PLSE - Earnings call transcript Q1 2021

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Operator

Greeting and welcome to the Pulse Biosciences' First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure, to introduce your host, Mr. Taylor. Philip sir. you, Thank

begin. may You

Philip Taylor

you, operator. Thank

today, I Before in expectations uncertainties. Securities statements or that reflect and to our only and of filings you opinion more statements, estimates, result like of and a Actual may we results as management's will responses are plans, forward-looking earlier as call other issued begin, comments differ today's information. release Commission. to inform with uncertainties risks during press XXXX materially These and predictions, would today implied your include XX, May fully including our views and and from described and those expressed in risks certain and questions Exchange the

website are forward-looking update website. or at Our filings obligation disclaim forward-looking SEC the statements. cautioned reliance on to our Investors place statements. undue We revise these to any can be or on not SEC's found

page. non-GAAP including call the also Please these audio available like that, Executive for our pulsebiosciences.com will Relations found in at that regarding News press discuss the I certain measures be Events be financial GAAP conference this with comparable Uecker. reconciliations note, measures, disclosures President can Darrin on We Officer, measures, section call Investor will release. our financial non-GAAP would website and now over the to of Chief turn under to replay With most and

Darrin Uecker

offer our meaningful call Biosciences CellFX up exciting the at we is commercial, bioelectric in quarter and pleased question-and-answer everyone the then and details of the financial for with you, mission we'll system has clinical sell and updates, the will to Sandy will accomplishments Thank our for from recent clinicians. far to In this XXXX Biosciences. reality. so Pulse made and initial progress system, we at dermatology. have And XXXX. will been February, juncture our of business our the FDA provide the On regulatory that experience differences on joining commercial use afternoon make share this received the call, to services CellFX betterment first results. market discuss field in us then conclude Pulse today's This I'm for beginning, for for open CloudConnect with patients clearance we From with medical solutions now a a I product session. including

XXXX, priorities days into the Europe. prior in XX advanced strategy. Mark that approval had have These chapter market Just we our our CE the company received inform current two regulatory we achievements have growth. In corporate next to of system

Our focus dermatologists, on opinion the late executing the into top for CellFX a system set utilization, key patients. address the needs aesthetic continuing a systems the and expanding potential, commercial to XXXX controlled launch CellFX program of develop adoption by to XXXX foundation among priorities that full to commercial are applications large in drive leading of new

system the confident We will over focus objectives the resource these to the value allocation are disciplined market term. of CellFX the long and that in maximize

of the system. enterprise very the that about initial hearing other were through of CellFX the The profile perform range the treat with affects is of leaving by CloudConnect CellFX procedures and remind we the base everyone Stimulation suite multi-application are burden, that and constraints console, be NPS to and are seamless to with delivers feedback is connecting key franchise. conditions CellFX e-commerce address integration is the their have skin aesthetic model device our address utilization CloudConnect benefits aesthetic CellFX into inventory on system, challenging portal technology platform with dermatologic methods. able regarding alike. also We're provides will better into premier customizable system of traditional our to to of backbone its cloud-integrated I CellFX and the customer basis, CellFX novel a physician relationship specialists about It that with We the a productivity dermatology, desirable costs customers only our and and energy an provide models. customers only services and and experience desirable in of clinicians services software provides enable The and the and structures opportunity without the a levels energy other patients for in is integrates a we growth CloudConnect common proprietary integrated It the of describe medical that NPS resource would insights current customer utilization proven practices of procedural of kind to infrastructure, aligns needs their cellular which CellFX company healing unharmed, non-cellular practices devices. mechanism as advanced to utilization like action setting highly system management excited of of business diving The lesion services create is entirely first Physicians physical case metrics not proprietary energy specifically, it tissue from profitability the administers practice back address our into tunable, NPS skin patients. a charge uniqueness to procedures. CloudConnect. self-focus will Before and the to applicators a Built cloud our that Nano-Pulse of patient’s, has use a ability overall. of is energy multiple of called practice. believe medical this and nano-second its pulse, helps our technology interests based procedures, on in that to system CellFX for to promote rich disposable is CellFX skin collagen clarity customer, valued the end their non-thermal system model, and management but differentiated configurations is our unique planning generally with unmet the system or able tools drive per new wide as for track potential innovative software-enabled, suite been delivery into to dermatologic the internal data the that conditions. modality and

Turning benefits I'd novel our markets to for focus execution European advantages measured to and our aesthetic Controlled of our program. We're Launch technology and a our the the the US discuss year, for like out the launch of deliberate main program. introducing to control to through strategy and dermatologists. CellFX system rolling

broad in began goal anesthetic Our practices the of into the deep novel the of technology introducing with understanding The execute methodical CellFX and long and developed a ensure market. of in team best for launch our dermatology. has is control system rooted success dermatology this market, commercial and and to designed thoughtful a a adoption term program to aesthetic plan a use

starting in promoting control top of investment and among clinics Our partnering each qualitative These exchange toward CellFX participating the NPS. be feedback time leveraged first will advocates their the NPS These generate on a practices the The of guidelines represents incremental intention CellFX peers. cost by is franchises training to and system clinic. the multiple experiences patient and best proven aspects clinics programs. with other program KOLs critical patient to credits franchises. influential have practical commitment also a desire complete their produce partnerships offer implementing which and customers. across all indicated mutual CellFX trusted to they by virtual and and for their KOLs system for by training earn of data launch benefits document and technology procedure become CellFX have investing educate These strong They their and excitement outstanding XX of system new the the adoption to In of our system. Biosciences treat, Pulse can patients then

end I stated, are planning am previously EU the because able As onboarding to in and XX our preparation in with the to that details remind the ended We in we sites planning we on reviewer XX provide Canada question marketing program clinics our say the XX XX our this onboarded the to of the the is and include the control Launch trained consistent This by approval the very Health the responded believe the experience to the by will Launch with leading and US to clinics system. pleased early of US second the Health recently Canada patients. approximately in into of you, begin to and were with Controlled within Controlled two, we to what quarter the CellFX Ed first experience CellFX aesthetic weeks be date plan We team, final treat review participating to across one quarter of beginning majority the call. to clinics EU. and clearances Canada from program. expand fully expect both for pending completed quarter. is launch the also later have To three. quarter the to in remaining in we're

I with general will fully other as the in system priority be US CellFX regulatory stepwise aesthetic a In application by therapeutic the areas delivered clinicians the pursuing Pulse across research priority our at CellFX discuss strategy progress can indication includes and applications. is patients, dermatology CellFX realize Now system be and CellFX applications to and a To highly value work We will and investigational [ph] we high for Stimulation to clinical in clinical technology To our load that regulatory specific well. system effective XXXX. the potential additional offer Biosciences. believe for high beyond the full Nano-Pulse and potential effective strategy. current that top the indications has system multiple expand

and an stages the study in at the preparing submission final weeks. a FDA it all And a comparing system where and previously, small that face offer of study described sebaceous that comparative with treatments system are the we a to lesion sebaceous patients electrodesiccation. we IDE is the up the lack acceptable first outcome can XXX(k) are and CellFX treatment to using first the submission follow completed such to go cosmetic We for primarily a executed within of we clearance As point, durable approved lesion several expect quarter. treatment for an next the occurs clinicians and on hyperplasia, this patients. believe for and during CellFX the hyperplasia, this indication the I've specific the We in provides treatment benign suitable pursuing FDA

non-genital indication is cutaneous study. our The Approved are in comparison FDA continue patients treat second enroll specific to And we and pivotal we in IDE warts. pursuing

of We the the XXX to and have the second the expect in of enrollment early as quarter early or third patients as XXXX. of quarter study treated of complete XX end

drive to timeline, XXXX. of and We the quarter of XXX(k) to plan CellFX the as clinics. FDA for data fourth continue specific benign Given indications remain the lesions expand as we to use on to in utilization applications submission the track this to the in system early

specific clinical of patients. to which potential Whether focus We directly all But for not by to applications applications. benefited be maximize pursue applications intention the allows for and is our most the represent its will to indication that need specific market a among for by prevalent value those are these will of upon worth clinic all can the we'll expanding indication, ultimately on a those believe these dermatologist We some patients. that acne. CellFX and of and compelling their seborrheic of launched we have use But It investment. lesions keratosis, to system infeasibility along, the be data physicians good a lesions, Nevi today, applications validation. we indications compelling further further factors dependent and believe others is benign number commercially, all and that clinical syringoma, including additional number

today CellFX Skin the will milestones. to a study. smaller FDA development this CloudConnect BCC. standard lesions and each estimated the of commercial diagnosed the will and be provide wide study also XX of enrolled margin this and this patients such XXXX. is application treatment three. the quarter to the the in form a current of frequently applications the patients. on to is half are used reviewed pursue and lesion important believe advisors And for clinical We Cancer and by that of system call, if treatment will that constantly assessment beneficial of to system any excision. which area BCC outcome of XX evidence most to strategy US second cells in provide that our end The will all approximately an margin Basal X.X This study skin large can as represents to and our application expect BCC the cosmetic standard system, treatment [ph] lesion assessed and cell surgical provide CellFX lesions noticeable cosmetically form basal expanding their pivotal pleased will a applications after a fully to a to can the We're in timelines for the detailed of occurring objective study area. treatment. in may be be we scientific areas, Post-excision, study common cosmetic treat a sparing cases alone, we to of basal eliminate carcinoma would initial sufficient or CellFX support IDE cancer In study and specific range nature to will healthcare. this an get there study, in can treatment pathologist indication Foundation. we sensitive resect system and these be the CellFX the is can enrollment as cancers. lesions. an We care tissue feasibility days received expansion result About of therapeutic cosmetically the the for tissue million If the number are of our pivotal of successful be a by treatment, provide different the and wide feasibility approval the believe compelling excision, they be across quarter, follow begin get with year, according care study carcinoma most will we in with for determine this closer more for report relevant regulatory using plan The then BCC a believe for the are of to BCC We excised as noted the treated the to week QX believe non-benign face, ago, feasibility cell the in scarring. benefits In remaining a to inherent broader examining NPS outcome, follow of lead We demonstrate platform. applications

dermatology, We of of continue to and in early leveraging development the gained. the outside have we knowledge invest areas application experience

We are year, that and of second them the so an pipeline more detail to detail application R&D plans specific in these provide our can half we on pursue potentially in on the areas of Investor our planning growing provide day, applications.

committed these the development and As expanded this the and of teams we continue to will support our unlocking potential discovering will have our and efforts clinical to technology we remain investments. shown required with point, full powerful to measured

will For [ph] Ebbers. more the on that in Ed clinics right to call I turn now, over

Ed Ebbers

Darrin. Thanks,

I all, our the for Launch and just to first of XX, First America the helping say commercial be Europe it is onboard and in six field in in Controlled US to nine Europe experience. North growing great in the CellFX the want customers of team

are as uses among once reception controlled gaining system. early practical and in these the technology knowledge unique physicians is on with anticipated for The continuously KOLs for team contributing to intended the base CellFX exceeded itself going, our specific expectations are our Our experience both warm patients. has our participants

done solution in-hand to bar job with in participants medicine, cold. technologies to heat older that or needs this that Our CellFX technology. advanced a high and great thrilled that unmet offering now unique clinical profile with addresses are to have clear Controlled And NPS aesthetic scientific lesions our use technology for an a procedure difficult non-thermal patients are have setting Launch a first advisors

Launch our applications Launch support with stages our plan well platform. as clinical initial for scientific progress, community we of very projects a in the research on and its pleased continued Controlled our to CellFX While engagement report experience are of the with new still excited as KOLs, in an group with early is Controlled

specialty and noted, is has by shown modalities, in research have or system opinion in that experience, like the key energy procedure the new our we marketing As and aesthetic of heavily medicine. market acceptance influence KOLs of the adoption impacted leaders anesthetic CellFX the

instrumental with next required KOLs Launch very these best that as these and transition Launch guidance will controlled begins physician practices selection. the ensure Controlled with launch, advice In we prospecting selected the clinical high-end Controlled are use. commercial adoption the months launch and qualified in laying to experiences, early that we trusted users. trials system control from the a Launch preceding made energy Controlled for clinical franchise influence success we CellFX early of commercial their grow technologies commercial jump we established on program for the criteria, and the patient including the carefully new In in with future, be commercial learnings to and needed based we likely our expect positive participation success foundation to optimize as For to of the have adopters, Launch our experience designed candidates practices. the and past wave CellFX Controlled that partner new and clinician the these reason, commercial from clinics aesthetic discipline for in that

was goal to narrow CellFX roll out to system. to positions down XX the prices our Our

first after selection Launch wave final soon clearances. of of early was Controlled the completed Our participants regulatory

customer follow ensure clinical both spoke for the We special carefully Pulse managed. new pipeline patient CellFX as take Controlled the system for tactic Since that a our observing CellFX represents onboarding it with planned that sales emphasis and operation non-thermal no process includes learning be how a present to a the have to strive center onboarding, the This the significant observe being there and staff. CellFX and clearance the subtle for of for mechanism our over experienced procedures to process and future that into tissue Darrin time onboarding be [ph] up is the session, continue lesion their the begins describe patients, to our lesions by clear move so NPS physicians to for for mechanism day NPS overview whole process anesthetic entire the growing are changes This XX patient for our Since CloudConnect and can the directly is and Launch local each which is skin team the and The leading and Controlled present a implemented team. process, Controlled applications, to comparable and are participants of investment can each actual staff system, including user commercial practice on process comprehensive takes covering our after module, Launch as effects inherent healing helps a the or that that our technologies clinics patient the procedure diligent the a which experience management, clearance physician of physician action, we to Launch qualify the observation e-commerce have staff, so that set. of This by can end of portal, as to we about. action, CellFX procedure, of of administration patient techniques, expectations initial with healing by clear direct expectation time. onboarded the in well first the enabled direct quarter. progresses their initiating better technology conducted February,

the applying sites Imperative We and from continue this and clinics this experience procedure XX feedback initial or Launch to to Controlled three sites. patient protocol. taking to their as early the Launch months patience newly establishing take onboard is approximately complete Controlled to Controlled expect process planned Controlled Launch Launch commitment,

controlled Launch early like physician to patients during paradigm adopters. for from This continue interest predictable tuning and delivered formal and to staff presentations with American the our feedback experience. of a sessions data launch feedback that of ability empowers attention of the provides be have with will applicability these commercial and system the this platform energy to gathered deliver patient's for of of KOL content sites. meetings technology at broad major benefits and clinical critical in a Meeting The four outcome Launch, of managed in the aspects peer-reviewed Lasers feedback program structure growing uses introducing our stage as all NPS a of new to of will experiences and by delivered and significant controlled XXXX and this the experts and continue Surgery is impressive the that on podium CellFX, publications early commercial thermal process physicians cell our modalities. these our Society our our [ph] and and educational of expert, Unlike early of Medicine and the Discussion specialists. up procedure collection to Launch wave next next Controlled a presence future garnering of controlled parallel enforces major greatly enhances excel Notably, major to phase, the Annual Controlled the changing scale and clinical opinion optimize refine managing by Controlled trial, new wave expectations of of fine meeting be carefully the we early the CellFX Our technology launch key presentations adopters. podium potential our at In with NPS procedure -on the specific leaders. or ASLMS, different aesthetic notable purchasing consistent

president Dr. of system clearer with being durable solution or our Dr. hyperplasia. presented Colorado lesions, procedures, for clearing of feasibility by [ph] Austin, value finally, skin as and XXXX fillers. of over Suzanne study higher research will to present and cutaneous, and And Most parallel on known for of in a research consumer Sacramento virtual motivated launch back a deliver Launch growth. New would faithfully highly study efficacy other pursuit new Thank City are energy lesions applications, executed interim will Cohen aesthetic place results the severe new Academy as patients the data world report high the implications efficacy we advance for meeting and on as procedure new embraced Lain multiple our sebaceous procedure. promise of turn Ted the that continue that discuss single Tom applications procedure. Controlled team, optimize highlights as with to be positive our of Joel common First, on Katz Dr. skin moderate specialty over clearing CellFX CellFX moles, multicenter at of for for seek around of Denver, platform on clinical well our settings the that American highly and Dermatology, will dermal ASLMS application Dr. Sandy. excellent such more clinical trained Next, well sales the I mainstream will the feed future feasibility plans, a CellFX a aesthetic commercial our will the dermatology growing Kilmer of and Rohrer,, our and will will Botox, the overall and Texas the as of to to commercial common we as of our generally a warts the you pain the now better present recently, Dr. recovery Nevi, aesthetic The and treatment York Bruce current With maintaining non-genital call

Sandra Gardiner

Ed. you, Thank

increased increase million, headcount to by the increase was additional the primarily based operating year support expansion The compensation of the infrastructure, million in the including quarter operating expenses for XXXX XX% million operating million, first million $XX non-cash Operating driven $X million approximately were activities. year-over-year ended stock the $XX.X commercialization expenses year-over-year prior of $X.X year For included expenses. in March and versus $X.X representing XXXX months of increase the to compared three year-over-year. expenses commercial and XX, or period, to $X.X prior period, operational in of

SBA discussion measures. comparable well development in related the design, expenses today's and press enhancement to results into the of our focus manufacturing, of reconciliation million increased Please in same for non-GAAP consists personnel, move to $XXX,XXX month adjusted due and to trials devices new our related ended of costs from and for consulting prototype related by comments for in personnel, support refer in of consulting the facility release approximately development outside three my expenses, research our XXXX, XX, period period business. of submissions a expenses our Non-GAAP detailed expenses to year and research, and and to products. Research future the development. sponsored I our costs million measures trial increases reductions expenses, operating I'll primarily a clinical most and development All into $X.X non-GAAP ago. the with potential March $X.X development as provide or travel XXXX, the clinical partially offset salaries and and services underlying and expenses during As in GAAP and research insights from material as trends by on application

$X.X and personnel, Controlled expect receiving FDA and previously three Launch $XXX,XXX increase included sponsorships, month for to activities of consulting approval and the at expenses and remain levels to Sales expenses the as development of employee to compared promotional and Prior and year related XXXX, outside XXXX. and marketing ended $X million period general system well from commercialization sales research in application period by clearance activities. and for the the in commercial prior to period including incrementally month CellFX continue expansion We and shows, these trade salaries in CE CellFX also primarily $X.X for sales March Mark to elevated of the March CellFX XX, marketing expenses personnel, three million and expenses were expenses. in system. administrative included marketing million not XXXX, approximately to expenses services for consists marketing XXXX, invest non-cash system, period expenses and expenses commercial during the for as and support year, related the related operations, increased to same Darrin marketing approximately we Sales XX, to Non-GAAP discussed. fees, conducted the the other as operating professional initiatives,

expenses of and compared net $XX.X as first ended XXXX. as and of million first million, investments compared million loss to quarter CellFX We the incrementally the administrative to ATM support operations, throughout the expenses of increase and invest in General technology related resources, expect to of salaries including Controlled expenses continue consist the executives, year, increased three Launch personnel, December other balance in and and the Cash, broad quarter expenses marketing XX, activities in employee strengthened system. public million XXXX as a other we period fees and our for administrative quarter XXXX, term loss used approximately million, sales for warrants. human insurance cash through personnel, as costs, director XX program, XXXX, and $XX XXXX. the $XX.X $X commercial and expenses to the a fees, million we as will On facility information related Non-GAAP same of the legal, for costs totaled first XXXX, by million officers was offering expenses. to for patent insurance. equity corporate XXXX March from March, legal, $XX.X related under the costs, excluding professional primarily and million $XX.X XX, well ended loan $X period of loan of administrative accounting, June payable XX, net XX, sheet exercise during general, received in XXXX equivalents of company March term net proceeds general XXXX. $X.X or increases aftermarket month and $XXX,XXX the March to Non-GAAP in finance, was Cash

authorizing in of ATM program. will use best distribution discretion continue shares We to the under our

broad and will a activities million operations, building Inventories usage cost invest approximately increase million shares FDA. at at increasing and for period Europe, support team XX, ended expansion to issued and in were sold commercial of XXXX. the month aggregate as continue price indication at commercial offering conducting including $X.X proceeds an Cash in levels per incrementally we of support During the shares sales XXXX, stock to The we to March deducting $X net after share with ATM. common under March studies three additional the XXX,XXX inventory commissions were sold average payable. XX, $XX.XX

completes each take line, begin system. as to top the Controlled revenue generation CellFX On commitment will XX Launch and patient of clinic their elects the ownership

initial As such, our systems year, they calculated and investments implemented throughout the systems strategy adoption come complete practices through incremental implementation Launch Controlled drive growth. revenue We are generating and to online will procedures. long-term as focused on remain its and at

to the turn call Darrin. I'll Now back

Darrin Uecker

Thank you, Sandy.

to The the approvals, CellFX data regulatory library system organization. Pulse establishing have growing support strategy Over we which Lunch of team the months, and our NPS of a clinical KOLs from CellFX as and the foundation a We're by momentum applications. initial onboard future as executing can is and widespread commercial past Controlled positive exciting while all we utilization current achieve significant participants, progress gained drive project to technology. made the Biosciences system adoption a

Manager for Financial Joining and me now Vice Sandy and the please for open President Chief Executive Q&A Dermatology, Officer. General Ed are and Executive Ebbers, questions. call Operator, Gardiner, Vice President

Operator

from now question-and-answer with session. Instructions] Group. Anthony proceed Thank we you. Maxim question. Vendetti question our our And first Ladies your Please and have with comes gentlemen, will [Operator

Anthony Vendetti

the the on I of how KOLs? that was Thanks. on Have or XX XX had update Any that board are it point? KOLs this wondering feedback that protocol is the any patients in at terms treated just are too the on now. you by Or being early?

Darrin Uecker

for Anthony. in. for the Hey, thanks Its question, Darrin. Yeah, listening

yeah, the had the end by XX So we of quarter. first

And whole the like then March. the And from Ed patients until February, a overall, in staff treated have all the know, speed, I'll just quarter. of of that at roughly end in of the if heard of And, been up installations of sort The are but forward. here, the feedback in this training, second. positive, treatments initial don't to jump terms you know, and I we know very mentioned and point this patients. was, their script, moving getting Ed has physicians program, we've implementation certainly in let in and continued So you I think of you mid

it's very perspective. pleased an been execution from really So positive. We're

to to rolling. them them ability Our systems up get and get clinics, trained the get out

great. thus jump been think a I Ed, to far additional little there. So want color provide you in if and it's

Ed Ebbers

is participate. that, a really physicians I’ll the process collaborative that and to us our understanding that to asked from we between beginning. And it add was right

While what clinical in we might than diversity different encounter terms far in certainly diversity very lesions, practice, had trials, everyday of clinical one a those are of successful conditions patients. of a clinical

in are And continue are treating ways added them range learn basis. treated curve they've our a treatable, understanding wide potential we hadn't we ways, we lesions daily allowed that lesions they even in from get learning of diversity some the to to weren't lesions and believe and our we terms steeper new of us of really because to observe of in trials that So that clinical from in able the before. and that of to patients on they've evaluate

Anthony Vendetti

then you'll the so great. the the by or you that quarter? XX and of Okay, another second did second the XX And Ed, of in say, to XX then quarter, XX end end be at total by

Ed Ebbers

the and be second we'll finish right. XX. then probably and it added Yeah, quarter US And I between we'll up somewhere the of Europe. Anthony XX so mentioned, this third at quarter, XX in as end that's the and in then,

Anthony Vendetti

helpful. That's Okay.

And so of of FDA. ’XX? say the end sebaceous did non-genital the second by quarter the of to by year, hyperplasia, the submitted warts be end should end XQ by And you hyperplasia

Ed Ebbers

Yeah.

sebaceous enrollment right, the next. kind cutaneous quarter, that hyperplasia late next think weeks, that to good of then here that's And end we're be in in year. this XXX(k). get the completed, non-genital we just of XXX(k) to then the expect we finishing several up And with early puts So us to by warts, position

Anthony Vendetti

an just then know the general to And KOLs. overall these on I out are revenues. question

there's know, quarter feedback. by that you earning to there's a near some be - the still of, some lot by of detailed revenues, at because is providing have going So ability point? to third still the revenue system is term feasible, - some this reasonable generation But they're the not

Sandra Gardiner

This is Sandy. Hey, Anthony.

we additional the in finished expect and But until won't continue after the be So It we patient complete will would XX the fourth you systems actually three revenue see online Launch the Controlled - commitment. their commercial that's come after process we they'll be first course feel that here, quarters. have minimal when know, to revenues. we would that the quarter they

Anthony Vendetti

commercialization, commercialization correct? the stay And I could the just the Okay. of it beyond all terms in quarter, if turn that, you end back then If are out where of KOLs, onboarded the third KOLs over. on before it by roll the quarter fourth to in happen

Sandra Gardiner

correct. is That

Anthony Vendetti

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

Darrin Uecker

Anthony. Thanks,

Operator

you. Thank

Sean Our from Kang your question comes next with question. with H.C. Wainwright. proceed Please

Sean Kang

Hi. my Thank taking question. you for

So market. my Canadian regarding first is question

of all, Canada? would the expand you big how if to time, also, you So on And approval Canadian - how program the the Controlled include Canadian your current is first is large Lunch obtain market?

Darrin Uecker

Yeah.

on part. first the touch me Let

to yeah, this I have in based the We think in CellFX we've that So with point, as final that this answered the review. we're remarks, Canada mentioned, question. gain sort on we the And approval prepared at Health been of stage in Canada, system. Health final guidance for the of the process documents from

the the end based timing quarter, before again, So complete we’ll review just isn't that sort given take the that standard on of their we of guidance.

incrementally in do think number overall but in compared yet, exact an make I be of Canada, to the if yes, to So would approval And of get Controlled small would when And relatively on think small we've settled Europe. additional comments we would relatively clinics. it Lunch I be on program at an into we expect to sort regard in the to then want Canada? that you Ed, of US of market, time, relatively, a it terms expand number and with terms our that any don't

Ed Ebbers

total one Yeah. aesthetic and the The rule fifth market. seventh somewhere of the thumb US in it's between is, one

top hired in also Canada regional key we've that very talking those having participating come leaders fine a to we Controlled to their based high US. that, in begun Now, manage Canada, whom quality are Europe same we've in with opinion sites interest Launch and the of the already expect in and about said with there director some kind

definitely person, ready about trained we're in very and training governance. a optimistic We're Canada. very loaded to programs, locked about enthusiastic and are physicians our and future well with roll So who proven

Sean Kang

helpful. that's Actually,

carcinoma more one So study. regarding question basal cell the

any - pivotal for the So say before would you study study? you data share from would go you the

Darrin Uecker

think mean, be us scientific in I that wouldn't our clinical always to transparent with and we'll who's is data. that intention when see It Sean. Well, to meetings, Thanks, to surprise exposure open see would Yeah. our very we anybody we get I followed I'd if have there, data applicable.

would do for so we that. certainly opportunities to And look

an you Now, study. Approved know, this is this is, FDA IDE

and able, meetings But come have public scientific So we pivotal I be in desire clinical always and with of FDA, get release out data we that gets around, we've to data you that think, our to meetings, use as investigators data, as how for of know, of we're information. and you know, that as both publish the some our respectful study tried it. that those to finalized,

its that. know, get the during it much we're know, pleased think, soon I third remarks. you FDA. study So I IDE you data out And Approved with didn't our expect that you think can talk about just for we're to as do But to, us to I as now prepared very able

you And warts, through So go sequence ability hyperplasia, non-genital and collaboration with we the our clinic. good CellFX our cap advancing the and think and work system know, sort as studies, their our these you think, study, that non-benign a couple of I cutaneous demonstration of for and is, to it's something know, speaks and know, we very and sebaceous this as and know, collaboration on approval good that think, FDA. in I to with FDA, we'd of you of a be FDAs lesions, these to them, to have with that benign studies, get able highly agreement further now to and is we a into a you on our technology get real team technology, feather FDA from

to in pleased be very indication. we're forward moving this particular So

Sean Kang

helpful. Thank That's you.

Darrin Uecker

for All right, you Sean. very questions. much Thank your

Operator

the There this Thank At no to over for like are I'd you. questions. closing turn further remark. floor to management back any time,

Darrin Uecker

and much the are system applications. with our very more and received Yeah, stakeholders. we've update excited all appreciate system dermatologists aesthetic us And operator. joining thank you we out of We're you, strategy call. thank into get very into we where of from about the everybody, CellFX important the And our hands. move support our today all Launch, very and And on continue more CellFX that getting this Controlled we for much, on forward to out

thank forward very you all So soon. talking you to to Look much.

Operator

concludes this today's web Ladies conference. and gentlemen,

now may lines a You disconnect great have this your Thank your participation for you time. at and day.

Pulse Biosciences (PLSE) 11 May 212021 Q1 Earnings call transcript