VIVE - Earnings call transcript Q4 2017

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Operator

Good afternoon and welcome to the Viveve Fourth Quarter and Year-End 2017 Conference Call. All participants will be in listen-only mode. [Operator Instructions] Speaking today are Viveve's Chief Executive Officer and Director; Patricia Scheller; the company's Chief Financial Officer, Scott Durbin; and the company's President and Chief Business Officer, Jim Atkinson. Management will provide any overview of the fourth quarter and year-end financial and operating results before opening up the call for questions. Please note this event is being recorded. call Scott the turn now over Durbin. to I'll

Scott Durbin

everyone. you, operator, welcome and Thank

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

statements of forward-looking I now any relied call to over like Chief Officer. as as turn our be Financial views views should management's of date. this addition, In conference of the and management's representing call the upon any not only subsequent as date represent to would Patricia Scheller,

Patricia Scheller

our everyone for today's quarter our finish Good thank for today strategic discussing call you afternoon of brief Scott. and financial results. a XXXX. review XXXX year-end accomplishments and fourth Thank and initiatives and I'll discuss with you, Viveve’s by joining us in operating to begin

remarkable off for year-end very pleased are with We Viveve. and fourth quarter year results, capped which a our

over of for not course also XXXX the only technology, team of execution delivered the underscores but in by year. success the the our opportunity scope the remarkable our Our

We started significantly rapid physician Despite multiple as treatment by we as growth list. driven across in year, clinical technologies, for Fast XXX our the large Deloitte's approximately a Geneveve proud accomplished. I I'm sales the to portion continued employees and sheet rates, regulatory our hard strong As field set into revenue XX system over is licensed a XXX that from support trained very Colorado Index the Russell Technology Sunnyvale balance peer accomplishments with the remain XX and by stress into first growth. last We a measured We adoption approvals the base. proven XXXX new and financing. team treatment of Utilization new foundation or sales patent and in team around which full journals, market urinary the by million a team, tip in of on in growth small a strong for by about California first rigorously sales secured believe intellectual We equity new extremely our I of launched XX having employees the to $XX drove treatment here published evidenced specialties. the placements the saw sales year inaugural commercial articles which XXXX, increased substantial many with Englewood, our globe, strengthened achieved property facility U.S. approximately organization, XXX% consumable new incontinence. XXXX, and year, detailing record year only position. we their And expanded XXXX U.S. achieved In Geneveve our done across expanded future what review hired debt achieved clearances growth. in the ended the the single proceeds headquarters. and and direct with months install of expansion reflect continued of clinically growth, data Viveve defend and U.S. portfolio achieved two We our market was outcomes our the with and to work

commitment to sham-controlled Viveve-X based condition. commitment study physicians role the journal Viveve conducting health We clinical the the offering which strategic apart of energy of women’s set of to to of in field. the Our and scientific driving to clinical category performance. for and a from companies of journals preeminent consumers health. evolving based of across vital this vaginal in study, our the landmark significant providing journal medicine a sound Two detailing These in always sexual minimally and results the invasive Viveve saw publications, strong publication XXXX has set the conducting the wide sales growing believe commitment our two been address rigorous our articles, remains proclaiming and intimate research indication. reviewed trials of the evidence of blinded devices evidence randomized range results peer standard clinical results played detail and women’s of providing the treatments. in statistically has number for to

As the vaginal set vaginal treatment function. our In medical that markets standards these world. are are the in around countries up new were Several regions. is the to opening accounts South and approvals received their practices we approvals large to-date and available cryogen-cooled approvals countries in by system Viveve The static improvement countries other treatments. marketing granted of of around clearances sexual over or and countries awareness laxity number function. of approvals in dedicated regulatory rates response grown, XXXX the or and markets a of system strategies XX trends and around markets improved world, XXXX. we Korea and medicine have the in best for The indication. different outreach, and a some techniques the growth seen practitioners continued in and sexual shared benefits health regions our months. sexual next regulatory of achieve have clearances countries significant ongoing the Taiwan, with growth and in has of in to patented and XX improvement submissions utilization and customer those healthcare radio treatment regulatory influencing beyond CMRF have countries, expanding technology the world originally world for anticipate for and laxity company currently used frequency our new clearances seven has will approvals in in recognized demand we XX and XX We of current coupled position international countries, believe Geneveve being different Viveve Further, Mexico, effective the for in the additional such or receiving accounts majority The clinical With with of in monopolar increased. the regulatory are

the many device trial U.S. in questions the to U.S. under around a rounds that worked Viveve of that we regulatory De XXXK U.S. improvement with obtain front exemption to and call our several investigational of the FDA pivotal Moving Viveve-X. sexual year with function Last to an through we for approves submitted the our a submission, new report accepts and soon. has second held world, approvals a to Novo has the of If Viveve-X completed we multicenter agency. request in am the indication FDA consistent pathway the additional In last multiple the pleased hear response countries is in-vivo the the meeting to for successfully we study time year. study to study, to back quarter questions the initiate intent U.S. temperature IDE results, the in expect for been this history FDA tissue from agency’s I the no in and the a

second Assuming of in quarter conclude date, the start the XXXX. half second the could study

SUI indications function January, Alberta. that conducted expanded unmet patients the indication study, is an In from Director Allen Founder Center and addition among positive CMRF of who label treatment from can that in pilot technology sexual protocol, showing health percentage our or Dr. XXX% Calgary, common proprietary in a pursuing Allen's two outcomes. late represent included CMRF our technology patient treatment in results to an announced reported rates and and a strategy using Medical for different underwent expansion the U.S. pursuing patients baseline Viveve’s XX% In using we on intimate Dr. of responder address. Bruce other needs Allen, resulted with study by the improvement effectively women which centered

solutions to studies reduction months mean committed Viveve seen stress of the studies validated One on called conducting has registration study. purpose second endpoints two a at two positive incontinence. questionnaire of assess used blinded be studies. symptoms the of and and regulatory safety treatment XX% system multi-centered International, to sham-controlled LIBERATE moderate is Additionally, U.S. XX% disease in Based the obtaining the double this across improvement mild to to outcomes in to study, sustained unique pilot the experienced clearance and at in the the demonstrates patients SUI. XX Both addition will further of urinary the and The randomized, for our efficacy months globally to in and expansion intimate XX LIBERATE this CMRF dedication our The indication health. product including these new patented improve our platform into portfolio women's of of versatility advancing

that by treatment women's billion of a profoundly treatment We are for urinary $XX non-invasive on of market potential global incontinence. could billion estimated stress quality for the impact have a in the a excited positive the life $XX to

indications be ahead of data the believe XXXX, of use for Allen The applications expansion platform. the the of generated system. broadening clinical stress of Dr. to our include, urinary broad by beginning a first, we Looking the for areas incontinence our CMRF could will promising Viveve focus marks what

need. also to will and vaginal of regulatory randomized approvals working indications. represents lead unmet conditions that sponsored are and leaders additional program these our through significant such clearances opinion our closely for efforts explore blinded studies atrophy seek worldwide We to we that investigator other research with hope as areas SUI, Like key to sham-controlled

the our we global the turn and the expanding team our to our U.S. I our hiring our to In North expansion providing select sales demonstrate American service significant global enhancing distribution physician distribution XXXX, our distribution will energy building and direct to to meet in will world XXXX, Second, devoted presence teams of building level sales to we attention partnerships network. customers. by commercial our support business; around presence in and demand talent to These and our efforts commercial markets our partners support of highest local commitment the and the believe augment in

turn will the commercial officer. our operations. provide to and anticipate call systems fourth, price second gross awareness We around drive both to an utilization and of world grow market the due increased an our increase sales Business our Chief now of build direct Atkinson, U.S. selling of cost operating tips XXXX through we seek sold. technology to I'll in CMRF continuing in our in over President And the half the our and margin Who our of as goods treatment Third, the revenue improvement our force Jim of average and margins. overview to generation. enhancing to reduce

James Atkinson

response safe the by Geneveve sales Canada. our physician of appropriate and team provide Patricia. capital nine into represented you, Viveve deployed address target initial nearly systems gratified market. worldwide. Thank to results and people commercial largest United to demand customer The these support, launch last in were States were XXX capital and revenue. The Viveve was fall our XXXX, of U.S. our physician representatives XX% in XXXX highly two XX% strong XX,XXX very shipping effective our of Commercially U.S. treatment of achieved year to disposable the tips rapidly for total the increasing and enthusiastic in treatment. sales XXXX XX We The system of entry representatives represented expanded

to support efforts. addition, In associate U.S. field in representatives five in commercial sales hired were

end the North XX experienced XXXX, sales at specialties. have targeted America, professionals result a we with physician As of covering our whom working each of total had

marks multi-channel continued end part the providing offices These be to only of treatment based on procedure conditions team commercial unbranded global sales demand will and educational in The across single CMRF and is Our technology, clinical focus growth helped their organization expansion Geneveve the Consumer America awareness helped U.S. evidence awareness the increasing patients. options of that further of health of social XX increase Viveve clinics. fact for intimate professional entails the based intimate the educational procedure this successful physician dramatically year in support of regional are drive results of and of volume Many and we sales physician our sales that first marketplace patient and has the that customers technology initiated year, the fuel in practice in demand their development XXXX has the our within globe. marketing our have with multi-media and consumer campaigns, plan managers placements rapid seasoned representatives, marketing and have support for adoption on supporting managers. XX women’s treatment practice awareness a XXXX women’s growing Geneveve will development driving basis. practices, is XX associated XX on the a effectiveness representatives, treatment health including our professionals outreach. helped projected campaigns procedure clinical at North experiencing capital

patient We expect these through a clinic’s that population new treatments currently will patients expand existing performed on outreach to programs.

international, XXXX, in through in sales markets and commercial tremendous distribution the our quarter XXXX. of in distribution Since partners. third the to strong in launching show and Viveve network has Viveve XXXX, potential were Moving international network XXX internationally continuing to of systems placed our global global

physicians and XXXX to along continues region sales Pacific is regulatory be our States. procedures. fourth in positive launch largest with in quarter after resulting a Asia United by High sales of clearance second the patient uptake launch the

vaginal larger world last in indication penetrate and in expanded recent continues distributor the building medical throughout XXXX, in to leader granted which in is laxity that strong private partners to sales opinion interest overall the with utilization. Korea Latin these markets physician and hired America progress treatment Chinese year expanded recognized solid to Dynamic specific an South XXXX approvals projected sales are procedure country procedure technologies see regulatory XXXX. September for of market, our leads momentum of grow expanded May continues made in key utilization. team static with and currently

the commercial European in Our increased footprint in XXXX. markets

over a over hybrid XXXX, a launch by model. certain U.S. positively to Although and This Europe. in it countries, successfully Scott being sales anticipated. In look Durbin. physicians shadowed distributor utilization initiated European call received to sales throughout system was increased strategy forward model is and We the XXXX. I’ll driving this direct is as late turn was we in expanding now strategy new by the

Scott Durbin

providing full XXXX. the a to by our quarter, review followed year of fourth results Jim. financial Thanks, I’d begin like by for brief

million increase million. QX systems. a in driven by the For of tips. treatment the Gross fourth sale as of global the fourth product XXXX. increased over compared development and is operating XXXX partners the was to $XX.X development for line awareness. research to million to of support fourth expenses attributable our and the fourth international over disposable approximately quarter Making quarter $X.X accounted gross or fourth approximately in Viveve XX% quarter on XXXX year revenue X,XXX our third million expansion quarter was increased expenses base fourth primarily and system a additional our installed build increase $X.X to to of with of million, million of the in was the XX% $X.X Revenue engineering XXX% the efforts. quarter commercialization and mainly of for Sales XXXX. of The $X.X and and to manufacturing revenue sales administrative current quarter This $XXX,XXX or XX, associated fourth to Selling, a December $X.X and $X.X for for increase XXX U.S. the Total efforts, brand related during was the were XXXX. profit of increase million compared compared profit marketing XX%. general for expenses while in quarter market revenue contract the quarter revenue, accounted Spending quarter fourth work fourth approximately XX% quarter XX% with ago. of XXXX XXXX of only the XX is were marketing

was loss loss $XX.X per of million Our outstanding quarter based on or approximately the the net period. million share, of $X.XX during shares for weighted net fourth $XX.X XXXX a

the in financing $XX balance equivalents, sheet concluded we in perspective, and quarter February. million million $XX.X fourth a approximately the excluding ended from with Finally recent cash we

associated revenue of development from to research million million organization, of expansion associated treatment million $XX.X compared costs million was or versus and with in year sale sales, per Spending million XXX% the with revenue commercial This loss awareness, of The for accounted loss of and $XX.X approximately more a international for XX,XXX and for expenses to profit XX% U.S. revenue, and XXXX. $X.X the expenses additional compared $X.X per increase only increased system work sales the on financing gross $XX.X our engineering of increased during $X.XX company was in a a year-over-year. $XX.X year of XXXX, of with partners a for $XX.X XXX loss of market product of and was tips, U.S. XXXX. the XXXX. $XX than For administrative brand initial for again Total in rate $XX.X development Selling, XXXX was the increase profit were share full totaled million to XXXX contract to improvement XXXX. million net XXXX million for XX% related result revenue launch Gross for efforts. associated $X.X million of manufacturing loss net for million. approximately public and of and revenue to cost million growth mid-year XXXX, XXXX the compared accounted being of SG&A approximately Net compared in XXXX with were expenses share support XX% efforts or representing was full to or $X.X result the the marketing while building approximately $X.XX operating general efforts. XX%. a of for Sales or

Geneveve in our sales strongest. questions. we quarterly execute turn now and $XX million as year the revenue market million. Finally, will to a the And and the world, health and closing treatment. seasonality adoption growth quarters and do January, first system strategy we anticipate finally and in We XXXX of guidance the take both between believe I we intimate global will markets third women's back we our see tip with remarks fourth we around for in all in early who commercial XXXX the to continue softest however before full increased the and call being the will be to Patricia, of $XX treatment announced few say consistent quarter expect the second being with we

Patricia Scheller

of be summary, us. Scott. excited our you, a to In of and proud in the Thank ahead about lot pleased there was opportunity with We're XXXX. progress

and we of and we to that it question-and-answer turn significant look At of a growth have to passion over in because that explosive I'd realized XXXX. XXXX. And in the for forward For dedication talent because perseverance is team, seeing your operator time, Viveve together this what like achieved milestones your it the I is and can to accomplish that session.

Operator

[Operator Joshua Instructions] comes Our Please Company. Cowen Jennings first with from & ahead. quarter go

Joshua Jennings

Hi, the you you're level thanks help hoping Could was the today? are patients for patients stress for indication. patients. anecdotal us moderate back care think urinary all have to treated incontinence was on taking who laxity the patient of just you throughout with is of from questions for the rather to customers? out progress And I physician what the Geneveve with the your about standard seeing these feedback getting to maybe congrats XXXX. incontinence urinary mild start and I going for

Patricia Scheller

very urinary well products as seen can for we Sure, progress Kegel women controlled help incontinence right ask medical incontinence a address standard do do devices And being there well work her products women actually that to incontinence substantially to and different and of types stress actually issues. and one urge physicians incontinence have use so do now in various the exercises with incontinence options care have and other couple that are a of to conditions. as those stress

right on product we in providing now single a XX level to be out months helpful Our continuous of data I treatment. improvement have symptoms a will in very think

minimally allow single it women believe see can and will in a that's medical they So have with they maintain painless that be technology that a invasive, that control procedure and results to the one our we procedure products.

both sling the is have includes effects end vaginal women which side implantation with On mesh or the conditions associated of spectrum other which of and very of option, is them. risk significant with factors of course usually serious for a the there surgical

Joshua Jennings

giving request it you and if to-date the you this with with could follow-up like have II this FDA both think IVE Is that met. risk with once path, Viveve the safety question that And results. seems is you associated management, potentially which Does a you deliver on where process sounds dialogue? [ph] about agency around the the its of front the Great. have a It actual I FDA around review data. now and a real lower to made to just of are request fair world process loading the way two

Patricia Scheller

would have number know in we the study love safety been believe think all that in technology the And addressed Josh, loaded and laxity data ask and with have process the submitted of regards their technology to the has FDA efficacy in the of function. results in questions this questions. that they I we adequately has the that fact a the to from in of front of we demonstrated reduction the improvement the sexual the Viveve-X vaginal both of

am to is issues that they we there the further are. put time. is that of FDA. have study the my to ask caveat whatever until out their or obligated do satisfied do they that have the to would questions questions to they And continue have prerogative hope it get the I and course concerned But at So that address through clinical like no

Joshua Jennings

is my there in been types sales desk? of disruption some out taking in building maybe across that at of Thanks seeing question force how And look is you big And come of for Great. your last think of an the are as some space. you the resumes opportunity the just competitors then has questions. U.S. your

Patricia Scheller

would please Josh. question address And Great, for thanks that Josh. Jim

James Atkinson

treatment the technology are sham-controlled technology the studies they quite number the competitive seeing interest organization people past treatment CMRF Yes, on out Patricia. with only XXXX, these The we of U.S. a our based of And our are as companies. there. reps joining reps is resumes. enthusiastic XX being single in very thank static you, blinded a Currently single we about building in commercial to are

our specialties candidates will comment in getting not calling there. a to significant what’s good I question? have due that answer four going that number XXXX we’re adding majority add on But to of the quite and on are competitors the very currently. to on Does the of team, your people So we experience

Operator

Jason Raymond Please go And from our with Bedford next James. question comes ahead.

Jason Bedford

hear me you can afternoon, okay? Good

Patricia Scheller

Yes, Thanks joining us. Jason welcome. for

Jason Bedford

questioning, the Great, how on you add -- line how you going throughout that it will this of look last folks year? have thanks. the the throughout Maybe about like pace when being you just year? many maybe about so does when added these And to follow reps are far to year, -- XX come we think added

Patricia Scheller

maybe And Jim Great. can your expand you answer. on

James Atkinson

today currently so team at manager are six six capital the of in are we associate we reps reps, Yes, XX adding practice members. we midst are at right and

The second July In bringing on in member the to have the weekend. the bringing on half July right will after other be the year. the be will on full reps group slot of second Xth team the for

our is currently. that So plan

Jason Bedford

a effect you business, the expect business. trial you have to am in this realize existing just trial rest impact positive question couple do halo market LIBERATE the And wondering commercial if indication, commercial the bit maybe can’t your for to just have a you I that on of SIU I the expect of but a of Okay. on meaning centers,

Patricia Scheller

become doctors get the these we in around saw study, with the once world as just done Yes, studies of published being work that’s Viveve-X other these indications. aware the

we've international the year. hopeful attending, And saying are we've of this LIBERATE of all effect. as So been I quarter second which we study, be the get a in conferences, will that do underway believe been will in halo the there

is have protocol very few We non-registration in the submitted had a non-dealing protocol had to for questions Canada, study Health the and review previously under it with protocols reviewed they itself. and that

study the hopeful particular end into would So, allow of months of available that before public obviously year, could XXXX. us information get beginning the to period with which that on the be a the the six present for the before are to we follow-up investigators out

Jason Bedford

you tips? but you the and is data more I on gave environment that's can capital helpful. the And the Okay, appreciate last so maybe us, about my just in all talk this U.S. with pricing question,

Patricia Scheller

Jim, one and Sure, you. turn back over that to I'll

James Atkinson

clinical we in we're Pat. pretty physician and seeing tip single on we but seeing increase also stable And side past companies. for pricing are capital consistent at it United currently we've States. you, still the think seeing done the the the an down thank Yes, charge, I the we all And our sale studies prices treatment, are In price. ASP fact pricing charge, a there a single in out that the only this different the to patient the point, of in comes are an increased treatment very

only physician And to have treatments. so to for to times return that brings value multiple the not but patient practice, the they multiple don't

Jason Bedford

Great, thank you.

Operator

ahead. Jeffrey Ladenburg & And go our Thalmann Cohen next Please question comes from Company. with

Jeffrey Cohen

Good afternoon, me Can and Patricia, Scott James. hear you okay?

Patricia Scheller

Yes, us. we can. Thanks, Jeff for joining

Jeffrey Cohen

speak. Wonderful. Patricia I hope to you’re so well and you’re on around your feet running

Patricia Scheller

can, thank I you.

Jeffrey Cohen

can a you force XX? timing earlier of you the what's first with the this to bit and going on guess the that my what maybe question perhaps talk about is total ratification the specific in territories, Jim, so more that first for elaborate hybrid the So if model commercial the year? And I which upon

James Atkinson

XX the And a put working quarter with signs the months. Europe and timeframe, direct in of early States Managing we right now Yes, positive technology. from adoption new very have rep number. We the three capital seeing Director direct that a UK. the has physician we we In have a for us been are in hybrid the the and United the fourth capital in initiated France rep is in model

the very data study we for the seeing are seeing Canadian and We more there results. very, but on are future model, the And into also early LIBERATE positive patient U.S. studies. based utilization over

coming next follow to frankly to well working distributors and the it. do quarters. Pat, over add you with this is will this excited our we have anything So, But about very that? model

Patricia Scheller

thanks it. James. Great, I you No, cover think

Jeffrey Cohen

us how bit you helpful. talk portfolio. may to bit And as this talking or of about or that -- then a the of as kind sorts? that expansion Could then Okay, numbers the for well? the wave form we And some may with technology what and factor get tips about more a for a into that's specific R&D could specific went through also same I are rollout or little a energies length that the Scott and and -- treatment discussed a specifics precise know referring to on the see about you bit it you about envisioning of and little is sideboard SUI

Patricia Scheller

new a set Jeff and so to product our regard indication. Yes, with rollouts with how SUI

course in have it significant year reduction of a discussed goods our is the of the a introduction half this intent over model. our newer the costs to with previously As we've of back of

new similar our very skin our us to that platform, And will look will SUI existing one. some model introducing characteristics to that but treat allow a at different point condition. and than will tips new that be for have will have that performance will we So, characteristics treatment that have existing

Jeffrey Cohen

That’s me. for it perfect. for taking questions. the Thanks Okay,

Operator

And our Group. from Anthony ahead. next Please Maxim Vendetti go with question comes

Anthony Vendetti

it XXXX? Thanks. I say you questions by questions was commence expect if come temperature you've you back no just wondering to the if second did study, submitted no quarter tissue after come back

Patricia Scheller

Yes.

Anthony Vendetti

thinking? get is And are what pushed XQ guess are that questions into there you if I Okay. it could

Patricia Scheller

time profile, the we of around believe have year, of indication concern any them any we could most we’ve from have the areas on all certainly temperature new of pushed it now be later What history part addressed. which recently centered we into not Anthony Yes, the right had the FDA. heard has

from back come FDA to would a this were new be that area. the anything point at on So

Anthony Vendetti

anticipating probably likely based there would I have that so why it, new a are that if was most you on mean sooner, that’s popped up And Okay. not correct? area

Patricia Scheller

get process that dialogues discussions fairly on the start new FDA table typically thoughts in think I the the early does concerns. try previous and during about and Yes, the

that and haven’t not don’t surface. they know but any, or whether point seen at we nothing this We have has

very might us are study. back we soon the So hopeful that they start us allow to come and to

Anthony Vendetti

call why systems? percentage there going of margin approximately? what there the Okay. mix margins just at have the for this tips is on look a top of that tips then a And it Scott, because that stated do should maybe U.S. or of And XXXX was the in the and was we know is for versus have price margin higher improvement, from then -- transfer I were that higher, the there a U.S. growth gross sales of greater came to isn’t just gross involve the but you on just than on terms is of system from a is lot

Scott Durbin

Thanks, Anthony.

related So, the -- gross with we’re respect margins as was the seeing your the Jim ASPs was the think treatment it tips. a And think we’re in and XXXX tips combination to treatment specifically to ASPs or U.S. console it’s mentioned QX, on of seeing I on factors increasing globally. in increasing I questions

to an to the XX% increase we cautious and the And we’ve in see so and both we of increasing this -- early an the sort increased all in you been going margin end XXXX, respect any With the can in which gross market We to QX. of mix of have tell that utilization XXXX, particular not you with see launches margins continuing will how given the give coming up in margins, very period associated anecdotally year. increasing XXXX, we in a guidance are and relative increase gross every gross in not that specifically in but towards margins definitely ASP is believe of that know global we as we’re see for region, increase the XXXX.

Anthony Vendetti

the great. in systems lastly in the Okay, how then U.S.? guess, were fourth -- quarter, the And I on there many were sold XX

Scott Durbin

referring what Canada, States so is were and XX North XX now placed internationally. the and in to America United we’re

Anthony Vendetti

queue. hop Okay, I’ll the great, Thanks. back in

Operator

from comes ahead. Securities. with Bulo Your Please question go Mizuho next Alexander [ph]

Unidentified Analyst

this questions. Hey, the taking on Thank guys, is actually. good afternoon for you Yang Difei for Alex

for I could first discuss QX. was versus you the just QX if consumables maybe in the utilization rate wondering question, So

Patricia Scheller

Sure, so thank you Jim, joining take much the Alex you us. for question please? utilization would

James Atkinson

Yes, thank you, Pat.

Asia increased the the primary doing in a utilization only in the are with helping the being utilization added area China In managers increased Korea and on the approved States that probably Korea. increased have the globe. have We their information the in a standpoint license of Taiwan have distributors accounts South function the on fourth China, not medical from quarter physician’s markets in moved laxity we but in from those that and South is in enough treating our Those in Interesting continue over seeing that SUI. coming United bit practice of what’s Libare license vaginal procedures, three States the in see of And technology. to practice physician's little based which are [ph]. out utilization older United practices and license sexual based patients to on for the having

team companies the that and in where year than a utilization. quarter fourth this Pat as on increased seeing had dynamic to as States the other We are fact management [ph] seeing did. practice in Celtic the United earlier bringing approved Scott such Due

States currently year, even we So March based our Xst. being through full full are on through not the with early United year while in a launch again a

customer those Asia. do the practice seeing the Viveve we are with see seen procedure to increasing that being We uptick and figures the service practice United have system in and giving like managers the we expect have correct good in utilization out States

Unidentified Analyst

you. wondering And mentioned great. bulk your specialties these orders. That’s pretty the represent there of split? thank very then helpful, have much four all physician they are you that Okay, just -- earlier sort of equally Is you

James Atkinson

here four surgeons, technology. not have you to the split continue side XX-XX is and seeing the the the and and of may there world the other which spas in URO/GYNs, on we the of change aesthetic and of specialties Yes, in United market, surgeons We're not URO/GYNs one aesthetics and States, a We're see GYNs may the not going have stay. adoption about in considered plastic around that's dermatologist still the equation plastic it's maybe women's But on quickest And four three United is are the few intimate are that years the the the or procedure the this the technology. a the last was I months been the This actually States. adopter. think half dermatologists in that ago, longevity. to around over world reason why and health a three last But adopting only to going sure is GYNs. but years probably

procedure like plastics dermatologists and young to GYNs need the practice so adopt into And URO/GYNs the especially are. dermatologists their

dynamics very around of are for the that's seeing And kind world. us. So same the we exciting

Unidentified Analyst

you much. helpful. thank Very very Great,

Operator

And with Baranowski Please go Craig-Hallum Lucas our ahead. Capital. next comes question from

Lucas Baranowski

is at Lucas this on Craig-Hallum. Yes, Matt here for Hewitt

quarter, the treatment X,XXX the were split you North during provide at the versus I was Looking on tips international? that wondering America that, could sold

Patricia Scheller

maybe Scott can And you address that?

Scott Durbin

about Yes, America hi tips Lucas. The split in was and about tip X,XXX X,XXX international. treatment North treatment

Lucas Baranowski

That's Okay, helpful. one question other And thank you. here. then

earlier that a pricing was the it of mentioned to international had year treatment globally bit on like pressure and due You little the there are side increasing sounded ASPs tip in competition.

So started that competition has that? what's abate or driving to

Scott Durbin

Yes, we in did particular make China. and that Lucas mention country one of that being

gained Latin adoption the to in of greater as direct world, as think parts model see Jim I has distributor regulatory clearances. in mentioned the other we’re through America beginning Europe additional

And increasing of is tip so from a treatment ASP to perspective the unit mix sales. related regional

Lucas Baranowski

That’s helpful. queue. you. hop thank very back Okay, the I’ll in

Operator

question And comes ahead. our Zacks. with next go Brian Marckx Please from

Brian Marckx

everybody Hi, quarter congrats year. good the and and on another

SUI, that need some bit for a different Patricia tip? that there was a little or did miss might Just that different a Jim require SUI say said it heard SUI, I of actually utilization clarity but I on thought you tip, does understand I

Patricia Scheller

ultimately of has we treatment way a current a with to could us and address Bruce Yes, be SUI Allan specific protocol easy track tip different indications. having we tips conditions treatment have Dr. these for treatment very and that our utilizing patients believe been been treating that each

tips. treated with our treatment SUI is now right being So existing

Brian Marckx

that come model, menu guess for? that to in function sort item sexual that I -- patient that would Okay. And for how SUI, the a market do or an a laxity be own essentially its of would by its upsell vaginal own or be then would you in SUI guess, terms commercial envision indication, you I would get the clinician an assuming of

Patricia Scheller

it large be the that vaginal for cultural we function. going willing function issues needs is to markets and billion that it that to own I its almost deal right, of think practices lead market every market, patient different incontinence are It’s incontinence. see are sexual entire think is the very in more that in think it could much around will $XX for incontinence represents we see urinary sexual own market about their one double and of fact but the population bring to potential with, we this and And a to billion and up stress that certain $XX each I so stress laxity to treatment Yes, market, its opportunity. stress doctors has in

Brian Marckx

two, if function. sexual what co-morbidity would SUI have idea do that people Patricia, have any the you percentage you have what between is the the rate is of

Patricia Scheller

creates Well intimacy. of a part there with SUI very during strong degree women stress because the a incontinence great on experience of particularly sexual function who overlap, is very concern and moments of incontinence that

one their they So tend those of life which their to in from is having is express many of physician tend away moments, shy that to un-sexuality. different their concern they their to impacting it ways, quality

a two it’s think whether I overlap between there So cause, whether the conditions. effect, is an it’s that

Brian Marckx

would submitted study is or was data, in that you submitted information most the it data to or or hope Viveve-X, that sheep something that IDE you to then FDA I else? data think regarding of And terms submit you Okay. that recently for the that the you’re going

Patricia Scheller

that the various the surface of study tissue sheep the record to to to and the technology sheep FDA did data that at FDA of lamina from earlier which that supported we they expansion very the And in submitted was depths seen to provided strongly time that the have felt down the and we in study procedure we data the temperature was FDA with study requested. for the vaginal propria. temperature And conducted look field. at this safety this an submit profile We an history we previously the had

we that during supported very event associated in have we adverse a the technology product. clinical profile. now study And serious use people seen the commercial of data never this with many safety in our believe As studies or generated strong the the

Brian Marckx

safety of in safety is looking seems the has or would anyway that cautious, essentially technology this else that guess, outside at odd, on Is concern technology being is been think fairly the the the that when somewhat concerned a anything that there that from shown they FDA given is I proven overly seems that it to over this point that profile. the have seems specific a essentially FDA anything be is you is such Patricia, a odd that about which safe. it just

Patricia Scheller

good and that’s Brian that internally Yes, often. ask question a very one

area this are on thoughts my twofold. So

FDA a is based is devices. group this within that First, the with familiar as not energy

what familiar that to So present become it them about risk. is learn technologies they they safe or to areas of make the that have have potential

technology that to part our the so been rest laid any this patients. process believe and fears FDA represent that the And they extent educational has have hopefully risk specifically we elevated I have for of for an to

point, risks years the has in of number would contraceptive note that for this within the created that morcellator, assure significant a vaginal have is the of the On had device. second vaginal serious devices women recent group FDA very safety a that also I thinking mash, swings,

So they and women’s also I think and health devices sensitized now safety to highly are issues.

I think in role that a caution. played is also their So abundance of

Brian Marckx

Viveve you the in customers the Okay. can service, of And service, of about the that current to it relative that with the it? to feedback customers relative just terms satisfied can relative is the it Is one, of about to is they from essentially profitable down those of comes providing talk not. you side are one or everything last and any there economics system it is providing to anything economics talk obviously

Patricia Scheller

I’ll Jim one. Brian Well, question, that’s weigh and on great in a that

James Atkinson

the the New maybe thank Brian, And nation a patient a standpoint sale energy $X,XXX. minute price within return the cities practice. $X,XXX of they to question. United in such little procedure physician The higher between for York the it have of States then averages XX their maybe you ASPs bit a probably LA, probably larger one higher. somewhere is for the around as the to From Yes the in

each that technology. the utilization physicians month And the is increased on positive feedback the having the are we from very so seeing

hour look you at Othera If for procedure. somewhere half other and was side the around an technology [ph] $X,XXX

very $X,XXX URO/GYN hour and in out consistent physician around GYN that an half we coming at aesthetic level. for for procedure, any there for And that's So pricing see and very, profitable physician.

Brian Marckx

lot a thanks Great, everybody.

Patricia Scheller

Brian. Thanks,

Operator

disconnect. as question-and-answer And thank you well may you as today's time session We for This attending conference. at presentation. concludes today's this our

Viveve Medical (VIVE) 15 Mar 182017 Q4 Earnings call transcript