NDRA - Earnings call transcript Q1 2020 | ENDRA Life Sciences Inc.

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Operator

Hello everyone and welcome to this ENDRA Life Sciences First Quarter 2020 Earnings Conference Call.

During today's prepared remarks all phone participants will remain in a listen-only mode but later you will have the opportunity to ask questions.

As a reminder today's conference is being recorded. And to get us started with opening remarks and introductions, I am pleased to turn the floor to CFO, Mr. David Wells. Mr. afternoon Good Wells.

David Wells

afternoon business Good a to first ENDRA's release Thank, and and financial XXXX update afternoon. issued conference quarter this Jim. welcome call. press We

the don't For you of our in have release, www.endrainc.com. section you at a the those Investors can who copy of website it access of

commercialization regulatory company efforts required are Except of or as any and financial the today's the timing objectives, begin, of statements. update otherwise statements any disclaims for including historical forward-looking that approvals forward-looking receipt results required condition, costs, All and to by presentation as laws, anticipated strategies, plans revise undertaking operations, we well launches development Before and securities note statements our obligations statements. federal product as facts, regarding or statements. includes please forward-looking and other statements of our than

for Please of better XXXX the fiscal refer year risks a forward-looking the Form and to our with get understanding SEC related statements. to to XX-K the filed uncertainties

over will Officer, turn I now to the Michelon. our Francois? Francois Chief Executive and Chairman call

Francois Michelon

you, on Maloberti, and And Thornton, Along for David to ENDRA's me Technology us today business are call quarter thank ENDRA’s Officer; and with everyone. David. first Good joining review update. XXXX Officer. and you Chief performance Thank Commercial Renaud today's afternoon, XXXX Chief Michael

Let agenda. through today's me go quickly

will open by who update And finally provide I'll Europe. key First, Renaud for review with the will additional milestones XXXX, highlight a call Q&A. our commercial recent on activities our an followed on expectations David Then I’ll commentary achievements we'll financials. focus and and on for provide

a member and as who the frontline want the or a friend, I to help those are all out providing particular patient, all well goes begin, you with wishes people to I thoughts of are and appreciation dealing Before caregivers acknowledge need. our with in COVID-XX family our parent, to

ability to will in the this to system while bring align our market level, company's detail we've the actions XXXX. corporate environment a also structure with David TAEUS ensuring On proactive taken to

quarter on milestones. Right discuss now I'd XXXX commercial to like stated our progress during objectives the and the company's

initial For Acoustic tissue ENDRA's times and Disease the as where an before Enhanced clinical of of the to high aware point affected ways those billion allow visualize possibly people at MRI of assess liver a Non-Alcoholic unmet tool NAFLD; fibrosis, Fatty goal to to acute and conditions similar the than Non-Alcoholic we bedside. helping need the and ENDRA's known monitor of known more known Thermo pioneer but our as develop TAEUS. to lower as cost cancer. Steatohepatitis, Liver for practical cirrhosis who may and fat for focus clinical are TAEUS clinicians not in the X technology TAEUS is to will on need be UltraSound applications in an story NASH, globally at patient areas is XX progress by there's

states. received this During Fatty the for first when as Probe, FLIP. a Liver achieved TAEUS milestone of approval way Imaging also commercialization We for major Mark CE paving we received our the quarter, we known FLIP TAEUS a Mark CE with in Mark geographies CE complies European Union of TAEUS the EU all schedule member ahead that and which March. regulations the and XX The include indicates other directors applicable European in system

term our specifically, return evaluation potential to in More opportunity achieve patients, first a on and partners’ by we've approval brought Europe TAEUS to and using as followed by continued first to recruiting be enthusiasm evaluation In operations TAEUS we pandemic, training to partners, advantage. to encouraged mover normal. we've target our spite this success. launched clinical summer. And new We scanning this the summer of at our tools commercial the hospital and cycle our by on COVID-XX Mark slowdowns aggressively over start gaining where momentum will install network our TAEUS of This we see sites are the Europe CE global the are the and in sites greatest near soon capitalize move education see as on remain advancing system. to

Renaud the will provide ramp more underway a minutes Europe. in details regarding the activities important in to few support commercial

position SEC remain current during Turning with completing the the we of receive to the position the the hand, activities U.S. resources to significance upcoming the FDA an this FLIP track and in begin TAEUS our acute to approval our our year. the in the and now this cannot XXXX, liver and market will overstate simultaneously verification ramp to regulatory make major which each labeling assuring the XXX(k) Europe, the quarter, effective quarter. with to Mark ENDRA requirements, With we cost progress I'm milestone in approval application happy and key half during a we're will on on the for diagnostic the commercial need second I two testing, our FDA practical in initial to the U.S. second final as making markets focused U.S. to of CE commercially current regulation solution. in of report in compliance submission finalizing FDA system ENDRA

in quarter, we the January includes of to the milestone GE with first advance In This our to extending continue of agreement U.S. term agreement’s our renewing activities anticipation the the collaboration XXXX. during Healthcare FDA pre-commercial

GE a for respect liver the will manufacturing the use activities support under and application. liver TAEUS of to commercialization GE offer for return, GE its will As certain Healthcare technology to by ENDRA’s TAEUS with facilitating fatty customers. reminder, rights licensing to agreement, the for of introductions the ultrasound in application ENDRA first terms continue afford Healthcare In

companies. existing impacted new clinical trials has countless COVID-XX for reported, and widely As

gradually for the Medicare from more? the encouraged partners. getting by aligns healthcare facilities we're electric However, procedures Centers What's normal. facilities with fact feedback about appear we clinical to be that The guidance recent healthcare returning restarting our are to

our Center, experimental Pittsburgh and design clinical with our even to recruitment has operations. On patient partners, hospital affected relationship Rocky as the of and strengthen University U.S. that finalizing front Medical COVID-XX Vista we University continue

And soon as normal June As see sites be happening to will we ready. that ENDRA ready July. in these are resume and operations

an using ahead data clinical with U.S. Review regulatory required want submission not Board which the low Rocky to from IRB, were our Vista I make are sites, very use University clear. U.S. clearance. and this institutions As for deemed Pittsburgh, quarter. to that technology that's and UPMC the of two process, agreements the to signed known a FDA XXX(k) Institutional the risk VISTA reminder, of planned evaluation be as allows Rocky also research The important

our data we anticipate before year. ahead the launch, support that we'll even of XXX(k) So U.S. be commercial collecting the game, later receiving this approval clinical can

Following teams. as XXX(k) leveraging highlight Rocky approval, I’d for Vista sites U.S. additions we commercial and can recent the UPMC to reference to ENDRA like our Organizationally the team. look forward to great

Malik, Associate addition Disruptive During with Dr. Board Hepatology QX, Basenese, Gastroenterology we added Founder we Research ENDRA's Raza to Division Advisory Director expanded recently, of Center and the of Tech at More of Louis Board of Tufts Medical Chief, our of Scientific in Boston. Directors.

clinical as and our commercialization expertise us worldwide to help While to bolsters the Dr. ENDRA in investors phase. forward community, institutional of well leveraging Malik look awareness health broaden strong begin patent-protective identifying of Louis’ our advocating on behalf technologies, liver disruptive with professionals corporate retail to we as as already communications team we

made track to the with could pleased be advanced Europe the during on we've and company not and approvals critical on receive these challenging times keep commercialization schedule progress Bottom-line, the United to activities States. in more regulatory

quarter review first financial ending March I'd turn David? Wells results for XXXX. like David the to to to the the call over XX,

David Wells

XXXX quarter Thank provide reported you, results. a Francois. will I of first financial now our summary

Our operating to $X.X million same expenses the XXXX, March for $X.X for the XX, from quarter million XXXX. up in period increased ended

sales marketing quarter. decreased costs increased and while $XXX,XXX, our research Our $XXX,XXX the and by spending development year-over-year for

spending and costs were on general for costs, publicly Our with stock non-cash $XXX,XXX, increased Relations, a for employment being compensation, up traded by and costs company, due Investor associated including expenses insurance. administrative including to cost related additional

XXXX loss million of a net ended to the net compared quarter March the quarter XX, March as $X.X Our million XX, was XXXX. loss for $X.X for ended

comprising for totaled non-cash which debt equity-based included and charges, compensation, Our net of amortization $XXX,XXX, loss discount. expenses

XXXX per Our and share. net ended was quarter per loss for March XX, $X.XX diluted share basic the

spend associated costs for well XXXX, preparation for key compared approximately regulatory The for XX, million as of approximately the to filings, to normal in sale $X.X the as We of December as operations, do as of with balance XX, systems. inventory the of this XXXX. submission for first as our remainder the year. persist totaled cash spending level is result quarter the cash Our $X.X decrease elevated in TAEUS million, not expect of of of of March the purchase

now advantageous environment of find In relevant model. in our fact, challenging shareholders reminded and This is uncertain our of during advantages that the operating especially and call, last the the we ourselves. asset-light economic I

These of directors for a retainers earlier, cost structure XX% mentioned cash. the pandemic paying company's COVID-XX the of salary and of actions company's remainder as annual has management include instead form taken for with units while our market environment, has ENDRA XXXX, reduction also ensuring the in to of the TAEUS the this preemptive cash implementing XXXX. non-employee As bring ability to to system unfolded, team, restricted in align Francois stock actions

received April this the Paycheck application me, the submitted the year And XXnd on Administration's approximately in was an The under the or application approved. also proceeds of Program this excuse of this year, loan PPP. amount XXnd of Business $XXX,XXX. We on of we Small Protection May PPP --

sheet actively research We partnerships, various ahead. opportunities, academic exciting as strengthen market-based commercial company opportunities for that outstanding the and non-dilutive growth balance pursue of and warrants, to opportunities exercise evaluate our lie the our as This well includes continue to position brands. funding strategic

turn now Renaud. over will the I Renaud? to call

Renaud Maloberti

sales target progress technology mind XXXX, well strategy approval. into I'd sites faster way ENDRA on these springboards. we key establish Since securing investors fastest is progress. upon France, commercialization hands is a market usage, ENDRA's With go-to-market and that of early our the for Immediately European we believe and ramp. serve you, to today, establish including as adopters reference made TAEUS like purpose evaluation the awareness ahead sites to European as Thank to secure great in to in and in accelerated achieve this sales our clinical The building Germany, approval, markets, strategy clinical UK. efforts clinical will Mark sales Switzerland, of We of update who technology David. TAEUS joining have as the seeding each initial key the CE May commercial of get in the reference regulatory

our selected U.S. the important we in On Europe track beginning call, two sites We anticipate evaluation XXXX. the summer. this last starting TAEUS the Mark purposes on EU with efforts. to and very our first to in remain of and plan indicated support These serve site systems this goal sites to commercialization half evaluation evaluation will the CE second liver we that deploy our

First, TAEUS help these clinical sites our our will liver device. build with human data evidence,

As a have on we've data of mentioned to base clinical value to a proposition. before, compelling technologies old medical which strong build need

Second, serve these new and teams, potential customers anchor also with allowing evaluation use. the them as regional to concrete bring clinical to in in see sites commercial reference product will sites

reinforces engage awareness relationship to and grow We is ENDRA’s maintain and This digital market new earlier liver pipeline also into approach to that to adapted languages of due expansion. April and on industry commitment site to educate better, our in commercial reformatting degree venues focused XXth COVID-XX. our to to a launched our online being audiences clinical a the multiple NAFLD/NASH. format support market enabling with high that translated despite we of key discussed To clinical conferences the website target detection end our of

partners Healthcare. interested available educational marketing is X,XXX Liver over key in participation a also conferences We entitled These shared TAEUS have Device, on clinicians with to GE global clinician contributions developed new from and through the relationships clinical which Use our How been website. outreach, video like

to with our we regarding continue content add this to months and all as week new our communications as website and check relationship we commercialization. regularly and part to important and database marketing commercialization partners potential begins. updated system information increase people each plan pipeline market encourage for opportunities. our as of an view We investors begin We as TAEUS is This

to plan will specialists job with TAEUS our learn credibility clinical of making to local sites development who This focus commercial key TAEUS are team We excellent of partner on-site training development in leaders, the small continue making to June. in final team market start building our GE work Europe also progress fostering in recruitment Healthcare support strategy our relationship specialists execute at in ENDRA and a to and market with We plans provide technology local clinical launch direct awareness markets. on and will reference and for offers small clinical target candidates and the level. build a commercial

to initial and updating are we coming So our to initiate on very sales look our Europe activities you quarters. into forward in excited I commercial progress and

turn make will to some Francois remarks. who I final call Now the will

Francois Michelon

Thanks wrap points key very call before up much, XXXX: forward looking the Renaud into Q&A David. the I'll following and with

finalizing we progress in U.S. First, up on the to laser-focused ramping we the to the in updates weeks and key in with submission forward as Europe; fronts. our on two investors both FDA providing specific make remain We and commercialization milestones; activities look XXX(k) months coming

companies for the several with one the drive in development the are Second, equipment but overstate facing sense of or liver A is monitor our for ENDRA and companies same and I would these mentioned an pharmaceutical I as nicely ENDRA’s a who in of I in MRI as screen their partnership approaching sectors partnership GE of contract we've therapies want partnership trials organization seen these NASH. strategic last and side. the complement believe efficiencies fit don't Q&A these call, for patients during to progress natural and research with clinicians perfect definitely makes NAFLD uptick biopsy and ultrasound of studies. seeking from the the technology ENDRA while to the our in to impracticalities clinical quarterly the involved with partners discussions,

call With for Operator? like that, to I'd open the questions.

Operator

Capital. O'Neil first here We'll with Street Instructions]. the of Lake line Brooks [Operator from

Brooks O'Neil

forward guess two I balance to how your the burn think rest trying commercialization, speed ultimately that year understand rate do factors and how obviously of and against in these the key of to how in available the you think to I'm U.S.? cash Just always, your kind of through and cash? you Europe up? assess trying the as about And So, both balance

Francois Michelon

the model, think the what clearly finalized as commercial earlier and building the terms is product ramping ramping on mentioned engineering operating I we're of up our down So David in asset-light historical spending. spending carefully

a service and per we're in David commercial having Europe. engineering. the Renaud to build as That's not out with of see partnered underfoot. se of commercialization a benefits providers you're net mentioned, timing, have very going being our and the team of So doubling And spend of careful one about with small also

have starting clear, out ultrasound to. very But something of in complemented control. candidates. So at I the has with us idly we've a But our in helpful right sake. believe We're that right GE couple want engaged small partner cost generous in answering company to customer sharing also information, their And opportunities now, any June, investors to that'll help us continue in GE. people payroll the got introduce that final on that sites, evaluation is be with locally people abdomen to allows great And five by carefully with be carefully in And evaluation want Europe. your customers focused question. as Europe. destiny liver. sitting Healthcare, we partnership commercial to pipeline to And building and and our commercially mentioned, hope as it'll we GE it will we having we're us managing our reasons. mentioned. very we've time, on in Europe manage some structure sites we that's historically don't our a going And to team for there small start in of the pursuing the I talking been to team. anticipate and One, we're the to four is a for that, I control that be

Brooks O'Neil

indeed. helpful Very

move how regulatory you on you just curious less all? down U.S. you or approval? towards you I'm approval that slowing impact you and head question. the do pathway COVID-XX view as to do second schedule more can things think see So at Or forward on U.S. continue

Francois Michelon

returning quarter David operations, are of the all for procedures. joints, other no or submission and impact positive. general bread is us are procedures. has Brooks as submission I and many I our discussed, Yes, in terms orthopedic elective surgery and control you many, FDA, cosmetic we've as can getting Medicare, elective the speak what we're They're signals this in procedures butter but hand COVID. from certainly we procedures the issue can't tell mentioned, for the not those referenced to and there's

that imply, will, ENDRA. you not So, I evaluation that the otherwise seeing changing since not game impacted U.S. seen certainly from is the am opening in same technology getting or FDA that I regard have up. like have and We're be to our focused, also European feedback if from remaining being efficient And sites. and I

So that the June in we timelines, hope the will, year that I file end the November. that's in of the to XXX(k) us position helpful. get U.S. historical will by and to remain approval I confident in according

Brooks O'Neil

Yes, how it's we I the place. current see agreement? very envision of helpful. of extending GE value partnership, you begin might organization on speculate in had And you Can a to huge deadline question the then relationship the brand have the the the they last is, beyond obviously,

Francois Michelon

Yes, initially working local be to of fair with building already markets to what I terms target to out carefully both with a GE what of we the we think is in them us, teams. have on in focus need hand

generous, they've also in and company regular other we that very invest with so and don't capital systems GE that. demo in with to introductions. small helpful have We global process contact support said, very us of are as efficient ultrasound further Healthcare in our terms are provided the a to They've teams. that I been capital But

prove with of we're as And enlargement half very parties So this is may a with this to or best and all help. is I second will to indeed as I be the executing the on Brooks, that and attractive question and plan in successful we relationship dodging the sidelines partners that that contract commercialization believe. think a other without path others sitting GE success proving GE's who product the think

So in I helpful hope the that's answering as question. well

Operator

[Joe Next, Michael] we'll the [Catalytic]. ahead. of at line G. from Please go hear

open. is line Your

Unidentified Analyst

really. Just question one

XXX(k) you look think what a I should centers. early the assumption understand the influences approval your these in through I here in in -- that this So, to process of focused well, year, the going me with centers make Europe around Can of adopters U.S. reference and like? commercialization leap you you’re I'm where sense commercialization strategy the have the walk

Francois Michelon

similar Europe. it's question. in Yes. putting to what Great very Frankly, we're place in

With we we'll exception started, To we've and the -- people approach as U.S. the I through say already would with we evaluation so commercial working data that five evaluation clinical specifically, commercial the build a your answer XXX(k), started have throughout the probably team regionally Rocky number UPMC locally the similar with and will in question U.S. sites. of small out Vista. a here or

have cultivate the I that are confidence the in round around two the commercially announcing have those evaluation will We we'll that Others next coming we And And the months. those of be sites. we mentioned. pipeline. adopters over

your enhance Vista and in in that Rocky of customer we're the taking reference question? from liver a European our the repeat sites, going in model small data having reaching a clinical that now the U.S. GE Joe, to utility ultrasounds of and be those shared the out hand use today. efficient That's ultrasound way device leveraging Europe. to to answer leveraging really data to database So Does that a -- and offering UPMC, you imagine and team, commercial can sites, it's TAEUS

Operator

with Wainwright. of Vernon. will H.C. the come ahead, Our next go line question Please Vernon Bernardino from

Vernon Bernardino

question I'm in on for good hard taking especially like approval. Definitely seems a environment. Mark there. was earlier get surprises and CE expected of sure Hi, that than work to this and guys. congrats Thanks my lot the

a So I about ask to just few the wanted questions digital format.

could the for you provide ready kind a if assume wondering of I detail, already you already have that little Just presentation. perhaps videos

Francois Michelon

company. it's them Leveraging to in clinical videos explain our And in proactively plans engaging new easily X,XXX also and with can articulate directly website is the how publicly interviews which and very emphasize, the own to engaging number is start CRM Vernon, show format content. be But simply the progress our clinicians that a also their this on build-out. real in -- for the video practices. clinicians by available And we new that this at first the voice, of integrated but begin, think endrainc.com. in time our you'll through main And own the way, repository, there, you’ll I seeing seamlessly just yes, of our see a animations mine we're the now and product current a to as

Vernon Bernardino

be example, live centers, you these possible, protected is especially And Okay. other companies cases. I mean especially is hospitals. in you I and that in wouldn't where that everybody a and sure -- plan? data that Where will cover small -- something, can't have there that got I'm not in often the the -- for situation procedures, be in

Francois Michelon

the market Yes, of in it We to soon demonstrations for easy. we're fully it. to and our us in intend which as then the reference very and key as as are it's way, possible which mentioned Europe, the absolutely we as this of each call is approved, I think our in on so paperwork, into sell is to get testimonials several we video product product, And is by with case we product that and sites of market -- in those, the demonstrate. non-invasive, have to finalizing we have Europe, the soon CE agreements verbal approved -- and have approvals

prevent an a surgery. be like would don't the have that that. limitations or sharing from outside You COVID There's in of nothing really MRI us to special room

see can use, in and product to And that and the both we so, in Europe. in content U.S. intend more out clinicians so our investors certainly build

Vernon Bernardino

see these with are pace to U.S. that clinical in at continue slower a their that I they're small clinical able trials centers. And the companies especially these I some as non-hospital concerned as from Okay. although in work trials, of far follow

in the see where you U.S. is Europe? that's initial these to going commercialization also target in the as for that and TAEUS procedures Now you're see with indication do FLIP,

Francois Michelon

Yes.

presentation investor our our So Vernon. in clinical targets terms shares of segments,

foremost, the XX abdominal for that currently upwards and of ultrasound they do, sort fat that First but for reasons, way liver XX do reasons. other scans of the perform and other can't we million measure they radiologists million to

in there's hospital clinic So typically And small clinical are or established setting. a an practice. those radiologists

later hepatologists. segment tools, ultrasound the are and in the new clinical gastro And them U.S. Those so. others the come But especially to expressed the Europe, specialists. are online few enormous Second they've be starting liver have with frankly, to approved Zydus a already, to in use appetite of less quite therapies are that are with them would assess on the those this tool year, screening have Those messaging of that that private And clinic in new and for hepatologists clearly we then therapy outreach a awareness allow and are. clinicians where hospital drugs. to and of both those and practice patients also and progression gastro settings. monitor

to that and getting I from in our and and small both will some hepatologists question, return elective radiologists your are part are to starting network say procedures. of in the we to answer signals consider, facilities, large other cases,

and so, and I to the comprehensive. helpful that's but we we first institution from systems start summer. July, very clinicians be hope It good through at that confidence our and we'll those And June is to. going have talking placing in evaluation the dependent, we're continue have feedback sites

Vernon Bernardino

other? missed And question. one think Germany, so was you one mentioned I I Switzerland, that UK, Renaud, more it, there and if

Renaud Maloberti

France. And

Vernon Bernardino

sense. makes That okay. France,

Operator

and hear Mr. from of Ed line Capital Ascendiant Woo. Next the we'll

Ed Woo

do the these U.S. do geography centers? reference you pretty centers, is will and targeting on certain more target you When will get approval you or question the My it depending be be broad-based on

Francois Michelon

Yes.

One, excellence the influencers that those So our selecting to can clear regard. are us center help that facilities several, have a and they're of liver have be for criteria sites in evaluation in in they clear. but

any ultrasound. not as Pittsburgh of It's in in facility. transplant leading we're picking example to University my have and Pittsburgh. happens just world Medical So community is liver that health liver Mid Center, hospital class of Atlantic, hometown a the a an

that'll a anchor there. so account great be And

excellence the adopters your in focused our the centers same leading vein is place clinicians. in on and to in Europe is goal early but of Our U.S., -- systems regional question with

could to likely often ENDRA's regionalized And the And look around centered U.S. the I five around forward naturally that and next adopter liver to. sell most to clinical a But a in geographically early of excellence, proposition centers diversification, see model urban you'll other of influencer buy. large have regional centers announcements payroll. mentioned, and help us can support that so with in we value who that importantly, the commercial develop to that think clinicians you U.S. very can influence out customers on that population adjacent having round spread and the will clinicians people be us help I

Ed Woo

And have evaluation long set for you Great. these a how last? timeframe then periods will

Francois Michelon

question. great Yes,

in ultrasound study put already. the many evaluation depends last these of they years. in we that necessarily typically. we're sites, to XX several that it doing. And patients So target when says of nine type is targeting as on the radiology base have XXX have it six are in the perspective, with about a can Typically, just But of scan department. accelerate case months to patients everything how it could something we not achieved talking a by don't [loaner] could that evaluations length patients pharmaceutical they the We're that site to be can that doing to evaluation equipment to also depend providing on facilitate in so the

I GE we'll regard. the a clearly already I use XX that in very recruiting in And they study. hope patients, we've radiologists because The helpful to that to nine I patients of question, And thumb for success that's can existing established patients. answer those have believe months hepatologists is good has have those. rule been strong So and helpful. of that in pipeline think six that

Francois Michelon

very seems you the of I to the And much. questions. think be Thank end operator, that

up. to I support final to listening analytical it very progress and this the thank of community, all again with speaking the But look you appreciate after coming the to you. and weeks you next optimistic we'll wrap we So from forward investors over everyone continue to months. story and Thank quarterly call. in, remain the inform directly, calling our can our the our of on you getting investors, we're we and both all And

Operator

team, of and you. thank of leadership And the thank the Renaud you Francois, Michael, joining rest on behalf all today. David, for we

disconnect You lines a good have hope now that we your may and you evening.

ENDRA Life Sciences (NDRA) 16 May 202020 Q1 Earnings call transcript