SUPN - Earnings call transcript Q3 2018 | Supernus Pharmaceuticals, Inc.

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Operator

Good morning ladies and gentlemen and welcome to Supernus Pharmaceuticals Third Quarter 2018 Financial Results conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions will follow at that time.

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.

begin. may You

Peter Vozzo

market, Good us Gigi. financial and you of thank conference release a Thank these announcing for morning Supernus joining results. the close the today Yesterday XXXX company Pharmaceuticals for issued call. press you, after everyone the third results quarter

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

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

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

of management During other be make These the course identified words as expect, by on and existing may, of this and Any perspective uncertainties, of in future current and forward-looking call, events are projected report statements performance XX, those involve for future on forward-looking regarding annual such believe, Form performance. XXXX words the trends forward-looking may Supernus’ our company’s Risk these should, and risks will, intend, XX-K may future of statements. the ended results materially on XX-Q plan, and differ report can statements and not and such XXXX. March anticipate, quarter meaning. reflect statements similar in Form from forward-looking quarterly noted certain those Factors information guarantees the including Actual section

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

Jack Khattar

period once we as product the quarter for Peter. another us to quarter sales. results. Supernus for again third new million. to the Thank we generated time net $XXX.X per increased and quarterly quarter year, achieved by join Operating discuss record to everyone Good product growth, in XX%, our thanks solid million, in income a morning of strong setting taking to share XXXX you, sales third Compared and of diluted XX% net reaching XX% same per growth by $XX.X increased $X.XX earnings share. last the

financial by of performance XX% XR XR demand Our for last IMS mainly products. reported the Trokendi of Oxtellar was Total same XXXX to prescription and as increased XXX,XXX, solid year. quarter period third the by prescriptions driven over a the our in increase

grew increase XR, the declines slightly an expecting. IMS ending anti-CGRP third compared during XXXX period the the same XXXX competitive by Trokendi were prescriptions landscape prescriptions XX% the three resiliency months in at representing is steady market over XR great nine the reached a same prescriptions shown X% many year. of has of quarter year. Oxtellar migraine the same XXX,XXX, were in XX% of XX,XXX, last quarter last period year, For increase for and and the which over Despite the launch of September people reported are topiramate instead significant of Total topiramate products, to last that holding the by as increase,

important prevention the remain with the quarterly numerous most its foundational As topiramate in therapies of as we migraine. we that of last of discussed in one the believe will mechanisms call, action

in the therapy of the feedback more of field In a prescriptions switch XX% than instead add-on are form that the from current anti-CGRP fact, shows physicians from and therapies. of

Trokendi of other XR it ending preventative above market to X%. its August that is months during months an period the topiramate market report as Trokendi September September by XX% September last of its topiramate ending that by IMS, in with high the prescribe In the who physicians they nine share two reached period compared reported combination XXXX, XXXX, share reported months the of the IMS, In addition, using majority during Moreover, XR and XR treatments. Trokendi the XXXX. are all-time has by nine grown share

by for excited XR that company Trokendi are placebo-controlled This experience These The patients than Trokendi complete treatments, of physicians. more XX% the are cut and including XR, pragmatic assessment migraines from Oxtellar Finally, of partial clinical patients has that growth to clinical from in a seizures to have migraine rather XX% well of on freedom. expansion the real-life the [indiscernible] could other label a represent the patients for but have potential opportunity half XR a and or study actual shown reflecting data reported their term. patients reviews who of be long about continues very anti-CGRPs. in any significant level in efficacy of compares monotherapy not

district the Supernus’ is orange seizure that Circuit million As infringed subject decision and after infringed for that New Jersey affirming growth three Actavis has previous in December decision XX TWI more the call, patents. Appeals were mentioned This XX, the monotherapy XR Court all by XR affirmed these year. Oxtellar all book a that U.S. between market of are become relevant the especially also This patents also that court District the valid. a patents ruling Federal a XXXX three prescriptions litigation, the the same Oxtellar for opportunity of XX partial and Court earnings follows appellate decision

issued reminder, than As protected eight that a XXXX. expire XR Oxtellar by earlier no is patents

SPN-XXX, for patients with novel our our onto our SPN-XXX, of completion NDA and impulsive treatment time filing. pipeline, for and ADHD, of aggression Moving an on non-stimulant treatment we ADHD, exciting X towards Phase it’s the as Supernus novel progress

development to company approval has NDA SPN-XXX accelerated potential SPN-XXX launch for and positions the U.S. of commercial it timeline the the Given the ahead regulatory its potential filing recently commercial for of of resources prioritize in directed launch SPN-XXX, that and

and plans the timelines updated following candidates. for As are both a product result, the

old. PXXX patients that trials early XX in December and from announce placebo-controlled to The program patients are trials and expects For to years first the line Phase consists from XX PXXX, in SPN-XXX, four and company XXXX, and PXXX PXXX in six PXXX old, X SPN-XXX in end first of second and concurrently PXXX the expects launch data XXXX. half adolescent by the XX data Top by PXXX Phase years the of from pediatric XXXX. of of three-arm an line XXXX. the trials: adolescent of half top PXXX, trial to to XXXX expected NDA December trial, the and are X the the the it USFDA approval second X Consequently, end second of Phase pending submit to for in company trials quarter

be released of from instead as PXXX X given patient trials is its This second change can of PXXX, completion does timing both until adolescent the trial, dependent given of SPN-XXX, Phase however, expected, enrollment first NDA the top some expected has NDA the from the on for trial concurrently that prioritization that For population. is sequentially. PXXX, reached the around X line to data submission target; SPN-XXX not the data impact active submission data the of of trial, generation original and keep company mid-XXXX, and in decided PXXX the Phase of the the SPN-XXX has enrollment

SPN-XXX patient open in of is months, average, study extension to and tolerability in continues remains study open on for encouraging at believe observe which or treatment efficacy label higher. SPN-XXX for label of the the XX% we the enrollment an In X.X Supernus a addition, On SPN-XXX. sign

that commenced. pleased the we’re X Finally, trial patient dosing adolescent SPN-XXX Phase in has also

in plan second and the continue of to XR the XXXX. of bipolar treatment Oxtellar work is program for Phase we a disorder, the Regarding to that X commence program expected towards half

Moving forward, be as program to this SPN-XXX. will referred

now for Biscayne extended a Finally, novel with an assets our in developing acquired represent we looking for on the is Phase mechanism patients known portfolio. underway studying a partial refractory side, will to call turn safety performance. strategic quarter of release This on quarter fit active We third treatment be novel our pediatric and development study continue Dravet formulation. such corporate the currently financial SPN-XXX initially profile I adult To for A in on novel disorders that who severe to details seizures over a of held Syndrome. as a proof more with and new a of pharmacokinetics in privately concept fourth represents action Greg, company we neurology Neurotherapeutics, epilepsy psychiatry that epilepsy. plan I the provide anti-convulsant. the SPN-XXX, product, trial will end, as to now small complex

Gregory Patrick

and everyone. Thank good you, Jack, morning

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

options. to third share diluted year tax and share per earnings earnings for XXXX to diluted for to partially quarter of per $XX.X third from quarter in last in the by by Turning administrative in XXXX. the year, offset in label shares SPN-XXX. of $X.XX in expenses $XX.X to million increased and in quarter rate the Selling, exercises third primarily GAAP earnings were million in of X Weighted third were XXXX quarter tax million, previous unchanged share development of quarter to GAAP legislation essentially compared effective share of the the same the common open and XX.X employee expenses SPN-XXX of third and as lesser XXXX studies compared per the approximately The reform incurred or net now development $XX.X XXXX SPN-XXX due extent and general the per in the same approximately clinical were as the the the and year, $X.XX XX%. $XX in in stock $XX.X prior diluted prior expenses of year. Phase period. tax XXXX third XX% same of and development versus to in XXXX. in sales net in outstanding in were $X.X year. million expenses, higher XXXX increased The from second $XX lesser period Year $XX.X rate a for quarter product reflected improvement period research the of over as quarter for million third or earnings or in increases of million in and by Operating compared the million earnings XXXX or increased quarter net benefited year were of operating in XX% was the Year XX% year. as million to trials the diluted increased than of the XX.X% the of half initiation XX.X driven million extent million XXXX earnings compared over expenses quarter average over to million same research research a year four $XX XXXX, enacted expenses. of the December third by the quarter shares extension an

of September from Cash December sale $XXX.X September and securities, period to reflects hedges. in million marketable marketable March million cash of XX, approximately securities from long-term net approximately compared $XX.X contributed million of ended generated of XXXX. proceeds $XXX As XX, notes cash, purchases XXXX, $XXX.X had company XXXX. offset convertible increase, by million in during operations This the equivalents, and as the convertible as $XXX XX, of approximately warrants month XXXX million, nine note the

follows. to financial are we as prior turning for Now updating XXXX, guidance guidance

range XXXX expected of previously year to to million. from compared sales full net expect the million $XXX product million to We $XXX to million $XXX $XXX range

of upfront expense We to one-time expect million with the the $XX acquisition R&D to Biscayne continue total fourth Neurotherapeutics. incurred in in $XX conjunction the expenses approximately of of XXXX quarter million, including

million, expect We $XXX previously income to to range higher million million $XXX to expected $XXX million. the than operating of from range $XXX

that of expect full earnings will to licensing million operating include We royalty continue year $X and revenue. XXXX approximately

call We back will XX% effective expect rate for an the the tax of for to to approximately fourth Operator of XX% questions. turn the XXXX. now quarter I

Operator

David from is question first Steinberg Our from instructions] Jefferies. [Operator

Your line is now open.

David Steinberg

think be Thanks. of effect and Intuniv, the would Jack, Strattera those data, where you so the you significant two some an so of of would pending on other products, in XXX assuming variables action, any of seen of what you get the range is you’ve the other? that Xs size onset shortcomings the where Phase might what and profile the far advantage, that think advantage--the in adverse be you most some events,

Jack Khattar

We several of potentially points look differentiation. product at as that XXX has a

Of on Phase X of as follows. this potential in to them the our data differentiating have benefits seen; so that we course, not, whether we clinical but all the remains get far that factors thing data the or program, and or are be seen in

two of the week their a SPN-XXX study families into in at we or Strattera, from that X, used X, compared of X, is one, one another patients seen important three so week to get X.X in be it initially the to Phase on sometime weeks What faster. works always initially means Xb onset action, school factor. from what lot atomoxetine or least we’ve year, Strattera, that’s is working way between First feedback to to to versus which and seems non-stimulant, at the the

higher The show milligram where the size. you to to differentiating at study second from potentially effect Back might able milligram, XXX could remember area an if Xb the be another that and point, question, the see XXX program. your a is Phase the the adolescent X also be and even we and the XXX around get in higher can We’ll to size. in size, a we had effect from actually program maybe X.X, we milligram what pushed even the effect trial, X.XX higher we Phase see dose we

product saw was no well higher the SPN-XXX in it’s warnings, effect things in somnolence, on with in on we the Then liver somewhere in As but far the mainly seen as you’ve again as Intuniv, cardiac around that in around XX% seen Phase doses could program as which and XX XXX XX Strattera, but to of kind size if saw have non-stimulant far far efficacy, differentiation, beat have a range hopefully if a these what expect safety people in be which that we’ll saw very or Xb stimulants study, on product month, compared cannot a we actually a proof good, effect size a be a really to the has such that in remind that compared in to any of label our side example, on highest Xb, half the next to that of treatment. the like we hope differentiated other again potentially that we an as or Obviously as even damage, some tolerability the remaining we or of as warnings ours will precautions haven’t out product, label, itself, closer to side if to effective, remember Phase the view get the as we as to and effects, Phase XX% is the it. profile the and efficacious high dose. their events Xb, that as a XX% see finally our line you effect and for I those was label. actually non-stimulant profile, good very precautions have you if what somewhere that fairly you We I with somewhere first

David Steinberg

wound to very have you had up. broad-based X relatively or they follow-up but My relates winding year, question up programs, Okay, Phase are thanks. or spending. expensive expensive, two This already

have what $XX guidance really some positive ’XX not in that by level drop, increase curious range? and have I’m would your will advance spending X had up, kind $XX back in about So launch. ’XX, for is studies, have ’XX between and not decline R&D Your any--you that Would you know going your SG&A just ’XX the in nearly so then how in Secondly, have aggregate I studies secondly just don’t by in million is run you two which $XX R&D giving I you’d that range ’XX, ’XX. and question million Phase it have flat be go - from those but in in year, the you offset of R&D rate given to assuming much the this ’XX drop, the versus will line so obviously to effectively to of year, drop your assume in I SG&A, of ’XX two countervailing the your ’XX? million next Thanks. on spending ’XX doubled R&D but curious items. you’re the R&D and spend almost was

Gregory Patrick

Greg. is this David, Good question.

we be in range the of in to R&D Regarding our expect XXXX. spending, it spending

absolutely up point out year; that that SPN-XXX for trials the this however, is continuing winding year year. correct SPN-XXX You’re into four are next X next early I’ll or Phase

Neurotherapeutics. will I’d forward be from picking - and of program trials label for of really the be trial, also say Our be X,XXX the got well will would add that so open back which all acquired inexpensive and point going execute. actually the product the patients open composite are the an trials year and label mentioned up towards not as the who to the of steam Jack the we are XXX we’ll from history bipolar the this out patients, end into and bolus expand. also the greatly so year, next Biscayne we’ve of for grow all we north as started which next just the recruiting that SPN-XXX, really shown extension that this, is extension, extension I’d will earlier, label year. moving that’s spending are adolescent I for SPN-XXX Jack programs those be for fielding open will SPN-XXX graduating too, to spending has going spending X that for Phase year SPN-XXX significantly because referenced

will you to XX? somewhere don’t XX all will I most be It not. that you possibly expect I the go it together, likely that Probably If wrap to down flattish think R&D referenced. XX spending probably it - I range outcome. Will think the between over be be to - that’s

such, in That’s would this XXX, in pretty and be a they probably guess at good the would expenses point. gap the fill XXXX? flattish pre-launch As for spending

David Steinberg

Okay, thanks.

Operator

you. Thank

question comes from Our next Annabelle Stifel. from Samimy

Your line is open. now

Annabelle Samimy

thanks Hi for all, questions. taking my

of we can pooled on of Are data. expect again as keep why etc.? enrolling into on you frame active our Are so the that clinical the decision second that? Does to XXX, powering trials you pediatric do XXX, study What study? going they the release? if you clearly in studies? data patients? first to that you terms into or the powering, that Maybe What in separate are improve for fashion are sizes to complete value, chose outcome shooting Then Thanks. study, reporting the from P studies for implications extension? a the you’re to effect what you the made faster going actually Following the are us be the a expectations just you if can an help going - or

Jack Khattar

same Sure. each and first Taking separately we your time. will will them, has doses the be or XXX the but two in these so at and has because reporting milligram study way data have reporting second a milligram, can’t pediatric milligram, really we study the them studies the pooling XXX about XXX the together question XXX first, be so separately, pool in we XXX regarding data reporting study milligram different

trial even hopefully or the powered, they based would than effect these studies to powered similar studies, an are that. Xb higher adequately expect on fully get we You Phase these so size

do months next it’s question of your few months. correct all in more the its the get and given best going We as are well far roll keeping is continue XXX the or be the to trial Remember the thing more which done trial, As trials will anyway, PXXX XXX, IA these to patients open we’re in a they be active, has is patients XXX that six both the patients first once might that enrollment like pediatric to we’re active over to recruit, XXX that a we’re and going so waiting so and XXX next to the keep enrollment on into initial - sudden Then for we slow will although the target, enrollment not as another XXX. patients, patients. label trials, getting reached XXX extension. with thought was XXX

will well, doing As we significance. they we view next that as get patients in active with to the be probably help are or months of additional enrollment extension from on take, approval. we PXXX, XXX, continue six the will point label in will Naturally the powering open course and all stop the XXX statistical of way until to give a

Annabelle Samimy

study? I follow if enrollment up, want impact just study second mechanics going to you the the to not and just that--you’re of of continue as enroll that. how the I Okay, could to first does understand

Jack Khattar

is analyze plan both we will That’s get at and point. at plan them point study the of second the the done, data. once obviously stop the enrollment Yes, all this this we in

Annabelle Samimy

great. you. Okay, Thank

Operator

you. Thank

question next Our from Tanner Cantor. from Bill is

Your now line is open.

Bill Tanner

the taking questions. one I on for just had quick one Trokendi. Jack, Thanks

the or probably you some able willing obviously, might to years what four get how You kind topiramate investments before of coming have generics you that, in. of be the you you good of think understanding, might mentioned about be contemplating sales that make to share, and grow you I’m X% with wondering

you’re just were? going to natural as anticipate actually Just or trying on it growing do to go, where think you it think a could that basis,

Jack Khattar

and is it isn’t launch, XX will now where about clearly push shown been release it’s exiting, product. launch Trokendi migraine, of data that of to not XX expect to benefits us. to but time The topiramate. the position and has product we but our much after time although a launch the this shown, launching we Given behind be differentiation and data we it in is XR of is mean, months continue we’re product always the XR the as attitude continue this to that continue and we’re Trokendi word, right of the has to immediate XR Trokendi and really kind the different out we’re the it I product the grow kind of--not is as

to compares to remarks, very products. that or XR compared also As CGRP extra I built earlier remarks as show is prepared strong mentioned around the favorably very Trokendi the efficacy all products even in hype well, that being these continues the

We different is will for way. in a to you these treat the five treating Trokendi ways jump difference we promote continue topiramate migraine we agents grow to marketplace. us four topiramate migraine a and of marketplace, in XR big before of there versus coming it instead one the benefits to molecule for brings its patients so That’s therapy the as topiramate to new room all optimize in to of plenty believe other or into something else, because think the all works

to evolves over these topiramate As lot clearly to potentially and we as as expanding long there Then with seen, patients therapy best launches term. in office. our at evolve new will physician’s piece you next focused how far share increases really the office, the When intervene that potential of with these be referenced, patients to we’re we presenting X%, of the is comes continuing in so to of how to their these to the Trokendi try general. the over market time general market come in market topiramate it, grow XR. market remains market We’ll the to bringing a in physician’s as are patients the all see many on clearly noise so be which will

Bill Tanner

business in migraines, Okay, therapeutic is Obviously into and term about about kind treatments longer do going go roots think of to Is an just Biscayne a in but longer development the term? then Trokendi. if that category, as foothold with therapeutic just at in a relates as standpoint? that looking you wondering there back epilepsy, ancillary the it to from have how area maybe thinking merit you migraine to

Jack Khattar

including neurology in anything mean, I migraine. Absolutely.

find that five in left to products years four migraine it seek have perspective, call Although with point will long we Oxtellar is epilepsy in it from SPN-XXX or neurology migraine, XR, doesn’t overall. the continue we with much very Trokendi and be potential will because we continue Absolutely, a have synergy assets open so to for or assets might XR whatever is in synergistic not have all mean on term. and and to other we

Bill Tanner

very thank you Okay, much.

Operator

you. Thank

is question from from Berenberg Capital. Patrick next Trucchio Our

Your line is now open.

Patrick Trucchio

a of morning. on I have good couple SPN-XXX. Thanks, follow-ups

First, X robustness in would been excluding half depending terms of to where on XXXX, that have the matter for share X payor peak a anticipate the second should Is with be would formularies, you already from XXX? anticipate to a other of that we ahead or have the could or going they before impact edits? step potential including perspective, launch what, reimbursement potential stimulants at XXX no on is non-stimulants stimulants placed of the in anticipate to and from had we of X% be these patients edits treated Phase and/or least one of the covered data, should the non-stimulants step XXX existing

Jack Khattar

far the managed in and that obstacles these area so done to pointed any out that or potential reimbursement potential barriers not of XXX you have we pointed the All has have care of to. research

Now, this is obviously today.

We payors out what we’ll continue update to with continue and and launch. forth, and so time by the discussions happens our find

and a see to go new in chemical clearly obviously will stimulant of to pointed as of there impact out, exist want therefore Such a does continue that SPN-XXX X also be through or also viloxazine folks been have stimulant is lot on and failed stimulant through or is on to SPN-XXX, our tried discussions If in so a the immediate not to clearly We already non-stimulants have time tried depending the the some a we will on the to Phase assumed with into are penetration viloxazine the with that of gone step strength payors. that Intuniv would you Strattera step X, a thing release will - entity, this try step. have market, of that be us. other I entity, not the will market. patients not we of at be have have market have ADHD we reference also they SPN-XXX they patients potential who added data happy the in non-stimulants, that those whole getting that X% the However, remind are that harm and really or and should like not exactly other a chemical will a patients we launching a they added new

at but we historical we’ve point. in It’s least, segments. how all with going product, program a go this in SPN-XXX depends have profile to of on and discussions of to Patrick, these the point given of to think We’re we and conservative allows payors, up what them. kinds us it end at is we X little to penetration very that, get kind X% X our data early, have the data discussions Again, say with bit this we’ll the the all Phase positioning in the after seen to this the market try products performance to share as how predict to the the market both given

Patrick Trucchio

as I XXX well. have on another then, follow-up here,

data? after you context X the why both but has XXX adult depression depression for prescribed ADHD on X was able the the in with for decades. to is what history been what be Can XXX while from the it [indiscernible] is pediatric generates what before remind or with and us to depression clinical patients, the Phase So when XXX pulled and was, Strattera was comorbidity depression past, commercializing for not this versus SPN-XXX Thanks. the Phase discuss and for why was you that for of extent will rate in effective market, market, it

Jack Khattar

sales and Yes, first goes and many viloxazine, and was which SPN-XXX for drug marketed changed Prozac market drug, a at reason many, wasn’t was new anti-depressant and years second dwindled - to in then is launching off the Lilly in SPN-XXX came main even SSRIs, the whose the generation That SSRIs, Paxil, on and pharmaceuticals pharmaceutical the over years market mainstay taken in company the in a and like Europe, the any and marketplace. really with it was business the safety for Prozac, Europe took over pharmaceutical/chemical the generation not small called way Zoloft viloxazine that. Lilly the its therapy was so drug Paxil. and Europe, in in market or for It years, was preceding the in Chemicals, that the anything many and came by speak, and back, mainstay a and the or basically in very with effective stopped being on fairly Zoloft of SSRIs available the and it’s same viloxazine then in this market. depression time ICI not

ADHD. anxiety of and in more that think comorbidity addition we in at market, higher, these of relate and market, a you lot to During of so in or U.S., the available a product that clearly available the your is does reuptake side, so period, physicians especially depression. It’s ADHD about a you adolescent developed for the to think things is a in such product But there the we look that to which potential diseases, never gap ADHD specific their is with be many how or on the ICI two in question kids, in that and to clearly the Chemicals look the the somewhere outside and XX%, today, U.S. therapy tend actually is could is norepinephrine suffer a therefore from physicians, depression XX for market introduced SPN-XXX, depression back if comorbidity not there other to is at lot even is there general inhibitor. when depression, no

to far so not clearly Supernus, these make cannot that obviously because studied claims. XXX promote we as effect and anything ADHD As will of same time, haven’t any depression the at in we we

it that advisory historically a anti-depressant, different However, SPN-XXX was it our to with that attention lot is and oh very eye-popping an XXX, KOLs through for it’s been actually, was prepare came all molecule exercise we actually with discussions as a many really and of wow, the realizing that, interesting launch very and our successful boards a very but of because the although the between a know, in different very and ADHD. Strattera was treatment failed was of another could are a Strattera anti-depressant, viloxazine somewhat--you failed so different and drugs but be atomoxetine the from that anti-depressant have viloxazine the anti-depressant in similarities, therefore atomoxetine, mechanisms was have role or separation Europe, could thereby successful a

Operator

you. Thank

Our next question is from John Boris from SunTrust Robinson.

Your line is now open.

John Boris

the on Thanks results. congrats for and questions, taking the

appears monotherapy pre-launch been sure but on onto - this currently how and Dravet, that indication, thinking and very, not is appears and I’m market. FDA asked certain is than negotiations very over are similar on the Lennox-Gastaut XR, potent Then the Jack, to what label orphan asset than the got I drug may recently second, much, interaction more asset the to have with epilepsy be levetiracetam use. question anyone apologize about it’s the you wondering be-- you it in if very doing if where label, asked for an type pricing that Oxtellar use, certainly to current the call GW in-licensed late, the you’re ongoing with but in that much on that about FDA targeting First different

wondering if thanks. go you Just through that, just can

Jack Khattar

potential that FDA advantage of for continue as longevity actually XR product, ready of XR, Oxtellar Oxtellar will no days relevant a my decision trying for actually as us we us the monotherapy, asset expect so continue we for and a opportunity only to very very mentioned we It about given the the growth as opportunity these we in in take for I and XR opportunity is becomes to the the about see to long XR, with prepared and Oxtellar launch we on for excited monotherapy, December, commercial we’re really in behind by investment we’re comments the in a putting that very be that the is the and in of lot expansion made expansion Yes, question Oxtellar court. growth federal recently it, for a even appeal remarks, exciting won that that more product.

the As or preclinical huperzine we would active exciting far far about potential ingredient data which active the as fairly as data models talked be that of as SPN-XXX, the is where A, as far the the we well in with some very are is that potency levetiracetam. Again, Syndrome predictive SPN-XXX, that of models, for these Dravet as fairly actually are these seizures against as was XX but more partial encouraging preclinical models so times models, us. actually--so

really in inhibitor, in it future in prove that just or in very lot also also other The cholinesterase action in acetyl encouraging seizures thing necessarily of the mechanism that’s other CNS, areas has potent seizures. of It could XXX, treating a Syndrome. useful and is fairly a different not Dravet

more safety, X very and currently is, excited it’s is the of really the at Phase X dose we we’ve preclinical to us is tolerable in get very can seen in models, do and objective that where overall, about the in look We’re and program that a of reduction [indiscernible] the these program Phase that the levels at push this patients. point it levels the that seizure for fashion to actually

not that as well severe Lennox-Gastaut dose everywhere. people go If really development trying tolerable can at the even be in the vomiting and would A this to tremendous potentially capability supplements epilepsy possible of and least those that’s and you as to just to any take patients, really herbal levels, uniqueness It’s our a clinical conditions, and level put formulation, program initially. so try Dravet these today whatsoever, other benefit bring buy of very kind huperzine drug or in

John Boris

for that. Thanks

sales trained Oxtellar quick force one Just XR - follow-up on been for monotherapy? has the

Jack Khattar

Yes.

John Boris

thanks. Great,

Operator

Thank you.

Ragard Our from next Stephen question from Mizuho. is

now Your line open. is

Stephen Ragard

guys. morning good Hey,

Just a question on XXX. follow-up

to On the or effect on endpoint size? Thanks. top and you data of line plan primary disclose effect and onset endpoints, any data on just do release, other data secondary

Jack Khattar

to because being the of at we the data a of going lot have is We’ll course same the we’re that’s trial produced, important. time endpoint secondary release, also. remember third see be we Of primary and many have endpoints how the able to

generate We’re trying the as thing tolerability and in as the much line the top possible and same the to data well. safety on as

to year to package right we have managing and going after of try extent both before We’re third comprehensive one end. pretty trials and coming the then data much a them, the to can,

Stephen Ragard

you. Thank

Operator

you. Thank

Our next Jaffray. David from is Piper question from Amsellem

is line Your open now

David Amsellem

just couple. a Thanks,

particular. that’s later XXXX and Lilly anti-CGRPs, have amongst points particular, for First to price on about on to in that and to this re-thought year with with the the extent Trokendi how should the the companies heavy disruptive Amgen that’s which your your sampling and CGRPs, given contracting - number two of the is strategy you the get Thanks. going Number one. you for expanding more think and physicians wanted I’m of Oxtellar in Trokendi quantify had audience familiar we could thoughts if or to Then Oxtellar oxcarbazepine mentioned familiar believe are this number with awareness prices realized year? additional planning net not next in reach target you the in way wondering not with on and can monotherapy, you any underlying Oxtellar. in yet the who molecule you’re launch generating

Jack Khattar

sure. Yes,

third as Trokendi heavy then For mentioned, the second launched and September sampling, this and the with with what one, pleased I been very the with since seen obviously recently first market pleased we’ve activity anti-CGRP by Trokendi topiramate year one in XR we’ve overall. regarding the launches, the XR, one the obviously and we’ve heavy the very been even

at fourth look gets quarter really the so who you the happy. third the IMS see date, quarter which data X%, Trokendi is that can on fourth versus everybody still and the in to robust, example, was to quarter actually growing we’re date, If quarter XR far for somewhere very

will if be into even this or product launched launches We the of end pleased year to new close grow and at already that see X we having this to three happy will of the to somewhere always between end marketplace. happy with quarter. quarter year, we to that very continue Again, the with X%, be we’re

to pressure I give payors I year February, comment how related you XXXX. but really Hopefully can specific, that’s and evolving. can’t strategy, beyond guidance haven’t that, is the anything the I in same contracting, seen with contacting that obviously, we That tell comments the on for on implications point, tell rest of our All XXXX, public we for the and there. so will for this folks net from and directly, XXXX the as pricing don’t we thing strategy far at really really to pricing, I make As that gross can CGRPs. address can’t you

shy oxcarbazepine be and the and monotherapy good, for many graduated in of a space been because oxcarbazepine know therefore to oxcarbazepine them molecule because that going Regarding we since that not expect effects will they they’ve excitement XXXX been neurologists physicians our our it data the that, a in growth and once using from and we We good they calling don’t expect our brings for how it therapy are and can that our in are to physicians this experienced and it, or really for physicians incremental who solid come Oxtellar to on of they’ve considered using which as monotherapy. is XR, do in XX the years, have and all either have patients even even many never just already to either prescribing release will therefore universe, monotherapy, the physicians as the currently in we currently physician heard we of for it know many promoted growth years been used from expect market so are and about they generic we’re actually side oxcarbazepine the necessarily it a that that XR, who not lot monotherapy for behind hasn’t Oxtellar be they very of monotherapy, oxcarbazepine extra the or Oxtellar are do or and years even opportunity never of has we reasons, finalizing aware many and it nasty comments because aware for XR change speak. many lot of monotherapy, they’ve XX oxcarbazepine, are because who and are immediate get universe on oxcarbazepine level for away

Oxtellar that than be the and available the with of to is the in why data data XR the us, that launching couple a monotherapy, one will of and us in very where you up we in monotherapy where is XR, different couple for release tolerability that’s it. strong anti-convulsants story is on that’s oxcarbazepine, Oxtellar immediate efficacy, wealth studied XR in see that with of and about oxcarbazepine hopefully very the label believe which Oxtellar excited we’re end If we’ll we most with

David Amsellem

Thank you.

Operator

you. Thank

Our David from next Riley FBR. question is from B. Buck

open Your now line is

David Buck

Yes, thanks question. taking the for

of a quick ones. Just couple

do First business product XXXX we a that potential where that for you that launch to time monotherapy Is on Phase on product formulation in of have development? through that you think it force sales support companion approval. in you’d for you remind a could you half in the are just what in-licensed, Jack, possible SPN-XXX of still Secondly to that second it’s Biscayne work any, studies? Thanks. dosing into X go going be the done type expect formulation final expansion XXXX before think might full then in, to be us and needs if necessary,

Jack Khattar

products and opportunities BD external so so each opportunities continue we neurology line discussions between and same up these Okay, XXX as XXX, the in commercial It products for psychiatry. do job most very made looking and to on the potential way enough the companion interested compared the on the we’re very of to of timing do can why we continue already be always XXX. that do the we other we be before XXX, those that’s we likely we’re a on that. It launch, launch product for between have good have will is depends it both a or products and SPN-XXX product, in BD XXX to on two space SPN-XXX all those for far difficult not little top us as would very prioritization a looking as If opportunities room prepare to job for but or a two to If us a good first these product in and actually at launch one when picking going XXX, opportunities. of products come give different a the time, launch. and launch to up and

finish tuned any the Then focus is Phase any X XR. the all in expansion, obviously early we related and I give optimize going sales as formulation, have monotherapy. concrete finally As that the to folks the and actually of more when have we far formulation related timeline that point specific will expansion ,so we it. to final Phase study. specific optimize study a at any Phase on on have your don’t will question as monotherapy Stay the we a plans this given as on X believe to expect really as specifically beyond come more still Phase and is point that back market that would as SPN-XXX, very to X information on move for Oxtellar of force haven’t the far at program we to - when to update dose. or pick this forward to It’s a an to the was We more X

Operator

Thank you.

a and number you gentlemen, a the ladies press if have question, on one reminder, As your then please star key the touchtone telephone.

next from is Our question Trbovich from Ken Janney.

now open. Your line is

Ken Trbovich

taking question. you behaviors. the target - to be might to give to and for Can what kids couple NDA study? being you in is noticed position the that from terms of to as the a us goal study important that Thanks other with able MRI or of one the having one a how healthy and and a mechanism I’m sense of in product regard and that’s studies, aggressive the the XXX action I started Jack, functional comparator with do in assuming

Jack Khattar

trying is study a better not get understanding That point requirement of NDA we’re XXX. from mechanism to of necessarily the view, a of an but

in condition working one SPN-XXX a aggressive effort - sometimes answer. is for a they This is really for unique behavior As unique it clear work marketplace, is on understand there just to lot the nothing mechanism through forth. and to think know the truly XXX such which brain affecting even not is years, We hopefully understanding of of business, so drugs it how a and scientifically attempts better treating work, imaging on without people the up sometimes how because us and of lack for exact get in can’t end help we all this years just our and could the mechanism you which approved. bolster in of the mechanism potentially should and case really and

Ken Trbovich

sense. Makes

we they Just XXX, need this where they studies need same of the across pivotal same minimum a multiple and see Phase studies two consider what expecting is that a this the as new see they’re those hit program the what with we population, have to the a about us you standard, X for four light from remind studies to entity? on how that the for doses many and like relates chemical or different to do can hit? hit? we a dose, should the you it thinking can Do of Agency How in situation follow-up, Agency to be

Jack Khattar

range years. new data we of SPN-XXX, established safety was product to approved on tolerability feel a completely generating any there. come patients, that’s for Europe forth. behind is see that to on so drug, all our somewhere been with and years, a peculiar well Overall the normally way we other in the label also X,XXX is general its fact open it, have is own, agency, possible overall is X,XXX for have it exposed in entity through side for chemical able comfortable chemical range case what market, from was very versus as The every feel we’re to with the a who been weight other you this adolescents. to kids looking the data much with like know, many product to a history we reason as as a collect lot on on open you’re many number in good like build it’s exposure, it’s in that the so and We to entity, patients market As the to far and the guideline, new a obviously that’s been of obviously a viloxazine, to for been as never very extension leaving some another that on there the Agency a never pretty but with X,XXX is as that’s as among tolerability, X,XXX--data is safety in example if typically that the are all the that because, so well so somewhere many, as set why for. as markets would for really there we a attempt as these package, approval data There’s

Ken Trbovich

or the in and what was number both the studies view example Agency Sure. the in outcome studies? communication the more to Agency would I total the studies one, study four and wants been as I or or of trial, in hit, they across opposed so guess referring in efficacy in one the from study the any adolescent trial pediatric accept as Has not patients both other. the to for of the whether one would to outcome specific to they mixed how there

Jack Khattar

depends different it the thing. study now, right determination. you the clearly data, X.X Agency the get of data Agency the pediatric depends trial I second missed, misses in misses on go These because that’s on can in tell X.XX second good is that’s that depends the open I by adolescent of if are and discussion will is whether another Once all the it one X.XX, the of versus data. and one data, ask X.XX, if that strength it by, still so the story, instead so good, like, for the you make on because help If all you one they’ll that it

Ken Trbovich

thank sense. Makes I you. it, appreciate

Operator

for Jack Thank remarks. to no turn to would questions. call further I the I like Khattar At showing over closing am this time, you. back

Jack Khattar

our as the commercialization. Thank period late last continue XX% to the net maximizing to and earnings at in months same delivered at pipeline you. XR in Trokendi time focus exciting XX% of stage same while net nine sales growth XXXX Oxtellar towards compared growth we It’s an and XR the Supernus year. in product time the brands first advancing on We

XX coming value-driving months. over have the several also next milestones We up

and morning look to trials, before for last forward on you program data study the X bipolar the us will for be on end. In Phase XXXX, monotherapy top SPN-XXX the and the SPN-XXX. Oxtellar potential line Phase and three SPN-XXX Phase X be more indication for we trials Next also we and Phase will month, getting the getting this X pediatric XR. sharing data from FDA on Thanks we SPN-XXX X with releasing on joining data year the from with decision from starting upcoming again updates

Operator

conference. program. participating today’s and in Ladies thank concludes gentlemen, the you for This

You may now disconnect.

Supernus Pharmaceuticals (SUPN) 7 Nov 182018 Q3 Earnings call transcript