Jeremy Feffer LifeSci Advisors
Marc Oczachowski Executive Chairman & CEO
Francois Dietsch CFO
Frank Takkinen Lake Street Capital Markets
Andrew D’Silva B. Riley Securities
Arthur He H.C. Wainwright & Co.
Call transcript
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Greetings, and welcome to the EDAP TMS Fourth Quarter and Full Year 2020 Earnings Call. [Operator Instructions]. Please note, this conference is being recorded. I will now turn the conference over to your host, Jeremy Feffer.

You may begin.

Jeremy Feffer

Shomoli. you, Thank thank TMS and conference joining for us Good quarter you XXXX EDAP fourth results financial the morning, for and call. operating Chief of call, from Dietsch, today's will Executive Officer. Oczachowski, Officer On Chief Financial and Board; the we Chairman and Francois Marc hear

materially may subject the are and begin, include, today are statements. company's expectations a Chief Factors expansion Such but would Exchange statements growth Marc? on now like risks Commission. from that filings management's the described I that difference limited which such management's and and Oczachowski. not company's a those statements, I over we results could to and to, remind and would such forward-looking Before that number of those Chairman described cause turn to EDAP's are in Executive include based current to everyone to in Securities to may call Marc like the remarks contain statements regarding forward-looking uncertainties Officer, the differ plans. actual cause with

Marc Oczachowski

you, everyone. to start our operational performance. a brief Francois turn I and over review and morning, then Thank with update, Dietsch the financial will call good Jeremy, to

on quarter continued announced we previously we notwithstanding record effect fourth XX, As in XXXX of turned the January the revenue, pandemic.

to of Health at Keck are $XX.X midway New of Clinic. or These the million, Center San the and such through sales a XX% South growth quarter. In devices are fourth for by given over that sites regarded addition total during more revenue that Cleveland This in rise Medical again as caused again, of HIFU Francisco reflects adjusting Medical in world the XX% environment generated XXXX, driven XXXX University results quarter, the Center and €XX.X renowned successfully our we team revenue University and drastically Notably, X by period. pandemic. represents institutions technology. in altered our sequential Sinai same York and These third the report. of System in every quarter growth fact, quarter COVID-XX Mount highly these to throughout California, the to to the entire work of revenue the including reported in impressive the We the are all quarter important to increase of total we of case EDAP counts hard during the HIFU began California around institutions work reference the million, revenue sale over which, in generated

solutions interest the many our So even Focal in as COVID-XX, One with patients and devoted to treat infected hospitals ExactVu remained high.

at have resulting As issued level high-growth business, margin you financial this of careful time. during complete our also we our yesterday and prudently management of release, seen we that manage results managed may to evening, in pandemic expenses Thanks future. for difficult in a to XXXX the as successful to our positive maintain demonstrates were that press This me continue for here environment. the the complicated EDAP have we the was for income operating it for year. achieved such and generating This foundation optimism company, particularly great a gives great solid we in achievement established the our full is

of more cash to XXXX. or of €XX €XX million to our end We XXXX the than the at also at increase managed $XX million million end position from

final U.S. reimbursement rates received consistent repeating. we rules the quarter, X front, on of the And fourth were this while with of reimbursement it into effect the for HIFU, news U.S. very rule XXXX previously positive reported, January proposed which year. final bears During publication on went with the

on APC. payment performing a a the level payment HIFU the translates a adjusted maintains for X urology in average, side, hospital hospitals based within the classification, or HIFU payment hospital a national increase procedure of HIFU On index. locally from a the the the of received This from procedure the in $X,XXX payment ambulatory for rule represents into Medicare as wage final patient XXXX around Medicare on the an sequence X% This around procedure context.

most physician fee the -- the challenge change, sorry, exciting occurred and However, in schedule.

has the performing For malignant set payment CMS a setting, facility a translates established payment on tissue to in a Medicare relative on first procedure of an average the value to $XXX. for HIFU time, Based prostate CMS on the procedure HIFU performing physician in patients U.S. a by physicians this units a

performed higher reference, yield respectively, and than laparoscopically. pay established $XXX, under performing radical and setting is as much more minimally a treatment One cancer, amount, the is partial brachytherapy comparable though if patient is This would invasive cryotherapy a same conditions. therapies of A doing or for the of of higher average a and it surgeries prostatectomy As an done $XXX prostate payment is treatments. far time $X,XXX Focal a and Focal a average $X,XXX

HIFU expand Advisors. in the announced have increased reimbursement, we recently and partnering side, accelerate technology We XXXX very reimbursement established physician catalyst a having relative X that a leading support with payments. our widespread further on our reimbursement MTP more continue globally, be of and time gives it adoption we To and the both particularly So competitive believe HIFU, to to and beyond. consultancies: by Argenta towards and of market physician will spent, access

possible device of most just equipment, patients universal an physicians distribute significant investments market perfect In of and forward Outside long medical cutting-edge in study largest Directors in is the ExactVu exclusive and The a viable took the coverage so Urology is available interest solutions, will HIFU one shoes toward the January, by of HIFU were the and supported mutually surgery body forward is a of hospitals in look and leading AFU of for their evidence, nonrandomized, X,XXX and patients through market. efficacy a are surgery the and enrolled versus growing radical of making large the coverage This HIFU other favor creation payer prospective, prostate including in we HIFU the study Ministry treated distributor presented further medica man example the is in AFU, the that with of as whether XXXX, medica study radical are The policies. important with results sponsored radical difference at care supported to XXXX. Italy patients was make will HIFU, broadly French our to the to we and with distribution securing Europe, and HIFU comparative of public automatic alternative Association, as prostatectomy. noninferiority in we X,XXX the commercially on we and growing study reported by robotic fourth In in prostatectomy, beneficial versus of ab with and we Between as of they us. X,XXX partnership. France. in medical parallel, and primary as reimbursement approach. medical private a multicenter, Congress signing to assist standard of step a Italy. or we decision-makers cancer. current in with across hospitals, results widely a by Health. and The radical Medicare with the XXXX work French One XX surgical a U.S., or a demonstrating With insured. to November prostatectomy regarded prostate significant of guidance, agreement ab Focal

by X This ISUP majority the superiority beam XX and, the for X In in median are the radiotherapy a the naturally the achieved result external HIFU cancer with the The the to average and Grade significantly groups baseline. with in the fact from therefore, significant treatment more interim PSAs than of patients characteristics, comparable more of survival likely of efficacy of analysis HIFU older were on that salvage terms better was rate surgery. treated years XX-month suffer as these patients with compared hormone the issues. therapy recurrence-free equivalent HIFU, undergoing and/or arm show at despite to patients defined

a Turning we across patient period. and of over of women treated Recall a granted quickly later. of treatment authority and by to follow-up completed health XXXX, endometriosis a A treatment months full X weeks were the Phase be for will few in French the initiate the France our clinical first deep that study II invasive HIFU at assessed to approval just hospitals major trial enrolled in endometriosis, and XX program. August total we X

HIFU in and this of During in trial. investigator the by process Lyon this study, additional its pathology. safety is XX of date, to investigators Enrollment program Phase X To The in our currently for lead patients we advancement will enrolled opening of trial participate with is consistent study. have forward opportunity efficacy our We Dubernard, and evaluate apprise global are the François? We a the of exploring for we endometriosis look of example these strategic HIFU, market sites believe II Hospital to to continuing, some you the shift HIFU Croix-Rousse just benefit Professor at technologies. efforts financial CFO, R&D and into we will details HIFU one results. other pipeline our Francois and significant can expand noninvasive large our And indications. very opportunities. Dietsch, from is now in clinical of endometriosis our that towards keeping condition provide our see Gil

Francois Dietsch

everyone. morning, are in Please good percentages, on and Marc, you, except euros. that for Thank note figures,

of quarter a quarter a XXXX. COVID-XX XX.X%, conversion revenue the million the the HIFU quarter rate fourth treatment increase new €X.XXXX €X.XXXX Total was our and ongoing For despite was record XX.X% XXXX, €X.X XXXX of XXXX. for of purposes, reaching business compared revenue. for the impact year million, euro-dollar versus the on €XX million, of in to of QX level for million exchange XXXX €X.X the our fourth an for QX quarter revenue, Total €XX.X fourth average for for fourth increase our was full in revenue

the X during XXXX was increase for sold of XXXX. same €X.X lithotripsy period and the We quarter the the we same last of €X.X million, quarter, Ones quarter quarter a X the XX in year. fourth the sold in million Ones X Focal revenue versus fourth period Total year. compared LITHO the During business for X last devices in Focal to versus XX.X% Ablatherm

was the is thanks of was the XX.X% profit XXXX quarter the the in Gross compared of agreement. and in quarter XXXX fourth year-ago Imaging the compared for the €X of Distribution fourth on quarter HIFU million was The revenue to U.S. in on as to dollar operating XX.X% €X.X quarter diluted compared the of €X.X quarter to income Gross for Operating of in regular per million, the quarter net of net sales. million €X.X XXXX a margin improvement fourth XXXX was sales for fourth Net license million total tax a distribution or profit year-ago the of of Lastly, year-ago XXXX, profit million to XX% from quarter Exact higher million noncash income year-over-year an the to million, the diluted fourth share, currency impact, period. and to €X.X increase loss million compared loss business XXXX. to €X.X the fourth fourth period. for period. due €X.X of in XXXX of €X profit the €X.XX for an mainly primarily was €X.XX per including share exchange compared

Turning to full €XX.X the decrease Total XXXX. million, were revenues a XXXX. year X.X% compared to

full the million profit the in Operating of the to XXXX. period. for million was the to €X.X lower for to in XX.X% of million an impact mentioned, business compared €X.X for was XXXX. revenue sales decline Gross €XX XXXX activities. driven Gross company's year HIFU gross Marc The compared by XXXX in COVID-XX. the operating ongoing profit profits due of and pandemic was profit reflects of XXXX for year-ago to sales for million was XX.X% mainly COVID-XX XXXX the €XX.X net profit the and margin As compared

€X.X Marc COVID-XX, Net this competitive year XXXX due As per a per compared mentioned, for in to €X.X million a diluted to report €X.XX an environment period. or net share on loss operating as diluted the income of year-ago was pleased or the million in are to €X.XX very profitable we basis. share

rate These the as very XXXX. as conversion well represents the and strong COVID-related institutions. full generated received reflecting of cash fourth or quarter cash were over €XX.X €X.XXXX. year flow Lastly, Japanese of third and €X.X of a strong cash mainly of loans million, during XXXX, from million the with using XX.X management a quarter French, monitoring we USD of balance positive euro-dollar and loans This U.S. of million XXXX finished second

turn me Marc. call now Let to back the

Marc Oczachowski

Thank you, François.

strategic our start operating the for to increasing and highlight the key our like call HIFU I sustained extremely feel the constructive milestones to clinical clinical We the successfully pandemic we significant turning fact session, U.S. programs again cash the Before back positive year, achieved operator we the would million, Even profitability. the and to and to significantly program. in our in projects, of continues the our company. continue turns that, full the economy XXXX reimbursement out our position, despite our to HIFU challenges in advancement as question-and-answer sales of if €XX.X We year endometriosis be well milestones such marketing achieving to and it positioned to XXXX. post, impact this global strengthened great in

We will to call Operator? now open questions. the your


Instructions]. [Operator

Our first Capital is from Street Frank question with Lake Takkinen Markets.

Frank Takkinen

environment. a year Congrats great uncertain on such such on an

Marc Oczachowski

Frank. Hey,

Frank Takkinen

placements. is trends should are me about XXXX placements, speak in guys placements abate quarter. guys How your more the positive? to fourth for X HIFU trends throughout you to be a was had could and COVID towards A Starting in starting solid with from looking given thinking quarter you couple we reimbursement today. expectations that hoping regard I XXXX such with

Marc Oczachowski

Yes. Thank as the mean, speech we Frank. don't we it's you just give positioned. explained now, I end mean, company we Well, give I the forward-looking pipeline -- strong the didn't feel usually projects. is have know well right at guidance, you of for question, that that statements. we too And the a of sure much I

We have momentum.

good are yet but for we well do May. that our and and have positioning during call very news in so in us XXXX, are XXXX reporting any 'XX, not of information we'll We achievements

Frank Takkinen

into a your Argenta, sense. for we some specifically, commercial expectations could bit more consultancies, bring in That and those us what organizations regard take Okay. could of see do the you deeper makes XXXX? And little to In you to issuing MTP believe policies? could some start

Marc Oczachowski

as with earlier increased to -- and previous in I communication, we past. work the the MTP we explained support, we actually, in So our used

code. with working and CPT was So getting and the supporting us in then C-code MTP us the

work increased strong and and of existing idea is deeper access access The and Now in -- on market by really a supporting on investment again and we getting giving Argenta reimbursement to have board. on good coverage Advisors working coverage, probably different in support -- with to get but as also institution to the or both the coverage the as different private claim Medicare private payers their in well payers. both sites placing and working Medicare, and new max from sites to automatic positive

to insurances. the coverage and the max we very the want the really again, the and market better is coverage. more and coverage the increase and and get have we and get expectation, to, obviously, support idea more So strong commercial and from from policies And goal at Medicare payers

Frank Takkinen

a bit Perfect. And organization. commercial one me, you then last for higher-level Can the about question. little --

understand United more exercised out approach Focal the the Tier rolled as I of U.S. the in of you've only a centers you X targeting kind States So tempered in One

going start to next institutions the commercial after developments around Focal developments expect One reimbursement, guys the MTP the as adoption in or start you X and more Given U.S.? for we well, to further Argenta of of Tier behind to Tier of the kind X a the should wave the to organization fund step natural significant place next

Marc Oczachowski

right, that's you're and No, the plan. absolutely

and increase we coverage the is As a to technology commercial to X network. expand idea require expand the organization payers the indeed and from and more Tier will the paying X, and and that and broader more Tier have supporting it, institution


Securities. is question B. from next Andrew with Riley our D'Silva And

Andrew D’Silva

quarter. strong the on Congrats

quick few a Just ones for me.

at relates the the the your make relates at the we start, were Just to first carry ability do half you -- since so XXXX? do during the the capital the play has if perhaps the demand strength as there were very was it Or limited quarter other quarter? And change? could, you fourth think to to of investments pent-up tied customers the the first first or -- XXXX? quarters it X quarter, to the to momentum fourth continue more of in momentum you to as quarter see from fourth of you the over end from of did believe Or factors XXXX, into

Marc Oczachowski


fourth seasonal capital the and in I quarter, There effect right. always as absolutely there one is quarter the of because on the to fourth of we if in they sales the most are And always cases, fiscal made first, first be the not the offering. is, made bigger end year. as that's, has year, and usually, the a think before investment are say, you're of were such equipment, we -- in

extremely that the the So or COVID-XX to worldwide. happening phenomenon we amplified end by the the this done the investment think of new crisis usually year, at year, that of year. hospitals been I have more first was effect which increased completely -- by hospitals slow has half private seasonal of And due and

we the crisis. it quarter, was got but a So again usual strong amplified by

turning I bit impact momentum, getting the so the economy, beginning or think we and would money year. I Now be understand visibility might very I year are are entering the year. in before, but over. it still though the the I little have last Even at amplified say, very strong the that this to pandemic that and of -- like there the things in was as unfortunately said not lack slow worldwide is of a is Like very, is usually, a it people XXXX, investments still very by in improvement spending vaccine seen, the shy

investment. the in interest that is in we grow well in number institutions So momentum from rest the or as we've pipeline what in the seen the terms interested to continuing the of similar of technology see as something of last have for U.S. again, we appetite Though year and, -- our world.

Andrew D’Silva

of just to what And saying. you're Okay. recap

been, grow, COVID-XX of would than to continuing have typically took an during ever it's as winter. of XXXX and large of to as seasonal see because second is more first quarter actually and pipeline likely you the the augmented wave that impact the the place interest while is basically, So is

Marc Oczachowski


this last least the seasonal in yes. I general year maybe year, the at the effect in year, beginning and think amplified, be over will

Andrew D’Silva

into Great. facility And surgery referenced And initiatives was final significant I January? you any now, differences then between to fee One. then, okay. fee? tie just there reimbursement an it Focal the in provided positive Are an development there's hospital facility before, with you to facility you been fees are that Okay, know a maybe center, as ASC say, put ambulatory before able in but place hospital is reimbursement? took Or HIFU pipeline that place the reimbursement and

Marc Oczachowski

And a that a long CPT code something think time. that's I the not was the got we've for bit known of both. of beginning fact the surprise. again, mean, execution the that's in I year at a

was as and everybody the So hospital prepared, well.

say, a still would difference payment So as grant same think come It been CPT since is code. news And a difference between CPT and hospital ASC -- the it news. -- the the procedures. didn't from breaking by got CMS I an or -- a all we the the for I year same the known as in the law, almost always a in was on for from has

Andrew D’Silva

if reimbursement Okay. Or can just have just reimbursement? dedicated do my a working you exactly last you for And work ExactVu? on Wonderful. refresh obtaining And are is thing, there? you ExactVu. reimbursement memory on How dedicated

Marc Oczachowski

capability dedicated the or reimbursement for device. of -- reimbursement have using is well, of and/or the MRI don't the targeted No. have for We the -- ExactVu. for And reimbursement ultrasound sites today, biopsy fusion capability are or don't the our what we micro-ultrasound a

You -- including micro-ultrasound and biopsy capabilities, has ExactVu as well know MRI the a device then as a being targeted images fusion capabilities. a ultrasound, lot does that normal of the Exact different being

for reimbursement something is but a is and dedicated we're on. first, micro-ultrasound, the yet for the there working So reimbursement X not this


with is He H.C. question next Wainwright. our from Arthur And

Arthur He

This two is RK. Arthur have I questions. for

feedback could color -- your the CPT during us of all, after the -- of you anecdotal from payer? there First discussion guys -- any regarding Could the you with implement -- same give code? the code, the is

Marc Oczachowski

that we particularly, level that the the have private that I payers medical mean, before, access increasing that's we I sure and And with we the market exactly If understand the level. and max question. accelerating we strategy, discussion -- Directors are said includes as I'm are code, as question, at as more our answer. and, well payer not now was

Arthur He

the the you on for question gross can Is second fourth be gross part. that could margin. my is the the give margin regarding rate if XXXX? color at And run us Or quarter more

Marc Oczachowski

product, give at mean, yes, the to I statements. between be is we margin divisions. the effective the run three the rate. difficult It's don't forward-looking it get Again, sort same we answer. If mix But pretty gross could of

the usual. we've the same, any the sales if same yes, be on mix But as it full seen consistent. that in So what about far should case, XXXX, is momentum remains shouldn't in year the be and from the


over Marc And turn the now we to have session. closing for reached the call question-and-answer end of remarks. Oczachowski I'll the back

Marc Oczachowski

you, and be joining everyone, of during our discuss results. thank call for you our keep QX further and our We'll for Thank to pleased posted we'll informed operator, today. earnings developments, XXXX us you, next and of start

all You day. have good a


Thank And this this at your conference, may time. lines and concludes you disconnect your participation. for you today's