ICCM - Earnings call transcript Q2 2024

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Operator

Good morning, and thank you for standing by. [Operator Instructions] Please be advised that today's conference will be recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.

Michael Polyviou

Thank you, Joni, and welcome to IceCure Medical's conference call to review the financial results as of and for the 6 months ended June 30, 2024, and provide an update on recent operational highlights.

the that to this issued refer morning. may earnings we release earlier You company's and Shad Tsimerman. is is last Shamir, of COO, joining CEO, Eyal the Ronen Medical's IceCure traveling the in participate communication VP company's in today and are dial American minute network due and his to location Sales, unable North and Therefore, Good; poor a to CFO

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

and codes into normally this review [indiscernible], in objectives jurisdictions, and we device for example, our and of statements with when a expected demand time for analysis discuss we're expenses physician adoption of reporting commercial FDA to we have in regulatory approvals regulatory XXXX the pursuit presentation market including that by belief line the of XXXX. our IceCure's interim reimbursement potential regulatory regulatory commercial execute in to of invasive respect clinical upcoming its panel process advancing for the technologies, in begin probation for ICEX marketing forward-looking strategies reusing to resources the advisory For various medical of

December The risks or Factors of on implied the set and statements call which materially the uncertainties, those contained section are SEC of available we implied those current the in this subject the are control the XX-F and actual IceCure including with company's XXXX, for to X, call. www.sec.gov. to based on statements results, XXXX, annual April are website or forward-looking and/or risks performance future at SEC's IceCure's achievements forth report such of year Because with and statements company, described filed the subject Risk Form this of various to uncertainties deal XX, during ended during expectations, other differ is by on which from the many and events beyond on the

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

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

IceCure Sales. over turn the I of Good. please go ahead. North Shad to call American will now Shad, VP Medical's

Shad Good

for Michael. Hello, today. us Thanks, everyone, and thank joining you

As is unable a the minute to difficulties, call due I AL Michael so overview. provide will network on his business mentioned, get to

growth demand experience of for press in evidenced XX% as reported ProSense today. ProSense as the half the During sales we and first in sales. to year-over-year earlier increased XXXX, probes systems disposable continued release for our

grade cancer early breast we the rest While on engagement greater magnitude reporting over medical XXXX of catalysts level XXXX IceCure. other an is IC positive physician in the upcoming have positive December, cancer the anticipate with kidney of conversations specific truism, believe impact may trial. along a analysis of in conferences growth at indications Moreover, to of we indicator, and and

the on technical matters expert help regulatory year on ProSense a to sound FDA in obtain FDA advise the breast device the that second early us Later meter. related scientific, note quarter, policy and make the care as to not It's ProSense minimum the health important During a the stage FDA's the We surgical by to that it advisory panel. will decision adviser importance the importance regulated for making medical informed decision women's States. convene believe of on public independent approvals with this of of extreme demonstrates FDA. health of and surgery being and standard of low-risk specifically base alternative is breast a cancer procedure early-stage public panel to a United the to women current being the available in

our a objective to in some more U.S. same ProSense to treat access ensure and women benefits. global jurisdictions, reminder, approved already available breast and the have is and same is As the cancer other realize to the care and

women from recently numerous the that who often around hospital calls near or ask use position they and world and with Our the breast team in cancer, the have U.S. received diagnosed been for process to avoid surgical its acquisition. to and they the by they travel many plane because travel to treatment a in incenses have have of are they because willing minimally choice want invasive

a wealth data of independent growing number been panel and participating ProSense advantage our have of ICEX our overwhelmingly study clear and advisory of the has from make believe, studies, and The crystal a consistently for including people that studies The evidence discussion. investigator-initiated we in study and positive. of the the set watching cumulates third-party

option panel FDA In therefore adoption by will should authorization in States fact, recommend authorization. United transparent the advisory granites forum marketing and the followed we a believe raise supported awareness that ProSense nonsurgical the of and as public rapid

for commercial U.S. initial team is prepared sales the Our push.

Per a [indiscernible] evaluation estimated of local similar current were both analysis more recurrence This recurrence. to expense treated a As hormone physician study, reimbursement a of expected by proantiblation, be to rates the the already subgroup followed reminder, patient patients expense in or rate In the the follow-up reimbursement, our for doctor therapy in with X-year surgery solicited is applied including at XX% $X,XXX care. of ICEX facility for and be free authorization. were place is XXX%. from very for satisfaction at of standard

low-risk We cancer. be strong a breast to are confident that there cryoablation treat for will demand early-stage

a from metastatic a and and studies Journal presented of breast Society minimally results at British independent with Annual treatment patient among for clinical cancer of and excellent of investigating clinical the overarching more medical cryoablation see populations, influential based breast of advanced were cancer breast cancer Cancer as of to XX-second continue the the publications theme. we Europe, of In such Radiology including Promising highly demand the an Breast results Meeting care Japanese cancers. varying

to in first Our company breast and approval partner device interest XXXX. quarter the also team for attended, we of that the our pleased Japan through largest ProSense's country, of very high of early-stage distribution level and the cancer endocrine therapy regulatory with were ProSense. medical in with plans low-risk file in in

panel cases performance world will the a be We around data the of it engine activities We submitted clearance. factor All be in FDA FDA our will the our will conducted from advisory committee well this post to the positive believe over data process. clinical panel. as as next enhance that decision the several very from believe months

good radiologists, at planning audience, are breast very United with our radiologists west surgeons. and be to the conferences medical States where be including Europe target We in in and interventional will we engaging

Thank Now going go it to I'm numbers. turn to over you. Ron over to the

Ronen Tsimerman

you, Thank Shad.

momentum crop Shad and continues ProSense earlier, counsel for As disposable sales. acquirer mentioned growth

$X.XX Asia, ended months partly territories in million probes months U.S., China. decrease XX, disposable XXXX, Europe, the the XXXX. For to by increased June primarily and XX% ended sales X by sales higher X Japan the million and in ProSense offset sales Driven June other for by compared a systems to in $X.X in XX,

ProSense for Total to million in XX, and other Japan compared X revenues from $XXX months decrease of due the were X.X% ended XXXX disposable the in to recognition of XX, as services XXXX, first systems including X services our by to months Japan the in the June $XXX,XXX and and revenue Terumo million partially in in $XXX,XXX grew offset XXXX, June months which recognition of the respectively. XXXX, and was and sales agreement for increase other revenue by $X.XX a ended X

the June Non-GAAP XX, Gross and XXX,XXX XXXX. ended the which grew by ended profit for ended months for from XX, the profit, X June XX% and the profit the XXXX ended X for remained XX, June margin Gross to $XXX,XXX gross of X consistent recognition gross from June months agreements months XX X compared XX, XX% X XXXX. months months tons, for The June X sales compared represents XX, XX, XXXX, XXXX, products gross the June XX% margin $XXX,XXX grew to XXXX. June ended for from months not the June for ended ended months XX, $XXX,XXX including revenue XXXX. to non-GAAP our distribution ended for for X X XX by increased the months

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

of had the cash the cash As of company July approximately XXXX, $XX.X of of company cash had XX, and equivalents June million. XX, equivalents approximately million and XXXX, as cash $XX.X and

$X.XX ATM sales During the the gross facility. ordinary XXXX, our first million half shares raised in under we of from of proceeds

XXXX upcoming of catalysts FDA quarters positioned as advisory execute quarter first coming of The in XXXX. major QX subsequent the has pan the decision clearance and the marketing FDA anticipated management prudent expected cash us to in including the in

Best also New will XX they to addressing of Annual Global provide Additionally, story we about note held York overview in Investment be technology. and our opportunities X participating to process IT Wainright's York Conference normal be being are the participating on Finally, H.C. the a investors New from educate Ideas September not at being September I'd Growth [indiscernible] with an Annual level the that will like Conference at in

for now call will Q&A. open we the Operator,

Operator

[Operator Anthony question of Maxim Group. Vendetti Instructions] The is first from

Anthony Vendetti

by to wondering I just commercialization It's that Are you're you go. And working a starting you outline you XXXX. the in XXXX? early beyond ready adviser pipeline, Can force FDA you with? KOLs, in know with just recommend approval AOL I have committee the physicians the out Ronen, what's how get then was do the you rollout? the the planned sales plan

Ronen Tsimerman

for will I Anthony, to and questions, you, So for joining us the refer thank Shad.

Shad Good

very to strategy targeting certain we key detailed development, we of And can KOL really a authorization, you growth a we hear that societies, we've plan expect. years. kind to Yes, here roles received next that just the the a we but X approval assuming in combination hopefully, developed it's also we're of support that have with me for FDA put U.S. into place working post the Anthony, okay.

Anthony Vendetti

talk in you Terumo. the the then plan I there? Can about there? Japan, And working And know with you're expectations

Shad Good

Yes, Anthony. Yes.

early in approval expecting Terumo in quarter. So that XXXX request the are for FDA file we the will first the

Of course, some also have of it based trial them. the data actual they that with on will be

So we're with them, with working there team regulatory very over regular their Japan. our closely with KOLs in and

Operator

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

Brian Kemp Dolliver

Right.

to first X half. on working regard curious why half, behind And inventory the of First, China year-to-date? just factors with just the Medtronic first in was the a or matter other performance I'm if Shanghai this is the

Ronen Tsimerman

Kemp. and you, other this thank own has bit its is territories, than China So a little different complications.

X sales in So are -- and sometimes, the quarter.

We in future. are they certainly in the quarters. able different China. the that China we guidance we can't really regarding Sometimes and optimistic, quarters give will But any be believe we're next in to

Brian Kemp Dolliver

the Okay. in plans your to The to data next leverage data the that question and and ability in U.S. ICESECRET particular? relates

Ronen Tsimerman

and in focusing Asia and what data at this definitely Europe, in breast Southeast the to Kemp, but in on territories So least also focus we're we're on, in going year, in is for the U.S. this utilizing other currently, we're America. next South mostly

us. assist definitely will it So

Operator

of is Street. Haynor next from Lake question The Ben

Benjamin Haynor

patients First slightly seems for some cancer several these are looking well ICEX one in different just that was. cohort patient less and me, than they like actually, the off cases, independent are for breast populations of at studies, it

the of Just And curious commentary if investors of potential capability ProSense? for away that? broader kind guys have your take on any you a what from

Ronen Tsimerman

joining. for Ben, and you thank again,

And their cryoablation promise. activity as So important and thing see most see do we potential showing We they KOLs choose the can in a the at side. own order independent understand in and to think also very set that consistent our to great very thing from data of group good I look is that is studies. the our it

provides we encourage which course, So their all papers very studies -- important to all next see can which physicians our for the the we and steps. of do do abstracts, and with own are us data

Benjamin Haynor

performed like sense. out is unfair there. studies something Makes helpful. you in then is XX That's know think And there release so you look any that to I question. this highlight the call. specifically I might press be? for an independent maybe an the or Are investors to ongoing being just that mentioned But be there But not take if should not on fully attention are and all curious any you're -- it paying a at, there

Ronen Tsimerman

of the So soon most were to we're But studies see more choosing about release or I or again, X for to submit abstract order very provide in if an we the so And as KOLs soon not not We independent course, everyone. studies. because, data study we submit this breast the And noting do happy sponsors. cancer. we, want the an decide correctly, of breast than we in again, are as really data are in to remember it, do to We as of conferences. mostly that to of studies. the when have our breast paper as the it's cancer, are the it independent a systems XX can't one optimistic

presented. Of course,

Benjamin Haynor

Got and good at it. progress on the Congrats luck the committee. gentlemen, advisory

Operator

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

Yi Chen

Would means, community how to comment the fourth early of quarter whether the submitted or numbers the they will the to in I will take you end FDA? place have the many able adviser of be kind year. material on the community towards in and whether be

Ronen Tsimerman

Thank question for and to refer for Thank you the the you, questions. Yi. thank Shad. Okay. you joining I'll

Shad Good

date of you meeting have to details. I'll notification, for the we'll and the the to first of second shortly. the the we second Yes. part we answer the available FDA can Also, the issue But your that repeat webcast question, the And meeting expect the have provide a you repeat receive receive the a release once to will part part for link announcing press question. event. make of we'll the question? And

Yi Chen

review will the will the only they committee many be submitted in material How members and to FDA? whether

Shad Good

number So and support also event. exactly well behalf we we're will yet, out to we surgeons, right be FDA. expecting of clinical to know the now, -- lot the met the as will oncologists numbers on experts don't additional exact used of participate the breast expecting help radiologist this don't know we're who regulatory our be there on the a event efforts data that of in that's And breast in

Operator

the Tsimerman this ahead. [Operator further time. concluding will Instructions] call now statement. Ronen his over There at to I no go turn are questions for Please

Ronen Tsimerman

So we we of of have everyone And indications. for and on call. early XXXX goals and cancer through to other more first studies our today's we participating thank want the achieved on 'XX, data from XXXX. half expect independent remainder for the breast into

in everyone, we FDA release. as the you, and who through today. press the date for soon panel, will a call details public share on in the have with Thank those As participation the for the our participating in you advisory

Operator

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

You may disconnect. and go ahead

IceCure Medical (ICCM) 20 Aug 242024 Q2 Earnings call transcript