NDRA - Earnings call transcript Q4 2023 | ENDRA Life Sciences Inc.

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Operator

Good day, and welcome to the ENDRA Life Sciences Fourth Quarter 2023 Financial Results Conference Call. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the call over to Yvonne Briggs. Please go ahead.

Yvonne Briggs

Thank you, operator. with Briggs Yvonne is LHA. This welcome Good Quarter Life Fourth ENDRA Business afternoon, Update and XXXX Call. and Sciences Conference to Financial Results today, Investors press is Earlier a this issued which topic, release available of section on the ENDRA's website. in ENDRA

commercialization today's These note All management the condition, strategies, include anticipated statements costs, regarding timing efforts. statements begin, plans required than include facts and historical objectives operations, by will product of financial that regarding and we partnership regulatory forward-looking expectations and launches. discussion of The Before as clinical and are other results of please statements. potential statements well forward-looking receipt studies, statements. company's regulatory of clearances development as opportunities processes,

any refer update statements. information uncertainties fiscal for as forward-looking any forward-looking about the revise to year obligation filings and to for Except federal and company by required the Please or more risks Form securities statements. company's XX-K laws, SEC XXXX to subsequent disclaims related the

In fourth ENDRA's terms Thornton, turn Chief Irina Director to and the prepared to Michael today's Francois? by followed Michelon, of will Mr. remarks we'll followed be questions. I'll results the begin of Francois of Officer; your Thornton Senior will Executive Michelon. review now by the Technology the quarter Officer. structure Chief financial Francois Pestrikova, Chairman and then Finance, call, take over call

Francois Michelon

two, as made build thank the financial and body joining our our significant We've three, building Number Number the with new which the review to developing maintaining steady position revolutionize through activating four, awareness-building We're the local strengthening application us existing monitoring a five, detection target and foundational and regulatory through for success. of by of close areas. Number our commercial clinical progress number beyond markets Yvonne, to for to in following X at Number you well clinical agency. disease, key FDA results rapid blocks collaboration our and current new TAEUS for positive commercial and partner opportunities and De and liver of the which and practical XXXX you, business as our fourth cadence key health sites achieving element Novo relationships Thank advancing is property. to level, with metabolic opportunity. the markets of ENDRA's evidence nurturing today in our mission to our quarter one, commercial strengthen liver looking And advancing leveraging position clinicians to license new evolution treating ENDRA's activities. disease. industry intellectual diagnosing and technology developments.

Now the And will it as performance. Moreover, and this about of opens clinical will for strengthen within the We're base journal. be United the ways. system on X update needed evidence Technologies to national TAEUS business medical to publication fundamental are excited of crucial expected comparing provide and liver ENDRA's U.K. findings the the doors will assessment clinical data accuracy is clinical national This U.K.'s include fat and subjects a the sites achieved body of I'll study peer-reviewed the recognized Liver health partnership TAEUS's crucial Hospital of aims in MRI, the milestone a elements. markets for key London, extensive collaboration ENDRA's network. Mike opportunities Kingdom. a support these prestigious for we TAEUS leading institution health strategy strategic service generating sites. evaluating our King's system these is our standard. elaborate in in active each introduction service The market. entails pending one submitted on research College XX target of to evidence in potentially our the provide in clinical approximately an Recently, by installing a in to study to

our supports and sites First, and current regulatory evidence claims. from filings future these reimbursement clinical

abstracts the to hinges the Second, hepatology ENDRA's convince of technology's Liver to segments propositions our markets. Association on build of demonstrating target do economic continuing the traction market. settings sites key European in feedback enable endocrinology, further endeavors They the in Study our bolster by each highlight product evidence. the and and improvements. Gaining and year our we ENDRA's real-world enable serving of in sites to through segments third, other technology compared the impressive evidence our base clinical clinical commercial ongoing last ENDRA's And expand so in at marked innovative approvals real-world at clinical regulatory clinical must to the and commercial of of progress. These performance compelling target future technology presentations technology The of presented level. traction, clinical local leading value standard. MRI in technology target sites pool reference additional help potential and customer as commercial value, we of enhancement users the Yet, gold clinical for our market encouraging our us develop

As will the successful and such essential in you're the for global of like adoption second these new activating ENDRA's. sites others announce College U.K. accelerating Clinical hearing, quarter. efforts by in the King's we're innovative new is technologies as evidence

we're XXXX, areas. advancing key the Looking ahead addition of into evidence, building in foundational in work also to clinical other

received Mike the quarter elaborate technology. market. the FDA a year the with the second XXXX, in advancing Thornton FDA, FDA for minute. open confirmed the predictable be and this in address and agency. this the to submission our to We've third First closely held in of information additional with items on our a Novo meeting will pathway our ensure we're of And submission regulatory in Since engaged regulatory request U.S. we've an and quarter the from we're De importantly,

awareness activities, the clinical in our ENDRA's these of to base technology's achieve commercial with in Association team and The of American hosted our for for proactive in markets hosted College at CE by Liver attending other and clinical to sales has Disease, mark and Study ENDRA year with U.K. propositions. In engaging the conferences. Notably, as MASH. France, key in our platform also panel adopters growing initial expect by discussion the King's and to area enabled a major the value been this this with sites unique economic TAEUS on Germany, we key the of Dysfunction-Associated Steatohepatitis, of second as perspectives technology known stakeholders Europe early target from opinion parallel leaders our the sharing our and hepatology, endocrinology leveraging and Metabolic Meeting radiology. clinical multidisciplinary managing data Liver generating showcase And

European industry technology. Plans Professional are U.K. to contribute participation European our the in as technology's and to critical this year and International in and to Congress the and underscores awareness American XXXX, with highlighting of most our Meeting TAEUS commitment in in visibility relationships conferences ENDRA's Care cadence the Diabetes partners the X potential. such customers the attend fostering potential conferences of place Liver raising ENDRA's

exploring opportunity The market of is market. in a and bariatric mandate the intriguing drugs, surgery-centric approach popularity third broader is from area management the Because new a disease rapidly as FDA in U.S. obesity of alignment we're an initiatives this evolving to with our management centers. GLP-X the metabolic

ENDRA's opportunities are to biomarker X addressable by so disease journey for and in fat beyond key market patients and far monitoring ENDRA. demand aligns and motivated self-pay is on visits for characterized with treating X to relative high a holds and elasticity really indicates loss for for crucial revenue a self-pay since technology relevant companies rapidly syndrome. Our is diagnosing, providing and with for affected basis, three patient who based support This broader that highly expands metabolic liver per services the market per liver ENDRA's obesity managing streams clinically potentially price the hope hepatology patient like well this management scan. On weight with year. endocrinology And blocks market their promise research building advancing, millions

The clinical societies screening first already leading guidelines for building block liver. updated is have their fatty that

Endocrinology people Association an Association the and million guidelines diabetes XXX U.S. with recommends of the disease of the and adult prediabetes the alone liver XX% diabetic As fatty the who approximately either Clinical obese. for or American That's populations and population example, are prediabetic, in patients. Those screening of now XX% obese American alone. U.S. U.S. Diabetes encompass for

ICD-XX-CM global and ICD-XX-CM second markets. is the block for Europe facilitates Organization indicates and diagnosis for a it a liver World The the specifically insurance processes disease. other building a that and documentation new code issued billing standardized system has fatty purposes, The is U.S., coding reimbursement that Health for in

ENDRA believes opportunity diagnosis significant the for the specifically innovation. for KXX code ICD-XX represents liver issued of a fatty

path like As integrate health have care ENDRA's. a more providers diagnostic now advanced straightforward to technologies

liver liver Madrigal FDA's a therapy, management. the recent the targeted in including treatments involves Rezdiffra, NAFLD/NASH, advanced along Blue of like impact for Cross pioneering disease can criteria both new approval beginning and to exam block fat providers, health significantly of specific marking Rezdiffra, XX,XXX requiring insurers drug most of This MRI-PDFF X building for estimated emerging disease for authorization liver the insurers be chapter only therapy Pharmaceuticals will patients. Major care performed third world's MRIs. other whole by with the are And the adherence which subset an

diagnostic that NAFLD/NASH diagnosing and drugs and tools demand TAEUS and disease, the X point-of-care monitoring ENDRA's are need in underscores similar for managing treatment. complexity screening affects like liver people. which accessible of precision billion This the over the of highlights and Rezdiffra facilitating capable more will for drive of consequently

and engaging the platform liver. applications By our analysis issued new Finally, to collaborations TAEUS we're far been global efforts. leading issuance property spearhead competitive to the and to capitalize TAEUS medical will set Europe of landscape advisory evolving and position engaged exploring aim year. and patents landscape and the intellectual in portfolio a leveraging the potential new ENDRA's firm opportunities enable this pathways that TAEUS therapeutic on XX in strategic our of in end, intellectual partnerships actively expand intellectual with M&A opportunities. we've U.S., the the We and valuations areas. We've in of property out-licensing This new strategic in for patents of X beyond rapidly explore PatentVest, the outreach to IP, us collaboration property and XXXX platform. To our expanding of our a China the aggressively strengthen technology so

These patent system now our over With an the integral edge patents these issued the TAEUS worldwide. to estate Chief that in patents to Mike? call the safeguard Thornton, reached market. I'll key Officer. turn has are competitive our impressive Mike additions, Technology XX reinforce innovations ENDRA's and

Michael Thornton

information compatibility included The additional to the XXXX, from related submitted safety of Thanks, an XXXX request The testing the as AI of related our received known cybersecurity. Francois. ENDRA nonclinical In system. such and fourth and FDA final AI an submission. data electrical De as configuration Novo to clinical the questions our quarter request testing

significant of and prepared regarding weeks, for XXXX. In request was our pre-sub has the data ENDRA study understanding of meeting in-person reviewers data on an additional configuration ENDRA required data quarter in-person including the and alignment FDA close for ENDRA design version believe meeting. on to interactions information. The multi-site we've And protocol at pre-sub request interactions grant historical and the the for clinical final technology. The the can Over conferences. design. We study for the product has platform presented and communication configuration and were of supplementing number operation time of hypothesis produced analysis with a a of outcome. the successful protocol and an specific ENDRA additional a anticipation with provided confirmed that FDA a the with as additional we've At in the of clinical clinical past FDA product's plan our providing task the related statistically that of our clinical Liver understanding and with granted the powered statistical of that first study the FDA to pre-submission. to regulatory summary, has a recent based a believes obtain the our FDA, clinical XX FDA potential performance European demonstrate with technology. In alignment TAEUS of meeting, device testing, the the XXXX had on meeting achieve device plan our subjects, the alignment and XX part the submitted we This and principles for further in collected latest using proposed second

to we're as London Francois added excited have earlier mentioned, this year. clinical As a collaborator KCH site

The ultimately, currently TAEUS to our Rocky both King's derived including happy in In IRB team our efforts the and at our The Medical and Michigan. study studies the That clinical forward ENDRA's to KCH initiated Wisconsin, University measurements X, global recently to that clinical I subjects. sharing several calls. recruited the MRI-PDFF active Michigan validation study clinical and to this in addition, brings are clinical progress fraction excited Michigan a and in comparing University, in look have supporting State more about we approval ENDRA's partnerships received for of collaboration and about of the These Vista in College report ENDRA adoption fat technology. to study new subsequent College with conference our critical sites XXXX, activities is area U.K. I'm

Pestrikova Now with to over that, for I'll a financial Irina Irina? turn it update.

Irina Pestrikova

Thank you, Mike.

review to a performance. recent now of Turning financial our

For decreased in from ended XXXX, million The expenses. XX, to the and XXXX. due period our $XX.X decrease year expenses December same to the million $XX.X and was development and sales operating marketing for lower research mainly

research Our we year-over-year completed of by initial development and decreased as our product. expenses approximately million development the TAEUS $X.X

management departure fees. write-off due expenses and $XXX,XXX and decreased approximately sales marketing of due approximately a bonus Chief mainly X-year Our administrative to by mainly lower $XXX,XXX the and our Officer. General expenses professional Commercial decreased by to

million a ] per $XX.X $XX.X (sic) or [ XXXX. in of share per $X.XX was loss million XXXX or compares in loss net This net $X.XX with share. $X.XX Our

Cash XX, through the as exercise and million gross company $XXX,XXX equity of capital In million warrants. to provide facility alternatives for the proceeds at-the-market $X.X of needs. funding quarter, $X.X XXXX. currently to our equivalents of raise and sale cash were the in December common We're from stock evaluating future from raised the fourth

Now I call back to will the Francois. turn

Francois Michelon

And and and the listeners, the driving leveraging activities. our the new to market developments our through beyond accelerating want with our the ready intellectual disease clinical one, and FDA behalf continuing ENDRA's team, Number And the we're in and Irina we levers: to continued committed position. focus. On call entire for open to for grow our current to strengthen our commercial summary, clinical Thanks, to strengthening remain regulatory markets market innovation in now, ENDRA clinical through sites the shareholders U.S. of our our U.S. treatment Europe build extend relationships evidence Fourth, the in number partner property leveraging following presence In activating their awareness building and goals. X fifth, thanks two, and advance closely our support. of body the our commercial engage submission I to achieve to three, to Number regulatory local position the to liver questions. of detection and and for Mike. operator,

Operator

Instructions]. [Operator

Our first Woo from Ascendiant with question Capital. comes Edward

Edward Woo

there time guidance think XXX expect like frame been the on FDA It a decision or Congratulations be past any have. the pushed new progress of you made? deadline may you well guys looks has to decision when days. Is

Francois Michelon

Yes. Thanks for that.

So from the to we be days range goal on clear, review XXX a of and of was we hope terms FDA website the referenced FDA. target And clearly this in is by their part the a I days. that a emphasized

the is they some say news and meeting First, clinical the the demonstrate good a that I close the thing. fact is and The of to communication would clearly the FDA. review data good to in us with granted discussion advance engaged a product we're

that Mike, data can, based although don't doing the it take we're the we've things and well and that the together. I positive the my cannot, from the not outcome give because however, bad received that type and news. we this within I Ed. of reach all will confident we've as before everything these performance over we the the on entire we of process, as guidance can't control to remain tone control clinical is is turning think questions FDA I a collected time. And we

is have want quickly certainly understand the as that to working possible. thoughts So you with engaged to sign. Mike, But I And think closely want I good aligned fact do way. happen in and might other we're add? we that is a things the very you as FDA ENDRA

Michael Thornton

In better we discuss regulatory with that timing if those we've we'll several Francois events clinical required as be with the the made. the mentioned, on and other forecast in up in-person that, Yes. up second process. specifically on in our to pre-sub And had -- them individually subsequently have weeks, look and coming studies, we and some to past subgroups. much align to reviewers meeting is study key XX Once design I interactions quarter. of in the able the just of the comments follow at will And something

Francois Michelon

a I Ed. hope and answer, that's transparent fair

Edward Woo

good. Sounds

You second meeting disclosed that the date announcing quarter. there's after mentioned will the any... be you will a just have you you meeting and when happen? that in Or Would

Francois Michelon

things These can shift.

in sequence And update reporting confirmed, with even quarter, that have the FDA meeting. we assuming always it's it's will so second on to investors the it's we'll as that, of And we then out done, if sticks quarterly it. have

set. it's second It's update that. after we'll accepted, attending in So quarter, of been investors number people and the

Edward Woo

getting Is had from And different in you requiring? last Great. very as approval something that's like didn't question FDA getting the many the EU. the terms different issues in in is of it approval seem my just EU, the there what is,

Francois Michelon

that the you Europe, major Yes, quite Mike higher thank but and but a for to And it's FDA bar. CE highlighting great we in that let is the a question, a fact different. approval, have distinction, regulatory speak I'll definitely they are mark

not and you'd time But And it a why the takes distinction little the help longer. and our Mike, FDA work approval. so it's the surprising tend be to more listeners to better that normally get understand little bit bit if requirements lines a that

Michael Thornton

Sure.

So processes. as clinical greater true and much has largely more same ours technologies on novel such items The And such including absolutely including clearance focused safety new as ours, of a on medical then technologies with efficacy. CE and technology. new even FDA focused that's scrutiny is and those devices, is efficacy, on

Novo is. De Novo So for as other would the through and pathway just ENDRA since directed pathway, the process the they've most companies through describe being going now pathway I introduced De like more the more

similar pathway And De for definitely of that very pieces key being That's process, data. we're differentiates technologies, new one the I pursued liver said requires the including think similarly XXX(k) Novo from earlier. treated which clinical ones Francois we to it other really the health.

Francois Michelon

tag of an product mentioned, of bit as I mark users But Europe. reaffirming clinical some the of what target enables in link. to body us market each the said, Ed, And Thanks from a missing CE Mike. the extra sell is having just on to local in we've evidence

clearly to And to being and see the in data. be other site. customers from able U.K. a be what potential in will we a of the source our that, in do good We'll be bring the study. of able the and able College that companies so markets. to system visit example that's in be same eventually we'll Germany, review data to that U.K. They'll They'll the the ground other on France And and King's do

is great the mark starting a So CE point.

it lead building, will And And to same clinical helpful. hope here parallel, will I we're the in think product I with thing with happen that's quality. the the certainly, FDA. that in reflects combined that data commercialization. the U.S.

Operator

I like closing the session. any question-and-answer turn to back concludes remarks. This over our would to for Francois conference

Francois Michelon

you, Yes. the Thank to Easter celebrating Easter. progress. progress. Bye-bye. Thank to we And weekend, to for And long our you and you're team close wish thank with operator. call I'll if updating everyone listening as a good the everyone to listeners and my today news looking forward you.

Operator

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

You now may disconnect.

ENDRA Life Sciences (NDRA) 28 Mar 242023 Q4 Earnings call transcript