PLSE - Earnings call transcript Q2 2020

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Operator

Thank you for standing by. This is the conference operator. Welcome to the Pulse Biosciences Second Quarter 2020 Earnings Conference Call.

As a reminder, all participants are in a listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. now Investor turn Relations. would to conference I Taylor, Philip Instructions] like the to over [Operator Please ahead. go

Philip Taylor

Thank you, operator.

of today's views products the and including include financial expressed opinions commercial, timelines plans and the such in outcomes, or Before we XXXX pandemic responses during XXXX regarding uncertainties. for and Actual and you in only uses, products, projection, are that most and reflect including our the from begin, with of expectations implied I'd filed forward looking detail statements like described differ statements uncertainties commercial to benefits to and clearance, the and strategies, and will your as risks August those of a May risks today, regulatory may future events. as inform process applications and include results relating comments call XX, Form and scientific, Covid-XX the other and management's clinical certain These operational, statements. XX-Q These recent our to XX, regulatory questions our impact SEC. result materially of expected

place to of replay Executive on statements. like our website. call President Relations call the Our Investor our section be at reliance SEC's With Darrin our News pulsebiosciences.com page. I Officer, not on available Events found website and now for Investors be will turn Please at over and forward-looking undue Uecker. that, would the Chief to are website SEC the on note, that cautioned conference or through can filings this audio to

Darrin Uecker

update outside all by providing afternoon me pandemic to everyone business. today. the you recent you for ongoing of at us important the and with Biosciences. our our is Thank before Pulse team This impacts afternoon. made But we we it look Good recognize joining Covid-XX progress forward the to on begin, an for

patient commitment bravery care. their the First, healthcare workers all unwavering I'd like frontline and for to continued to thank

business thoughts It health will been we has this to every The our in around priority, has by and workplace safety affected we local virus. have for to the with we Our ensure and day in top regulations our to to must all state lives pandemic are and possible our many some taking in employees guidelines. vigilant and as are the that, health precaution observing well. had safest With be persist communities at this create experienced the department those as clear an and protect that is all so efforts pandemic our in disruption us. of day our their everyone remains continue who point while time, impact

the have are However, have our concise not unique market. internal System location with we relied landscape aesthetic execute clearances of phase on intention over maintained remain of attitude we strategy growth remain the versus about responsible of dermatology of objectives of and along proprietary From the times, of clear our bringing and that through growth. have our fortunate as current our single these state internally, the we these on the workforce our our work The onset regulatory our our next with ahead these challenging focused have technology significant. of and We to we current communication times. and beneficial productivity. introduction conditions. can the we progress Amid navigate opportunity to of commercialization achieving been company, focus maximize our we continued confident, about circumstances, CellFX towards improved uncertain the And as these full issues been today we excited

I'd Biosciences, our a background business. anyone Now to quick to provide Pulse new for like on

typically we nano-pulse units controllable enterprise our practices believe CellFX betterment lesion the so bioelectric is be are System the the offer capable a our customer clinicians. operational make to practices financial a call with metrics per of System medical an customer to NPS by our planning meaningful for System, the nanosecond utilization specific needed is other that Dermatology patient that We physicians CellFX a patient multi-application highly is aligned of In we the and management while cleared; the CellFX older be company. the System. and healthy utilization-based basis, mechanism designed is where by have which and and on design benefits. integrated Cloud lesion stimulation e-commerce lesion, friendly our same a and of difference could It units and clinical more per the on and CellFX a clinicians, costs System, preference. not non software that worse lesions are to connectivity with outcomes, Cloud device skin. infrastructure such pulses to modalities is technology. improved and industry of offering cells, proprietary is adjacent data cloud the the technology internal CellFX ability cellular The harnesses patient's software cycle download our mission The the customer that to preferred and device to relationship track experience than fixed portal, Cycle our provides more System area Connect. non-thermally purchase original addressable systems. The backbone action This practice operational the electrical the tools delivers of patients per the enabled once charge patients, to lesions will Connect customer prevent the basis tissue. address of accommodate cycle enables This wireless previously, makes a solutions sparing on damage the of surrounding model Based and platform possible clear that well units clinical result CellFX and time differentiated, extensive Our and the were between tracked management appearance it collateral clinicians directly with consumed. energy as aligns is the wirelessly that through undesired cell to cellular at enables patient console-based workflow CellFX collaborative CellFX interests identifiable our skin the resource portal innovative, generate process caregiver in condition. business dermatologists.

the as with disposable currently connectivity software Pulse contrast device note remotely the is use upgrades prevent those real well us as Cloud System physician customers. clinical growth to practice model the of clinician and in the and facilitates functions System because maintenance that workflow support in to CellFX it models. to enablement allows occur CellFX CellFX provide single time friction Our the direct unprecedented the clinic streamline, ability for several provide that perform to employed the about Connect responsive and for based removing One to last medical can future disruption service models, and for be

development call laid objectives, progress our we're the highlight and priorities Turning now we business to to pleased the out on today, our our in three-quarter on last call.

other of outside our the CellFX the from of corporate proceeds for has for XX, of warrants. exercise potential in priorities System by and U.S. of two launch and company runway start additional $X.X On territories to and I progress preparations our sheet of key both European and commercial necessary clearance with recent our financing. successful System territories closed launch the gross the the through third, off in namely U.S. the provide we regulatory Canada the The Union shareholder will in significantly friendly of will June June. offering XXXX closing addressing clearances rights the rights First; million and the capital generating close CellFX with commercial million transaction strengthened the offering and the net preparations. issued $XX.X these proceeds regulatory financing the for resulting second; balance for

display call. will this provide strong for from details support thankful in additional confidence this Sandy later very are the successful and We on financing stockholders.

front, clearance the Now our on use CellFX objective an in System second dermatology. top to priority, achieving is our for XXX(k) for regulatory indication with general the

XXX(k) would cu-sub previously, we confirmed studies general XXX(k) of skin a animal all items FDA's their May our or clearance. in and we items. the received have be confirmation our submission. path with for It of System, indication which dermatologic the The As note that subsequent FDA, good human the the and imperative device be practices our work. this predicate studies three in for indication important proposed regarding solid for no CellFX adequacy meeting selective these would the performed regulatory We for mentioned support studies pre-submission and to we is the use sufficient preclinical preclinical of laboratory further under confirmed required

operating capacity; at a at extent study With design to locking, activities Because were we the not on study. It facility the the our June the to full the XXX(k) restricted is protocol dermatologic GOP XX we submit in capacity our next animal working expect general plan in to you of currently initial labs several after operating an our began still pilot XX we and weeks update are begin capacity and COVID-XX, this and as these days. today. for with we study constrained

pathology for treatment have side, time include next assessments positive skin to the completed submission. we the points. we samples it the The report On preclinical the the up and required in with data analyze, of all treatments XXX(k) will will are hand, the follow pleased prepare steps now evaluate different at we that the for Then, study. the

being optimistic of more the a provided knowledge the combined potentially of year that be We in result system submission straightforward somewhere XXXX. continue QX could with the the advantages XXXX between December our end prior indication and general and dermatology data being FDA's to clearance

pursuit step initial Our the following of the will continue indications System regulatory with specific wise approach CellFX clearance.

for will to last the meeting and SH. next FDA next setting very in design a similar request. a FDA just path will is CellFX May our were move SH and enrollment able to Barring FDA a we with meeting are to submit Hyperplasia approximately of would protocol exemption specific submissions begin we investigational The COVID-XX, reported after this, achieve and warts we to SH. that to provided indication Update parallel of System be or indication our weeks formal required productive device three due quarter. the a keratosis June basic is we any important We the Today, fourth for Call, the with study the sequential, pre-submission compare had upcoming and it the commercialize our on FDA anticipate FDA. on indications on Union design. to be Based the for support or by delays trial study for The to the the to the take from clearance in submission draft to and Seborrheic feedback report efforts agree the the the received execution Leading our Sebaceous setting. meeting feedback that requested investigational to on report we meeting to next we On we Onto some pursue able the We device meeting into forward will IDE in we'll enrollment exemption that to week European couple those we While our on meeting, with meeting incorporate in months. was clinical with calls. approval FDA follow would discuss step of to the CE and pleased mark. Investor the timeline obtaining estimate this requesting with plan is our we path we're work. to

the to nine that in investor for report an in the of to would devices As to mark previous six receive of plan. have call, System implementation we COVID-XX impact delayed And continue able accelerated we the has to provided potentially months CellFX opportunity CE medical according the our are regulations new this we otherwise to EU we due discussed sooner to. than track pleased to been for

to we worked CE we CellFX quarter System the of the required with EU mark. mark. is the compliance mark The several currently on all Over continue notified CellFX European application Directives for or gain Device milestone CE believe and the the documents submitting we in in recently the discussions, application authorized The assess XXXX, company MDD for System and the Medical approval in will leading review to authorize we last the with of under based one And CE months, closely the EU. our commercialization support have important for of body. use our our achieved

the for and first also the progress We Health important leverages half on regulatory believe Health work in CE clearance we'll another The position territory. submit to mark for to for a Canada in process are year the Canada Canadian to Canadian approval, CellFX we of QX make this System doing the we in continue our the of therefore, application be XXXX.

to details will with turn dermatology our the scientific to engagement more continued I Ed call community. Now, over provide on

Ed Ebbers

recovery research customer. the will I dermatology continued sharing in Darrin. begin Thanks new target business aesthetic on practices by our on marketing

are and As I who there procedures resume, measures. patients COVID-XX are navigating elective staff safety

the survey the more months. May, of procedure peer I various new difficult to almost important elective being and the community our July fielded procedures continued of of both our due with offices foundation continued complete less science. procedure Compared research projections next over the published market in events newest will of shows practices and elimination or And continue market Next, the of opened elective May recovery last were recent on that majority published a to to research the new now NCS additions to skin recovery COVID operating demand than this marketing to our concerns ever-expanding restored office regarding compared clinical technology engagement volumes more procedures. constraints. issues. same peer research the XX% volumes procedure with our including our to use aesthetic current capacity of May, recent continued as services. in dermatologists survey, of to clear levels XX% bullish Starting patients describe six successful the patient and of in aesthetic been research procedure majority Back most In these marketing in presented to is highlight and normal at trends have scientific as to aesthetic of clear have increases regarding reported

patient months for of more majority the volumes. volumes, procedure expectations future take return to will to of about to predict, continue the six normal physicians Regarding

practices their to properly as appointments guidelines on safety safety themselves signs their being is and for that research new from prudent of Again, is Taken with reflected a optimism represents of specialty high their research new growing patients by that whole, this dermatology further invite they and levels projects confidence demand and keep Pulse. is optimism COVID findings patients, backlog marketing to in encouraging Scientific recent back and a Board implementing reports from several a new for marketing This position point appointments the companies practices equally clinical staff patient the expand like and are of is months procedures. of Advisory to office patient into trending supported future that and normal procedure procedures. aesthetic measures growing continuing our scheduling experience aesthetic research appointments. these have aesthetic backlog This aesthetic intentions for all can procedure continue safe for elective true those to

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on this Medicine Surgery preclinical call, total NPS mentioned Lasers we The at of their with the annual Technology on device of its of of and a ASLMS and meeting. energy updates device, and as selection category featured important clinical of large for five presented Society virtual energy e-posters month, this three including studies the new the two recent own conference abstracts American for or papers specialist. on our As hosted a surgical studies previous conference past as with

have newest results KOL presented who President Dr. a clearance Our XX% commercial were presented pivotal member, that He in NPS past with opportunity large study from Victor warts, to our high reported warts methods. in Ross, clinical previous Scientific warts Advisory and clear represent difficult the failed cutaneous future. new non-genital the treatment in showing of to data significant in including of treat clearance complete a a by data fungicide ASLMS works. These early for rates in clearance

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meetings keratosis, delivered carcinoma. technology, non-genital information applications importance impact benefits of Ross highlighted dedicated sebaceous scientific including XX-minute Next, virtual clinical cell of a dermatology. the and where presentation properties non-thermal and and in are a Dr. with validating to continuing investment NPS recent applications across of unique mechanism cell its evidence cutaneous two to NPS in for spectrum Victor technology, clinical the basal scientific action testament dermatology potential several hyperplasia, our specific warts a These in broad of common he seborrheic growth

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technology in commitment commercial leaders generated Our in advocacy device NPS a clinical most of high of foundation us acceptance closer that receptive dermatology some for a leaders. based with optimization development science quality advances key opinion to the brings in partnership scientific in and on respected important in growing market among resulted product to introduction. has and And outcomes

COVID precautions ongoing and virtual may meetings, in have presence While is community. physician our scientific alive live the prominent constrained

to Now the the over call on more for I'll financials. turn Sandy

Sandy Gardiner

Ed. you, Thank

patent offset same fees Research and primarily in decreased to the the consists for product. finance, research administrative million by expenses development months ended increased approximately from development a general $X.X of XXXX, General XX, year consist expenses. increase Research design, and and expenses for related manufacturing, and by as $XXX,XXX prior to personnel, development $XX.X a of period of million period. as for and stock-based for administrative and compared ago, period partially Net quarter million executives, related professional the three potential $XX.X costs XX, costs, general million, research $X.X period in expenses million to and XXXX, employee for the the Development expenses loss XX, were related expenses and associated in during by marketing insurance from related General expenses as the increases $X.X outside legal, administrative enhancement offset $X.X clinical in non-cash expenses well clinical to costs. consulting year quarter million, $X.X the June XXXX million trial June CellFX ended and development in $X.X and in the costs expenses and to and million related of reduction service XXXX, Operating corporate future and the sales personnel as three-month of year technology second three versus from marketing, our administrative XX, trials XXXX, ended period costs June primarily expenses compensation included quarter costs. ago XXXX, information System. same ended during to XX, to $XX.X and $XX.X For was human the other costs for June due for operating and resources, development second well personnel, compared with million fees, reduced million ended $X.X were for Decreases the million period. and the second by XXXX. months salaries XXXX, salaries June

amount. to company maintaining to offering their position. subscription the transaction net rights the rights maximizes of of to offering XX, proceeds public offering XXXX, The the by proceeds ownership the as important minimizing in afforded It $XX stockholders XXXX. far March right second common traditional as oversubscription totaled successful a $XX.X equivalents Cash, serves used the June of basic the net compared Excluding The ended $XX.X and of totaled $XX proceeds this and $XX.X million months Cash in million received the structure it of quarter million. transaction purposes. total XXth. two generated to costs million completion and offering cash received the million, the stock $X.X investments of million. participate three The June compared to XX, net exceeding

price Our of April the average subscription of expiration Board common period, price was subscription XXXX warrant of Xth. $X.XX offering. be on of stock unit unit day expiration the the Directors the the closing per rights for approved the $X.XX, warrants the for common exercise the price the cash Upon with and five-trading in for also to equal volume through were including XX, per with lesser period for subscription XXX,XXX stock subscription June $X.XX, price date to price share issued approximately weighted determined a of

the approximately Additional received $X.X million these gross proceeds exercise from maybe of of warrants.

addition was participation approximately with by display confidence support confidence excludes of also participation million. In internally totaling Chairman to and This Robert from $X.X our strong the reflected Dugan. stockholders, this insider

are from with this offering sheet. results sense our the We the very in of pleased balance

Now to the I'll turn Darrin. back call

Darrin Uecker

you, the challenging and Biosciences. To Pulse circumstances productive quarter conclude, a Sandy. COVID-XX, Thank we had by persisted amid at very created

while the We driven our collaborative of prioritize maintaining to safety have operations adapted our our employees and culture.

the to a milestones, We study Mark, completion regarding occur are multiple the our studies the our Again, space the upcoming over benefits. expect the technology. QX. indication to the opinion with expect albeit which like and for positive to approval dermatologists reiterate I on in leaders dedication for paths comparative its U.S., many Working commitment to begin process the other Canada the progressing few the these notified in high. which have XX variety support to in time, continue virtual and indication of of to CellFX XXXX. XX would Health SH expected Nano-Pulse for a the our one our we review and same And we in to towards Canadian day. We thank specific CE progress our FDA, and through in to months. employees early XXXX. their educate scientific support Starting within of programs technology our for past quarter we with indications regulatory key trying in expect remains first multiple To like engagement our investigational Stimulation body with featured Recent half dermatologic community digital our and new At approval. System events along submit Mark mediums next CE platforms XXX(k) a general

All efforts coming collaborative Through strategy for months the will are we achieve to CellFX appreciated. of and strong your confident approval our able be our a execute throughout are continued effort, we System.

NPS the benefits potential clinicians We across in will you excited to to about provide are unmet look providing various updates forward the future. needs. patients and We

Richard into of like our to move I Q&A, we Before Board welcome to Broek Directors. would van den

to the We are leadership brings he very experience the and company. excited about

Joining Q&A Vice and for open Operator, for call the Chief Executive Manager question. Officer. me let's is Sandy Ebbers, President at Gardiner, Dermatology; Ed General Financial President Executive of and Vice and

Operator

Thank you.

question-and-answer today begin now instructions] [Operator Wainwright. from will question We come Kang Please with session. first the Sean go H.C. ahead. The will

Sean Kang

is This of Sean HC. Hi. Kang

expecting regulatory I U.S. hear made of you that First your or correctly all, progress is approval in 'XX, quarter. Did this did in correct? XQ late you single early on say are 'XX congrats you

Darrin Uecker

Yeah. correct. Yeah. That's

progress dermatological review the the study. as in good point, to FDA period. expect GLP completing the XX general quarter on At we that review on operates mentioned, all so And XXX(k) we sure on days. I'm submit our last is a it to we've cycle. For next throughout the XX a treatments, XX-day FDA's made indication, basically And very as

cu-sub will so, optimistic we that and efficiently. had. very with or familiar go we're pre-submission the System, that study very on And based our very because The meeting is familiar GLP review the FDA with CellFX

quarter of of So, or into that will put first year, XXXX, XXXX. us the we think, December end just

Sean Kang

I see. Thank you.

away? product? would you pandemic commercialization the to indication you Would launch follow to - question than pandemic commercializing right for on now. approved I your So, Since, plan. the a volume the do your additional Or you start waiting right have regarding impact considering product get up due be the

Darrin Uecker

good a Sean. question, That's Yeah.

I of think comments. as in months as to being contact KOLs to we soon to where the speak close commercially you very We're clearance. they're systematic kind And very heard, in we're of as FDA an of going many be get of its prepared the as about today, in about in COVID-XX. So, able launch with a where their practices the done at understand at space. kind they're surveys think We've and they number of derm given coming optimistic

plan launch we current meaning from we as our is as FDA. clearance to as get a So able, as soon soon are

And go that into change our can and to being optimistic in certainly environment. we're in going practices going the continue are half at said think to year. year early that CellFX are Now, their I time. prepared of physicians the be the to that strong the back next things deliver to But

Sean Kang

It's see. I very helpful. you much. very Thank

just provide then question, maybe last rate? on for run expenses Just cash the operating could and general commentary half on you second

Sandy Gardiner

Sure.

the cash that both see ended the run million. expenses the do million three our for half that first for the these of the were travel material for $X.X for quarter this to expenses So just the see year. able some due in of largely was we of related months COVID-XX, were actually quarter, stay - at to The we and balance in this down. $X weren't you instance, expect But reductions year, that utilization types under expenses. the There are slightly to specific rate

million $XX utilization half first year, at back we So in looking the first look as range. utilization the so of the year the to cash rate, forward, cash just was same in with if terms all, of of on half million. total the $XX really we it $XX.X run be ending to year, the million And I expect the said

Sean Kang

for very Thank you I you. have That's Thank much. all now.

Darrin Uecker

Thanks, Sean.

Operator

The next investor. go Instructions] question will Please ahead. Mike come from [Indiscernible], private [Operator

Unidentified Analyst

be a quarter challenging times. what productive Hi, to seemed during congrats on

strategically, question like SK. seems is you have First on data robust pretty

on most get So, comparative a the doing been approval, you on logic what's hasn't your the oppose to as something explored not as assuming robust study indication general XXX(k) much.

Darrin Uecker

question good a that's Yeah, Mike.

on think to strategy the been But communication something bit I a call. - on first close this our we with FDA. is little So of that we this have in may last and be basically touched

pursue and you indication suggested So, like its indications. first, like the specific general then

so very reason to and able to SH to to the to be we is, think allow markets going we're indication need SH the unmet is, things, for so market physicians in that specific their today want directly and high in market one therefore something And to two clinical pursue patients.

various it to And also order a specific indication two very that provide will to marketing physicians to good do things, do best so, market to But in materials that it then the do patients. and have data enable directly which us to so for will their can that is to additional way they generate one data.

is be being an able something that - feel we market important to so, the that like SH. And contributor to that will in us expand

trial we've look them about from feedback really that comparative talk like a that on based trial. And so, to first efforts what previously our gotten on would FDA doing comparative

along will based of the a specific a the that we think we or is now to follow. study we had, so design guidance indication along it And meeting lines think on that that formal lead those really good we indications have to for and framework

a So sort good, on framework quick have need I number to we very of as other FDA with think of that much to executed. as a studies these now we're how leading another with SH, go our - good plan indications after be is

Unidentified Analyst

formulae, be Okay, could the and discussion you or thank the to you general clarify, via just SH you. doctor's less clinical SK treating data? just with And upon

Darrin Uecker

various general to clinical and ability. us so Yes. be of it us doesn't FDA which physicians That's the indications have choosing. indication give to doing ability and exactly the those flexibility a treat market that the for through things will ability It right, their give that will to additional dermatologic or work directly so

Unidentified Analyst

And you. Thank my last is… question

Darrin Uecker

it's No way [Indiscernible].

Unidentified Analyst

it. Got

Darrin Uecker

Sorry. ahead. Go

Unidentified Analyst

have is On requirement the so there itself been approval? able an to the regulatory sites there in other IDE, these before device any use

Darrin Uecker

maybe sorry am executing the question. - am the purposes I not sure SH IDE the of I I understood is for I study. The

ahead FDA approval so the gives us us in go execute And that to for gives study that the U.S. that once

Unidentified Analyst

exemption so regulatory requirement A Uecker allowing just to Okay, you Darrin Yeah, no another that, there correct. than that's is potentially? from do other -

Unidentified Analyst

much. Thank you very

Darrin Uecker

right. All Thank you.

Operator

to queue for to will and there question-answer are over this today's now turn closing the conference in questions session. time, would management the I further back this like no At any remarks. conclude

Darrin Uecker

forward to you XXXX Thank updating you look call. our the us in We second future. everybody joining quarter on for

Operator

you you now presentation concluded. disconnect. has Thank now conference attending for The may and today's

Pulse Biosciences (PLSE) 11 Aug 202020 Q2 Earnings call transcript