Earnings call transcript Q2 2023

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Operator

Good day and thank you for standing by. Welcome to the Talis Biomedical Second Quarter Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to conference like speaker to now Ms. today, would hand over the your I Vice Communications President Senior Faucette, Emily Corporate and Relations. Investor ahead. go Please

Emily Faucette

Good you. afternoon and thank

Officer; Interim today Becky me are Kelley, Chief Joining Rob Markovich, Financial Chief Executive our Officer. our and

website business accessed Earlier and for page on Xth, A the financial June press that our update copy today, Investors ended released of quarter at release results company XXXX. the talisbio.com. a the can of be

will Federal management remarks like within material to These could Before call events results that remind are during statements cause we uncertainties get I that anticipated. or that this to started, the would you meaning Securities involve make forward-looking differ statements materially those actual and of risks the laws. from

and section these in press appear the in regarding entitled Statements Talis information Bio today. the release Additional risks issued Forward-Looking uncertainties

list XX-K see SEC the For description, its form on including a March from other maybe time-to-time filings. Risk in supplemented company's the company's Factors the and more section of XXnd, XXXX filed filings report with as complete please on annual the

Talis otherwise. by contains information or because Bio the of forward-looking August and XXXX. new accurate on whether XXth, any events, obligation to intention law, call update financial or statement required Except of future only as information, projection This or conference revise or any disclaims is time-sensitive live broadcast

to would the over call like I turn With that, to Rob.

Rob Kelley

for today's joining Good on you Emily. and us thank Thanks afternoon everyone call.

to two Bio. we begin, like Talis to Before distinguished leaders this would take welcome I to opportunity

his at him opportunities Molecular track Dreismann ahead Executive large over corporate record President Roche, Heiner's appointed of vision fit the we the XX-year and a Roche Directors. Officer including at functions Heiner for Chief Dr. as Board multiple us. make our tenure of and May, Systems, great In course of to leading entrepreneurial

regulatory, experience in Dr. years newly diagnostics Officer. the Scientific role leadership week, than of responsible will President manufacturing With and be XX more and our the Executive in for industry, created operations. Andrew Lukowiak team and senior Andrew joined clinical Last of Chief clinical R&D,

During this have to to Talis market period Executive Andrew's to the experience menu. we One, teams deliver to at concept execution Bio, test commercialization of the pivotal and will strong bring built ability proven fortify products from Talis

We both, look forward to our and benefiting testing, advance the accurate seasoned moment as to we the of infectious at Heiner Andrew's deliver need from in perspective, mission disease point-of-care.

laid to now we business progress support imperatives Turning to, recent out the May. our strategic in that

offer sexual of prioritizing we providers want reminder, development to point-of-care a based on market test our health are infectious at As women's disease that four the and the panels research.

Our initial or Influenza Infection Herpes Simplex Chlamydia, in Panel. consists menu test COVID-XX A, Virus and Panel Fluid, of Respiratory a Influenza vaginalis, Trichomonas or B and planned HSV-X/X gonorrhoeae, Vaginal CT/NG/TV; a or for

possible, panels test of are support clearance made bring these Talis leveraging as development soon In broader of complete order as test to with menu. progress to-date to we One XXX(k) market while test to we System, our our the COVID-XX

towards progress to a important end before minimize and test panels goal strategy our have risk disciplined to We are securing and executing three accelerate regulatory XXXX. time commercialization for of clearance designed of made the

a COVID-XX the is are for for clearance System underway. our to clinical Specifically, panel. And to panel support fluid study fluid preparing clinical we our initiate XXX(k) study

Testing the market that care. course women for research interested a their pregnant our Ob/Gyn's reminder, of from are in patients know we Respiratory As and in

complete platform while XXX(k) we experience we with of plan such, development demand fluid our broader to As to clearance fluid panel our menu. our of initial create test panel and pursue

Care and that Ob/Gyn centers. STI our select collectively and to up work clinics, CT/NG/TV across pre-submission We offices, our are also Study for Clinical patients to beginning FDA to enroll Urgent HSV on will X,XXX sites for

The differentiated for on Infectious menu. IDSOG, viable Turning we and Ob/Gyn's month presented a path us meeting the now last annual are developing to Clinical Diseases test gives that to Development, Society at data confidence new

First, minutes, molecular our a assays performance feasibility study widely of XX clinical less development on-market tests. used to comparable in stage and CT/NG/TV demonstrated than

residual for performance TV clinical that to Lab neat matched samples initially a XXX% generate preliminary minutes and platforms was result and comparators, clinical for This assessed CT tested Central the while CT, XXX% result. results for NG agreement using positive TV. XX up NG by In urine, mail negative XX% to require, and matched against

negative only tested matched and were In at matched XXX%. were tested, XXX% CT/NG separate for swabs In previous samples XX% NG a positive where the TV were the against results comparators. Vaginal CT for results vaginal study swabs against comparator,

We that to access stewards molecular informed to a will single multiplex a believe point-of-care decisions, system, enable is test CT/NG/TV test and and a providers are make better visit encouraged use. feasible of during treatment patient become antibiotic results on

on presented demonstrated IDSOG life under a minutes is achievement system. study to panel. A in our also challenging the developing second critical One in Talis point-of-care at infection our four ability step pathogens vaginal This fungal effectively

at IVD One performed system studies on limits of scientists lysis systems bead-beating that on-market and cartridge to three with demonstrate tests. to the for Our of lysis on species, efficiency mechanical candidiasis effective concentration mechanical vulvovaginal bead-beating on using initial lysis Talis without Candida lysis used sufficient the determine experiments levels chamber. These releasing comparable target multiple nucleic detection led of detection acids to

differentiator Based of to system XX test minutes and will concentrate platforms. to tests. We faster acids be less minutes that XX on a results, lyse a these positive time approximately these difficult from to to having may believe the the than than turnaround to be key detection, achieve current comparator ability while XX is lab-quality limits early these One able results in Talis and pathogens deliver purify nucleic

address where with flexibility our all we Moving to to manufacturing stages have capabilities of the business. and stability established

efforts. line manufacturing now our early Chicago validation cartridge to eventually operational all of and upcoming semi-automated is and support Our in verification activities commercialization

spending to restructure the produce capacity our contract drive operational with to has partners. manufacturing X,XXX reduction, cartridges this efficiency continue To day. reminder, As line we per relationships a and further

while ramping the During inventory. transitioned new a up now our and to to instrument of quarter, the second from instrument we we internal partner, draw manufacturer new continue our process are in

previously to materials have date we several raw more. instruments and have build to As disclosed, hundred built thousands

we transitioned located to supply our card to the away streamline from United partner our manufacturer in have chain, new here raw Additionally, in States. Germany a

cartridge. agreement scale required manufacturing when will We also manufacture license these to new to entered further believe we of into with changes increase We commercialize. a respect our freedom to key the to and allows operate that our quality this component ability speed with us

progress imperatives. our In strategic summary, across is team's focused delivering our execution

is study underway. COVID-XX Our

support continuing for to menu, we all panels, clinical commercialization have efforts. support develop optimize preparing processes our to positions broader upcoming and well studies, we studies are as early to that CT/NG test positive of generated our and manufacturing to infection are differentiated as vaginal data We us clinical

deliver of accomplishments, well-positioned are cleared XXXX. for to women's believe we panels With we the health these the sexual three and test by end markets

to turn I through over results. to quarter second Becky the Now, our walk will call

Becky Markovich

Rob. Thanks,

During NIH we quarter, which the was grant by $X.X second recognized driven million revenue, income. in mostly

XXXX XXXX, to investments XXXX. the raw in expenses last spending million the the million quarter development compared decreases was of in Second of card $XX Research same same inventory million primarily year. compared $XX in $XX well reductions last in were due for million to force Selling, and period quarter These by period second total in were as and operating $XX driven to lower manufacturing primarily in cash our to conservation from and quarter of in administrative the million as general $X second million ongoing quarter XXXX costs. headcount the expenses compared second head year's count and efforts. lower costs were $X

the as $XX XX, Unrestricted to of sheet. balance and cash million. cash Moving equivalents XXXX, June were

months support conserve To to activities range by by into we to cash a in of this target and in Redwood year-over-year used in footprint continue smaller which financial an our monthly burn facilities California, objectives, quarter, the of delivering rate million reduced improvement net a first moved XX% We $X our space two-thirds. cash with our average XXXX long-term within during $X lab office cash X City, million. operating

of million life over savings the lease. cash the We approximately of expect $X

sheet no remains to and conservation. we on debt, balance Our continue cash strong with focus

ensure into that operations objective our cash current fund are to to sufficient Our XXXX. is reserves

the for remarks. I'll closing With turn Rob that, to back call

Rob Kelley

Becky. market generate address the effectively of respiratory point-of-care to most accurate molecular and beginning positioned data numerous to limitations, the patient closer bring pandemic designed growing platforms make we to of a of the are well impact a COVID-XX these The and testing rapid care. and development to you, The is few delivery address capture needs accelerated sexual suggests the on patients. that meaningful Thank and testing. large are women's timely Unfortunately, very importantly, health Talis Bio to

to are for women ahead opportunity We health decentralize sexual excited in testing. the

early optimizing and multiple our executing down road delivering efforts. development to manufacturing our heads support capabilities focused and map is Our organization studies strategy, commercialization regulatory continuously our and on on clinical

With that, the I it for turn over questions. operator to open now it will to up

Operator

Instructions] [Operator Our question. first Certainly.

Our Massaro Mark coming first from question of BTIG. be will

Your line is Mark. open,

Mark Massaro

for Hey, question. the Thank very guys. you much taking

on off to on thoughts you and sense to XXX(k) give sure correct? right that's with for study of stand-alone the lines for submission, clinical us maybe the are kind This start just roughly I now your wanted samples, time how just what Can for track. I'm So a underway is a COVID. many make

Rob Kelley

Mark. to nice as And Correct. you well, speak to

enrollment in is June study of start positives and XX me clinical XXX let target this year. So with the the officially negatives. And CXX began

geographically was get have us the that We can started takes we're study. those, as about XX%. to staggered the prevalence clinical of when And two-thirds it approximately some enrollment currently And We the just background, way of sites. study, the obviously, the we through prevalence distributed four to through the drive target. start time and our

it X%. the started approximately late we early summer, As towards to spring, getting dropped

So that slowed little bit. down a

to that the rise to target into help However, pick the get starting enrollment. see close fall we'll up hopefully, we again. as And continue are out see we us that to

now. that general that, the about? anything else for So from that Is missing there like that's you'd know to I'm update

Mark Massaro

That's really all that Yeah. helpful, detail.

you and late to ballpark? XXXX, approval somewhere XXXX. might fair the end an can right near Is the be that in then you it would of study, mid that it would So think the perhaps to complete happen think submit

Rob Kelley

understand time a it. do the specimens, think analysis we write difficult to the also for December all the we'll I reports is way FDA. good about a that's I have to of Obviously, collect the think up that and after

a the So submission expecting probably at it. I best very early XXXX look in way to think is

Mark Massaro

Yes, that makes sense.

hear first -- time on you've timing this the think to might I great launches. provided test panel it's be you So that

that the So the are you end four -- there are that the that those fair by of three think three of all three other? you've are of four laid clearly out, of you game, -- or ahead

Rob Kelley

Yeah.

by the cleared clearance, launches, that talking is that end instrument which or XXX(k) in talked other we going I'm hope have about which forward we of giving verification panel, not believe panel, talking of three would is XXXX So, panels fluid but CXX followed clearance, well, for the us we have, the submissions is with about the the absolutely. which critically currently previously, that by that us to We and stage. about the any important

But C-XX, end CLIA gone XXX(k) waiver instrument the for CLIA regulatory to three applying is the by CLIA-waiver it's why in hope would are But time. already of that since important will then clearance, of we've CT/NG/TV our be part we note, which, time XXXX instrument for be that of this And it the waiver to that's CT/NG/TV the with well process. cleared have strategy product, our the those the have to as are and is with fluid going before fluid first as course, also as de-risks submission and it. we for instrument associated about

Mark Massaro

reasonable And panels to -- Okay. be these they're to after to Thanks. shortly it would commercialize cleared? seek

Rob Kelley

Yes.

first. me one make other Let comment

mentioned four You assays.

feasibility fourth where So is currently our in start pre-sub. we HSV, between and and somewhere the HSV is the pipeline in is feasibility development one

started end encouraging. we have the have that. before that year. and very hope And So of development pre-sub has timing been the the We to submitted the

mentioned could is that is are in the HSV we we right the one an we're have can ones HSV three into that that we XXXX. and with potentially upside I confident opportunity hope now, expedite. So there that pull But

In about comments terms launch. of your

of the item driver, health in adoption assay So end we volume driver, possible. would to drive it's the to an adoption users it's be. sexual absolutely our our is women's like our platform product as what is a women's first soon going CTNG, opportunity of take But what it's and will to really hands as -- get health

So when with full-scale CT/NG/TV. we we're that linking about clearance about think commercialization, thinking up of the

to get customers some we as opportunity of well. and experience the those other as the meantime, utilizing However, market to of I do the those there's us think hands get in great for get products clearance in

Mark Massaro

the And It in sense. makes looks declined That quarter. me. cash the one last for Great. to like million burn one $XX just Okay.

a about XXXX still sense pro there. then you're you're burn you XXXX. can a I $XX think so you're about And previously, us quarter, to of and balance forma a you talked just about what $XX Is into million hoping already thinking million that sheet how for for? the give

Becky Markovich

Great questions, Mark. Yes.

coming Fortunately, strength. position we're a from of really

$XX of have second that of And million you million to future. repeat average an on $X debt. target to your are last or part $X the put into sheet, the of our we the million Can have We we the basis. question. part and balance expect of your continue cash near spending per the year, we month on in reduction with at our no that And place programs we last did question

Mark Massaro

Yes.

the balance sheet The XXXX XXXX. about second thinking part you're and the how of question into was

Becky Markovich

Yes.

So, we with strong sheet do cash balance position. a our have really now right

So to fund we fund the growth commercialization our we operations. expect future But line. order down and that in have to raise we know to capital essentially to continue will

Mark Massaro

much. very Thanks Okay.

Operator

-- to Rob further call turn question. for closing remarks now showing no I'm like questions would to And back I the

Rob Kelley

time Thank Bio. and joining today you your us for in for and interest Talis

Operator

This concludes call. participating. you Thank today's for conference

now You disconnect. may

Talis Biomedical (TLIS) 10 Aug 232023 Q2 Earnings call transcript