ReShape Lifesciences (RSLS) 7 Aug 232023 Q2 Earnings call transcript

Good afternoon, and thank you for joining the ReShape Lifesciences Second Quarter 2023 Conference Call. I would like to turn the call over to Michael Miller from Rx Communications.

Good afternoon, and thank you for joining the ReShape Lifesciences second quarter 2023 earnings call. I'm pleased to be joined today by Paul Hickey, President and Chief Executive Officer; and Tom Stankovich, Chief Financial Officer. Paul will provide an overview and update on the company's activities, which will include a discussion with Dr. of Advisory member a Ren-Fielding, ReShape Board. Scientific Christine financial the period. Tom will for the review Then results He turn open some closing a will Paul session. remarks, to then question-and-answer after the call which we'll the to over call back for

materially Reform well to unknown recent additional results identified the company's As factors SEC Exchange and those ReShape Private report meaning from Investor annual fully are section of risks, filings known call contains and could website, factors. Litigation uncertainties XX-K. the Lifesciences' of those most the These including risk described as the on as the a Form and risk Act website, forward-looking due and conference Actual reminder, filings Information this in differ uncertainties of as Securities including XXXX. other with and factors statements discussed the factors in and Securities Commission, company's more within the

reminder, symbol NASDAQ, ReShape on stock listed As an RSLS. additional is the under trading

turn the I'll Paul? Hickey CEO Lifesciences. call and Paul now ReShape of over to President

I'd for like afternoon you joining of for to call all thank this Mike. XXXX second us quarter our you, earnings Thank

Dr. member After activities, we'll a of Division the of on Management I and update Scientific Weight Surgery Program of NYU Professor Ren-Fielding, of ReShape's Chief our the of an Advisory by joined provide Medicine, Director of be overview Bariatric Board, at Christine School and Grossman NYU Surgery. Langone

adoption field, GLP-Xs leader market. her insight opinion and I asked on the an As her key impact the and to of in clinical Dr. have expert on Lap-Band, the bariatric Ren-Fielding provide

this during later bit little a her from hear You'll call.

obesity associated costs. occurring repercussions will the comment rate a highlights, the lifelong and growth medical all I'd you assume has obesity significant of listening market, on our it disease, market second economic important to as like I that the and alarming I obesity quarter discuss the as recap size an of globally is understand that well today. and within events Before

actively I worldwide to marketing of daily, aware of of and benefits type The brought adoption suffering the loss related to GLP-Xs intervention. weight the previously to Big obese sure Further, those the occurs we other television on number loss. Pharma's Big and weekly, X have all channels. weight not helped am media for efforts managed exposed that prominence normalize individuals medical now of has the who doubt GLP-Xs that significantly have around the related seeing efforts and medically popularity expanding often significant marketing use is overweight has stigma Pharma seeking and from are you diabetes, and no There today obesity are we're the surgery of if the avoided increased

and ultimately that to shift known bariatric increase while past, of personal awareness as her the seeking replace has greater for care GLP-X surgical consults a will has perception the short both is potentially the and adults pleased not acceptance limitations. telling therapy U.S., augment to in and to been are in sensitive treatment we obesity a children. normalized, see have Ren-Fielding in Dr. been this Shortly, how I'll as well of While topic obesity delaying and the the the us out are experience. speak across its or adoption, GLP-X surgery term, physicians But number patients critical

of Lap-Band Lap-Band our We offering feel the future our very confident with expected X.X. and

for had least loss historically and that the safest invasive, these loss have an durable managed We uniquely are positioned option surgery. aversion weight to medically patients and weight with having

our remain growth shareholder on and quarter profitability second you a executing highlights key dedicated creating emphasis understand Now from to call growth turning our discussion achieving back by and of today's takeaway of A we is maintaining for value. initiatives. to strategies all to our that

strategies or remind our me of primary growth you for three Let pillars growth.

with business disciplined our revenue is a model. The through business approach scalable operate to metrics-driven sustainable expansion and predictable drive first a pillar to

expand Our pillar continuum. the pipeline and portfolio care is across to our product to continue second

Scientific last, on loss initiatives. is for our our weight our key Board And third pillar, Advisory strategic to our validate to insights leveraging solutions, continue evidence-based

specifics Now more let on me our you first provide pillar progress.

numbers this adhere every impacted key our in growth see that metrics. P&L You'll has maintain we executing discipline as pillar department and almost to

$X quarter. a July, operating am in to than reduction made on revenue report factors, focus caused expenses market GLP-X direct year's were to As I compared XX% we to shortfall savings total in and Further, estimated company's we able result other to by with X, in operational a annualized adoption of the response pillar our recognize pleased million. last additional that more second to improvements,

operating We invest in our this continue growth our expect to impact continue ultimately of and the allowing our to cash throughout we extend expense positively organization remainder optimize runway our to to year us into level while to 'XX, further initiatives.

generation Our our reengagement and a progress patient revamped lead growth evidenced initiative. is with our first digital by pillar also

recently SMS efforts agreement new seeing lower-cost exclusive leads will improve that increase software Medical, in surgeon optimization We align patient accessing Hive markets utilizing this to lead are marketing is -- higher-quality our by patient with improvement and yield steadily our signed specific Key and self-service with that patient volume an technology. patient advocates. AI, engagement assessing

at platform scheduling co-op plus select increase XXX% also revealed the our during the quarter. medical Hive the accounts, marketing, first have over testing Lap-Band impressive an where prior we generated data quarter in Importantly, in of consultation

highly any navigate allows targeted easily with individuals a the professional quickly hurdles campaign, an to marketing our and Hive and direct-to-consumer with patient platform intake book appointment new at conjunction time. In medical

of anticipate we will lead generation date, in best in and platform improvement to XX% our these at co-op sites practices. executing learnings our that approximately result marketing Hive adoption on Based

key of towards quarter. touch points on of surgery, develop target which to to for experience, in we As target continue a end website launch our patient's process improved part an the decision the strategy the to we are third

The include exciting, comprehensive shift our joyful, lead tone platform lead friendly, qualify to platform that with This automation, comes customer in. lead leveraging to patient-centric. new also will every routing chat and web in conversion fun, for improved will importantly, and lead integration text, connect most e-mail, provide and calendar capturing and

building these are efforts. the us responsive nurturing our call align Hive more better nimble in-house, patient lead will leads. competencies including to marketing center be with address marketing We allow to marketing This automation strategy to and core

Taken together, we believe patient of address needs strategy this more conversions intent will ultimately, the surgeries. with and better increasing Lap-Band

to second to next-generation Now In progress physician for let's a improve our we experience. June, our pillar. discuss executing application Lap-Band FDA supplement X.X, PMA feedback our develop patient submitted the the growth

in of Lap-Band, comfort, adjustable eating current is to Lap-Band Similar to decrease the increase an individual's and order improving optimize therapy X.X band to effectiveness. postoperatively or thereby habits our the the opening

At a then is Lap-Band feature of to food pass the technology valve. through the reservoir serves the its too diameter. feature same momentarily resting created band as return because can Lap-Band to time, are allows that by X.X large of that passage pass the the current Pieces relief new band through to narrow a new and the a relax

allow band for require discomfort satiety, from patient helping in increased could otherwise food, result in-office pieces emergency constriction and Lap-Band swallowing adjustments. of This may while large which to minimize

feedback by latest. early year-end We expect the FDA XXXX at or

the allow about the X.X noted surgeons reengage past, new in historically. of will us and those spoken improved product to Lap-Band have the I've the many believe have engage I As with surgeons used Lap-Band who

we wellness best-in-class second a continue to our part pillar and health of ReShapeCare. growth, expand of As awareness our program, of

launch ReShapeCare already patient been lifestyle an surgery, that and is surgery, video-based board-certified has this or modification. approach health providing health initial convenient, we that all bariatric effective with coaches, seen have focused either our outcome and app, program program wellness ReShapeCare's easy-to-use have responses within positive population. to to sessions bariatric uses our virtual holistic on patients are on a pursuing

have our care to to provide self-insured order in positively benefit reduce employers often We several employers' are thus, linked and an discussions These ReShapeCare overall are the enrollment costs. impact a period. long health also cycle with to employees sales employer's health and to discussions continuing

with Importantly, with customized are the par for, that be companies of employees. holistic can and ReShapeCare the approach meet employer to is needs a their on looking what

details ReShapeCare are have that women ability more health replace health have information than seeking fact, wellness our much and the then ReShapeCare has vendors provide that employer-sponsored or with further to current future Excitingly, we In unique consolidate have from programs. care in We'll or three employers care some recognized four program, indicated updates. needs.

This on stages. life health to impact presents by positive ReShapeCare tailoring women's have through to help opportunity a us an incredible for issues advance gracefully women

spoken Lastly, blood one is device, vagal Diabetes selectively of calls. pancreas, respectively, block to glucose under The past manage and liver the our and nerve stimulation development in Bloc-Stim our about or neuromodulation most proprietary DBSN's insulin to vagus Neuromodulation, I've dual which modulates and levels. innovative DBSN products

type for we'll X Society and in the in at diabetics' or or Annual and a upcoming evidence individualized Surgery multiple to Metabolic preclinical compelling ASMBS conferences, the and Disorders on promising including Obesity again Keystone on be reduce IFSO medications Surgery at do the later the for We DBSN presented in Symposia very Meeting dependence technology May this month. this on Metabolic so June. And Bariatric may Notably, XXXX American meeting manner. Federation International of able the diabetes

nondilutive NIH pillar June. grants our our nondilutive on meeting potentially our Advisory in with the trials. was additional further clinical or with Board third we'll including grants in DBSN achieved human funded growth seek to have We last support and with Progress first development, Scientific

the in already and Our our to internationally disease revenue of are obesity expand insights and valuable fields. experts pipeline. surgeons drive metabolic our and proving SAB is for Their growth initiatives comprised recognized product

also prescribed to publish our gastric therapy. using have surgeries, our data in is other and did plateaued Specific combination their supporting weight our strategies X.X to clinical Lap-Band, on engaged loss. therapies our enhancing Combination fully including and are and Lap-Band help to on products, SAB with comprising patients are collect data being who as both helping develop who Lap-Band GLP-Xs today those us GLP-Xs the

As a this to exciting Chris Well, retrospective combination with as goal this GLP-Xs introduce study soon possible. Dr. time, a like exploring Ren-Fielding in our I'd data with result, of reviewed at as Lap-Band are peer published and NYU. have to from we

Advisory of is key Scientific previously mentioned, been leader surgery of opinion a As decades. our for bariatric expert Fielding has and Dr. a field and Board in member

overall GLP-Xs give you you today. available Chris, have changes the recent field then and your the they'll I'd impact on the the feel view in including adoption treatment, like your on the the to give obesity of ask and procedures surgical everyone background maybe and to

Good gentlemen. Paul. and afternoon, Thanks, ladies

NYU the It at actually with Grossman Bariatric myself the School York manage was mentioned Center Division Surgery surgeon and I following being XXXX I of City. I the of I'm Surgery be NYU Chief Program, the Director of surgeons one I'm on first recruited the approved Bariatric of of FDA and at earlier, New I build in year Professor NYU. the Medicine, XXXX As division. in in bariatric the created was training, to NYU the Lap-Band U.S. at in that of a Langone implant the Weight first first and Management out a Surgery the how division Langone to Medical was the I'm device. to when became trained of was

So Lap-Band implanted research approximately became then I've X,XXX owned prominent workshops within and surgery outcomes published Lap-Band now approval, I XX other advisory of conferences. my busiest and trained complications. running BioEnterics on their on and an Allergan other the that In performing FDA for quality to specifically I and surgery. at over first workshops ReShape the institutions, surgeons the involving Lap-Bands. consulting articles, two surgeons a board. training national subsequent I Lap-Band I academic surgery on one surgery consultant effort months I in roles years became after other a those proctor. improve decrease with Lap-Band, and and Lap-Band and most by sat clinical Inamed, companies continued after I lectured international Lifesciences. scientific being being at XX at approval,

year. And psychologists surgeons, the surgery. XX NYU, one Bariatric Lap-Band registered perform grown years, worker. Surgery gastrectomy, a includes I division nurse That dietitians, past consists the and of approximately as we, X,XXX bypass and social a have and six operations gastric sleeve it two now at bariatric group, five Over bariatric three practitioners,

medical our patients not internist, by replacements she's and did and diet surgical surgery surgery complements of corrective program includes program or the on reach XX% our practice doctor weight meal and nonsurgical for helping obesity created are many who utilizing plans, undergone our their medications. bariatric referring operations practice, levels, their management specifically and about weight had years an regain weight I or complication. medicine patients This However, exhaust an loss Over hiring it management operations grown who options. goals to but treat revisions and by XX weight ago, also

have of we've Lilly, weight otherwise Victoza, medical Novo is involved Wegovy. Eli successful weight both with been Ozempic Our so the clinical liraglutide also Nordisk, medications we of and with or with known Saxenda, tirzepatide and loss loss maker semaglutide, new trials maker been Mounjaro. of as that involved program And

from In are which game fact, new two doubt we stay. There is arena these market on treatment in yet. are not have and to obesity companies the the a to grants new just medications, received GLP-Xs trial are that here no changer

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factors majority these However, on which about of utility The do companies a of an cost. making $X,XXX run GLP-Xs, are medications, not insurance impact primarily many cover month.

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to to from where the the Wegovy drug working In addition, the longer they and was then effects are many switching no Mounjaro. becoming or is patients of feel Ozempic tolerant GLP-Xs,

that Mounjaro presently obesity, and -- for be provide the continues not patient to is indication access is the to here problems. diabetes problem treat But which

patients Finally, The who many nausea. take contraindication. are will the because most side effect there cannot not or of or is side GLP-X common effects

are However, agonists. for many effects who take complications get GLP-X which surgery to for removal or trying to the these pregnant Women long do medications use gall and There most unknown cancer. serious attacks, of fear pancreatitis side attacks. require want patients are who as cannot bladder term not are such pregnant

surgery. patients development with bariatric now are obese a unreliability supply, number of we of these tolerance, who solutions So are the driving the the form be for along seeing permanent long-term in more of want surgery. patients with GLP-X growing reliance force oftentimes a for come of issues The and frustrated will and to

loss have of to the also case surgery the come has because intervention. underutilized. will intervention modern be utilizing vastly Bariatric for gateway medical modern drug patients been a surgery GLP-Xs a XXXXs, been for medical they had successful weight since but has

fact, patients people surgery. for However, in than who actually X% obesity of are surgery naturally surgery. of with And have afraid qualify less bariatric

operations rearranging but removing presently The the stomach operations surgically and and performed gastric stomach bypass, are and most the sleeve require being common intestines. these or cutting gastrectomy

experience. is are studies very and are sleeve can surgical by Although personal there operation proven and gastrectomy safest that are vast bypass gastric large far and nutritional occur people safe, complications population multiple and Lap-Band, The by afraid. as

weight the loss to pregnancy weight been because It after and delivery. primary outpatient every band. gave loved with came and it to them. of adjustability band with intake Patients Childbearing it during for management and allowed quick because to the long-term that band be the successful of retightened procedure the practice, to and the could time then was recovery uptake was be in time tightened. accountability after surgery have the the which them Lap-Band for back reason in an very also women during XXXXs. motivated -- office This their more lose connection initial delivery weight with they pregnancy loosened of them rapid The

for years loss. over weight of maintained XX have I XXX-pound still had their patients day, a attached have this and To Lap-Band who have hundreds

regards management it However, were when over obstruction. of loosening with required the it, band to urgent afterwards time, there issues in adjusting food to particularly relieve

an for patients and disenfranchised became will Lap-Band surgeons the this device. believe system. of reservoir issue and self-correction, Both eventually that ability I with utilizing because frustrated X.X became address the internal

is weight and of regain for weight because all not surgery for eventual for been obese condition regain understood. Lap-Band This over primarily addition, the years, after clearly it holds by an why have true operations utilized has been natural with issue the patient reasons myself In GLP-Xs XX as have agonists bypass. loss such as been surgeons well, which to weight shown augment to regain. bariatric sleeve of weight our patients widely help after is GLP-X complement their utilized been gastrectomy gastric and has and

our Lap-Band believe becoming tremendous which of surgery interest make now personally We the who in the surgery. operation. the bariatric never have demand and seen field, to for to a in after I Lap-Band have otherwise result is Multimodal surgery. therapy invasive a Lap-Band may surgery Lap-Band in patients would GLP-X more attractive will this practice that device greater the more improvements combination use in mainstay

qualify who who term. the will XXX GLP-X the been over A helpful. want today long-term which a them be or will million available are surgery. GLP-X for and hope on These medications bariatric sustainable or develop people looking dependent qualify option, able for for who be be to insights Lap-Band to surgery. long percentage I obese will my have Americans not continue is are surgery, safest There surgery into to and Lap-Band also world the is significant will not tolerance different

now I to call back Paul. pass the will

you, thank Chris. Well,

insight provided You an to our excellent listeners.

irreversible GLP-Xs, substantial that reversible of a surgical pharmaceutical a issues less the Chris for durability asked along with to evident So our anatomy-altering, and invasive be surrounding known call as other and bariatric adjustable of of approaches, Q&A Lap-Band. modification, therapies need is limitations this such effects there call. side for with nature the listeners should it stay with end at know, session on our behavioral today's I've Well, the that

solution, to and noted, effective safe, Chris loss. long-term durable weight be proven As providing product our has

alone and to believe be to can health plateaus coaching, that in attain known long-term personalized with for pharmacological evidence ReShapeCare loss. effects, a often growing resources, necessary therapies we including loss the due to changes these can patients, to lifestyle weight their make adjunct weight them currently results notable to noncompliance due helping Additionally, side lead the with meaningful

the now call our turn provide to of over Tom? like I'd Stankovich Tom to financial performance. to a recap

all And afternoon. this joining our thank webcast Paul. you again, once Thanks, for

full As and discussion is available financials a press in a XX-Q. reminder, release our our of

or reported or out some $X to discuss our to operating details, I I compared XX% of compared quarter $X.X XXXX, want a and first operating the reduction point improvement all second the reduction Before in which in million XX% improvement million second expenses efficiencies. our XXXX, the overall expense an of quarter our the reported financial of the half in exemplifies categories across first achieving of and greater focus on half were to consistent

combined system, impact Lap-Band the positively July, to operating and revenue for million. annual sell from combined expectation with cash that in flow of beyond campaign remainder reductions our with Hive resulting Additionally, our of digital expected move savings on the near for breakeven. focused revenue rollout and with closer expenses bariatric we platform ReShape centers These reduced geographies are increased further surgery to the expected approximately XXXX $X the of targeted media

Moving XX, other the on quarter to June key financial ended metrics for second XXXX.

The decrease same revenue Europe. ended sales June X months in of for of $X.X in was compared to XXXX. primary and reason the which Our reduction XXXX, represents U.S. period a million $XXX,XXX the volume the throughout in totaled XX,

while for new the and X on marketing June strategies increasing months surgical bariatric its targeted campaign reducing a the media company XXXX, XX, ended cost efficiencies. centers, near During digital through focused

the XXXX. expect during growth that growth through will these help of drive our XXXX, half and the We pillars executing of second remainder efforts

decreased ended of in million in marketing profit was million period XX, XXXX, to gross for and ended the June of $X.X revenue the decrease in million the million $XXX,XXX. million in months XX% was X XXXX, XXXX. June to due compared volume compared primarily percentage compared total $X.X for X Gross $X.X to profit same for the June the XXXX. by is for The $X.X XX%, decrease or to XX, XXXX, same down period ended as a months XX, profit decrease to for expenses XX% a Sales in of months for the the X percentage Gross sales. $X.X period same XXXX,

the decrease expenditures, digital is decrease and totaling marketing to The due travel a of payroll marketing compensation, also primarily expenses services, a due $XXX,XXX. to including commissions, million $X.X reductions in in were all campaign. and targeted stock-based There move to consulting-related advertising

in and stock-based expenses payroll, to $X.X decreased reduction XXXX. XX, by for to XX% to $X is decreases compensation, decrease approximately legal-related million X and due reduced a $X.X totaling in million million costs $X.X and other June expenses General million ended approximately million. $X.X the months for administrative all the compared period XXXX, amortization primarily in rent, The or same

for expenses. same remain ended for cash Research with the balance equivalents by June million compared due XXXX, months the to XX% X decrease is consulting in XXXX. declined and ended approximately primarily XX, We expenses, payroll and to or and expenses The development the debt-free lower $X.X cash on our period $XXX,XXX $XXX,XXX along clinical-related with in and to sheet. $XXX,XXX quarter

we anticipate we continued a in expenses. reduction and and beyond, our continue XXXX in our revenues operating As increasing

that, turn call over Paul. now will With I back to the

Tom. Thanks,

Before and further to call reducing lead improving components for to it to generation, reiterate critical our lead conversion, lead generation we that open optimum and are lead nurturing while ensure is committed bringing systems we in-house important costs. marketing Q&A, the

offer We with more bariatric patient-friendly, and the patients selection develop services to weight invasive differentiated healthy, non-anatomy-changing, technologies that transformative help of will and portfolio of lifestyle-enhancing from is provide a alternatives to competition surgeries durable that consists and a continue that programs achieve products, loss.

Board to we plan market treatments in success global in in a operating our fashion obesity. have that is safe so expenses and closely for aforementioned the across strategies. invest growth normalize all Advisory to continue changing significantly reduced effective categories we world-class for And finally, our with can will detailed, Scientific we work historic Tom As

This concludes our prepared remarks.

to like the call your we'd open now So questions. to Stacy?

Maxim. ahead Anthony Instructions] your [Operator question. Anthony, Our go from with first comes Vendetti question with

was fantastic call, question but little Dr. if you first -- last a I you get the Chris. what name GLP-X your on Thank bit maybe drugs, wondering And the is so ahead, with then talk side the -- And that I just just something it really for follow-up remote you're didn't doctor terms them? seeing go go ahead. I to the about of swelling one in brain you're being was they're stay, pancreatitis. one them not if could it's of a low about? you. wondering, so, Is here effects, concerned said of

no, No, I thought want didn't with no, sorry, question. I finished apologize. I you your were -- just to

No, is Yes. Or no, loss drugs use weight that no. recommended? just, the it conjunction That's Lap-Band probably possible fine. And is in follow-up then with the is you could that surgery? not

Okay.

GLP-Xs. So typically know thank but as stomach stays fashion. the familiar apologize stomach your much decreases I -- stomach emptying you, fuller it way leaves so of already food all slower and Anthony, for the work, this, that stomach you leaves with in not side if that the of a Brain swelling, GLP-Xs the that a effect and -- questions. am It's I

effect, really is if that and not I have because which bladder something the we're pancreas, it patient. extremely I are But They'll people sure full affects the of. side less. most they the a it get about. heard that's affects stomach, one. because is swelling rare aren't And the is seen it brain certainly it of personally common of But gall why why the also hungry. not not that's movement And the of in movement it's So They way eat have as the -- through food faster. nausea

helpful. helpful. That's Okay. very That's

GLP-Xs. been it for a should conjunction it do studies And them your after of The to a and Lap-Band had what, Lap-Band being surgery, question, the surgery right absolutely And conjunction to GLP-Xs little they we with We've we get start is, we'll with second know now. in is add right And stall, bit who've at are use surgery? using patients actively time. possible immediately addressed question then years. the time so all and you those GLP-Xs in

GLP-Xs So perform who there we'll stay do on surgery, actually There do right surgery not and continue to start patients and are just to reason those already no on Lap-Band away. we'll they'll are them medications, and great. is they

you, is Two to to answer. points. this add obviously I'm agree. Anthony, the just for totally Chris, Paul. that. going Thank I

think out can obese, of for and the obesity of Dr. Ren-Fielding you negative that other terms with that I side I just the just studied. with think, effects rates risk there's in GLP-Xs. And the disease as and the cancer a with have obviously to years well, are of on that to potential related going cancers, carrying being are increased comorbidities of comment balance any not cancers well risk of this obesity

And on market. face, this Wegovy many GLP-Xs of There's stomach what benefits our to talking doubtful, or that's life short Advisory read Wegovy on I'm and the I whatever. kind hear paralyzed and as the so about, -- losing I've fingers, obviously, other that Board overall to weight based that these have a

the benefits the was here on they one that comment. they're stay provide. based Yes, all think to I

in the a that's to for have they we point get shut therapy, that then has other look their that study of several already other giving of weight -- And don't that off an they terms making the for weight that GLP-Xs where a row loss is so getting done trying of to retrospectively and a addition in retrospectively bit, down it loss on how are to obesity system adjustment. months way path. Lap-Band, so GLP-Xs kind back But boost I of of which plateau, where patients can combination the places that well at NYU we're they've data and was collect think in

potentially of a you time then bit that comments think give of then Great. more a of a line approval? quick Okay. ultimately, like know be and Paul, Lap-Band you little could of can window follow-up And gave X.X. on just I when approved, back sort you but a an update,

We're with to bit, so all waiting at FDA. Yes, chomping sure. for the the speak,

with announced -- and tell reviewer required. all they settlement adherence it We it sort to in we waited all the of and the for they sort submitted, a we June, boxes we FDA. minimum know that a boxes, they we they what actually day waited rejected. going the a assign they checked PMA what -- not So until it's we gave to looked at be Once us to of check they the

got high interactive So We we But those at that terms their in FDA have look expect -- one our reviewer do I the level several submission to of to. at a a And FDA's the questions start job comprehensive. more but getting very hurdle. looking that we've on with next over that's we submission. past the softball again, is months And think, we We've question, responded with it. that's the had of believe to scrutiny.

so next ramp kind Our expectation is we to questions, for can it's should we're at hopefully the of waiting ongoing quarter, getting with concerns or more of that -- how we'll that we're a phase appropriate. And their as But it up as the just end year approved first the know the share the we'll with certainly FDA. focus so those interaction and which commercialize. to of and latest, have on far, of interaction starting lot the we by FDA be it,

remarks. our Please Paul question-and-answer back for over to would closing I Hickey like go session. conference ahead. any to concludes This turn the

transparency you shared our Sure. appreciate and enthusiasm the road Well, call hear and the excitement during I and hope ahead. candor for this

will to evidence-based devices organization to We disciplined, therapeutics. and be commitment our work in streamline continue we build And diligently personalized our to sustainable provide to to more scalable. continue

today's and call Chris Ren-Fielding the Q&A as thanks well. participating A for special to in Dr.

engage loss our Board look premier of and As stakeholders, customers, continuing shareholders. consultant to our to employees, suppliers, shareholders mission always, partners new advisers, I physician-led for ReShape your to members, want to on weight and support existing our continued as the health company. with care do become forward progress we I thank

attending The concluded. Thank conference you for has call. today's now

You disconnect. may now