Second Sight Medical Products (EYES)

Lisa Wilson IR
Will McGuire President and CEO
John Blake CFO
Dallas Salazar Atlas Consulting
Amit Dayal H. C. Wainwright & Co
Call transcript
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Ladies and gentlemen, thank you for standing by and welcome to the Second Sight First Quarter 2018 Results Call.

During the presentation, all participants will be in a listen-only mode and afterwards we'll conduct a question-and-answer session. [Operator Instructions] As a reminder, the conference is being recorded Thursday, May 10, 2018. And now I'd like to turn the conference over to Lisa Wilson, Investor Relations for Second Sight. Please go ahead.

Lisa Wilson

you. Thank welcome first and call. XXXX Second to afternoon quarter Sight's earnings Good is Communications' In-Site Wilson Relations This of Sight. Investor Lisa for Second on Will are Officer Chief today's and Officer me Financial Sight. Executive Blake, and McGuire, Second of Chief John With President call the market, months detailing three issued a March XX, XXXX. of financial close press for results the company At the ended release The of website Sight the press at release can be accessed through Second the Investor Relations section secondsight.com.

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

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

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

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

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

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Will McGuire

Orion Sight to is first quarter, all our the our to Second better this Thank management thank key ever before by several our the review reach and I'd technology. since first directors. and treat afternoon. advancing board our and you blind like than developments of I during of call With and to the joining Lisa, expanding team Argus for solution believe you changes key positioned

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to expanding to you market a know, announced the bring the of as the working with contributed of Bob enjoyed Bob options pioneer officer As Directors I our for as in industry and from advance extensively company. technologies the an Greenberg Second of resignation Board Dr. Robert Sight's in worldwide. is and and them breakthrough we to blind. April,

years and sincerely announced as appreciate Second insights we technical his Also, contributions well. previously wish Sight extensive of Gregg team, his March, appointed was of Williams the leadership clinical and and Board. the has benefited industry in the On from entire him knowledge. Chairman behalf over

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to path Our and can FDA sufficiently, goal is Orion year clinical we this for regulatory with so regarding that the investors update the through advance the discussions later to commercialization.

now turn Let's to Argus business. the

with completed implants During have North QX in Argus QX, we ten begun momentum. II America and substantial

team early XXX U.S. and March outreach over entire patients, US grown Our gain XXX of strategy the our end covering Centers now efforts, to the and database traction the to at of in third full US. quarter. place has a Due have clinician-qualified XX patient Excellence to patient we our in the in up from continues

a expect source qualified We the Argus for individuals database growing to implant. of be an

during the quarter of Care In and additional came the fact, from Ontario Ontario discussed In for eleven Technology and based currently of Committee. Health for scheduled year. previously an Health in individuals database Long-Term America recommendations approved the Advisory Ministry II four this implanted Canada, surgery are Argus the the first North the funding later on

of US With Excellence expect center the reimbursement in planning in under our strategy in the is first scaling growth our evaluate we we growing Centers next of number to and expanded America. Argus II US program North Toronto reimbursement and Our to patient patient continued XX implants in shortly. our expect Canada, two the in days, nicely, implant and the database patients

implants the the quarter XXXX. Europe, completed East, Middle to and Asia, we during first of six Turning

team currently in With discussed region our business As quite refining progress many is that Innovation Program. overall France, to American different than the we good making and the potential and perform additional commercial in the to approved with continuing markets secure variability three part implants the this as have in reimbursement sites markets. said, of In for market. strategy complex Forfait is more past, North much the

were a accepted number program to France. expand or in on in national are CtE NHS that funding a was French the through accepted the in first are data and authority collecting a innovation mid-year. the After a reimbursement, the England's we implants Commissioning innovation longer-term performing allowing France report also XX planning Evaluation centers accelerate ultimately positive patients, were Program transition program of outcome We us the to now the believe will reviewing We the program promising we introduction expected, reminder, similar launched in early to under supporting first of the optimistic company be by As the to Forfait implants XXXX. reimbursement data to slower have progressing decision. reimbursement also which France. program to not final and Innovation in is than This but submit begin will program to to the and XXXX the is or medical late we support until

XXXX, early with XXXX. implants had with have Before entered completing our discussing patient as in markets highlight five strategy four well. XX new we've since markets implants, I'd distributor we've success the great of like our a impressive revamping completed since markets more late some outcomes had we've R&D, or the In in to total Overall, three each. results we

on the front, testing portion Again, Turning stimulation include the that on a so to We which II. the and on population ready, RP late new reach a testing developing stimulation experience to VPU We make Argus vision in this current a generation first programs are users regulatory track our eyewear, and requesting treatable platform. usefulness next is and/or externals work by the been XXXX. our supplement technology are process. Argus submissions would the provided to completed we the our the programs, will FDA only new the for during patient patients. we that can anticipated be label in adjustable advanced to technology hopeful also remain better Argus of to we we the improving are but of improve with a summer expand and externals, we meaningful focused externals submitted US launch our our more has an that difference. that programs newer HDE patients market capable next-generation could the various of On these R&D, quarter Once improve our change the not to to continue stimulation camera, advanced able vision for in will remain expand quality design complete whom

in We a delay and appropriate. note, and the focus with With are vision the to On to optimistic about market. a as made John our remain we'll first call in would better related you like the RP quarter to submission desire label now to trial over concerning our John? in that, moving forward discussions update US have on our FDA ability to US I Germany decision review substantially we the results. expand the our with larger to financial given turn our

John Blake

about on part of be I'm in to I'm our pleased look. meeting and as products Second CFO be now create forward excited dive shareholder Will. you, that and get plans first optimism with our the I've my sharing a call to value you to to and been Thank I'm closer investors joining and team. my to Sight looking able

first of during Our quarter. XX implant during units compared to XXXX the increased XX volume the quarter prior

for During experience. in were units average XXXX. $X units deferred apply and the this Europe, sales our the with East, without quarter was four $X.X to quarter approximately last without guidance quarter quarter and of the the quarter, in gross year, the quarter was $XXX,XXX units XXXX. of or loss to XXXX coverage million nine recognized new North a of were America implants same quarter the sites ten nine the the compared XXXX. $XXX,XXX and the Revenue in for invoice Gross remaining Middle deferred and for the price million six in recognition recognized Net as $X.X revenue in first implants prior first Asia. we we of performed million reimbursement for compared new MAC both quarter The first was margin two. to In were

progress making efforts on per are a our unit with We reduction basis. cost

variability our production unit reminder, on due to absorption our a subject primarily overhead volumes As to based costs the rate. are

quarter of in overhead million R&D our in of the goods services studies We prior is $X.X compares increase million level increased services $X.XX and reflects $X.X share study. during to loss to internally remaining products. infrastructure XXXX of million an loss as million $X.X compared quarter million expenditures during outside attributable of increased the market higher XXXX. units. to year. our million of of $X.X to This the the million were expenses related of $X.X enrollment marketing increase and for first outside expenses XX sales the personnel related and were feasibility of compared costs. first quarter, of stabilize increase $X.X $X.X personnel-related to produced field $X.X administrative first primarily of Clinical during XXXX executive $X.X General an prior and the $X.X increase activities. last and expenses to of first by year $X increase to of related net the loss Selling months over expenses This per million $X.XX relates to transitions $X.X the XXXX a largely expect million million expenses first produce million with absorption Net our XXXX next-generation primarily was in headcount XXXX in in driven the cost $X.X compared of of $X.X excess quarter. and to particularly per related associated we post-market million This to share. $X.X more to quarter This to million million quarter prototypes and or compared implants an increase of in regulatory to the due and last and quarter for and were in of reserves the expenses million first to quarter loss Orion development XXXX. or inventory

our full end quarter share GAAP of found reconciliation XXXX. the excludes the A loss per can release. per non-GAAP to compared including the in $X.XX net both a changes net net at loss compensation of excess for share be the items which loss loss in first Our first quarter $X.XX inventory of and stock-based in was our XXXX reconciliation non-GAAP non-GAAP per of reserve tables our of noncash a share earnings to our net

we balance and cash Moving March onto $X no million carry had equivalents sheet, the XXXX, as of XX, of cash we and debt.

week, provides our proceed His received II the for common stock With key this of for Operator, proceeds us Argus price announced entities with in instructions. by Williams. placement with Gregg questions. funding private current achieve owned and at will working to from Chairman we our As $XX Orion million and beneficially milestones commercial gross I please capital year call the programs. the that, development open with market


is line question first proceed. our of And from Instructions] Salazar, [Operator the please Dallas

Dallas Salazar

guys, Hey here. for few a questions. taking I thanks have

we So them. work through if can

The Can you about to regarding any then in end. that talk ramp I of first implant the is you QX. the and ramp conclude Argus you level further have one year expect have how optimism into

Will McGuire

we're QX. XX tell scheduled optimistic is now I or take that. Will, quarter. we I'll either right this In Sure Dallas, short, for are the complete about that can about surgeries you have

side, Now future plenty keep that could surgery some have scheduled. XX this completed additional to in to that are But in surgeries quarter also have are scheduled mind of left scheduled the of but or about period, those be still occur. have rescheduled point, flip at either we a time on are we the for

be - in us think I another think I for strong it'll QX. So in short, quarter

of As the continued for growth. - remainder expect the year, I growth

there. some you and distributors, if before, our reimbursement, in consist times some reimbursement, more business and of have outside business through Europe, to different direct, much The over product many with we're have even to without said others would with I've time. to fluctuations look East, quarter going expect some we will cases, Asia some markets, North of I But As become America, fluctuations the definitely quarter don't that time, registration. smaller grow Middle and

the added and the QX. we hopefully Centers with team; we are in of covering far Excellence, signed U.S. we've covered have I or mentioned the year think more patients as now, QX. in we've do then XXX year I the two I Centers America, probably North QX, at U.S. point. XXX% And the for with QX covering during centers. meaningful of for adding in surgeries patient starting and probably database about new I'm XXX% new our qualified that of of this one we're We clinical of do also we'll the increased a remainder we're XX% growing a have US, in contracts so we Excellence because ago, our call, expect growth I that only been As optimistic mentioned

to So in QX US US well. in remainder tell I good year indicators of strong will that the be me as the and going would the think is quite be a lot of the

Dallas Salazar

is And just that zero right? of assumption Argus, on baked to label clarify is that expansion your the outlook for

Will McGuire

expansion, right. right which plenty each more the of by are centers we outreach that's us our could patients question. better Zero label put a much expanding room but right, of expand now to label funnel position that That's increasing have in we through just would one Centers the in good of Excellence, just then our in we If expand and to able efforts.

Dallas Salazar

part if the that. with sort you And color just elaborate ask as progress stage background? the I just in that, of or conversations quickly a all really with can on any at to to made Like maybe of the kind B FDA you've

Will McGuire

call with made that Sure. to submission actually do label that the And of future. trying would another discussions the just is much appropriate we I say the our the better a phone in under too submission the and scheduling last these discuss to what to they couple can't near we HDE with weeks a them FDA in - of we're FDA, understanding other be change will the had call get approval. of than we through scope we had consider a here

population general, in point better let's be very a down, be would a the a into then patients. have to minute a Centers one larger clearer, to that well get ago comfortable think respond increase We to remain we To increase going they're say the to the much much to submission So Xx treat to patient they'll said of these try our a better one a with translate patients RP market FDA by is conversation go, as I the ability to opportunity to another would vision with. about of another It's there and as - Excellence. a potentially treated in Argus, number retina. just the to they're excited of in significant which less also each much diseased really

would the So, organization. to get really commercial in of allow more us our investment

hopefully, have future. near here excited, in very the positive to some news So, we'll report

Dallas Salazar

round And I out and this here then last is to promise. just one, questions the my

any Orion the expansion on the of market things guys the some kind of on and And conducting? you're the back patients in then, that more jump Regarding I'll color the in of can kind any of anecdotes you testing queue. and provide pipeline, additional

Will McGuire

Sure. can have I sort I all, to I mean any blind regain no and to to who information, we out These option the Orion participate if any can't patients disclose - patient patients, course. they who excited are were them describe their But, first confidential trial. generally, in the there all of other of are are of vision.

say is is very A Argus. with us. ages range treat is it a Orion there's typically them So also Argus I typical older. as wider to exciting would of than to we patient

three Here Argus that typical we four I'd finally, say are two patients, subjects of younger we be our also at average much going for think of on are to look they're patient. if probably then period time. shorter have first these than And the reasons. that for they four you And different blind a blind

we're one on not just focused disease one or type of So blindness. again,

that's bit them The and any it I and what in there's of testing, currently little before, long we kind or of we as blindness can we script they a a technology like maybe visual go maybe therapy it's almost and did not more this really better. through cortex I'll a the and swath treat as treat as form functioning have testing, So on comments few a said large approved cut a explain Argus. a that to

with right the through - one of to trying get parameters phases and certain now. involves basically electrodes each light if XX testing the it one phase And fine-tuning it first involves go three the two will best light with to the which at or are spot we've fine-tune we patients, and you each We and electrodes of go first patient. a possible of energizing the we process the then change especially of done of can through

visual map, patients. that. done light the phase has get they that say field. that we've has two on electrodes spot screen to kind touch light thrilled in where patients. that electrodes over go I in is will were of one a again, electrode now front exceeded so Dallas, seeing well. and touch patient's each moved their both the over there. connection was create do create it's we'll So a one of of that's XX that light And of the and It's to we a the we really there, would will the both visual through we repeat of for each what reliable. my through to then light their to And in and of where patient We where trying to and field, can death we're And field. again we'd indicate them expectations We've they're then it on between from gone visual and and it one electrodes, a go we of each energize establish spatial each that creates in repeatable

of dancing in their getting we in So, is not we're point patient electrode field the light on for same around example, visual XX when moving around. a energize one, spot or

front to and we with those to replicate the other and from which energize to important the we phase artificial create to be to the of the to the create images us map an we and electrodes can vision scene the for then things that now really that know use take to or or spatial last object in we that's for patient. we is, now have complete patient develop them. images And finally power camera we So algorithm or able this to take know

the there. where the quite create you first that we now. spots said, of the we're light turned I for the know we patient I'd doing first And exciting that's on process, well, just patient on but just that and phase that So camera as say process a piece, starting

light it that ever when we it's our of of to but I wow say first the work most really hard forward patient, with to map have two over camera, really we doing looking that are I've I'm repetitive. created patients again, where point it then patients, and spot becomes next questions. for with to commented that's on these patients gets beautiful we then get first a days. eventually mean Hopefully, patients But spatial the the forward patients turning seen. somewhat the the question the really and to I'd the One with XX and or this all looking doing XX testing two here exciting but that answers your for

Dallas Salazar

know I'm No, does. being liberty upset for FDA more of did, of getting the that including know path commercialization? have that you a up bit the that breakthrough you're of I little here, and it is on with other another just here of to folks which regarding the you familiar What The here, regulatory path follow commercialization me Orion device sort some the taking things. caused and ultimately type ask impact risk program. kind of you [indiscernible] processes to these does but that of

So path for and how would how take through some your regulatory with that program, history of things into commercialization approved to break you getting what the does can the bodies Orion? factor device all that from

Will McGuire

faster. basically clinical commercialization to get to Yeah, to new technologies of device breakthrough designed them an program the got few unmet FDA treat assist need that first was is comments, promising all, designed it. the by or A

it So, a very a for as we much us. positive view

it the that and the we what so of details, we first follow-up out just yet, way should what works our happen disclose post-market with won't finally, follow-up approval the feasibility FDA document data And patients the to the document we type support should or so we'll appropriate. happen be don't application continue get of with And what we the we we patients. what and propose first the be think the so, think And document, what endpoints that propose we patients, safety receive to into the we the should trial, and after is to And trial, details we done what we patients, of from product. submitted in many approval, is want Then then FDA. follow-up, the the our pivotal to and - how five done also want setting. think in basically is should post-market commercial should we of type collecting a we the in setting type but efficacy first those see lay and what to that length the of

timeline start and get us understand you expenses you could of we that, And And a FDA the want advantage is, that. a share like it with earlier. now market, that and of have of dollars patients agreement to and and get where back be translating that forth proposed number and sometime with it then So we you year pathway to have all to Orion much know we things of of what this kind will to FDA. with that we and of timeline point take thinking you allows should of to course, into later the can the entire it be

a we then get be and a post-market before dataset would then of approval. opposed on agreed for in follow-up the initial So, in shorter can perhaps what fill to I'd commercial But device the the well breakthrough could generally just you smaller and speaking the that to of approval patients. patients be along with feasibility or and pivotal approval that provide all we way the advantage non-breakthrough would we commercialization a post again, us the is the the the with expectations intent as program to we we trial and out as FDA, less perhaps the endpoints would the approval implant then should will get with the a and device in patients FDA number with would data to trial say, cost that to less and sooner FDA. expect designation, And if to getting data the of continue follow-up collecting those


Dayal Amit H. Co. from Please Instructions] a C. [Operator question And from ahead. go we Wainwright & have

Amit Dayal

the Congrats to Orion, on the first know I Maybe of cetera. stage patient testing slightly progress the stuff. question lot be ahead others just front on a of is, on answered that seems terms really of questions exciting all for et me Orion. you with of the in one

are how this FDA discussions maybe does for cetera? patient with what next situate with So et steps and you the that

Will McGuire

- is period, don't I just the So patient say what will time - work camera on, this do we know live the and start more but camera patient, we basically I XX have doing will would turned so next just on first with I'll the XX be real-time over we video. have the more we so the feeding we'll days say to video, and next the

So walk each like they have the map start it algorithm we do vision Orion producing an have they'll patients. that. now right Argus have like camera each video front using patient developed just this an task developing and working. in for spatial patient. them for we'll of specifically a and to is because each They'll for the around developed system, we capturing system things And individual artificial start and do And entire can have and we'll algorithm and

the point the home the this first setting protocol, be gets outside it in with at protocol testing, system to of then the certain we exciting to get then the using per really able point start in patient. per and actually some So now a after would the lab. it the patient take And

going point XX second but know just initial And the near And and at happen recently some I exact the future. so the future. in or be four, the patient implanted timing patient. at we three of in would then the is Amit, for don't of And near next of that, some the to maybe that XX we we then in point that weeks them that activation will have couple probably session days patients. expect each here patients and one behind those

we're that fifth we patients. out I of for individually the before those near of will of And And to so then the start each patient that's future, agreed end quarter, the this think activating where feasibility we as certainly hopefully, the said, we'll enroll for five electrodes finally, one the study. in

Amit Dayal

on turned And the testing just other is curiosity, for is times you guys so doing just out are or while at turned of on patient? it this

Will McGuire

Good question.

seen. events is environment it we someone on or not want just to system unexpected now, and going watching seizure cause because want do events controlled while pre-seizure hospital and the no at in a to the is which we not adverse patient. the testing have very events with high and them closely to Still, testing adverse or of we get that's any make we're watch we're right or confidence a turned doing there's there So, activities that adverse with to closely type sure

at getting it So, near and point, basically overseeing UCLA you start Baylor we'll the use in point or hopefully will be patients it without of without using that future we the overseeing now take it. the then one. that someone home system And or to with here can from us say

to So goal. getting yet, closer that's not there to Amit, certainly we're that,

Amit Dayal

XX implants this XX of in saw play Argus screening what some of the you're just the going Can to side, driving type II is us it variability continue going help implant implants of to we queue the quarter in is fourth on the you patients get in Just understand first XXXX. line this the to of is the for out? and variability, forward, quarter,

Will McGuire

North the lot a factors, most is different variable. It's question. America Good of outside of

a to pushed a from be was driving of QX it that sequential US I in America end believe variability did think would that I XXXX, show indirect by just decline factors as team that's again well. few ordinarily one outside in in recall, less QX, of if and even the to happened in And like But lot may markets there. a so… variability. units the direct six. that's at just to North driven get have We of the that's Much each maybe the There of it XX year. X the I

John Blake

XX. To

Will McGuire

US you XX, it's To or of less I let's year, going had in take the America North a America, take stretch ten to even that because but smaller quarter a we XX, I'm I see would the should sorry; much say XX would year rehab to activations get past, expect the Amit, implanted the the say like XX, going in it that. of - to last in difference forward, in the last if variability North four. things for a to do point, was team, we we bit and to do was patients, do fourth implants team it at in a team the And

and So issue the America. as our think quite North - forward. have sites the half I in don't one We kind that's And were on power in is said we we far two site last of would and person in QX, quite the or more going few think say an of in coming QX as we in stretched then parts also second of manpower US a new a year. year as

to see times rest prior in do eliminate I time you'll variability consistent the variability. as and and see US So said growth versus North some that before more US American but the situation I both going of ability the optimistic year, for to year prior you're outside quarter will versus about the very, think many quarter I've of to think forward. quarter very some it we again, growth going be do the consistent But the

Amit Dayal

in sort the wrong. front, cash quarters just until the you of reading good guys another it commentary maybe the your I'm we aren't the of two included But placement worth that have - this at end XX unless looks of the the year. first sort that of indicated expenses looking happened, like the quarter, of call On million

could help reconcile me So you please? this,

John Blake

John. is this Amit, Hi

financing, able key that to the on Argus will will recent execute early And to milestones earlier. that extend we in QX. safety QX results into us and subjects runway enable projected Orion be regarding II I Orion feasibility will most interim our importantly with the our talked first With late or the report in programs our on that study about five the And importantly efficacy. and

year believe takes cost us position So to in this lower later able a a capital. that we to of be financing to achieve the really

Amit Dayal

holding one final rates Are one guys, for you reimbursement steady me. from Just any front? changes that on

Will McGuire

the since of year. changes beginning No the

the reimbursement the the for and XXX,XXX. average device procedure Our in US is

past that's in talked could we location. average, upon an geographic As actual the vary based reimbursement the

lower lower So higher a cost areas reimbursement, reimbursement. a have have higher cost areas

changes to US, actually line in - any And to in our of maybe Canadian one and reimbursement and is had I the so little in quarter US reimbursement much the the more in a don't the Ontario cause US. reimbursement than location bit with is think the to vary very very close quarter we actual US, the would implants. be could of reimbursement that just Outside thing

reimbursement as well. strong in So good Ontario

John Blake

add or favoring that than better our we year we mix to that had what will geography wanted as given that region ASPs American overall Just project overall. the North Europe this in XXXX support versus to be good

Amit Dayal

I seeing reimbursement was market. rates we're of what ask international the going kind to in average on

John Blake

I think XXs. the we're in seeing

average. So, markets around I pretty indirect consistent something the in pretty and some we've some of XXs of low the there on couple variability in like last between direct there years XX,XXX, think but it's the with reported - Amit, our what consistent, or that is markets, ASP the maybe somewhere


hand at time questions for Will all questions like believe have back we this I it the McGuire. to or I that's to time.

Will McGuire

day, our update a our joining forward an call. on Have thanks. for I and look call today to great everyone again next Thanks providing

John Blake

Thank you.


and for please that that and for ask today. participation the concludes Ladies your gentlemen We you your you thank line. call disconnect