NDRA - Earnings call transcript Q2 2021 | ENDRA Life Sciences Inc.

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Operator

Good day, ladies and gentlemen and welcome to the ENDRA Life Sciences Second Quarter 2021 Financial Results Conference Call. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host, Yvonne Briggs. Ma’am, the floor is yours.

Yvonne Briggs

Thank you, operator. This is Yvonne Briggs with LHA, ENDRA Life Sciences’ Investor Relations firm. to conference quarter call. welcome and business and results financial afternoon ENDRA’s XXXX second update Good Earlier on this ENDRA topic. today, issued a press release

can endrainc.com. you a Investors For don’t of access you section at of the it website those ENDRA’s in who copy, have

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

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

Francois Michelon

is Acoustic technology results success afternoon, for the putting second for of and Good building we’re TAEUS. global blocks update. thanks known today ENDRA our in ENDRA’s capitalized and you, joining XXXX everyone for UltraSound Thermo and well place Yvonne. Enhanced as financial us the business quarter Thank

of as for including supporting our measuring sites, focused regarding a control, similar the assessment as or care clinical our in the Although our enhancing NASH. plans use evaluation pandemic, TAEUS existing commercial inflammatory ultrasound highly the in steatohepatitis platform times on application processes application also our and and disease for patient MRI, lower its well elements are tissue mark out visualize TAEUS CE the the simple non-alcoholic known to of fat as ways in a early fatty to allows point it’s known clinicians technology to COVID XXX(k) TAEUS as non-alcoholic at XX Europe capabilities we’re an the proprietary on of and By focused stage regulatory NAFLD cost. non-invasive is for advancing of liver submission. certain first remaining liver FDA systems, responsive but NAFLD/NASH TAEUS its to Europe. and with

FDA submitted In addition, with year. the last a XXX(k) application we U.S.

them review FDA’s this XXX(k) the may clearance ultrasound securing TAEUS to technology represents as careful reviewed represents effectiveness the ultrasound previously we ultrasound that intended When only clinical compared confident advancement a a evaluation that than understand in first submission FDA and require in submitted three predicate in to first ensure of use, remain safety period We safety our of each submission requires technical typically or presented additional scanned more incremental our and globally, liver in part on compared systems. and of patients six device that results. the when To ultrasound total to date, no questions a steatosis analysis and partnerships new are time safety fat with in and of existing similar very TAEUS the to that concerns advancement our involves to comparable Europe. compared technical appear is medical conventional three system scan small MRI-PDFF we Although protocol devices, optimistic scans as cleared couple about with site expected, comparability with a to the be FDA within review of patients performance device of performed those both an XXX(k) review hepatic at demonstrate U.S. weeks presents device our of and submission devices. TAEUS and the review device. the The been predicate we comparing both have same the and has longer TAEUS year. for of a of indications TAEUS

the three able partners have been restrictions scanning. Europe, not in commend Given those pandemic to

at Utah underway of in with here goal the Rocky Vista a patients. U.S. in However, scanning scanning is XXX University

hospitals expected September. MRI of In under of start tied to University the procedures remind in as availability Center of elective evaluations in for pandemic and many postponed are clinical during returning equipment, scanning listeners volume backlogs used Medical is in that heavily is to of patients causing high MRIs. the which were now Pittsburgh scheduling being is our temporary of approaching procedures I is the its backlog addition, MRI the end that

longer between scan. MRI taking are procedures cleaning related pandemic each addition, In

we now, capacity but our evaluation committed communication eager who ENDRA. for with So MRI in constrained remain is working partners close and remain with to

we valuable through look the for kicking remaining data As off forward sites TAEUS. their backlogs, to hospitals the work and generate

these are not related clinical evaluations to reminder, our a FDA As submission.

trade once companies virtually pursue We participating new exhibited year, specialties. as TAEUS to research members to in well European June, noted Association conferences by at as exhibit Annual collaborations. conferences a other more several and section plan the shows industry and for the technologies approximately look website. the attended of of our We was endocrinology on this Events which drive at later to industry by context In We quite come as the and of gastro we clinicians, clinical awareness system built to up network industry continue clinical in learn possible. forward researchers Liver Conference, corporate where these to X,XXX many and Study through in-Person and in hepatology, TAEUS resuming conferences pharmaceutical clinicians about

in key to regions. sales Our start ease hard team at Europe restrictions work in is as

of the their four on call at a is team team partner our sales base This country our ultrasound target appropriate of total customer adding on existing time. each commercial representative and in have We of the leverage GE Europe to with radiologists. people Healthcare a in working goal with

team addition, details and as our of calling we year, customer TAEUS a technology agreement Xb Phase sales on Renaud study more in independently treatment endocrinologists. Pharmaceuticals in-person, for collaborative their In Hepion will other the both incorporate provide NASH. Earlier hepatologist such activities to in in gastro segments, upcoming this our commercial is on moment. virtually our and a Europe signed with

an be and fat. screening support to with We’re Hepion TAEUS add-on working biomarker to will technology used of patient liver as be pleased as measurement

organizations opportunities to efficiencies provide can organizations. in contract key these research As we believe drug increase three development, and seek pharmaceutical companies to TAEUS benefits

screen efficiently this the to First, meet evaluate surgical costly with criteria. cause an screening industry like typically the to enrollment and of they Currently allow in and or XX% of MRI over if process, stage, during the rejected ENDRA’s pharma follow. companies technology biopsy study will the can potential delays a at Hepion, patients to inconvenience recruits be the

and trial liver which fat pharmaceutical throughout MRI Second, can of TAEUS drugs, trends identify also the measurements, liver the companies earlier. help can provide biopsy to measurements CROs or prior fat convenient

who first for as collaborations Hepion step to as these user that and as customers pharmaceutical collaboration end commercial serve identify pursuing once and a to pharmaceutical therapy their TAEUS is are then monitor our patients in the approved radiology assessment addition opportunities important suitable can drug develop lastly, an additional and to tool beyond clinicians for the an progress. sale, and for Third, help market salespeople are TAEUS, in targeting. hepatology view We're to

filed both current Finally, we grown current continue eight to issued. Renaud? bolster to as to technology turn provide patents on With future commercial that which globally patents and to call in detail applications to we with update, intellectual issued to I'm the property proud year-to-date. like say and Renaud our portfolio our our protect very XX more portfolio activities. has Maloberti preparation, for assets, define IP our over to I'd

Renaud Maloberti

Francois, you, afternoon, good Thank and everyone.

TAEUS solid are restrictions initiatives create with the even COVID-XX commercial challenging in as We environment. Europe, to continue progress a system making for our

the the coronavirus throughout health even While Europe, to easing has we have region, stemming slowly opportunity seen some variant, so have from across and we Delta vaccine increased had restriction administration cases the conduct time. Europe UK, as France ENDRA for the in and commercialization with the part of Germany. our in-person Francois efforts four as have we earlier, in Correctly, professionals representative mentioned first sales activities

we of adjust our Europe In growing seeking add assess we fat our interactions, cost by continue addition the the sector our outreach organ have continued and as recipients. and structure a in team look appropriate in to liver to easing. closely aware to being the customers market to Transplant and growth for and received more sales and transplant forward personnel one to in our will our COVID to open, are opportunities. conducting were potential monitor meetings marketing where started conference Europe of in database, we to we are Interestingly, visit are The sales donors, video historical in surgeons to to physical well where transplant monitor sales flexible during fat plans as optimize restrictions remain customer Hepatology making liver interest made

driving Visceral clinicians to look commercial the this with attending As To Surgery, the sales our supplement with with local of and where a forward interest answer and needs segment activities, key be result, we French Digestive is clinical Association awareness better this how TAEUS on focused will building the we of we to AFSDV, team relationships can PS. understand building system. direct

and TAEUS. awareness by We for a videos, information our of papers producing website publishing data valuable educational are white campaigns various and the on benefits as creating utilizing through e-marketing resource and

participated potential with to expand obesity, targeting Associated syndrome This Liver diabetes, markets. Metabolic new the and co-morbidities. extension MAFLD other year The ENDRA’s liver disease was the hypertension which as NAFLD very virtual the Francois disease this Fatty addressable for cardiovascular NAFLD/NASH Disease, in As drug recently and interest diseases on in has additional disease bodes a annual International such medical liver on basis. to well or the associated focus with Liver diagnostics, includes we theme the a mentioned, and beating to other and non-invasive and EASL Congress specialties metabolic

have sales industry to more and great conferences quarter We in venue the with and to a our fourth in be attendance. network in-person are in-person this a expecting contacts. several to proven expand year industry planning and both leads participate to These virtual tradeshows few

our a also leverage Healthcare is base working to with team Our significant clients. partner of sales ultrasound GE

regular of goals views have feedback. market. our strategic collaboration resources a allocated XXXX. place share the plans, that through perspective, long-term as with liver end key And in to diagnostics commercial and market GE is We coordinate agreement

team commenced we commercial evaluation they facilities clinical is supporting also their six Our partners when have studies. Currently, on tasked our with worldwide.

adoption drive to partnership data, will will evidence sales, We generate submitted of clinical the technology. support with to independent our publication are seeking for the that commercial expectation additional be and

building believe indirect markets commercial in also We part a certain of our global vital strategy. is distribution channels

we As to substantial of premier these will the in more of have were to We discussed, medical to immediately Upon basis. the approvals, distribution signed which value forward market sales look opportunity. agreements distributor. added on a a receipt distributor we initiate able clearance we local a XXX(NYSE:K) be and Vietnam, this of present technology executing global

We continue fats. liver valuable TAEUS foundation a measure effective the as for lay cost to device to

awareness clinical with enhance to are relationships strategy. efforts growth elements Our advancing key valuable of our our along

pandemic more challenging, the confident. process has made Although we sales the remain

this on We day sales to book I will updating year. you first forward look of progress. our our

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

Irina Pestrikova

Renaud. you, Thank

follows. quarter second the of XXXX for results as are financial Our

quarter the and the same XX, from in increased commercialization of XXXX, primarily period increase ongoing product spending million increased for due $X.X TAEUS to operating was XXXX. June development. million They For in $X.X to expenses our ended

year-over-year approximately increased and spending increased to due Our expense product research by and activities ongoing for $XXX,XXX regulatory development development.

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

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

adequate current cash June we had XXXX, $XX half We hand of is believe million. to the of cash through in first of fund our and planned operations As cash equivalents XXXX. XX,

opportunistic in from facility. basis mentioned As we conference realize current expect quarter, the any have facility to did ATM utilize future. not and sales previous Last the on an this calls, in we a facility

to a maintain We initiatives. advance continue to we commercialization our our approach structure, cost as conservative

As solid balance a sheet. a have belief, we

our leverage will shareholder have to We strategic operation to evaluate that continue potential investments value. create and the

Now Francois. I'll turn the call back to

Francois Michelon

business like deeply ENDRA involved much, Renaud since accounting of appointed study facilitate Irina positioned partnerships commercialization efforts. both and and been XXXX we're has like U.S. first hit number enhance and our four, is clearance support for and In to pharmaceutical Thanks I'd continuing SEC and supported Number mention generate the opportunities. year. in we're conference and adoption evidence very analysis, two, accelerating securing bolster clinical through our want Irina. a commercial questions. has now closing, in the Number of protect strategically TAEUS ground XXXX; to functions. industry board. TAEUS that the highlights reopening beyond data and I in very set revenue to number for She call. financial seeking her was expanding our Irina's to have number plans our our one, that U.S.; five, Irina on Operator? the sites the With other the Senior three, global open five markets planning to Finance. this in clinical property our to with Director recently user this financial I'd to to objectives review portfolio review activities to global technology marketing reporting market; the key in intellectual fortunate accomplish to line running results, channel our and FDA Europe out-licensing and and end with expanding and call of

Operator

[Operator Please Markets] from first question state Capital Woo. Ed your Instructions] question. Our [Ascendiant comes

Ed Woo

luck. question they on started the My wish in Irina, you still process? up sites. yet? I the evaluation ones good Europe in is Have Are

Francois Michelon

Yes, for Ed. question. thanks Hi, the

COVID summer XX started early anticipate opening as a approximately yet fall, European definitely of reopening and the those this calls but sites I've So previous are in in have year, studies mentioned later each We those up this restrictions. not because protocol. patients

six times those months. not nine run normal so are And They'll long-term in studies. typically to

ourselves these three can interim of next value, teams. own getting its obviously base of results year. that commercial studies more than France, we local just U.S. sites in sites a we since So Switzerland, from also are clinical we think And do half, locally, in Germany, for these also but and first certainly and our the create anticipate the evidence positioned reference regional There partnered and in for the

each committed they with press, question. as answers roles But ready we're And much slowly in as And remain to contact play of way. very remain up. until I can sites. in us. the Europe we so both bounce they soon as to these your reopening read that that you They is open hope

Ed Woo

stand it did. the beyond the a Yes, you now? focus you Would on commercial, for just consider six

Francois Michelon

a No, that's great question.

can to typically have want with we sites who sites, areas technology. plus have So if mentioned you got think of geographic it, I sites. the in is terms find that pipeline partner. the commercially and one. and we we good there the early goal to adopters to been develop a one that of the we've benefits find Two, additional of to in representative And These are Hepion, number help right speak clinical cultivating work us the six of

that them. very think we effectively that could sign Ed a the we we were of we that's small sure we is beyond And plus of looking say that sites that another I'd I probably one you're the manner team six yet support just so up efficiency And and a in making other capital for. pipeline twice condition many proud we the can have. third were and phase Hepion or the quality Because

But people forward. into so that to And to we definitely already and pipeline therefore six. is on a we the focus, sure cadence building expand we make what again, this in going have Asia. want them, want Definitely beyond can pipeline about want going expand, and support that have train properly to to the good executing we’re

not managing will it’s be about it, that very six end the pipeline of but effective. So

Ed Woo

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

Francois Michelon

more Thank Yvonne, so we’re some see you some your you questions, while investor much, if to got coming questions perhaps Ed. waiting Actually to there you’ve are on end.

Yvonne Briggs

is that coming kept what receive did in going I commercialization And are asking from investors. color you’re Europe? one reception efforts getting? more of a question on kind for how up And Yes. few your emails

Francois Michelon

do exciting to sales I’m as a same now in-person evolution. in conducting the the demonstrating it’s months. being Renaud, being it’s to the I quite and been with the room and that a turn obviously calls and virtual I few Yes. we’ve mean, because But not thing it’s prospecting think over product going quite good there for same clinician.

Renaud’s that So leading charge love your that and been get your sales to team. I’d on from Renaud perspective

Renaud Maloberti

question. good a That’s Yes.

Europe. our effort to starting on traction get in actually We’re commercialization very good

Our approaching as team been COVID two in as allow. rules virtually customers in-person, has ways, in Europe as obviously, well

actually. they been seen people level very physician have Our have by encouraged interest the from of sales

you during weeks face period, slow at as example, to even had they the very multiple to demonstrations in If have vacation schedule we they in look France face and meetings summer ahead. all continue for know, the receptive

are So at of measuring care it’s when disease liver that’s reversible. easily in their very early as Clinician interest of confirming encouraging. liver fat a the still detecting mean point

talked So the interesting screening elsewhere. that opportunity surgery transplant and from UK that we about the we’ve came discussion note in physicians also with perspective various had earlier to it’s

So despite of challenges some per very are I’d that the expectation starting to having, say we’re doing and we we’re traction. good get pretty

Francois Michelon

high I if our year of announcing certainly. and we’re remains Yes, that know year revenue to any with confidence looking Renaud. we the forward it’s Operator, and see busy don’t this and generating a other earnings. calls, time Thanks, with goal of

wrap all evening. call get can investors we the their let to and think I the back

it as appreciate joined we well our tirelessly things to and this Greatly Thank months team like continue keep point the weeks as move of in investors as ahead. ENDRA the to you at forward. And informed all. happens everyone progress will working I’d thank to who’s efforts. So everyone’s are who

Operator

call. your conference today’s you concludes participation. We thank This you. for Thank

time lines day. great and a may at You this have disconnect your

ENDRA Life Sciences (NDRA) 13 Aug 212021 Q2 Earnings call transcript