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Chembio Diagnostics (CEMI)

Participants
Philip Taylor Investor Relations
Rick Eberly President & Chief Executive Officer
Neil Goldman Executive Vice President & Chief Financial Officer
Catherine Schulte Robert W. Baird
Kyle Bauser Colliers Securities
Per Ostlund Craig-Hallum Capital
Bruce Jackson The Benchmark Company
Call transcript
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Operator

Good day, ladies and gentlemen, and welcome to your Chembio's Second Quarter 2020 Earnings Conference Call and Webcast. All lines have been placed on a listen-only mode, and the floor will be open for your questions and comments following the presentation. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host, Philip Taylor. Sir, the floor is yours.

Philip Taylor

Thank you, operator. and Chembio's joining, earnings quarter for call. conference you welcome second to XXXX Thank all in participants time, this At are a mode. listen-only that will we will conduct question-and-answer time. at session, Later, and a follow instructions

conference As reminder, we're today's a call. recording

If time. you at have may objections, disconnect any this you

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

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

Rick Eberly

for all us this you joining Thank afternoon.

to times and remain those I work who frontline Before the cared challenging their care the that Thank pandemic continue this affected in by service amid our health we begin, steadfast communities. persists to virus. directly for you must we recognize COVID-XX as sacrifice, in workers

through public and to aimed crisis the you we the will you. to of to solution our business your I development our all a initially a face. our products I new at with new products. are driving in applaud Thank to our strategic partner by products also bringing the health undertaken initiatives have COVID-XX drive testing updates dedication employees. being we thoughts direction customers provide Our resilience on Today, new for of

Next, answers. call together development provide revenue commercialization business for for business products. this the over Disease infectious new release, appropriate Infectious we the remarks had and international I After our will was by United much recall results. call emergency of initial customers testing in a as or This The In the quarter. In tests that of grant quarter the outside quarterly and and regulatory second I in the of and second of COVID-XX shipments negative States. the determined R&D turning of customers Neil impact not with this gross the I'd license, our accounting At in before preliminary further also of quarter States. million detailed our R&D open XXXX. second provide resulted our of recall, implement by on was the of profit management. it the certain COVID-XX cost U.S. same like for the for and the questions will XXXX, disease it system, authorization, the margins review on the reviewing we to our from model triggered we product system use noted and Based Neil resources revenues resources services quarter unused significant will time, financial COVID-XX were that the margins revenue of the million. second revenue revenues product of IgM/IgG key foregone revocation that, our The FDA's from thoughts. The cost recognize we executed resulting aware product results in $X.X start reporting our $X.X their And includes second concluding EUA, that, United included vertical revocation legacy briefly and COVID-XX the are gross results. $X.X comments described chip and royalty to on legacy to revenue on the total product the on in focus is in tests a of sales, in DPP focused our million. the of of steps financial previously impact negative to and quarter, treatment. for

seconds up also incubation tests providers patients rapidly testing. with [ph] allows the and central to customers to laboratory I bring the to results labs. of XX you pandemic, behind of collaboratively minutes to specific As accurate assure original revenue results with I the portable, and including performance States, be ultimately The provide to the closer same detect Clinicians cartridges conference reader our intent multiple closure diagnostic applications. and and technology and the tests core for offset July working are it period. our we to blood simultaneously The designed treatment make is these workflow facilitates time, recognize said away provides that. XX the could associated discreetly. the DPP at made is test testing point-of-care From well run inserted data can from of the that patient call, decisions finger biomarkers believe COVID-XX provides DPP resources. proprietary closely decentralization from testing the technology with freeing hospital during easy to is COVID-XX micro benefits X and our value that related real-world more time combination results we to and our required use following can outside readers in United system. the suited stand system across the clinical in same because while stick How scalable. are The recognizing several obtain micro or samples we test management in to the technology At we be only shipments other the XX-minute multiple with

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in revocation. Fisher the demand outside together $XX mid-quarter and States prior million EUA Our the sales second million rate to indications United of implied sales quarter run $XX shipment direct range opportunities other the from to schedule,

this the test. testing have up market, keep On and cannot we logistics antigen exists scale to accommodate the now, similar the we to for From observed Right additional a prepared with for demand manufacturing front, capacity demand were the level with opportunity what of in manufacturers accordingly. tests.

micro to regulatory unmet been once decentralized fulfill assays testing obtained, utilizing approval and market. needs described, we has readers a so I've DPP set As and tests, plan complementary offer of the in to

on in call Before infectious over touch will terms our turning and the legacy services R&D vertical the I disease vertical. the to Neil, of both business

Chikungunya our will focus demand received as system. approval XXX(k) from and positive the also Zika, represented assisted was fever mentioned, million $X.X on micro tests an had this long-term The we reader for for for a of tropical the IgM/IgG order slowed test our government we used disease Zika also the additional purchase test. combat clearance notably, NGO In resources and a sign, and readers. As assay an Dengue DPP BARDA. FDA and under arrangement Also previous efforts their by that and with placed our This IgM be award COVID-XX. HIV multiplex COVID-XX to customers UNICEF for FDA the first development micro of

selected of utilizes Pharmaceutical reader Regarding has research Takeda The review and been conduct program Company continue to technology regarding with and development PMA Multiplex Chembio the HIV-Syphilis R&D we their second the services services Limited. our FDA the for systems, of program Chembio's DPP reproducibility DPP the analyzers. micro In study. our vertical, dialogue a

of know, and in As likely in company world. largest largest is you Asia the Takeda the pharmaceutical the one

the Now, the to detail our second over I'll turn for call quarter of financial Neil results.

Neil Goldman

on how revocation going some I second of the of And the an I'm will as the results. quarter XXXX. comments overview indicated, to financial Thanks. impacted results start provide our with Rick for EUA

IgM/IgG to XXXX XX, royalty the quarter months to June June excuse total of ended the XX.X% XXXX, gains expenses. June License $X.X of XXX.X% and ended the Gross and XXXX, for our XX, that were by sales the Latin to the were in to in COVID-XX year year down the during product to United margin compared me, XXXX, prior R&D decrease second America, includes tests. the the occur prior utilized quarter product months to related overall product from cadence XX, and the first, COVID-XX COVID-XX prior revenues things: of Net million, ended a Europe, which were decrease X million an were not the revocation experienced gross and $X.X of period. period. for the following and and Net of X product combined the timing related to flat sales months the Middle were three HIV incur reduction systems certain of sold R&D compared X subsequently compared indeed, certain returned the quarter. to The East the and - For million, performance sold product were sales produced program U.S. the to in year $X.X sales is continue systems compared resulted to was prior gross Asia, respectively, year but grant in Compared in the declined by product quarter. months million, EUA. FDA's increase a XX.X% shift obligations, XXXX, ended customers revenue related of figure by a the $X.X focus of and to XX.X% from customers States revenue June in that DPP those an increase in and were and do customers. then and X relatively period, net the the of Africa XX.X% margins we and in always XX, XX.X% negative cost of margins cost

revenue due of our sales in situations. the the This degree not similar will requires influence, from recognized Many of that that which that of a Accounting that a of or from but a product high us, significant shipments third things that GAAP that unable confidence those the of parties degree produced considering COVID-XX includes occur. decided of evidence we Principles that quarter. Accepted revenue recognize revenue to consideration, not confidence is U.S. it and the Generally the the we reversal systems second factors affect high U.S., significant quarter in the have a hurdle After due to requirement in were shipped probable outside in occur. and probable including actions was the Second, reversal to for not is information cost available is were also can will cost revenue as examples, all to that outside scenario we

to time, a allow on certainly recognize that the be satisfied revenue date. affect consideration in hopeful are us this factors We will that to future

While we could of similarly, fourth margin. possible XXXX, required describing all, it is the accounting what the inventory in future, the time. of happen is revenue recognition is that XXX% on recognition sales, third recognized that treatment that in value cost the at of in second not this will gross recognize in accounting implications a at sales final point were because or and quarter of our shipment might cost be as revenue quarter the happen of I've reflected to product of in product shift been the the it if the One

As original with our and and recognizing we earlier, the to and Rick with of closely with working data S. collaboratively we are clinical customers associated our COVID-XX the non-U. including closure these bring said them. performance shipments stand real-world intent behind revenue system, to the

down income Now, I'll statement. continue moving the

that previously is made announced. the Renaissance, During progress implementing the quarter, which we we reduction expense project program

have nonessential organization, measures costs. rightsize We and reduce to taken expenses remove operating the other

taken the facility As workforce to and evaluation, Malaysian our steps part there. we have this retrench of

allowing corporation million $X.X X.X% to continuing research diluted for by are the administrative severance, million our time, months if includes restructuring to $X.X general X or which XXXX, in combined preserving there XXXX, related excluding growth the the prior will focused. future. and increased ended million remain and the XX, the year to X and million share expenses operations prior $X.X does development related other period. Selling, for or upon ended of in declined costs and the million, June period. are needed expenses enable modestly June profitable for XX, period. net the quarter $X.XX compared $X.X months selling, XXXX, per At year R&D were registrations ended loss and Malaysia and this in active, or Renaissance. June share XX, $X.X by costs compared the administrative $X.X Project Net we $X.XX investment which to We in year not million product of general a in diluted expenses, Other prior $X.X per the million loss was compared

cash June as stock million, capital sheet, and $XX.X as of XXXX, May. million June balance equivalents XX, the working common of million. XX, Net including $XX.X On public $XX.X our was totaled net XXXX, from of of cash proceeds offering in

Now the for to back turn remarks. Rick call concluding I'll

Rick Eberly

readers. To up, in wrap company assays you, DPP summary, our towards point-of-care driving Thank of the diagnostics we a Neil. utilize micro that menu expanding creating are by high-value

We number As opportunities the we are pursue excited infectious approval expand that pace health COVID-XX to have over Starting growing in look proven long-term. today from then gain we States. customers in these FDA using care from and markets the gastroenterology to our and same regulatory to testing, across our leadership micro subsequent disease neurology. care United of high-value the with internationally of do with with new forward the tests, can described relationships we additional a like areas to tests point reader plan the of testing benefit

all and questions. technology execute drive expand along Again, long-term on and our legacy upon our that, would for with a like priorities call to progressing defined you can to We joining and are business our please and thank hard open our path confident that forward on the to to create next I With we us increase their you and our operator, work look are dedication, diversify employees up value. growth, team, and sustained thank today. We profitability for strategic updating to call.

Operator

Catherine first, we Baird. with go [Operator Instructions] Schulte And to

Catherine Schulte

first antigen moderate from settings for it antibody you and just that and have then a wage tests at to that for your date? enable Or EUAs. have packages original the intent testing were both and your tests submit available guess, complexity settings the the for do cover wave antigen later I high your plan approved pursue EUAs their get-go? to two data EUAs to first, Is and in to

Rick Eberly

the for thanks Catherine, question.

we're antigen are an pursuing micro point-of-care terms application. of in micro same run the tests reader be reader, will to will original product, tests have Both a for our What data stick and will the X. which of and micro as application. is the include We well a planning the as on reader both point-of-care support identical antibody of test finger the X and serology EUA features claim benefits submission a

is will are that So the revised serology be we and pursuing, test. that what

In terms of the antigen test, for a that we point-of-care are pursuing claim also assay.

So ordering. will for provide to that of or It antigen the X the a antibody X either micro and is acquires customer to micro the reader depending on the the And run who user. clinical offer what the option answers have the question. your need have the test products reader that test, portfolio customer. to the either a clinician for way, that hopefully, we'll And flexibility will or

Catherine Schulte

flu planning past a still that potential the COVID guess application? submission in the and line versus the pursue for about talked development Are there? Okay, multiplex what's to great. you've I test. time you And

Rick Eberly

Yes.

We're doing discussions We timing flu research season. on internally. currently under that. are to relative looking at market the We're also

stages committed resources not So in we upon of that we development. product planning, but execute the have are to early

still do But the the to decision. point since we've we've demonstrated will up that the at for Certainly, X that. it. single can So like current there's multiplex future on to a at targets stage, look we DPP our technology continue once we the the we options. technology market. device, and at make product a evaluating ability a market multiplex position think different in we a look We competitive certainly some think at to final the and the And we that we're announce got

Catherine Schulte

Okay. Maybe for Neil. one

Just step-up in the given organization, an talked how the think half? magnitude you've of should about about back ramping in the up types of OpEx we investments your commercial

Neil Goldman

Yes.

thanks the time of at in in We're of So numbers. not this terms question. for the terms guidance the forward-looking, giving

opportunities you to infrastructure the are I and and Rick it characterize sales what would the not refer in that investing for position So in on pass Also, a the we've rightsized that we see indeed stated due it's position in as reflect you. course. fact in I'm like off of product But the to a to the we commercialize is much test demand our we marketing in better through step a back to remarks, relates in positioning way the of launch, that time in the to that that based believe to achieved shared the to when the Rick prepared marketplace. we're comments as first

Operator

Kyle to go Colliers Securities. with we Next, Bauser

Kyle Bauser

from with targeted Maybe the spike a pretty is But you know were test. NCI targeted of that NIH start the accuracies the I and the rather the COVID original other group. on I'll antibody were companies being focused plus test. the nucleocapsid independent to target nucleocapsid in than couple is what and there able achieve XX%

differed initial you protein the nucleocapsid tests you will test? the new in how can and the your talk And their be from So spike about targeting version?

Rick Eberly

Thanks Kyle, the this is for question. Rick.

the And on serology other system. we say, did that preselected using, same the And quarter spike product, we to All with group in reagents, to year so did evaluation original I only our protein, the will opening first by limited of EUA the what The terms group; NCI study, would that's spike in, in the we in when about remarks, the we the we the system original the by talked submission. methodology into the evaluated back product used In that pursued ensure that developed this terms the the NP to cartridge. the go done choose methodology NCI of of study that's in the of focus the protein. the are that what to correlation is study does the components revised assay. NCI, the And targets study, samples terms have our change have have kit. were we've the NCI protein. when protein the components Relative NCI we is as that the that that is by the we

at protecting NCI aimed human antibodies, study So, the which group. spike how the samples system is largely preselected protein, is the revised by are the

Kyle Bauser

Okay.

the just internal So initially how so just still able nucleocapsid kick just a that for those were use out confused doing to I them also achieve size? Was favorable with competitors little of guess, targeted guess a acceptable results. function that did validation clarity, target about that companies accuracies. and I'm that larger sample I a

Rick Eberly

our by stand do for EUA or we clinical Kyle, the data FDA to submitted we EUA. that So the to original

how of by going the they revise speak we have going competitors are terms is and when can't the that I ensure that NCI the NCI, that the decided point in So evaluation. study pass they and assurance great I did we're think to their But we what for we that system other designed evaluated to to assays. we're

Kyle Bauser

it. Got

Okay. looked of just have bread butter. been was on are application, assays Chembio's a mean, HIV with same how switching on the from but little surprising the protein. which was since the if we like And I reactivity move you that as and cross issue addressing maybe high, reactivity quite bit, It the spike test well? HIV cross

you down? kind what confident reactivity XX% happened are So of number that there? And come will

Rick Eberly

we other - studies, revised at for terms the can't assay of but point. this original targets I HIV, for done the EUA for process Kyle. we're that in But all have from that development, of in to reactivity extensive assay submission. required cross a also we the completing speak the the only reactivity Yes, cross not have

Kyle Bauser

what if lastly, do road, with that? timing just do Or And it's down FDA? may. - then NIH are is that? is the antigen for on - internal send the And you your validation do but resubmitting it. that I the the the you for to for I the application estimates it know before submitting done after got for process independent What's submitted approval? packet you've your what then Okay,

Rick Eberly

Yes, Kyle.

question to it's the evaluation. notification that followed NCI first the different we The submission relative by of EUA the followed our serology EUA submission than in original submission the have product, by study no process

we're test. what not Kyle, be to expecting sequencing, in submission. to the of it our was phase we're So that test, original antigen the Relative antigen different with still the development than any

partner initial their has us development the in by as basis that opening remarks, in As day been with positive day are for encouraged BARDA see can you the our in tell us, results market the we with great the test. a antigen of to as I and the partnership the a BARDA. antigen and in great working scientists said literally other we're and companies on do need the They with a accelerate out see you on market. I

optimistic through that funding product with possible. accelerate we're their EUA will and submission as assistance development that quickly So, as BARDA's an we that

Operator

Per Our comes Craig-Hallum Ostlund next question with Capital. from

Per Ostlund

with dovetail probably what the the sheet, correct? start I at assume deferred when to to spike up Is haven't is spike here. OUS represents Neil, that I'm recognized those we there for revenue million, Rick balance sitting the into see that towards going that $X shipments is that revenue a [ph] you in look the the we revenue you for.

Neil Goldman

of it. part That's

a majority different for Some it the we of that a it it see prepaid and details customer shipping there's majority relates [indiscernible] be more - the to for the just time, where it's of to part that period Q clear, will program filed. in over is you'll be program, that when of sorry, of that - the here

Per Ostlund

to OUS not relating that Okay. convert [ph] What come Nevertheless, around in guess, that acceptance this where say, any I sales broadly I as of jurisdictions the is through Or going there the we're formal factors, of those back into million of shipments those gating the have the and in then where having could return just revenue OUS to Is revenue? for speaking, second resubmission OUS activity going you? process guess, OUS dollars essentially kind they to that what's into second a to can process half? ongoing hey, half way Fantastic. And you the Or is revenue find their process? into the year. holding turn of go outside today? back into this work there to the pattern decision-making to in are couple U.S., everything

Rick Eberly

to to among of Rick. as to those FDA's shipments. a for the the we decision relative the high handle the made revenue, the with is States, our due United what system. recognize original in how shipments we world Thanks around heightened outside that COVID-XX, turn At the we're a decision question. to level, dealing the we this Per, accounting I'll to saw bodies it measures for Neil on largely our did over terms Yes, awareness regulatory serology not

closely and questions product that answering revoke heightened on to And decided decision issues United so the shipped to, aware with any the continue the to what awareness in of, to work States. we were around we them work collaborate have so we and/or do to ongoing to customers very, was with our to FDA's very who serology product

to think go which going number we're more criteria have make a of given questions. little that detail. the work So through those we factors that monitoring, on can into decision Neil we're in a And based continue I to to

Neil Goldman

Yes.

respectively, can go detail, can as to - imagine. level that So and a only Per, of we certain you

going going get the consistent otherwise, of monitoring in was appropriate customers. around or what's the Rick environment and into and with particular specifics into. in transactions the getting isn't on transactions to with on But what saying, what's just So underlying the it's relationships in the

described, factors there's other things to the certainly that. that of outside I attention parties talked a variety I and that can third evidence influence, we but our pay like. and into go about As are close

and imagine, I is line. getting that which happen. on So as But and to why are have. work make doing way will, assurance focused treated we we you we hard, try know we us certainly can said, no things we're the as we you I can the be over described, there as and these as it goal very we But

it. on So well we're focused obviously

Rick Eberly

to and evaluating So customers is we I of stages of product had said what revocation. and product different up after international number the shortly the the that add would the buying into thing Neil at a Per,

with working So those we are customers.

Some are through distributing in we're announced approvals. product the any to international other antigen EUA that with interest too, continuing the we revised entertain their to same as once look on the to have them, at product. And platform, decided to FDA dialogues product. the current as test have passed regulatory publicly beginning Others and/or the it is

their that process, for they're in of particular the needs through sort what's evaluating their countries. where in we're phase taking best customers we're early and So

Per Ostlund

That all Okay. very sounds reasonable.

COVID here study the on some to is to of largely is with don't that there realizing just you pivot how us, an But queue give HIV here that of Can in it's you. are you now. the outside and update and overwhelmed simply much the step, any COVID, felt if the right appreciated. diagnostics but had know you that Turning I the things I other to resubmit reproducibility think, other I for us like acknowledging but high-value syphilis perfunctory a FDA waylaid know a that have there, updates bit submission?

Rick Eberly

Per. to do Happy Sure, so.

as review dialogue continue by FDA. branches PMA, both be the active reviewed know, The is CDRH, of CBER the in of the We may being with an to FDA. X you and

of we to So to And continue in to answer relative both study. be continue we with FDA submission. dialogue for branches reproducibility the questions PMA their the the

relative And And view at those in we review FDA we to process so - questions. they what it's in being what believe final think to And progress the answered. and estimate going their the the continued quarter is questions discussions. an active timing this is ultimately, dialogue can't making time to relative back we're

closer their it so continue move questions approval. And to to and hopefully PMA we'll answer

Per Ostlund

of can elaborate but guess the say interesting program Okay, then initial type another I just duration size, catalyzed second about it's there's Takeda for clearly, be gotten one to suspect way me. a successful hopper. much of it, that is, sort you secondarily, was development whether maybe how the the of lot question thing? by anything that the question that's well. And first. last going I can the its that's fair has to as you a not program, into on One that see say to

Rick Eberly

Yes, Per.

the of we success of building is that program in off second the the the certainly, proud of had one things the with program think we're is collaboration team. Takeda first the I

and we're nature about due the it, and it with the the technology and in the the of and the and of So what to really announce funding biomarker the point-of-care can second drive we levels. platform program program the certainly delighted the asset. of But program any Takeda, terms program, the of DPP limited second to to we're we're scope the to the take on say and demonstrates enhanced a think ability excited in specificity sensitivity I capability, confidentiality

Operator

question Jackson Benchmark We line take Company. our with or The comment of Bruce the from final

Bruce Jackson

eosinophilic test status of In in that the terms you've you've other so new been out for asthma the of AstraZeneca. been What's the terms with of new the - test watching program? that the we that tests working for

Rick Eberly

in you'll our first again take Yes, XX-Q, the second this in Bruce, you if the the go section. a in and and look in quarter Q, table MD&A see quarter

has to all we there's there - where now development. Mark about talk products use to tables in described research process can this inside see we have various available That's And of XX else months. it similar gotten time. at from went that, And what through We the the as you'll the some X you around documentation CE about said, that's Takeda. for is that say only. And test -

Bruce Jackson

along? Can things any other question is if all on that be you're the can great. LumiraDx. would provide program moving details just on, at on that on that And how Okay. working a comment of you And then, quick you types

Rick Eberly

a agreement Yes, was Lumira Bruce, announced, the we as relationship. strategic

a of company, fact with So to terms in Lumira limited we say. what development can is We're given had and strong we the very speak we've can't private But very, Bruce, that positive, their LumiraDx. a program. very collaboration generally,

continue to in so strategic that And we're relationship. in move to And that we be we'll relationship. that forward hopeful continue

Operator

Mr. does Okay. It go conclude please ahead. Eberly, question our period,

Rick Eberly

all Thank good you appreciate for questions a and you. of time your and We day. thank interest, your today. your So, have

Operator

you does teleconference. conclude your This for Thank you. participation. We thank today's

You a time. day. this at may disconnect Have lines your great