GWPH - Earnings call transcript Q2 2019

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Operator

Greetings, and welcome to the GW Pharmaceuticals Second Quarter 2019 Financial Results Conference Call. [Operator Instructions] Please note, this conference is being recorded.

I’ll now turn the conference over to Mr. Stephen Schultz, VP of Investor Relations. Thank you.

begin. may You

Stephen Schultz

I’m Officer. you, Officer; for of our Officer; Steve Financial you joining Officer; Cline, Knappertz, GW. for Vice Chief Volker Gover, Welcome, Officer; Dr. Tovey, Executive second and Scott our quarter and Chief today Darren Today, at Relations our of Chief I’m Medical by results us Giacobello, Justin President GW’s Commercial all U.S. Investor thank joined Chris call. Chief Schultz, Operating Again, Chief

We a while press and our had hope issued we release tomorrow. XX-Q file our you’ve review to chance to a ago, short Form expect

regarding As These performance, activities, regulatory applications, today’s statements call, future acceptance clinical during timing a current patent launches and potential. commercial of GW’s market be statements expectations to regarding reminder, not making statements financial statements. reflect and but relating events and certain forward-looking including, product we’ll to, limited

uncertainties, from risks A events be as involve actual could Securities only company’s risks statements found uncertainties in associated materially date, These and today’s and X, and list August in with Commission. the statements an forward-looking the differ GW Forward-looking and U.S. with investment of speak herein. can and description projected filings XXXX. those Exchange of

today’s an Relations website in section. posted Finally, the of call to archive Investor be will the GW

I now turn the call Gover, GW’s over Executive Officer. Justin Chief to

Justin Gover

all have us joined to who today. those welcome and Steve, you, Thank

Epidiolex in We are U.S. once to again the pleased of sales strong report

Cline in by our more still and provide continues on by market U.S. progress demand are healthcare we early receptivity of moment. strong to prescribing determinations. detail commercial payor success coverage ongoing patients, While the by our providers increased achievements Darren in U.S. stages fueled a will product this in be launch, and

with reported to see associated our results patients in positive X we Epidiolex. the continue May, with trial of sclerosis seizures significant tuberous complex. in Phase We In growth for potential

which fourth should FDA this Epidiolex call. approximately FDA on mid-XXXX this into on lead other with expansion sNDA provide decision, progress Epidiolex high We in approved to more and for quarter, of the the patient expect to market in Knappertz R&D and TSC if this a Volker need the for file the will color of patients. XX,XXX population

European very opinion Outside will in the States, Committee have and reached CHMP this a now approval were provide This or later readying the call. launch. pleased European our Europe October on Medicinal approval Products in we expected that preparations recommending United from is of positive Chris our launch an for in Epidiolex. Tovey early team commercial for is the update

CFO will Finally, on call this Scott results. Giacobello, provide financial our

provide me update. by Let Darren? commercial to begin asking U.S. Darren the

Darren Cline

the be in U.S. pleased GW’s Thank Justin. million to Chief net first for sales and second the first U.S. of million $XXX.X presenting were quarter I you, in the $XX.X time Commercial to you am Epidiolex Officer. half as results XXXX.

the pleased eight Epidiolex, and a strong results and very the for the these brand. launch. all show encouraged by are which with We support caregivers patients, very solid months in since payors to for building The is foundation continue uptake first

There significant several QX. the were in for drivers in revenue uplift

for X,XXX from X,XXX X,XXX XX,XXX up prescription of patients through Epidiolex, patients strong increase an status; commercial lastly starts; the third, at the and March. expanded strength high expansion retention second, continued new of access over from patients over coverage. received and First, a of and continued open-label physicians have Epidiolex, end to of transitioning the written Since over patient the launch end completion payor have March,

we early in the by the The was second demand half with than extend EAP year. pent-up to further to to and early numbers. to quarter growth transition had QX, anticipated. impressive QX for patients strong and is rate OLE did be seen contributed which products, commercial uptake high, the continue driven We the and impressed retention also and physician The the excitement continued revenue for forward more into these patient Epidiolex, look of second through which

we to and see subsequent did more product. expected the of of the that patient With with to starts. experience identification transition as are new a in beginning organic during new is their This physicians evaluating the said, phase quarter, be patient the

of successful Moving which with forward, think analog see healthy be new product will to a expect launches. more other we starts, we consistent rate patients

label efficacy the XX determining assess a the Physicians continue to at per to that milligrams dose. before at per dose whether remain of line Epidiolex titrate at start beginning in the day and titrate kilogram guidelines. window tolerability to typically higher and to with They dose up

early still The be increased product. average dosing the dose, range, end the slightly expected patient early which launch, to quarter. the of at remains While the during in physician is however, dose we use lower the observed of during

to broader efficacy maximize get set using tolerability. physicians as As escalate of to we managing a while more expect experience Epidiolex, aim physicians doses

while we’d research adult mix. other of for roughly increase utilization previous was performance. This as the As is an positive. than XXX%, higher quarter, Epidiolex Market market the quarters is longer-term. this adult during than higher utilization is observed their us conducted the XX% anticipated. future, in Dravet and These satisfaction unaided we and believe with usage aided the syndrome LGS nearly and metrics products very bodes and the during Dravet true in XX%. provide the brand pediatric research physicians mentioned utilization remained the Epidiolex well long-term XX% while confidence quarter quarter class. the outpacing awareness caregiver to Three for We in approximate expect in awareness LGS adult expected

been launch During our update continued our and targets. with prescriber has period customers, to healthcare engaging sales team we as the have

the universe to increased the number brand into months X,XXX. result, X,XXX patients of prescriber with time representing product just having prescribers target at this new approximately the target XX% the launch, to As targets increased potential of from a has the number. We for X,XXX adds the on of eight already think X,XXX launch

of prescribers as as existing by the gaining the remaining excited well utilization X,XXX increasing those for start experience are by product. to opportunity both the the with We prospect

major a a be in building field focus of to into continues brand Epidiolex execution commercial the in Our epilepsy. leading

Our how patient seizure marketing sales identification. and patients resources on present the including focus the they and the professional enter how around types new The resources and several launch disease to teams evolve, adulthood. and as diseases age healthcare education the

key Our sales epilepsy and reach to force continues healthcare targeted professionals. centers

our programs see continue other high customer initiatives. We focused in to speaker interest and

earlier, I these our mentioned all are positive influence having dynamic. programs I As launch a on believe

to payor now the Turning U.S. coverage in

the been has strong One results of payor execution. for early our launch the catalysts

Medicaid mix prior XX% XX% and Our Medicare and coverage commercial current commercial, and of of Medicare other. payor less Approximately indication all lives and now in Medicaid to is or which U.S. approximately managed authorization are restrictive. a XX% determination XX% have XX% Medicaid the

labeled be and to priority access the LGS for to patient believe physician efforts expected, And the and successful. that ensure smooth for As first highly these have Dravet our we has year been indication. to been

course are of other accessing that epilepsy studied do refractory interested which patients are and types, needs were unmet program of understand Epidiolex. rare in with in medical that many there with EA We serious our

branded area further the eight we payors but months their ahead. increasing months this to constructive with working access, new treatment, educating course reasonably be assessment will Overall evidently approach consider years of an in patient appropriate a be to are time. takes into and continue one focus as in current for the as be launch assist to of can be payor the access expected and We

distribution Our partners important and specialty pharmacy are of launch. our component an

pharmacy this we prescription weeks expect pleased serve physician medium during Our fashion. to hold is network quarter network the approximately our time was our an and patients This to and in specialty I continues am and how forward. their delivering. fill two families steady moving a expedited to with

into months, impressed I’m GW the company, team three last over settled these very this with and having closing, the brand. commercial In

as epilepsy we and level is excitement benefit breakthrough As all for keep the community, patients, in patients have to field us the struck and within exciting the The I’ve been as for stories believe invigorate and access gotten and and possible out an Epidiolex. speak to the all of my passion focus caregivers with physicians, can epilepsy. team I’m what that that of conviction by from communicated field me patient’s that the wider assisting treatment many

over the Chris to Europe. turn to discuss call Chris? our progress in I’ll Now

Chris Tovey

to ago. week In Darren. were the received we CHMP one you, Thank pleased positive very have opinion Europe over from just the

CBD is families approval expected one have news in. wonderful early to a EU occur Europe across that waiting elements approved of modern one all October. for Formal and has and been prescribing medicine, This confidence is a can physicians patients in regulatory medicine day in those fully had European access to the that for

launch clinics approval completed place assessment, of since their U.S. take and physician in and the already for Once is Clinicians in familiar experiences expect the The arrival conclusion their France have to practices. patients we process are very into to European once a of with product high which is the communities. the in pre-launch that their expected soon well of advanced These first the supply is after that launches chain, economic ask both Similar Epidiolex about have clinicians very U.S. colleagues U.S. imminent excited and patient Epidiolex of for CBD. reported awareness in launch the course the and and NICE is two we we a Germany. the EU expect UK approval. health frequently

are expected major during finalized. appropriate discussions all pricing remain XXXX the encouraged quality and our in by authorities reimbursement Spain are Continuing with of We pricing markets. on, ongoing and negotiations Italy the once and reimbursement pre-launch launches the

leads team in of support time for is markets. The these major GW in organization to and some commercial European country in having a medical place XX and five European ready with place launches now MSLs and the now been

epilepsy model reflects Newly of in opportunity of specialist X,XXX with concentrated key base undergoing the the experience U.S., different epilepsy comprehensive clinicians. prescribing recruited and the France, of disease is a and them in about it training. specialized Whilst more many staffing Germany prior now are from professionals sales that

Epidiolex connect with through to national major exposure the medical international meeting markets continue key and all physician profile high the congresses communities data, and opportunities. medical of We key through other in

major the syndrome an XXXX five countries. an patients was the Lennox-Gastaut of and the for and end access initiated now European syndrome, patients at obtain only XXX we numbers anticipated initiated This program across approval. Dravet U.S., could registered was plus As impressive early program prior so access the appropriate case that in to

a already As where into launching have environment with experience an developed a number of management large important we’re clinical result, Epidiolex. clinicians

that point as support will will new and in medicine be their to starting to prove a into this confident clinics. aid practitioners have strong experience introduce sharing the learn amongst We this they

to away is capacity our in European more from falls responsibility chain, both manufacturing and requirements also U.S. continues supply sufficient run confident smoothly than my under Moving meet that we’re commercial, and our which commercialization, global the and Europe. to

capacity future term expansion plans demand. are we expect to longer track our addition, on robust manufacturing long term be In what service to

let Thank for you. to And me the his update. call now Volker hand

Volker Knappertz

Thank you, Chris, and everyone. good day

XX, As thank opinion authorization success. Chris in would marketing adopted granting reported another like the my congratulate positive colleagues achieving a a regulatory recommending of July Europe. for the on to I for CHMP important Epidiolex and

we trial reported positive the with Epidiolex of tuberous treatment May, X sclerosis In Phase associated seizures for data and complex.

are excited the expanding to applications the after. to the remain this track TSC of label We on Epidiolex soon and with submission to end supplemental FDA the about follow EMA by year submit to

with syndromes Dravet evolution We because typically the believe epilepsy and drug label childhood-onset will syndrome. seizure that that it and of LGS associated indication the that involves third for will important of with market, a the associated types to Epidiolex the are form not in resistant add TSC TSC be

also Beyond Rett seizures in in trial recently seizures on this have we for our non-seizure of trial, aspects experience syndrome, have a while patients begun our syndromes, Phase placebo-controlled Epidiolex focused some with into the patients disease. associated Rett X investigation the program we recruiting

seen for potential complexes also that disorders, only will Rett of source symptoms to important with a related the disorders Children treatment development. syndrome deficits the mood of the symptom exhibit and autism efficacy of several loss information and it spectrum patients see are for disorders. are and specifically, as trial this safety other from but commonly and not of range Therefore, behavioral movement epilepsy outside symptoms of breathing Epidiolex as problems, of and cannabinoids indeed CBD assessing with we ranging common in on communication severe cognitive Rett many neurodevelopmental syndrome also an in broad to serve on the

and approval next Beyond we asset Epidiolex, the launch U.S. advancing which for are pipeline for Sativex. of plans

the countries treatment reminder, extract Sativex outside a and United other in the both a including multiple XX is non-cannabinoid components. sclerosis. is already approved of States THC CBD The and As well standardized cannabinoids over plant to as product botanical spasticity in as due

to is X with year, initiate an X XXX physical to mechanistic endpoint ago, three trial, will which European directly are data we preference manifestations studies Phase meeting for intended To initiating are supplement placebo-controlled spasticity. trials from This that later the months of about to this approximately trial preparing FDA’s is primary additional our also expected focuses each of Following on and XX this patients FDA trial small several positive this we indication. enroll two patients. Phase address compliment in the

sufficiently Our years. recent cannabinoid a over have work treatment ensure spasticity activities highlighted weakening to to experts of oral developed over effecting mobility, field in the anti-spasticity interest muscles, The living. spasticity a patients. XX daily is comfort, of from MS been maintaining XX% without adequate field new for complications to are there tone with no feature and in that novel to while goal common MS is management there treatments option order severe in the support increase the for as prevent MS relieve Moderate significant spasticity

Additionally, the of important brings a for are mechanism reduction to where but to opportunity sharing potentially There’s there treatment the portfolio. conditions. valuable continues Sativex a to for with spasticity not look action MS psychiatric asset space need see actively developing be expand time, a the improving product to muscle we pipeline We other only spasticity function. representing very painful spasms, in a as as and subsequent well the forward to are be due In spasticity are novel often neurological parallel, over bladder use goals advancing Sativex a program, you field bowel its and which of therapies. in of for new plans real indications and potential in but within the to course. the those

begin study in autism, year. end patients the progress disorders. will to field which continues in approximately is to program enrolling autism CBDV open-label XX towards of patients the A include spectrum-related Our the company-sponsored, due of

investigator trial led syndrome recently in seizures open-label addition, XXX since and commenced. in actively earlier autism patients recruiting Another year placebo-controlled with Rett in has spectrum-disorder this an been has study

Of United expected Hypoxic-Ischemic resulting we birth acute to XX% neurologic from injury for medicines are NHIE Fast cases XX% expected during specifically in Designation to of are die each condition. in to hypoxia. early the our GW NHIE or GW of are also life There currently sub-acute is for estimates in Drug this and program States Separately, received advancing NHIE XX,XXX approved indicated or no are Encephalopathy. and deprivation Track persistent to for FDA X,XXX brain develop Neonatal treatment the FDA oxygen the year. these Orphan CBD of disability. has and occur Designation from

to year. X we expect neonates volunteers regarding under an We expects you programs CBD development now healthy to year. have and later this pipeline provide this Phase of trial IND the a completed of to a in quarter study GW and pipeline more in the fourth the commence multiple intravenous They additional safety formulation information are in

And to Giacobello hand the financial now provide call Scott me let you. the Scott? to review. Thank

Scott Giacobello

Volker, the provide I’ll financial results this more ended you, with XX-Q quarter on discussion XXXX. June week. XX, detailed for high the level results good in be six be Thank will provided SEC filed of our and and some afternoon. comments A later to months

prior product $X.X was X% sales of net due This quarter. of quarter of sales, year million, in in quarter. product to million the $XX revenue the or of million sales compared million quarter. sales $XX.X or $X.X prior $XX.X Cost to million to primarily net amounted from year the net the with XX% start revenue. U.S. is Total of I’ll for an Epidiolex increase increase

improvement U.S. accordance of Cost year, accounting with is net the approval, to in prior partners. inventory launch product the U.S. sales Epidiolex of prior the U.S. outside Epidiolex is due This of expensed in In sales of was the consisted impacted to by favorably guidelines. Sativex sales produced which licensed through

from Total approval, Moving decrease R&D quarter were year. quarter period $XX.X and broadly same in the line in the decrease which growing expensed Epidiolex was inventory with million. prior spend. previous build $XX.X prior the expense incurred a development This is million due XXXX. research for to to as cost-related in mainly to of the represents and This at

in Following are approval, costs these now inventory. capitalized

the for the $XX.X Epidiolex Selling, U.S. of and operations and the to increased and both build our XXXX. SG&A. in to is to Turning million of cost-related This general result administrative $XX.X quarter the the launch the million significant in Europe in out expenses period commercial of increase in from U.S. the same primarily

the an over second previous spend million The quarter quarter. $X.X represents increased

we quarter, for Priority closed our of Voucher the the million. second on $XXX During sale Review

from all recognized proceeds transaction a intangible one-off the as in a is an to net other $XX.X income. but $XX where prior year net non-operating this the sale This compared million, of income loss of in quarter. net million then on resulted for of The the $XXX.X of asset, gain quarter million

of quarter net Excluding $XX.X the would’ve Priority the for the Voucher, been Review loss sale million.

month used Net the for $XX.X the Moving XX by sale the cash Priority amounts to million compared to cash cash activities flow. reflecting million investing six provided June Review operating from period. the proceeds year Net ended of was prior six months the activities period $XX.X $XX.X Voucher. the in million in for for

decrease held million, million. for Capital of investments continued million amounted cash compared to the the in The of million. in equivalents and period cash six-month equivalents prior expenditure facilities. period, for XX, cannabinoid $XXX.X we production the net $X.X and $XX.X expansion period At June the cash amounted our cash $XX.X year reflecting for resulting to

Turning to guidance.

XXXX related XX, the reflecting Epidiolex the and in in the We in range in the million, expansion. ramp $XX expenses investments continued in $XXX continued to million our range preparations million We launch launch year expenditure million R&D Europe to to portfolio. the of U.S., to anticipate capital manufacturing $XXX December of the operating mainly of up ended expect for $XX

I’ll now the turn call you. Thank Justin. back to

Justin Gover

continue Thank planned in date. you, closing, to be With In drivers look Epidiolex year. as to additional Epidiolex growth evolving to all other later investments maximize very as broaden launch new to invest protection. as with in this we excited and order with the execution, Scott. forward continue these commercial Europe measures to the indications formulations experience launching U.S. about key exclusivity and into we well parallel, In to opportunity, we

Epidiolex, Beyond development XX-year uniquely of and medicines. the continue positioned in GW that commercialization we cannabinoid believe to a leadership on is

It of appreciated across is therapeutics clear is community medical the and and world that the as not scientific patients, potential widely by cannabinoids by governments. the

additional We that of term that are positive investors. believe medicines difference committed in to result our continued bring value cannabinoid this pipeline to make meaningful long term near and a patient series novel to lives can advancing prescription and market a to for

would Thank for in call open questions. your you like now few for time I GW. your to and today And the for interest a

Operator

Instructions] Ahmad America. this we Bank question-and-answer question At of be with a is first you. will conducting from time, Thank session. Tazeen Our [Operator

Tazeen Ahmad

afternoon. questions. good Thanks for Hi, taking my

me. question one Justin, So from

for to a you be? are XXX% You’ve of providing trend another kind sense full – sales wouldn’t first ramp quarter from you’ve about I a that have another sales might you’re this on Epidiolex, of of upside, Analysts get got prevents quarter what for tied here, in XXX% the would the you to of Epidiolex what continue, quarter. help maybe for innings where you that, example, what sales in And why that now thinking Thanks. XQ upside you second reported completed thinking haven’t launch? guess how early quarter your us from guidance of realistic north of a from given potentially

Justin Gover

and comment reflects think recognize We has QX Hi, on and said that obviously, I the from a Darren from of and his beyond, start think, Thank important commercialized that we great expectations. you QX for the I you comes patients. to I clearly, been think a early that would has as year and as demand into recognize mean, experience has into when to level coming high But launch lot and in Tazeen. enter some I invitation we of of of that this assets. at awareness, great come point move time. see state normalized And more – development half happen in second to and ask this to a we really it’s the investors it that, we that remarks.

the confident we different need And make think think investors you understand inevitable sure only entering the into into But to I I remarks, about that, we’re so, that a as eight from can that tell do months that we’re launch. now the which is we’re future. phase,

point. to of at guidance, setting no expectation With guidance there’s this regard

indication, to guide. we’re a for this We’re well, even feel all be and market that with board then be still today unwise point at as ourselves. in coming getting into TSC going looking this think of TSC And would to I predicting on you it when

Tazeen Ahmad

Okay. dosing. Thanks then question that on a color. maybe for the And

keep the you but You moving those for up? doctors for that talked are dose before moved how to patients lower on dose, how higher about up most wants on are average, them lower dose still on have the getting to a been who patients long sense

Darren Cline

Darren. Hey, question. for Tazeen, Thanks it��s the

I away we we but dose, are from start still early. trying since experience eight In out, bit months, my managing little to launch see understand think doctors a prescribing efficacy. what Epidiolex, need time before more see the launch, encouraging. we And understanding are settle is, the they’re it tolerability, to it’s

product, I Dravet. it’s kind also the payer understand the the of kind LGS on and encouraging perspective They our understanding physician a from two, couple fronts. I this. One, and experience, of for lower of – patient think of think from and that benefit coverage of

pleased think it’s seeing, what with little but comment. I a early too we’re we’re to So

Tazeen Ahmad

guys. Okay. Thanks

Operator

Salveen next Goldman Our is question with Sachs. from Richter

Unidentified Analyst

of is question. very the all was similar trials. you some if taking I and the more provide question Salveen could adults question a [indiscernible] in mix for between new the Thank and I This you. that wondering and compliance color patients Thank you’re on high And is, had the talking European another on quick sort to you launches. clinical had and compares pediatric rates Hi. I expect do the Yes. progress. about – congrats on it for you that the on how

Justin Gover

Yes.

bit Regarding this it’s we what I kind too anecdotally And of the we’ll approach the to providing hear as again, But get we outcomes we’re little farther think with more dosing for early, compliance patients. little a field. from a measured away. think understand is rate, pleased good bit I again,

I – think the second pediatric we while than part mix, we adult of it’s better the anticipated.

around think we post too it’s at now. farther, I pediatric, more equivalent a away may adult get see do we Europe? Chris, you but comment launch, early on to tell right to want

Chris Tovey

you, Justin. thank Yes,

a in think we’re I see pediatric more Europe, split. to likely higher adult

in think children be I So prioritized. the in the particularly the of days launches early Europe, will

see think adult Europe. a pediatric higher I So split in we’ll

Unidentified Analyst

a Thanks it. Got lot.

Operator

question Our Kasimov JPMorgan. next from with is Cory

Cory Kasimov

Hey, question continued which I in quarterly the effect, the you in with wanted this May. call, the last good launch. for your bolus was first and on great follow-up in taking about Thanks question afternoon AED, this congrats to this guys. mean I talked

XQ. into XQ into I far mean this you’re but pretty and now So thinking continued

see? – I’m So start context of to and rate is a steady or of I expecting seeing prints full how Are not sure not here currently you this the up something we in the in be about should more to put the dynamics of I’m you terms this run thinking today. fully patient, you’re understand

Darren Cline

interest bolus this tremendous EAP out, to up the Darren. pin are it’s I look impact awareness, Justin demand, – with a that we pointed think starting such to in the high the those at more AED Cory, as commercial. see and transitioning patients launches, if Hey, OLE the and Yes, other you

those Onfi you of point. of think acquisition organic starting And see this If – you at other and through and patients identification saying we’re that and launch, starting look XQ our patient to kind at more look kind look on starts. then at I

But So starting to product, in and what pleased prescriber the interest we still uptake, the are with our I base the see thrilled that. expanding.

the pleased of you’ll start very and this growth we’re but moving start forward. with organic kind see to So

Justin Gover

I’ll Cory, add. just

launch just it little right, we I we QX. has by and think can than have point, bolus think some probably and normalize. to only once, a – you But extended definition at expected have I it longer in

Cory Kasimov

qualitative Do Right, initial TSC have have use of terms quarter that no, some commentary much data at any totally if that. half of how may potential the all? in positive you back the understand on spontaneous impacted

Justin Gover

No. I – we’re don’t aware has the at not data that least, not impacted current think, TSC we’ve the quarter.

Cory Kasimov

about on the what that question little then the U.S.? you label talk I Epidiolex opinion, there? what Okay. to just of as that versus on you Europe, characterization if over an in what a I have bit And – can. Can mean, differential therapy CHMP drove one of clobazam adjunctive kind

Volker Knappertz

Thank the Yes. Hi, you this is Volker, for Cory. question.

same think the the the As a in data, regulatory reviewed really we all correct is know one. we interactions. on essentially indication to data of there the that wish practice, and important don’t you was details to public in FDA that improved the interpretation the that want States United to it’s comment But for of the which is

said, good in we not clobazam. which uncommon have and statement, opportunity labels reference an with a that Europe. And to not application obtain are indication different believe does very that So the we TSC U.S. between the Europe

our move keeping than that be the moving will Europe. And eye there. of the year years end around labeling to TSC we us towards think have fighting I in towards opportunity also So into on that in an will

Cory Kasimov

taking sense. Okay. makes I the It questions. appreciate you

Operator

Thank you.

Stanley. next from Lebowitz Our David Morgan with is question

David Lebowitz

the much very physicians the changed you’re adults going Has I than expected my forward? that, guess coming you to way I product taking the Thank guess marketing you therapy. onto proportion higher question. of for had initially given

Justin Gover

question. interest and patients. from to But children child – patients’ I key we diseases, were think that pediatric were Dravet if the from neurologist. – for launch, thanks these neurologist focused we general are physicians treat They with both look at and these Yes, on well LGS as young adults. At adult as you as epileptologist there transition young and is

phenomenon. that experience to starting We’re

neurology doesn’t few And change toppled really into physician target other launched initiatives like it for grow that broader a then adulthood. with What our again, So quarter than to patients that we the it messaging a these in around looks expansion. diagnosis. just

around I will Epidiolex think stay of tolerability our to efficacy patients. and needs same our of organically the the benefit messages just the

David Lebowitz

on How lion’s the Hub? for – from you seems the specialty the additionally, does specialty it And a and Thank that. Epidiolex pharmacies. pharmacies the how share network, is breakdown clearly, the Engage between now coming distribution is

Justin Gover

– we up, key And to operating. needs pleased the how it since physicians community. with network launch specialty we’re and Well, expanded way distribution I set pharmacies pleased we’re it our that of with a in We’ve haven’t the yes, we meet their role. playing very the patients we’re think really

David Lebowitz

questions. my taking for Thanks

Operator

Our comes next Stifel. from with question Paul Matteis

Paul Matteis

Great. you so in what could then adults, dose and it but I pricing a on one for there’s on lower, about been congratulations patient and had IMS adds on to into the Thanks delay, on question one forward? much ask good. a we On should what the where this greater much. pricing, expectation very forward. progress. so quarter all you adds expect patient been going going question secondarily, wanted envelope adds from Is of our later, have had your the now the maybe comment looks back smaller patient – like, proportion of as map, the scripts of seeing that And look you’ve last And on EAP. you year accelerated from average the $XX,XXX quarter, commented came that a may Thanks go less like even looks commented proportion there correct? it

Justin Gover

point. new patient at allow adds, EAP think adds breakout on the I wouldn’t this I Yes, the

will is that, positive price, don’t again, outcomes, comment to understand the efficacy around movement average Pricing, patient slight dialogue on to utilization we that we feel we’re And And did honest this do we having again, price. kind good healthy as physicians. side, we a what granted, pricing, a we robust exceed we relates at But for $XX,XXX have know the dose patients spot payer it think Just favorable having able and end. and it And tolerability. is see of view the and they’re lower the upward. the they’re as in adds. the

Paul Matteis

one quick ask Okay. Thanks. question If I reimbursement. could more on

been willing you’re breakout? said more this to prior label know, what payer stage are in don’t are subset how or lenient conversations? to are either covered lenient. I think even XX% you of Can that’s and off you that lives at less if tracking your I mostly than the indication

Justin Gover

more coverage. Yes, payer of we’re you more from pleased this with escalation to a if little open. the again, will kind restrictive There’s bit

think like point. that Dravet, community to that look looks the to if at we LGS, those very, But find breaking – at out there. execution not around I this you We’re favorable what the payer to utilization very be

So very pleased with we’re it.

Paul Matteis

Congrats, Thanks again. lot. Okay. a

Operator

Our Cowen and question Nadeau with Phil from next Company. is

Phil Nadeau

for Thanks the congratulations launch. Good questions afternoon. my and on taking

sense a show IQVIA a is First accurate signs just of it for on, you have NRX is? on does question don’t like, bolus July. example, Do how follow-up It any through the look data. going of

quantitative of So trends and I’m curious IQVIA you what data. the think

Justin Gover

the for question. thanks Yes,

concerned it I at months room it’s remarks, And originally As with the a patients evolve created we’re happened of on said our launch beginning a this AED patient six to in in successful inevitable not we’ve the the we this we medicine to commercial had solid launch think we in saw and for the the category. first rate base the There’s indeed in occur of grow the valuable more influx considerable we’re what of patients and than consistent expected. in launch, highly a has clearly growth much seen immediately having us. launches. Well pattern But journey. very at brand later in successful future, very that’s with that bolus big beyond, Epidiolex other do but the launches that will new other

I if launch bolus the that think the last revenue at forever. that you can’t look

as see can’t data, demand pretty good a and non-prescriptions. picture total away get to depicts while but basis, it start on over you a that You’ll of predict month-to-month time, we farther

Phil Nadeau

Perfect. That’s helpful.

was you Second, inventory QX? during where channel there today? on stands any And do know inventory, inventory built

Scott Giacobello

Yes, on Phil. It’s Scott. don’t We channel comment inventory.

I from no would build say So any, I really don’t quarter-to-quarter. have but significant

Phil Nadeau

it. Got

Can suggested And for to In you me last it’ll sense to prepared you question persistence. is trekking remarks, your today where ahead of normalize give think be. persistence it time? Okay. do it’s where us thought some then and over where you is on was you somewhat that going of

Darren Cline

Yes.

not any that. just not We’re for too providing to a little on – metric us provide again, color any that, around early

Phil Nadeau

take Thanks for questions. Great. my

Operator

from with question Goodman Marc Leerink. next SVB is Our

Marc Goodman

us to business from in to key that more that the get all, you versus that. Sativex, the LGS are anecdotal obviously end of information, and are? might Can then points information the trials, give Dravet few, you are? nets you you of what secondly a research the trials. can is percent market other sense can the are now, us just are have first you some for on versus just give don’t gross you what a here Epidiolex. sense secondary color mentioned patients of, give talked the key And have from any that other doing those of if that purpose you’re know endpoint primary maybe us a Thanks. you smaller the that? the sense product? Can the these what study there with that I exactly Yes, us of field those And any market on there’s some of tell research, second, or FDA And you you commercializing but about

Scott Giacobello

Marc, it’s one first And question the net. thanks the on to by way. the gross for take Scott. I’ll

have we the it point. can disclosed be is, the net into this we’re What and launch expect say months to overall this point. percent a to perspective I We where not from at eight net gross at to gross

from I net we’re contracts. But, number to gross As Medicare Medicaid been we’re settling is be at this of a reiterate coverage this Darren you’re months limited and channel through that mix XX% mentioned, determination achieve point able still commercial to would a and of perspective. as have expected we’ve eight lives to a The in. where

Darren Cline

Darren. it’s Marc,

Volker, have and And research think I breakdown, something the this you we’re Regarding providing just market the it’s it. point. not at

Volker Knappertz

Yes.

for – So interest you in thank regarding this. Sativex Marc your

in that are to the studies, two mechanistic as the critical which to with They’re at be symptoms agency is but remarks, weeks in are is And of nature. at looking months, the specificity, sort of discussions are odd a setting nature, studies. of in going the we looking of prepared studies, United really precise that the three mechanistic type muscle regulatory think So and in in to with States. some smallish very we’re cardinal ensuing and initiating common regards are direct in the the our for in more I them neurological which laboratory effects we said the other hypertonia of features these

Regarding the in primary us studies MS endpoint endpoint. and positive selected we’re comfortable This something for spasticity, the our quite Phase and and to spasm as is supportive the X endpoint. symptoms features the which frequency study, with. at from trials wants We’ve three used spasticity is MS core we the cardinal have spasm looked data of FDA focus and We back of in quite primary before on. this clinical prior our this

Marc Goodman

Thanks. Yes.

Operator

and is question Esther from Company. next Our Oppenheimer with Rajavelu

Esther Rajavelu

Thank average? you my each from good come that on the XQ per questions. how Good seen on or prescriptions morning have many does vials Based taking attain equate of script afternoon. vials much quarter, QX? how have to the for you And to to in script this

Justin

Yes. Justin. This is

of not those a of goes in prescription number up. things vials Obviously, time as as that average the level giving up, granularity. We’re moves on, go

we’re not give that yet number. So at where it can has increased, we a stage you but

Esther Rajavelu

question a Got pricing differently. ask then you. I’m the little And going to

where to are patient this Someone of asked XX to but on XXX else you guidance launched? price netting annual relative per now that when had you before,

Justin Gover

question. of first your way another It’s asking

per Of the price a bottle, course, you do have only of course the product. for price there is

dose dosing lower end guiding, the the are is the range. we at So, of

to got You’ve so XX% these have adult, await drugs. you

of be I’m sort like giving So this to dynamic, giving feel enough understand but I afraid you not you we’re more to able to frankly, try detail. information we’re

Esther Rajavelu

Got you. Thank you.

Operator

from next Yatin is Our with question Guggenheim Suneja Partners.

Yatin Suneja

launch. great a on congrats guys, Hey

Just two me. questions for

light label size you And comment then have? U.S. have the I follow-up. just How big market? the relative is on in of of you could European First, to the on a that the add

Justin Gover

Chris?

Chris Tovey

Yes.

we European think to the of there’s in market U.S. the a I about – the about third is said market. quarter past, So a

largely now what I terms of our it’ll successes business. we’re of think, far European that of reimbursement. physician we’ve been analysis pricing is in got is reimbursement. that is, It’s community we positive XX in expectations impact for that opinion that has so years. aware, on Europe’s label week an see not And done to label they’ve on we’ve European I and we ago, for everybody’s And seeing this predicated impact think opinion know a much clobazam extensively from don’t important the nearly know or that, from using what the so pricing

application so very have include reference. good statement, doesn’t obtain with that limited TSC they chopping to impact. the therapies and very Europe and in opportunity optimistic a And we’re in clobazam, comfortable clobazam changing generic therefore indication of Europe, a and an It’s which their got we’ve use the any obviously

about the an label don’t much has Europe and of of third So we a a quarter impact. U.S. the to think

Yatin Suneja

Got could and going time up were it. at full at you Thanks. And data cognitive now data? look the present related on following then whether that data, that the have but just are behavioral TSC you you on think benefits some to to you I comment some to analyze more of point, able

Darren Cline

Yes.

those exploratory endpoints to are we the getting of just some So within TSC study.

focus any other patients in So seizures not had I about or per high recall, to XX keep frequency. on were If really And we that overwhelmed with have see. patients mind studies really full can on these it month. you but data, the seen designed these seizure so signal average

really now, strongly. by chosen seizures is that will really in be prepared guiding have aspects. seizure the my as the the we not the probably I effect in seizures to Rett So very that I said need for confounding and think non-seizure on focus understand to large us data remarks and And of example, so the those the you reduction

on assess non-seizure X we’re cognitive in us aspects and now we However specifically periods really to focusing designed here the Phase help behavior, treatment these. the of where aspects Rett to understand mood, next study development Rett longer will that really also

exploratory on these that to want this reporting TSC. cognitive study endpoints seizure manage But be neuro that as a by to understanding it’s function and have on just also focus programs, your in and and separately endpoint cognitive we’ll better duration, other expectations really assess really So, a we development. was

Yatin Suneja

Great. Thank you very much.

Operator

David Capital. from is Kideckel with AltaCorp question next Our

David Kideckel

thanks quarter everybody. taking on Hi. and my for Good afternoon, call. Congratulations the

here. questions of Just a couple

to. that these newly prescribe medications that the identified say with prescribing seeing or that patients. patients curious number a on organically just you’re patients physicians Firstly, and are too that Epidiolex Epidiolex you Would is I’m are altogether grown are physicians other material there or most drug currently of

Darren Cline

Yes.

I think commercial our in patients or clinical pairing four is trial co-administered experience be, three could – potential if – therapies had you with these at the they have where out or the Epidiolex. I think have look that

David Kideckel

to do not with category, the has using the Dravet. Epidiolex refractory maybe patients the Thank just guess we’re other are not reimburse comment payors for of qualitatively in associated refractory Epidiolex do necessarily conditions, My you Okay. next so willing I with see, but epilepsies. this so epilepsies you you. in called on question to or or called numbers LGS Can the

Darren Cline

Yes.

point an reflect launch, DS for to this those in need and for payor of DS don’t been Let much at the absolute me it’s have But the this and into LGS remind unmet you stated, have eight I visibility our access metrics and priority appreciation patients. of really access that patients. launch, we and and on label into diagnosis of the months as payors others. provide And a LGS promote only clear execute

rare access there and were do in decisions in that to we for wish an need. these them to payors epilepsy are recognize access patients Epidiolex may with ongoing other responsible basis as engaged patients appropriate Now help refractory to make

I treatment that to broader in and of in out early and would But access options. these need unrestricted not very you sick the by the you, payors. are population of this one new pointed see expect remind this kind And patients patient in launch,

commercial instances and to Epidiolex have AEDs. expect But to However, we patients. access do the do time already, see in comparable over both similar we some Medicaid

David Kideckel

quite both autism is and – disorders question, be as similar given be I gears entirely then to well to different or going are being bit treat they and as for this a are potentially guess in between curious I’m manifestations spectrum to manifestations CBDV disorders going just shifting of autism Rett? here helpful. to Rett final it That’s Rett. potentially spectrum used disorders targeting CBDV cannabinoid My dissimilar, you. CBDV, that actual is autism Thank just

Justin Gover

Yes.

on autism a Phase our X in days early Rett, in other still the we’re related CBDV it’s priors and lot of So Rett are in based areas. development, although

to make differences. that of ASD. I substantial So not the course, are believe, is Rett I trying case there was

other they overlapping are hand, features. the On

including on Rett potentially I there’s serve to autism and And what I learnings of we’re trial which conclusion. think symptomatic believe pivotal the think think of our RSBQ, scale it. purposes, overlap course being use the indication. lot the Rett to XX pharmacology behavioral study can I we items from for of symptomatology. And we’ll multiple is to this CBDV. consider and will And Rett But really I spectrum going disorder this the that to as a type I ASD really generally we think broadly where mix in use and understanding of match between come

David Kideckel

it for very Thanks me. great. Okay, That’s much.

Operator

Brill with Jaffray. next Danielle is from Our question Piper

Danielle Brill

me. few for Thanks A quarter. the question for and on congrats guys. the Hi,

to dispensing So gross this past still refills said, I missed missing pharmacies. quarter? know the And average I’m you And I per but that’s the What do patient data know accurate. curious number you it. the of per if net? in seven just I was then top asked, know was had the IMS

Darren Cline

not stated, think small had what I total. does of data it’s IMS you remains So capture, still a sample size

on not at refill color Second question, refill metric persistency any or again, of – we’re or level providing point. this

Scott Giacobello

Scott. Yes. it’s And then Danielle,

the we we would at is point to gross think net to this should On we’re where disclosed in that say net, the the gross launch. we haven’t percent. be we right What

of able through achieve of Medicaid limited this lives, at point that and which and been number a We we’ve to have contracts. coverage determination XX% have commercial Medicare a

still is think to should perspective. where right need but channel So a to gross out, we overall we be be from where we’re mix net we settling or

Darren Cline

much. Okay. Got it. Thanks so

Operator

management the We turn the the for session. I’d question-and-answer to of now reached have end call remarks. over closing

Justin Gover

forward to This all look and is you your QX And time. you QX thank year. on and reporting progress results this later Justin, just updating for Great. we

attention today. So for your thank much you very

Operator

Thank you. today’s conference. This concludes

for lines at thank and your time You this participation. may disconnect your you

GW Pharmaceuticals (GWPRF) 6 Aug 192019 Q2 Earnings call transcript