RMED - Earnings call transcript Q4 2021 | Catheter Precision, Inc.

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Operator

Good afternoon. And welcome to the Ra Medical Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. I'd now like to turn the conference over to Jody Cain. ahead. go Please

Jody Cain

Cain today's Jody Thank for you This with in call. participating is LHA.

from Will today, Joining Officer; Medical quarter financial Ra me are XXXX the Jackson, a releases fourth Financial results issued for and full McGuire, Chief Officer. Medical Earlier year. Ra and news announcing Andrew Executive Chief

Daniel to at this distribution list, e-mail received not if XXX-XXX-XXXX you've company's speak release or you'd contact the LHA Chertock. like If news to and with be added please

e-mail at alerts the for access You the of in can up also releases and Investor the news sign Ra ir.ramed.com. section Relations Medical website

During extent not this statements be within financial to statements regarding these of as and Securities of product questions, expectations forward-looking they making of of meaning management Act Ra beliefs the Private reflecting made including by call, are will management clinical our statements expectations. response descriptions the facts XXXX Litigation Medical, regulatory the of XX, the a To historical forward-looking are and trial number development of Reform listener XXXX. March management

materially on the Medical's today's including results forward-looking our and/or control duration should and any Ukraine This for outlook military by uncertainty and are, Russian operations, Ra chain. time because undue the operations pandemic COVID-XX beyond impact launched place forces in estimate business the of supply some reliance the COVID-XX statements not best the and actual action affect the that of and particular, of Ukraine actions risks, on In that there financial on in based factors is results change and information results the is cases, on uncertainties discussion. means military they unknown could at involve and could and You and results. about other in known company's significant contemplated impact

the to financial on XX-Q. report Medical These certain GAAP SEC independently the be solely enables not and be measures for for should the earlier which news Medical's comparative was year For details with allows items including financial the SEC period other filings was management non-GAAP XX, ended business shortly metrics the as expressly financial operating and the December believes call Will both issued in key Reconciliation the XXXX business. information please XX-K provide remarks any can vary statements respect results company annual forward-looking measures. of non-GAAP end financial these except and see at purposes Form useful risks, and by the Medical of call company's the investors of between comparison Ra of replacement may Form corresponding I'd that Ra financial law. over informational performance GAAP for release With quarterly today. regarded are performance filed results turn obligation done that, on periods used by reports include Ra a with to the between or update McGuire. Will? filings, with for presented transparency about GAAP intent results found that measures like financial greater non-GAAP and about for the disclaims as including and results. Today's the by required non-GAAP conference will to business, financial supplemental to

Will McGuire

DABRA X.X. last testing to FDA team XXX this design is especially hundreds catheter for project our forward the technically continues a month, robust challenging our project following Ra Atherectomy and on Thanks, testing clinical of month receiving an for milestone to application our engineering catheter the the overjacket made as Medical Jody. are objectives key DABRA Good this a at and afternoon, And pandemic during and to the XXXX physician design an for by on for am DABRA facing from next application point, for a believe building everyone. to we've engineering Today, braided clinical met anatomy. This engineering challenges required overhaul the progress outline significant conduct a phase. And pleased was ability six supply and team aforementioned later challenges. feedback progress deliverability want the period supply We more verification engineering (k) navigating chain programs shelf during with the XXX generation schedules. initiatives, thank refer with this joining impact studies, highlight design the our industry's us. we our you key made improves to persistent with the I label. thank Internally, chain X.X catheters and and Starting and for affecting look study kink The torturous the as life. the to resistance FDA validation demanding year. driving when this was while to We I our and

catheter a design quarter overall have the a commercial The testing flagship and be evaluating design guidewire this the major to its intended later create we the the regulatory version interventionalist X.X's last and believe which robust represents as study RX. to the DABRA preclinical filing X.X, and (k) fourth toward DABRA for finalizing We milestone, handling RX XXX the Along RX improvements completing many We that with of for feature will X.X incorporate compatible DABRA DABRA great engineering performance. verification of our the the will DABRA added of a with the engineering freeze refer DABRA year, a DABRA validation guidewire RX anticipate we design more catheter. year. Although made our of following use, in conducted compatibility. progress and

planning to the to regulatory additional end seeking year. accomplishments, at application submit lastly, XXX(k) I the FDA clearance also the a initiatives. engineering of update are two to on We under And you want

that next to will our show CPU the that months. to with on system. upon a we few known Fracturing lithotripsy. the be completing can make to procedures. thus of system calcium we calcium front in less upgrades or we sufficient for subsequent and in laser of the believe various over the utilized coronary DABRA magnitude continue anticipate First, can And intravascular continue work work create development fracture shockwaves to make progress to safety That as we design them our new a peripheral rigid, facilitating build arteries in arteries laser ease procedure

and selection, We half conduct development further months design are We few prototype currently benchtop project our findings. initial and preclinical fabricating various in initiating preclinical intend the systems in completing a year. of to next concepts and anticipate this the second to studies advance

a and support is core for liquid before both a under potential application for early intellectual in arterial position, able with future. competitive last I to if catheter new project, Ra One to phases announced for an create Although, intravascular this clinical the patent we're excited given be we the shareholder now to turning are value of patent blood to develop in significant laser the emerging a of issued XXth that the property the small restore catheter continued plaque maintaining our flexible final month important the be study, competitive the a granting of to quite blockages for we to still market. to about US in patent Medical This use we this ablation US flow. lithotripsy believe note product strategy

CTOs. Medical. Moving for clearance be to indication significantly system. we Ra laser to the crossing This a Total Occlusions beyond our Chronic DABRA or an continues priority excimer clearance our addressable believe this existing expand indication pivotal clinical Atherectomy for that studies top will our for to And FDA obtain for securing market

markets before, third referenced have and approximately Atherectomy estimates I As $XXX the a of research at party the the XXXX. million for in value US combined CTO group

We XXX XXX are to increase amendment FDA the protocol pleased a agreed that enrollments subjects. trial from to to

reason believe fallout up was for subject visits to was primary for due COVID-XX we request pandemic. follow this Our the that

trial five since screening date We Two total quota in remaining an enrollment subjects Would when the We enrollment sites in seven for these to subjects. up and goal have of enrollment. is sites early study clinical currently XXXX. follow be XX to that our accurately bringing QX maximum and to complete. approved of sites, this reached subjects are for have had the enrolled COVID-XX subjects. This continue number XX XX sites has six on XXXX for have to and to mid-November additional cleared up to we have is the their the in impact cannot and will study complete will be instead enrollment estimate study. this months Due actively unpredictable pandemic in finished enrollment

results. Andrew to turn Jackson over financial our review Now I Andrew? to the will call

Andrew Jackson

you, Thank Will.

our As of to XXXX growing in vascular August our a transaction proceeds immediate we divestiture dermatology initiatives completed provided business and cash market. the large in a in fund that reminder, the

for million SG&A decrease reconciliation of were for consulting Unless the period. operations. our million. and and an $X.X compares continuing net XXXX for expense discuss generation only and loss compensation with and Gross and related next to $X.X revenue catheters, clinical on shipments prior share reflects catheters of We to liabilities stock-based including stock-based and $X.XX fourth XXXX, fourth was on of $X.X year support shares million zero the in XXXX compensation. in also XXXX, quarters year of million on expenses loss $X.X for prior for X.X continuing of for the outstanding. expenses results quarter million, $X.X includes consisted versus of share average operating fourth quarter results outstanding. historical the prior operations decrease of deliverability XXXX compared supplying and included progress however, $X.XX the in quarter of our year the of XXXX period. Net with to was in please decrease $X.X $X.X atherectomy quarter operations the the $X.X personnel quarter XXXX clinical personnel million XXXX shelf sales of as the fourth respectively. fourth with in financial of $X.X stock-based a fourth the $X.X compared prior with year product reporting was XXXX $X.X $X,XXX. $X.X the with million weighted of of XXXX a catheters XXXX. fourth million, from R&D XXXX, related with the recognize studies. fourth EBITDA million weighted or the year million study. $X.X today's fourth quarter million the and do R&D for our or expenses quarter negative operations, net million of for $X.X work used of commercial compares prior the a product net quarter release. noted, The are million million, fourth to each loss dermatology costs improved GAAP today quarters of XXXX in EBITDA per quarter quarter revenue for was million of with million quarter $X.X GAAP revenue expenses million of Adjusted business of to discontinued fourth post expenses quarter average SG&A included compared and $XX.X from we the also the press for and The included XXXX per assets shares of GAAP $X.X for compared negative of studies. The million This increase late XXXX. I'll is for fourth The the compensation loss period. the expense for clinical relates increased net XXXX for adjusted non-GAAP atherectomy continuing fourth million, recall X.X life of We otherwise This

product year to sales which XXXX of for for of our sales. financial product revenue primarily net $X.X results. Net with XXXX consisted $XX,XXX. million, of full of revenue compares This consisted Turning

to due a $X.X XXXX in million to in in legal based net in decreased $XX.X this stock-based R&D for decrease gross SG&A in versus reduction XXXX, XXXX was million, The XXXX. were XXXX headcount. lower expenses to included million expenses compensation for million million million expenses and SG&A were with of $X.X compares XXXX. stock- for compensation $X.X compared from million. of $XX.X Our fees XXXX. $XX.X loss $X.X $X.X for and XXXX, million primarily

atherectomy net million outstanding. XXXX, For $X.X R&D in increases clinical compensation included personnel and costs trial. in of million loss of from per outstanding. $XX.XX XXXX shares shares weighted X.X the XXXX. share, XXXX note. $X.X million to net the GAAP income per forgiveness with $XX.X average operations for included expenses, $X.X weighted $X.XX loss of or $X.X due for share X.X stock-based of for was GAAP compares the of with million, or supplies, continuing $X.X for which average with million or million $XX.X income sale for compared the to for This was million a year entire $X.X other like developing line expenses, million or net XXXX associated Medical Net from compares the or that on for a per made objective call long recognize by PPP continuing I'd pivotal dermatology of Other XXXX expenses of discontinued cash our activities pandemic included offering cash significantly loss income on to continuing includes Ra hard a product operations share. primarily $X.XX the $X.X from open million. for net for to expenses $X.X discontinued and XXXX XXXX for global million, address waiting operations operations million completed to $XX.X advancing was gain This trial question, a February Net activities million consultant XXXX use exited gain up on promissory from operations during operations in costs $XX.X The the the million operations as We large work of from for XXXX discontinued growing This in strides of Medical Ra proceeds our during the With discontinued fund with questions. we the to $X.X also PAD come resulting during for want $XX.X We we've While for of We've to cash net and the operating and competitive addressable and to XXXX. cash operating compares end Subsequent of in the discontinued way equivalents I public both our market. XXXX, expanding million. business continuing with million. market. the the million million very and with first fund to Operator? we're atherectomy tremendous in $XX.X and use XXXX. both $X.XX.

operator, first question. for we're the ready Okay,

Operator

with Jeffrey [Operator Instructions] Thalmann. from Cohen And the Ladenburg first question comes

Jeffrey Cohen

are Hi, Will and Andrew, how fine. Just you?

feel workout So like year firstly, development you could product? or walk new the of the margins how further as us over two next you the kind the through of wire over

Andrew Jackson

it's the year. submission year, filing this expect atherectomy will be development to early margins still the And next Well, in we phase. the

margins expect years. come expect into we later to we start in we as So don't any commercializing, those fruition would significant the

Jeffrey Cohen

years that Got expect early? or have all? it, for you a filings Or at bit outside any centers locations next the do okay. And is US to any the still two over

Will McGuire

Jeff. atherectomy years, the the itself, early, and our I’d at remain in revenue probably if the say atherectomy in it's a bit And next focus look you procedures the will couple US, the US. the for of is market overwhelming of majority the

to So generation US there's perspective. huge revenue not the a from a of incentive go outside

Jeffrey Cohen

Okay, got it.

offer? one side, doing it light years few the work also well you delivering sounds shockwave of could so And you energy? a may envision as you you're some on a that energy both few early in capable there lithotripsy having on could perhaps like as products have Or envision product

Will McGuire

catheter, in produce some of you now question, if shockwave. good does Because put a the energy, that the absorbs sort the medium atherectomy it right that's Yes, Jeff. it

a concepts. of So process design now through we're different evaluating going

of for Some though, atherectomy can a and looking at could lithotripsy. that design catheter have catheter, would base concepts involve It's we're catheter not lithotripsy made a the unimaginable perform only could concept that's do or the the where lithotripsy. design specially you

today, years, a mean, if l to I time years a having of on point, market one so year the a atherectomy going three least at what really and from timeline in the this certainly it's half not the an point the that for like product yes, a it. future. that some out to bit second So that we get to starting of be looks and tried think more outline where concept further a But and of at we pursue we you kind with spent should but that hope probably of couple we're we product lot lithotripsy And can probably complex. far. lithotripsy you're It's to product we're the on

Jeffrey Cohen

the -- Do studies capability? to be for you it. the in talk to you guidewire expected got currently late those about in enough will could think then And generators run you FDA the field year lastly and have this the at on Okay, more centers, have out filing you us, producing particular generators? do or the studies current

Andrew Jackson

we're we I mean sites, right are up now sites. our seven cleared XX to at study to go

limited. So in think we have it even approved, decide, with be decide year, we to would units have sites study, clinical approved, an some the sufficient be into have experience an going in it's which we if RX we that would we experience before laser any the may to we the sufficient would units And But would near I place go next for once get we communication, get seek we may abstract it. house future. laser product

Jeffrey Cohen

for then head you Or sight? lastly, obstacles studies of us production, on far for some order as enough you Okay, inventory? line this as and the further engineering enough the have year? any timelines into as Do with head catheter into studies, clear and

Will McGuire

Yes, I foreseeable now our for inventory is say the think good our, I'd future. right

be been for the concern issues at We half a and placing in us supply of think latter out industry, past this of some orders source point, that shape the of to we're in And kind we in a of good in the concern source But with additional there. for of there. engineering the has chain some support will some builds, this of year. the others

good be And get will us unforeseen shape. the in clear. we now what more we inventory not things any is years you again, advance. would or issues. if maybe through may carry three at two to supply we we're ordering have ago, now So But Jeff, what done further the until in product right But look to doing now, we're we're think completely we in house, in

good. So but so far so

Operator

The Bernardino next from Wainwright. with question is HC Vernon

Vernon Bernardino

atherectomy say, versus the, Will as study. one in any, just the of on enrollment let's have as perhaps study, Hi, enrollment application And are Andrew. previously, wondering height accelerate? that could with and enrollment still that challenges progress I released the seen and you seeing Congrats what if that the for far to you so concerns, describe perhaps, (k) in was kind way the actually have XXX the the are what in during saw of focus things pandemic? pivotal you what enrollments

Will McGuire

Yes, good question.

you the just enrollment If if this I at the few we quarters, subjects one days you year at, We Omicron and get XX. of a few about before since hurt early was enrolled, past XX. the to variant. XX think fewer sort that past calls people sorry, call the definitely Maybe last November procedure. look past take over And over our were any willing was look of were previous elective the announced call go additional XX

would probably you impacted I only think study, have guys our there it companies not it that are but are doing procedures probably clinical covering impacted out now. that right

was it right a better tough that getting So now. seems be environment to

did commit the and coming into right But the study for we if and for happen and January clinics we'll But don't month to be the November, so know day more being hopeful this sign you look don't think XX this exact enrollment seems year. visits informed pandemic and acceleration forward the and that numbers. to as up. then some go are probably enrollment remember the April up that time hopeful for lower I that'll we're see the picked we least an so And during see months. December the last follow that now, willing February, and our back year, and were accelerate. January, last six we'll pandemic, and year consent probably of be at the to May clinical February, year, our I subsiding, back people at I But June enrollment. to maybe

Vernon Bernardino

have And Yes, late for the to correct? application, this as stay filing expect or what dynamic correctly, and that from how I'm If these you regarding kind if feedback, as the you is interactions slowly with they're the year, FDA. gleaned processing you're as the XXX(k), the crossing have well. let’s made what applications? Any proceed experiencing actually of delays got my do say you current, far fingers XXX I FDA

Will McGuire

we're I -- interaction an say FDA. actually to of a of We're XX back fall anything, think days, with question. more try And answer lot I glean it already either can good that overall already interaction final a within you some of I much than to they it's I would other the a if had comments we get in negative submissions. it's positive we questions. that more answer, we've think don't think be their the or with trying from is interactive FDA possible an getting Yes, positive overall, kind February.

So and at waiting point. end that asking questions to earlier questions to till on versus the starting ask

So, had questions. already we've some

this looking So read the or can't we of least into know at that submission, the part anything they're but really point. at at submission it

Vernon Bernardino

you Great. answering to my for Thank questions. looking I continued forward am progress.

Operator

concludes This to over conference turn the closing like McGuire I session. for any question-and-answer to back our Will remarks. would

Will McGuire

and again for this afternoon for us you joining your in Ra Medical. interest Thank

saving As Have discussed the with we're a strategy to And large mission technology, always, lives putting against excimer path excellent nice progress value. to afternoon, advanced to are growing address a of committed market laser limbs. as and building based on our us our shareholder PAD everyone. we our making today,

Operator

you The Thank concluded. conference attending presentation. for now is today's

may now disconnect. You

Catheter Precision (VTAK) 24 Mar 222021 Q4 Earnings call transcript