ICAD - Earnings call transcript Q1 2018

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Operator

Good day, everyone, and welcome to the iCAD Incorporated First Quarter 2018 Earnings Call. Today's conference is being recorded. And at this time, I would like to turn the conference over to Brian Ritchie with LifeSci Advisors. Please go ahead, sir.

Brian Ritchie

Thank you, operator and good afternoon everyone. in participating for you today's call. Thank

ending from and Rich me iCAD financial X-month iCAD Earlier are Officer; Executive announced period the for Chief Ferry, results XX, Christopher, afternoon, XXXX. Ken this Joining March Chief Officer. Financial

statements. including, like begin, contains I comments that made caution we and iCAD. may Commission, limitation, any with identify call to the results this forward-looking no ICAD accurate content described obligation this date is that involve XXXX. statements Securities in Forms contains review you and to information risks as the to after or or broadcast, from to Furthermore, conference Before Company's turn conference of only revise pleasure the XX-Q regarding Ferry, undertakes to by Exchange to live or of over future call. Company's the of this of the the the my this filings of CEO. the operations call circumstances date XX, that specific encourage and risk would time-sensitive call the cause to events May without statements those I that XX-K, which management it's conference Ken update materially factors differ forward-looking during With said, that and Ken? uncertainties results reflect events actual

Kenneth Ferry

greater detail. the prior for on XX, Rich's today. key I'll conclusion turn us CFO, call who update growth March opening with comments will then call thank programs begin over joining our quarter remarks, brief for results the on to financial Thanks, results the an you of Brian. review our for the questions. Rich in our financial At and I'll to afternoon, I'll provide Christopher, Good call some the XXXX. everyone ended today's first

strong offering skin While of note were revenues down when after flat our the of it quarter business throughout due QX to strong were the revenues was a to to effect off in topic in line the which of start on fourth top shutting XXXX important the quarter quarter, comparative More during got slower XXXX that weaker essentially part as to update. later for particularly our part subscription results revenue compared anticipated, XXXX. Mammography of is XXXX. than adjusting MRI this first product in

the detail Now, Rich. on financial to I’ll will additional turn call who the provide quarter, over Rich

Richard Christopher

you, afternoon’s in financial Ken XXXX afternoon disclosed Thank I’d good were highlights Company’s like and earnings review first this to everyone. which release. the quarter

I our first quarter, financial As refer highlights The I’d on and first to you the Form XX-Q quarter detail. expects SEC discussing XXXX for of for Form more tomorrow. the to will results our only be specifics with for of Company like its the to the quarterly file report XX-Q

during I view would well comments measures. believes will the financial highlights, Company. measures the with today, begin as I better to investors, that note of non-GAAP way Before financial referring the be I performance the provide my Management that information reflect like to meaningful to that operating as we these certain

our that of first at of release. the will earnings our non-GAAP covered, GAAP reconciliation find You the quarter. With the to summarize a can for results now measures financial I end

performance X% of decrease $XXX,XXX segment. entirely million, total a was of quarter driven The prior reflecting detection XXXX, was year first revenue by change our the For a $X.X or quarter. from revenue comparable the

year-over-year of or a the revenue impacted negatively in detection. results be the for begin segment, our revenues year was revenue with $X million, noted $XXX,XXX prior quarter. segment year XX% of comparison It prior Total our MRI that the representing let’s by $XXX,XXX As detection first inclusion period. by from decrease XXXX was we should quarter examine the in in our

assets in quarter MRI calls, earnings previous of of year. last we the the on detailed first As completed the sale

the in product versus decrease decrease revenues detection year-over-year X% The $XXX,XXX TLMA in of result to our the The to were revenue in adjusted the product. the Excluding MRI a service prior million follow-on flat service focus the revenue our front as $XXX,XXX year Shifting revenues year-over-year totaled cancer prior quarter. the of setting revenue was detection to of shortfall therapy the decrease in and in first quarter. product, and or $XXX,XXX XXXX both sales segment, service cancer result our in a $XXX,XXX revenue. decrease our was on quarter detection the revenues, whereas decrease a decreased detection compared was year $XXXX revenue of impact product driven by a therapy $X.X related

therapy As subscription impacted business call, in skin This this of adjusted to February of periods, did decision we actually our of by the has earnings XX company last the skin in in or quarter in created revenue increase impact negatively our revenue result therapy the year-over-year. the of exit $XXX,XXX If year. noise a both were effective detailed and was sale $XXX,XXX. XXXX. controllers of on our exclude – incremental decision $XXX,XXX comparison first one subscription the the therapy revenue The X% so adjusted the by some increased numbers to revenue success quarterly made in year-over-year

gross XX, quarter. decrease. percentage first first as in the XXXX. to a attributable the business skin profit prior On quarter February in of effective Moving lower compared for was revenues dollars XXXX, topline for The of in from basis, subscription profit year-over-year onto in of quarter first incremental million quarter gross XXXX XXXX the exit the of compared was gross unprofitable as our a to was quarter was gross percentage $XXX,XXX first gross The $X.X to XX% the detection profit due change XX% margin recorded XXXX. profit; million year $X.X to the

to margin expect as experience further of the gross positive We begin see impact to full throughout in exit. we year percentage trends quarter this

assets. quarter XXXX million totaled million, the $X.X of XXXX, the In represented of million the quarter expenses, MRI a recorded company XXXX. on gain quarter $X.X first the first first of for over operating operating the a sale $X.X As the expenses this for of increase

the for represented of XXXX dollars. by our million. share primarily VX quarter $X.X our the X.X prior prior program $X.XX detection per our to the This Summarizing net of operating $X.X of from as of year gain assets of by development $XXX,XXX for was offset marketing $X.X prior research The expenses the or the research product quarter, XXXX sales net the costs Tomo The our incremental total quarter study our in $XXX,XXX year-over-year period. losses of year the loss software. prior quarter. this our net driven million loss increase first quarter $X.XX metrics, flat the on and by over costs. million first fully incremental was Version loss $XXX,XXX million The in year for was the PowerLook decrease primarily of gross per incremental were the GAAP a was development lower increase and the comparable Excluding costs EBITDA net margin gross were sale Tomo On of $X.X or loss a gain the and and basis, compared a profit and year-over-year advancement in development were of the margins. for in share reflective the adjusted the MRI year cost detection driven non-GAAP the absence increase in decrease

sheet; the cash quarter the million compares we $X.X XXXX XXXX. of Moving on now hand as had This to first $X.X ended hand. the of balance to with we million XX, on in December

XXXX XX of quarter cash to report improvement both in that are takeaways to of skin and the are performance first, key the in summary, first result first follows; dollars burn exit decision We quarter we totaled gross our subscription the a our business. margin as as $XXX,XXX. In pleased just percentages experienced from

would associated on reap benefits we ahead, further Looking expansion our skin therapy model. margin sales execute as within expense capital the savings anticipate of the we and

the Version was at of software. accomplished same PowerLook while on be which one-time quarter compared the of sale XXXX expenses associated time flat the the It of our absorbing that of first Tomo gain the with recorded the first excluding Detection first quarter XXXX, effectively XXXX. operating incremental in the were the program MRI X.X of should noted to cost development advancing assets managed we quarter product as Second, our this

are was just burn we burn. reduced and cash our $XXX,XXX. resources cash successfully our managing the our Third, prudently In of XXXX, quarter first

of already So in expected the our the exit with closing, as by quarter the to and highlight of in detection concludes subscription we improvement growth skin the flow did has company along break financial section the successfully XXXX, first it plan overall topline its year-end. better which towards cash head February cash during This continue anticipated result This, gross margin will from Disposition is company executed positions XX. to which our low business as revenue of business, in presentation. burn. on

call again over Now I Ken. turn would the like back to

Kenneth Ferry

Thanks, Rich.

our Let’s cancer business. begin with detection

We be with continue marketplace. Detection PowerLook pleased demand the Tomo in for the to

breast As for today for Software that GE AI detection customers the and a available XD first learning reminder, on product on commercially based is mammograms. cancer is this machine the deep of

iCAD in be to As have driver this for said I the will come. years a past, significant growth platform for product

received remained we very to had imaging sites many and returned feedback end, this of we positive on recently workflow We of are innovative the assist on today software breast customers, there positive workflow mammograms. interactions maximizing for focus using value the XD As XXX potential from our To where our solution. commercial such, prospective society software. over worldwide clinical with of interpretation this meeting

two customers with personal the sharing an Tomo detection your past weeks, each experiences use the is registrants we practice. webinar their educational in hosted PowerLook that of Within of also XXX with

with next considerably we’ve of increasing all Version of suppliers significant systems. also that, it detection, X.X. are version XD is mammography development very traction to we of completed Tomo the expands of this market our of addressable This version major While the the PowerLook current in product commercial version important our

in that recall February. late version detection Mark PowerLook CE X.X will Tomo You received

Congress As place we February XX which to on to call, we are X Radiology Vienna. discussed product our this European of to pleased introduce in March took last

shortly product shipments outstanding have This Europe that FDA U.S. We be expect it of meaningful sometime results for a based of to the in Clinical on you in in quarter beginning on submitting in Reader be this we Moreover, the first this that impact will make product inform will to results year. financial Study. Pivotal anticipate I’m of days. will and our third approval this pleased the our coming submission the

specificity reduction use publication the with cannot same in of medical significant time. say radiologists patient recalls, a many our a exams on too exams read publish substantial the a sensitivity, reading productivity excellent significant plans reduction forward to exam these radiologist detection, in increasing false I details positive can through soon claims I share addition to in major saw cancer in lead reader a a from specific results, further, details with without meaningful look and and to increased journal. reading providing results could to the data to results study time the it. versus the unnecessary pivotal while While reading we prior increase the significant of in software to reduction that These more specific in We

XXXX results also Society the We at in intend November. Meeting America study North Annual to present the Radiology

of of software anticipate deep of X.X FDA launch roadmap second on investing sometime to version half AI will of year. PowerLook broader approval, and the committed ICAD solutions, this machine development a of receipt learning. based remains in in Following detection commercial the we the occur

recently highly innovative approval robust lastly And have portfolio for intend engineering experience well area, development our significant and density and breast and long We we of software. term. continue and this as received over this near expanding the to to advanced platform in as we FDA a XD our end, solutions

We breaking to customers which Shifting are to breast begin to subscription launching therapy. We’ve in XD like skin update therapy, the to the in service this our enhance product skin therapy radiology to process I’d breaking further discontinued model adds with workflow an of in with capabilities business. U.S. our on to exams. offering

this discussed over negative would the overall shift strategic quarter, believe area. term on this in we provide our had in sales call, on our a end long we our on revenue XXXX for sustained year slightly capital substantial While impact opportunity focus the success model

of commercial ongoing to centered expanding strategy targeting now practices. addition strategy cancer dermatology is on radiation in and in on Our the oncologists focusing centers

a cancer across As XXXX where successful in a making over centers states us reimbursement there reminder, had market the opportunity. we’ve are skin attractive U.S. experience particularly

the completed we first bullish As opportunity. in focus shift execution and the this significant solely quarter, can we strategic we on long-term now market on remain

critical technology emerging presentations favorable option in in and this in Academy treatment Annual factor results, to in long-term was Skin of continues meetings an eBx the to several which success. Importantly, meeting discussed of in support continued as the the non-invasive QX pain grow clinical be commercial with driving data and e-dermatology free market February. including held adoption Also podium Dermatology

Additionally, are eBx update media strategic working demonstrating we and events let therapy other referrals an treatment With with Skin provide on and through awareness sites, local areas. now strong utilization to drive our potential. with in marketing, customized that, you collaboration me

experiencing currently breast for are U.S. is with interest Interest We stronger the U.S. growing by large and communities in in driven rural urban being IORT. facilities. competition

XX% the in recruitment point, QX sold continue a breast national record in and awareness is quarter. we growth in and increasing units see by and XXXX. procedure disposable oncologists in sales oncology parts U.S. of We this growing dedicated To we underscore to in units, health and applicator Internationally, achieved Additionally, increase XXX care versus surgeons of of the interest strong IORT companies systems Europe Asia. IORT the

Centers major recent a that addition, the growth GYN currently sales Chinese we and system our therapy OUS we standpoint, IORT Over our a business. From treating and IORT be approval, In and general will applicators. with believe GYN in time, applications. centers and China, XX have for there to our access treatment growing we’ve in breast, with U.S. interest regulatory patients see first market opportunity XX begun

experienced projects IORT prostate, in commercialize and global including strong, new rectal applications, We to interest continue market applicators. and general have these treatment active underway brain

the we clinical with in data are pleased Miami including Centers, occurring Consortium at in Breast particularly European momentum Oncology. seeing Society of with QX numerous presentations meetings the of are the National strong and Breast major We Radiology,

to be IORT evaluating our important further positive study We you in that system race enrollment the study years. of treatment recently two of for forward. Xoft we recall To this for patients. occurrence adoption under an of to expert expect the have data will catalyst patients U.S. early-stage this of cancer the use completed end, of up the low XXXX breast just date the follow median treated in been to moving

treat, continue of be which of results second over half key to XXXX coming adoption to the to We publication will increasing these target for the the years.

and sales cycle continued reality International. in lengthy the a in anticipate a segment, While remains XXXX placements in this progress system we both in U.S.

Mexico. markets Arabia, year Saudi also key focused emerging additional in on this are We multiple India, opportunities OUS in Columbia and

the in focused therapy the With maximizing increasing well. on areas then and now our system are business application growing the as placement, GYN strategic complete, follows opportunity capital base we of long-term the our shift in and customers recurring breast, revenue market and new that

questions. that with call us I for the now think open it’s to concluded, So for Operator? time up

Operator

from Instructions] question Group. [Operator you. our Craig-Hallum Thank Per Ostlund first We’ll with Capital take

Per Ostlund

in start product to guess Thanks, detection good with Wanted the I afternoon guys. sales sales detection just out or general.

did you’d and was commented I previously indeed you that think I expectations, quarter to you had coming guess year? -- more maybe it little a attachment beginning or that this in Tomo any change into of interest or you and than bit in re-acceleration GE fourth shipment think consistent for first quarter of XQ. Would before coming seen quarter, potentially you retrench say that in strong it a your I expected very the have it thought, beginning with a was rate out the related it the level softer the XD did

Kenneth Ferry

pretty look see product for When a for specific stronger Thanks was. as did we Did not first anticipate as question. Per XXXX it would essentially detection. had expect with all in continue Fuji, to something revenue but significantly with down all Siemens, much, down the as in quarter strong be team. in back consistently what board at on We channel three to somewhat cylinders. had expect some. strong year-end We we because it direct in strong on we to was a in those QX a the a perfectly in what sales quarter revenue to when be the you we expect and had $X it first different the didn’t We spiked specific did certainly be it everything QX, GE. we million QX, a across quarter quarters. over the product We angles well by average down proportionately. with had our look then memo expected did we strong achieved you in hit we And of were didn’t that of with approximately quarter And QX

forward, them this the product GE in only one that of that challenges with is in embrace so, And Tomo terms to anticipation GE our going getting progress differentiated of aggressively really our our and product marketing this and we’ve it. with available GE. of is and really context had And challenges as our

So first corner quarter where is for they that fourth hurt the to they QX first sold in our the more favorable in they of more us that actually the XD, XD help prices XD XD, versus things it one seem turned seem have certainly and quite than Unfortunately the that in cause. quarter the XD selling did did with transfer they to are to the quarter ever. given revert back not

we quarter trickling only couple see orders through orders. to to XX All the partners So I XX trying weeks and are we is can the about a that with of obviously we the April three our saw working to other of two are weeks, say try typically work with business. point to this and in at we in new first first or in strengthen that of GE couple

XXXX behind year the focused a frankly first to company markets. energies to last three further very of in performance in X the we’ve terms was exponentially just share opens beyond it International my quite in and and than quarter we us real hard rate encouraged run fashion lot to XX% try that of in the are the for say quarter to expectations working second version other by of contrasted a be U.S. So improve market who while of product, has opposed quarter, I can’t put both very a on relying specific up one really as that, the the to first because of market approximately I

Per Ostlund

in of well as window number reasonably be Taking lot have I terms from but in manufacture it come a May. that guess perhaps seen data a guess demand about is sense. just suggest the to the least thinking might that I'll seems you MQSA your that of acceleration that as know and the that the tomosynthesis of adopting And benefiting? inflection that a a from here then like sounds where placements you to early at sites back certainly who you be true might or makes at material it to April. is might in I as both X.X That have well. of perspective cautiously a would number to do have manufacturers look or seen related coming first in question into which second,

Kenneth Ferry

a think it’s good question. I

to math, XXXX quick obviously which look I about that's per do back a the you system were particularly per MQSA, quarter. there strong If placements XXXX QX quarter. And believe about XXX system was

was it it in go in think I but was XXX. XXX to XXXX, as systems, QX

a To rate we going much high October. your its of actually seems back this and when since placements month a point probably XXXX think the still January to So is and had which and strong we're I was think but number extremely and pretty run single month August that I higher, strongest XXX think actually was was on the quarter. XXX April, I about be systems of

for hard shifting the just seen have of significant the market to So, at unit whether second volume quarter to It's this really of to in point placements. us quarter a you in share I terms it's be tell. really not beginning XXX in in of terms really strong shifts month for or at capacity time. or hard tell a with makes honest any changes

well similar encouraging of really to going we'll really soon at quarter the and too look see exceed volume I period the because So all if draw starts to we hopeful really a it's analogy. a data, are I'm hard one that worth XXX conclusion. to data something to we But month But certainly draw units it's benefit. think MQSA when our it's

Per Ostlund

fair. That's and Coming entirely you submission the FDA to imminent mention that's did X.X back certainly hear. to is since great

the that relevance X.X not the tool You versus about Does feel guess Tomo utilizing whatsoever? mention do think study have the original -- utilizing product? in since same I talked the of you any with I process before reader you've you've through been guess first maintain do tool. been once you version the that where versus And terms maintaining it the utilizing the still you I confidence

Kenneth Ferry

said a slight all, of a I X And meaningful to to a achieving just tool in enough detection non-inferior sensitivity Well, not job result. We performance reduction XX% was with to what in reiterate before, tool. I've I a kind I of terms was of sophistically increase think of relevant in great guess, get first time Version XX%, we superiority reading than that but claims. did more had believe workflow from

However, the is workflow a very effective of is X a the Version from detection tool combination really tool. standpoint. workflow a tool and product

they some almost a increase which mark equal so tool. XXX as tool almost had without larger than see Version read that sensitivity believe its difficult study cancers, We our we distinct with study we read to increase non-inferiority. claims get readers these differences. very X. superiority the which is false-positives was than meaningful XX very means the more had is sensitivity, substantially, did you very was and the when detection will in sensitivity go are you very false-positive. which were study was increase radiologist subject obviously we studies they increase an up with to – performance there a the in in essentially torque are hopeful the had to we of What statistically in actually than cases, in or move the which specificity we achieved, an surprised specificity, in something we cancer an extraordinary algorithm was XX more And they reader more corresponding get we the ruled We So typically out which that's is

of Version at ruling What the mark our unnecessary increased to comparing in there We we reading a as was reading actually tool time the mammography, of our with false-positives reducing meaningful recalls. finding meaning – studies the they at enhancement without exams when some potentially comparable that showing look demonstrated same X surprising our improvement out in So, they when the with And reading really you benefit XD tool is with our performance. so mammography out in improvement have us the in benefit performance of performance of with superiority has XD president the tool. radiologist without versus tool, and read tool. of a and our XD the

sense false-positives actually how you and when mammography recalls, reduction at both to unnecessary sensitivity radiologist a when in something think disruptive that. versus the read in from and we improvements the tool about being and performance our did XD XD its comparable achieve going they So when look important with you in

be have how excited the And were any of week. we said, we'll by is reader results what really With study So product, see at end to the expect hopefully FDA the it just goes. the is. we're that day it process about outstanding. And this to

than of the bit are results with with a that reader more a well first for but than We version the longer as quite are we said had Version we reasons variety X products for as confident anticipated. were of experience

what So saying we're and confident product. the the really we a us to cause performance FDA not going but is of predicting extremely excited into relative extremely time, are the

Per Ostlund

Can it. for you that. Thank appreciate I

of if is on customers but back tail gone? or that is the the this those further to same may, last becoming from Just or to at with down greater some I now and truly revenue ask the to there customers benefit from customers I Are the And decision goes then a question expressing quarter former that are that that business. last And is guess we're I businesses full think cost in left that quarter – looking of thing side, on the one now of relates we expressing subscription months gone shuttering capital the I all now side those close model couple interest then subscription them? coming removed. or that

Kenneth Ferry

Rich. Why pass to not I Sure. just it over

Richard Christopher

Okay. shutdown is of down of To the cost piece, costs February some full the the the successfully us. now were end in We shutting business upon hit behind the March. cost as of with residual

starting the you'll see that. of the quarter savings second the of quarter So full impact in to related XXXX first

far equipment will As that a customers to XX on the on agreement. eight revenue there are transformed tail as service only and and actually be to source

trying and control So were a five in of model remaining from at subscription we'll piece and so handful accounts moving actively left point source of as the towards pulling this the away agreement, sell to a well. that still and to business the maintain service And above time. beyond we're that

been in intents all and and its purposes the for full see the second impact shutdown quarter. So you'll

Per Ostlund

guys. you it. Thank Appreciate Excellent.

Operator

with François Laidlaw. to We'll move Brisebois next

François Brisebois

coming wondering detection the in Hi. you on a fourth Thanks for mentioned taking my questions. I and just side low. quarter, the this little is how was in

happen quarter to the then a thoughts and to it on mentioned of could been happen? first how would either to this kind drive of move that more XD here. What from kind You they'd quarter XD Any could make fourth XXXX that? as XD you in potentially came what the back the

Kenneth Ferry

sites still to that diagnostic adding the transaction. exclusively can XD is And to I the in XD license. is screening every they're XD logic adding that not And think That's product on both a a to to to using them current for question, interested some for patients XD margin screening there good would All primarily as callbacks selling they going in Frank. just license. GE extremely obviously these were to and still be on customers are conscious if customer that is say up I and working

a license the a less and XD Hologic And our that a And adding longer pricing of and new not to served site still years Powerlook as two so XD site because old a compatible also just to we've buy not server. the the customers eventually to good have a on with protocol a system is customers as will over software because their an XD very because XD price XD screening term for a because have said go to already competition. that Fuji XD than is time have competitive CAD customers and brand-new XD option to along we those particularly on and systems. number competitive the the unfortunately those And margin they competitive and over of in where going they becomes essentially products existing with next from diagnostic work software well license get being Those customers but and for there a will screening to a customers capability is be by the lot make XD where nicely. add option adding and have cost-effective circumstances transition PowerLook going it now to XD its no-brainer Over have expensive as XD its it’s caught to add current adding to against think only, Siemens they is be still option I in a have a possible. that they and going

with XX/XX and that XD for exclusively would would disappointed direct get extra rapidly because to aggressively said XD we run would now customers them continue will do or that And to and a have XD. with really we more game more work mix we'll believe product if mix really We in team. outpacing given this work has changer directly much properly expected welcome and to continue will we progress ultimately that have X made anywhere And it's GE come as the work in I that capabilities, hope because but the make it ultimately unfortunately to we've relative them. get like our be its near migration, to progress positioned with so close time the with XX/XX And would motivation move more to tremendous to transactions believe more that I customers over customers software. we the we I product XD to just market our Version some to unique get own with do continue long We that GE. XD pay not XD of not said, with as that With

François Brisebois

as a quarter this Okay or decrease us Can guys on XXXX, the but the is is breakeven there that be is mention quarter, might subscription And discontinuation? but third end yet? there, burn you on year end that you what service. the that they not done this discontinuation more since cash the for at in you quantify Richard the cash that great. thrown whole XXXX that is by when Ken. And Thanks fourth entire probably hitting may for quantify, year flow can you for have year

Richard Christopher

to related with skin part full answered question has so for and of be the the the to savings earlier the basis And question of would the lot Well, quarterly there. we business. your shutdown It on QX in year. QX the subscription not do a part of but

the we cost line so goods of and we first second sold first to as X didn't at quarter certainly X saving impact item. half the cost in the but that quantify the quarter full the million in and of a of million annualized $X million a coming beyond in about had I our quarter, have a have related annually. two we months the We think worth out of ton that

François Brisebois

reader at. you. just in Okay, so And the you great. terms study mentioned to looking All right. Thank that revealing then, I'm of

got the data X.X, in with shown yet study kind to then submitted this EU, get to because you you happens, and we and top remind FDA, I but positive has of you which line little when yet can X.X been but we shown And but then guess happens, when then mentality its contracts me top in about how line that it? FDA there data study. CE affect pickup? the Version haven't any the when on U.S. of never reader for different haven't Can after in the hopefully should You time marking the is the just then that and any again as this that for the expect the know just expect publication – terms of and Version Europe you really the you a reader

Kenneth Ferry

Sure.

Europe the nearly X on contrast in when with of Version we start Version CE supplement Version PMA the PMA CE States. has so in X regulatory to mark from maybe its you not X, and a obviously So, mark Mark, the to the process United benefit CE as onerous as to going a

knew said, radiology X. to the from X that With about some really to and And used ability for quickly to late did now ability have So GPU still us six cards to needed we Congress part weeks. X reason a product time that of have us early it for we February get servers Version market four Version was or the we of the the that that forth, cards for knew aggressively to to significant CE take quantity hardware which actually so get newest we source it the was us really additional was test the Mark have and to the to we and benefited March. helped in do Version European work be more mark GPU EU and with CE we because was in able which going very to

companies work We also a compatibility packs their wanted workstations, that whether with addressable the this we're on dedicated or Europe is for product so number of is the companies just go in with workstations partner we not would all working given to to our our partners mammo compatibility when it with market GE. of that

of or building. to probably bit there's So we work products and able so within in ship we being our week a process And quite through think first that's to whole interest a Europe of Frank. we're that

U.S. full-blown and completely As reader Mark we pretty And it's to and required CE X. it Version will relates to effort to scenario another substantial. amount get required the for do of the was we different where to time do cost not will a which study

supplement, cycle we regulatory process XXX-K XXX to a mean to with the the the I up enter as be to respond. We're in PMA days. from days up So, XX into standpoint has will the FDA

as them communication We've from to Now we hear we from had to expect we we've having them. submission. of surely them. have about into their make to ourselves to talking relates little when depending better We've with history a try the of U.S. hope that the months so market, to us their really submission bit we're and don't XXX feedback the what of put put would to will give where we it questions product will so properly, bit how see that of in predict around submission getting been been be to a the hear go a the lots challenging in We the the day. timing to that's go. But discussions make that as it's and in sure days a indication response on to dynamic matter any And the of submission. good that's

François Brisebois

right. All it you. That's great. me. Thank Okay, from

Operator

move [Operator is Instructions] We'll Research. Investment with question, from to our Marckx next Brian Zacks

Brian Marckx

around just your to is provide more you to terms of of of then little would differentiation guys. I be that in a terms may it have can that important able guess that of when you claims whether if you superiority what guess in in be that I superiority competition? U.S. kind pursue? terms you is know today relative how Ken, competitive to Hi, referenced a something And claim would may bit pursue, in the

Kenneth Ferry

Sure.

not a performance have And sense again I'm just from it that Brian, roughly washout to general just a goal. greater when want be call term, that they and standpoint. in a average said of do read what you then period. the broad you I With increase substantially achieved X% they On exams sensitivity or when that the think that. tool same with we using looking do so use the our a detection would when I and you're versus detection in just was see measure radiologist it use general our a than the accuracy tool,

gives had we can claims. false-positives. relative reduction it's feeling then increase your us relates it what and we're similar a investigating lot unusual cancers and when with to that exact in Because it to actually you you and this that a I on more that to have not and confidence you the for mentioned or show something sensitivity [Indiscernible] decrease to increase But significant but unheard-of your specificity negative. a a it payers increase system may actually to which about way do to earlier finds almost to Same its really sensitivity in superiority only studies ultrasound radiologist money, product. in degree that to we product, if you apply of or for think as So as go own if can help relates out since biopsy that as basically of their additional relative recalls to lot MRI, find only reduce you its unnecessary this you reimbursement a whether with can save or find with do meaningful right, false-positives

our excited so to So they performances deem claims. approvals part be to will ultimately our superiority have feel we application the as the studies ability decision interprets we optimistic over was be will whether results. to product. the in prior use enough comparative hopeful we our wait into good would see of the if as pretty call. tool about really We're without them and have And that and They But improvements significant that the get the very world reader to how about superiority of we're the but a the give prior process. XD performance and these FDA's just will us reading going to is that claims make ultimately be it done FDA

Brian Marckx

has could the FDA filing, that upcoming that filing. upcoming it your So filing your approval right? get with potential you sounds claim a superiority that like Is

Kenneth Ferry

the be is a statistically big, Yes. To detect it big a without a to then and earlier using more ultimately tool advantage able to because is other us. deal point, could competitive for differentiator cancers be huge a relevantly big

study was which average this first improvement I lot reader we The the reduction is In with performance We to reduction close time. thing in this had XX%. reading significant time the in even didn't time a on a larger XX% of reading study. in also other in had an spend

think So almost unnecessary and about your radiologist false your detection we productivity reduce literally gain and think time XX% reject substantially about able increase capability positives. and when workflow, being you to reduce reading the

in fact competitive around they for huge be outstanding differentiator and development us skills that learning. have to competent machine could a and this assimilated it's the team really the marketplace think I really real deep testament really and a our

we're market. the Version Don't on the but reflected images available developed the bringing in progress out the anything have with have that commercially. X and build one base you very with data to about there And on the at compare the least pleased customer we have space, every second capture made. where significant team working did thousands getting and it hear over version we version as of are prior product. and product and we the a A And that on thousands an expect We that improvement should that into very comparison make AI often a Version we X their of the work thousands we you all first if time, is of the companies spot. continue of they're capability to are a and we lot upon

Brian Marckx

Thanks Ken.

Operator

That includes at time. Ken session to call answer Ferry Mr. turn our back the this to remarks. closing like and for I'd question

Kenneth Ferry

maximize breakeven also roll reiterate the Thanks, and the expenses meaningfully reiterate global it then rate XD addressable in reach by States run Two, Version for detection the on year-end. closing basis. for we operator. as later a priorities our base breaking in business, IORT the expand this today. Tomo use first capital available customer to To manage GYN so X, of Europe flow software In continue market the on in success major within and customer will skin lastly market our United I'd cash year. be increase will to out is to our as therapy to the And One, base the the market and while a we the our cash forward. Version our systems mammography prudently, all expand like to PowerLook of X version going next software to

of second call to With Good for we the these for joining forward first today again closing on and thank XXXX following updating you remarks, close you quarter. our of the look day. we quarter

Operator

call. conference do our Everyone, conclude does for we your you thank participation. That

now disconnect. may You

iCAD (ICAD) 14 May 182018 Q1 Earnings call transcript