ENDRA Life Sciences (NDRA) 26 Mar 202019 Q4 Earnings call transcript

Good day, ladies and gentlemen and welcome to the ENDRA Life Sciences Fourth Quarter 2019 Financial Results Conference Call. All lines have been placed on listen-only mode and the floor will be open for your questions and comments following the presentation.

At this time, it is my pleasure to turn the floor over to your host for today, Mr. David Wells, ENDRA's Chief Financial Officer. Sir, the floor is yours.

Jess. you, Thank welcome XXXX and fourth and quarter Good update to and year business financial full afternoon ENDRA's conference call. press We a release afternoon. issued this

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

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

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

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

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

go Let me through quickly today's agenda.

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

a COVID-XX dealing the all friend. people as to are I Before want or begin a parent, patient, member I with family acknowledge who

to unprecedented well goes with providing our particular are and those These and in out you all times. thoughts of front-line are to help caregivers appreciation need. wishes the Our

implemented we work and you guidelines for social public inherently our protocols health recommended are have on remote herein Like staff. distancing

transitioned to that for to the impact liver and we and monitoring. on a diagnosis commitment required remain all care team I new our am Nash positive unified chronic our has patients has adjustment some a proud and better in normal NAFLD of this say While make to like disease with

S let's focus ahead. what's progress recent on and

know ultrasound as of the As TAEUS. bedside. clinicians pioneer cost TAEUS allow ENDRA known similar but times is tissue to in acoustic at enhanced at patient you lower will thermal of the many to MRI XX ways visualize

clinical which nonalcoholic Our goal develop is for assess need as we've fatty areas with hepatitis the to a application Nash. as non-alcoholic and developed is disease technology unmet associated of liver also known and fat also TAEUS liver elevated applications out in to known TAEUS high and monitor of stay NAFLD

our globally These decent diagnostic conditions often to to liver is believe are at of currently fat well-positioned billion to point-of-care. practical TAEUS X clinicians. and available We noninvasively liver affect need application assess over safe fat procedure the cost-effective the address amount clinicians unmet chronic enabling people with a tools no by liver

elucidate given us in productive XXXX has forward of inhuman liver support case to informed technology research required filings, provided a feasibility with use regulatory and number improvements TAEUS measurement which study for Robarts Institute, first data helped of initial the fat. the Key clinical include, for highly fat strong on remains we bringing successfully to liver ENDRA XXXX. ENDRA first TAEUS highlights was completed application movement. XXXX a year the market and focused

database use device and activities. of commercial our and Rocky University widely the the also our Center Pittsburg our two data clinical patient will population on will support studies partnerships Medical conduct institutions will clinical Vista results We with that gather University of established strengthen target with of regarded independent which clinical

relationships strategy. Amy our our to US bolstered areas Commercial Vice Officer, with and market of Chief Renaud of Maloberti Engineering a developed the leadership expanded Programs strengthened number in and and with go President Europe key In opinion in We and leaders We position. of strong key XXXX and property our we team addition clinicians built Sitzler. intellectual

Our and stands issued defined, licensed. portfolio XX filed, assets currently IP at

device implemented for number management in the technical commercial our TAEUS enter secured momentum quality important review system the in and which body notable we submitted for our year CE And of Europe. company. and include certification. has will finally for XXXX a file also We notified XXXX and ahead milestones clinical to We companywide with our enthusiasm Mark for and regulatory, the ISO-XXXX a

mark Already CE NAFLD a mark of in on also geographies charging known secured Germany in in indicates for our probe with and EU now in strategy other NASH. regulations XX fatty member imaging including each details the our flip the CE commercialization system European states. regulatory we in directives provide that CE registering France all including TAEUS Union QX complies enable it's Europe commercialization The the marking and is few mark in market liver to flip applicable as will initial and each approval market. CE the the Renaud TAEUS more ENDRA TAEUS minutes. and target product European

GE In will commercialization term fatty GE GE offer TAEUS return January with first agreement's will support ENDRA of liver in afford to for the Healthcare to certain also XXXX. technology the to for and extending facilitating our QX application. application continue to liver rights by ultrasound renewed of we the Under activities Healthcare introductions rights licensing the of customers. GE ENDRA's respect agreement collaboration In for Healthcare use manufacturing agreement with terms the its

assess Vista Ruben Associate joins Dr. and of University Raza [ph] And for Michigan Medical finally Dr. Stanford, from the in of Board ENDRA’s to as Center. monitor of practical Hepatology tool and Gambhir and Dow Dr. with Malik, liver we Dr. Scientific at Advisory Director of Rocky advocate from Malik from QX distinguished fat. a Tufts expanded Dr. Gastroenterology and and Division Chief clinician addition clinically University noninvasive the

the essential we which the enter delivering aid in of TAEUS phase addition year. commercialization Malik's clinical proposition liver TAEUS community to worldwide Dr. the us value as is will this to the health team

let EU our on commercialization our other key provided Now regulatory and updates timeline. more provide me on as Last week plan you we detail topics. saw FDA

clinical mark in hand EU establishing as relationships as ways European number of on over CE hepatology radiology a reference our and well initially commercialization in coming implementing in product including in efforts markets it's clinical focused as conferences. months TAEUS events campaigns, the tools deepening target well initiating and ENDRA key mobilizing education sites digital communication as marketing is With the education participation

awareness more companies to COVID-XX through other able to in and be all and industry, minutes. Like tools. those the due ramp potential our to communications this are to in anticipating support moment scenarios other conference will plan and presentations in webinars maintain at we digital cancellations Renaud audiences These for target including and commercial our are few will provide the learning Europe a important details in activities deliver

in as a pathway believe previously bolster TAEUS, for we US will XXXK pursue ENDRA to that to TAEUS remain our ENDRA cleared regulatory of regulatory of XXXX had our offers we early in finalizing believes devices became compared the testing strategy what and confident to our predicate in advantages device the clearance Regarding a and XXXK package from with ENDRA's additional recently submission. been a process able advisors utilize. submission XXXK In that we regulatory our to liver system we're aware

of clearance additional we in time decision strongest equivalence modest amount new we testing result mitigate further during demonstration to filing the of invest predicate FDA XXXK second submission yield regulatory will the half XXXX. clearances. possible made a to substantial We XXXX, We support the application the of a of in to spent. FDA believe of to As the this which and position receive anticipate system view FDA this the the well which TAEUS will as to time quarter second us

elements trial US using our that of the with also design regulatory extend features will CE initiations. enhancements with systems and US Mark University current case with in standards required our Rocky Pittsburg a of included clinical and working platform in of be submissions. sites for Center respective and preparations and include and These compliance closely sites fact will recent upcoming their support making number evaluation and TAEUS the We're Medical final Vista clinical

communications may near-term aware but also Recent new this in move on pandemic. existing least and their these forward we're with to with refocus facilities COVID-XX impact at as to acutely healthcare the very has an confirmed trials enthusiasm sites have fighting that clinical clinical testing resources

and research will as we'll environment. work their keep closely in the facilities need they partners updated So with plans. Bottom this our to ready, collaboratively ready evolving if are when you we when we ENDRA and rapidly be make can as best adjustments clinical healthcare line to

XX, results to the I'd for the now review over December XXXX. to like full the to year David call financial fourth quarter David? and turn ending

in year period full in XXXX. I of $XX.X François. now for to XXXX of ended a the XXXX XXXX line. as We year you, XXXX no from $X results. XX, up was Nexus provide increased service in earned reported for will revenue a had revenue or for December XXXX. to million year same result XXX million for $X,XXX now financial ended discontinued our the XX, same December summary expenses Operating product the the are compared Revenue period Thank

due operating in with almost of TAEUS line. increased our the year-over-year cost development increase was exclusively expenses The to associated product

XXXX. for million the December loss for the loss a net $XX.X million to XXXX was $X.X ended ended compared XX, December net Our XX, year of year

the we million. sale year and based and $X.X our to charge liability sold for warrants the a only earnings non-cash to December. of not resulted It preferred preferred obligation. adjustment a stock is other represent totaled a or This that stock dividend related in we tangible charge the from During a GAAP which incurred does

year and As share per this net December per diluted the $X.XX was loss XX, charge our a ended of XXXX result share. basic for

XX, $X.X our December activity of approximately million the for decrease year. of as of as approximately result $X.X is small funding XX, the cash totaled offset to The operations as XXXX. throughout by in our Our cash year-over-year compared December normal XXXX spending million

it approximately debt planning million we COVIDXX is raised over of the tenuous at past best. of world and capital. to crisis new of equity dilemma retired December the future of million makes With magnitude the and XXXX $X the forget the easy considering In current $X successes

on are and as markets the COVIDXX near-term. have this which completed capital funding fortunate capital to We the provides all we impact financial adequate weather

ENDRA continued to and We and in are that proud many their investors express its continued team accomplishments faith confidence management investment. our and through of honor shareholders and

what that do regards, and management at emergencies, are prior successfully and unheralded ENDRA. other experienced an our Directors While near marched that say many team seasoned of years well experiencing We is I'm of intend to and side. Board and in just to proud seen the we today having on panics ENDER's team is anomalies

model For operating than approach the phrase right light many never has and quarters asset used relevant we more this been now. had

adjusting year, growth balancing between acceleration. the We continue related for projected actively our to and review product spending plans capital preservation expenses,

we suppliers am, as this secure as what are, might and with engaging on supply chain. and lenders actively and and of ENDRA fortunate ready resourceful and have delivery. TAEUS we who impressive uncertain We to of building task you reliable I believe an the are to imagine product No climate set but our are services our suppliers chain opportunity we in easy supplies supports to able assembled for our a appreciate therefore finished that is focus

we road every Like I on we don't what stay the uncertain responsive ahead. can in nimble don't we'll and lies assure company you environment, know growing but this which know

opportunities market-based, sheet will strengthen capital. including that growth our actively or opportunities, evaluate balance company to continue sources we pursue for ahead, lie and partner and provided of government-funded position our Lastly,

value Our delivering patients, shareholders. we TAEUS see proposition the our great focus of the with and benefit remains and on clinicians

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

conferences have in communities and our growing XXXX. Thank strong the like presence made total joining at cost-effective we that great with you, tool Europe there for building need progress in and US TAEUS like Since a point-of-care XXXX validate for interaction community is gastrohepatology in interest in seven radiology, a the and leading awareness noninvasive clinician and in formal gastroenterology. TAEUS. radiology assessment My a ENDRA and clinical relevant had an clinician ENDRAs hepatology we in David. technology, network In May

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is executing target UK Switzerland into the Union springboards. investigators Establish reference sites TAEUS the and stringent our set priority European and the criteria. evaluation We're the plant commercial following and get hands a begin of picking based France, to market this elements. early including sites My on in each us commercial near-term reference products key comprises of serve clinical to Germany, which adopters European

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format ENDRA had conferences, participate and effort we risk clinical in Given multiple of to resourced awareness well the market camping, well digital target adapting our digital our education will degree our opted re-racked approach base clinical we some grow targeting a relationship. marketing high a engage in company and postponement of first maintain cancellation website in community as by focused audiences initial with or clinician of tools to a be This planned to of TAEUS are products the at liver as languages.

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in to commercial We our are look on coming in excited very quarters. updating and Europe progress initiate forward to you I the our activities

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

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

precommercial care our our TAEUS the of First and reception about of potential remain been on and diseases very market clinical we make the of impact a are activities, focus the patients NAFLD ongoing by highly liver encouraged Nash. to liver the to device. strong like positive goal optimistic focused on chronic date We've on community with

with NAFLD billion people X over Nash globally. and are There

are have available, of rigorous address liver We're targeted still gap. potential and become fat to excited measurement need patients. and practical monitor clinicians starting While therapies to a and TAEUS don't tool significant clinical this identify to diagnostic the about

initial in XXXX. to in place the we second expected Second CE the in submission Mark up solid activities which The commercial FDA. half in us foundation the our in submission US approval building the second to XXX receive precommercial to activities our we positions have Europe quarter is finalize launch and implement XXXX as a on of of ramp approval

the situation clinical and will remain plans community finally where we're respect businesses adapt necessitated nimble COVID-XX and monitoring our to closely by with the And our our to vigilant COVIDXX.

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

[Operator instructions] first question Capital. at take our from O'Neil We'll Brooks Lake Street

hope I the you're situation. COVID surviving

efforts in are a slow simpler it more as you to result So you you going see just would me a responding say initial as or is just actually can for cause changed highlight more of to spend result and environment thinking more a to sense expect COVID commercialization you spending you the make money situation general having could your planned? that to current you the you that how

see me that. if address I let can Thanks. Yeah.

So elsewhere in that out still leveraging we terms us. have very overhead and to model the help and we're side of of on pointed partners engineering asset this low spending light had as have David lucky in

If heavy of So COVID have on many we timing for in don't burden. may a to due evaluation clinical sites. example of the are be some affected terms we as implementations

we of still First to lot do. a all have

activities that cost-effective audiences active it's Renaud training the in necessitated. our lot We to goes conferences of in communication is probably these that awareness are through say going to building on clinical of Marketing and electronic. terms bringing mentioned unperturbed than something more that I very the a would if

that Rocky not be unabated data UPMC. filing in QX pointed either approval on does to very continues from regulatory as or XXXK the out Vista depend just Obviously I clear

is something highlight. to important that So

sales continue capital we very see come are build if certain efficient as hire we've doesn't and spend. do ready and think Spam that not to a thought we early be to it that to hospitals have in to now back to the candidates those identify in flexibility a to today make our very, in down that trigger over your pipeline sense markets I and we rep to burden example people as country We'll but the good of locked years. so Just hire the Brooks to the been pull for scenario,

So restrictions very much forward also engaged and to to if that that would current plan. spending flexible. I sure but programs with we to us maintain everyone I make that your model very us commercial the decrease, be COVID and to with I our have momentum imposed understands allows would want probably on say we that I necessary as hope have been in pivoting online to other are question. answer marketing helps think

second So understand to that the competitive are the market unique? with to are still XXXK about another confident am a predicate question feeling have commercial I trying you is very capability you the just or device bring found device you the

a no competitive that's to to I let great way. a not Yeah little in but more it's question. Thornton am any Mike a detail speak going new threat

been people inflammation can look at trying in time. number the are a and As There liver are you of other to imagine have the ultrasound at liver looking fat. that fibrosis, technologies long for interested and a and

best to Clearly find the if I which Thornton interested that a say Our CE would FDA to a but bar technology to example than predicate it's to lot color my to on launch more so technology as submission which new but a to at seek the predicate application. possible. mark, knowledge higher it's exercise attempts are is some performing similar remains threat. there but directly, good FDA is of would and question people unique the a of our highest your points reference the we find no competitive far you Mike answer and clearly for an

Sure thanks François.

on or requiring predicate correct coolants know an first that process to clear for critical successful substantial select filer XXXK technology. existing demonstrate you time As device us use a it's predicate a to based Sa a we the is device XXXK submission. the

our and identifying earlier, this to is is are really us. and reflect device helpful this that to François As submission thing aligning mentioned newly clear we a for great us

two or one more quick. add just real I Can

approved So drug on things is that you… are any therapeutic in any change evolution side that any there the the advancing

that company our the Phase up drug and as the XX in of approved pipeline targeting that of to at been Yeah XX liver. view and we minimum therapeutic market focused several drugs measure be that a the are blood first in from as pipeline called much those fat the NAFLD of both too on the Nash which There of fat we a and our from X root you and one X picked in in liver are fatty Zydus of recently, it conditions is we liver. liver know own as press estimate or in has among the did and Nash demonstrated in India in about coming in the that test disease no are pick release therapies of cause months three is up fat

patients. disease so to and over these we available these of with in this think and first therapies now that the screening of billion follow and affected terms just people And Zydus highlight intersection monitoring liver becoming are by others that bottleneck

where for insert say but painful Just section needle in bleeding. frankly expensive, between you the slow measure heard it's of the other only tool effectively ribs, in liver good monitoring very which liver the situ who tools the Brooks not large for today risk is it very and those a is patients and a tool gauge good MRI are haven't invasive, before of a is extremely liver, is biopsy aspirate internal there ongoing a and it's screening fat me a and that you

conditions and these more liver So are screening that's advanced to of impractical for -- stages being daily with and and disease early the example patients that's reason for really the ENDRA. of completely these with used only carcinoma monitoring liver which later what tools typically are hepatocellular for progress for disease

on you that little a hope what asked. expand I So and helps bit answer

the like so. saleable price that you I seem it's you're a last about pretty get of or the way, one then in gotten does failure I'll is and have any XX,XXX to initial and think your one talking marketplace, Absolutely cell out reaction

am guy I target want commercial you least years Yeah for on I before as cost-plus XX margins you that build being said price multiple factors great the and question. get. to

value to hepatology offerings, the of as understand of which by well have product geographic markets. very customers department understand is potential have the what the the sensitivity offerings, to you competitive frankly are to as You versus you're understand price you radiology have

a stethoscope So that high-end target that we portable value XX,XXX are in something abdomen ultrasound really that to point because practice to is in from the essentially example is offers that like the a tools think but this can enormous to is ultrasound in price go used in space image car-based not liver to kind regular and considerably the XX,XXX for that ranges XXX,XXX up clinical compared and car-based more.

are the like felt it an existing ultrasound value to bring is and range we appropriate. in But price that relative share offering

interactions at as imagine conferences conferences, well the also bring value have could over price both a and we've feedback years We proposition the price. been very all at of has the these the at it sharing been supportive also point field that clinician can the the value since you through economic that what the and in propositional clinical clinical so to but been

to I is us great data of additional take we think Renaud is maybe can commercially. but as I because we're it in with out price any it, mentioned. I way effectively with pricing want to try you bit get bring a Personally, just and thoughts to the from that into there there a as the thought topic and clinical market and ask out good to to that market put to today Renaud more your we place in a best chime little determine would go lot end the on laying marketing have

think understand in I to is can pricing value right from we you're that standpoint important clinical think bring where market. I No it's the

talked haven't to I price whether from the we or that something anybody we're pushback and we adequate various back this that of the has talked heard any talking think point. around not we've Europe been from anybody major the it's a that sold countries pricing to we've about US push is price but in turn to. have we yet not $XX,XXX in cause at in that have Obviously

won't separate because piece sells I final the market. the from this this stage one scarring tool the with I measures the in consider. very develop is a liver their what and attraction in to well-established that tool that value company manufacturer Brooks a measurement has measuring enough helped therefore which quantifying view good the point. to of market question. $XXX,XXX to the of the there for we later And the which of that you than name is I the but marketplace of only and kind us early there fibrosis love scarring we're think as price to $XXX,XXX We considerable of is comparable on, factory very, additional hope gives more and

the All that's good performing good appreciate Keep that color. Thank much. you very work.

Dougherty at Bauser Kyle Company. and next Our

that guess but the much Kyle today. FDA can you able This submiited. more Is thanks technical is there the before on taking have I provide steps remaining for that application. file on first you're questions little you for mark Greg color requirements CE to submit actually you more

Sure.

expert to kind here that Michael articulate our is please. Thornton me Let who of ask

key we addition testing and Briefly all the file, documentation to systems comply regulation to in the with and technical different quality process additional EU actual require from standards. that the FDA are

of things audit. might regulations SEC you different but rather form it's submission just imagine than One these technical a of a is as file

Europe Are are options? And how as commercialization you thinking or you regarding about leasing exploring rental in pricing?

the time and avenues your point-of-sale, and point could you is capital first in of view? I a your up to whether consideration lot that Yeah speak topic on type budgets Renaud since took price the of maybe we're leasing another

that avoid to the point buy standpoint being tender at the it's have price the in Global a a US to us price actually obviously allow because Europe point certainly is outright. threshold and whether to are hospital options good simply Europe ability from or capital the have we provide chosen in good equipment

type We of we'll to customers will we for yet customers also -- option but developed haven't our consider well absolutely. for type this offering any type we of obviously that and as our market this be of completely leasing as option developing go XXXX

last a to question be just you'll be deployed It GE? about then relates GE your you partnership as launching for at be more it sort can of your speak Europe like able might what support sales bit to at And business? sounds to

pointed GE's finalize through either demonstration system was demo helps site we very evaluation well product. and invest systems ultrasound the the with of cycle to as to us so us just been development not out these develop as product. us that in the with our commitment help to to systems $XXX,XXX generous or deploy commercially They’ve which have as Yeah we

they’ve been helpful there. very So

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on think sales market also reps engage may best what build I call future call control and ultrasound an it's understands for on model. may on who experts also team. with provide can capital but the who us not and today hepatologists, to to own and liver that a GE want know partnership call a hybrid not GE to way small is this that I and good That that leverage so it's efficient I to they on a

see So for yeah time thanks the there. and you out

[Operator instructions] We'll next at Catalyst Georgia Michael Capital go to [ph] Group.

along receiving a questions. to in the have quick drug compounds what you number bit those little of and interest lines. I the you're on you give Can wanted partner something development ask any pharma side. Couple you identifying front about development, on pharma progress on seeing potentially of maybe made inbound a more or are

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trials. cost add drive the value early on screen just failure screening can to very low a we site lower help efficiencies in and rates However, these

to expectations operate answer to our and listeners GE a as partner. freedom that natural or we that had ultrasound but hope alongside our I So CRO with Naturally complement with line in the completely pharma I a think these the new your manage partner answer take is helps several want a of our things time, to approaches. we've I view question.

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just price centers. a with to question, really should or of initially great point that's this market of to last more sort beginning awareness at think in your and versus revenues. you're and then sales as in of bit reference Is this drive the the is about going one process model we we've It discussed this

question. Great

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they will us sites in of contrary in revenue is success. key They place So for the evaluation opinion be of half half for critical a leader year. quite flood putting the our enable the revenue drive will to back us the not these second in

you're it source helps hear of into, use rollout can and that milestone? each a does an this for to it as assume Can sort I expect I basis ongoing as assume going me the new about think we'll you center process.

communication everyone good is I've over and absolutely feedback critical. certainly that Yeah and for during this difficult time

we be pipeline. discussions. are a good are we've discussions new will These These announcing, started. had So have certainly we not

the the announcing I COVID I despite there use actually even imagine with can sell this situation mark that you in it oh sites over Joe, CE European want is it the can if my thing country. Now

those way. announce the So we and certainly those out point will along

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