ATRS - Earnings call transcript Q1 2018

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Operator

Ladies and gentlemen, welcome to the Antares Pharma First 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 would now hand to conference call over to Jack Howarth, Antares' Vice President of Corporate Affairs. Please go ahead, sir.

Jack Howarth

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

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

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

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

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

call the over X. I'll Bob update Bob? will After X. with presentation, number turn highlights, slide and the our Bob and Please financial to business our we review your then recent quarter Let's first Apple. open commercial begin the you review questions. results, and give to catalysts. will quarter will present number for call will turn now lines on review the today's agenda a for first Slide Bob the of Fred

Robert Apple

achievements. had our I joining first release, to hope this Jack and morning's which on and a you us of highlighted good call. morning, Thanks, operating today's press to financial quarter chance review everyone results several

our in a million for grow continue and quarter proprietary X% revenue products was both period comparable last sales product the growth arthritis front, reported versus On we $XX by year. sold product of to our through The in our OTREXUP, scrips first partners. the and sales. of driven net rheumatoid financial $XX.X increase devices million in

market in approximately Our take The we investments growth. few short-term preterm Operating approved the Fred Sumatriptan just its mostly auto injector, to quarter recently number Please partner’s you turn had quarter subcutaneous Makena birth product to on injector for auto for minutes. attributable financial our migraine up in positive Slide in steady and by product Teva headaches were through share first million. X. impact the cash prevention research development sold the continued X%, $XX.X will and increased and investment of of expenses detailed ended with results a sales. climb a

ease the Makena less partner we using improved our companies. to and the who This work was the been has of Makena that products it’s have is products. IM AMAG, technology providers combination subcutaneous the the the March already been get and experience nurses progress underway front, partners auto the quarter is QuickShot injector On early injection QuickShot other The during has for providers. positive. to or our physicians, significant while than first the the with their in indicated much very feedback by development AMAG AMAG they in achievement first auto week use received patient have thus that launch know we how FDA. and our FDA. launch, emphasizing healthcare according approval approval speaking from U.S. auto patient approved both far. injection the month the our pass with launched injector easy of using product and for much QuickShot invasive been the proves still We they is that notification and at that team anecdotal pleased have over AMAG’s the last device was the of a the The in and when to use are injector nurses for indicated just validation with are physicians commercial believe application from a device to

the weeks of enrollments through Connection of auto injector. potentially patient their enrollments continue give Makena to the AMAG grow to the quarter Care patients start on AMAG earnings Makena are injector current call time for the in last after this the According the the our occur four new approximately their to IM XX% subcutaneous data. the sales auto starting injector future program patients leading will On injector a convert Makena AMAG on injector percentage generic and good good market preserves AMAG more greater portion on entry to early administration the believe could and disclosed AMAG, helps we of has mid-year. finder as position two second from in potential to indicator by based Makena auto is The a new potential IM Makena new in treatment with franchise. a in weeks. Makena a the their to off therapy auto with seat sales auto These enrollment launch the believes week, launching and per enrollments read

Slide Moving X. now to number

During resubmission. a minutes held we Once FDA, the the participated analyzed, Type the team resubmission the with FDA XYOSTED. Type the discussions the discuss we first received based quarter, official for and A in received After were A meeting, on to our a CRL regulatory filed upon understanding package face-to-face and clinical from that our meeting the we day. our began to assemble

year. labeling acknowledged CRL we X, strategies. of had On potential of as to our of risk a XYOSTED and response existing complete submission a XXXX approval a receipt PDUFA April the the a response this will date. post-approval considered XX, goal Our with data, X Class later reanalysis proceed potential September assigning planning at included the toward The FDA mitigation announced that as draft well FDA

discuss In first number of in needle-free $XX.X payment end received last two now we payments the ZOMAJET of Fred? and will of quarter year. totaling over turn We upon paid would million. Ferring million $X.XX Slide XXXX. the which rights this billion be four to results. price the $X.XX $X.XX completion announced two already will Now Pharmaceuticals totaling milestones first final this the kindly and to auto year of the first financial be the contractual to year, I this who prior in our a October closing of The for will turn X. customary two been at of received be device will worldwide transaction call The to million conditions. the Fred remaining for received like injector installments, completed purchase have anticipate including the installments sale the paid quarter

Fred Powell

Bob. Thanks,

in ended proprietary begin in decreased quarter revenue to in of March year, XXXX, million Product products was the compared Let’s XX, driven the million first period by Total a revenue months $X.X compared quarter to of million to quarter for period for the and to $X due for the of an first revenue were XXXX, compared quarter the our deferred. of sales product an a to Product sales injector of million. XXXX. of was devices for OTREXUP first sales looking estimation details at in was last Makena versus represents as X. as $X.X The million our on quarter first primarily decrease same by XXXX, the additional period in three X% previously of $XX.X accounting for XXXX primary improvement of a sales recognition device the the increase. $XX The last the of million comparable $XX million year recognition change number or of the the quarter Slide revenue increase. OTREXUP sales partners. in XXXX reason the that X% $X.X for in first auto components $XX.X and to million was for first result the revenue same

a the to this for Excluding quarter of The product. first quarter revenue unit revenues development by revenues XXXX quarter the primarily result in of the the comparable to million Typically, XXXX development for products three the increase activities year OTREXUP development versus the $X.X of AMAG injector XX% towards the commercialization. decreased period driven in this in sales million revenue compared for in months a Makena $X.X was was year effects last to of moved increased with auto the first first XX, decrease compared XXXX, reduction XXXX. potential revenues for of one-time Development March ended as recognition, distributors. in change

million $X.XX quarter and development per operating Turning expenses year which the year for increased $X.XX compared the and likely deferred a expense. as future The in from increase Slide The receipt loss will products, $XX.X as $XX.X gain XXXX. quarter in XYOSTED million quarter this net expenses was share with million once to installment primarily first to timeline. year. Operating as is associated the now with $X.XX the the of installments additional any Pharmaceuticals recognized regulatory spending gain probable first last as it in first of quarter in benefits and compared approximately an happen associated the excludes gain the will increase and a Ferring X. considered quarter received not compensation research $X.XX based recorded for period pipeline fourth comparable This due of The a Net this the expenses in to was to be were million balance that number potential of reversal the significant on loss for was the on anticipated closing sheet. will occur. XXXX,

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

Robert Apple

catalysts. business provide in and Thanks, commercial Please on first I continued that read XX its OTREXUP will update steady number turn growth quarter. the Slide a Fred. our potential to some further

the Fred change reported involving revenue one-time due we earlier mentioned quarter revenues first of recognition. a an to sales OTREXUP in in included accounting XXXX, As increase

for an XXXX. first by Excluding increase the in price increase of change, as OTREXUP estimated allowances. driven period same in increase distributors compared in sold, increased XX%, sales was and offset to revenue to effects by the units quarter the this one-time a an This

are can where Slide can before. over have attributed insurance success data areas XX, OTREXUP’s be reps analytics auto double-digit see to XXXX impressive and you year the sales enhanced numbers we As Much first the adopters and year the our to prescription injector on target of using growth the coverage. number same reflect quarter last period strong

sales affordability. Our product refine marketing as the and well to and as messaging, team around access improved continues perception

We be will solid continue to our believe growth. a contributor to OTREXUP top-line

Turning to XX. injection on now Slide Sumatriptan

$X.X Sumatriptan million. XXXX was quarter First revenue

the it’s revenue quarters, previous As the received highly device prefilled Solutions, Symphony syringes XXXX. share, Teva’s basis. fourth discussed in therefore According we Teva quarter-to-quarter from has Sumatriptan Teva’s to distribution and injector of forecast is on quarter achieved quarterly reported market, of in a from for Sumatriptan Health Sumatriptan XX% a of TRX up that arrival dependent and mostly upon variable our the sequentially auto XX%

commercial all teams in can penetration major pleased this pharmacy strong into other and with translate Teva of very successes presence market the of future level projects. are We Teva’s with

the catalysts We complete Let outlined letter and two XX. our me Slide significant potential the dialogue XX number September resolving activities. FDA. made commercial on targeting pending The to turn and now current towards planning resubmission goal we to The a late launch response some XYOSTED believe in progress resumed launch through tentatively approval. has FDA deficiencies we is are PDUFA date XYOSTED constructive XXXX team

with Moving new the injector, have was increase existing, XX the seen our a strong steady that auto The on product. most the to IM first success. vial new price now due FDA to parity the injected indicated has weekly of recent patient coverage patient insurance for via partner product auto They – enrollments. and remains Makena in single-dose March approval AMAG

continuing they are them We vouch our will part do as in for received. fill to

reminder, the royalties non-core a with we transaction. products of ZOMAJET Makena margin AMAG continue and sell asset receive receive nature royalties was on we auto legacy in sale the to until packaged will product the of the those strategic ZOMAJET partners on ship single-digit to completion our fully to the high end-sales As of a sales and injector and product. low-double-digit

pipeline Moving we AB a projects stand is devices still to them Teva, XXXX when EpiPen ongoing with supplying been already XX continues to launch additional start anticipating in an of of the Teva in rated countries ANDA ready Teriparatide patent Forteo going of is to needed. XXXX the clearance reported Teva generic and the is Lilly the U.S. billion. and launching. Europe before and worldwide approved pursue $X.XX awaiting sales pathway in approval of with

be terms. do disclosed not for competitive has half settlement Teva great did and it earlier that last Teva Lilly expect as the it could the litigation enter us. late products this settled a second and So the than to to as well the opportunity for year XXXX. disclose any market not however have of Lilly

approval following Finally, as for Teriparatide. is Exenatide - the pathway ANDA same

on generic We support sell receive we Teva commercial standpoint, three ANDAs. a Teva will and the devices royalties of the on margin continue to these will From end-sale with their all product. a as needed of

pre-clinical pipeline on our projects, been have now potential to opportunities conducted and a product reviewing of compounds. have to one number Turning own development of we add significant our to work these

candidate this update expect our the year. pipeline to to continue We pipeline, since believe we in I months to the add made of quarterly last second a progress half Overall, lead ago. our excellent on two and commercial our business

That the forward about We to product candidates today. at providing numerous operational now answer prepared updates and I our for lines are excited for throughout remarks look session. Thank have your many FDA. and you the you currently and potential catalysts could to investors our attention. question commercial the XXXX. and concludes are Operator, the open pleased for

Operator

with H.C. from take Instructions] Oren Livnat will Wainwright. question ahead. our [Operator Please And first Absolutely. we go

Oren Livnat

resubmitted you are do got around, Thanks little study us a the on given the And have I XYOSTED, how it’s that wants what color package, thing think if not questions. pressure you give have Thanks. or do and minutes, in turn everybody data ambulatory taking you’ve a NDA Hi the follow-up. an now may may was been obviously, safety about On that blood fast there to prepared after week guys. you specifically, there? in to for more to I know that a

Robert Apple

was comment as turnaround. the mean, the current piece, response quick as far thanks that it I a Yes, for

we and of the since We But, data. felt any working been contain submitted medication of labeling Phase wasn’t the of time ABPM for pretty in had post-marketing to X an that need the protocol any It as more program. kind release, I the And the got that just we had we around forth be FDA think our during strategies. really study back data. and for we reanalysis it between so quite and will in that was there believe comfortable FDA said it mostly performed additional I press CRL. on have We some the part

Oren Livnat

So, just on follow-ups a couple that.

original ABPM that a can in study clarify your you do? you safety or the if X supplemental Phase So, that was of guys had is part to

Robert Apple

part the was it study. safety supplemental of Yes,

Oren Livnat

And, yes, right. All go ahead.

Robert Apple

and add FDA, with met we of get patients patients the to on wanted the When they us one more an elements to ABPM. was of those some

Oren Livnat

or from around plans Perfect. potential perhaps that your and might all potentially? about that And, REMS communication mentioned, information is about I just commercial REMS be, differ restrictive guess, meaningfully expectations be about a would Can label? how in you something that talk it that original more you

Robert Apple

then have attached have Well, other I the the because group REMS the FDA that’s transference then going around forth answer and if FDA don’t think vary types degree we made those and don’t shocks. back and to again going clearly, by Testosterone not REMS really But REMS. this in know as of state. be to between That to any programs division difficulty. - have is them we been around covered is I the safety REMS as products weed vision and to the the well mean, that, junks there the topics anaphylactic All they the with has of

in issue every an was really label increase products. blood potentially around which pressure see Our of in we hypertension Testosterone

REMS going we the know So that from to don’t a how handle FDA standpoint. is

Oren Livnat

so right. much. Appreciated. All Thanks

Operator

Thalmann. next question Please will from come ahead. with Our go Matt Ladenburg Kaplan

Jack Howarth

we can and to Matt, go next the question are you Ebenie, requeue. mute? on maybe can Matt

Operator

right. All

ahead, go. Matt. we Here Go

is open. Your line

Matt Kaplan

question. Thanks you. my taking thank for Hi,

you given point focus what Just doing of FDA? for are prepare that bit more, XYOSTED a with the to the launch XYOSTED rapid you this little had on turnaround at the

Robert Apple

our if and in that may helping in standpoint, But for well our accordingly, the last our at at is still refreshed targeting and point to as as starting to for docs of managers and we to marketing this changed as that. agents may see relook with at been they person really interim he reps. forth, not so looking like materials developed training they sales year the all Obviously, sales is top or managing XYOSTED, they’ve at district OTREXUP. since of all the from getting are And changes the a label. happen So, the of training trying relooking reflect detail as team things lead a have number and all far is that’s and candidates the

Matt Kaplan

And if if you approval are to launch planning September? get year this you late

Robert Apple

of, If That September being the date with before yes. year. most kind the do and believe that we we a reps of soft XX – PDUFA the we launch of end our could

Matt Kaplan

And How then, to the a question performing Makena. in far Makena shifting QuickShot so was marketplace?

Robert Apple

above last I can week. CEO But, hear disclosed AMAG earnings the from tell I of as Heiden think week. far – auto I what and of point. beyond what the really of XX% mean, are auto the on the adoption starting they so from expectations week call is Bill injector injector as as publicly XXXX the the our you higher that of patients last this of this all or I was well new on at

the really they’ve really are great switch for of any reason I doctor the IM not a injector to reason auto think ready the really for the giving to and payers block same they price I market as the the not it. injection. were giving job getting for any done a in Therefore not keeping we wise think

product They are aspects a quite of arm to now versus being in the more second are But And injection the far, that back think being like right is as converted how the doesn’t opposed as one and there they a minute. patient. rapidly. was the the so the it’s of the evidence, the that disrobe XX It’s product launch and Bill key. or advocates to nurses, booties it’s for convenient doctors a product. convenient injection believes like far I importantly, and the is But to I as so patient going the of so, and would the importantly, anecdotal they IM say, great so the have lot best is the

feel far. So the strongly positive and really so launch we about

Matt Kaplan

Great. the Thanks the for progress the taking on and congrats questions during quarter.

Operator

We with question Please ahead. now Wainwright. go follow-up Oren Livnat take H.C. from a will

Oren Livnat

thanks. Fast So, turnaround.

that can’t on Just on care Obviously, speculation, all partner, XX% new for your them based of your the speak share maybe a follow-up interactions great. and patients, Makena. is your but you with own Makena obviously

their hurdle On imagine no would there they the that to converting specialty XXX% formulation. through other could I from be a and hand, closer it if something better are a to to channel coming is

So do channel inventory manually, I you intentionally everybody up switchover, being switch half are do yet so to Or still or patients of aren’t in some can converting reason think their staged best existing think wondering, soak limited vials? that and for that other just that the the am that’s and for maybe they reasons? the they trying you

Robert Apple

their is Bill with as quick of there deplete conversations I Heiden, to goal switches But their my In on to the back just inventory. don’t possible. think is as on patient IM holding any clearly, get every kind

aware the am and discussions of that, average through territory is in things with the that again weeks. whole gets REMS XX in I One our Bill of

number routing sales just that force happened. the are haven’t size so, the of of and the And detailed auto a doctors injector the by and nurses virtue been of that there

And weeks so, we are it. only into four

Makena theory, few think at weeks of heard so, the they is a least directly rep got in pretty auto about that I amount docs been just the in two-thirds injector from the and high. So, actually having conversion of

Oren Livnat

do Makena get they want it them, asked at Actually, write goes think maybe Okay. needs Do strength and we Makena answered and don’t writing get know for a or to up it’s ex and sell if injector what back-end which just just the auto auto to you you I I them? for an the quarter become doctor cares then now. question, to actually back it for injector to an specifically last to are that you to

Robert Apple

maybe the the I than I not like Well, – mean, know other rated I mean, don’t directly only generic. answer thing

get or to right make guess back automatically they but for my level so them Makena the they may I Makena. I bet have assuming at And write connection, am I they doesn’t think comes detail switched sure is when it cares it definitely not pharmacy that, injector. the Makena But don’t, if the that, my it auto and to auto of if it’s call they that automatically don’t want injector. know maybe that switched having, sure. So,

Oren Livnat

Got you. Okay. Thanks.

Operator

next And we move Anthony ahead. with Please Instructions] [Operator Jefferies. Petrone will to go

Anthony Petrone

Thanks.

a Bob So, of And the concern any generic Thanks. injector the of about there, on entrant. stay shift Are are maybe, space? then then thoughts may just secondly, a the there aware preliminary direct-to-consumer for may a for subcue – any to still generic do not that you on have with entrant on or you for I second there follow-up. injector? of And pricing Makena part one is sort advertising on obviously into AMAG how that, the subcue

Robert Apple

the of I Yes, possibly, they – iPhones, any think know, through obviously your through as am happens chance generic going AMAG. a But better patients are is sure on or AMAG media for I the as for advertising, question not longer, things we they what probably as AMAG the the this there like a year. some and media, go without mid-year Non-half sure, don’t is switching and by has far surface patient I don’t and direct-to-consumer the well patients know generic a that, go to of they longer can that’s entrants, are injector. of type re-detailing stated ads so as market, auto the some forth only we that as I one detailing into as that. or far that the the believe but

either the do generic is at and it such show pricing look of know as you of But much sure may is As no so show that, AMAG’s other not really a the if product. also have think shows PX how them when, if really is they doesn’t front are many out going tell because am is I up filing no like pricing not as again, and function to a other AMAG a clarity up. this is than much I up. that into I many filing of have obvious some than how generics. And generics coming there strategy far we a it’s if around occur with concerned, required in us this, market that

Anthony Petrone

it there those question post-CRL, discussions. Thanks. shifted still and just on to of discussion back they sounded are I’ll shift how with payer queue. in Did like the Maybe to late XYOSTED. a those then was What the helpful. year CRL resubmission, over patterns some And gears the just last That’s ongoing? around ongoing year? thoughts are next your early get shifts Maybe

Robert Apple

Sorry, Anthony. reaction? the asking again? about what? ask Could payers’ that Are you you Is that

Anthony Petrone

we know company’s your they just with I CRL. payers no, course, have of No, XYOSTED. at last were discussion around – the that the ongoing some point year, then but

come the discussions the market any terms with So payers, there this product of to should year? later update was in

Robert Apple

talking mean, the plans. the still we are health landscape, the majors I Yes, large in to PBMs, clearly the large payer national

would only probably a carries any we that put are their like Tier-X And has that rebate away. to on if coverage, that, we go in get which can through of And Tier-X time. in type get changed be again, a the thing right best covers the which have they so understanding products, nothing is what we They believe far would the requiring. the will of possible and targeting outcome We be know The lunch products a thing at low co-pay is don’t review. will say Tier-X that, a with do one formularies something market-leader. relatively typically an where formulary AndroGel us with coverage assist that we

with formulary the a a rebate typically clinical to at And or ways that to are and get on requires the in so, level PBM we of some that at looking plans. health order review form accelerate team review at the launch

is And of to continuing has the up based on days based The range. starts so, month things and be still like number this in million and X market prescription that. changed. new on goes a every nothing down It and

amount it’s the more that are gels The get late I available like of percentage an So gel only patients the market the went in of the to AbbVie’s right the is do to is product feeling The a market went continues Lilly’s or branded well really now But grow. voice they fully still IM because start of when that’s IM I think on available. function the of the too Axiron intact. that marketplace. you Lilly think generic. AndroGel. generic fact also, market is that, in year. Obviously, last lose And it’s the the

think seeing And also IM gels. versus on a the of you change why patients the that’s in so, are I are that amount

Operator

There that was If question? your sound. no answer

We next to Small Vandermosten Please Capital with go Research. ahead. will move Zacks John

John Vandermosten

Good guys. morning

Robert Apple

good Hey, morning, John.

Fred Powell

Good morning.

John Vandermosten

of calls questions. on morning. missed couple the I’ve some this a Jumping

So, from the won’t the I been one anything depression will But of ask kind that of already that covered. response them? to and you you but and was know, things FDA’s with address just wanted I think that’s was what the concerns pressure satisfy you

Robert Apple

have do our ABPM we as could have. really there that, more that, What we heard had give discussion any all had two X. nothing Well, is that, I announcements study of information is the FDA believe in issues. you may Phase labeling already think our with the conduct would this our not will CRL than be we with And in we those of since we to part else we said safety an what study a that around us

where the in highlight mitigate – in the pressure, that, any where will increase blood that think how highlighted we looking we I so, and do there agency any risk if we we area. be how at And

a and the thing, typically with or same co-morbidity. you far hypogonadism it’s in that As depressed the it’s as depression see depressions, class, been –

so, and there standpoint from And around those our be believe strong PK issues concern. that. a I safety no in held if because some around was clinical again, labeling we’ll raise very data It was FDA concern two the was

John Vandermosten

FDA or kind is Okay. give their from as opinion negative area just positive just Lipozene’s take what is either on, second in to here? XYOSTED And response the supposed question a of takeaway a similar the you on product today will and

Robert Apple

to has an oral all. on which I different at our Testosterone NDA. injectable - Actually, I It’s really am are Lipozene product. product not read bears very think don’t much than their file our a it

there what So But Nadcom obviously front Clarus’ both were to of I Testosterone. theirs and both did their they in oral are. They I don’t Nadcom. was get know – issues I listening and the

really don’t FDA the product. of today on any action whatever today them if seen takes I it’s So correlations versus our

that hope them think I the has I type at on it’s us any very and a I of best. think different it delivery, don’t all. But PK, bearing different

John Vandermosten

much. so you Thank

Operator

conference are further Instructions] time. [Operator telephone does questions back additional turn like I’d to appear to Jack at for It closing or the over that there no Howarth remarks. any this

Jack Howarth

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

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

Operator

participation. your Thank you for

disconnect. may You now

Antares Pharma (ATRS) 8 May 182018 Q1 Earnings call transcript