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Second Sight Medical Products (EYES)

Participants
Lisa Wilson IR
Robert Greenberg Chairman
Will McGuire President & CEO
Tom Miller CFO
Dan Weston Pinnacle
Amit Dayal H. C. Wainwright & Co.
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Second Sight Fourth Quarter 2017 Results Conference Call.

Now during today's conference, all telephone participants will start in a listen-only mode, but later we'll conduct a question-and-answer session. [Operator Instructions]. And a quick reminder, today's conference is being recorded, it's Wednesday, March 07, 2018. All right. to Wilson, pleasure Relations. my now introduce Investor Lisa It's Please go ahead.

Lisa Wilson

Lisa At Good David. Executive XXXX financial to and is are for a the Dr. afternoon the today's Second Chief Chairman of for me Chief you, Sight. Tom Officer. close issued XX detailing secondsight.com. earnings Financial the Investor With release can and Second Sight's XX, This press market, three Robert year the be welcome release December accessed and call the of website full Directors; XXXX. and Thank results Second section press Will of Officer; the on at President company ended Relations and fourth through call. of Greenberg, Miller, months Relations Wilson, Board Sight quarter Investor The McGuire,

can from access call You there. webcast this the also of

get materially available guarantees Before and statements of Sight's press or future the Reform performance. today's performance, would including by not that to on those on as results of remind Second in to management from Sight's made differ be today projected statements. company's expectation, we forecast, and release statements based are noted in statements Securities forward-looking Private Such These involve are statements belief, the that defined information Act. uncertainties, and the started, any afternoon's risks Second those this SEC forward-looking may filings. forward-looking forward-looking events considered Actual and I a may regarding future projection, call everyone conference as future like Litigation express intent anticipation,

by call A statements or this available obligation after will telephone for completion two except disclaims replay any as update to Second weeks. the next intent these the Sight call shortly of be of forward-looking law. required specifically

today's the in archived available one be for website, information webcast dial-in company's month The press on release. will the secondsight.com. find You'll

and was topics to webcast, XX, recorded Sight or have benefit related of listening to replay then, the Second call be the this the XXXX. For Since discussed. may held archived may on announcements those who made March

recent filings. and Chairman, over SEC please the Greenberg. with to most I'll company's So, the reference that, press call Second Sight's Dr. turn releases Robert And

Robert Greenberg

strategy this XXXX Second for world significant new Thank in you, our We joining with we new momentum Sight patients Argus we call our which as and and the II and with Europe of U.S. you the centers We've result of efforts and begun thank a excellence markets steps all our in around our important the implemented to an XXXX took year. afternoon. for year direct while into Asia. reach Lisa our patients funnel in implanted validating XX strengthen the was of growing expanded position last

we achieved continuing Importantly, in XXXX. into momentum see XXXX the we

of advance also our expansion capitalize is R&D clinical Sight efforts. research on our markets to we as well-positioned and Second addressable

was Houston able successfully a few an the also UCLA tested. is four additional spots with or in no patient events. every in feasibility doing phosphenes, patients Medicine adverse year. on this with this continue an plan of College electrode study serious light to the We nearly This at Baylor the of and subject well UCLA. and first This at to a for Just short weeks advancing our important Orion ago, Orion. company The cortical in activated implanted prosthesis human we patient achievement milestone and is visual significant with see in

include of who market, usable our real treatable sighted to Our no to suffer better otherwise RP vision. efforts the also expansion extend individuals from

Current requesting finish humanitarian out a in look expansion and focus the efforts by vision XXXX this provided that another we the to enrolling time. and patients opportunities validation to U.S. we extend advancing the the on our currently trial not opted in FDA regard patients. but our significant now Tom? for better performance updating at With anticipate Second ready the forward device study fourth AMD our intend the research and in RP we Next exciting vision commercial midyear to U.S. a Instead, And the justify full-year to does you a to better Manchester, generation and Orion. it undergoing supplement externals the year to Sight us would looks to having and verification and turn by In submission a launch be by regulatory RP additional allow over call or with like are to label I'd continued review Tom clinical financial results. U.K. progress. year-end. our on R&D and exemption to not quarter treat that, expand submitted to we've

Tom Miller

Bob. you, Thank

increased For quarter fourth sales the in net to of the fourth number by million $XXX,XXX to of driven XXXX, quarter mainly $X.X of compared higher XXXX, implants. the

higher sales doubled million implants For $X average implant. higher per compared driven to in a the $X year, million net a number of more than revenue to by and XXXX,

of fourth units, during Our year record increased quarter to seven XXXX the XX implant prior to volume a compared the quarter. during

XX For higher. to revenue reflecting The in in the selling XX $XX,XXX had was compared per XXXX. XXXX, implants American North implants, where the prices of higher benefit are implant of and year, CMS $XXX,XXX in we pricing mix to higher average generally the compared XXXX

in performed implants Asia. the North the During East were XX and America Europe, in XX and Middle quarter,

in a million including performed the were compared to grant to XX gross compared previously the was to of included gross a remaining implants unabsorbed of partially in quarter $XXX,XXX the $X.X XXXX. million fourth costs. of overhead costs. inventory expense inventory gross $XXX,XXX $X.X for North $X.X the and in and unabsorbed generated slow-moving million fourth a the due quarter, a Gross $XXX,XXX was XX overhead fourth quarter of in in XXXX of in was quarter $X.X the North $X.X that an charge fourth for quarter during of the the to reverse $X.X full loss grant year, million to included compared of for America the prior Grant The outside offset slow-moving profit of the of markets gross compared utilized loss the revenue in a million for in due We quarter with profit XXXX a reserve profit charge of million quarter was in of $XXX,XXX for the XXXX for XXXX. fourth R&D to by credit loss quarter. For $X.X a quarter fourth fully XXXX. established million approximately XXXX America. reserve of $X.X XXXX the Gross first year revenue of the to end million year

$XX,XXX the fourth quarter decreased quarter XXXX, of in versus R&D revenue, spending grant or current in mainly this XXXX fourth Excluding consultants cost by the to quarter. outside lower of supplies due the and about X% on

reflects $X.X outside in clinical as vision $X.X to and during of to Argus $X.X staff Germany. million XXXX of decrease consultants quarter $XXX,XXX million better regulatory a we were in For increased the in on II and year, The in of prepare the at to our million compared new grant revenue costs for patient quarter. products. for investment R&D the year spending result higher compared as clinical trials the and increase prior testing Clinical the costs year fourth Orion

to compared and XXXX. $X up general $X.X regulatory the clinical $X.X XXXX, million were costs million million. were administrative Selling, compared and to of costs in during increasing For fourth the $X.X from X% XXXX year, million to quarter

$X.X XXXX to year. million legal a $X.XX to was XXXX. a loss current loss increased For $X.XX million increase expanded share of the $XX.X related well costs $XX.X commercial $XX.X million or million This million year, X% or the was XXXX $X.XX XXXX SG&A the share. to loss higher $XX.X by to quarter Net net of II share per compensation Argus in $X.XX in reflects loss per and The as XXXX. compares in per our loss loss to a compared in efforts the of per in for million share fourth XXXX. loss as or compared a net of a loss or net of of $XX.X a of

our share the fourth XXXX. quarter loss non-GAAP non-GAAP $X.XX XXXX. including per-share the found end to loss net a loss per in $X.XX net of of year at net tables quarter loss of our loss earnings net the of non-GAAP reconciliation $X.XX Full full be the in was Our to per a was to compared non-GAAP a fourth non-GAAP of loss for A share net per $X.XX share can compared reconciliation our net in GAAP release.

also shelf as to balance million are note, December call the on Form money statement quarter on Financing debt. another Arrangement million prices, Moving that cash review filed like yearend, XXXX, ATM. to Will? This turn registration. recent as we the we original million means to of I'd business as The with $X.X sheet, that our qualifies that, of $XX.X limitation Aftermarket no that stock over results. XX, includes had the registration our ATM. balance $X as we've that our raised full-size fourth we subject longer Will part part now of of year-end the in market to the on filing. million based With I'd Since $X.X SX noted we to a annual no funds raised or in

Will McGuire

us Thank for all you you, joining thank today. and Tom

our with XXXX. with excited I XXXX Before stating first activation to our of successful the in begin discuss I'd progress Orion, about human patient pleased that the our in I'm like by and opportunities

we to achieve XXXX If you set will in primary objectives. recall, three out

North the of to and America Oakland Centers Steve our or for was demonstrate team commercial Excellence objective first with COE model. Our traction

America. completed As QX surgeries Tom North stated, during Argus in XX we

our January the no flow it the or More confident at qualified the XXX at per more of North America set more this new and an patients, key database XX XXXX. patients that North of of XX clinician-qualified American the four awaiting am Argus performing of our of By Excellence. patient as year, of excellence. in strategy end now over a centers have of The has database level or XXXX. way this we I development understand meet ensure that in different performing and up as of definition of goal establish to to XX is Center Argus importantly, in to believe we had we the patients what committed comparison, center centers Today from our part support are quarter XXXX. year clinician in takes the implants U.S. half each one and we quarter American to commercial begin we North of COE scheduling, of third sites a XX second

team for as commercial The we refine well With said, potential patients the the the complex database America with XX QX believe of different Iranian of team our the through evidence The variability in and three the patient also ultimately of securing market majority the Frank quite in in the various the business I'd the and a a options that North grow continue importance Asia eight American and adding up and quarter treatment the like receive expanded Middle We with January. as efforts new Singapore market. Argus in our in QX first As considered for the of XXXX. Argus am complement North fantastic that patients the with is overall on the and more business as during as team surgeries. that center implants will be or Europe than Europe, future. will such XX strategy we a outreach reimbursement could QX I in the treated much in markets. the in East Frank database confident of to in II many implant identified markets Orion opened the were Vandeputte

of vision. data. Our who expand multiple patients vision Argus are the efforts the for to goal, of externals, underway new There otherwise achieve ability have demonstrate II of second market clinical treat to advanced the objective programs this calculation and no addressable our the usable development the real better stimulation including development was to and supporting

verification essentially As past the validation generation is developing calls, externals, we which and currently discussed VPU. next eyewear Engineering testing. are and work camera undergoing and include complete in is system the

our will the are important regular regulatory the providing for half programs. midyear future, XXXX. submissions that These processing launch a as stimulation they new support to enabling to expect of upgrades platform power the a serve as and complete externals of in anticipated software with well implementation advanced We as second

their XX we the half and by of second specifically externals, are somewhat in various is and testing varied by software. Results During limited patient the programs stimulation XXXX, of hardware generation performance patients. current completed

stimulation a submission U.S. This platform. recently add and submitted vision takes to U.S. Humanitarian better Our NextGen HDE goal the this testing gathered to continue Exemption year to the population in data and the be aforementioned patient Device will the on program Pursuant an outside newer, a broader we expansion U.S. patients. request in expanded more to algorithms include supplement to label the a externals label our on the some FDA. of patient capable

We the expect XXXX. a second response from the of FDA quarter in

better We best issues in for at patients screening has path trial we're several sites this the sites hampered vision also began RP at forward. of been a Germany. by the of startup several study evaluating clinical personnel The and

As human subject activated first our in with Bob earlier mentioned, we and quarter. implanted this Orion

and recall, may was the and You of goal that the third breakthrough XXXX. a Sight this This for truly ambitious for a team tremendous our is most achievement Second blind.

which results no is light electrodes. during serious phosphenes, to UCLA. patient reported Orion reported XXXX adverse almost electrodes first all XX, was patient individually is of with The first have testing encouraging implanted the been well The patient at XX phase The with stimulated. Our there on events. spots seeing the were or January of up doing and phased

Over to exceeded artificial my in have the appropriate system testing we point the via utilizing expectations. multiple The a to next Orion or certainly of vision will eyewear continue results stimulation patterns. few from the as the create met quarters, early video advance electrodes input of real-time

with in plan We've Medical running Baylor for the to a over all timelines. remain Our indicating in our subjects I'm first is total Center include in for is Houston. that subjects calls interest. additional track UCLA XXX trial we'll strong recruiting ads been five internal both subjects is the generated of as during and The able week markets. to on the Orion be study. recruit radio-ads five confident

evaluation. it disclosed, faster. to breakthrough meeting XXXX, first potentially FDA our review officially to technology for quarter of fourth plan making eligible as commercialize and previously We device As designated priority the the allowing during Orion the was discussions with be is our the us a pivotal by at request FDA, assembled to-date to a post agree the goal a testament regulatory to over development to The and of Sight. multiple soon and the on teams data Second market plan through will feasibility course from R&D deep progress clinical

well experts past to we the breakthrough Orion strongest continue the stimulation assembled execution vision further team year, advancing and look Over in We we as as of even the brain forward become artificial from field in this as technology. have updates expertise to added providing stronger. to project relative

relating a I'd to on with concluding Before objectives, touch XXXX like to reimbursement. few additional updates

the this As the formerly GBA reported is surgical to received Cahaba, week, latest procedure. Palmetto we MAC notice coverage that the earlier provide for related Argus II and

now brings As the will states, territories a XX include decision result District Tennessee. of II Argus this Georgia coverage Alabama, Columbia. two of total and the the to coverage This in of

to the policies We MACs two nationwide. are remaining working further with our expand nine actively coverage with coverage

the in annual rate We are discussions regarding Medicare procedure. for Argus also our with II outpatient the in CMS associated surgical engaged payment the

you start during implanting the second proposed the to expect of the updates Reimbursement of Innovation. we England XXXX recipient accordingly. the French Funding in of publishes recall, payment patients France this Program. CTE as part to the will Forfait half the as CMS we Outside was In As Second entitled update U.S. Sight first may Innovation investors of rate, National Government England year, Healthcare NHS

FDA take In We that are moving national reimbursement. will process a current expand by sites to reimbursement Number a requirements XXXX. like we filings and submit submission breakthrough externals will for of could start complete, additional execute overall but trial will initiation We for Argus secure next trial. increased our plan the to prepare progress the treating in visibility yearend. Forfait is of closing, implanting preparing complete we implant market numbers in likely better overall each the the US model we commercial Orion’s expansion of larger and pursue vision three and trial Orion coverage centers to market. five, from the patient three, mid-year process goals The to to to North US In continue in database one America. positive the approved number COE outline populations I'd patients. our watch the include RP including markets, a French the to go feasibility or patient for gen And if grow two, country. to program. to to sites regulatory Argus indirect path, as distributor before the and of coverage that and number newer enrolment pivotal II gain scalability in four, across the from II authorities demonstrate commercialization device Number year label number for Number on pivotal work

note questions call the I'd to cash to half into we XXXX. company that the opening second for the of sufficient like June also fund Before have

are feel available. several reviewing the with company options highly viable and confident currently We for board have the we options that financing

that will as instructions. please update call Operator, we open for always, appropriate. As the I'll investors With questions. proceed with

Operator

[Operator The Yes of question Instruction] Dan line coming Weston. the sir. is first from

You now proceed. may

Dan Weston

ramp Yeah or for of throughout that progress, be kind taking linear questions year first that see should implant Orion just looking at and I terms, congratulations look questions happening the at we especially you hi, Thanks that? couple Should the implant. and on guys. your on as expected your the on a Argus on good afternoon, for I ramp how successful in continuous a had XXXX.

Will McGuire

I take I’ll couple Dan, a Hi going make expect. comments XXXX, Yeah, but I give to to like this what for actual we're that. Will, is of not would guidance about

in and much of ramp we've confidence the of to in strategy of really Excellence our forward attribute America, volumes North Centers as discussed. that great ability First have I to all, I going

in we each they volume centers and of these I'd things clinician-qualified and that XXX of what three addressed at volumes in got drive candidates to as the do understand would will that to Obviously, procedures. we've support every think these the I patient be the probably and there's database the Argus funnel in greater future, order continued one, growing main of one has database. ramp centers higher we to say will to and drive keep need got of as grown most to be we've said the we'll a issues patients the remarks, able the we kind quarter.

sure to Medicare a that's swath these we second our of reimbursement go We consistent We've The centers. job still level to expansion, of thing pretty predictable account make add functioning with the XX think is I expanding coverage. is finally kind good And a the expect have from we're of is we then done of right North overall the is of center in U.S. centers U.S. we coverage. forward. important remarks, good in coverage on and know excellence. whether rehabilitation, need the still the ancillary as making number etcetera, now other to we're not upgrades and you covered. programming, working XX% But and still coverage going are it approaching XX we maintain what all progress things that reimbursement at also momentum intent And that be have have of that of America good of But that the is a etcetera. again, our said

served out So, we for areas of a just a which there add lot still there's or centers, not few to means have quite us. population that's underserved

lot you'll North again, continued So in confidence a continued see of America. ramp that growth,

seven did -- implants in I it's year. of on different geography. it's think eight eight complex countries. America in We're or countries We outside really and pretty of a Just comments couple different a North last XX

markets patient we direct still are of we we're don't markets like reimbursement programs then our national get Some and place are the the distributor in and outreach do the in U.S. to majority have partners working these also others with served and

XXXX growth we'll those think that So you there I could and to make I clear I the forward. expect But it growth want I volatility but have very markets, in in is confident -- more do in see think feel what outside could of the and see that you'll Frank again, in America I markets going and as doing North again, I team that well beyond. market and

Dan Weston

I Very if you couple more a good. mind. have don't

and -- relate the there better Just you're of on to wanted of Centers on or touching for Centers and excellence of Excellence, the ramp little I strategy of get know centers to can Excellence a your strategy implant the how maybe the handle volume? overall on expansion

Will McGuire

and ready we of last so would Dan centers or it how Sure. five many we're I year. per one quarter we’ll probably all to year, give rate. a more the think I add on don't do than only to four, the add would centers to guess this be I say two which was new range certainly units the perform in XX expect at we that center prediction

success. -- good and had we've had good we've So,

if and you calculate look added just And new one per at If all and a units contributed of at were they added the when four of the we look kind centers were you XXXX, they for rate rate performing those XX centers then units at quarter. year. two to

more So, that the we add in of we could we centers they XXXX And this year per at centers to as two they right fully demonstrated quarter one would that, I will perform. I those and add expect that perform units well. will and think that now last

short versus very XXXX. to answer that growth XXXX would in could a add be yes, a the significant the new we driver be centers So,

Dan Weston

and for Europe, that gene how there be My just just great. you your last that terms maybe or in landscape, out whether what question one terms Maybe discuss of we all I of in be in That's relates therapy should appreciate Pixium think company? the I in it's looking in that. to it companies can the other general? Well competition, of competitive out

Will McGuire

and in glad then your be I'd can Pixium probably I Great. comments will to. a make and therapy. concerning gene address Bob few jump Sure.

there's Pixium, days. Pixium XXX announcements been last really from XX announcements two the over -- two from major to So,

then In and at received they approvals AMD, dry targeting in PRIMA feasibility they're both they feasibility to which for five-patient a and called these Pittsburgh so is they're patient two Paris, announce retinal device study in to studies newest their did device of UPMC. five they two patients. announced study France studies feasibility start targeting First, and AMD sub it's that a

been So implanted and they have said far, there activation. successful the that said implanted in they update and Paris, activated was they a has to patients

The it’s a market withdrew device. similar called a and CE They a they of IRIS expected the from news to epiretinal device announced it second, the IRIS and their mark Argus, I guess, that more to Pixium had is II, bit product was was that from they the the developments withdrew it due in and postponement trial failures device European to II. also then than earlier

So, going they to that. some developments postpone life-expectancy they were do were but the they implants to improve

So, They're the know is in is on have Europe. They I was essence market. And bottom this our feasibility from studies. new the actively to improve competitor removed removed PRIMA, guess market. back in really significant sub now entering line retinal device, on to get it it the you that they they're working most not focusing it probably the product which just

Robert Greenberg

for question. Dan Thanks thanks. the Bob

gene December. as therapy in defect lately Spark there that's some RP. Therapeutics very approved gene been a product the was therapy company progress question about that for in your the FDA and been has a It's on So, a in by news particular gene has

affects genes, -- Spark’s those one of those The one for gene currently chose they XXX different primarily. approvals particular there's And there of cause genes genes. that children treats, pigmentosa, there the over the plus of is Argus those retinitis So which XXX one that in disease. well is one that

haven't average their who And I XX. patients vision so, lost treating around the And they're trial also was age their think completely. in the,

were So, they ability trial light light showed improve light of patients they lower in able their to lower and that to conditions. amaze navigate the

this sight these sighted able of as result lower conditions, So, of gene patients are a to were their partially therapy. use light that sighted this and

have our think to small with the don't U.S. as at even sales. it's indications current - population. patients our small and doesn't it Argus XXX the on a in going small patient Argus significant really for impact quite Their as perhaps we is So, all population overlap

and onetime Medicare $XXX,XXX agreed but that pricing for quite they've of payment looking closely. instalment not treatment interesting about is announced we're and One including them this something their that that's plans. at it's the something plans things to is success-based that plans has novel They're yet, following

that those could are these Argus the things impact And of positively therapies much levels industry for payment moves to so higher patients. this if

Dan Weston

Bob. a point That's great

think what to going I I'm back jump queue. in

Congratulations. else a I chance. want And on have news. really to especially just somebody Orion. that's exciting congratulations Let say

Robert Greenberg

Okay. very much. you Thank

Operator

Dayal Instruction] question now you line from C. of [Operator & H. proceed. comes may Wainwright from the Next Co.

Amit Dayal

Thank you. Good guys. all Good see Congratulations. afternoon, to progress. the

Just terms that could you a from us timeline broke I of coming QX, the terms should in up, Orion Orion from through? more how perspective granularity here. bit milestones of like in we of you little progresses a the coming know out give are expect steps some QX, QX, against company's what

Robert Greenberg

is take Bob. This Amit. Sure one. that I'll

what forward. the So, let the and -- you we going are about more bit and maybe of plans me kind implanted go our back patient that tell you a little

-- Argus implant two-hour surgery surgery that implanted, our mentioned compares a four call, our this to our and study is that is patient the first as that implanted the five-patient patients to So, patient for surgeries we this plan was we so far on the a early and plans the remaining hours. The and year. study were we

home of you out surgery give surgery week idea, Sutures to Argus straightforward an was the went this about is So, the The Patient hours. later about surgery. an half a day. is and them average today. that. week time activated next after a a three Argus It we quite came

individual we've this electrodes for every going was electrode mentioned able tested and visual perception. that patient, forward we So, plans to produce the

going begin system. patients, that Orion assess So, activate the And is FDA is we're the us we video, be that and we the to mentioned additional the the can status milestone multiple plan we'll breakthrough so then talking full obviously to for electrodes the has to that implant about on four clinical way is given another running important so the benefit. the plan to

So with to be. that process what plan exactly begins a will negotiation as market the to FDA our

post-market. the and a what get to be required will might work additional market So, to for approval required what work be

what's the feasibility to far think granularity, break patients year I as, also implanted from which to have we're going and trial full and As certainly ready things five agreement we that with this quarter, down all don't to have but this to expect happen, video. operating with FDA

Amit Dayal

you're expect And know commented waiting Do Perfect. CMS the regards come to by? rates, think for through reimbursement Awesome. you with to when should Will we year. for then that still data this I

Will McGuire

Yes.

we're constant with So, CMS. contact almost

sometime similar that So timeline the would together rate we around guess and then will X and in early XX will usually after is already that for they put a they XX-day discussions rate XXXX published what Halloween. very the that's there then after is rate period around to that to comment or a I begun published a that's period be have years very, comment about published final just Amit get and have it few the move will be to preliminary July last and July, which

So around July would timeline. first we week the sometime I the be there a that get sometime X preliminary of final November, as second rate or said a rate should around

Amit Dayal

is going? patients RP color in study that that regards to patients, is how Understood. the sighted enrolled? And Any or the therefore Germany, then better on progressing, how are

Will McGuire

Yes. started screaming We've patients. the

we slower. We're the detail in that As over the sites. comments, start, go a couple the of I disappointed in little started issues can't much there's frankly but said it at been a certainly into

only right now. personal we reasons the them, most the primary spend in one lab day can our of investigator who One at have for

So, hampered going the had person They get site's of and patients work screening actually, or some it's to or they to reassigned. we issues left got site the the running another enroll then institution patients. and were with actually that persons who really do together and up to the ability

to do there anyone the have screening. didn't we So,

So, to part the would the more just get path include that considering other is without it did very We're assessing for data of a in etcetera. move looking our say data kind and it gathering forward best an say at we useful you etcetera, forward, of slow forward. additional trying which in We're sites, and to have some yet, some I could kind which right interested kind any but believe the talked about, still ready collecting start. will now of Still we could resources really path strategy best that data. the sites not include of U.S. know, additional there.

have to expand only the but us so not key our more past, that of there large expand to quite it's there So, label know we've expand out those from waiting the a -- start think U.S. vision hopes in no talked the the vision, HDE We U.S., U.S. could we're and data of can the support in and really U.S. label data our submitting for patients we usable putting that key in that there as said, some together we're got without the this label talked and patients those FDA but as numbers the and about we outside putting we that's data. label strong outside that to still treating supplement have in as the we've is for in expansion, you but better key there in additional past. we've a quite a can that some about

Amit Dayal

And from FDA? is the going the part to expecting quarter of that response second you're it be

Will McGuire

know could could we'll any data. agree proposal. everything see, we response, or see want great above course when be, Amit, your is it don't of we upon we'll to have be accordingly their we be and respond more the the We inform response more of definitive we'll -- will just It something investors. wait The based and could response, so then with and

Amit Dayal

doing in you're last new one in terms year seeing It just those anything year that. some of you're the doing on were in building the results this from patient you're for last or taken building by-plan? are Just like Is year? some U.S. there of one efforts know guys me looks terms you there from I final what initiatives

Will McGuire

I think probably on for building the and most more advertising gotten probably we've part, now. I we're would efforts. aggressive the more doing say,

or phone of gotten in typically radio, where because the national So, centers radio were news we and felt excellence focused were last a we And we that radio. started past, centers just us in end and doing local on expanded the doing talk had few areas we at we ads recently Sirius would ads that of calls year be I've XM. in quite for

be Sirius U.S. broadly going would the expand on within the advertising comfortable that we're this good we the in year, U.S. So, we thought go to centers XM. expand ahead more it of and number feel to and start

that So, response great. to has been

you We and talk step. did in as we've we local mention bit quite Amit, some that as if pipeline mentioned, about and usual, and last Orion also that again, we up As advertisements did I'd But some year the had radio well. added a far in Houston doing I'll done an extra so business response building will you for LA and tell ads. from a tremendous the

the is yeah, this we when we means a year, has the the check qualified, potential them gives green had or coordinator added that's on say of at the to extra like have candidate them basically referring a we and with a step, the them sites, clinician and one move candidate says from and phone, a that a that having step clinician to So site. discussion the our surgical from we we and that discussion last a actually which good should seems site examination next which

much in So, candidates year did candidates confidence we ago, have a higher than those we

Amit Dayal

That's I much. so it. you all Got Thank have.

Will McGuire

you. Thank

Operator

right. is further queue. All in questions no There

back Will. call over Let turn me the to

Will McGuire

the your Have today. Okay. Thanks team thank call Sight again and to in day. for great participation you a Second our

Operator

that your lines. today. disconnect And you. you Thank call ladies may for and Thank your and gentlemen, will now you the conclude for participation conference