ICCM - Earnings call transcript Q1 2022

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Operator

Welcome to IceCure’s First Quarter 2022 Results Conference Call. Management will provide an overview of IceCure’s financial results as well as clinical and operational highlights.

On the call today are IceCure’s CEO, Eyal Shamir and CFO, Ronen Tsimerman. They are joined today by Dr. Richard Fine. Dr. investigator Low-Risk ICEX Breast trial cryoablation trial a small of cancer. is for clinical IceCure’s on Fine Dr. Fine is Surgeons, also Director Comprehensive the the American Breast a Surgical of past President of Breast Germantown, at Society and Research American Center and of the Fellowship in Breast Oncology Program Education of Society Director and Chairman West of Tennessee.

read and session. provisions variations the available laws. for Reform brief and Act answer I Words Following of intended presentation now statements to such Harbor and be statements. "plans," of moment securities Harbor contains the "expects," Securities as a within of Safe "estimates" will to presentation, Federal statement. This "intends," the words Dr. Fine "anticipates," are IceCure’s other the the of a will forward-looking such "believes," identify management take Private forward-looking or XXXX expressions Litigation question "seeks," Safe meaning and similar

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

Eyal Shamir

for and call quarter joining Hello, first everyone XXXX today. our thanks

will call the developments We will our year. Ronen, financial of turn results. review overview for of I start since business with a the the significant Then, beginning the of over to an

to call then will over Dr. turn We Fine. the Richard

us who to provide with We are can potentially it’s his Dr. ProSense optimize planned treatment our Fine insights valuable ICEX is of uses time today. investigator him He a an clinical early-stage cancer. for breast sharing trial low-risk ProSense and patients. his on grateful with how in and

again. of indications customer approved our Several post-pandemic systems front, commercial installed four will reopening in-person business reality clinical visits travel remind ProSense in for large that strong base. key various the and making year new the part with in we On the is countries. I of listeners global a due started ProSense were

twenty countries U.S. commercial a have in We presence including the

which kidney, tumors. coverage lung liver, We as is have cryoablation such breast for bone a CPTX benign code procedures fibroadenoma, and of cancer,

for code also CPTX breast cancer. have We

demos and sessions. site resumed visits We in-person on conducting have have training hands practitioner been and

opportunities. close Our on team to able sales pursue development and is effectively now business more

Europe data important demos the grow hands that symposia. are in to and well U.S. oncology in presentations at We increased received QX. extremely on in U.S. and happy our through ProSense the very sales report was three conferences and

Dr. American the Notably, in the and generated of at of of is publication for and is published study explore Meeting Society significant a The deal Society of of into breast originally April, regarding results We and our scientific in great and ProSense. the cryoablation in in online. breast for excitement very ICEX and breast interim U.S. XXrd President related Surgeons cancer. to Oncology the the of cancer Breast a Breast journal, Annals chosen articles treatment Surgical improvement our data standard-of-care Pass ProSense Dr. as who have at potential a of medical cancer presentation best conference. organization care the of presentations can that cancer IceCure of to standard early-stage annual American the made the in Breast large low-risk influential beta Annual were thousands was guidelines our of Pass, of of in-person Helen annually. American professionals published Society as the conference Surgeons study Surgeons highly in the was address the sets the breast view of XXXXfrom one audience the a presented surgeons regarded part deliver the breast These attending of

During filed package procedures. final we of to is had for for risk cancer sprint The breast work patients end pre-submission the proposed under cancer. a of last Novo In our classification, year. high discussion with approval submission, request continued the plan including De early-stage for previously intended a our suggest early-stage We in for FDA towards surgery. the quarter, at second breast November USFDA we to FDA use the ProSense in

designation were discussions the year. part our last device we FDA continued granted with Our is breakthrough of

a Recurrence benefit interim ICEX the clear the System stream patients Our five in will the ProSense including I show XX% the to over patients almost results this that with treatment patients the the reached call receive with of and the of XX% cosmetic indication XX trial financials. published years cryoablation Ronen will satisfaction reported results. having for turn doctors now XX% of post-treatment. or

Ronen Tsimerman

while IceCure transitioned Eyal. and innovative successfully our Thank the into work. company has clinical R&D you, commercial-stage continuing

distribution from as as rise to sales. recognition into revenues continue viability quarter-over-quarter expect well to international Our agreements we due future in foreseeable revenue and this the

ended approximately agreement by is XX, the XXXX, of recognition in March For approximately the single-probe compared million the million XXXX million, March last compared The revenue decreased in to approximately year. million decreases attributed development U.S. is is first due three to approximately activities. Company's first $X.XX The ended attributed efforts to to the and quarter restrictions million XXXX, decrease Gross Research $X.X with XXXX COVID period the of for for NASDAQ $X and approximately in marketing, for These a the three expanding to Selling, the in the the March $X.X $X.X Terumo commercial ended attributable to is revenue compared XX, increase associated for decrease decrease XXXX. XX, March operating malignant increase the gross XX% were increased March of which to first Japan, million, months approximately commercialization margin administrative impacted quarter months activity. and breast sales The margin months activities. listing the three revenue the aggregate expenses. XX, in Asia three operating Thailand to development months expenses for for for by on and three in approximately to million million decreased XXXX, were XXXX for related treat of tumors of quarter were commercialization, agreements. is $X.X for three ProSense Total commercialization The the The approximately the the sales ended to $X.X in is region, three clinical ended ended listing compared recognition distribution an months increase for profit expenses million by related months XX% partially in months decrease three XXXX. in last development, XX, were the ended distribution $X.XX expenses, $X.X and in Gross March was XXXX. and months Singapore regulatory to acceleration compared the to million XXXX. year. million from of attributable period and system the the IceCure's $X.X $X.XX increased next-generation and March and XX, period from was XX% to increase the surges general expenses same compared Terumo XX, in March NASDAQ in mostly the the XX, for to the offset

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

has Dr. $XX.X American of Surgeons the now Breast has turn XXXX. since $XX.X of approximately March been cash Consortium the Program Board XXXX had I trustee XXXX. Dr. of Accreditation Fine Member with of approximately President XXXX Fine. the Breast a The Dr. the December National of from National will there Breast of XXXX, call in Society. million the of cash Chairman was million, and Society American XX, over as and equivalents Centers XX, to As including organizations to compared Fine surgeon served the and the Board XXXX of XXXX, the or Centers, Company in Cancer breast and as

Richard Fine

treatment the that older the early-stage designing if Thank trial of goal excision This I XX for I we benefit Surgical journal and surgical multi-center one efficacy they in room actually going removal Annals There cryoablation evaluate and know the across without results you. the year. members to cryoablation board review, early-stage to Surgeons of the country. American papers the had a wanted ICEX patients Shamir approximately on from trial. brought of to better Society cancer the trial. avoiding I fall Mr. of was advisory prospective the were see of operating to the breast of in in past was for breast at of non-surgical breast tumor. cancer the with the as interim low-risk sites scientific safety The this Oncology attention of a it from to trial the the published risk Breast prestigious The the was was mentioned that would surgical the

Margaret I’ll patients that the promising results Germantown be had to the with offer minimal XXX surgery, alternative this the actually at trial on very in XX about per This was the Our only procedure was put years or the interim of minimally-invasive questions three of risk. were X% a answer successful it four that, but received patients site that the the The was Breast West end of happy benefits Center cryoablation Comprehensive we a trial. at recurrence. the any exciting to at had protocol. Tennessee XXX showing also a

code cancer code, benign this for to work of well mentioned X College American as Society convert – the I ICEX very as trial. cryoablation as coding Mr. the as today. other exists couple such been the of for The Surgeons, continued tumors. Society breast breast excitement X the on last indications treating technology that we’re is about organizations working X because, developing Radiology Shamir which also a cryoablation for the expand Surgeons with to to already the American new that’s We the Mr. Breast to able of reason Breast increases help The for was successful cancer, code important thing for registry Category Category mention be in has Shamir of cryoablation getting will of of Category and breast that mentioned of with for a as other as as a we patients from cancer. wanted American areas exist the on cryoablation cancer, well breast utilization years The

XX. group age of down expanding age We the to are the

also are effect on more post-cryoablation that standardize the and its radiation we treatment breast. to evaluate We patients’ can so the going

So up so many ICEX answer questions the on were brought that trial. exciting trial it’s to that

centers is are across that’s have including creating in that, interested thing cryoablation as as exciting times Mayo University Rochester, the other well from their or been Washington. registries trials. approached They I the own Clinic The country of in all multiple

in excitement cryoablation patients. of country terms appropriately of the using lot a in the avoiding in for is there surgery selected So the patients purpose these of around

any am and bring that those is to a questions answer points So I quick to make wanted points happy summary up. that I the of

Operator

go of Haynor Alliance the ahead. Instructions] Partners. is Please first And Global question Ben [Operator from

Ben Haynor

Good question. taking morning, gentlemen. Thanks for the

a FDA you that to with request got got your correct? then, that are Just clearance? where discussion (k) when package pre-submission for general that de submit sprint a suggest and you And the and do is XXX the novo you planning expect and on to firstly and classification

Eyal Shamir

this is Ben, the much Very CEO. [Indiscernible] Eyal,

is to This our going means which in first be the continuing - year We’d enrolled risk at completed novo. lead the early-stage are this working info a to full – the submission XXXX. clearance cancer be be of study, closely of for follow-up and XXX(k) of a de with which for surgery. which our XXXX XXXX, is years in spring process to as five endpoints breast approach. the requires order full We it’s like who sharing cryoablation FDA XXX(k) of are operations high The all will five us to patient remind to February February last will ICEX our

got self-indication and surgery. after FDA we cancer for grant device discussions the the with approach the Our spring for designation the get high-risk is to breast and low-risk breakthrough

As we This process soon and is submission, of a update the investors as process. this finalize we have we will will will still accordingly. full in course

Ben Haynor

is a necessarily out. of figured timeline that on This you would have – be don’t Okay. when kind

Eyal Shamir

we course, we have agency be and working and able with still will full soon are the finalize a We make will the announcement. submission of as it, then to will we as

Ben Haynor

on their and then, in Have NMPA, as impacted the to update lockdowns. any the front China? those COVID in And it. they’ve Got more regulatory China, well timeline clearance had obviously, the Okay.

Eyal Shamir

approval moment can that that have well. hope it this the year. delay our This the We is the before assumption too much lockdown and Shanghai the be with not in September, to China, our at expect year. that We to NMPA this of end the as probe October Beijing in discussions assumption our both by

Ben Haynor

year? for Okay. throughout this to just expect of move do operating QX a good kind And mean, expenses of then, as throughout Ronen, runrate track Got this like look year? it. we you kind I the forward how

Eyal Shamir

Ronen?

Ronen Tsimerman

Thank you, Ben.

also next-generation multi-probe and systems. of So, single our probe our next-generation research and our we development accelerated

we push expenses incline. forward, the course, as also So, of

be So will I how this on area. in would fast it depends and how that the But are we runrate expect forward. again strong pushing

maybe will in the Okay. accordingly These decisions – future. accordingly and are made made

Ben Haynor

Okay.

do of of it. a receptiveness the excitement And with amongst there some kind Got own cryoablation Okay. to cryoablation maybe it of characterize other Fine, you and Dr. to general and your studies. like Mail centers brewing level then, kind Can their around is colleagues? just Image sounds fellow looking just awareness

Richard Fine

Yes, Thanks. Ben.

Eyal Shamir

Fine. Please Dr. Yes, go ahead.

Richard Fine

Oh sorry.

Okay.

are There ICEX interim lot and they with lot followed that a are for, did removed right. of is and publication of I think patients think you that were that they results well. I people the did their the of and to a as that tumors cryoablation So, that not who waiting well of wanted have see treated excitement

completed were of only in of years has As one follow-up entered in and that the April, of XX recurrence patients been there that has additional the trial five time.

surgery. results showing are of have be that there with a that that’s patients I alternative to sub-group of going very that a favorable. are lot people good been So that more that is equivalent to that for excitement has conservation a biology this And breast think tumor publication, recognizing

recognize is of we’ve different. happen One breast that’s the cancer to are things able been that in cancers

to we aggressive to situation. a go that’s surgery, And Some not that having ones if lot are non-aggressive. treat ideal but very aggressive, as are the are that there of without are can them an

Ben Haynor

the sense. of when makes – with gravitate patients as they that of cancer they cryoablation patients just kind on do treatable have kind your mean, I the It And well? would surgery, towards curious receptiveness over then, be a of cryoablation. are Okay.

Eyal Shamir

I scar because don’t lymph to group, wanted the even patient into they very have was about those to on on think explained trial. check a during a cryoablation years excite have go patients all work breast, you’ve the having features, some and And of a at were a younger to the option non-surgical already in participate. didn’t favorable patients encouraging having surprised things removal patients I in towards patients to the surgery mention volume them has they When those a very the breast. to readily. those it’s Even I more the having actually that to pleasantly then was gravitate they nodes from have hard you and on non-surgical that very option, have very the breast I age terms patients to not putting surgery. the that tumor their about require

participate. being actually to how women able was much very about excited actually I So, very were pleasantly surprised

Ben Haynor

Okay.

have of for be CPTX cryoablation? So, once that the before long the patient good clearance, quite hopefully a expect are trying them would you would as that lot choose to code FDA too candidates you

Eyal Shamir

very in I Yeah, confident that. feel

Ben Haynor

have sense like then, you… And I look would like Great. that the What Okay. in what to line? do the a on or you XXXX CPTX code? is that time would get mean,

Eyal Shamir

and to clearance Dr. with of and will need for Society reinvestment. much us from Coding code. Breast supported then the Surgeons to very and Hence they Fine the FDA move Chairman CPTX will and and which in the coverage apply of come CPTX to is course to American CPT get order we the also get of CPTX to the together

cash So, to I users cash coverage is even CPTX be be CPT and covered that who until assumption. different for able I just to think work at will by treatment this it beginning, payment we - and the that possible But partners that a pay of the is all will be believe and have able reimbursement. the to coverage. kind – an This that. fully and XXXX, the in patients need coding We with stop will will reimbursement that

Ben Haynor

That’s helpful. Okay.

I taking for the on the congrats gentlemen. I Thanks had, questions and progress. that’s think all

Eyal Shamir

you. Thank you Thank very much.

Operator

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

Kemp Dolliver

Hi. day Good to everybody.

five sounded the this with be in relates year. next years or you to Has Previously, were also of because changed of that discussions discussions. impression sometime early tenor the the able FDA the the thought or the early is getting to available you First mentioned XXXX. would file maybe it year we data FDA question having that calendar you

is? of are provide you detail status thinking the what you can more So, regarding

Eyal Shamir

Thank you much. very

risk agency the during FDA, do discussions the to and will our As test for will launch indication, again I for until first surgery. and patients early-stage study high the mentioned, all our the patients We are first ICEX Therefore follow-up. don’t it will when years with cancer I XXXX, intention, is repeat this breast year. the five with plan be submission of pass which will be for who early completed

So to the is do the this still submission this plan year.

Kemp Dolliver

it. Got

way, in then first this you and to fair the you the would submission the pretty would of for that of that the in appropriate population population the patient balance subset about will then was when Is the a way trial. a the think a description? have file be So, data, as broader

Eyal Shamir

early are be to do They Absolutely. as low-risk cancer. indication a long as of a will breast we XXXX, of able submission early-stage the

So this started. is the the indication that started we – ICEX

Kemp Dolliver

right. All

Dr. the Good. types maybe give under indication that just patient around would to And or treat submissions probably of second a follow-up in to you able typically indication? this, is gating clarity some with How for distinction years significant be these and procedures anyway, those adoption regard rates. Fine the Okay. initial take on rates can are that submission it. versus the new factor initially a several Adoption population

you do on perspective what Fine? Dr. So, have that

Richard Fine

Yes.

So, broad. that what talking are of But for to somewhat are sub-group that patients high are submissions we we making the trying the is, got criteria about I high-risk feel those keep surgery we like you’ve risk when for surgery.

that if would they’ve they’ve and patients have – are in so the that Okay, a of things hypertension, patients got – been like they’ll lung will disease smokers meet diabetes. have general They’ll have older usually have lot criteria that.

indication, makes keep Does that that at that patient of sense? able make keeping higher risk, we’ll to of keep to I what under broad. treated be pretty the eligibility be to in able surgical eligibility patients narrower the be description we’ll criteria criteria a think the by that So

Kemp Dolliver

Yes.

Eyal Shamir

can make on lots have treat So, who who going it a say medical patients older are be store, is we patient to to not narrow we let’s treating death are that so we problems. are only, trying of that

the so, risk. that’s And how patient to are high we frame trying at

Kemp Dolliver

All right.

think of to a to and makes That lame clinically people. Okay. lot also I sense

to still So, is Terumo topics, other just business. on to contributor a moving significant your

QX, decline that QX? in is a any in the markets You there of in have Terumo recovery sign mentioned

Eyal Shamir

especially And got What Japan the mentioned, for a we for we question. Thank of rule of PMDA to a Terumo explanation after the Ronen going busy for according you, pandemic, is some some application Japan. still as Singapore extremely course, approval signed Singapore to approval Terumo working to that Thailand, the distribution These remember the during Thailand. from IceCure over are content the for recognition recognize this that. rights now them IceCure we for and agreement that regulatory is revenue time. need they period distribution Kemp with all time, Japan, started and brought and the At regulatory is down. Japan, sell they in

Japan of are perspective, So, future will declined The business time business the that just mainly recognition life the revenue this they to and the business is to that started come did we the from revenue we over of some from was the part markets. growing not Singapore according with operators. a the from Thailand penetrate

Kemp Dolliver

Okay.

revenue can of is is because shipments revenue. from get the decline if if to So, activity there of an correctly actual be recognition some to I that, then revenue may the think you and actual revenue both not element them I remember I amortization for – that rephrase related levels, there

Eyal Shamir

Yes.

not the and revenue Ronen the all upfront them of day-to-day explained we agreement. sales as millions activities. is This according we dollars signed distribution as For This to got recognition. nice distribution is just what from the rights,

Kemp Dolliver

Excellent.

any just – that institutions regarding trials. you And another do Thank probably registries but, these start? question will How expressed the Okay. timeframe the you. for expect thinking the quickly of the that in or what’s registry? for process their have you Dr. And interest the Fine, implementation expect and

Eyal Shamir

that. answer to start will I

do from like with a on of on finalized society announcement, approaching number work number the the being with everything growth-wise the to we their will I to with the of will course, the and to and Fine very of patients board, to group would We of who also are we society, closely under but who Dr. reduce the supposed that the Fine to And be mentioned with society proper the finalize work course, age closely. very the we’d see were it that rules to aside basically like protocol sites, then like sites them patient the and working work to drug be the and closely course start have of of together additional traditional the publication. Dr. and society leadership future with together make manufacturing and data it the made from to entity work Fine, the this Dr. to and continue of you anything add? exempts in if to able to study collect to course of

Richard Fine

Yeah, okay. I’ll add a couple of things.

So, we have because want been protocol strong. to very protocol, working on the be the registry we the for

that already submissions, the have the be the We’ve to make also We review because all some is addressing the society collected the the beneficial will sure had back. going of committee at consultant this over comments been is time that be FDA for that research gives those of with also comments registry data looking worked design and to helpful.

towards end there So, are or feel would like hopefully accomplished. the are fall. this the diligently of things the be would working to get beginning to timeline very goal of started I these or all we get summer

the So that that would latest. be for my be to wishes

Kemp Dolliver

you. there some one there those in one-time are in first G&A to ongoing question, nature just or listing a in last Fabulous. discussion Are the Thank costs quarter? reference that cost. around NASDAQ And was the expenses were

Ronen Tsimerman

insurance know, especially for Well, listed last two question. the costs companies. years, the in NASDAQ raised you for have as you Thank

in the expect decrease last but say are submission, to in will costs insurance the really what So, going costs significantly. these looking that next insurance example, I – I costs. for be again, we are do other the insurance not can’t cost and

as So, I look believe up. you at will cost that them can go

Kemp Dolliver

Great. Thank you so much.

Operator

statement? your time. make at you to are would Shamir, There this questions no Mr. like concluding further

Eyal Shamir

all taking I us to time to thank, us would the I Thank you today much. Dr. and the all Day. of in like very wish for and join participants Fine especially, the present Investor

Operator

Medical This Conference you participation. for Results First IceCure Limited Quarter concludes you. Thank Thank the Call. your XXXX

disconnect. and ahead go may You

Eyal Shamir	Chief Executive Officer
Ronen Tsimerman	Chief Financial Officer and Chief Operating Officer
Richard Fine	Investigator of ICE3 Clinical Trial
Ben Haynor	Alliance Global Partners
Kemp Dolliver	Brookline Capital Markets

IceCure Medical (ICCM) 18 May 222022 Q1 Earnings call transcript