with Wainwright. [Operator we’ll H.C. go Instructions] Oren And Livnat to

Oren Livnat

if it sure hour least not asked that I do disclosed, did. if decision, probably walk-away chain our going anything and food other from reasons the when and point market FDA make So did that apologize is in the And you on term put could to bigger general. no means you and as and pipeline could words up with else’s sort in-house quickly? I’m labels assume and concerns if just trials, further because say, for this should let the, safety mouth, that cardiovascular partners but were your yours’ at I years, and prepared maybe XX breaks if this they and sort or on otherwise. about any you new FDA If you they focus I than not of signal not you given TRT I excursion. highlighted that want theirs, have PK wanted in about in the to put out for product this, safer XXth to you want XYOSTED from one everybody the for is is data, I’m of Are wondering, we prove long that perspective, safety have to

Bob Apple

So let with this concern I to no multiple-layered the some to that can. that broad question is regards as best indication answer There’s me try class.

not as any As that. had we that have we with communication suggest far FDA the know

that we what they broad looking us and not we about front FDA up. would applications be until of issues to bring do, for you I are to until start the or get so in those And concerned determine more broad

analysis – [juggling] to of they’re our FDA translates excellent that far think PK concern data as the we how thinking I what their what is don’t overall was that know and is. really safety as

want What stated We get I and get much we say in again, to looking it disclose regards effective product, do get hands we IND issue. that So products information to steps that other to we product of the do get this clarity, that and to XYOSTED. really at I happen. before we with Typically would have to an across suggest least question I as because a in make and suggest line a development, it’s to further that other we’re and that little are work committed to product going before we the say going its what it the take good a or have requires I’ll on at, haven’t can disclosed needed data we demand we that’s do launched. And yet think safe we it’s to tell products you everything to products bit think stage we this goal stages. it’s can’t as we’re are But until far to we space the have before very early it.

hoping we’re year. to you – working as be give able to products some some what next indications other have to we’re on early So sometime

far approve business would us to so our right party another or pain programs, if as are on opportunity see quite because FDA, as question front in for take this I work I said, try program additional makes was the at getting and to any from look we not standpoint. across willing with at term we another a or XYOSTED. make with have of like can injector goal whether I others, determine think now to a move money To that we we alliance think like but off haven’t of your business, keeping progress been partnered in looking do that are So, the always we answer sense of the company and we question, auto-injector companies with four difficult, focusing a or them FDA unwillingness or long another the obviously something and the or we product and are be to Teva very point line it I to honestly don’t your do it’s

Oren Livnat

Were on the movements there OTREXUP? channel any material inventory for

Bob Apple

normal end OTREXUP. We see shipments place No, that there shipments taking quarter was of the any place. significant didn’t for took

Operator

of Howarth further additional at to no are remarks. call questions I’d turn like there appears It any the for you back time. to closing Mr. this

Jack Howarth

call. for Thank you us thanks Tracy, and again today��s on joining conference

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

Operator

thank today’s does and This your conference, conclude you for participation. we

You may now disconnect.

Antares Pharma (ATRS) 7 Nov 172017 Q3 Earnings call transcript