IceCure Medical (ICCM) 26 Nov 242024 Q3 Earnings call transcript

Good morning, and thank you for standing by. [Operator Instructions]. Please be advised that today's conference call is being recorded.

I will now turn the conference over to Michael Polyviou. Please go ahead.

and welcome results Medical's the as ended XX, and review call X Joni, on September financial update the of XXXX, you, to highlights. conference IceCure to months recent Thank operational an provide and for

the You that we press issued may earnings release this earlier refer morning. to

Tlalit IceCure CFO company's Development Business VP Chief today's Tel-Tzure. Officer; Operating Marketing, on Participating Medical, Ronen call of and are and Tsimerman; the Global and

wish will also IceCure is Chicago, be Clinical Levav, I Additionally, seeing They call of America some Applications, session. personal questions-and-answer that of everyone on Quality will North Thanksgiving be and of Regulatory unable a U.S., and matter RFNA you today's there. radiological his Shamir Happy the and Affairs, join Annual IceCure Meeting Society VP and join due I'm all Eyal or for to in ask call sure in Shay behalf. CEO, to attending the a him will next week's

we securities of forward-looking and plans, statements. Litigation statements. now laws. Before safe of about that and Securities of other intended question-and-answer the statements the identify our variations call follows are anticipates, meaning to expressions the Private Words forward-looking of take to expects, XXXX or believes, session and as Reform similar read provisions within begin, Act the such a contain This statement estimates federal forward-looking moment harbor will intend, that seeks, such words I

its in results worldwide. growing the that financial belief forward-looking system example, demonstrate For discuss we for traction the using this presentation we statements when are adoption company's cryoablation

the that The efforts. the gives final from Advisory authorization confidence Process concerning the efficacy safety process a and to decision and potential believe doctors growing supports company's across that FDA's commercial indications milestone Panel receiving authorization. decision the FDA Meeting evidence the the body patients belief on marketing marketing benefits potential and of a timing authorization prospective marketing the on prior is for FDA that The

The expected on are that upcoming has in the in worldwide well Process catalysts growth Terumo the sheet the Corporation file revenue belief the belief to grant approval XXXX. to marketing cancer balance FDA company execute in authorization XXXX company's of that early-stage it that positions The in breast first to several breast cancer. opportunities regulatory Japan quarter value the enhancing with of

momentum should FDA prospective the the call Any revenue. trend uncertainties, sales a during clearance as in or upward company, those events current deal to and they in risks of risks the that this this are could the other set ProSense, statements which implied on future such the call. are in on section Commission U.S. many available forward-looking Factors Because contained of expectation add are from with including in with to implied of XX-F website, actual Risk to are forth the grant result beyond December The will expectations, the various X, subject and control on of Exchange materially its those further current achievements and subject or and or and to based on statements by IceCure IceCure's uncertainties performance described results differ of filed year-end report XX, XXXX, www.sec.gov. April XXXX, SEC's which Form company's the the on the annual Securities is statements

events call XXXX. conference today, whether to information, obligation, or future update or company law, This otherwise. contains because The time-sensitive only information XX, of the as by new intention any November disclaims or of any required live statements, revise as except broadcast forward-looking

measures information reconciliation issued that the these point. this we tables course and about of we during release will to non-GAAP addition, included are that metrics discuss the we this refer you call, certain non-GAAP earnings and earlier other in In measures, press the

Global and to over call Business Development go ahead. Tlalit, Market, I will the turn now Medical's please IceCure of VP

Thanks, trajectory. and our for growth both truly you metrics and months a XXXX us This improving has in our for financial asset transformative joining review been Michael. Hello, to everyone, X results. year terms thank today of milestones,

X increased XXXX, more as sales by gross process first non-GAAP XX% drop by from gross increased and profit year. of and months the last XX% growing XXX% same the margin to continent than During to compared non-GAAP XX% doubled, period

our prepared Our adoption demonstrate results and remarks. during the his growing Ronen will worldwide, financial for numbers traction cryoablation over go system

April completed trial. In successfully XXXX, we our

is early-stage conference, as peer-reviewed Society ProSense including an us positive prestige breast of American in earlier We Following impressive presented of the were at this, corner and influential, the Breast to potential closer lampextomine this on up marketing Surgeons the leading process. authorization. towards leading patients cancer believe decision the low-risk authorization the alternative FDA FDA's one the final data highly outcome bring for advisory this to publication published marketing milestone step for were month,

addressed We remain labeling and the in engaged are FDA ensure process. both the of of the panelists regarding to the opinion authorization

offer FDA the decision occur the in quarter next few the in nonsurgical of is early that or lumpectomy a The potentially would as expect the us to to will U.S. allow continue We to women XXXX. it in sortation marketing first months. received, alternative

Our U.S. deliver. are ready sales poised team and infrastructure and to

including Upon reimbursement, we X for as known We applying marketing physicians already established reimbursement additional code. widely for have will a authorization, code the expense, CPT expense. the facility be

radiologists, the an and were believe which published gives will other evidence confidence independent efficacy been of process, start and XX oncologists indispensable quarter, efforts. cancer and interventional ProSense have commercial studies on most in present breast on cancer. our of breast large as interventional presented as growing doctors for the surgeons, tool indications, that become and body in for breast patient astonishing of support believe alike. safety We patients and well the Since third and an We

as breast are of one largest date. study that the We world's was chosen exclusive to system pleased cryoablation recently particularly the Process cryoablation in

Institute both led by of multidisciplinary by of and the Umberto study. European The collaborators breast on which Health and XX expand our the in age ICEX PRECISE at luminal patients A will study with patients Interestingly, the XXX also is luminal older and and Italian study will will population treatment oncology. younger PRECISE Foundation treat treat financed treat the Prestige Veronesi women, this Ministry will cancer. and

mean the year value in we that of to we Interim several a results demonstrated ICESECRET at is the from XX.X at early cancer. for Prior enhancing. of recurrence-free prospective trial of expected follow-up that upcoming rate the ahead catalysts an ICESECRET Looking December. interim multicenter of are rest kidney have ProSense clinical XXXX, are believe single-arm a months. our study results treatment XX.X%

in cancer Corporation file receiving to Terumo with expected Japan, regulatory process in approval aim of XXXX the in Japan partner for of clearance. is for Our breast

expect medical numerous will journals We that presented be medical throughout on third-party at also Process data XXXX. additional published conference and in prestige

to the call Ronen? Ronen the to go turn Now over numbers. I will over

Thank Tlalit. you,

months XXXX, by the mentioned Terumo higher and other ended of ports X the in disposable in Tlalit momentum in and Japan and $X.XX as the grew ProSense for to increased million recognition including U.S. XX% revenue Japan revenue XX, when probe the and months disposables, continues as Total sales September the XXXX, agreement million XXXX. services from driven Europe, primarily a $X.X of by by earlier, to by for which for September $X.XX sales September due compared at ended XX, X X $XXX,XXX compared months of services months million in X our to end 'XX, XX, a Systems the offset partially systems to decrease Japan. As other XXXX months in XX, revenue Corporation process sales respectively. September to recognition million and and growth and $X.XX in $XXX,XXX for and sales. was the increase XX% X for first

XX% increased months by ended margin $XXX,XXX compared XX, September increased ended September ended September XX, the X% the in the months XXXX. XX, compared X X XXXX, months profit to XX% months $X.XX ended XX, X XXXX. Gross million for to for for the September X to XXXX, Gross to

We to more from recognition September sales from months not agreement for increase profit, report XXXX, gross non-GAAP our XX, XX, products, for of the the including XXXX, of profit ended distribution doubled are ended XXX%. months represents than $XXX,XXX revenue to which an from X pleased gross that September X

for loss the to the million $XX.XX narrowed or expenses operating for the during to and mostly non-GAAP from are XX, X the $X.XXX September decrease the a XX, Net expenses. earnings $XX.XX XX% attributable these in gross general figures press months share September research XX months per Total ended to September and loss XXXX, X for of increased for release development months the Reconciliations the ended XXXX. in per XXXX. a administrative months September and $XX.XX $X.XX or net ended is X million today. ended Non-GAAP included to ended reduction $XX.XX million compared last XX% to X of earlier margins decreased that same for X XX, months period XXXX, million September issued are share compared The year. and XX,

As cash and approximately And XX, and equivalents equivalents million. had of XX, had $XX.X cash of company of September million. cash as XXXX, approximately the of XXXX, cash company $XX October

the expected we of We cancer. the opportunities growth that now FDA first should Q&A. During Operator, XXXX ordinary for particularly market shares milestones the our U.S. from the marketing the net sales to and quarter of for worldwide XXXX, call raised will facility. revenue under $X.X breast the on first execute early-stage grant us X in proceeds the believe months of million position open authorization well in sales the processing we

Instructions]. [Operator

Vendetti first of The from is question Maxim. Anthony

you. Thank

be both the in In later? partner you file to decision press your for is know X romo, And you ProSense. is 'XX, the they half talk ADCOM March? -- in first meeting in approval have 'XX? that I given U.S. second what's soon they once then favor and likely on Japan, guidance for they of to of likely discussions it with mentioned for be in the I a end Could Based XXXX, expect then the Japan. process make would first, -- or file it in release there regulatory the you the X want half to approval? FDA, the for And before that approval about it to your could So then that

Hi, thank will your U.S. I your start that. questions you the regarding FDA for questions. the and with Anthony, with in

final exact to somewhere provide QX. clearance. the we providing the didn't answer discussions should in timing our we that on expect receive believe, for So based FDA But us do

we share have Of when to more with we'll be data, the course, public. happy

very working the do forward submission in in assisting the We're on Terumo As far our know Japan, to they date. we on them using data, we probably planning not update in that it everyone them. and work working XXXX. go We're as are with we But again, are the are will with closely. They we're as trial Terumo.

clock a how Just a though. of I approval process in that, the don't actual works Is once there know you on the terms actually reviewing application. Is ticking? like follow-up file? Japan

So answer? this I will defer please question Shay, you can Shay.

Yes. Anthony.

with into taking be account Terumo Japan data, from the outcomes So by the will submission the including study ICEX the done FDA. that in

We until approval PMDA expect approximately a from the year that submission it will in from Terumo the get will Japan. be

Markets. of from Dolliver The is Kemp Brookline next question Capital

Thank in build-out the -- timetable regard U.S. you you look of effort. 'XX for taking the your question. pace U.S. Where what's assuming -- into to you your as are you expected of mentioned with approvals and sales XXXX, of you've team. do commercial pace And the stand the

the question. for Kemp, you, thank So

sales the will to we reps year have sales reps currently XXXX with clinical start will our support. we We we currently, of number And and VP, start Shad Mr. have. the Good same

we XX As that approach add XXXX, be based around the probably sales continue a FDA but our on sales we step will plans, and to to clearance, it at expect get reps, we finalize reps. will between X hopefully, will we grow

spending of to regard I'm in your though you was with decreased the probably year appeared that this R&D period, decline preparation it this assuming was ADCOM. And Great. it as the expense has expected, smaller. in

somewhere as the look year the the R&D any balance level? say, further early expect spending of do into, and current we around So sequential or -- next you in year, the decreases

new the expenses, we R&D expect a to reduction since development see the system. our for finalized as accent costs of far as in R&D did we So

system. now, but We on new on do the working but start we costs definitely are work multi-prop we In to system. new Actually, same are it's probes, developing did our right a too work. XXXX, the as say expect early also completely not to

So work we on in will that XXXX. to continue

of Yi next from Wainright. is Chen The question H.C.

Do five homeless So do report concerned? address ProSense upgrade aspects voted not risk you that be think that no. do future believe And as of there's who for panelists any process you those those improving benefits the think the and could to valid?

your to Shay. for will you thank question. and defer Hi I

question. this for Yes. Thank you

panelists the So that the mentioned five explanation no, the also it voted during to actually, they voting.

they define was the encourage post-marketing they the way most said in FDA maybe the on of of The have with of for to to them a vote to ISO order performed three if the reason special control would on efficacy field. them work product main could. it controls closely have continuous safety So control that to the and and and in

statistical more was One are of the widely. that and who and -- one something study, believed voted person in start uncertainties an there the some use to no, additional our the it by getting that the product approval who this is II

We are to data, results being in are we out able seen seen to the study. we determine similar what -- collecting the the that will and field be be have will three there in the that

little No using about said novo this device. FDA in clearance work who us. a the is panelists the bit own of de they that special get our controls the predicate that some worried their And that like would order they companies some to of for are voted requested other I also to with

next Instructions]. is [Operator The a Anthony Vendetti. question from follow-up question

Yes.

out On the you by you lung, -- then talk But as 'XX, U.S. ProSense of 'XX treatment road because are liver, the in the curious, far end kidney And know market, line also is is the I we just cancer other treat you discuss of results in still And breast the expecting the 'XX, opportunity that terms about we and -- think kidney? tumors. opportunity Trial, that the down cancer can other interim can in the kidney, ICESECRET for there's what's indication indications, priority. top know is what I'm can how December?

Great. Thank you, Anthony.

approximately to the -- expect So see still regarding these follow-up. somewhere the first And week. results interim the with them of -- beginning we or on are years is the trial, X this about lease in results ICESECRET December, at

are year. as the As XX,XXX about U.S., patients we the new far in indication every that know there

So this to is, all, use see as we cancer mostly U.S. and but need is because the utilization cancer, And process looking priority you breast and first the in definitely is it traction demand, also do we're also at have. breast of that the extremely an said, high. our in and unmet the unmet see our the need, first for we we

call Ronen a over this at Tsimerman I will There are statement. no time. turn further questions the for to concluding

for Thanksgiving. grant participating early-stage authorization upward We in to those add for everyone, the Thanks, breast cancer. to the to trend the forward then on in U.S., today's FDA's happy FDA the our revenues. have call on momentum a look and we expect listening decision further marketing sales clearance, in of in current Should U.S. process

will San reach I in meeting if Also, Thank meeting. Mike Please Eyal January the Conference. all. Healthcare a and and in to JPMorgan be you early to during out schedule want investors you Francisco

Quarter Third the Thank Thank XXXX Call. participation. concludes Results your you. for you IceCure This Conference

ahead go may You disconnect. and