VIVE - Earnings call transcript Q1 2021

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Operator

Good afternoon, and welcome to the Viveve First Quarter 2021 Financial Results and Corporate Update Conference Call. All participants will be in listen-only mode. [Operator Instructions] After the today's prepared remarks, there will be a brief question-and-answer session. Please note, this event is being recorded. I will now turn the call over to Jeannie Swindle, Viveve's Senior Director of Corporate Communications. ahead. go Please

Jeannie Swindle

and operator, Thank welcome, you, everyone.

with Company. begin, you subject available from cause described remind risks we events of the uncertainties results more of annual other historical that could the like a actual are made is statements to this conference or Form uncertainties the the to performance fully financial upon Also, would These fact that future call SEC, which differ statement call statement future that statements. views not Before on regarding we materially the Any may representing is of management's Company's and forward-looking remarks date contain call the report on statements those judgments on are forward-looking projections, statements in represent of statement. described website. numerous relied the in only of plans, XX-K conference as conference and expectations, of to as any this filings date. this the be date forward-looking as Company's forward-looking are and a view about beliefs risks not This any and based as the and includes subsequent corporation's management's and of These should important analysis are prospects. and also

today's Jim now will turn call Chief Robbins, Speaking the Finance Viveve's on Administration. and call will I be to Senior Officer; of Executive Durbin, Scott and Vice President over Jim.

Jim Robbins

approximately $X.X call quarter consumable And turn of Today, you treatment first afterwards, the provide and then revenue Scott, reported joining call I from everyone, you, call of Systems global questions. tips. will results. to thank a sale begin of the for for and with to financial over I Viveve we quarter Jeannie. our afternoon, Good the who X corporate review Thank today's we'll open X,XXX will call total the update. XXXX the first will brief million a today.

our quarter a had million, program. to March clinical of the last focus strong in Total result an the the Company's to $X for decreased development Viveve burn for from cash first due current in offering and operating year. installed were SUI and base reduction of the quarter expenses as the our XXX ended of of the our Company million decrease on cash $X.X Systems position worldwide. We a XXXX, equivalents cash $XX.X the organizational to period $X.X of of The quarter realignment in January million. QX. is a operating of end same million As first Cash lowered public XX success the

Before call the recent We June turn X the to conference our encourage Scott. would vote. of to Viveve's handing Meeting Viveve's please XXXX due lack Thanks. over I'll remind will Stockholders' that of call call was on adjourned Annual Scott, shareholders like record this all a afternoon to to quorum. to shareholders to I now

Scott Durbin

the a development our a SUI achievement our United in organization, in today incontinence Company the of are afternoon, financial just a And the to today's Viveve on potential results Good milestones to we that I of States. our as thank dedicated listening of indication Today, in for Jim critical SUI give will you or to Jim. execute stress the the Thanks, in perspective capital new ability and financial begin result of remarks my positive efforts clinical urinary and entire again, strategy everyone. position to call. program reported. position strong achieve confidence

X-hour supporting PURSUIT trial our core areas: middle achieving in linkage includes remarks XX base objective compared who points and the monitored ratio, to is a will January, toward subjects underway at urogynecology, efficacy receiving control I'd PURSUIT randomized, next the number cryogen-cooled, at study to enrollment one, currently resources XXX the as U.S. support increased to with pad treatment. our treatment readout are is direct in customers is in an end The on point a following also to of up in PURSUIT is installed end the and also study and standardized third, to test, nearly these plan study committed we several and up our of With Randomized all continue focus XX and and urine new late treatment enrollment operations in study. the voiding XX% through the mls XXXX, continue to of focus moderate sites. positive XX to end sales. the our a strategic weight behavioral areas X-day intended of in tip advancing of on leakage versus achieving are weight capital Subject sham-controlled assessed States. the Launched our of trial data drive SUI FDA-approved, than procedure. with in XX double-blinded, subjects PURSUIT milestones The entire core receiving critical an successful women; arm regions program through core improve patent-protected positive, pad posttreatment finally, to commercial sham radiofrequency, Pacific to United our while or SUI. other ongoing if organization test CMRF proportion targeting launching the initiatives secondly, be the months successfully X-hour inert safety XX in This potential Asia inert on with thereafter, as or of active pivotal and to the X-hour to the pad and defined our in the development questionnaires. X:X test we market the baseline United my urethral greater focusing first throughout of sites like subjects experienced the the the efforts clinical comparison urology hypermobility consumable the primary SUI advance States of development office-based gynecology urine using The patients weight in now in for expansion year; utilization secondary treatment, reduction and a commercially endovaginal diary greater PURSUIT SUI our than at bladder mls the sham specialties; indication and trial. is and also a strategic quality-of-life trial Viveve monopolar energy-less treatment

Although a bit and quarter anticipated, third now is year. enrollment accelerating, we slower than completion we the in of expect this

support to million in in marketing with condition positive few effective estimated our data United represents results consumable that treatments available opportunity label with $XX for a reduce SUI XX million alone. States United a PURSUIT an from new Importantly, may women this that estimates, associated a market total SUI Based the the on States. is billion today to noninvasive SUI. affects to $XX exist a billion XX-month application XX leakage

As positive a and Viveve. a PURSUIT FDA outcome approval result, for a opportunity opens commercial multibillion-dollar

the and front, our during medical improvement see and to is In Asia the focus, challenges clinics from COVID-XX-caused market development full past commercial continued the to targeted gradually year regions by of volumes. procedure Pacific, flow and U.S. steady elective patient progress we the On endured practitioners and worldwide. operations, returning

Viveve the and to through high-quality continue dedicated our team service U.S. tip partners treatment in internationally. utilization We support care procedures to increase and distribution customer and provide

associations. for and distribution the country; efforts our opinion growing. with technology States. urogynecology, report United and our events the with physician of One that gynecology. market the that these Asia pleased in months, physicians receptivity exclusive grow in innovative medical who, included successful directed to and previously select The is relationship-building uro an core another our societies opinion and were partner female, group to and planned specialties are coming a Pacific addition U.S. U.S. influencer are our recently entitled Beijing, China, influencer Network]. will leader network Viveve, in incontinence We're towards and strong launch Paragon in development of with urology, and leaders Two I dual-energy stated, urology urogynecology programs As [EmpowHer of in efforts conducted: key urogyn key event in in Several Meditech, and

to supports of increase and SUI quarter the to make treatment the a the of the clinical advance Our this awareness of upon first U.S. safety Viveve and of of efficacy tradition In indication as in year, and evidence significant towards goal program clinical build body continued potential that scientific strides. is the our rigor we our Viveve new

is and Asia achieved, past XXXX U.S. PURSUIT in enrollment; targeting treatment considerably medical through lowered tip Pacific, and has operational burn which to rate focus we complete year. our Our the expand have supporting the efficiencies Systems Viveve existing installed sales; our utilization specialties; to of drive the core increased over base continue cash and to customers

and conference this to we extraordinary team quarter any prepared like Operator, Viveve questions. I'd this at our call open tremendous you. thank for as their participating call Finally, concludes our the for remarks, Thank efforts well to as today. can everyone the in

Operator

question first AGP. from comes Haynor [Operator Ben with Our Instructions]

Ben Haynor

off, getting XX ramped First on congrats sites. the to all up nearly

the that you expect quarter. mentioned You in completion third

I the sense call, late or think that I Any acceleration? of there early the QX talked would you be QX. the expect mean, given mid-QX about kind should still helpful. QX? Or is we on recent color

Scott Durbin

Appreciate just anybody as does. trial, joining fast goes enrollment hopes for thanks Ben, as never it respect it. the call Yes, today. with the to

to of a COVID-XX clinical March, and execution expected sort played greater the I on sort but of enrollment little think clinics logistics see the a February and through be we of impact trial bit part.

you are. encouraged that little A you more very got is lot I patients -- we And tell we've of population screened. so have we're bit inclusion the sure by that a can pivotal trial where as And treatment. been patient appropriate enrolling have to outcomes in who to the strong know, from fairly strict have most is going we a make are criteria we color

today. and we're randomizing accelerating good almost and XX spot nearly are enrollment that speaking, sites in fully the sitting all generally operational see a So patients. now enrolling We

is the can early half third to the a going quarter. But third in enrollment. And it's to of be predict little quarter, our complete quarter, the we difficult certainly in it's hope whether mid-third so first

Ben Haynor

of up been that may helpful. could we of impact That's a XX-odd percent. revenue year U.S. definitely have kind revenue than the than it then you even. COVID was I better bit It year And like a last looking suppose, more looks breakdown, QX at in expected. was Okay. just this say there arguably,

What's it there attribute right I think is board? mean, regions So can to? certain to you the about of Is way the it well? across performing of I mean, kind that? that, performance are that is the specific on that kind anything

Scott Durbin

Yes.

I our function were the trial. of part was still think, we program it was development We clinical our and -- year, commercial a -- opportunity. prior the were That readout specialties, and to commercial the as remember group opportunity that last sexual of the I we to target through XXXX clinical focus broad focus for SUI. our and around and of think, SUI began to continuing shift a program to went potential development

has gynecology dividends, in the positive we and think the SUI in achieved positive particularly what's really urology paid focus targeting August. I clinical of that's U.S. data And urogyn and last driving preclinical impact and following think I the the

has got developed treatments. successful tremendous care well, really in practices customer for be As we've and team physicians a helping who patients for clinics recruiting best

that's so QX in element difference the an as year And that I contributed to think well. this

Ben Haynor

That's kind in is good of political see talk engaged overall? just helpful. business are, the technology? program you female receptive a more Okay. To is the me initiate to Or that that of or something going here. [EmpowHer] about on on do environment, that for for it to current physicians you average, that it the lastly kind then can the are the extent And guys you thing more

Scott Durbin

gender characterizations I make don't physicians. want sort to the for of

Ben Haynor

I bit might little a figured it problematic. be

Scott Durbin

But let But -- this. just say me yes.

was infancy by tell can its I sales derived right team, team, our a it in individuals it's certain idea. our tremendous concept sales the in you was think that now. And I and

incontinence female first It is a very positive. to the stress had We population, incredibly urinary enthusiasm in on sort our of physician a have and focused network, overwhelmingly was event. attended, participate for female-only well was opportunity which for

And event. Again, had first now. so right we in our infancy its it's

to it's and is do it's planned. a good We area, company we several this We to also health lot could for are a business. that it have regard. step what think But in that and we of more in advocate certainly can and women's -- events gain forward try momentum, a

Operator

comes next Jeffrey Cohen with Our question Ladenburg from Thalmann.

Jeffrey Cohen

current I'm and political the on going we'll to is, what go straight that had. the skip any few environment I to questions

-- sense a you talk the the of firstly, us can trial. the give of So better pace about

throughout that about sense will and how third Will sites some number us accelerate swiftly? the kind gave of looks. quarter? accelerate You more linearly it that and the second of Or

Scott Durbin

We think to it's sort linearly. going accelerate of

change roughly. give these numbers a on across me XXX you Let there. We've daily basis. some perspective screened XX subjects And obviously, centers,

mentioned important I have really measuring that the criteria weight incontinence urge pad some a we making a as bunch trial, incredibly the some response, at who stress in predominant have reduction inclusion patients We this -- of a in responders outcome predominantly want ultimate strict incontinence don't strict We previous of patient population patients. we are sure have from for aimed perspective.

those now from doing submitted but have around And XXX I'll media randomized we've just and are the our local up XX an social centers seen got trial. treated who been in all perspective, we are in participating proportion advertising we've X,XXX And of a so that forms today, you sites. interest-level interested and all of tell women be by enrolling.

are So we're numbers confident that there. the

we'll there randomizations think environment, move in to quarter took, of a anticipated through the of next treatments months. it get and continue as couple and first I But the we're think the up I accelerate think longer and early in sort COVID to I had bit we now, see than rolling. we

Jeffrey Cohen

Okay. Got the directly? play approval, about it U.S.? and it. here, that go and with be clearance CE would data you how Would outside for you out Could talk the an -- something with others if that may

Scott Durbin

Yes.

to can particularly the other Canada, United's for to do CE PURSUIT Health approval that on outcome want to to may States. And we there. a speculate possibilities But certainly an we everything I positive will leverage clinical country. We countries willing clearance -- data, the and Mark in about be FDA accept in that allow an best from don't

go to process that that at it, there's believe we but have opportunity significantly we'll time. through So leverage to an

Jeffrey Cohen

Okay. or what look a of in and compare current like demographic trial as that Could U.S. and how far the the then that with give you sense as think you that us maybe may and the age contrast TAM abroad? about

Scott Durbin

are between perspective, our the on there patient a a focused we're differentiator focused the single enrolled think Well, we TAM population for population from and I biggest -- trial. been premenopausal going into because trial is inclusion SUI, pivotal. part in our to been has historical That's criteria history. that We want variables it didn't effort we did of new of the and our the introduce

have I a the going total and between trial from can't that's said, single to a available is if type characteristics who used get has in outcome don't suggest opportunity indication. FDA being for There's market. patient a nothing think an positive severity. limit that factor our clearance perspective treatment we to patient the That the that of SUI I trial and biggest and stress be incontinence our postmenopausal believe similar

So that's the biggest difference.

Jeffrey Cohen

the on Okay. line? sense statement, Got a of would think give a previously the going it. And then lastly to for in towards income second me, like the Is the it R&D quarter out I year. of peak for thought earlier quarter? part bit be Does seem Jim, can going come kind third the to had of we the us little latter that or it you us? that's

Jim Robbins

in peak then mean, too it's little -- the the I back to quarter and be pick dramatic, bit but more will in to down level the quarter back the year. it's not third back that. in I that Yes. then it's level down quarter, anything but start fourth a and second going the come mean, it's it we and then to next to after through then going in quarter second later down -- so expect going up and

Operator

the presentation. Thank now conference and session, concluded. question-and-answer our concludes for attending you today's This has also

now disconnect. may You

Viveve Medical (VIVE) 14 May 212021 Q1 Earnings call transcript