ICCM - Earnings call transcript Q1 2024

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Operator

Good morning, and thank you for standing by. Currently, all participants are in a listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded.

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

Michael Polyviou

operational and review Yoni, ended IceCure Conference on Medical's XX, Thank financial welcome results to recent update an the and months for call XXXX, you, provide to highlights. the March X

You CEO, issued today's morning. we release and this of CFO Shamir; Marketing, to and may Bussi IceCure Tsimerman Participating Global Medical's Business and the VP refer are press that earnings call Eyal on Tel-Tzure. COO, Tlalit Ronen Development

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

adoption boost through U.S. breast and positive expect commercial of commercial for and cryoablation. the response including cancer applications treatment regulatory using the treatment this to the that and commercial sales as the many positioning forward-looking advance strategy sales we of growth regulatory For in accomplish example, community make commercial our to statements adoption continue to we medical potential of a future clinical we positive jurisdictions, presentation for in continued as market various that discuss goals achievements regulatory expect minimal the cryoablation in are women to for including experience continue the available be of traction from we significant we approvals technology, year, breast invasive advances for cancer ProSense in of will the IceCure's cancer pursuit outcome our that expansion to footprint strategies when markets, key advancing breast in cryoablation indications, will this expectation U.S. or

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

law the any call events The company conference the as exactly an future live of broadcast statements, update, time-sensitive contains whether we'll forward-looking information, required to any intention This in revise because XXXX. or obligation of May and XX, otherwise. or information disclaims by only today speaks

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

I Eyal ahead. CEO, Medical go over will the Please to turn now Shamir. call IceCure

Eyal Shamir

the the ProSense. will system an XXXX, indicator I'm in quarter worldwide. the the demand first Ronen to very adoption go for more the we continue pleased Michael, sales. XXXX, see us of continued XX% everyone, for The the ongoing and the you trend for hello, utilization of joining same that compared this and year our need growth up period Thanks, thank were is and Product in for in quarter details. sales and today. numbers report first cryoablation to to in of demonstrating over positive consistent and encouraging

revenues in potential and needle we fluctuation achieved recently significantly us. quarter-over-quarter, to the had the for during of move While quarter believe we XXXX catalysts that strongly the see we the first major may

This and data catalyst, to of the to including completion set the data, submission ICEX our ICEX set of full the the FDA. the ICEX publication study, of study

and outpatient been breast we During X-year of surgery the in in more its ICEX as offer first were has the compared ProSense patient U.S. study, rigorous XX-year last procedure our long without a completed results, to excellent. our largest lower hospital. knowledge, faster, QX, follow-up accessible the our cryoablation of in advantages the kind a cancer clinical the The excision the for to of study, that believe, clinic-based we study open completed. and cost

cancer. follow-up Per to the hormone estimated patient be XXX% the ProSense subgroup ICEX Tlalit satisfaction today. point recurrents. believe globally, with adoption will Along was local this free in reported. ProSense supportive a treated to cryoablation physician these wealth results, with produced breast patients especially at for data speak of that and ICEX by approved the in of the were from we therapy of which it already X-year analysis is evaluation, is countries of XX.X% followed

surgeons by by Society ICEX investigator, Dr. ICEX well was the data the very was of at where Breast presented American The it Surgeon's the breast received Annual Richard Meeting, Fine.

the for of American fact, and its final patients a month, a of therapy. see with data care. hormonal marketing requested towards for and to cryoablation presentation and TX ProSense oral standard breast Last significant to of new early-stage we the the with his Breast of full authorization cancer ProSense FDA adjuvant indication Surgeons In Scientific potential won and Society demonstrating the invasive impact cryoablation the treating submitted

file. to patients product commercial continue a markets Since the the cleared team on this ProSense that we especially is in more impact significant the growth U.S. on they also FDA will reimbursement if lead women is and alternative rollout. our surgery We coverage is to U.S. free our for world, in a are as believe for to in delivering marketing, breast in we continued review intend believe options treating U.S. We substantial the cancer. the largest as discussions sales, This one of with to the work ready with in our have FDA

Breast the centered as engage cryoablation. interest continue lot the X a created U.S. breast around American We talks more, see Meeting, and were them following We we as they and approval positive building potential practice. a Society Surgeons of come demand ahead with to Annual in learn a our many incorporating had into to to surgeons presentations booth data their consider of cryoablation

data ProSense. Japan, cryoablation. our study where results. the XX to study at finding validation, breast to to for of Italy comment found the early-stage our breast reported regulatory XXXX, ProSense of Tlalit. Terumo, independent following in of the development, the cancer file approval the recurrence study recent XXX% similar commercial went global Further in X I U.S., ICEX on call treatment like with The a the the local further cancer and reduction Japan distributor over in to and published would in tumor the our second To progress In X months following Italian turn half

Tlalit Tel-Tzure

Indeed, Eyal. in growing well physicians' you, as clearly independent of cancer as demonstrates ProSense. indications the breast studies enthusiasm other number using Thank about

In women patients scale in median treatment a a on to found that of addition reporting from France, cancer some pen of mentioned, ProSense, reported X of a conducted endometrial an study Eyal X median to reduction with with that to after even studies X X. the XX breast

data In the changes. endometrial necrotic signals other and included in development This disappearance of additional of hemorrhagic evidence independent of study to [indiscernible] studies. this the from adds endometriosis

Endometriosis for is there which a alternative on a market is treatment the very large good not indication today.

cancer. standards believe cancer In health. the in India establish as cryoablation already indications addition gold globally, We Circling back countries to in breast which women's breast the breast are Europe, such for has cancer, Brazil. and breast our data particularly ICEX helps as we many in for to approval focus in set exploring other full ProSense regulatory ProSense

are We saw Brazil general, in out In world that also of and with for the this the found the Romania. cancer This the FDA certainly case data in closely of very first trial, recently breast we doctors procedures as comes the ProSense. approvals. supports more and performed around data they watch utilization ProSense U.S. interested

were Society meetings featured the Globally, the training in conference at India at including American for Interventional conference Japan. and and after ICEX Resurgence annual just data ProSense of world the XXXX, of in physician the ProSense the first U.S. of sessions Society medical featured quarter was and was Oncology presented During across

European the ICEX X the in strong which Oncology, conference, Four benign Interventional Hungary data. X of Germany from for were more for Conference place cancer At took featuring tumors. and were interest breast was a last accepted from and of ProSense and there at abstracts month, this breast France were India which presentation for

ProSense conference. researchers of more seeing also and to presentation are and We doctors studies submitting poster an their various other medical abstract and

the and as medical for the footprint a have continued conference We commercial schedule positive from remainder we XXXX, expect very response our expands. of full community

as Ronen? in the worldwide FDA's I about over of to for outcome go indications optimistic Ronen adoption continued financial for commercial decision. worldwide. will this the are we for to look call ProSense We traction many turn believe, regulatory A now ahead we indication over positive for the would cancer, boost breast U.S. the results.

Ronen Tsimerman

mentioned their consistent product As our growth. earlier, Eyal sales continued

for XXXX, sales driven the XX% sales to U.S. For March increased higher ended compared months probes XX, $XXX,XXX to X Japan. months by primarily systems the the ProSense March XXXX, and XX, and X in disposable ended by

X% was ended compared to XXXX, an to due March March or increase X the for of months of $XXX,XXX X revenues the Total ended sales of ended partially the ProSense XX, from increase no Japan, exclusive XXXX, months revenue XX, for Terumo products, XX, in months agreement the Corporation distribution an $XXX,XXX March recognized for was XXXX. revenue rights the which by the in X in offset the recognition end which with

profit months March a XXXX. to for XXXX, months $XXX,XXX ended $XXX,XXX X or an for the March ended XX, X months margin Gross March X months increase was X XX% gross months March compared profit compared to X XX% $XXX,XXX ended for XXXX. ended March March X XX, Non-GAAP the was XXXX, the compared XX%. $XXX,XXX XXXX, for months was the XX, XX, $XX,XXX to ended the XXXX, the XX, Gross for of for XX, ended

was March approximately XXXX. X the XXXX, to Non-GAAP gross XX% months expenses million Total X months $X.X margin the XX, the XX, for months operating approximately ended compared March March million XXXX, the to months ended for for XX, for XXXX. compared $X.X were X ended XX% March XX, X ended

reductions or expenses. ended to to administrative mostly last compared months loss $X.XX is XXXX, was and per period year. loss development of share approximately $X.X or general per attributable the million and March Net X XX, research in a same for $X.X for net decrease the share, $X.XX approximately The million

deposits $XX XXXX. XX, million, the As of short-term March of company XX, cash on the and had December equivalents, as cash XXXX, approximately including same

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

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

study, manage for as to now value-driving to resources Q&A. of and we as worldwide, our achieving well commercial open milestones and the data activities well, supporting cash completion call continue submitting our such ICEX We the analyzing through while data sales key Operator, growth reporting and FDA. the will as

Operator

gentlemen, the Thank you. we Ladies and at time, question-and-answer session. begin this will

Instructions] [Operator

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

Brian Kemp Dolliver

the with relates question Can the far. so to you've first since So them you and FDA the communications with application application? characterize filed your interactions

Eyal Shamir

Yes. Hi this Eyal. is Kemp,

the Q&A. We had discussions on them month, submitted data have continued regular we set last with that

we additionally are that they any information working, and While providing waiting ask.

Brian Kemp Dolliver

regard that to you're And outright? them? to -- finance, bringing the of sales finding What they U.S. systems regard there? -- to these how are how Is the the them so seeing they Are as far probes, patterns transactions, system structure with opposed you Great. nature of the they're purchasing there are are the practice the yet are trying in-house. leasing with any to any

Eyal Shamir

It's also a higher monthly It's combination leasing a of for purchasing of a a quantity probe combination of the placement a for system. minimum and price.

model point the actually the what of is see a we business and business market, the different of combination view from models. So in

Operator

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

Anthony Vendetti

receive to there in expected talk Terumo. Japan you relationship play How the that And them, you're a out then of I just with in could was the is about distributor from if payments that? terms schedule this for year? to is expected wondering

Eyal Shamir

of is Yes. and PMDA, ICEX busy you Terumo Yes, data, with our the agreement. support agreement finalize with including will the Anthony. the Terumo other Japanese the submission local to FDA Japanese a use Thank is is data. to the which course, they strategic distribution

of So this be this is to semester supposed second the on year.

approval, As and submission supposed by reimbursement health agreement milestones submission. the rights million the regulatory part office, the the we some of be and the after could after we signed the distribution which get will that also $X welfare of by time, announced to agreement, that the we submission distribution -- additional get by we X the Japanese in

milestone we buy they will props. rights. distribution to have back their course, to of commitment to another behind So And some get then, of -- consoles

Anthony Vendetti

And control why? then I What how a is that elaborate patent do little bit How from Japan. if on see in And wondering the differentiated an you can was so, that you as competitors? your if that is advantage? cryogen

Eyal Shamir

that Helium have Argon the very regulatory and and competition could Japan a that This is is old only we complicated The kidney they now see approval a technology in only. very expensive system. in

this role considered gas. price and view, is following strictly is very Argon Argon And in of pretty because put a of is point patients the you more cost same the For importantly, high-risk the the constant as the gas expensive. room Japan the that cannot

the didn't try any they globally and U.S., do in not in do didn't in and not not breast, They Japan.

not the breast. to are we going them seeing So

from any at this view, see competition. stage, don't point of we So cryoablation

Anthony Vendetti

Okay. cancer. be forth. potential update system on could focus early-stage to endometriosis? the be you I for the have -- and used obviously you Can obviously fibroids know is do ProSense tumors But on the so and for breast any other ProSense for used

Eyal Shamir

Yes.

even now had Europe in we publication We we it. as [ now doing well, we indication some under the the of and same endometriosis our U.S., treating GI ] ProSense are are that part was are as in

[ be ] as fibroid. part to endometriosis the women look in we uterine interventional So health, it which would future and also our will we, like after indication, oncology of breast

to we ] flexible of be And as of a on system XSense with also quite us would have also allow the to which unmet the submitted interventional be XXX(k) able only but into will indication we to lung. our the bronchoscope the not lung, general big to and which look work like the is the develop that part able agent compatible assistant of a mainly will need that FDA to new nodules to will an probe, opportunity some a robotics [ we

Anthony Vendetti

on sales that's force. plans where to you cancer, at question us for then of breast is build approval I FDA you've team. And the the of and for last are in Can XXXX? started Okay. sales tell anticipation know the early-stage rest the what

Eyal Shamir

Good for from as experience X, almost Johnson America, Mammotome started XX Mr. mentioned our breast we months about announced bringing As and the Vice X President, Sales & ago, him of in hired we coming and Johnson, North Shad with field years others.

will and building and So clearance, the Shad U.S. is the in car the Shad team that we before team. have to build continue just

the So this to support XXXX growth able will and new on. plan be team that we for the that we'll add current team,

Operator

of is Capital next Street Haynor Lake question from The Ben Markets.

Benjamin Haynor

you system might and with be could how on data new get Any the that the clearance. there like FDA Congrats breast both the a submission. and about on line it the commercialize indication? me curious into to on breast the the the on the as commercialization -- mean once cancer submission similar XSense you there, I time thoughts in cancer U.S. Was the sounds clearance the

Eyal Shamir

you are Yes, right, thank for you Ben, the and questions.

get XXXX. to expect early XSense on We clearance the

really now now have footprint and Shad footprint some not We weight together They're of the lot that it's the much This activities most freezing size we XXXX. system, this liquid Good. are just system always will Mr. like give what that technology launching is additional early that building start and advantages, of which will continuous ability. we state-of-the-art has And probably of the the half a with benefit longer clinics, an issue. of is nitrogen in

be to will a the the consider a which will we launch of also and probe, again, But to And also indication. will I additional flexible would us during for in a start platform additional believe development allow indication we market. U.S. mentioned, give XSense as that XSense XXXX,

Benjamin Haynor

come? -- cancer of that Okay. rules. be Or clearance, clearances covered the And me, breast you then Great. you with would already anything just under once that kind do that the get special FDA to is remind do need

Eyal Shamir

understood I'm correctly but that will Again, not sure try. I I question, your

All be we it to on to the cryoablation for get cancer that the ProSense, the But breast be ProSense. add Firstly, clearance breast will the clearance on the will will current will the of XSense. on for ProSense we after we indication be have the the course, , the XSense. cancer immediately able

So day, same at the end the of be the both with will indication.

Benjamin Haynor

Okay.

the biopharma from cell kind You [indiscernible] T do you instance, got of exactly immune there? that And asking. the boost have I seeing And was to what studies that benefit. future see much applications on firms show heard, taking response guess, I there? -- you're the you. for a of the say, cancer the Thank then going developing as notice effects how you how investigations

Eyal Shamir

I Researchers interventional many even see both lectures call more U.S., what In radiology globally, you after cryoimmunology. or nothing and found research on faster. liquid Europe deeper conferences, you nitrogen, with could could much much even allow the more now physics This to is all [indiscernible] cryoablation after in again, say, could do liquid hear feel almost especially they of you and and nitrogen that . and to that

drugs immunotherapy some immune the will the intratumoral to with immunotherapy of looked drugs system researchers with and and and the better for of basic patients. cryoablation additional way combination be the effect, even of try treatment this immunotherapy future cryoablation that immunotherapy and the drugs pharmaceutical and that drugs enhance companies showing or much cell find treatment enhance patient, the support after it could one like So improving

Operator

Instructions] [Operator

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

Yi Chen

on the Are to two Can eventually between again what or XSense, supposed one systems and the the supposed is I clarify together market is mean, -- you ProSense? be replace to ProSense? the system, XSense please difference key

Eyal Shamir

the half. way and will devices state-of-the-art allow and its be as basic to allow a platform at very a us the from Yes. like management is also an time. new liquid do technologies that for longer The continuously indication. the of different, XSense probe, flexible nitrogen system, This it to allow totally will us weight like for new even all will and additional use it system much technology that footprint to catheter of the of The really freezing consider

will give surface the just inside robotic -- the for could but be treat on for For potentially of it in the to -- the the one broncoscope will lung. work lung, not tumors compatible percutaneous example, ability lung cancer that treatment of tumors with us the assistant

So technology, additional additional open us it will platform for of also indications.

support your And the of a and will U.S. be the with But the going XSense the to second course, part to the launching U.S. for future question, will soft in in we product for in the main replace, of other will we start the And XSense continue gradually, and in U.S., U.S. in leading but will be it's later user sell to the product probes markets. current ProSense of the flagship to IceCure and the old

Yi Chen

Got with the to then for breast it. reported relatively start numbers cancer? remain and those quarter respect ProSense stable are obtain with for until marketing And the approval FDA an numbers operating you first expenses,

Ronen Tsimerman

Yes. Thank you.

So an yes, we expect relatively that have the numbers until we would stable approval. stay

from we there You sales. in steady increase ramp-up a be only clearance the FDA. after we can the again, believe have that see will that a is But

Yi Chen

obtains is last XSense? for plan for FDA approval, you do indication to start an once additional additional ProSense clinical my And trial question

Eyal Shamir

clinical of to to consider order will in indication. study we level point, do additional some additional try some In to mainly get

the one specific moment, competitors has no a the of indication example, endometriosis. endometriosis of For at

will So that additional we results. after something some consider this we is will get

in we in this will treat. consider GI as this of of new would we that future that could a indication, to will if something kind or but the specific off-label treat to the order is have like We additional indications indication, get part we

Operator

no hand call please go time. to further back make There questions I'll are at concluding the to Eyal a this ahead. Eyal, statement.

Eyal Shamir

Thank for our you, participating everyone, on call today.

breast new full XXXX could entire and on we please sales minimally ahead major cancer growth. is for cancer in boost in treatment indications, the the to invasive our women with U.S., stay FDA you. ProSense to the continue U.S., the While decision Thank breast across steam a working await the for IceCure potentially team tuned. Momentum many worldwide bring our

Operator

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

disconnect. and You may go ahead

IceCure Medical (ICCM) 28 May 242024 Q1 Earnings call transcript