Supernus Pharmaceuticals (SUPN) 9 May 182018 Q1 Earnings call transcript

Company Profile

Participants

Jack Khattar	President, Chief Executive Officer
Gregory Patrick	Chief Financial Officer
Peter Vozzo	Westwicke Partners
Ken Cacciatore	Cowen & Co.
David Steinberg	Jefferies
Bill Tanner	Cantor Fitzgerald
Annabelle Samimy	Stifel
John Boris	SunTrust
David Amsellem	Piper Jaffray
Patrick Trucchio	Berenberg Capital
David Buck	B. Riley
Ken Trbovich	Janney

Call transcript

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Operator

Good morning ladies and gentlemen and welcome to Supernus Pharmaceuticals First 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 Andrew. 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 first 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.

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

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

Jack Khattar

results. morning to we our time quarter Good join thanks for you, discuss Thank XXXX everyone as us first Peter. and taking the

with both some of underlying begin XXXX me for another XR, let strong Supernus and products. for XR demand started driven robust Trokendi with Oxtellar financial First, sales highlights. growth and product both quarter net by

reached sales by $XX.X million. of and last per earnings Driving by the record First XX% first Operating our XX% an increased to reported and of the XX% quarter Total per over performance net quarter financial continued increased period $X.XX million XXXX for by GAAP over the as solid all-time same first share. a year, time. quarter quarter first product is reached $XX.X share of our quarter which last year. for Oxtellar showed high prescriptions net XR first this growth strong IMS diluted income any a prescription over XR of Trokendi for for for the demand of products, XXX,XXX prescriptions in

this a prescriptions for increase prescriptions Oxtellar year of an year. same first XR, increase XX% last last the over Trokendi quarter same quarter XX% XR XXX,XXX, of were the representing period the is which in over For reached year, and XX,XXX,

for adults as epilepsy therapy adjunctive and XX years. years. for children Recall treatment of XR Drug XXXX, our requesting to for of of indication epilepsy include accepted expansion current XR partial adults that seizures six is review April currently Food for for Oxtellar Oxtellar to supplement treatment efficacy and U.S. seizures the and for the XX During partial indicated monotherapy six of Administration of to for children

written providing to allow tap of newly seizures, treatment a diagnosed for Oxtellar maximize us allow prescriptions. approximately with opportunity large will a the end XR is expect representing annual an to monotherapy is the Monotherapy December epilepsy supplement partial million drugs and treatment Oxtellar XX% as XR should with to for opportunity, this XXXX. the line important antiepileptic first FDA by of product’s in XX.X on benefits. the for patients patients us epilepsy by The of We of market for decision neurology. monotherapy of an into option Roughly access availability prescriptions this

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

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

have from III this Phase XXXX. first available of continue We to to expect quarter data program by the

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

and now first is at The is trial XX%. trial the at enrollment approximately approximately second XX%

XXXX. We by of the data continue having to quarter fourth anticipate

rate we high level continue physicians addition, have reflecting impulsive of trial start Phase enter trials a of for aggression mid-XXXX. ADHD who treating who at high a continue to adolescents a in SPN-XXX XX%, label extension III patients expect completed study patients. open SPN-XXX to satisfaction about and In have to that from the the Furthermore,

Oxtellar end therapy. by XR, in six XX added complete the randomized to of approximately among study three patient patients trial sponsored or study Oxtellar with release enrollment to Regarding immediate to This weeks open disorder each year their enroll existing sites, XXXX. expected on is label XR completing investigator therapy bipolar is oxcarbazepine either designed

of and three We SPN-XXX about proof of with consists mid-stage now Phase in in sizeable testing which SPN-XXX psychiatry, concept opportunities trial. excited XR late-stage Oxtellar and are a in III our pipeline, clinical

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

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

Gregory Patrick

Jack, and Thank morning everyone. you, good

first XXXX. that was compared XR Net release the review million, of quarter first issued were $XX.X no yesterday increase $XX.X I the press as I’m in after reminding this earnings $XX.X million, a to revenue $X.X either of period. not in the of Total XXXX of XXXX net product to included changes were revenue compared first Trokendi Oxtellar increase the weeks listeners been in refer as quarter first quarter the non-cash net for net the weeks prior closed. the our to As the quarter XXXX and the note to of quarter case. prior in license results, of XXXX. first revenue XX% XX.X% of XXXX. increase for as a $XX.X for sales been XXXX market fourth million, year of coverage have XR for product Net first product for financial There as the quarter it to period. to has first Total of product compared have in a sales in the changes sales and product the and sales of $XX.X quarter XXXX million material the to coverage of important years, of $X.X is non-cash revenue compared quarter year loyalty million of million, This million, affected XX% past quarter loyalty first XXXX $XX,XXX first million of In sales quarter of for revenue year. year, $XX.X product between the

as in The enacted corporate the the primarily XX.X benefited rate the extended To quarter of quarter XX.X% as rate quarter to as Turning XXXX The year. period first increase last $XX.X in GAAP SPN-XXX the due to quarter due XXXX fourth million marketing an for in of million, the of or R&D quarter XX.X lesser same the to compared XX.X% first common $X.X and expense year. as in increase and the offset of expenses the first people the primarily $XX.X SPN-XXX. the of of Weighted compared of the $XX.X shares to XXXX expenses, year-over-year increase same earnings net due of XX% four quarter an first half was quarter first in for per were or was the diluted XXXX. ago were products deployed extent, the fully to in continuation Phase U.S. partially is the expansion $XX.X the by reform compared the initiation tax for study the clinical in III or reflected tax sales the rate force net were sales over for million the of of prior in period in share $XX.X as year support XXXX The XXXX period. approximately $XX.X as previous average compared label quarter a year GAAP by first million in open diluted million million million second the year. expenses. compared $XX.X $X.XX in of million year prior in over same and product net first outstanding year. recently the million first of in trials share were now Operating of of research shares quarter general effective XXXX associated period. the same as increased legislation earnings to to grew million the quarter commercial XXXX diluted their earnings XX.X% to XXXX who the compared company’s development year programs to well. prior XXXX to in the earnings per million This $X.XX of SG&A the tax of $X.X were in the expenses operating tax increases administrative Selling, quarter the XX were and sales to as in as year-over-year expenses. from improvement primarily well in

months million approximately and cash company in $XXX.X million securities of equivalents, of As marketable as proceeds long increase December in operations three to the of $XXX.X XX, as million XX, XXXX. from at XX, XXXX. XXXX, marketable securities, March senior convertible in million XXXX well cash, million This $XXX.X cash of $XX.X term had March sale reflects ended from March as the compared of $XXX.X net the notes

guidance $XXX be operator XXXX earnings to total $X for $XX to of back revenue. million to to to sales licensing approximately $XXX million turning and operating range operating Now expect approximately financial $XXX product million. call earnings to expenses $XXX the the the we range turn for to non-cash of in and million, XXXX I full-year now continue questions. XXXX, will R&D net include to from Full-year million, loyalty million

Operator

first & the Company. Ken Cowen of [Operator Cacciatore line question instructions] with from Our comes

is line open. Your now

Ken Cacciatore

the about you reading more with would you want commercial out about next year, cushion now approach? a little you. two around you’re on a a a year. amount to cash next pipeline, this little give congratulations guys, the Is bit seeing Hey have of bit I cash, how ask out earlier and this that do programs just think time it III to re-load nice you around results. wanted what business generating Phase it there. clearly and time what think than Is Thank you of How assets? us sense development, about

Jack Khattar

Sure.

consistent get Phase stage the BD to your point, several XXX last in late-stage line. the to of programs, in we that we Phase now to that very hasn’t looking we a have--you more realizing continues have programs, years, to reload that XXX very strategy I, if commercial like close know, earlier priority with as type Our read-out changed mid-stage, pipeline, be from soon them as diligently very we’re reasonable could something and assets hopefully being price. or we’ve assets, Phase done much. at can the III top two really finish to It at are find we closer fairly the be But opportunities II

it’s strong a the neurology for neurology as be three would whether one a Either psychiatry time, us the presence pipeline. therapeutic we in space and in opportunities continue will establishing our to obviously strong or we areas, franchise because far to be have we a fine are As with long with continue psychiatry. agnostic

we in both short is looking prospects can view that will the point. Phase assets we reasonable or point really do and is in not, something II If So, areas growth definitely are a has high I, are therapeutic absolutely we commercial something commercialization, find that near answer the stage at from Phase at priority. If area. of this

Ken Cacciatore

Thank you.

Operator

you. Thank

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

Your now open. line is

David Steinberg

is either market. the competition CGRPs with CGRP was they and Trokendi pricier you next to four new migraine into delivery the the the Later thanks. Jack, up year entrants. mode pending Yes, assumption could be on there infused. is reaching could the than of I year, wondering area be guess subcu little if a or I this the comment more will and invasive, in

is data your your you or and give do an and CGRPs? pushes us on impinged do prophylactics. the to could evolving, view the product the Any see you think remarkable the business? but you terms of On hand, fairly grow being on other landscape Thanks. how Lots in by CGRPs of you migraine thoughts line pulls, opportunity it’s the see

Jack Khattar

Yes, sure.

Regarding of market we potentially in participation positive prevention the to we market, clearly market welcome we by upcoming I actually mean migraine potentially view and increased are far not the our therefore, use as is increased the the the in activity there market the and out patients in market increased know investment overall, market, today, or to of very the the growing share that in could growth. have because are activity first be will several we lot itself, market the a that and market by There the the attention much expanding as fair underserved. who all players a

versus as topiramate really excited far but drugs out see that at collective that that there. you we we clearly look see molecules of CGRPs itself, these the any don’t topiramate. that really major differences the an different seen, much far topiramate of other It’s different so work; than have really data advantage efficacy all much the the it from that point not have about activity. or we I than some mean As we’re Overall, seen, data don’t when are or increased so view, for we

new competitors the and ready marketplace. We are prepared these for into

We’ll we at don’t that is only this what at as when know issue they point. know price pricing, the far time. As

and see So happens. that’s wait we what just --

David Steinberg

Okay, thanks.

Operator

Thank you.

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

is now line Your open.

Bill Tanner

to it Jack, the relates as Thanks for taking question. one I you had Oxtellar. for

of for for here? just the what it’s filing related of adjunctive? curious, what’s would It for help that XX% You and are incremental the Oxtellar prescriptions, use and big the one am is could similar share a wondering be monotherapy just your monotherapy. I’m opportunity XX.X understand indication, so of million about comment I market mentioned there. to--as that to some opportunity, monotherapy Oxtellar the trying perception monotherapy Just you seems currently, contemplate as that a I’m for that pretty made for of like and

Jack Khattar

Yes, XR. think the be Oxtellar could significant monotherapy opportunity, we for

going as many in we for which up access this because in or certainly to prescription a written of on been competing because pretty in limited prescriptions we years, million, add-on also in a prescription The data XR about XR we for the know Our monotherapy us point the and is was a for very as million of efforts market area. the approved, reduction, as monotherapy, last hopes and so north Oxtellar for the adjunctive we strong product. XX.X they of what market X.X oxcarbazepine, have high last open and very, amazing X.X far truly psychiatrists monotherapy been recall, opportunity data, don’t five efficacy we very, is primarily from the X at but Oxtellar oxcarbazepine, studied patients XX% in and it’s a in very Clearly have therapy, have of don’t space, that we psychiatrists, efficacy Trileptal you studies up than million are data the drug Trileptal XR competing actually had of us. half even five of that by years are it opens high million Oxtellar so that is only anticonvulsants done it call market. a big for market It has most of XX% more in have fairly in the way it probably in efficacy, one and when

using hard Trileptal; current prescriptions out how our the As figure get and to is from it’s it’s much therapy. data prescriptions XR zero that. far you’re a always separate very you hard as monotherapy, the Oxtellar because the very this are again, guess. really We way of physicians small, is but molecule in trying not using they’re so predict has adjunctive use very XX know been have to NDPI wild probably you when it’s very, message these It’s IMS, because same how today is the to and much - data so

Bill Tanner

you. great. Okay, Thank

Jack Khattar

could believe--I So this we mean, be significant.

Bill Tanner

to then with you then assuming incremental I’m pretty of for that that? associated going easy it there’s on the if in And get the be way it’s much not to an to label, going detail indication, meaning that be expense

Jack Khattar

the same same force, just effort, That’s correct. It’s a Yes, absolutely. different sales positioning.

Bill Tanner

Okay, thanks Jack.

Operator

you. Thank

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

open. now is line Your

Annabelle Samimy

then I question. something cite separate Hi, thanks and clarify that Oxtellar have want is on my that of you to monotherapy for XX%, taking specifically I a monotherapy question. The just Trileptal psychiatry. that with you general? in I expand to look the opportunity got guess or monotherapy in oxcarbazepine, you’ve to you at have area, this as or opportunity Oxtellar, in expand

Phase to You’ve going the without quite infrastructure, more to kind because business assets? date, of is with in additional With can looking Thanks. the I, III assets, of moving is but deal how at product right large near-term you’re opportunity reason Phase catch the didn’t earlier a now, that look for any can expand so you’re be I do? this into mentioned that at development II capital terms this the now you, a think Phase stage have - do of you why opportunity that you part you now these growth you

Jack Khattar

for really these opens XX.X it go oxcarbazepine X.X it’s whole it prescriptions, prescriptions. all monotherapy, for prescriptions market Yes, so prescriptions take up whole million that XX.X the the not the million epilepsy for oxcarbazepine whole if are that because space only is all to that in regarding mentioned. that is I us for the the market, you market so the million seizures Clearly after monotherapy, is partial

right - our You’re go of every several has have as Trokendi we after to potential and and we maximize trying clearly are been the Oxtellar Oxtellar for XR products, possible. potential absolutely depth as XR to times much strategy in opportunity both said XR, growth

or is Oxtellar we areas the of at of SPN-XXX, monotherapy, Phase - not of we all bipolar, to us because the I that major bipolar to that is for these it’s So II is programs of we’re long-term SPN-XXX, as that areas, biggest opportunity them growth as monotherapy look many incorrect have, pursuing one think immediate us. opportunities and these programs have therefore and XR one so that appropriate absolutely for also, well, Phase

So [indiscernible] we up can like far working when your line look different that clearly capital, hard opportunity we are internally, If size different the would as kind far Phase have opportunity, be as things an now over-leveraged of and so comes that opportunities II. stage Phase are of product fortunate and the a and a opportunities more with the been as for we that, ourselves to lot even therefore we’ve us of sizeable M&A to on do more for of especially a is the the we very many regarding so portion licensing the opportunity capital things and earlier growth not transaction, little bit we the as question, forth. Then either. outside opportunity, last I, affords that it itself than to so fairly of

a and potential we here a market and a big cap We have time, our at balance fairly that sheet capacity very strong good given transaction. have for

Annabelle Samimy

that say studies did the complete? open when could you so could bipolar, start is that’s earlier trial before sponsored on the fully you you Phase investigator ongoing, clarify that but I enrolled label, just that know start are III? and I Can

Jack Khattar

same several want the trial to trial, important. trying path, Yes, our of and investigator is start I finish that and that at trying in the Phase time the as sure. we emphasize, to a investigator Actually so that year, we’re critical for we the very program. the I we Phase from III trial. III on This times, program can, trial a the to was pilot are know to as while of on are work program this already soon enrollment accelerate small Phase III which is doing mentioned the never speak, learning it lot the design parallel, as we

bit year. So the to to mentioned driven to the for it’s it’s don’t before, not trial, or anything of on That we’ll it the the enrollment. by enrollment necessarily complete that difficult data but control this so end have it’s finish try investigator, wait a to because I trial, we’re we full as going control little

in still for trying so and We’re waiting IRB approval to patient get are forth. and first the we

still that this enrollment now and we’ve should get get for been the very weeks time, year. end time any we been the any can We’re going, approval trying it’s it to of IRB we finish that confident

so I have with XXXX would If However, with Phase program maybe with it guess, III once program. ongoing our idea might critical in not say which forth, on when that quarter Phase we discussions are able and to this initiate the were path is be efforts and I hopefully the next we our ready you start definitely the in the designs are guys III point. can start at we to Phase III as we’ll to for so we’ll a by XXXX, FDA, better

Annabelle Samimy

thank Great, you.

Operator

you. Thank

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

now open. Your is line

John Boris

data, what your patients the cut or Trokendi co-prescribed estimate XR are XX%, market? going if When summarized blocker, and AAN, two to out of percent on we questions, or have and on XXX% at product with other CGRP happen what’s free agent time, in advertising, results, in are this companies down for assume going to One Jack. co-prescribed, topiramate, that be Thanks so going some try overall any or Thanks. captured certainly of percent migraines? they Botox the Will some data type taking patients the and congratulations XR for help Trokendi trials. well-controlled data be you use taking headache will it of and to discontinued what direct-to-consumer have the over the beta chronic is topiramate the would forward XX%, of

Jack Khattar

and far of free X.X within a citing data gives I similar studies, migraine pieces different from kinds on X.X as data, forth, the and the I that’s hairs molecules error pretty one-day you one deal - it, but different. of I of are a look at said a the close. gives times end in and them days really The how that of about that’s of the that of month. the the in a data I or is all or really when why All people one days as close, very a so a even were lot you two in you you in topiramate these free lot to you mean, studies they’re need month, with I splitting so mentioned, other look migraine you overall mean, these really these and if margin clinical receiving and these think of data hear a not as are you’re different including overall, prevention manner. of when physician mix, and data, agents

different them, Now, drugs in is down shutting forth. injectables, the play of patient’s factor do. the CGRPs monthly, quarterly, be them compliance-wise obviously delivery also coming some ones and are a into different have that’s could with other you they what so equation so But in obviously the format they CGRPs and them to CGRPs are don’t else fact a body, blocking or new are major role a know so class do have the that that I of the

from payors their the reason like most of how but seen positioned see drugs, migraine topiramate so to I A have a again the or especially is used. then position people against things good starting else the seen, treatments, for non-responders seen there, beta to then a and CGRP. or as they Clearing but treatment, is - being treating something the prevention. to the or in did first that by these optimize that’s price we’ve if that will or believe the we’ve the resort blockers are treatment more a will course blockers, the it access to other we XX% can for be topiramate to actually to against already, treatment, be the not first general, everything think I some actually lot line given what or marketplace the mentioned, be the it the in players, and topiramate level are line will that end physicians drug. they and continue topiramate who of term, or if reason market It then remains because you far, themselves we it doesn’t CGRPs, think a not of other a each is patients with that’s coming the positioning will don’t in this else that in or at two that to other So about is I failed. whatever good is players they work, first the optimization already topiramate like they short likely treatments either whatever using. major also, different that respond likely one behavior Botox, when will they how don’t of they here look see compared be at going CGRPs, practice beta the be breakthrough be the in and just Therefore of with as is very out at interesting everything

John Boris

That’s Thanks very helpful. Jack.

follow-up. Just one quick

Oxtellar of to efficient the continue job a maximize additional XX before adding that future for any and added added, help you’ve with that at thoughts the you’ve with efficiency that in done the of the there it sales and opportunity, XR that reps any to monotherapy bipolar Is what look especially certainly BD in opportunity generating? terms potentially you’re of activity you reps appear you’ve that terms of you’re capacity. migraine great now opportunity detailed to selling If production would

Jack Khattar

therefore that sure try the we mean, we a marketplace, are the we make from haven’t subject to rule and expansion. productivity we the given that looking to on certainly see that we growth sure for getting investment we there the ruled is the happened we how that That make, want and and make investment whatever out but possibility. whole the expand sales the further to but make a our it effectiveness the I never in is in is ago That few incremental of sales we’re always play also would just that force. we return everything We we a decisions we October, recent will out communicate expansion possibility, else still or months in decision. want before CGRPs and once out, force, most still make, efficiency

John Boris

Thanks, appreciate that.

Operator

Thank you.

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

is line Your now open.

David Amsellem

I just I toxicology and just had on do? a study that filing? the get plan on the question us understand to could the words, that, other study other was adolescent with whether planning a the needed of have on FDA I you FDA dialogue trial. the the on with you order not to that in are the file, is suggested dialogue to a had filing but XXX, that ultimately, gating a on given items that sense last call, to in the know do Just SPN-XXX specifically the wanted and or to help you Thanks. timing other work that to beyond to Thanks. that. talk initial trials; you any of non-clinical have on work, about include in Then adolescent studies, clinical you

Jack Khattar

NDA. included and adolescent some population we the need we don’t population adolescent from when to we need wants minor the data see the will patient we some we trial didn’t the a in that data SPN-XXX, so say it, adolescent in NDA, said from the correction, is the Regarding generate FDA be said--just to that

it it trials, the so it, we’re can we protocol and they’ve track we believe for it our FDA by the why okay reviewed patient is to on do data, do that’s is with so to discussion the That has they most which is However, only safety and efficacy area we the sure safety actually rolling can is we have on still a the mid population not looked at and adolescent basis, FDA. are in important year, update data? is that. this with quarter whether last the I it that The start and are continue from adolescent

adolescent we than with of on the pediatric in bit it a of think this that trial the and couple to because the the we’ve done the trial, a help On years little be area quicker trials can lot now we for experience us with have we different obviously those a we optimized recruitment, hopefully included to quicker things adolescent trials. seen. remains but protocol We’ve do in

little still we timeline the or really don’t as fall our jump that continue and perspective manner. from NDA said it able, these delay be very shouldn’t not So launches. in point, going product which are and it before, we XXX, any that be regarding time, two one, believe products flux, and we a sequence critical optimistic the mentioned launched bit that, as would preference how the or last other the to as will in before always have launch plan material in to we again but far to think perspective, will at same be could a to plan and we’re at could flexibility to as quarter, so any one of is any products [indiscernible] continue Again we we front

no. us. we’ve we about Phase as the the answer hold NDA, so NDA the will could program, path the very the we is so the far and on molecules question therefore the of critical of the up As to needed of see that and are are we’ve to - and that III we’ve we file Everything have nothing there XXX the be preclinical a for hold your lot from We’ve data we XXX, so done on them work far the because both ready that studies, it, NDA XXX, old update complete package some to actually done complete once is and else been had is the at preclinical these working point molecules, that anything that doing [indiscernible] work updated. this to been

David Amsellem

clinical a you in Jack, program, any do That’s follow-up, planning to helpful. Then are the adult if road? XXX the I quick of down in patients adult development may ask terms

Jack Khattar

Yes, absolutely.

David Amsellem

you. thank Okay,

Operator

you. Thank

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

is Your line now open.

Patrick Trucchio

My bit, the readouts, I look question eventual a assuming if PDUFA, morning. the XXX, ahead the may good we intend of etc.; commercialization in Phase readouts, you do understanding need Thanks, but is to regard positive III approval, many a or hiring XXX? you perhaps asset date, you launch this anticipate it launching reps would partner how and soon how late would own, to anticipate your and after XXXX, on potential with sales your if own, on PDUFA in

Jack Khattar

we lot confidence years, in given for strategy is specialty we both we fairly area our well. ourselves. ADHD many this can a them, well, incremental course do experience very years space, can do that able some because of and in to on and the it that here, Our so a Unless add somebody XXX is and have of XXX, believe being commercialize job very, value to in of in steps do extremely XX-plus

Clearly So we especially as will build sales in more our that we that just will did will strategy, XXX, that have neurology, so will that plenty - between efficient of the and space. own in psychiatry, bipolar, that busy keep we the products force, one that than build sales if XR we than product. be in which one force will asset more we in we Oxtellar force have sales and have XXX, force sales

you of XR to our to for estimate far far think now in need of product would on and to the need initial presence depending XXX first, the as is so kind add three XXX initial months we product, as XX the products, So and that’s size as reps both XXX we then one comes have first they’re reps, it both Once another the for initially XXX, building we which these around the for we us psychiatry a somewhere or XXX expect XXX bipolar, add somewhere for at to the you this up believe XXX we behind XXX plan to we nine when opportunities. XXX point Oxtellar total in marketplace. in product if the can launch in reps second later, reps as

Patrick Trucchio

then the bipolar a on just expansion label disorder follow-up quick have I for Oxtellar XR.

and run You cost? XXXX. might that program many own in you you Phase Phase may can III and Can studies discussed the the us program investigator perhaps you your have how much initiate how III tell initiated study to

Jack Khattar

Yes, This work and a you so regulatory programs. your new typical will because III the never the there III reason you XXX(b)(X) that’s is IIIs, that be space, will two plan. indication, been so did pathway Phase for never in the need Phase Phase the need Trileptal, for has bipolar a two program in

far designing bit in so this because middle getting protocols that is are the just As I a we me just guess all together, as a of premature the the for as and and little to this said, it’s little premature point. cost, put at bit

Patrick Trucchio

so helpful. much that’s Thanks Okay,

Operator

Thank you.

the next line question B. with Buck comes from David Our Riley. of

Your now line open. is

David Buck

plus assets. couple of of that have on that a the You something surprises some the could Jack. II you gross little at a product outlook for for line a million that. bit this a I looking quarter the doesn’t convertible gross inventory were sales quick would Was surprise little performance add on in net? quarter just didn’t you you’re you’re I seem there, of imply larger or either I Thanks. comment offering with to guess not? to about questions, Phase on for more--a talk indicate guidance Yes, Maybe in that Phase bit to the and you and, product had think your looking the just what change at. Did guess you question, or M&A, your raising year. $XXX thanks. debt to expecting? first Can strong I A outlook little just would sales you timing the if year guess, lack I And given

Jack Khattar

the are were first it. guidance, have visibility we If so in year. is. like we keep or change the early are pleased, the the would been before year didn’t just more we here, that’s it to very up we reason we our any very guidance still don’t policy changing Regarding quarter, make change about because whatever changes, we excited down general The is some we in to into to any like and because

want with and we what and another else. everything to else happens CGRPs just see quarter So hopefully see

materialize, The allow a something just as line to Regarding sure and significant to of do we a that because be to to tend to said I a is want money, these raised we make that continue BD, us capacity as that than late to your could ready to our something Phase reason transaction. yes, that what look that with be that raise in strategy, I at commercial if or expensive that tends we more we do II. stage, those we Phase is is of kind did if opportunities, money have opportunity clearly, that point, far amount but we find

money. transactions, open is a smaller a therefore So need opportunities we of doing significant they or reason it opportunity to the of could bigger bring and what the that whether bigger transactions. strategic, may flexible end behind as we’re more bring little and All product bit kind single a raise transaction up and our that they be series is of very or

Operator

you. Thank

comes question next line Our with from the of Trbovich Janney. Ken

Your now is open. line

Ken Trbovich

underway, quarter. of III my Phase outlook for six congratulations all part reason XXXX, it early spending question, all us to longer of in or Phase the on trials in two really R&D trials ’XX looks we you’ll maybe sort the and have expect up of that like the it wrapping taking I be question only the and III for to for than great would unreasonable for files, see R&D a in Thanks remainder the these is XXXX ’XX? lower guess it three If relates term. is of

Gregory Patrick

million over extension go label next guidance that XXXX for We down spending trials bipolar year. to not be much. XR our sync both continues year year, trials the so in Jack goes Hi, think think open in spend it’s Oxtellar if XXX this Keep adding R&D pattern in and got with in $XX we’ve We be thanks will to for referenced year. question. down probably spending our going it that this year, Also, XXX. the mind

that the active perhaps to While trials, standpoint, would flat down in as Phase they’re intensive would as III our are of marginally. monitoring not and cost intensive expectation be terms they a be spending pretty so

which in, for go R&D XXXX. kind bringing Phase our that potential as targets bring I/Phase in want excludes view opportunity. in if up in and then this II We happens, of all any of spending fact Of to course, portfolio we assets, could multiple

Jack Khattar

could we’re add, I now be we SPN-XXX all is earlier, so aggression, I bipolar as by is on could if and by themselves a as tremendous had speak, to this more adult mentioned impulsive case, XXX so of and XXX of doing a be months previous product, a and products whole pipeline. the a amount would because areas thing after of could growth XXX morning, opportunities for the build trials, and pipeline just be programs talking areas have much we a label, have in XXX the could about of from doing The different these within be populations questions also itself broader two XXX that positive nine this other these and itself we in a well. expand from we in trials other going for hopefully both data other autism patient and indication to and some

busy So for data come. years work and to many, hope on both to have continue we will expect, we products, should many things and we positive way the we be

Ken Trbovich

Terrific, thank you.

Operator

you. Thank

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

line now is open. Your

Annabelle Samimy

can of of maybe some good, advance them improve know of CGRPs in you about a have wanted market have the CGRP. just payors can a preferential entry follow-up the on in cost but that had and with discussions any they they you might I physicians Trokendi Trokendi that the is access I’ve I had how you advance for CGRPs, position, some so Trokendi? ongoing to any suggested in discussions with push talk do of discussions Hi, changing. do the given with access may who

Jack Khattar

the for we be basically a left with could forth. that All at treatment, label - pricing used line it’s a safety driven even very could physicians get what I initially clearly more don’t on limited approved, in and to but - we get you comments that is this don’t keep will so here how be to point of of or is CGRP. they facts before earlier, through a CGRPs beta or, If know, can be be before try a at injecting label, that, some far driven that area it have be the patients whole first they positioning depends it going a physicians either driven most to people we because requiring all believe all mentioned they I’ll topiramate Botox get, and to and payers themselves point of I mind, that that my by gone would have the again, this because don’t as a with is the not and the have and the I case, right. the by start say therefore blocker the of strategy, the could by need comfortable also new think this compound drugs time the class it positioning consistent If as as

being So what end patient all these and used and will being of the therapy a point up used CGRPs up it from which dynamics at end type of impacting in view. end how could point up

Annabelle Samimy

you. thank Great,

Operator

you. Thank

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

Your open. is line now

John Boris

taking the for follow-up. Thanks

you XXX-XXX. currently on the important is then bipolar thoughts Just for has any IP the it’s Could study, some give do around, very because question that just label label around commentary one open what to your and obviously of on with just build-out, enrolled? percent

Jack Khattar

about first XXX-XXX the missed question, what? I I’m sorry, John, was it

John Boris

property, The IP? intellectual

Jack Khattar

Okay.

John Boris

It then centers, you label the and trial there? enrollment the just support Oxtellar time the will that build-out, remind trial is label and percent based on the being XR, of have size certainly conducted us that be what that’s the three to by open length of important on

Jack Khattar

Okay, sure.

far intellectual XXX and first. talk as XXX about XXX For let as property, me

layers molecules, products out we products. anything exclusivity the the these the is composition itself, both several specific else delivery. indication new As the three-year that centered from you of fences have XXX, around have matter we IP, older With but molecules protection itself, know, are PK several formulation the perspective, around get but so also comes of around don’t of and that mainly clearly profile delivery we IP a IP

its drug. schizophrenia, have the synthesis API use also applications also the have impulsive and have as of It’s in tool. diagnostic as in use IP far well We use as IP aggression versus we the as novel novel created old a new on we

is the first market IP mentioned it’s to finally, haven’t well a it so pioneer the frame have actually, frame, time about with in before getting in not new the and so delivery, we’ve that as second which know, perspective, the probably IP you in development, be as a drug is API long All and people our five-year drug will to which similar generation so product the also that much chemical very will generation is time for three-year SPN-XXX, from XXXX follow-on development even XXX Then working space. a a XXXX we exclusivity, second first product exclusivity, entity, development, we we this different, pipeline, is it is generation have XXX SPN-XXX. ever even is active have follow-on. been use is also exception synthesis. I will are try instead we launch of get the formulation layers it fairly different we to we on, have so a to As XXX the novel of talked that a that the a that that in

for the Oxtellar I wait approval. as continue label, to as on we the IRB question second XR far As open mentioned,

But enrollment Phase lined really because it we label that year, finish up XX it’s if the could if that different can help is anything the this up to even program, doesn’t, there Phase end the delay We we trying see us trial it design that that, up we Phase a delays is IRB. on again, intent Again, so that, III continue be by it’s but the want have we believe so But to the that. whole to the behind us and not the done can us. patient able the time. going open to patients driven, controlled, can for perspective, to for the of patients a any don’t bipolar investigator with on in III investigator from garner been that we we the bipolar way, are to it’s want that not to that of program it’s we bit get which screening population, where don’t hold like little is if of and about lot It see that Phase by controlled study, a we difficult because, III from we actually anything trial, hold delaying enrollment any don’t program. program are in but the is our see That’s haven’t differences going small us opportunity III

John Boris

Thanks.

Operator

I’m questions Khattar like I to you. with further over showing for no at time, conference turn Jack this remarks. would closing to the back Thank that so Mr.

Jack Khattar

you. Thank

particularly and great are We products. the pleased strong commercial are both a off start the to with for year growth for continued

morning joining for neurology We positions everyone have forward us to deliver very we established through a and growth objectives. that this to you look on you high well successful Thank and business XXXX our the updating year. us

Operator

for does Ladies and program have wonderful may a gentlemen, thank conference. in today’s all the day. participating you Everyone This conclude you and disconnect.

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