GWPH - Earnings call transcript Q2 2020

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Operator

Greetings and welcome to the GW Pharmaceuticals Second Quarter 2020 Financial Results Call. [Operator Instructions].As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Stephen Schultz, Vice President, Investor Relations. Thank you, sir.

begin. may You

Stephen Schultz

Today, you, Commercial chance for press Tovey, of Chief I'm you joining Darren Operating at for Schultz, We GW's Justin Medical Welcome Executive issued Chief Giacobello, second Scott and Financial and while our quarter today Officer; we GW. Relations Officer; Investor our President Officer. U.S. Again, Chief joined ago our tomorrow. XXXX us Chris expect our by our Vice you've hope to Gover, Chief a short all Cline, of thank a I'm to Officer; results Steve had Officer; release Form Dr. Volker review Chief and Knappertz, call. XX-Q file

today’s the as A based an discussions contains in with begin, the GW and we and U.S. include of Before forward-looking company’s risks can environment filing be it associated and we uncertainties and that on Commission. currently such see Exchange does and description Securities uncertainties. risks with let me list everyone the in as statements investment found remind

call Executive of the call an now to the GW GW's Relations section. will the today's be I'll turn posted archive over Gover, Justin website Officer. Finally, in Chief to Investor

Justin Gover

those to they months, to medicines. ensure who safe. the to a smoothly May, have all to to in pandemic that operations COVID continued continued work-from-home the Thank in our to call these In medicines the and responded somewhat joined time all I adopting to to COVID-XX, manufacturing protocols you come continued the team, of operate receive one those you, access extraordinary under all the had need. most of everyday few grateful quarter early I which our welcome remain At our policy strict company Steve. and us work of to have And to that staff operate manufacturing patients by last patient with our healthy remain times have the who today. In GW exception ensure safety hope for the that

both field Our engagement commercial clinicians and via with been U.S. prescribing able the maintain teams Epidiolex. Europe active remote in to channels have

our QX, pandemic in Overall, using net adapted virtual how quarter-on-quarter extremely we marketing even proud delivered material QX rapidly remote and educational in for in well to with environment pivoted the reaching tailored Epidiolex have sales of I’m of challenges face U.S. the the in During unprecedented this organization million. engagement. U.S. revenue growth of the sales $XXX the

is need of growth a to of Epidiolex with the to serious importance organization commitment seizures, treatment and meeting a testimony I real the and their to think families. our patients in unmet this in these patients resistant

early of were week, associated treatment this for tuberous Epidiolex TSC. to of new milestone the delighted that target beyond. complex Within year we the through near to will expect be expansion of we our review not, to if us of the strong Epidiolex the in At to on we and momentum novel as announce term. of June, will seizures be we the our the of webinar, offer approval what have to a the that in which to and or product. This have designed the as I we Epidiolex for this sclerosis approved including multiple we commercialization a of launch believe cannabinoid and clinical coming webcast U.S. several accelerated next believe We of first the population. medium support the homepage. the available half the pathways this as indication view the hope year, website move commercial in second over investor long provides potential nabiximols as an the medicines from next very the commercial program of We month and significant strategy NDA summary, nabiximols, end to hosted on platform emerge had was market archive by the Epidiolex, short, FDA patient representing is commercial GW In announce years. doubling a that opportunity the details development for last you a believe that is with submission, significant the an chance very

update, and hear this our results. will review from update respectively. and provide Darren You an U.S. on will Chris European financial commercial R&D will and then Volker call Scott

Let to U.S. Darren for update. me now over call the hand commercial

Darren Cline

the to despite million impact continuing the on with the Thank the pandemic, a to own continues We're so you, this U.S. to Dravet million launch, in humble for remain compared professionals QX healthcare through I which syndrome. QX have challenges $XXX our with second to growth Justin. in in of The US of team their also quarter, net lives. last while managing showed COVID. sales that since the the on support $XXX Lennox-Gastaut effectively, of In thank by the commercial we result, and impact million year the patients Epidiolex want of half year. pleased $XX and achieved Epidiolex from personal very

to will in plans to We in are increase of opportunity Epidiolex can with continued pleased patients launch speak average enable on dose. The the during Epidiolex demonstrated a commercial TSC I with Epidiolex about expand TSC. TSC be and of the a attributes the modest in impact persistency strong label, sustained our inclusion which have the very and new us moment. will the quarter. that

at stages also ensuring With a Epidiolex as are prescriptions a during of rate seamlessly specialty network safely While rate to new an the pandemic, role of average a patients quarter. strong throughout decreasing played network resulting XX access played in we healthy a role ensuring the QX, by delivery new pre-COVID. to as refills ensuring pharmacy to fill report received I'm specialty in than below starts a and about pharmacy focus key prescription and heightened during able patients, our patient the time at patient albeit products lower possible, continued in concerned on important were our to days initially our The were pleased performance. a acquisition impact early on that

During second visits. to clinic by To telemedicine significant we the in we the virtual also our a quarter, and patient during the meet to needs, customer and promotional providers, reduction institution model shift witnessed transition a quarter.

engage engage While transition to to our this sales ability are impacted willing of our with XX% customers, customers our team. virtually our approximately

available formats, are tools sales art teams to our field virtual of master of digital and our continue in customer engagement. the All

may neurologists we start providers, a channel. have our Epidiolex YouTube as To providing to virtually hcp.com recently our of remote ensure recently the help To we engagement Epidiolex have As as support engaging customers indicated, high. a access can into patients get of for be some self-service launched of patient, with enhanced well, who the we face-to-face information is willingness healthcare result, the quality hands website, visits. easily

Our remaining vast a on live The country. engagements virtual. the at setting. and Field fluid And Sales the HCPs overall interactions Team pandemic care very the of very began highly remains in variable, situation basis limited parts dependent time different on majority to June. this of customer region remains Access impacts as

the progress during U.S. wanted you We changing segment to continue the landscape our year. in long will update into navigate of care I remainder on this to the term also the

driving during especially focused has made and on by the quarter team been COVID-XX, has hit While hard a with effort this progress education. engagement segment the

to can continue identifying centered with it's work that finder We the and education around from the appropriate on therapy. largest Epidiolex patients benefit

are pleased far. We with thus our progress

Epidiolex at majority de-scheduling we of recent some the has to federal the the remaining efforts COVID. be to a of as The nearly half states our the now product. rescheduling by continue states the the recognizing conversion Epidiolex, XXXX. been states converted impaired of anticipate end by progress we non-control of level, with Following state But of U.S.

Now indication TSC. turning to newest our in

States, noteworthy a in individuals reminder, which two Market an highlight the there whom a their and suffer approximately TSC treating medical in research seizures patients thirds there from dissatisfaction therapies. to is United would nearly unmet XX,XXX like indicate need current with I two items refractory. XX% and of and are As label. physicians with are with the

patients This all first update the an only two to the Epidiolex limit, down years from down indicated and age The year older of is indications. age safety in of one now lower which the one. is profile is TSC for age Epidiolex for our newer, of to range. the approved specifically seizures or directly product to age age speaks syndrome, Dravet with associated of

per The for day recommended kilogram of LG range milligram which per now kilogram differs XX second to TSC pertains includes label milligrams XX to dosing. patients, Dravet. and from maintenance per XX the per for a The day dose

critical success factors for focused TSC be two will launch. We on the

refractory for choice in the in Epidiolex. first TSC a to reduction reduction spectrum We treatment XX% Epidiolex with a with seizure The seizure of of range the TSC. seizures on the first a be specific prescribers TSC establish patients associated and will seizure in efficacy types wide class demonstrates broad believe and of AED with as effect

medicines. Additionally, Epidiolex important the of anti-seizure novel mechanism remains other to from action distinguish

clinics of treatment will is across focused States. initiative algorithm. TSC United use the uptake drive we on One to The the XX in swift second increase and Epidiolex the specific be earlier is executing

clinical personal peer-to-peer well clinical ancillary their leaders These virtual trials. these of review investigators be specific centers the data webinar respected will field targeted across Three in TSC opinion a our implementing are as the key experience salesforce. at specifically and their subsequently the We directors country. approximately via program XXX own and staff reviews will at followed data

identification. will focusing TSC of other been TSC patient indication. drive with reviews team TSC augment The these preparing initiatives for and programs, data to sales the field We launch speaker has also a on virtual additional

expansion method would prefer. with exciting we customers execute label are launch interactions customers, prefer this launch using to to prepared we whichever live this While our our with

Now the U.S. turning in to payers the

reminder, plans. the payers. count for with TSC, team Medicaid of presentations As coverage our commercial XX% conducted largest payer and currently Epidiolex enjoys the Medicare across In clinical commercial approval has a preparation

approval. to of We reimbursement payers expect the commercial TSC at PBMs health the indication age large lower anticipate P&T number plans and to range immediately remainder add next their of add a TSC commercial post We and review.

continues XX XX the payer to policies. will barriers, XX in into of TSC Florida, Medicaid channels California, states, will state within adding Epidiolex all the be immediately TSC so objective. intervention be management utilization that can including their programs team's payer Removing Certain anticipate and access their patients also without policies days. across include We Illinois,

While their across New these pick second of the now of widening by end the to authorization expect see the updates QX, Michigan, Epidiolex lives XXXX. examples, more up of were pace Medicaid, we like To efforts than some starting some anticipate Hampshire's COVID recent wins to half We occur the gaining unrestricted year. X from before Tennessee, million additional prior access. removed two and adding these and access affected are in in provide

the we our accordance educational the product building significant roles patients and coverage helping team The gain payer to will been policy. interact These to reimbursement patients the for and of important by an specific in prescribing made. in uncover area During support new made with progress be HCP reimbursement quarter, and will August. manager in deployed the HCP will We decision been staff after in play believe role with reimbursement this access team. offices field Epidiolex provide filled their needs, has have

challenges and TSC an the month, you Epidiolex treatment Our supporting focus forward commercial In will look launching will patients our and despite I during very focused demand. the initiatives option conclusion, and progress. to families. COVID, patients these look indication generating patients. later advance new that continue quarter, remains for offer the on of and to continue this force team the their proud sales new updating identifying to We our on to that important believe I'm forward Epidiolex

turn the over Chris? provide update Now Europe, in on progress our Chris call I'll to manufacturing. an in to

Christopher Tovey

Thanks, Darren.

we've First the in Epidiolex on currently In further against our progress five looking focused is major quarter, launch plans. good which Europe, made at predominantly markets. our launch second

submission currently engaged in January. price well we're European reimbursement conclude status in later experience same basis of a in in SMR in year, pricing pricing end year. and GBA this conclude where ATU also the As program sponsored to countries, XXXX, securing this, patients Denmark and its in the physicians we're enjoying year. authorities, NHS are secured from or England enjoys year. the of reimbursement focus successes, of pricing launch early two NICE, in which the represents previously, putting pricing Epidiolex grow, on engaged us clear pricing number the phase. these reimbursement. Commission was our a success per value pricing start. I reimbursement of the considered In with authorities reimbursement U.K. progressing Along from temporary principle to which central this endorsement in shape clinical Epidiolex we're rating. reimbursement to innovation early recognition Epidiolex in with major later mg awarded exhibitions for which the currently reimbursement of National with negotiations the regulatory granting hospital sales are for on Central the markets. solid stated following and with Transparency In introduced day and within ex-U.S. negotiations, and with kg enrolling million We're negotiation to wave of second the and secure authorities, received expect and negotiations Epidiolex. we conclude with We're be now Italy, benefit review. GBA of funding continues anticipated evaluation importance XXXX XX by $XX also is agency Germany, conditions medicine ensures this Sweden, In the Epidiolex Epidiolex the good in in is wanted quarters France, In later under Further, per the net patients, dossier We're which an position parallel expected the was to orphan in still early a our Epidiolex In towards funding. French early rating the European which progressing in that favorable the the pricing to the following clinical Epidiolex considerable, access status we've in and with whilst the our first of process, good positive of

QX had case. the lower to be stated sales expected QX As a as we COVID, the at indeed time of marginally our was we which of results, QX result ex-U.S. than

show recently prescriber research Germany, to conducted U.K. intent launch strong Epidiolex countries, Looking commercial to use. market the increase ahead, and in continues

to we new do However, and treatments by very be expect during month, we be QX, although muted normal to impacted prescribing expect customary be beginning to and more Europe. impacted to holiday sales the epilepsy and in European practices, by to continue initiations COVID is growth in clinics which Consequently, anticipate return we patient limited QX.

customer-facing medical and working through staff the in home Our majority European commercial are digital largely engagement customer still is from channels.

to monitor engagement adapt However, where appropriate, we we have changing face-to-face limited to and recently the field restarted and environment. continue

update falls supply an which under provide my on me and let oversight. Finally, global manufacturing chain,

continues operate of its facility levels deliver at production to schedules. efficiency, and manufacturing planned Our highest against

investment production We also continue a to our benefit from limited reliance on other manufacturing consequence years. organizations in significant processes, recent facilities our own our in over of

on-going As a to continuity, supply chain and through with restrictions. significant build to products. European deliver these months result, maintain recent we've our U.S. been coded supply though stocks able and resilience patient even continues And of even ensure to

Volker addition, robust, call manufacturing to In to capacity be are the And his for plans track let our term me to longer expect on what long expansion demand. Thank you. we term hand service update.

Volker Knappertz

day good And Chris. you, Thank everyone.

with age from or diagnosis. to these all This because forms infancy, the of approval of to heard associated indication, one now treat early are indications. Along patients are complex. of epilepsies enabling with Epidiolex onset Darren, we pleased approved for in new for tuberous includes of range these treat physicians time often is age three Epidiolex older at important you've Justin with year very the childhood and this now diagnosed syndromztic sclerosis patients the seizures As

accelerated regulatory recent development Looking for Epidiolex. strategy our webinar, and beyond discussed we At investor nabiximols. our U.S.

tone meetings All submit three multiple and the European with supplement to agreement data We've for We XXXX. one these -- the to NDA in pivotal nabiximols. us soon the will positive positive commence path data study. from the bridge to for be we've different regarding one half gained had the last the Over the existing and in this months, first from FDA results to thus collaborative an of we XX any believe sufficient the either as as be NDA. or our with we spasm endpoint. of pieces enabling primary At by to be year muscle trial spasticity NDA of muscle or of more one detailed the NDA first other anticipated five trials from of MS XXXX, are half the anticipated submitted to program either as have which the are the data trials, webinar, of with place, two that

XXXX. course The next first such be and should of of opportunity XXXX mid be there data trials the year. over intervals will remainder readouts the from And four regular at remaining the

Our confidence broader our several patient discussions for population, common injury conditions. spasticity therefore provide manifestation over program lead ability is expansion a neurological to with may spinal to that gain And The may time. FDAs view cord to not spasticity believe allow broad in specificity also which for that the indication. FDA only spasticity to to is study is label nabiximols but we a this a

We injury to have and have Phase commence we additional cohort in CBD Stress Traumatic the With of indication selected intravenous specificity, formulation. using first with cord X/X Disorder Neonatal nabiximols our spinal recently an Post three respect XXXX. the newborns first development expect study the Hypoxic-Ischemic target planned Encephalopathy, a half program for beyond other studies, or programs, we as completed of of to NHIE and

studies of in but in syndrome, interruption Dravet study the study the are still studies. recruitment This are tried Epidiolex will in study other We activity September. several start autism experiencing resumed. see phase in For X to Schizophrenia, that phase starting we parts the again and phase trials, includes several collaboration Xb X believe

study, XXXX. and the hand studies nabiximols controlled now in all to of placebo phase study. X phase me frequency are XX the MS you spasm spasticity and to placebo nabiximols let are commence financial the X XXX start first half trials controlled patient call on track the tone fourth the remaining the Scott of We three provide review. studies to quarter. Giacobello to Thank These The in Scott? also expect two patient muscle the MS

Scott Giacobello

million $XXX.X Thanks results on good to million quarter the is relate will I'll gross prior to deductions $X.X be compared quarter, level Epidiolex six the over sales prior million in and quarter quarter. of from revenue the Cost for due Volker, net a XXXX. financial QX. amounted $XX the for QX the mix million $XX.X quarter Total months of product of of primarily sales and a global or tomorrow. $XX.X filed unfavorable or allowances to quarter compared was consistent improvement in provided Medicaid provide year and to discussion the Gross A June prior XX, to due million, XX-Q net sales X% start in the SEC net with $X.X from afternoon for sales in seasonal ended year high QX, mainly comments the million year, net by product to prior Epidiolex. to of Epidiolex increase in substantial as quarter. I'll net in offset be largely revenue. This increased with the the to results for now year impact sales million to $XXX.X X% sales period. the for with in our to Total higher detailed compared was were

program, expense million and year expenses related as as research nabiximols from Moving $XX.X represents the and programs. of pipeline Epidiolex readiness well was of to in with line increase quarter, previous quarter the the of prior advancing program our and the an development $XX.X development ongoing reflects other million. clinical the R&D to This spend,

in in recorded U.S. to priority primarily quarter the of is quarter. voucher were same to in loss included and compared has of XXXX. all Epidiolex of and quarter to the results net income. review a XXXX sale our to This million, resulted which expenses general $XXX.X Selling, in million year increase related for the from of our the in SG&A. costs to net operations due $XX.X the net of million QX in income the increased $XX.X other build-out commercial $X.X from the Europe. period million launch the proceeds Turning of in non-operating prior in million $XX.X administrative This The

Capital of cash operating used $XX.X compared Moving period. to XX six to amounted in million period $XX.X cash the the included proceeds used cannabinoid and million. net was for cash expenditure to our the continued The $XX.X six investing from the period, for expansion Cash $XX.X reflecting the cash for resulting decrease the cash production period And million $XXX.X Net prior was facilities. the the million. the year investing of the which in period, ended flow to month million cash equivalents Net prior month $XX.X for million cash was investments sale provided of in year the the for ended to with million, and quarter $XX.X priority month prior in in compared six six for activities voucher. compared the $XX.X net year activities for period. we months of period equivalents June million by activities review

which guidance, continues expenditure the to our the remainder the extent full year will COVID-XX uncertain. of for be Turning the to to pandemic impact

the However, Justin. are guidance, the million and for to lowering now expect and call million. and now the modestly expenses million SG&A range of I you. in to hand And in million to $XX of back R&D expenditure range will capital our $XX $XXX Thank XXXX $XXX we

Justin Gover

In TSC indication, U.S. of and hand, the quarter, strongest the performance growth our in GW’s are of Scott. XX-year In we second Epidiolex growth are with U.S. is this in solid you, revenue through Thank which beyond. particular, closing, the the XXXX now approval during business pleased a launch history. the should with continued seeing very we provide for quarter. poised of the team Epidiolex And in commercial new for tailwind our important

about progress access. are are about see the we and label this of payers in starting to impact very expanded widening U.S. We the excited with

of in the real quarter, further continue XX We brand. the exclusivity in the the in last patents these of orange providing XX of we now patents position to In the patents the this added to durability confidence a three total listed, book, XXXX, also expire solidifying Epidiolex. progress make further bringing

a formulation formulation We of new recent addition three patents patent to the important Epidiolex. directed One an the the the portfolio. of is is of of think patent non-U.S. oral feature this first

We continue and patent file to prosecute related applications to expect to further grow.

under patent corresponding granted continue the complex the position to growing under and and patents addition this progress portfolios we In review, exclusivity patent We and composition is application. appreciated. to believe

Epidiolex, soon Beyond NBA year. an now program line our on nabiximol multiple new as offers horizon as We a have path investors. an for next goal exciting clear to perhaps with new shots

believe pipeline GW this is the coming time United complex States as providing future. meeting broadly, none. to that in additional across broadly and the continues questions. Thank also important that your products multiple the forward our to And a in We believe nabiximol today, leadership in that you patient in botanical is stage medicine leadership believe our would I well indications to the now for into like earliest I and has investors the intend look time offers More future a maintaining on you second open indication this extended the to potential developing growth composition of exclusivity for progress. the driver we to cannabinoid needs another on few it that now numerous in ideal medicines to for due call evolve. become updating to for strongly emerge We of medicine. product used years,

Operator

America. question [Operator Bank from first with of Instructions].Your Tazeen comes line of a Ahmad

Tazeen Ahmad

my taking questions. for Thanks guys. afternoon Good

Just a few.

thoughts the wanted of your some just get itself dynamics. I and on quarter to the Justin,

it Medicaid I ` on about believe, tick-up And that you XQ on first My there have ads? new statements question? up was Is a You you expect added follow what percent the was what split And Can he that you I after also you us patients in talk about like possible patient this for might to prepared sequentially far continue? quarter. that. what [ph] do talk about to to that was? Can an grouping so XQ? talk did the looking then by new tell increase were from

Justin Gover

ones few, to few go. goodness a few Hi, me -- Tazeen a

I'll gross -- Scott dynamic to the me and let net Let mix. talk to

patient I to think more I those broadly, into on continuing as we the QX. adds think, new QX, continue did -- are said, we in trends see

assuming there, in continues, growth see to So world very QX. out fluid assuming, trends in those but it's you'll a continue

the physicians are world, -- is navigating percentages think point? in which is the think engagement elaborate I’m would on Scott, so, of remote a there's with we norm unusual the to where patient in and you and And mix where like to I genuinely is we give high. norm. the and It Medicaid not remains world going telemedicine just that dynamics we're a been quarter-on-quarter you But, situation well, detailing your on numbers.

Scott Giacobello

Hi, Justin. Thanks, sure. Yes, Tazeen.

Just the comment context that on overall.

the consistent, I think it's And may continue little the but it mix the we not in a up anything overall And Medicaid up. mix, trying to in that moving the just very of we worried the dynamics, what that back did perspective U.S. that actually. we side. not given what the there in that's you to we there's quarter. half QX, that was And pretty normally gross what see it's like, expect seasonal to all from allowances about; -- tick to be net really And modest we a is we movement. were a tick all-in-all; see a some to tick there slight little surprising. QX. see really year economic actually would on from bit the enough better a versus were up communicate, it's payer And calendar QX be your saw of And in QX, in was happened to given an environment

don't I think So anything to be concerned about.

Tazeen Ahmad

this the in were seeing and in your in compare prepared to did so continued growth little remarks of you cadence U.S. growth? in movement you talk say are the a a modest that you seeing you about Can Okay, quarter. Maybe bit Medicaid, that had those what you it for XQ?

Justin Gover

his I in continued pre-COVID think, as level I today remarks albeit in mean or time a mean, new seen essentially patient in QX. we've in general, Darren said at starts that QX? at the QX May, through and April, we is You put that dynamic in continuing lower -- than that, that we

product come we the so, therapy. very important seek be to we think continue through new see we're and quarter the And, can on later this the And of will patients is I into And roll I go QX. dynamic think absolutely obviously new indication. an as latter moment part we launch as of And month. TSC it important out this it a course, to to about for that to

Tazeen Ahmad

Right.

comments how was Okay, about worked potentially. July just some looking for qualitative

Justin Gover

said, what seeing I were as But with we I in Okay. consistent June. July think of looking is kind

Tazeen Ahmad

Okay. Thank you.

Operator

next the Cory Kasimov line Our question from with of is JPMorgan.

Cory Kasimov

good Thanks question. guys. my Hey, afternoon, taking for

Now use year indicates this of I a or older, market label incrementally the potential and target term Epidiolex change of have the can one And like it in potentially means terms product? trajectory what the either follow longer you talk could in how and that patients the up. broadly your

Justin Gover

Darren, the you Hey hand for thank Cory, one that I can to question. you?

Darren Cline

Yes, Hi, an Cory. important component for Yes. question. label the it's the Thanks of expansion.

are not As their lives, Dravet many TSC our in birth. by if in particular, and their early very Volker patients said, of with diagnosed

component of now earlier And And continue the think label, the of in age. down think we're I to both syndromes to so, just they'll and of it within understand, directly an TSC year seizures is one I of out, associated I one this with go educate as option I an at Dravet look as speaks Epidiolex to And as to therapy. clinicians they'll patients. think and with pointed profile around and this we important look, the the safety only

to exciting early think broadly and think I diagnosis of it's now will more think So, as they continue these about patients. physicians

Cory Kasimov

anticipating patients changed And kind Darren COVID launch the online? you can has you a of effect coming then thinking this initial previously TSC but you If envision Okay. this on has? And maybe bullish of how phase, talk how front? about not indication you're in mentioned, your potentially it

Darren Cline

Yes, I XX launch I patients we've, the was backlog thought I -- months and of kind the think I've was list folks to referenced right. think prior patient of think, that the way of ago,

patients, and list evaluating within armamentarium. their this I it's that about is their Epidiolex at but the and in Dravet, looking be used at LGS within For physicians about less it's where now TSC fact can their than practice one think actually but different now

that's our of what think and some look think adboards it I and how customers through we research of market So, at it.

as think initiatives clearly to talked it down. regarding this important the goes TSC unprecedented for in But it’s don't we've as an I engagements have those about physicians about constantly. very expansion maybe now feel this little a is watching of want label hear clinics. know, will times my we're important fluid physicians got we expansion. you question, bit and I visits an have stated, it's we've aimed your this kind want about. in important customer Patient person. and and physicians And staff been is it's as country spoke COVID this, down to as been Regarding TS remarks, at label And that very treatment some And And really prepared label that clinic's patients. within specific we expansion know these key backwards,

Cory Kasimov

taking for questions. Thanks great. the Okay,

Darren Cline

Thanks, Cory.

Operator

Richter from with Salveen is Sachs. Your Goldman next question

Salveen Richter

questions. my taking for Thanks afternoon. Good

engaging up. comment that expansion, have And your you're how follow label? TSP on label if under help just would LGS as Dravet in falls So comfort the on this regarding any? and a could focal And you restrictions the then, market I seizure overall existing discussions current pair this the

Darren Cline

Yes. Thanks.

Justin, assuming take… want to I'm me you

Justin Gover

go Yes. ahead. Yes,

Darren Cline

with over into engaging intersecting the policy, mean, general with Thanks, pointed refractory with epilepsies last is as not just of expansion what on think Epidiolex and only we're as LGS we've payers been Salveen. just natural Yes, the evolution several I've we other the now label. TSC and I out, the months

again, continue so, discussions go to And well. those very

commercial now within and P&T days depending XX they'll reviews which they're definitely forward. to on at plans manage as be it within evaluating indications policy and going some our whole how Epidiolex XX, available some TCSC and relates I over the it time the there to three same be will the next that moving think the XX entire are as

the again context surprising, very in it's that to XX. the even the efficacy, dose up of efficacy. the the profile, So, received, label They that's it in safety dose not of now, and well understand shows the

and fourth both third with Medicaid lives. to progress the those we the continued I continue momentum commercial and think look So to quarter forward and across

Salveen Richter

the the the I greater term wave on the half? care then long were targeting? you and of elaborate second might impact outreach how prescribers and provider can And then Great. your cohort, just XXXX, think segment, you than next further that to

Darren Cline

between us. continued in and and focus force the at for back visit, move patient kind time definitely replace the move it's looking we're of again, communication physicians. stepping mean, of this I And to sales think, never I unprecedented kind and our this the the in-person Yes, telemedicine, to promotions, in-person virtual can

they're community, neurologist the not only are a we'll now not but and manage the give does of think high centers, treated their also our but also their at I the focus with I so, they throughout XX second the TSC TSC on expansion prescribers the do by because, -- patients moving And continue to by portion disease. the seizure and only the TSC TSC, tier. And U.S., us treated patients within label think, the forward,

of safety within So, it's and us for Epidiolex, and to point nice practice. can another impact communicate entry broad efficacy it patients their the how

Justin Gover

again, and continue And pharmacists these long large feel group And particularly some focus regarding hit that's good buying and a that are around pleased care their segment, with of groups been our been January very with in progress to hit we've education we term setting that's hard, progress field team been hard. actually focusing homes, at in particularly the and the really made. since we're again, And about Epidiolex clinical dedicated it's the been there. now particularly very on the but

Salveen Richter

Thank you.

Justin Gover

You’re welcome.

Operator

line from with of Goodman, SVB Your next the Marc Leerink. question comes

Marc Goodman

Hi.

just the why virtually you are you virtually the You talked about XX% to to customers said are in engage – willing know which of XX% it like engage. quite I means the about not What that? few talk yet. about pediatrics problems? how this is maybe you Can willing I for are was all think you give talked normally well for as quite versus you and is not flavor call, adult like conference to so last a set just is related up Can the were getting centers epilepsy telemedicine, us there working do? Thanks. a

Justin Gover

thank Marc, Darren? you. Hey

Darren Cline

increase. Yes, time customer we just transition to some four regarding And gotten plus fill months Yes, engage. virtually thanks, -- that those willing, it's communicate think seen with about has now that expansion the past. question. I everybody's ability the and think centers numbers epilepsy month-by-month, there's of to forward, And large just label some have the think we we in engage. year. and of moving I just willing around have that of the updates that do descheduling based not The increase with TSC TSC will now, for that will label much And base mix, better question customers. our of we expansion, a our -- I feel kind think have engage. be XX some majority feel on we that to number that ability waves the I customers throughout alluded unchanged. regarding And greater that it’s that, to our a we've previously. we tactics I particularly say, on at the point with regarding the the your XX, It largely to will as that sits Marc important

Marc Goodman

Thanks.

Operator

along from question with Paul Your comes of Stifel. next Matteis

Paul Matteis

patient much wondering for if I on taking my you could Hey, retention. really thank it. you appreciate questions. I so was comment

math, where model how quarters retention patient lot patient down dynamic net And inform to XQ? did [ph] XXXX you in this ads XQ of that relevant XQ, for of And starts, patient had kind would XXXX is you again, forward? both had and by go went ads a of per Thanks sort then average going of this which up helpful for the in script be our similar base I think the net patient and that to talked should lot. I script off to said and said about were we think new a I separately, but patient was you quarter, cover. this backing think say those around into You XQ

Justin Gover

Hey you Paul, we're that can Darren, of sure go? not get for granularity level I'm a numbers. the actual this But to going give

Darren Cline

you previously. Yes, healthy then, the of during about did I, then the that, the And so have said Justin, towards at the we, we QX, to of year that seen build starts some we COVID and quarter not then momentum end of kind of know, we I so, the we've the seasonality, level first while and started overcame think hit.

patient's think time fundamentals up the of ensure business really about I brand. for the quarter down dropping that a their our specialty got stepped persistency, during the that solid and therapy the pharmacy and the again are fill. of even the So, and strength ability on you the The and again remains ability the of network to time, to spoke that

remain for think you say future look an strong the I in with the half again, the And that we to proud giving speaks in being really second so result and just persistency time. a beyond. kind But that I it the of fundamentals during we're We're is business I, I'll the So, remains and now the TSC think to a year, pretty strong, patient to forward remainder us new year. tailwind and the for of QX continue, the this of in put nice up know, there. us ads, of unprecedented of

Operator

Needham. Serge question of Belanger line the next Your with comes from

Serge Belanger

afternoon. taking my for Good Thanks questions.

of to to Dravet First talked one patient you’ve population. past, about being XX%. the Lennox-Gastaut the related syndrome penetration in in close is Like

what at that that And if is Just to moved forward? number all? XX% wondering market increasing outlook going penetration your is

Justin Gover

Thanks, it’s Darren, again. you Serge.

Darren Cline

are, but in of person this XX% to there's COVID with Yes, brand. thanks forward. grow still for but Yes, we're opportunity, the listen, said, I the moving we Epidiolex, think still the mean, has in question, is with attributes so be Dravet it I although even with a we faced now plenty think visits blockbuster Serge. are key the with think we'll I do that about how to return, environment. below that we we've LGS We said, feel again we syndrome, opportunity all And continue to brand. need higher,

focus payers once a on intervention Epidiolex by our and those, where no prescription. there's payer increasing writes the with physician think I a the that policies, anything

we think now I fundamentals again, strong the provided are expansion TSC think moving label and forward. for with the business what

Serge Belanger

happen won't in likely should And growth look third given a or or payer then the terms the for off something few the in growth determinations we we quarter here, for expect the TSC coverage half for TSP that should really driven Okay. on as sequential as towards we payer second of that to months, take soon fourth quarter? expect

Justin Gover

Serge, Justin that maybe it’s here. Yes, I'll I think think

Darren know and to actually covering be be there's the expect within Medicaid with has some straight we to states Actually, days within think XX away. said commercial that that it's commercial we'll think for they reasonable coverage both in and place. TSC remain plans I Medicaid I environment, major

coverage QX. you’re timing And in last -- we of sort recognize I are terms does think through of of launching this indication, point And the coverage. so, favorable. course of to midway the looks And we're well question think of your very set I be

but So, what TSC whilst first we full still I some think quarter of important progress we're be remainder see to excited can fourth TSC the with to quarter, inevitably, TSC, we're through of expect QX. do with the will see

Serge Belanger

you. Thank

Operator

question next Your from comes David with Kideckel Capital ATB Markets.

David Kideckel

couple taking of questions Thanks questions. for evening. the on A good my quarter. congrats Hi, and

patient LGS COVID. expectations new Dravet were starts First, that good. due to they They Darren think while and I you necessarily both mentioned meet your and understandably the didn't for

on you type is also provide that? that of a this meet your by, given in benefit guess for was can the engine, in another maybe increase Epidiolex, I efficiency of for color magnitude point Europe, patients, tap So given bringing descheduling what the mean, U.S. just but expectations etcetera. bit access my in to that of the and not I question use rescheduling did of part

each So be I'm just points wondering out, how at Thanks. slightly do or the kind both differently? I should these cancel do of other it of looking

Justin Gover

David. But Yes, Bear want Darren, comment I that. I has more to didn't further? Darren, actually, you met you correct just I mean, expectations. will in it mind. -- take expectations. don’t We meet think

Darren Cline

I yes, and David exactly. no, Yes,

reduction pandemic reopening shutting visits by vast patients, of I in much think the epilepsy you to that, in-person shelter of would knowing kind essentially quarter. have We wanted the the actually saw not capacity. during a of impact we and at centers, knowing what reduced down place --

I I on we knew the in kind I quarter. what if what of am think to very able with commercial the team the at starting, actually based was quarter pleased look deliver

in that And facilities the are good we how care to I'm We've which regulations. the that's so, state just get based term being I long your within to on around there always highlighted think for our it's network, Using things prescriptions longer lens key in And it. regarding [Indiscernible] So, able right the prescriptions. brand. second question de-scheduling. dose looking to at

second And the going be so, we're de-scheduling, really of optimistic about very year and to half beyond. the a but it's

As I half stated in my prepared remarks, have just about states descheduled. U.S. the

end remainder the We year. of by expect the the

latter when benefits a unfold that as you absolute positive. to start of it's able So for something view update be complete. physicians, and I again, it over we will the half that for to the we'll it’s It's good year it's patients, good we'll outlined. see those And, and

David Kideckel

Epidiolex Got know obviously, price I price, well, weight it. average average but and know currently as Dravet be Thank the you. the And is for will of for based mark, just a TSC that in U.S? that similar LGS TSC. I it’s price X the for [ph] around for follow XX up

Justin Gover

Darren.

Darren Cline

Thanks question, Yes, for average and price Dravet X. for the Yes. LGS is XX the around David.

milligrams the XX really to seen too per how do it's early to up think is It of dosing. in noted, to per day. we've the dose as I kilogram be physicians while U.S. see maintenance TSC, impact the remains

dosing are we'll couple how of it. of, have out, think And are, so of idea I quarters can a of you an have better idea a physicians

was and of dosing Epidiolex how year Just to starting dose. particularly with a and remind familiarity you the dose, approved ago. a There's and around half lot physicians that escalate it, a there

is dose provide additional dosing physicians good obviously so does think XX product. the with that on it because data I And of is, having

it'll the next will of think out quarters, play couple dose I what be. price over So and impact of the

David Kideckel

Thanks much. Understood. very

Operator

question the Your next from Neena of Bitritto-Garg comes with line CITI.

Neena Bitritto-Garg

thanks Hey, my taking for guys, question.

And TSC think we uptick a that sounds then of starts. Dravet you of of a time, period July, of longer and to I starts you question quarter kind LGS an the kind impact kind you do just new the will we see of again, new to of launch? it around you of a if flat. So mean, normalized come the level back for like kind take did pace of your counting does in the commentary on Or of kind get patients [Indiscernible] I know, guess, into in kind telemedicine prior of on kind the to end then to second for not period a and that to over stick back have if it can off Thanks. back telemedicine remained start has go of have office? I expect from guess

Justin Gover

give Maybe break. Darren it’s I'll Justin here. just a this to Neena, take

know, I -- sort the of think flowing perspective from in you of what QX. it's and the ebbing pandemic given a

remarks. noted you our think, I from

well. solid about not I real. become we've feels the the we see sort coming trends change board, dynamic cautious trends for already dynamic. because may, navigated didn't be TSC but feel we within think life very just we quarter. quarter, I of pretty that that field. with they of With Darren's the swings they And, We quarter well may through with the have overall, been it's, changing does throughout. of, attributing COVID like been as the dramatic challenges all it within on But think think mentioned, I know as, this telemedicine, it have part living

all in of reasons we pretty as compelling world. get be level there new used COVID a is indication for reason, shift particular, this the in dynamic a increases And going to as launches. I living So think Epidiolex this that think there's interaction in to to

kind whilst So, about through, into the coming I uncertainties got sort of how think fluid, we've QX. with pretty of and feel we're it's QX I good the of -- think

Neena Bitritto-Garg

you. thank Okay,

Operator

comes from question with Suneja Yatin next Your Partners. Guggenheim

Yatin Suneja

for you taking Thank my you. question. Thank

QX ones. couple me, a real expect for Just mention did quick be muted. you In you EU to

use down were is, in are about of already So other -- some more are expecting think maybe the if talk uptake? the let's the Dravet quarter, in average can to that could there dose, now TSC. the suggesting on be Gastaut, you seeing you there us some is the use couple indications any You're And where off first a you last and final question remind I quarter our a checks label than you second on is question And say, crack? versus not EU front. it dose that's

you if provide visibility maybe So of can level much. so you use if have what that Thank on you any front?

Justin Gover

have you comment want on quick Chris, to Europe? Yatin. Hi, a

Christopher Tovey

thanks Yes, the Yatin. for question

be going in complicated quarter. But month. I we're be not Europe think, no, holiday it's down a by expecting little a the to to

July COVID-XX. during I of to prescribing months. So QX. August the to although everyone now no, that spread tend It's is not Combine be pattern think holiday that see I Europe and starting near big positions, treatment think, return for sort normal normal pretty we're anywhere aware a it's with across of more and

in Now, be that adapter I of get I have the research the already the don't and the feedback think satisfaction markets physicians we for do expect Epidiolex Thanks. in launch in from the we by and market particularly intend remain all those Germany, to we an excited think around we and prescribed prescribe to U.K,

Justin Gover

talk [Indiscernible]. And side Darren to you new want south our to

Darren Cline

or specificity we other don't regarding don't it's have that pinpoint, hard vast we this we from the the opportunity we know, a TSC, We with us are tremendous used very But appeal from TSC of our that for no fam you it have And, data. in pinpoint level of getting of anecdotally to that into use epilepsies. to peer it's so that think hear Yes, again, not utilization, peer an it's similar those and to our it's there's we context obviously and we options have them use, we much hilarity payers particularly the hear obviously does do getting feel patients. majority [ph] that but there's in moving hard forward. get paid. because for really it's these refractory and of And used other a it's of whether and know discussions

Yatin Suneja

Okay. Thank you.

Operator

Dou next Your H.C. Tsao is with from question Wainwright.

Unidentified Analyst

jumping hope Hi, Chris question. all for taking Allison [ph] calls I've for on day. asked. been I Doug. Thanks it been my hasn't

on to to that? Do GWP clear schizophrenia. So going I a a you the plans? negative symptoms? or for symptoms You have give treat more the XXXX. little to are trial try you Are I know you any us positive guys know about expecting in all want

Justin Gover

Hey Volker.

Volker Knappertz

the Yes, XXXXX you for schizophrenia. interest thank for for in well, me

and characterize looking So this of best probe endpoints we're for it. a compound is this breadth a at study to study really

this both of on the be suggested symptoms. on may you at is that this of and The side. if initial we'll But by positive affected both negative symptom take So this study published. piloted predominantly the those efficacy be results, domains domains a at looking both And positive look these pharmacology.

Unidentified Analyst

Thank you. Awesome.

Operator

Laura question next Cowen. from Your with is Christianson

Laura Christianson

taking Hi, thanks my for question.

know trends past I right to less QX. actually Just quarter-over-quarter a from pretty in one. the be capture. [Indiscernible] the reliable quick the indicative than seem theoretically now low are But in

So I'm that see also wondering that if the going fluke? just as of forward expect Or you to you if be kind case? a

Justin Gover

Hello, extreme think continue it’s They're we not express I services. data around Justin caution here? Yes, the reliable. to data,

Laura Christianson

Got helpful. Thanks. it. That's

Operator

for At remarks. turn back it to closing over this like to time, I would management

Justin Gover

an Right. I run hour. Well, through think we've

So for everyone your today. thank you attention

results excited let later to launch year. reporting QX how this TSC and know, you know You goes

So goodbye thanks your for attention today. now. for And

Operator

This you. conference. concludes today's Thank

you if speakers disconnect, now may You the line. hold

GW Pharmaceuticals (GWPRF) 6 Aug 202020 Q2 Earnings call transcript