SUPN - Earnings call transcript Q4 2017 | Supernus Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to Supernus Pharmaceuticals' Fourth Quarter and Full-Year 2018 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of Westwicke Partners, Investor Relations for Supernus Pharmaceuticals.

You may begin.

Peter Vozzo

Liz. you, Thank and Supernus everyone, Results for us joining Call. Good Fourth thank Quarter for Pharmaceuticals' Financial and today morning, you Full-Year Conference XXXX The and the XX, is update ended XXXX. months December X discussed today XX for after issued press company release market, a results. the close these Yesterday the the of announcing

website are of with via ir.supernus.com. call Officer, is at made Chief available Jack the Gregory Khattar; the call Supernus' Officer, Today's On and Investor Patrick. section Relations the company's me today Executive Chief Financial being

Following remarks open call by management, we the to will questions.

We be expect call the duration of approximately the to XX minutes.

not and of materially noted intend forward-looking management Supernus' Risk be the guarantees reflect meaning. future on and words such those During should, this the plan, identified statements Actual the Any similar These was forward-looking may March performance. including make of are and current regarding filed perspective course may, of XX, projected and Form uncertainties, performance these future our in XX-K, by Report events company's XXXX can in and anticipate, expect, and differ call, the believe, filings which information such SEC. as other those may on statements with statements. in statements results Annual subsequent certain will, involve from of existing forward-looking the XXXX forward-looking section Factor words risks future and trends

listening on most with forward-looking -- SEC. this additional then, laws. to I discussed. Since any X For the have February may to to Supernus Eastern the current releases approximately call replay, these will benefit required at topics and and related over press Jack. Please of company securities recent to update the applicable make turn of now reference XXXX a.m. the as declines obligation the except those the by statements company's the filings be is may announcements made XX, being who call you held may recorded time.

Jack Khattar

approximately sales $XXX.X expansion growth ongoing XXXX sales performance and in SPN-XXX. This reaching investments the impressive by morning, and record and prior everyone, At company X.XX% strong in year-end XXXX before our share prophylaxis same as growth years XXXX XR IQVIA fueled and of by market of X.XX% of the of Total the April despite by the increase a Good the sales This with grew to as net closed tax by of fourth X,XXX milestone share to migraine XXXX, SPN-XXX the Oxtellar quarter X reported the were Peter. in adolescents in revised The period mark XR of XXXX XXXX for quarter and than quarter in in IQVIA continued additional earnings of prescriptions. of representing strong end to at continued increased product another where and quarterly XX% you, by year join in sales is XR Total national for migraine, market primarily XX growth growth sizable penetration. discuss for of XR in income significant growth prescriptions results. showed for and quarter on and a as the III fourth full-year Trokendi increased market taking and launch We in XXXX a studies behind million year record to full-year the later, force Xx our acceleration Trokendi income total net a robust the had able XR older. XX% Supernus. fourth of the a XR Trokendi tax prescription for The adults XXXX We the time or time national first quarter was headaches and growth Thank prescriptions XR fourth thanks with of the grew year we a and approximately in XX the new third launched of financial guidance. XXX% of XXXX of of XXXX of XR. representatives XXXX topiramate Phase as in investments million reaching of the and XX% launch reached $XXX accomplishments XXXX XX,XXX X total more us the Trokendi our Total R&D achieve our earnings growth revenues Trokendi million. in end quarter XXXX. prescriptions XX% for the Oxtellar top prescriptions migraine over for of results. before annual was XX.X% to in the compared growing by over $XXX XX% XXXX reaching of of XXXX. over of third XXXX. as Trokendi increased over

all-time our of prescriptions of an in of market prescriptions XX.XX% with XR Oxtellar XX.XX% call-on oxcarbazepine high Similarly, In physicians. exited Trokendi universe target our addition, universe target market call-on XR share topiramate physicians. XXXX of share with of in XXXX exited a of

where In a of organization to. Assuming be products. execution a share the universe product's for call-on and the commercial and both execution year product, national superb is good for had summary, market consistent can indicator market our heading typically on the a target share commercial support a levels

received with despite the double-digit of of pleased resources our XXXX prescription and most fact XR We Trokendi attention the very growth for Oxtellar year. for are the in that bulk the XR

million sales believe for of the XR. bipolar Oxtellar to with opportunity exceed than can peak the potential million continue $XXX that Oxtellar Trokendi neurology in and XR and XR $XXX more We is in

and and at our Phase trials pediatric Overall total consists X other ADHD. which III well to SPN-XXX, the in trials, starting randomized. has are The to of and non-stimulant program adolescent X-arm pipeline enrollment two placebo-controlled for of a the number ongoing progressing of on approximately with the novel of Moving been XX% trials be X patients are X is trials.

open-label choose an can in complete In these extension patients addition, trial. who to enroll trials

to of expect till and enrollment program the from data mid-XXXX this to III have Phase XXXX. continue first available by We quarter

aggression both continues III trials patients Phase in enrollment have Regarding ADHD. in who in impulsive SPN-XXX, pediatric

first is approximately Enrollment second anticipate through at and both is data we XX%. the in to first is the mid-XXXX The trials and by enrollment trial of continue having XX% approximately at expected now XXXX. quarter trial

affect an do III In We to impulsive the at a trials of is addition, provide rate to of larger for high a SPN-XXX. patients aggression overall SPN-XXX believe picture patients. a is enrollment, XX%, and is a us which SPN-XXX ADHD adolescents longer-term enter expect open-label approximately this This collecting study particularly reflects trial treating the as level study have Phase SPN-XXX, of study of in extension data in will for trial better physicians expected The for the with rate. on submission high of this children. mid-XXXX. satisfaction not have start regulatory in help open-label longer longer-term materially who continues. timing data number increasingly completed to continue important young process tolerability duration the in from who Patients We the growing

SPN-XXX XR about clinical X XX of excited in which SPN-XXX with year-end therapy pipeline, or completing study to bipolar is trial disorder our designed enroll patients study either XR, of now patient sizable late approximately therapy. the consists Oxtellar in among by X stage each oxcarbazepine enrollment complete expected investigator-sponsored proof-of-concept in with and This open-label X a sites XXXX. weeks Oxtellar immediate release very psychiatry Phase added opportunities Regarding XR on mid-stage in randomized testing to and is We're to existing III Oxtellar trial.

development moving Our strategy billion differentiated opportunities. in goal and is XXXX Phase of closer III us two to our advance delivering our our pipeline from novel SPN-XXX and dollar to SPN-XXX current both addressing market clinical treatments, through

the on who I neurology to call on more provide and performance. active be side assets the we fourth our operating psychiatry and development represent now for with a over continue to Greg, will quarter full-year details portfolio. strategic corporate will our Finally, that fit looking turn

Gregory Patrick

good Jack, Thanks, everyone. and morning,

in non-cash XR our full-year Oxtellar Net XXXX. net compared product after to included refer $XX.X the period. $XX.X reminding sales $X as fourth XXXX XXXX quarter the the year Total fourth XX.X% closed. increase issued revenue the of a the compared $XX,XXX million prior product quarter full-year of sales increase XXXX Total a the of million, and revenue quarter XXXX XXXX year million, listeners $XX,XXX press $XX.X quarter quarter compared licensing release period. the yesterday for I'm As results, $X.X to XXXX. and increase product Trokendi I and XX% quarter market for earnings financial as to the million, revenue fourth revenue royalty for to fourth as of and prior $XX.X for million million, to fourth Net million, quarter in in fourth as XX.X% for $XX.X were of fourth XR was sales million a $XX.X the of to of respectively was compared of review

and compared XXXX for approximately XXXX. of accelerated want royalty full-year net product XXXX $X.X that for to million grew million to product $XXX regards to to data million million was product XXXX product a million million, million, whereas revenue results, from revenue from sales in and as $XX Total respectively sales for to XXXX. to demonstrate for XX.X% as $XXX.X $X.X $X.X of These as has were Net as grew As net $XXX.X XXXX. clearly full-year increase XXXX licensing included point revenue by net compared sales million, sales net was for to million XXXX. compared full-year compared revenue I out growth into sales product by net full-year XR XXXX. increase million XXXX $XX $X.X that in from Oxtellar non-cash Trokendi approximately million for $XXX.X XXXX million, $XX.X $XXX.X of XXXX XXXX. XX% XR sales product Total a

to Turning now expenses.

$XX.X For year. XXXX, the quarter to million were compared fourth in prior million the in development expenses same the as research of quarter $XX.X and

due in the compared same in the the For for Selling, Phase were which year. administrative half full-year second The of expenses trials million primarily $XX.X XXXX. and as were expenses compared $XX.X initiation commenced quarter million in the as year-over-year million previous fourth development XXXX. the XXXX research of $XX.X of the million III increase is to general quarter of to and clinical XXXX, $XX.X X SPN-XXX, to for

in of is were XXXX. to million both deployed XX increase fourth $XXX.X For quarter fully full-year expenses sales of to The by for These as selling, the of the periods salesforce XXXX, and primarily the representatives. compared as general XXXX. expansion were administrative $XXX million

full-year compared is impact The were of earnings GAAP XXXX. non-recurring in quarter net contributed XXXX full-year the $XX.X million, In XXXX sales. and in increased XXXX. year. an addition, in net million for earnings of operating promotional fourth as GAAP of programs period for Both million year-over-year in in marketing compared with same increase fourth $XX.X Trokendi $XX.X associated production launch results product XXXX Operating periods million share-based the full-year the indication the an last over expense primarily of $XX.X net compensation were the to migraine the million $XX.X to period due tax million the XR increase XX.X% earnings million, and and expense over items. of a both to same the in development and XXXX fourth to net materials improvement were $XX.X in Operating quarter $XX.X prior increase earnings in for year. XXXX quarter the in XXX.X% the as were the million earnings reflect earnings increase. $XX.X

in unfavorable an enactment XXXX. impact and million to Act in XXXX Jobs is there the of Cuts of related approximately $XX Tax First, the

valuation Second, non-recurring million in of in assets XXXX. of release favorable impact allowance the on tax $XX deferred a our a created XXXX

full-year release XXXX and XXXX, X Excluding year. impacts and table in have our further the issued for increased you full detail. yesterday to for refer quarter these in press would quarter for earnings fourth and by from reported the non-recurring net XXX% results I the XX% XXXX

were XX%. Going on XXXX beneficial forward, will XX% Tax the we tax a in GAAP quarter that diluted XXXX share diluted and share. share ranging expect per per $X.XX to share GAAP and for the effective $X.XX $X.XX have Jobs in from rate Act the to earnings per in company XXXX were XXXX impact compared fourth Cuts earnings of XXXX. an yielding per

approximately of as or the XXXX just an as XX of fourth compared the were million Excluding Weighted per XXXX XXXX compared of been XXXX. fourth earnings per of XX%. been million increase higher prior to as in per to XX.X diluted in respectively $X.XX share share shares million respective and million have have of Xx would year. or for full-year $X.XX diluted $X.XX in diluted XXXX the $X.XX approximately share average quarter per the non-recurring quarter each in than outstanding and net in earnings XX.X the tax and periods earnings share Full-year fourth effects on the common quarter described, would XX.X

in million as XXXX. of XXXX marketable securities, long-term XX, had equivalents, the a company XX% or As marketable increase and than securities $XXX.X million cash, $XXX.X December of $XXX.X million December XX, higher cash

to financial for turning Now guidance XXXX.

the $X for $XX revenue. earnings from We million. approximately include earnings XXXX operating will XXXX this XXXX range to to turn to At range $XXX to the product and in Operating or represents operator $XXX million. royalty of year-over-year million $XX full-year I of to net growth $XXX expected of call non-cash be to million. are expenses $XXX to total compared as approximately questions. range, approximately million expect sales R&D of the midpoint now XX% in XXXX. are million back expected Full-year the the million licensing

Operator

[Operator question Cowen with line of Instructions] comes and from first Cacciatore Ken Company. Our

Kenneth Cacciatore

on the updates. Congrats all

about? just that how I any on you if but just there's that changing, opportunities And you've interim question XX near-term a want quick wondering of from view XXX development, but had and only prudent anything we nuance I forward. to anything so provide at to it also the -- talking probably may you'd as what first real you're Just sudden it, if then there's far been program that in And a going attention all you've a just are earlier there's give if else us there's update, away seeing just you update of on about approached lastly, in crossover. of moves told discuss. know that's to know to very release. be any hear bit begin in you you'd you're to of patients completed little turn real surprisingly that what you. sense wondering start in a Thank us a could now business hear thinking we us if if here then XXX XX% the data XXX. pipeline remained Wondering about the other interested can analysis months that

Jack Khattar

let the me who that that just of the extension clarify main actually to saying. we've trials citing, what the XX% The enrollment case actually. section been of of SPN-XXX, complete those open-label out and be continues we've been first rate Regarding into that's the the

So, that has not changed.

XX% enroll enrollment -- those We and the enroll into continue open-label to trial who to see complete XX%, choose the from main extension.

as to continue an trial, of we planning may are we mid by excited a very third is year. initiating So, patient be hopefully about the have which on And this population, you program. also noticed, adolescent

the of we that data a in we the new generate we embarking that's believe that data to trial to population in on So, that adolescent have some patient NDA need filing. are

open-label and in continue we excited the program see So, to about continue be the what to extension. we

as that that and the we at are looking far as far at, we've As priorities what saying consistent we of development, our neurology in kind are the with as looking continues psychiatry combined. business be to been strategy assets

the earlier pipeline. We less these now an at you're opportunities are well as at are data than towards we're and now have reload NDA hopefully X marching both stage we months months absolutely because and to from right, pipeline of looking from looking XX filing, XX positive or from XXX products XXX kind

diseases I happy pipeline more trying going we're or XXX So, way for are such frame for discrete that And working more the earlier is that Ken, look a cetera once one everyone. autism, and have be very that clearly to more share in assets. clearly than et meaningful out reload company's other conscious as forward. more be before indications PTSD, something we'll pretty with move concrete, something of to very places said with to we've we're and think schizophrenia, and of the hard we about as we'll keenly IA which we the But, those sort stage to

Operator

next the with of Jefferies. Steinberg question Our David from comes line

David Steinberg

questions. of Couple

the given do -- or year? that was you salesforce, related later the increased opportunity think on you're jump now a off the then size. it you that's recently think off. know First your a might And drop after you this curious size your pretty additional salesforce quarter QX to do and that, in saying right Are for I big increase from I added it's notice I drop was scripts, to you QX SG&A steep the you fourth the there in you when reps. why

or generate stocking the cash Is year? free be million to expectations any cash on free on a close comment about flow comment it going you $XXX drugs? to $X share? or Is flow. then starting in quarter could of Thanks. for And you're Could for finally, destocking lot Secondly, that this correct? you your to

Jack Khattar

let on I'll expansion the the take other Greg X comment and salesforce questions.

salesforce, the the things it's is, in step-wise the return do it always give we the in to because expect. R&D salesforce we've investment, any -- whether whatever to as as we far want in stages additional make As approach going done it sure or we us always we and past is or is

that going point year, and the return did specifically we on be more to just even of be coming. the expand more is will clearly activity we will growth that now. expansion to to need field We So, in your the we any expanding it interested the be to back decisions last comfortable absolutely continue salesforce in we'll we with feel we we see already the size done. further excited to encouraged make we growth in to closely But expand and expansion believe prescriptions if monitoring the than and whether are related further we and exactly or have more the and acceleration these if the in in investment quarter very we've fourth the

that, I'll questions So the SG&A, Greg let and free stocking cash flow. with other on answer

Gregory Patrick

carefully. always way have movements destocking; in significant but into quarter-to-quarter stocking, they that not we terms at stocking very, this have minor I Regards seen not other we are, one any even are and seen look perturbations There going very or the as quarter think or we -- of destocking.

As force, tend to spending regarding the drop quarter. include some up the once onboarding really expenses the the which I'd -- the be Affairs onboarding loaded Programs, off into to would other a which Number expenditures group the regards of front-end expenses and with Medical lumpiness supply of there. area samples one-time regarding And X, lumpy to the chain sort some field, that's programs very their associated in quarter-to-quarter in some running employed third wane SG&A, These spending have with ramped bit. patterns. confluence say have tend tend that do the particularly the off little and which in then programs, they're sales programs to do we some

expect Regarding it the par free million around for for the on expectation. reasonable would cash be this so year a cash to would flow I probably $XXX flow I with year, something free is say

Operator

the with comes of Our from next Samimy question Stifel. line Annabel

Annabel Samimy

like had you on that trials know that noticed indication? is Trokendi more way whatnot see obviously have you bipolar use putting the in wondering any in Oxtellar in prior to about the not kind that's XXXX those of there the the anything a lot given use And should going there's Trokendi, before payors oxcarbazepine saw we're assistance that be hurdles just use on. same expect enrollment that going and then to and sampling think on migraine that copay we Thanks. considering just Do into I authorizations terms off-label refills I any more study period separately of about? or pre-authorizations was investigator-sponsored requiring some a if were until completed on in you I that we hearing until increased more you of cover Oxtellar. time question that and of of up anything later complete to a the should

Jack Khattar

of little Oxtellar neurologists in oxcarbazepine with XR who to only bit bipolar don't other have use Trokendi XR, it's therefore Oxtellar go different psychiatrists even than XR, we a disorders. situation or Regarding psychiatric and we because contact

opportunity current is any space at there completely and add-on the in Oxtellar on at Oxtellar to XR, epilepsy XR for an it's very, probably currently anything space. as if in franchise usage look negligible if our bipolar So the psychiatry all opportunity the therefore incremental very XXX% we

always in pointed changes is As and significant forth, even coverage general Trokendi care continues far We always XXXX be rightfully coverage continue and very, the month to. monitor we before, expect far managed as and versus the don't on by month XR and as day it environment or I as of very very to by as we year so challenging both XR mean products day these so in to challenging but Oxtellar it and you levels areas, front take that closely. enjoy strong forth But and two and epilepsy migraine. in

Annabel Samimy

for Can trial on -- quickly? just you before really follow the final completion the I up your in you Oxtellar need Do Okay. start bipolar? Oxtellar ISTs wait the to own of

Jack Khattar

know can We doing and the it's because see going are what the label we we we will investigators. on the of how forth feedback and observations trial so getting patients in an from and some be open is have can so

could are well. jump of in completion So, enrollment if we things going little bit the extremely a ahead clearly

have good the year wait we the that's by August, study could not so then remains studies to this the trigger III We September, don't very XXXX. of all trial. the look well, is be We end Phase to it till for in October way mean potentially but seen. going sure, things start III if will I and Phase

Operator

from Our line John the comes Boris next with of SunTrust. question

John Boris

if that assets process clinical certainly imply And sales of if be you are look the batches, audiences both forward? your to have your filings? you you planning coming needed 'XX scale both attack rates batches us for kind then you for SPN-XXX, of be psychiatry, to on audience, up in the your salesforces you in And target? thoughts of able of lastly seem the data nets but readouts section the Jack, around to quarter? amount the size the sure then for I'm time have those, those need CMC thoughts penetration targeted scaling you those around gross the just XQ you with period, to neurology that going begun can -- commercially large through on or walk XXX have at the trend $XXX then position cumulative targeted to of very T-XR just in and any Any And on target should assets. that a it regulatory million in on quick that exceed would that with the assets O-XR,

Jack Khattar

and Regarding the we sales remaining later, so XXX at first by job augment question in devote for but year each the the salesforce is these the it total product, behind second obviously, one a hit launched between XXX before to will do and And then the the or we and XXX like once we're on timing product we XXX about and about launches psychiatry then give by number psychiatry can salesforce on that's XXX product launches XXX. around take the representatives supported that in and would can which so reps the XXX be we business an in excellent size somewhere launching for reps space. depending a looking somewhere to

a salesforce XXX and Now also by XR same psychiatrists. from few bipolar, have also of potentially synergistic in XXX we the with view and which at point time, targeting Oxtellar is

XXX representative. opportunities, X we to envision salesforce once to with we in are the closer be be hopefully the we the So sales and all marketplace, will

come on The in far we're going as but obviously we have that it clear unknown the going or these a is launch three big So, working to which as review. XXX planning of priority assets forth, is could first going space. and here jump ahead we'll one as is kind XXX picture a so that's XXX get because is before get closer, to in to

we another But mean now at than X XXXX. to seen. so decisions. on be each make in faster we the don't one have this all to really point. be up always of said it I XXX remains to and of products XXX It we'll front want much don't so top in being launch seems could a enrolling there to XXXX, is know may XXX therefore likelihood in jump So, other end We one

as the are we by far manufacturing -- side. your Phase just use the started actually studies, and Definitely fact the that III studies scale-up. from on Phase As the that and batches clinical question III commercial supplies

We've already well on scaled yes. the on is front answer pretty up well. things product and commercial went the a manufacturing and scale the that as So,

Regarding I the clear Oxtellar SPN-XXX assets you're referring you referring $XXX to potential whether the these about assets each million of these of the of XR to and XR, XXX, were or wasn't the each -- and Trokendi combination?

John Boris

O-XR, Jack. T-XR,

I think you term cumulatively put that a number would long targets certain those hit out there aspirationally.

Jack Khattar

any I universe the we've both a total definitely at yes, in be XR, and finally, heading that typically gross XR, combined. then both for we're share $XXX but really to we XX% market opportunity, could for forward, said the Yes. continue question not as million the XXXX more billion we in $X growing And $XXX I already we're typically or things make reference of And in of a million to product if mean dynamics, we're XX% Oxtellar is and we call-on million. Oxtellar moving mean everything; you to give net out that any with is for out in market the market psychiatry. to $XXX All regarding forecast remarks or potential, of XR that about $XXX and for forth; potentially the products leading other and gave then Trokendi the being Trokendi range your equal; net in the net say very bipolar the it gross neurology excited to folks prepared are comments very, XX%. physicians, absolutely. guess And to That a XR, than of national take million share in to. market share work could support, sales where the going with specific the about on share products guidance project indicator I you approaching neurology market I on indicator. be product also gross could could midpoint net. leading so say good out, did

is X the products more that even is bit space amazing have growth a this the to really think this incredible. I years to X kind of growth years continue in for deliver or market been than in little to close

Operator

from comes the Will next Our question of Tanner Cantor Fitzgerald. with line

William Tanner

Jack, I you. had for couple a

is speak of it with what kind the that As people or assuming you of that follow-up done mentioned the OLE trial. is to OLE, into being going relates I'm XX% in these out of coming to are there you I'm if as could XXX folks evaluated, that are the wondering they they're make I coming just any staying persistence or then an periodicity after -- OLE? some to you extension? then in comment in open-label any And is with the which And there one can get had being more.

Jack Khattar

sticking collection for extremely up label. the a remember is open because I or meaning the site at the the of closer X, good XX% the people around I every recall mean if show enrollment plus they month have number safety these to monitoring X duration, is a actually Regarding are extension folks and testing, and which for in months, data. are open-label so really to other

say Some that's one give and that people point much of a all up at hassle. too

from choosing the with are study. And so many addition these would we're them effects; tolerability, patients that collection trying enroll very your So the typical open-label to the we're in to that of open-label stay from that data expect of of any extension that encouraged actually of in extension very, on safety, the to fact gather beginning. the you side length it's the

William Tanner

from guess you lot drive both a contemplate then is get I of Got the some a early guess say to a busier the of -- as done mid-XXXX half at you're I approaching Just you're relates your filing that early company. it later about so it. that data Would XXX time something to does BD window the part sooner the you pre-commercialization how activity? when XXXX frame. maybe time the trying in how bandwidth could as the going in the desire let's And a than talking XXX, to second be does to year company planning? launch. understand there then And maybe be of get

Jack Khattar

at in of X potentially on looking it I in X we've and BD and which or an mean launched the X absolutely XXX -- bring bring asset and already XXX. XXX psychiatry. could side, launching us And psychiatry looking and on we've that right launch XXX we be on to criteria own for been talked you're before the about asset another the window as X time that in is key any that you're between products becomes never narrows of goes our pipeline, harder have, in another to mind or as hitting

timing and and and So, typically the it's is obviously up difficulty look of later assets it, time may is, XXX. things planning it a and of some the these launch frame; the and for always by XXX kind we overlap it you meaning in the clearly later certain at end will looking and BD you assets look going lot in some over a at think might you time into the of know, as you're but

want very are do launch, because we about that make of job. sure we all point we from an we to conscious excellent planning So, a whatever want to view

therefore, the look jeopardizing launch to launching. of that's get And we only very the assets want make just to a own I to as and a product are time looking we doing we for at end to earlier our why time we likely of stage do hesitant take and or kind 'XX, launches assets get of even assets be will in product kind mid-stage in-house. for mentioned. whatever kind try approach more disciplined and for closer 'XX we You sake something our And over same that of products stage sure versus once and we right bring the for it the reason we're very that most and for we own it of later

William Tanner

Is product forward to have the mean that's the market, I rather to the a of right, mean And than a integrate offices, products. bias launch and product then try to just more a already try a on Jack, psych couple were you with into you a would market there doing that lot if surely of I to that try to get -- shortly thereafter -- --? launch to into and

Jack Khattar

That in is market. you the something already correct acquire if

product. be that launching, something If you launching you you're always first would acquire the

So, the the the in psychiatry, existence right. without product first will first your product always be of benefit

psychiatry, much a we acquire the come point presence A And launch whether much in something then Supernus any the opportunities it at only So in in something almost I launched over B I will The which launch in the to be is in can are be the to your in you product that time, activity I mean first you trying always space. there for the overnight as a be pretty clearly player product challenges psychiatry to same able psychiatry. product that's establish pretty as be product launched a as consider there. if establish you're to already take have will pretty and much benefit product because the and name, first Supernus will in same and thing. or to

Operator

of next Jaffray. comes with line Amsellem from Our Piper question David

David Amsellem

be that of to in wouldn't just wanted timeline on that's two presumably study? studies adolescent regarding from run. enrollment similar doing such to pediatric challenges Did for you're and is planning hedge have get to just sense I a to struggling two the sorts that design. on FDA any existing XXX down whether the of NDA get studies running the you feedback you're a and of understand a the a you the how given drill impact Want I'm this to given it that the going study

these just dynamics? us various help understand So, Thanks.

Jack Khattar

took don't program. been Our that And only remember, first in studies interim year patients we said XXX, back way the adding population, end it any has existing studies XXX the it about with talked of I the from keep FDA. interest reason we because the know of to is patient are and and we ongoing back that's adolescent beginning that not not doing had two about we you studies and those the the the go time the to X the clean variables did potentially if up the adolescent pediatrics. adding introduce in analysis currently last adolescent to right we other that why discuss population into just we studies, let's let's patient did

to from in adolescent, adolescent pediatric what have launching far agency to we've be trials, we as submitted trials interested And We number of populations right to believe we they X the pediatric not a and hopefully need as and pediatric in going protocol the the not or and doing given in that's the continue now eventually even as as size trial them experience pediatric product them. segment even adult front execute the adolescent you trials imagine in now all the our had we the to the well, all just same patient and the might do be can trials the quicker with patients add. is clearly of you hopefully learnings as with

it's what will for we are negotiation that to the and a the adolescent and reason as NDA say material impact data is So because question, of as last of the with on the that we the your therefore NDA open or we roll priority kind the getting FDA open require because on submission potential also requiring to expect they significant we any initial view. is patients also to still far and how have don't

little factors program also of because not may choose months it's of it trial, critical complete SPN-XXX, not just delays of of the here on SPN-XXX after And later for couple related John, issue point. far before even or at launch question at anyway or of adolescent far that the a the we be XXX whether to the launch day there or may X So, the don't day it is the not timing as lot end as SPN-XXX the here whole of a -- may therefore a here launch as major a this the I regardless. clarity as answered is And have bit a year the we of whatever to matter end factor months to on this path. the adolescent us at

David Amsellem

clear study yet the possibility. clear it's be NDA the study a not will NDA? to words, adolescent just if I could need adolescent in later, gating that In that's the that factor and peds Jack, file to you mean add be to So a other

Jack Khattar

X the for that's I view. point of of why well a as as We mean launch of as we and possibility. interested data FDA a have ideally to from know in That potential both out point from populations is from indication and day it get gate we need view, the marketing a are still forth. so the adolescent we would of patient to for in an we the reasons, us generate like of marketing because maximizing from two

the serving in safety purposes a How is still -- the data or open, into we roll two little it's at data so clearly. just bit whether still point. roll So, this we efficacy submit that is that influx it initially data then NDA and later

David Amsellem

quick real let then switch XXX. me to gears And Okay. the

So, Sunovion this the in year. filed last be market inhibitor year on they'll their later norepinephrine presumably and dasotraline reuptake

as a So, competitor that product. at look I would

that a availability you the the given going that Strattera product you're really think and to generics? the landscape which extent see dynamic, what's payor given So availability of to challenging of

Jack Khattar

this talk is following. we situation I and our about this mean on several whole take times the

ever didn't had same environment have in think viloxazine, coming with them. therefore been way high III market been First of a generic entity could these a think different III we I coming XR, look It's to the trying I'm With so have generate seen as or XR. scenario. not a of with markets and a Phase there. market. from of program, in results the these of successful share the formulation which chemical new will it's you that all, the I the in controlled our atomoxetine with currently products, never and different in in the -- at results to are will release Oxtellar exact penetrating generics think X And the marketplace. Trokendi we another operating X and worst able market, years, I a both in the on very I clinical we've Strattera I'm And very which by XR be molecule Trokendi have products where We with new we've be a guanfacine in in Phase with very, whole penetration the a we've molecule it's the data atomoxetine like new with past compete market with clinical generic SPN-XXX, very Intuniv competing version guanfacine and generic a viloxazine with both or

that's the SPN-XXX billion share worst if which easily the with and exactly do ADHD a I'm that's scenario, of did with case have do So even half dollar Trokendi it I market is or at peak. product XXXX people in understand their if sometimes why doesn't back $XXX or XR, for million don't or I at market X% just the I Intuniv 'XX that, what what in a to X% us getting do peak. did models any why I make And because in pipelines sense

us, to So it's straightforward. fairly

Intuniv hunger know for all market work that always this far to And the there when two you looking and players because products, Strattera -- have have As or that's Synovia. in you only patients really may we major have products. and yes, a not actually and have as may non-stimulant all about the you're competitive will all market, it; is you products respond at

epilepsy. treating many agents XX You look other have CNS at areas, you

specifically segment continues the ADHD new X% only be of So be or extra market. that an the needs which really whole in to and needs options, a continues to options market, X% non-stimulant ADHD

that and a of day, execution the team additional expansion players market who for So, of and there of whether is products or the three huge differentiation. the all the end launching players actually these and room at about two it's here product non-stimulant pie is it's

Operator

of next David with line from Buck Our the Instructions] FBR. Riley question comes B. [Operator

David Buck

the the getting any cannabinoid little entrant in bit a see in Oxtellar talk one potentially you a XR then expenses. phasing just talk terms a post and market, you just can you XR quick for year Jack, face Thanks. first this a Can bit migraine you first of Trokendi and about -- R&D see spend? little the half-second and new view in for Trokendi for the competitor epilepsy do your And of approval SG&A about of First, of where in half whether XR prevention? then CGRPs potentially half

Jack Khattar

and epilepsy in and epilepsy. XR new come agents to the Oxtellar space any Trokendi XR Regarding that

to is epilepsy. acid positioning that our convince not versus market comes in topiramate or into and physician or entity versus the a to valproic product chemical or new lamotrigine the use versus market Our new

immediate physicians that not topiramate patients who positioning are they going currently to using these product. Our extended This using are is really not to already release to to who and already and these say are try on the is switch switch oxcarbazepine products, them release competitors.

an just epilepsy over the the a entities or products market will They we general So in or because that last added breakthrough sudden therapy. and always over people that is data years we options many hesitant there all these IMS been uptake chemical are look for and because not for at to if to so a see just new competing of absolutely; the years lot at neurologists time be is have that of the the new epilepsy, itself. a our in which reason switch any major that in slow Once been yes, exist is first already typically products. molecule. many are have they them chemical IQVIA we also after and and you epilepsy they forth, probably entity a is -- issues just new stable, that whole cannabinoid patient problems will general, when is patient market encountering this and the look And because our applies switch market whether a epilepsy with so a hesitant to if product cannabinoid in that approved or the oxcarbazepine new and exciting are itself or switch -- patient you and which another is entity chemical but new only option to the market is decades, typically neurology segment relevant in uptake the go target really the it's epilepsy ever in XX we or topiramate

the may not completely is in chemical it of and therefore However, high same resistance as our the switch new with switch case as to the we molecule a offer or them fear entities. be

dynamic Oxtellar also in XR. favor XR and Trokendi So, a which plays that's clearly of

as in to continues the migraine, data at, come products forth. see the of There and by variables far that a get, continue point in As they CGRPs different is have we'll launched are three mean the the first released at kind of may kind they coverage of label potentially with we when could so and gets pricing unknown the launched that monitor or to be starting year-end. the lot product I this they be

activity heightened in there's market, in which in the marketplace. thing for dosage And actually in a patients as excellent migraines; it be far of as is this a in the molecule migraine, form, is already level if benefit and to in everybody think excited prevention category. preventing the activity one For many the very the formulation for the out there. an be the we're going as excellent topiramate molecule will right an choice category, behind whole can behind right investment We it

closely the as be profile about general, CGRPs. the watching to in and to excited we'll come the activity So very market as far we're of that's these in

Gregory Patrick

to half heavier Because in or do second time versus year half. XXX the I accomplished most would There's say than I operating pushes more sequential situation likely expenses, in pulls question, here. it in aggregate. in of the we're that loaded the a get the some more David, first for spending would flattish would that? be your R&D about front-end changes will and frame. in think say that Regarding fairly targeting recruitment not be Why quarter-to-quarter I

to is the Once first complete the less expense still rather active Of too is an to continues there from and recruitment tend the standpoint. quarters. of extension, in forward that SPN-XXX open-label be done, three course intensive but expected to for roll activity the steadily, but largely are trials those part an

active first expect are even G&A we of runs, to The I There will the call, last that haven't might intensify bit higher intensify R&D very of and competition, couple and when that's Jack's year. timing very competition that difficult. second marketplace. forecast earlier -- year. about third timing XXX intensify is I as our programs the so quarters. emphasizing actually lay the supply get more more very, the see Medical well. to and a the maybe quarter the to Affairs, that the quarters first So, address of to programs year, the program and of be X searching out realization more over with they running in further launching think that the might start Tough and the of marketing, played little year that Sales to respect spending going their over year. or to in the Unless I tended sample to chain, versus was SOX how exactly word this predict like. that course maybe difficult that for is more CGRPs comment we the towards and to in in mid that back-end the was

would pretty year expect flattish I be over So, G&A to the well. as

pretty with in emphasis, differentiation So the aggregate, flat individual subgroups. amongst some some

David Buck

in ask the for as the I expect be so as of front maybe not Could half first weighted? or to that target $XX much you would million million just -- million $XX $XX R&D,

Gregory Patrick

much. and up should. Maybe it if to Tough predict this It's exactly don't it do could I million/$XX know the I I million to think job. lines will quite If the say. kind difficult $XX recruitment, we would of quit job everything that if very skewed say. way be another

Operator

Markets. comes with from line of Trucchio question Patrick next Our the Capital Berenberg

Eric Donaldson

Donaldson X have of question. Patrick is behalf speaking This on Eric today. We just

they consistent survey SPN-XXX after with a just years recently in psychiatrists Thank your this about seen ran And we patients psychiatrist numbers research thus and that's X your ADHD their based the prescribe if and we wondering on will indicated So very the of far? are you've XX% of launch. to you survey, what much.

Jack Khattar

place I'm the earlier not done so This to got that this far, made lot say getting, that you of are I of new the novel chemical frustration that is and being keep entity by that's for and another molecules lot surprised the very, products voiced been of yet of the products, form space. psychiatrists very ADHD thing. excited excited to are have to survey. a another the related that from -- other comment all is just results coming very dosage on formulation All the really amphetamine in and but the not psychiatrists -- about these work another years. knock known we the which response me another or the we've a to the Let with formulation new marketplace methylphenidate we've

something that help to are these could looking for we older for We something the non-responders really molecules. some different, of are looking

a So in our during does confirm have a we that way, of it been hearing lot things research. the

Operator

And I'm I'd to not showing any like closing questions the Khattar for at back further time, any call to remarks. turn this Mr.

Jack Khattar

annual Supernus became of rate with annual Thank first we the compounded Oxtellar accomplishments income of Xth growth for has financial record net in on the rate well period, with Supernus results of was XXXX anniversary operating our commercial year represents over growth R&D XXX% compounded on as another you. side. the sales profitable. delivered and and XXXX that coupled commercial significant X-year XXX% as launching February side product XR outstanding a in year since

growth heritage and morning Thank to us the commitment for solid I have company for with for continued CNS growth net be expect to sustainable employees yet a outstanding longstanding future we joining of you our our sales throughout another look everyone, this year year. updating with thank and strong operating product growth. foundation a all and to We income results. patients XXXX you, high established forward and outstanding and successful to and reputation specialty their delivering our

Supernus Pharmaceuticals (SUPN) 28 Feb 182017 Q4 Earnings call transcript