ICCM.TA - Earnings call transcript Q3 2022

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Operator

Welcome to IceCure’s Conference Call on the Financial Results for the Nine Months Ended September 30, 2022, and update on recent operational highlights. Management will provide an overview of IceCure's financial results as well as clinical, commercial and operational highlights. Participating on the call today are IceCure’s CEO, Eyal Shamir; and CFO, Ronen Tsimerman. They are joined by Dr. Hania Bednarski, Oncoplastic Breast Surgeon and Cryoablation Specialist at Serenity Surgery & Wellness in Myrtle Beach, South Carolina. in only are participants all a mode. listen Currently,

and will be the presentation, for Bednarski management IceCure's session. Following available Dr. the question-and-answer

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

For key from example, approvals regulatory when ended in forward-looking expected CEO, subject statements described clinical XXXX adoption market to the with our applications call including on on growth, the control sales and in regulatory we as is variations strategic and will The quarter-over-quarter this revisions jurisdictions, XX, in and this The business uncertainties clinical deal now plans, statements differ the the risks from the commercial trials, Annual and except IceCure's X, those advancing section potential over of in release, statements turn and other risks forward-looking for presentation and contained IceCure’s or the on actual other implied Because April website, subject such XX-F presentation. highlights Factors for of we forth the presentation technology, this these operational are or are Shamir. IceCure’s many future minimally-invasive using by to required obligation implied cryoablation they various no current available with future expansion I performance, Eyal by those and and IceCure of www.sec.gov. Risk results discusses set achievements in on various revenue could company, or to of are of strategies and materially after changes of pursuit commercial year date Form expectations, or future in are events to of results, statement release which statements update based are Report of December SEC the or the uncertainties, company the undertakes filed of SEC’s beyond XXXX, company’s which law. periods. this

Eyal Shamir

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

We this the interview development will months an of third our XXXX. significant quarter results the review ended financial XXXX followed the start business XX, for of nine by of of September

her hear XXXX. of cryoablation performing who doctor on Dr. before from breast share then And Q&A. from Bednarski has breast since malignant technology, the the tumors Bednarski, call breast Dr. thoughts will for tumors opening a cryoablation will already perspective We the for and been benign surgeon's

reduces from of strides cancer end marketing a to of the following huge in current are submitted a breast surgery low for for XXX,XXX authorization early FDA reflecting breast recovery future, In trial explore our for submit XX FDA the made immediately of final women broader U.S. group outcomes. both the we the indication the first for the the in alone five risk Novo at During October, stage breast rate clinical ProSense of better suitable the cases alternatives. indications cryoablation, third breast cancer importantly, ICEX with improving Luminal filing In to (ph) XX,XXX with indication the which results the surgery, cost, lumpectomy. and recurrence without XX%. older, and the the interim more for expect treatment not patients cancer ICEX population entire approximately plan study are stage able early initial data Most age that on ProSense cosmetic interim An At U.S. tumors we at estimated a total marketing low In additional show quarter, analysis. of with cancer. of cancer on who De we reimbursement [vast] risk very destroys are patients classification release women XXXX, U.S. clearance half our to of for represents the of the therefore and regulatory all breast ages request U.S. annually. a annually. trial clinical of based Minimally-invasive standard and of time approximately XX,XXX risk, stage commoditization in in annually for need These for We in approximately year the ICEX to believe for towards alternative representing of women the part We the time, to indications subgroups care fronts. risk on ProSense women regulatory we for to we open cancer early A breast follow-up. the and plan while surgical low free results strong were of file that our

based treatment on While for additional and will I Category go receipt the FDA for the on treatment CPT approximately nitrogen cryoablation FDA category knowledge, $X,XXX. the Services cancer the factors, cancer. expect alternative we significant have liquid at trial breast for ProSense able forward our of X, payments November, low-risk largest CPT breast the In first permanent the of authorization company ICEX III ever and of conditioned the into were we to treatments. Medicare small only ProSense’s U.S. Under specific our breast is achieved multicenter in Category and of stage to breast physician the on look a results as surgery. cancer. fee IceCure cryoablation controlled assigned will achieve concurrently is tumors try to the coverage, in Medicare the response To based reimbursement We Center the we our in an to file for CPT the filing, facility study, cancer cancer our early of code, a of CPT Medicaid marketing January this of our several coverage for including XXXX. a III for clinical including milestone performed code breast which FDA's the to alone, cryoablation malignant ProSense code, code, This establishment the which the effect U.S. for upon receive

additional for essential We for cryoprobes are regulatory proud outcomes of position, the leadership on which achievement ProSense Applications front. financial were Globally, this for use approval for pave and deliver palliative In we I other treatments wider to to Brazil, turn will in that also Canada minimally-invasive tumors interventions. the and of regulatory helps the and benign the single and our for filed which breast and components are Ronen our ProSense use the system received our cryoablation disposable better way over indications results. introducers, made cancers, Vietnam. ProSense call advances patients. now of including

encouraging This of want out a very indicates the the ProSense and increasing in conducted disposable that the across to world. I the our system do, is I treatments of installed point are increase being number Before of with trend sales use that probes. single base

nitrogen in into may ProSense for near acceptance we be our indicator which based translate While liquid cryoablation a sales. see will as variable to future, believe continue market therapy, we positive Ronen? our the on quarterly revenue the

Ronen Tsimerman

you, Eyal. Thank

and $X.X due nine period same million of million distribution systems approximately as is for of with clinical were compared the revenue probes to months XXXX, from which sales offset approximately disposable and September by installed revenue Corporation decrease decreased the sales The For a sold to recognition was previously agreements Terumo the in decreased $XXX,XXX XX, for new ended to decrease $X.X last year. by approximately partially of in utilized XX% procedures systems, higher settings.

$X.X September The in the Europe in approximately Gross and million development in were sales period in approximately XXXX NASDAQ attributed single expenses million administrative and expenses compared Sales, expenses to same XXXX. system the approximately was U.S. period for The For Terumo XX%, by months next XXXX million September The $X.X development same increase the compared were year. nine decrease $X.X compared for and for and the decrease nine attributed profit nine activities. in and approximately a XXXX, margin nine Total and in in approximately due $X.X months last related was expenses to period expanded Asia to was were ended listing last sales in operating million development, XX% September clinical to to the XXXX. regulatory approximately period XX, Gross $X XX% increased listing period compared attributable the XX% for The the by offset nine same ended for and XXXX acceleration compared increase in period and million XX, the period XX, to operating for same to the XX, the approximately compared probe to was million increased efforts, territories. respectively, approximately months ended for year from two, last Europe expenses. the approximately increase in the activities. U.S. year. the $X.X generation September XXXX marketing primarily sales ended approximately the XX, months commercialization same $XX.X XX, and to other IceCure’s of The months ended increase the in attributable and same in for and last was increased Research was to margin to commercialization related NASDAQ recognition same agreement. distribution September XXXX. decrease nine the for mostly million months company's gross to ended September the from the sales million $X.X revenue and XXXX, compared general year. was in

increased was $X.XX nine loss of share or last period a months loss of the $X.XX result share year. compared September with and per a for ended for the approximately XX, approximately or $X.X to million per net same As operation XXXX, reported activities, net million revenue increased $XX lower

to of XXXX, Cancer cash XX, radiologists. where Beach, $XX.X through Treatment. turn breast received an in owner Wellness approximately of and including breast. is tumor An the breast breast well cash recently Bednarski Myrtle book Bednarski. Dr. Carolina, Alternative also deposit I She she had fellow the is term procedures biopsy surgeons To IceCure Hania reconstruction an for CEO breast is is Guide Breast and Your She co-hosted oncoplastic now over of of equivalents, will surgeon the from Cryoablation Breast million. author and cryoablation. As wide in Surgery webinar call Freeze Bednarski Serenity September by that Cancer, & IceCure Tumor surgeons breast specialist Dr. Dr. Breast and short of performing a of the South was titled array

us have to pleased very today. are her join We

Hania Bednarski

Thank much. you so

since I've procedures. So I simple easy my system readily XXXX-XXXX. truly And This based ProSense to handle. use. system Liquid cryoablation patients cryoablation saves system. since nitrogen available, the easy recently, the regularly been a few the and it's source and to up often the lot the want more to single about using It's It's things mentioning time super XXXX a of the on area. to is start really by for set It's for in to providers. just office. in easy office

an done a are soon cryoablation XX procedure, half. treated just minutes ultrasound with of breast and resume as few the depending can on comfortable can after There very in the cases under to be biopsy. need can is they XX hour would fibroadenomas treated they This So for hour anesthesia. to cancer activities Patients and anesthesia. location guided as as purely is within normal as an an local their throughout tumor. no general and be And size

breast, tumor often well The regardless other if do of results cosmetic the be really defect the very more breast. regardless self-conscious visible. really really that. in a position and get there can the I area, size of about cryoablation scar, appreciate breast that, for can tumors when take even cancers, upper in tells at have the the little we patients positioned, breast tumor get the inner we is And we thing There's that's the tissue very a wonderful even that don't the if surgery they Unfortunately, and especially for of patients defect, is of breast quite have first all scar defect out can when the a in place. tissue decolletage that we of

study least States The look XX% that surgery are applications. [indiscernible] statistics mention the that, general in other the about United on at depending XX% at I'll thing you for to that is

cancers our in to of So when we do go have breast surgical of for XX% excision the we clear. to margins margins, not back additional meaning, XX% are cases, that

margin one one is aim cancer minimum or either of for accepted for say There breath is no a So of we one that's studies surgery some cryoablation, the have margin margins. we generally the for surgery. very tumor, we edge breast removed. but will that And the millimeter a found With breast with of a close ink on actually at centimeter cancer millimeter are margin. margin aim interestingly,

the procedure. actually margins room, In in operating patients is use take ultrasound take are this It breast practice, feel XX And able of problems So I my and at and support more willing to doesn't issue, up out team. pocket to need can really procedure, private I've lot millimeter it's ice with achieve. difficult, gives the pay and They're I watch real everything lot confidence with staff of willing long very use pocket achieving no me this feel do in to really that training for using really pay office insurance system. from that ultrasound. that. a really the the all. My a of that's the been any procedure. with gotten facile personally set in great of time IceCure's on I've even want cryoablation clinical you minimal And to really I the wonderful in to refreshing. ball been and comfortable can system a they that is And the form out margin not that quite

for good to I'll been questions. procedure over procedure patients And it's office, have to and to to So my refreshing any it really this give turn really success.

Eyal Shamir

insights. for shareholders clinician as who Bednarski practice has sure a a been appreciate sharing we to our for Operator, open the using your I'm questions. private Dr. ProSense. perspective now you, your Thank like in would call

Operator

this at [Operator we the gentlemen, and Ben ahead. Alliance go Partners. First Global of question is question-and-answer time session. begin Ladies you. Haynor will Thank Please from Instructions]

Ben Haynor

for Thanks questions. morning. Good the taking

the a appreciate system. Dr. lot you with a First versus patients you perform presented with for off, also sharing when that for are lumpectomies? into Do if Bednarski, patients? do, IceCure decision option lumpectomy? goes What And experience your you of cryoablation

Hania Bednarski

do. absolutely I Yes,

an in discussion. same. the am lumpectomies, and do This Breast are and that biopsy absolutely and reconstruction, Oncoplastic everything through partial my meaning, I interesting is So practice mastectomies, from Surgeon, reconstruction I do I mastectomies an

making at So criteria very undergoing I for at the point. point should process, a that much it's personal personal fit patients that say, discussion of cryoablation, a that decision as

at I far As -- point. that as equally both offer

A over they really So if they age, XX either or. tumors have years women fit the of criteria for could in Luminal

is just But breast not cryoablation of the the woman go necrotic she's the out, dissipated tumor not zone, a that So then a for tumor point, a desk. obviously, if and some there we the simply at not freeze slowly going then that cryoablation. stays tumor that and are on it's in very on -- is will cryoablation With offer does over much And decision time. the cryoablation, until the patient's part tissue that the sitting to is really of rest women that. type pathologist's person wants

I cost, take practice. that insurance my of other is, point at The don't again, part in it

making However, no the points. or But I apply And much reimbursement question insurance. patients say biggest for hoping are that's cryoablation. partial future. is that for to there's than this a can in it it's that time at to I'm those easier mastectomy for decision two would that now, for lumpectomy going change the get

Ben Haynor

sense And women on of that? want for the the what's tumor see ones what that the to want of to table, see your proportion

Hania Bednarski

it's number. out XX% we're about So would not angle, of probably cost It's those a talking patients. that just if I the equation, taken is of big about specific if say only

Ben Haynor

Okay.

use color stacks like And since maybe sounds [Multiple I that helpful. a a as then Is Any would ProSense. color it So But It bit it XXXX. there liquid you. And other than like how you'd for Speakers] case? better sounds [indiscernible] little the on it's experience small. any systems be cryoablation fairly nitrogen mean, up?

Hania Bednarski

Yes, you're absolutely right.

that is systems. other I machine. came to do a tried system really the ProSense itself system. came IceCure I back speaks use. with market like least couple ProSense best it do at I I for for my really guess me, their So that on I feel to I this it. back started the I of the and for system. And And

I that aspect sized liquid it's feel the think easy, the cold margin other trust for really it. I simple. liquid well coolness, our we And and solutions. good I a get that is nitrogen straightforward, achieve really nitrogen I probes very very the patients. of are the that with than better much feel

Ben Haynor

Okay. Thanks. about there's moment, think do they cryoablation? a on sense you known quickly of the an that will of FDA do once kind I you or clearance pretty progress? think think your of label modality colleagues mean, get That's what just And how or cryoablation think at becomes peers bigger your I peers helpful. a then mean, your it

Hania Bednarski

Yes.

of to of this left of So actually you're And last versed not May at And the cryoablation, Society behind. be past Breast well is being how it President, in about the talked true. important that's was you're who American conference cryoablation. in the do Surgeons if I that year, meeting believe our doing essentially, speaker

truly such do is for answer about your more process, to there. take hopeful colleagues that a on clearance, that our will I'm and I my more wonderful think the FDA with because that yes, of awareness question thing patients. it's So just we awareness, this definitely can

Ben Haynor

then guess, couple And Eyal. for I Excellent. for, Okay. a

[indiscernible] of might of anything handful financials the the on in on that of there revenue or weeks side? QX considering can the -- QX. you on left should side for Just anything kind like terms share be got look what now we've Is a looked expense we in

Eyal Shamir

Ben, expenses, normally. giving revenue And guidance we give you thank for it for and much -- at the are of right? beginning will report we or year, the any you we doing as didn't as know, We it question. very the you Ben, are not

Ben Haynor

on And submission. Okay. enough. Have you I'm with you FDA guys that a share process? on had the submission post conversations then again try. the FDA anything That's fair and can congrats the just got any

Eyal Shamir

the we to in a have clearance. We sharing but don't the the after on discussion report, to had submission information we are yet XX. order continuous them with agency with October anything We get have

Ben Haynor

Okay.

So no stoppers that or show there's point. on surprises

Eyal Shamir

stage. this at Not

have We good continued discussion.

Ben Haynor

Okay. for and the taking the on guys questions Well, all thank you congrats progress.

Eyal Shamir

much. you very Thank

Operator

Maxim Group. Anthony next of question Vendetti ahead. The is Please go from

Anthony Vendetti

start I'll Thank you. with Bednarski. Dr.

So so expertise. there with there's sharing up just feel a I set on on or your is be that the used tumors? for that you limit to and ProSense way is size was much size, the was limit based it system, and And helpful. wondering your larger just really experience do patients you the Thank tumor -- with that right the consumable? a for believe system you the could now do

Hania Bednarski

Thank the question. you for

we way cover we're So the than currently probes go centimeter two a make tumor. a probe we'll a because That cancer around. entire margin manage manufactured, the about talking to to way you all centimeters. the cancer, want one centimeter can't there's maybe to for that tumor, breast are multiple that place much probes with the breast We bigger say here, be like nothing to tumor to sure don't really each able said, hypothetically, that X.X within

larger tumor a have overlapping larger, tumor if to balls could pro So cover a overlapping positioning ice you is potentially size. and

Anthony Vendetti

now, evolving about later that of then, cancer. in talk that's be the you stage stages, once early for to stage terms see to or it's That's treat options? gets when able later it Do different you And stage right helpful. Okay. breast

Hania Bednarski

both of available. I that Well, some is think

used to So see larger stages. being the tumors, yes, system able later I do be for

centimeters. is stay now, for, less a centimeters to used breast tumor as five than essentially stage into that two them it's one being two Tumors is cancer. right a bumps defined automatically So two what which

potentially yes, matter for be simply definitely I cancers no larger same the are So not cryoablation, what. treatable breast useful see would some time, At tumors. it being by there that

cancer things that's cryoablation. by itself, the should not treated treated actually inflammatory that that nipple not be be like should breast cryoablation. So something infiltrate Tumors with

for think that cancer. many certainly So generally, used different in can but this limitations, be are applications I system quite there breast extensively

Anthony Vendetti

And very you you cryoablation the That's can doing Okay. this competitive XXXX, systems Bednarski, helpful. to there. since out back you've I since more little color said know been system. if on the you just a give came ProSense Dr. us

it color this about liquid helpful. ProSense of just systems very terms nitrogen best else what that is out more the much. you you on in specifically or would out Just other said system so are Thank a anything there, that there? system the clearly Was the be little

Hania Bednarski

Sure. Thank you.

from mention, believe, mentioned support earlier, the So it that IceCure. I one I'll thing I is

feel organ are at breast think that there least. why of yes, cold. but a and Certainly, tissue of they organ my used subpar, for that systems market, effective breast more aspect be are other I said, can The I for honestly, feel not literature. competing experience came are probes It system. that my I to get the maybe from mainly reviews cancer on really is facily, the the that I based huge back is some use does And cancers, quite not That the cancer, systems based. much as for smaller. as

believe that that trying there there on minute, to There market. only facilitate nitrogen's is don't far as talk past some the IceCure As based are right nitrogen competitors, believe the and now. I this that are cryoablation in some heard I themselves. system were some any I've liquid right know liquid the But I

Anthony Vendetti

you received Okay, or you approval great. question That's Eyal. very helpful. one know in for for and in -- you Brazil those. submitted approvals Vietnam, you I then submitted just approval and Canada regulatory And

a little on Just Brazil, you. Is Vietnam? you approval there? you commercialization talk about in And on expectations. bit the that and that Canada schedule in any Thank have now can about then, update

Eyal Shamir

Anthony. Yes. you, Thank

ANVISA like review, two got regulatory I I already, about that from we my clear required got in as mentioned probes. we to Brazil. firstly use So Brazil approval so would submissions, our on the single

semester the This of should get on to machine on waiting during approval We first next our are be box. the still year. our

signed launching some actually distribution and to to breast soft [indiscernible] and U.S. already agreement even some started sending the training they do have in We

regulatory will start which Canada well we as to So the as first next year be we also to as commercialization, Vietnam. soon be during expected has semester the in as get [indiscernible]. supposed will approval, of is

the So this plan. is

Anthony Vendetti

Okay.

everything's So on schedule.

Eyal Shamir

Yes.

Anthony Vendetti

queue. All much. Thank right. Okay, you great. hop the I'll so in back

Eyal Shamir

Thank you.

Operator

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

Kemp Dolliver

Thank you, questions good day. related couple Dr. and a I have for practice. her to of mainly Bednarski,

many how high do in percentage see the cancer So been breast does data low that about square point? are cases how is cases demographics patient of with as you versus And that population the talked to annually? with a your the risk press risk release and has cases regard starting

Hania Bednarski

Yes.

So in I the change practice. that had will have -- question. for I will mention recently a mention thank I my you

So in I as came in hospital doing an hospital been employment practice. practice. employed And I've in recently and earlier in the aside, back and private private the both cryoablation year was

So averaging I've about my And past, cancers now, right my little. a practice XXX I has changed about cancers the I'm new say year. a numbers probably would to year. per bit, averaged XXX dropped so breast that a In XXX have

change numbers So especially percentages dropped said, that in follow going population. population the my patient That all do my practice. the to bit, I with a really cash based have feel practice general with little

X So line patients about of I would XX% the there. with say cancers, XX% Stage in really which are is there's And general difference population. A my no to Luminal that

cryoablation to about into see, XX% So criteria that's that patients for the very I fit XX% think easily procedures. the I of

Kemp Dolliver

younger tied patients you is they're want And instance, are more -- I'm versus do emotionally be XX% your open that earlier if there trying may patients here? you. just lumpectomy these wondering of something any who just the roughly -- older lumpectomy. curious, I'm are patterns new. notice to who For you mentioned demographic Thank to Great. patients And

Hania Bednarski

I seen differently that very same difference. interestingly, respond really very No, and I've at all would similarly both time. there's the tell you demographic no

not that assessment. that that fit specific I of type So demographic would into say a there's

patients to Although much on that such anxious of word have out. becomes are the those thoughts more and what an a you I of it and our them, it's put breast really ones not that that is tumor we get they demographic is really no this, them that emotional want that emergency want that emergency I ones medical but will reality an The even cancer there the a in we good call together cancer are will a certain stuff, some can not patients steps that out. tell that and when that time tell all are say emergency. and it's the row our that they And all that, automatically just hear tumor matter

Kemp Dolliver

see you. like what the Thank improvements it. the you And Got would to in either or console probes?

Hania Bednarski

to Yes, is difficult little hose think probe console see connects love that that I the the only to improvement would is point the that I at this the a bulky and to maneuver.

think But would hand. for my but from a a to machine, it. I nice. that large I practice, the easy we footprint maneuver, is console little works probably bit as I fits console the very concern. footprint. I think I just possibility to don't smaller know honestly, guess, mid it's use. it more of think I footprint have the the of -- have pliable, my hand be that it works The if The that it's smaller just make I if that is. fine. heavy, really it a but there's my very only a It’s in woman, a to it a, say that's nicely not to It's probe that would So make handheld could hose easy to

Kemp Dolliver

question you how are transaction? presumably structure Thank options Great. how to And did of you that you. the numerous out system? last Because is there and one with there finance the the acquisition regard

Hania Bednarski

Correct.

So am working I'm out currently that's leasing I And very purchasing the the unit well. and disposables.

Kemp Dolliver

Thank answers. you Great. your for

Hania Bednarski

you. Thank

Operator

at Global [Operator time. Alliance is Instructions] are this a question Partners. no of further from There Please Ben There ahead. Haynor go questions follow-up

Ben Haynor

as quick your office treatment of it Or a couple folks the of you a you mean, and Hey, every your Bednarski. just you their choose I days is couple are do structure Dr. weeks ones cryoablations? of and patients? do do into the it How come of modality? for do just handful kind when doing

Hania Bednarski

sets doing to now, I averages it of And right Wednesday we're So out Monday, week. timing. say, every other in about Tuesday, them would

three a I'll then a can more within we and bunch interview do we do then honestly bunch cryoablation, days, we So again. whole and for off time patients whole have so our that

So feel and doing see I'm it's But get of to are patients procedure. for this busier. refreshing really now, been how opting busier I in right going kind many And we're bulk. them just to that

whole off do a then do we'll two and bunch a So or whole then and a week bunch we'll take again.

Ben Haynor

sense. makes being you've crackers had the your away the then you've what's breast, couple of that in And just a patient furthest that That book on come? cryoablation Okay.

Hania Bednarski

So Myrtle and lot I question, I of fun about. to South talk I'm Beach, it's think Carolina, in this appreciate really a because

So that's to from been patient now me patient Angeles, Gibraltar. right Los from California. have to come I out me do has the a currently reaching furthest that's

So but She had we her reach over. I'll patient has to had I've patients me. -- today. her from out But speaking only Canada I actually good you from out not have be me. not tell from can she's with exciting. I yeah, But a it's super reached later all have for procedure. LA she's cryoablation to with not decided candidate had me, that a already the the patient

Ben Haynor

curiosity the Well, than okay. about that. more up my own taking from for think There's you question. Thanks follow

Hania Bednarski

course. Of

Operator

participation. you the for quarter results This third IceCure conference your call. XXXX concludes Thank

You may disconnect. and go ahead

IceCure Medical (ICCM) 5 Dec 222022 Q3 Earnings call transcript