NVCR - Earnings call transcript Q4 2018

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Operator

Good day, ladies and gentlemen, and welcome to the NovoCure 2018 Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to hand the call over to Ms.

Ashley Cordova, Senior Vice President of Finance and Investor Relations.

begin. may You

Ashley Cordova

our year and NovoCure's everyone, I for us Chief Bill joining joined Wilco our Good and Groenhuysen; quarter thank and review our Doyle; Chairman, Executive fourth by Officer performance. Asaf full to Danziger; today CFO, and morning, Science our you CEO, year am XXXX on located for Development, by clicking www.novocure.com, the & Research slides fourth of on Relations website, and Kirson. The our results presented page. the our link XXXX today Events section Head Eilon can in quarter full be financial viewed Investor on

which I like except required and could statements number of in forward-looking start, statements, to we time in materially beyond intend you Before to include any this uncertainties, involve described a results including actual projected update We would not our These time differ uncertainties that during and our statements. discussions those do and will as risks of from remind publicly call are by conference statement, some those law. to these risks from our filings. SEC control, forward-looking

XX, our are press remarks our Following call this morning. both open will turn for to December I the in now we the available three of the prepared over and will were release ended months Doyle. and questions. released earlier for our twelve line today, in which Financials XX-K, XXXX, With that, Bill

Bill Doyle

productive was with particularly XXXX Thank two everyone. year NovoCure. you, priorities. We Ashley, good and the clear a for entered year morning

defined EF-XX Tumor to with densities our by data tangible program. first our in business STELLAR pipeline. mesothelioma, We and $XX development China. the III continue We our and Highlights in signing with quarter, for growth fourth Lab Specific and net research treatment posted XX%, Optune quarter who on efficacy therapy. dose outcomes. survival. XXth our best year density presented to we the GBM pivotal business patients clinical to in our and trial improvement to more towards adoption With our patient demonstrating survival for October to independent of our clinical included PANOVA active second, this post-hoc Zai invested energy time system A In of Optune Tumor analysis of energy delivered. survival. on the patient showed trial, can as times Treating in survival since highest our and therapy In are in EF-XX geared Fields time increased analysis tumor on published presentation EF-XX higher was Neuro-Oncology predicted ASTRO in advance Optune of globally to of growth December, levels the million our to that initial million presenting in increase agreement that the GBM development. the predicted now dose progress our Optune collaboration our of $XX bring at revenue the pleural growing engineering globally and in malignant the Phase X Fields Journal data. our commercial grow extend consecutive enrolling in increased pancreatic annual than efforts the received the drive GBM of revenues First, more post-hoc Treating nearly and separate finished The be of cancer bed the recorded knowledge, at time of GBM at

an from Moving indication mesothelioma torso. XXXX. malignant currently malignant in for on are the our outside approval from and pleural for first mesothelioma We pleural in hope to approval the receive application brain. FDA would approval in We've our mesothelioma response. comments FDA Approval the be preparing received the for

III trials pivotal pivotal are a and non-small preparing ovarian to lung cancer and pancreatic additional Phase brain Phase open cancer. cell three metastases, III have fourth We in trial cancer in

in trial in pilot II Zai Phase a trial China. recruiting gastric to pilot and a liver are cancer in II Lab cancer Phase with working also initiate are We

a research Research, high-growth Tumor Cancer Treating with basic Treating at do on EANO on to future brands on Tumor Fields support at and company there Novocure research Tumor opportunities fourth ASTRO, Treating research treatment. effort of modality Treating more will potential Tumor members meeting perform American quarter, on innovative and representing continue oncology in XX also December, SNO. Fields, inaugural AACR, Fields joint Tumor Treating of We XX XX In Fields. XXXX in In the on as we GBM growth Fields were presentations presentations on annual with presentations remaining Tumor four the indications. in to at Fields Tumor at a Fields the scientific fourth the is than community. and a promote cancer its include Association special AACR Treating in titled Treating a session significant announced

strong. able to with ended sheet And and Optune is XXXX with cash, have largely and flow been the We trials clinical investments our technology GBM Our fund in balance in short-term investments. from cash $XXX improvements cash million equivalents business.

to GBM within iceberg grow With outcomes quarter. tip the provides color While for an represents for revenue, patient company. opportunity a the share bit more that, on now Asaf, I'll commercial it will over important the the improve alone call who Novocure hand and execution to the of

Asaf Danziger

with the Optune for in newly with grow number the total in Bill. patients GBM diagnosed XX% to year-end. you, In XXXX. quarter-over-quarter. newly for almost GBM total Year-over-year X,XXX grew prescriptions The were continue on patients patients quarter. at grew novel diagnosed of fourth U.S., There the X% prescriptions prescriptions Thank

our improvement the in Germany in notably revenues in by the confidence the community quarter-over-quarter, We individual In of and net grew newly about in XX% driven In benefits more claims XXX setting, grow contracts total to excited hospitals EMEA, in the revenues. was almost the diagnosed continue first the XX% therapy particularly Optune on approval XXXX XXXX, million and provide individual Asian sales Austria. and this In Optune claims of and full to key of XXX Optune grew Japan. of to than GBM signed prescriptions in for in further $X.X and XX%. market. adoption activity increasing We among year approval than oncologists. delivered reimbursement adoption increasing our with opportunity rate rate commercial to increasing focus now prescriptions We clinical quarter-over-quarter, by we Germany, remain filled physician marketing belief patients. more efforts net in is adoption

GBM Looking forward, is our we significant further in believe across for geographies. opportunity there growth business

can adoption now over turn review driving Our are physician to Wilco call believe to well to that, on direct-to-patient and are currently who education, on continue from Optune the financial outreach. I'll results. there teams focus permitted than patients our With research clinical benefit therapy. more many We through

Wilco Groenhuysen

fourth year to quarter you, for position. on Thank a Asaf, this ended the were was by us margin. more profit patients. and revenue a in everyone revenues thank $XX.X Net $XX.X XX% million revenues quarter Full [indiscernible] quarter-over-quarter. X% We financial $XXX increase growth than growing grown million. strong morning. Gross gross in reflecting joining an XX% million, driven active and Sequential were you in call the year-over-year the was

expenses million development statement, in $XX income research we and with the down to increase the in quarter. R&D continue in investments Moving

future anticipated the GBM to patients flow across our clinical investments funded R&D R&D work quarters. increased in in three enroll business. Notably, to we increase from we expenses programs, we III with will continue As Phase cash

$X marketing expenses were fourth million in expenses in quarter $XX.X increased increases include compensation. to adoption, force support including non-cash million Our our share-based globally. SG&A expenses sales SG&A Optune

loss development. Our was investments Net contributing business fourth in quarter loss or by and share. to income operating XXXX generated research was with million, quarter operating for million $X.X $XX.X the per GBM $X.XX the

believe with PP&E. cash ended in with as operations $XX.X cash, from related million $XX.X of flow our in Treating $XXX.X execute NovoCure, approaching financial to fourth million quarter we Fields. survival we by net late runway cash At extend of in cash million, developing aggressive quarter. the investments investments, most and revenues into of stage net that growth Tumor an annual call activities pipeline With and the I'll forms positive continued questions. working principally value. cash used fourth short-term that third $X.X have With we both the provides positioned open deliver for equivalents in we strong shareholder Operator? of to $XXX million and our balance with million indications stability a in have long-term are and flexibility near-term We sheet, and cancer some four strategies. quarter well investment core commercializing the the significant extended to versus move we We increase believe XXXX, an NovoCure We

Operator

Our Instructions] question the of of Evercore [Operator first line Thank Vijay from ISI. comes you. Kumar

Your is open. line

Vijay Kumar

my guys. question. for Hey, Thanks taking

I Bill, high-level, you just start the optimism was around guys, XXXX a of opportunity. lot the fantastic for at a maybe, to pipeline So year want

expecting, script right? growth It like How I be revenue volume volatile. has some gotten What on thinking been is that you that, we be we I've volumes? mentioned think of guidance. script few I metric little should that number preparation think a questions XX%. and maybe should of seems revenue And

should color we script So maybe on any be thinking the volumes? about how in

Bill Doyle

do we straight where we a progress Thanks a don't anything can't I've to of and made in the the incident That – participate weeks But, small has Hi, have I'll what add. GBM it's for to said in that notwithstanding by opportunity draw significant a GBM so indication business grow in we take Number which because relatively more the there. we and the to the by line. and mean order called… in U.S.A. that start believe we other two, investors, that markets if I'll participate. divide couple and noting then year. we not you It is Vijay. guide, markets and and make in – much the to in have small as I've XX that in you of as we always very relatively many comments incidents see Asaf know, the I fact, said,

Asaf Danziger

world [Indiscernible] some other he right the technical on the now. of problem, side is

the think Basically, continue. that I'll in diagnosed, grow that patients therapy. we in a lot as is So efforts can and putting newly from enough adoption. we still usual of to benefit are we And continue

continue with every in put to all, very more on we're all So patients and we therapy happy quarter, that.

Vijay Kumar

one follow-up. maybe just then And

Was you on half? heard just versus mentioned approval first from the the whether FDA. Bill is this half cycle? you. the second this second Thank think time curious I'm mesothelioma, I review you've line

Eilon Kirson

will is Vijay, that I take one. Eilon. this

expected to receive approved in currently comments planning based results you approval answer remind extension standard of Treating this we that Fields our first do soon. standard FDA, response first median on So compared the is FDA Tumor are all, patients ongoing with submitting is from and We the control. XXXX alone, which we months, in I'll okay. with showing presented in fact XX.X is with productive at discussions have Again, to to are IASLC that FDA. okay. compared – did we overall to submission a discussions We're together we question and will get historical treated okay, and on in with soon. we in survival be median significant review months the we And XX.X XXXX, the of survival productive directly, expect the cycle, saw continuing chemotherapy, I'll chemotherapy very this submitting

Vijay Kumar

if Got I gross you, margins. one apologies more, can have on

think number off. And what comments any hop Q-on-Q, GM maybe I around the line? I'll moved that moved

Wilco Groenhuysen

one-time patients, margin opening so we increasing. it Yeah, think gross improvement affected is a Fourth to a expect of improve more margin the our can from future. gross to that in this fourth which and Thanks we related further Wilco. it improving Vijay, number with to charge over been impact – by is and volume our European the was one-time expect EU quarter quarters, improving in the for a has question. Overall, serve of quarter efficiently Operating the we was the our Center trend affected continue

Vijay Kumar

guys. thanks Okay,

Operator

you. Thank

question is the Yang Mizuho Our Securities. of from next line of Difei

is open. Your line

Difei Yang

Hey, good taking morning and my question. thanks for

a couple, the a rate would year Germany us So what ago? remind reimbursement just in was you

Wilco Groenhuysen

Good morning.

considerable XX% coming about As a think, And mid-XXs it's it's we from, I – is improvement. about said, now, XX% in XXXX. which

Difei Yang

How then Okay. question around second for commercialization is And Sweden? we think uptick Sweden. should the in about the

Asaf Danziger

your question. It's you Asaf. for Thank

in that The we right GBM Sweden. there are and doing basically different reimbursement the right region. thing, implement infrastructure our signed in process in many to the therapy. to Sweden is that over patients by And different national So benefit in we Sweden and areas a of the have from now we are reimbursement we feel treat really we Sweden, going building we're that our know patients

Difei Yang

it a be thinking find Japan should more trying in growth year? less reference or standpoint, Or resembles we revenue slower, Sweden point? about faster, in From be the last will to

Asaf Danziger

the very in difficult national put the reimbursement, pleased Japan. that It’s say. starting certainly of on think, to margins perspective. we're to and it's is we've put to predict to the We to very whether to hope opportunities about in more know. working opportunity put Swedish the the trajectory going difficult more seen We're It's as German – but very overall, activities identical have patients as We're hard with now therapy. XX% on market so, patients therapy. our you We

Difei Yang

Then the to you. my thank evolving final Okay, is cancer landscape. regards therapy question with

know we are of agents PD-X standard thinking or with to in you trials how take the about So IO change And to care. some started inhibitors? potentially combo with checkpoint – of the TTFields running

Eilon Kirson

Thank question. you This for that is Eilon.

time, inhibitors cancer cell steps seeing of with and work checkpoint it patients checkpoint actually already shift really types immuno-oncology, a with of immuno-oncology, I Treating receive Tumor various of all, standard-of-care first tumors. Fields. lung inhibitors oncology, to exciting non-small LUNAR with think, the together together So to taken our, in in trial a allows we're is We've very in in in emergence

we're yet The in checkpoint not standard-of-care. are on other inhibitors working indications

be such synergy we where it's we Fields And various we'll know our additive If emerging least the to latest with not ourselves, we Treating used keep taxanes the there trials, so real with Tumor and and into we we that effectively speed the take future checkpoint that had effect when we a is chemotherapies. inhibitors. planned always And care. definitely this therapies, have at classic of immune plan And standard but consideration pre-clinically with together there of can types up therapies. latest know also together is with know as

able and of together of trials gives that all of care. continue to lot plan a standard so our and with up-to-date the in be confidence most we're And this to ourselves going to us perform combination latest

Difei Yang

you questions Okay, and my a thank taking great congratulations for for XXXX.

Asaf Danziger

Thank you.

Wilco Groenhuysen

Thank you.

Operator

you. Thank

of of the question next JPMorgan. Kasimov Our from Cory comes line

open. Your line is

Cory Kasimov

appreciate you’re guys. the Thanks. Good I questions. morning, taking

be you're thinking at I'm the of outcomes of about to points Medicare the what potential curious key So first all, week's you expect next focus meeting? How CAC there?

Bill Doyle

Bill. This everyone is Cory. Hi, me? hear Can

Cory Kasimov

I hear you. can

Ashley Cordova

hear can We you, Bill.

Bill Doyle

I of am Hong the Kong Society calling from Neuro-Oncology.

side the of So world. as other subset the a

reconsideration request all, So reconsideration October coverage request now XXXX. first calls Medicare what we midst or reconsideration June just CMS local of The XXXX. we're accepted to decision of process. the the DME process have to in the everyone in We remind our that for – LCD MACs in our submitted

to plan novel all they they're new said Although a for process they that that follow implementing DME.

process, if Cory, this probably So would than, and true. because tried we know it's a less new were we than

been As have present you will the reconsideration. our the said, week we for published. next NovoCure and CAC will our on And that meet opportunity to Xth. The the data agenda has rationale know

our, additional at public, and as of survival don't Optune's them poses time, also the the because minutes within session hour hour community. and And you the a and will opportunity prepared also review question we of in to the Medicare this is for our do is decision all summary MACs. end. have manual an CAC members discussion, details. an the know to open we this process is there policy have that rest that and have the XX and minute fair know, final in and will key is point the data. then stated review state the the Committee XX that a panel questions with in where They this At an present general the data will best-in-category team. acceptance ask I'll we our We Advisory have CAC Q&A know physician that will We're to

Tumor work with generated on was to the to continued on all educate them Fields. Treating that based be We Medicare, data continue new

the know. – presentations other Cory, year. and noted in the number But back tremendous that, we As than were what in there script, we're last that's half of of we've publications

Cory Kasimov

your interim, Okay, think. see these the that early was a first that’s helpful. year. wondering positive about data follow-up is at them futility I'm efficacy? interim is III Or around do into these next And analysis? looks then likelihood I And power my how stopping at for If that is EF-XX of passing recall question the have will more interim? trials built I you stopped you start Phase this reasonable correctly, for trials much

Eilon Kirson

Sure, hard overall almost us of is analysis early very analyses. with long-term trial, said, first going the certain This But and if the interim JAMA in all patients I point, control Eilon. progression-free allowed survival what to happy predict at was – to at EF-XX that. all, Cory. highly also be so We'd at survival that have these was which outcome, being you’re over a what's on the Thanks, had say enrolled full which stopped interim will the we the be in due To XXXX. it's already right. the the take successful to to extent, luckily, happen will we advantage of group. that happen cannot trials. a analysis in really but would published future data, that

We’re alpha interim not between detail. trial. These specific right event-driven sure each that this the very final and we P-value there, now it's or are in split we discussing the be exact the will in I'm and split as the disposing the analysis. much to get calculations

Cory Kasimov

will event non-small have rates, Okay, release it cancer on is current right? the the first lung and cell based that interim

Eilon Kirson

it like. what looks that’s Yes,

Cory Kasimov

luck week. thank guys. next Good Okay, you

Operator

of Thank Our next you. [Operator Biegelsen question line of from Fargo. Larry Instructions] comes Wells the

Your line is open.

Larry Biegelsen

at. quick taking percent for a Hey, gave revenue "guidance" the for Thanks. think, questions. what bit of year. at I start just ones A me. XX guys. XX, in for of the you start, year, billing, Thanks to a us couple it GAAP of gross Wilco, the the Good morning. last came little as That's

would the a LUNAR, And to second the STELLAR one half idea any Cory's on and any analysis or follow-up. on Eilon, XXXX? that? the just first I had of – follow on up that color half interim question be XXXX, For then, And

Asaf Danziger

Yes, thanks, Larry.

net. we in. the to up me that on come Let did at take gross with expected question the in We to levels come

think that’s a as still well. I good for handle XXXX

the next substantial step be potentially impact material course, a percentage. on Medicare. Medicare outcome of have Of would would The that

Eilon Kirson

I the this second is will take Eilon. Okay, question, Larry.

again, we So, are these – analysis. event-driven interim

it depend both And doing the will treatment patients controlled patients. the and how on so, patients are really trial,

in. so predict where to And come this exactly press could it's hard XXXX in really

Larry Biegelsen

on you reimbursement for Any Thanks approval. the Okay, out on mesothelioma and for the these thank get add you can you. today taking And just once are color funds that There then do available questions. might lastly, there. patients. play how

Asaf Danziger

have Larry, we don’t additional color.

now Our focus right is approval. on

expecting also We're this are but We – we that color year. approval don't have this any and reimbursement on time. for preparing launch, at the additional

Larry Biegelsen

right questions. guys. the All for Thanks taking

Operator

this at no to questions. the closing And time, back for am remarks. you. to further Thank Mr. Doyle I would the showing conference over like I turn Bill

Bill Doyle

So, feel to support in to globally really clinical sides priorities, thanks your mentioned are We the really had growing XXXX. core interest outstanding continued we Wilco that his And and pipeline. and into all everyone jump two our continue GBM NovoCure. our from of positioned well exceptionally execution in remarks, we business for advancing as an XXXX

a day. So and thanks great again have

Operator

and the thank you gentlemen, today’s Ladies conclude for your This does in conference. program. participation

Everyone You great day. a may now disconnect. have

NovoCure Limited (NVCR) 28 Feb 192018 Q4 Earnings call transcript