NDRA - Earnings call transcript Q4 2021 | ENDRA Life Sciences Inc.

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Operator

Good day and welcome to the ENDRA Life Sciences' Fourth Quarter 2021 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Yvonne Briggs

operator. you, Thank Briggs Yvonne This with is LHA. and XXXX quarter afternoon ENDRA’s fourth update and to business financial Good welcome results call. conference available ENDRA today, topic, of issued press website. in is ENDRA's release section the Earlier Investor on a which this

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

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

Francois Michelon

The is FDA. Novo pathway, TAEUS the to De have with strategy noteworthy for U.S. quarter business. you, Good our that been several clarifying year thanks including fourth Thank and and regulatory discussion XXXX accomplishments, update afternoon for productive strategy supported and system on full joining everyone a months first, a financial Yvonne. few our ENDRA’s ENDRA the us today of for an last time a results by a for

our research partners commercialization U.K., China global of Second, efforts. supporting data which will securing the expand the sources new and clinical in

of the XXX(k) Novo new our submission, with in yield approved. Novo submitting require. generating the aligned an and same with our as additional Novo lifted be technology an enhance elements end data. strategy. to we extensive sixth, in test the efficient advantages De opportunity for our regulatory as entirely the our XXXX. request support Third, expand are second important and intend to to the adoption strengthens Last data opportunities. partnerships. Fifth, subset strengthening sustainable including our pandemic in months. product in from to data for And portion commercial a to committed on which leverage key for many now our of announced as with classification, able with De update we're needed safety business request, property The Novo platform, We include De substantial we efforts Europe I'll builds signing Fourth, the with is portfolio global in clinical and completed balance solid for of start and provides maintaining bar U.S. submission, that TAEUS possible and the partnership a XXX(k) this clinical and up on pharmaceutical believe FDA month, the on operating We'll commercial our market. dialogue of De protect scope the they a sheet restrictions our capital quickly set model pursuing productive to the FDA, our Andrew the TAEUS which can the user clinical intellectual our out-licensing the We're a a beyond to coming encompasses geographies. once liver system. order us efficacy a data ramping to of process after plan And

of with that will the efficient. optimistic De Novo familiar is our FDA the be XXX(k) process we're since key Finally, elements submission,

for precedent CE our current Mark earlier secured an is TAEUS focus. upon importantly, of important throughout Institution, the which regulatory quality I'm means our Europe, foundation additional that happy we commercial validates we a As the actively announce which XXXX and and previously in can which recertification received as market the approvals reminder, more which world approval, system from our today, to the we management Marking. we the sustainability XXXX obtained CE British Standards ISO serves

addition, the of harmonize to regulation the standards international FDA want I adoption system standard. In an ISO to proposed note with quality effort has that its these in

ahead So, game ENDRA is here. the of

positive COVID-XX globally the a a from In perspective. recovery is terms of mortality trend commercial activity, on

continues at However, to levels. impact individual countries the pandemic different

in system As such, allowed virtually ENDRA's in-person sales team as awareness for TAEUS geography. and our each is driving

still in a sales Germany, conferences go conducting in growing that calls. sales the a in-person technology to In U.K., of and in-person demonstrating and in moment. clinical France virtual sales increasingly, hospitals, we'll encouraged visits in-person we're commercial and now number into restricts which at activities know example, For our calls and we're endocrinology. our We conducting Hepatology I'm depth

We've to entry grown market approximate XXX that's this the strategically A++ how global research France, U.S. month, ranking key awarded data clinical by partnerships estimated our and only Each ENDRA Commission. This the for of Switzerland, scanned in China U.K., expect rating fat in good adoption a to China's from had year of data to and sites scan China's both commercial XXXX. a the the performs of in same local we to with to China these collection the activity. with the This address sites help new with eight in four MRI, participants two facilities. providing in point Europe, initiate research three possible classification few with the one healthcare is clinical is Chinese highest our data a TAEUS to provide patients, clinical world with Germany, affected assessments China's research local compared an study liver expanded TAEUS performed evidence to of by of its is XX patients comparing in globally, underway of We've of We another clinical has In research National XX,XXX of third standard in will comparability ensure independent NASH. focus the into eight and site with a partner NAFLD gold one we people to primary tails from in system in be pioneering which in the Health with renowned of scans in believe results. one Asia. system the US, an start liver General in our in the into TAEUS partners teaching healthcare million a strongest at partners hospital for of to Hospital King's prestigious our the Collecting Shanghai clinical sites weeks. be College London, Hospital, turn December, Let's will market, MRI. couple added next weeks driving recruitment each of disease. Last

clinical previous of the world's for activities year calls, on due noted paused we many last As two research or COVID. were to

our bit. a progress So slowed been has

and systems sites While is need with Internationally, I'll to and all support healthcare see MRI. hospitals running patients to high up backlog speak potential clinical returned end procedures team of which coming getting research connect have of elective looking published resource and development. remain postponed and to relative operations in be don't encouraging point to MRI be buyers we to were committed active, XXXX, European Germany, out scanning of continue Switzerland XXX by anticipate our we stronger are in an need sales team. performing overall access recent a so sites the U.K., that TAEUS some can in discuss France, studies globally how XXXX. we The completed the just our investigators the and to months. and XXX our told, to volume. TAEUS sales study And to

BGI industry the into upfront incorporate beyond starting and collaborative as companies are now average in drive in trial endocrinology. opportunities to radiology, efficient We happy We holds their clinical to face believe for pharmaceuticals of on research with XX% cost studies potential has which contract agreement studied a company to their XX rejects By can developing need currently technology enrollment disease are research several measurement well liver pharmaceutical clinical working biomarker an help be pharmaceutical that underway. national patient to conducting and phase high the process, determine during cost hepatology, NASH. incurring pay and over companies their savings for to associated metabolic upcoming tests time or there first us their potential signed partnerships they're taste to believe frontline the metabolic of our in screening technology and treatment technology In fat biomarker. liver our with pharma up have two drugs, MRI other Turning technology our TAEUS a as with to discussions on biopsy. secure important with the MRI organizations hundred trial. of after ENDRA's support recruits, is add Technologies pilot role November, two meet and ENDRA's existing and area, as or an patients may sent if biopsy. in and before companies they study's agreement criteria and the belief sites This follows to practical substantiated screening Health an over this to count, by we commercial inconvenience and a an on active with as collaboration NASH an each considerable value This drug way to measure our clinicians study.

fourth globally as patents Turning In of domestic indications, China. were To-date for the now as and protect intellectual grow patents the technology been U.S., of patents out-licensing patent multiple were have in our issued XX to to issued portfolio two our total XXXX, positioning issued ENDRA to in our for U.S. Europe, has in XXXX, been property, continue opportunities. for four issued one a well in two the in quarter

Maloberti define Renaud? Our turn XX With update, preparation activities. or call over Renaud on IP in current I'd detail to more as like issued. at stands that our which patents we to global the provide commercial to assets, filed portfolio

Renaud Maloberti

good afternoon Thank everyone. you Francois and

in awareness system restrictions four team Currently, and we commercial are European the Germany. for have to to easing. continues where their TAEUS U.K., representative COVID Our France, and our in commercial enhance sales drive the efforts region

while Norway, and marketing structure. In visits diligently meetings, COVID sales certain cost conference to currently like and other a including As Austria, higher and efforts video U.K., while managing levels degree of the in group able Netherlands, are to still are value to in intend we activities add execute our with and case we markets, France limited high personnel demonstrations. Germany, outreach countries, lower in-person pickup,

of are proposition will be expect the we first average, liver more the to expand time we in begin its as fat to and novel to TAEUS efforts a as interaction confident demonstrations. cycle equipment commercial that customer sale capital our assess gain On months technology marketplace in-person given TAEUS with traction We the product the value from more several the for purchase.

we that by will institutions. widely and this vary customer Although expect by

TAEUS We our market also to to target clinical partners understand sales. research from each data clinical in generating converting and that demonstrations is MRI essential

GE a significant Our sales partner to long supplement our installed Healthcare clients. base providing efforts has standing valuable direct GE ultrasound is as assistance of

coordinate diagnostics. to We GE's on sales in continue given leverage activities presence dominant resources global marketplace collaborate and imaging to the market to positioning in

this X plan seven on penetrate on of week, ENDRA to we outreach last TAEUS booth our hepatology. the at various diabetes the white leveraging media. market, TAEUS. metabolic our a year. who occurs and data salespeople These benefit to which This strategy video website NAFLD team it -- technologies a assess e-marketing obese Society TAEUS Conference, booth outside Attending has for XX% Through clinician to by year, field build is radiology focused Diabetology diabetes. media, the of of last focused booth social patients campaigns, that of our include well-attended social interest we on identify tools on awareness are to We the as show advanced conferences over seeking which and clinical and Type another diabetes to XX of become to treatment Last was adults range our addition increase over endocrinologist In patient clear the individual create practical a our fat XX% conferences and clinical commercial dual diagnostic attracts and part sales information XX% We clinicians clinical for X,XXX health. use and to French pursuing had educational exists, XX% is which in and on at images grow resource liver targeting well-attended and of technology global demonstrating marketing to in of each our in of posted the meeting in of and work activities, sales initiative papers, are with markets our further XX% and system. conference year, France like attended with opportunity diabetes.

go many see, for NAFLD with deteriorates. undiagnosed as You health asymptomatic and years patients are their liver

In scarring fact, an fibrosis, develop and which can failure. of result liver XX% in patients estimated NASH permanent

such, for endocrinologist on one-time continue with access. well-trained and point-of-care system on assessing of the in diagnosis. capital standalone As By despite In TAEUS for additional in call a expands monitoring a active non-invasive identifying to assist to a during is market are them the the and for limited to to system the addressable NAFLD sales their early ENDRA, we budgets some and to rental on we stratifying generate launch radiology like potential have TAEUS. to beyond the a after revenue summary, benefit and team learning initial dynamics. to of headwinds, unit. what approach versus health of point, it customers' In as adding recurring and stages liver if agreements TAEUS service addition have it hepatology builds response remaining patients data endocrinology is a ground. tool sales to the the at sale are COVID developing our TAEUS is imperative risk diagnostic and also time-consuming adoption options in the The and/or this sales facilitate market phase ENDRA

are this new our customer will including our we yield We and clinical we new options, are high XX% confident outreach by value we at segment, expanding are which revenue all developing year; purchase of increasing clinical conferences endocrinology; ENDRA. for are presence to

turn Now, the to to like to financial our I'd call Irina recent over results. review Irina?

Irina Pestrikova

Thank you, Renaud.

the and follows. for XXXX fourth are results year as quarter financial full Our

higher For in from XXXX, period to million $X.X increased and same the quarter million was ended increase December to regulatory our The primarily for XX, expenses. headcount the $X.X operating XXXX. expenses due

share net a and the $XX.X marketing and sales Our million Overall, XX, $X.X or Increases fourth in the year unchanged ago. with per year decreases expenses loss XXXX million was XXXX, ended $X.X research were share offset per of development $X.XX loss $X.XX for general net quarter for December December in or operating ended were XX, compared as and from administrative by expenses XXXX. million, our expenses. a

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

extend year Our $XXX,XXX to headcount. by decreased expense our increased we administrative including our adding sales due as for efforts, and sales Relations approximately expenses General legal to marketing by the for $XX,XXX, fees. Investor began to approximately reduced spending and

was as XXXX for million in or share loss of per a net $X.XX $XX.X million per or $X.XX Our with $XX.X compared share loss XXXX. net

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

to an offering $X.X our for through December support XXXX Novo have Europe our on opportunistic our basis. of million XX, FDA. in sheet well-capitalized to had with utilize As believe the prepare we equivalents activities balance a the and De continue we of and cash We availability XXXX, request cash from solid as market which at we're will program, commercial

turn the call I'll Francois. Now, to back

Francois Michelon

much very and Thanks Renaud Irina.

milestones, to several on look regulatory we include; focused and the request. advancing XXXX, process these balance As achieving and the submitting TAEUS of a we're through Novo De first U.S. significant

Second, submission to strategically clinical generating sites regulatory additional commercialization. and data our positioned value research by support demonstrating our with TAEUS'

in for global outside reopening user activities and marketing securing TAEUS to our opportunity commercial clinical market. of and line partnerships pharmaceutical TAEUS to business increase and the With Third, And highlights Fourth, of property to that other the markets additional potential and for the generate end channel expand industry I'd orders use accelerating our call results, to our now with Europe. the strengthen open out-license Operator? its technology, to like our intellectual our protect in questions. to proprietary review financial continuing area opportunities. fifth, portfolio expand

Operator

Thank you.

will session. question-and-answer First Ed now the Woo Ascendiant go [Operator comes with Please We ahead. from Capital. begin question Instructions]

Ed Woo

established operations you're progress Or are -- country on congratulations has equal feel question do that thanks each Do taking all my territories? Europe. -- your in in guys Yes, that and better feel particularly commercial you for more the certain you you opportunities? doing,

Francois Michelon

for thanks and the for the joining Yes, call. question

deployment I listed, we the we lie. the salespeople Germany, really think across represent biggest and U.K. market in what very key are and opportunities think of four close France the our largest Europe, healthcare the the historically but certainly France, markets the Germany, U.K. behind.

resources research with good So, Renaud we'll markets, like your headcount of think in other answer for that's got commercial focus markets premium touched prices, as that's the through to to potentially focusing. present the Europe think Thanks or question go base themselves, distribution market first. But today, we're top clinical we've really markets on partners plan opportunities Scandinavia. well can your I really a that at into where our in -- as ENDRA either in both question. as and partners I where bear

Ed Woo

it for is approval or your TAEUS, it Does is EU-wide country-by-country?

Francois Michelon

Mark CE product at countries the XX us the does we product each market CE the to locally plus the yes, then market. the level, So, in and Mark each ability give with register

So, is that's the members other so I've process those really, the certainly include the yes, the countries EU. mentioned a that But plus of all follow-on. and markets

Ed Woo

have guys impact last are, U.S. does my Novo as And FDA, the the prepare distribution filing Great. at I that for in the for all De Vietnam? guess, do is you question you

Francois Michelon

FDA culmination receive awaiting productive. a remind FDA, been discussion So, good It we memory. is first that and, and at it mentioned, I that currently Novo not XXX(k) Vietnamese ENDRA that our just good systems is a under of with approval. of least Novo the this do submission commitment approval Vietnam once to to differentiation with approval, the XXX(k). have reflect builds De it's distributorship lot it's the exclusive FDA the a our will we approval something go live have distribution afford in would likely way And to once I so very agreement receive under some pathway FDA on but we of the we Yes, have received commercial listeners we signed on the is very that's want De as otherwise the XX

and FDA excited the your will system. that approval very for we much So, questions. for very Thanks receive about we're that TAEUS confident

Ed Woo

Thank you. Great.

Francois Michelon

seeing not on questions Investor we're our is Yvonne Briggs other if questions, Operator, some perhaps Partner Relations getting any online.

Yvonne Briggs

efforts color market? commercial the of additional Could you are from received specifically how your endocrinology Yes, in but some segment the provide Francois. on Europe, being

Francois Michelon

I'll speak he's ground. Renaud? team that I his Renaud it let since think to on to the closest with

Renaud Maloberti

depending not may be the needs markets segment big radiology bit Yes, Francois, made exciting is specialty tell need it's training we metabolic new to that experience What deal. countries, than that learn this system French-speaking pursued which France, be, a lot we TAEUS we that of recent Belgium, for segment at a to is as good to had more a for demonstrated on a also interest Congress question. certainly our on good historically the radiology the booth. more of the from you can other lot Actually, Switzerland, clinician coming to the I Clearly, is the mean Diabetology, endocrinologist. mean, I I that here contacts focused the and our about countries, we've pathology. is XX and course, think [indiscernible] a very little and like other ultrasound I French about is need health, they is on but

the to that opportunity we we are pie the increase are have basically looking we at. So,

Francois Michelon

operator, your or received. you please? And Renaud. questions other question any hopefully Thanks online that Are that the see, Yvonne? Yvonne there answers

Yvonne Briggs

any impact future? supply over question. last issues, been you the the concerns regarding Obviously, the all? at has impacted the a do Or in in concern marketplace ENDRA Yes, have there's global chain

Francois Michelon

thankfully, a don't supply companies but issues see in constraints lot made we bulk indeed, buys facing In components. Yes, or are in supply XXXX, chain near-term. we critical affecting of ENDRA of distribution, the

continue needs avoid suppliers and our We to actively issues. to assess

we think shape but the within the Yvonne that operator, there if and we'll continue can situation I Thank I we're you predict more questions, today, in think good can't and I proceed no are to for actively close call. coming to So, completely very future, the months. manage that.

Operator

Thank you. back to our Yes, would closing the over session. I this for conference any remarks. question-and-answer like to concludes turn Francois

Francois Michelon

you just a call our in wish our to And well to and progress thank Thank ENDRA you investors, good you the next you, listeners, keeping We conference as again I our operator. quarterly forward on you speaking team. our all evening. closing and look updated as with

Operator

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

You may now disconnect.

ENDRA Life Sciences (NDRA) 30 Mar 222021 Q4 Earnings call transcript