PLSE - Earnings call transcript Q2 2019

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences' Second Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Speaker Brian Dow, Pulse Biosciences Senior Vice President and Chief Financial Officer. Please go ahead, sir.

Brian Dow

Thank you very much, operator. welcome Biosciences' and Analyst Investor everyone, Call. Update afternoon, to Quarterly Pulse and Good

with are our me President call Dermatology. the On today Executive and Manager and President and Darrin Officer; Ed Vice Ebbers, Executive General of Chief our Uecker,

applications to statements. and during financial Actual questions and projections; in regarding expectations clinical plans These detail products, and as of from as including such Form include responses management’s differ only, and risks our relating may in of today’s and X, and clearance, process the today, those events. statements expected August Our risks filed commercial, uses XXXX reflect and including to future result will are views or earlier operational, These today. implied your and a uncertainties other comments and call described materially XX-Q of expressed our include the products; regulatory forward-looking outcomes; our results certain uncertainties. scientific,

be can website not reliance statements. forward-looking filings Investors or on to place SEC cautioned website. SEC’s found are Our the undue at our through

conference this the section call News our Events be page. audio replay available that on pulsebiosciences.com our and note Please on Relations Investor on for website at will

in session. on a release press posted by has described In of addition, today’s release press Today’s followed and our is announced today, question-and-answer format you highlights our been of of as quarter XXXX, available with website. earlier providing consist will our second

With turn Darrin Uecker. our that, call Officer, I Executive now Chief President would like to and to the over

Darrin Uecker

today’s call. for to everyone, you us taking on Good afternoon, Brian. Thanks, time and thank join

System a in of near-term that for Our a viable is meaningful betterment and our commercialization mission driving in focus proprietary the Biosciences clinicians. build patients CellFX pursuit of Pulse company the difference makes to of dermatology aesthetic at our

recent once receive programs, of over provide preparations clearance. important CellFX and then an update. update update financial I System will process, will turning regulatory before Ed additional some on with we updates to the our Brian for clinical the an updates, commercialization our call then including provide our start to I’ll Today, on a FDA on

System Necessary the to is U.S. the United our Administration. States commercializing obtaining in Drug clearance the Food CellFX and from

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the letter path is regulatory after XXX(k) remain making the System. and to appropriate route AI AI thorough We the and are and Importantly, CellFX good a the review preparing FDA, we confident in clearance. path XXX(k) response the discussions a XXX(k) to letter the are in our standard progress we of process, with for review

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Ed Ebbers

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turn back now Darrin. to call will the I

Darrin Uecker

will I clinical pipeline. on Ed. Thanks, update provide now growing our application an

would I discuss program. warts to ongoing First, our like

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the over call I will turn second to financial results quarter. the to now Brian discuss from our

Brian Dow

today’s we for announced before the Shortly second call, XXXX. Darrin. quarter ended XX, our Thanks, June results financial

Our for progress in quarter infrastructure clinical by those financial reflect and the programs, the endeavors. for support achieved development accompanied requisite the our results

Cash to the totaled first quarter approximately compared which million reflecting is quarter our cash cash end quarter, second at use million million, and investments at than the $XX.X first of use the the quarter of $XX.X end second million. $X.X of XX% $XX.X of higher

quarters. will incurred is during our Although clinical associated we year. to The use of the to general development corporate for increased be a policies quarter this the with of of the studies, cash increase our relating renewed growth the expenses portion also policies activity due $X business, and insurance second million of annual in the our next recognized several over technology renewal policy XXXX/XXXX

with associated renewals, use XX% timing the over quarter Excluding cash our insurance quarter. approximately increased

increase compensation $X.X quarter of million Net stock-based loss XXXX charges of quarter million, the for the a million $XX.X million the for XXXX, net of $X.X second or included million Net totaling non-cash and reflecting for to XXXX. for quarters $X.X the the second loss losses compared totaled $X.X XX% respectively. and quarter for

later continued XXXX planned manufacturing continued and programs, by operations, early commercial expansion year of June and This the This CellFX is sales, XX represents associated this clinical progress to loss the of is in work our a our from of the increased headcount, for year. our study earlier. XX, the in including growth growth System our warts our net includes company announced study leading marketing with in today. the exemplified towards cost which increase by The the introduction accompanied pivotal to our at commencement growth XX of

of R&D portion of increase to quarter XXXX. our headcount for the second of $X quarter as XX% June System. XX increased XX million the $X.X million A reflects the to related to of in increased of increase June compared R&D XXXX $X.X second at or reported an personnel significant XXXX. development XX, expenses and to work development and XX, million CellFX the for increase XXXX, from Research

to study support increased for and ongoing deployment Also manufacture Systems acquisition of engineering relating prototypes contributing increase and of preparation our expenses, initial studies; clinical launch; increases and our R&D components and in sites; of to in to breadth expenses late-stage inventory design, reflecting in clinical CellFX expenses the and are: R&D. the development commercial prototyping

preparation expenses feasibility R&D to in studies; commercial reflecting will that System to clinical development and ongoing engineering expect continue future introduction; We our focused our work CellFX work, increase for on refinements on current forward, planned ongoing going and and applications. our

last year. on for Turning same matters, XX year in the organization for $X.X G&A reincorporation over from year-over-year second million to our our current were general now compared prior increase compensation corporate accompanied Delaware. are headcount, in to the administrative increases and expenses $X.X in reported increased in the increased compensation including quarter that to expenses. totaling marketing The remained current numbers year quarter has associated the of the basis Reflected in legal to primarily million a with by and G&A expense for year by the consistent decreases stock-based in reduced quarter in period expenses two mitigated costs compensation, sales compared period. prior XXXX

support marketing sales, our of depth our during out System the the IT will build remainder of to of to path increase and to expand on the maintain continue breadth expect expenses continue continue XXXX. we estate, CellFX our commercialization and that we G&A operations to and As and

I Darrin to would to call closing like turn that, the With for back comments.

Darrin Uecker

the work Thanks, the Brian. in aesthetic dermatology. collaborative questions letter. productive great and progress conversations and our We made in goal towards had AI in of System as very we CellFX We’ve FDA commercializing our the QX through with clarification

expect for FDA path. clearance appropriate provide System we QX. four. to by the to end the FDA being confident We working close responses to look are finally, do the and we that We to are forward path an CellFX XXX(k) letter believe in able obtain our to to with quarter the AI the of And is

sales our by driving launch application we as QX, preparation to We business as commercial and In and enabled multi-application implementing specialists utilization-based build successful regional well that be controlled added post-FDA clinical for out team directors, in responsible continued model our clearance. will tunable and for experienced a System. networked, our CellFX

treatment to multicenter We and follow in and in this, SKs, patients. enable both effective will look will our of macular viable pipeline to building applications multicenter and believe forward the our completing warts QX dermatology treatments partners aesthetic We’ve and we enrollment our studies mission System of quarter study continue needed We to initiated capabilities unique to delivery XXXX. a for make through developing physicians our believe pivotal in safe doing up to we progress in of In offer our achieve and fourth a provide the applications. study CellFX company. wanted that

call to prepared questions. our concludes for like would That remarks. open We the now

Operator

[Operator of Wainwright. Instructions] Swayampakula line Your first question comes Ramakanth of the from H.C.

Swayampakula Ramakanth

comments and exhaustive Darrin on how company for team you, the is the Thank progressing.

Regarding how a you and confident QX to for – decision end could FDA And approval, a decision are understand to the that even just by such of end a the normal time you is by the of of quote-unquote QX. submission QX, response get response? takes by you also, of on submit if there that what’s – in normal, QX a make trying based expectation a a submission

Darrin Uecker

the a a to there’s and Thanks kind XXX(k) that get is as Yes, has for the AI process normal RK. as on that to would – respond question. mentioned such is Yes. in remarks, of I to company, Hi, for the XXX letter. process dialing the I opposed thanks there letter, you The say a time. the company the to days prepared once normal

letter. been with over working essentially not it being process. through ends a really kind doing up reviewer. with the on parallel what questions serially of asked do we’ve in It so we’ve and And to been they that the part engaged It’s the months the couple last FDA, possible AI is serial for the most

are example, a for about there or a of technology or maybe of questions, testing. questions the bench set some of So the about set

with next FDA, then on responses and questions. get comfortable that once questions we’re call their address those would with our a potentially will address we FDA, would questions, conference we to move on So

all working we’ve send kind at are in to, as way I to And questions. months, the so to we’ll in very be end then able that questions the the that over that, being responses the last of letter. through of and our formally been couple all We we’re those to close mentioned, think

So three, to I we quarter happen that said make to the expect work closely happen. by as end and we’ll FDA of that with

their right XX beginning used clock. approximately their we And back review Once strives they do time. within And to review review the we to FDA is that, – they’ve get they days then letter, the or goal response. from through the review days. then of basically XX is put FDA on now formal response the the once full their do on hold send AI end until

responses will period what’s to our So to review, lot have Typically over try lingering go interactive email days. objective XX the any so back to forth as that’s their the work through and agency be a XX review to They of roughly of you with they try within always that But letter time. be questions. called there’ll can still days.

the So, is I typical think process. that

that get of everything that’s at should to end FDA that in gives something think expect the fourth the comfort can what I we quarter. us we third quarter, assuming the

Swayampakula Ramakanth

just you. about indications, sure apologize. bit know about and understand what’s your regarding situation to you acne. did, I spoke with expectation warts if Thank a And you you the not regarding data. I’m acne, I’m spoke the I then But and trying follow-on little Okay.

Darrin Uecker

Yes.

enrollment. we XX mentioned those end patients is up enroll and to And our expanded by did to patients objective the So with follow acne, the the we just investigators and that year. we’ve that of increase to

acne we’re currently the So feasibility. ongoing with

upcoming terms – do over next and data But we’ll we’ll an conference, we’re look a the out steps of are potentially be follow now, of in to an And acne in to to think communicate right months at to describe that will to continue We and I out upcoming get patients enrolling time, position the next conference. then end those derm fully the application. good year. in that more the several our we’ll what patients or

Swayampakula Ramakanth

is And from last in then the me let’s get approval we say QX. question

to your you from of to be immediate launch in out how So facility? terms would it getting the ready roll for product, CellFX devices

Darrin Uecker

Yes.

timing to our out for happens, I if systems that preparing roll and that terms when to controlled prepared talk we’re launch. in for When inventory that that we’ll be in now having So of customers. ready about being think to ready and happens,

other very make based post of at clearance happen that. What in you quick commercially on clearance, an can you do which distribute to FDA the FDA once requests about and requirements. actually because expect it can have certain we’re for be product some you to clearance can work We those end labeling FDA preparation is an get things, full the before

that’s on to But it’s order of a that. than weeks as month typically longer the to – anything opposed

eventuality, that are and shortly preparing ourselves for we be after So, a go. to clearance, ready we’ll

Swayampakula Ramakanth

my taking for all Thanks you. questions. Thank Okay.

Darrin Uecker

it much. Yes. very Appreciate Thanks, RK.

Operator

time. back I��m turn like Darrin. to I would this at now showing to questions no conference further the

Darrin Uecker

on conference you’re connecting listening. dialing you, right. very QX if everybody, and you, listening Thank much your appreciate and in All for We Thank for operator. call. everybody joining and our computer

conference all you about much. and making, we excited again them. and the updating very a progress great forward happen to We’re release providing we’re they the Thank updates you and call we quarter look Have and day. third very as

Operator

this and for wonderful conference. gentlemen, Ladies a have today’s day. you your concludes and Thank participation

disconnect. You may all

Pulse Biosciences (PLSE) 9 Aug 192019 Q2 Earnings call transcript