Supernus Pharmaceuticals (SUPN) 8 May 242024 Q1 Earnings call transcript

Good afternoon, and welcome to the Supernus Pharmaceuticals First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to Peter Vozzo of ICR Westwicke, Investor Relations representative for Supernus Pharmaceuticals.

You may now begin.

Thank you, Mark. thank Quarter joining Call. XXXX and Supernus today everyone, First Pharmaceuticals' Financial afternoon, you us for for Good Results Conference after results. the press of the company Today, a issued market, release the these announcing close

Officer, On the today and me call Dec. Financial Tim Jack Chief Officer, are Chief Khattar; Supernus' with Executive

via is ir.supernus.com. available Relations of the call Today's made the section Investor being company's at website

company's reflect future performance. call, are SEC course may performance make such statements regarding of These the uncertainties, statements latest and future company's this Any management involve those current and existing events the not filings. on the Risk noted During forward-looking and information. the future perspective trends in Supernus' forward-looking section certain Factors including risks guarantees and of statements forward-looking of

in differ statements. may materially forward-looking projected those from these results Actual

discussed. For Since who the to update Please May laws. to this and SEC. obligation call be any the press recorded the being additional the related except securities required then, Supernus X, declines made by with company releases replay, listening on most current as applicable benefit held have announcements and filings recent those is forward-looking XXXX. may the topics of to may statements, these the company's reference

to now turn the I will call Jack. over

you, Thank time call. Peter. to taking thanks for everyone, and join Good the afternoon, today's us on

all-time year XR. Driving with reported growth company growth and IQVIA first we successfully excluding on the sales which improvement to total net double-digit with to Qelbree's the were quarter XXXX at in last growth net in prescriptions the an long-term Gross net period benefited a first sales. of the exclusivity strong quarter first in XX% well Oxtellar same $XX Trokendi the of XR, XX% impact mitigate minimized performance another is impact beginning Following prescription high position the resets of to in in range from XX% delivered have of XR have from is year million. and compared year which Growth XXX,XXX we considering sales insurance the the and XR in and quarter across encouraging execute net deductibles reached during to on of Oxtellar and pressure both productive the of Trokendi growth loss strategy net quarter Prescriptions the revenues, quarterly year. our within this are first our gross was generic typical XXXX in by continued from and to as for to that pharmaceutical and potential the of this growth target seen industry. XX%, growth high

remain expect XX% For that you the to the a for to remainder quarterly would of on of basis. XXXX, Qelbree net XX%, to with in gross expect we fluctuations the typically range

base with expanded of for from XXXX. quarter, account Qelbree total During ending XX,XXX, XX% the of from XX,XXX in the approximately its Prescriptions approximately further Qelbree's adult now prescriptions. quarter the first up prescribers of fourth quarter patients

to patients. for sales to example, These for XXXX. existing to net to growth of and now the Medicare We the based on new and closing on quarter first to Parkinson's increased X% GOCOVRI dynamics on deductions our saw pressure brands costs lower of contributed our gross the with increased compared to higher in out-of-pocket our Switching in funds rebates leading, of same patient-assisted franchise. net period brands the

their to sample This physicians patients GOCOVRI patients. to we XX% increase in to increase also allowed costs. by waiting a out-of-pocket quarter, hit distribution in while stay many sample usage the maximum saw on During significant

patients their already their as have seen samples in the quarter back a believe refilling from started to the GOCOVRI We bounce in second prescriptions. business transitioning we

in the legacy quarter were to last year. XXXX first XR $XX.X $XX.X quarter our million Switching compared products. sales for million to of Oxtellar net first

of generic first the of XXXX. introduction in Oxtellar the September XR expect We

For continue quarter to Oxtellar from XR we the expected net sales label sales this of same the million erosion quarter combined million, year. XR With entry in year, were to and $XXX Trokendi genetic and be of $XXX $XX XX% anticipate further Trokendi XR XXXX XR XR, by range first the last to of Trokendi of net down an million. Oxtellar in

Regarding SPN-XXX.

ready As complete we company's in that application for in response FDA will present but form. The its April, was disclosed resubmission to month. company the this that meeting the later FDA announce complete review the with the in issued the the for after for is response the indicating letter cycle application a NDA, not filing its approval

and to potential need Parkinson's are the to SPN-XXX committed patients to this marketplace. who option We bringing new treatment

Moving on of product novel to our emerging candidates. CNS pipeline

the up in We coming catalysts have XX next months. exciting

patients. currently Regarding is more data the patients open-label SPN-XXX, The depression half targeting IIb the a number total its adults provide IIb study treatment-resistant major of to disorder. total of XXX company XX% of study about recently achieved II than enrolling expects with first from Phase The in depressive XXXX. Phase XX targeted with the study of and enrollment in Phase

of Phase patients, data than the X/X greater The approximately to company treatment-resistant total of from seizures. targeted. expects SPN-XXX patients IIa XX the study Regarding randomized now for interim originally report

the second to examining adult these therapy study SPN-XXX the of As This plan tolerability of hold such, seizures. call in is results in the are Top efficacy to half XX treatment-resistant XXXX. interim on the conference with we safety, expected full study and line adjunctive for report patients as May data.

candidate new of plan we submission study and application. stimulant-like ADHD In a an drug SPN-XXX single-dose of healthy initiate Phase in product CNS is investigational new following adults disorders. I for to addition, other SPN-XXX our

strengthen in future active position to CNS. our for and strategic leadership in further looking opportunities development, corporate growth remain we Finally,

will Tim. With that, turn call to now over the I

Jack. Good you, Thank everyone. afternoon,

today's was release filed As please I results, earlier review that XXXX first our quarter refer to today. XX-Q and press

was Oxtellar of and quarter million and of quarter Total was a revenue in $X.X product decline the The million product net was million sales XXXX comprised in offset quarter. by licensing of million. net compared and product XR in first $XXX.X of revenues XR, million of million sales net year the partially of $XXX.X $X.X XXXX revenue due in decrease royalty to million for sales Qelbree. a the primarily net Trokendi to $XX.X prior product Total first of increase sales $XX.X in $XXX.X

product the sales XR of XR periods, Excluding and XXXX Oxtellar the net year Trokendi for XX% of in to both quarter. quarter first compared revenues total increased prior

$XXX.X combined due programs loss we for XXXX for year the SG&A basis an to $X.X first as SPN-XXX for the of was the quarter on million pipeline. clinical year the to period. were of million $X.X associated prior expenses quarter million and of GAAP For to first quarter. for continue with and compared The XXXX, progress primarily SPN-XXX as prior increase spend $XXX.X million R&D a compared was to as Operating earnings the our operating R&D

of as $XX.X adjusted income On tax the of prior same to was million which in of quarter. contingent in Income same tax and share million $X.X the $X.XX benefit share-based prior quarter to $XXX,XXX earnings operating compensation, depreciation, for a per GAAP earnings the of million first $XXX,XXX of first $X.XX intangibles, basis, quarter XXXX $XX.X first net million XXXX. or compared period an $XX.X XXXX of or GAAP quarter compared expense per the year. was share of for amortization net earnings in in non-GAAP XXXX compared quarter consideration diluted for of diluted of excludes year the the the earnings was earnings to

The company XX, of approximately as XXXX. March potential to have compared had XXXX, opportunities. a due of cash with and million December for financial XX, cash to As other company continues equivalents in cash, The the strong to generated primarily increase sheet significant operations. $XXX.X or million balance $XXX.X securities from M&A flexibility value-creating marketable was

guidance. to turning Now

year and financial total SG&A guidance its revenue, and reiterates full XXXX, expenses operating R&D company earnings. for the For non-GAAP combined

licensing million net million, expect to As range product royalties $XXX $XXX of from such, we and sales, revenues to total revenues. comprised

operating full For call breakeven between pipeline identifies million range various $XXX we release ranges full range and from combined and spend press our GAAP we expect million level items R&D from reconciling to in of year of $XX and Please to million. $XXX earnings that XXXX, the GAAP R&D $XXX reflecting to as range XXXX operating progresses. Overall, SG&A to the loss year earnings in non-GAAP. expenses increased million, the million expect issued this non-GAAP to refer to to $XX prior the

call turn I to operator Q&A. the will back now that, the With for

Instructions] from [Operator comes Andrew first Our question with Jefferies.

So congrats on progress, too. the

then as Change And real the see -- the curious Healthcare guys been is just in and attack you We're growth quarter-over-quarter on expect First TRx should relatively one Qelbree. this saw you what similar in QX where Would when I'm acceleration scripts one we well? we you month impacted by to the Or QX quarter? have is be into QX. cybersecurity an acceleration?

last Andrew, X%, fourth X.X%. first versus or the the seeing if first XX% XXXX is year, by you prescriptions We're if second X%, quarter sequential quarter, quarter-to-date, if in about about grew second mistaken, growth sequentially growth of the of versus quarter, look you the I'm sequential already at look quarter the not quarter XX%.

looks lot your so starting which so forth. is issues QX up. it and and down to of it's typically forth answer then So it activity question, like The pick time a yes, and phenomena, to maybe of insurance

second looking the we're quarter So at in already. acceleration

or back-to-school clearly with to season, I be strong quarter mean, how that season, second be as the quarter remains that healthier. before. third quarter the year versus seen back-to-school we expect the to versus third Certainly, to

for second Regarding could provide issue. and service other the the answer the impacted question, continue providers Change by Healthcare We step were in no. had We not that to customers. our is

the XX this seizure existing to be data kind whether much think Okay. what month, SPN-XXX you And be later us can drugs we'll or talk maybe should surpass on we interim higher those With How rates? all on have expecting And rates than then freedom epilepsy data SPN-XXX. of set. and patients? show follow-up

-- XX somewhere have as first more did the far mean, the Yes. mean, in press or question as patients. said still in our data we're We release, as to few on a I remarks, we I follow-up. not we much around patients study. going report my how still

of will we data the a have study, so to handful to report on set year finalize when the full all we this report in So report full we of the on. patients second more half can

refractory. I one as seizure second data far was XX% and If around I seizure as XX% very But are freedom solid mean, for refractory of XX% of anything for with above patients definitions XR. use seizure a patients. Clearly, remember seizure XR, are different space, whole host freedom, a people especially Oxtellar freedom. typically, that give is product, many who for at regarding there to had the some those freedom. so example out a this I'll there of And many are are we the good point you agents XX% example, typically which of Oxtellar one rates, ranges on so number, in question the Regarding the there

population. on depends you within seizure one it are patient getting So freedom

those to If are X%. are you're you're who and But free, from seizure with throw in taking and drug have people the not then as it's be that and beginning even refractory turning not taking disease patient treated impressive. epilepsy if getting them is that from you're incredible, you who if they is early their probably seizure-free on badly, started them as progressed a

a of population. and variety patient measure in of how there's So them lot what people

it. In general, you of do terms is have quick picture. firepower last think guys it. Got M&A? much Got you then or bigger in BD And question how

could million mean simplistic to transactions could equity. $XXX higher the very if get we a we way, it In probably I $X use billion, do in

against as the paying will profile maybe assets you're So become kind cash does candidate, allow that it And flows, the situation it that then the able a company cash company for it all acquisition. mix sized as generate transformative as of acquisition these of you transaction, itself with has, far an for go bigger part that leverage equity significant that depends come and to on flows is transaction. that to to if could what well

with. range. a So but wide I know it's think $XXX fair we're range, situation depends $X a on is all the billion it billion I dealing million to to $X

Sandler. comes question with next from our David And Piper

just I a So have couple.

First, Qelbree. on

net is, in you the the dip year to getting given the net of So tougher, it in Just to wanted what that nicely to to XQ, the possible talk in if doing seasonally to mid-XXs. you I already gross is as target just it's progresses? terms low guess given that XX% that, below you it you're see could gross can. where

learned And SPN-XXX. infusion elaborate issue device? the maybe the Then the secondly, that Can in what was on the the for issue, CRL not or anything you the master file you've forward is since there raised interfaced but us CRL two. on on as in works. regarding believe can Phase number Can of with you lastly, you the the the remind that SPN-XXX. is this And us? the then path you've IIb Phase just with that's in manufacturer I share So IIa? CRL beyond

that to talk design study. the So of

Yes, sure.

first the First net. we year, we to in question if to start full The bit the absolutely are to quarter-to-quarter, quarter, is target net gross improve we on Qelbree but reason XX% to for XX% typically, is gross good a and better the here. in because little place or improves. remain said with, we you're to And to a there nothing from had right,

or something which to The some that sometimes fluctuations, only high come this, are like of unexpected could we in. caveat quarter-to-quarter or return see unknown a

potential it against the the shorter Yes, lower a else end put this here. that the range, of end that's we makes we're sense. or may on equal, So me only the way. guarded to be is let Everything that that there end if year being thing trying

learning secured as SPN-XXX, we're when and did later as are announced which areas with one already the month. the these quality CRL, that, manufacturer having a around far more that and I we we're and addressed master more FDA around mention mean can now we think the we the are one this be couple areas, As of meeting directly around a with discussions we there

later pretty sure that can, address on. as these are we're So up hopefully to new issues fast, there moving really fast issues as wanted we to pop no and make also all

like we trying sure make So before And everything on SPN-XXX. we have we have meeting before question first then we last the for time would resubmission. the that's need why any to to that we're communicate line resubmission. And

looked a study many an Just seizures, we're so on current we open-label us to which doses, Phase step. typically study of next continues and types to we as at at it IIb our study the the where different exploratory is several was data reporting on, help is meant interim as learn the looked reminder, which as time study, enroll, be us help goes on, designing in would the

So the the details share and will after May next with is Phase on you open-label clearly, step study, the guys we that IIa XX. natural

that it possible a FDA. on in quality? said on There to also the if And SPN-XXX. meant was other on quality believe raise you I was that the may you product's I sneak just follow-up -- product issue what submitted was elaborate data and by Is to

I get I don't to the regarding formulation Yes. into all mean It's the want details. itself.

So it's not a device issue.

to product, we the data so when the It related formulation, FDA the quality. product as solution, this So yes, that's That's say time time was at didn't we more that submitted can at And share speak. point. apomorphine to far have or some didn't we to the the review review. have as that

So else sufficient. meeting clearly, us upcoming anything very be whatever be for we the meeting, submitted need the they important clarify, on will of that or do top to to

meaning. of purpose the that really that's So

Stacy And TD with our next Cowen. question comes from

the quarter. on Congratulations

have few we do So follow-ups. a

That's year? making be fluctuations, year? a about consider going net question. on quarter-to-quarter, pricing strong just the we're patients gross that more -- mix it price of Is Just whats' look Is increase? season we net back to, these co-pay that stable Qelbree. kind of Is it adult the first QX, kind driving because seeing we alluded still back-to-school are we as one more higher investments That we to in it price that? then you pulling doses as the think we that being And should are you program? for Just of assistance forward, the more added? kind are as expect this

on enrollment than a going is to went be And faster then bit the question It like sounds expectations. SPN-XXX. second

move you talk set competitive and just the the to and move So be is curious this to in about understanding May data of to just do label expectations, the among reductions help late set can And for late decision Street. you give what study an broadly demand patients? open then you're to But seizure will just expectations expect going May? forward this into

Yes.

patients regarding actually and there can to through perform daily very the be with day. and comfortable doses basis, the are more that is in of adult, different net and effective actually quarters to it's and of that and physicians and the get end grow to to at the to function medication the treating getting higher to price for the typically doses, daily continue up titrating drivers are what key they taking symptoms. whether for a the well a we on really several pediatric continue Qelbree product and grow more Clearly, Qelbree, need to talked to well continue dose Regarding avenues, use daily highly that or real that about obviously we

And communicate in III what III on up they total are data. that the with line should to both And daily did Phase in physicians to we patient data, the be Phase working that is dose to based continue populations. the target our

goes we time to these product. the speed -- a speak, So because prescribers getting which hard always perspective. always there titration completely it there, obviously, it's are take predict, we to from prescribers clearly, new you so have low to new always on, by as and And slow, that the new are will is get

combination depends also it, how with on stimulants. using It if they're using in they're it

the stimulant it stimulant regimen Qelbree, on. go reduce the the take therapeutic they already Sometimes dose. from Qelbree slower adding much patient And because is to the will they to lower the as and increase much the they're that that and try for stimulants patient adding they off and

So case-by-case patient function that of a a that's basis. on

doses population. higher clearly impact final the the that then will is And dynamic adult

clearly, the daily total dose piece of total a our the and in going to and becomes on increase basis, bigger us of adults continues of price our grow to gives a franchise, the benefit blended a that's As higher prescription. mix business

the last first always to price first guess, net fourth divide that's gets year. you the was quarter. prescriptions gross which $XXX the of net of net I quarter worse versus number previous the quarter the sales about little And if which So the is in year because million, versus quarter the million, $XXX the the quarterly in down was bit a in this by

our As far on, and goes year the so forth. as investments

to Now we push continue moment, this in at adult.

push and to her female very ADHD we Busy some in it great absolutely tremendously. in She's we helped like her mean product adults, with partnership experience have pediatric, experience We've influencers not. Philipps, doesn't So which about ADHD really neglecting signed that we're especially as continue But up a in talking with has Qelbree recently. adults. and and announced her

we disease, have don't there. talk struggle education be with out conditions, to about that to which there every non-stimulant the these substances their is actions that the Qelbree. that and very options to So be about they continue be the to encourage case can They they can effective, and very let stimulants. with have are And market be day patients things know about single hope and forward step their a them don't well-tolerated controlled and good

fast, In that on, product and well every kids adults. works really and data have it at works and more metric, and with the evidence goes more time and will we we Qelbree look it and works really as more

season. investments of prioritization will clearly, back around back-to-school the we to as in to more continue get to make and areas. invest we'll resources we So season, more closer school these And the

end XR in even with eventually. are and Again, epilepsy many for than Trokendi XXrd more And as Carbatrol day, that clearly, end years I that become mean, and want refractory, mean, been way and you the unfortunately many we the of product review, I the mean respond to many don't out drugs you medication. at that -- we've the at one Oxtellar so landscape, works. May before way up earlier, on and agents back. there, X Regarding of referred or XX a And so they look they May. to many and these on patients course, space patients XR, I when the profile. I data of will there SPN-XXX

I you're need make try that is a or the so for goes you gold patient time become you clearly, really even they works delayed and to that's mean, early works And of well. that these well the therefore, to responsive you drug them and it works refractive. And avoid having that progress to hopefully, treat as and responsive patients medications, worsening standard on. condition looking the and their is are to progress their

SPN-XXX, as early So in we've it's back far, so From as looks R&D effective back an some study. seen of way we've had October medication. the Day data in shared we the the from patients well earlier like what in Australia

action specifically so this have So That a well. drug given procognitive actually of and attributes, in profile also have would if it works we a mode some that in be would huperzine again, be to does hope patient that forth, A, And huge. huge its of population.

we So that we will of XX. analysis the share lot literally analysis, than more a expected. speak, May that initially see, we as we we'll patients on completing all little we're a And of given as bit had that

And with from Stifel. our Annabel question next comes

This for Annabel. is Jack on

comes there better here, that onset? So and onboarding in strategy? trying existing identically Essentially these Qelbree it Or you've responses naive both things is initiate Qelbree differences about to previously the two when patients I populations the know are Are are XX% switches of from patient populations have treatment to to XX% like that effect any there they once other therapies. of mentioned do speed perform Qelbree? a ask

label franchise as is from the fast, of between works Not mentioned, because have slower It on Qelbree. really. to depending earlier. right? from of the as all, titrating or remarkable, if patient that, they or efficacy you physician feedback And I of whether like have they're or the adolescent to bit adult where an mean, or the mean titrate, far Qelbree as has I is whether obviously, get you a little the the to patient, need do on older the an weeks, patient, as pediatric it's choose just whether X field to titrate. is consistency on you the titrating to I week you adult, come pretty the have a an first we

and But Actually, feel over of seen onset they in of improvements -- the the have this results titration start fairly some physicians you years, it that seeing Strattera action weeks. we time they we who within experience average they've patients that fairly use on for since X week X have Strattera. during is X think had the tell nevertheless, used and Qelbree many to least or the during launched and weeks, Strattera the and I product, quick. And survey at a works Qelbree an given known see, themselves even they with they've

of the that regardless product naive know beginning. switch or the whether Qelbree a well, working from or got who you completely on we a is patients you're are new So really

Got to of then one it. kind more. ask just And

Speaking about feedback. physician

to how I performing any data see the heard in we're you're formally the looking maybe going that the So in you reports in But know IV, meantime, at comorbid that might about real-world Phase of involved trial patient population? physicians be the not anecdotal this Qelbree Qelbree eventually. symptoms, in in and or kind have from more mood

on formal was it were doing we us We blinded started see that and data actually of anecdotally, we from collection it. interestingly this or like telling even top nothing some back anything, that who anecdotally investigators was at even way studies -- time hearing when again, first the about --

but is their pay were time, feeling getting or know overall they're attention in looks Qelbree that telling don't they at better just just better not they're talking taking taking placebo the whether they or we like focus So us is patient whatever, patient or general. more can because about it

the it, of we not say, about idea. say, tell more and on or know And and whole then course, they an do the are of to you be placebo. not on hyperactivity patient, or know these focus knowing oh, what forth on they you why, patient, whole whoever to, and that anything even impulsivity and an so works not they attention mood the being that, don't the ADHD. being what knowing But do it's for would just could that molecule have antidepressant the would serotonin investigators then, again, they of okay, well clearly, So molecule specific have referring the we patient get we forth. so is them of And

come with So anxiety, a helping that other know why is working in orders And disorders. of comorbidity looks they then that these ADHD. lot areas, depression, mind maybe it their have of was different that like ADHD better patients we modes may course, it for yes, does really across because speculate, clearly, across anecdotally, just not it things again, different mood like, probably bipolar, that's

This question-and-answer concludes turn now would over like closing session. for back to it I remarks. Jeff our to

GOCOVRI catalysts. investments significant you on and portfolio, forward We rest allowing cash upcoming call. remain long-term updating our second, have our you. Qelbree, And portfolio together afternoon, R&D next and growth our we the and focused continue driving and several drive concluding clinical of on, flows, this exciting pipeline. in to of us afternoon. that to the Thanks innovative the In differentiated us with Thank joining first, this call to the generate first-in-class growth of company strong with our look for molecules continuing our progressing milestones by

Thank everybody, you, your for participation the program. conference today's call. does conclude in This

disconnect. now may You