Chembio Diagnostics (CEMI) 4 May 192019 Q1 Earnings call transcript

Greetings, and welcome to the Chembio First Quarter 2019 Earnings Conference Call and Webcast. [Operator Instructions].

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Philip Taylor, Investor Relations. you. Thank Mr. begin. may you Taylor,

you. Thank

the Before we company's May you the the meaning me XXXX, the XXXX current beliefs today, made during let of of the remarks within today, forward-looking remind Act this of include concerning that company. statements begin Securities conference X, call

projected. Risk to assumptions, including Forward-looking control, uncertainties and materially including numerous uncertainties, and time Chembio's of filings, risks Factors time SEC in are under Chembio's from XXXX. statements on to which in many those risks XX-K described and Form differ today. Chief filings SEC the subject concerning those Chembio's annual are Chembio's Sperzel, or elsewhere from made I beyond may results report for revise encourage With publicly these and you President John with and the other all obligation I turn undertakes Officer. company's to Chembio matters. would to like to the call statement update any that, to forward-looking review Executive over no of

joining for off to start XXXX business. us Chembio's you Thank strong continue across the as execute to in we a today.

now U.S. the order delivered initiated test, Brazil. and our We significantly test revenue quarters. development received funding DPP fully of point-of-care period, regulatory compared Zika, for test validation approval from Brazil's our and we the an of our chikungunya year plan. from additional ANVISA, first the initial completed margins facility and the $X.X and our representing recent which health manufacturing Science, X% line, agency, first Our team concussion. this growth million XXXX, for received to expansion advance gross product test multiplex and compared prior provides of to We increased of in for quarter improvement is for We automated with an to dengue producing and new recently signed agreement Perseus support which a

advancing Today, million. results, growth. of in revenue few are three closing $XX million a for the open Then and progress on preparing our call discussing then pipeline full our financial the $XX year for first to we'll and reiterating our expanding start quarter make XXXX R&D we priorities commercialization, guidance questions. review by Finally, remarks we'll XXXX: additional

expand priority first to is our commercialization. Our

from our sales quarter first multiyear state by sales strong Germany United the led which In States, in quarter and functioning of sales commercially operationally characterized by our including to opTricon, has Zika, continent, product HIV Diagnostics demand first by chikungunya a country of Brazil for that in Chembio epidemiological that multiplex the product sales customer, Brazil, increase complex including a and for approximately due antibodies driven in we Brazil's benefited test material dengue is center for simultaneous now resume. was STAT-PAK circulation under allowed The that public And surveillance. products. regained received the sales recognize compared we in in prior In detection viruses, second-half with for increase Zika, sales sales In technology. contract HIV increase the self-testing prior calls, of and annual growth shipment throughout for performance to acquisition raw active important of offset be and these to potential our were disease States Ethiopia. and health ANVISA large the by HIV We're Europe, The increases both large the which the we treatment of strong, of increased multiplex during infectious Africa, discrete government from during $XXX,XXX three also These And Brazil and of sales On resolved States, to test, unable X% Europe expect single a pleased chikungunya. exposure new continue we our to we more our identified quarter drivers as to year. tests three we weighted. XXXX. the both excellence we issue XXXX, to contributed to were continue to tests multiplex growth scenario allows been fact XXXX sales and during products arboviruses. of very now approval as and remains anticipate the dengue we HIV and and United optical to to simultaneous as test recent these United Chembio's for Africa. sales several

between the sensitivity specificity yielding results and and of provide highlight quality issues. production the our to XX-microliter finger-stick is potential order. drop outstanding the Brazil's health results the quantitative performed characteristics XX to and the supplier specificity, There's XX.X% and sensitivity, like in ability the results Brazil recently multiplex our multiplexing when we and chikungunya dengue Reader. and of a the simply XXX% has of advanced evaluation long-term received subject An test Xx Zika, average to no optical initial our for critical agency, a minutes These It's mark into channel you samples company's dengue certain Zika, new handheld agreement our results XX.X% our with and order from test Control perspective, inform tests committed regulatory that Ministry both between in $XXX,XXX. performance. provides Brazil National in noting current performance, technology: the blood and using following worth analytical all only performance unique certification Micro and endemic also of about with in million Institute for than six of our differentiated of optimistic it To our chikungunya in believe performance XXX%. for an for testing and outstanding received INCQS, Quality that we're patient order million ANVISA region evaluation Our test due our including test to prices. test totaling or conditions, Health, long-standing quantitative X that these has both exceed Considering greater small handheld of other and rapid and and analyzer. such UNICEF of pleased multiplex opportunity $X.X CE stand-alone for the Brazil I'm for halted Brazil's XXX DPP test current annual and commercialization under this in highly with world. alone initial using ANVISA, in the a Health, showed tests are we analytical to by $XX Brazil's products a could demand Brazil put for our selling prices and to also to over

performance UNICEF recent in test Brazil, December analytical LTA valuing a our UNICEF the up through our agreement, in is valid study XXX-patient meet allows to the $X.X of additional requirements. total The million. $X government million, our of to analytical of XX, XXXX, performance which long-term and Given ability purchases clinical by we're confident for

second to pipeline. Our R&D is advance priority our

and the During advances first quarter, we regulatory significant affairs. R&D made in

the acquisition product business Following optical our added development our in we and opTricon, development, analyzer handheld of broadly activities. commercial

advanced the the tests commercialize technology, analyzer ultrasensitive also and low-picogram level that allows detection to a biomarkers us level. develop at which We fluorescence-sensing using incorporating of require optical by

XXXX. as significant point-of-care reducing a with room both room, million triage to a the funding test the Perseus emergency sensitive a complete developed for we'll point-of-care advance and Finally, We test TBI-related highly costly scans. working or excited in our expect Prevention has emergency A the under for support receive be need already by see of development analyzer, for X.X which Disease recent in Science which visits in end Brazil We're time-consuming opportunity market and about we our concussion be the Control prototype agreement team concussions. to to could for next-generation of used and CT XXXX. the Centers MRI reported of our patients test

clinical followed Brazil's our is As XXXX. validation nearing of development believe previously work We our regulatory. regulatory phase dengue be to verification, as be in ANVISA, are to agency, quarter tests test the discussed, A second will R&D approved regulatory this during of obtain pipeline the program by by we approvals. health commercialization number and in

our already test Zika, chikungunya ANVISA Reader. reminder, test; test; a and dengue Zika the As Micro approved chikungunya; and for multiplex

and on initial from was received the dengue in already mentioned, As test outstanding, for Brazil. product performance our this Brazil orders multiplex we

recent $X.X of performance a ANVISA our So our realize the $X.X believe confident XXXX. million test ability CE the in of are the test chikungunya and highly is multiplex mark. Obtaining CE to are obtain will dengue order required our about Zika, approval. We increase second potential the Based obtain highly from UNICEF of Brazil, the again for million. quarter on one multiplex we to we confident during the total the in to to mark mark CE with conditions of

the We BARDA, we'll BARDA, or government rapid Our which FDA clinical Zika U.S. the use test. also only second U.S. XXXX. and XXX(k), the is completed emergency the studies Zika by funded authorized by funded quarter during for of XXX(k) the test, is submit recently

HIV quarter during for we're the of first professional same submissions fourth during the of and XXXX. note quarter on already in was the and these prequalification is anticipate use. WHO second CE using for submitted We Our marked for of XXXX. filings that these product XXXX the CE mark to prequalified self-test quarter It's WHO feedback for important

test Food submitted and was U.S. HIV-syphilis previously Administration. the Drug to Our

and to to which collect we submit our As FDA related last the a mentioned year. decision FDA, the women, will made this anticipate we of half a on second decision to the call, from during we additional pregnant data

which funded proposition disease test. being value test, European studies used by assess AstraZeneca marked, are to commercial strategy Our CE is is designed to for support eosinophilic this is the which and respiratory and

As of we agreement pathway along this support the the our process, study FDA. on partner a note DPP once to AstraZeneca's timing through We'll and of update including de for pivotal for trial pathway. pre-submission novo are combined to the U.S. choice with agreement we clinical develop finalizing the mentioned on working regulatory in It's a test have XXX(k) FDA March, with with program. filing important platform the the to

potential We of optimistic a that the of compared our the create fluorescence-sensing given diagnostic has we're other use technology, the with number biothreat opened inclusion tests optical positioned incorporating to to collaborators platform and and about biomarkers additional previously our discussions cost of potential which detection to believe unavailable. are commercialize level allows platform. the to we growth using both performance, a of by opportunities in we're of The And Finally, drivers. enhance well develop of analyzer, companion ease to were analytical us number DPP technologies.

is priority to for third additional Our growth. prepare

our two from we manufacturing, to targets, United the achieve automated Over XX% and XX%, manual years, States, respectively. In To growth capacity. manufacturing future we our top is last line facilities transition well the and increase must expand grew automate our our underway.

capable lines lines we test, Our first line and for producing XXXX. and producing in manufacturing operational our CHECK States market. professional primarily is in tests. automated STAT-PAK We've automated SURE international to plan Africa; self-testing these the market United ordered two end the by test, additional of of operational DPP And be sold fully the two and sold

to increase capacity, to We expect the margins as flexibility and in investment gross as automation increase manufacturing well product efficiency.

third, and for are operating I now the leased development; we improving underway To phases: second be quality. research prepare as consolidating are The planned of obtaining by our toward Phase we for into three has of is half As shipping in expect World the we're the consolidating, the occur the single advancing The warehouse first facility, square end previously the well for approximately XXXX. occupied II and totaling facility is buildings a of to a discussed, XX,XXX the and in administrative move our and is manufacturing additional administration, shipping; Phase our growth, and prequalification. historically company Health quarter. III first, U.S. warehouse in Organization radius. feet new new XXXX, facility. within second, will Phase of second In goal four facilities. functions expanding and XX-mile XX,XXX-square-foot half and Malaysia, we're planned and

prequalification, cleared end follow-up anticipate Malaysia of We second to we supply this HIV will WHO will by submit STAT-PAK to facility Once the of the quarter in the a additional products month and this the be inspection documents XXXX. the Africa. WHO required for by manufacture receives

goods. We increase to of cost expect our as well this capacity manufacturing as to facility reduce our

turn I'll to over on our to financial Neil Now details provide it results.

is million, increase million, first quarter to XXXX. an royalty quarter in comparable the Good XXXX. R&D of were XXXX compared of grant Net XXXX. XXXX, In total first was $X.X revenues combined first of revenue compared which of XX% X% for $X.X and first to the of quarter and quarter first sales the product of an the the increase the afternoon. quarter of were of to and License $X.X XXXX first million, quarter

to successes due to to compared U.S. resolved. winning Brazil offset from The lower product XXXX, sales the commercial to quarter and decline average was affecting the first due region. large compared first with America with the was from XX.X% of the since margin a by Latin Europe, as material product continued of prices in the delay to that mentioned, well XXXX back to the state government's and tests. primarily direct net first dengue that product Gross ongoing issue lower was both in decreased Asia the U.S. for first in of margin of increased markets a has America quarter sales Latin a Gross for of and quarter The Africa, of sales XXXX program And labor shipment manual decline associated assembly Ethiopia program. benefited to to due XX.X% Asia. benefit John percent XX% XXXX. in quarter in As growth dollars by Africa a our as compared selling increased been tender. in raw the costs

comparing XXX revenue. spending, XXXX SG&A to the expenses, general equity expenses, the with XXXX. margins with point million and development improvement product in $X.X noncash by the higher which to fourth quarter to our by Chembio administrative when costs. by of million of of the pleased compared Germany, R&D increased quarter Diagnostics of selling, XXXX and a grant through sequential new first R&D other basis higher increased and combination related compensation Other research for were higher of $X.X the quarter $X.X directionally and XX% first are XXXX. acquisition legal of offset We rent includes facility million first quarter the and which is cost R&D and associated leasing in costs

the compliance $X.XX we period. year per a XXXX, prior $X.X million loss quarter, $X.X of the per loss million of acquisition. incurred the costs, $X.XX including in first auditing $X.X $X.X first related diluted Germany or the share was Net the During net in or share Diagnostics and to million million costs with diluted Chembio acquisition of compared of quarter

of to On of XX, March the totaled of balance sheet, and XX, cash as was a XXXX. million. decrease as $X XXXX cash million March million, XX, capital working XXXX equivalents compared December Net $X.X $XX.X

$XX full we XXXX mentioned, John As year our $XX to are million. reiterating of revenue guidance million

turn have We make continue to adequate an support John we call to confident forecast. place back And structure remarks. be to capital some current in that our the now I closing to will

pipeline confident platform, by combined We're test with and our through and sustainable in and pleased DPP continued internally growth. platform advancing optical ability through leverages execution our that We with in our additional very encouraged and share full XXXX. our gains priorities, to increased our quarter and growth market We're plan patented is handheld growing to first With of collaborations. the broadening progress growth across analyzer demand drive penetration revenue for business geographic market key presence. our confident prospects. the Bolstering we're in our a and high-quality point-of-care our create

consecutive it Finally, capacity. are questions. building on open and growth I'll in automated Operator? years of manufacturing, With for growth, expanding investing preparing high two future up now manufacturing fully our by increasing facilities to that, we

Instructions]. [Operator

Company. Kyle question Bauser, from & Dougherty First is

concussion the agreement a patented I on leverage develop up here. clearly following to significant Just biomarker test. with their to market a Perseus very mean,

a any a First, to point-of-care are are test? biomarker concussion patented you trying organizations that aware of other for and have develop

commercially their FDA-approved biomarker. that proprietary one put Sure, the biomarker the the is along i-STAT on has to Biomarkers only. of research commercially system licensed combination have put on They've And also to their available with company to one their is patent on One Banyan have a patent of biomarker. on available. They aware proprietary, to system, and use biomarker. that other use VIDAS their to they a actually only for Abbott bioMérieux Kyle. We're the

Okay. this dollar milestones And size or consist the what partnership? in agreement of can the about talk this of you

Sure. test. funding development actually the Perseus the of is

Perseus this This a arrangements commercial We haven't at time. any we ourselves. is to channel that communicated build intend with

of Okay. to test FDA collect favorable on expand the HIV-syphilis this kind weeks. to out course, PMA efforts for past and several you about reached the over It's, activities that data talk update for Basically, Can for indication. the the just you're of type comments overall this collecting, of efforts data to on this generate the And additional the for testing required pregnant FDA? an of thanks the help has women. your

mover ability the priority as share. super high us. market needle in a in We've U.S. described our meaningful capture for terms Sure. It's a a of to HIV-syphilis

are very We dialogue Head Regulatory FDA. I having to and can today, our the the agency working spoke matter. regular with on I satisfy with we're earlier this that hard Affairs say of

So the it to on to as so that get appears pregnant the the goal that and can there data We're get we on to collect the to working that as interest fast can our to on line, there's submit side. women, is we a agency back certainly a strong agency's decision. data side

As the second that opening I we said happening in the before anticipate half remarks, of year. the in

Ostlund, Capital Per question is Next Group. from Craig-Hallum

wanted I product margin. start on gross to

it much a very noted also as was sequential you down you year-over-year on was expected, but up it as basis. So very noted, nicely

the for probably So I was was to that or with QX. position DPP assumption contribute that I the really line that if in sequential modeling increase, because there, we drove was not more could absolutely not automated start to curious a what less

just So drove what that. curious

because the you're of of DPP assembly our started Per, Yes. automated we QX. end right at test

quarter. the reduce that weekend well contract during reliance increase that of manually come to What minimize products from that workers as automation the of quarter. at benefit our during cost reduce work been all able a on the any meaningful drove and as premium for we've see assembled these didn't was overtime we the So first

good. Very Okay.

have of that think of layer lot next couple a of the over impact on to product-wise, you both XX-plus-type about margin you gross and a realizing in next before is quite to can appropriate quarters effects So mix wave automation? geographic- that

couple Well, of a things.

pointed definitely diversity the that geographic you does impact of does to business, out, year. course have our As a continue mix and the over

a today, benefited, spoke quarter, the about on as talked only the call as in won During having we back not I also about program also state think the QX here first U.S. but we John significant

average certainly growth price to and standpoint, well. contributes helped us an that from So selling naturally that margin as

look will today we the of As diversity planned mix forward, particular We've business going from to a Ethiopia timing a about talked in continue shift substantially still experience is how to all about, as back first others Brazil towards other of weighted talked out then being the year. of during the half half year. there's more John the the And balanced dimensions and standpoint.

Okay.

Let's stick and automation. looking specifically the with concept of the at margin

line running one So DPP. operational you've the got

other to is, that two? how Will going disruptive and the got you -- phasing And do the new won't to one automated You've learned of the where your layer to you guess touch learned the expected. consolidated establishing you've the admit line what you're directly is just the think facility, from two facility those gone to you then I what without about validating question anything? you in today? than all now But order. at that's being longer a which the to probably two they I how -- even kind plan have do And your improvement. one, layer or on little they guess go help commentary I that other about have of first you'd and I my took John, appreciate you move through

Okay.

have by out reverse of we take we and blessing tests, and sold them That's on for Line So take current when we line order, whether want produce on plan and dependent of need when number our we ANVISA to whether in or is products facility. me three produce number lines which possession let to we number in automated largely producing Bio-Manguinhos' three. today we certain automated those We're two line those working blessings detailed for are in line, contrast line those and both still manually Per. or demand products, number get line. the on in DPP would two them facility the And regulatory the take wouldn't the that possession one on Brazil. our we number new already somewhat and whether have

and those operational. So quarters, where be be and on as we'll a be line when more validated two we subsequent into received, able lot three get give they how and color to be line will will it will number number exactly

we've is year. said the business lines our those now, of going to the For automated by entire and be end

and first of likelihood, to we of two But part question number few in a we over how how that's verification play from that the learn next you the when that. In and did To we might line the out of all what line -- and thinking we're idea building. the months. So what about talk the gives line an start about three. little validation got bit existing about number first we again, benefit

The has is one for first X first inside from say line, was is STAT-PAK, of which test I inside. Contrast strip to the with anywhere X with our is would a DPP, two that cassette. number strips which line lateral-flow standard thing

the that just the is installed. more much required software the line efficiency, optimize the the to So complicated output line, of we in

number line line easier go learned through two one. verification and validation So the number will what based we've on of much and

the is number of CHECK. Line first two. Okay? So care takes SURE that for three

Now more a SURE it like clear. strip of inside that's CHECK the a form factor of with looks pen

vertical a pretty really than The mechanics lines should engineering end the and validation on is what is -- heard And a are of and straightforward. placing complexity strip down is different. would the horizontal that and line in that inside on three more and tube so bit the cassette little their is a all verification the it to people in And from actually of strip versus we've developing a suggest fashion. a I that flat placing a be fashion the place

those and of that all by three operational that we can pretty lines So get said, we're them get them verified year. validated of place, get the in and confident the end

mentioned certainly to sure and make separate we one see question. initial of on the in question, I fever encouraging Excellent. a Brazil, I Since And have to just order test. want it's then thing, that come a

comments gets -- even So programs. That's light order ANVISA how awards think halt you was have didn't being or you own not of party? of of to past your the the did current two, Ministry the though about some it that it part the they done to current its then actually dengue dengue what made the because was for have do part didn't having yet? in simply within by And talked XXXX In production award the about one. to Health fever of the want commercialization to they've party, much award made manufacturer, that lack

I'll Okay. take those in pieces.

as we dengue an is of test So antibody antigen an included order, for plural. our would the as first as we well all, which I describe That order initial tests, received, an have test that dengue.

the dengue included neither test our as as test, two included So They yet. Zika our chikungunya and our Micro tests, well which are multiplex Readers. the test approved order

possibility that's of we're probability approved. or optimistic about very the So our dengue getting of that reasons one tests the

I the products of they the that Ministry supplied company regarding first these Health, that is is Second of the to recognize thing to Okay? were types standard lateral-flow think tests. previously

took lateral-flow which them or something combination put standard multiplex a is present to time. a X was very that that X they X had meant X fairness, complex tests the it's and all actually for or in you X the or they together So activation a in all that X or holder, that order approved mean, test, had, solutions. customer. solution it's a I samples, But that for at in company

had really fact which analytical -- ANVISA stopped has commercialization the tests. now, those is have the of they've been quality performance both problems well and the that and performance Given quality aware government and of aware in problems, problems the production and the of stepped we are

window an is that in stronger believe that had door opportunity at we now we opportunity we was While there Brazil, -- open now we is always a that, because as look where before, a believe it the much open.

far But the through award in typically these peak Brazil them. summer really Brazil as the tests October, in mosquito of season in their now, and year-round. runs for parts August. Keep many in is November for and real the in that concerned, essentially timing summer mind, starts is As is happens

still toward which be the anticipate a to better, half order win go of delivered though. larger we a we still the Chances in So XXXX, will back but it. got lot have year, just

That's excellent.

Chembio if will? an there into development, summer, those grant winner, when initial last has were Great. you quick it I HCV including maybe program the -- for there question distillation fall. been the me. update three parties any bake-off any Is on Okay. in maybe But last FIND? it One of awarded for wasn't a three think parties with fall sort was the of or maybe

Yes.

antibody So none C There is rapid all hep the hep C testing an is in an to on test. All done antigen-based develop the companies test. today. work world

if with they out sensitivity I a have FIND to company hep develop believe, was antigen-based so received that And tasked C test specificity. high an with see and around go $XX million could from money and Unitaid,

companies, of forward. discussions the as were a mentioned. about of supplied was now with path you and them evaluated. the It we we're tests, We FIND So supplier's our one evaluated test. has all in

more have will report, I do as soon to I As so.

Massaro a Canaccord We of Mr. Mark question Genuity. have from

This is for Max on Mark.

with stuck million. million of you guide $XX to your year full $XX revenue So

in of -- include of it the level, guidance? high idea need a about source us give conviction can particular some conviction you your at need you just the you revenue to to level So level have a for

approval of that very getting It's to regulatory with we I'd a fair order. a confidence question. close our being an and say start first, then level increases

we that that of got a and XXXX dengue think success have we we're areas coupled multiplex one in just better, the our the So things with contributor award the we Zika, we was outlined a we chikungunya. stand-alone the test an felt our last address Zika, we Max. of about feel in or fact combination have, the for could chances we million million say the you of there that those and product mark, can lot I can probability between I we that we've be -- some and the and highly The can underlying call question get approved think of in test fact for where and products how $X.X chikungunya and have $X.X dengue now that quarter dengue indicated and UNICEF belt the by next telegraphed get a for from Brazil we've I'd confident under hopefully CE number

That Great. helpful. is very

the So revenues. weighting just Brazil regarding back of half

were first roughly we incrementally that between and for half prior expectations for So second I to was think the XX%-XX% and half, Brazil. looking split previously back-end-loaded

that So make want I we're to calibrated. just sure

do -- Or back-end XX-XX loaded how look? think going even be that than you it's you split do so to So does more that?

think I another that's be two the second half in Max. percent of could It pretty or year. the close,

if one can. then Great. And I more

the So you've indicated particular isn't drugs, to pegged that application but their market. that compounds has your it broad test respiratory with or rather any AstraZeneca to of

XX in by indicated it has their -- think I XXXX. medicines used million AstraZeneca patients that respiratory So were was over

the market? that clinical about expect think in from the come broad the the of tests used in also should setting? in cash And portion solely addressable how revenues we we or research respiratory to I Just guess used your be terms, from setting could should

clinical our second Chembio entire That's setting. used question part the the way test of would So in your I collaboration. is the envision and that be think AstraZeneca the both

lot number number all we're most times particular that What You're test, different rapid have we AstraZeneca to different has hyper-focused right of incidents really an handful we to diagnostic finally, for disease. is tests. tests a a we on get a the we with And awful of believes particular of tests find diagnostic remember compounds. of a the interesting a folks that talk developing about the then opportunities because times, positives diagnostic get the it's people when time disease. We've of And a for of absolutely run negative. lot for application run

you think have limit about to thinking about of particular number not test disease I would lever. incidence find that to suggest to that and just So the the people a of really

from Benchmark The have We a Bruce Company. question Jackson,

test an with us on update give company? the you unidentified the cancer unidentified Can

Yes.

first call. which a everybody couple the I we're to embargoed else are as other probably on not hate we are. we think Bruce, unidentified to say, as but prefer to of be the we I listening is much collaborations, Unfortunately, thing on as that

And I test. can are in two So multiplex It And their and they had on our analyzers that one which we've the what completed that is is test we about target sophisticated a development analyzer. they of quantitative excited that cancer say large, company things analyzer. product, have run It different is this requires the test. for of diagnostic that biomarkers. to is the got is the a result laboratory particular that, that they was on. same partner that It so the achieve we

by with That point-of-care be would the oftentimes, oftentimes In tests. the close DPP interpreted with try can impossible detection level visually to profile was as case, lab of we it exactly number. eye. get be the difference. kind a Even cetera, that the specificity, Now achieve, a sensitivity, tests good of impossible et same there's test would and to our a any result, product requirement as

able introducing more really now gives extremely fluorescence others that tests the and like entire to test these fact that require to so opens critical. otherwise. an confidence we low our introduced even been can look capabilities we've biomarkers The that analyzer detection, for of us at we've levels cancer us And possibility up commercialize into analyzer advance that never was

has test test. that we'll moved short that update that, regulatory phase, be for pathway into the relatively able once and validation to But be get through more on particular that we can phase. So verification, a

could after would And it verification soon be and how to the FDA? go before you validation, then Okay.

clinical we're go Well, agencies. trial, then through regulatory and to a going we would appropriate the

Okay. and it. you we to And with might about an when the hear regard contract they apologize where missed testing I can fever give process earlier then something the them? in if But Brazil, this I you stand if talked from on update in us tropical

typically April Sure. main for Brazil, The country October We runs and August. but starts comes that, around it. out I'm in and the into did just May. happy cover award highlight summer generally to the

local of a commercialization. for in opening tail So remarks, their I supplying at Brazilian mentioned and end summer. as of we're those has the that sort been products, But company was ANVISA the production by both the company, stopped

to we of sell ahead pretty in what we a opportunity is product have So tender. believe significant go and that

time. to questions no like at over Please for further back are I'd to John this There Officer, Executive ahead. turn the go floor and Sperzel, President Chief comments.

our first XXXX for we made quarter us and you progress review results Thank joining priorities. toward our the to today

our focused a our forward Thanks pipeline relentlessly and call. great are day. our on advancing you have We for growth. and additional look updating to commercialization, next R&D preparing We expanding on