NDRA - Earnings call transcript Q3 2021 | ENDRA Life Sciences Inc.

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Operator

Good day, and welcome to the ENDRA Life Sciences’ Third Quarter 2021 Financial Results Conference Call. Today, all participants will be in a listen-only mode. [Operator Instructions] Please note that today's event is being recorded. I would now like to turn the conference over to Yvonne Briggs at LHA. Please go ahead.

Yvonne Briggs

operator. you, Thank Briggs firm. Yvonne ENDRA Sciences’ Life This with Relations Investor is LHA, Good quarter ENDRA’s and to afternoon welcome and third conference financial call. XXXX results update business release Earlier this a ENDRA press today, topic. issued on access of you of have you Investors And for it at who the endrainc.com. those in website a don’t copy, can ENDRA’s section

operations, laws, other objectives the or note historical facts, the of company’s product statements. uncertainties partnership receipt are well SEC please related required begin, will to Except to regulatory forward-looking company’s the we regarding required revise Please statements. results more any and refer XX-K statements. statements financial today’s discussion and of and studies, Form and securities include opportunities filings otherwise commercialization timing about statements company than to regarding obligation costs, forward-looking any as anticipated for clearances Before processes, information efforts, disclaims expectations of that potential forward-looking statements. as of update and strategies, condition, subsequent All and plans statements launches development as XXXX including federal regulatory clinical the forward-looking by risks

the call, Chairman Chief prepared Pestrikova, will Francois? turn Senior Francois Michelon. Officer With said, of terms Finance. and that Chief the structure the Renaud I Francois remarks; now will and Michelon, begin Maloberti, by then to Irina In Executive followed call ENDRA’s of Officer; today’s Commercial Director over of

Francois Michelon

XXXX today results update. Yvonne, discuss you, and Thank good quarter and joining afternoon, and financial to for everyone ENDRA’s third thanks us business

and in market with end channel activities, include commercialization expanding asset finally, a evidence path our as the property model. our partners to set TAEUS I'll clarity forward, with clinical discussions gone as accelerating the operating activities adoption COVID which evaluation cases enhance definitive of within FDA data Europe, support despite on bolstering in our to protect beyond company our the hope additional now. on portfolio to have with I'd the our each COVID-XX uptick global and marketing well commercial progress pharmaceutical our While in these our And I user partnerships of an and am of remains pleased control, facilitate on to opportunities. securing leverage technology light capitalized our to ENDRA efforts, isn't clinical intellectual Europe. licensing elaborate continue we out from

as with COVID group but to of a virtual to Germany XX%, segments to since Coronavirus two system later we've new awareness TAEUS, Radiological also gastrohepatology. to and customer Healthcare Disease, user XX% AASLD. up our has nation's leads, according RSNA, conference forward end an in facilitate America fact, conferences opportunity Liver the We've ENDRA’s visits Recently, continue virtual technologies, the medical partner our cases booth the our at to known is in American to clinical And staggering new had Many the learn and our ENDRA at and and pharmaceutical of been events sales sales as Society deeper TAEUS conferences. these this the we possible well a in our pipeline October, as our U.S. marketing look in companies specific efforts. the of every In potential to demonstrations clinical of good in the build customers. country has Chicago team participated John clinicians and conduct targeting we in Hopkins UK we’re in booth a participate Continue radiology leveraging largest pursue to presence known for up key building system, about GE and commercial month. to new showcasing October, Study the well as sales in we And and as number TAEUS attend ENDRA European of attendance North wrapped in drive as Association and are in-person demonstrate cases France system next just since France, research to increase in Europe a TAEUS conferences collaboration. to Center, XX% expand in up opportunity been in-person

As details these commercial a our the website conferences a reminder, on in activities and provide will on moment. of corporate posted are event section Renaud more

as outreach, to for TAEUS. In valuable online we real and collect the world clinical our continue sites commercial to to addition advance they support evaluation data come

of and liver have these ENDRA’s You'll a those Europe. patients by scans couple assessments weeks comparability each three system performed six are support will recall, results. of build TAEUS both base scanned we patients world to with of Studies of These ensure to total with U.S. clinical real commercialization. clinical a other the in with evaluations to comparing data within same in fat partners of in the three MRI globally, partnerships scanned

world to real Pittsburgh valuable for performing And FDA and our study to U.S. largest manage possible scans as starting with University they started needed. is submission, look the of Vista and contact close linked backlogs and of evaluation procedures. Utah and remaining the currently Rocky in not backlog University may patients, are the Center our the scanning European have We sites with MRIs begun if Vista clinical FDA Rocky these study data partners. performing U.S., In XXX in temporary to restrictions for subside. clinical forward Medical the patients UPMC it While studies of its we its approximately for provide as pandemic as remain while XX MRI soon continues patients.

and In commercial addition clinicians ENDRA. endocrinology market for radiology, as a hepatology to

and metabolic considerable provide believe studies companies fat our key clinical areas. holds research organizations efficiencies are for that and can liver in believe pharma conducting space. over companies value clinical measurement three the to also technology XX in liver that We pharmaceutical TAEUS We disease

meet support scan. recruitment fat liver historically incurring screening liver criteria a an process can they to potential cost enrollment and technology MRI First, the convenience and of of and efficient the the study's more trials, ENDRA’s before liver a of which patients biopsy of XX% during time drug determine if or reject recruits.

to patients and used will Hepion provide XX enhance trial our may our underway, as multiple in for Xb as convenient similar at their biomarker technology third to technology four stay patents identify NASH their the or monitor a Earlier clinical screening This here. of can stands had TAEUS And quick study define year, an fat. portfolio and In is progress. IP for of with can evaluation liver measurement collaborative plans, pursuing Phase U.S., suitable support between which intellectual TAEUS our we preparation for our the tuned technology biopsy In add-on regard patient continue measurement agreement approved, signed the we're with total assessment clinicians, our a for property commercialization measurements in XXXX. be MRI we in filed to therapy first additional ENDRA and Europe. to our TAEUS issued and to of a incorporate to globally care measurements, TAEUS we point drug serve collaboration in Pharmaceuticals indications. fat treatment portfolio QX once in to as identify quarter, assets, of finally, patents once position, easy is and we Second, current this to And so tool help fats TAEUS which of protect earlier. provide our our endpoint the liver liver pharmaceutical opportunities part will at issued. the sites XX as data patents

future. we are TAEUS simple serve the not may to Clearly, work be And run. the to very many Indeed, has device to Those boxes TAEUS state. unique Let the property believe which however, may is come check other intellectual TAEUS benefit with in the pace a long same well such a contributing attributes, review growing potential be to the me in These looking the FDA. at we've to competitively and of those extended regulatory as back mean may deliberate and considerations tie for that TAEUS secure applications considerations, process. this global our attributes last FDA and is also large a why point FDA the able about unique submission patent been protect predicate the application.

engaged We're the potentially on providing device definitive the than the collaboratively and longer review we technology, additional be ultrasound represents working including expected. with forward data taken Because and discussion real its remain our world importantly profile. an agency period agreement continue confident has safety regarding We analysis a submission. we actively FDA and advancement the in XXX(k) to technical path considerable as TAEUS of for TAEUS with review performance But requires in the time. clinical the

granted all that needs. likely to for to our evaluation world ongoing we on with will partners you, and commercial the FDA update, clinical as review process, Renaud? TAEUS that we're the to regarding be our I emphasize discussing I with identify for their requests. the regulatory would And FDA of continue will clear I from responsive mentioned, highly within path clarity we potential their an gain be clearance to optimistic And we our want secure to we clinical the goal to to additional detail this over and the are with seek everything efficient to which turn into forward I'd With data, provide like real our although extend timely can system, we're TAEUS. With more year. next advancing in activity. that to provide our doing control manner. process assure that Renaud remain call discussions FDA definitive the

Renaud Maloberti

good Thank you, afternoon, and Francois, everyone.

COVID-XX to in we activities. the with In-person Our some to good build our commercial momentum European solid as starting commercial our efforts sales markets increased system. TAEUS ease team continues progress restriction with and for sales are have visits make

We to Germany country Europe, four UK, we France one our representatives total person. we the each target on appropriate at in and time. expect commercial sales the have and a team Currently, of in people have have representative in pan-European ENDRA and a

and optimize and continue to monitor historical video sales will activities personnel opportunistic as as areas. well marketing market the to the conference demonstrations, and add our visits include to remain meetings structure. cost in-person Sales certain outreach group in We

purchase is customers new the a are we we cycle initial by from sales and and Given interaction that in-person our an institution. be although vary to market, to TAEUS expect these months the by customers, capital several with equipment

sales effort, as be their leverage potential received significant to are supplement being base we potential with GE are our our To ultrasound with optimistic direct continue feedback to leadings of Healthcare –positive working from install We clients. partner customers. well the

look has imaging collaborative and GE market presence. sales calls a is to in highly review held sales coordinate given market partner diagnostics, with team their global activities at resources valuable and Our GE feedback.

to markets. As indirect distribution channel we part global build certain out an plan strategy, commercial our also of in

which Vietnam, of opportunity represents a we a prior XX mentioned premier calls, and technology system approvals. clearance medical commitment a I signed to in FDA have As of distributor local in revenue TAEUS receipt substantial value upon sales added

Additionally, build is our system. commercial team to focused interest with numerous initiative marketing TAEUS on the

awareness campaign and to utilizing various resource as benefit and educational publishing We for videos, the on papers have producing by white a and created TAEUS. information our of valuable e-marketing website data

ability in Francois conferences trade we demonstration participated network France clinician. our two with to mentioned, of As add in the conduct and to

several trade These industry contacts. that have to of planned for We balance rich be a this will the year industry of pipeline events. and to to extend be more shows network also our and continued resource conferences sales in-person

and iterated back – diseases. topic better of multiple of as meeting of Liver prominently was coming costly of which where liver early the fat seen Study the NASLD, the American the are cause at onset we Study for from Disease the a discussed root is evaluating way just for need Association the the the We of condition AASLD, for

expanding to summary, our day enhancing sales lead our to we of our and and in updating to strategy relationship. our TAEUS on booking pipeline continue developing first awareness our look by forward clinical progress. advance you So growth sale We of of

the turn XXXX. the results Irina call the review third to to to for like Irina? of quarter over I'd Now financial

Irina Pestrikova

Renaud. Thank you,

in third for development XXXX. Our decreased $X.X September XXXX, spending the million to product For primarily of for expenses XX, financial from and quarter quarter results investor The for $X.X to reduce same decrease XXXX the due operating was the million ended our are relations. period follows: as

by Our research expense to and due product approximately development decreased reduce $XXX,XXX spending year-over-year for development.

by and headcount. to approximately $XXX,XXX costs quarter to increased due and began for we sales General investor reduce approximately adding expand expense marketing spending and our legal sales including relations the as to for administrative decreased our efforts $XXX,XXX by Our fees.

for the share share year compared net loss $X.XX per $X.XX Our was third per ago. a quarter loss XXXX with

We commercialization to model asset continue operating cost an we conservative with maintain structure light a advance initiatives. as our

cash have and XX, million. $XX.X we of As cash XXXX, of equivalents September

which facility, a engage to the future. capitalized Europe in the with balance to pending opportunistic we're activities solid ATM with our support as XXX(k) expect We believe TAEUS utilize in have a we FDA current commercial sheet basis to gain on on well an the We submission. clarity we

turn the to Francois. I'll Now back call

Francois Michelon

summary, bolster with licensing these Thanks of in which Irina. market commercialization efforts, COVID-XX and Renaud marketing clinical enhance and our Pittsburgh accomplishments Vista opportunities. clinical to and channel end partnerships partners will to of property Europe, to today, intellectual technology and despite evaluation I'm of that our very much our pleased our portfolio evidence facilitate commercial TAEUS activities In include support an set global continuing in our cases with the Rocky data securing starting uptick adoption out University to pharmaceutical user protect beyond and at accelerating build

initial our working for our definitive of Europe the my I U.S. clearance system. opening TAEUS FDA sales secure regulatory with As forward in closely in to the to highest clarify priorities simultaneously are while path mentioned remarks,

business like results, that review and with So of open call to questions highlights operator. the for our financial I'd

Operator

We will Instructions] question-and-answer [Operator now begin the session.

Francois Michelon

Thanks. questions on investors from to like your online you'd side And while some to Briggs, investor for perhaps received operator share. you’ve Yvonne questions queue waiting that we're

Yvonne Briggs

with GE entity Sure. that ENDRA’s industry standalone Will into with announced we divisions splitting a up agreement question is effect recently XXXX. Healthcare restructuring that it's received being specific GE? in One GE

Francois Michelon

question. Yes, to Europe the I'll I I great give working teams because GE his us thoughts think he's a ask that's Renaud locally closely. with in And think

some be have you that'd if super. on Renaud, question, that So thoughts

Renaud Maloberti

GE change its number not for split a reasons. with question. It's will relationship a and great sure. ENDRA Yes, of

GE central GE is not division, First, entity. Healthcare corporate ENDRA’s which with agreement is a

Second, options ENDRA’s engage occurs. the agreement renewal end And of before GE spin extends until discuss we'll XXXX. GE of with the to

We with have a good relationship GE.

multi-channel it. futures not GE’s and finally that to enabling on for partnership from equipment it's customer not perspective, commercial GE. with benefits industry ultrasound involve on want a ENDRA’s So while ENDRA’s that's depend sales remember to way investors approach from a does heavily people to for resource ENDRA its the single important broader dependent own overly relationship ENDRA and direct success we be introductions,

Francois Michelon

Great, Yvonne, if more there. if have thanks I know any you And Renaud. don't

Yvonne Briggs

of in that mentioned a the the questions you ENDRA of with you FDA other would in conversations One kind came the one dialogue what engaged characterize asking? FDA. that tone is actively the How and

Francois Michelon

is place And I in I We're top think back engaged make to FDA. the that's not communicating want for with be. obviously many mind Yes, of the sitting certainly people. I FDA mean, waiting indeed ENDRA right emphasize actively to to for a decision. that's

co-lead methods effectiveness, We use, outcome. of to rigorous. with and the the the those. the exploration want of have I FDA and the the characteristics think both collaborative demonstrate intended to to parties system discussions we've areas this used And scientific safety certainly tone The of our and a is naturally testing technological successful include, that

the their is that to to best get means also quickly point this very in unique as think to requests. I think technological the always the line as we check And as the is I not to for the boxes out So regulatory positively remarks attributes, I’d submission mentioned and way I respond goal due which rigor across earlier it's to simple FDA, my TAEUS want a part it on respect. the application. of ENDRA’s us

will we than and capacity. process expected, granted that has very TAEUS regulatory our but So optimistic taken we're longer the be remain that the working review system clearance in I for

we to any So more, could asked operator’s Yvonne, the go that. I have if thank you, know you over don't whoever otherwise Q&A.

Yvonne Briggs

you… can Operator, Yes.

Operator

Yes.

Please question proceed. Ed Ascendiant phone first Capital. comes with from Woo The

Ed Woo

Europe? call spread you guys my for what in of you meet in-person know a visits half that question. you're in I COVID the about guys guys think scheduling you given on you people you you mentioned What the actively are think or Thank terms Yes. Europe. in you think, are do ability you do My question, taking XXX%, capacity had to

Francois Michelon

fluid lead I it's the that excuse numbers reality a perhaps it's We're tired all of it, on in COVID. Yes, but those with shared I want and based remarks. to Europe an prepared in unfortunately reality and of don't more

So sales will we're to say are I opportunity seizing a product securing mobility certainly. to capacity think the as XXX% terms in teams UK trying those convert possible our don't question, I commitments answer change we're in meet to direct France, virtual every at of in-person. visits. your Germany, But to our demonstrate Whenever and into things

think I our clinicians by want capacity, you Renaud I to certainly point have even don't opinions on at if due but that. peak I in-person not preferences personal And a say on number or know yet. mobility to don't hospitals at other add versus for So access touched might this put Renaud issues, to meeting would that I to you and virtually. thoughts We're that. want to

Renaud Maloberti

on to best everything us we make think, you're this hard that It's point. presented I that to of correct. it, doing number advantage at can is every put sure a opportunity take we to but we're

Francois Michelon

Yes, examples, and of a couple Ed.

customers. interest markets interact liver As focused demonstrate to to these we in France, on want a of product, the two booth penetrate conferences clinical to able have and we with be deeply, in-person were directly we the more attended thrilled

So on our are that. hands. we to whenever don't But want able, we sit we also do

We tools also to and in virtual leverage manner. that want outreach

that So we're helps trying in Hopefully every answer Ed. your way possible. question

Ed Woo

strategy? returning questions, normal still Yes, trade that are that's important to mentioned of you When to held how it terms and same they And are shows being what's commercialization ask back hit in-person or trade one in shows. back great. I you your to miss or guys then of last are the overall question, kind shows

Francois Michelon

question. Great Yes.

all conferences to they partners. say the clinicians, and all insurers, these the So, to ENDRA providers, let are for the new research. go very healthcare strategic new most new involved, technology the And we the these because important that, technology, meeting learn all, providers, point me about meetings to parties first clinical treatments, are of

a last in-person in been, the and has mix going the happy I'm field say of year to half has virtual globally that also very seven six these a some since while very been conferences So meetings. more I XXXX. of gradually returning would to actively to ENDRA physically

in someone we block elsewhere, handicapped introduce not to all able to only conferences. se to of kind and Europe University per of ourselves partners, virtually, new as be clinical we're the these our Pittsburgh collaboration and of So trying met at who's

building the only Liver participate continuing it example so I'll Disease Association And a for good that that's And and option. of to you went big for of came virtually Study And virtual a on just That's momentum that just COVID. U.S. when of converted. the by we everyone. big American we're back from give reasons surprised a was meeting meeting

waiting So else for there, people. not is just passive virtual we have virtually. like booth we everyone we someone participated, website have a It's who present a

someone room We are chat as And scheduled us a or there. meeting, engages soon a via participate. as in with we

GE us a have but to and forward that looking than we there. And our demonstrating attendees, to it's for partner and us. good RSNA, next conferences one Radiological finally It's North a little a certainly in it's your Society conduit XX,XXX close in-person. XX,XXX Healthcare. with So to of world, smaller But huge biggest vehicle Ed, the effective product a question, in the is a for U.S. sort of of we're America historically very right to the booth GE,

forward, be So back, steps pace one step but step we're the back, meeting of two but the way. world seems to there I think it every is the coming

Ed Woo

Thank guys and answering wish Well, you for my luck. thank you questions you. Great. good I

Francois Michelon

a Ed. Thanks lot,

Operator

Please H.C. Our comes Bernardino from Vernon with next question Wainwright. proceed.

Francois Michelon

Vernon Hi,

Unidentified Analyst

behalf Vernon. is Hi, [ph] this of Ryan on Johnson

Francois Michelon

Hey, Ryan. hi,

Unidentified Analyst

many so any the just any like have been about particular Rocky maybe or performance workflow on in study been how patients or Hi. screened far clinical there Could feedback? Vista I has ask updates

Francois Michelon

Yes, great questions.

clinical is in and will first to that So that maintain say but patients just we certainly I We independent it's was performance haven't our it study learning. disclosed data, a real the an of and our XXX. number started we certain want besides and of goal time independence, we collecting study kind

can is the up users clinical feedback some technology our learned the process and that learning in terms interface. how terms we've of just picking objectively say so And positioning is besides what from people, in these contribute. important pure the train in data clinical of that of an to some field part And clinical I'd a of of natural sites

one with each that so deeply will we're we've site. Rocky learned is one also I Vista a radiologically And say is learning, driven thing

new way of And ultrasound. hepatology so in but naturally was their it global University they for they're trained interest Pittsburgh this of excellence, more this a add liver capability space, a have intuitive because to obviously them enormous center has people. to

And take partners, And our we think so less adapt dealing customers. much and I we train little bit had commercial ultrasound it people but that clearly we who longer, additional were train we a workflow to didn't how training with informs had how experience.

very And that's everyone we're in. happy so for along deeply happy to participate but and helpful in Ryan. interested remains that we're way, Hope the this space

Unidentified Analyst

predictions you. you kind It readout up quickly any And some have can when on that? I is. with the other or from loose of expect Thank study? can possibly just follow we Do

Francois Michelon

Fair question. Yes.

kick ourselves it's MRI by we it's and on quickly that But the compare So then which small, fat fairly scanned most impractical, in by XXX, measurement were on when the for factors, number have of I small believe it research, accurate, in mean, they we Rocky these useful compared because remaining that our it's which Ryan. gold U.S. where global and to MRI and the we has fraction the very wanted is to a proton expensive most depends standard to system albeit though of density, we even studies Vista, patients Europe except XX these off design, tool.

So or study of gets shut other down it facilities ours. when COVID the just potentially delay not swamped with is, that accessibility a that a good example priorities

MRI that is element touched I've other on The backlogs.

because hospital but the pile patient procedures mentioned prepared remarks, need else have scan when wait up weeks the MRI has person MRI system because six and in on changed treatment a patient then something can have I on or to we want clinical MRI them to scan may ourselves an in I a and think chemistry. we're those this comparing for lost our for may an weight that to don't their

And close of together. get a may of the good read a not so two sort out we

operations, variability in MRIs, in would UPMC, in be And more that certainly world studies returns case that I These health studies. thumb. I you So the but care the of in to say time, timeframe, a not to more anticipate six the of are two rule normal months more they normal say, these experienced length. would of the as three-year nine can are some good under a these should year, to a

So design. certainly reputation, but by geographic and I helpful contributions, But objective as supporting they that location, are virtue will you'll we those these be next evidence. ENDRA very year Ryan. it by independent helpful, think studies of Hope builds to its base them. of start are that's And seeing their clinical

Unidentified Analyst

It is. you. Thank

Francois Michelon

else, up we wrap call. we I if don't can not, if Thank anyone have you. the know Operator,

Operator

No.

for and showing are questions time session. this like back call And closing to the concludes question-and-answer turn remarks. at Michelon We Francois the no to over this any further I'd

Francois Michelon

want for Well, you today. thanks. progress. our updated do I on And our look to keeping forward We us investors to joining thank

the the very topics, year, We updates we call proactively a meeting we limit gladly and that's through calls material investors. to the quarterly of including evening. on of our the forward have ENDRA And go Have plan of next appreciate to investors. not as And look forward. or any our our the event. definitely these speaking news will end ourselves will support again, to if And good or call a ENDRA, and you we inform at

Operator

Thank may now attending The is And disconnect. today's you now presentation. concluded. for conference you

ENDRA Life Sciences (NDRA) 16 Nov 212021 Q3 Earnings call transcript