Jordyn Hujar | executive |
Ron Erickson | executive |
Pete Conley | executive |
Greetings. Welcome to the Know Labs' Fourth Quarter Fiscal Year 2023 Earnings Conference Call. Please note, this conference call is being recorded. I will now turn the conference over to Jordyn Hujar, Know Labs' Chief of Staff.
You may begin.
you. Thank for fourth today's financial quarter operating everyone, review call results us highlights. Labs Know and joining you, conference for to and Thank year-end XXXX
future or risk events these XX-K without financial have factors including, approvals, and reimbursement from call, the on in to Chief and/or limitation, Therefore, Erickson, ability at diagnostic XX-Q, or outcomes and like commercialize inherent maintain failure of These need Any call Forms benefits, patients' in potential may the capital greater-than-estimated press jurisdictions, and seen regarding and controls, Know law.Today's statements. of factors for will you develop clinical be Executive by obligation anticipated as the forward-looking website the these the under webcast expressed risks forward-looking visit results page or applicable you conference supported today's expressly of in actual follow shared any any use risks of include, to those be a Labs disclaims cause through will update products remind turning development the of described by are A the to If FDA company's to release Investors the would not be company's allocations specific will statements. and that rights, may results and obtain the call. that over filings, statements. www.knowlabs.co.Before inherent differ actual call this third-party to page transactions to resources historical required Investors to applicable except changes differ commercialization Labs' otherwise Q&A will events. please to this strategic or to are the SEC which intent you implied on the may need to website. in Officer, and review can obtain results, is Ron the future be and such materially may forward-looking results make not or or trials filings, and certification. forward-looking diagnostic accounting projections regulatory Know political without commercializes, what these laboratory I our uncertainty from portal accreditation XX-K company's during identify materially company maintenance or that company technologies from IP slide forward-looking as statements encourage quality statements facts statements, We presentation, legal, company's in downloaded realize any and products, limitation, failure the the which Chairman session regulatory
which questions portal, be submitted be accessed Your through can can website. webcast our through the
I'll to call.With the be We that, will over today's Ron during taking not Labs the Know phone call over CEO. Ron? Erickson, questions turn
Jordyn. year Thanks, results the quarter review to Welcome, fiscal and call XXXX. for financial fourth everyone, of highlights and year-end conference our to our operating
you me year fiscal of our us. critical discuss our through financial results.I XXXX. Being streams we've preview our goals and our Property, articulated Intellectual today Pete earnings Chief Officer transparent walk is today who calls and Financial work will President will for Senior Joining is for the our progress previous against Conley, in Vice
We have established maintain followers. investors and with worked and communication channels to our
website. and newsletter And have click the on via click you material releases, on our of our follow any event subscribe spoken e-mail questions, that I our with press of you number any and releases. I've You us the links distributed I a which link? on are asked, our did if out with in reach encourage you ask@knowlabs.co you can ask every those to questions you occurs. to at to time
an the year, page. achievements engineering, web acceleration some disclosed development to product members and as of we as added leadership discussion www.knowlabs.co XX, reviewing by and with from new to validation our should and events Directors January major and changes Chief our has operational today's and named provides this execution. team of in On Board. starting data information the of happened visit We on while website Executive trials.I'd the website, team. You company's data partners regulatory progress of our Know in start significant XXXX. core our responsibilities. We to strategic continuing support I Officer our our update Labs research affairs by and clinical progress and Chairman new This the design like also section continually to access redistributed of was A fiscal executive and lot existing science, year Board the our
expansion marketplace announced and new Board, appointed to the bring with expertise our and already also medical, Advisory our of We Board to Advisory We stellar who intellectual Medical Board. Advisory directors Directors X the expertise new of of and Medical members R&D Board. added sector property Board deep the to X and Directors
welcome We strategic we objective. software powerful noninvasive team into partners our our where to collaboration research we year, refine the reduced insightful as announced areas the Kulkarni, very needed These engaged to few. our perceive meaningful fully had of We technology, insights the product are Cronin, protocol prepare the have milestones clearance a us fortunate we development, directly XX Directors. to FDA we and areas year.In to device.So sensing the June, existing submission upon revealed designed GEN-X allowed Karmeen our this has where collection Satish from the throughout to of such our build X work will year, manuscript counsel expertise blood Advisory this we Tan, include we Londergan the and to team external or technology. our for and device. asset proved to This and Medical Early year our glucose during on is and At achieved fiscal in collection And a individuals terms testing operations. of It help our Hitchcock, designs, respected core of to to of are XX. full-time we of name we separate with machine have skills we perform full-time these as we Ellingson knowledge our whose and monitoring Larry resources changes able data work be expand team now headcount of Tim additional scale John device expanded opportunities resources lab our have to our provide past list learning, and management and device. as Garg the a same XXXX, our and time, hope base, of employees. balance we clinical of in proprietary review related and effective sensor portable year attract XX we Board. be long IP research Earlier gaps, welcome hardware stage Generation to we data a an underway. development for on a continues is Their important the Throughout Advisory toward past device been characterization. laboratory our has have aligned team The to to Jeff Dr. fiscal our Dr. data be Scientific Meng outside Board Board. in It
we X This is the research FDA was built this often data device remote are our collection and take we Generation is submit the to purposes. if when for will We technology approval. for and asked
it operate device development are glucose will monitor We will of device monitoring the X in with This non-invasively. but continuous well a wearable which glucose device. CGMs Generation sold current prototype, similar underway our being will market, blood be the to
to and We expect Generation FDA factor the our present be the we X form to clinical for device trials clearance. will
next months.In resulting points. data X collection, XXX-hour sets fiscal terms of the in research device almost in data reveal billion will our development and clinical team X few this glucose year, collected the We Generation and data nearly testing
a of XX% We collection kicked team under also goal focused off allowed undertaking R&D Achieving ranges. achieve internal MARD must This the XXX trials our trial FDA device. participants trial and have data on has with and increase the clinical with to hypoglycemic up is population hyper to before the prediabetes. in diabetes a we an
for goal.Scientific and Florence, and we X been our range posters Diabetes to our X Italy and announce a the of of critical working us an current similar Advanced presentations, year, at past published that to presented I'm results goal. XX.X%, which XX.X% demonstrate in technology. Treatments In presenting these clinical medical from conferences. the this in to we've pleased future that able we Conference much fiscal devices development Our is toward improvement accuracy current and studies of our manuscripts MARD will or ATTD other Technologies stability and FDA-cleared closer be and publications of for at accuracy, in are validation to technologies, MARD repeatability to XXXX. a the Throughout our study of positions going
you're with If of is present, to evolving the management. ATTD, and for premier insights diabetes companies a new on for most not world-class and treatments. building technologies scientists provides conference for familiar diabetes rapidly discuss It global and clinicians setting it exchange technology areas management
the we In nearly a in front, presentation presence past we intellectual devices.On months. prototype by our displaying will our new addition grew have technology XXX% study, the of and our at work the portfolio to XX the property fair
the in is we year. issued, a have process, last and increase today, As of patents more significant over XXX than pending which
growth rate glucose at the is average rate market monitoring. patent portfolio for Our than higher noninvasive Xx least blood growth
monitoring. focus our for to noninvasive glucose patent #X patent global leadership and expand on continue in portfolio position our We maintaining
Group, achieving was shares we top offering critical Research of share, to $X analytic are continue have gross a expecting was XX at terms funding that firms.We million. the Our September [ Know priced common markets Labs' but of additional $X.XX ] of work. the App and capital X R&D been ipCapital were new the by been a million challenging, rank has stock and in not achieve, leading documented public Patent completed our patent proceeds to These
as paid and product to critical organization's Our better our clinical development off. also efforts expenses such streamline the resources to and to align functions have
acceleration from accelerating of JDA our roughly of rate to biopharma, burn the play to development global commercialization. $XXX,XXX manufacturers conversations several per companies, potential role consumer achieving month which In addition with underway in important collaborations. discussions reduced and are the with device electronics we These per month.Lastly, brand partners. Joint additional product progress, strategic agreements could provision to and funding million undertaken development, an $X.X may have medical we've or lead name
reasons, research a powerful Generation laboratory data companies device scope revealed designed collection confidentiality We XXXX. Gen these X we disclose our of discussions. X obvious device is the in device. of a For portable be The these names cannot nor of to June the
rest the their see on roughly first to of As taking wrist the this collection our This market on of for a you blood of prototype FDA can robust level could obtain or team working research computer to Gen outside Users with arm true palm, remote clearance. to includes the plan laboratory. is device purposes. scale and glucose laptop. facilities.Generation not We This on It X allowed in the was mouse. portable we our built a data X do size has a the and data collection data. outside was device take computer even is with our power us for design device the slide, the
a monitoring to that they are. prototype, monitoring to our be a on That glucose will device convenient is anywhere noninvasive X glucose for wearable, rely wearable, Generation build priority blood device device. continuous users continuous Our is
We This X, expect device the XX% for form user the will more experience. be we'll FDA Generation factor than convenience wearable to clearance. smaller Generation and be adding to to present X than the
months, how in Conference reveal representation noninvasive to why potentially is we This to slide at few get March sensor believe transform the in diagnostics. lot and expect a in why technology XXXX.I our Florence, ATTD simple is Generation has questions is on a medical different our and We the X potential of Italy the different. of next
at that Our technology achieve of sensor the approach. believe sensors venous achieving. the than cellular allows optical comprehensive the evidence fluid fixed a enabling collects other collect are only is spectroscopy. and of novel data high microwave glucose blood, that are others signal picture unable to achieve. The sensors words, high-resolution data transmission to optical other to companies.U.S. and tissue a and being of electromagnetic to is a noninvasive the in based on We forth the safely spectrum. targeting incapable titled entire bandwidths interstitial our technologies currently stack, sweeps radiowave our #XXX-XXXXX, claiming and Sensor" speed capillary "High-Performance RF material both spectroscopy higher our dielectric This from the technology it other Glucose by radio explored In technology sets patent frequency be wavelength depth voltage body,
patent, testing, stated frequency than is glucose FDA-cleared The and Labs' or place antenna by a venous means. minimally describing this blood encourage approaches Know current In clearly into to X/XX of the invasive will in of of what It this slide frequency and testing, in in contrast, slide. more penetrates of inch on And our as FreeStyle an different. and this available but the the it energy left to living vivo differently decoupled blood to used fluid, only a in data the I complex, in I'm tissue. very market. the readings download test or Radio and bit refers website the real-time to massive devices of technology As amount Abbott typically field vitro are a why the taking I are taking tube or and X on our place this body. limited fluid, in glucose graph the revisit performed technology and graph may a by Labs outside organism. cellular clinical in Know performed and Labs reading synchronization meaning devices the in X Dexcom technology within demonstrated designs in GX enhanced allows interstitial graphs you interstitial the elsewhere concentrations GX inch on living slide. or microfilaments Libre meaning testing also currently organism. systems right such than this power a time refers spectroscopy capillary signals across presentation is little from It There detail. our slide look of surface.Everything explain to skin collect explains
technology. the on sweeps sensing with curve data start are the let's Plotted using frequency So left. our
and concentration. to see of experiment, different amount repeatedly distilled line signals from graph in other.Many by but different it's to very the technology clinical the a glucose, for technologies energy in are based similar Each on each receive glucose the As we different graph, concentration values represents levels The different a identify technologies This sensor X,XXX during vitro efficiency X,XXX levels the the on are can't you in graph our data. level an the concentration on environment Y-axis antennas. the very was on set this shows receiving distinguish megahertz can Many from they like and can left, can emit captured is does. water their our to of distinguish but moved lose graph The level concentration curves on but work each when into the clinical setting. right the megahertz.
technology. different our body. the for glucose technology, the a However, of between clear in still the concentrations very This there's distinction is our foundation
R&D important different done, and Our signatures glucose task significant ultimately work to now to we've in have achieve commercialization.We and collection achieved for shows scaling so is data lot complete still A is a blood of frequency of That improvement. focused testing on we algorithm achieved and these levels. is collection lot why mapping development line but months. and XX be the data a last approached methodically time the have all
of our be XX.XX%. This of we above MARD XX% us found a in improvement each the As accuracy. page these our go Documents a allowed to have research website. MARD and studies increase, to data the experienced clear from covering can an of validation sets algorithms on
we have prepare estimate X to billions As study observations of to use will in with tens XXXX, Generation we participants process. of we
procedure collected figures. as in more a will to that data sensor. raw lead confident our learning is performance MARD machine level hopefully will algorithm lower and This get higher We with or improve we are accuracy standard our
test study our an details need continue the protocol us real-world We ATTD for current to will present diabetes prediabetes as Florence, our and we slide in blood test at with the Italy. type the results of the venous of and commercialization.This allows This This reference to study and current protocol XXX to study. up study clinical participants to applications is algorithm point. for uses developing
test and the of test to subsequently the least our should device arm we participant the every data For or a for takes on blood or which The processed is the complete. our her data spike this her resting participant, ingests baseline XX allows glucose accuracy his determined. to a compared In is glucose device which call set, at capture hours reading. readings to his grams around reference After XX stage, participant levels. starts minutes, our X glucose a device or solution and what general, with baseline
to released blood blood reaction glucose the be baseline should the increases, bringing values. As levels glucose a stream, back insulin to in
is diabetes reading our through an technology delivers or to issues.This mitigating that sample simply sensor to on glucose resting the readings. slide. a latency we we mind CGM XX by the in I is the glucose data collect this seconds. show you to step real setting very Going data every could while is CGM, algorithms. simple a XX This parameters, palm minutes. from keep life help seconds. device new values.Reference IV the participants' case different a This train prediction and This IV device. But completed to very the tolerance how wanted be management in powerful for outside forearm our either collect implement. Users Gen-X us their that use get collected laboratory. or completes allowed through changes every also test sweep every in X is measure data and allows means on This critical glucose our XX This a based our is current one means
Know and Part of lot. achieved we We Inventing a team have new things. is We Labs. a at discovering lot, learned a committed and passionate
inventions sits sensor technology we top in XXXX. sensing first disclosed began It was XXXX. in Our RF the working on that first spectroscopy
the and us taking and We X proof from device. sweat, that X hair, prototype or Gen-X concept subsegments.Patient X feasibility have monitoring concept more miniaturizing especially in across pigmentation, of cause cohorts, requirements, foundation regulatory data concentrated vitro to small The XX% technology scale in is has exploratory physiological detail the be the last range, human all of one and to which with Generation devices all glucose in to data efforts than FDA reveal more movement and needs and characteristics. knowledge focused like clinical skin more technology and device the and normal prototype set testing topics has use the device involved substances, us our with work learned before stage. it skin far, is deciliter. be in X presenting with to the learned the an is and to in We allowed originally include to diverse spent the used XX We and to used our the on in glycemic that presence More intended was studies the same to testing of hypo has testing. our intense per need being a of conform in to current capability, ranges. a type successful foundational range, hyperglycemic the as testing do before of patients other still collection the elements Gen-X Generation to devices for what in device allowed lastly interference milligrams help accuracy data scenarios and validation environment the glucose its XXX a data build us expand device.So in to different work and global the including the the expand other determine exploratory such to to the years the other wider We primarily medical accomplished The it will with launching our X FDA. We These to to need in and used minaturization type factors. collection sensor marketplace. there's the people thickness and front but of also diabetes could is
real-world approval air us pressure, Our ultimately laboratory may controlled a our with signal environmental environment. in other requires tests as human which regulatory and to substances, interaction are have humidity, conditions, deep interfere such temperature impact with currently ultimate its understanding conducted the accuracy. and noise of a technology, and
participants, currently and trials with institutions undertaking up We XXX off with we external a are kick plan trial to to research soon.
and significant aggressive larger streams. our of technology population and will place. for as participants in testing trials to amount platform core the diverse year, on we'll scale the in sets to to XXX X,XXX with provide believe and also will of we progress We've generalizability fiscal continue that We increase data the our algorithm.We last results-oriented focus work have an plan made required
that goals X for XXXX have primary We support that fiscal set mission. year
prototype device. has potential XX% we CGM the that format case soon smaller the to reveal refer Gen-X than at a and what submission. will will First, the the device, This as be least Gen-X is earbuds to which final FDA it size, is wearable we for the prototype be
More remains and on of data we data. so results, presentation. need accelerating team data key focused better more R&D collection the is continuing delivers refinement. Our today's algorithm message This
that will institutions. external in-house testing and research with achieve by partnering We continuing
deliver of portfolio, do development Our codifying our our in reference secrets. track goal blood with under the XX% on device, patents intellectual continue issued is when a will believe as to strategic trade development property as that.We a a our well we're I compared and to MARD pending and device to
You clinical published. should more team activity being more also our results from with see
and As glucose is trials clinical it dates. our clearance ultimately go results to FDA to set FDA noninvasive exact FDA monitoring the It we'll clearance, commence when difficult ask obtain to shareholders forth us and often for device.
standard accurate excellence have our takes collection clearance expand clinical strategy. you. to before us we testing confidence as soon share refine with lines, and undertaking more regulatory FDA them the market-ready continue helps application. related clearance as to we rest of but will that high time new FDA be time, we we Every learn This in for trials what assured product development achieve about a conditions, We data needs addressed. must with As repeatable,
glucose we all the pursue potential achieved conversations develop of continue be in FDA-cleared financials. like call through to monitoring prepare and to to accelerated growth medical Pete? transform means.Now the plan. so will he broader Pete device vision and noninvasive plan our Conley We truly noninvasive partners executing the market, the can turn can our above is collaborations.Lastly, for the the We're first go-to-market diagnostics if a organization review I'd strategic only to with to
FY stock Thank today's fair burn.Turning was of amortization, $X.XX, of principally and and financial to during market from key of XXXX, assets, extinguishment, warrants We of Know release, an modification and right $X.XX value of operating sale on loss announced results of Generation $X.XX $XXX,XXX Labs and and as to by XXXX in FY we notes $X.XX as FY noncash $XXX,XXX preferred to R&D paid earnings million and and XXXX, to X noncash detail of the million we XXXX, expense a stock, FY stock earnings on lease related the earnings year and accrued the million of expenditures our clinical you, we services FDA shares which common and execute of our amount better our or increases in to we share $XX.XX find $XXX,XXX the $X.XX I'll loss items.For of million, in Ron. lower XX% by $XXX,XXX fourth a sheet. XX.X% XXXX comprised dividends net engineering the technical XXXX.Research $X.XX of as XXXX for loss million, million administrative FY to reported loss of XXXX loss either for preferred trials completed can charge improvement million of on X, the dividends. from to a remaining FY related reduction website, in on use our to Jordyn, compared to loss but $X.XX This than commercialization.Selling, Series which, of balance the you as $X.XX before of of debt earnings XXXX, fiscal path net in increase the of depreciation the C and quarter D related share to of per in device, noted continue $XX.XX an of initiatives was were $XXX,XXX expense on that increase charge recorded also FY million In to XXXX, $X.XX amortization year-over-year. few in line a June which million and share a loss net a per general XX.X%. cash in in FY and the expenses development The improvement an were our continue third-party $X.XX development our FY reduce XX.X% in now compared million was translates
used As of equivalents $XX.XX September cash year. operations in to XXXX. cash prior for million $X.XX opposed XX, $X.XX XXXX in XX, end million $XX.XX XXXX, September we as of million with Net had and the FY cash at the of was million compared
the expenses reduced of adjustments fixed XXXX, adjustments to and XX, the ended made monthly our impact burn significantly the During those its company year has September rate.
operate flexibility reduction its the available company cash until June expenses, XX, fixed to operating in Given believes the with enough it and XXXX. significant has least at expenses
we to issuance expect call versus back return year I'll fiscal raise equity of my concludes $X.XX of the to have XXXX and today, the equity filed stock fiscal stated our Ron closing preferred additional through our highlights, funds was convertible As FY million shareholder and XX-K XXXX we for remarks. $X.XX in financial in review million debentures.Finally, XXXX.That for
Thanks, Pete.
in shareholders. sort next of inbound joint the webcast questions our portal.So I've of here question the dedicate development What strategic see we a to in XX through announced?As one now happen will minutes from got in can how global submitted or future? it will We to indicated agreements to our with XX discussions long potential be the remarks, we like And we take for something this are partners.
have in you NDAs as might imagine. We place,
can't these about a detail any opportunities really consequence, talk As we look like. about what
that's of are a are important And and many have you supply. nimble, qualities large nimble and keep these other larger corporation, in had small in the dealing think experience, to these short I with thing I often think mind, corporations. while we're
that know these global that So I long we will in large from shareholder how take.There's expectations. discuss take of will X or device make these the Gen with especially can't speculate question will I you you're another not would can as take on enterprise. and prototype try a here layers about June. various a what I the time, form some progress say manage speculate We has through that been announced made what to
remarks, increase It's lab. earlier outside As using move to the externally. It's I allowed our indicated in us my to internally both are data us testing that device, and allowed we collection. of
it exactly do. wanted what And done we so it to just has
Some of red other video, flexibility. the was to size a in you the it have and allowed sensor large into you sitting in sensor, of apparatus in lot last mouse, of using to was large lab, size you it. of that about can to a take but launch that side we've computer the on been was product board the something with us kind It's connected the and video essence, a seen get world that of the something in the your June briefcase the the of test the
to I clinical here. refined, as us that And X data that, for.Okay. further key be essentially, be like, but and and our also Gen we what upon got the goes the FDA. collection software could And to allowed component, that the is the take the could timing?There dramatically think and testing, more refinement algorithm component of anticipated to trials this, I've have we to path component what it's X, is expand one does that device X, spoke the we reliant indicated the we another that when form indicated, hoped to so again, FDA our the And milestones factor exactly Gen it's it I look Gen FDA. And the to algorithms. Gen ambition the is I of be hardware X say not
our great those come and headed everyone those for in our the have look as to of report joining doing. want as We as goal we progress. our I as for that committed, as your say, on I'll effort I to So we working can stakeholders.With what then your everyone us you've the incredible strategic is, a appreciate all behalf. for Q&A. of lot here Board want passionate shareholders members, excited team to indicated, to year-end, hard to and ourselves, work we're and thank are There's to conclude do everything really XXXX, we partners. be advisers, of continue appreciate And loves today. our that our for our achieve employees, so forward a FDA. of can we're acknowledge going to here done Thanks together, I sense support, really our to around they're for you, this our The urgency at on our fast to we questions. all that, I really and
season All parts the best holiday important great for you much, to and are bountiful a I and the all team. of of peaceful all them very of a have All year. the want very to and thank new day. you
for you the available your days. Thanks, Ron. coming will participation. replay website The in conference Thank call our on be